bioihbjkbjnl/mcl2 huggingface dataset:
Study of Binocular Computer Activities for Treatment of Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play
      7 days per week with 2 hours/day patching 7 days per week in children 5 to <17
    

Detailed description: 
      The purpose of the study is to 1) compare the effectiveness of 1 hour/day of binocular game
      play 7 days per week (minimum of 4 days per week) with 2 hours/day patching 7 days per week,
      in children 5 to <13 years of age (younger cohort), as a non-inferiority study; and 2) to
      compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4
      days per week) with 2 hours/day patching 7 days per week, in children 13 to <17 years of age
      (older cohort), as a superiority study.
    

Intervention name(s): iPad®; Patching 2 hours per day, 7 days per week
Intervention type(s): Device; Other
Intervention description(s): Binocular therapy on iPad®
Other intervention name(s): Patching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amblyopia
Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine
Condition: Haemophilus Influenzae Type b Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine
      co-administered with or without Chinese DTPw vaccine administered alone in healthy infants
      (3, 4 and 5 months of age)
    

Detailed description: 
      All subjects will be randomized into two groups. One group will receive DTPw vaccine
      co-administered with Hib and another group will receive DTPw vaccine alone. A specific
      follow-up of solicited local and general symptoms after each vaccination. A specific
      follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events
      reported during the study period.
    

Intervention name(s): Haemophilus Influenza type b vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Turkish Version of the Smartphone Impact Scale
Condition: Addiction Psychological; Healthy; Addiction
MeSH terms: Behavior, Addictive
Study type: Observational

Summary: 
      Smartphone Impact Scale (SIS) was originally developed in English to determine the cognitive,
      affective, social, and behavioral impacts of smartphones in everyday life. The purpose of
      this study was to translate and cross-culturally adapt the SIS instrument into Turkish and
      investigate its psychometric properties.
    

Detailed description: 
      Smartphone Impact Scale (SIS) was originally developed in English to determine the cognitive,
      affective, social, and behavioral impacts of smartphones in everyday life. The purpose of
      this study was to translate and cross-culturally adapt the SIS instrument into Turkish and
      investigate its psychometric properties. Two hundred healthy young adults will include. For
      cross-cultural adaptation, two bi-lingual translators used the back-translation procedure.
      Within a 5-to-7-day period after the first assessment, the participants completed the Turkish
      version of SIS (SIS-T) to evaluate test-retest reliability. Cronbach's alpha (α) was used to
      assess internal consistency. The correlations with the Turkish version of the Smartphone
      Addiction Scale (SAS-T) and Turkish version of the Nottingham Health Profile (NHP-T) will
      determine to check the validity.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample will consist of volunteer, healthy participants.
      
Keywords: smartphone; technological addiction; smartphone psychosocial impact; smartphone use
Evaluation of The Effectiveness of m-DAKBAS on Foot Care
Condition: Diabetic Foot; Foot Ulcer, Diabetic; Health Knowledge, Attitudes, Practice
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      Aim: To develop the Mobile Diabetic Foot Personal Care System (m-DAKBAS) related to foot care
      for diabetic individuals and to evaluate its effectiveness.

      Method: The study involved 88 patients who applied to the Diabetes Polyclinic
      (intervention=44; control=44). While the intervention group used m-DAKBAS (for 6 months), the
      control group was provided with a verbal foot care training once, as a standardized procedure
      of the hospital. Data were collected using the "Socio-demographic Form", "Diabetic Foot
      Knowledge Form - DFKF", "Foot Self Care Behaviours Scale -FSCBS", "Diabetic Foot Care Self
      Efficacy Scale - DFCSES", and "m-DAKBAS Assessment Form".
    

Detailed description: 
      Diabetic foot, one of the important complications of diabetes, is a health problem that
      affects quality of life in a negative way, that has high treatment and care costs and
      mortality rates, long hospitalization duration and thus with all these aspects a
      psychological, physical, social and economic priority. Despite all these, diabetic foot
      complications and amputations could be decreased with the help of a good foot care, education
      and a multidisciplinary team work. Mobile technologies have been continuously increasing
      worldwide for the management of diabetes, and the use of these technologies is recommended by
      international institutions as well.

      Therefore, the purpose of this study is to develop a Turkish mobile application that would
      increase patients' knowledge levels about foot health and care, improve their behaviours and
      self-efficacy, and evaluate its effectiveness so that it could be possible to prevent foot
      ulcer and the related amputations in individuals with diabetes. The Mobile Diabetic Foot
      Personal Care System (m-DAKBAS) developed for this purpose enables to increase individuals'
      self-confidence, improve communication with the health personnel, involve patients in their
      own care in an interactive way, and take responsibility.

      The usability of the application was indicated by the patients' feedback, and in line with
      the purpose of the mobile application, improvements in the patients' knowledge, behaviours
      and self-efficacy about foot care in diabetes.
    

Intervention name(s): knowledge, behaviour, self efficacy
Intervention type(s): Other
Intervention description(s): Knowledge, behavior and self-efficacy of both groups were measured before and after the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetic foot; health technology; mobile application
Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules Containing Memantine Hydrochloride in Healthy Adults
Condition: Alzheimer Disease; Gastric Retention; Healthy
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To assess how long memantine hydrochloride (HCl) (50 mg) extended release capsules stay in
      the stomach as determined by imaging assessment (MRI or abdominal ultrasound).

      To evaluate the safety of a memantine HCl extended release capsule formulation
    

Detailed description: 
      This is a single centre, open label, single dose study in healthy adult subjects.

      Eligible individuals will be admitted to an inpatient unit in two or more cohorts. Enough
      eligible individuals will be admitted allowing for the enrollment of the Sentinel (n= 2) and
      Main Group (total of n=8 in Main), and an optional Supplemental Group (n= 6), if required.

      All enrolled subjects will be dosed with a single administration of an extended release
      capsule containing memantine hydrochloride (LYN-057), 50 mg. Dosing will be conducted in an
      inpatient clinical unit, with access to an acute care facility. Subjects will remain in the
      inpatient unit for 7 days after dosing. During this time, subjects will undergo intermittent
      imaging assessments for gastric retention [magnetic resonance imaging (MRI) and abdominal
      ultrasound (U/S)], safety assessments, blood sampling for evaluation of memantine
      pharmacokinetics (PK), and faecal collections for assessments of formulation components and
      bowel movement characteristics.

      Subjects will return to the clinic for PK sampling and safety assessments on Days 10, 15, 22
      and Day 29 (End of Study Visit). In addition, some subjects may continue to perform faecal
      collection and/or may undergo imaging assessments on Day 10 based on clinical criteria. On
      Day 29 (End of Study Visit), subjects will undergo final safety and PK assessments and will
      be discharged from the study.
    

Intervention name(s): LYN-057; Imaging Assessment (MRI); Imaging Assessment (U/S)
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Administration of single dose of LYN-057 presented as extended release capsule containing 50 mg of memantine hydrochloride (HCl); Imaging assessments [MRI] will be performed on specified days according to protocol; Imaging assessments (abdominal U/S) will be performed on specified days according to protocol
Other intervention name(s): LYN-057 (50 mg); MRI; Abdominal Ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sub-acute Exercise Following Sport-Related Concussion
Condition: Sport-related Concussion
Study type: Interventional

Summary: 
      Determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase
      of recovery following sport-related concussion.
    

Detailed description: 
      The main objective of the proposed study is to determine is exercise during the first 3-7
      days following a sport-related concussion can help improve the systemic neurological
      dysfunction following a concussion while examining the safety and efficacy of a 20-minute,
      low- to moderate-intensity (40-60% of HRMAX) controlled treadmill aerobic exercise as a
      therapeutic modality to improve cardiovascular, psychological, vestibulo-ocular, autonomic,
      and cognitive function.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): HR-controlled treadmill walking
Other intervention name(s): Aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized block design using age and sex to randomize into 3 injured groups (40%, 60%, CON) and matching for 3 healthy groups (40%, 60%, CON)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: concussion; aerobic exercise; sub-acute
Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and
      dexamethasone offers a clear advantage over placebo for protection against
      chemotherapy-induced emesis in both acute and delayed phases. However, its side effects such
      as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort,
      irritability, increased appetite, weight gain and acne are gathering increasing concerns.
      Several clinical trials have shown that olanzapine plays an important role in treating
      delayed, refractory, breakthrough nausea and vomiting. Its side effects mainly include
      sedation and weight gaining. At present, the NCCN guidelines have recommended
      olanzapine-containing three-drug regimen for Highly Emetogenic Chemotherapy (HEC) and
      moderate emetic chemotherapy (MEC) to prevent vomiting, but its data in the Chinese
      population is limited. Hence, we initiated this prospective, multi-center, phase III study to
      validate the dexamethasone-free protocol: applying olanzapine to prevent CINV instead of
      dexamethasone.
    


Intervention name(s): Olanzapine+NK-1 RA+5-HT3 RA; Dexamethasone+NK-1 RA+5-HT3 RA
Intervention type(s): Drug; Drug
Intervention description(s): On day 1-4, Olanzapine (5mg) is delivered orally after dinner.; On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg.
Other intervention name(s): Acidocont; Deronil; Dexacortal; Desameton; Fluprednisolone; (11β，16α）-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
Intervention MeSH terms: Dexamethasone; Fluprednisolone; Olanzapine; Serotonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nausea; vomiting; antiemesis
Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
Condition: Atherosclerosis; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of
      MEDI6012 in subjects with stable atherosclerosis.
    

Detailed description: 
      A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety,
      Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects
      with Stable Atherosclerotic Cardiovascular Disease
    

Intervention name(s): MEDI6012 40 mg; Placebo; MEDI6012 120 mg; MEDI6012 300 mg; Placebo IV Push; MEDI6012 IV Push
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.; Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.; Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.; Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.; Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.; Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atherosclerosis; Cardiovascular Disease; CAD; Atherosclerotic Cardiovascular Disease
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the efficacy, safety, and tolerability of single
      doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive
      pulmonary disease (COPD).
    

Detailed description: 
      This was a single-center, randomized, double-blind, cross-over, placebo-controlled study.
      Following screening, each eligible subject was randomized to a dosing sequence. Study
      subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period.
      Doses A, B, C, and D were administered in a double-blind fashion, in sequences generated by a
      4-period Latin square design. The 4 dosing sequences were: ABCD, BDAC, CADB, and DCBA. Dose E
      was administered in an open-label fashion as the final dose in each dosing sequence for all
      subjects.

      Subjects reported to the clinic the evening prior to each dose. Protocol assessments were
      carried out until 24 hours postdose. Pulmonary function testing (via spirometry) was captured
      at specified timepoints at baseline as well as before and after dosing. Other efficacy and
      safety outcomes were assessed according to protocol. Blood sampling was performed for
      assessment of trospium concentrations at specified timepoints.
    

Intervention name(s): Placebo; TrIP-2D; TrIP-2SS; TrIP-2D; TrIP-2SS + Foradil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler.; Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.; Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.; Trospium inhalation powder containing 400 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.; Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.
Intervention MeSH terms: Triptorelin Pamoate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; pulmonary; inhalation
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation
Condition: Mitral Valve Insufficiency
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      Annuloplasty device for repair of mitral valve regurgitation with option to adjust device
      post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional
      annuloplasty ring, the Cardinal system offers the clinician the opportunity to make
      adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce
      the number of patients leaving the operating room with residual regurgitation after mitral
      valve repair.
    


Intervention name(s): Adjustable Annuloplasty Ring with option to adjust off pump.; Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
Intervention type(s): Device; Device
Intervention description(s): Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty repair, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.; Evaluate the performance and safety of the investigational adjustable annuloplasty ring device for the treatment of mitral regurgitation, with option to adjust on and off-pump.
Other intervention name(s): Valtech Cardinal Adjustable ring
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Diseases; Heart Valve Diseases; Cardiovascular Diseases
Evaluation of Intravaginal Gel and Ovule Formulations of TOL-463
Condition: Vaginal Infection
MeSH terms: Vaginitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, local tolerability and pharmacokinetic
      parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females
      following single dose administration (Part 1), and in nonpregnant women with vaginitis
      following multi-dose administration (Part 2).
    

Detailed description: 
      The purpose of this study is to determine the safety, local tolerability and pharmacokinetic
      parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females
      following single dose administration (Part 1), and in nonpregnant women with vaginitis
      following multi-dose administration (Part 2).
    

Intervention name(s): TOL-463 Vaginal ovule; TOL-463 Vaginal gel
Intervention type(s): Drug; Drug
Intervention description(s): TOL-463 Vaginal Ovule; TOL-463 Vaginal Gel
Intervention MeSH terms: TOL-463
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bacterial vaginosis, vulvovaginal candidiasis, TOL-463, intravaginal therapy, vaginitis, women, cross-over
Clinical Trial to Evaluate the Efficacy and Safety of the Probiotic Strains Limosilactocillus Reuteri DSM 32910 and Lacticaseibacillus Paracasei DSM 32851 on Glucose Homeostatis in Prediabetic Adults
Condition: Prediabetic State; Dysglycemia
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The aim of this international, randomized, parallel arms, double-blind, placebo-controlled
      clinical trial is to investigate the safety and efficacy of a combination of the two
      Lactobacillus strains (NZ-GHMH-01) on glucose and insulin metabolism, in prediabetic
      subjects. This trial will include prediabetic (insulin resistant) subjects with excessive
      body weight (over-weight or obese, showing abdominal or visceral obesity) to be able to
      investigate the effect of the probiotic NZ-GHMH-01 on glycaemic control.
    


Intervention name(s): NZ-GHMH-01; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each randomized subject will consume 1 capsule daily bringing 100 mg (≥ 2 x 109 CFU) of active ingredient during 16 weeks (from V2 to V5 visits).; Each randomized subject will consume 1 capsule with no active ingredient daily during 16 weeks (from V2 to V5 visits).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention