louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03313414: HCV Post-Exposure Prophylaxis for Health Care Workers
Official title: Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hepatitis C
Keywords: HCV
Needlestick
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2017-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an unblinded, observational trial of sofosbuvir-velpatasvir in adult health care workers who are exposed to hepatitis C virus from needlestick injury with hollow-bore needles.

Detailed description: The goal of this study is to assess the safety and tolerability of the use of sofosbuvir-velpatasvir in the setting of post-exposure prophylaxis among Health Care Workers exposed to HCV from needlestick injury with hollow-bore needles

Eligibility criteria: Inclusion Criteria:

* Healthcare worker with exposure through needlestick injury with hollow-bore needles to source patients who are HCV positive
* Healthcare worker must be HCV Ab-

Exclusion Criteria:

* HCV Ab positive
* HCV Ab negative and HCV RNA greater than 1000 IU/ml
* Active malignancy
* Positive urine pregnancy test

Primary outcomes:
measure: Undetectable HCV RNA
timeFrame: 12 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560014: Nutrient Levels Alter Transplant Outcome
Official title: Role of Immunonutrient Levels in Preventing Complications After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Disease
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-11-19
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to look at lipid profiles of plasma and RBC and amino acid profiles in plasma to determine if they are associated with allograft rejection, calcineurin inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving dietary supplements with arginine and omega-3 fatty acids.


Eligibility criteria: Inclusion Criteria:

* Renal transplant recipient
* Appropriate blood samples drawn and analyzed

Primary outcomes:
measure: Plasma and red blood cell lipid profiles
timeFrame: Within 1 year
measure: Plasma amino acid profiles
timeFrame: within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital
state: District of Columbia
city: Durham
country: United States
facility: Duke University School Of Medicine
state: North Carolina
Study officials:
affiliation: UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
name: J. W. Alexander, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander JW, Goodman HR, Succop P, Light JA, Kuo PC, Moser AB, James JH, Woodle ES. Influence of long chain polyunsaturated fatty acids and ornithine concentrations on complications after renal transplant. Exp Clin Transplant. 2008 Jun;6(2):118-26.
Clinical trial NCT05182814: Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid
Official title: Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Sleep Disturbance
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess Collagen Drink on skin condition and sleep quality improvement


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing
* Constant drug use
* Received facial laser therapy, chemical peeling or UV overexposure (\>3 hours everyday) in the past 4 weeks.
* Students taught by the PI

Primary outcomes:
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 8 weeks
measure: The change of skin texture
timeFrame: Change from Baseline skin texture at 8 weeks
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 8 weeks
measure: The change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 8 weeks
measure: The change of skin L* value
timeFrame: Change from Baseline L* value at 8 weeks
measure: The change of sleep quality
timeFrame: Change from Baseline sleep quality at 8 weeks
measure: The change of AGEs of blood
timeFrame: Change from Baseline AGEs at 8 weeks
measure: The change of TIMP-1 of blood
timeFrame: Change from Baseline TIMP-1 at 8 weeks
measure: The change of desmosine of blood
timeFrame: Change from Baseline desmosine at 8 weeks
Secondary outcomes:
measure: The change of skin melanin index
timeFrame: Change from Baseline skin melanin index at 8 weeks
measure: The change of skin pores
timeFrame: Change from Baseline skin pores at 8 weeks
measure: The change of skin a* value
timeFrame: Change from Baseline skin a* value at 8 weeks
measure: The change of skin hydration
timeFrame: Change from Baseline skin hydration at 8 weeks
measure: The change of transepidermal water loss
timeFrame: Change from Baseline transepidermal water loss at 8 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
References:
Clinical trial NCT01243814: A Double-blind RCT of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle
Official title: A Double-blind, Randomized, Placebo-controlled Study of the Relative Efficacy of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: hyaluronate
hyaluronic acid
viscosupplementation
Lead sponsor: Henry DeGroot, M.D.
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 69
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: To compare the therapeutic effect of single intra-articular injection of hyaluronate with a single intra-articular injection of normal saline (placebo) for osteoarthritis of the ankle.

Detailed description: This study is a randomized, prospective, double-blind (blinded observer) , saline solution-controlled, parallel experimental design. The study device is SUPARTZ (Seikagaku Corporation, Tokyo, Japan) a brand of sodium hyaluronate.

Eligibility criteria: Inclusion Criteria:

* To be eligible, subjects had to be at least 18 years old, not pregnant, and have pain and osteoarthritis of the ankle of at least stage 2 on the Kellgren and Lawrence scale.
* Their AOFAS score had to be 90 points or less out of a possible 100 points.
* Eligible subjects had to be willing to discontinue all pain medications and NSAIDs other than the rescue pain medications provided in the study.

Exclusion Criteria:

* Persons with systemic inflammatory condition or infection of the ankle or nearby soft tissues,
* an injection of steroid or surgery on the involved joint within 6 months,
* local cellulitis, rash, skin condition
* diabetic or neuropathic Charcot arthropathy,
* significant vascular insufficiency,
* current treatment with anticoagulants,
* lower extremity pain syndromes, sciatica, sprains, plantar fasciitis,
* significant ankle instability or malalignment,
* any known allergy to any of the components of either injection, known or suspected allergy to birds or bird products,
* disabling degenerative joint disease of the ipsilateral hip, knee or foot were ineligible for the study.

Primary outcomes:
measure: AOFAS score, difference from mean at 6 weeks and 12 weeks
timeFrame: 6 weeks 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newton
country: United States
facility: The office of Dr. Henry DeGroot
state: Massachusetts
Study officials:
affiliation: Newton-Wellesley Hospital
name: Henry DeGroot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00729014: A Study of Drug-Induced Kidney Disease
Official title: A Study of Drug-Induced Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Keywords: herbal nephropathy
Chinese herbal nephropathy
nephrotoxicity
renal disease
adverse drug reaction
Chinese herbal medicine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2008-08-06
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: a medical center

Brief summary: The purpose of this study is to identify incidence of Chinese herb nephropathy in a medical center

Detailed description: This is a retrospective study, by computer screening, chart review and phone survey to find herbal nephropathy and determine the cause-relationship.

Using ICD-9-CM code as a tool to screen the newly diagnosed ESRD in NTUH computer data base, and divided patients into those with underlying disease(s) that cause the renal failure and those without.

Eligibility criteria: Inclusion Criteria:

* patient who was newly diagnosed as end stage renal disease who need dialysis

Exclusion Criteria:

* started dialysis before 2000

Primary outcomes:
measure: The incidence of herbal nephropathy
timeFrame: 5 years
Secondary outcomes:
measure: The epidemiology of primary diagnosis for end stage renal disease in Taiwan
timeFrame: 5 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Kwan-Dun Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00103714: Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: lung disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-02-15
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.


Eligibility criteria: Inclusion Criteria:

* Have confirmed diagnosis of CF
* Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
* Have oxygen saturation greater than or equal to 90% on room air
* Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
* Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

* Have changed their physiotherapy technique or schedule within 7 days prior to screening
* Have clinically significant comorbidities
* Using prior and concurrent medications according to the protocol

Primary outcomes:
measure: respiratory function
Secondary outcomes:
measure: adverse events
measure: change in standard safety parameters
measure: respiratory symptoms via questionnaire
measure: pulmonary exacerbation
Other outcomes:
Locations:
Study officials:
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT04096014: Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Official title: Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatic Encephalopathy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
* at least 1 hospitalization for documented HE within the last 12 months.
* abdominal CT scan anytime in the past

Exclusion Criteria:

* Patients with MELD score \> 35
* end stage organ failure (major dysfunction requiring organ support)
* kidney injury defined by a creatinine \> 2 mg/dl or rise in creatinine by 0.5 gm/dl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm/kg up to 100 gm/day)
* active malignancy
* uncontrolled diabetes mellitus with A1c\>9.5 (to avoid altered muscle protein metabolism
* medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass
* recent gastrointestinal surgery within past 12 months
* ongoing infection (positive blood or other body fluid cultures)
* active gastrointestinal bleeding.

Primary outcomes:
measure: Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.
timeFrame: Day 0 & Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
Clinical trial NCT01996514: Food Advertisements, Satiety and Food Intake in Children
Official title: Effect of Food Advertisements on Satiety and Meal-Time Food Intake in 9-14 y Old Boys and Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Prevention
Keywords: Children
Food advertisement
Obesity
Television viewing
Food intake
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-11-27
Enrollment: 59
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: We hypothesized that FA in a TV program watched during a meal, would block satiety responses to pre-meal energy consumption and delay satiation in OW/OB but not in NW boys and girls. Food intake was measured at 30 min following a glucose (1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the presence of food advertisements. Subjective appetite will be measured as well.


Eligibility criteria: Inclusion Criteria:

* born at full-term and of normal birth weight with no emotional, behavioral or learning problems

Exclusion Criteria:

* emotional, behavioral or learning problems dieting

Primary outcomes:
measure: Food intake
timeFrame: at 30 min after treatment
Secondary outcomes:
measure: Subjective appetite
timeFrame: 0 to 60 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01038414: Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence
Official title: Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tobacco Addiction
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-12-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt.


Eligibility criteria: Inclusion Criteria:

* Daily Cigarette Smokers

Exclusion Criteria:

* Smokers with active atherosclerotic heart disease, severe cardiac arrhythmias, uncontrolled hypertension, severe peripheral vascular disease, pre-controlled diabetes mellitus, pregnancy, lactation or likely to become pregnant during the study period, and chronic dermatologic disease.
* Smokers who meet DSM-IV lifetime criteria for conditions such as schizo-affective disorder and schizophrenia, bi-polar disorder, or who have had alcohol or drug dependence issues within the past year.

Primary outcomes:
measure: Proportion of subjects abstinent by treatment group at 1 year post-cessation.
timeFrame: One year
Secondary outcomes:
measure: Proportion of subjects abstinent by treatment group at 2 years post-cessation.
timeFrame: Two years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
References:
Clinical trial NCT00446914: High Blood Pressure Strategy (HBPS)
Official title: High Blood Pressure Strategy: Hypertension Management Initiative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Blood Pressure
Lead sponsor: Heart and Stroke Foundation of Ontario
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2007-03-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This program developed by the HSFO aims at helping people of Ontario and their primary healthcare providers better diagnose, manage and control high blood pressure. The High Blood Pressure Strategy brings together healthcare providers and patients to improve the way in which family doctors, nurse practitioners and pharmacists work together and with patients towards improved control of high blood pressure through the use of evidence-informed tools combined with local systems change.

Detailed description: Approximately 5,000 patients will participate in the study at 11 family practice sites throughout Ontario. Each of the 11 clinic sites will be randomised to either intervention or delayed intervention 9 months later. The intervention is a systems change involving interprofessional education and management tools to bring together physicians, nurses and pharmacists with the patient. Patients will be monitored by their family doctor or nurse practitioner at scheduled follow-up visits during a period of 36 months for an effect of the intervention over time on the patient's blood pressure.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older
* History of elevated BP reading or primary hypertension diagnosis

Exclusion Criteria:

* Major mental health illness of cognitive impairment
* Language barrier (unable to speak or read English)
* Lives in a long-term care home
* Secondary hypertension

Primary outcomes:
measure: Blood Pressure
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Heart and Stroke Foundation of Ontario
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Sheldon W Tobe, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart and Stroke Foundation of Ontario
name: Margaret Moy Lum-Kwong, BSc.N., MBA, CHE
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart and Stroke Foundation of Ontario
name: Shirley Von Sychowski, BA, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tobe SW, Moy Lum-Kwong M, Perkins N, Von Sychowski S, Sebaldt RJ, Kiss A. Heart and Stroke Foundation of Ontario (HSFO) high blood pressure strategy's hypertension management initiative study protocol. BMC Health Serv Res. 2008 Dec 10;8:251. doi: 10.1186/1472-6963-8-251.