louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04215926: NAFLD in HIV-infected Patients
Official title: The Epidemiological Investigation and Pathogenesis of NAFLD in HIV-infected Patients: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-infection/Aids
NAFLD
Keywords: HIV infection
NAFLD
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
First posted: 2020-01-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected outpatients who was not coinfected with other form of viral hepatitis or drug induced liver disease, some severe systematic disease

Brief summary: The prevalence of NAFLD (nonalcoholic fatty liver disease) in HIV-infected patients is higher than that in general population, but the causes of morbidity and pathogenesis have not been fully explored. The investigators are planning to consecutively enroll 400 cases HIV-positive outpatients, and to detect NAFLD by ultrasound. The fecal and blood samples were also collected to explore the mechanism of NAFLD. The investigators aimed to determine the prevalence and risk factors of NAFLD in HIV infected patients.


Eligibility criteria: Inclusion Criteria:

* Age 18\~70 y;
* HIV-positive patients;
* written the informed consent

Exclusion Criteria:

* coinfected with HBV, HCV;
* secondary causes of fatty liver (eg, consumption of amiodarone and tamoxifen) and decompensated liver disease;
* significant alcohol consumption (\>20 g per day for man, \>10 g per day for woman);
* received antibiotics in preceding two months;
* autoimmune disease;
* severe heart, lung, kidney, brain, blood diseases or other important systemic diseases;
* pregnant or lactating women

Primary outcomes:
measure: morbidity of nonalcoholic fatty liver disease
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00001226: Lipoprotein Metabolism in Normal Volunteers and Patients With Abnormal Levels of Lipoproteins
Official title: Lipoprotein Metabolism in Normal Volunteers and Dyslipoproteinemic Patients (Stable Isotopes)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Hyperlipoproteinemia
Keywords: Nonradioactive Isotopes
Lipoprotein Kinetics
Apolipoproteins
Dyslipoproteinemia
Healthy Volunteers
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis).

Patients participating in this study will receive an intravenous (directly into the vein) injection of a small amount of specially prepared amino acids. The amino acids being injected are the same amino acids present in a normal diet. The amount of amino acid given will be less than the amount eaten in a protein-rich meal. The amino acids will be labeled with nonradioactive heavy isotopes which are also present in the environment n low amounts.

Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.

Detailed description: Apolipoproteins regulate the metabolism of lipids and lipoproteins in plasma of humans. In order to investigate the roles of apolipoproteins in these processes, we plan to quantitate the kinetics of the metabolism of apolipoproteins utilizing nonradioactive isotope labeled amino-acids.

Eligibility criteria: The subjects for these investigations will be either healthy normal volunteer control subjects or patients who have a dyslipoproteinemia.

Subjects must be 18-80 years old.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Gordon T, Castelli WP, Hjortland MC, Kannel WB, Dawber TR. High density lipoprotein as a protective factor against coronary heart disease. The Framingham Study. Am J Med. 1977 May;62(5):707-14. doi: 10.1016/0002-9343(77)90874-9.
citation: Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts. JAMA. 1987 Jun 19;257(23):3233-40.
citation: Brown MS, Goldstein JL. A receptor-mediated pathway for cholesterol homeostasis. Science. 1986 Apr 4;232(4746):34-47. doi: 10.1126/science.3513311. No abstract available.
Clinical trial NCT05430126: Hepatotoxicity Related to Protein Kinase Inhibitors
Official title: Hepatotoxicity Related to Protein Kinase Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the FDA Adverse Event Reporting System (FAERS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 600000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients treated with protein kinase inhibitors and experiencing hepatotoxicities.

Brief summary: Although protein kinase inhibitors (PKIs) have proved effective in treating many cancers, few patients receiving PKIs may experience rare but life-threatening hepatotoxicity such as hepatic failure. Today, there is no large-scale retrospective pharmacovigilance study focusing on protein kinase inhibitors-related hepatotoxicity.

The objective was to investigate reports of hepatotoxicity related to protein kinase inhibitors using FDA Adverse Event Reporting System (FAERS).

Detailed description: The investigators plan to include FDA approved PKIs from PKIDB, a curated, annotated and updated database of protein kinase inhibitors (https://www.icoa.fr/pkidb/).

The search terms of hepatotoxicities will be extracted from "Drug related hepatic disorders-comprehensive search (SMQ)" in MedDRA (Medical Dictionary for Regulatory Activities).

Eligibility criteria: Inclusion Criteria:

* Case reported in the FAERS database of individual safety case reports at the time of the extraction,
* Patients treated with at least 1 PKIs.

Exclusion Criteria:

* Chronology not compatible between the PKIs and hepatotoxicities

Primary outcomes:
measure: Hepatotoxicities cases reports related to PKIs (from FAERS database).
timeFrame: From 2004 to Sep, 2021
Secondary outcomes:
measure: Description of the time to onset of hepatotoxicities after PKIs exposure.
timeFrame: From 2004 to Sep, 2021
measure: Description of the fatality cases.
timeFrame: From 2004 to Sep, 2021
Other outcomes:
Locations:
city: Changsha
country: China
facility: Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT04368026: SARS-CoV-2 (COVID-19) and Surgery
Official title: Surgical Care in Poland After COVID19 Outbreak - a National Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study group included Polish surgeons and surgery residents working in surgical departments during pandemic.

Brief summary: Importance: During COVID-19 pandemic, it is necessary to collect and analyze data concerning management of hospitals and wards in order to work out solutions for potential future crisis.

Objective: The objective of the study was to investigate how surgical wards in Poland are managing during the COVID-19 pandemic.

Design, Setting and Participants: An anonymous, online survey was designed and published on the official website of The Association of Polish Surgeons. Data was collected between March the 30th and April the 6th of 2020. After data analysis responders were divided into two groups: Group 1 (responders currently working in a "COVID-19-dedicated" hospital) and Group 2 (responders currently working in "non-COVID-19-dedicated" hospital). The study group included Polish surgeons and surgery residents working in surgical departments during pandemic.

Detailed description: Main outcomes and Measures: Descriptive data on perceptions of current status of surgical wards during the pandemic and impact of the pandemic on conducting surgery.

Eligibility criteria: Inclusion Criteria:

* The study group included Polish surgeons and surgery residents working in surgical departments during pandemic, who granted an informed consent to participate in the study. .

Exclusion Criteria:

* Retired surgeons, physicians and residents with non-surgical specializations, medical interns, medical students, other health-care professionals were excluded from this study

Primary outcomes:
measure: Descriptive data on perceptions of current status of surgical wards during the pandemic and impact of the pandemic on conducting surgery.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: 2nd Department of General Surgery, Jagiellonian University Medical College
state: Małopolska
Study officials:
References:
Clinical trial NCT06276426: Plants Optimizing Development Study (PODS)
Official title: Plants Optimizing Development Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Children
Keywords: soy
isoflavones
cognition
body composition
fecal microbiota
metabolic risk
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Soy Nutrition Institute
First posted: 2024-02-26
Enrollment: 96
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.

Detailed description: The central hypothesis is that greater soy isoflavone consumption does not alter sex steroid levels but is associated with beneficial clinical outcomes of body composition, metabolic health, and gut-brain axis among pre- and early adolescents.

Eligibility criteria: Inclusion Criteria:

* Child assent and parent/guardian consent
* Free of any food allergy
* 8-11 years of age
* Tanner scale score of ≤ 2
* 20/20 or corrected vision
* No antibiotic usage in the past 3 months
* ≤1 serving/d of soy food habitual consumption

Exclusion Criteria:

* Non-assent or consent by child assent and/or parent/guardian
* Presence of any food allergy
* Younger than 8 years or older than 11 years
* Presence of specific neurological and genetic disorders (i.e., Autism, Cerebral Palsy, Multiple Sclerosis, Down syndrome)
* Presence of endocrine, metabolic, and gastrointestinal disease e.g., hypertension, diabetes, celiac disease
* Tanner scale score of \> 2
* Not 20/20 or uncorrected vision
* Antibiotic usage in the past 3 months
* \>1 serving/d of soy food habitual consumption

Primary outcomes:
measure: Sex steroid excretion
timeFrame: 3 months (Baseline vs Follow-up)
Secondary outcomes:
measure: Gut microbiota
timeFrame: 3 months (Baseline vs Follow-up)
measure: Attentional Accuracy
timeFrame: 3 months (Baseline vs Follow-up)
measure: Attentional Reaction Time
timeFrame: 3 months (Baseline vs Follow-up
measure: Hippocampal-dependent Relational memory
timeFrame: 3 months (Baseline vs Follow-up)
measure: Body Composition
timeFrame: 3 months (Baseline vs Follow-up)
measure: Metabolic Markers
timeFrame: 3 months (Baseline vs Follow-up)
measure: Pubertal Staging
timeFrame: 3 months (Baseline vs Follow-up)
measure: Cognitive Abilities and Academic Achievement
timeFrame: 3 months (Baseline vs Follow-up)
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
References:
Clinical trial NCT00687726: Simple Home-Based Exercise for Knee Osteoarthritis
Official title: The Relationship of Knee Joint Osteoarthritis to Balance and Walking Ability.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
knee
exercise
balance
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
First posted: 2008-06-02
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Simple home-based standing balance training and isometric knee extension exercise for 4 weeks would improve functional ability and knee muscle strength of patients with knee osteoarthritis.
2. The outcome of standing balance training is different from isometric knee extension exercise.


Eligibility criteria: Inclusion Criteria:

* Clinical criteria for knee osteoarthritis

Exclusion Criteria:

* cardiovascular disease
* Parkinsonism
* osteoporosis
* inability to walk for 15 meters
* intra-articular injections

Primary outcomes:
measure: Knee osteoarthritis outcome scores (KOOS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Knee muscle peak torque
timeFrame: 4 weeks
measure: Aggregate functional performance time
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ongkharak
country: Thailand
facility: Faculty of Health Science, Srinakharinwirot University
state: Nakhonnayok
Study officials:
affiliation: Srinakharinwirot University
name: Kanda Chaipinyo, PT,PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaipinyo K, Karoonsupcharoen O. No difference between home-based strength training and home-based balance training on pain in patients with knee osteoarthritis: a randomised trial. Aust J Physiother. 2009;55(1):25-30. doi: 10.1016/s0004-9514(09)70057-1.
Clinical trial NCT04104126: Blood Flow Restriction Therapy in Achilles Injury
Official title: Blood Flow Restriction Therapy in Achilles Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Achilles Injuries Tendon
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 57
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: Blood flow restriction (BFR) therapy is a brief and partial restriction of venous outflow of an extremity during low load resistance exercises. It is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. This prospective, randomized study will look at the implications this form of treatment has on the rehabilitation of Achilles injuries.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Achilles Injury
* Must be at least 18 years of age and younger than 65 years of age
* Intention to receive physical therapy as standard of care

Exclusion Criteria:

* Patients with intention to receive standard therapy and not the study therapy
* Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension
* Younger than 18 years of age or older than 65
* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
* Any patient considered a vulnerable subject

Primary outcomes:
measure: efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength
timeFrame: 12 Months
measure: Measure of pain using Visual Analog Scale (VAS)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Guillem Gonzalez-Lomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122926: Intensive Discharge Intervention in Diabetes
Official title: Effects of an Intensive Discharge Intervention on Medication Adherence, Glycemic Control, and Readmission Rates in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes
Cardiovascular Disease
Keywords: Transitions in care
discharge intervention
RCT
readmission rates
medication adherence
glycemic control
ED visits
medication reconciliation
Coleman Transitions Coach
telemonitoring; hypoglycemic events
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2014-04-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to design and implement an intensive discharge intervention for inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the intervention on post-discharge insulin adherence, glycemic control, cardiac medication adherence, hypoglycemic events, and emergency department visits and hospital readmissions.


Eligibility criteria: Inclusion Criteria:

* Adult inpatients at BWH on the medicine or cardiology services with a primary care physician who belongs to a participating practice or has not explicitly opted out of the study
* Type 2 diabetes
* Active cardiovascular disease
* Likely to be discharged home, and one of the following:

  1. prescribed insulin prior to admission
  2. prescribed two oral agents and with an A1c \> 8.0 within 30 days of admission. - Practices that have already agreed to participate in this study for all their eligible patients.

Exclusion Criteria:

1. Discharge to a location other than home or rehabilitation (or to a caregiver's home)
2. Patient does not administer own medications and absence of a caregiver who lives with patient and administers all medications
3. Police custody, no telephone or homeless
4. Previous enrolment in the study within 90 days of discharge
5. Patient unable to communicate in either English or Spanish
6. Participation in the Integrated Care Management Program (iCMP)

Primary outcomes:
measure: Cardiac medication adherence
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Glycemic control
timeFrame: 90 days after discharge
measure: Emergency department visits
timeFrame: Within 30 days after discharge
measure: Number of self-reported hypoglycemic events
timeFrame: Within 30 days of discharge
measure: Number of patient-days with hypoglycemia
timeFrame: Within 30 days of discharge
measure: Cardiac medication adherence
timeFrame: 90 days after discharge
measure: Hospital Readmissions
timeFrame: Within 30 days of discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeffrey L Schnipper, MD, MPH, FHM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03517826: Validity and Reliability of The Turkish Version of Breathlessness Beliefs Questionnaire
Official title: Validity and Reliability of The Turkish Version of Breathlessness Beliefs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
COPD
Keywords: COPD
Dyspnea
Kinesiophobia
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients

Brief summary: In our study, we aimed to evaluate the validity and reliability of the Turkish version of the Breathlessness Beliefs Questionnaire-BBQ in our study.

Detailed description: Pulmonary diseases are a common cause of mortality and morbidity throughout the world. In pulmonary diseases such as asthma and COPD, the main symptom is dyspnea and it causes activity limitation. Dyspnea is defined as the difficulty that a person experiences during breathing. As a result of painful situations or injuries, avoidance of physical activity or movement due to the fear of repetition of the problem are defined as kinesophobia. Pulmonary patients are compensated by reducing the rate of activity, while avoiding dyspnea.This reduces the severity of the symptom that precedes the symptom that may occur. As a result, dyspnea causes kinesyphobia. Decrease in the level of activity; social isolation, fear of dyspnea, depression and anxiety result in a stubborn cycle, quality of life is reduced. The Breathlessness Beliefs Questionnaire (BBQ) was developed based on the Tampa Kinesiophobia Scale to assess dyspnea and dyspnoea-related kinesophobia and anxiety in respiratory diseases.

Eligibility criteria: Inclusion Criteria:

* FEV1/FVC\<%70
* To be able to read and understand Turkish

Exclusion Criteria:

* Having undergone a COPD exacerbation in the last 6 weeks
* Having comorbidities affecting ambulance
* Having cognitive disorders

Primary outcomes:
measure: Breathlessness Beliefs Questionnaire-BBQ
timeFrame: 3 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
affiliation: Bezmialem Vakif University
name: Seda Saka, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Peuter S, Janssens T, Van Diest I, Stans L, Troosters T, Decramer M, Van den Bergh O, Vlaeyen JW. Dyspnea-related anxiety: The Dutch version of the Breathlessness Beliefs Questionnaire. Chron Respir Dis. 2011;8(1):11-9. doi: 10.1177/1479972310383592. Epub 2010 Dec 20.
citation: Wu Q, Guo A, Zhao Y, Li S, Huang H. Reliability and validity of the Chinese version of the Breathlessness Beliefs Questionnaire. Chron Respir Dis. 2018 May;15(2):114-122. doi: 10.1177/1479972317715551. Epub 2017 Jun 21.
Clinical trial NCT01264926: Evaluation of the Difference in the Acromion Humerus Gap at Sitting,Lying
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Impingement Syndrome.
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-12-22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men and women with or without shoulder pain0

Brief summary: The Objective is to evaluation the difference between the upper end of the Humerus head and the bottom end of the Acromion in sitting and lying, and to examine this difference to shoulder pain.


Eligibility criteria: Inclusion Criteria:

* men and women with or without shoulder pain.

Exclusion Criteria:

* unwillingness to sign informed consent

Primary outcomes:
measure: level of pain as measured by the visual analogue score
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: