bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded
Condition: Cognitive Rehabilitation
Study type: Interventional

Summary: 
      With this study, it will be tried to determine whether the addition of physiotherapy program
      to the education of mentally disabled individuals is effective and necessary in terms of
      mental performance.
    

Detailed description: 
      Mental disability levels IQ = 50-79 individuals with mild / border mental disabilities will
      be included in the study. The disability status of the individuals will be determined by the
      health report, and the cognitive status of the individuals will be determined by the report
      given as a result of the evaluation made by the Guidance Research Centers of the National
      Education Directorates. The 45-person study group will be randomized to 3 groups of 15
      persons each. The first group will not be subjected to any application except education. The
      second group will be the control group and will be taken to the balance training in addition
      to normal education. In the third group, dual task balance training will be applied within
      the scope of cognitive rehabilitation
    

Intervention name(s): dual task balance training
Intervention type(s): Other
Intervention description(s): The studies were planned to be 2 times a week for 12 weeks. The 20-minute Dual Task balance training program is planned to be composed of two sections of 10 minutes. In the first 10 min section, the individual will exercise with the multi-task mode of CogniBoard on the balance ball. . Stroop study will be performed on the balance ball in the second 10 minutes of the exercise.
Other intervention name(s): classic balance training
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The 45-person study group will be randomized to 3 groups of 15 persons each. The first group will not be subjected to any application except education. The second group will be the control group and will be taken to the balance training in addition to normal education. In the third group, dual task balance training will be applied within the scope of cognitive rehabilitation.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cognitive rehabilitation; Dual task; Balance; Motor skills
Micronutrient Supplementation and Incidence of Common Cold
Condition: Immune System Diseases
MeSH terms: Common Cold; Immune System Diseases
Study type: Interventional

Summary: 
      This study investigates the effects of a dietary supplement - a cocktail of vitamins and
      minerals - on the incidence of common cold in a cohort of middle management employees.The
      primary outcome is defined as the number of duty days lost due to common cold/flu. Further,
      immune parameters and markers of redox biology/oxidative stress will be determined. The
      wellbeing in the cohort will be evaluated via questionnaires.
    

Detailed description: 
      randomized, double-blinded, placebo controlled trial 82 Subjects, men and women, 25 - 50 yrs,
      non-smokers, employees of middle management, 24 weeks of supplementation/placebo, 4 wk
      wash-out of all supplements and dietetic products, undersupply of fruit, vegetables (< 4
      portions/day) and whole grain food (< 5x/wk)
    

Intervention name(s): vitamines and minerals; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): given for 24 weeks, after 4 week wash out of all supplements and dietetic products; given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: common cold, immunity, oxidative stress
Study of Chiauranib in Patients With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Chiauranib, which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases
      involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory
      microenvironment.
    

Detailed description: 
      Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the
      angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related
      kinase Aurora B and chronic inflammation related kinase CSF-1R in a high potency manner with
      the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high
      selectivity in the kinase inhibition profile with little activity on off-target non-receptor
      kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms
      of clinical relevance.

      Because of its broad preclinical anti-tumor efficacy and the potential to improve
      conventional TKI kinase inhibitor therapy in various cancer indications, Chiauranib has now
      entered phase Ib clinical trials.

      This clinical trial is studying the efficacy and safety of chiauranib works in treating
      patients with advanced hepatocellular carcinoma, in the meantime, exploring the latent
      biomarkers accompany with chiauranib, as well as the relevancy of which and clinical benefit.
    

Intervention name(s): Chiauranib
Intervention type(s): Drug
Intervention description(s): 50mg, orally once daily
Other intervention name(s): CS2164
Intervention MeSH terms: Chiauranib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Venous Thromboembolism Prophylaxis in Medical and Surgical ICUs in a Single University Hospital
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      Venous thromboembolism(VTE) is the third most common cardiovascular complication among
      hospitalized patients, and can even cause death. VTE often occurs in intensive care patients
      and there had been many efforts to prevent such complication. The American College of Chest
      Physicians (ACCP) had published evidence-based clinical practice guideline for VTE
      prophylaxis.

      This study focuses on how VTE prophylaxis is being performed in both medical and surgical
      ICUs in a single University hospital, and sees the differences in such prophylactic patterns.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        ICU admitted patients who are indicated for VTE prophylaxis.
      
Keywords: Venous Thromboembolism Prophylaxis; ICU
Impact of Changing the Dosing Regimen on the PK Profile of ODM-203
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study in healthy male volunteers will evaluate the impact of the effect of food
      on the pharmacokinetic profile of ODM-203.
    

Detailed description: 
      This study will be a single dose part randomised cross over study with up to 6 study periods.
      ODM-203 may be dosed using a variety of different conditions with respect to food depending
      on emerging data. The impact of changing the presentation of ODM-203 may also be assessed to
      determine the PK of alternative formulations and identify appropriate drug formulations for
      further development.
    

Intervention name(s): ODM-203 (Period 1); ODM-203 (Period 2); ODM-203 (Periods 3-6)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ODM-203 400mg as tablets taken 30 minutes after food; ODM-203 400mg as tablets taken 1 hour before a light breakfast; ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
An Investigational Study to Assess the Effect of BMS-986177 on Aspirin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177
      when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of
      BMS-986177 or placebo, with a once-daily dose of aspirin. The safety, tolerability and
      movement of BMS-986177 into, through and out of the body (pharmacokinetics/PK) will be
      assessed, as will the effect of BMS-986177 on the PK of aspirin.
    


Intervention name(s): Aspirin; BMS-986177; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 x 325 mg tablet of aspirin administered once daily; 200 mg of BMS-986177 administered twice daily; 200 mg of Placebo administered twice daily
Other intervention name(s): Acetylsalicylic Acid
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy participants; Healthy subjects; Strokes
Single Ascending Doses of ZP4207 Administered in HV and in T1D to Evaluate Safety, Tolerability PKs and PDs of ZP4207 Compared to a Comparator
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is a randomized, double-blind First in Human trial to evaluate the safety and
      tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D
      (type 1 diabetes) subjects as compared to native glucagon. The trial includes two parts.

      Part 1 includes dose escalation of ZP4207 in cohorts of 8 subjects. In each cohort, subjects
      will be randomized 3:1 to receive either a single ascending dose of ZP4207 (6 subjects) or a
      single fixed dose (SD) of native glucagon (2 subjects). The doses will be administered s.c.
      in 4-5 cohorts and i.m. in 3 cohorts.

      Part 2 includes two sequence groups of 10 hypoglycemic T1D subjects. The subjects will be
      treated with fixed single doses of ZP4207 and native glucagon s.c. in a sequential cross-over
      design in a randomized treatment order.
    


Intervention name(s): ZP4207; Glucagon
Intervention type(s): Drug; Drug
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multicenter,2-Arm,Randomized,Controlled Study Evaluate the Effectiveness of the UltraShape® Contour I VER 3.1 System for Non-Invasive Reduction in Abdominal Circumference
Condition: Body Sculpting
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1
      System on abdominal midsection circumference reduction relative to no treatment.

      The secondary objective of this study is to assess subject satisfaction measured with a
      self-assessment questionnaire
    


Intervention name(s): Non Invasive Ultrasound
Intervention type(s): Device
Intervention description(s): Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: focused ultrasound; mechanical fat destruction; Body Sculpting
Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections
Condition: Thyroid Associated Orbitopathy
MeSH terms: Graves Ophthalmopathy; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The study objective is to investigate the efficacy and safety of periocular injections of
      methotrexate in management of patients with active moderate to severe thyroid associated
      orbitopathy in comparison to periocular injections of triamcinolone acetonide.
    

Detailed description: 
      Recruited subjects will be randomized such that one orbit receives 3 periocular injections of
      methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone
      acetonide at day 0, week 3 and week 6. All study subjects will be followed up for 6 months
      where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last
      injection
    

Intervention name(s): Methotrexate; Triamcinolone Acetonide
Intervention type(s): Drug; Drug
Intervention description(s): Three periocular injections of methotrexate at week 0, week 3 and week 6.; Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Methotrexate; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thyroid associated orbitopathy; Grave's orbitopathy; Periocular injections; Methotrexate; Triamcinolone
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in
      subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic
      function
    


Intervention name(s): MCI-186
Intervention type(s): Drug
Intervention description(s): 30 mg of edaravone will be administered intravenously over 60 minutes
Other intervention name(s): Edaravone; Radicut
Intervention MeSH terms: Edaravone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This multicentre, non-comparative design study will monitor the impact of long term
      management of DH with daily use of a sensitivity toothpaste on the quality of life of a
      population of sensitivity sufferers. Changes in oral health related quality of life will be
      monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will
      be conducted in participants in good general health, with pre-existing self-reported and
      clinically diagnosed tooth sensitivity at screening.
    

Detailed description: 
      This will be multicenter, non-comparative design to monitor the impact of long term
      management of DH with daily use of a sensitivity toothpaste on the quality of life of a
      population of sensitivity sufferers, using the DHEQ. Changes in DH will be monitored
      clinically over the 24 week treatment period.
    

Intervention name(s): stannous fluoride
Intervention type(s): Drug
Intervention description(s): 0.454% w/w (weight per weight) stannous fluoride
Intervention MeSH terms: Fluorides; Tin Fluorides
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Other
Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational [Patient Registry]

Summary: 
      The TOPP-2 registry is an international, non-interventional, prospective registry including
      children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further
      insights in the disease course and long-term outcome of PH in childhood.

      Patients will undergo clinical assessments and receive standard medical care, as determined
      by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically
      designed to capture the variables that have been proposed as treatment goals in PePH and the
      reasons for changes in treatment strategy.

      The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World
      Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations
      for children with PH.

      The registry is planned and implemented under the scientific leadership of the Association
      for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.

      All enrolled patients will have a follow-up period of 18 months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Children and adolescents, newly diagnosed with PH (incident PePH patients), meeting
             the inclusion criteria. A patient is considered an incident patient if the time
             elapsed between the diagnostic RHC and the initial visit at the site including the
             patient is less than or equal to three months and if the time between diagnostic RHC
             and informed consent is less than or equal to six months

          2. Ex-incident patients from the previous TOPP-1 registry.
Depression Prevention Program for Adolescents
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will compare the effectiveness of two programs designed to prevent depression in
      adolescents.
    

Detailed description: 
      Major depression is one of the most common psychiatric disorders in adolescents. In many
      cases, the condition is recurrent and can result in serious psychological impairment. A high
      number of depressed adolescents never receive treatment; therefore, it is crucial to develop
      prevention programs for this disorder that are effective and can be easily disseminated. This
      study will evaluate and compare the effectiveness of cognitive behavior therapy (CBT) and
      supportive/expressive (S/E) therapy in preventing depressive symptoms in adolescents.

      This study will last 2 years. Participants will be randomly assigned to receive six sessions
      of CBT, S/E therapy, or standard depression education over 2 years. The CBT intervention will
      focus on reducing negative thoughts and increasing engagement in pleasant activities. S/E
      therapy is designed to allow adolescents to express their negative emotions and talk about
      recent stressful events in a supportive environment of their peers. Surveys and psychiatric
      interviews will be completed by all participants and their parents at the beginning and the
      end of the study. The surveys and interviews will assess depressive symptoms.
    

Intervention name(s): Cognitive behavior therapy (CBT); Supportive/expressive (S/E) therapy; Bibliotherapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will complete worksheets and group discussion on how to increase positive mood and activity.; Participants will be encouraged to express feelings and emotions without advice giving.; Participants will be given a book on how to increase their mood.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; CBT
A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After Laser Hair Removal in the Groin and Intimate Area
Condition: Skin Recovery
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, researchers want to learn more about the effect of dexpanthenol dermal spray
      on skin recovery after a dermatological procedure for hair removal (laser depilation) in the
      groin and intimate area in adult women.

      After the hair removal procedure, participants will return within 3 weeks for 3 visits to the
      study center to investigate the skin condition such as redness, irritation, softness of skin
      and possible side effects. Study participants will also be asked about their general
      acceptance of dexpanthenol dermal spray.
    

Detailed description: 
      The primary objective is to evaluate the efficacy of the test product to aid skin recovery
      after lasering depilation in the intima and inguinal region.

      Secondary objectives comprise clinical efficacy with respect to skin hydration, softness,
      vitality, appearance etc. and skin recovery, consumer judgement of product performance and
      acceptability, and safety.
    

Intervention name(s): BAY207543 (Bepanthol, Bepantol® Derma Spray); Semisolid vaseline
Intervention type(s): Drug; Other
Intervention description(s): Product is applied to one side of the inguinal region.; Product is applied to one side of the inguinal region.
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dermal spray; Laser depilation; Skin hydration; Consumer satisfaction; Sensorial perception
Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery
Condition: Hemodynamics Instability
MeSH terms: Spinal Cord Diseases
Study type: Observational

Summary: 
      Positioning a patient in prone position under anaesthesia significantly alters cardiovascular
      physiology. Cervical myelopathy patients are known to have autonomic dysfunction. Such
      patients when positioned in prone position under anaesthesia carry a higher risk of
      developing hemodynamic changes and this can compromise spinal cord perfusion.

      This prospective observational study was conducted on 30 patients with cervical myelopathy
      who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive
      cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic
      parameters. The hemodynamic parameters were recorded at baseline, post induction, post
      intubation, prior to prone position, post prone position, and every five minutes thereafter
      upto 20mins.

      The hemodynamic parameters that were recorded using the NICOM monitor:

        -  HR - Heart rate (beats /min)

        -  NIBP - non invasive blood pressure (mmHg)

        -  MAP - mean arterial pressure(mmHg)

        -  CO - cardiac output (l/min)

        -  CI - cardiac index (l/min/m2)

        -  SV - Stroke volume (ml/beat)

        -  SVV -stroke volume variability (%)

        -  TPR - total peripheral resistance (dynes. sec/cm5)
    


Intervention name(s): Prone Positioning
Intervention type(s): Procedure
Intervention description(s): Noninvasive cardiac output monitoring parameters were recorded before and after prone positioning.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Cervical Myelopathy undergoing elective cervical decompression in prone
        position.
      
Keywords: Prone positioning; Non-invasive Cardiac Output Monitoring