louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05568368: Time-to-Detection in Culture of Mycobacterium Tuberculosis
Official title: Time-to-Detection in Culture of Mycobacterium Tuberculosis : Performance for Assessing Index Cases Infectivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Tuberculoses
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 705
Sex: ALL
Minimum age (years): 2
Maximum age (years): 94
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all cases of pulmonary tuberculosis who had a sample analysed by the laboratory of bacteriology of Nice University Hospital, and that was positive in culture before treatment and of which contact cases were explored by the CLAT

Brief summary: determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission


Eligibility criteria: Inclusion Criteria:

* have at least 1 contact case explored for tuberculosis
* latent tuberculosis infection

Exclusion Criteria:

-

Primary outcomes:
measure: tuberculosis transmission
timeFrame: 2 months
measure: contact case tracking
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT04538768: Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh
Official title: Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional LLQ Hernia
Keywords: lateral incisional hernia
mesh augmentation
prevention
stomal closure
Lead sponsor: Buccheri La Ferla Hospital, Palermo
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 y.o.
* stomal closure
* elective surgery

Exclusion Criteria:

* patients \< 18 y.o.
* emergency surgery

Primary outcomes:
measure: rate of postoperative lateral incisional hernia after P4HB mesh placement vs direct fascia suture.
timeFrame: 1 week to 18 months after surgery
Secondary outcomes:
measure: surgical operation time in P4HB mesh placement group vs direct fascia suture group.
timeFrame: intraoperative
measure: length of hospital stay in P4HB mesh placement group vs direct fascia suture group.
timeFrame: From the starting date of the study until the date of its completion, assessed up to 18 months"
measure: rate of surgical site infection in P4HB mesh placement group vs direct fascia suture group.
timeFrame: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
measure: rate of seroma formation in P4HB mesh placement group vs direct fascia suture group.
timeFrame: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
measure: rate of hematoma formation in P4HB mesh placement group vs direct fascia suture group.
timeFrame: 1 week after surgery; 1 month after surgery; 3 months after surgery; 6 months after surgery; 12 months after surgery; 18 months after surgery
measure: assessment of quality of life (QoL) through QoL scale in P4HB mesh placement group vs direct fascia suture group.
timeFrame: 18 months after surgery.
measure: cost effectiveness analysis of the P4HB mesh augmentation technique vs direct fascia suture group.
timeFrame: through study completion, an average of 1 year .
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Ospedale Buccheri La Ferla Palermo
Study officials:
affiliation: Ospedale Buccheri La Ferla Palermo; University of Palermo - Department of Surgical, Oncological and Oral Sciences
name: Leo Licari, MD
role: STUDY_DIRECTOR
affiliation: Ospedale Buccheri La Ferla Palermo
name: Cosimo Callari, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00741468: Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects
Official title: An Open-Label, Multiple-Dose, Non-Randomized Study to Assess the Drug-Drug Interactions of Proellex® (CDB-4124) With Cytochrome P450 Isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interactions
Keywords: Drug-drug interactions
DDI
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

Detailed description: This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.

Eligibility criteria: Inclusion Criteria:

* Healthy adult females
* A body mass index between 18 and 30 kg/m2, inclusive
* Negative urine drug and alcohol screen .

Exclusion Criteria:

* Significant medical condition,
* Significant physical examination finding
* Clinical laboratory
* ECG abnormality
* CYP2D6 "poor metabolizer"

Primary outcomes:
measure: Plasma AUC Ratio of Day 1 and Day 8
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Clinical Research Center Advanced Biomedical Research Inc.
state: New Jersey
Study officials:
affiliation: Repros Therapeutics Inc.
name: Ronald Wiehle, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02255968: Evaluation of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of EDP-788
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, and Pharmacokinetic Study of EDP-788 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Normal Volunteers
Safety
Pharmacokinetics
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2014-10-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to determine the safety and tolerability of multiple doses of orally administered EDP-788. Secondary objectives of the study are to describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after multiple doses of orally administered drug.

Detailed description: Three cohorts of subjects will be enrolled to receive either EDP-788 or placebo. The dose of EDP-788 will be increased with each successive cohort. In addition, a 4th cohort may be enrolled, depending on clinical findings (tolerability, safety, pharmacokinetics) observed in the first 3 cohorts. In each cohort, 8 subjects will receive a q12h oral dose regimen of EDP-788 (6 subjects) or placebo (2 subjects). All subjects receive multiple doses of study drug (EDP-788 or placebo).

Eligibility criteria: Key Inclusion Criteria:

* In good general health
* BMI between 18 - 32 kg/m2
* Women must be of non-childbearing potential (surgically sterilized)
* Normal electrocardiogram
* Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 17 - 19 day post-dosing visit

Key Exclusion Criteria:

* Hypersensitivity to macrolide antibiotics
* Abnormal laboratory values
* Gastroenteritis within 1 week of study drug administration
* Use of any investigational drugs within 28 days of study drug administration
* History of gastrointestinal surgery which may interfere with drug absorption
* Active Hepatitis B, Hepatitis C, or HIV infection
* Use of prescription or non-prescription drugs within 14 days of study drug administration
* Use of nicotine within 3 months of study drug administration

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: From time of dosing to 20-23 days after receiving last dose of study drug
Secondary outcomes:
measure: Changes from baseline in laboratory values and vital signs
timeFrame: From time of dosing to 20-23 days after receiving last dose of study drug
measure: Pharmacokinetic parameters
timeFrame: From time of dosing to 3 days after receiving the last dose of study drug
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase 1 Clinic
state: Texas
Study officials:
References:
Clinical trial NCT01308268: Management of Soil-transmitted Helminthiasis and Strongyloidiasis
Official title: Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helminthiasis
Strongyloides Stercoralis Infection
Keywords: STH
Soil-transmitted Helminthiasis
mass drug administration
Lead sponsor: Universidad Nacional de Salta
Sponsor class: OTHER
Collaborators: name: Fundación Mundo Sano
name: Albert B. Sabin Vaccine Institute
First posted: 2011-03-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a highly endemic area in northern Argentina with a multidisciplinary approach. The specific objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration regimen with albendazole and ivermectin.


Eligibility criteria: Inclusion Criteria:

* All persons that are living in the working area at the time of the intervention and wish to participate in the study.

Exclusion Criteria:

1. All persons that live within the study area but do not want to participate in the study.
2. Pregnant women or women who are likely pregnant.
3. Women during the first post-partum week if they are breastfeeding.
4. Children who weigh less than 15 kg.
5. Persons with a history of hypersensitivity or intolerance to ivermectin, albendazole or to the components that make up those drugs.

Primary outcomes:
measure: Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy
timeFrame: 15 months
Secondary outcomes:
measure: Validate serology methods for diagnosis of S. stercoralis infection
timeFrame: 15 months
measure: Assess the tolerability and safety of the combination of ivermectin and albendazole
timeFrame: 15 months
Other outcomes:
Locations:
city: Orán
country: Argentina
facility: Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta
state: Salta
Study officials:
affiliation: Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales
name: Alejandro Krolewiecki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06486168: Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery
Official title: Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diaphragmatic Dysfunction
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS).

Participant will be evaluated during surgery, 2 hours and 24 hours after surgery.

Detailed description: This is a prospective longitudinal single-center study conducted on patients undergoing non-intubated video-assisted thoracoscopic surgery. The main indications for this surgery are wedge resections, pneumothorax repair, and pleural biopsies (with or without talc pleurodesis) for pleural effusion.

Except for the inclusion visit, each patient will be evaluated twice, 2 and 24 hours after the end of the surgical procedure. The data from each evaluation will be recorded by the physician in the electronic CRF

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older
* Patient who has read and signed the informed consent form for participation in the study
* Patient undergoing surgery with video-assisted thoracoscopic surgery without intubation

Exclusion Criteria:

* Known or detected diaphragmatic dysfunction before the intervention
* Patient not affiliated with the French social security system
* Patient under legal protection, guardianship, or curatorship
* Patient already enrolled in another therapeutic study protocol (involving medications or non-drug therapies)
* Patient in an exclusion period from a previous clinical study
* Mental deficiency or any other reason that may hinder understanding or strict adherence to the protocol

Primary outcomes:
measure: Diaphragmatic excursion
timeFrame: Hour 24
Secondary outcomes:
measure: Pain evaluation
timeFrame: Hour 2
measure: Pain evaluation
timeFrame: Hour 24
measure: Diaphragmatic thickening evaluation
timeFrame: Hour 2
measure: Diaphragmatic thickening evaluation
timeFrame: Hour 24
measure: postoperative complications evaluation
timeFrame: Hour 2
measure: postoperative complications evaluation
timeFrame: Hour 24
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
References:
Clinical trial NCT02224768: YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey
Official title: YERVOY Risk Minimisation Tool Evaluation Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HCPs and Patients in EU member states where YERVOY has been marked for atleast six months

Brief summary: To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in terms of awareness about these tools, their utilization, knowledge and comprehension of Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional (HCP)s and patients

Detailed description: A total sample size of 160 to 200 HCPs and 160 to 200 patients

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* HCP experienced in the treatment of patients with the research compound and patients that have received at least one dose

Primary outcomes:
measure: The proportion of YERVOY HCPs that are aware of the existence of the risk communications tools and how the tools were accessed (i.e. paper or electronic versions)
timeFrame: 6 months
measure: Questionnaire: "Who uses the RM communication tools, how, when they are used and how often they are used"
timeFrame: 6 months
measure: Level of knowledge and comprehension of the key elements of important identified risks associated with YERVOY treatment based on the scores obtained from the Questionnaire Surveys
timeFrame: 6 months
measure: HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bristol-Myers Squibb
state: New Jersey
city: St. Ives
country: United Kingdom
facility: Local Institution
state: Cambridgeshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06516068: A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
Official title: A Multicenter, Randomized, Open-label Phase II Clinical Study on the Efficacy and Safety of HRS-1893 in Obstructive Hypertrophic Cardiomyopathy Subjects.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy


Eligibility criteria: Inclusion Criteria:

1. Age 18-85 years old, gender unlimited;
2. The diagnosis was obstructive hypertrophic cardiomyopathy.
3. Echocardiographic laboratory tests showed LVEF≥60%;
4. No previous left ventricular systolic dysfunction at any time (LVEF \< 45%);
5. Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.

Exclusion Criteria:

1. Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM);
2. Previous left ventricular systolic dysfunction at any time in the clinical course (LVEF \< 45%);
3. Previous history of aortic stenosis or subaortic fixed stenosis;

Primary outcomes:
measure: The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver
timeFrame: After 12 weeks of HRS-1893 treatment
Secondary outcomes:
measure: Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2)
timeFrame: Baseline to Week 12
measure: Change in LVEF
timeFrame: Baseline to Week 12
measure: Change in LVOT-VTI
timeFrame: Baseline to Week 12
measure: Change in LV-FS
timeFrame: Baseline to Week 12
measure: Change in LV-GLS
timeFrame: Baseline to Week 12
measure: Change in Rest LVOT-G
timeFrame: Baseline to Week 12
measure: Change in Valsalva LVOT-G
timeFrame: Baseline to Week 12
measure: Change in cardiac troponin
timeFrame: Baseline to Week 12
measure: Change in NT-proBNP
timeFrame: Baseline to Week 12
measure: Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
timeFrame: Baseline to Week 12
measure: Proportion of participants with ≥ 1 class improvement in NYHA Functional Class
timeFrame: Baseline to Week 12
measure: Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE)
timeFrame: Through study completion, an average of 68 weeks
measure: plasma concentration of HRS-1893
timeFrame: Through study completion, an average of 68 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
state: Beijing
Study officials:
References:
Clinical trial NCT03805568: A Postoperative Sore Throat After Thyroidectomy
Official title: The Effect of Dexmedetomidine and Remifentanil on the Postoperative Sore Throat After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Sore Throat
Keywords: postoperative sore throat
dexmedetomidine
remifentanil
thyroidectomy
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was performed to compare the effect on of a postoperative sore throat between dexmedetomidine and remifentanil in patients undergoing thyroidectomy.


Eligibility criteria: Inclusion Criteria:

* Patients who scheduled primary thyroidectomy were enrolled and their physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion Criteria:

* Patients with respiratory tract disease, previous head, and neck surgery, preexisting steroid or non-steroidal anti-inflammatory drug use, and known or suspected difficult airway

Primary outcomes:
measure: incidence of postoperative sore throat at rest
timeFrame: 6 hours after surgery
measure: incidence of postoperative sore throat at swallowing
timeFrame: 6 hours after surgery
measure: severity of postoperative sore throat at rest
timeFrame: 6 hours after surgery
measure: severity of postoperative sore throat at swallowing
timeFrame: 6 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Eun kyung Choi
state: Korea (the Republic Of)
Study officials:
References: