bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
Condition: Progressive Familial Intrahepatic Cholestasis (PFIC)
MeSH terms: Cholestasis; Cholestasis, Intrahepatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the investigational treatment (maralixibat)
      is safe and effective in pediatric participants with Progressive Familial Intrahepatic
      Cholestasis (PFIC).
    

Detailed description: 
      This study was conducted at multiple sites in North America, Europe, Asia and South America.
    

Intervention name(s): Maralixibat; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Maralixibat oral solution (up to 600 mcg/kg) orally twice daily for 26 weeks.; Placebo matching to maralixibat orally twice daily for 26 weeks.
Other intervention name(s): Formerly LUM001 and SHP625
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cholestasis; Maralixibat; Mutation; PFIC; PFIC2; Bile Duct Diseases; Liver Diseases; Biliary Tract Diseases; Digestive System Diseases; Pediatric
Lorcaserin for Preventing Weight Gain Among Smokers
Condition: Tobacco Use Disorder; Weight Gain
MeSH terms: Body Weight; Weight Gain; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This will be an open label clinical trial with all subjects receiving both lorcaserin and
      varenicline with a primary aim of reducing post cessation weight gain.
    

Detailed description: 
      This will be an open label clinical trial with all subjects receiving both lorcaserin and
      varenicline. The investigators will obtain preliminary data on the efficacy of lorcaserin (10
      mg twice daily) for 12 weeks in 20 adult weight-concerned cigarette smokers with a BMI of 27
      to 40 simultaneously receiving 12 weeks of open-label varenicline and a behavioral
      intervention to assist with stopping smoking. Secondary aims will be weight, waist
      circumference, and smoking cessation.
    

Intervention name(s): Varenicline; Lorcaserin
Intervention type(s): Drug; Drug
Intervention description(s): All subjects receive Varenicline; All subjects receive Lorcaserin
Other intervention name(s): Chantix; Belviq
Intervention MeSH terms: Varenicline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity
A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to evaluate the long-term safety, tolerability, and efficacy
      of MP-214 in patients with chronic phase or elderly schizophrenia.
    


Intervention name(s): MP-214; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214; Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic Agents; Mental Disorder; Psychotropic Drugs; Dopamine Agents; Risperidone; Central Nervous System Agents
Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and
      safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with
      Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the
      Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.
    


Intervention name(s): pramipexole immediate release (IR); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Hepatitis A Virus Vaccination Among Homosexual Males at Risk for Hepatitis A Infection
Condition: Hepatitis
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional

Summary: 
      Male homosexuals are at risk for hepatitis A virus (HAV) infection, and HAV vaccination has
      been recommended to prevent HAV infection in male homosexuals. HIV infection may impair
      serological responses to HAV vaccination in HIV-infected patients. The investigators
      hypothesize that 3 doses of HAV vaccine will improve serological responses to HAV vaccine in
      HIV-infected patients.
    

Detailed description: 
      In this study, we aim to compare the serological responses to HAV vaccination between
      HIV-infected patients who receive 2 doses or 3 doses of HAV vaccine and HIV-uninfected
      persons who receive 2 doses of HAV vaccine. Persons who identify themselves as male
      homosexuals aged younger than 40 years and are seronegative for hepatitis A virus will be
      enrolled. HAV vaccination will be provided free-of-charge. HIV-uninfected persons will
      receive 2 doses of HAV vaccine that will be administered at baseline and 6 months after the
      first dose, while HIV-infected patients will be given 2 doses or 3 doses of HAV vaccine; for
      those who choose to receive 3 doses, a second dose will be given 1 month after the first
      dose. A longitudinal follow-up of serological responses will be conducted to assess the
      effectiveness of HAV vaccination; HAV IgG will be determined at 6 months after the first dose
      of HAV vaccination(before the administration of the second dose), 12 months and 18 months
      after the first dose of HAV vaccination .
    

Intervention name(s): Hepatitis A vaccine
Intervention type(s): Biological
Intervention description(s): 2 or 3 doses of hepatitis A vaccine to HIV-infected male homosexuals and 2 doses of hepatitis A vaccine to HIV-uninfected male homosexuals.
Other intervention name(s): HAVRIX (1440 ELISA unit)per dose.; MSM
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatitis A vaccine; male homosexual; HIV infection; male homosexuals who are seronegative for hepatitis A virus
Dog Hair Extract Study
Condition: Potency of Dog Hair Extract
Study type: Interventional

Summary: 
      Liquid allergen extracts contain proteins, such as (but not limited to) tree, weed, cat,
      cockroach, and nuts, and are used to identify allergies by observing the body's reaction to
      the introduction of extract underneath the skin. There are a few dog allergen extracts
      commercially available in the US for allergy testing; however, none of these products are
      standardized, meaning they are not required to be the same strength. Because some extracts
      are not as potent (strong) as others, it's possible that some patients' allergies are
      misdiagnosed. Typically, the most potent (strong), but safe extract should be used so that
      allergic patients are correctly diagnosed.

      The purpose of this study is to compare the safety and potency of an investigational (not
      approved for use by the United States Food and Drug Administration [FDA]) dog allergen
      extract with two commercially available dog extracts, which are of differing potencies.
    

Detailed description: 
      This study is designed to assess the potency of a modified dog hair and dander extract in
      comparison with the two commercially available dog hair and dander extracts. This is a pilot
      study to estimate a target strength of dog extract in order to proceed to further studies.
    

Intervention name(s): Dog Hair Extract, ALK-Abelló, Inc.
Intervention type(s): Biological
Intervention description(s): ALK-Abelló dog epithelial 1:10w/v glycerin
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Skin tests; Dog Hair; Allergy Extract
Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
Condition: FSGS; MCD; Focal Segmental Glomerulosclerosis; Minimal Change Disease
MeSH terms: Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The researchers are testing adalimumab, a treatment which blocks tumor necrosis factor (TNF),
      to see if it changes levels of urine biomarker levels (TIMP1 and MCP1). The outcomes may help
      develop individualized treatment options for future patients with TNF driven Focal segmental
      glomerulosclerosis (FSGS) or minimal change disease (MCD).
    


Intervention name(s): adalimumab
Intervention type(s): Drug
Intervention description(s): Adalimumab will be dosed based on weight
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Kidney Disease; Minimal Change Disease; Nephrotic Syndrome; Focal Segmental Glomerulosclerosis; FSGS
A Study to Assess Injection Comfort of Two Formulations of ATX-101
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately
      following injection and at regular intervals up to 24-hours post-injection following
      subcutaneous administration into the submental area.
    


Intervention name(s): ATX-101-BA-free; ATX-101-BA
Intervention type(s): Drug; Drug
Intervention description(s): ATX-101-BA-free; ATX-101-BA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Formulation Comparison
The Effect of Deep Tissue Massage on Respiratory Parameters in Healthy People.
Condition: Spirometry; Massage
Study type: Interventional

Summary: 
      Deep tissue massage (DTM), based on deep palpation and elimination of fascia restrictions,
      can reduce symptoms resulting from fascial disorders. The goal of this study was the analysis
      of the DTM effect on respiratory parameters in healthy people. People of both sexes living in
      the city of Cracow were recruited to the study by the authors personally and through social
      media. An original questionnaire was completed in the presence of the examiner in order to
      collect the participants characteristics data. Questions about past diseases, previous
      surgical procedures or injuries, currently taken medications or the level of physical
      activity were asked to check the inclusion/exclusion criteria. The study involved a group of
      40 people divided into two subgroups. The experimental group underwent a single DTM session.
      Classic massage was performed in the control group. Before and after treatment the lung vital
      capacity, chest circumference and oxygen saturation were measured and a spirometry test was
      performed. The main hypothesis assumed that static respiratory parameters should increase
      after the treatment session more in the experimental than in control group while the dynamic
      respiratory parameters would not differ significantly in both groups before and after
      treatment.
    


Intervention name(s): Deep tissue massage; Classic massage
Intervention type(s): Procedure; Procedure
Intervention description(s): Administered as a soft tissue mobilization performed by the therapist with fingertips, knuckles, elbows and/or fists on the tissues that manifest symptoms of fascial restrictions. The techniques were performed with individually adjusted force until the change (eg. increased mobility) in the tissue being treated was stated by the therapist.; The subject was lying supine on the table, with a roller placed under the knee joints, the upper limbs along the body. The following sequence of techniques was used in the longitudinal and transverse strands and in the intercostal spaces (excluding the breast in women): effleurage, friction, petrissage, pressures, tapotement and vibrations.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: deep tissue; massage; spirometry; chest; fascial release
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase III trial is to evaluate the efficacy of intravaginal
      dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
    


Intervention name(s): Placebo; DHEA; DHEA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo vaginal suppository; Vaginal suppository containing 0.25% (3.25 mg) DHEA; Vaginal suppository containing 0.5% (6.5 mg) DHEA
Other intervention name(s): Prasterone, Dehydroepiandrosterone; Prasterone, Dehydroepiandrosterone
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulvar/vaginal atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa
Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy
Condition: Heart Failure; Patients Undergoing CRT-D Device Implantation
MeSH terms: Atrial Remodeling
Study type: Observational

Summary: 
      Cardiac resynchronization therapy with pacemaker alone, or in combination with a
      cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in
      patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS
      duration 6 months after cardiac resynchronization therapy. Such phenomenon is called reverse
      electrical remodeling of native conduction. Retrospective analysis showed that reverse
      electrical remodeling of the native conduction after at least 6 months of CRT is associated
      with decreased rate of ventricular arrhythmias and better survival. This study is designed to
      study reverse electrical remodeling prospectively.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Heart Failure Patients undergoing implantation of cardiac resynchronization therapy
        defibrillator
Quadriceps Muscle Plasticity in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Our primary aim is to determine whether and how muscle architecture of the quadriceps muscles
      in cerebral palsy (CP) adapts to two separate training programs: traditional strength
      training (ST) vs. velocity-enhanced training (VT). For the ST group, we hypothesize that
      muscle size will increase in conjunction with strength. For the VT group, in addition to the
      above, we hypothesize that fiber length will increase with measures of muscle power. We also
      hypothesize that walking velocity will improve in both groups but that knee motion and step
      length will improve only with VT.
    

Detailed description: 
      Cerebral palsy (CP) is the most common physical disability originating in childhood,
      occurring in 2-3 per 1,000 live births. Although the primary deficit in CP is injury to the
      brain, secondary impairments affecting muscle function such as weakness, contractures, and
      spasticity are often far more debilitating and lead to worsening disability throughout the
      lifespan. Some have suggested that these muscle changes in CP may be irreversible; however,
      it is now known that muscles are one of the most 'plastic' tissues in the body. In fact,
      recent evidence suggests that gross muscle hypertrophy and architectural changes within
      muscle fibers can occur as early as 3-5 weeks after resistance training in healthy adults. It
      is also unknown how effectively muscles in CP can adapt to training stimuli that target
      specific muscle architectural parameters, such as fascicle length and cross-sectional area.
      These parameters have been observed to be decreased in CP, suggesting loss of sarcomeres
      in-series (fiber shortening) and in-parallel (muscle atrophy). We propose here that specific
      training-induced muscle architectural adaptations can occur in CP, leading to improved motor
      function.
    

Intervention name(s): Traditional strength training; Velocity-enhanced training
Intervention type(s): Other; Other
Intervention description(s): Performed 3 x week for 8 weeks on an isokinetic dynamometer (knee extension exercise)at 30 degrees/second; 6 sets of 5 maximum-effort concentric actions; Performed 3 x week for 8 weeks on an isokinetic dynamometer (knee extension exercise). Subjects will perform 2 sets of 5 concentric exertions at 30°/second. The following 4 sets of 5 repetitions will be performed at a faster speed, starting at 60° /second. The velocity will be increased weekly in 15° /second increments up to a maximum of 120°/second.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; muscle strength; muscle architecture; ultrasound; rehabilitation; rectus femoris; quadriceps muscle
Examining Rapid Acting Intra-Muscular Olanzapine in Japanese Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the clinical therapeutic dose in Japanese agitated
      patients with schizophrenia.
    


Intervention name(s): Olanzapine Hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bilirubin Increases the Risk of Nosocomial Infection in Cirrhotic Patients
Condition: Nosocomial Infection
MeSH terms: Infections; Communicable Diseases; Cross Infection
Study type: Observational

Summary: 
      Nosocomial infection (NIs) is a major challenge in healthcare facilities and has been
      associated with prolonged hospital stay as well as increased morbidity and mortality.

      This research aimed to estimate the impact of acute decompensation (AD) consequences on the
      successive risk of nosocomial infections (NIs) and the go after outcome.
    

Detailed description: 
      Cirrhosis is the 14th most widespread cause of mortality worldwide [1], cirrhosis can take
      one of the following forms: compensated and decompensated phases [2]. The latter is related
      to subsequent complications such as ascites, hepatic encephalopathy (HE), gastrointestinal
      hemorrhage (GIH), jaundice, or spontaneous bacterial peritonitis (SBP) [2]. Decompensated
      cirrhosis is a common cause of frequent hospital admission and high fatality rate [3].
      Patients with cirrhosis and decompensation have bacterial translocations (BT) and immune
      deterioration [4]. Therefore, they are susceptible to getting infections and septic shock
      [5]. On the other hand, the infection can worsen the course of cirrhosis and hasten the
      progression of related morbidities with a subsequent increase in death rate owing to its
      ability to accelerate organ failure [6]. For cirrhotic patients, the occurrence of NIs is an
      essential standpoint [7]. Several studies on cirrhotic patients revealed that the incidence
      of NIs is much higher in patients with cirrhosis and thus worsens the prognosis [8,9]. Recent
      studies showed that around 30 to 50% of bacterial infections (BIs) in patients with
      decompensated cirrhosis are NIs which is related to a higher risk of acute-chronic liver
      failure (ACLF), severe sepsis, and mortality [10-12].

      Nevertheless, current studies have not clarified how decompensation differentially
      predisposes to the occurrence of NIs and affects the outcomes. Henceforth, this study aimed
      to assess the incidence of NIs in cirrhosis with differential decompensation consequences,
      the bond between the type of decompensation at admission and the progress of NIs, and the
      synergism between decompensation and subsequent NIs on the outcome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients were diagnosed with cirrhosis based on liver biopsy. Decompensation was defined as
        acute deterioration in liver function accompanied with acute onset of complications such as
        ascites, HE, GIH, BIs, or jaundice at the time of hospitalization
Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      People with poor insulin sensitivity do not respond normally to elevations in blood sugar.
      This may increase their risk of developing diabetes in the future. The purpose of this
      research study is to determine if the nutrient betaine, found in beets, spinach and wheat
      products, can enhance the production of fetal growth factor 21 (FGF21), a molecule that is
      believed to promote insulin sensitivity.
    

Detailed description: 
      AIM: To determine if betaine is a modulator of FGF21 in humans. Low plasma betaine is
      associated with an increased risk of metabolic syndrome, but the mechanisms modulating this
      correlation are poorly delineated. Betaine bioavailability in humans is determined by dietary
      intake and genetic polymorphisms that influence betaine metabolism. Therefore, moderating
      betaine levels could be particularly beneficial for some individuals. FGF21 is elevated in
      response to insulin insensitivity and is under active investigation as a therapeutic
      modality. The mechanisms of action of FGF21 and betaine on insulin sensitivity in humans are
      incompletely understood. This study tests the hypothesis that betaine induces FGF21 secretion
      and insulin sensitizing actions in humans by measuring plasma FGF21, betaine, choline
      (betaine precursor), glucose, insulin and adiponectin in response to betaine supplementation
      over a 24 hour time course in 20 healthy, lean individuals. This pilot nutrition intervention
      will provide key preliminary evidence for understanding whether and how betaine exerts
      metabolic benefit in humans and will inform a future study to investigate the novel
      betaine-FGF21-insulin sensitivity axis in a larger cohort.
    

Intervention name(s): Betaine; Dextrose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage; 6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage
Intervention MeSH terms: Betaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science