bioihbjkbjnl/mcl2 huggingface dataset:
Interaction Effects of Vitamin D Supplementation and Aerobic Exercises on Balance and Physical Performance in Children With Down Syndrome
Condition: Children With Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Objective: To investigate the interaction effects of vitamin D supplementation and aerobic
      exercises on balance control and physical performance in children with Down syndrome (DS).

      Methods: Forty-five children with DS ranging in age from 8 to 12 years will be selected and
      will participate in this study. They will be assigned randomly using sealed envelopes into
      three equal groups (A, B and C). Group A will consist of 15 children and will receive the
      conventional physical therapy program (CPTP) only. Group B will consist of 15 children and
      will receive the CPTP plus the aerobic exercises. Group C also will consist of 15 children
      and will receive the CPTP, the aerobic exercises and Vitamin D supplementation in the form of
      an oral dose of vitamin D3 1000 IU (Cholecalciferol). The program of treatment will be 3
      days/week for 12 weeks. Evaluation of balance by using the biodex balance system and physical
      performance by using the six-minute walk test (6MWT) will be conducted at baseline and after
      12 weeks of the treatment program.
    


Intervention name(s): Aerobic exercises and Vitamin D supplementation
Intervention type(s): Combination Product
Intervention description(s): Aerobic exercises:
Children in groups B and C will receive aerobic exercises in the form of bicycle ergometer and treadmill training for 15 min 3 days/week for 12 weeks. The procedure and goals of exercise will be explained to all children before starting the exercise program. The child will stop exercising immediately if he feels pain, fainting or shortness of breath.
Vitamin D supplementation:
Children in group C only will receive vitamin D supplementation in the form of an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) for 12 weeks.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children will be assigned randomly using sealed envelopes into three intervention groups (A, B and C groups). Group A will receive the conventional physical therapy program (CPTP) only. Group B will receive the CPTP in addition to aerobic exercises, whereas group C will receive CPTP, aerobic exercises in addition to an oral daily dose of vitamin D3 1000 IU (Cholecalciferol). All groups will receive the treatment program for 12 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aerobic exercises; Balance; Down syndrome; Physical performance; Vitamin D
Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections
Condition: Urinary Tract Infections; Infection; Urologic Diseases
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Urologic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of a cranberry juice beverage on rates of
      Urinary tract infection (UTI) recurrence in women with a history of UTI.
    

Detailed description: 
      Urinary tract infections (UTI) are the second most common infection of any organ system and
      the most common urological disease in the United States, with a total annual cost of more
      than $3.5 billion. Although UTIs can occur in both men and women, they are about 50 times
      more common in adult women than adult men. It is estimated that 25% of women diagnosed with a
      primary UTI will suffer a recurrence within two to three months. While no universal
      definition has been accepted, recurrent UTI is usually defined as three episodes in the last
      12 months or two episodes in the last six months following initial infection. In an estimated
      75 to 95% of cases of uncomplicated UTI, Escherichia coli (E. coli) is the underlying cause.

      Cranberries have historically been associated with urinary tract health, but only recently
      has the biologic plausibility of cranberry use in the prevention of UTI been addressed.
      Current research suggests that A-type proanthocyanidins, a specific class of polyphenolic
      compounds found uniquely abundant in cranberries, inhibit adhesion of bacteria (including
      multidrug resistant E.coli) to cultured epithelial cells of the urinary tract.

      This study will compare the effects of a cranberry juice beverage vs placebo on rates of UTI
      recurrence in women with a history of UTI.
    

Intervention name(s): cranberry juice; placebo beverage
Intervention type(s): Other; Other
Intervention description(s): cranberry juice beverage at a dose of one 8 oz. beverage per day for six months; placebo beverage at a dose of one 8 oz. beverage per day for six months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Urinary tract infection; Recurrent urinary tract infection; Cranberry; Prevention; E-coli
Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension
Condition: Sarcoidosis; Pulmonary Arterial Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Sarcoidosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension
      with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.
    

Detailed description: 
      Pulmonary hypertension has been described in sarcoidosis. It can be a significant problem,
      not responsive to treatment with anti-inflammatory drugs for the sarcoidosis (1;2). Inhaled
      iloprost has been approved for treatment of pulmonary hypertension (3). We propose to study
      the effectiveness of inhaled iloprost for sarcoidosis associated pulmonary hypertension
      (SAPAH). This is an open label trial, with patients receiving 16 weeks of therapy. Clinical
      and hemodynamic outcome of therapy will be assessed.
    

Intervention name(s): Iloprost
Intervention type(s): Drug
Intervention description(s): Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day
Other intervention name(s): Ventavis
Intervention MeSH terms: Iloprost
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sarcoidosis; Dyspnea; Interstitial lung disease
Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In
      other regions where tumor incidence is relatively low and patient characteristics are
      different, developments in this issue have been limited. In this study, the investigators
      aimed to compare the early results for patients who underwent open or laparoscopic
      gastrectomy for gastric cancer in a center in Turkey.
    

Detailed description: 
      The patients who were operated in Kocaeli Derince Training and Research Hospital between
      January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The
      diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical
      staging was done using contrast computed tomography (CT). Positron emission tomography (PET)
      was used in patients with suspected metastasis.The patients were divided into two groups
      according to the technique applied (open, laparotomy). The first group (Group 1; n: 30)
      consisted of patients who underwent open surgery, and the second group (Group 2, n: 30)
      laparoscopic surgery.
    

Intervention name(s): gastrectomy
Intervention type(s): Procedure
Intervention description(s): gastric resection with lymph node dissection(D1+,D2) for stomach cancer.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The patients who were operated in Kocaeli Derince Training and Research Hospital between
        January 2014 and January 2019 consecutively due to gastric cancer.
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification
Condition: Neural Tube Defects - Spina Bifida and Anencephaly
MeSH terms: Spinal Dysraphism; Neural Tube Defects; Anencephaly
Study type: Interventional

Summary: 
      The aim of this study is to examine whether the same total daily dosage of folic acid, when
      taken as a single daily dose or as multiple divided doses throughout the day, results in
      different blood folate and homocysteine levels at the conclusion of the study. Further, a
      comparison of blood folate and homocysteine levels among women taking daily low-dosage
      (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly
      high-dosage (4000mcg) folic acid will be conducted.
    


Intervention name(s): folic acid
Intervention type(s): Drug
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Probiotics on Sleep Among Adults Study
Condition: Sleep Disturbance; Sleep Patterns
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine the impact of a probiotic formulation on subjective
      sleep patterns. It is hypothesized that participants given the probiotics will improve their
      sleep patterns compared to participants receiving placebo.
    

Detailed description: 
      Participants with symptoms of insomnia and work-related stress will be recruited to
      participate in a randomized, placebo-controlled, double-blind interventional study for
      approximately 15 since the signature of the informed consent. Participants will first be seen
      at the Screening visit when they will be administered several questionnaires to determine
      eligibility (assessing symptoms of insomnia, work-related stress, psychological distress and
      other sleep disorders). Participants will receive a 2-week sleep journal and an actigraphy to
      record their sleep patterns. At visit 2 returning participants will be randomized to receive
      probiotics or placebo for the following 12 weeks. During this visit, participants will be
      administered questionnaires assessing sleep quality, work-related productivity, quality of
      life, and mood. Participants will also be asked to bring to site a stool sample and saliva
      samples.

      Participants will be asked to return at 6 weeks for visit 3. During this visit participants
      will be administered questionnaires (insomnia, sleep quality, work-related stress and
      productivity, quality of life, mood and psychological distress).

      They will also bring two saliva samples. Two weeks prior to visit 4, participants will be
      asked to complete another sleep journal and be dispensed another actigraphy which shall be
      returned at visit 4. Lastly, participants will return on for visit 4 at week 12 in which the
      same questionnaires as visit 3 will be administered. Participants will also be asked to bring
      to site another stool sample and two saliva samples.
    

Intervention name(s): Probiotic formulation; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.; Participants will be asked to take a placebo capsule daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study comparing 2 formulations of bosutinib in healthy subjects.
    


Intervention name(s): SKI-606 (Bosutinib); SKI-606 (Bosutinib)
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg commercial formulation film coated tablet, administered once daily; 500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
Other intervention name(s): Bosutinib; Bosutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of single oral
      doses of GC021109 when administered to healthy adult subjects.
    


Intervention name(s): GC021109; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs
Condition: Urinary Tract Infection
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic
      treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured by
      the proportion of patients who received an additional antibiotic treatment for acute lower
      uUTIs during the trial.
    

Detailed description: 
      The trial is designed as a comparison of two different modes of action in order to look for
      alternatives to antibiotic treatment of uncomplicated UTIs. Treatment with CLR is a
      nonantibiotic therapy and is compared to an antibiotic treatment. Thus, the trial aim is to
      reduce antibiotics use and moreover to reduce the pressure of developing bacterial resistance
      against antibiotics due to widespread use, which is an additional advantage of the CLR
      therapy.

      The trial results are expected to demonstrate that antibiotic prescriptions in women for
      treatment of lower uUTIs can be reduced by an alternative and safe non-antibiotic treatment.
    

Intervention name(s): Canephron® N; Fosfomycin trometamol; Canephron® N-placebo; Fosfomycin trometamol-placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 tablets 3 times a day for 7 days; 1 sachet of 8 g of granules; one single dose on Day 1; 2 tablets 3 times a day for 7 days; 1 sachet of 8 g of granules; one single dose on Day 1
Intervention MeSH terms: Fosfomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uncomplicated urinary tract infection
Mnaual Therapy in Treatment of Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      2 groups of patients randomized for the treatment.
    

Detailed description: 
      One group treated with neurodynamic techniques and the the other with the desensitization
      maneuvers.
    

Intervention name(s): Manual therapy
Intervention type(s): Other
Intervention description(s): strching neck
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status
Condition: Sarcoidosis; Sleep Apnea, Obstructive; Fatigue
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sarcoidosis; Fatigue
Study type: Interventional

Summary: 
      Sarcoidosis is a multisystemic granulomatous disease that affects individuals worldwide
      without known pathogenesis, and the role of comorbidities has not been fully assessed in the
      scientific literature. An increased incidence of Obstructive Sleep Apnea Syndrome (OSAS) has
      been described in Sarcoidosis although this association has not been explained yet and no
      data is available about the effect of treatment with Continuous Positive Airway Pressure
      (CPAP) in Sarcoidosis. Also, patients affected by Sarcoidosis usually experience a state of
      physical and mental weariness called fatigue and reported in approximately 60-80% sarcoid
      patients and thought to be a consequence of inflammatory mediators but the high prevalence of
      OSAS could be a remarkable bias in clinical evaluation because fatigue is also strongly
      associated with sleep disorders.

      Thus, there is a real need for assessing not only the real prevalence of OSAS in Sarcoidosis
      but also the effect of CPAP treatment on fatigue status experienced by sarcoidotic patients.
    


Intervention name(s): Continuous Positive Airway Pressure (CPAP)
Intervention type(s): Device
Intervention description(s): Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea Syndrome (OSAS) management when moderate-to-severe. Subjects with OSA will be trained in the use of CPAP and will be instructed to use it every night for 3 months. These subjects will then return for a post-treatment completion of questionnaires (ESS and FAS) and compliance analysis.
Other intervention name(s): positive airway pressure; positive pressure ventilation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CPAP
Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application
Condition: Preterm Infants; Nasal Continuous Positive Airway Pressure; Pain Management
Study type: Interventional

Summary: 
      Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice
      on pain and comfort levels of preterm infants during nasal CPAP application.
    

Detailed description: 
      Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice
      on pain and comfort levels of preterm infants during nasal CPAP application.

      Design and Method: The study, which used a randomized controlled trial, included 124 preterm
      neonatal infants a gestational age of 28- 37 weeks and received nasal CPAP. The infants were
      treated with Mother's Voice, Therapeutic Touch, and Mother's Voice+ Therapeutic Touch. The
      Neonatal Infant Pain Scale (NIPS) and Premature Infant Comfort Scale (PICS) scores of the
      infants were measured before, during and after the nasal CPAP application.
    

Intervention name(s): Mother's Voice; Therapeutic Touch; Mother's Voice +Therapeutic Touch; Control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The audio recording was made to listen to the baby for 15 minutes during the nasal CPAP application. The NIPS and PICS scores were evaluated and recorded before, during and after the application.; Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.; Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.; The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Other intervention name(s): Mother's Voice Group; Therapeutic Touch Group; Mother's Voice +Therapeutic Touch Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study used a randomized controlled trial. A parallel trial design was used describing three different experimental groups (Therapeutic Touch, Mother's Voice, and Therapeutic Touch+Mother's Voice) and a control group.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Nasal continuous positive airway pressure (NCPAP); Therapeutic Touch; Mother's Voice; Pain; Comfort
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder
Condition: Bipolar I Disorder
MeSH terms: Mania
Study type: Interventional
Phase: Phase 3

Summary: 
      This extension study is designed to investigate the long-term safety and tolerability of
      licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind
      study CLIC477D2302.
    


Intervention name(s): Licarbazepine
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Bipolar I Disorder
Post Market Clinical Follow Up Study for Evaluation of Agluna® METS
Condition: Infection
MeSH terms: Infections
Study type: Observational

Summary: 
      The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of
      the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk
      of post surgical infections after orthopaedic endoprosthetic replacement surgery.

      This Post Market Clinical Follow up study is designed to retrospectively establish the
      infection rate of a cohort patients who have received an Agluna® Treated METS implant and
      compare the clinical data to patients that have received an untreated METS implant; in order
      to provide evidence to support the investigators' clinical claims.
    

Detailed description: 
      This post-market clinical follow-up study will be a retrospective data comparison study of a
      series of Agluna® treated and untreated METS™ modular prostheses conducted at the Royal
      National Orthopaedic Hospital, Stanmore. The expected sample size will be 106, with 53
      patients in each treatment arm (Agluna® treated vs untreated). However there will be an
      initial pilot of 20 subjects to evaluate the feasibility of the study conduct and to identify
      if any further study design modification are required.

      The primary outcome is the estimation of the infection rate over 12 months following an
      Agluna (silver) treated METS™ endoprosthetic surgery. This will be compared to the infection
      rate of non-Agluna Treated devices in a similar population. Incidence of infection will be
      measured according to the accepted definition of periprosthetic joint infection from the
      American Academy of Orthopedic Surgeons. The study follow up period is 12 months after
      implantation. Secondary objectives are to examine the health economic impacts of using the
      Agluna® Treated METS™ Modular Tumour System in comparison to the untreated METS™ Modular
      Tumour System and to establish clinically relevant superiority of the Agluna® Treated METS™
      Modular Tumour System in comparison to untreated METS™ Modular Tumour System.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Male or female subjects aged between 18 years and 70 years who have been implanted with a
        METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore and the patient
        has been followed up for at least 12 months following implantation