louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02134626: Simvastatin Effect on Portal Hypertension
Official title: Simvastatin Effect in Portal Hypertension Measured by Portal Hemodynamic Gradient and Azygos Vein Doppler in Echoendoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Portal Hypertension
Esophageal Varices
Liver Cirrhosis
Keywords: Portal Hypertension
Hepatic Venous Pressure Gradient
Esophageal Varices
Liver Cirrhosis
Simvastatin
Nitric oxide
HVPG
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2014-05-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that simvastatin can lower portal pressure.

Detailed description: The simvastatin can target the liver enhancing nitric oxide intra-hepatic and lowering resistance that may be responsible for most of cirrhosis complications. Indeed, the potential use of this drug may ameliorate the HVPG and azygos flow. Portal hypertension is responsible for most of the cases of death in cirrhosis. The esophageal varices, ascites and hepatorenal syndrome are the most harmful consequences of cirrhosis that should be prevented. In that way, simvastatin appears as a promising therapy.The study will include two groups of patients using aleatory randomization and one group will receive simvastatin while the other will receive placebo blindly. At the start and at the end of the study the patients will be submitted to HVPG measurement and azygous vein flow measure.

The endpoints will be the normalization of HVPG or lower significantly(20% or more.

The patients will be followed for 6 months after the end of the study.

Eligibility criteria: Inclusion Criteria:

* Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.

Exclusion Criteria:

* Child-Pugh C decompensated or encephalopathy
* Malignancy except basocellular cancer
* Hepatocarcinoma
* Anti-viral therapy
* HIV
* Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months

Primary outcomes:
measure: Hepatic venous pressure gradient (HVPG) in mmHg units
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
Study officials:
affiliation: Federal University of Rio de Janeiro - UFRJ
name: Priscila Pollo-Flores, MD, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00301626: ROSCAP: Reduction of Smoking in Cardiac Patients Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Tobacco Dependence
Cardiac Disease
Keywords: tobacco
nicotine
smoking reduction
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2006-03-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Background. The ROSCAP Study was a randomized controlled trial in heart disease patients to test the effect of a smoking reduction intervention on cigarettes per day (cpd) and biochemical and clinical indicators of tobacco exposure. .


Eligibility criteria: Inclusion Criteria:

* smoked at least 15 cigarettes per day and had one of 11 cardiovascular disorders: history of myocardial infarction, coronary artery bypass surgery, angioplasty, stent placement, thrombolytic therapy, angina, arrhythmia, a history of cardiac arrest, greater than 50% coronary artery stenosis by angiography, ischemia on exercise tolerance testing or congestive heart failure, required to confirm that they were unwilling or uninterested in setting a stop smoking date in the next 30 days.

Exclusion Criteria:

* 1) unstable angina within the past 2 weeks, 2) unstable psychiatric or substance use disorders or 3) contraindications to nicotine replacement therapy (including pregnancy or intention to become pregnant)

Primary outcomes:
measure: Smoking reduction
Secondary outcomes:
measure: Smoking cessation, biomarker measures
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VAMC (111-0)
state: Minnesota
Study officials:
affiliation: Minneapolis VAMC & University of Minnesota
name: Anne Joseph, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06477926: A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants
Official title: A Phase 1 Relative Bioavailability and Food Effect Study of ABBV-668 Extended-Release Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
ABBV-668
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.


Eligibility criteria: Inclusion Criteria:

* BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of any clinically significant sensitivity or allergy to any medication or food.
* History of any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Participant using any medication, vitamins and/or herbal supplements (including traditional Chinese medicine), with the exception of hormonal replacement therapies for females, on a regular basis.
* Any use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of ABBV-668
timeFrame: Up to approximately 47 days
measure: Time to Cmax (Tmax) of ABBV-668
timeFrame: Up to approximately 47 days
measure: Terminal Phase Elimination Rate Constant (Beta) of ABBV-668
timeFrame: Up to approximately 47 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-668
timeFrame: Up to approximately 47 days
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668
timeFrame: Up to approximately 47 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688
timeFrame: Up to approximately 47 days
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Day 47
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 266960
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01549626: Effects of Flaxseed Flour in Appetite Sensations, Lipid Profile and Pressure Levels Among Overweighed and Obese Women
Official title: Effects of Flaxseed Flour - Whole Brown Flaxseed Flour, Brown Defatted Flaxseed Flour and Golden Flaxseed Flour in Appetite Sensations Satiety, Lipid Profile, Pressure Levels and Associated Costs Among Overweighed and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Women
Overweight
Obese
Keywords: Flaxseed
Women
Obesity
No smokers
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-03-09
Enrollment: 54
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Inclusion of foods rich in fiber, such as flaxseed, is a nutritional strategy for treating obesity. The hypothesis of this study is to compare the effects of three types of flaxseed flour - whole brown flaxseed flour, brown defatted flaxseed flour and golden flaxseed flour in the sensations of appetite and satiety, lipid profile, pressure levels and associated costs in overweight and obese women.


Eligibility criteria: Inclusion Criteria:

* adult women

Exclusion Criteria:

* women diabetic
* menopausal
* smokers
* pregnant
* using anorectic and satiogenic drugs

Primary outcomes:
measure: Appetite
timeFrame: Up to 2 months
Secondary outcomes:
measure: Satiety
timeFrame: Up to 2 months
measure: LDL-cholesterol
timeFrame: Up to 2 months
measure: HDL-cholesterol
timeFrame: Up to 2 months
measure: Total Cholesterol
timeFrame: Up to 2 months
measure: Triglycerides
timeFrame: Up to 2 months
measure: Glucose
timeFrame: Up to 2 months
measure: Uric acid
timeFrame: Up to 2 months
measure: Systemic blood pressure
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Clementino Fraga Filho University Hospital
Study officials:
References:
Clinical trial NCT01911026: The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy
Official title: The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy; Randomized Single Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ottawa Scale <6
Keywords: Bowel preparation
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 205
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effective bowel preparation is important for examination of the entire colon adequately and for identifying colonic lesions during colonoscopy. However, it is well known that bowel preparation of inpatients is much poorer than that of outpatients. Our goal is to improve bowel preparations with reinforcement of nurse education that explains the steps required for bowel preparation for inpatients undergoing colonoscopies. The education will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. Patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a explanation from reinforcement-educated nurse. The investigators hypothesize that patients received a explanation from reinforcement-educated nurses will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and patients' satisfaction for colonoscopy.


Eligibility criteria: Inclusion Criteria:

* all inpatients
* age \>18
* referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

* outpatients
* pregnancy
* breast feeding
* prior history of surgical large bowel resection
* patients allergic to PEG-ELS based laxatives

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: day 1
Secondary outcomes:
measure: Patient compliance
timeFrame: baseline
measure: Colonoscope insertion and withdrawal times
timeFrame: day 1
measure: Patient's willingness to do bowel preparation next time
timeFrame: baseline
measure: Preparation associated side effects
timeFrame: baseline
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Eun Soo Kim
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Eun Soo Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01378026: Study of the Role of G72 in Amyotrophic Lateral Sclerosis: Biomarker Discovery and Mechanism Investigation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Alzheimer Disease
Parkinson's Disease
Keywords: Amyotrophic Lateral Sclerosis
G72
SNP
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 120
Sex: ALL
Minimum age (years): 32
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients were from Taipei city hospital-ZhongXiao branch.

Brief summary: G72 gene is located on the common linkage locus in bipolar disorder and schizophrenia, and it encodes D-amino acid oxidase activator (DAOA). There are evidences that elucidated G72 and D-amino acid oxidase(DAO) together playing a critical role in the pathophysiology of schizophrenia. Recently, reports discovered missense mutations in the DAO (R199W DAO and R38H DAO) are associated with familial amyotrophic lateral sclerosis (FALS), and our preliminary data showed that the level of G72 autoantibody decreases in patients with ALS compared with normal control. Thus, we want to find out whether G72 plays a role in ALS and neurodegenerative diseases including Alzheimer disease and Parkinson's disease. First, we detect G72 protein and its autoantibody in sera of neurodegenerative diseases patients using ELISA and Western blotting, and the data are compared with normal control. We hypothesize the levels of G72 protein and its autoantibody in neurodegenerative diseases are less than those in normal control. Then, we extract genomic DNA of neurodegenerative diseases patients, and use polymerase chain reaction(PCR) to detect single nucleotide polymorphism (SNP) of G72. We aim to detect G72 missense SNP variants presented in ALS, AD and PD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease, Parkinson's disease and amyotrophic lateral sclerosis

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06246526: Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).
Official title: Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Chronic Pain
Neuropathic Pain
Keywords: Saluda
Spinal Cord Stimulation
Lead sponsor: Saint Francis Hospital
Sponsor class: OTHER
Collaborators: name: Saluda Medical Americas, Inc.
First posted: 2024-02-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.


Eligibility criteria: Inclusion Criteria:

Be 18 years of age or older at the time of enrollment.

Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.

Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.

Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.

Be willing and capable of giving informed consent.

Be willing and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

Subject is pregnant or nursing.

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.

Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.

Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).

Have prior experience with SCS.

Be concomitantly participating in another clinical study.

Primary outcomes:
measure: VAS - Visual Analog Scale
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: PROMIS-29
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: The Spine and Nerve Center of Saint Francis Hospital
state: West Virginia
Study officials:
affiliation: Spine and Nerve Center of Saint Francis Hospital
name: Timothy Deer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615926: Assessment of The Clinical Course of Dyspnea in Acute Heart Failure Patients
Official title: Assessment of The Clinical Course of Dyspnea and Its Association With Respiratory Rate in Patients With Acute Heart Failure Syndromes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Heart Failure
Dyspnea
Keywords: dyspnea
shortness of breath
respiratory rate
orthopnea
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who present to the Emergency Department with Acute Heart Failure

Brief summary: Acute heart failure (AHF) is defined as a gradual or rapid change in heart failure (HF) signs and symptoms, such as shortness of breath (also called dyspnea or breathlessness), leg swelling, fatigue, breathlessness with exertion, trouble sleeping flat at night, and weight gain resulting in a need for urgent therapy. AHF results in over 1 million hospitalizations every year, resulting in an enormous public health burden. Approximately 1/3rd of patients will either be re-hospitalized or die within three months, and the resultant financial costs are large. As such, improving outcomes for AHF patients is critically important. Shortness of breath is the most common reason why patients with AHF present to the ER. As such, understanding how severe this symptom is, how much it improves with current treatments is very important to both patients and physicians. The purpose of this study is to determine the degree to which your shortness of breath improves during the first few days of hospitalization and its association with how fast you are breathing.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years of age
* AHFS is the primary working diagnosis for ER management and treatment with planned admission
* Have received IV diuretic therapy
* Enrolled within 3 hours of initial diuretic dose

Exclusion Criteria:

* BNP level is ≤ 300 pg/mL (may be initially enrolled and then will be excluded for second assessment)
* Transplant recipients of any kind
* Fever \> 101.5
* Severe lung disease (required home O2 or daily oral steroids)
* Any ACS event within last 30 days
* Life expectancy less than 12 months for any reason
* Current treatment for any malignancy of any kind
* Cardiogenic shock and/or requiring IV inotropic therapy
* Pregnant or recently pregnant within last 90 days
* Inability to give appropriate written consent

Primary outcomes:
measure: To determine the association between respiratory rate and self-reported dyspnea in AHF patients.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Peter S Pang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05804526: A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours
Official title: An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC88 Combined With Sintilimab in AdvancedSolid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumours
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours


Eligibility criteria: Inclusion Criteria:

1. Voluntary agreement to provide written informed consen
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
3. Predicted survival ≥ 12 weeks
4. Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma;
5. Adequate organ function required
6. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

Exclusion Criteria:

1. Cancer metastases in the brain
2. Active infection or past hepatitis B or C infection
3. Major surgery less than 1 month before the start of the study
4. Uncontrolled heart disease
5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds

Primary outcomes:
measure: RP2D
timeFrame: 28 days after first treatment
Secondary outcomes:
measure: ORR
timeFrame: 24 months
measure: Maximum Concentration (Cmax) of RC88
timeFrame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours
measure: Progression Free Survival (PFS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Leading PI
name: Shi Yuankai, M.D.
role: STUDY_DIRECTOR
References: