bioihbjkbjnl/mcl2 huggingface dataset:
REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Observational [Patient Registry]

Summary: 
      REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory
      patients with chronic, advanced, systolic heart failure that will provide a greater
      understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD
      use and death), and of how baseline clinical risk measures are related to prognosis.
    

Detailed description: 
      REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory
      patients with chronic, advanced, systolic heart failure that will provide a greater
      understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD
      use and death), and of how baseline clinical risk measures are related to prognosis. Within
      the broader goal of 1) improving prognostic assessment in chronic, ambulatory, advanced
      systolic heart failure, additional targeted goals are to 2) better inform the selection of
      appropriate candidates for a future study of a strategy of early LVAD therapy vs. optimal
      medical management in this population, and 3) determine the feasibility of identifying
      candidates for such a trial. Therefore, the target population will have known high-risk
      features for increased mortality and hospitalization (e.g., frequent hospitalization, reduced
      exercise capacity, elevated BNP or N-terminal proBNP, increased Seattle Heart Failure Model
      risk score, reduced Heart Failure Survival Score).

      The REVIVE-IT Registry (i.e., REVIVAL) is a prospective cohort study to be conducted in up to
      twenty five (25) participating Clinical Sites in the USA. The study will continue until up to
      400 eligible heart failure heart failure subjects have been enrolled (estimated length of
      accrual is 12 months).
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): Not an interventional study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Medical records should be reviewed to assess for potential enrollment into the REVIVE-IT
        Registry. Heart failure subjects that meet all criteria should be approached to consent for
        this study.
      
Biospecimen description: 
      Biomarker Samples will be collected at the Baseline B assessment. Samples for Genomic
      Analysis will be collected at the Baseline B visit for subjects that consented to collection
      of this sample type.
    
Keywords: Heart failure; HF; Heart Diseases; Cardiovascular Diseases; Heart Failure NYHA class III; Advanced heart failure; Systolic Heart Failure
Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how
      the drug is absorbed and eliminated and its effect on the body in healthy subjects.
    


Intervention name(s): HSD-016; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover
      euglycemic clamp trial in healthy Chinese volunteers.

      Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence
      comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or
      simultaneous administration of Humalog® and Lantus®.

      Subjects will come in a fasted state to the clinical trial centre in the morning of each
      dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been
      terminated.
    

Detailed description: 
      Subjects will attend the study site in the morning in a fasted state and will be connected to
      an automated glucose clamp device (ClampArt). Prior to dose administration plasma glucose
      will be stabilised at a defined target level by means of an intravenous infusion of glucose
      or insulin. IMP administration will be done by an unblinded person by means of subcutaneous
      injections in the abdominal wall.

      Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30
      hours.

      The pharmacodynamic assessment will be based on the time course of glucose infusion rate
      (GIR) and plasma glucose.

      Plasma insulin concentrations will be measured using a specific validated bioanalytical
      method differentiating concentrations of insulin glargine, of its main metabolites
      insulin-glargine-M1 and insulin-glargine M2, and of insulin lispro. Pharmacokinetic insulin
      assessments will be based on total insulin concentration.
    

Intervention name(s): Euglycemic clamp with BC Combo THDB0207; Euglycemic clamp with Humalog® Mix25; Euglycemic clamp with Humalog® and Lantus®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure; Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure; Simultaneous administration of Humalog® and Lantus® during an euglycemic clamp procedure
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three-period crossover
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Efficacy and Safety of Atorva® 20mg Versus Lipitor® 20mg
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The generic formulation of atorvastatin (Atorva®) 20mg was not inferior to the branded
      formulation of atorvastatin (Lipitor®) 20mg in this 8-week treatment of hyperlipidemic Korean
      patients. In PP analysis, the LDL cholesterol goal achievement rate was significantly higher
      in Atorva group. Both treatments were well tolerated.
    


Intervention name(s): generic formulation of atorvastatin (Atorva®); branded formulation of atorvastatin (Lipitor®)
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks; Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atorva; generic; atorvastatin; hypercholesterolemia
The High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to characterize novel mechanisms whereby HDL may exert potent
      vasculoprotective effects independent of reverse cholesterol transport, in particular the
      effect of HDL on the regulation of the vascular NAD(P)H oxidase enzyme system, a major
      vascular source of superoxide, known to be important for endothelial dysfunction. In
      addition, the present study will characterize the effect of HDL on endothelial progenitor
      cell (EPC) mobilization, nitric oxide production and in vivo regenerative capacity.
    


Intervention name(s): Extended-Release Niacin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Extended-Release Niacin tablets week 1-4 500 mg/d week 4-8 1000 mg/d week 9-12 1500 mg/d; Placebo tablets
Intervention MeSH terms: Niacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; High Density Lipoprotein; Extended-Release Niacin; Endothelial Function; Endothelial Progenitor Cells
Effects on Liver Cirrhotic Patients' by a Nurse-led Clinic
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis
Study type: Interventional

Summary: 
      This study compare the effects of traditional follow-up by physician with a combined
      follow-up alternately by physician and nurse-led clinic. The main variable is; health related
      quality of Life. Participants are randomized into control group or intervention group.
    

Detailed description: 
      The incidence of liver cirrhosis in Sweden increase mostly due to life style factors. A large
      need of care is common in the end stage of the disease. Nurse-led clinics for other groups of
      patients, e.g. coronary heart disease, have shown high quality which has resulted in an
      established part of the follow-up.

      This study is a randomized controlled study at six Swedish hospitals to study the effect of a
      changed follow-up process for liver cirrhotic patients by adding a nurse-led clinic to follow
      up by physician. The intervention implies a larger extend of nursing interventions at the
      outpatient clinic to increase the patient's quality of life, quality of care and reduce the
      need of inpatient care.

      A few hospitals in Sweden offers a nurse-led clinic for liver cirrhotic patients, the
      interest in other hospitals are raising. Though there is a lack of evidence in nursing
      intervention within this population and it is still unknown what the effects are for the
      individual or on the health economy.
    

Intervention name(s): risk factors; self-care; nutrition; lifestyle; psychosocial needs; Nurse-led clinic
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): monitoring risk factors due to deterioration of the liver disease; information and motivation to adherence to self-care instructions and medical treatment; nutritional assessment and activities to prevent malnutrition; motivation of lifestyle changes essential for disease progress and; psychosocial care.; compensated disease once yearly, decompensated disease twice a month to every third month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Quality of care; Health related quality of life; Nurse-led clinic; Health economics
The Electroretinogram in Healthy and Glucose Intolerant Young Men
Condition: Electroretinography
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose is to investigate the electroretinogram (ERG) in young, healthy men in the
      normoglycaemic and hyperglycaemic state before and after intervention with corticosteroids
      treatment, high calorie diet and exercise restraint.
    

Detailed description: 
      The subjects will be fasting from midnight the day before the experiment. Standard procedures
      (including pupil dilation, dark adaptation, and local anaesthetics) are carried out to allow
      the ERG to be obtained. After electrophysiology, the subject will be clamped at a plasma
      glucose level of 10 mM (~180 mg/dL) and after a stabilisation period the ERG protocol is
      repeated.

      Each subject is examined twice on two different days. The first day the subjects are
      normoglycaemic in the morning (first examination) and hyperglycaemic (clamped to 10 mM)
      throughout the second examination. The second day subjects are also normoglycaemic and
      hyperglycaemic but shows up after 7-12 days of daily intake of prednisolone, high calorie
      diet, and exercise restraint.
    

Intervention name(s): Prednisolone; Lifestyle change
Intervention type(s): Drug; Behavioral
Intervention description(s): 12 days of corticosteroids treatment (prednisolone 37,5 mg/day); High calorie diet (130 % of recommended daily energy intake) and relative physical inactivity (no exercise and at least 8 hours of rest/day)
Other intervention name(s): Prednisolon DAK, Nycomed, Zurich, Switzerland; Behavioral regimen
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Retina; Electroretinography; Diabetes Mellitus; Glucose Intolerance; Physiology
NIPPV vs.nCPAP During LISA Procedure
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus
      NCPAP during the LISA procedure in very preterm infants.

      The main question it aims to answer is:

      • Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or
      the need of mechanical ventilation during the first 72 hours of life in comparison with
      NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do
      not require VM and treated with NCPAP and FiO2 >0.30 within the first 6 hours of life who
      received the first dose of caffeine will be eligible for enrollment in the study Participants
      will be randomized to receive surfactant with conventional LISA procedure, i.e. performed
      during NCPAP, or with LISA procedure performed during NIPPV.
    


Intervention name(s): Nasal Intermittent Positive Pressure Ventilation (NIPPV); Nasal continuous positive airway pressure (NCPAP)
Intervention type(s): Procedure; Procedure
Intervention description(s): In this group, infants will receive NIPPV during LISA procedure.; In this group, infants will receive NCPAP during LISA procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Surfactant; LISA procedure; Preterm infant
Medical Treatment in Ectopic Tubal Pregnancy
Condition: Ectopic Pregnancy
MeSH terms: Pregnancy, Ectopic; Pregnancy, Tubal; Cardiac Complexes, Premature
Study type: Interventional

Summary: 
      Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all
      pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women
      with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed
      multiple doses, single-dose as well as two-dose regimens have been in practice for treating
      EP, but no consensus exists regarding the optimum dosage regimen.
    

Detailed description: 
      Literature reports multiple dosage regimens of MTX to be associated with increased rates of
      side effects. Single dose protocol has good compliance and fewer side effects but is linked
      with lower success rates in comparison to multiple dose protocols.

      A new treatment protocol involving "two-doses" of MTX for medical management of EP was
      introduced in 2007 but most of the research conducted so far has been retrospective in nature
      and limitations in study designs. No such study in recent years has been done in Pakistan to
      compare the success and safety of single-dose and two-dose MTX protocols so this study was
      planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX
      in tubal EP.
    

Intervention name(s): Methotrexate
Intervention type(s): Drug
Intervention description(s): Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7.
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders
Condition: Child Behavior Problem
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      This study aims to examine the immediate and longer-term effectiveness of a group cognitive
      behavioral therapy intervention (GCBT) in reducing internalizing and externalizing symptoms
      in children treated for mixed psychiatric disorders in naturalistic clinical settings.
      Further, the effectiveness of GCBT is compared to a treatment-as-usual condition (TAU).
      Within this study, it is hypothesized that children with mixed psychiatric disorders will
      exhibit improvements in parent-rated internalizing problem behavior and parent- and
      teacher-rated externalizing problem behavior following GCBT.
    


Intervention name(s): The Friends program; TAU condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A GCBT intervention comprising ten weekly 60-minute sessions followed by two booster sessions; A TAU waitlist condition during which participants received routine care services tailored to each child individually.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children; group cognitive behavioral therapy; cognitive behavioral therapy; internalizing symptoms; externalizing symptoms
Treatment of Negative Symptoms and Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique,
      tDCS (transcranial direct current stimulation) used as a complementary treatment on negative
      symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will
      be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include
      neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social
      functioning.
    


Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Daily Steps on Fat Metabolism
Condition: Atherosclerosis; Metabolic Syndrome
MeSH terms: Atherosclerosis; Metabolic Syndrome
Study type: Interventional

Summary: 
      Reduced ambulatory activity has been shown to effect the response to a high fat tolerance
      test (HFTT) after acute exercise. This study will evaluate the effect of varying levels of
      daily ambulation on response to a HFTT after an acute aerobic exercise bout.
    


Intervention name(s): Very Low Steps; Low Steps; Moderate Steps
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Very Low Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.; Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Low Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.; Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Moderate Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will complete three experimental conditions which include 2 days of reduced step count (2,500, 5,000, and 7,500 steps/day) with 1-hour of exercise at 65% VO2max.
Masking: None (Open Label)
Primary purpose: Prevention
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and
      vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic
      dermatitis.
    


Intervention name(s): TER-101; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Active Comparator; Placebo Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
Condition: Improvement of Abdomen Appearance
Study type: Interventional

Summary: 
      The subjects will be enrolled and assigned to a single study group. They will be required to
      complete two treatment visits and come for a biopsy procedure.
    


Intervention name(s): BTL-899
Intervention type(s): Device
Intervention description(s): BTL-899 therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality
Condition: Cancer
MeSH terms: Dyspnea
Study type: Interventional

Summary: 
      This study was planned to examine the effect of progressive relaxation exercises applied to
      lung cancer patients receiving chemotherapy on dyspnea, pain and sleep quality.
    

Detailed description: 
      It is thought that relaxation exercises reduce respiratory distress and improve sleep quality
      in lung cancer patients.
    

Intervention name(s): Progressive Relaxation Exercise
Intervention type(s): Behavioral
Intervention description(s): In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test contro
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Cancer patients; Pain; Sleep quality; Progressive Relaxation Exercise
Human Psychopharmacology of Salvinorin A
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is characterizing the subject-rated and behavioral effects of salvinorin A in
      healthy volunteers. The investigators hypothesize the salvinorin A will have
      hallucinogen-like effects.
    


Intervention name(s): Salvinorin A
Intervention type(s): Drug
Intervention description(s): This is an initial dose ranging study
Intervention MeSH terms: Salvinorin A
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy volunteers are being studied to evaluate the subject-rated, behavioral, and abuse liability effects of salvinorin A