louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02296853: Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Official title: A Phase 1, Open-Label, Parallel-Group, Single Dose Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B Virus
Keywords: Severe Hepatic Impairment
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe hepatic impairment.


Eligibility criteria: Key Inclusion Criteria:

* Screening laboratory parameters within defined thresholds
* Creatinine clearance must be ≥ 60 mL/min

Key Exclusion Criteria:

* Females who are pregnant or nursing or males who have a pregnant partner
* Infection with hepatitis B virus (HBV) or HIV
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF
timeFrame: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1
measure: PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF
timeFrame: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1
measure: PK Parameter: AUClast of TAF, Its Metabolite TFV and Free (Unbound) TAF
timeFrame: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1
Secondary outcomes:
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 plus 30 days
measure: Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities
timeFrame: Day 1 plus 30 days
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: San Antonio
country: United States
state: Texas
city: Munich
country: Germany
city: Gratton
country: New Zealand
state: Auckland
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05198453: Impact of Vaccination in Acute COVID-19
Official title: The Impact of Vaccination in a Cohort of Patients Hospitalized for Acute COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 529
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for acute COVID-19.

Brief summary: The aim of this study was to evaluate the association between vaccination with one of the four SARS-CoV-2 vaccines authorized for use in the European Union-BNT162b2, ChAdOx-1S, mRNA-1273 or Ad.26.COV2.S-and progression to critically severe disease among adult patients with PCR-confirmed acute COVID-19.


Eligibility criteria: Inclusion Criteria:

* age 18 yers or more
* hospitalized for acute COVID-19
* PCR confirmed infection with SARS-CoV-2

Exclusion Criteria:

* hospitalized for other conditions

Primary outcomes:
measure: number (%) with critically severe disease
timeFrame: assessment performed at a minimum 30 days after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References:
Clinical trial NCT01433653: Cognitive Behavioral Therapy for Complicated Grief
Official title: Randomized Controlled Clinical Trial of Cognitive Behavioral Therapy for Complicated Grief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Keywords: Comorbid
Complicated
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for complicated grief is superior to wait list condition in patients with comorbid complicated grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be compared to changes in the wait list group.


Eligibility criteria: Inclusion Criteria:

* age complicated grief diagnosis

Exclusion Criteria:

* acute suicidality

Primary outcomes:
measure: PG-13 (Prolonged Grief Interview - 13 Item version)
timeFrame: Change between intake (t1) and end of treatment (t2) in complicated grief severity within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
Secondary outcomes:
measure: Symptom Checklist 90 revised (SCL-90R; Subscale General Symptom Index, GSI)
timeFrame: Change between intake (t1) and end of treatment (t2) in general distress symptoms within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
measure: Comorbid Diagnoses by DIA-X-Interview
timeFrame: Change between intake (t1) and end of treatment (t2) in number of comorbid psychiatric diagnoses within 5 months; t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU
Study officials:
affiliation: LMU
name: Rita Rosner, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosner R, Pfoh G, Kotoucova M, Hagl M. Efficacy of an outpatient treatment for prolonged grief disorder: a randomized controlled clinical trial. J Affect Disord. 2014;167:56-63. doi: 10.1016/j.jad.2014.05.035. Epub 2014 Jun 2.
citation: Rosner R, Bartl H, Pfoh G, Kotoucova M, Hagl M. Efficacy of an integrative CBT for prolonged grief disorder: A long-term follow-up. J Affect Disord. 2015 Sep 1;183:106-12. doi: 10.1016/j.jad.2015.04.051. Epub 2015 May 8.
Clinical trial NCT00870753: Yoga in Treatment of Eating Disorders
Official title: Yoga in Treatment of Eating Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Eating Disorders
Keywords: Eating disorders
yoga
body awareness
depression
anxiety
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2009-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: to examine effects of hatha yoga in treatment of eating disorders.

Methods:

Participants: patients with DSM-IV Anorexia Nervosa, Bulimia Nervosa or Eating Disorders Not Otherwise Specified will be invited to participate in this study. Exclusion criteria will be age under 18, serious medical complications, psychosis or increased risk of suicide.

Design: randomized controlled single-blinded trial. Intervention: 2 x 90 min weekly group sessions for 12 weeks with hatha yoga. Main outcome measure: reduction in Eating Disorders Examination score. Secondary outcome measures: reduction in body dissatisfaction, depression and anxiety

Detailed description: For the last years, yoga has become a popular "body-mind" form of exercise in western countries (Daubenmier, 2005). Yoga has shown good effects on increasing muscle strength, flexibility and stability, in addition studies have found reduced stress level, improved mood and breathing (Astin et al., 2003; Gimbel, 1998b; Granath et al., 2006; Lavey et al., 2005; Manjunatha et al., 2005b; Netz \& Lidor, 2003a; Telles \& Naveen, 1997b; Yadav et al., 2005b). Previous research have shown a tendency for persons practicing yoga improving body awareness and body sensitivity, and reduction of body dissatisfaction (Daubenmier, 2005). In addition, two studies have examined yoga in treatment of binge eating disorder (Daubenmier, 2005; Gimbel, 1998a). Results showed reduction in number of binge eating episodes in the intervention group compared to the control group. No available studies have examined effect of yoga in treatment of the eating disorders types Anorexia Nervosa or Bulimia Nervosa.

Eligibility criteria: Inclusion Criteria:

* age 18 or above
* DSM-IV Anorexia nervosa, Bulimia nervosa or Eating disorders not otherwise specified

Exclusion Criteria:

* serious medical complications
* psychosis
* suicidal behavior

Primary outcomes:
measure: reduction in eating disorders symptoms assessed by Eating Disorders Examination clinical interview
timeFrame: after 12 weeks
Secondary outcomes:
measure: increased body awareness
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences
Study officials:
References:
Clinical trial NCT05448053: Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures
Official title: Clinical and Radiographic Evaluation of Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Type III (A&B)Pediatric and Adolescent Tibial Shaft Fractures
Ilizarov Fixation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Ilizarov method is our usual treatment of choice for open, complex, physeal or unstable fractures and for patients in whom non-operative or other treatments have failed .

Detailed description: Tibial fractures are the third most common injury involving a long bone in children. Most occur in the distal third, and approximately 10% are open.High-energy injuries with soft tissue compromise or segmental bone loss, present specific challenges. There is a significant risk of nonunion (7.5%),malunion (17%),infection (10%),and loss of reduction (32%).Many forms of treatment are available including a cast, elastic nailing, and external fixation using either a monolateral fixator, or a circular frame . In complex adult tibial fractures, evidence for the effectiveness of definitive external fixation using a circular frame continues to emerge.Fixators may be used for the correction of tibial deformities in children.Currently, only relatively small case series have been published describing their use for trauma in children and adolescents, albeit with good results.

Eligibility criteria: Inclusion Criteria:

* Patients aged 8-16 years old.
* Diagnosed to have open grade IIIA and IIIB tibial fracture according to Gustilo-Anderson fracture classification system.
* Fractures of the shaft of the tibia or distal tibial fractures involving the ankle joint and were complicated by bone and/or soft-tissue loss of more than 3 cm.
* An external fixator could be placed in the proximal lower extremity, distal lower extremity, or foot, and normal bone segments available for osteotomy.
* Admitted in the duration between 1st of January 2022 until end of December 2023.

Exclusion Criteria:

* Patients requiring free flap or local flap transfer to close the wound.
* Open grade IIIC tibial fractures (with vascular injury).
* Loss to follow-up.

Primary outcomes:
measure: Union of tibial fracture
timeFrame: 1 year
Secondary outcomes:
measure: Determine alignment
timeFrame: 1 year
measure: Patient reported outcome measures
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT06875453: De Tethering Exercises for Scolisis
Official title: The Effect of De-tethering Exercises on Muscle Tone in Patients with Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scoliosis Idiopathic
Exercise
Muscle Tone
Keywords: scoliosis
exercise
muscle tone
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 15
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effect of Detethering exercises on muscle tone in patients with adolescent idiopathic scoliosis.

H1: Detethering exercises affect muscle tone in patients with adolescent idiopathic scoliosis.

Detailed description: This study is planned to include 15 patients diagnosed with adolescent idiopathic scoliosis.

Muscle tone and trunk rotation degree will be measured before and after the application of detethering exercises.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 10-30,
* Being diagnosed with IS
* Cobb angle between 20º and 50º,
* To be able to continue the program to be implemented,
* No chronic disease requiring the use of any neurological or psychiatric medication,
* Parents and/or child volunteering to participate in the study.

Exclusion Criteria:

* The patient has any contra-indication for exercise,
* Previous spine surgery,
* Having a curve with an apex thoracic 6 and above,
* The presence of any mental problem,
* Scoliosis is not idiopathic but has different causes (neurological, congenital, etc...), neurological, psychiatric, muscular, rheumatic or orthopedic diseases are present.

Primary outcomes:
measure: ATR - Angle of Trunk Rotation
timeFrame: 1 week
measure: Muscle Tone
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bandırma
country: Turkey
facility: Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation,
Study officials:
References:
Clinical trial NCT02376153: Air Barrier System for the Prevention of Prosthesis-related Infections
Official title: Air Barrier System for the Prevention of Prosthesis-related Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prosthesis-Related Infections
Lead sponsor: Nimbic Systems, LLC
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 816
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier System device reduces the incidence of surgical site infection after total hip replacement, acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.

Detailed description: This project is an evaluation of a novel device, the Air Barrier System (ABS), to reduce the risk of prosthesis-related surgical site infection in a multi-center clinical trial. The ABS shields surgical incisions intra-operatively by creating a field of high-purity air surrounding an incision that prevents airborne microorganisms from entering the incision.

This research will evaluate ABS performance in a prospective, randomized, blinded multi-center trial. The surgical procedures studied will include total hip arthroplasty, trauma-related acetabula reconstruction, posterior instrumented spine fusion, and prosthetic vascular graft procedures. Patients will be enrolled during the first two years of the study, and CDC guidelines require a one year follow-up period to monitor patients for potential prosthesis-related infections.

Eligibility criteria: Inclusion Criteria:

* Total hip arthroplasty;
* Acetabular repair with instrumentation;
* Posterior lumbar, cervical, or thoracic (up to and including 6 vertebral levels) spine fusion with instrumentation and vascular prosthetic graft implantation.

Exclusion Criteria:

* History of prior prosthesis infection;
* Active infection;
* Open traumatic wounds as is the case after some acetabular fractures.

Primary outcomes:
measure: Clinical incidence of surgical site infection
timeFrame: One-year post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Investigator
name: Sean Self
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01108653: A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
Official title: A Structuralised Sick-leave Program Compared to Usual Care Sick Leave Management in Patients After an Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Keywords: Cardiovascular diseases
Heart diseases
Myocardial infarction
Rehabilitation
Health Economy
Randomized controlled trials
Non ST Elevation Myocardial Infarction (NSTEMI)
Cost analysis
Sick-leave
Quality of Life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
First posted: 2010-04-22
Enrollment: 120
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study the investigators aim at comparing the effect on quality of life and the cost-effectiveness of a structuralised sick-leave program compared to usual care sick leave management in patients after an acute non ST myocardial infarction(NSTEMI).The investigators hypothesize that a structuralised sick-leave program after an acute NSTEMI is cost-effective without a negative effect on quality of life compared to usual care management in this patient group.


Eligibility criteria: Inclusion Criteria:

* Patients with acute NSTEMI who are revascularized.
* 65 years old or less
* Self caring
* Adequately literate in Norwegian
* Have a regular work in at least 50% position.

Exclusion Criteria:

* Patients not willing to participate
* Professional drivers
* Patients with alcohol or drug abuse
* Severe complications after the myocardial infarction such as malignant arrythmias, heart failure and major bleedings.
* Patients with recent CABG ( coronary artery bypass graft operation) within the last 6 months.

Primary outcomes:
measure: Cost effectiveness
timeFrame: one year
Secondary outcomes:
measure: Quality of Life measures are estimated at baseline and after 6 and 12 months using the standard Medical Outcomes Study Short form( SF-36)questionnaire and the disease-specific Utility-Based Quality of life-Heart questionnaire(UBQ-H).
timeFrame: one year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
state: Trondheimsveien 235
Study officials:
affiliation: Oslo University Hospital. Department of Cardiology. Trondheimsveien 235, 0514 Oslo, Norway
name: Stefan Agewall, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03182153: Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy
Official title: Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any HCM patient followed in the Chanin T. Mast HCM Center at Morristown Medical Center, Morristown, NJ, who is prescribed holter monitoring for risk stratification for SD.

Brief summary: Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring.

Detailed description: Eligible subjects will be monitored with a SEEQ device. The SEEQ device is a patch-like device that is worn externally on the chest and continuously monitors heart rhythm. Each device is worn for seven days and replaced with additional devices for a total of 28 days of monitoring. Subjects will return the SEEQ equipment at the end of the monitoring period. Subjects will be contacted by telephone or seen at the clinic approximately 60 days from the first day of monitoring. Information will be gathered about medications and any cardiac interventions the subject may have had.

Subjects will again be contacted by telephone or seen in the clinic approximately 1 year from study start. Information will be gathered about general health, changes in medications, and cardiac interventions or events. Cardiac testing results will be reviewed.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of HCM Scheduled for routine ambulatory monitoring for risk stratification Followed at the Chanin T. Mast HCM Center at Morristown Medical Center

Exclusion Criteria:

Prior implantation of an ICD History of persistent/permanent atrial fibrillation (AF)

Primary outcomes:
measure: Risk Stratification for sudden death (SD)
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Detection of Atrial Fibrillation
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
Study officials:
References: