bioihbjkbjnl/mcl2 huggingface dataset:
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Condition: Germline BRCA1/2 Mutations and; Metastatic Adenocarcinoma of the Pancreas
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance
      Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose
      Disease Has Not Progressed on First Line Platinum Based Chemotherapy
    

Detailed description: 
      Approximately 145 patients will be randomised using an Interactive Voice Response System
      /Interactive Web Response System (IVR/IWR system) in a 3:2 ratio (Olaparib:placebo) to the
      treatments as specified below:

        -  Olaparib tablets p.o. 300 mg twice daily

        -  Matching placebo tablets p.o. twice daily Eligible patients will be those patients with
           pancreas cancer previously treated for metastatic disease who have not progressed
           following completion of at least 16 weeks (can be more) of first line platinum-based
           chemotherapy. All patients must have a known deleterious or suspected deleterious
           germline BRCA mutation to be randomised; this may have been determined prior to
           enrolment into the study or may be assessed as part of the enrolment procedure for the
           study (via centrally provided MyriadIntegrated BRAC.

      Patients will be randomised within 6 weeks after their last dose of chemotherapy (last dose
      is the day of the last infusion) and treatment started as soon as possible but no less than 4
      and no more than 8 weeks of the last chemotherapy dose. At the time of starting protocol
      treatment, all previous chemotherapy treatment should be discontinued.

      Following randomisation, patients will attend clinic visits weekly for the first 4 weeks of
      treatment (Days 8, 15, 22 and 29). Patients will then attend clinic visits every 4 weeks
      whilst on study treatment. Patients should continue to receive study treatment until
      objective radiological disease progression as per RECIST as assessed by the investigator and
      as long as in the investigator's opinion they are benefiting from treatment and they do not
      meet any other discontinuation criteria.

      Once a patient has progressed the patient will be followed for second progression (PFS2)
      every 8 weeks and then survival until the final analysis.
    

Intervention name(s): Olaparib; Olaparib; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet -100mg; Tablet-150mg; Match Olaparib 100mg placebo; Match Olaparib 150mg placebo
Intervention MeSH terms: Olaparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BRCA, metastatic adenocarcinoma pancreas, maintenance olaparib monotherapy, first line platinum chemotherapy, pancreatic cancer, PARP inhibitor
Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
Condition: Parkinson's Disease; Multiple System Atrophy; Orthostatic Hypotension
MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Hypotension, Orthostatic; Hypotension; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with Parkinson's Disease or Multiple System Atrophy (MSA), and symptoms of
      orthostatic hypotension, are eligible for the study. Each patient will have three weeks of
      conservative therapy, three weeks of therapy with fludrocortisone, and three weeks of therapy
      with domperidone. Autonomic testing, a symptom questionnaire, bedside blood pressure testing,
      and Unified Parkinson Disease Rating Scale (UPDRS) will be performed after each intervention.
    

Detailed description: 
      Enrolled patients, ages 40-95, must have Parkinson's or MSA, diagnosed by a neurologist, and
      symptoms of orthostatic hypotension. Each patient will fill out two validated questionnaires
      to determine if they are candidates for the study. Baseline patient details, such as their
      medications and UPDRS, will be recorded. Medications must be held stable during the period of
      the study.

      Each patient will then have three weeks of conservative therapy, three weeks of therapy with
      fludrocortisone, and three weeks of therapy with domperidone. Autonomic testing, a symptom
      questionnaire, bedside blood pressure testing, and UPDRS will be performed after each
      intervention.
    

Intervention name(s): Fludrocortisone; Domperidone; Conservative Measures for Orthostatic Hypotension
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Fludrocortisone; Domperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Orthostatic hypotension; Parkinson's Disease
Patients' Opinions and Responses to the National Cancer Institute's Colorectal Cancer Risk Assessment Tool
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Little is known about the impact of risk assessment tools on decision-making by patients and
      clinicians. In particular, even though the NCI Colorectal Cancer Risk Assessment Tool is one
      of the most prominent risk assessment tools available, no study has quantified its usability
      or impact on decision-making or uptake of screening. In this study, we will measure patients'
      satisfaction with the NCI CRC RAT, their perception of its usability and helpfulness, and its
      impact on their decision-making and behavior. In addition, we will assess the impact of
      adding information about their chance of having an advanced adenoma.
    


Intervention name(s): Patient views NCI CRC RAT; View presentation regarding current chance of having an advanced adenoma
Intervention type(s): Behavioral; Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      The purpose of this feasibility study is to obtain preliminary safety and effectiveness
      information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX
      System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).
    

Detailed description: 
      Study subjects followed to 12 months post implant outside the U.S. Study subjects followed to
      5 years post implant in the U.S.
    

Intervention name(s): Magnetic Anal Sphincter
Intervention type(s): Device
Intervention description(s): The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FENIX
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 2

Summary: 
      Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with
      sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be
      studied in these patients. In addition, tumor responses and overall survival will be
      assessed.
    


Intervention name(s): sunitinib malate dose escalation; sunitinib malate
Intervention type(s): Drug; Drug
Intervention description(s): sunitinib starting dose will be 15mg/m^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).; sunitinib 50mg daily on Schedule 4/2
Intervention MeSH terms: Sunitinib
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children and young adults with GIST; sunitinib malate; pharmacokinetics; tumor response; overall survival; tumor KIT mutation status
Effect of Fish Oil on Markers of the Metabolic Syndrome in Overweight Adolescent Boys
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of the study is to investigate if dietary fish oil has a beneficial effect on blood
      pressure, insulin sensitivity, blood lipid profile, body composition and metabolic rate in
      healthy, but slightly overweight, teenage boys.

      We hypothesized that the n-3 long chain polyunsaturated fatty acids from fish oil might have
      greater effect during growth and development, as intervention trials studying the effect of
      fish oil on babies have shown greater effects than in adults.
    


Intervention name(s): Dietary oils (fish, vegetable oil)
Intervention type(s): Dietary Supplement
Intervention description(s): 6g pr day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Blood pressure; Insulin sensitivity; Blood lipid profile
TAK-875 Glimepiride Drug-Interaction Study
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and safety of TAK-875, once
      daily (QD), with and without glimepiride in participants with type 2 diabetes mellitus
      (T2DM).
    

Detailed description: 
      TAK-875 is being developed at Takeda Global Research and Development, Inc. as an adjunct to
      diet and exercise to improve glycemic control in participants with T2DM.

      This study will determine whether administration of glimepiride alters the pharmacokinetics
      (PK) of TAK-875, and whether TAK-875 affects the PK of glimepiride.
    

Intervention name(s): TAK-875 and Glimepiride
Intervention type(s): Drug
Other intervention name(s): Amaryl
Intervention MeSH terms: Glimepiride
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Drug Therapy
Stroke Prognosis in Intensive CarE
Condition: Acute Stroke Patients Requiring Invasive Mechanical Ventilation
MeSH terms: Stroke
Study type: Observational

Summary: 
      The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study
      which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the
      trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on
      functional outcomes at 3 months and 1 year following ICU admission. This project is funded by
      the French Agence Régionale de Santé (ARS).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subjects included in this study are adult patients requiring invasive mechanical
        ventilation at the acute phase of stroke (within 7 days of stroke onset), irrespective of
        indication for intubation.

        Prolonged mechanical ventilation of several days to weeks in ICU may be required for some
        patients, with various ICU discharge trajectories in survivors.
      
Keywords: mechanical invasive ventilation; course of the care; prognosis; stroke
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to use an investigational device to record brain activity for
      12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The
      goal of the study is better understanding of brain activity in Parkinson's disease and how
      they relate to DBS and pharmacological management, not to bring new devices to market.
    

Detailed description: 
      Experimental: chronic brain recording This is a one-arm, single-center study of the
      neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of
      chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa
      PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded
      from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS).
      2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility
      of the use of brain signals as feedback either directly to the patient or for DBS stimulation
      adjustments.
    

Intervention name(s): Activa PC+S
Intervention type(s): Device
Intervention description(s): DBS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Parkinson's Disease
OVCA-NAC-P2: Study of Chemotherapy Followed by Cytoreductive Surgery for Ovarian, Tubal and Peritoneal Cancers: JCOG0206
Condition: Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms
MeSH terms: Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive
      surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as
      ovarian, tubal and peritoneal carcinomas.
    

Detailed description: 
      The purposes are to assess the safety and efficacy of the treatment starting with NAC and to
      know whether we can accurately diagnose these advanced carcinomas by imaging studies,
      cytologic findings and tumor markers without staging laparotomy or laparoscopy. Fifty-six
      patients with advanced mullerian carcinomas will be recruited to the study. After
      confirmation of diagnosis by laparoscopic inspection and biopsies, patients undergo 4 cycles
      of chemotherapy as NAC followed by ICS and additional 4 cycles of postsurgical chemotherapy.
      The primary endpoint is proportion of clinical complete remission after accomplishment of the
      protocol treatment and the major secondary endpoint is positive predictive value of diagnosis
      before laparoscopy regarding tumor origin, histology and stage. Based on the result of this
      study, we will conduct a phase III study to compare the treatment starting with NAC and
      primary cytoreductive surgery followed by postsurgical chemotherapy.
    

Intervention name(s): Neoadjuvant chemotherapy (Paclitaxel and Carboplatin)
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian neoplasms; laparoscopy; neoadjuvant therapy; interval cytoreductive surgery
Auditory Evoked Potentials and Experimental Pain
Condition: Pain
Study type: Observational

Summary: 
      Monitoring of auditory evoked potentials (AEP) in patients during general anaesthesia is
      commonly used to ensure a sufficient hypnotic level during surgery. The amplitude of AEP
      (AEPa) has in clinical settings been found to correlate to pain. The aim of the study was to
      test, if AEPa could detect increasing experimental pain stimulations in healthy volunteers.
      Electric nerve stimulation, cold and heat pain were used as pain models.
    

Detailed description: 
      During the AEP monitoring, healthy volunteers were exposed to experimental pain. At study day
      1: Firstly, single electric nerve stimulation and repetitive electric nerve stimulations
      causing temporal pain summation. The stimulations were given at 50, 75 and 100% of the
      thresholds for pain tolerance and temporal pain summation. Secondly, the volunteers were
      exposed to cold pain by use of two different Cold Pressor Tests (CPT) with water temperatures
      at 8 and 1 Celsius. All measurements were repeated after an hour to test reproducibility.

      At study day 2: Brief Thermal Stimulation were used with two different temperatures and
      duration.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Keywords: AEP; experimental pain; healthy volunteers
Free Fatty Acids and Vascular Function in Subjects With Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will test the hypothesis that reduction in release of free fatty acids from
      adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal
      muscle glucose metabolism in subject with type 2 diabetes.
    

Detailed description: 
      During the past two decades, there has been a steady increase in the incidence of diabetes
      mellitus, such that nearly 17 million people are now afflicted. The vast majority of these
      have type 2 diabetes. Over the next 40 years, the type 2 diabetic population in the United
      States is expected to increase to nearly 30 million.

      Diabetes substantially increases the risk of atherosclerosis, and thereby, cardiovascular
      morbidity and mortality. Indeed, cardiovascular disease causes more than 50% of the mortality
      in patients with diabetes. People with type 2 diabetes manifest two cardinal signs of
      dysmetabolism: hyperglycemia and insulin resistance. Insulin resistance is a progressive
      phenomenon that occurs well before the onset of frank diabetes, and results in alterations in
      insulin signaling. Experimental studies suggest that insulin signaling is required for
      vascular homeostasis, and its impairment is associated with endothelial dysfunction. In the
      clinical setting, insulin resistance is associated with atherosclerosis and predicts
      cardiovascular events independent of hyperglycemia. Therefore, we will study the importance
      of insulin signaling in endothelial biology in humans and the effects of free fatty acids on
      endothelial function in people with type 2 diabetes.
    

Intervention name(s): acipimox; placebo
Intervention type(s): Drug; Drug
Intervention description(s): subjects will receive acipimox 250 mg orally every 6 hours (or matching placebo) for 7 days, including a dose at 6am on the morning of the study testing visit; matching placebo
Other intervention name(s): Olbetam
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin resistance; insulin signaling; endothelium-dependent vasodilation
Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative PK study after single SC application of Afolia and the reference product (US
      Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference
      product for the area under the curve (AUC) of Afolia.
    

Detailed description: 
      To demonstrate equivalence within the 80% to 125% margin of the reference product for the
      baseline corrected area under the follicle-stimulating hormone (FSH) serum concentration-time
      curve from time zero to the last quantifiable concentration of AFOLIA compared to the
      reference product (United States [US] Gonal-f® RFF)
    

Intervention name(s): Afolia; US Gonal-f®
Intervention type(s): Drug; Drug
Intervention description(s): During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:
Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.
Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27; During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:
Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.
Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27
Other intervention name(s): Follitropin Alfa; Follitropin Alfa
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Afolia; Follitropin
Biological Markers Predicting Exercise Capacity in CF-LVAD Patients.
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Establishing the association between biological markers and exercise capacity in
      continuous-flow left ventricular assist device patients.
    

Detailed description: 
      The aim of this study is to investigate if specific biological markers can predict exercise
      capacity in advanced heart failure patients supported with continuous-flow left ventricular
      assist device patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stable CF-LVAD patients.
      
Biospecimen description: 
      Blood samples in biological bank.
    
Keywords: Exercise