bioihbjkbjnl/mcl2 huggingface dataset:
Adjunctive Renal Denervation in the Treatment of Atrial Fibrillation
Condition: Uncontrolled Hypertension; Atrial Fibrillation
MeSH terms: Hypertension; Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of the H-FIB trial is to determine the role of renal sympathetic denervation in
      the prevention of Atrial Fibrillation (AF) recurrence in patients with hypertension for whom
      a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF
      catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.
    

Detailed description: 
      The purpose of this study is to examine the potential additional benefit of performing renal
      sympathetic denervation at the same time as an AF ablation procedure, in order to improve the
      long-term success of the AF procedure.

      To take part in this study, you must meet all study requirements. Screening visit tests and
      procedures such as a physical exam, blood pressure, review of medical history, blood sample,
      and a Transthoracic Echocardiogram (TTE) are done to see if you are eligible to be in the
      study.

      Patients who qualify for the study and provide consent will undergo catheter ablation for AF.
      Very thin electrode catheters, similar to long wires, will be inserted into blood vessels in
      the groin. Using the ablation catheter, we will "ablate" or damage the tissue adjacent to
      your pulmonary veins that is not behaving normally.

      Immediately following the catheter ablation, patients will undergo a renal angiogram in order
      to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is
      an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities
      that could be affecting the blood supply to the kidney. It is performed by injecting contrast
      dye through a catheter (a tiny tube) into the blood vessels of the kidney.
    

Intervention name(s): Boston Scientific Vessix Renal Denervation System
Intervention type(s): Device
Intervention description(s): Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
Other intervention name(s): renal denervation; denervation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: renal sympathetic denervation; renal catheter ablation; hypertension
Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children
      that greatly influence their quality of life. Many efforts have been directed toward the
      investment of effective drugs with high safety profiles and with oral administration for
      better compliance. The development of a new direct-acting antiviral (DAA) made it possible to
      achieve these goals.
    

Detailed description: 
      The calculated sample size of the study was ....participants at 5% level of significance and
      80 % power, using the following formula:

      N= (Z1-α/2+Z1-β) 2 σ1* σ2 / δ 2 This study aims to evaluate the safety and efficacy of the
      combined Sofosbuvir/ Ledipasvir regimen given for 12 weeks in children aged 12-18 years or
      weighing at least 35 kg with HCV genotype 4 infections.

      Patients will receive Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg
      Ledipasvir, 400 mg Sofosbuvir) taken orally once daily at a fixed time with or without food
      for 12 weeks. Visits will be arranged at 4, 8, and 12 weeks. Patients will have easy access
      to the pediatric hepatology unit and the treating physician if any urgent problem happens in
      between the visits.

      The SPSS software version 24, SPSS was used for data processing
    

Intervention name(s): Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet
Intervention type(s): Drug
Intervention description(s): proper history was taken. HCV genotyping was done revealed GT 4 in all included patients. Basic ECG and abdominal US were performed prior to treatment. Concomitant HBV infection was excluded by HBs Ag and anti-HBc antibody HIV screening was done prior to treatment. Basic investigations were done prior to therapy. All included patients received Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks. Regular visits were arranged at 4, 8, and 12 weeks with easy access to the pediatric hepatology unit and the treating physician if any urgent problem in between the visits. Every visit, laboratory investigations were checked. Adverse events (after excluding other possible causes) were reported for the safety profile of the drug. The efficacy of the drug, HCV-RNA was assessed by quantitative real-time PCR at 4 weeks and after the end of the treatment course (12 weeks)
Intervention MeSH terms: Sofosbuvir; Ledipasvir; Ledipasvir, sofosbuvir drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Egyptian children; Sofosbuvir; Ledipasvir
Strategy for Daily Activity Improvement in Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The symptoms and signs of patients with Parkinson's disease (PD) include bradykinesia,
      rigidity, tremor and poor sensory integration, which result in mobility disability. Present
      integrated research project tries to investigate the effects of different physical therapy
      interventions on daily activities in patients with PD. This integrated research project
      includes 3 subprojects as follows. The title of Subproject 1 is "Three dimensional motion
      analysis of daily activities with functional insole in Parkinsonian patients". The title of
      Subproject 2 is "Immediate and long-term effects of novel plantar mechanical device on
      postural control in standing and gait performance in people with Parkinson's disease". The
      title of Subproject 3 is "Upper extremity hand function and coordination during functional
      movement in patients with Parkinson's disease".

      This multidisciplinary research project collaborates with Department of Physical Therapy, and
      Department of Medicine in Tzu Chi University. Furthermore, this integrated study also works
      with Department of Neurology, Department of Neurosurgery, as well as Department of
      Rehabilitation in Tzu Chi Hospital to improve the mobility in patients with PD.

      This is a three-year integrated project, and the common purposes of this project in each are
      as follows. In the first year, it is to compare the daily functional difference between the
      healthy and the Parkinsonian patients. In the second year, it is to examine the immediate and
      short-term effects of different interventions on daily activities in Parkinsonian
      patients.The third year is for upper extremity functional assessment.
    

Detailed description: 
      In the first year, it is to compare the functional difference of biomechanics and motor
      control between the healthy and the Parkinsonian patients. In the second year, it is to
      examine the immediate and short-term effects of functional foot insole and the kinetic
      training on daily activities in Parkinsonian patients. In the third year, it is to examine
      the hand tremor during drawing, and the coordination during reaching in Parkinsonian
      patients.
    

Intervention name(s): foot insole
Intervention type(s): Device
Intervention description(s): arch support and toe extension
Other intervention name(s): spiral drawing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To compare between experimental and control groups.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Parkinson disease; Quality of life; Physical therapy; tremor; coordination; gait analysis
Moses vs. Thulium Laser Study
Condition: Urinary Tract Stone
MeSH terms: Urinary Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      The incidence of urinary tract stone disease is increasing. According to the National Health
      and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United
      States are affected by renal stone disease. This has led to an increased demand on Urologists
      for efficient and safe surgical treatment of stone disease. Over the past two decades,
      ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and
      renal stones globally. The holmium laser is considered the gold standard for laser
      lithotripsy. Holmium laser lithotripsy with Moses and the thulium laser are new technologies
      meant to improve the efficiency of laser lithotripsy. Both are FDA approved treatment
      modalities for stone disease. Two in vitro studies have compared Moses versus thulium and
      shown that thulium has higher ablative volumes then the holmium laser with Moses, but no
      clinical trials have compared the two treatment modalities.

      In this study, investigators are going to conduct a prospective, randomized clinical trial to
      determine whether there is a difference in procedural time, intraoperative parameters or
      stone free rate between the Holmium laser with Moses and the thulium laser. This is
      significant as this may lead to shorter overall operative times, which may result in
      decreased operative costs and complications.
    


Intervention name(s): Holmium laser with Moses lasers; Holmium laser with thulium lasers
Intervention type(s): Device; Device
Intervention description(s): The holmium laser with Moses is FDA approved. It emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. The goal is to increase stone ablative volume and decrease retropulsion of the stone.; The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized (ratio 1:1) at the time of enrollment to be treated with either the holmium laser with Moses or the thulium laser. Investigators will use Permuted Block Randomization (stratified by stone size 3 - 10 mm or 11-20 mm) (block size 4).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Lithotripsy; Holmium laser
Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD)
      study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study
      site in Canada.
    


Intervention name(s): MCAF5352A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): may receive up to 3 subcutaneous doses of MCAF5352A; may receive up to 3 subcutaneous doses of placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 1 Study of Relative Bioavailability of PPI-668 New Tablet Versus Capsule Formulations
Condition: Pharmacokinetic Assessments in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the blood levels of PPI-668 resulting from two different formulations
      - the current capsule and a new tablet, T003.
    


Intervention name(s): PPI-668 tablet; PPI-668 capsule
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
Condition: Immunologic Tests
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to develop and characterize immunological assays on blood
      samples.
    


Intervention name(s): Blood withdrawal
Intervention type(s): Other
Intervention description(s): A single blood sample was to be taken from all subjects at the study visit. No study-related treatment was given to the study participants.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Immunological assays; Chronic hepatitis B
Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on the Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 15 mg in Japanese Healthy Male Adult Subjects
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers in this study wanted to compare the effect of the formulation (orally
      disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban
      (brand name: Xarelto) at dose of 15 mg in Japanese healthy male subjects aged 20 to 40 years.
      Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by
      blood clots. Currently, there are two formulations of Rivaroxaban available on the market in
      Japan and they are film-coated tablets and fine granules. To further improve patients'
      convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form
      designed to be dissolved on the tongue rather than swallowed whole) is under development. The
      goal of this study was to compare the effect of this new formulation with film-coated tablets
      when taken with or without water.

      Participants in this study received one oral dose of rivaroxaban 15 mg ODT either with or
      without water and one oral dose of rivaroxaban 15 mg film-tablet. There were at least 5 days
      between the two doses. Observation for each participant lasted about 6 weeks in total. Blood
      samples were collected from the participants to measure the blood level of the study drug.
    


Intervention name(s): Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg as 1 x 15 mg orally disintegrating tablet (ODT); 15 mg as 1 x 15 mg film-coated tablet
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Trial of Simvastatin to Treat Generalized Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators purpose is to initiate a phase II, randomized, placebo-controlled clinical
      trial to test simvastatin, an FDA-approved medication for hypercholesterolemia, as a new
      treatment for vitiligo. The aims of this placebo-controlled study seek to determine the
      safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male patients
      with generalized vitiligo. Additionally, the investigators will collect blood to examine the
      effect of simvastatin on autoreactive CD8+ T cells in vitiligo patients.
    

Detailed description: 
      Vitiligo is an autoimmune disease caused by autoreactive CD8+ T lymphocytes that target
      melanocytes, and interferon-γ-induced CXCL10 plays an important role.1 Simvastatin inhibits
      interferon-γ signaling by blocking activation of STAT12 and prevented and reversed disease in
      our mouse model.3 A case report described a patient with vitiligo who repigmented with
      simvastatin.4 We conducted a small, randomized, double-blind, placebo-controlled, phase II
      clinical trial to test simvastatin as a treatment for vitiligo. After obtaining informed
      consent, we enrolled men ages 18 to 64 years with vitiligo affecting 3% to 50% of their body
      surface area (BSA). We excluded patients with a segmental presentation; those already taking
      3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor; those with existing thyroid
      disease; and women, based on their increased risk of simvastatin-induced myopathy.
    

Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated; Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitiligo; simvastatin
Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 3

Summary: 
      As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg
      for the treatment of premature ejaculation
    

Detailed description: 
      Randomized, double blind, placebo controlled, prospective and parallel trial. Men with
      premature ejaculation using the Diagnostic and Statistical Manual of Mental Disorders, fourth
      edition, text revision criteria for at least 6 months, with an intravaginal ejaculatory
      latency time (IELT) ≤ 3 minutes. Three treatments are to be compared: placebo, 15 mg or 20 mg
      paroxetine for 12 weeks.
    

Intervention name(s): paroxetine; paroxetine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): daily dose of paroxetine 15mg for 12 weeks; active daily treatment with paroxetine 20 mg; active daily treatment with placebo
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: premature ejaculation; paroxetine; daily treatment
Low-dose Fostemsavir Extended Release Relative Bioavailability Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study. Part 1 will evaluate relative bioavailability of temsavir (TMR)
      following single dose administration of the reference fostemsavir (FTR) compared to two
      low-dose ER tablet formulations of FTR. In Part 2, the effect of food on the bioavailability
      of TMR will be assessed on the selected low-dose ER tablet formulation from Part 1.
    


Intervention name(s): Fostemsavir 600 mg; Fostemsavir 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): Fostemsavir tablets will be administered via oral route.; Fostemsavir tablets will be administered via oral route.
Intervention MeSH terms: Fostemsavir
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a two-part study, where Part 1 will be conducted as a randomized three period, three treatment crossover study and Part 2 will have a randomized two period, two treatment crossover design.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Temsavir; Fostemsavir; Bioavailability; Extended Release tablet; GSK3684934; Food effect
Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
Condition: Cerebral Palsy; Hemiplegia; Children
MeSH terms: Cerebral Palsy; Hemiplegia
Study type: Interventional

Summary: 
      A randomized control trial examining the relationship between changes in hand function and
      brain plasticity following intensive therapy. Two treatment approaches are used:
      constraint-induced movement therapy (CIMT) or Hand-Arm Bimanual Intensive Therapy (HABIT).
      The protocols have been developed at TC Columbia University to be child friendly and draw
      upon our extensive experience with constraint-induced movement therapy in children with
      cerebral palsy. Our center has been providing interventions camps for children with cerebral
      palsy since 1998. The interventions are performed in a 15 day day-camp setting with several
      children and at least one interventionist per child. The aim of the intervention is to
      improve the use of the affected hand and quality of overall movement in a fun, social
      setting. PARTICIPATION IS FREE. Please check out our website for more information:
      http://www.tc.edu/centers/cit/
    

Detailed description: 
      Constraint-induced Movement Therapy and Bimanual training are motor-learning based approaches
      to engage children in fun activities. This study looks at what areas of the brain are
      responsible for recovery after intensive training. We are trying to understand how the brain
      responds to movement training and hope that in the future we can develop new treatments for
      hemiplegia based on what we learn about the brain in this study.

      To study the areas of the brain we will use Magnetic Resonance Imaging (MRI) to take pictures
      of the brain and Transcranial Magnetic Stimulation (TMS) to determine parts of the brain
      involved in using the hand. TMS uses a brief magnetic field over the scalp by using a wand
      that looks like a figure 8. The wand can make brief magnetic fields over a series of spots on
      your child's head to activate the brain cells under the wand. Non-invasive, single pulse TMS
      will be used in this study, which is considered minimal risk and tolerable to children. If
      your child has a recurrent history of seizures after two years of age, he/she might not
      qualify.
    

Intervention name(s): Constraint-induced Movement Therapy; Hand-arm Bimanual Intensive Therapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; HABIT; CIMT; Cerebral Palsy; Hemiplegia; Children; Therapy