bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder
Condition: Female Sexual Arousal Disorder
MeSH terms: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral
      engorgement in pre-menopausal women, as well as examining the safety and toleration of the
      drug.
    


Intervention name(s): Sildenafil 100 mg; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Acute Dystonia or Parkinsonism
Condition: Schizophrenia; Extrapyramidal Syndrome
MeSH terms: Dystonia; Parkinsonian Disorders; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      We initiate a study with research grant from department of health and Taoyuan mental hospital
      and choose risperidone and olanzapine as study medications. We compare the incidence of using
      anticholinergic drugs in schizophrenic patients of Han ethnics with neuroleptic-induced acute
      dystonia or parkinsonism to test the hypothesis that these two medications have different EPS
      incidence in EPS intolerant population.
    

Detailed description: 
      Objective: First generation antipsychotics frequently induced extrapyramidal side effects
      (EPS). Second generation antipsychotics were the choices for EPS intolerant schizophrenic
      patients. But which one of second generation antipsychotic was the better choice did not have
      definitive results. We compared risperidone and olanzapine in schizophrenic patients with
      acute dystonia or parkinsonism side effects and observed the incidence of needing concomitant
      anticholinergic drugs. We also collected the data of average dose of risperidone and
      olanzapine to help the dosing strategy guidelines for EPS intolerant schizophrenic patients.

      Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients
      from Taoyuan Mental Hospital from July 2000 to July 2003. Schizophrenia (DSM-IV) patients who
      met the research criteria of neuroleptic-induced acute dystonia or parkinsonism research
      criteria of DSM-IV and greater than moderate severity (>4) of global impression of
      extrapyramidal syndrome rating scale (ESRS). 70 patients were random assignment to
      risperidone or olanzapine for 8 weeks. The primary outcome was to compare the incidence of
      concomitant anticholinergic drugs.
    

Intervention name(s): Risperidone and Olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Schizophrenia, EPS, risperidone, olanzapine
Effect of a Novel Nutraceutical on Weight Loss and Weight Maintenance in Obese Subjects
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this 2-stage intervention study is to investigate the effect of a novel
      nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and
      weight loss maintenance in obese participants.
    


Intervention name(s): THIAA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day; Placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Periodized Aerobic Interval Training in Metabolic Syndrome
Condition: Metabolic Syndrome; Metabolic Syndrome X
MeSH terms: Microvascular Angina; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Autonomic disfunction present in metabolic syndrome subjects is related by a greater
      vulnerability of the heart and risk of cardiovascular events. In this context, aerobic
      interval training has been highlighted by its easy applicability and benefits effects in
      autonomic modulation in different populations. Therefore the studies that use de aerobic
      interval training in this different populations didn't realize a periodization of training
      with preparatory periods with progressive increase of load, specific phases with less
      duration predominating the intensity and transition periods for recuperation. Additionally,
      there isn't studies that investigate the effects of aerobic interval training in autonomic
      modulation of individuals with metabolic syndrome. In this context, periodized aerobic
      interval training can arise like a new type of treatment that offering security and efficacy
      in subjects with metabolic syndrome. So, the aim of the study is evaluate the effect of
      periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and
      anthropometric parameters of individuals with metabolic syndrome.
    


Intervention name(s): Periodized aerobic interval training
Intervention type(s): Behavioral
Intervention description(s): The periodized training program consist in 3 phases: light (I) (training range varying between 20 to 39% of heart rate reserve and active recuperation of 19% of heart rate reserve); moderate (II) (training range varying between 40 to 59% of heart rate reserve and active recuperation of 30% of heart rate reserve) and high (III) (training range varying between 70 to 90 % of heart rate reserve and active recuperation of 50% of heart rate reserve).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic syndrome X; Autonomic nervous system; Aerobic exercise; Exercise; Heart rate
Exercise Training in Dystonia
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate how the brain and motor behavior changes
      in individuals with dystonia and other involuntary movement disorders and healthy individuals
      over time with exercise training.
    

Detailed description: 
      The study team plan to conduct a randomized prospective, parallel-group, controlled study to
      examine the effects of exercises in dystonia and other involuntary movement disorders.
      Patients will be randomized to receive either progressive resistance training or a control
      treatment following the modified fitness protocol. The study team hypothesize that
      progressive resistance training will result in better outcomes compared to modified fitness
      protocol.

      Data collect includes 1) data about clinical movement disorder history, age, gender, height,
      weight, and other medical conditions; 2) clinical neurological examination; 3) tests
      assessing cognitive abilities (the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins
      Verbal Learning Test, COWA and Animals, and Brief Test of Attention); 4) tests assessing
      motor abilities including Toronto Western Spasmodic Rating Scale (TWSTRS) and
      Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS); 5) measures of anxiety and depression
      (Beck Depression Index, Hamilton Anxiety and Depression Rating Scales); 5) Cervical dystonia
      related quality of life (CDQ-24); 6) Visual Analog Scales-Quality of Life (VAS QOL)
      evaluating of health related quality of life.
    

Intervention name(s): Progressive Resistance Training
Intervention type(s): Behavioral
Intervention description(s): Participants will perform required resistance training exercises at regular intervals for a period of up to 3 years. They will be tested at a baseline visit, then every 6 months for a total of at least 5 visits. During these visits, they will be asked to complete the following: questionnaires about quality of life and depression, tests to measure strength and motor function, tests to measure cognition, an orientation session to learn a precision griping task, structural and functional MRI scans of the brain, measurement of brain waves using a non-invasive technique called electroencephalography (EEG) and muscle activity using electromyography (EMG), measurement of brain function with TMS, pregnancy test (if applicable).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo
      after 26 weeks of treatment on the percent change in body weight from baseline and to assess
      the safety and tolerability, in non-diabetic severely obese participants.
    


Intervention name(s): JNJ-64565111 Dose Level 1; JNJ-64565111 Dose Level 2; JNJ-64565111 Dose Level 3; Liraglutide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.; Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.; Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.; Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.; Participants will receive matching placebo SC once-weekly until Week 26.
Other intervention name(s): Saxenda
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand whether BIIB014 has potential to affect how
      certain drugs are broken down by the body.
    


Intervention name(s): BIIB014; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d; Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d
Intervention MeSH terms: 3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Healthy Volunteer
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily
      in reducing urgency, urinary frequency and urinary urge incontinence in female patients with
      incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.
    


Intervention name(s): trospium chloride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks; Placebo once daily on an empty stomach for 14 weeks.
Other intervention name(s): Sanctura XR®
Intervention MeSH terms: Trospium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Tart Cherry Juice in Reducing Muscle Injury and Biomarkers of Muscle Damage Among Healthy Adults
Condition: Inflammation; Pain
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effects of tart cherry juice to reduce serum
      biomarkers of inflammation and reduce muscle soreness in healthy adults who undergo a bout of
      controlled eccentric exercise.
    

Detailed description: 
      Numerous antioxidant and anti-inflammatory agents have been identified in tart cherries, and
      a study among healthy, non-exercising individuals demonstrated that tart cherries decreased
      post-exercise weakness and muscle pain. The purpose of this study is to assess the analgesic
      and myoprotective effects of tart cherry juice among healthy subjects in a randomized,
      placebo controlled, double-blind, crossover design trial. Fifteen healthy individuals will
      perform a bout of eccentric elbow flexion contractions (2 x 10 near maximum), and will then
      ingest 10 fl oz of a cherry juice or a placebo juice twice a day for four days, beginning
      immediately post exercise. Before and after exercise, and for three days following the
      eccentric exercise, blood will be drawn to measure serum biomarkers of muscle damage and
      muscle soreness will be recorded. The protocol will be repeated after a 9-10 day washout
      period with subjects consuming the alternative juice for the second trial. The opposite arm
      will perform the eccentric exercise for the second bout to avoid the repeated bout protective
      effect. The study's outcomes are 1) to assess changes in serum biomarkers of muscle damage,
      and 2) to assess changes in muscle soreness.
    

Intervention name(s): tart cultivar Montmorency cherry juice; placebo cherry fruit drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; inflammation; muscle damage
Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to test plasma exposure to PF-05089771 with same formulation will be used for
      phase II trials (capsule).
    


Intervention name(s): PF-05089771; PF-05089771; PF-05089771
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 450mg; 450mg; 450mg
Other intervention name(s): no specified; no specified; no specified
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing
      conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects.
    


Intervention name(s): NNC0113-0987
Intervention type(s): Drug
Intervention description(s): For oral administration. All subjects will be treated for 10 consecutive days with five days on 5 mg NNC0113-0987 followed by five days on 10 mg NNC0113-0987. Dose escalation is chosen to increase gastrointestinal tolerability.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Condition: Healthy; Term Infants
Study type: Interventional

Summary: 
      The purpose of this two-month follow-up study is to continue to follow growth, safety, and
      other health outcomes of infants fed a new infant formula for term infants or comparator
      formula. A reference group of human milk-fed infants will also be followed. This study is
      designed in accordance with Good Clinical Practice guidelines.
    


Intervention name(s): Study Formula (SF); Comparator Formula (CF)
Intervention type(s): Other; Other
Intervention description(s): New infant formula for term infants fed ad lib; Commercially available infant formula for term infants fed ad lib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Infant; Infant Formula; Healthy Subjects
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
Condition: Primary Biliary Cholangitis (PBC); Liver Cirrhosis, Biliary
MeSH terms: Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose
      of OP-724 against Primary Biliary Cholangitis patients.
    

Detailed description: 
      This trial is a phase I trial aimed at examining the safety and tolerability of OP-724 in
      patients with primary biliary cholangitis and determining the recommended dose.

      The subjects are patients diagnosed with primary biliary cholangitis and diagnosed as
      progress of fibrosis (Scheuer stage III or higher) as a result of liver tissue examination.
      As a dosing schedule, OP-724 is intravenously administered twice a week (4 hours) for 12
      weeks. However, once 7 days prior to the first cycle of administration, a dose scheduled for
      the first cycle will be administered once by continuous intravenous administration for 4
      hours, and safety and pharmacokinetics will be evaluated on the day of administration to the
      next day after administration. The dose level shall be 3 doses (140 mg/m2/4hrs, 280
      mg/m2/4hrs [starting dose], 380 mg/m2/4hrs), of which 2 doses shall be registered for up to 6
      patients each. The safety and pharmacokinetic data after OP-724 administration will be
      decided comprehensively to determine the recommended dose in the next phase.
    

Intervention name(s): OP-724
Intervention type(s): Drug
Intervention description(s): Twice a week for 4 hours continuous intravenous administration of OP-724
Other intervention name(s): CBP-beta-catenin inhibitor; PRI-724 (former name)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Biliary Cholangitis (PBC); Liver Cirrhosis, Biliary; Cholangitis, Chronic Nonsuppurative Destructive; Liver Cirrhosis, Obstructive; Secondary Biliary Cholangitis; Primary Biliary Cirrhosis; Secondary Biliary Cirrhosis
TAP-patients With Robotic Assisted Lap Prostatectomy
Condition: Postsurgical Pain; Analgesia; Prostatectomy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to assess the safety and efficacy of EXPAREL when administered
      via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical
      analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
    

Detailed description: 
      Assess the safety and efficacy of EXPAREL when administered via infiltration into the
      transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men
      undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of
      abdominal analgesia from the infiltration into the TAP as measured by the time to the
      subject's first postsurgical opioid administration.
    

Intervention name(s): EXPAREL 20 mL; EXPAREL 40 mL
Intervention type(s): Drug; Drug
Intervention description(s): EXPAREL 266 mg (undiluted); EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.
Other intervention name(s): bupivacaine liposome injectable suspension; bupivacaine liposome injectable suspension
Intervention MeSH terms: Bupivacaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TAP, robot-assisted prostatectomy
A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study will be to examine the efficacy, safety, and tolerability of
      ruxolitinib cream in subjects with vitiligo.
    


Intervention name(s): Ruxolitinib cream; Vehicle cream
Intervention type(s): Drug; Drug
Intervention description(s): Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Other intervention name(s): INCB018424 cream
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vitiligo; depigmenting disorder; topical JAK inhibitor
Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to measure longitudinally the availability of the PDE10A enzyme in
      HDGECs using the radioligand [18F]MNI-659. The study will be a follow-up, examining HDGECs
      from the CHDIKI1201/PET-HD-PDE10A (NCT02061722) study from 18 to 28 months after the initial
      PET measurement.
    

Detailed description: 
      The HDGECs will perform 2 study visits: Visit 1 (screening) and Visit 2 (PET analysis
      utilizing the radioligand [18F]MNI-659). There will also be 2 telephone follow ups; one after
      Visit 1 (telephone follow-up after screening) and one after Visit 2, (telephone follow-up
      after PET). Study visits and telephone follow-ups will take place during a maximum of 97
      days.
    

Intervention name(s): Radioligand [18F]MNI-659
Intervention type(s): Radiation
Intervention description(s): The effective radiation dose for the injection of [18F]MNI-659 is approximately 5.6 mSv (approximately 2 years of background radiation in Sweden) for an average person weighing 70 kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes
Condition: Vitreous Disorder; Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To determine the surgical outcome and patient satisfaction in patients who underwent AT LARA
      lens implantation during or after vitrectomy at a relatively young age (around 55 years of
      age), mostly to treat (urgent) retinal detachment.
    

Detailed description: 
      The surgical outcome is defined as the patient satisfaction determined by patient
      questionnaires.

        -  Visual quality: CatQuest questionnaire

        -  Near vision: NAVS questionnaire

        -  Glare: APPLES questionnaire

      These questionnaires are standardized and validated, although no cut-off values have been
      determined. Hence, the results drawn from these questionnaires are descriptive only.
    

Intervention name(s): intraocular lens implantation
Intervention type(s): Procedure
Intervention description(s): Lens surgery during or before vitrectomy surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group 1: patients that had a LARA IOL implanted in combination with vitrectomy group 2: patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: LARA EDOF lens; Intra ocular lensimplantation; cataract; vitrectomy