bioihbjkbjnl/mcl2 huggingface dataset:
Girls Can...Move! Testing the Feasibility of a Community-based Physical Activity Intervention for Adolescent Girls
Condition: Physical Inactivity
Study type: Interventional

Summary: 
      The purpose of this research is to learn about how to promote physical activity among
      adolescent girls by testing the feasibility and initial effectiveness of the Girls
      Can...Move! intervention. Girls Can...Move! will target each component of physical literacy
      by providing opportunities for adolescent girls to gain knowledge about their own physical
      activity level, to explore and practice different types of physical activities, and to learn
      from active female role models. Female participants (n = 30) from one middle school will be
      randomly assigned to the Girls Can...Move! intervention group or a control group at a 1:1
      ratio. The primary outcome variables, physical activity and physical literacy, will be
      assessed before and after the 8-week Girls Can...Move! intervention using accelerometers and
      online surveys.
    


Intervention name(s): Girls Can...Move!
Intervention type(s): Behavioral
Intervention description(s): Girls Can...Move! is an 8-week intervention designed to increase physical literacy and physical activity among middle school aged girls. One-hour, in-person sessions will be held twice per week for a total of 16 sessions. Each session involves: a brief educational lesson related to physical activity participation, a 30-minute group physical activity session, and a take-home challenge. The physical activities will prioritize enjoyment of physical activity and promote the development of movement competence. These activities may include: yoga; Zumba; Pilates; strength training; kick boxing; circuit training; etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: physical literacy; female; accelerometer; exercise
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20161 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open label, crossover study to explore drug-drug interactions between DWC20155
      / DWC20156 and DWC20161 in Healthy Volunteers
    


Intervention name(s): Co-administration of DWC20155/DWC20156; DWC20161
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Desmopressin Response in the Young
Condition: Primary Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether desmopressin administered as a melt tablet
      is effective in reducing the number of wet nights in children and adolescents who suffer from
      bedwetting.
    

Detailed description: 
      Primary nocturnal enuresis (PNE), or bedwetting, is a common childhood urological disease.
      Factors contributing to nocturnal enuresis include nocturnal polyuria due to, at least in
      part, a relative deficiency of antidiuretic hormone arginine vasopressin (AVP) which has been
      supported by the finding that some enuretic children lack a nocturnal increase in endogenous
      AVP secretion. Desmopressin, a synthetic, structural analogue of AVP, selective for
      V2-receptors and with a longer half life than the natural hormone, has been found to be
      especially beneficial in PNE subjects with nocturnal polyuria and normal functional bladder
      capacity.

      A melt tablet formulation offers benefits compared to regular tablets and nasal spray.
      Regular tablets are more difficult to swallow for some patients and require fluid intake for
      swallowing. Nasal spray absorption may be altered by seasonal allergies, upper respiratory
      infections or improper administration.
    

Intervention name(s): desmopressin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime; placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime
Other intervention name(s): DDAVP
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery
Condition: Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Study type: Observational

Summary: 
      This study evaluates the retinal vascular features using optical coherence tomography
      angiography in patients that received endoscopic endonasal approach for the removal of an
      intra-suprasellar pituitary adenoma compressing the optic nerve.
    

Detailed description: 
      To investigate the potential role of optical coherence tomography angiography in predicting
      the postoperative recovery of retinal vascular network of the optic disc in patients before
      and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar
      pituitary adenoma compressing the optic nerve.

      The optical coherence tomography angiography represents a novel and non-invasive diagnostic
      technique that allows a detailed analysis of retinal vascular features.
    

Intervention name(s): Endoscopic Endonasal Pituitary Surgery
Intervention type(s): Procedure
Intervention description(s): Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 45 years with pituitary adenoma. They did not present other
        ophthalmological and neurological diseases.
Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis
Condition: Chronic Cavitary Pulmonary Aspergillosis
MeSH terms: Aspergillosis; Pulmonary Aspergillosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether there itraconazole is effective in the
      treatment of chronic cavitary pulmonary aspergillosis
    

Detailed description: 
      The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary
      aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing
      hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.
    

Intervention name(s): Itraconazole; treatment in cavitary pulmonary aspergillosis
Intervention type(s): Drug; Drug
Intervention description(s): Tablet 200 mg twice daily for 6 months; Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)
Other intervention name(s): Study group
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Itraconazole; chronic cavitary pulmonary aspergillosis; Aspergillosis; fungal ball; mycetoma; efficacy; safety
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
Condition: Tibial Fractures
MeSH terms: Tibial Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for
      extra-articular tibial fractures treated with Smith& Nephew's Trigen META intramedullary
      nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee
      flexion) and Group B=with the semi-extended surgical technique. (2*100 patients)

      Research Objectives:

      The primary research objectives are to evaluate:

      i) anterior knee pain and ii) the nail position and overall fracture alignment

      Outcome Measures:

        1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.

        2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by
           means of Patient questionnaires

        3. Knee-related adverse events

        4. Overall fracture alignment
    

Detailed description: 
      After surgery with standard intramedullary nailing technique in tibia fractures, 40-80% of
      the patients still complain of anterior knee pain postoperative. The expected advantages of
      the semi-extended nailing technique is less anterior knee pain and less malunion of the
      fracture.

      Using the semi-extended nailing technique also might give the advantage of better position of
      the nail by a more concentric reaming of the tibia, due to less tension on the patella tendon
      during reaming process.
    

Intervention name(s): Semi-extended Surgical Technique; Standard Surgical Technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.; Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.
Other intervention name(s): Trigen META Intramedullray Tibia Nail; Trigen META intramedullary tibia nailing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intramedullary tibia nailing; Anterior Knee Pain; Nail positioning
Stepped Care Treatment for Binge-Eating
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      Temple University is looking for women to participate in a study to evaluate the treatment
      options available to women living with binge eating disorder.

      Binge-Eating Disorder is a significant public health problem for women. Despite this, there
      is limited research on how best to treat this disorder at varying levels of severity. The
      purpose of this NIMH-funded study is to enroll individuals in a brief form of
      cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly
      assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or
      Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been
      adapted for women living with binge-eating disorder and are free of charge.
    


Intervention name(s): Therapy
Intervention type(s): Behavioral
Intervention description(s): Individual Therapy and Group Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Binge Eating Disorder; overeating; binge eating; women; overweight; compulsive overeating
The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokine in COPD Patients
Condition: COPD
Study type: Interventional
Phase: Phase 3

Summary: 
      Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is
      steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as
      atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that
      statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD
      patients.
    


Intervention name(s): simvastatin, placebo
Intervention type(s): Drug
Other intervention name(s): Bestatin; B1-6-12
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Statins; Cytokines
Taperloc Versus Taplerloc Microplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This evaluation is conducted to evaluate the safety and performance of two different stem
      lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are
      compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and
      radiostereomektric analysis
    

Detailed description: 
      Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip
      and eligible for total hip arthroplasty will be asked to participate in the study.

      Periprosthetic bone loss, migration of the components and clinical scores will be recorded
      prospectively at 3,6,12 and 24 months.
    

Intervention name(s): Taperloc Microplasty; Taperloc standard
Intervention type(s): Device; Device
Intervention description(s): primary total hip arthroplasty; primary total hip arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Short femoral stem; Stress shielding; Stem migration; Implant Survival; DEXA; Radiostereometric analysis
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted globally. The aim of this trial is to investigate safety,
      pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the
      effect of the investigated drug on the body) of concizumab administered subcutaneously to
      haemophilia A subjects.
    


Intervention name(s): Concizumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg); Administered subcutaneously (s.c., under the skin)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram
      (mg) tablets and capsules.
    

Detailed description: 
      The drug being tested in this study is called esomeprazole. Esomeprazole is being tested in
      healthy participants in order to evaluate the bioequivalence between a single oral dose of
      esomeprazole tablet and capsule. The study will enroll 52 participants. Participants will be
      randomly assigned (by chance, like flipping a coin) to one of the two treatment sequences:

        -  Esomeprazole 40 mg capsule + Esomeprazole 40 mg tablet

        -  Esomeprazole 40 mg tablet + Esomeprazole 40 mg capsule

      All participants will be asked to take one capsule or tablet on Day 1 of each Intervention
      Period based on the treatment sequence to which the participant has been assigned.

      This single center trial will be conducted in the United States. The overall duration to
      participate in this study is 36 days. Participants will visit the clinic on Day -1 and
      remained confined until Day 1 of Intervention Period 1 and 2. A washout period of minimum 6
      days will be maintained between the dose in each Intervention Period.
    

Intervention name(s): Esomeprazole Capsule; Esomeprazole Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Esomeprazole Capsule; Esomeprazole Tablet
Other intervention name(s): Nexium; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn if initiating treatment with
      BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in
      patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes,
      when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety
      of this treatment will also be studied
    


Intervention name(s): Dapagliflozin; Metformin XR
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, Once daily, 24 weeks; Tablets, Oral, Once daily, 24 weeks
Other intervention name(s): BMS-512148
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts
Condition: Pancreatic Cyst
MeSH terms: Cysts; Pancreatic Cyst
Study type: Interventional

Summary: 
      This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous
      pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA)
      procedures.
    

Detailed description: 
      Mucinous pancreatic cysts are considered pre-cancerous. The standard evaluation of pancreatic
      cysts usually includes endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). The
      cyst fluid sample from EUS-FNA is routinely sent for lab analysis (carcinoembryonic
      antigen-CEA) and cytology assessment. The diagnosis of a mucinous cyst is usually based on
      those results.

      For study participants undergoing EUS-FNA, a small portion of the cyst fluid will be analyzed
      for glucose levels using a bedside glucometer in addition to the routine analyses. A low cyst
      fluid glucose level may correlate with a diagnosis of a mucinous cyst. The primary aim of
      this study will be to determine if a low cyst fluid glucose level correlates with standard
      laboratory cyst fluid analysis (CEA) in establishing a diagnosis of a mucinous pancreatic
      cyst.

      Secondary aims of this study will be: (1) comparing the accuracy of cyst fluid glucose to CEA
      level among subjects with a proven diagnosis of a mucinous cyst (based on surgery or
      cytopathology findings), and (2) determining the optimal cyst fluid glucose level that
      correlates to a proven diagnosis of a mucinous cyst (based on subjects who undergo surgery or
      have a diagnosis based on cytopathology).
    

Intervention name(s): pancreatic cyst fluid glucose analysis using a bedside glucometer
Intervention type(s): Device
Intervention description(s): Small amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Relationship Between Psychosocial Factors Affecting Pain Perception and Physical Activity Level in Pregnant Women With Lumbopelvic Pain
Condition: Investigate the Relationship Between the Psychosocial Factors Affecting Pain Perception and Physical Activity Levels in Pregnant Women With Lumbopelvic Pain
Study type: Observational

Summary: 
      Lumbopelvic pain (LPP) is a common condition encountered during pregnancy. During pregnancy,
      50% of women experience LPP. This study was planned to show the relationship between
      psychosocial factors affecting the perception of pain such as pregnancy-related psychosocial
      factors, pregnancy-related distress, catastrophization and pain self-efficacy and physical
      activity level in pregnant women with lumbopelvic pain. This study was conducted using the
      questionnaires.
    

Detailed description: 
      In pregnant women with lumbopelvic pain, physical activity during pregnancy has many positive
      effects on both maternal and infant health. Therefore, it is necessary to know the factors
      affecting physical activity during pregnancy and make arrangements regarding these factors.
      This study was planned to reveal the relationship between pregnancy-related psychosocial
      factors, pregnancy-related distress, catastrophizing, and pain self-efficacy, which affect
      pain perception, and physical activity level in pregnant women with lumbopelvic pain. The
      study was conducted with 60 pregnant women who met the inclusion criteria. This study was
      conducted using the questionnaires prepared in the electronic environment and sent to the
      participants. This study aims to investigate the relationship between the psychosocial
      factors affecting pain perception and physical activity levels in pregnant women with LPP.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women between the ages of 18-45, who had lumbopelvic pain
      
Keywords: lumbopelvic pain, psychosocial features, physical activity, pelvic pain, pregnancy
International Classification of Functioning, Disability and Health and Lower Extremity Orthoses in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      International Classification of Functioning, Disability and Health (ICF) is a coding system
      developed to describe the health status of individuals in a universal way. The increasingly
      common core sets are short forms of ICF categories that are specifically selected for
      diseases. The aim of this study is to investigate the relationship among the lower extremity
      orthoses commonly used in children with cerebral palsy (CP), body structure and functions,
      activity and participation level, and is to determine the relationship between clinical tests
      and ICF CP core set. For this purpose, a total of 75 children with ages between 3 and 18 will
      be divided into 3 groups, including using a walking orthosis, using a resting orthosis, and
      using both walking and resting orthoses. Children's muscle tone, joint limitation, gross
      motor functions, balance skills, activity and participation levels and quality of life will
      be assessed with the tests frequently used in the clinic separately and with the core set in
      a holistic framework.
    


Intervention name(s): ICF CP Core Set
Intervention type(s): Other
Intervention description(s): Core set
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The children who will come to the investigator's unit, Cerebral Palsy and Pediatric
        Rehabilitation
      
Keywords: Cerebral Palsy; Lower Extremity Orthosis; ICF Core Set