bioihbjkbjnl/mcl2 huggingface dataset:
The Scleroderma Biorepository and Pathogenesis Study (STOP Scleroderma)
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Observational

Summary: 
      The Scleroderma bioreposiTOry and Pathogenesis Study (STOP Scleroderma) will help researchers
      use clinical data and human biospecimens to investigate why scleroderma patients develop
      certain complications from their disease. Patients with confirmed scleroderma, raynauds or
      positive autoantibodies are invited to participate. This research may help us understand how
      to prevent and treat scleroderma and other diseases.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with scleroderma, raynauds, or with positive autoantibodies
      
Keywords: scleroderma; biorepository
Effects of Mucoprotective Product on Xerostomia
Condition: Xerostomia
MeSH terms: Xerostomia
Study type: Interventional
Phase: Phase 4

Summary: 
      In the present study with a randomized, cross-over, blind, placebo controlled design, the
      effects of a salivary substitute product and a new mucoprotective product with similar
      mechanisms of action but with different composition and characteristics will be evaluated in
      cancer patients suffering from xerostomia.
    


Intervention name(s): XER2020
Intervention type(s): Other
Intervention description(s): mucoprotective product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: xerostomia, saliva, mucoprotection, oral health
Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Condition: MDS; Myelodysplastic Syndromes; Thrombocytopenia
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Thrombocytopenia; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The Data Monitoring Committee (DMC) for study 20060198 recommended that all subjects
      discontinue treatment of study drug and continue to be followed for long term follow-up.
      Amgen adopted the DMC recommendation.
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, double blind, placebo controlled study designed
      to assess the efficacy and safety of romiplostim (formerly, AMG 531) treatment in
      thrombocytopenic MDS patients. The study is composed of a 26-week placebo controlled test
      treatment period (romiplostim versus Placebo), a 4 week interim wash-out period, a 24-week
      placebo controlled extended treatment period, and a 4-week follow-up period followed by an
      End of Study (EOS) visit. During the interim wash-out period, a bone marrow biopsy will be
      performed in the absence of growth factor to assess changes in the marrow. In the extended
      treatment period, safety assessments will continue and participants will be allowed to
      receive any standard of care treatments for MDS. Patients will be followed for survival for
      an additional 60 months following the End of Study (EOS) visit.
    

Intervention name(s): Placebo; Romiplostim
Intervention type(s): Drug; Biological
Intervention description(s): Placebo is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.; Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: MDS; Low Risk MDS; Intermediate-1 Risk MDS; Thrombocytopenia
Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux
Condition: Gastroesophageal Reflux; Obesity
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of
      choice for patients suffering of gastro-esophageal reflux (GER). However, long term
      instrumental evaluations of GER after LRYGB are not available.

      The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric
      Bypass (LRYGB) on gastro-esophageal function.
    

Detailed description: 
      Consecutive morbidly obese patients selected for LRYGB were included in a prospective study.
      The investigators performed clinical evaluation with GERD-HRQoL and GIS questionnaire, upper
      endoscopy, esophageal manometry and 24h-impedance pH monitoring (24h-MII-pH) preoperatively
      and at 12 and 60 months after surgery. Patients were divided into 2 groups according to the
      presence of GER at preoperative 24h-MII-pH.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive morbidly obese patients selected for LRYGB
      
Keywords: Gastroesophageal reflux; Obesity; Esophageal manometry; 24 H impedance pH-monitoring; Laparoscopic Roux-en-Y Gastric Bypass
Contraceptives Containing Drospirenone and Blood Pressure
Condition: Blood Pressure; Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP);
      however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This
      study has the objective to assess possible differences in BP associated with the use of COCs
      containing DRSP with different doses of ethinylestradiol.

      Materials and methods: This open-label parallel-group randomized clinical trial involved
      women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime,
      nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the
      beginning of the trial and six months after drug therapy.
    


Intervention name(s): 30EE+DRSP; 20EE+DRSP
Intervention type(s): Drug; Drug
Intervention description(s): Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months; Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months
Intervention MeSH terms: Drospirenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Ambulatory Blood Pressure Monitoring; Drospirenone; Oral contraceptive
The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
Condition: Cerebral Palsy (CP)
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is a group of disorders of the development of movement and posture but
      often changing motor impairment syndromes. The spastic subtypes are the most common
      manifestations of cerebral palsy who perform movement difficultly due to hypertonia. Decease
      of spinal cord pathway, hyperactivity of alpha and gamma motoneuron and reduction of
      presynaptic inhibition may cause tendon reflex increase and hypertonia in individuals with
      CP. There are many ways to improve the hypertonia. In the past studies, the fast repeated
      range of motion could reduce muscle's activation effectively. The polyarticular movement
      training might increase joint range of motion and reduce the muscle activation. But the
      polyarticular movement training is difficulty for some individuals with CP. The single joint
      movement training may achieve the same effect as the polyarticular movement training. The
      purpose of this study was to investigate the effects of continuation passive range of motion
      (CPM) training whether could get the improvement of soleus hypertonia in individuals with CP.
    


Intervention name(s): Ankle continuous passive motion machine.
Intervention type(s): Procedure
Intervention description(s): A rehabilitation program of machine driven passive stretch.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; Continuous passive motion; Hypertonia
Neurodevelopmental Therapy for Spastic Cerebral Palsy
Condition: Cerebral Palsy; Spastic; Diplegia, Spastic
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This study was conducted to find out the Effects of Neurodevelopment therapy (a
      rehabilitative program designed by Bobath) on Gross Motor Function and Postural Control in
      Children with Spastic Cerebral Palsy. To investigate either there was a significant
      difference between the effects of neurodevelopment therapy and routine physical therapy on
      gross motor function and postural control in children with Spastic Cerebral Palsy.
    

Detailed description: 
      A randomized controlled trial was conducted at Department of pediatric rehabilitation, Sher e
      Rabbani Hospital, Sheikhupura. Sample size was 66 and purposive sampling technique was
      adopted to collect data. Sample selection was completely based on inclusion and exclusion
      criteria. A diagnosed Spastic Cerebral Palsy patient aged 2-6 years with no other severe
      abnormalities such as seizure were recruited. While patients with mental retardation or
      undergone medical procedures likely to affect motor function such as botulinum toxin
      injections, orthopedic remedial surgery were excluded. Data was collected at baseline, 4th,
      8th and 12th week of the treatment sessions. Gross motor function measure scale (GMFM-88) and
      posture and postural ability scale (PPAS) were used as data collection tools.
    

Intervention name(s): Neurodevelopmental therapy; Routine physical therapy
Intervention type(s): Other; Other
Intervention description(s): NDT is a hands-on, 'problem solving approach'. It is used in the management and treatment of children who have disorders of function, movement or postural control because of damage in their central nervous system.; stretching, passive range of motion, and active range of motion).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurodevelopmental therapy; NDT; Spastic cerebral palsy; Physical Therapy; Rehabilitation; Neurorehabilitation
Follow-up of Eating Disorder Patients From a 15-year Period.
Condition: Eating Disorder Symptoms
MeSH terms: Feeding and Eating Disorders
Study type: Observational

Summary: 
      Retrospective follow-up study of former eating disorder patients in child- and adolescent
      psychiatry on psychiatric symptoms and social intelligence.
    

Detailed description: 
      Former patients and their parents were contacted 3 to 15 years after their completed
      treatment for eating disorders at Levanger Hospital, Child and Adolescent Psychiatry
      Department, in the period from 1988 to 2002. Interviews focusing on general psychiatric
      symptom, specific eating disorder symptoms, social intelligence and consumer satisfaction.
      Parents were also contacted and interviewed on consumer satisfaction.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        former eating disorder patients
Immune Characterization of Subcutaneous Adipose Tissue
Condition: Determine Immune Cell Types in Subcutaneous Adipose Tissue
Study type: Observational

Summary: 
      The overall goal of this proposal is to characterize the immune cell profile of subcutaneous
      abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate
      potential associations between different adipose tissue immune cell types and metabolic
      profile.
    


Intervention name(s): Liposuction/lipectomy
Intervention type(s): Procedure
Intervention description(s): Subcutaneous adipose tissue will be obtained from liposuction/lipectomy to determine the types of immune cells
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        50 women already scheduled to undergo liposcution/lipectomy procedure for breast
        reconstruction associated with prophylactic mastectomy or mastectomy for in situ ductal
        breast corcinoma, cosmetic surgery, or abdominal lipectomy for severe obesity at either
        Barnes-Jewish Hospital or Barnes-Jewish West County Hospital. Subjects of all races and
        ethnicity, with a body mass index (BMI) greater than or equal to 18.5 kg/m² and between the
        ages of 18 and 65 years of age will be included in the study.
      
Biospecimen description: 
      Serum and plasma samples will be obtained Abdominal and thigh subcutaneous adipose tissue
      obtained during surgery
    
Keywords: Subcutaneous adipose tissue; Lipectomy
A Bioequivalence Study of TAK-536 Pediatric Formulation
Condition: Japanese Healthy Adult Males
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of a single oral dose of 2
      different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536
      commercial tablet in healthy Japanese adult male participants.
    

Detailed description: 
      This study was designed to evaluate the bioequivalence of a single oral dose of 2 different
      drug forms of TAK-536 pediatric formulation (dry syrup, granules) and a single oral dose of
      TAK-536 commercial tablet by using open-label, 2 × 2 crossover design.
    

Intervention name(s): TAK-536 Tablet; TAK-536 Dry Syrup Formulation; TAK-536 Ganule Formulation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-536 10 mg tablet; TAK-536 dry syrup formulation; TAK-536 granule formulation
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chocolate and CVD Risk in Postmenopausal Women
Condition: Cardiovascular Disease; Heart Disease; Stroke
MeSH terms: Stroke; Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      The investigators will conduct an epidemiological analysis of data from the Women's Health
      Initiative to investigate the prospective association between chocolate intake and the risk
      of heart disease and stroke.
    

Detailed description: 
      BACKGROUND: Three recent meta-analyses found significant prospective inverse associations
      between chocolate intake and cardiovascular disease risk. Evidence from these meta-analyses
      suggests that such inverse associations may only apply to elderly individuals or those with
      preexisting major chronic disease.

      OBJECTIVE: The investigators will assess the association between habitual chocolate intake
      and subsequent incident coronary heart disease (CHD) and stroke, and the potential effect of
      modification by age.

      DESIGN: The investigators will conduct multivariable Cox regression analyses using data from
      83,310 postmenopausal women free of baseline preexisting major chronic disease in the
      prospective Women's Health Initiative cohort. Chocolate intake was assessed using a food
      frequency questionnaire. Physician adjudicated events or deaths were ascertained up to
      September 30, 2013.
    

Intervention name(s): chocolate consumption level; physician diagnosis of first occurrence of serious chronic disease
Intervention type(s): Behavioral; Other
Intervention description(s): level of consumption of 1 oz. of chocolate, as assessed at baseline
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community residents
      
Keywords: Coronary heart disease; stroke; chocolate consumption; postmenopausal women; nutrition; dietary intake; epidemiology
Anesthesia for Pain After Ankle Fracture Surgery
Condition: Chronic Pain; Ankle Fracture Surgery; Regional Anesthesia
MeSH terms: Chronic Pain; Fractures, Bone; Ankle Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study will test the hypothesis that prolonged regional peripheral nerve block will
      reduce development of chronic pain in patients undergoing surgery for ankle fracture compared
      to standard of care. Subjects will be followed for one year.
    

Detailed description: 
      This pilot study will test the hypothesis that prolonged regional peripheral nerve block will
      reduce development of chronic pain in patients undergoing surgery for ankle fracture.
      Regional nerve block using local anesthetics delivered by ambulatory pump is used in some
      types of surgeries but is not routine for ankle fracture patients in our hospitals. Patients
      will be randomized to standard care (single shot peripheral nerve block prior to surgery) or
      experimental (the same single shot nerve block, followed by continuous popliteal nerve block
      with ropivacaine starting just after surgery). The primary outcome will be scores on a
      validated ankle/foot pain questionnaire that includes questions on function. Subjects will be
      followed for one year. Secondary outcome will be postoperative opioid use.
    

Intervention name(s): Ropivacaine; Nerve block
Intervention type(s): Drug; Procedure
Intervention description(s): Single injection of ropivacaine immediately prior to surgery.; insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
Other intervention name(s): Naropin; no other name
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease
Condition: Autoimmune Hepatitis
MeSH terms: Liver Diseases; Hepatitis, Autoimmune
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study evaluates the effect of erythropoietin on the number and function of regulatory T
      cells in adults with autoimmune hepatitis. Participants will receive a single dose of
      erythropoietin, and then the investigators will collect blood at different time points for
      analysis of regulatory T cell number and function.
    

Detailed description: 
      There is data from the laboratory that erythropoietin helps stimulate regulatory T cells, a
      type of immune cell which is thought to combat autoimmunity, but this study will look at
      whether it does the same thing in adults with autoimmune hepatitis.
    

Intervention name(s): Erythropoietin
Intervention type(s): Drug
Intervention description(s): Subcutaneous injection of erythropoietin 10,000 units
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Comparative Study Between Radius and Capitate Shortening in Ulna Minus Variance Kienbock's Disease
Condition: Avascular Necrosis of Lunate
MeSH terms: Osteonecrosis; Necrosis
Study type: Interventional

Summary: 
      1. Kienböck's disease refers to avascular necrosis of the lunate carpal bone, known as
           lunatomalacia. It was first recognized and described by Austrian radiologist Robert
           Kienböck's in 1910

        2. The lunate is the central bone in the proximal row, and it articulates with the
           scaphoid, capitate, triquetrum, and occasionally the hamate. More proximally, the lunate
           is a component of the radiocarpal joint, and it also articulates with the ulna via the
           triangular fibrocartilage complex (TFCC)

        3. The exact cause of Kienböck's is not known, though there are thought to be a number of
           factors predisposing a person to Kienböck's. Although there is no evidence that
           Kienböck's disease is inherited, it is possible that unidentified genetic factors could
           contribute to the development of the condition, It is multifactorial, related to the
           following variables:Ulnar negative variance (or ulna minus),Vascular supply to the
           lunate bone,Lunatemorphology,Radial inclination angle,multiple wrist trauma

        4. Kienböck's disease is the second most common type of avascular necrosis of the carpal
           bones, preceded only by avascular necrosis of the scaphoid. The typically affected
           population is males aged 20-40 years

        5. Patients usually present with unilateral pain over the dorsal aspect of the wrist,
           limited wrist motion, weakness, or a combination of the three. Wrist extension and axial
           loading exacerbate pain. Symptoms range from mild to debilitating. It is rarely
           bilateral, and trauma is often absent. Physical examination commonly reveals wrist
           swelling, tenderness over the expected location of the lunate, synovitis, and loss of
           grip strength

        6. Kienböck's disease is a clinical and imaging diagnosis. Both radiography/computed
           tomography and magnetic resonance imaging (MRI) are highly specific. However, MRI is the
           most sensitive and detects radiographically occult cases
    


Intervention name(s): Henry approach; volar approach; dorsal approach
Intervention type(s): Procedure; Procedure
Intervention description(s): Radial Shortening : Supine position, general anesthesia, volar approach, Henry approach, osteotomy 1 inch from radio-carpal joint surface, shortening 2.5 mm of distal shaft radius, fixation by small DCP or small T plate.; Capitate Shortening : Supine position, general anesthesia, dorsal approach, separation between 2nd and 3rd compartments of extensor tendons, osteotomy & shortening 2.5 mm of capitate, compression by Herpert screw.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment