bioihbjkbjnl/mcl2 huggingface dataset:
Micturition Reeducation in Children With Cerebral Palsy
Condition: Daytime Urinary Incontinence
MeSH terms: Cerebral Palsy; Urinary Incontinence; Enuresis; Diurnal Enuresis
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of a voiding reeducation program as treatment for
      incontinence in children with a brain injury.
    

Detailed description: 
      Children with cerebral palsy (CP) (Rosenbaum, 2007) gain bladder and bowel control at older
      age compared to typical developing children (Ozturk, 2006). The incidence of urinary
      incontinence during day and night, fecal incontinence and constipation is higher in this
      population.

      Incontinence in children is often treated with urotherapy. This is a nonsurgical,
      nonpharmacological treatment for lower urinary tract dysfunctions. Standard urotherapy is
      noninterventional and it includes giving information, instructions, advice regarding
      life-style, fluid intake and bladder diaries. Additionally specific interventions can be
      used, such as: various forms of pelvic floor training, behavioral modification, biofeedback,
      electrical stimulation and catheterization (Neveus, 2006). Recent research has proven
      urotherapy to be successful for the treatment of children with daytime incontinence (Mulders,
      2010).

      Despite the high prevalence of incontinence in children with CP the possible treatment
      strategies in this population are poorly investigated. Far too often, urinary incontinence in
      children with CP is considered a normal, unavoidable and even a minor problem.

      Aim: Investigate the influence of individualized urotherapy on the (in)continence of children
      with CP.

      The included children with CP will be randomized and stratified for type of CP and mental
      abilities into 2 groups: the intervention group and the control group. The intervention group
      will receive immediate therapy. After one year of therapy, a follow- up of 6 months will be
      applied. The control group will start 6 months later and information will be used as control
      group. Incontinent children without CP will receive therapy and will also act as control
      group.
    

Intervention name(s): urotherapy with or without pharmacotherapy
Intervention type(s): Other
Intervention description(s): Individualized
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urinary incontinence; cerebral palsy; urotherapy; child
Objective and Subjective Outcomes of an Electronic Chest Drainage System
Condition: Lung Cancer
Study type: Interventional

Summary: 
      This study is designed to compare the Thopaz chest tube drainage system to the traditional
      collection chamber system. The Thopaz system is already in clinical use in the United States
      and throughout the world. As such, this study is not evaluating safety or efficacy of this
      system both of which have already been demonstrated. This study's primary aim is to determine
      whether the use of a digital chest drainage system compared with a traditional system affects
      duration of chest drainage and length of hospital stay.

      Furthermore, we aim to determine whether the use of a digital chest drainage system compared
      with a traditional system increases the total distance of ambulation in the first 48 hours
      after thoracic surgery and affects overall patient satisfaction in the peri-operative period.

      Finally, we want to determine whether the aforementioned outcomes relative to the chest tube
      drainage systems differ in different parts of the world.
    


Intervention name(s): electronic chest drainage system
Intervention type(s): Device
Intervention description(s): Patients in the intervention arm are connected to Thopaz, electronic drainage system immediately after closure of the chest, patients in the control group are connected to a traditional system. Chest tubes in both groups are then connected to suction of -20 cmH2O and maintained at that level until post-operative day #1.
On the morning of post-operative day #1, presence of air leak will be recorded on suction. Then, suction will be decreased to -8 cmH2O (so-called water seal). At that time, management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms, and surgeon preference following the standard clinical algorithm for post-operative care of general thoracic patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: chest tube; lung resection; patient satisfaction; mobility
Subcutaneous Contouring Using High Intensity Focused Ultrasound
Condition: Body Sculpting
Study type: Interventional

Summary: 
      The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt
      subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such
      as a reduction in waist circumference.
    


Intervention name(s): LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)
Intervention type(s): Device
Intervention description(s): Study of Adipose Tissue Treatment Using Focused Ultrasound
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Ultrasound Treatment of Subcutaneous Adipose Tissue
Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery
Condition: Diabetes; Bariatric Surgery; Obesity
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80%
      of patients submitted to Roux-en-Y gastric bypass (RYGP). Otherwise, many patients
      experienced no resolution of their diabetes despite massive surgical-induced weight loss.
      There appears to be a variable response to surgery depending on surgical and patient factors.
      To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed
      to make a description of effects of surgical procedures on incretin, insulin production and
      sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.
    

Detailed description: 
      Diabetes reversion is observed after bariatric surgeries even before significant weight loss
      could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic
      diversion or duodenal switch), followed by those combining malabsorption and gastric
      restriction (83,7% for Roux-en-Y gastric bypass). Changes in the hormonal communication
      between the digestive system and the pancreas would explain the antidiabetogenic role of the
      surgery, so this effect could be obtained in nonobese, diabetic individuals.

      To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed
      to make a description of effects of surgical procedures on incretin, insulin production and
      sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with DM2 and obesity undergoing RYGB with remission of DM2 and without remission.
      
Keywords: diabetes mellitus, type 2; Insulin resistance; bariatric surgery; Glucagon-Like Peptide 1; Gastric Inhibitory Polypeptide; insulin; glucagon; ghrelin; adiponectin; Cytokines; gastric bypass; Obesity
Stereotactic Radiation Therapy in Treating Patients With Brain Metastases
Condition: Metastatic Cancer
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor
      and cause less damage to normal tissue.

      PURPOSE: Phase II trial to study the effectiveness of stereotactic radiation therapy in
      treating patients who have brain metastases.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of stereotactic radiosurgery without whole brain
      radiotherapy in elderly patients or patients with poor performance status who have brain
      metastases. II. Determine the neurologic function in these patients after receiving this
      treatment regimen. III. Determine the quality of life in these patients with this treatment
      regimen.

      OUTLINE: Patients undergo stereotactic head frame placement, followed by stereotactic
      radiosurgery using Gamma Knife, on day 1. Quality of life is assessed one week prior to and
      one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at
      one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6
      months for 3 years.

      PROJECTED ACCRUAL: Approximately 52 patients will be accrued for this study within 2 years.
    

Intervention name(s): stereotactic radiosurgery
Intervention type(s): Radiation
Intervention description(s): Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tumors metastatic to brain
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
Condition: Graft Versus Host Disease; Hematopoietic/Lymphoid Cancer
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in
      treating patients with hematological diseases. Giving chemotherapy before a donor stem cell
      transplant helps stop the growth of cells in the bone marrow, including normal blood-forming
      cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused
      into the patient they may help the patient's bone marrow make stem cells, red blood cells,
      white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an
      immune response against the body's normal cells (called graft-versus-host disease). Giving
      cyclophosphamide after the transplant may stop this from happening.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine if haploidentical stem cell transplant using post-transplant cyclophosphamide
      results in 60% or better disease free survival (DFS) at 12 months at our institution.

      SECONDARY OBJECTIVES:

      I. To determine the rate of acute and chronic graft-versus-host disease (GvHD), non-relapse
      mortality, and relapse.

      OUTLINE:

      PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) once daily
      (QD) on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV
      every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity
      conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also
      receive cyclophosphamide IV QD on days -3 and -2

      TRANSPLANT: Patients undergo stem cell transplant on day 0.

      GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days
      5-180, and mycophenolate mofetil on days 5-35.

      After completion of study treatment, patients are followed up periodically for 2 years.
    

Intervention name(s): fludarabine phosphate; busulfan; cyclophosphamide; allogeneic hematopoietic stem cell transplantation; tacrolimus; mycophenolate mofetil
Intervention type(s): Drug; Drug; Drug; Procedure; Drug; Drug
Intervention description(s): Given IV; Given IV; Given IV; Undergo myeloablative or reduced intensity allogeneic stem cell transplant
Other intervention name(s): 2-F-ara-AMP; Beneflur; Fludara; BSF; BU; Misulfan; Mitosan; Myeloleukon; CPM; CTX; Cytoxan; Endoxan; Endoxana; FK 506; Prograf; Cellcept; MMF
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Busulfan; Fludarabine; Fludarabine phosphate; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness,
      and markers of atherogenic risk in patients with moderate to severe active rheumatoid
      arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab
      8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg
      weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus
      methotrexate.
    


Intervention name(s): Tocilizumab; Placebo; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered by intravenous infusion, 8 mg/kg every 4 weeks.; Placebo to tocilizumab administered by intravenous infusion every 4 weeks.; Administered orally or parenterally, 7.5-25 mg weekly.
Other intervention name(s): RoActemra; Actemra
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time
      in human study of AMP-110 in adult subjects with rheumatoid arthritis.
    


Intervention name(s): AMP-110; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Dose levels 1 through 7: Single intravenous infusion on Day 0; Dose levels 4 through 7: Single intravenous infusion on Day 0
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis; Rheumatoid Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Antirheumatic agents
Assessment of a Weight Management Program for Weight Gain in Patients With Schizophrenia
Condition: Schizophrenic Disorders
MeSH terms: Weight Gain; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to develop the weight management program, which is combined with
      healthy diet, proper physical exercise, and behavior modification, related to patient's
      quality of life. The patients groups are in routine practice with 5-20 mg olanzapine. The
      study results may be utilized for patients who have gained weight on olanzapine and also
      other antipsychotic drugs.
    


Intervention name(s): Olanzapine Hydrochloride; Weight Management Program
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type
      2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone
      is efficacious in terms of improving glycemic control.
    


Intervention name(s): Rosiglitazone 4 mg
Intervention type(s): Drug
Other intervention name(s): Insulin
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insulin; BRL49653 /rosiglitazone; Type 2 Diabetes Mellitus
Comparison of Attention of Physician After Outpatient Clinic
Condition: Disturbance of Activity and Attention
Study type: Observational

Summary: 
      The attention and clinical performance of physician might be decreased after outpatient
      clinic session compared to those measured before outpatient clinic.
    

Detailed description: 
      A large body of data shows that fatigue impairs human performance. Additionally, many studies
      have provided evidence that fatigue can worsen mood, as indicated by increased scores on
      measures of depression, anxiety, confusion, and anger. In this context, we examined
      attentional and emotional changes in physicians after they completed an overwhelming
      outpatient clinic in a university-affiliated tertiary referral hospital in South Korea.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        physicians with outpatient clinic sessions in Seoul National University Hospital
      
Keywords: attention
Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.
    


Intervention name(s): ABT-288; donepezil; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will take 4 capsules once daily for 12 weeks.; Subjects will take 4 capsules once daily for 12 weeks.; Subjects will take 4 capsules once daily for 12 weeks.
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolomic Profiling in Adolescents With Obesity and Diabetes
Condition: Metabolomics; Obesity; Diabetes; Diabetic Nephropathies
MeSH terms: Diabetic Nephropathies; Diabetes Mellitus; Obesity
Study type: Observational

Summary: 
      The purpose of this study is to identify unique metabolite signatures associated with the
      development of Type 2 diabetes and diabetic kidney disease in children.

      We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A)
      in the urine of adolescent females with polycystic ovarian syndrome.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from clinical practices affiliated with Rady Children's
        Hospital.
      
Biospecimen description: 
      Plasma and urine
Patient Positions and Perfusion Index
Condition: Perfusion
Study type: Observational

Summary: 
      The association between patient positions including supine,prone, trendelenburg,reverse
      trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position and
      perfusion index.
    

Detailed description: 
      Participants are taken to the recovery room and they will wait 15 minutes until measurements.
      After monitoring the perfusion index using the right ring finger, first the participant will
      be taken to supine position. The perfusion index value will be obtained after three minutes
      of measurement. Second, the position will change to 45 degrees back up sitting position and
      the measurement will be repeated. Then the participant will be taken to Trendelenburg
      position, reverse Trendelenburg position, prone, 45 degrees legs lifted supine position
      respectively, and same measurement will perform.
    

Intervention name(s): Perfusion index
Intervention type(s): Other
Intervention description(s): supine,prone, trendelenburg,reverse trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Volunteers American society of anesthesiologists score of 1
Human Ovarian Follicular Dynamics and Emergency Contraception
Condition: Contraception
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      The researchers hypothesize that emergency contraception (EC) will initiate the changes
      associated with atresia or ovulatory failure at all stages of follicular development and that
      the image attributes associated with atresia will be similar regardless of the diameter of
      the dominant follicle when ovarian suppression is initiated. Second, changes associated with
      atresia may be observed, but ovulation of the dominant follicle is unimpeded.
    

Detailed description: 
      This study is a single-center, randomized, open-label, double-controlled protocol to study
      the pattern of ovarian follicular growth and regression in two groups of women. The first
      group will use Plan B, which is a progesterone only OC containing 0.75 levonorgestrel. The
      second group of women will use the Yuzpe regimen, which uses 50 mg ethinyl estradiol/0.5 mg
      levonorgestrel pills at different stages of the menstrual follicular cycle.
    

Intervention name(s): 0.75 levonorgestrel; 50 mg ethinyl estradiol/0.5 mg levonorgestrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: emergency contraception; follicle; ovulation; blood pressure; Fertility Control; Inhibition of fertilization