louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000338: Infusion Laboratory: Protocol 2 (Lisuride) - 3
Official title: Infusion Laboratory: Protocol 2 (Lisuride)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate clinical safety issues pertaining to lisuride, to cocaine, and to its interaction in a chronic, crack dependent population, and to determine how pretreatment with lisuride modifies the subjective as well as physiological effects of cocaine.


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Primary outcomes:
measure: Degree of drug craving
measure: History, incidence and amount of drug use
measure: Type and severity of stimulant withdrawal symptoms
measure: Characterization of study population
measure: Population incidence of symptoms of depression, po
measure: Frequency and intensity of drug use and sexual beh
measure: Evidence of change in neurophysiology and brain ac
measure: Evidence of change in subjective responses to coca
measure: Clinical physiological response to cocaine challen
measure: Degree to which study medication influences change
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06911203: A Study of BGM0504 in Participants With Obesity
Official title: A Phase II, Randomized Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BGM0504 Compared to Tirzepatide in Adults Who Have Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 90
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: To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* ● Able and willing to provide a written informed consent.

  * Male or female subjects, 18-65 years of age at the time of signing informed consent.
  * At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;
  * Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.

Exclusion Criteria:

* ●History of chronic or acute pancreatitis.

  * History of severe drug allergy or specific allergic disease or severe allergies.
  * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).
  * History of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\].
  * Suspected or confirmed history of alcohol or drug abuse;
  * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
  * Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
  * Pregnant or lactating woman.
  * Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.

Primary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Week 0, Week 26
Secondary outcomes:
measure: Change From Baseline in BMI
timeFrame: Week 18, Week 26
measure: Change From Baseline in Waist Circumference
timeFrame: Week 18, Week 26
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Week 18, Week 26
measure: Change from Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Week 18, Week 26
measure: Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
timeFrame: Week 0, Week 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00188903: Diastolic Dysfunction and Atrial Fibrillation in CABG Surgery
Official title: Diastolic Dysfunction and Atrial Fibrillation in Patients Undergoing Coronary Revascularization Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Atrial Fibrillation
Keywords: Cardiac Surgery
Diastolic Dysfunction
Atrial Fibrillation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective coronary artery bypass graft patients either on or off pump in acute care centre

Brief summary: Left ventricular (LV) diastolic dysfunction is a common manifestation of heart disease that is responsible for significant morbidity and mortality.It is present when the ventricular filling is impaired as a result of delayed relaxation or decreased compliance. During Coronary artery bypass grafting (CABG) surgery, LV diastolic dysfunction is a frequent occurrence. Failure of the left ventricle to dilate normally causes an increase in LV filling pressure. Atrial fibrillation (AF) is a common complication after cardiac surgery affecting 20-30% of patients undergoing coronary revascularization procedures. AF is associated with significant morbidity and mortality and has been identified as a causative factor of increased length of both hospital and intensive care unit (ICU) stay after CABG surgery, resulting in increased resource utilization and medical care costs.The primary aim of this study is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.


Eligibility criteria: Inclusion Criteria:

* scheduled for elective CABG or OPCAB surgery
* signed informed consent

Exclusion Criteria:

* Patients with a history of previous heart surgery and/or undergoing valvular heart surgery.
* Patients with preoperative atrial fibrillation.
* Patients in whom TEE is contraindicated.

Primary outcomes:
measure: Is to determine if patients with preoperative diastolic dysfunction are exposed to higher risk of AF after coronary revascularization surgery.
timeFrame: pre and post operative
Secondary outcomes:
measure: Is to determine if diastolic dysfunction and AF are associated with increased perioperative cardiac morbidity and reduced event-free survival.
timeFrame: post operative until discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital, Univsersity Health Network
name: George N Djaiani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashes CM, Yu M, Meineri M, Katznelson R, Carroll J, Rao V, Djaiani G. Diastolic dysfunction, cardiopulmonary bypass, and atrial fibrillation after coronary artery bypass graft surgery. Br J Anaesth. 2014 Nov;113(5):815-21. doi: 10.1093/bja/aeu208. Epub 2014 Jul 8.
Clinical trial NCT02527603: Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation
Official title: Randomized Clinical Trial Comparing the Spaso Maneuver Versus the Self-assisted Boss-Holzach-Matter for Anterior Shoulder Dislocations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for anterior shoulder dislocation and the Spaso method performed by a physician.

Detailed description: Introduction: There are many described maneuvers in literature describing how to reduce an anterior shoulder dislocation. Most of these maneuvers are performed by a trained physician, however, seldom are these taught to patients in case of recurrence or accidental dislocations that may occur far from a trained professional to treat. The Boss-Holzach-Matter maneuver is a simple, easy to understand and easy to perform self assisted method that has not been compared to any other method.

Hypothesis: The Boss-Holzach-Matter method is a less painful maneuver compared to the Spaso method assuming an equal success rate.

Objective: To determine whether the Boss-Holzach-Matter method is a less painful method for anterior shoulder dislocations compares to the Spaso method assuming equal success rate.

Methodology: Fifty six patients presenting acute anterior shoulder dislocation will be randomized, at the time of the admission , to either Spaso reduction method performed by a physician or the self-assisted Boss-Holzach-Matter method.

Eligibility criteria: Inclusion Criteria:

* Patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area.

Exclusion Criteria:

* Fracture luxation of the same shoulder.
* Inability to cooperate due to mental or physical condition.

Primary outcomes:
measure: Change From Baseline in Pain that the patient experiences during the reduction procedure
timeFrame: Patients will be assessed throughout their visit to the Trauma Unit. No further following should be necessary.There will be no change in pain measurement, only the amount of pain felt during the manoeuvre.
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporación sanitaria Parc Taulí de Sabadell
state: Barcelona
Study officials:
affiliation: Doctor
name: David Marti, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01101503: The Effect of Intensive Multifactorial Therapy on Endothelial Function in Newly Diagnosed Type 2 Diabetes
Official title: The Metabolic Memorial Effect of Early Intensive Multifactorial Treatment in Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endothelial Dysfunction
Keywords: Newly diagnosed type 2 diabetes
Endothelial dysfunction
Intensive therapy
Metabolic Memorial Effect
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The endothelial dysfunction is the early event in atherosclerosis. The investigator previous study showed that impaired endothelial function exist in newly diagnosed type 2 diabetes. The investigators hypothesize that intensive multifactorial therapy including intensive blood control and intensive hypertension control as well as intensive blood lipids control of 1 year can improve vascular endothelial function. Moreover, the improvement of endothelial function maintains after 5 years or 10 years of intensive multifactorial therapy, called "Metabolic Memorial Effect of improvement of endothelial function".

Detailed description: * We select 1000 patients with newly diagnosed type 2 diabetes. They are divided into two groups, respectively (Intensive multifactorial therapy and conventional multifactorial therapy groups). After those therapy for one year, a 10 years of follow up study will be performed. During this period, we take them together intensive education, and take conventional multifactorial therapy for both of two groups.
* At the beginning (0 year),the end of intensive multifactorial therapy (1 year), 5 years and 10 years, we will measure the endothelium-dependent arterial dilation, endothelium related cytokines such as ET-1, vWF,as well as blood glucose, HbA1c for all of individuals.
* We will compare the endothelial function,endothelium related cytokines such as ET-1, vWF,as well as blood glucose, HbA1c between intensive therapy group and conventional therapy group at different time points.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed type 2 diabetes,
* Age: 40 \>= age \<=70 year old,

Exclusion Criteria:

* Type 1 diabetes,
* Mitochondrial diabetes
* Patients with clinical detectable angiopathy,
* Body Mass Index (BMI) \> 30 Kg/m2,
* Age \< 40, or \> 70 years old,
* Malignant neoplasms, renal or liver diseases,
* Smokers
* Known diabetes

Primary outcomes:
measure: The metabolic memory effect of endothelium-dependent arterial dilation
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan City
country: China
facility: Department of Endocrinology
state: Hubei
Study officials:
affiliation: Wuhan General Hospital
name: Xiang Guangda, MD.Ph D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05258643: The Role of Natural Killer, Complement and T-lymphocytes in COVID-19 Disease, a Prospective Monocentric Study
Official title: The Role of Natural Killer, Complement and T-lymphocytes in COVID-19 Disease, a Prospective Monocentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complement Abnormality
Peripheral Blood Mononuclear Cells
Covid19
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is an open, non-randomized, monocentric, and interventional study. CoViD-19 patients will be recruited at UZ Brussel after informed consent is obtained. Whole blood and serum samples will be collected during acute disease (inclusion and 7 days after inclusion) and during patient follow-up at 2 months after infection.

Sample storage and subsequent use in fundamental research will be performed at VUB Neuro-Aging and Viro-Immunotherapy.

Additionally, medical records of UZ Brussel will be searched and epidemiological, clinical, radiological, and biological data of the selected patients will be obtained at the diagnosis time point and during follow-up.

Healthy volunteers will be recruited as well in the current study, as a comparison arm, after informed consent is obtained.


Eligibility criteria: Covid-19 patients

Inclusion Criteria:

* Positive nasopharyngeal reverse transcriptase-polymerase chain reaction for SARS-Coronavirus-02
* Signed inform consent

Healthy Volunteers

Inclusion Criteria:

* Signed inform consent

Primary outcomes:
measure: Difference in complements or peripheral blood mononuclear cells between CoViD-19 patients and controls
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
affiliation: UZ Brussel (Vrije Universiteit Brussel)
name: Sabine Allard, PhD
role: STUDY_DIRECTOR
affiliation: Vrije Universiteit Brussel
name: Joeri Aerts, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03202043: The Juice Study: Sensitivity of Skin Carotenoid Status to Detect Change in Intake
Official title: Sensitivity of Skin Carotenoid Status to Detect Changes in Intake of Varying Levels of Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2017-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids.

Detailed description: The US Dietary Guidelines for Americans recommends that individuals consume approximately 2-4 c of vegetables each day to reduce risk of chronic disease, but current methods for assessing intake are either inaccurate (self-report) or invasive (blood carotenoid levels). Recent research indicates that skin carotenoid status may be a useful biomarker of vegetable intake, but the sensitivity to dose in unknown. In this study, we propose to test the dose-response of skin carotenoids to consumption of 3 different levels of vegetable juice (with a control group receiving water). We will test skin carotenoids in two ways: using resonance Raman spectroscopy (RRS), which we have previously validated, and with a new technique, pressure mediated reflection spectroscopy (RS; the "Veggie Meter"). We will compare the two techniques during an 8-week provided tomato-based juice intervention. Skin carotenoid readings will be compared to blood carotenoid concentrations and single nucleotide polymorphisms (SNPs) of genes related to the uptake, transport, and metabolism of carotenoids will be examined in blood and saliva.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5-29.9 kg/m2

Exclusion Criteria:

* weigh less than 110 lbs
* currently dieting to lose weight
* allergic to tomatoes or vegetables
* pregnant, lactating, or planning to become pregnant
* currently use tobacco products or vape
* eat more that 2 cups of vegetables per day
* have high blood sugar (≥200 mg/dL)
* have high blood pressure (≥140/90 mm Hg)
* have a medical condition such as diabetes or high blood pressure
* taking medication that lowers cholesterol or triglycerides

Primary outcomes:
measure: Change in skin carotenoid concentration as measured by pressure-mediated reflection spectroscopy (RS)
timeFrame: 0, 4, 8 weeks
Secondary outcomes:
measure: Usual intake of carotenoid-rich foods and beverages
timeFrame: 0,4,8 weeks
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02383043: Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
Official title: Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Active Cocaine Users
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use, otherwise healthy

Exclusion Criteria:

* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease

Primary outcomes:
measure: The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
timeFrame: 9 choice trials per cocaine dose level with each trial separated by 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Laboratory of Human Behavioral Pharmacology
state: Kentucky
Study officials:
References:
Clinical trial NCT04814043: PD-1 Antibody and Lenvatinib Plus TACE-HAIC for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial
Official title: Systemic PD-1 Antibody (Sintilimab) and Lenvatinib Plus Transarterial Chemoembolization and FOLFOX-based Chemotherapy Infusion for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: systemic PD-1 antibody and lenvatinib plus TACE-HAIC for potential resectable HCC
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, less than 20% of newly diagnosed patients can undergo radical resection. Our latest study showed that 48% potentially resectable HCC received hepatectomy after transarterial chemoembolization plus FOLFOX-based chemotherapy infusion (TACE-HAIC) treatment. Recently, several clinical trials (LEAP-002) showed that PD-1 antibody and Lenvatinib had an ORR of 36% for advanced patients. The combination of TACE-HAIC with PD-1 antibody and lenvatinib, theoretically can significantly decrease the tumor burden and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to investigate TACE-HAIC plus PD-1 antibody and Lenvatinib will increase the resection rate for those patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as potentially resectable with consensus by the panel of liver surgeons
* stage BCLC A/B/C, without extra-hepatic involvement
* No previous anti-HCC treatment
* Eastern Co-operative Group performance status 2 or less
* Liver function: Child's A or B (score \< 7)

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy

  * underlying serve cardiac or renal diseases Known or suspected allergy to the investigational agent or any agent given in association with this trial
  * Patients ineligible for hepatic artery embolization, or PD-1 antibody

Primary outcomes:
measure: conversion rate to resection
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan
role: PRINCIPAL_INVESTIGATOR
References: