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## Protocol Section ### Identification Module **NCT ID:** NCT04128579 **Acronym:** EQUALISE **Brief Title:** Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis **Official Title:** A Phase 1b Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis #### Organization Study ID Info **ID:** EQ001-19-002 #### Organization **Class:** INDUSTRY **Full Name:** Equillium ### Status Module #### Completion Date **Date:** 2024-01-18 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-02-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-02-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-16 **Type:** ACTUAL #### Start Date **Date:** 2019-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2019-10-16 **Type:** ACTUAL **Study First Submit Date:** 2019-09-30 **Study First Submit QC Date:** 2019-10-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Biocon Limited #### Lead Sponsor **Class:** INDUSTRY **Name:** Equillium #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis **Detailed Description:** The study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for Type A-SLE and a single dose cohort of approximately 20 open-label subjects enrolled for Type B-Lupus Nephritis. Subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (Type A) or 13 (Type B) doses with 4 or 12 weeks of follow-up after the last dose of investigational product. ### Conditions Module **Conditions:** - Lupus Erythematosus - Lupus Nephritis **Keywords:** - Systemic Lupus Erythematosus - Active Proliferative Lupus Nephritis ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** cohort based escalation of 6 subjects (Type A) single dose cohort of 20 subjects (Type B) ##### Masking Info **Masking:** NONE **Masking Description:** Type A and Type B are open-label. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 55 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** EQ001 administered in an unblinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 2 doses (up to 5 cohorts with dosing to be determined in the range of 0.4 -- 3.2 mg/kg). **Intervention Names:** - Drug: Itolizumab [Bmab 600] **Label:** EQ001 Type A cohort **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** EQ001 administered in an unblinded single dose cohort by subcutaneous injection every two weeks for a total of 13 doses (1.6 mg/kg). **Intervention Names:** - Drug: Itolizumab [Bmab 600] **Label:** EQ001 for Type B cohort **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - EQ001 Type A cohort - EQ001 for Type B cohort **Description:** EQ001 **Name:** Itolizumab [Bmab 600] **Other Names:** - Bmab600 - Itolizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. **Measure:** Incidence of Treatment Emergent Adverse Events **Time Frame:** Type A up to Day 57 or Type B up to Day 253 #### Secondary Outcomes **Description:** To characterize the pharmacokinetics of itolizumab **Measure:** To characterize the PK of itolizumab **Time Frame:** Type A up to Day 57 or Type B up to Day 253 **Description:** the % levels of free versus EQ001-bound CD6 receptor on T cells **Measure:** CD6 receptor occupancy **Time Frame:** Type A up to Day 57 or Type B up to Day 253 ### Eligibility Module **Eligibility Criteria:** Type A Cohort Key Inclusion Criteria: 1. Is male or female, age ≥ 18 and ≤ 75 years 2. Has previously been documented to have met or currently meets Systemic Lupus International Collaborating Clinics (SLICC) and/or American College of Rheumatology (ACR) criteria for SLE 3. Received at least 1 immunosuppressive or immunomodulatory treatment for SLE at any time in the past or currently 4. Has documented elevation of antinuclear antibodies (ANA) in the past or during Screening 5. Restricted SLE treatments are stable and/or washed out 6. During Screening, has adequate hematologic function Type B Cohort Key Inclusion Criteria: 1. Is male or female, age ≥ 18 and ≤ 75 years 2. Has a diagnosis of SLE 3. Kidney biopsy with a histologic diagnosis of LN Classes III or IV (+/- V) 4. Has a urine protein to creatinine ratio of \> 1000 mg/g 5. Requires induction treatment due to newly diagnosed LN or relapsing/flaring disease or has an incomplete response to current treatment 6. Has adequate hematologic function 7. Restricted SLE treatments are stable and/or washed out 8. Most recent eGFR ≥ 40 mL/min/1.73m2 9. Has evidence of serologic activity Key Exclusion Criteria: 1. Acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy 2. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV 3. Active TB or a positive TB test **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Sun City **Country:** United States **Facility:** AKDHC Medical Research Services, LLC **State:** Arizona **Zip:** 85351 **Location 2:** **City:** Chula Vista **Country:** United States **Facility:** California Institute of Renal Research **State:** California **Zip:** 91910 **Location 3:** **City:** La Jolla **Country:** United States **Facility:** University of California San Diego Perlman Ambulatory Clinic **State:** California **Zip:** 92037 **Location 4:** **City:** Clearwater **Country:** United States **Facility:** Clinical Research of West Florida - Clearwater **State:** Florida **Zip:** 33765-2616 **Location 5:** **City:** Fort Lauderdale **Country:** United States **Facility:** Centre for Rheumatology, Immunology and Arthritis **State:** Florida **Zip:** 33309 **Location 6:** **City:** Gainesville **Country:** United States **Facility:** University of Florida, Division of Rheumatology **State:** Florida **Zip:** 32610 **Location 7:** **City:** Leesburg **Country:** United States **Facility:** Clinical Site Partners Leesburg, LLC **State:** Florida **Zip:** 34748 **Location 8:** **City:** Miami **Country:** United States **Facility:** SouthCoast Research Center Inc **State:** Florida **Zip:** 33136 **Location 9:** **City:** Miami **Country:** United States **Facility:** Hope Clinical Trials **State:** Florida **Zip:** 33165 **Location 10:** **City:** Orlando **Country:** United States **Facility:** Omega Research Maitland, LLC **State:** Florida **Zip:** 32810 **Location 11:** **City:** Tampa **Country:** United States **Facility:** Clinical Research of West Florida - Tampa **State:** Florida **Zip:** 33603 **Location 12:** **City:** Tampa **Country:** United States **Facility:** University of South Florida **State:** Florida **Zip:** 33606 **Location 13:** **City:** Lawrenceville **Country:** United States **Facility:** Georgia Nephrology **State:** Georgia **Zip:** 30046 **Location 14:** **City:** Bronx **Country:** United States **Facility:** Albert Einstein College of Medicine, Montefiore Medical Center **State:** New York **Zip:** 10461 **Location 15:** **City:** Great Neck **Country:** United States **Facility:** Northwell Health / Division of Rheumatology **State:** New York **Zip:** 11021 **Location 16:** **City:** New York **Country:** United States **Facility:** Columbia University Medical Center, Div of Nephrology **State:** New York **Zip:** 10032 **Location 17:** **City:** Bethlehem **Country:** United States **Facility:** Northeast Clinical Research Center, LLC **State:** Pennsylvania **Zip:** 18017 **Location 18:** **City:** Dallas **Country:** United States **Facility:** Dallas Renal Group **State:** Texas **Zip:** 75230 **Location 19:** **City:** Houston **Country:** United States **Facility:** Prolato Clinical Research Center (PCRC) **State:** Texas **Zip:** 77054 **Location 20:** **City:** Chandigarh **Country:** India **Facility:** Post Graduate Institute of Medical Education and Research (PGIMER) **Location 21:** **City:** Gurugramam **Country:** India **Facility:** Medanta - The Medicity Hospital **Location 22:** **City:** New Delhi **Country:** India **Facility:** MAX Super Specialty Hospital **Location 23:** **City:** Puducherry **Country:** India **Facility:** Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER) **Location 24:** **City:** Warszawa **Country:** Poland **Facility:** Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ **Zip:** 04-749 **Location 25:** **City:** Łódź **Country:** Poland **Facility:** SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii **Zip:** 92-213 #### Overall Officials **Official 1:** **Affiliation:** UCSD **Name:** Kenneth Kalunian, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** company website **URL:** https://equilliumbio.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000005921 - Term: Glomerulonephritis ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12338 - Name: Nephritis - Relevance: HIGH - As Found: Nephritis - ID: M11178 - Name: Lupus Nephritis - Relevance: HIGH - As Found: Lupus Nephritis - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: HIGH - As Found: Systemic Lupus Erythematosus - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M9031 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown - ID: T3523 - Name: Lupus Nephritis - Relevance: HIGH - As Found: Lupus Nephritis - ID: T2525 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009393 - Term: Nephritis - ID: D000008181 - Term: Lupus Nephritis - ID: D000008180 - Term: Lupus Erythematosus, Systemic ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT05646979 **Brief Title:** The Effect of Emotional Freedom Technique Applied Before Cesarean Section **Official Title:** The Effect of Emotional Freedom Technique Applied Before Cesarean Section on Perception of Anxiety, Fear of Surgery and Traumatic Birth #### Organization Study ID Info **ID:** Inonu Universty, Malatya #### Organization **Class:** OTHER **Full Name:** Inonu University ### Status Module #### Completion Date **Date:** 2023-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-03-02 **Type:** ACTUAL **Last Update Submit Date:** 2023-02-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-12-31 **Type:** ACTUAL **Status Verified Date:** 2023-02 #### Study First Post Date **Date:** 2022-12-12 **Type:** ACTUAL **Study First Submit Date:** 2022-12-04 **Study First Submit QC Date:** 2022-12-09 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Inonu University #### Responsible Party **Investigator Affiliation:** Inonu University **Investigator Full Name:** Sinem GUVEN Santur **Investigator Title:** Pirincipal İnvestigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Since all the follow-up and care of the pregnant during the prenatal period are carried out by the midwives, the care provided by the midwives to the women during the prenatal period plays a key role for the woman to have a comfortable and healthy pregnancy. Midwives should take psychological approaches in order to reduce the negative feelings of women before cesarean section. Considering all these, it is thought that Emotional Freedom Technique, which does not require any invasive intervention, is inexpensive and easy to apply, will contribute to women's feeling better by reducing pre-cesarean anxiety, surgical fear and traumatic birth perception. **Detailed Description:** Although childbirth is a normal physiological event for the female body, it causes stress for the woman and brings with it many risks. Cesarean section, which is one of the birth types; It is a surgical procedure that enables delivery to occur through an incision made on the abdominal wall and uterus of the mother. Although the cesarean rate recommended by the World Health Organization (WHO) is 15%, the rate of cesarean section in our country is 52.1% according to the Turkey Demographic and Health Survey. Every surgical procedure to be performed, the decision of surgery and the waiting period may cause anxiety in individuals. Anxiety and fear experienced before surgery; It can cause individuals to experience uneasiness, restlessness and dissatisfaction due to the uncertainty they are in. Preoperative pain, fear of death, the thought that the body will be harmed and suffering, fear of losing consciousness and control due to anesthesia, and the uncertainty associated with anesthesia may cause fear of surgery. Anxiety before cesarean section is multifaceted, and it has been reported that the pregnancy process increases anxiety. In studies, it was determined that the anxiety level of mothers before cesarean section was high. The extreme degree of anxiety and fear plays a very important role in the formation of traumatic perception towards birth. Many methods are used to reduce negative emotions in the prenatal period. Emotional Freedom Technique (EFT), which is one of these methods, is a method used to resolve emotional blockages in the energy body of the person. EFT aims to reveal all the points where there is a possibility of negative emotion experienced in the past and stuck in a part of the body. By focusing on the emotions that negatively affect the person in EFT, the energy flow is regulated with stimulations often made by touch. When administered to pregnant women, it may contribute to a decrease in post-traumatic stress disorder and to reduce the level of anxiety and fear. Since all the follow-up and care of the pregnant during the prenatal period are carried out by the midwives, the care provided by the midwives to the women during the prenatal period plays a key role for the woman to have a comfortable and healthy pregnancy. Midwives should take psychological approaches in order to reduce the negative feelings of women before cesarean section. Considering all these, it is thought that EFT, which does not require any invasive intervention, is inexpensive and easy to apply, will contribute to women's feeling better by reducing pre-cesarean anxiety, surgical fear and traumatic birth perception. ### Conditions Module **Conditions:** - Cesarean Section - Emotional Regulation - Surgery - Traumatic Birth **Keywords:** - Cesarean section - Emotional freedom technique - Surgery fear - Traumatic birth perception ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The randomized experiment was designed as a control study. ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 53 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** EFT application will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation. **Intervention Names:** - Behavioral: EFT group **Label:** Experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Women in the control group who will have a cesarean section at 32-38 weeks of gestation will not be interfered with. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** EFT protocol will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation. **Name:** EFT group **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The negative 10 feel the greatest pain, disappointment, fear, stress, sadness, or discomfort imaginable. When it reaches Positive 10, the client feels very different and wonderful. The meanings of the ratings in this range change gradually. The scale has no cutoff score. It is interpreted according to the mean of the scores and its relevance to other variables. **Measure:** Subjective Units of Experience- (SUE) **Time Frame:** Each participant will be evaluated for 1 week. #### Secondary Outcomes **Description:** The scale consists of a total of 13 questions covering thoughts and feelings such as anxiety, fear and anxiety that the woman feels when she thinks about the concept of birth. For each problem, a score is given from 0 to 10, whether I'm afraid or afraid. The lowest and highest scores that can be obtained from the scale are 0 and 130. According to the total mean score of the scale, the 0-26 score range is "very low", the 27-52 score range is "low", the 53-78 score range is "moderate", the 79-104 score range is "high", and the 105-130 score range is "very high" indicates the perception of traumatic birth. **Measure:** Traumatic Birth Perception Scale **Time Frame:** It will be applied as a post-test 1 week after it is applied as a pre-test to the pregnants between 32-38 weeks included in the study. **Description:** The scale is in 11-point Likert type, consists of 8 questions and scores between 0 and 10. The scale, each of which consists of 4 items, consists of two sub-dimensions measuring short-term fears and long-term fears related to the source of fear. Items 1 to 4 in the scale measure the fear of short-term results of surgery, while items 5 to 8 measure the fear of long-term results. The items in the scale are evaluated as "0: I am not afraid at all" and "10: I am very afraid". **Measure:** Surgical Fear Scale **Time Frame:** It will be applied as a post-test 1 week after it is applied as a pre-test to the pregnants between 32-38 weeks included in the study. **Description:** The State Anxiety Scale is an individual's at a certain moment and under certain conditions; It requires him to describe how he feels. The emotions and behaviors expressed in the inventory items are indicated by choosing one of the options "(1) Not at all, (2) A little, (3) A lot and (4) Completely" according to the severity of such experiences. The total score obtained can vary between 20 and 80. **Measure:** State anxiety scale **Time Frame:** It will be applied as a post-test 1 week after it is applied as a pre-test to the pregnants between 32-38 weeks included in the study. **Description:** Pregnant information form prepared by the researcher in line with the literature, socio-demographic (pregnant woman's age, education and employment status, income status, family type and place of residence), obstetric (current gestational week and pregnancy history), psycho-social and medical history (desire for pregnancy) status, whether there is a chronic disease) consists of questions. **Measure:** Demographic Descriptive Data **Time Frame:** It will be obtained in 1 month at the beginning of the research. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years or older, * at 32-38 weeks of gestation, * Cesarean delivery planned, * Not carrying any risk factors (preeclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy, * Single pregnancy, * Not having any problems (such as fetal anomaly, intrauterine growth retardation) related to the health of the fetus, * Pregnant women who do not have conditions such as infection, wound, scar in the tapping areas. Exclusion Criteria: * Diagnosing a risky pregnancy during the research process, * Participant's unwillingness to continue with the EFT protocol **Healthy Volunteers:** True **Maximum Age:** 49 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ysinemguven@gmail.com **Name:** Sinem Güven Santur **Phone:** 05424640068 **Role:** CONTACT **Contact 2:** **Email:** zeliha.ozsahin@inonu.edu.tr **Name:** Zeliha Ozşahin **Phone:** 4223410220 **Phone Ext:** 3792 **Role:** CONTACT #### Locations **Location 1:** **City:** Malatya **Contacts:** ***Contact 1:*** - **Email:** ysinemguven@gmail.com - **Name:** Sinem GüvenSantur, phd - **Phone:** 05424640068 - **Role:** CONTACT **Country:** Turkey **Facility:** Malatya Training and Research Hospital **State:** Kayseri **Status:** RECRUITING **Zip:** 44000 #### Overall Officials **Official 1:** **Affiliation:** https://akademik.ksu.edu.tr/Default.aspx?kod=CfTMEAi69foG7wFizm48ztSNEmgmVjdANJTT1Xcj9gA= **Name:** Esra Karataş Okyay **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** https://avesis.inonu.edu.tr/zeliha.ozsahin/bilimselfaaliyetler **Name:** Zeliha Özşahin **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** In the research, data collection forms will be filled by face-to-face interview method. Data will be collected with Personal Information Form, State Anxiety Scale (STAI-I), Surgical Fear Scale, Traumatic Birth Perception Scale (TDAS) and Subjective Units of Experience (SUE) Scale. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007232 - Term: Infant, Newborn, Diseases - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M5002 - Name: Birth Injuries - Relevance: HIGH - As Found: Traumatic Birth - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001720 - Term: Birth Injuries ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01216579 **Brief Title:** Steroid Titration Against Mannitol IN Asthma **Official Title:** Titrating Inhaled Steroid Dose Against Mannitol Hyper-responsiveness or BTS Outcomes: Comparative Effects on Asthma Exacerbations Over 1 Year #### Organization Study ID Info **ID:** FARD002 #### Organization **Class:** OTHER **Full Name:** University of Dundee ### Status Module #### Expanded Access Info #### Last Update Post Date **Date:** 2010-10-07 **Type:** ESTIMATED **Last Update Submit Date:** 2010-10-06 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2010-02 **Type:** ACTUAL #### Start Date **Date:** 2004-03 **Status Verified Date:** 2008-03 #### Study First Post Date **Date:** 2010-10-07 **Type:** ESTIMATED **Study First Submit Date:** 2010-10-06 **Study First Submit QC Date:** 2010-10-06 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Dundee #### Responsible Party **Old Name Title:** Professor Brian Jonathon Lipworth **Old Organization:** University of Dundee ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators hypothesise that titration of asthma medication against mannitol challenge results will reduce the number of mild asthma exacerbations, in one year, when compared with titration against BTS guidelines. To test this hypothesis the investigators propose a primary care, parallel treatment, patient blinded study in which matched groups of asthmatic patients will be treated in accordance either with BTS guidelines or with our treatment algorithm dependent on mannitol challenge result. Purpose of the study is to evaluate the efficacy of a treatment algorithm based on the measurement of airway hyperresponsiveness to mannitol challenge, a surrogate marker of airway inflammation, in the long term treatment of asthma in comparison to BTS guidelines. ### Conditions Module **Conditions:** - Asthma ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 164 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Asthmatic patients managed as per British Thoracic Society guidelines by symptoms and lung function. **Intervention Names:** - Other: mannitol (an airway challenge agent) **Label:** Reference arm **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Group of asthmatic patients managed according to their mannitol challenge. **Intervention Names:** - Other: mannitol (an airway challenge agent) **Label:** Mannitol managed arm **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Mannitol managed arm - Reference arm **Name:** mannitol (an airway challenge agent) **Type:** OTHER ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female asthmatics aged \>/= 16 years * Females must be non pregnant and non lactating * FEV1 \>/= 50% predicted * Mannitol PD10 \</= 635 mg at end of step down period * No recent exacerbations of asthma requiring oral prednisolone in the previous 3 months * Able to perform all the techniques necessary to carry out the challenge testing and lung function and compliant with taking the study medication * Good inhaler technique which will be reinforced at each study visit Exclusion Criteria: * Male or female patients aged 15 or below * FEV1 \</= 50% predicted * Patients who are currently taking a pulse of oral corticosteroids * Patients with the following concomitant illnesses:bronchiectasis, allergic bronchopulmonary aspergillosis, COPD, heart failure, pulmonary fibrosis, rhino-sinusitis with polyps * Immunocompromised patients * Patients with recurrent LRTI * Patients with documented aspirin induced asthma on LRTAs * Pregnancy * Known or suspected hypersensitivity to ICS or other excipients of the MDIs * HIV/Hepatitis B or C positive **Maximum Age:** 65 Years **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** University of Dundee **Name:** Brian J Lipworth, MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3. **PMID:** 28065396 **Citation:** Anderson WJ, McFarlane LC, Lipworth BJ. Prospective follow-up of novel markers of bone turnover in persistent asthmatics exposed to low and high doses of inhaled ciclesonide over 12 months. J Clin Endocrinol Metab. 2012 Jun;97(6):1929-36. doi: 10.1210/jc.2011-3410. Epub 2012 Mar 21. **PMID:** 22438232 **Citation:** Lipworth BJ, Short PM, Williamson PA, Clearie KL, Fardon TC, Jackson CM. A randomized primary care trial of steroid titration against mannitol in persistent asthma: STAMINA trial. Chest. 2012 Mar;141(3):607-615. doi: 10.1378/chest.11-1748. Epub 2011 Oct 13. **PMID:** 21998259 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Ancestors - ID: D000004234 - Term: Diuretics, Osmotic - ID: D000004232 - Term: Diuretics - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11342 - Name: Mannitol - Relevance: HIGH - As Found: Abuse - ID: M7411 - Name: Diuretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008353 - Term: Mannitol ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01584479 **Brief Title:** Periodontal Disease Prevention Study **Official Title:** Periodontal Disease Prevention Study:A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease #### Organization Study ID Info **ID:** HUM00037624 #### Organization **Class:** OTHER **Full Name:** University of Michigan ### Status Module #### Completion Date **Date:** 2012-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2015-07-09 **Type:** ESTIMATED **Last Update Submit Date:** 2015-06-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2012-03 **Type:** ACTUAL #### Results First Post Date **Date:** 2015-07-09 **Type:** ESTIMATED **Results First Submit Date:** 2014-06-13 **Results First Submit QC Date:** 2015-06-17 #### Start Date **Date:** 2010-12 **Status Verified Date:** 2015-06 #### Study First Post Date **Date:** 2012-04-25 **Type:** ESTIMATED **Study First Submit Date:** 2012-04-12 **Study First Submit QC Date:** 2012-04-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Michigan #### Responsible Party **Investigator Affiliation:** University of Michigan **Investigator Full Name:** William Giannobile **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is one component of a program to improve the maintenance of good dental health and the prevention of disease by use of risk stratification methods to efficiently guide increased preventive services to adult dental patients who are at increased risk for the major dental diseases, caries and adult periodontitis. The investigators will use a retrospective cohort model to analyze a large dental claims database to determine if the frequency of preventive services influenced the periodontal disease outcomes and to determine if periodontal risk assessment information can be used to stratify dental patients into "high risk" and "low risk" categories that influence the effect of preventive services on periodontitis outcomes. Primary Objective To evaluate whether dental patients who are classified as "low risk" for periodontal disease progression, based on history of periodontitis (claims history), smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year. Secondary Objectives To evaluate whether dental patients who are classified as "high risk" for periodontal disease progression, based on a history of periodontitis, smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year. To evaluate whether dental patients who have had one dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk." To evaluate whether dental patients who have had two dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk." ### Conditions Module **Conditions:** - Periodontitis **Keywords:** - periodontitis ### Design Module #### Bio Spec **Description:** buccal swabs **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 5117 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1 visit - Low Risk \~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) **Label:** Low Risk Experimental Group #### Arm Group 2 **Description:** 2 visits - Low Risk \~1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) **Label:** Low risk Control Group #### Arm Group 3 **Description:** 1 visit - High Risk \~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) **Label:** High Risk Experimental Group #### Arm Group 4 **Description:** 2 visits - High Risk \~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) **Label:** High Risk Control Group ### Outcomes Module #### Primary Outcomes **Description:** Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years. **Measure:** Percentage of Participants With Tooth Loss Over 16 Year Period **Time Frame:** 16 years #### Secondary Outcomes **Measure:** Change in Total Dental Claims During Monitoring Period **Time Frame:** 10 and 15 years **Measure:** Change in Total Periodontal Claims During the Monitoring Period **Time Frame:** 10 and 15 years **Measure:** Change in Periodontal Surgery Claims **Time Frame:** 10 and 15 years **Measure:** Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire. **Time Frame:** 10 and 15 years **Measure:** Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories **Time Frame:** 10 and 15 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental. Exclusion Criteria: * Organ transplant recipients are excluded. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 34 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental. ### Contacts Locations Module #### Locations **Location 1:** **City:** Ann Arbor **Country:** United States **Facility:** Michigan Center for Oral Health Research **State:** Michigan **Zip:** 48106 #### Overall Officials **Official 1:** **Affiliation:** University of Michigan **Name:** William V Giannobile, DDS, DMedSc **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Giannobile WV, Braun TM, Caplis AK, Doucette-Stamm L, Duff GW, Kornman KS. Patient stratification for preventive care in dentistry. J Dent Res. 2013 Aug;92(8):694-701. doi: 10.1177/0022034513492336. Epub 2013 Jun 10. **PMID:** 23752171 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M13419 - Name: Periodontal Diseases - Relevance: HIGH - As Found: Periodontal Diseases - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis - ID: D000010510 - Term: Periodontal Diseases ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module **Description:** This is an survey research study with the patient collection of their own biological specimen and the filling out of a survey to release their payer data (non-interventional). #### Event Groups **Group ID:** EG000 **Title:** Low Risk Experimental Group **Description:** 1 visit - Low Risk \~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) **ID:** EG000 **Other Num at Risk:** 732 **Serious Number At Risk:** 732 **Title:** Low Risk Experimental Group **Group ID:** EG001 **Title:** Low Risk Control Group **Description:** 2 visits - Low Risk \~1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) **ID:** EG001 **Other Num at Risk:** 1686 **Serious Number At Risk:** 1686 **Title:** Low Risk Control Group **Group ID:** EG002 **Title:** High Risk Experimental Group **Description:** 1 visit - High Risk \~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) **ID:** EG002 **Other Num at Risk:** 852 **Serious Number At Risk:** 852 **Title:** High Risk Experimental Group **Group ID:** EG003 **Title:** High Risk Control Group **Description:** 2 visits - High Risk \~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) **ID:** EG003 **Other Num at Risk:** 1847 **Serious Number At Risk:** 1847 **Title:** High Risk Control Group **Frequency Threshold:** 0 ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 732 **Group ID:** BG001 **Value:** 1686 **Group ID:** BG002 **Value:** 852 **Group ID:** BG003 **Value:** 1847 **Group ID:** BG004 **Value:** 5117 **Units:** Participants ### Group **ID:** BG000 **Title:** Low Risk Experimental Group **Description:** 1 visit - Low Risk \~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) ### Group **ID:** BG001 **Title:** Low Risk Control Group **Description:** 2 visits - Low Risk \~1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) ### Group **ID:** BG002 **Title:** High Risk Experimental Group **Description:** 1 visit - High Risk \~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) ### Group **ID:** BG003 **Title:** High Risk Control Group **Description:** 2 visits - High Risk \~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) ### Group **ID:** BG004 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 732 #### Measurement **Group ID:** BG001 **Value:** 1686 #### Measurement **Group ID:** BG002 **Value:** 852 #### Measurement **Group ID:** BG003 **Value:** 1847 #### Measurement **Group ID:** BG004 **Value:** 5117 **Class Title:** >34 and < 55 years ### Measure #### Measurement **Group ID:** BG000 **Value:** 461 #### Measurement **Group ID:** BG001 **Value:** 1130 #### Measurement **Group ID:** BG002 **Value:** 537 #### Measurement **Group ID:** BG003 **Value:** 1238 #### Measurement **Group ID:** BG004 **Value:** 3366 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 271 #### Measurement **Group ID:** BG001 **Value:** 556 #### Measurement **Group ID:** BG002 **Value:** 315 #### Measurement **Group ID:** BG003 **Value:** 609 #### Measurement **Group ID:** BG004 **Value:** 1751 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 732 #### Measurement **Group ID:** BG001 **Value:** 1686 #### Measurement **Group ID:** BG002 **Value:** 852 #### Measurement **Group ID:** BG003 **Value:** 1847 #### Measurement **Group ID:** BG004 **Value:** 5117 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Description:** The participants analyzed had to be within this age range during the year 2010. **Parameter Type:** NUMBER **Title:** Age, Customized **Unit of Measure:** participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants **Population Description:** See Giannobile et al 2013 manuscript included ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** wgiannob@umich.edu **Organization:** University of Michigan **Phone:** 734-764-1562 **Title:** William Giannobile, Principal Investigator ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ### Outcome Measure 4 ### Outcome Measure 5 ### Outcome Measure 6 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 16.4 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 13.8 - **Comment:** - **Group ID:** OG002 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 22.1 - **Comment:** - **Group ID:** OG003 - **Lower Limit:** - **Spread:** - **Upper Limit:** - **Value:** 16.9 **Title:** #### Outcome Measure 2 #### Outcome Measure 3 #### Outcome Measure 4 #### Outcome Measure 5 #### Outcome Measure 6 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years. **Parameter Type:** NUMBER **Reporting Status:** POSTED **Time Frame:** 16 years **Title:** Percentage of Participants With Tooth Loss Over 16 Year Period **Type:** PRIMARY **Unit of Measure:** percentage of participants ##### Group **Description:** 1 visit - Low Risk \~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) **ID:** OG000 **Title:** Low Risk Experimental Group ##### Group **Description:** 2 visits - Low Risk \~1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) **ID:** OG001 **Title:** Low Risk Control Group ##### Group **Description:** 1 visit - High Risk \~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) **ID:** OG002 **Title:** High Risk Experimental Group ##### Group **Description:** 2 visits - High Risk \~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) **ID:** OG003 **Title:** High Risk Control Group #### Outcome Measure 2 **Reporting Status:** NOT_POSTED **Time Frame:** 10 and 15 years **Title:** Change in Total Dental Claims During Monitoring Period **Type:** SECONDARY #### Outcome Measure 3 **Reporting Status:** NOT_POSTED **Time Frame:** 10 and 15 years **Title:** Change in Total Periodontal Claims During the Monitoring Period **Type:** SECONDARY #### Outcome Measure 4 **Reporting Status:** NOT_POSTED **Time Frame:** 10 and 15 years **Title:** Change in Periodontal Surgery Claims **Type:** SECONDARY #### Outcome Measure 5 **Reporting Status:** NOT_POSTED **Time Frame:** 10 and 15 years **Title:** Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire. **Type:** SECONDARY #### Outcome Measure 6 **Reporting Status:** NOT_POSTED **Time Frame:** 10 and 15 years **Title:** Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories **Type:** SECONDARY ### Participant Flow Module #### Group **Description:** 1 visit - Low Risk 732 evaluable subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) **ID:** FG000 **Title:** Low Risk Experimental Group #### Group **Description:** 2 visits - Low Risk 1,668 evaluable subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) **ID:** FG001 **Title:** Low Risk Control Group #### Group **Description:** 1 visit - High Risk 852 evaluable subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) **ID:** FG002 **Title:** High Risk Experimental Group #### Group **Description:** 2 visits - High Risk 1,847 evaluable subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) **ID:** FG003 **Title:** High Risk Control Group #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 732 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1686 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 852 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 1847 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 732 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 1686 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 852 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 1847 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG002 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG003 **Number of Subjects:** 0 **Recruitment Details:** From 25,452 individuals meeting inclusion criteria, 9,927 (0.39 of eligible) consented to participate, and 5,117(0.515 of consented) returned completed questionnaires and were successfully genotyped. **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT01602679 **Brief Title:** Acute Effects of Progesterone on LH Pulses During the Follicular Phase (CRM006) **Official Title:** Acute Effects of Progesterone on LH Pulses During the Follicular Phase #### Organization Study ID Info **ID:** 16085 #### Organization **Class:** OTHER **Full Name:** University of Virginia #### Secondary ID Infos **ID:** R01HD058671 **Link:** https://reporter.nih.gov/quickSearch/R01HD058671 **Type:** NIH ### Status Module #### Completion Date **Date:** 2015-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2018-10-16 **Type:** ACTUAL **Last Update Submit Date:** 2018-10-15 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2015-07-31 **Type:** ACTUAL #### Results First Post Date **Date:** 2018-10-16 **Type:** ACTUAL **Results First Submit Date:** 2018-07-31 **Results First Submit QC Date:** 2018-10-15 #### Start Date **Date:** 2012-05 **Status Verified Date:** 2018-10 #### Study First Post Date **Date:** 2012-05-21 **Type:** ESTIMATED **Study First Submit Date:** 2012-05-17 **Study First Submit QC Date:** 2012-05-18 **Why Stopped:** Interim analysis suggested futility. ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) #### Lead Sponsor **Class:** OTHER **Name:** University of Virginia #### Responsible Party **Investigator Affiliation:** University of Virginia **Investigator Full Name:** Chris McCartney **Investigator Title:** Associate Professor of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The rapidity with which progesterone slows LH (and by inference GnRH) pulse frequency in women is unclear. The investigators hypothesize that progesterone slows LH pulse frequency within 10 hours. The investigators propose to assess this further with a randomized, cross-over, placebo-controlled study. Regularly cycling women without hyperandrogenism will be admitted to the Clinical Research Unit on cycle day 5-9 (mid-follicular phase) for a 10 hour frequent sampling study to observe LH, FSH, estradiol, progesterone, and testosterone. Either oral micronized progesterone suspension or placebo will be administered at 0900 h. During a subsequent menstrual cycle, subjects will undergo another study identical to the first except that oral progesterone will be exchanged for placebo or vice versa in accordance with a crossover design. **Detailed Description:** The rapidity with which progesterone slows LH (and by inference GnRH) pulse frequency in women is unclear. The investigators hypothesize that progesterone slows LH pulse frequency within 10 hours. The investigators propose to assess this further with a randomized, cross-over, placebo-controlled study. Regularly cycling women without hyperandrogenism will be admitted to the Clinical Research Unit on cycle day 5-9 (mid-follicular phase) for a frequent sampling study. Beginning at 0900 h, blood for LH, FSH, estradiol, progesterone, and testosterone will be obtained over a 10-hour period. Either oral micronized progesterone (100 mg p.o.) suspension or placebo will be administered at 0900 h. During a subsequent menstrual cycle, subjects will undergo another study identical to the first except that oral progesterone will be exchanged for placebo or vice versa in accordance with a crossover design. The primary endpoint of interest is LH pulse frequency; the investigators will compare LH pulse frequency after progesterone administration to LH pulse frequency after placebo administration. ### Conditions Module **Conditions:** - Female Reproductive Physiology ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Randomized, placebo-controlled, crossover study ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 12 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants first received oral micronized progesterone (100 mg p.o.) suspension. After a washout period of approximately 20 days, they then received placebo (matching oral micronized progesterone suspension). **Intervention Names:** - Drug: oral micronized progesterone suspension - Drug: Placebo **Label:** micronized progesterone, then placebo **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants first received placebo. After a washout period of approximately 20 days, they then received oral micronized progesterone syrup (100 mg p.o.)Placebo contains only inert ingredients and is not expected to exert any direct physiological effects **Intervention Names:** - Drug: oral micronized progesterone suspension - Drug: Placebo **Label:** Placebo, then micronized progesterone **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Placebo, then micronized progesterone - micronized progesterone, then placebo **Description:** oral micronized progesterone (100 mg p.o.) suspension **Name:** oral micronized progesterone suspension **Other Names:** - Progesterone **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo, then micronized progesterone - micronized progesterone, then placebo **Description:** Placebo contains only inert ingredients and is not expected to exert any direct physiological effects **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint is the change in the number of LH pulses per hour (over 10 h), comparing (a) number of LH pulses at baseline to (b) number of LH pulses immediately after progesterone or placebo administration **Measure:** Change in Number of LH Pulses Per Hour **Time Frame:** 10 hours following administration of micronized progesterone or placebo #### Secondary Outcomes **Description:** This secondary endpoint is the change of the mean LH (over 10 h), comparing (a) mean LH at baseline to (b) mean LH immediately after progesterone or placebo administration **Measure:** Change in Mean LH **Time Frame:** 10 hours following administration of micronized progesterone or placebo **Description:** This secondary endpoint is the change in the mean LH amplitude (over 10 h), comparing (a) mean LH amplitude at baseline to (b) mean LH amplitude immediately after progesterone or placebo administration **Measure:** Change in Mean LH Amplitude **Time Frame:** 10 hours following administration of micronized progesterone or placebo ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects will be healthy women with regular menstrual cycles and no evidence of hyperandrogenism. * Subjects will be 18-30 years old; the investigators use a cutoff age of 30 years because age-related alterations in the hypothalamic-pituitary-ovarian axis is uncommon before age 30 years. * Subjects will be willing to strictly avoid pregnancy (using non-hormonal methods) during the time of study and must be willing and able to provide informed consent. Exclusion Criteria: * Pregnancy * Lactation * History of allergy to progesterone * BMI \< 18 kg/m2 or \> 30 kg/m2 (underweight and obesity can affect hypothalamic-pituitary-ovarian function) * Excessive exercise, defined as routine and current engagement in either (a) moderate exercise (e.g., brisk walking) exceeding 14 hours per week or (a) vigorous exercise exceeding 7 hours a week. * Clinical hyperandrogenism (primarily hirsutism) * Abnormally elevated free testosterone or DHEAS concentration * A previous diagnosis of diabetes, a fasting glucose ≥ 126 mg/dl * Abnormal TSH (subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded; or, for a new diagnosis of hypothyroidism, further study will at the least be delayed pending appropriate treatment) (confirmed on repeat) * Abnormal prolactin (confirmed on repeat) * Evidence of Cushing's syndrome by history or physical exam * History of venous thromboembolism, breast/ovarian/endometrial cancer * The investigators will exclude women with any other cancer diagnosis and/or treatment (with the exception of basal cell or squamous skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years. * Women with anemia (hematocrit \< 36% and hemoglobin level \< 12 g/dl) will be treated with iron for a maximum of 2 sequential months before the 1st admission and/or before the 2nd admission. If they remain anemic after 2 sequential months of ferrous gluconate (325 mg bid), they will then be excluded from further participation in the study. * Women with a significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; known or suspected coronary atherosclerosis; asthma requiring systemic intermittent corticosteroids; etc.) will be excluded. * Women with liver enzymes, alkaline phosphatase, or bilirubin \> 1.5 times upper limit of normal (confirmed on repeat) will be excluded, with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. * Abnormal sodium or potassium concentrations (confirmed on repeat); bicarbonate concentrations \<20 or \>30 (confirmed on repeat) * Women with abnormal renal function (i.e., serum creatinine \> 1.4) will be excluded (confirmed on repeat) * Due to the amount of blood being drawn in the study, subjects with body weight \< 110 pounds will be excluded from the study * Being a study of the acute effects of progesterone on the hypothalamic-pituitary unit, subjects must not take hormonal medications (e.g., oral contraceptives) or other medications known to affect the reproductive axis for 60 days prior to the study and during the study. **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Charlottesville **Country:** United States **Facility:** Center for Research in Reproduction **State:** Virginia **Zip:** 22908 #### Overall Officials **Official 1:** **Affiliation:** University of Virginia **Name:** Christopher R. McCartney, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** We do not have current plans to share IPD **IPD Sharing:** UNDECIDED ## Document Section ### Large Document Module #### Large Docs - Date: 2014-09-24 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 1004760 - Type Abbrev: Prot_SAP - Upload Date: 2018-07-03T15:29 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000011372 - Term: Progestins - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M14245 - Name: Progesterone - Relevance: HIGH - As Found: Chinese - ID: M14244 - Name: Progestins - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011374 - Term: Progesterone ### Misc Info Module - Version Holder: 2024-05-24 ## Results Section ### Adverse Events Module #### Event Groups **Group ID:** EG000 **Title:** Oral Micronized Progesterone Suspension **Deaths Num At Risk:** 4 **Description:** Oral micronized progesterone (100 mg) suspension **ID:** EG000 **Other Num Affected:** 1 **Other Num at Risk:** 4 **Serious Number At Risk:** 4 **Title:** Oral Micronized Progesterone Suspension **Group ID:** EG001 **Title:** Placebo **Deaths Num At Risk:** 3 **Description:** Placebo contains only inert ingredients and is not expected to exert any direct physiological effects **ID:** EG001 **Other Num at Risk:** 3 **Serious Number At Risk:** 3 **Title:** Placebo **Frequency Threshold:** 0 #### Other Events **Term:** Irregular Menstrual Bleeding **Assessment Type:** NON_SYSTEMATIC_ASSESSMENT **Notes:** Temporary spotting **Organ System:** Reproductive system and breast disorders **Source Vocabulary:** **Time Frame:** From start of study procedures until end of study participation, up to 6 months ## Results Section - Baseline Characteristics Module ### Denomination Counts **Group ID:** BG000 **Value:** 4 **Group ID:** BG001 **Value:** 3 **Group ID:** BG002 **Value:** 7 **Units:** Participants ### Group **ID:** BG000 **Title:** Oral Micronized Progesterone Suspension, Then Placebo **Description:** Participants first received oral micronized progesterone (100 mg p.o.) suspension. After a washout period of approximately 20 days, they then received Placebo. oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects ### Group **ID:** BG001 **Title:** Placebo, Then Oral Micronized Progesterone Suspension **Description:** Participants first received Placebo. After a washout period of approximately 20 days, they then received oral micronized progesterone suspension. Placebo contains only inert ingredients and is not expected to exert any direct physiological effects Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension ### Group **ID:** BG002 **Title:** Total **Description:** Total of all reporting groups ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** <=18 years #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 7 **Category Title:** Between 18 and 65 years #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** >=65 years **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 7 **Category Title:** Female #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Male **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** American Indian or Alaska Native #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Asian #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Native Hawaiian or Other Pacific Islander #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** Black or African American #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** White #### Measurement **Group ID:** BG000 **Value:** 0 #### Measurement **Group ID:** BG001 **Value:** 0 #### Measurement **Group ID:** BG002 **Value:** 0 **Category Title:** More than one race #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 7 **Category Title:** Unknown or Not Reported **Class Title:** ### Measure #### Measurement **Group ID:** BG000 **Value:** 4 #### Measurement **Group ID:** BG001 **Value:** 3 #### Measurement **Group ID:** BG002 **Value:** 7 **Class Title:** United States **Denomination Units Selected:** ## Results Section - Baseline Characteristics Module ### Measure 1 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Age, Categorical **Unit of Measure:** Participants ### Measure 2 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Sex: Female, Male **Unit of Measure:** Participants ### Measure 3 **Parameter Type:** COUNT_OF_PARTICIPANTS **Title:** Race (NIH/OMB) **Unit of Measure:** Participants ### Measure 4 **Parameter Type:** NUMBER **Title:** Region of Enrollment **Unit of Measure:** participants ## Results Section - More Information Module ### Certain Agreement ### Point of Contact **Email:** cm2hq@virginia.edu **Organization:** University of Virginia Center for Research in Reproduction **Phone:** 4342430329 **Title:** Dr. Christopher R. McCartney ## Results Section - Outcome Measures Module ### Outcome Measure 1 ### Outcome Measure 2 ### Outcome Measure 3 ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 0.28 - **Upper Limit:** - **Value:** 0.77 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 0.35 - **Upper Limit:** - **Value:** 0.79 **Title:** #### Outcome Measure 2 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.2 - **Upper Limit:** - **Value:** 5.8 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.3 - **Upper Limit:** - **Value:** 4.6 **Title:** #### Outcome Measure 3 **Class:** ##### Category **Measurements:** - **Comment:** - **Group ID:** OG000 - **Lower Limit:** - **Spread:** 2.8 - **Upper Limit:** - **Value:** 4.3 - **Comment:** - **Group ID:** OG001 - **Lower Limit:** - **Spread:** 2.8 - **Upper Limit:** - **Value:** 3.6 **Title:** ## Results Section ### Outcome Measures Module #### Outcome Measure 1 **Description:** The primary endpoint is the change in the number of LH pulses per hour (over 10 h), comparing (a) number of LH pulses at baseline to (b) number of LH pulses immediately after progesterone or placebo administration **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 10 hours following administration of micronized progesterone or placebo **Title:** Change in Number of LH Pulses Per Hour **Type:** PRIMARY **Unit of Measure:** pulses/h ##### Group **Description:** oral micronized progesterone (100 mg p.o.) suspension oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension **ID:** OG000 **Title:** Oral Micronized Progesterone Suspension ##### Group **Description:** Placebo contains only inert ingredients and is not expected to exert any direct physiological effects Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects **ID:** OG001 **Title:** Placebo #### Outcome Measure 2 **Description:** This secondary endpoint is the change of the mean LH (over 10 h), comparing (a) mean LH at baseline to (b) mean LH immediately after progesterone or placebo administration **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 10 hours following administration of micronized progesterone or placebo **Title:** Change in Mean LH **Type:** SECONDARY **Unit of Measure:** IU/L ##### Group **Description:** oral micronized progesterone (100 mg p.o.) suspension oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension **ID:** OG000 **Title:** Oral Micronized Progesterone Suspension ##### Group **Description:** Placebo contains only inert ingredients and is not expected to exert any direct physiological effects Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects **ID:** OG001 **Title:** Placebo #### Outcome Measure 3 **Description:** This secondary endpoint is the change in the mean LH amplitude (over 10 h), comparing (a) mean LH amplitude at baseline to (b) mean LH amplitude immediately after progesterone or placebo administration **Dispersion Type:** Standard Deviation **Parameter Type:** MEAN **Reporting Status:** POSTED **Time Frame:** 10 hours following administration of micronized progesterone or placebo **Title:** Change in Mean LH Amplitude **Type:** SECONDARY **Unit of Measure:** IU/L ##### Group **Description:** oral micronized progesterone (100 mg p.o.) suspension oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension **ID:** OG000 **Title:** Oral Micronized Progesterone Suspension ##### Group **Description:** Placebo contains only inert ingredients and is not expected to exert any direct physiological effects Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects **ID:** OG001 **Title:** Placebo ### Participant Flow Module #### Group **Description:** Participants first received oral micronized progesterone (100 mg p.o.) suspension. After a washout period of approximately 20 days, they then received placebo. oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension **ID:** FG000 **Title:** Oral Micronized Progesterone Suspension, Then Placebo #### Group **Description:** Participants first received Placebo. After a washout period of approximately 20 days, they then received oral micronized progesterone suspension. Placebo contains only inert ingredients and is not expected to exert any direct physiological effects Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects **ID:** FG001 **Title:** Placebo, Then Oral Micronized Progesterone Suspension #### Period **Title:** Overall Study ##### Milestone **Type:** STARTED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 3 ##### Milestone **Type:** COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 4 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 3 ##### Milestone **Type:** NOT COMPLETED ###### Achievement **Group ID:** FG000 **Number of Subjects:** 0 ###### Achievement **Group ID:** FG001 **Number of Subjects:** 0 **Pre-Assignment Details:** 12 subjects enrolled in this study. 5 subjects completed screening procedures only (these 5 subjects were withdrawn from study prior to being assigned to an arm of intervention). **Has Results:** True

## Protocol Section ### Identification Module **NCT ID:** NCT02562079 **Acronym:** VISS **Brief Title:** Vasculopathy, Inflammation and Systemic Sclerosis **Official Title:** Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation #### Organization Study ID Info **ID:** CHUBX 2011/37 #### Organization **Class:** OTHER **Full Name:** University Hospital, Bordeaux ### Status Module #### Completion Date **Date:** 2016-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-04-07 **Type:** ACTUAL **Last Update Submit Date:** 2017-04-05 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2016-12 **Type:** ACTUAL #### Start Date **Date:** 2012-03 **Type:** ACTUAL **Status Verified Date:** 2017-04 #### Study First Post Date **Date:** 2015-09-29 **Type:** ESTIMATED **Study First Submit Date:** 2014-12-29 **Study First Submit QC Date:** 2015-09-25 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Societe Francaise de Rhumatologie #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Bordeaux #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** False ### Description Module **Brief Summary:** It is a study of basic research with mechanistically objectives and including clinical biological samples. **Detailed Description:** Systemic sclerosis (SSc) is a rare and severe disease characterised by a fibrotic process and an incompletely elucidate physiopathology. Several shared featured have been identified between SSc and another autoimmune disease, the systemic lupus erythematous (SLE) as an interferon-alpha signature, the role of platelets and the polymorphism of OX40 ligand (OX40L). In SLE, OX40L has been shown highly linked to the active form of the disease, was increased by the CD40L of platelets and induced the CD8 cytotoxicity while inhibiting the suppressive functions of regulator T lymphocytes. The third main factor of the SSc physiopathology apart from autoimmunity and fibrosis is the vasculopathy with an important role of endothelial cells (EC). They turned out to be half-professional antigen presenting cells and can modulate the adaptive immunity. ### Conditions Module **Conditions:** - Systemic Sclerosis **Keywords:** - T lymphocyte - OX40/OX40L ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 350 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Blood samples - Biological: Biopsy **Label:** subjects SSc diagnosed **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Biological: Blood samples - Biological: Biopsy **Label:** subjects Localised sclerosis diagnosed **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Biological: Blood samples **Label:** subjects Sc **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - subjects Localised sclerosis diagnosed - subjects SSc diagnosed - subjects Sc **Description:** * biological features of the standard follow-up * 2 more blood tube for the biological collection (serum and PBMC) **Name:** Blood samples **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - subjects Localised sclerosis diagnosed - subjects SSc diagnosed **Description:** Skin biopsies **Name:** Biopsy **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Measure:** Assessment of OX40L expression in endothelial cells and skin biopsies. **Time Frame:** Day 1 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age from 18 to 75. * SSc diagnosed according to the American College of Rheumatology (ACR) criteria. * With skin manifestations since less than 10 years. * Localised sclerosis (LSc) diagnosed, morphea type. Exclusion Criteria: * Age inferior to 18 or upper than 75. * Skin manifestations since more than 10 years. * Haemostasis diseases (independent from treatments). * Stem cell transplant. * Immunosuppressive treatments in the last 6 months. * Associate autoimmune disease. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bordeaux **Country:** France **Facility:** Service de Rhumatologie - Tripode - Hôpital Pellegrin **Zip:** 33076 #### Overall Officials **Official 1:** **Affiliation:** University Hospital Bordeaux, France **Name:** Marie-Elise TRUCHETET, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: HIGH - As Found: Systemic Sclerosis ### Condition Browse Module - Meshes - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000045743 - Term: Scleroderma, Diffuse - ID: D000012598 - Term: Sclerosis - ID: D000007249 - Term: Inflammation ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT01497379 **Brief Title:** Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients **Official Title:** Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Mono- & Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Degenerative Retinal Disease Patients. #### Organization Study ID Info **ID:** HKCTR-1198 #### Organization **Class:** INDUSTRY **Full Name:** Retina Implant AG #### Secondary ID Infos **Domain:** Clinicaltrials.gov **ID:** RI-MC-CT-2009 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2015-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2017-03-29 **Type:** ACTUAL **Last Update Submit Date:** 2017-03-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2014-01 **Type:** ACTUAL #### Start Date **Date:** 2011-10 **Status Verified Date:** 2017-03 #### Study First Post Date **Date:** 2011-12-22 **Type:** ESTIMATED **Study First Submit Date:** 2011-12-15 **Study First Submit QC Date:** 2011-12-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Retina Implant AG #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** Patients who are legally blind, caused by retinal degeneration of photoreceptor rods \& cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially. ### Conditions Module **Conditions:** - Retinal Degeneration - Retinitis Pigmentosa **Keywords:** - Hereditary retinal - degeneration outer - retinal layers - photoreceptor rods cones - Retinitis pigmentosa - blindness - reading ability - retina implant - subretinal ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 2 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** intra-individual implant activation **Intervention Names:** - Procedure: surgical implantation of subretinal device **Label:** intra-individual implant ON **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** intra-individual implant deactivation **Intervention Names:** - Procedure: surgical implantation of subretinal device **Label:** intra-individual implant OFF **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - intra-individual implant ON **Description:** surgical implantation of subretinal device **Name:** surgical implantation of subretinal device **Other Names:** - Retinal implant, subretinal implant **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - intra-individual implant OFF **Description:** intra-individual implant OFF **Name:** surgical implantation of subretinal device **Other Names:** - Retinal implant, subretinal implant **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients **Measure:** Safety **Time Frame:** 1 year **Description:** Activities of Daily Living \& Mobility are significantly improved with implant-ON versus OFF, as shown via tests: * Activities of Daily Living tasks or * Recognition tasks or * Mobility or * a combination of the above **Measure:** Efficacy **Time Frame:** 1 year #### Secondary Outcomes **Description:** Patient long term safety: * stability of implant function * stability of body structure \& function related to implant system **Measure:** Safety **Time Frame:** 1 year **Description:** Visual Acuity / Light-perception and/or Object-recognition are significantly improved with implant-ON versus OFF as shown via: * FrACT or * BaLM or * Grating test (e.g. BaGA) and/or Quality of life * Quality of life (questionnaire) or * a combination of the above **Measure:** Efficacy **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods \& cones. * Pseudophakia * Angiography shows retinal vessels adequately perfused, despite pathological RP condition. * Age between 18 and 78 years. * Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation (impaired light localization or worse). * Ability to read normal print in earlier life, optically corrected without magnifying glass. * Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year Exclusion Criteria: * Period of appropriate visual functions \< 12 years / lifetime. * Optical Coherence Tomography (OCT) shows significant retina edema \&/or scar tissue within target region for implant. * Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT). * Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP). * Heavy clumped pigmentation at posterior pole * Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment). * Amblyopia reported earlier in life on eye to be implanted * Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases). * Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression). * Hyperthyroidism or hypersensitivity to iodine * Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study. * Participation in another interventional clinical trial within the past 30 days. **Maximum Age:** 78 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hong Kong **Country:** Hong Kong **Facility:** Ophthalmology Eye Institute, University of Hong Kong **State:** Cyberport **Zip:** 100 #### Overall Officials **Official 1:** **Affiliation:** Chair Professor in Ophthalmology Eye Institute **Name:** David Wong, Prof., MD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Stingl K, Bartz-Schmidt KU, Besch D, Chee CK, Cottriall CL, Gekeler F, Groppe M, Jackson TL, MacLaren RE, Koitschev A, Kusnyerik A, Neffendorf J, Nemeth J, Naeem MA, Peters T, Ramsden JD, Sachs H, Simpson A, Singh MS, Wilhelm B, Wong D, Zrenner E. Subretinal Visual Implant Alpha IMS--Clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23. **PMID:** 25812924 #### See Also Links **Label:** Hong Kong clinical trials registry **URL:** http://www.hkclinicaltrials.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000015785 - Term: Eye Diseases, Hereditary - ID: D000058499 - Term: Retinal Dystrophies - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5047 - Name: Blindness - Relevance: LOW - As Found: Unknown - ID: M15008 - Name: Retinitis - Relevance: HIGH - As Found: Retinitis - ID: M15009 - Name: Retinitis Pigmentosa - Relevance: HIGH - As Found: Retinitis Pigmentosa - ID: M14997 - Name: Retinal Degeneration - Relevance: HIGH - As Found: Retinal Degeneration - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M18339 - Name: Eye Diseases, Hereditary - Relevance: LOW - As Found: Unknown - ID: M29107 - Name: Retinal Dystrophies - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T4945 - Name: Retinitis Pigmentosa - Relevance: HIGH - As Found: Retinitis Pigmentosa ### Condition Browse Module - Meshes - ID: D000012173 - Term: Retinitis - ID: D000012174 - Term: Retinitis Pigmentosa - ID: D000012162 - Term: Retinal Degeneration ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04756479 **Acronym:** COVID-AGEBRU **Brief Title:** Mortality Due to COVID-19 in the COVID-AGEBRU Study **Official Title:** Predictors of Intrahospital Mortality in Older Patients Admitted Due to COVID-19 in the COVID-19 AGEBRU Study #### Organization Study ID Info **ID:** COVID-19 AGE-BRUGMANN 2020/111 #### Organization **Class:** OTHER **Full Name:** Brugmann University Hospital ### Status Module #### Completion Date **Date:** 2020-06-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2022-04-06 **Type:** ACTUAL **Last Update Submit Date:** 2022-03-28 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-06-30 **Type:** ACTUAL #### Start Date **Date:** 2020-03-01 **Type:** ACTUAL **Status Verified Date:** 2022-03 #### Study First Post Date **Date:** 2021-02-16 **Type:** ACTUAL **Study First Submit Date:** 2021-02-08 **Study First Submit QC Date:** 2021-02-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Brugmann University Hospital #### Responsible Party **Investigator Affiliation:** Brugmann University Hospital **Investigator Full Name:** Murielle Surquin **Investigator Title:** Geriatrics Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The COVID-Age Brugmann study aims to identify the clinical predictors of mortality risk in older patients admitted to an acute care unit due to COVID-19 **Detailed Description:** The COVID-19 disease has been shown to be associated to higher mortality risk and health adverse consequences. Despite of the fact that the SAR-COV2 virus has been shown that affects every populations, the negative impact is higher in older people, pointing this population as the most severely affected. The COVID-Age Brugmann study aims to identify if comorbidity, geriatric syndromes, and health issues at admission are associated to mortality risk in older patients admitted to an acute care unit due to COVID-19 ### Conditions Module **Conditions:** - Covid19 - Old Age; Debility - Morbidity, Multiple ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 160 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Vital status was obtained from medical records **Measure:** All-cause mortality during hospital admission (admission up to discharge time) **Time Frame:** Through study completion, an average of one month. #### Secondary Outcomes **Description:** Clinical and demographical conditions, and geriatric syndromes **Measure:** Prevalence of medical diseases and geriatric syndromes **Time Frame:** Through study completion, an average of one month. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 70 and older * Patients admitted to an acute care geriatric unit due to COVID-19 * Patients with COVID-19 by PCR, serology or CT scan suggestive of this disease Exclusion Criteria: * No other demographic or clinical exclusion criteria will be applied **Minimum Age:** 70 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Consecutive patients aged 70 and over hospitalized in an acute care unit in Brugmann university hospital, in Belgium, due to COVID-19 in the period Mars to June 2020. ### Contacts Locations Module #### Locations **Location 1:** **City:** Brussels **Country:** Belgium **Facility:** CHU Brugmann **Zip:** 1020 #### Overall Officials **Official 1:** **Affiliation:** CHU Brugmann, Director of the Geriatrics Department **Name:** Murielle MS Surquin, MD PhD **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### References **Citation:** Mendes A, Serratrice C, Herrmann FR, Genton L, Perivier S, Scheffler M, Fassier T, Huber P, Jacques MC, Prendki V, Roux X, Di Silvestro K, Trombert V, Harbarth S, Gold G, Graf CE, Zekry D. Predictors of In-Hospital Mortality in Older Patients With COVID-19: The COVIDAge Study. J Am Med Dir Assoc. 2020 Nov;21(11):1546-1554.e3. doi: 10.1016/j.jamda.2020.09.014. Epub 2020 Sep 15. **PMID:** 33138936 **Citation:** Menager P, Briere O, Gautier J, Riou J, Sacco G, Brangier A, Annweiler C, Geria-Covid Study Group OBOT. Regular Use of VKA Prior to COVID-19 Associated with Lower 7-Day Survival in Hospitalized Frail Elderly COVID-19 Patients: The GERIA-COVID Cohort Study. Nutrients. 2020 Dec 24;13(1):39. doi: 10.3390/nu13010039. **PMID:** 33374341 **Citation:** Miralles O, Sanchez-Rodriguez D, Marco E, Annweiler C, Baztan A, Betancor E, Cambra A, Cesari M, Fontecha BJ, Gasowski J, Gillain S, Hope S, Phillips K, Piotrowicz K, Piro N, Sacco G, Saporiti E, Surquin M, Vall-Llosera E. Unmet needs, health policies, and actions during the COVID-19 pandemic: a report from six European countries. Eur Geriatr Med. 2021 Feb;12(1):193-204. doi: 10.1007/s41999-020-00415-x. Epub 2020 Oct 15. Erratum In: Eur Geriatr Med. 2021 Jun;12(3):667. **PMID:** 33057981 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M1175 - Name: Frailty - Relevance: HIGH - As Found: Debility - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000073496 - Term: Frailty ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT02312479 **Brief Title:** Safety and Performance Study of the Nyxoah SAT System for Treating OSA **Official Title:** Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea #### Organization Study ID Info **ID:** SAT2014A #### Organization **Class:** INDUSTRY **Full Name:** Nyxoah S.A. ### Status Module #### Completion Date **Date:** 2016-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2016-09-27 **Type:** ESTIMATED **Last Update Submit Date:** 2016-09-26 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2015-11 **Type:** ACTUAL #### Start Date **Date:** 2014-12 **Status Verified Date:** 2016-09 #### Study First Post Date **Date:** 2014-12-09 **Type:** ESTIMATED **Study First Submit Date:** 2014-12-04 **Study First Submit QC Date:** 2014-12-04 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Nyxoah S.A. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea ### Conditions Module **Conditions:** - Obstructive Sleep Apnea ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 6 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Nyxoah SAT system **Label:** Nyxoah SAT therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Nyxoah SAT therapy **Description:** The Nyxoah SAT system is comprised of an implantable nerve stimulator implanted over one of the tongue muscles via a minimally invasive procedure. Stimulation of the Hypoglossal nerves causes the tongue muscles to contract, thus maintaining an open airway during sleep. **Name:** Nyxoah SAT system **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of serious device related adverse events **Time Frame:** 6-months post-implantation **Measure:** Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation **Time Frame:** 6-months post-implantation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosed with moderate to severe Obstructive Sleep Apnea * Have failed or have not tolerated CPAP treatment * Willing and capable of providing informed consent * Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires Exclusion Criteria: * BMI limits * Subjects with complete concentric collapse at the soft palate level per endoscopy **Maximum Age:** 70 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Edegem **Country:** Belgium **Facility:** Antwerp University Hospital **Location 2:** **City:** Mannheim **Country:** Germany **Facility:** Universitäts-HNO-Klinik Mannheim #### Overall Officials **Official 1:** **Affiliation:** Universitäts-HNO-Klinik Mannheim **Name:** Joachim T Maurer, OA Dr. med. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Universiteit Antwerpen **Name:** Evert Hamans, PhD Dr. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001049 - Term: Apnea - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M4361 - Name: Apnea - Relevance: LOW - As Found: Unknown - ID: M15694 - Name: Sleep Apnea Syndromes - Relevance: HIGH - As Found: Sleep Apnea - ID: M22010 - Name: Sleep Apnea, Obstructive - Relevance: HIGH - As Found: Obstructive Sleep Apnea - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012891 - Term: Sleep Apnea Syndromes - ID: D000020181 - Term: Sleep Apnea, Obstructive ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT03786679 **Acronym:** NOSWEPH **Brief Title:** Non-operative Treatment in Sweden of Proximal Humeral Fractures **Official Title:** Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial. #### Organization Study ID Info **ID:** 06000836 #### Organization **Class:** OTHER_GOV **Full Name:** Linkoeping University ### Status Module #### Completion Date **Date:** 2024-02-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-03-08 **Type:** ACTUAL **Last Update Submit Date:** 2023-03-07 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-02-25 **Type:** ESTIMATED #### Start Date **Date:** 2019-02-25 **Type:** ACTUAL **Status Verified Date:** 2023-03 #### Study First Post Date **Date:** 2018-12-26 **Type:** ACTUAL **Study First Submit Date:** 2018-11-05 **Study First Submit QC Date:** 2018-12-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Lars Adolfsson #### Responsible Party **Investigator Affiliation:** Linkoeping University **Investigator Full Name:** Lars Adolfsson **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Proximal humeral fractures are common especially in the elderly population. The majority of these fractures are minimally displaced and may be treated non-operatively. There is however a controversy about which fractures that need surgery and randomised trials have not been able to show a clinically important advantage in patient reported outcome measures for those operated. The trend is therefore that also displaced and comminute fractures are treated non-operatively. There is however very little scientific support for how the non-operative treatment should be designed and performed. Therefore this prospective multicenter study is aiming at investigating the benefit of a four week immobilisation orthosis as compared to early range of motion exercises for those patients not assigned for surgery one week after the trauma. ### Conditions Module **Conditions:** - Proximal Humeral Fracture **Keywords:** - Non-operative treatment, orthosis, healing, rehabilitation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel assignment ##### Masking Info **Masking:** SINGLE **Masking Description:** The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation. **Intervention Names:** - Device: Ultrasling ER III orthosis **Label:** Orthosis group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The patient is instructed to start early rehabilitation about one week after the trauma. **Intervention Names:** - Device: Ultrasling ER III orthosis **Label:** Early rehabilitation group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Early rehabilitation group - Orthosis group **Description:** Application of orthosis and start of rehabilitation after four weeks. **Name:** Ultrasling ER III orthosis **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** recording of fracture union on radiological images **Measure:** Union of fracture **Time Frame:** Followed 12 months #### Secondary Outcomes **Description:** Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points **Measure:** Oxford shoulder score **Time Frame:** 12 months **Description:** Patient reported outcome measure of pain at rest, at night and during activity in scales with 10 steps grading subjective assessment of pain **Measure:** Numerical pain reporting scale **Time Frame:** 12 months **Description:** Patient reported outcome measure of shoulder function in a 11-item PROM **Measure:** Quick DASH **Time Frame:** 12 months **Description:** Patient rated assessment of global improvement in a numeric scale with 7 steps **Measure:** Global assessment of improvement **Time Frame:** 12 months **Description:** The elevation, abduction, internal and external rotation of the injured shoulder **Measure:** Shoulder range of motion **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A proximal humeral fracture verified on radiology no older than 7-10 days. Exclusion Criteria: * Surgically treated proximal humeral fracture * Fracture only involving the greater tuberosity * Previous surgery in the fractured shoulder * Ongoing malignancy in the fractured shoulder * Neurologic disease * Radiating pain from the neck in the affected arm * Associated vascular or nerve injuries * Dementia * Alcohol abuse * Unwilling to participate in the trial **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** hanna.bjornsson.hallgren@regionostergotland.se **Name:** Hanna C Björnsson Hallgren, MD, PhD **Phone:** 0046709473276 **Role:** CONTACT #### Locations **Location 1:** **City:** Linköping **Contacts:** ***Contact 1:*** - **Email:** hanna.bjornsson.hallgren@regionostergotland.se - **Name:** Hanna C Björnsson Hallgren, MD, PhD - **Phone:** +46101031000 - **Role:** CONTACT ***Contact 2:*** - **Email:** lars.adolfsonb@regionostergotland.se - **Name:** lars e adolfsson, MD, PhD - **Phone:** +46101031000 - **Role:** CONTACT **Country:** Sweden **Facility:** Lars Adolfsson **Status:** RECRUITING **Zip:** 58185 #### Overall Officials **Official 1:** **Affiliation:** Linkoeping University **Name:** Lars E Adolfsson, Professor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Linkoeping University **Name:** Hanna C Björnsson Hallgren, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. **PMID:** 35727196 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050723 - Term: Fractures, Bone - ID: D000014947 - Term: Wounds and Injuries - ID: D000001134 - Term: Arm Injuries - ID: D000070599 - Term: Shoulder Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: LOW - As Found: Unknown - ID: M9869 - Name: Humeral Fractures - Relevance: HIGH - As Found: Humeral Fractures - ID: M15592 - Name: Shoulder Fractures - Relevance: HIGH - As Found: Proximal Humeral Fracture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M4444 - Name: Arm Injuries - Relevance: LOW - As Found: Unknown - ID: M602 - Name: Shoulder Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006810 - Term: Humeral Fractures - ID: D000012784 - Term: Shoulder Fractures ### Misc Info Module - Version Holder: 2024-05-24

## Protocol Section ### Identification Module **NCT ID:** NCT04236479 **Brief Title:** Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP) **Official Title:** Mesenchymal Stromal Cells Delivery Through Cardiopulmonary Bypass in Pediatric Cardiac Surgery #### Organization Study ID Info **ID:** Pro00011914 #### Organization **Class:** OTHER **Full Name:** Children's National Research Institute ### Status Module #### Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2023-09-21 **Type:** ACTUAL **Last Update Submit Date:** 2023-09-19 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2020-07-29 **Type:** ACTUAL **Status Verified Date:** 2023-09 #### Study First Post Date **Date:** 2020-01-22 **Type:** ACTUAL **Study First Submit Date:** 2020-01-15 **Study First Submit QC Date:** 2020-01-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Catherine Bollard #### Responsible Party **Investigator Affiliation:** Children's National Research Institute **Investigator Full Name:** Catherine Bollard **Investigator Title:** Director, Center for Cancer and Immunology/ Center for Emerging Technologies in Immune Cell Therapies (CETI) **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life **Detailed Description:** This study is a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life. The dose-escalation methods with a modified continual reassessment at the five dose levels (1x10\^6, 10x10\^6, 20x10\^6, 40x10\^6, 80x10\^6, cells/kg) will be performed to determine safety and feasibility of allogeneic BM-MSC infusion during pediatric cardiac surgery and the maximum tolerated dose in infants with CHD. In addition to the primary objective of assessing the safety and feasibility of BM-MSC delivery through CPB, our secondary objectives are designed to develop biological signature measures and clinical outcome measures feasible for use in larger efficacy and effectiveness trials with a particular focus on neurodevelopmental outcome and early postoperative course after BM-MSC treatment. We will determine actual magnitude of differences in neuroimaging and neurodevelopmental variables and postoperative inflammatory and pathophysiological variables after BM-MSC delivery in infants with CHD. Enrollment, follow-up, and analysis are planned to occur over 36 months for the treatment and initial follow-up portions of the study. Long-term follow-up until 18 months of age will be subsequently reported. ### Conditions Module **Conditions:** - Congenital Heart Disease (CHD) ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 17 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The dose-escalation methods with a modified continual reassessment at the five dose levels (1x10\^6, 10x10\^6, 20x10\^6, 40x10\^6, 80x10\^6 cells/kg) will be performed to determine safety and feasibility of allogeneic BM-MSC infusion during pediatric cardiac surgery and the maximum tolerated dose in infants with CHD. **Intervention Names:** - Biological: BM-MSC **Label:** Bone marrow-derived mesenchymal stromal cell (BM-MSC) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Bone marrow-derived mesenchymal stromal cell (BM-MSC) **Description:** Allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery through cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life. **Name:** BM-MSC **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Dose Limiting Toxicity is attributable to the MSC administration. **Measure:** Number of subjects who experience serious adverse events, adverse events, and/or early treatment discontinuations. **Time Frame:** 45 days following the MSC administration #### Secondary Outcomes **Description:** Secondary objective will be measured by using the Pediatric Cardiac Critical Care Consortium (PC4) registry system. **Measure:** Actual magnitude of differences in neuroimaging and neurodevelopmental variables will be measured after MSC delivery. **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Neonatal and young infantile patients who are ≤ 3 months of age * Scheduled to undergo reparative two-ventricle repair for congenital heart defects without aortic arch reconstruction, including the following: a. D-Transposition of the Great Arteries (d-TGA) Group: i. d-TGA with intact ventricular septum (d-TGA, IVS) ii. d-TGA with ventricular septal defect (d-TGA, VSD) b. Ventricular Septal Defect (VSD) Group: i. VSD without aortic arch obstruction (AAO) ii. Complete common atrioventricular canal defect (CAVC) c. Tetralogy of Fallot (TOF) Group: i. Tetralogy of Fallot (TOF) ii. Tetralogy of Fallot with Pulmonary Atresia (TOF,PA) iii. Truncus arteriosus (TA) iv. Double outlet right ventricle (DORV) * Scheduled surgery at or before three months of age. * Parent/guardian capable of providing informed consent. Exclusion Criteria: * Birth weight less than 2.0 kg * Recognizable phenotypic syndrome * Associated extracardiac anomalies of greater than minor severity * Previous cardiac surgery * Associated cardiovascular anomalies requiring aortic arch reconstruction and/or additional open cardiac surgical procedures in infancy * Prior severe hypoxic event * Significant screening test values that place subjects at increased risk of complications from participation in the study **Maximum Age:** 6 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Washington **Country:** United States **Facility:** Children's National Health System **State:** District of Columbia **Zip:** 20010 #### Overall Officials **Official 1:** **Affiliation:** CNMC **Name:** Richard Jonas, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000018376 - Term: Cardiovascular Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M9418 - Name: Heart Defects, Congenital - Relevance: HIGH - As Found: Congenital Heart Disease - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases - ID: D000006330 - Term: Heart Defects, Congenital ### Misc Info Module - Version Holder: 2024-05-24