bioihbjkbjnl/mcl2 huggingface dataset:
H-1337 Ophthalmic Solution Phase 1/2
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study will evaluate the safety, tolerability, and preliminary efficacy of three
      concentrations of H-1337 and vehicle administered twice daily in a parallel group,
      double-masked design for 28 days of dosing in patients with elevated intraocular pressure
      (IOP).
    

Detailed description: 
      Study ALY337-201 will be a double-masked, randomized, placebo-controlled, dose-response study
      assessing the safety and ocular hypotensive efficacy of H-1337 ophthalmic solution in
      subjects with ocular hypertension (OHT) or open angle glaucoma.

      During screening, subjects who meet the preliminary inclusion/exclusion criteria will
      discontinue use of their ocular hypotensive therapy during the washout period. The washout
      duration will be dependent on the subject's pre-study ocular hypotensive therapy. Starting on
      Day 0, those who continue to meet the inclusions/exclusion criteria and the diurnal IOP
      criteria will be randomized into one of the treatments arms and dosing will be initiated,
      continuing for 28 days.
    

Intervention name(s): H-1337 Placebo; H-1337 [1]; H-1337 [2]; H-1337 [3]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): H-1337 Placebo Vehicle; H-1337 Ophthalmic Solution Concentration 1; H-1337 Ophthalmic Solution Concentration 2; H-1337 Ophthalmic Solution Concentration 3
Other intervention name(s): Vehicle; H-1337 conc 1; H-1337 conc 2; H-1337 conc 3
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-masked, parallel
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: glaucoma
Evaluation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration): Electrocardiogram (ECG) Study in Healthy Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary:

        -  To assess the effects of ascending repeated-doses of oral [p.o.] neramexane at
           therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc
           interval) in healthy male and female subjects.

      Secondary:

        -  To assess the pharmacokinetics [PK] of neramexane and N-OH neramexane (if a validated
           method will be available for this metabolite) following repeated daily doses of 50 mg
           (steady state), 75 mg (steady state) and 87.5 mg (steady state).

        -  To assess the safety and tolerability of neramexane 50 mg, 62.5 mg, 75 mg and 87.5 mg
           repeated-dose treatments when gradually up-titrated in healthy subjects.

        -  To assess the concentration-QT relationship.
    


Intervention name(s): Neramexane
Intervention type(s): Drug
Intervention description(s): Dosage form:
25 mg immediate release [IR] tablets (=15.9 mg neramexane free base)
37.5 mg IR tablets (=23.9 mg neramexane free base)
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease
Condition: Lesch-Nyhan Disease
MeSH terms: Lesch-Nyhan Syndrome; Self-Injurious Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of ecopipam in patients with
      Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the
      brain that helps nerves talk to one another; ecopipam does this by stopping the chemical
      (dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very
      rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam
      causes in LND patients, and whether ecopipam may be able to relieve the self-injurious
      behaviors seen in these patients.
    


Intervention name(s): Ecopipam
Intervention type(s): Drug
Intervention description(s): Tablets, once daily, for two weeks up to 200 mg/day
Other intervention name(s): PSYRX101, SCH 39166
Intervention MeSH terms: Ecopipam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ecopipam; Lesch-Nyhan Disease; Safety; Self-Injurious Behavior
Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and safety of SVG101
      (dispersible tab. of everolimus) in healthy volunteers compared to Afinitor tab. after oral
      administration.
    

Detailed description: 
      This is a randomized, open-label, single-dose, two-way cross-over study to investigate the
      Pharmacokinetic characteristics and safety after oral administration of SVG101 (dispersible
      tablet of everolimus) 5mg and Afinitor 5mg in 26 healthy volunteers.
    

Intervention name(s): SVG101 (T); Afinitor (R)
Intervention type(s): Drug; Drug
Intervention description(s): 5mg of SVG101; 5mg of Afinitor
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Everolimus; Healthy adults; Disperse formulation
A Study of the Efficacy of the Code Stroke in Spain
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Code Stroke is a system for the rapid identification, pre-notification and transport of acute
      ischemic stroke patients. The objective of this study was to define quality indicators and to
      compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals
      without the use of Code Stroke (control patients).
    

Detailed description: 
      In a first step qualitative technique has been conducted to define treatment quality
      indicators of acute ischemic stroke patients. In a second step a prospective study is
      conducted to collect data of 240 inpatients from two groups of hospitals. Two hospitals
      applying Code Stroke (N= 120) and four hospitals non-applying Code Stroke procedure (N=120).
      A consecutive sampling method will be conducted. Inclusion criteria: acute ischemic stroke
      patients treated in the hospitals during the field study. The referral to the hospital could
      be from primary care, Emergency Unit of other hospital. Patients will enroll after inform
      consent.

      A Singer-blind- research method will applied. Quality indicators defined in the first phase
      will be applied and comparisons will be realized using ANOVA.
    

Intervention name(s): Code Stroke
Intervention type(s): Procedure
Intervention description(s): Apply a protocol called Code Stroke that involves the entire care chain from emergency teams outpatient specialists of Neurology, Internal Medicine, Radiology or Intensitivos Care, among other hospital areas.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: acute ischemic stroke; quality
FLIPS: Ferfer Liposomal Iron Performance Study
Condition: Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of
      Haemoglobin and Haematocrit levels
    

Detailed description: 
      Anemia, described as a low blood Haemoglobin concentration, has been shown to be a public
      health problem that impacts low-, center- and high-earnings nations and has great unfavorable
      health results, as well as unfavorable influences on social and monetary development . even
      though the most dependable indicator of anemia on the populace stage is blood Haemoglobin
      attention, measurements of this attention by myself do now not determine the cause of anemia.
      Anemia may additionally result from a number of causes, with the maximum great contributor
      being iron deficiency. approximately 30%- 50% of instances of anemia are taken into
      consideration to be because of iron deficiency.

      Doctor will evaluate on the basis of inclusion or exclusion criteria, lab values and overall
      assessment and then enroll in this clinical trial. During the study patient will visit the
      Doctor four times, Day 0 week 4, week 8 and week 12. Doctor will investigate the Hemoglobin
      level and Hematocrit level and also evaluate the adverse effects and tolerability of Ferfer®
      at week 2 and week 8. Doctor also instructed to take the food supplements, twice daily, once
      in a morning and once in evening independently by food intake as Ferfer® has no interaction
      with food.
    

Intervention name(s): Iron Supplement
Intervention type(s): Drug
Intervention description(s): Ferfer® is a multi-ingredient supplement containing micro-encapsulated iron pyrophosphate (to form liposomes), vitamin C and vitamin B12 which are valuable for the control of nutritional deficiencies or increased organic needs of iron.
Other intervention name(s): Micro liposomal iron
Intervention MeSH terms: Iron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IDA; iron deficiency anemia; iron supplements; Pakistan; Liposomal iron
Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD
Condition: Attention Deficit/Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective of this study is to evaluate the safety of treatment with modafinil
      film-coated tablet.
    


Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit/Hyperactivity Disorder
Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine,
      VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will
      be tested.
    

Detailed description: 
      The worldwide HIV epidemic highlights the importance of developing an affordable, globally
      successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study was
      developed to incorporate HIV genes from multiple virus clades, representing the viral
      subtypes responsible for about 90% of new HIV infections in the world. The purpose of this
      study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV
      uninfected individuals.

      Participants will be randomly assigned to one of three groups and will be followed for one
      year. Study injections will be given by needle-free intramuscular injection at the start of
      study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group 2
      will receive 2 injections of the study vaccine (at start and Month 2) and injection of
      placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit,
      study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days
      for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All
      participants will undergo physical exams, blood and urine tests to assess measures of health,
      and blood tests to assess HIV infection and immune response to the injections.
    

Intervention name(s): VRC-HIVDNA009-00-VP
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
Efficacy of Selegiline in Negative Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however
      their efficacy in treating negative symptoms is limited. This study wants to evaluate
      efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in
      inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients
      will select to receive selegiline or placebo.

      Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1-
      Patients with moderate to severe negative symptoms 2- Patients with at least one year
      antipsychotic drug therapy, at the current dose >= 1 month. 3- No other psychotropic drugs
      during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse,
      severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during
      past month.
    


Intervention name(s): Selegiline
Intervention type(s): Drug
Intervention MeSH terms: Selegiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Seligiline; Negative symptoms; Schizopherenia
A Model-based Health Education Program to Improve Oral Health in School Going Children
Condition: Oral Health
Study type: Interventional

Summary: 
      This was a randomized controlled trial to assess how an education program based on health
      belief model (HBM) may affect oral health status in the elementary school going children. For
      this, a convenient sample including 112 school going children aged between 6-12 years old
      were recruited and randomized into intervention or control groups. Education program
      consisted five weekly session each lasted for 1 hour approximately. Based on the main
      constructs of the HBM, each session was organized and a combination of educational methods
      were used in the intervention group while the control group only received the routine program
      provided by the dental clinic. Measures such as papillary bleeding index; decayed, missing,
      filled teeth (DMFT) and a scale based on the HBM were used for data collection. Three months
      after the intervention the measures were administered again and comparisons between baseline
      and follow-up were done.
    

Detailed description: 
      Oral health problems especially dental carries are common in school children and education
      programs may help to prevent these conditions. The aim of current study was to investigate
      how an education program based on health belief model (HBM) may improve oral health status of
      the elementary school children.

      One hundred twelve 6-12 year children along with one of their parents assigned into trial and
      control groups using a randomized controlled trial. For trial group 5 education sessions
      based on HBM were held, whereas control group only received routine education program
      delivered by the dental clinic. Decayed, missing, filled teeth (DMFT) score, papillary
      bleeding index, and HBM questionnaire for oral were used for evaluation of the program. Three
      month after the intervention reassessment was performed and the changes were measured by
      student t test as well as analysis of covariance test.
    

Intervention name(s): Education program based on health belief model to improve oral health
Intervention type(s): Behavioral
Intervention description(s): Five weekly sessions each one lasted for one hour to encourage participants to follow healthy behaviors on oral health.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group received the intervention and another received the routine program.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Oral health; Gingival health; Health education; Decayed teeth
Proposal Evaluating Time-specific Relationships Between Variables of Pain, Stress, and Bloating in IBS Diarrhea and Constipation Symptoms Using a Palm Pilot
Condition: IBS, Diarrhea Predominant; IBS, Constipation Predominant; IBS, Mixed Symptoms
MeSH terms: Constipation; Diarrhea
Study type: Observational

Summary: 
      Purpose: The associations between pain, stress, bloating, and their short interval temporal
      relationships to defecation in IBS D, C & M are of great interest to the field of functional
      GI disorders, but have not been adequately studied. Broad recall based assessments (i.e.,over
      past week or month) of pain and bloating have been key features of the diagnosis of IBS,
      however such long term retrospective recall of symptom experience has been shown to be
      unreliable and influenced by outside factors (heuristics, recall bias, etc.). Short interval
      assessment may provide a more accurate picture of patient symptom experience Participants:
      Patients with IBS in general and IBS subtypes (IBS-C, D, M) Procedures (methods): Study
      participants could be asked to record data at randomly assigned points throughout the day, as
      well as during the course of a diarrheal or constipated stool (i.e., prior to and right after
      a bowel movement).
    


Intervention name(s): palm pilot recording responses to questionnaires
Intervention type(s): Other
Intervention description(s): Short interval assessment (provided by data from palm pilot) may provide a more accurate picture of patient symptom experience.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        80 male and female subjects will be recruited: 20 with IBS D; 20 with IBS C; 20 with IBS M;
        20 control (no bowel symptoms).

        We will target patients who have maintained a diagnosis of IBS with Diarrhea (IBS-D), IBS
        with Constipation (IBS-C, IBS with Mixed Stool pattern (IBS-M), using Rome III Criteria as
        well as control subjects without bowel symptoms. Subject participation will be limited to
        patients who maintain mild or moderate symptom severity score on the functional bowel
        disorders severity index (FBDSI.) providing they have at least 3 symptom episodes of pain
        or discomfort in a given week, to assure adequate data collection.
Comparison of Sit-to-stand Test With Six-minute Walk Test in Bronchiectasis and Healthy Children
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Observational

Summary: 
      Children with bronchiectasis and age-matched healthy controls will be evaluated with
      sit-to-stand test and six-minute walk test and utilization of STST in determining functional
      capacity will be investigated.
    

Detailed description: 
      Bronchiectasis (BE) is a chronic condition which is characterized by the permanent abnormal
      widening of the bronchi as a result of repetitive airway infections and inflammation.
      Disabling cough and shortness of breath, excess mucus production, progressive airway
      obstruction and loss of skeletal muscle mass are the primary factors that impairs exercise
      tolerance in BE patients. Imaging modalities and pulmonary function test are insufficient to
      determine disease burden or the prognosis thus it is stated that exercise tolerance and
      quality of life should also be evaluated in these patients.

      Exercise tolerance can be evaluated using cardiopulmonary exercise test by directly measuring
      oxygen consumption but the field tests such as six-minute walk test (6MWT), shuttle walk test
      or stair climbing tests also provides reliable data on exercise tolerance by measuring
      functional capacity. Among field tests, 6MWT is the most commonly used test for evaluating
      functional capacity in cardiopulmonary patients. Although 6MWT is easy to apply and does not
      require any special equipment, it still requires a 30-m long corridor and a total testing
      time of approx. 20 minutes considering the pre- and post-test resting periods which may
      impair its feasibility in some clinical settings.

      Sit-to-stand test (STST) is firstly developed for older population to measure mobility
      related function and physical performance. Today, it is widely used in various populations
      including cardiopulmonary diseases such as cystic fibrosis, chronic obstructive pulmonary
      disease and heart failure. The investigator's aim in this study is to investigate whether
      STST is utilizable for evaluating functional capacity in children with BE.
    

Intervention name(s): Measurement of functional capacity
Intervention type(s): Other
Intervention description(s): Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children diagnosed with non-cystic fibrosis bronchiectasis and age matched healthy
        volunteers who do not have any diagnosed chronic diseases
      
Keywords: Bronchiectasis; Exercise capacity; Six-minute walk test; Sit-to-stand test
Single Session of Anodal Cerebellar vs Cerebral Transcranial Direct Current Stimulation in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To compare the effect of anodal cerebellar transcranial direct current stimulation (ctDCS) vs
      anodal cerebral direct current stimulation on balance, mobility and cognition in stroke
      patients in stroke patients
    


Intervention name(s): Anodal tDCS cerebellar stimulation group; Anodal tDCS cerebral (M1) stimulation group; sham group
Intervention type(s): Other; Other; Other
Intervention description(s): Single-session atDCS (2 mA, 20 min). The active (anode) and the returning (cathode) electrodes will be placed bilaterally over the cerebellum (1 -2 cm below inion of occipital bone) and the right buccinator muscle, respectively Xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins will also be given; single session a-tDCS (2 mA, 20 min), the anode will be positioned over the lesioned M1 (C3, International 10-20 system) and the cathode would be located over the supraorbital area. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.; single session a-tDCS (2 mA, 20 min), Sham tDCS followed a similar protocol as Anodal tDCS cerebral (M1) stimulation and arrangement but stimulation for 30 s, after which the current was ramped-down and turned off for the rest of the treatment. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation; Anodal Cerebral