louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05110963: Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments
Official title: Intervention to Improve HIV Care Retention and Antiretroviral Adherence in Stigmatized Environments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV I Infection
Keywords: HIV
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
First posted: 2021-11-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral skills training to improve medication adherence
Primary purpose: TREATMENT

Brief summary: Retention in care and persistent adherence to antiretroviral therapy are necessary for the successful treatment of HIV infection. HIV-related stigma is a known impediment to the care and health outcomes of people living with HIV. The proposed study will test theory-based interventions designed to manage HIV stigma in order to improve care retention and medication adherence in communities with high-levels of HIV-related stigma.

Detailed description: This trial is conducting a randomized test of a behavioral self-management intervention designed to improve HIV treatment outcomes in people living with HIV in stigmatized contexts. The trial includes a control arm and a non-stigma enhanced treatment adherence intervention arm. Participants living in an economically under-resourced area of South Africa are recruited through clinical care settings. The goal of the research is to examine whether directly addressing HIV stigma and medication adherence management improves treatment outcomes beyond those observed from a standard behavioral intervention without added stigma-addressing components.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. current clinic visit to receive cART in differentiated care outside of an adherence club
3. unsuppressed HIV at the most recent clinical testing confirmed in run-in
4. access to a phone

Exclusion Criteria:

Not meeting inclusion

Primary outcomes:
measure: Medical Records of Care Appointments
timeFrame: 12-months
measure: Blood Plasma RNA
timeFrame: 12-months
Secondary outcomes:
measure: Antiretroviral Medication Adherence
timeFrame: 12-months
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
city: Atlanta
country: United States
facility: University of Connecticut Field Site
state: Georgia
Study officials:
References:
citation: Kalichman SC, Mathews C, Banas E, Kalichman MO. Stigma management intervention to improve antiretroviral therapy adherence: Phase-I test of concept trial, Cape Town South Africa. Glob Public Health. 2019 Aug;14(8):1059-1074. doi: 10.1080/17441692.2018.1552307. Epub 2018 Nov 30.
Clinical trial NCT01591863: Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Official title: A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile-associated Diarrhea
Keywords: Clostridium difficile-associated diarrhea
CDAD
Pediatric
Lead sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).


Eligibility criteria: Inclusion Criteria:

* Male or female 6 months to 17 years 11 months of age, inclusive;
* Female subjects of childbearing potential must use adequate contraception
* Diagnosed with CDAD

Exclusion Criteria:

* Concurrent use of oral vancomycin or metronidazole or any other effective treatments for CDAD
* Fulminant colitis
* History of inflammatory bowel disease
* Pregnant or breast-feeding
* Need for concurrent use of some P-glycoprotein inhibitors during therapy

Primary outcomes:
measure: Number of Participants With Adverse Events.
timeFrame: Enrollment through end of study (Day 38-41)
measure: Investigate Concentrations of Fidaxomicin in Plasma Samples.
timeFrame: 3-5 hours after administration
measure: Investigate Concentrations of Fidaxomicin in Fecal Samples.
timeFrame: End of Therapy; Day 10-11
measure: Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.
timeFrame: 3-5 hours after administration
measure: Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.
timeFrame: End of Therapy; Day 10-11
Secondary outcomes:
measure: Evaluate the Clinical Outcome by Assessment of Clinical Response.
timeFrame: Day 10
measure: Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.
timeFrame: 28 days post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: O'Gorman MA, Michaels MG, Kaplan SL, Otley A, Kociolek LK, Hoffenberg EJ, Kim KS, Nachman S, Pfefferkorn MD, Sentongo T, Sullivan JE, Sears P. Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):210-218. doi: 10.1093/jpids/pix037.
Clinical trial NCT04602663: Optimal Time for Follow up After Variceal Band Ligation
Official title: Optimal Time for Follow up After Variceal Band Ligation in Cirrhotic Patients: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Varices
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined

Detailed description: Optimal time for follow up after variceal band ligation in cirrhotic patients remains to be determined. So, we designed this trial to answer this question.

Eligibility criteria: Inclusion Criteria:

* cirrhotic portal hypertension with medium or large sized or risky varices or variceal bleeding

Exclusion Criteria:

* non-cirrhotic portal hypertension

Primary outcomes:
measure: Number of patients with eradicated varices
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Al-Azhar University
name: Mohamed Alboraie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Ahmed Maher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05692063: Anomalous Aortic Origin of Coronary Artery
Official title: Anomalous Aortic Origin of Coronary Artery: From Pathophysiology to Risk Stratification Through a Patient Specific Computational Simulation Model
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anomalous Aortic Origin of the Coronary Artery (AAOCA)
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (adults and pediatrics) with diagnosis of anomalous aortic origin of coronary arteries

Brief summary: This project has several objectives ranging from clinical data analysis to computational simulations as listed below:

A) Clinical objectives:

1. Retrospective review of all patients with AAOCA treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to identify risk factors for ischemia or sudden cardiac deaths.
2. Prospective follow-up of all enrolled patients, treated and followed, in adjunct to all the new patients referred aiming to follow across the years any potential rare adverse event (ischemia, angina event, sudden cardiac death).

B) Experimental objectives:

1. Retrieve morphological measurements from CT or MRI (de-identified) of the aortic root and the coronary vessels following the previous work of our group.
2. Construct a parametric model of the aortic root defined by population-based morphologic parameters to describe both healthy/diseased population.
3. Run solid mechanics simulation mimicking the movement of the aortic root in order to test configurations at more risk.
4. Reconstruct 3D surfaces representing the coronary vasculature from imaging for automatically perform the parameter estimation and run computational fluid dynamics simulations.


Eligibility criteria: Inclusion Criteria:

* All patients (adults and pediatrics) who have been diagnosed with an anomalous aortic origin of any of the coronary arteries (AAOCA) without any other congenital heart disease and diagnosed/referred or followed at the IRCCS Policlinico San Donato.

Exclusion Criteria:

* Patients with other major congenital heart disease with associated coronary artery origin anomalies will be excluded.

Patients with anomalous origin of the coronary artery from the pulmonary artery (ALCAPA or ARCAPA) will be excluded.

Patients women who are pregnant.

Primary outcomes:
measure: ischemia, angina event, sudden cardiac death
timeFrame: 10 years
Secondary outcomes:
measure: risk factors for ischemia or sudden cardiac deaths
timeFrame: 10 years
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: Irccs Policlinico San Donato
state: MI
Study officials:
References:
Clinical trial NCT05207163: Continuing Medical Education to Improve Knowledge of Viral Hepatitis B-C in Primary Healthcare Workers
Official title: Continuing Medical Education (CME) Intervention to Improve Knowledge About Viral Hepatitis B-C: A Randomized Controlled Trial Pilot at Primary-level Hospitals in Ho Chi Minh City
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Viral Hepatitis
Lead sponsor: Pham Ngoc Thach University of Medicine
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 88
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of study is identifying the effectiveness of 'continuing medical education' (CME) to primary healthcare worker to improve knowledge about viral hepatitis B-C


Eligibility criteria: Inclusion Criteria:

* Currently working at Outpatient department, Primary-level hospitals
* Having Practicing Certificate
* Not attending any long-term education
* Accepting ICF

Exclusion Criteria:

* Not attending the full number of lessons
* Not answering the questionnaire

Primary outcomes:
measure: Change in Test Scores on Knowledge about Hepatitis B-C from Baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tháng 07
country: Vietnam
facility: Lê Hồng Đức
state: Ho Chi Minh City
Study officials:
affiliation: Pham Ngoc Thach University of Medicine
name: Lê H Đức, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02598063: A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B
Official title: A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult participants 18-65 years of age
* Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (\>=) 6 months
* Receiving lamivudine currently, and for \>=6 months
* hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased \>=2 log during lamivudine treatment on \>=1 occasion
* Absence of cirrhosis confirmed by liver biopsy in previous 6 months

Exclusion Criteria:

* Other drugs with activity against HBV within the prior 6 months, except lamivudine
* Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (\<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
* Decompensated liver disease
* Medical condition associated with another chronic liver disease

Primary outcomes:
measure: HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72
timeFrame: Week 72
Secondary outcomes:
measure: Loss of HBeAg
timeFrame: Week 48, and 72
measure: Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)
timeFrame: Week 48, and 72
measure: Alanine transaminase (ALT) normalization
timeFrame: Week 48, and 72
measure: Hepatitis B surface antigen (HBsAg) seroconversion
timeFrame: Week 48, and 72
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Jinan
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00325663: Acupuncture in Osteoarthritis of the Knee
Official title: Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: acupuncture
double-blind
sham control
osteoarthritis
pain
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: The German Society for Traditional Chinese Medicine (DGTCM)
First posted: 2006-05-15
Enrollment: 125
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee

Detailed description: Background: Acupuncture is one of the most frequently used complementary therapeutic approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings of previous randomized controlled studies, controversy persists whether the observed effects are specific to acupuncture or non-specific consequences of needling.

Objective: To compare classical Chinese acupuncture, semi-standardized modern acupuncture and non-specific needling by means of a double-blinded repeated measures cross-over design.

Intervention: Within three weeks all patients receive three treatment modalities in a random order in a double-blind study design.

Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.

Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.

Eligibility criteria: Inclusion Criteria:

* Patients above age 35
* knee osteoarthritis grade II or III according to the Kellgren classification.

Exclusion Criteria:

* orthopedic deformations of the knee,
* malignant disease
* auto-immune disorders
* surgery including arthroscopy during the past 12 months
* pain medication with steroids
* physical therapy or acupuncture within the last for weeks
* no or a pain medication in continuous dosage

Primary outcomes:
measure: Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
Secondary outcomes:
measure: Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
Other outcomes:
Locations:
Study officials:
affiliation: University Heidelberg
name: Max Karner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Society of Traditional Chinese Medicine
name: Johannes Greten, MD
role: STUDY_DIRECTOR
affiliation: Shen-Centre for Traditional Chinese Medicine, Erlangen, Germany
name: Oliver Gerlach, MD
role: STUDY_CHAIR
affiliation: Centre for Chinese Medicine, Bremen, Germany
name: Frank Brazkiewicz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06721663: Multisensory Environment Stimulation Therapy on Postural Control in Cerebral Palsy
Official title: Effect of Multisensory Environment Stimulation Therapy on Postural Control in Spastic Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the Effect of Multisensory environment stimulation therapy on postural control in spastic hemiplegic cerebral palsy.

Detailed description: Fortypatients with spastic hemiplegic cerebral palsy will participate in this study.

The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to Multisensory environment stimulation therapy, three times per week for three months. The evaluation methods are BIODEX, The Pediatric Balance Scale, and multidirection reach test

Eligibility criteria: Inclusion Criteria:

* - Forty children with cerebral palsy,
* Age will range as (9:12) years old
* spastic hemiplegic cerebral palsy
* Normal body mass index standardmore than 50th and less than 85th for age and sex compared to standard Egyptian growth charts adopted by the Faculty of Medicine, Cairo University and National Research Centre.
* Gross motor function classification system: level I\&II

Exclusion Criteria:

* • difficulty to communicate or to understand program instructions

  * any other neurological deficits or orthopaedic abnormalities,
  * secondary musculoskeletal complication
  * vestibular problems

Primary outcomes:
measure: biodex balance system
timeFrame: three months
measure: The Pediatric Balance Scale
timeFrame: three months
Secondary outcomes:
measure: multidirection reach test
timeFrame: three months
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama S Mahmoud
state: Select State
Study officials:
References:
Clinical trial NCT02287363: Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis
Official title: Genetic and Morphological Analysis of Thyrotoxic Periodic Paralysis:an Observational Study of Sichuan Individuals in China.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyrotoxic Periodic Paralysis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 160
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese han population within Sichuan province who is diagnosed with TPP.

Brief summary: The study aims to analyze the genetic variance between thyrotoxic periodic paralysis (TPP) patients and pure hyperthyroidism individuals. Meanwhile, the investigators also intended to evaluate the morphological difference in effected skeletal muscles and investigate their relation with genetic variance.

Detailed description: Chinese males of their third and forth decades are extremely predisposed to periodic paralysis when they are hyperthyroid. Due to their imbalanced predilection to the disease, genetic variance is considered to be critical to the pathogenesis. In addition, since proximal limb skeletal muscles are the major sites of target, and they are also believed to play a role in the disease generation. Thus, we intend to analyze the genetic and morphological variances between TPP patients and pure hyperthyroidism patients and simultaneously the relation between genetic variance and morphological difference. In this way, we hope to provide evidence for a better understanding of the disease.

Eligibility criteria: Inclusion Criteria:

A recent history(within three months) of acute limb muscle weakness, hypokalemia and decreased TSH with elevated free FT4, FT3.

Exclusion Criteria:

Hyperthyroid myopathy with long term muscle weakness, family periodic paralysis, renal tubular acidosis, hyperaldosteronism, hemiplegia, paraplegia, or any history of other metabolic or traumatic muscular disease,

Primary outcomes:
measure: Single Nucleotide Polymorphisms
timeFrame: 2 years
measure: skeletal muscle size of biceps brachii and quadriceps femoris
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Haoming Tian, MD.
role: PRINCIPAL_INVESTIGATOR
References: