bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study population will be 80 adult men who have been diagnosed with prostate cancer who
      are scheduled to have their prostate surgically removed at either the Medical University of
      South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men
      will be randomized into two groups: one group will take vitamin D3 supplementation and the
      other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of
      the study and again after two months, just prior to the surgical procedure (prostatectomy).
      Prostate tissue will be obtained from the surgical procedure and studied for the effect of
      vitamin D on the prostate cancer cells.
    

Detailed description: 
      This study will enroll 80 (40 per study arm) subjects (>18 years of age), recently diagnosed
      with prostate cancer (histologically documented adenocarcinoma of the prostate), who are
      scheduled to undergo prostatectomy.

      Eligible subjects will be recruited in the Urology Clinic at MUSC or Ralph H. Johnson VAMC.
      All subjects will be refered to the study by their Urologist. At the baseline visit, consent
      will be obtained before any study procedures are initiated. A blood sample will be obtained
      for 25(OH)D3 analysis. Subjects will be randomized to either the intervention group (vitamin
      D3 4000 IU daily) or the placebo group and take the study medication for approximately two
      months before their scheduled prostatectomy. The final study visit is the day of surgery. A
      blood sample for 25(OH)D3 analysis will be obtained. Prostate tissue will be collected from
      the Pathologist for (a) genomics (RNA sequencing) analysis; (b) proteomics (proteins, glycons
      and lipids) analysis and (c) Vitamin D Receptor (VDR) by immunohistochemistry.
    

Intervention name(s): cholecalciferol; placebo
Intervention type(s): Drug; Other
Intervention description(s): softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy).; softgel containing no active ingredient daily for approximately two months prior to surgery (prostatectomy).
Other intervention name(s): vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: prostate cancer; vitamin D
Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effect of arterial cannulation on the
      continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy
    


Intervention name(s): arterila cannulation on same arm; arterila cannulation on different arm
Intervention type(s): Other; Other
Intervention description(s): arterila cannulation on same arm receiving continous hemoglobin monitoring; arterila cannulation different arm receiving continous hemoglobin monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Relovair PD PK in Chinese Healthy Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, fluticasone furoate (FF) and vilanterol (VI) in different dose combinations
      (50/25mcg, 100/25mcg and 200/25mcg) will be administered from a single dry powder device to
      evaluate the PD, PK, safety and tolerability of the combination in healthy Chinese subjects.
      The information gathered will be used as a support of the clinical development program of the
      fixed dose combination of FF/VI inhalation powder in Chinese population.
    

Detailed description: 
      This is a single centre, double-blind, placebo-controlled, four-way cross over, randomized,
      single and repeat dose study. A total of 16 healthy subjects aged 18-45 years will be
      randomised with the aim of achieving at least 10 evaluable subjects to each treatment period.
      The primary objective is to evaluate the systemic steroid PD effects (serum cortisol 24 hour
      weighted mean on Day 7) of FF and systemic ß-adrenergic PD effects (ECG maximum QTcF 0-4h and
      whole blood potassium 0-4h in Day 1 and Day 7) of VI; the secondary objectives are aimed to
      evaluate the PK, safety and tolerability of FF/VI inhalation powder after a single and repeat
      dose administration.
    

Intervention name(s): Fluticasone Furoate/Vilanterol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50/25 or 100/25 or 200/25 mcg inhaled once daily for 7 days in each treatment period.; Placebo inhaled once daily for 7 days in each treatment period.
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacodynamics; Fluticasone furoate (FF); novel dry powder device; Safety and tolerability; vilanterol(VI); Healthy Chinese subjects; Pharmacokinetics
Adolescent Fibromyalgia Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare pregabalin with placebo over a 15 week period in adolescents with
      fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
    


Intervention name(s): placebo; pregabalin (Lyrica)
Intervention type(s): Drug; Drug
Intervention description(s): matching placebo capsules twice daily.; 75-450mg/day pregabalin dose optimised at start of study
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: juvenile primary fibromyalgia syndrome; pediatric fibromyalgia; pregabalin; and Lyrica
Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Overweight; Syndrome
Study type: Interventional

Summary: 
      Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a
      major source of morbidity and mortality in this population. It can lead to sleep apnea, cor
      pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set
      it apart from other forms of obesity including insatiable appetite and food-seeking behavior
      which can be disruptive to home and school activities, and can cause severe social and
      psychological turmoil within families. PWS is also associated with unique hormonal
      abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the
      stomach that stimulates food intake during a fast. It is hypothesized that the extremely high
      ghrelin levels in patients with PWS may cause or contribute to their insatiable appetite.
      Exenatide, a medication used in the treatment of type 2 diabetes mellitus in adults, appears
      to suppress ghrelin levels and cause weight loss. It was designed to mimic glucagon-like
      peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and delays gastric
      emptying, among other effects. In the present study, the investigators will investigate the
      effects of a 6 month trial of exenatide in overweight adolescents with PWS. The investigators
      will quantify the changes in weight and body composition, as well as subjective measures of
      appetite, and concentrations of appetite-associated hormones. The investigators hypothesize
      that exenatide will improve weight, body composition, appetite, and plasma ghrelin levels
      during the treatment period.
    

Detailed description: 
      BACKGROUND:

      Prader-Willi syndrome (PWS) is associated with hyperphagia and hyperghrelinemia with major
      morbidity because of obesity without effective medical treatment targeting hyperphagia.
      Exenatide (Byetta [synthetic Exendin-4]; AstraZeneca, Wilmington DE) is a GLP-1 receptor
      agonist which reduces appetite and weight and may be an effective treatment in PWS.

      OBJECTIVE: The objective of this study is to determine the effect of a 6-month trial of
      exenatide on appetite, weight and gut hormones in youth with PWS.
    

Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prader-Willi Syndrome; Obesity; Weight; Exenatide; Byetta; Pediatrics; Adolescents
An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C
Condition: HIV Infection; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm the safety, efficacy and delineate the
      pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child
      Pugh A compensated cirrhosis and or Hepatic fibrosis
    


Intervention name(s): nelfinavir 1,250 mg twice daily; Zidovudine 300 mg twice daily; Lamivudine 150 mg twice daily
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Nelfinavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects
Condition: Food Selection
Study type: Interventional

Summary: 
      The goal of this study is to determine subjective gastrointestinal tolerance response and
      differences in breath hydrogen response following the consumption of two types of juice. This
      double-blind crossover study requires participants to arrive to the lab 12 hours fasted,
      consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as
      produce samples for breath hydrogen analysis at various time points over the next 3 hours.
      Subjects will be asked to complete additional questionnaires at 12 and 24 hours post
      consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior
      to their scheduled visit times to assure compliance.
    


Intervention name(s): White grape juice; Apple juice
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study of MK0431 in Patients WIth Hepatic Insufficiency (0431-017)(COMPLETED)
Condition: Liver Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare the plasma concentrations of MK0431 at different times in patients with
      hepatic insufficiency vs healthy control subjects.
    


Intervention name(s): sitagliptin phosphate
Intervention type(s): Drug
Intervention description(s): sitagliptin phosphate 100 mg MK0431 (2 x 50 mg tablets) taken orally after overnight fast; Duration of Treatment: 5 Weeks
Other intervention name(s): MK0431
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cathepsin Activatable Fluorescent Probe
Condition: Sarcoma; Soft Tissue Sarcoma; Breast Cancer
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Real-time detection of cancer cells during surgical removal of a tumor is important.
      Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology
      when the margins (edges of the tissue) are examined to see if cancer cells are present. This
      may take a few to several days. Patients tissue with positive (cancer cells present) margins
      may require additional therapies including surgery. The purpose of this study is to determine
      a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that
      will show in the tumor area during surgery and may help facilitate visualization of tumor for
      its removal.
    


Intervention name(s): LUM015
Intervention type(s): Drug
Intervention description(s): LUM015 assigned dose given once by IV push
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the Time To Disease Progression (TTDP) between those
      patients with unresectable, locally recurrent or metastatic breast cancer who are treated
      with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy
      of Docetaxel followed by Gemcitabine.
    

Detailed description: 
      This is an open, multicenter, two-armed Phase III study

      Patients will be randomized to either of the following two arms:

      Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1
      and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine),
      repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8
      cycles will be administered.

      Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22,
      followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will
      be given. Both drugs will be administered in a 3-week schedule.

      Bimonthly follow-up for patients without confirmed disease progression until progression of
      disease. Long-term follow-up for patients with confirmed disease progression will be done in
      4 intervals.

      For therapy control frequent blood chemistry and hematology, physical examination, weight
      control, potential adverse events and imaging procedures (CT, X-ray, MRI, Bone scan) am
      foreseen.
    

Intervention name(s): Docetaxel; Gemcitabine, Docetaxel; Docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.; rm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.
Intervention MeSH terms: Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Docetaxel
A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as
      mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16
      weeks.
    


Intervention name(s): HS-20004
Intervention type(s): Drug
Intervention description(s): treatment
Other intervention name(s): Noiiglutide Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Condition: Fibromyalgia; Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only
      quantitatively but not qualitatively different from healthy controls (HC). Thus WU
      abnormalities of FM patients could be the result of supra-spinal and not the result of spinal
      pain mechanisms. The study team will test this hypothesis by sensitizing FM patients with
      topical capsaicin.
    

Detailed description: 
      The study team hypothesizes that at baseline the slopes of sensitivity adjusted WU of FM
      patients are not statistically different from HC. However, after capsaicin application, the
      slopes of sensitivity adjusted WU will be significantly different from baseline and greater
      than those of HC, suggesting central sensitization. This would imply that FM patients are
      sensitive to heat pain but not sensitized.
    

Intervention name(s): Capsaicin Patch 8% or 0.1% Capsaicin Cream; Vehicle Patch
Intervention type(s): Drug; Other
Intervention description(s): 0.1 ml of 8% capsaicin topical patch or 0.1% capsaicin cream; Control patch will be the same topical solution but will not contain capsaicin.
Other intervention name(s): Qutenza; Capsaicin No-Fuss
Intervention MeSH terms: Capsaicin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents living in or near Gainesville, FL
Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
Condition: Nasopharyngeal Neoplasms; Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to estimate the Complete Response rate of docetaxel to the
      combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in
      the Induction treatment of Nasopharyngeal Carcinoma (NPC).

      The secondary objectives are to determine:

        -  the safety of TCF in comparison to CF after induction treatment of NPC,

        -  the pharmacokinetics of docetaxel when added to CF,

        -  the Overall Response rate of TCF and CF on completion of induction and consolidation
           (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and
           CF.
    

Detailed description: 
      Planned treatment duration:

        -  induction period: 9 weeks of induction treatment

        -  consolidation period: 9 weeks of chemoradiation treatment.

      The consolidation treatment was the same for all participants: radiation therapy for 7-8
      weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
    

Intervention name(s): docetaxel; cisplatin; 5-fluorouracil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution for infusion
Route of administration:intravenous; Pharmaceutical form:solution for infusion
Route of administration:intravenous; Pharmaceutical form:solution for infusion
Route of administration:intravenous
Other intervention name(s): Taxotere®; XRP6976; 5-FU
Intervention MeSH terms: Docetaxel; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal carcinoma
Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
Condition: Pulmonary Arterial Hypertension; Right Heart Failure
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, single-center, randomized placebo controlled trial of famotidine (an H2
      receptor antagonist) in adults with pulmonary arterial hypertension. The study will evaluate
      the safety and clinical efficacy of a 24-week course of famotidine.
    

Detailed description: 
      Pulmonary arterial hypertension (PAH) is one of many conditions that put stress and strain on
      the right side of the heart. This stress and strain can cause right heart failure. Although
      there are medications to treat PAH, there are currently no medications that act directly on
      the heart to improve right heart function. This is different than left heart failure where
      one of the cornerstones of treatment is medication targeted at the heart to improve left
      heart function.

      Famotidine is a well-tolerated, over-the-counter, and inexpensive medication. Preliminary
      results suggest that famotidine may help the right heart to adapt and strengthen when
      stressed instead of fail; however, these results are suggestive and not definitive. A
      randomized controlled trial is required to evaluate the possibility that famotidine can
      impact right heart function.

      Participants in the study will take famotidine or placebo for 24 weeks. They will have three
      study visits at 0, 12, and 24 weeks. These visits will add 20-30 minutes to the standard
      clinic visits at those time points and there will be an echocardiogram at weeks 0 and 24.
      There will also be one phone visit at 4 weeks to check-in. Some participants may elect to
      participate in exercise testing and/or right heart catheterization at weeks 0 and 24;
      however, this is not required to participate in the trial.
    

Intervention name(s): Famotidine 20 MG; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Famotidine 20 mg capsule taken daily for 24 weeks.; Placebo capsule taken daily for 24 weeks.
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: famotidine; H2 blocker; H2 antagonist
Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)
Condition: Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and
      sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which
      stimulates V1-receptors in the vascular bed and may change both central and brachial
      hemodynamics and plasma concentration of vasoactive hormones.

      The purpose of the study is to measure the effects of tolvaptan on renal handling of water
      and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide
      (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA).
    


Intervention name(s): 15 mg tolvaptan; 30 mg tolvaptan; 45 mg tolvaptan; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 15 mg pr day for 1 day; 30 mg pr day for 1 day; 45 mg pr day for 1 day; 1 tablet Unikalk pr day for 1 day
Other intervention name(s): Samsca; Samsca; Samsca; Unikalk
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tolvaptan; L-NMMA; Healthy subjects; Nephrology