louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02030977: The Effects of Resveratrol Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Official title: The Effects of Resveratrol Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non Alcoholic Fatty Liver
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older;
* Evidence of nonalcoholic steatohepatitis with steatosis grade higher or equal to 1 in ultrasonography;
* No history of Alcohol consumption or consuming less than 10 grams alcohol per day in women and less than 20 grams per day in men;
* Absence of other liver disorders, malignancies, cardiovascular, respiratory, and kidney disorders;
* Absence of pregnancy or lactation;
* Absence of taking any medications in the past three months;
* Absence of weight loss in the recent three months;
* Absence of endocrine and metabolism disorders.

Exclusion Criteria:

* Weight loss more than 10% of baseline body weight during the intervention period.
* Pregnancy;
* Disliking to continue the study.

Primary outcomes:
measure: Alaninaminotransferase(ALT)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Faghihzadeh F, Adibi P, Rafiei R, Hekmatdoost A. Resveratrol supplementation improves inflammatory biomarkers in patients with nonalcoholic fatty liver disease. Nutr Res. 2014 Oct;34(10):837-43. doi: 10.1016/j.nutres.2014.09.005. Epub 2014 Sep 23.
Clinical trial NCT01291277: Time Interval for Endoscopic Variceal Ligation
Official title: Appropriate Time Interval for Repeat Sessions of Endoscopic Ligation for the Eradication of Esophageal Varices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Variceal Bleeding
Keywords: gastrointestinal hemorrhage
esophageal varices
gastrointestinal endoscopy
ligation
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Yale University
name: VA Connecticut Healthcare System
First posted: 2011-02-08
Enrollment: 90
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: Patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). The current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding varices. Patients generally receive ligation at the time they come in with bleeding and then return at regular intervals to have repeat ligation in order to eradicate the varices. However there have been no studies to determine the appropriate intervals for esophageal variceal ligation until eradication. We will conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients that have presented with bleeding varices. Our hypothesis is that one-week ligation will achieve more rapid eradication than the two-week interval with a greater proportion of patients achieving variceal eradication at 4 weeks after the index bleeding episode.


Eligibility criteria: Inclusion Criteria:

* Patients who presented with acute upper GI bleeding due to esophageal varices and underwent successful endoscopic variceal ligation.
* Patients who would normally receive repeat endoscopic ligation therapy to eradicate varices.

Exclusion Criteria:

* Persistent bleeding despite endoscopic and medical therapy
* Platelet count \< 40,000

Primary outcomes:
measure: Proportion of Patients With Eradication of Esophageal Varices
timeFrame: At 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: L.A. County + U.S.C. Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Loren Laine, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02482077: Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients
Official title: Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
First posted: 2015-06-25
Enrollment: 112
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: The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.


Eligibility criteria: Inclusion Criteria:

1. Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;
2. Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
3. HCV RNA \> 10,000 IU/mL at Screening;
4. Screening laboratory values within defined thresholds
5. Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

1. Pregnant or nursing female or male with pregnant female partner;
2. HIV or chronic hepatitis B virus (HBV) infection;
3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
4. Active or recent history (≤ 1 year) of drug or alcohol abuse;
5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).

Primary outcomes:
measure: Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy
timeFrame: Post treatment Week 12
measure: Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
timeFrame: Baseline up to Week 24
measure: HCV RNA levels and change during and after treatment.
timeFrame: Baseline up to Week 24
measure: Proportion of participants with on-treatment virologic breakthrough and relapse
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
state: Beijing
city: Hong Kong
country: China
facility: Humanity and Health GI and Liver Centre
state: Hong Kong
Study officials:
affiliation: Humanity and Health GI and Liver Centre
name: George KK Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02287077: Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
Official title: A Randomized Controlled Trial of Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic Ischemic Encephalopathy
Umbilical Cord Milking
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India
First posted: 2014-11-10
Enrollment: 101
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.

Detailed description: Hypoxic-ischemic encephalopathy (HIE) is a brain injury in neonates due to inadequate blood flow and oxygen delivery to the neonatal brain. Umbilical cord milking can potentially improve brain injury in neonates with HIE. The objective of this study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth. The investigators hypothesized that umbilical cord milking is feasible and safe in neonates who are depressed at birth. The investigators also hypothesized that umbilical cord milking will increase stem cells in neonatal blood circulation and improve short term outcomes in neonates with moderate and severe HIE.

Eligibility criteria: Inclusion Criteria:

* Term and near term neonates (35 weeks and more)
* Depressed at birth

Exclusion Criteria:

* Congenital malformation of central nervous system
* Chromosomal abnormalities
* Major congenital malformations

Primary outcomes:
measure: The number of depressed neonates in whom umbilical cord milking was performed.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.
timeFrame: 24 hours
measure: The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.
timeFrame: 24 hours
measure: The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.
timeFrame: 24 hours
measure: Survival and short term outcomes in neonates with moderate and severe HIE
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences
state: MS
Study officials:
References:
Clinical trial NCT03724877: Effectiveness of Triple Therapy in COPD
Official title: Comparative Effectiveness of Triple Therapy in COPD: A New-user Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 8853
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Incident new-user cohort design with high-dimensional propensity scores to match the two comparison groups of COPD.

Brief summary: To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.


Eligibility criteria: Inclusion Criteria:

* New users of long-acting bronchodilators, Long-acting beta2-agonist (LABA) and long-acting muscarinic antagonists (LAMA) on the same date or of LABA, LAMA and inhaled corticosteroids (ICS), either as a fixed-dose combination (LABA-ICS) or free combination, on the same date between January 2002 and December 2016.
* Diagnosis of Chronic obstructive pulmonary disease (COPD) prior to first maintenance inhaler and age ≥ 55 years at first maintenance inhaler.

Exclusion Criteria:

* Less than one year of medical history information prior to the date of combined treatment initiation (study cohort entry)
* Asthma diagnosis prior to study cohort entry

Primary outcomes:
measure: Number of Participants Hospitalised With Severe Exacerbation
timeFrame: 1 year
measure: Number of Participants Hospitalised With Moderate Exacerbation
timeFrame: 1 year
measure: Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia)
timeFrame: 1 year
Secondary outcomes:
measure: The Rate of COPD Exacerbations Over the One-year Follow-up
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Clinical Practice Research Datalink
Study officials:
References:
Clinical trial NCT06356077: Trends and Satisfaction in Hypertensives Using Aktiia Optical BP Monitoring Device (SHINE)
Official title: SHINE Study: Blood Pressure Evolution and User Satisfaction in a Hypertensive Population Using the Aktiia 24/7 Optical Blood Pressure Monitoring (OBPM) Device: a Prospective Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Aktiia SA
Sponsor class: INDUSTRY
Collaborators: name: Lindus Health
First posted: 2024-04-10
Enrollment: 1729
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The final study population should cover the following phenotypes:

* Close to 50% females and 50% males,
* At least 20% of non-Caucasian participants,
* At least 20% of participants with Systolic Blood Pressure (SBP) ≥150mmHg (assessed at baseline via the study device).

Brief summary: The SHINE study aims to gather data on the evolution of participant's blood pressure and to correlate this with demographic, lifestyle and health factors in a hypertensive population as well as, to gather data on participants' perception of the device under test (Aktiia 24/7).


Eligibility criteria: Inclusion Criteria:

1. Adult participants aged 22 to 85 years old
2. A participant whose last blood pressure reading was within the last 12 months and was either:

   1. SBP ≥145
   2. or ≥DBP 90
3. People who use either an iOS or Android smartphone
4. People who have 2 arms
5. Able and willing to provide informed consent and to adhere to study procedures.

Exclusion Criteria:

1. Participants whose BP data submitted is \>180 mm Hg systolic OR \>120 mm Hg diastolic .
2. Participants with a self-reported known diagnosis of

   1. atrial fibrillation
   2. congestive heart failure
   3. heart valve disease
   4. pheochromocytoma
   5. Raynaud's disease
   6. arm lymphedema
3. Participants who take insulin
4. Participants who are on hemodialysis
5. Women who are self-reported to be pregnant
6. Participants whose arms shake uncontrollably or are paralyzed (cannot move)
7. Participants with upper arm circumference \<22 cm or \>42 cm
8. Participants with wrist circumference \>23cm
9. Participation in another interventional clinical study or use of investigational drugs in the last 30 days.

Primary outcomes:
measure: Blood Pressure evolution over 12 weeks
timeFrame: 3 months
Secondary outcomes:
measure: Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor
timeFrame: 3 months
measure: Correlation between the data from Aktiia 24/7 device continual BP monitoring with sociodemographic, lifestyle and health factors.
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Lindus Health
Study officials:
References:
Clinical trial NCT02419677: Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases
Official title: Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Keywords: radiofrequency ablation
cytokine-induced killer cells
colorectal cancer iver metastases
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with colorectal cancer liver metastases (CRCLM).

Detailed description: The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with resectable CRCLM.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed adenocarcinoma
* Primary lesions (colorectal cancer) are resected
* Must have undergone prior complete resection of the primary tumor; liver metastases
* Must be resectable or accessible for radiofrequency ablation (Five or less lung metastases measuring 5 cm or smaller).
* Serum bilirubin level of 2.0 mg/dl or less.
* Performance status of 0 or 1.
* Expected survival of 1 year or more.
* Informed consent from the patient.

Exclusion Criteria:

* With extrahepatic metastases
* With other neoplastic disease that is measurable or being treated other than colorectal cancer.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: One year
Secondary outcomes:
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
Study officials:
affiliation: The First People's Hospital of Changzhou
name: Changping Wu, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05555277: Retrospective Examination of Electroencephalography Signals of Individuals With Different Eating Disorders
Official title: Retrospective Examination of Electroencephalography Signals of Individuals With Different Eating Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Bulimia Nervosa
Keywords: eating disorders
electroencephalography
depression
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals aged 18 years or younger with AN and BN who were administered scales of depression, anxiety and eating attitudes

Brief summary: The aim of this study was to investigate the difference between electroencephalography (EEG) data and current psychological status of individuals diagnosed with anorexia nervosa (AN) and bulimia nervosa (BN).

Detailed description: The data used in this study were obtained from individuals aged 18 and younger with eating disorders who applied to Üsküdar University NP Istanbul Brain Hospital. Two different diagnostic groups, Anorexia Nervosa and Bulimia Nervosa, were included in the study. Demographic information, secondary diagnosis status, Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Eating Attitude Test - 40 (EAT-40) scores and EEG data were used to investigate the differences between eating disorders. Comparison of neurological differences between individuals with AN and BN was done retrospectively.

This information, which will be obtained for AN and BN, which are diseases in which severe deterioration in behavior and perception are seen, can give advice to experts in planning treatment and rehabilitation processes.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with anorexia nervosa or bulimia nervosa to the DSM-V diagnostic criteria
* 18 years and younger
* Having an EEG data

Exclusion Criteria:

* Having an EEG data taken in a center other than NP Istanbul Brain Hospital
* Lack of "Beck Depression Inventory", "Beck Anxiety Inventory" and "Eating Attitude Test-40" scale values in the patient file

Primary outcomes:
measure: Differences between EEG data of patients with anorexia nervosa and bulimia nervosa
timeFrame: April 2022-September 2022
measure: Differences between depression levels of patients with anorexia nervosa and bulimia nervosa
timeFrame: April 2022-September 2022
measure: Differences between anxiety levels of patients with anorexia nervosa and bulimia nervosa
timeFrame: April 2022-September 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Fatma Demir
state: İ̇stanbul
Study officials:
affiliation: Research assistant
name: Fatma Demir
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate professor
name: Alper Evrensel
role: STUDY_CHAIR
affiliation: Assistant professor
name: Tuğçe Ballı Altuğlu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01022177: Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus
Official title: Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the influence of specific eye acupuncture to the ocular microcirculation in diabetic and healthy subjects.

Detailed description: Diabetes is combined with severe vascular damage at the different stages of the disease, causing reduction in retinal perfusion. Acupuncture is supposed to regulate the perfusion. We propose a study to evaluate the effect of acupuncture to the vascular auto regulation in patient with Diabetes, compared to healthy people without vascular or retinal diseases. The perfusion of the retinal vessel will be examined by Retinal vessel analyzer (RVA), Heidelberg retinal Flowmeter (HRF) and the Ocular blood Flowmeter (OBF) before, during and after standardized specific acupuncture at healthy volunteers and patients with diabetes.

Eligibility criteria: Inclusion Criteria:

* persons over 18 years, men or women, diabetic diagnostics within the last year

Exclusion Criteria:

* medical use of anticoagulative substances, use of dorzolamide, use of immunosuppressive medication
* psychiatrics, epileptics

Primary outcomes:
measure: retinal perfusion by HRF/OBF/RVA
timeFrame: post acupuncture (one day measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Carl Gustav Carus
state: Saxonia
Study officials:
name: Janek - Haentzschel, Dr.
role: STUDY_DIRECTOR
References: