bioihbjkbjnl/mcl2 huggingface dataset:
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The primary objective is to demonstrate safety and long-term effectiveness of the
      irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used
      for isolation of the atrial pulmonary veins (PVs) in treatment of participants with
      paroxysmal atrial fibrillation (PAF).
    


Intervention name(s): Pulsed Field Ablation (PFA) Therapy
Intervention type(s): Device
Intervention description(s): Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the
      treatment of major depressive disorder (MDD) as measured by mean change in total
      Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.
    


Intervention name(s): Antidepressant + SPD489 (lisdexamfetamine dimesylate); Antidepressant + placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks; Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
Other intervention name(s): LDX, Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparison of Long-acting Injectable Medications for Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to compare the "real-world" effectiveness of two
      FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone
      palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective
      disorder who are expected to benefit from the improved medication compliance associated with
      injectable medications. The goal is to evaluate the effects of the medications on outcomes of
      importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy
      makers (all of the above plus costs).
    

Detailed description: 
      The purpose of this comparative effectiveness research study is to learn more about different
      medications called antipsychotics that are used to treat schizophrenia or schizoaffective
      disorder. Specifically, we are looking at long-acting medications that are given by injection
      every month, instead of being taken by mouth every day. In this multi-site study, we are
      comparing the risk and benefits of two FDA-approved long-acting injectable medications
      (paliperidone palmitate and haloperidol decanoate). Study participants with schizophrenia or
      schizoaffective disorder are expected to benefit from the improved medication schedule.

      This study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for
      whom treatment with a long-acting injectable antipsychotic medication is likely to be
      helpful. Study participants will be randomly assigned to treatment with either paliperidone
      palmitate and haloperidol decanoate for up to 24 months. Participants will have an equal
      chance of being assigned to each medication, however participants will not know which
      medication they are taking.
    

Intervention name(s): haloperidol decanoate; paliperidone palmitate
Intervention type(s): Drug; Drug
Intervention description(s): haloperidol decanoate injections, 25-200 mg once a month; Paliperidone palmitate injections, 39 mg - 234 mg once a month
Other intervention name(s): Haldol; Invega Sustenna
Intervention MeSH terms: Haloperidol; Paliperidone Palmitate; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV116 in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blinded, placebo-controlled, single-center phase I clinical
      trial. The objective of this study is to evaluate the safety, tolerability, pharmacokinetic
      profiles of VV116 tablets after multiple ascending doses administered orally to Chinese
      healthy volunteers.
    

Detailed description: 
      Multiple-dose ascending design is used in the trial, VV116/Placebo is administered
      sequentially from low-dose to high-dose and each subject can only orally receive one dose
      level. There are 3 dose groups (200mg, 400mg, 600mg), investigational product is orally
      administrated BID for 5.5 days, the last dose is taken in D6 morning. When 7th day visit
      after last dose (D12) is completed for previous dose group, investigator and sponsor will
      evaluate the safety and determine whether the next dose group can be started. 12 subjects
      will be enrolled in each dose group and the ratio of investigational product to placebo is
      3:1.
    

Intervention name(s): VV116 200 mg Group; VV116 400mg Group; VV116 600mg Group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;; Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;; Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: VV116; Phase I; dose-escalation; Healthy Volunteers; Safety; Tolerability; Pharmacokinetic
Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy,
      safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1
      diabetes and are currently receiving insulin treatment. This study will determine whether
      REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks
      of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.7 ng/mL at
      Screening.

      The study will be conducted at multiple sites in the United States. Approximately 150
      subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1
      fashion into one of three treatment groups.
    


Intervention name(s): REMD-477; Placebo Comparator
Intervention type(s): Biological; Biological
Intervention description(s): Administered as repeated SC doses in subjects with Type 1 Diabetes; Administered as a repeated SC doses in subjects with Type 1 Diabetes
Intervention MeSH terms: Volagidemab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects
Condition: Healthy Volunteers; Pharmacologic Action
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, 3-period crossover, single dose study. Three (3) single
      doses of AZD3293 (2 different tablet formulations, and an oral solution) will be administered
      with a washout period of at least 1 week between the doses to investigate the relative
      bioavailability of AZD3293 after administration via 2 tablet formulations compared with oral
      solution and to evaluate basic systemic pharmacokinetic parameters of the tablet formulations
      compared to the oral solution of AZD3293.

      The safety and tolerability of AZD3293 in healthy subjects will also be assessed in the
      study. AZD3293 is being developed for the treatment of Alzheimer's disease
    


Intervention name(s): AZD3293 oral solution; AZD3293 tablet formulation A; AZD3293 tablet formulation B
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15.; Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15.; Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15.
Other intervention name(s): Beta secretase inhibitor; beta secretase inhibitor; Beta secretase inhibitor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: phase I; healthy volunteers; AZD3293; bioavailability; Pharmacokinetics
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome
Condition: Assisted Reproduction
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe
      ovarian hyperstimulation syndrome and had cancelled embryo transfer
    


Intervention name(s): Cetrorelix
Intervention type(s): Drug
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Frank Score and Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Patients with coronary artery disease (CAD) were enrolled. CAD was diagnosed by coronary
      angiography which also resulted Syntax score. Images of left and right ears were captured by
      a digital camera. Frank score of each patients was calculated based on characteristics and
      numbers of wrinkles of the earlobes. Statistic analysis were carried out to analyze the
      correlation between Frank Score and Syntax Score.
    


Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized patients receiving coronary angiography
      
Keywords: Syntax score; Frank sign; Coronary angiography
Body Composition: a Predictor of Mortality in Subjects Over 65 Years
Condition: External Causes of Morbidity and Mortality
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether body composition is associated with a higher
      risk of mortality in subjects ≥ 65 years.
    

Detailed description: 
      Study centre: University Hospitals of Geneva Study type: retrospective study Study duration
      (anticipated): 1 year for collection of data(1.10.2011-1.12.2012)and 3 months for statistical
      analysis and writing, leading to the completion of the study by march 2013 Study hypothesis:
      A low fat-free mass (FFM) and a high fat mass (FM) are associated with a higher risk of
      mortality in subjects ≥ 65 years.

      Aims: The primary objective is to evaluate the relationship between body composition and
      mortality in men and women ≥ 65 years, while taking into account co-morbidities. The
      secondary objectives are to compare this relationship a) with the relationship of body mass
      index (BMI) and mortality, b) with the relationship of body composition changes and
      mortality, c) between healthy subjects and subgroups of patients with chronic diseases
      Methods: Included are all subjects who had a measurement of body composition by bioelectrical
      impedance analyses, performed in the HUG from 1990 until december 2011. Excluded are subjects
      living abroad. Body composition measurements will be retrieved from DPI and 4D which preceded
      the use of DPI in nutrition and is presently only used for research. Diseases and specific
      laboratory values at time of body composition measurement will be retrieved simultaneously.
      Mortality will be retrieved from the population registers for death.

      Statistics: The relationship between body composition and mortality, in the total population
      and subgroups of patients with chronic diseases, will be evaluated by Cox regression,
      adjusted for age, gender and co-morbidities. The variance of mortality (adjusted R2) related
      to FFM will be compared to that related to BMI and FFM loss.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a historical cohort study of prospectively collected measurements of body
        composition performed by bioelectrical impedance analysis, between 1990 and 2011.
      
Keywords: fat mass; fat free mass; body mass index
The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      To investigate the effect of "High Tone Power Therapy" (HTPT) on fatigue and functional
      outcomes in multiple sclerosis (MS). BACKGROUND: Fatigue and functional limitations
      considered serious disorders in patients with multiple sclerosis that lead to impairment of
      the physical activities and disruption of the quality of life (QOL).

      HYPOTHESES:

      This study hypothesized that:

      High Tone Power Therapy will have a significant beneficial effect on fatigue and functional
      outcomes in in multiple sclerosis

      RESEARCH QUESTION:

      Is there a beneficial effect of High Tone Power Therapy on fatigue and functional outcomes in
      multiple sclerosis?
    

Detailed description: 
      Double blind randomized study including 40 patients with MS. The patients will be randomly
      allocated into 2 arms: active arm and placebo arm; in the active arm patients will receive
      "high tone power therapy" in addition to the physical therapy conventional selected exercise
      program, and the placebo arm will receive the same physical exercise program with sham "high
      tone power therapy". Either program will be applied 3 times per week for 4 weeks.

      The evaluation methods will be done using:

        -  Expanded Disability Status Scale (EDSS) / Functional Systems Score (FSS),

        -  Fatigue severity scale and Modified Fatigue Impact Scale. before the exercise program
           and after finishing the exercise program, The assessor of the patients, before and after
           the program, will be blinded to the technique used (whether active or sham).
    

Intervention name(s): High Tone Power Therapy; exercise program
Intervention type(s): Device; Other
Intervention description(s): High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany).
The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort.; physical therapy conventional selected exercise program inform of functional activities of daily living
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy".
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Tone Power Therapy; fatigue; functional outcomes
Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits
Condition: Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The present study will explore the effectiveness of a computer based neurobehavioral
      intervention in alleviating symptoms and improving emotion regulation in psychiatric
      populations. It will increase understanding of psychopathology at a neural-circuit level and
      aid development of new non-pharmacological treatment for emotion regulatory deficits.
    


Intervention name(s): Computerized Neurobehavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): Targeted, computerized interventions completed from the participants' own home on a computer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Computerized neurobehavioral intervention
Effects of Exercise on VLDL-TG Metabolism
Condition: NAFLD - Nonalcoholic Fatty Liver Disease; NASH - Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis
      to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis. New evidence
      indicates that NAFLD is associated with development of heart failure, abnormal ventricular
      glucose and fatty acid (FA) utilisation and cardiosteatosis. The mechanisms behind cardiac
      involvement and the progression from NAFL to NASH are poorly understood but must include
      altered cardiac and intrahepatic lipid handling. In collaboration with renowned research
      groups from Oxford, Mayo Clinic and Copenhagen we plan comprehensive kinetic studies of heart
      and liver FA uptake and oxidation, ventricular function and substrate utilisation, and
      hepatic triglyceride (TG) secretion in order to assess mechanisms governing cardiac and
      hepatic lipid and glucose trafficking in subjects with NAFL and NASH and the relationship
      with heart function. In addition, we will assess skeletal muscle and adipose tissue enzyme
      activities, gene expression and protein concentrations in these subjects to define mechanisms
      involved in the cross-talk between heart, liver, muscle and adipose tissues. We will address
      these questions using innovative tracer techniques (11Cpalmitate, 11C acetate, 18FDG glucose
      PET tracers and TG tracers) in combination with hepatic vein catherisation to study cardiac
      and liver substrate trafficking, as well as NMR spectroscopy, echocardiography, muscle and
      fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics,
      gene- and protein expression. Effects of acute exercise as well as GLP-1 agonist and SGLT-2
      inhibitor treatment (alone and in combination) will be assessed. The overarching goals are to
      define abnormalities and differences between NAFLD and NASH in hepatic lipid (FA and TG)
      metabolism and to assess hepatic, adipose and skeletal muscle lipid and substrate
      utilisation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI > 30). 8 obese subject
        men with NASH (MR spectroskopi, fibro scanner) (BMI > 30).

        • age between 40-70 years Written consent before the start of the study
Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma
Condition: Medulloblastoma
MeSH terms: Medulloblastoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an international prospective randomised trial, which will compare two radiotherapy
      regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully
      staged 'standard risk' medulloblastoma.
    

Detailed description: 
      Patients eligible for the study will be those with non-metastatic medulloblastoma (by imaging
      and CSF cytology) at diagnosis. Patients randomised to the standard arm will receive
      conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the posterior
      fossa and 23.4 Gy to the craniospinal axis. The experimental arm will be hyperfractionated
      (twice a day) radiotherapy (1 Gy b.d.) with a dose of 60 Gy to the posterior fossa with an
      additional 8 Gy to the tumour bed and 36 Gy to the craniospinal axis. Both groups will
      receive identical chemotherapy consisting of eight weekly doses of Vincristine given with
      radiotherapy and 8 courses of CCNU, cisplatin and vincristine following radiotherapy.
    

Intervention name(s): Standard Fractionation Regimen; Hyperfractionated Radiotherapy
Intervention type(s): Radiation; Radiation
Intervention description(s): 1.8 Gy daily, 5 fractions per week
Cranio-spinal axis:
23.4 Gy in 13 fractions of 1.8 Gy
Posterior fossa:
30.6 Gy in 17 fractions of 1.8 Gy; 1 Gy b.d. (minimum interval between fractions 8 hours). 10 fractions per week
Craniospinal axis:
36 Gy in 36 fractions of 1 Gy
Posterior fossa:
24 Gy in 24 fractions of 1 Gy
Tumour Bed:
8 Gy in 8 fractions of 1 Gy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
Condition: Scar Prevention; Scar Reduction
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the safety of AZX100 Drug Product and to determine
      whether it was effective in preventing or reducing re-growth of surgically removed keloid
      scars.
    


Intervention name(s): AZX100 Drug Product; Placebo; AZX100 Drug Product
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.; Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.; Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: AZX100; Patient and Observer Scar Assessment Scale; POSAS; Visual Analog Scale; VAS; Keloid; Scarring; Scar reduction; Scar prevention