bioihbjkbjnl/mcl2 huggingface dataset:
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the relative bioavailability of different oral formulations of AZD9291 and the
      effect of food in healthy volunteers.
    

Detailed description: 
      A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to
      Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the
      Effect of Food
    

Intervention name(s): AZD9291; AZD9291; AZD9291; AZD9291; AZD9291
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Volunteers will receive a single 20-mg dose of AZD9291 as a capsule on day 1, in Part A, Period 1, in the fasted state. (Treatment A).; Volunteers will receive a single 20-mg dose of AZD9291 as a solution on day 1, in Part A, Period 2, in the fasted state. (Treatment B).; Volunteers will receive a single 20-mg dose of AZD9291 as a tablet on day 1, in Part A, Period 3, in the fasted state. (Treatment C).; Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 1, in the fasted state.; Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 2, in the fed state.
Intervention MeSH terms: Osimertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I, healthy, bioavailability, pharmacokinetics, safety, tolerability.
A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Type 2 diabetes results when the body does not produce enough insulin to regulate blood
      sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin
      secretion by the pancreas.
    


Intervention name(s): Vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Vildagliptin; Type 2 diabetes; Insulin secretion; Beta cell
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to examine the effects of SB-480848 on plasma
      lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a
      4-week treatment with SB-480848.
    


Intervention name(s): SB480848 40mg EC Tablet; SB480848 80mg EC Tablet; SB480848 160mg EC Tablet; SB480848 Placebo Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet once a day; 1 tablet once a day; 1 tablet once a day; 1 tablet once a day
Other intervention name(s): Darapladib
Intervention MeSH terms: Darapladib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SB-480848; Dyslipidaemia
Effects of Chantix on Relapse Prevention for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of the proposed study is to validate an experimental paradigm to assess medication
      effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence
      and a programmed cigarette lapse.
    

Detailed description: 
      The proposed human experiment will test the validity of a novel paradigm that may provide a
      method for distinguishing compounds that are likely to have efficacy from those that are not,
      before they are tested in more costly large-scale clinical trials. Specifically, in a
      within-subject (cross-over) behavioral pharmacology investigation of 60 smokers, we will test
      the effects of varenicline versus placebo on smoking behavior in the natural environment
      following a 3-day period of monitored abstinence and a programmed cigarette lapse. A positive
      signal for varenicline effects in this study would provide support for the sensitivity of the
      paradigm. In addition, following completion of all assessments, participants will be followed
      in a 13-week open-label varenicline smoking cessation trial to determine whether response to
      varenicline in the laboratory study predicts clinical response in the open-label trial.
    

Intervention name(s): Placebo; Varenicline
Intervention type(s): Drug; Drug
Intervention description(s): Participants will take placebo pills for 21-days using the same regimen as the varenicline study period.; Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - End of Treatment 1.0mg twice daily
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Varenicline, Working memory
Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist
Condition: First Episode Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      Psychotic disorders are often chronic conditions that lead to impaired functioning, quality
      of life and social integration. Current research and recommendations for good practice are
      moving towards early detection and intervention. It is recognized that this leads to better
      adherence, alliance to care and knowledge of pathology for the patient, especially in young
      patients. For more than a decade, early intervention services (EIS) are opened in France over
      an increasingly large territory. Still too few studies assess the impact of these structures
      in France. These EIS offer a multimodal intervention (social, professional,
      psychotherapeutic). The intervention of case managers (or care coordinators in french) seems
      to be the core of EIS. The case manager has a fundamental role in the process of recovery in
      coordinating each individual's treatment and ensuring continuity of care.

      The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program
      for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of
      young people with a FEP.

      A qualitative evaluation of case management practice in EIS seems essential to assess the
      impact of case managers under real conditions.

      Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case
      management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate
      the practice of case management in the EIS in France. This check-list contains different 35
      items. The final score between 1(poor) to 5 (good) is established to determine the quality of
      the case management. Qualitative data are also collected during the interview with the
      participants.
    


Intervention name(s): evaluation of professional practices
Intervention type(s): Other
Intervention description(s): Evaluation of professional practices : evaluation of the case management carried out in a program for early psychosis in France using a checklist according good practices guidelines
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Professional working in an early intervention center treating first episodes of psychosis
      
Keywords: first episode of psychosis assertive community treatment; early intervention in mental health; case management; assertive community treatment
Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation
Condition: Bone Cyst
MeSH terms: Bone Cysts
Study type: Interventional
Phase: Phase 1

Summary: 
      There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone,
      but they are most commonly seen in children and young adults while their bones are still
      growing. Living with a bone cyst and determining treatment options depend on the type of
      cyst.

      Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who
      do not experience any symptoms.

      Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the
      area of the bone starts to thin out. The investigators aim to assess the clinical efficacy
      and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.
    

Detailed description: 
      Bone cysts are benign lesions usually discovered in children from age of 5 to 15 years.
      Treatment options include observation, corticosteroid injection and surgery. Sometimes the
      risk of surgery is comparable to the likelihood of fracture without treatment. In orthopedic
      surgery, bone chips , various types of ceramics, natural and synthetized bone mineral
      hydroxyapatite and tricalcium phosphate, as well as numerous polymers and co-polymers of
      alfa-hydroxy acids are used to perform as an osteoconductive and rarely osteoinductive factor
      to help bone formation.Some evidence demonstrated that bone marrow mesenchymal stem cells
      deposited on the surface of this constructs enhance its osteogenic differentiation. In this
      study the investigators seeds cultured bone marrow derived mesenchymal stem cells on bone
      matrix, to evaluate its therapeutic potential in repairing unicameral or aneurysmal bone
      cyst.This composite is placed in the bone cyst after its curettage during a
      surgery.Post-operation assessment is done by X-Ray examination and MRI at 1, 2, 6, and 12
      months after treatment.
    

Intervention name(s): cell injection
Intervention type(s): Biological
Intervention description(s): injection of mesenchymal cells to bone cyst defect
Other intervention name(s): cell transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone cyst bone defect mesenchymal cell
Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating
      children who have solid tumors that have not responded to previous therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose and dose limiting toxicity of vincristine when
           administered in combination with irinotecan in children with refractory solid tumors.

        -  Determine the safe and tolerable phase II dose of this combination regimen in this
           patient population.

        -  Determine the pharmacokinetics of this combination regimen in these patients.

        -  Determine the incidence and severity of other toxicities of this combination regimen in
           these patients.

        -  Determine preliminary evidence of antitumor activity of this combination regimen in this
           patient population.

      OUTLINE: This is a dose-escalation study of vincristine.

      Patients receive vincristine IV on day 2 of the first course (day 1 of subsequent courses)
      and days 8, 15, 22, and 29, and irinotecan IV over 1 hour on days 1-5 and 22-26. Courses
      repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients
      with responsive or stable disease receive additional courses of therapy for a maximum of 1
      year.

      Cohorts of 3-6 patients receive escalating doses of vincristine until the maximum tolerated
      dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3
      or 2 of 6 patients experience dose limiting toxicity.

      Patients are followed every 6 months for 4 years and then annually thereafter.

      PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.
    

Intervention name(s): irinotecan hydrochloride; vincristine sulfate
Intervention type(s): Drug; Drug
Other intervention name(s): CPT-11; NSC #616348; VCR; Oncovin; NSC #067574
Intervention MeSH terms: Irinotecan; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific
Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease
Condition: Parkinson's Disease; Treadmill
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Treadmill training has been shown to be beneficial for reducing motor symptoms of Parkinson's
      disease (PD). The mechanisms for the therapeutic effects of treadmill training remain
      unknown. However, specific types of intrinsic feedback generated from muscle spindles (detect
      changes in length of muscle) and golgi tendon organs (detect muscle force) seem to be an
      important factor for achieving the reductions in motor scores. This study will compare a
      treadmill program that generates a high rate of intrinsic feedback to a treadmill program
      focused on generating a high magnitude of intrinsic feedback.
    


Intervention name(s): rate group; magnitude treadmill group; regular treadmill walking
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): walking with a high cadence (steps per minute)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: treadmill; parkinson's; proprioception; cadence; step length; intrinsic feedback
Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior
Condition: Hand Hygiene; Handwashing
Study type: Interventional

Summary: 
      Objective of the randomized controlled trial is to assess the impact of a digital
      intervention on hand hygiene of young children. Children in intervention kindergartens /
      elementary schools will see live instructions and feedback on their current hand washing
      activity while washing hands. We hypothesize that the digital intervention will improve hand
      hygiene practices of children in kindergarten / elementary school.
    


Intervention name(s): Live feedback during handwashing
Intervention type(s): Other
Intervention description(s): Live feedback provided during handwashing on display
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Bandage Contact Lenses Versus Eye Patching of Müller's Muscle-conjunctival Resection
Condition: Eyelid Diseases
MeSH terms: Eyelid Diseases
Study type: Interventional

Summary: 
      Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection
      (MMCR) may experience postoperative pain and discomfort related to the suture material on the
      palpebral conjunctiva. This study aims to compare the postoperative subjective complaints,
      such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the
      cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was
      managed by either a bandage contact lens (BCL) or eye patching.
    

Detailed description: 
      Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection
      (MMCR) may experience postoperative pain and discomfort related to the suture material on the
      palpebral conjunctiva. This study aims to compare the postoperative subjective complaints,
      such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the
      cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was
      managed by either a bandage contact lens (BCL) or eye patching.
    

Intervention name(s): bandage contact lens
Intervention type(s): Procedure
Intervention description(s): bandage contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: patient comfort
Neuromuscular Electrical Stimulation Versus Intermittent Pneumatic Compression for Blood Flow
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among
      hospitalized patients, with death occurring in approximately 6% of cases. It involves the
      formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the
      legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),
      hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to
      blood vessel wall), collectively known as Virchow's triad.

      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have
      been shown to improve lower limb blood flow. However, few studies have directly compared the
      two methods and those that have, have used outdated NMES devices.

      The objective of this study is to compare the effectiveness of a modern NMES device to
      intermittent pneumatic compression in terms of blood flow.
    


Intervention name(s): Neuromuscular Electrical Stimulation; Intermittent Pneumatic Compression
Intervention type(s): Device; Device
Intervention description(s): Frequency of 36Hz, a balanced biphasic waveform with a pulse width of 350μs, a ramp up time of 500ms, a contraction time of 1s and a ramp down time of 500ms.; Programmed to deliver compression every 20 seconds at a pressure of 130mmHg for a 1 second duration over a period of 5 minutes.
Other intervention name(s): Custom-built, two-channel stimulator (Duo-STIM, Bioelectronics Research Cluster, NUI Galway); Novamedix AV Impulse System Model 6000 (Novamedix distribution Limited, England)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Deep Vein Thrombosis; Neuromuscular Electrical Stimulation; Intermittent Pneumatic Compression; Doppler Ultrasound
Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC
      patients during adjuvant AIs treatment in terms of: the change of the trial outcome index
      (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit
      approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR
      (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The eligible patients will be recruited when they start their upfront AIs adjuvant
        treatment within 7 days.
      
Keywords: Quality of Life; postmenopausal HR(+); Early Breast Cancer; adjuvant AI treatment; Quality of Life in Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment
Fertility Preservation in Cases of Klinefelter Syndrome.
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Study type: Interventional

Summary: 
      Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn
      males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly
      non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%)
      have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of
      sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some
      pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since
      1997, more than one hundred births are described.

      As some studies shown a decrease of successful sperm retrieval with the increasing of age, we
      plan to compare the potential of sperm retrieval between two groups "adult" (23-55 years) and
      "young" after the onset of puberty (15-22 years). The study will be performed by searching
      spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if
      the azoospermia is confirmed on semen analyses.
    


Intervention name(s): Seminal analyses and testicular biopsy
Intervention type(s): Procedure
Intervention description(s): Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Klinefelter Syndrome; Azoospermia; Seminal analyses; Testicular biopsy