bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2339345.
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of the sodium channel inhibitor, GSK2339345. Cohort 1 will assess the safety,
      tolerability and PK of single ascending doses of GSK2339345 administered via an aqueous
      droplet inhaler in healthy subjects. Cohort 2 will assess the safety, tolerability, and PK of
      repeat doses of GSK2339345 administered four times a day for two consecutive days via an
      aqueous droplet inhaler.
    

Detailed description: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK)
      effects of GSK2339345 in healthy subjects. GSK2339345 is a blocker of neuronal voltage gated
      sodium channels in development for the treatment of chronic cough, excessive cough and
      post-viral and viral (acute) cough. Inhaled pan NaV inhibitors are associated with
      oropharyngeal sensation perturbation and so this study will establish the potential local
      sensate effects of GSK2339345 at multiples of the predicted inhaled therapeutic dose. This
      study also aims to define the maximum tolerated dose of GSK2339345 administered via an
      aqueous droplet inhaler. Cohort 1 is a randomised, double-blind, placebo-controlled,
      cross-over, inhaled single-dose escalating study using an aqueous droplet inhaler. Cohort 1
      will include assessments of sensate changes via a 4 point scale, assessment of taste via an
      11 point scale, and PK assessments to investigate the PK profile of GSK2339345. Cohort 2 of
      this study is a randomised, double blind, placebo controlled, parallel group, inhaled repeat
      dose study using a aqueous droplet inhaler. Subjects will be randomised to receive 2000
      microgram of GSK2339345 or placebo four times a day for two consecutive study days. Similar
      assessments of sensations to those used in Cohort 1 will be performed. The potential for
      systemic cardiovascular (CV) or central nervous system (CNS) effects will also be assessed
      throughout the study via observation. Cohort 2 will also include PK assessments to
      investigate the PK profile of GSK2339345. Placebo will be used throughout the study as a
      control.
    

Intervention name(s): GSK2339345 (Inhaled) Single Dose; Placebo (Inhaled) Single Dose; GSK2339345 (Inhaled) Repeat Dose; Placebo (Inhaled) Repeat Dose
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): 250, 1000 and 2000 microgram (proposed doses); Inhaled 0.9% sodium chloride solution; 2000 microgram (proposed dose) administered 4 times a day for two consecutive days; Inhaled 0.9% sodium cholride solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety and tolerability, pharmacokinetics, cough, voltage gated sodium channels (VGSC), anaesthesia
Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases
Condition: Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional

Summary: 
      This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as
      primary radiotherapy for multiple brain metastases.
    

Detailed description: 
      This is a single-arm, single center, phase II trial to investigate the feasibility and
      toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).
    

Intervention name(s): tomotherapy
Intervention type(s): Radiation
Intervention description(s): Whole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple brain metastases; Tomotherapy; fractionated stereotactic radiotheray
Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      CBP-174 after a single oral dose in healthy adult subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose study in
      healthy subjects to evaluate the safety, tolerability and pharmacokinetics of CBP-174
      compared to placebo. The study plans to set 6 dose escalation cohorts with single oral dose.
      Each subject will receive only one dose regimen in this study and the total duration to
      participate the study is approximately 1 to 4-week.
    

Intervention name(s): CBP-174; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CBP-174 oral solution, given once; Placebo oral solution, given once
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential for cardiac repolarization, according
      to electrocardiographic monitoring (including QT and QTc intervals), of two dose levels of
      CHF5993 pMDI (beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide
      (BDP/FF/GB)) and of one dose of CHF5259 (GB) in healthy subjects compared to moxifloxacin and
      placebo.
    

Detailed description: 
      The main purpose of this study is to evaluate the effect of a single supratherapeutic dose of
      inhaled BDP/FF/GB on cardiovascular safety. The secondary purposes of the study are to: 1)
      evaluate the effect of a single supratherapeutic dose of inhaled BDP/FF/GB and GB on
      cardiovascular safety; 2) establish assay sensitivity by demonstrating the effect of a single
      oral dose of 400 mg moxifloxacin on cardiovascular safety; 3) determine the pharmacokinetics
      (PK) of single, inhaled therapeutic and supratherapeutic BDP/FF/GB doses and supratherapeutic
      GB dose; 4) determine if there is a relationship between the duration of the QTc intervals
      and the plasma concentrations of the B17MP (beclomethasone 17monopropionate active metabolite
      of BDP), FF and GB following the administration of BDP/FF/GB and GB pMDIs; 5) generate
      additional safety and tolerability information.
    

Intervention name(s): CHF5993; CHF5259; Moxifloxacin 400mg; CHF5993 Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BDP/FF/GB 100/6/12.5 μg pMDI; GB 12.5 μg pMDI; 400 mg Oral Tablets; placebo pMDI
Other intervention name(s): beclometasone dipropionate /formoterol fumarate/glycopyrronium bromide; BDP/FF/GB; glycopyrronium bromide; GB; Moxifloxacin hydrochloride; BDP/FF/GB Placebo
Intervention MeSH terms: Moxifloxacin; Beclomethasone; Glycopyrrolate; Bromides; Norgestimate, ethinyl estradiol drug combination; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Two groups of women with preterm labor will be included. One will receive magnesium sulfate
      for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler
      indices will be measured before and after intake of either magnesium sulfate or placebo to
      find if any significant changes occur in fetal cerebral blood flow.
    

Detailed description: 
      The study will include women with preterm labor with gestational age less than 32 weeks.
      women will be randomized to receive either magnesium sulfate (loading dose 6 g over 20
      minutes followed by maintenance dose of 1 g/hour for 24 hours), or placebo in the form of
      sodium chloride solution 0.9% over 24 hours. Fetal middle cerebral artery Doppler indices
      [Peak systolic velocity (PSV), Pulsatility index (PI), and resistance index (RI)] will be
      recorded before and after treatment in both groups. Results of Doppler indices will be
      compared between both groups and before and after intake of magnesium sulfate to find out if
      middle cerebral artery Doppler of the fetus can explain the mechanism behind the use of
      magnesium sulfate for fetal neuroprotection in preterm births.
    

Intervention name(s): Magnesium Sulfate; 0.9% sodium chloride solution
Intervention type(s): Drug; Other
Intervention description(s): magnesium sulfate will be given for 24 hours; normal saline will be given as intravenous drip over 24 hours
Other intervention name(s): MgSO4
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Mobile Application for Integrative Diabetes Care
Condition: Diabetes Mellitus, Type 2; Depression
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The investigators have developed a mobile application named 'DangDang Care' (which conveys
      the meaning of managing diabetes confidently and consistently through psychological care)
      designed to provide psychological support and enhance diabetes self-management for people
      with type 2 diabetes experiencing depressive symptoms. The application incorporates a
      behavioral activation program. Subsequently, the investigators conducted a 12-week randomized
      controlled trial, enrolling individuals with type 2 diabetes and mild-to-moderate depression,
      with the assistance of public health centers. The trial aimed to assess the effectiveness and
      feasibility of the application in promoting consistent diabetes management through added
      psychological care.
    


Intervention name(s): Mobile application 'DangDang Care' under usual care
Intervention type(s): Device
Intervention description(s): The application incorporates a behavioral activation program to provide psychological support and enhance diabetes self-management for people with type 2 diabetes experiencing depressive symptoms, alongside conventional medical therapy.
The intervention group receives the mobile application with usual care.
Other intervention name(s): DangDang Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effect on body weight of a combination fenofibrate and metformin on top of
      a moderate balanced calorie-deficit diet.
    


Intervention name(s): Metformin and Metformin + Fenofibrate
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Weight loss and diet.
Cranberry Enhances Human Immune Function and Reduces Illness
Condition: Healthy Humans
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether consuming a beverage made with cranberry
      polyphenols and proanthocyanidins is effective in modifying immune function by enhancing
      immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell
      proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.
    

Detailed description: 
      The study will be conducted as a randomized, double blind, placebo-controlled parallel trial.
      Subjects will be randomly assigned to either the Treatment (cranberry beverage) group or the
      Placebo group and each will be instructed to consume the test beverages twice a day for 70
      days. The beverage is not commercially prepared juice, but is a beverage prepared with an
      extract of cranberry that contains polyphenols and proanthocyanidins. Blood is taken at
      baseline, and day 70. Subjects are given a diary to keep a record of their cold and flu
      symptoms. Serum is used to determine the antioxidant activity by the ORAC method. Peripheral
      blood mononuclear cells are isolated from the blood draw and used fresh, cultured for 24
      hours or cultured for 10 days. Freshly isolated cells will be used to determine αβ-T, γδ-T, B
      and NK cell numbers and then cultured in autologous serum for 10 days to determine how well
      they proliferate. The supernatant of 24 hour cultures will be used for cytokine
      determination. If cells have been primed by the beverage made with cranberry compounds, the
      investigators expect the cells to proliferate to a greater extent and have modified cytokine
      production compared to placebo. If the beverage made with cranberry compounds enhances the
      proliferation of one or more of these cell types (αβ-T, γδ T, B or NK cell), then it is
      possible that there will be fewer cold and flu symptoms in the group consuming the cranberry
      beverage. Incidence of illness is not expected to change, only the severity of the illness.
    

Intervention name(s): Beverage made to look like the cranberry beverage; Beverage made from cranberry compounds
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): one 15 ounce bottle of beverage consumed daily; one 15 ounce bottle consumed daily for 70 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: gamma delta T cell; proliferation; cytokine secretion; immune function; antioxidant status
Influence of Sensorimotor Treatment in the Balance of Soccer
Condition: Ankle Sprain
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      This study presents the hypothesis that the sensory processing engine improves balance and
      agility for football athletes.
    

Detailed description: 
      Objectives: To investigate the influence of the sensorimotor treatment in balance, agility
      and functionality soccer players assessed using force platform, functional tests and
      questionnaires.

      Methods: This study was characterized as a randomized clinical trial. 20 male soccer players
      was assessed by means of questionnaires, force platform in one foot, and functional tests of
      balance and agility (Side Hop Test, Figure of Eight Hop Star Excursion Balance Test and
      Test). To the platform, the parameters of the center pressure (COP) in the anterior-
      posterior and medial -lateral directions was used for analysis, to functional tests the
      time-second performance was analyzed. Initially all athletes respond to the questionnaires,
      was evaluated on the force platform and through functional testing by blind evaluators.
      Following, they were randomized to treatment groups (n=10) and control (n=10). The treatment
      group performed 6 weeks of proprioceptive exercises with shifts and one-leg jumps and bipedal
      support.

      The control group remained in soccer training. At the end of the treatment protocol and all
      were reassessed following the cross-over, where the control group performed the same
      treatment sensory motor was developed.
    

Intervention name(s): proprioceptive exercises
Intervention type(s): Other
Intervention description(s): Exercises with movements, jumping and imbalance.
Other intervention name(s): treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postural balance; Athletes; Sports; Soccer; Physiotherapy
Physiotherapy Intervention for Provoked Vulvar Vestibulodynia
Condition: Vulvodynia; Provoked Vulvar Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      Hypothesis:

        1. Specific physiotherapy interventions will decrease pain, improve pelvic floor motor
           control, increase self efficacy, improve sexual function and decrease pain
           catastrophizing behaviour in women with provoked vulvar vestibulodynia.

           This study will look at specific physiotherapy treatment interventions to see if they
           decrease pain, improve pelvic floor motor control, increase self efficacy, improve
           sexual function and decrease pain catastophizing behaviour. Participants will fill out a
           questionnaire on their pain symptoms and complete standardized scales prior to starting
           treatment and after 4 sessions to determine change due to interventions.

        2. A combination of physiotherapy, group educational sessions and group cognitive
           behavioural therapy will have better outcomes than physiotherapy alone.

      Results of physiotherapy intervention alone will be compared to results of those treated with
      physiotherapy, group educational sessions and group cognitive behavioural therapy at a
      separate treatment centre. Physiotherapy interventions and outcome measures are the same
      between both groups.

      Justification:

      Standard treatment is hard to identify as many approaches are taken, none with any evidence
      to support them. This study aims to look at specific techniques (pelvic floor coordination
      and relaxation exercises, education on female sexual response and pain pathophysiology
      education) to see if there is a benefit.
    


Intervention name(s): Physical therapy treatment
Intervention type(s): Behavioral
Intervention description(s): Subjects will be given pelvic floor motor control,proprioception and relaxation exercises. This will be with and without the use of external surface Electromyography (EMG) biofeedback. Education will also be given on pain management, female sexual response and vestibulodynia. Subjects will also practice inserting vaginal inserts of graduating diameter into their vaginas, practicing the skills learned in physical therapy sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: provoked; vulvar; vestibulodynia; vestibulitis
Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with
      mycophenolate sodium dose increment will preserve renal allograft function without rising
      adverse effects

      Primary endpoints:

        1. estimated GFR (MDRD equation) 12 months after randomization

        2. estimated GFR change from randomization to end of the study (calculated by MDRD equation
           and Nankivell equation)
    


Intervention name(s): routine dose tacrolimus and less myfortic; reduced dose tacrolimus and conventional myfortic
Intervention type(s): Drug; Drug
Intervention description(s): oral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day; low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunosuppression control in kidney transplantation
Deep Brain Stimulation for Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe
      disability due to Traumatic Brain Injury.
    

Detailed description: 
      The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe
      disability due to Traumatic Brain Injury. DBS has been proven safe and efficacious for
      remediation of multiple neurological conditions. It is the hope of the study team that the
      protocol will provide further insight into the potential of DBS to improve the quality of
      life and functioning of persons with severe disability due to TBI and at the same time can
      provide new clinical insights that will improve treatment for the entire spectrum of injury
      severity.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Brain pace maker, implanted in the brain
Other intervention name(s): DBS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Traumatic Brain Injury; DBS