bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Novel Therapeutic Vaccine for Hepatitis C Virus
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      HCV002TV is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine
      against Hepatitis C virus (HCV) in chronically infected patients. The vaccine is based on the
      sequential delivery, by intramuscular route, of two different adenoviral vectors, of
      chimpanzee and human origin respectively, bearing the same genetic information for HCV
      antigens (NS region).

      The two recombinant vaccine vectors, called AdCh3NSmut and Ad6NSmut, are weakened and unable
      to multiply within the body; they are designed to induce an immune response against HCV
      proteins. AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy
      volunteers with very good safety and immunogenicity results.

      HCV002TV is a dose-escalation study; the AdCh3NSmut is administered as priming vaccination
      and Ad6NSmut as boosting vaccination.

      The trial includes:

        -  Arm A, in which vaccinated patients are into Interferon-ribavirin therapy (the gold
           standard therapy for hepatitis C);

        -  Arm B, in which vaccinated patients are not into therapy.
    


Intervention name(s): AdCh3NSmut; Ad6NSmut
Intervention type(s): Biological; Biological
Intervention description(s): Genetic vaccines against Hepatitis C virus infection; Genetic vaccine against Hepatitis C virus infection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Adenovirus; Vaccine
Dipeptidyl Peptidase-4 Inhibition and Immune Function in HIV
Condition: Diabetes; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We will test the safety of a new class of anti-diabetes compounds (DPPIV-inhibitors) in
      people living with HIV. Future trials will examine efficacy for treating diabetes and
      reducing cardiovascular disease risk in people living with HIV.
    

Detailed description: 
      Human immunodeficiency virus (HIV)-infection and treatment with antiretroviral therapies are
      associated with several cardiometabolic risk factors; insulin resistance, diabetes,
      dyslipidemia, central adiposity, that increase risk for MI and stroke. A new class of drugs
      used to treat type 2 diabetes has been introduced; Dipeptidyl peptidase-IV (DPPIV)-inhibitors
      (Januvia®, Onglyza®, alogliptin). Dipeptidyl peptidase-IV (DPPIV)-inhibition could be a safe
      and effective therapy for HIV-associated insulin resistance and diabetes. However, no safety
      data exist. The research question is: If HIV+ adults with stable immunologic (CD4+ T-cell
      count >350 cells/μL) and virologic (plasma HIV RNA <50 copies/mL) function are given a
      DPPIV-inhibitor would their CD4+ T-cell count and plasma HIV RNA level increase, decrease, or
      stay the same? Theoretically, DPPIV-inhibition could enhance their immune system by
      increasing SDF-1α levels; a potent inhibitor of HIV-entry into T-cells, or harm the HIV+
      immune system by inactivating CD26 on immune cells. We hypothesize that DPPIV-inhibition will
      not harm the immune system in HIV+ people. We propose a blinded randomized controlled pilot
      safety trial of an FDA-approved DPPIV-inhibitor in virologically- and immunologically-stable
      HIV+ men and women. We will monitor CD4+ T-cell count, plasma HIV RNA levels, immune
      activation markers, and safety outcomes (lipid/lipoprotein profiles, blood pressure, kidney
      and liver function) during 4-6 months of DPPIV-inhibitor exposure vs placebo in 20 HIV+
      adults. If safety is confirmed, the efficacy of DPPIV-inhibition in HIV+ with insulin
      resistance will be tested in future trials that examine potential glucoregulatory and
      cardiovascular benefits.
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg sitagliptin daily for 4-6 months; Daily placebo for 4-6 months
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
A Study to Evaluate the Effect of GRF6021 on Postoperative Recovery Following Primary Hip or Knee Arthroplasty
Condition: Postoperative Recovery
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and effect of GRF6021 on clinical recovery
      parameters in patients undergoing primary hip or knee arthroplasty.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind pilot study to investigate the effects
      of GRF6021, a 5% human plasma protein fraction administered by intravenous (IV) infusion, on
      intracellular signaling cascades in blood leukocytes in subjects undergoing primary hip or
      knee arthroplasty.
    

Intervention name(s): GRF6021; Placebo
Intervention type(s): Biological; Other
Intervention description(s): for IV infusion; for IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total hip replacement; Total knee replacement
Brain Imaging and Retreatment Study of Persistent Lyme Disease
Condition: Lyme Disease; Lyme Neuroborreliosis
MeSH terms: Lyme Disease; Lyme Neuroborreliosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether patients with persistent memory problems
      after Lyme disease benefit from an additional longer course of IV antibiotic therapy; to use
      modern brain imaging technology to determine whether the problem in the central nervous
      system is primarily one of poor blood flow or one of impaired nerve cell functioning; and to
      try to identify biological markers prior to treatment that will identify patients who are
      more or less likely to respond to the study treatment.
    

Detailed description: 
      Some people with a history of Lyme disease continue to have problems despite having received
      "textbook duration" antibiotic therapy. When memory, attention, or thinking problems persist,
      the syndrome is called persistent Lyme disease (PLD). This study seeks to answer critical
      scientific questions about the treatment and cause of PLD symptoms.

      This 24-week treatment study will evaluate each patient's response to treatment using
      neuropsychological testing and state-of-the-art brain imaging. The brain tests include
      neuropsychological testing of memory and attention, brain imaging (MRI and PET scans) to look
      at blood flow in the brain and nerve cell structure and metabolism, a neurological exam, and
      studies of the fluid that surrounds the brain (cerebrospinal fluid). The treatment involves
      10 weeks of either intravenous antibiotic called ceftriaxone (also known as Rocephin) or
      intravenous placebo (inactive substance). After the first visit to Columbia Presbyterian
      Medical Center, the remaining treatments will be done in the patient's home. Patients will be
      screened over the phone and in person to confirm study eligibility.
    

Intervention name(s): ceftriaxone
Intervention type(s): Drug
Intervention MeSH terms: Ceftriaxone
Allocation: Randomized
Primary purpose: Treatment
Keywords: neurologic Lyme disease; Lyme disease; ceftriaxone; Rocephin; PET scans; Lyme encephalopathy; neuroborreliosis; borreliosis
The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain
Condition: Low Back Pain, Mechanical; Low Back Pain, Postural; Lower Back Pain Chronic; Low Back Pain, Posterior Compartment
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is a major public health problem and is associated with a high rate of
      absenteeism at work, functional disability and frequent use of health services. Suction cup
      therapy is a common technique of traditional Chinese medicine (TCM), which has been around
      for about 3,300 years in Asia and the Middle East and has as its main feature the decrease in
      signs and symptoms of chronic pain. The technique was widely used in the 19th century
      throughout Asia and Europe, and in recent years demand has been increasing, possibly due to
      the inefficiency of conventional therapies and medicines. Objective: To verify the
      effectiveness of the suction cup therapy technique associated with conventional physiotherapy
      in patients with chronic low back pain. Method: We will include individuals between 18 and 60
      years old, both genders, with low back pain for more than 3 months, without having received
      physical therapy treatment for a period of 6 months. Individuals with severe spinal diseases,
      root conditions of the spine, carriers of vascular diseases and pregnant women will be
      excluded. They will be randomly divided into two groups, Conventional Physiotherapy (group 1)
      and Conventional Physiotherapy associated with suction cup therapy (group 2).
    


Intervention name(s): muscle strengthening exercises; muscle strengthening exercises and dry cupping
Intervention type(s): Other; Other
Intervention description(s): segmental stabilization exercises; segmental stabilization exercises and dry cupping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Clopidogrel on Blood Pressure
Condition: Blood Pressure; Endothelial Function; Platelet Function
Study type: Interventional
Phase: Phase 4

Summary: 
      Context: Soluble CD40 ligand (sCD40L) released from activated platelets induces inflammatory
      transformation of the vascular endothelium and is an independent predictor of cardiovascular
      events. Arterial hypertension is associated with platelet activation, increased sCD40L levels
      and endothelial dysfunction suggesting that inhibition of platelet-derived sCD40L release may
      improve endothelial function and lower blood pressure (BP).

      Objective: To determine the effects of clopidogrel on sCD40L, endothelial function and BP.

      Design: Randomized, controlled, investigator-blinded, parallel-group, 2-phase trial in
      patients with coronary artery disease and essential arterial hypertension and those without
      hypertension.

      Intervention: Participants receive a single 600-mg clopidogrel loading dose (phase I)
      followed by a daily 75-mg clopidogrel maintenance dose over 28 days (phase II).

      Outcome Measures: Primary outcome measure is the change in BP from baseline. Secondary
      outcome measures are changes in biomarkers of platelet and endothelial function and their
      correlation with BP.
    


Intervention name(s): Clopidogrel; Clopidogrel; Clopidogrel; Clopidogrel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of an Educational Intervention on Emotional Intelligence in School Students
Condition: Emotional Intelligence
Study type: Interventional

Summary: 
      Objectives: Evaluate the effect on emotional intelligence levels of an educational
      intervention.

      Design: Randomized Clinical Trial

      Methods: An intervention on emotional intelligence was conducted in a Primary School.
      Students were recruited and randomized into intervention or control group (no intervention)
      by class (cluster). Total sample was 179. Results were measured with EQi-YV and ERQ-CA
      questionnaires. Statistical analysis was made with Student's t and Mann-Whitney's U tests.
    


Intervention name(s): Emotional Intelligence lessons
Intervention type(s): Behavioral
Intervention description(s): 6 lessons were given to the students in separated weeks by the same investigator. Lessons were 45-60 minutes long and each one was dedicated to one of the main aspects of emotional intelligence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: emotional intelligence; students; randomized clinical trial; schools
A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, randomized, double-blind, placebo controlled, parallel group study is being
      conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of
      multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM)
      inadequately controlled on metformin and/or diet and exercise. In addition, the study is
      intended to enable selection of efficacious doses for future clinical development of
      PF-06882961.
    


Intervention name(s): Placebo; PF-06882961
Intervention type(s): Drug; Drug
Intervention description(s): 4 matching placebo tablets taken twice a day (BID); Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of AM001 Cream in the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the
      treatment of Actinic Keratosis (AK) Lesions
    

Detailed description: 
      A Phase 2, Single-Center, Randomized, Double- Blind, Parallel-Group, Vehicle-Controlled Study
      Evaluating the Efficacy and Safety of AM001 Cream in the Treatment of Actinic Keratosis (AK)
      Lesions
    

Intervention name(s): AM001 Cream, 7.5%; Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): Active Cream; Placeo
Other intervention name(s): Potassium Dobesilate; Placebo Cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct
      comparative safety and effectiveness studies of dabigatran and warfarin using real world data
      from Humana's health plan operations.
    

Detailed description: 
      Study Design:

      n/a
    

Intervention name(s): Observational
Intervention type(s): Drug
Intervention description(s): Retrospective Chart Review
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        NVAF
Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
Condition: Hysterectomy
Study type: Interventional

Summary: 
      Background

      It is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or
      sexual function than total abdominal hysterectomy.

      Methods

      The investigators conducted a randomized, double-blind trial comparing total and subtotal
      abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most
      of the women were premenopausal. The main outcomes were measures of bladder, bowel, and
      sexual function at 12 months. The investigators also evaluated postoperative complications.
    


Intervention name(s): Total abdominal hysterectomy; Subtotal abdominal hysterectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Total abdominal hysterectomy and Subtotal abdominal hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Total hysterectomy; subtotal hysterectomy; urinary function; bowel function; sexual function; Quality of life; Psychological function
A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration
      with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after
      coadministration with CC-92480 in healthy participants.
    


Intervention name(s): CC-92480; Rifampin; Itraconazole; Digoxin; Rosuvastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): BMS-986348
Intervention MeSH terms: Itraconazole; Rifampin; Digoxin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CC-92480; Healthy Volunteer; Pharmacokinetic
Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Insulin Resistance; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to help scientist better understand the effect of a 12-week
      single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U.
      S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep
      or staying asleep). The study will measure levels of inflammation, fasting insulin and
      fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.
    


Intervention name(s): ramelteon; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Rozerem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia
WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to see how safe and effective and tolerable the use of
      colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in
      combination with other anti-diabetic drugs.
    


Intervention name(s): Colesevelam hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes Mellitus
The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker
Condition: Aortic Blood Pressure
MeSH terms: Sick Sinus Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is divided into two parts:

        -  The first part evaluates the acute effect of non-pharmacological heart rate change on
           central hemodynamic parameters noninvasively in sick sinus syndrome patients with a
           permanent cardiac pacemaker

        -  The second part evaluates the acute effects of atenolol, nebivolol and ivabradine on
           central hemodynamic parameters noninvasively in sick sinus syndrome patients with a
           permanent cardiac pacemaker at different pacing rate levels
    

Detailed description: 
      Patients with sick sinus syndrome and a double-chamber cardiac pacemaker are studied.

        -  To investigate the role of non-pharmacological heart rate change on central hemodynamics
           in the first part of the study, the investigators acutely change pacing rate from atrial
           paced-atrial sensed (AAI)-mode 60 to 40 to 90 bpm and obtain hemodynamic parameters
           noninvasively after a short stabilisation period after each pacemaker rate change.

        -  Subsequently, to investigate the acute effects of beta-blockers or ivabradine on central
           hemodynamics in the second part of the study, the investigators obtain central
           hemodynamic parameters noninvasively after acute administration of atenolol, nebivolol
           or ivabradine at the same pacing rate levels used in the first part of the study
           (AAI-mode 60, 40 and 90 bpm).
    

Intervention name(s): AAI 40 bpm; AAI 60 bpm; AAI 90 bpm; Atenolol Pill; Nebivolol Pill; Ivabradine Pill
Intervention type(s): Device; Device; Device; Drug; Drug; Drug
Intervention description(s): Cardiac pacemaker of the subjects is set to AAI-mode 40 bpm in the first and second part of the study; Cardiac pacemaker of the subjects is set to AAI-mode 60 bpm in the first and second part of the study; Cardiac pacemaker of the subjects is set to AAI-mode 90 bpm in the first and second part of the study; 50 or 100 mg of atenolol is administered to subjects in the second part of the study; 5 mg of nebivolol is administered to subjects in the second part of the study; 5 or 7,5 mg of ivabradine is administered to subjects in the second part of the study
Intervention MeSH terms: Atenolol; Nebivolol
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Basic Science
Keywords: sick sinus syndrome; heart rate; aortic blood pressure; artificial pacemaker; beta-blockers; ivabradine
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions
Condition: Discoid Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical
      forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease
      confined to the skin.

      The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream
      0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.
    


Intervention name(s): ASF 1096 0.5 % cream applied twice daily; Cream vehicle for ASF 1096 cream applied twice daily
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Discoid lupus erythematosus