louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02006017: Do Clinicians Want Recommendations?
Official title: Do Clinicians Want Recommendations? A Randomized Trial Comparing Evidence Summaries With and Without Evidence Based Recommendations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Individuals (Clinicians)
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 467
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The use of the best evidence available for decision-making is nowadays an undisputed goal in health care. However, this is not always achieved in the context of clinical practice. Two of the potential solutions to bridge the gap between evidence and the clinical practice are the "evidence summaries" and the "evidence based recommendations". However, it is not clear, and frequently controversial, to what extent clinicians consider helpful recommendations accompanying evidence summaries. The investigators will explore this question by conducting a study where clinicians will be randomized to receive a clinical scenario accompanied by an evidence summary plus a recommendation and a second clinical scenario accompanied by only for an evidence summary (group A) or vice versa (Group B). The outcome will be clinicians' preferences.


Eligibility criteria: Inclusion Criteria:

* Were trained as Medical Doctors
* Practice primary care or general internal medicine.

Exclusion Criteria: none

Primary outcomes:
measure: Preferences
timeFrame: Immediately after the intervention (Survey)
Secondary outcomes:
measure: Understanding
timeFrame: Immediately after the intervention (Survey)
measure: Interpretation of benefits and harms
timeFrame: Immediately after the intervention (Survey)
measure: Intended course of action
timeFrame: Immediately after the intervention (Survey)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Holger Schunemann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neumann I, Alonso-Coello P, Vandvik PO, Agoritsas T, Mas G, Akl EA, Brignardello-Petersen R, Emparanza J, McCullagh L, De Sitio C, McGinn T, Almodaimegh H, Almodaimegh K, Rivera S, Rojas L, Stirnemann J, Irani J, Hlais S, Mustafa R, Bdair F, Aly A, Kristiansen A, Izcovich A, Ramirez A, Brozek J, Guyatt G, Schunemann HJ. Do clinicians want recommendations? A multicenter study comparing evidence summaries with and without GRADE recommendations. J Clin Epidemiol. 2018 Jul;99:33-40. doi: 10.1016/j.jclinepi.2018.02.026. Epub 2018 Mar 9.
Clinical trial NCT02263417: A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia
Official title: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dystonia
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
First posted: 2014-10-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.

Detailed description: In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.

Eligibility criteria: Inclusion Criteria:

1. Subject is aged 18 to 75 years old, male or female.
2. Diagnosed with cervical dystonia by a movement disorders neurologist.
3. Has cervical dystonia alone, not generalized or multifocal.
4. Has had adequate trials of medical therapy.

Exclusion Criteria:

1. Cognitive impairment.
2. Abnormalities on pre-operative magnetic resonance imaging (MRI).
3. Medical conditions precluding general anaesthetic or surgery.
4. Unstable psychiatric disease.
5. Previous brain lesions to treat cervical dystonia.
6. Attended some other trials within three month.

Primary outcomes:
measure: Burke-Fahn-Marsden Scale (BFM)
timeFrame: Change from baseline in BMF at 1, 3 months and 6 months
Secondary outcomes:
measure: Quality of life (SF-36)
timeFrame: Change from baseline in SF-36 at 1, 3 months and 6 months
measure: Psychiatric assessment (HADS-D and PANSS)
timeFrame: Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Beijing
Study officials:
affiliation: Tsinghua University
name: Li Luming, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03234517: Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis
Official title: Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bacterial Vaginosis Treatment
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2017-07-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

Detailed description: Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.

Eligibility criteria: Inclusion Criteria:

* more than 18 years
* has recurrent Bacterial Vaginosis

Exclusion Criteria:

* pregnancy
* use of other antmicrobial
* not provide informed consent

Primary outcomes:
measure: initial cure rate
timeFrame: 2 months
Secondary outcomes:
measure: recurrence rate
timeFrame: 4,6,8and12 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
name: Ibrahim A EL sharkwy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04811417: Frailty Assessment Among Kidney Transplant Candidates
Official title: Frailty Assessment Among Kidney Transplant Candidates on the Waiting List
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Kidney Transplant; Complications
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 500
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: KT candidates (\>18 years-old) accepted for the KT waiting list and willing to participate

Brief summary: Frailty is common among chronic kidney disease patients who are on the kidney transplant (KT) waiting list.

The aim of this study is to assess frailty according to different frailty tools among KT candidates and to establish potential biomarkers of frailty.

Detailed description: This is an observational study where KT candidates will be assessed for frailty according to:

* Frailty Fried Phenotype and
* FRAIL scale

Sociodemographics and clinical variables will be collected and serum samples will be obtained in order to implement further studies regarding biomarkers of frailty..

Eligibility criteria: Inclusion Criteria:

* KT candidates accepted for the KT waiting list

Exclusion Criteria:

* No willing for participating
* Difficulty in understanding Spanish or English

Primary outcomes:
measure: Prevalence of frailty among KT candidates
timeFrame: 2015-2020
measure: Biomarkers of frailty among KT candidates
timeFrame: 2015-2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01077817: Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)
Official title: The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Squamous Cell Carcinoma
Adenocarcinoma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: World Health Information Science Consultants, LLC
First posted: 2010-03-01
Enrollment: 684815
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who have at least two years of experience in the GPRD and are 55 or older between 1996 and 2008; all cases of esophageal cancer were identified and matched to all women in the comparison sample (all women with same year of birth drawn from the random subsample of 25,000).

Brief summary: This is a 2-phase retrospective database study, using both case-cohort and inception (intention-to-treat) cohort analyses to evaluate any association between oral treatments for osteoporosis and the risk of esophageal cancer in women.


Eligibility criteria: Inclusion Criteria:

* Cases:

  * Women in the database aged 55 or older between 1996 and 2008 with diagnosis of esophageal cancer
* Comparator Controls:

  * Each case was matched to all women in the random subcohort of 25,000 who had the same year of birth as the case and were in the database at the time of diagnosis.

Exclusion Criteria:

* Women with diagnosis of any other cancer or Paget's Disease or who have received oral or intravenous steroids before the index date

Primary outcomes:
measure: Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)
timeFrame: Exposure to study drug at least 720 days before disease onset
measure: Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)
timeFrame: Up to approximately 7.3 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: World Health Information Science Consultants, LLC
name: Alec Walker, MD, DrPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT00166517: V260 Registration Study (V260-013)(COMPLETED)
Official title: Immunogenicity and Safety of V260 in Healthy Infants in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus
Keywords: Gastrointestinal Rotavirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 178
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Immunogenicity and Safety of V260 in Healthy Infants in Korea


Eligibility criteria: Inclusion Criteria:

* At first study vaccination, age 6 weeks through exactly 12 weeks

Exclusion Criteria:

* History of congenital abdominal disorders, intussusception, or abdominal surgery
* History of known prior rotavirus disease
* Ongoing chronic diarrhea or failure to thrive
* Clinical evidence of active gastrointestinal illness

Primary outcomes:
measure: Serum Anti-Rotavirus IgA Response
timeFrame: Baseline and 14 days Postdose 3
Secondary outcomes:
measure: Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
timeFrame: Baseline and 14 days Postdose 3
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kim DS, Lee TJ, Kang JH, Kim JH, Lee JH, Ma SH, Kim SY, Kim HM, Shin SM. Immunogenicity and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy infants in Korea. Pediatr Infect Dis J. 2008 Feb;27(2):177-8. doi: 10.1097/INF.0b013e31815aba79.
Clinical trial NCT03464617: Doppler Flow Classification of Saint-Bonnet
Official title: Doppler Flow Classification of Saint-Bonnet : A Non Interventional Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 1000
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: Patients addressed in a vascular center for vascular ultrasound

Brief summary: Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease

Detailed description: Patients who have Doppler ultrasound scanning in clinical practice currently have a systematic record of Doppler flow on arterial axes of the aorta and right and left lower limbs. The investigators will analyze a posteriori Doppler flow of patients by classifying them using the 3 classifications. The patient will have no constraints related to this study since the recordings are currently performed in clinical routine.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years;
* Social insured
* Patients referred in the department for any arterial examination of the lower limbs.

Exclusion Criteria:

- Patient unfit to understand the instructions of the study

Primary outcomes:
measure: Doppler flows
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU de Caen
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: CHU de Limoges
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: CHU de Toulouse
city: Vichy
country: France
facility: CH de Vichy
Study officials:
References:
Clinical trial NCT00683917: Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Official title: A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Detailed description: The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Eligibility criteria: Inclusion Criteria:

* Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
* Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
* Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
* Regular or steady menstrual cycle lasting from 24 to 36 days
* Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
* Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug

Exclusion Criteria:

* Documented endometriosis or active pelvic inflammatory disease
* History of alcohol and/or drug abuse
* Any history or diagnosis of gynecological cancer or cervical dysplasia
* Use of an IUD
* Use of prohibited concomitant medications:

  * Use of Depo-Provera must cease 10 months prior to first dose of study drug
  * Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
* Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia

Primary outcomes:
measure: The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Physician Care Clinical Research
state: Florida
city: Houston
country: United States
facility: Advances in Health, Inc.
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Services
state: Texas
city: Mexico City
country: Mexico
facility: Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)
state: Federal District
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre vanAs, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05295017: LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)
Official title: LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Keywords: liquid biopsy
multi-cancer early detection
glycosaminoglycans
Lead sponsor: Elypta
Sponsor class: INDUSTRY
First posted: 2022-03-24
Enrollment: 1235
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults between 55 and 80 years old with significant smoking history ("high-risk adults").

Brief summary: LEVANTIS-0093A (LEV93A) is a prospective cohort observational clinical study to validate the plasma free GAGome MCED test in adults at high risk of developing cancer ("high-risk adults"), specifically in 55-80-year-old adults with significant smoking history.

LEV93A will use plasma biospecimens collected within the Yorkshire Lung Screening Trial Biomarker sub-study and corresponding participant data prospectively collected within the Yorkshire Lung Screening Trial (YLST) and the Yorkshire Kidney Screening Trial (YKST) all of which are sponsored by the University of Leeds and funded by Yorkshire Cancer Research (Award references: L403, L403B L403C), in collaboration with the University of Leeds, with the University of Manchester and with the Leeds Teaching Hospitals.


Eligibility criteria: Inclusion Criteria

* Adults aged 55-80 years old
* Significant smoking history, defined as current or ex-smokers and any of the following criteria:

  * 30 pack year history of smoking and current smoker or quit within the last 15 years (USPSTF criteria).
  * Lung cancer risk of ≥1.51% over 6 years as calculated by the PLCOM2012 score
  * Lung cancer risk of ≥5% over 5 years as calculated by the LLPv2. Score
* Consenting to participate to both YLST and YLST Biomarker trials
* Able to donate a blood sample

Exclusion Criteria

* Deemed medically unfit for sample collection
* Contraindication for study procedures or sampling
* Not consenting to participate to YKST trial

Primary outcomes:
measure: Sensitivity and specificity of the plasma free GAGome MCED test
timeFrame: Within 365 days after the biosampling visit
Secondary outcomes:
measure: Accuracy to the "putative cancer location" (PCL) model among cases (confirmed cancer diagnosis)
timeFrame: Within 365 days after the biosampling visit
measure: Sensitivity and specificity of the plasma free GAGome MCED test followed by low-dose computed tomography (LDCT)
timeFrame: Within 365 days after the biosampling visit
measure: Sensitivity and specificity of LDCT followed by plasma free GAGome MCED test
timeFrame: Within 365 days after the biosampling visit
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leads Teaching Hospitals Trust
Study officials:
affiliation: Elypta AB
name: Francesco Gatto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06838117: From Variability to Standardization: The Impact of Breast Density on Background Parenchymal Enhancement in Contrast-Enhanced Mammography and the Need for a Structured Reporting System
Official title: From Variability to Standardization: The Impact of Breast Density on Background Parenchymal Enhancement in Contrast-Enhanced Mammography and the Need for a Structured Reporting System
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: To Establish a Standardized Background Parenchimal Enhancement Classification System
Lead sponsor: Link Campus University
Sponsor class: OTHER
Collaborators: name: Link Campus University
name: University of Campania Luigi Vanvitelli
First posted: 2025-02-20
Enrollment: 213
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 years and older who underwent CEM for diagnostic or surveillance purposes.

Patients with recorded BPE levels and BI-RADS breast density classification.

Brief summary: This retrospective study includes 213 patients who underwent CEM, mammography (MG), and ultrasound (US) between May 2022 and June 2023 at the P.O. 'A. Perrino' Hospital, Brindisi. BPE was categorized into four levels (Minimal, Light, Moderate, and Marked), while breast density was rated according to the ACR BI-RADS (A-D) classification. A statistical analysis was performed to assess the correlation between BPE and breast density, supporting the development of the BPE-CEM Standard Scale (BCSS) to standardize reporting and improve interobserver agreement.


Eligibility criteria: Inclusion Criteria:

Patients who underwent CEM, mammography, and ultrasound between May 2022 and June 2023.

Availability of BPE assessment and BI-RADS density classification.

Complete imaging dataset available for analysis.

Exclusion Criteria:

Patients with prior breast cancer treatment that could alter BPE.

Incomplete imaging data or missing classification values.

Contraindications to contrast-enhanced imaging.

Primary outcomes:
measure: Correlation between breast density and background parenchymal enhancement (BPE) in CEM.
timeFrame: Data analysis within 12 months of study completion.
Secondary outcomes:
measure: Development and validation of the BPE-CEM Standard Scale (BCSS).
timeFrame: Within 12 months of study completion.
Other outcomes:
Locations:
city: Brindisi
country: Italy
facility: Pellino Hospital
Study officials:
affiliation: Link Campus University
name: Graziella Di Grezia, Medicine and Surgery
role: PRINCIPAL_INVESTIGATOR
References: