louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04070729: Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy
Official title: Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CHRONIC PERIODONTITIS
Lead sponsor: Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid.

120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.

Detailed description: The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.

Eligibility criteria: Inclusion Criteria:

* Patients are in general good health.
* Patients having minimum of 20 permanent teeth.
* They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
* Presence of periodontal pockets (≥5 mm) and clinicala ttachment level \> 5 mm.

Exclusion Criteria:

* Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)
* Clotting and Hematological disorders
* Patients with grade III mobility.
* Patients with smoking and alcohol consuming habit.
* Pregnant and lactating female.
* Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use)
* The teeth with poor filling and ill fitted restorations

Primary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: 3 Months
Secondary outcomes:
measure: Probing pocket depth
timeFrame: 3 Months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05057429: A Bioelectric Dressing for Post De-Roofing Treatment of HS
Official title: A Bioelectric Dressing for Post De-Roofing Treatment of Hidradenitis Suppurativa (HS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Vomaris Innovations
First posted: 2021-09-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to test if the use of a bioelectric dressing can improve healing after a surgical procedure called de-roofing.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years old and older.
* Have diagnosis of HS confirmed by a dermatologist
* Have at least two ancillary tunnels in separate anatomical sites
* Able to provide informed consent

Exclusion Criteria:

* Individuals who are not yet adults
* Subject is allergic to any of the materials and dressings involved in the procedures
* Women known to be pregnant
* Prisoners
* Subjects, who in the opinion of the PI, cannot comply with hope application of the treatment

Primary outcomes:
measure: Healing Rate
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Average time to complete healing
timeFrame: Up to 8 weeks
measure: Number of subjects with complete healing
timeFrame: Up to 8 weeks
measure: Number of subjects with nodule and/or tunnel recurrence
timeFrame: Up to 8 weeks
measure: Average pain as assessed by the Numerical Rating Scale (NRS)
timeFrame: Up to 8 weeks
measure: Number of subjects with tenderness at surgical sites
timeFrame: Up to 8 weeks
measure: Quality of post-surgical scars as measured by the Hurley Stage score
timeFrame: Up to 8 weeks
measure: Amount of exudate at surgical site
timeFrame: Up to 8 weeks
measure: Shoulder range of motion
timeFrame: Up to 8 weeks
measure: Number of dressings used through to healing day
timeFrame: Up to 8 weeks
measure: Pain after procedure as assessed by the NRS
timeFrame: Day 2 (24 hours post procedure)
measure: Days of work lost
timeFrame: Up to 8 weeks
measure: Change in Quality of Life as measured by the DLQI
timeFrame: Baseline, Up to 8 weeks
measure: Tissue analysis of microbiome
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00993629: Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
Official title: Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Post-traumatic Stress Disorder
Major Depressive Disorder
Keywords: PTSD
Depression
Neurosteroids
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.

Detailed description: PTSD and depression are critical areas of immediate impact to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veterans. Current treatments for PTSD (which frequently co-occurs with depression) remain limited, with many patients remaining symptomatic despite single or combination administration of SSRIs, mood stabilizers, antipsychotics and sedatives/hypnotics. In addition, many patients treated for depression remain symptomatic. New interventions are thus urgently needed in PTSD with co-occurring depression to ensure optimal functional outcomes for our Service members and their families.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PTSD,
* diagnosis of MDD,
* age 18-55,
* no change in psychotropic medication for \>=4 weeks,
* no anticipated need to to alter psychotropic medication for duration of study

Exclusion Criteria:

* Unstable medical/neurological illness,
* diagnosis of bipolar disorder, schizophrenia or other psychotic disorder,
* cognitive disorder,
* substance dependence,
* positive urine drug screen at screening,
* use of hormonal supplementation,
* pregnancy/lactation,
* female patients who are sexually active and not using acceptable non-hormonal birth control,
* initiation/change of psychotherapy within 3 months of randomization,
* recent/current electroconvulsive therapy,
* regular use of opiates/barbiturates/benzodiazepines

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: VA Medical Center, Durham
state: North Carolina
Study officials:
affiliation: VA Medical Center, Durham
name: Victoria M Payne, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05565729: A Phase I Study of LY3471851 in Healthy Participants
Official title: A Phase 1, Randomized, Placebo-controlled, Participant- and Investigator-blind, Single-dose Study of the Pharmacokinetics of LY3471851 Following Subcutaneous Dosing of LY3471851 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Interleukin-2
NKTR-358
Pharmacokinetics
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2022-10-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare two different formulations (test \& reference) of LY3471851 in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving the study drug that is LY3471851.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical history and physical examination
* Have body weight greater than 45 kilograms (kg) and body mass index within the range 18.0 to 32.0 kilograms per square meter (kg/m²)
* Male and female participants must agree to adhere to contraceptive requirements

Exclusion Criteria:

* Have an abnormality in the 12-lead electrocardiogram (ECG), vital signs, or both
* Have had symptomatic herpes zoster within 3 months prior to screening
* Have a known allergy or hypersensitivity to levocetirizine
* Intend to use prescription or nonprescription medication within 14 days or 5 half-lives prior to dosing
* Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
* Smoke more than 10 cigarettes or other tobacco products per day before study entry
* Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851
timeFrame: Predose up to 56 days postdose
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851
timeFrame: Predose up to 56 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas
state: Texas
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06837129: Intravenous Nalbuphine for Prevention of Intrathecal Morphine-induced Nausea and Vomiting in Patients Undergoing Cesarean Section: A Double-blind, Randomized Controlled Trial.
Official title: Intravenous Nalbuphine for Prevention of Intrathecal Morphine-induced Nausea and Vomiting in Patients Undergoing Cesarean Section: A Double-blind, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intrathecal Morphine
Caesarean Section
Postoperative Nausea and Vomiting
Neuraxial Opioid
Keywords: Postoperative Nausea and Vomiting
intrathecal morphine
caesarean section
neuraxial opioid
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We study efficacy of iv nalbuphine in prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section.

Detailed description: IV nalbuphine has been proved to help prevent intrathecal morphine-induced pruritus in some studies but results in nausea vomiting prevention have not been well studied. In Thailand, most caesarean section is done under spinal anesthesia with intrathecal morphine, proving that iv nalbuphine is effective would be beneficial for our population. This study aims to see whether 4 mg of nalbuphine is effective in reducing incidence of intrathecal morphine-related nausea vomiting in parturient who underwent C-section under spinal anesthesia with 0.2 mg of intrathecal morphine.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean section under spinal anesthesia
* age \> 18 years

Exclusion Criteria:

* Patients with known allergy to medications used in this study (nalbuphine, bupivacaine or morphine)
* Patient with medical conditions which spinal anesthesia is contraindicated ie. heart diseases, renal or hepatic impairment, obesity \>=100 kilograms
* Patients with history of postoperative nausea and vomiting (PONV) or motion sickness who may have preexisting risk factors for PONV
* Patient with known history of drug abuse
* Unwilling to participate in the study

Primary outcomes:
measure: Incidence of postoperative nausea vomiting in 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Severity of nausea vomiting
timeFrame: 24 hours
measure: Postoperative pain score
timeFrame: 24 hours
measure: Incidence of pruritus
timeFrame: 24 hours
Other outcomes:
Locations:
city: Pathum Thani
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Thammasat University
city: Pathum Thani
country: Thailand
facility: Faculty of Medicine Thammasat University
Study officials:
affiliation: Thammasat University
name: Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06642129: A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Communicating Hydrocephalus Undergoing Lumboperitoneal Shunt Surgery
Official title: A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Traffic Hydrocephalus Undergoing Lumbopeitoneal Shunt Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydrocephalus, Communicating
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age and older who require surgical treatment with lumboperitoneal shunt for communicating hydrocephalus

Brief summary: Target population: patients 18 years of age or older who require surgical treatment with lumboperitoneal shunt surgery for traffic hydrocephalus Estimated sample size: 30 cases. Study design: this study is a multicenter prospective observational study, with lumbar puncture pressure measurement before and during surgery, and shunt valve setting pressure set according to the requirements of clinical practice in the hospital where it is performed, and the collection of relevant data, including preoperative lumbar puncture pressure, intraoperative lumbar puncture pressure after anesthesia, shunt valve initial pressure, shunt valve pressure at 6 months pressure, length of the intravertebral shunt, and length of the intraperitoneal shunt. Complications, shunt effects, and the number of shunt valve adjustments during the 6-month period were also observed and recorded.


Eligibility criteria: Inclusion Criteria:

1. Age of 18 years or older;
2. Confirmed diagnosis of communicating hydrocephalus;
3. Signed informed consent for surgery and informed consent for research.

Exclusion Criteria:

1. Pregnant women;
2. Inappropriate for lumboperitoneal shunt surgery despite the diagnosis of communicating hydrocephalus.

Primary outcomes:
measure: primary outcome
timeFrame: preoperation to 6 months after surgery
Secondary outcomes:
measure: secondary outcome
timeFrame: preoperation to 6 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
Clinical trial NCT00764829: Blood Samples to Evaluate Biomarkers of Donor Chimerism
Official title: Blood Samples to Evaluate Biomarkers of Donor Chimerism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Hodgkins Disease
Non-hodgkins Lymphoma
Myelodysplastic Syndrome
Keywords: hematopoietic stem cell transplantation
fludarabine
mycophenolate mofetil
mycophenolic acid
biomarkers
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-10-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematopoietic stem cell transplant patients receiving fludarabine and mycophenolate mofetil.

Brief summary: We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with a hematologic disease or malignancy
* Scheduled to receive nonablative conditioning with fludarabine and total body irradiation
* Donor is well-matched by high resolution DNA techniques.
* Scheduled to receive postgrafting immunosuppression of oral MMF (CellCept) and an oral calcineurin inhibitor.
* Age \>18 years at the time of enrollment.

Exclusion criteria:

-Diagnosed with an immunodeficiency disorder

Primary outcomes:
measure: Donor T-cell chimerism
timeFrame: Day 28 post-transplant
Secondary outcomes:
measure: Exposure to fludarabine and mycophenolate mofetil and their breakdown products.
timeFrame: Before and after transplant
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Jeannine S McCune, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02209129: Digital 3D Breast Tomosynthesis Versus 2D in Clinical Evaluation of High Risk Women
Official title: 3D Digital Breast Tumorsynthesis Versus 2D Digital Mammography in the Clinical Evaluation of Women at High Risk for Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: digital breast tomosynthesis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with an increased risk for breast cancer \> 17% according to the IBIS calculation, and also defined by the Multidisciplinary Breast centre UZ Leuven, Belgium

Brief summary: Patients with a higher breast cancer risk (higher than 17% according to the IBIS calculation) will receive a 2D digital mammography together with a 3D tomosynthesis (so called combo tomo) of both breasts in two views in order to investigate the additional value of tomosynthesis in the diagnosis of breast cancer.


Eligibility criteria: Inclusion Criteria:

* women
* more than 17% risk for breast cancer (IBIS calculation)
* \> 40y old

Exclusion Criteria:

* \< 40y old

Primary outcomes:
measure: Tumor dectection rate
timeFrame: 2 years
Secondary outcomes:
measure: Falls negative, Falls positive results, accuracy
timeFrame: 4 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Chantal Van Ongeval, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398229: hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle
Official title: The Benefit of Human Chorionic Gonadotropin (hCG) Supplementation Throughout the Secretory Phase of Frozen-Thawed Embryo Transfer Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fertility Agents, Female
Keywords: In-Vitro Fertilization
human chorionic gonadotropin
frozen-thawed embryo transfer
implantation rate
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-11-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the receptivity of the endometrium and the embryo quality.The effects of human chorionic gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was shown to up-regulate gene expression during the differentiation of human endometrial stromal cells into decidua. The aim of our study was to assess the benefit of hCG supplementation throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.


Eligibility criteria: Inclusion Criteria:

* all women on frozen-thawed embryo-transfer cycle

Exclusion Criteria:

* any allergy to injection of human chorionic gonadotropin before

Primary outcomes:
measure: implantation rate
timeFrame: 4 weeks
measure: pregnancy rate
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical center
Study officials:
affiliation: Hadassah Medical Organization
name: Assaf Ben-Meir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00585429: Evaluation of Kidney Disease in Liver Transplant Recipients
Official title: Kidney Disease in Advanced Liver Disease Patients: A Study of Kidney Damage by a Urinary Cytokine/Chemokine Multiplex Assay
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Kidney Disease
Liver Transplantation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects on the liver transplant wait list, subjects who have received a liver transplant at least 6 months prior to enrollment, or subjects who have normal liver function and are about to undergo kidney biospy for diagnostic purposes.

Brief summary: A non-invasive urinary test that detects kidney injuries in liver transplant (LT) candidates would be useful for monitoring of kidney damage. Particularly, the ability to predict irreversibility of such renal damage or progressive nature of renal disease in LT candidates would be of importance to determine the need for dual kidney-liver transplantation (KLT) versus LT alone. We will correlate kidney histology with cytokine/chemokine profile expression in the urine as a potentially useful noninvasive diagnostic tool.


Eligibility criteria: Inclusion Criteria:

* Subjects on the liver transplant wait list, subjects who have received a liver transplant at least 6 months prior to enrollment, or subjects who have normal liver function and are about to undergo kidney biospy for diagnostic purposes.

Exclusion Criteria:

* Contraindication to kidney biopsy
* Inability to give informed consent

Primary outcomes:
measure: To determine the value of urinary levels of chemokines in the distinction between types of kidney disease in the setting of liver failure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References: