bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1, double-blind, placebo-controlled, multiple ascending dose study to
      determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy
      adults (Part A) with an open-label cohort of patients with Huntington's disease (Part B)
    

Detailed description: 
      This posting addresses Part B
    

Intervention name(s): SAGE-718
Intervention type(s): Drug
Intervention description(s): SAGE-718
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Korean CRC Screening Study PT13599
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Korean Americans report the lowest and declined rates of colorectal cancer (CRC) screening,
      compared to general population in the United States. The present study aimed to evaluate the
      efficacy of a community-based multifaceted intervention designed to improve CRC screening
      among Korean Americans.
    


Intervention name(s): interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care.; Education Session on General Health
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The interactive group education was aimed to increase participant overall understanding of CRC, screening methods, and utilization of available resources such as home test kit and navigation services, with the ultimate goal of increasing screening rates. Clinical partners provided clinical support and ensured successful screening assessment and follow-ups by offering more flexible hours of clinic operation with bilingual medical staff on site. Patient navigation assistance was also offered based on participants' needs. The range of assistance included scheduling appointments with clinical partners for sigmoidoscopy/colonoscopy for screening and diagnosis after a FIT positive result, assisting paper.; Participants in the control group received a group education session in a similar format with that of the intervention group delivered by trained Korean community health educators. Different from the intervention group, the education focused on general health education and primary prevention issues, including routine health examinations and screening for various diseases such as cancer. Korean version of work and communication with a physician, and arranging transportation. standard printed materials and guidelines related to the education contents were also provided, including CRC screening guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Screening
Assessment of Body Image in Patients With Rheumatoid Arthritis
Condition: Body Image; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem,
      function and quality of life.
    

Detailed description: 
      Methods: Forty-three RA patients and thirty-nine control patients between 18 and 70 years
      were evaluated. The RA group was made up of individuals with a diagnosis of RA and the
      control group was made up of individuals from the community, paired for gender, age and body
      mass index. The patients were assessed with regard to body image (Body dysmorphic disorder
      examination (BDDE)), self-esteem (Rosenberg self-esteem scale), function (Health assessment
      questionnaire (HAQ)) and quality of life (Short form-36 (SF-36)).
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        -  Rheumatoid arthritis in study group

          -  Community sample in control group
      
Biospecimen description: 
      None Retained
    
Keywords: Body image; Rheumatoid Arthritis
The Analgesic Efficacy of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty:
Condition: Total Hip Arthroplasty; The Analgesic Efficacy
Study type: Interventional
Phase: Phase 4

Summary: 
      Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an
      alternative for fentanyl for pain control in the postoperative period. However, it was mainly
      directed to control visceral pain, due to the mediation of analgesic effects by the kappa
      receptors. However, few studies compared the oxycodone to fentanyl for postoperative pain
      relief in patients undergoing total hip arthroplasty (replacement). Therefore, we established
      this randomized study to compare the efficacy of oxycodone and fentanyl for relief of
      postoperative pain after total hip arthroplasty (replacement).
    


Intervention name(s): propofol, rocuronium and fentanyl
Intervention type(s): Drug
Intervention description(s): In fentanyl group (36 patients), 50 ug of fentanyl, and in oxycodone group, 4 mg of oxycodone will be administered 20 minutes before the end of the surgery, in triple blind manner.
Intervention MeSH terms: Fentanyl; Propofol; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Oxycodone Hydrochloride; Fentanyl
A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain
Condition: Sciatica
MeSH terms: Sciatica
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate
      the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with
      sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is
      expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients
      will receive 1 injection under the skin of either active or placebo REGN475, and be followed
      over 10 visits for 12 weeks.
    


Intervention name(s): REGN475; REGN475; Placebo Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single Subcutaneous injection dose level 1; Single subcutaneous injection dose level 2; Placebo Subcutaneous injection
Intervention MeSH terms: Fasinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sciatica; sciatic pain; pain; back pain
A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill
Condition: Healthy Volunteers; Pharmacokinetics of Mirabegron
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the effect of multiple doses of mirabegron on the
      pharmacokinetics of an oral contraceptive.
    


Intervention name(s): Mirabegron; Minidril; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral
Other intervention name(s): YM178; ethinyl estradiol; levonorgestrel
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Mirabegron; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Oral contraceptives; Drug interactions; Pharmacokinetics of mirabegron
Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, two-part study to determine the absolute bioavailability (BA) of
      OZ439 using simultaneous intravenous [14C]-OZ439 microdose/800mg oral dosing and to
      investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses
      suspended in different volumes and when co-administered with a single dose of Cobicistat, a
      strong CYP3A4 inhibitor, to healthy subjects in fasted state.
    

Detailed description: 
      Primary objectives of this study are:

        -  to determine the absolute bioavailability of OZ439 following a single oral dose of OZ439
           dispersion and a simultaneous single intravenous (iv) microdose (100 μg) infusion of
           [14C]-OZ439 under fasted conditions (Part 1)

        -  To evaluate the effects of a single oral dose of cobicistat, a strong cytochrome P450
           (CYP) 3A4 inhibitor, on the pharmacokinetic (PK) profile of a single oral dose of a
           dispersion of OZ439 simple granules under fasted conditions (Part 2)

        -  To evaluate the PK of single doses of OZ439 granules when restricting the target dosing
           volumes to 64.5 or 100 mL (Parts 1 and 2)

      Secondary objectives are:

        -  To assess the safety and tolerability of OZ439 when administered alone, and to assess
           the safety and tolerability of OZ439 and cobicistat when co-administered as single doses
           to healthy subjects (Parts 1 and 2)

        -  To determine the PK parameters of OZ439 single iv microdose (100 μg) infusion of
           [14C]-OZ439 (Part 1)

        -  To assess the effects of the total dosing volume and of dose to volume ratio on OZ439 PK
           under fasted conditions (Parts 1 and 2)

        -  To determine the PK parameters and exposures of cobicistat (Part 2)
    

Intervention name(s): Single oral dose of 800 mg OZ439; Single oral dose of 400 mg OZ439; Single oral dose of cobicistat; iv infusion of [14C]-OZ439
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of 800 mg OZ439; Single oral dose of 400 mg OZ439; Single oral dose of 150 mg cobicistat; 15-minute 10-mL iv infusion of 100 μg [14C]-OZ439
Intervention MeSH terms: Cobicistat; Artefenomel
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part1: Open label, one treatment Part 2: Open-label, randomized, single-dose, 3-way cross-over study
Masking: None (Open Label)
Primary purpose: Treatment
Amyloid Beta and Cognition in Parkinson Disease
Condition: Parkinson Disease; Neurological Disorders
MeSH terms: Parkinson Disease; Nervous System Diseases
Study type: Observational

Summary: 
      The investigators propose to study persons with Parkinson Disease (PD) with detailed
      clinical, cognitive and imaging at the time of study entry and repeat these assessments 2
      years later. The study looks at how changes in activity of the neurotransmitter acetylcholine
      relates to changes in cognitive function and to see if there is presence or build up of
      amyloid protein.
    

Detailed description: 
      Participants with PD will be studied at initial visit assessing clinical, cognitive, and
      brain imaging. A one year and, if applicable, three year cognitive assessment will be done,
      and the entire/complete assessment (same as initial visit) will be repeated again at two
      years. There will be a maximum of three follow up visits. The imaging test battery will
      consist of amyloid and acetylcholine brain PET and MRI scans. The use of acetylcholine PET
      imaging will demonstrate how changes in activity of this neurotransmitter relate to changes
      in cognitive functions, such as memory and mental concentration. A key question will be
      whether persons with PD who not only are losing acetylcholine brain cells but also have the
      buildup of the Alzheimer amyloid protein have a more rapid progression with more severe
      cognitive decline and behavioral changes compared to persons who do not have the amyloid
      protein.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        UM and VA Movement Disorders Clinic

        Primary Care Clinic

        Community
      
Biospecimen description: 
      Saliva samples with DNA
    
Keywords: Parkinson disease; Cognition
Exercise Training Effects on Metabolic Syndrome: Interactions With Medication
Condition: Exercise Therapy; Metabolic Syndrome X; Cardiorespiratory Fitness
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To analyze the effects of different exercise training modalities (continuous, intervallic,
      and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome
      patients when this training interacts with their habitual medication.
    

Detailed description: 
      Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity,
      the effects of different modalities of exercise training on cardiorespiratory and metabolic
      fitness. The main objective is to weight the effects of exercise training separately and in
      conjunction with the subject's habitual pharmacological treatment to identify the best
      combination of drug and exercise.

      Methods and design: Randomized, pretest-posttest control group experimental design. Project
      developed in a single center with the collaboration of the regional public health system.

      Subjects: Will be referred by their primary care physicians to our study unit. Up to 40
      subjects all of them with metabolic syndrome will be recruited (at least 20% women).

      Measurements:

        1. Specifically, the investigators, will study cardiovascular adaptations that increase, i)
           maximal aerobic capacity measured by VO2max, ii) anaerobic and respiratory compensation
           point ventilatory thresholds, iii) arterial stiffness, measured by pulse wave velocity
           (SphygmoCor System), v) central and peripheral blood pressure, and iv) biological
           markers of endothelial dysfunction using reactive hyperemia with a laser Doppler
           fluxmeter in central and peripheral blood vessels.

        2. The metabolic adaptations under study will include, i) insulin sensitivity by HOMA-IR,
           ii) fat oxidation by indirect calorimetry
    

Intervention name(s): MEDICATION AND EXERCISE TRAINING
Intervention type(s): Drug
Intervention description(s): PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD.
THIS TESTING WILL BE REPEATED AFER 4 MONTHS OF EXERCISE TRAINING (48 SESSIONS OF 43 MIN EACH ONE).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Carrageenan's Effect on Insulin Resistance in Humans
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the ingestion of the common food additive
      carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes
      in humans.
    


Intervention name(s): Carrageenan; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Carrageenan 250 mg bid supplemented to a standard food; Placebo (Mannitol/Aerosil) bid supplemented to a standard food
Other intervention name(s): E407
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine potential pharmacokinetic drug-drug interaction
      when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.
    


Intervention name(s): Valsartan/hydrochlorothiazide (HCTZ); Valsartan/amlodipine; Amlodipine/hydrochlorothiazide(HCTZ); Valsartan/amlodipine/hydrochlorothiazide(HCTZ)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine
Comparison of ELDOA and Mechanical Traction Technique on Pain and Disability in Patients With Lumbar Disc Herniation
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      To compare the effect of ELDOA and Mechanical traction technique on pain in patients with
      lumbar disc herniation.

      To compare the effect of ELDOA and Mechanical traction technique on disability in patients
      with lumbar disc herniation.
    


Intervention name(s): ELDOA Technique; Mechanical Lumbar Traction
Intervention type(s): Other; Other
Intervention description(s): the patients treated with ELDOA technique, followed for 3 alternative days for 4 weeks.
the ELDOA techniques for level L4/L5 and L5/S1 were applied. the ELDOA positions hold for one minute, 3 alternative days for 4 weeks under supervision.
Hot pack (10-15 minutes) McKenzie Extension Exercises; Mechanical Traction Technique: traction unit, 50% of body weight was applied with the patients lying in supine position, with the hip and knee at 90 degree flexion, and legs were supported. Traction were applied for 3 alternative days for 4 weeks.
Hot pack (10-15 minutes) McKenzie Extension Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer
Condition: Advanced Breast Cancer; Breast Neoplasm Malignant Female
MeSH terms: Breast Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This exploratory clinical study aims to assess the safety and preliminary efficacy of an
      immunotherapy using PD-1 knockout anti-MUC1 CAR-T cells in the treatment of advanced
      MUC1-positive breast cancer
    

Detailed description: 
      This is a single-center, open-label, dose-escalation exploratory study investigating the
      safety,tolerability and preliminary efficacy of AJMUC1, PD-1 knockout CAR-T cells targeting
      aberrantly glycosylated MUC1, in the treatment of patients with advanced MUC1 positive breast
      cancer. The primary objective of this study is to evaluate the safety, tolerability,
      biological activity, and preliminary antitumor efficacy of AJMUC1. The study adopts a "3+3"
      dose escalation design to identify the maximum tolerated dose (MTD)/ maximum administered
      dose (MAD). Three doses are set: 3×105 CAR T cells/kg, 1×106 CAR T cells/kg and 3×106 CAR T
      cells/kg, with a total of 15 patients planned by the data cutoff date. Participants may
      receive one, two, three or more cycles of AJMUC1 infusion dependent on the adverse effects
      and potential clinical benefits.. This study is initiated by the investigators and approved
      by the Human Ethics Committee of Sun Yat-sen Memorial Hospital affiliated with Sun Yat-sen
      University. All patients have signed informed consent.
    

Intervention name(s): AJMUC1- PD-1 gene knockout anti-MUC1 CAR-T cells
Intervention type(s): Drug
Intervention description(s): AJMUC1 is a genetically modified T cell therapeutic product targeting the aberrantly glycosylated MUC1 protein. CAR targeting MUC1 is introduced into autologous T cells by lentiviral vector, so that T cells expressing the receptor can recognize and kill MUC1 positive tumor cells. Preclinical studies have shown that binding of scFv targeting MUC1 to the MUC1 epitope on the surface of the target cell can induce the costimulatory CD28 and CD3ζ costimulatory domains to activate downstream signaling pathways and promote T cell activation and expansion. Activated CAR-T cells secrete a series of inflammatory cytokines and chemokines, leading to apoptosis and necrosis of target tumor cells. Following introduction of a CAR structure, the PD-1 gene of CAR-T cells is knocked out using CRISPR/Cas9, so that the CAR-T cell does not express PD-1, resulting in improved tumor killing efficiency of AJMUC due to the release of inhibition in the signaling pathway PD-1/PD-L1 in the tumor microenvironment.
Other intervention name(s): Therapeutic T cells
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer, solid tumor, CAR-T cells, PD-1 knockout, MUC1
Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial
Condition: Stage IV Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The core hypothesis to be tested is that the use of consolidative SBRT followed by
      maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary +
      5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone.
    

Detailed description: 
      This protocol is a randomized phase II trial of maintenance chemotherapy versus consolidative
      Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy for patients with
      Stage IV non-small cell lung cancer (NSCLC).

      Prior to accrual on the trial, patients with Stage IV NSCLC will be treated with standard
      first-line chemotherapy. Patients who achieve a partial response or stable disease by imaging
      criteria with fewer than or equal to six sites of oligometastatic disease will be randomized
      to maintenance chemotherapy or consolidative SBRT to all sites of disease (followed by
      maintenance chemotherapy at the medical oncologist's discretion). Choices of first line and
      maintenance chemotherapy will be determined by the medical oncologist based on clinical
      appropriateness.
    

Intervention name(s): Stereotactic Body Radiation Therapy; Maintenance chemotherapy
Intervention type(s): Radiation; Drug
Intervention description(s): Maintenance chemotherapy
Other intervention name(s): SBRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment