louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01990326: Safety and Feasibility Study of XAF5 Gel for Reduction of Submental Fat
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of XAF5 Gel for Reduction of Submental Fat
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Excess Submental Fat ("Double Chin")
Lead sponsor: Topokine Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on excess submental fat, also known as double chin. The study will also assess the safety and tolerability of XAF5 Gel.


Eligibility criteria: Inclusion Criteria (paraphrased):

* Adult men and women
* Must understand and provide informed consent
* Moderate submental fat (as determined by the clinician)
* No laxity (looseness) or minimal laxity of submental skin
* Healthy skin upon which a skin reaction would be visible

Exclusion Criteria (paraphrased):

* A clinically significant health problem or recent illness
* A clinically significant abnormal result on physical exam or laboratory tests
* Neck or facial hair that would interfere with applying the study drug to submental skin
* Clinically significant skin disease
* Body Mass Index (BMI) \>= 40
* Plan to begin a diet or weight loss regimen during the study

Primary outcomes:
measure: Frequency of adverse events
timeFrame: From Day 1 to Day 57
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Topokine Therapeutics
name: Michael S Singer, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01150526: Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
Official title: Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Acute Exercise
Muscle Inflammation
CaHMB
HMB Free Acid Gel
Healthy Subjects
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iowa State University
First posted: 2010-06-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as either a single dose before a bout of acute exercise or in multiple doses (one before and three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in free acid gel will result in less muscle damage, diminished inflammatory response, and improved muscle strength recovery than either a placebo or CaHMB treatment following a bout of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and IL-18); and (3) muscle strength recovery and soreness.


Eligibility criteria: Inclusion Criteria:

* Must live within 50 miles of Ames, Iowa
* Free of cardiac, liver, pulmonary, and kidney disease
* Free of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
* Free diabetes mellitus
* Not classified as morbidly obese (BMI must be less than 40)
* Free of cardiac, liver, pulmonary, and kidney disease
* No other serious medical illness
* Normal menstrual cycle and not pregnant or lactating
* Able to consume supplements and perform required exercise testing

Exclusion Criteria:

* Live more than 50 miles from Ames, Iowa
* Presence of cardiac, liver, pulmonary, and kidney disease
* Presence of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
* Diabetes mellitus
* Classified as morbidly obese (BMI is greater than 40)
* No other serious medical illness
* Abnormal menstrual cycle, pregnant or lactating
* Not able to consume supplements and perform required exercise testing

Primary outcomes:
measure: Decrease in muscle damage and inflammation
timeFrame: 4 days post eccentric exercise bout
Secondary outcomes:
measure: Improvement in strength recovery and decrease in soreness
timeFrame: 4 days post eccentric exercise bout
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Metabolic Technologies Inc.
name: John A Rathmacher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487226: Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer
Official title: A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: Cervical cancer
Lead sponsor: Korean Gynecologic Oncology Group
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 69
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose Primary endpoint

* To evaluate the 3-year disease free survival Second endpoints
* To evaluate the 3-year \& 5-year overall survival To analyze the toxicity and the quality of life


Eligibility criteria: Inclusion Criteria:

* cervical cancer stage Ia2-IIa
* histology; squamous, adeno, adenosquamous subtype
* age; 20∼70 years
* performance status; GOG 0∼2
* no medical illness
* hematologic, renal, hepatic function; normal
* grossly no residual disease
* histologically confirmed lymph nodes metastases
* no parametrial extension and negative resection margin
* number of retrieved lymph nodes; ≥ 20

Exclusion Criteria:

* patients with grade 2 peripheral neuropathy
* patients with uncontrolled infection

Primary outcomes:
measure: Kaplan-Meier
Secondary outcomes:
measure: log-rank test Cox regression analysis
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KGOG
Study officials:
affiliation: Kyung-Hee University East-West Med. Center
name: Jong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097626: The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program
Official title: The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To examine whether starting an exercise program with or without education can influence dietary choices in previously sedentary of 20-40 years.

Detailed description: Subjects will complete an InBody test, demographic and physical activity survey, and food-frequency questionnaire via Qualtrics. Also, subjects may participate in a focus group and an individual interview.

A minimum of 150 minutes of moderate exercise required each week and must be spread out in at least 2 days.

Over the course of the study, subjects will complete InBody assessments, Food Frequency Questionnaire (items subjects are eating before, during, and after the investigator's study), and possible focus group questions (open-ended questions about thoughts and perceptions on exercise, nutrition knowledge, and health and nutrition history).

Eligibility criteria: Inclusion Criteria:

* Men and Women between 20 and 50 years.
* Previously sedentary for at least 6 months but have been exercising between one week and three months.
* Must be able to perform moderate intensity exercise at least two days per week in at least 30-minute sessions.

Exclusion Criteria:

* Pregnant women (self-reported).
* Currently injured that would prevent subjects from exercising.

Primary outcomes:
measure: Body Fat Percentage
timeFrame: change between baseline and visit 5 (six weeks after date of enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: JeJe Noval, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02180126: Differing Levels of Positive Anti-Neutrophil Cytoplasm Antibody (ANCA) Test and Their Correlation With Vasculitis or Malignancy or Chronic Inflammation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-07-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with borderline positive ANCA test results who had been hospitalized at the Hillel Yaffe Medical Center.

Brief summary: A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a high probability for vasculitis has high sensitivity and specificity for vasculitis. A positive ANCA test result in those patients who do not have a high probability for vasculitis requires extensive follow-up because those patients eventually present with malignancy or other inflammatory diseases. The investigators wish to investigate the correlation between the differing levels of positive ANCA tests and their relationship to vasculitis, malignancy and inflammatory diseases.


Eligibility criteria: Inclusion Criteria:

* Patients with borderline positive ANCA test results

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Borderline Positive ANCA
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Nina Avshovich, MD
role: STUDY_DIRECTOR
affiliation: Hillel Yaffe Medical Center
name: Tatiana Sivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006526: Coronary Calcification Progression Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-11-28
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigate use of Fast Gated Helical Computed Tomography (FGHCT) measures of coronary artery calcium (CAC), FGHCT-CAC, for discrimination of coronary artery disease (CAD) and to quantify progression of coronary artery calcium over time.

Detailed description: BACKGROUND:

While advances have been made in control of some coronary heart disease (CHD) risk factors, especially smoking and high dietary fat intake, much of the decline in age-adjusted CHD mortality rates has been due to medical treatment and procedural interventions for overt CHD as well as hypertension and hypercholesterolemia. In this context, the availability of an inexpensive, sensitive and specific method for noninvasive detection of both early coronary atherosclerosis and asymptomatic but advanced CHD could allow beneficial treatments to be targeted at many high-risk individuals. The study was designed to determine whether fast-gated helical computed tomography (FGHCT), a more advanced and readily-available variant of a technique (EBCT) that has not achieved its full promise, could play such a role.

DESIGN NARRATIVE:

Dr. Crouse and his colleagues augmented ongoing case-control studies, HL35333, "Carotid Atherosclerosis Progression Study" and HL59503, "Vascular Disease, Structure and Function". HL35333 comprises 280 symptomatic individuals \> 45 years equally divided between men and women, half with and half without angiographically defined coronary artery disease evaluated for risk factors and extracranial carotid intimal-medial thickness (ECIMT, with B-mode ultrasound) at baseline and yearly for three years. The grant has quantified the associations of coronary artery disease and coronary artery disease risk factors for ECIMT and its progression. HL59503 quantifies flow-mediated brachial artery reactivity (FM-BAR) in this cohort. Literature review suggests that while ECIMT predicts coronary artery disease status in clinical samples it does less well in asymptomatic samples; longitudinal data (CLAS study) suggest that progression of ECIMT best predicted incident coronary artery disease, and Electron Beam Computed Tomography (EBCT) quantification of Coronary Artery Calcium (CAC) likely has even greater discriminatory power for coronary artery disease than ECIMT. However, EBCT has limited accessibility.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University
name: John Crouse
References:
Clinical trial NCT02003326: Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)
Official title: Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).

Detailed description: Nowadays ARDS severity, and therapeutic efficiency are evaluated using PaO2/FiO2 ratio. Inflammation is a cornerstone of ARDS and the ratio is not a sufficiently accurate tool to predict the evolution of ARDS. A reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects.

The investigators made the hypothesis that patients moderate to severe ARDS (comparable PaO2/FiO2 ratio) with a higher strain may have higher inflammation.

Moderate/severe ARDS will be ventilate with protective ventilation (low tidal volume and PEEP set to limit plateau pressure under 30cmH2O). Markers of inflammation will be measured in the broncho Alveolar Lavage the first day and in the blood the following days. Strain will be measured at the bedside using the nitrogen washout-washin. Markers of inflammation and strain will be analysed with ventilatory and oxygenation.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe ARDS (Berlin Definition)
* Acute beginning \<1 week
* PaO2/FiO2 ratio ≤ 200 after 24h mechanical ventilation with PEEP≥5cmH2O
* Bilateral opacities on chest X-ray
* Respiratory failure not fully explain by cardiac failure or fluid overload
* Informed consent signed by the next of kin and secondarily by the patient when awake
* Patient with social insurance

No Inclusion criteria

* Age \< 18
* Pregnancy a pregnancy test will be done to women of childbearing age
* Chronic obstructive pulmonary disease
* Severe hypoxemia PaO2/FiO2 \<50% with high PEEP
* Immunosuppressive treatment
* Immunodeficiency onco-hematology, HIV

Primary outcomes:
measure: measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg
timeFrame: until the 13th day
Secondary outcomes:
measure: Mortality at D28
timeFrame: at the 28th day
measure: Ventilatory free days at D28
timeFrame: at the 28th day
Other outcomes:
Locations:
city: Nice
country: France
facility: Réanimation Médicale CHU de Nice - Hôpital de l'Archet
Study officials:
affiliation: CHU de Nice Hôpital de l'Archet
name: Jean DELLAMONICA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05096026: Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients
Official title: Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 8287
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older.

Detailed description: This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older. Patients who had not received a COVID-19 vaccination or appointment after previous outreach attempts were randomized to receive (a) an electronic secure message and/or mail outreach from their PCP, (b) similar outreach with additional culturally tailored content, or (c) usual care. The primary outcome was receipt of COVID-19 vaccination during the 8 weeks after the initial study outreach date.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

Received COVID-19 vaccine prior to Study Outreach 1.

Primary outcomes:
measure: Days to COVID-19 vaccination
timeFrame: During the 8 weeks after Study Outreach 1 was sent
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: The Permanente Medical Group
name: Tracy Lieu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lieu TA, Elkin EP, Escobar PR, Finn L, Klein NP, Durojaiye C, Prausnitz S, Quesenberry CP, Sawyer D, Teran S, Goler N, Parodi SM, Chen YI. Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2217004. doi: 10.1001/jamanetworkopen.2022.17004.
Clinical trial NCT03619226: Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
Official title: Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the evaluation
4. Have an abdominal area accessible for application of test product (assessed by investigator)
5. Negative pregnancy test for fertile women
6. Signed document claiming use of safe contraceptives for fertile women

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
5. Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation

Primary outcomes:
measure: Resistance (Moisture in the adhesive)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of the pre-clinical department
name: Lene F Nielsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142426: A Retrospective Analysis of Laboratory Testing on Chronic Wound Patients
Official title: A Retrospective Analysis of Laboratory Testing on Chronic Wound Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Chronic Draining
Keywords: wound chronic
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic wound patients

Brief summary: The purpose of this study was to pursue statistical analysis on a series of molecular laboratory results obtained from chronic wounds. It elucidated diversity, quantification, and other aspects of microbial diversity in chronic wounds.

Detailed description: The information was processed from culture results that were processed to compile an antibiogram for a laboratory.

Eligibility criteria: Inclusion Criteria:

-Patients with chronic wounds.

Exclusion Criteria:

-Patients without chronic wounds.

Primary outcomes:
measure: Improve selection of systemic antibiotics based on results using molecular diagnostics.
timeFrame: 1 year
Secondary outcomes:
measure: 2. Data Collection: The molecular wound cultures have been performed on thousands of patients from around the country. The information from the culture results that were processed were used to compile an antibiogram for a laboratory.
timeFrame: 1 year
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall D Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dowd SE, Wolcott RD, Kennedy J, Jones C, Cox SB. Molecular diagnostics and personalised medicine in wound care: assessment of outcomes. J Wound Care. 2011 May;20(5):232, 234-9. doi: 10.12968/jowc.2011.20.5.232.