bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of ziprasidone and
      risperidone for the treatment of schizophrenia in Chinese patients
    


Intervention name(s): Risperidone; Ziprasidone
Intervention type(s): Drug; Drug
Intervention description(s): Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6; Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6
Intervention MeSH terms: Risperidone; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
Condition: Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local
      control of cancer and prolong survival in patients with inoperable biliary tract cancer.
    


Intervention name(s): Irinotecan and Gemcitabine
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine; Irinotecan
Primary purpose: Treatment
Keywords: toxicity
Study of Effectiveness of Mexyn-A
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      Atomised Methoxymethane-in-Aqua (MEXYN-A) a new topical self-chilled, non-steroidal,
      non-flammable, pressurised spray which embodies in one simultaneous application, most of the
      currently recognised and effective chemical, mechanical and thermal anti-pruritic therapies
      and hydrotherapy.
    

Detailed description: 
      The primary clinical endpoint was to establish MEXYN-A efficacy and safety in abolishing or
      reducing pruritus related to cutaneous diseases, insect bites and poison ivy, within few
      seconds of the application. The secondary endpoint was to measure the itch free period as a
      result of the new intervention.
    

Intervention name(s): Mexyn-A
Intervention type(s): Device
Intervention description(s): Atomised topical self-chilled pressurised spray
Other intervention name(s): Clearitch, Itcharret, itchclear, Magicool-Plus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pruritus, itching, mexyn-a, clearitch, magicool-plus
Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing IL-5 in Children With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Single-center, randomized, placebo-controlled study to:

        -  characterize the subjects at baseline and discriminate groups of children based on IL-5,
           IL-17, IL-23 and INF-γ;

        -  investigate the effect of Resveratrol plus Carboxymethyl-β-Glucan, two sprays
           (100µL/spray) for nostril three times/day for 4 weeks, in comparison with placebo, in
           reducing nasal interleukin-5 (IL-5) in children with Allergic Rhinitis (AR).

      Secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in
      comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue
      scales for rhinitis, quality of life and quality of sleep, and the effect on objective
      parameters, i.e. nasal nitric oxide (nNO) levels, nasal cytology and acoustic rhinometry.
    


Intervention name(s): Resveratrol plus Carboxymethyl-β-Glucan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks; Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
Condition: Thoracic Spinal Cord Injury; Spinal Cord Injury; Spinal Cord Injury Thoracic; Spinal Cord Trauma
MeSH terms: Spinal Cord Injuries; Aortic Dissection; Wounds and Injuries; Thoracic Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the effect of single transplantation of HuCNS-SC cells into the
      thoracic spinal cord of patients with sub-acute spinal cord injury.
    

Detailed description: 
      Study subjects will receive immunosuppression for nine months following transplantation. All
      enrolled subjects will be followed for one year following transplantation and then will be
      enrolled in a separate long-term follow-up study for an additional four years.
    

Intervention name(s): HuCNS-SC cells
Intervention type(s): Biological
Intervention description(s): single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord
Other intervention name(s): Human central nervous system stem cells; allogeneic stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thoracic spinal cord injury; spinal cord injury thoracic; sub-acute spinal cord injury; human neural stem cells; stem cells; stem cells transplant; stem cells transplant spinal cord injury
Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators test the hypothesis that different beta-blockers had a different influence
      on chemoreceptor response and lung diffusion capacity.

      Both could influence exercise capacity in normoxic as well as hypoxic conditions.
    


Intervention name(s): carvedilol; bisoprolol; Nebivolol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Carvedilol; Nebivolol; Bisoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: exercise; lung diffusion; hypoxia; chemoreceptor; beta-blockers; heart failure
First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose
      study to evaluate the safety, tolerability, and pharmacokinetics of CEL383 in healthy
      volunteers.
    


Intervention name(s): CEL383; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive CEL383; Subjects will receive placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neurophysiological Effects of Dry Needling in Patients With Neck Pain
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Neck Pain
Study type: Interventional

Summary: 
      The present study aims to evaluate the differences that may be experienced in pain and
      cervical disability, before, during and just after the intervention of the Deep Dry Needling
      in the upper trapezius muscle in active, passive myofascial trigger points (MTP) or non-MTP
      in Patients with neck pain, assessing, in turn, the neurophysiological effects on the
      Autonomic Nervous System.

      Hypothesis: Deep Dry Needling of active myofascial trigger points produces a greater decrease
      of pain and cervical disability index and increase of pressure pain threshold; Than the Deep
      Dry Needling of Myofascial Trigger Points latent or out of Myofascial Trigger Points in
      patients with chronic neck pain.

      Objective: To determine the efficacy of Deep Dry Needling applied on Active Myofascial
      Triggers (MTP) vs. latent MTP versus MTP, on pain reduction and cervical disability, in
      patients with chronic neck pain attributable to Myofascial Pain Syndrome.
    


Intervention name(s): Deep Dry Needling
Intervention type(s): Procedure
Intervention description(s): Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Randomized controlled trial with double-blind
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry Needling; Myofascial Pain Syndrome; Neurophysiological effects; Autonomic Nervous System
Cognitive Training and tDCS for Children With FASD
Condition: Fetal Alcohol Spectrum Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional

Summary: 
      This is a randomized placebo-controlled trial of cognitive training with transcranial direct
      current stimulation (tDCS) for children and adolescents (ages 10 - 16 years) with prenatal
      alcohol exposure (PAE).
    

Detailed description: 
      Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and, as
      a result, has permanent consequences for cognition, learning, and behavior. Individuals with
      Fetal Alcohol Spectrum Disorders (FASD) commonly have a range of neurocognitive impairments
      that directly lead to practical problems with learning, attention, working memory, task
      planning/execution, and decision making, among other areas of functioning. Despite the
      profound public health burden posed by FASD, there have been very few treatment studies in
      this population. This study will examine the effects of a cognitive remediation training
      augmented with tDCS in children and adolescents with PAE. Functional magnetic resonance
      imaging will be collected to provide preliminary data of brain circuitry changes created by
      this intervention. The study involves a baseline visit with cognitive testing, MRI, 5
      sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and
      MRI. All sessions will be completed within a 28 to 56 day time window.
    

Intervention name(s): Active tDCS; Cognitive training; Sham tDCS
Intervention type(s): Device; Behavioral; Device
Intervention description(s): Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode); BrainHQ Computerized cognitive training; Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 randomized allocation to active tDCS or placebo (sham tDCS).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
Condition: Vaginal Disease
MeSH terms: Vaginal Diseases
Study type: Interventional

Summary: 
      This study evaluates treatment with the medical device Ainara on the improvement of vaginal
      dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison
      with the baseline condition.
    

Detailed description: 
      Detailed Description: This is an open, non-comparative, multicenter study that evaluates the
      performance and safety of the medical device Ainara.

      In this study the investigators use polycarbophilic vaginal moisturizing gel (Ainara) for
      symptomatic treatment of vaginal dryness and monitor its impact on vaginal dryness symptoms.
    

Intervention name(s): Ainara
Intervention type(s): Device
Intervention description(s): 1g of gel per administration
Intervention model: Single Group Assignment
Intervention model description: Open-label, non-comparative, interventional multicenter study. The recently developed polycarbophilic, vaginal moisturizing gel (Ainara®) is widely used by gynaecologists in Europe to relieve vaginal dryness and related symptoms. Regarding the design choice, the adoption of a comparison versus placebo was not possible for technical reasons (the impossibility to use a real placebo without moisturizing effects).
The Research Question of the present study is the following: in a population of post-menopausal women affected by vaginal dryness, will a 1-month treatment with polycarbophilic vaginal moisturizing gel (Ainara®) significantly decrease the symptomatology evaluated by VHI and VAS in comparison with the baseline condition?
Masking: None (Open Label)
Primary purpose: Treatment
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
Condition: Acute Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to demonstrate that canakinumab given upon acute gout flares
      relieves the signs and symptoms and prevents recurrence of gout flares in patients with
      frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or
      colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab
      was compared to the corticosteroid triamcinolone acetonide.

      The purpose of the first 12 week extension study was to collect additional safety,
      tolerability and efficacy data in patients who have completed the core study CACZ885H2357.

      The purpose of the second one year open-label extension study was to confirm the long-term
      safety and tolerability of canakinumab in patients who had completed the first extension
      study.
    


Intervention name(s): Canakinumab 150 mg; Triamcinolone acetonide 40 mg; Placebo to canakinumab; Placebo to triamcinolone acetonide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).; Triamcinolone acetonide 40 mg was supplied as a suspension.; Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.; Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Antibodies, Monoclonal; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Frequent flares; Gout; Anti-interleukin-1β monoclonal antibody
Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus
Condition: Status Asthmaticus
MeSH terms: Status Asthmaticus
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study investigators will use magnesium sulphate in the nebulized form in children
      between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study
      is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg)
      of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of
      clinical condition of the patient and length of hospital stay. There will be total 108
      patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given
      Ventolin and Magnesium sulphate.
    

Detailed description: 
      This randomized clinical trial will include 126 patients after taking informed consent who
      will meet the eligibility criteria. Patients will be randomly distributed in 2 groups on
      alternate basis as computerized generated number. Improvement will be assessed in terms of
      clinical condition i.e., Heart Rate, Respiratory Rate, blood pressure, pattern of breathing
      oxygen saturation and Pediatric Respiratory Assessment Measure (PRAM) score at start of
      treatment and then afterwards at 20 min interval up to 1 hour and then at 2nd hour and then
      after every 6 hours for 24 hours.
    

Intervention name(s): Magnesium Sulfate 500 mg/ml+ ventolin; Ventolin
Intervention type(s): Drug; Drug
Intervention description(s): 3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form; it will be given to control group in nebulized form after every 20 min in 1st hour
Other intervention name(s): MgSO4; Salbutamol
Intervention MeSH terms: Magnesium Sulfate; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients were divided in two groups. In group A, patients received 3 back-to-back nebulization with Ventolin solution only using nebulizer machine and face mask after every 20 minutes for 60 minutes. In group B, patients were divided into 3 subgroups and each subgroup received both Ventolin and MgSO4 with three different doses after every 20 minutes for 60 minutes
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: asthma; nebulized; magnesium sulphate
Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
Condition: Portal Hypertension; Hepatic Encephalopathy; Cirrhosis
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hepatic Encephalopathy; Brain Diseases; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in
      patients with subclinical hepatic encephalopathy.

      II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological
      tests.

      III. Assess which elements of the neuropsychological test battery show the response to
      lactulose.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients are alternately assigned to 1 of 2 treatment groups: no therapy
      for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no
      therapy for 3 weeks.

      A dietician advises patients on a 1 g/kg per day protein diet. The lactulose dose is adjusted
      to result in 2 or 3 loose bowel movements per day.
    

Intervention name(s): lactulose
Intervention type(s): Drug
Intervention MeSH terms: Lactulose
Primary purpose: Treatment
Keywords: cardiovascular and respiratory diseases; cirrhosis; gastrointestinal disorders; hypertensive disorder; portal hypertension; rare disease
A Prospective Cohort Study of Exercise Rehabilitation in the Treatment of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The investigators proposed to conduct a cohort study to observe whether Tai Chi intervention
      could delay the disease progression of Parkinson's disease (PD).

      PD patients were enrolled into 5 Tai Chi classes which began at different timepoints from
      Jan. 2016 to Jan. 2019. Each participant was assessed before participants joined the Tai Chi
      class. After the recruitment, participants accepted continuous Tai Chi training in the
      classes till the last follow-up. The investigators performed three times of follow-up in Nov.
      - Dec. 2019, Oct. - Nov. 2020 and Jun. - July 2021. Using propensity score matching, the
      investigators matched PD patients who did not receive Tai Chi training as control group in
      gender, disease duration, age, and Hoehn - Yahr staging. The aim is to observe the effect of
      Tai Chi on delaying the disease progression of PD.
    


Intervention name(s): Tai Chi training
Intervention type(s): Other
Intervention description(s): As for Tai Chi training, standardized Tai Chi was taught by professional Tai Chi coaches from Sino Taiji of Fuxing International in classes: Qishi ("Starting Posture"), Shangsanbu ("Twist Step"), Yema Fenzong("Part the Wild Horse's Mane on Both Side"), Jingang Daozhui ("Buddha's warrior attendant pounds mortar"), Shoushi ("Closing Posture"). Patients participated in this class were trained, twice a week, 60 min per time. PD patients whose attendance rate less than 75% were excluded.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dermal Micrografts in Regenerative Surgery
Condition: Regenerative Medicine
Study type: Interventional

Summary: 
      Objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with
      Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in
      an in-vivo homogeneous experimental human acute surgical wound model.
    

Detailed description: 
      The aim of the study is the objective assessment of the effectiveness of a micro-fragmented
      dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting
      the wound healing process in an in-vivo homogeneous experimental human acute surgical wound
      model. The study includes 20 patients with 24 acute post-surgical soft tissue loss and a
      planned sequential two-stage repair with dermal substitute and autologous split-thickness
      skin graft. Each acute post-surgical soft tissue loss is randomized to be treated either with
      Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with
      Rigenera™ technology (group A - Rigenera™ protocol) or with Integra® dermal substitute only
      (group B - Control). The re-epithelialization rate in the wounds is assessed in both groups
      at 4 weeks through digital photography with the software "Image J". The dermal cell
      suspension enrichment with the Rigenera™ technology is considered effective if the
      re-epithelialized area is higher than the 25% of the total wound surface as this threshold is
      considered far beyond the expected spontaneous re-epithelialization rate.
    

Intervention name(s): Integra® dermal substitute and RigeneraTM protocol
Intervention type(s): Procedure
Intervention description(s): Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study includes 20 patients with 24 post-surgical defect in any site of the body with a size range 4-400 cm2. The acute post-surgical soft tissue loss is considered the experimental unit of the study irrespective of the number of wounds per patient. Each unit is randomized to be treated either with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol (group A - RigeneraTM protocol - 12 units) or with Integra® dermal substitute only (group B - Control - 12 units). The expected endpoint is a spontaneous re-epithelialization higher than 25% of the total wound area in group A at 4 weeks. The secondary endpoint is the comparison of the re-epithelialization rate at 4 weeks after the first surgical stage between the group A and the controls. The re-epithelialization rate in the wounds is assessed through digital photography with the software "Image J".
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cell transplants; Autografting