bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is for men who have prostate cancer that has spread outside of the prostate gland
      and is no longer responding to hormone removal therapy. This study is designed to determine
      if a new drug combination will help to control the cancer. The medicines being used,
      docetaxel and diethylstilbestrol (DES), have been given to patients with prostate cancer and
      each drug has demonstrated activity in prostate cancer, either used alone or in other
      combinations. The objective of this study is to determine the effect of this drug combination
      on the prostate cancer and its response to disease progression.
    

Detailed description: 
      This is a single arm phase II trial of docetaxel and diethylstilbestrol for patients with
      symptomatic stage D3 androgen independent prostate cancer. Patients will receive docetaxel
      weekly for 10 cycles (each cycle consists of treatment for 3 weeks out of every 4) and DES
      daily for 40 weeks or until there is evidence of disease progression, whichever occurs first.
      Patients will be followed to determine PSA and objective response. Additional endpoints
      include time to progression, disease specific survival and overall survival. Disease
      progression will be defined as 2 consecutive increases in PSA and/or tumor growth as
      evidenced by examination or radiologic evaluation. Other secondary objectives will be to
      determine the toxicity, and impact on quality of life of this regimen.
    

Intervention name(s): Docetaxel and Diethylstilbestrol (DES)
Intervention type(s): Drug
Intervention description(s): Subjects receive docetaxel 36 Mg/m2weekly for ten cycles (3 weeks out of every 4) and DES 1 mg daily for 40 weeks or until there is evidence of disease progression, whichever occurs first.
Intervention MeSH terms: Docetaxel; Fosfestrol; Diethylstilbestrol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer; Hormone refractory prostate cancer; Metastatic prostate cancer
Sun Protection Factor Assay (338/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987521; SPF Control
Intervention type(s): Drug; Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code: Z11-004); Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      Children with Down syndrome often present with problems of posture & balance and mobility.
      Balance training is an important component of physical activity interventions, with growing
      evidence that it can be beneficial for children with DS.

      Objective: To determine the effect core stability exercises and balance training in postural
      control among Down syndrome.
    

Detailed description: 
      This study was a randomized clinical trail. Children with Down Syndrome were determined on
      inclusion & exclusion criteria. Children with Down syndrome were arbitrarily allocated into
      two groups with ages ranged from 5 to 17 years. The sample size was 20 patients. They were
      assigned randomly into two groups. Group 1 received balance training and Group 2 received
      core stability exercises. The duration of treatment was 6 weeks. Data is collected from
      Comprehensive Rehabilitation center Chakwal Postural stability was evaluated pre and post
      treatment by pediatric berg balance scale. Values which were obtained after this intervention
      were analyzed for any change using SPSS
    

Intervention name(s): BALANCE TRAINING; CORE STABILITY EXERCISES
Intervention type(s): Other; Other
Intervention description(s): Trunk, head, and upper limbs rotation from kneeling. 2- Upper limbs flexion and extension with simultaneous head movement from kneeling. 3-Pelvic bridging followed by raising one lower limb and extending knee. 4-Lifting opposite upper and lower limbs from Quadruped position. 6-Heel and toe raises, alternate rising of he right and left feet above the floor, and tandem standing. 7-Weight shifting forward. backward, sideward, and diagonally with eyes opened and eyes closed; Abdominal bracing while lying in supine position.
Abdominal bracing with heel slide while lying in supine position.
Abdominal bracing with Leg lifts while lying in supine position.
Abdominal bracing with bridging while lying in supine position.
Abdominal bracing while Standing.-Abdominal bracing while walking.
7-Quadra pod arm lifts with bracings while Quadra pod position. 8-Quadra pod alternate arm and leg lifts with bracing while Quadra pod position. 9-Side plank with knee flexion while side lying. 10-Side plank with knee extension while side lying
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Down syndrome; Core stability; Postural Control; Pediatric Berg balance scale
Clinical Study of UTD1 Injection in Combination With Capecitabine in Patients With Advanced and Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether UTD1 Injection in combination with
      capecitabine is effective in the treatment of advanced metastatic breast cancer using
      capecitabine as a control.
    


Intervention name(s): UTD1 Injection plus capecitabine; Capecitabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, non-comparative, Phase 3 study to evaluate the degree, frequency of
      response and safety of Kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years
      who have phenylketonuria and with elevated blood phenylalanine level of greater than or equal
      to 450 micromole per liter.
    


Intervention name(s): Kuvan®
Intervention type(s): Drug
Intervention description(s): Kuvan® (sapropterin dihydrochloride) will be administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment will be continued at the same dose for further 6 weeks.
Other intervention name(s): Sapropterin dihydrochloride; 6R-BH4 tetrahydrobiopterin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EMR 700733_510, Genetic disorder, Phenylketonuria, phenylalanine, Kuvan, sapropterin dihydrochloride
Different Doses of Vitamin A and Childhood Morbidity and Mortality
Condition: Mortality; Morbidity
Study type: Interventional
Phase: Phase 4

Summary: 
      Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio
      vaccine in national campaigns. However, it is not clear which dose is optimal. The two
      studies that have investigated the impact of different doses of vitamin A have both found
      that a smaller dose was better than a large dose. We therefore investigated if a smaller dose
      given with oral polio vaccine gives equal or better effect.
    

Detailed description: 
      Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality
      with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The
      currently recommended doses to be administered every 3-6 months are 100,000 IU for infants
      between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no
      clear evidence that a large dose is better than a small dose, the tendency being the opposite
      in the two studies of different doses of VAS that have been published so far.

      With the global effort to eradicate polio, national immunization days with oral polio vaccine
      (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV
      and VAS campaign took place in November 2002. Given the uncertainty about the best dose of
      VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half
      this dose gives a better protection against childhood morbidity and mortality.
    

Intervention name(s): Vitamin A
Intervention type(s): Drug
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vitamin A; Mortality; Morbidity; Doses; OPV
Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
Condition: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS); Human Immunodeficiency Virus Infections
MeSH terms: Virus Diseases; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is a Phase 2/3, multicenter, double-blind, randomized, parallel-group,
      placebo-controlled, dose-finding trial of Serostim® (mammalian cell-derived recombinant human
      growth hormone, r-hGH) versus placebo in subjects with human immunodeficiency
      virus-associated adipose tissue redistribution syndrome (HARS).

      The primary study objective is to determine whether Serostim® treatment reduces adipose
      tissue maldistribution more effectively than placebo. The primary co-endpoints are derived
      from measures of visceral adipose tissue assessed by computerized tomography (CT) and the
      ratio of trunk; and limb fat assessed by dual-energy X-Ray absorptiometry (DXA) scans.
      Anthropometric measures, physical exams, quality of life assessments, serial photographs, and
      various laboratory measures will be used to address secondary objectives. These secondary
      objectives relate to the impact of Serostim® on Physician and subject assessments of change
      in body shape, health-related quality of life, attitude towards medication compliance,
      metabolic markers, fat redistribution, and safety.

      On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive daily Serostim®,
      Serostim® and placebo given on alternate days, or daily placebo. Serostim® doses will be
      based on body weight, with a maximum dose of 4 milligram (mg).

      Therapy will continue for 12 weeks. Treatment will then be altered and the new treatment will
      be continued through Week 24. Interim Study Visits will be required at Weeks 2 and 4
      (Treatment Period 1) and at Weeks 14 and 16 (Treatment Period 2). Subjects will be offered to
      be enrolled into a maintenance Protocol (Study 23056) at Week 24.
    


Intervention name(s): Serostim®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Serostim® will be administered subcutaneously (daily or given on alternate days with matched placebo), at a dose based on body weight measured at Baseline, with a maximum daily dose of 4 mg up to Week 24.; Matching placebo will be administered subcutaneously (daily or given on alternate days with Serostim®), up to Week 24.
Other intervention name(s): Recombinant human growth hormone (r-hGH)
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS); Human Immunodeficiency Virus Infections; recombinant human growth hormone (r-hGH); Serostim®; Placebo
Probiotic Beer to Enhance Gut Health and Immune System Function
Condition: Inflammation; Nutrition, Healthy
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study investigates the immunological and gut microbiome effects of moderate probiotic
      beer consumption.
    

Detailed description: 
      Studies have shown that moderate alcohol consumption and probiotics have each shown
      immunomodulatory anti-inflammatory effects. However, to our knowledge, the effect of adding a
      probiotic strain to a beer drink, together with moderate alcohol consumption, on immunity and
      gut microbiome has yet to be studied. The probiotic beer used in this study taps on this
      unexplored research area and may potentially serve as a more healthful option to consumers
      than normal beer in the future, given the vast popularity of this beverage and probiotics.
    

Intervention name(s): Moderate probiotic beer consumption; Moderate normal beer consumption
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of one can of probiotic beer per day for 14 days. Blood and fecal samples will be collected at the start and end of the intervention to analyse for immunological biomarkers and gut microbiome.; Consumption of one can of normal beer per day for 14 days. Blood and fecal samples will be collected at the start and end of the intervention to analyse for immunological biomarkers and gut microbiome.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The experimental design used in this study is a randomised, controlled, within-subject cross-over design. Each individual will undergo a 2-week intervention each of moderate beer consumption and moderate probiotic beer consumption, with a 1-week period of washout in between. The total study duration will be 5 weeks.
Masking: Single (Participant)
Primary purpose: Prevention
General Risk Factors and Inflammatory Determinants in Older Patients With Asthma
Condition: Asthma; Late-Onset Asthma; Childhood Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      A cross-sectional study in asthma patients to determine if a late age of onset asthma (start
      symptoms >18 years old), is associated with more persistent airway/systemic inflammation,
      worse asthma control, more co-morbidity, a different microbiome and poorer quality of life
      despite the use of optimized asthma therapy.
    

Detailed description: 
      For ages, asthma has been considered a disease for children and young adults. However,
      nowadays 30% of all asthma patients is over 50 years old. Asthma in the elderly is generally
      more severe and approximately 50% of all deaths drom asthma occur in this age group. With
      rapid aging of the global population, the burden of asthma in the elderly will further
      increase.

      Asthma is a heterogeneous disease and the question is whether asthma in the elderly can be
      considered the same disease as asthma in children and young adults. The pathophysiology and
      risk factors of asthma in the elderly are still not completely understood. Good
      characterization of asthma in the elderly requires clinical phenotyping as well as a thorough
      analysis of the underlying cellular and molecular mechanisms. It is hypothesized that in
      older asthma patients, a late age of onset (start asthma symptoms >18 years) is associated
      with more persistent airway/systemic inflammation, worse asthma control, more co-morbidity
      and poorer quality of life despite the use of optimized asthma therapy.
    

Intervention name(s): Sputum induction; Blood sample
Intervention type(s): Procedure; Procedure
Intervention description(s): Sputum induction according to the ERS protocol; A blood sample of 100ml will be taken.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The aim is to enrol 30 patients with early onset asthma (age of onset < 18 years) and 30
        patients with late onset asthma (age of onset > 18 years); all with a smoking history of <
        10 PY. Both groups consist of 15 older asthma patients (> 50 years) and 15 younger asthma
        patients (< 50 years); per age group 15 healthy controls serve as comparison (no asthma).
        Asthma diagnosis is based on presence of typical clinical symptoms, reversible airway
        obstruction (+12% improvement in FEV1 after bronchodilator) or bronchial hyperreactivity
        (PC20 < 8 mg/ml) or a FeNO > 50 ppb. All asthma patients have GINA step 4-5 medication
        (high dose ICS/LABA) and are not adequately controlled (ACQ > 0,75)
      
Biospecimen description: 
      sputum, blood, NP swab, feces
    
Keywords: asthma; age of onset; inflammation; comorbidity; microbiome
The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria
Condition: Chronic Kidney Disease; Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of the study is to compare the effects of three different types of RAAS
      blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.
    

Detailed description: 
      Pharmacological blockade of the renin-angiotensin-aldosterone system (RAAS) is the main
      target of therapy to reduces both proteinuria and the rate of decline of the glomerular
      filtration rate in non-diabetic chronic renal diseases. Despite recent progress, however,
      there is still no optimal therapy that can stop the progression of these nephropathies.
      Therefore, it is necessary to optimize such treatment for further improving renal outcome.

      The aim of the present study was to compare the effects of three different types of RAAS
      blockade: (1) mineralocorticoid receptor blocker (MRB) + angiotensin receptor antagonist
      (ARA); (2) direct renin inhibitor (DRI) + ARA and (3) double maximal dose of ARA on 24 hours
      proteinuria in patients with non-diabetic chronic kidney disease
    

Intervention name(s): aliskiren, eplerenon, telmisartan
Intervention type(s): Drug
Intervention description(s): aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: aliskiren; eplerenon; telmisartan; direct renin inhibitor; ACE inhibitor; mineralocorticoid inhibitor; proteinuria; chronic kidney diseases; renin-angiotensin-aldosterone system
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
Condition: Stable Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in
      Adults With Stable Coronary Heart Disease.
    

Detailed description: 
      A Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the
      Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Participants with Stable
      Coronary Heart Disease.
    

Intervention name(s): MEDI5884; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.; Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary heart disease; Pharmacokinetic; Pharmacodynamics
Intermittent Theta Burst Stimulation After Acute Stroke
Condition: Ischemic Stroke,
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This pilot sham-controlled study aims to determine the safety and efficacy of repetitive
      transcranial magnetic stimulation given as a facilitatory intermittent theta burst
      stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute
      stroke patients.
    

Detailed description: 
      The patients with first-ever, MRI-confirmed monohemispheric ischemic stroke in the middle
      cerebral artery territory, and NIH Stroke Scale motor arm score 1-2 with recordable active
      motor thresholds (aMT) of the extensor carpi radialis (ECR) between 2-4 weeks after the
      stroke onset, are randomized into two groups to receive either iTBS1200 or sham stimulation
      over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks. All have standardized
      medical and intensive rehabilitation treatments. The outcome measures included Action
      Research Arm test (ARAT), Fugl-Meyer test (FMT), aMT and motor evoked potentials (MEPs) of
      ECR.
    

Intervention name(s): Intermittent theta burst stimulation
Intervention type(s): Device
Intervention description(s): Intermittent theta burst stimulation with 1200 pulses or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: theta burst stimulation, stroke, motor, plasticity
Computer Modeling With Reconstruction of Maxillofacial Skeleton
Condition: Maxillofacial Injury
MeSH terms: Maxillofacial Injuries
Study type: Observational

Summary: 
      Investigator initial study to evaluate the use of preoperative computer modeling and the
      intraoperative navigation to guide reconstruction of the maxillofacial skeleton.
    

Detailed description: 
      The concept of open reduction and internal fixation of facial fractures is well accepted.
      However, there are situations in which an accurate reduction and restoration of facial
      symmetry is challenging. In these more difficult cases, the PI uses computer aided
      design/modeling software as well as intra-operative computer aided surgical navigation
      systems to assist with repair of these complex injuries. A retrospective review of these
      cases has not previously been performed.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        UCDMC Patients with specific complex fractures
      
Keywords: computer aided design; maxillofacial fracture; orbital design