louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01910636: Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
Official title: A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: HCV genotype 2 (GT-2)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.


Eligibility criteria: Inclusion Criteria:

* Chronic genotype 2 HCV-infection
* Male or female, age ≥ 20 years
* Body weight ≥ 40 kg
* HCV RNA ≥ 10,000 IU/mL at screening

Exclusion Criteria:

* Current or prior history of clinically significant illness other than HCV
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants Experiencing Viral Breakthrough
timeFrame: Up to 12 weeks
measure: Percentage of Participants Experiencing Viral Relapse
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Akita
country: Japan
city: Chiba
country: Japan
city: Chiyoda-ku
country: Japan
city: Gifu
country: Japan
city: Ichikawa
country: Japan
city: Itabashi-ku
country: Japan
city: Izunokuni
country: Japan
city: Kita-Ku
country: Japan
city: Kurashiki
country: Japan
city: Kurume
country: Japan
city: Matsumoto
country: Japan
city: Musashino
country: Japan
city: Nishinomiya
country: Japan
city: Ogaki
country: Japan
city: Omura
country: Japan
city: Sapporo
country: Japan
city: Shinjuku-ku
country: Japan
city: Suita
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: Gilead Sciences
name: Steven Knox
role: STUDY_DIRECTOR
References:
Clinical trial NCT05980936: Screening for Obstructive Sleep Apnea in Medical Patients
Official title: Screening for Obstructive Sleep Apnea in the General Medical Ward in Tertiary Care Centers in the Middle East
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Symptomatology
Middle East
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without known OSA who are admitted to the general medical ward will be Screened for signs and symptoms of OSA by answering the questions that have the statement :Do you have...?". The symptoms include snoring, day time somnolesce, sudden chocking or gasping during sleep..

Brief summary: Obstructive sleep apnea (OSA) is highly prevalent in the general population and is associated with multiple adverse cardiovascular consequences.

Screening for OSA is recommended in those with typical symptoms, such as daytime sleepiness, loud snoring, or abrupt awakenings with gasping or choking. Patients admitted to the general medical wards with these symptoms will be evaluated for the possibility of having OSA.

Detailed description: Obstructive sleep apnea (OSA) is a disease that is highly prevalent in all communities and is associated with adverse cardiovascular events.

Screening for OSA is recommended in men and women who have the typical symptoms, including snoring, daytime sleepiness, or abrupt awakenings with choking or gasping.

OSA screening is also recommended for those with resistant hypertension, bradyarrhythmias, and atrial fibrillation.

Heart failure patients should also be screened for OSA. It is very important to increase the use of OSA screening especially in patients admitted to the medical floor in tertiary care hospitals. No study has evaluated this topic in the Middle East in the past.

Eligibility criteria: Inclusion Criteria:

* Willing to sign an informed consent
* Patient is admitted to the medical ward in a tertiary hospital

Exclusion Criteria:

* Patients known to have obstructive sleep apnea.
* Patients younger than 18 years of age

Primary outcomes:
measure: Number of Participants who are found to have obstructive sleep apnea
timeFrame: From date of study enrollment until the date of first documented diagnosis of obstructive sleep apnea, assessed up to 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Ayman Hammoudeh
city: Amman
country: Jordan
facility: Istishari Hospital
Study officials:
References:
Clinical trial NCT00778336: A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
Official title: Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Diseases
Thrombosis
Venous Thrombosis
Keywords: Peripheral Thrombosis
DVT
Limb Ischemia
AV Access
AngioJet
Thrombectomy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-10-23
Enrollment: 452
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with peripheral thrombosis treated with a AngioJet mid-length catheter that is indicated for thrombosis removal.

Brief summary: This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.

Detailed description: The PEARL Registry collects real world data about mid-length AngioJet catheters to:

* Characterize usage patterns, treatment approaches, and targeted vessels
* Document treatment strategies, including specific techniques and concomitant therapies
* Collect outcome data during initial hospitalization and at a 3-month follow-up phone call or visit
* Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis, and treatments provided
* Identify treatment strategies that may optimize procedural and clinical outcomes, to facilitate development of treatment guidelines
* Offer sites a valuable resource for tracking usage and performance of the AngioJet System at their institution

Information collected by the PEARL Registry is intended for educational and clinical research purposes only.

Eligibility criteria: Inclusion Criteria:

* Patient has been treated with a mid-length AngioJet catheter(defined as 90-120 cm in length)
* Patient has provided appropriate authorization per institutional policy and procedure.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline to Final Angiographic Results
timeFrame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment)
Secondary outcomes:
measure: Rethrombosis
timeFrame: 3 Month Follow Up
measure: Description of Treatments by Thrombotic Condition
timeFrame: Index Procedure
Other outcomes:
Locations:
Study officials:
affiliation: Chilton Memorial Hospital, Pompton Plains, NJ
name: Lawrence R. Blitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai School of Medicine, NYC, NY
name: Robert Lookstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samaritan Vascular Institute, Dayton, OH
name: Eugene Simoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03325036: Serum Immunological Profiles in Head and Neck Cancer Patients Receiving Curative Radiotherapy
Official title: Serum Immunological Profiles in Head and Neck Cancer Patients Receiving Curative Radiotherapy: Quantitative Analysis and Prognostic Implication
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancers Patients
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Serum levels of immunologic profiles before and after chemoradiotherapy will be prospectively evaluated.

Brief summary: The purpose of the study is to investigate the clinical usefulness of serum levels of immunologic profiles including pro/anti-inflammatory interleukins, other detectable serum biomarkers including transforming growth factor b1 (TGFb1) or soluble major histocompatibility complex Class I chain-related peptide A (sMICA), and leukocyte subpopulations in head and neck cancers patients receiving curative radiotherapy, as prognostic biomarkers for disease recurrence and survival.


Eligibility criteria: Inclusion Criteria:

* Patients with head and neck cancer receiving curative radiotherapy in NTUH radiation therapy department.

Exclusion Criteria:

* Patients with head and neck cancer NOT receiving curative radiotherapy in NTUH radiation therapy department.

Primary outcomes:
measure: Disease progression
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jenny Ling-Yu Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07024836: PRecision biomArker-Guided MAnagement of TuberculosIs Contacts: a Discrete Choice Experiment
Official title: PRecision biomArker-Guided MAnagement of TuberculosIs Contacts: a Discrete Choice Experiment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis (TB)
Keywords: preference
discrete choice experiment
qualitative
latent tuberculosis infection
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University of Aberdeen
First posted: 2025-06-17
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Adults tested, or eligible for testing, for latent tuberculosis infection in routine clinical services.
2. Nurses, doctors or allied health professionals who have any experience of testing or treatment for TB or latent TB infection in UK services.

Brief summary: This study is part of a broader programme of work to develop and pilot a randomised-controlled trial of new tests to identify people who will benefit most from preventive treatment for tuberculosis (TB). The aim of the current study is to explore factors affecting patient decisions to start preventive treatment. The specific objectives are to understand how patients make decisions about preventive treatment initiation for TB (stage 1); and to design and conduct a "discrete choice experiment" survey to further evaluate preferences (stage 2).

Detailed description: We will perform up to 30 semi-structured interviews among people undergoing testing for latent TB infection, as part of routine clinical screening programmes (stage 1). Adults (aged ≥18 years) who have been or are being tested for LTBI in routine clinical services will be eligible for inclusion through purposive sampling. The findings from the qualitative study will then be used to inform the a discrete choice experiment (DCE). The DCE will be conducted to quantify the trade-off between future TB risk and preventive treatment acceptance, from patient and healthcare provided perspectives (stage 2).

Eligibility criteria: Inclusion Criteria:

* Adults (aged ≥18 years) who have been tested for latent TB infection in routine clinical services, or are eligible for testing. Eligible people for testing include migrants from countries with high TB incidence (entered UK within 5 years), people with recent contact with a person with TB disease, and people eligible for LTBI screening prior to starting immunosuppression or through occupational health testing.

Exclusion Criteria:

* Unable to provide informed consent.

Primary outcomes:
measure: Preventive treatment acceptance
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Whittington Hospital
Study officials:
References:
Clinical trial NCT06117436: Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients
Official title: Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Wound Heal
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The growing incidence of DM can lead to the increased prevalence of diabetic foot complications, which have become a serious medical, social, and economic concern of global importance. this study aims to find a novel intervention that improve wound healing in diabetic foot ulcer to improve patients' quality of life, reduce amputation rate, and reduce the mortality rate among diabetic foot ulcer patients


Eligibility criteria: Inclusion Criteria:

* Eligible patients will be adult diabetic patients aged 18 years and older with non-ischemic diabetic foot ulcers Wagner's grade 2, 3, and 4.

Exclusion Criteria:

1. Wagner's grade 5 patients (because of the indications for amputation).
2. Patients with poor glycemic control at the time of inclusion (HbA1c\>12%).
3. Patients who need either direct graft or indirect revascularization procedure during the study.
4. Patients with Cilostazol or Selenium allergy.
5. Patients with Cilostazol contraindications (Heart Failure, bleeding disorder).
6. Patients with a history of comorbidities that interfere with wound healing (cancers, congestive heart failure, end-stage renal disease, and liver failure).
7. Presence of clinical signs of active infection unresponsive to oral antibiotics (oedema, erythema, discharge, regional lymph node enlargement, pain, or fever).
8. Patients who take medications that interfere with wound healing (glucocorticoids, immunosuppressive and cytotoxic drugs) at the time of inclusion.
9. Non-diabetic patients with foot wounds due to vascular or dermatological reasons.

Primary outcomes:
measure: Wound Healing size
timeFrame: 3 months
Secondary outcomes:
measure: Effect on Matrix Metalloproteinase-9 (MMP-9) level
timeFrame: 3 months
measure: Occurrence of infection
timeFrame: 3 months
measure: Treatment-related side effects.
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Institute of Diabetes and Endocrinology
Study officials:
References:
Clinical trial NCT02409836: A Study to Assess the Ingestion of Dentifrice by Children
Official title: A Study to Assess the Ingestion of Dentifrice by Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Individuals
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-04-07
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study was to examine the amount of dentifrice ingested and used by various age groups of children.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 2 and 12, inclusive
* Be healthy, with no illness that, in the judgment of the investigator or examining dentist, would interfere with the conduct of the test
* Be currently, and have been for at least three months immediately prior to the start of the study, brushing (or being brushed by care giver) their teeth on a daily basis
* Have parent/guardian complete and return the consent form

Exclusion Criteria:

* Have diabetes
* Be on dialysis
* Have an oral health condition that, in judgment of investigator or study medical personnel, could interfere with the conduct of the study.
* Wear metal braces
* Have an incomplete or missing consent form

Primary outcomes:
measure: Level of dentifrice ingested and used by various age groups of children.
timeFrame: 10 weeks
Secondary outcomes:
measure: Dentifrice ingestion amount as a function of dentifrice flavor and age of participants.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Hill Top Research, Inc.
state: Ohio
Study officials:
affiliation: HIlltop Research Inc.
name: John E Wild
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05440136: A Safety Study of LY3462817 in Healthy Japanese and Non-Japanese Participants
Official title: A Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3462817 in Healthy Japanese and Non-Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3462817 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3462817 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation
* Japanese participants must be first generation Japanese and have a body mass index (BMI) of 18.0 to 30.0 kilograms per square meter (kg/m²) (inclusive), and a body weight of 45 and 85 kg (inclusive)
* Non-Japanese participants have a BMI of 18.0 to 32.0 kg/m² (inclusive), and a minimum body weight of 45 kg
* Are males who agree to follow contraception requirements or females not of childbearing potential
* Have blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have cancer or a malignant disease in the past 5 years
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Are unwilling to receive study drug administration by injections or through the veins

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Week 12
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3462817
timeFrame: Predose on Day 1 through Day 85
measure: PK: Maximum Concentration (Cmax) of LY3462817
timeFrame: Predose on Day 1 through Day 85
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06118736: GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
Official title: GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Hip Dislocation
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent literature, the potential of guided growth of the proximal femur to modify hip growth in patients with cerebral palsy has been shown. Using medial hemi-epiphysiodesis of the proximal femur (TMH-PF) morphology of hips at risk of symptomatic (sub)luxation in cerebral palsy (CP) can be changed, aiming to reduce further hip migration and the need for more invasive surgical treatment modalities. Further research is necessary to assess if the results of TMH-PF in combination with adductor tenotomies are significantly better than the results of the current standard of care; adductor tenotomies alone.

The investigators objective is to determine whether guided growth of the proximal femur decreases the risk of further hip migration and need for further surgery in cerebral palsy patients.


Eligibility criteria: Inclusion Criteria:

* Spastic CP
* GMFCS level IV-V
* Aged 2-8 years
* At least one hip with an abduction in flexion ≤ 40 degrees
* Migration percentage of 30-50%
* Head shaft angle \> 145

Exclusion Criteria:

* Not fit for surgery
* History of bony hip surgery to the affected hip
* Severe acetabular dysplasia defined as a gothic arch, an incongruent joint or an acetabular index \> 30 degrees, consistent with A2 and A3 acetabular deformity according to Robin and Graham in an adequately performed radiographs

Primary outcomes:
measure: Treatment failure
timeFrame: from enrollment to the end of study (8 years)
Secondary outcomes:
measure: Radiographic parameters
timeFrame: from enrollment to the end of study (8 years)
measure: 3-dimensional shape analysis of proximal femur
timeFrame: directly postoperative, at 2-year follow-up and at 5-year follow-up
measure: CPChild questionnaire
timeFrame: from enrollment to the end of study (8 years)
measure: CPG questionnaire
timeFrame: from enrollment to the end of study (8 years)
measure: Secondary surgical interventions other than bony procedure
timeFrame: from enrollment to the end of study (8 years)
Other outcomes:
measure: Baseline measurements
timeFrame: At the time of enrollment
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Jaap Tolk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: