louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00886561: HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
Official title: HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Prevention
HIV Infections
Keywords: HIV prevention, female sex workers
HIV seronegativity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American University of Armenia
First posted: 2009-04-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pilot study will test the efficacy of a behavioral intervention in reducing HIV related risk behaviors among sex workers in Yerevan, Armenia.

Detailed description: The purpose of this pilot study is to evaluate the efficacy of an intervention to reduce sexual risk behaviors and enhance HIV-preventive behaviors among female sex workers (FSWs) in Yerevan, Armenia. The study design is a randomized controlled trial of 120 FSWs aged 18 and over recruited through Hope and Help NGO. Participants will complete an interviewer administered questionnaire collected at baseline, 3- and 6-month follow-up.

Subsequently, participants will be randomly assigned to either the intervention condition or a wait-list control. Those randomized to the intervention condition will receive a 2-hour one-on-one intervention session emphasizing HIV knowledge, self-efficacy, and condom use behaviors. They will also receive a 10-15 minute booster session at 3-month follow-up. The comparison condition is wait-listed, but have the choice of participating in the intervention program upon completion of the study.

The main outcome measure includes consistent condom use, defined as condom use during every episode of vaginal intercourse with clients. Other outcome measures are condom application by FSW and HIV- preventive behaviors such as condom use self-efficacy, knowledge of HIV transmission dynamics,perceived barriers to condom use and condom use errors.

Results from this pilot study are expected to inform a larger trial to be implemented with FSWs in Armenia, in an effort to devise gender and culturally relevant intervention programs to prevent HIV transmission in this vulnerable population.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* traded sex for money in the past 7 days
* cognitive ability to participate in assessment and intervention

Exclusion Criteria:

* younger than 18 years of age
* did not trade sex for money in the past 7 days
* cognitively unable to participate in assessment and intervention

Primary outcomes:
measure: Consistent condom use
timeFrame: 3 and 6 months post intervention
Secondary outcomes:
measure: Condom application
timeFrame: 3 and 6 months post intervention
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Hope and Help NGO
Study officials:
affiliation: Emory University
name: Ralph J DiClemente, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00392561: Bangladesh Vitamin E and Selenium Trial
Official title: Bangladesh Vitamin E and Selenium Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-melanoma Skin Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Dartmouth-Hitchcock Medical Center
name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2006-10-26
Enrollment: 7000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers.


Eligibility criteria: Inclusion Criteria:

* Manifest arsenic skin lesions (melanosis, leucomelanosis, or keratosis)
* Aged 25 to 65 years
* Permanent resident of study area

Exclusion Criteria:

* Pregnancy
* Clinically too ill (enlarged spleen or liver)
* Presence of gangrene
* Cancer

Primary outcomes:
measure: Skin Cancer
timeFrame: Incidence during the 6-year study period
Secondary outcomes:
measure: Mortality
timeFrame: Occurrence during the 6-year study period
measure: Diabetes
timeFrame: Incidence within 6-year study period
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Columbia University Arsenic Research Project
city: Dhaka
country: Bangladesh
facility: ICDDR,B
Study officials:
affiliation: University of Chicago
name: Habibul Ahsan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03403361: Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy
Official title: A Virtual Clinical Trial to Assess the Impact of Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Brain Cancer
Head and Neck Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-01-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this protocol is to refine the accuracy of proton beam therapy (PT) by the use of dual energy computed tomography (DECT), in conjunction with novel iterative image reconstruction algorithms, to more precisely determine the tissue properties through which the proton beam path travels.


Eligibility criteria: Eligibility Criteria:

Inclusion Criteria:

* Diagnosis of histologically proven primary or metastatic cancer requiring thoracic radiation therapy OR radiation therapy to the head and neck or brain
* At least 18 years of age.
* Planning to undergo proton or photon beam radiation therapy as part of the clinical management of the diagnosed cancer.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Implanted metallic objects in the region to be scanned excepting dental prostheses
* IV or oral contrast medium within 24 hours prior to DECT image acqusition
* Pregnant.

Primary outcomes:
measure: Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Clifford Robinson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06870461: Hepatic Excision and Ablation Log
Official title: Hepatic Excision and Ablation Log
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malignant Liver Tumor
Benign Liver Tumor
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who will undergo liver surgery or ablation.

Brief summary: This study aims to establish a registry for liver surgery and ablation procedures to improve patient care, advance research, and enhance surgical quality. The registry will collect pseudonymized data on patient demographics, disease characteristics, procedural details, and outcomes.

Detailed description: The purpose of this registry is to create a comprehensive list of individuals who have undergone liver surgery or liver ablation, allowing researchers and clinicians to assess their data in future studies if they meet the eligibility criteria. All patients who have received liver surgery or liver ablation procedures at our institution will be included in this registry.

Information collected as part of the registry will be used solely to assess potential participants' eligibility for research studies, allowing for the evaluation of long-term outcomes, identification of risk factors, and investigation of therapeutic interventions. This data will help to enhance the understanding of the patient population undergoing liver surgery and improve clinical practices.

A patient registry is an organized system that uses observational study methods to collect standardized clinical data and other relevant information. It aims to evaluate specific outcomes for individuals who have undergone liver surgery or ablation, serving scientific, clinical, and policy-related purposes. The registry will support the development of targeted research studies and provide valuable insights into the treatment and management of liver diseases.

Eligibility criteria: Inclusion Criteria:

* Both benign and malignant liver lesions are included

Exclusion Criteria:

- Intervention performed solely for liver biopsy, without any subsequent surgical resection or ablation.

Primary outcomes:
measure: Establishment of a Liver Surgery and Ablation Registry
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Antwerp
name: Thiery Chapelle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05856461: Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
Official title: Pulmonary Artery Denervation+ Atrial Fibrillation Ablation vs Atrial Fibrillation Ablation Only in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Pulmonary Hypertension
Keywords: Atrial fibrillation
Pulmonary Hypertension
Remote magnetic navigation
Catheter ablation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2023-05-12
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parellel groups
Primary purpose: TREATMENT

Brief summary: The goal of the study is to compare efficacy and safety of the pulmonary artery denervation procedure combined with atrial fibrillation ablation versus atrial fibrillation ablation alone in patients with paroxysmal and persistent atrial fibrillation and group 2 of the pulmonary hypertension


Eligibility criteria: Inclusion Criteria:

* Mean pulmonary artery pressure \> 25 mm Hg and pulmonary artery wedge pressure \> 15 mm Hg by right heart catheterization
* Paroxysmal or persistent atrial fibrillation
* NYHA II-III
* BNP \> 105 pg/ml
* Indications for catheter ablation of atrial fibrillation according guidelines
* LVEF \> 50%

Exclusion Criteria:

* Group 1,3,4 of the pulmonary hypertension
* Left atrium diameter \> 6 cm
* Planned open heart surgery procedure
* Previous heart valve surgery
* Severe aortic, pulmonary, tricuspid or mitral, valves regurgitation
* Thrombus in the left heart chambers

Primary outcomes:
measure: Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
timeFrame: 12 months
Secondary outcomes:
measure: Perioperative complications
timeFrame: 30 days
measure: Clinical adverse events
timeFrame: 12 months
measure: Number of hospitalizations
timeFrame: 12 months
measure: Mean pulmonary artery pressure
timeFrame: 12 months
measure: Pulmonary vascular resistance
timeFrame: 12 months
measure: Pulmonary wedge pressure
timeFrame: 12 months
measure: Systolic pulmonary artery pressure
timeFrame: 12 months
measure: 6-minutes walking distance
timeFrame: 12 months
measure: Atrial fibrillation burden
timeFrame: 12 months
measure: Brain natriuretic peptide
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: E. Meshalkin National Medical Research Center
Study officials:
affiliation: E. Meshalkin National Medical Research Center
name: Alexander B Romanov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01042561: Vitamin D Status and Dose Response in Infants
Official title: Vitamin D Status and Dose Response in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D
Prematurity
Keywords: vitamin d
prematurity
25(OH)D
infant
CRP
PTH
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Creighton University Medical Center
First posted: 2010-01-05
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.

Detailed description: It is hypothesized that serum 25(OH)D levels in infants 32 weeks and greater gestation are not maintained at optimal levels of greater than 32 ng/Ml with currently available infant formulas, and that this will have an inverse relationship with markers of inflammation and bone metabolism.

Eligibility criteria: Inclusion Criteria:

* greater than 32 weeks gestation,
* exclusively formula fed.

Exclusion Criteria:

* less than 32 weeks gestation,
* less than 1500 grams,
* recieving maternal breast milk,
* recieving parenteral nutrition,
* congenital anomolies,
* disorders of vitamin D metabolism,
* inborn errors of metabolism,
* seizure disorders,
* parathroid disease,
* liver, GI tract, or kidney disease, and
* disorders of calcium metabolism.

Primary outcomes:
measure: Serum 25-Hydroxyvitamin D [25(OH)D] Levels
timeFrame: 30 days
Secondary outcomes:
measure: Serum C-reactive protein (CRP)
timeFrame: 30 days
measure: Serum intact parathyroid hormone (iPTH)
timeFrame: 30 days
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Corrine Hanson, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Clinical trial NCT03824561: Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
Official title: Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2019-01-31
Enrollment: 1096
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UC patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care

Brief summary: The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.

Detailed description: The drug being tested in this survey is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC.

This survey is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 1,000.

This multi-center observational trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

1. Have moderate or severe active UC
2. Have inadequate response to existing therapies

Exclusion Criteria:

Patients with any contraindication for vedolizumab

Primary outcomes:
measure: Number of Participants who have One or More Adverse Events
timeFrame: Up to Week 54
measure: Number of Participants who have One or More Adverse Drug Reactions
timeFrame: Up to Week 54
Secondary outcomes:
measure: Number of Participants who have a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
timeFrame: After 3 doses of vedolizumab (Week 6 to 14)
measure: Number of Participants who continue the Therapy After 3 Doses of Vedolizumab
timeFrame: After 3 doses of vedolizumab (Week 6 to 14)
measure: Change from Baseline in Complete Mayo Scores
timeFrame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54
measure: Change from Baseline in Partial Mayo Scores
timeFrame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54
measure: Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
timeFrame: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54
measure: Change from Baseline in Fecal Calprotectin
timeFrame: Baseline and multiple time points up to Week 54
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03833011: Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery
Official title: Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Bariatric Surgery Candidate
Lead sponsor: MediSys Health Network
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Context Pain control is one of the most challenging problems encountered in postoperative period in bariatric patients. Currently there are no published studies evaluating Osteopathic Manipulative Treatment in bariatric surgery patients.

Objective The primary objective of this study is to determine whether Osteopathic Manipulative Treatment (OMT) can decrease pain score in bariatric patients. The secondary objective is whether OMT can improve patient satisfaction with overall treatment.

Design: A prospective randomized group controlled study.

Setting: A 293-bed non-for-profit teaching community hospital.

Methods Thirty-six patients scheduled for bariatric surgery as per ASMBS criteria were eligible for study from January 2017 through August 2018 at Flushing Hospital Medical Center, New York. Twelve patients were excluded.

Twenty-four patients were included into study and randomized to receive OMT(n=12) vs Control (n=12) intervention.

In Control group, patients received standard pain control protocol with morphine patient controlled analgesia pump (PCA) In OMT group, patients received standard postoperative pain protocol and OMT on postoperative day one. Three techniques were used (Sub-occipital Release, Thoracic Outlet Release, and Rib Raising). All patients received survey to complete prior to discharge measuring pain score (1-10), patient satisfaction score 1-4 (poor, fair, good, excellent) and data was analyzed.


Eligibility criteria: Inclusion criteria:

* Adults age 18 and older eligible for bariatric surgery as per American Society for Metabolic and Bariatric Surgery guidelines:
* BMI of at least 40, or greater than 100 pounds overweight.
* BMI of 35 or above and at least one or more obesity-related comorbidity such as type II diabetes, hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, lipid abnormalities, gastrointestinal disorders, heart disease, or osteoarthritis.
* Inability to achieve a healthy weight loss sustained for a period of time with prior weight loss efforts.

Exclusion criteria:

* Age less than 18.
* Pregnant patients.
* Patients with history of chronic pain.
* Patients with diagnosed psychiatric disorders.
* Patients actively taking pain medication before surgery.
* Patients with prior surgical history

Primary outcomes:
measure: Change in pain score
timeFrame: pre-intervention, post-op day 1, post-op day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Flushing
country: United States
facility: Flushing Hospital
state: New York
Study officials:
References:
Clinical trial NCT06313411: How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma
Official title: How do I Perform a Laparoscopic Removal of a Pelvic Retroperitoneal Schwannoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis Pelvic
Keywords: Endometriosis Pelvic
Schwannomas
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Adult patient (≥18 years old) having received treatment at the Strasbourg University Hospital during 2021 for a retro-peritoneal pelvic carcinoma

Brief summary: Schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. Retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. The malignant retroperitoneal form is, however, more common than in other locations.

Retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. Abdominopelvic CT and magnetic resonance imaging are essential to characterize the mass and verify its extension. The precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment.

Acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.


Eligibility criteria: Inclusion Criteria:

* Adult patient (≥18 years old)
* suffering from symptomatic deep pelvic endometriosis
* having received treatment at the Strasbourg University Hospital during 2021 for a retro-peritoneal pelvic carcinoma
* having not expressed, after information, the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Patient who expressed her opposition to participating in the study

Primary outcomes:
measure: laparoscopic removal of a retroperitoneal pelvic schwannoma
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Study officials:
References: