bioihbjkbjnl/mcl2 huggingface dataset:
Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor
      to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation
      directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

      PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when
      given with or without external-beam radiation therapy and to see how well it works in
      treating patients with localized prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the tolerability of 2 radiotherapeutic regimens (high dose-rate brachytherapy
           [HDR] with or without image-guided intensity-modulated hypofractionated external beam
           radiotherapy [EBRT]), as measured by the Common Terminology Criteria for Adverse Events
           (CTCAE v3.0), in patients with localized prostate cancer.

      Secondary

        -  Identify any associations between dose-volume parameters for organs at risk and the rate
           and severity of genitourinary or gastrointestinal adverse events.

        -  Evaluate patient preference with regard to selection of a second treatment (a second HDR
           brachytherapy session or an EBRT session).

        -  Evaluate patient-reported health-related quality of life (HRQOL) as measured by
           validated HRQOL instruments for 5 years.

        -  Describe the probability of freedom from biochemical and clinical failure.

        -  Describe the probability of freedom from salvage androgen suppression.

      OUTLINE: Patients undergo high dose-rate (HDR) brachytherapy (2 fractions ≥ 5 hours apart).
      Beginning 2-4 weeks after completion of the first HDR brachytherapy session, patients undergo
      either a second session of HDR brachytherapy (2 fractions ≥ 5 hours apart) OR image-guided
      intensity-modulated hypofractionated external beam radiotherapy once daily 5 days a week for
      3 weeks.

      Quality of life is assessed at baseline, prior to the second treatment session, at 1 and 6
      months after completion of treatment, every 6 months for 3 years, and then annually for 2
      years.

      After completion of study treatment, patients are followed at 1 and 6 months, every 6 months
      for 3 years, and then annually for 2 years.
    

Intervention name(s): brachytherapy; hypofractionated radiation therapy; image-guided radiation therapy; intensity-modulated radiation therapy
Intervention type(s): Radiation; Radiation; Radiation; Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I prostate cancer; stage II prostate cancer; adenocarcinoma of the prostate
Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation
Condition: Transplantation for Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF
      stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for
      Haematologic Malignancies.
    


Intervention name(s): G-PB Transplant; G-BM Transplant
Intervention type(s): Procedure; Procedure
Intervention description(s): G-PB Transplant; G-BM Transplant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
Condition: Autosomal Dominant Polycystic Kidney; ADPKD
MeSH terms: Arthrogryposis; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50
      milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney
      disease (ADPKD).
    

Detailed description: 
      Safety and efficacy of 50 mg tesevatinib in comparison to placebo in participants with ADPKD
      was assessed.

      The primary purpose of this study was focused on evaluating the change from Baseline in
      height-adjusted total kidney volume (htTKV) as measured by magnetic resonance imaging (MRI)
      at Months 12, 18, and 24, and 30 days post-dose in participants with ADPKD treated with
      tesevatinib or placebo.

      If eligible for the study participation, participants were randomly assigned to either
      investigational treatment group or placebo group. Treatment group received 50 mg tesevatinib
      once daily for 24 months and control group received the placebo once daily for 24 months.
    

Intervention name(s): Tesevatinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Tablet; Route of administration: orally; Pharmaceutical form: Tablet (identical to tesevatinib); Route of administration: orally
Other intervention name(s): KD019
Intervention MeSH terms: XL647
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADPKD; Autosomal Dominant Polycystic Kidney Disease; Polycystic Kidney; Tesevatinib; Polycystic Kidney Disease; PKD
Oral Paracetamol as Preemptive Analgesia for Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      It is a double blinded randomized control trial assessing the use of Oral paracetamol in
      managing the intrapartum pain.
    

Detailed description: 
      It is a double blinded randomized control trial comparing the use of Oral paracetamol to
      placebo in managing the intrapartum pain.
    

Intervention name(s): paracetamol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg oral tablet
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Food Intake and Appetite in the Children of Mothers With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This protocol is for study of the effect of inhibition of parasympathetic outflow on insulin
      secretion and glucose metabolism. Insulin secretion will be measured during infusions of
      escalating doses of atropine. Other clinical parameters of parasympathetic inhibition by
      atropine will also be assessed.
    

Detailed description: 
      Children of mothers who had diabetes during pregnancy are at an increased risk of diabetes
      and obesity in later life, effects partly mediated by the early environment experienced by
      the offspring of diabetic mothers in utero. In this protocol, we address why intra-uterine
      exposure to maternal diabetes might lead to later childhood obesity. Previous studies of
      children of diabetic mothers have not detected any alteration in energy expenditure, either
      as resting metabolic rate or physical activity. We will now examine whether they are at an
      increased risk of obesity due to differences in food intake. We will assess composition of
      the diet, patterns of eating, taste preference and physiological responses to a mixed meal.
      No previous work in human subjects has addressed these issues.
    

Keywords: Obesity; Etiology; Macronutrient Selection; Taste Preference; Mixed Meal Test
Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects
Condition: Healthy Male
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to assess safety, tolerability, and pharmacokinetics of
      Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects
    


Intervention name(s): Aldafermin
Intervention type(s): Biological
Intervention description(s): Single dose of aldafermin
Other intervention name(s): NGM282
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.
Condition: Breast Surgery
Study type: Interventional

Summary: 
      Pectoral nerve block (PECS) has been used for post-operative pain relief in patients
      undergoing breast surgery. It has been shown that adenosine has an effect on pain modulation.
      Magnesium sulphate has been used as an adjuvant to local anaesthetics in many nerve block
      techniques. We hypothesised that adenosine may affect the PECS block quality. We aimed to
      compare the effect of adding adenosine to the local anaesthetic and compare its effect to
      magnesium sulphate when used for PECS block.
    

Detailed description: 
      The present study was conducted on 90 adult patients aged between 20 and 65 years old.
      Patients scheduled for modified radical mastectomy with axillary clearance surgery American
      Society of Anaesthetist (ASA) classes I, II, and III patients were included in the study.

      Patients were randomly allocated into on of three groups according to the adjuvant used with
      the local anaesthetic, 30 patients in each group using a computerised program. All patients
      received PECS block. Group (C) received PECS block with 0.25% bupivacaine (control group),
      group (A) bupivacaine with added adenosine, and group (M) bupivacaine with added magnesium
      sulphate.

      The local anaesthetic syringes were prepared by an independent anaesthetist. The researchers
      and the patients were blinded to the local anaesthetic adjuvant in the syringes. All patients
      received 30 ml local anaesthetic for PECS. The 30 ml local anaesthetic used for each patient
      contained bupivacaine hydrochloride 0.25%, bupivacaine hydrochloride 0.25% and 12 mg
      adenosine, and bupivacaine hydrochloride 0.25% and 500 mg magnesium sulphate for groups C, A,
      and M respectively.

      Patients' demographic data were collected including age, BMI, ASA, and duration of surgery.
      In the post- anesthetic care unit (PACU) the visual analogue score (VAS) was assessed on
      arrival and then every 15 minutes. The duration and the quality of the block was recorded.
    

Intervention name(s): Bupivacaine 0.25%; Adenosine 12mg; Magnesium Sulphate 500 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bupivacaine 0.25% for PECS block; Adenosine 12 mg for PECS block; Magnesium sulphate 500 mg for PECS block
Other intervention name(s): Control group; Adenosine; Magnesium sulphate
Intervention MeSH terms: Magnesium Sulfate; Adenosine; Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Pectoral nerve block; Adenosine; Magnesium sulphate
pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for
      this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical
      Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a
      1-hour brain scan for both patients and controls. In the first 6 months of the study,
      investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement
      and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air
      and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI,
      pH-weighted imaging will be validated for its robustness and reproducibility.
    

Detailed description: 
      The contrast agent (Gd-DTPA, Gadavist) will be injected intravenously (IV) in the arm
      (patients only). The IV will be inserted by qualified medical professional at CBI. This
      contrast agent will be standard dose in accordance with its FDA approved labeling and dosing.
      Controls will NOT be administered the contrast agent.
    

Intervention name(s): MRI Scan
Intervention type(s): Other
Intervention description(s): MRI scans will consist of a 1-hour brain scan for both patients and controls.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapse-remitting multiple sclerosis from NYU Langone Health and age-matched
        healthy volunteers recruiting using previous database of volunteers
Effect of Dietary Polyphenols on Insulin Sensitivity
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      A large and growing segment of the population is prediabetic. Dietary interventions that
      improve insulin sensitivity may be important in preventing the progression to full-blown
      diabetes in these individuals. Foods and dietary compounds that increase insulin sensitivity
      are likely to help maintain a healthier body composition. This pilot study will provide data
      to evaluate the role of dietary plant polyphenols in improving insulin sensitivity.
    

Detailed description: 
      How does the amount consumed of cocoa and tea polyphenols (flavon-3-ol monomers and
      oligomers) affect insulin sensitivity in insulin resistant individuals?
    

Intervention name(s): Polyphenols (flavon-3-ol monomers and oligomers)
Intervention type(s): Other
Intervention description(s): Flavanols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Migraine and Body Composition
Condition: Migraine With and Without Aura; Chronic Migraine; Healthy Controls
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      This research is being done to look at the association between migraine and obesity.
    

Detailed description: 
      Research into the role of inflammatory markers and other obesity related proteins and
      chemicals may help us understand migraine and lead to new treatment.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Premenopausal Caucasian women ages 18-55 years with or without migraine.
      
Biospecimen description: 
      serum
    
Keywords: migraine; episodic migraine; chronic migraine; obesity; non-obese
Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism
Condition: Primary Hyperparathyroidism
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Primary
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate whether blocking the mineralocorticoid receptor, alone, or in
      combination with the calcimimetic cinacalcet, can lower parathyroid hormone and calcium
      levels in primary hyperparathyroidism.
    

Detailed description: 
      To conduct a double-blinded, placebo-controlled, randomized intervention study to investigate
      whether mineralocorticoid receptor (MR) antagonism, alone or in combination with cinacalcet,
      is an effective therapy for primary hyperparathyroidism (P-HPTH).

      Hypothesis: MR antagonism, as a monotherapy or in combination with a calcimimetic, is a
      mechanism to lower parathyroid hormone (PTH) in primary hyperparathyroidism (P-HPTH).

      Study Design: Sixty subjects with P-HPTH will be enrolled to randomly receive eplerenone (a
      potassium-sparing diuretic that directly blocks the MR), amiloride (a potassium-sparing
      diuretic that does not directly block the MR), or placebo for 4 weeks. Thereafter, all
      subjects will receive cinacalcet therapy (a calcimimetic that lowers PTH) in addition to
      their randomized intervention for an additional 2 weeks.

      Anticipated Results: In this proof-of-concept study, eplerenone therapy will lower PTH, serum
      calcium, and markers of bone resorption in P-HPTH, when compared to placebo. The PTH response
      to amiloride will resemble that of placebo, suggesting that the eplerenone mediated
      reductions in PTH are specific to interactions with the MR. Combination therapy with
      eplerenone + cinacalcet will result in additive or synergistic reductions in PTH, when
      compared to placebo + cinacalcet or placebo + amiloride.

      Implications: MR antagonism (alone or in combination with cinacalcet) may be a mechanism to
      lower PTH and calcium in P-HPTH, thereby identifying a new potential option in the limited
      medical therapies for P-HPTH.
    

Intervention name(s): eplerenone; amiloride; Placebo; Cinacalcet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): eplerenone, titrated up to a maximum of 50mg BID; amiloride, titrated up to a maximum of 10mg BID; Cinacalcet, as add-on therapy in addition to eplerenone/amiloride/placebo, titrated up to a maximum of 30mg BID
Intervention MeSH terms: Eplerenone; Amiloride; Cinacalcet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3-parallel-armed double-blinded randomized controlled trial wherein monotherapy of eplerenone or amiloride or placebo administered for 4 weeks. After weeks, an open-label extension addition of cinacalcet to all 3 arms conducted for 2 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of
      single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the
      efficacy and safety using an Environmental challenge chamber in male subjects with seasonal
      allergic rhinitis
    


Intervention name(s): GSK835726 (10mg); GSK835726 (50mg); GSK835726 (100mg); Cetirizine (10mg); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): GSK835726 (10mg) tablet; GSK835726 (50mg) tablet; GSK835726 (100mg) tablet; Cetirizine (10mg) tablet as positive control; Placebo to match active
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Proof-of-Concept; Allergic Rhinitis
Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
Condition: Health
Study type: Interventional
Phase: Phase 2

Summary: 
      The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though
      acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the
      phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the
      objectives of this study are to assess if tolterodine affects the speed at which food travels
      through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in
      healthy subjects.
    

Detailed description: 
      The specific aims of this study are to test the hypotheses that the non-specific muscarinic
      antagonist tolterodine will not:- i) delay colonic transit and the proximal colonic emptying
      rate; ii) delay gastric emptying; nor iii) delay small intestinal transit compared to placebo
      in healthy subjects.
    

Intervention name(s): Tolterodine
Intervention type(s): Drug
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Vitamin D and Arterial Stiffness in Elderly
Condition: Vitamin D Deficiency; Arterial Stiffness
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigators will examine arterial stiffness and pulse waveform analysis. Subjects with
      vitamin D insufficiency will be recruited. A double blind randomized controlled study will
      examine the effects of standard dose vitamin D3 (800 IU) versus higher dose vitamin D3 (5000
      IU)-given on a daily basis.In order to understand mechanisms of action by which vitamin D
      would improve arterial stiffness investigators will use biomarkers. Oxidative and
      inflammatory stress will be measured by plasma F2-isoprostanes and Sulforaphane levels.
    

Detailed description: 
      Cardiovascular disease disproportionately impacts the elderly. Current practice targets
      vascular disease with aggressive lipid lowering combined with brachial BP regulation, but has
      only achieved a modest degree of success. There is a need to intervene at a much earlier
      stage. Increased arterial stiffness is a marker for subclinical vascular disease and a
      sensitive predictor of ischemic stroke in the elderly. Vitamin D deficiency is linked to an
      increased risk of vascular disease.

      There is an urgent need for well controlled randomized interventional studies in healthy
      elderly individuals demonstrating that vitamin D levels can improve vascular function in
      healthy elderly with vitamin D insufficiency. High dose vitamin D (5000 IU) replacement is
      required to improve systemic inflammation which may contribute to arterial stiffness and
      vascular aging.

      The hypothesis is that daily 5000 IU vitamin D3 will regress or at least prevent progression
      of arterial stiffness as assessed by the carotid-femoral pulse wave velocity. Furthermore,
      investigators postulate that this improvement will be linked to improved oxidative and
      inflammatory status. Investigators will measure plasma measurements of Sulforaphane and
      plasma F2-isoprostane to assess the anti-oxidative mechanisms by which vitamin D could
      influence arterial stiffness.
    

Intervention name(s): Low dose vitamin D3; High dose vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Low dose arm-800 IU given daily; High dose arm-5000 IU given daily
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a double blind manner. Arterial stiffness and oxidative stress markers will be evaluated in the low dose Vitamin D (800 IU) versus a high dose vitamin D (5000 IU) over a period of a year
Masking: Double (Participant, Investigator)
Primary purpose: Treatment