bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after
      a single dose administration in rheumatoid arthritis patients.

      Secondary Objective:

      Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products
      after a single dose administration in rheumatoid arthritis patients.
    

Detailed description: 
      The duration of the study period per subject is 5-7 weeks broken down as follows:

        -  Screening: 1 to 14 days,

        -  Treatment: 1 day (2 overnight stays at the study site),

        -  Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be
           scheduled depending on the last results).
    

Intervention name(s): SAR153191 (REGN88)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution
Route of administration: subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both
      hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary
      mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall
      objective of the study is to evaluate the efficacy and safety of combining fenofibrate and
      simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
    


Intervention name(s): Fenofibrate/Simvastatin; Fenofibrate/Simvastatin; Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Combination of Fenofibrate 145mg and Simvastatin 20mg; Combination of Fenofibrate and Simvastatin 40 mg; Simvastatin 40 mg
Intervention MeSH terms: Simvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin
Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients
      with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate
      altitude.
    

Detailed description: 
      This randomized cross-over trial evaluates the hypothesis that patients with chronic
      obstructive pulmonary disease experience nocturnal hypoxemia, periodic breathing and sleep
      disturbances when staying at moderate altitude. Sleep studies and clinical evaluations will
      be performed during 2 days in Zurich (490 m, low altitude baseline) and during 2 days at
      Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m).
    

Intervention name(s): Altitude exposure
Intervention type(s): Other
Intervention description(s): Stay at different altitudes: 490, 1650, 2590 m
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Varenicline in Drug Treatment
Condition: Smoking Cessation; Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the efficacy of varenicline compared to placebo in tobacco
      dependent individuals who are undergoing concurrent treatment for alcohol dependence. As they
      will be inpatients and under 24 hour medical care for the first 21 days of treatment, or
      receiving outpatient treatment through the Alcohol Research and Treatment Clinic, this will
      allow for a comprehensive assessment of the safety of varenicline in this population with
      minimal risk of adverse consequences. The patients will continue their cessation treatment
      for an additional 10 weeks as outpatients through the Nicotine Dependence Clinic at CAMH.
      They will also be contacted at 6 months for follow-up.
    

Detailed description: 
      Drinking alcohol and cigarette smoking are closely associated and use of one often leads to
      the use of the other. Also, since tobacco-related illness is the number one cause of death
      among recovered alcoholics it is imperative that we provide strong evidence-based treatment
      options for this population. Since smoking can be a strong trigger to drink in those who are
      dependent on both alcohol and tobacco, treating both at the same time may result in better
      treatment outcomes. This study will examine the efficacy of starting smoking cessation
      treatment while patients are in residential treatment for alcohol dependence, or outpatient
      in the Alcohol Research and Treatment Clinic. It will compare the effectiveness of
      varenicline, the most effective medication for smoking cessation with placebo. Both groups
      will receive weekly cessation counselling and support by a trained research analyst. We will
      measure abstinence from smoking at the end of the 12-week treatment period and again after
      6-months to determine longer-term smoking cessation.
    

Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): one 0.5mg varenicline capsule on first 3 days one 0.5mg varenicline capsule, twice daily for 4 days one 1.0mg varenicline capsule, twice daily until end of treatment (12weeks of medication; lactose filler in capsules identical to the varenicline capsules one 0.5mg capsule for 3 days one 0.5mg capsule twice daily for 4 days one 1.0mg capsule twice daily until end of treatment (12weeks of medication)
Other intervention name(s): Champix; Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: varenicline; alcohol; placebo; smoking cessation
The Effect of Different Exercise Programs in Coronary Artery Patients: A Randomized Controlled Study
Condition: Exercise; Cardiac Rehabilitation
Study type: Interventional

Summary: 
      There are studies showing the superiority of HIIT protocols in patients with CAD in the
      literature, however there is no consensus on the use of HIIT protocols in CAD patients. In
      addition, in these studies, the HIIT protocols differ in severity and duration and there is
      no optimal HIIT protocol. Therefore, this study was planed to investigate of two different
      HIIT protocols and one MICT protocols, which are more commonly used in patients with CAD in
      the literature on exercise capacity, quality of life, body composition, physical activity
      level and fear of movement.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Modarete Intensity Continous Training: Medium intensity continuous exercise training will be performed. Exercise intensity will be adjusted as 50-70% of maximal power.
High Intensity Interval Training I: It will be four cycles consisting of 4 minute high intensity exercise phase and 3 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power.
High Intensity Interval Training II: It will be 10 cycles consisting of 1 minute high intensity exercise phase and 1 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Testing of Collagen and Zhuyin Drinks
Condition: Skin Condition
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      To assess collagen and zhuyin drink on skin & body condition improvement
    


Intervention name(s): Placebo drink; Collagen Cubilose Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume 1 bottle (50 mL) per day for 28 days; consume 1 bottle (50 mL) per day for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
Condition: Premenopause
Study type: Interventional

Summary: 
      GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in
      healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when
      administered in a single dose have been investigated in studies conducted using doses of 1, 3
      and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix
      rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent
      prolongation of the duration of LH suppression. However, there have been few reports of
      studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the
      present study, we investigated the effect of cetrorelix on LH surge when this drug was
      administered in single doses of 1, 2 and 3 mg.
    

Detailed description: 
      To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying
      the start of the LH surge in comparison with the control menstrual cycle when saline was
      administered, and also examined the mode of disappearance of pulsatile LH secretion during
      the cetrorelix administration menstrual cycle.
    

Intervention name(s): Cetrorelix
Intervention type(s): Drug
Intervention description(s): 1, 2 or 3mg, subcutaneouly dosed with single dose
Other intervention name(s): NS75A
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: infertility, menstrual cycle, LH surge
MSC and MC in Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cell injury in human islets induced by non-immune mediated inflammation occur in vitro upon
      hyperglycemia in type 2 diabetes mellitus. Infusion of autologous bone marrow mononuclear
      cells (MCs) is an emerging therapeutic approach for DM, which showed promising outcomes with
      mild side effects. Infusion of MCs and autologous bone marrow mesenchymal stem cells in
      combination might exert enhanced repairing effects. We hypothesized that infusion of these
      two classes of cells might provide multiple signals for regeneration and improve recovery
      from inflammation-induced lesion. The effects might be maximized by intra-arterial pancreatic
      infusion.
    


Intervention name(s): infusion of MSCs; infusion MCs; insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): infusion of MSCs; infusion of MCs; intensive insulin care
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mesenchymal stem cells; bone marrow mononeclear cells; type 2 diabetes mellitus
Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      The investigators conducted this retrospective study in a large single center with an annual
      birth of more than 20,000 newborns, from January 1, 2018 to December 31, 2019, to confirm the
      applicability and accuracy of pulse oximetry (POX) combined cardio-auscultation to screen
      congenital heart disease for neonates.
    

Detailed description: 
      All consecutive newborn babies were eligible, irrespective of gestational age, NICU
      admission, symptom presence or prenatal diagnosis.

      This study was approved by institutional ethical review board of Linyi Maternal and Child
      Healthcare Hospital. Spoken informed consent was obtained from the participating babies'
      parents.

      Physicians from departments of neonatal medicine and developmental medicine undertake
      auscultation screening. When abnormal murmur occurred, an echocardiography would be requested
      to confirm if the newborn has CHD or not.

      Physicians from obstetrics department and nursing staff from neonatal department undertake
      POX measurement. If a positive POX occurred, an echocardiography would be requested to
      confirm if the newborn has CHD or not.

      Physicians from department of ultrasonography undertake echocardiography confirmation for
      newborns deemed positive by auscultation or POX.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population focus on the neonates delivered in the two campuses of the study
        center which is the largest maternal facility in a municipality of 11 million population.
      
Keywords: Pulse oximetry; Auscultation; Congenital Heart Disease; Screening
The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services
Condition: Auditory Perceptual Disorders; Stress Disorder
MeSH terms: Auditory Perceptual Disorders; Perceptual Disorders
Study type: Interventional

Summary: 
      A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM)
      will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness
      of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and
      behavior regulation in the classroom. The LPP is designed as a "neural exercise" to reduce
      auditory hypersensitivities, to improve auditory processing of speech, and to improve
      behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural
      regulation of the middle ear structures to rehabilitate and to normalize the acoustic
      transfer function of the middle ear structures. The current study is being conducted to
      evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning
      challenged young people and will use objective measures to evaluate changes in acoustic
      transfer function of the middle ears structures, auditory processing skills, physiological
      state regulation, sensory symptoms, and academic pre and post testing.
    


Intervention name(s): Listening Project Protocol
Intervention type(s): Behavioral
Intervention description(s): The filtered-music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
The non-filtered music intervention will consist of the same music as the filtered-music intervention.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Autonomic nervous system; Auditory processing disorder; Social behavior
Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
Condition: Hepatitis B; Diphtheria; Whole Cell Pertussis; Tetanus; Haemophilus Influenzae Type b
MeSH terms: Hepatitis A; Hepatitis B; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the reactogenicity & safety of
      Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care,
      Tritanrix™-HepB/Hiberix™.
    

Detailed description: 
      Randomized study with four groups to receive one of the following vaccination regimens after
      a dose of hepatitis B vaccine given at birth:

        -  One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals'
           Tritanrix™-HepB (3 different groups)

        -  GSK Biologicals' Tritanrix™-HepB/Hiberix™
    

Intervention name(s): Tritanrix-HepB/Meningitec conjugate vaccine; Tritanrix/Hiberix vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection; The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.
Other intervention name(s): DTPw-HBV/Hib-MenAC conjugate vaccine; DTPw-HBV/Hib vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
A Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate safety, tolerability and pharmacokinetics of ABT-126 in up to 20
      male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's
      disease on stable doses of acetylcholinesterase inhibitors.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, multiple-dose, parallel group,
      multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's
      disease (AD) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled
      in this study. The study will be conducted in up to four sites. Within 28 days prior to study
      drug administration, subjects will be screened based on National Institute of Neurological
      and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association
      (NINCDS/ADRDA) criteria for probable AD, Mini-Mental State Examination (MMSE) and Modified
      Hachinski Ischemic Scale (MHIS) scores, medical history, physical examination, neurological
      examination, vital signs, ECG, laboratory tests and response to Columbia-Suicide Severity
      Rating Scale (C-SSRS).

      Subjects will be divided into two groups of 10 subjects each. In each group, 8 subjects will
      receive ABT-126 and two subjects will receive matching placebo. Group 1 will be administered
      Dose 1 of ABT-126 or placebo. Group 2 will be administered Dose 2 ABT-126 or placebo. All
      doses will be administered once daily in the morning for 10 days.
    

Intervention name(s): ABT-126; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose 1 is given to 8 subjects in Group 1. Dose 2 is given to 8 subjects in Group 2. All doses will be administered once daily in the morning for 10 days.; Placebo is given to 2 subjects each in Group 1 and Group 2. All doses will be administered once daily in the morning for 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
Condition: Major Depressive Disorder; Psychotic Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called
      cortisol. Under normal conditions, cortisol and other hormones are created by the body in
      response to physical and emotional stress, triggering a healthy stress response. People who
      suffer from psychotic major depression may have unusually high levels of cortisol circulating
      within them or abnormal patterns of cortisol levels, overloading the stress response
      mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If
      Corlux can keep the body's cortisol receptors from being overloaded, the stress response
      system may return to normal function, which may result in improvement of symptoms. The
      purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients
      who have been diagnosed with psychotic major depression (PMD).
    


Intervention name(s): Mifepristone; matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): daily for 7 days; daily for 7 days
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PMD; Psychotic Major Depression; Depression; Major Depression; Psychosis
Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine
      in adult patients with mild to moderate hypertension.
    


Intervention name(s): Valsartan/amlodipine 80/5 mg; Valsartan 80 mg; Valsartan 160 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily; 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily; 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Intervention MeSH terms: Amlodipine; Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension, valsartan, amlodipine, high blood pressure