bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Effects of CXB722 in Neuroendocrine Stress Response in Healthy Males
Condition: Stress; Anxiety
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of CXB722 on neuroendocrine stress
      response and subjective reports related to mood and stress during and after experimentally
      induced stress among healthy young males.
    

Detailed description: 
      Acute stress produces a cascade of physiological and psychological effects, including
      increased cardiovascular function, increases in circulating levels of stress hormones and
      neurotransmitter levels, and changes in mood and subjective state. The Trier Social Stress
      Test (TSST) is a standardized, well-validated procedure that was developed in order to
      provide a controlled method for exposing subjects to a stressor. The TSST consists of a
      public speaking and a mental arithmetic test performed in the context of a mock job
      interview.

      A drug that could safely block or mitigate the stress response would have multiple
      applications in medicine, beyond treating anxiety, because stress is associated with many
      disease states, including cardiovascular disease. The drug being studied, CXB722, is thought
      to show promise in diminishing the physiologic and psychological effects of stress.
    

Intervention name(s): CXB722; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 900 mg CXB722 oral liquid suspension twice a day for 8 days; matching oral liquid suspension placebo twice a day for 8 days
Other intervention name(s): Pivagabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immobilization in External Rotation of Acute Shoulder Dislocations
Condition: Anterior Shoulder Dislocation
MeSH terms: Joint Dislocations; Shoulder Dislocation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether immobilizing the affected shoulder of first
      time anterior shoulder dislocation patients in external rotation (vs immobilization in
      traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24
      months.
    

Detailed description: 
      Immobilizing the affected shoulder of first time anterior shoulder dislocation patients in
      external rotation (vs immobilization in traditional internal rotation)should reduce the rate
      of recurrent dislocations experienced in 24 months.
    

Intervention name(s): Immobilization in External Rotation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immobilization in External Rotation; Acute primary anterior shoulder dislocation
Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR and Pelubiprofen SR (as a Pelubiprofen 45 mg) Tablet in Healthy Subjects
Condition: Healthy Males
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate
      the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR
      (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single
      dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR
      (Pelubiprofen 45 mg) in healthy male volunteers
    


Intervention name(s): Pelubiprofen IR (Pelubiprofen 30mg) TID; Pelubiprofen SR (Pelubiprofen 45 mg) BID
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Feasibility Study of the Vedera KXS for Treatment of Keratoconus
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      The objective of this investigation is to evaluate the feasibility, safety and efficacy of
      the Vedera KXS for the reduction or elimination of myopia and astigmatism in patients with
      keratoconus, who are no longer able to achieve adequate vision with their contact lenses or
      glasses.
    


Intervention name(s): Vedera KXS
Intervention type(s): Device
Intervention description(s): One treatment session with Vedera KXS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Polyunsaturated Fatty Acids (PUFA)-Gene Interactions in Heath Disparities
Condition: Fatty Acid-Gene Interactions
Study type: Interventional

Summary: 
      A randomized, clinical trial to provide the first comprehensive investigation of the role of
      fatty acid desaturate (FADS) genetic determinants on PUFA biosynthesis and metabolism as well
      as levels of inflammatory markers in a controlled dietary environment using two (low and high
      linoleic acid) parallel diets.
    

Detailed description: 
      Participants will be provided (weekly) with food items containing most of (>90%) the daily
      dietary fat (25-30% of daily calories) to be consumed. All study-supplied foods will be
      prepared by or acquired by the Wake Forest University Health Sciences (WFUHS) Clinical
      Research Unit (CRU) Metabolic Kitchen and distributed by the same. These foods will include
      smoothies (containing flaxseed oil common to both arms), and arm-dependent oil-based
      condiments (salad dressing, mayonnaise, and margarine) and prepared snack foods, each made
      with the arm-specific oil, as well as several packaged snacks and food items. Participants
      will be provided meal plans and recipes for home preparation of meals that will allow them to
      adhere to the target fatty acid contents of the two dietary arms. The goal of the dietary
      intervention is to provide participants with the daily fat content of their diet (25-30% of
      the daily calories) and to educate the participant to select and consume the balance of
      nutrients (60-75% of daily calories) derived from non-fat/low-fat containing foods.
    

Intervention name(s): High Linoleic Acid (LA) Diet; Low Linoleic Acid (LA) Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers will be randomly assigned to consumption of a high [10% energy] LA-containing diet for 12 weeks.; Volunteers will be randomly assigned to consumption of a low [2.5% energy] LA-containing diet for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza Vaccines
Condition: Prophylaxis of Avian Influenza Vaccine
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population
      (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects
    


Intervention name(s): Fluad H5N1 Pandemic Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): Two 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm.
Other intervention name(s): Vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bird flu; influenza vaccine; prepandemic vaccine
Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT
Condition: Non-Hodgkin's Lymphoma; Leukemia; Multiple Myeloma; Acute Myeloid Leukemia; Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal
      Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem
      cells to replace the tumor cells.
    

Detailed description: 
      This randomized phase II trial studies how well giving low dose total-body irradiation (TBI)
      with anti-thymocyte globulin followed by donor peripheral blood stem cell transplant (PBSCT)
      works in treating patients with hematologic malignancies. Giving reduced intensity total-body
      irradiation and anti-thymocyte globulin before a donor peripheral blood stem cell transplant
      helps stop the growth of cancer cells. It may also stop the patient's immune system from
      rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into
      the patient they may help the patient's bone marrow make stem cells, red blood cells, white
      blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune
      response against the body's normal cells. Giving total-body irradiation together with
      antithymocyte globulin before transplant may stop this from happening.
    

Intervention name(s): Thymoglobulin; Total-Body Irradiation; Allogeneic PBSCT or BMT; Tacrolimus; Mycophenolate Mofetil
Intervention type(s): Biological; Radiation; Procedure; Drug; Drug
Intervention description(s): Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7.; Undergo TBI; Undergo allogeneic PBSCT or BMT; Given PO; Given PO
Other intervention name(s): anti-thymocyte globulin (rabbit); ATG; Genzyme; anti-thymocyte globulin; Rabbit; Rabbit-ATG; Whole-Body Irradiation; Total Body Irradiation [TBI]; PBPC transplantation; Peripheral Blood Progenitor Cell Transplantation; Peripheral Blood Stem Cell Transplantation [Allogenic PBSCT]; Allogeneic Bone Marrow Transplantation [BMT]; Allogeneic BMT; Allogeneic Hematopoietic Stem Cell Transplantation; HSCT; Fujimycin; Hecoria; Prograf; Protopic; CellCept; MMF
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total body irradiation; Allogeneic Peripheral Blood Stem Cell Transplantation; thymoglobulin
A Phase III Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      Fruquintinib/Placebo 5 mg, QD, orally administered under fasting conditions for 3 consecutive
      weeks followed by one-week off to evaluate the survival benefit of patients with advanced
      non-squamous NSCLC treated with Fruquintinib.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial
      in patients with advanced non-squamous non-small cell lung cancer (NSCLC) treated with
      Fruquintinib who failed 2 lines of systemic chemotherapy or with non-tolerable toxicities.

      Approximately 521 subjects will be randomized to Fruquintinib group or placebo group at a
      ratio of 2:1. Patients in the two groups can receive supportive treatment.

      Randomization will be stratified by EGFR gene status (mutant vs. wild type) and history of
      treatment by VEGF inhibitors (yes vs no) .

      All subjects will receive study treatment in 4-week cycles: Fruquintinib/placebo for 3
      consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in
      the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or
      death. Subsequent anti-neoplastic treatment and survival status will be followed up after
      disease progression.
    

Intervention name(s): Fruquintinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fruquintinib is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off; Placebo is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off
Other intervention name(s): HMPL-013; HMPL-013 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NSCLC
A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery Subjects
Condition: Induction of Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, propofol-controlled phase III clinical
      trial. The primary objective is to compare the efficacy and safety between propofol and
      HSK3486 for the induction of general anesthesia in elective surgery subjects, so as to
      provide reference for marketing registration of HSK3486.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose of 0.4 mg/kg followed by 0.2 mg/kg if needed.; Initial dose of 2.0 mg/kg followed by 1.0 mg/kg if needed
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Understanding Dexmedetomidine in Neonates After Open Heart Surgery
Condition: Tetrology of Fallot; Heart Ventricle; Hypoplastic Left Heart
MeSH terms: Hypoplastic Left Heart Syndrome; Tetralogy of Fallot
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine what happens to dexmedetomidine in the body after
      it has been given to a newborn after heart surgery. We want to learn how long the drug stays
      in the body, how the drug is metabolized by the body, and how well the medicine works at a
      particular dose or amount.
    

Detailed description: 
      This is a single center, dose escalation study of a single bolus dose of dexmedetomidine
      followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op
      from cardiac surgery, and require tracheal intubation with mechanical ventilation in the
      post-op period.

      Pediatric populations may benefit from the favorable pharmacodynamic effects of this
      medication.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Precedex; Open Heart Surgery; Dexmedetomidine; Sedation
Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures
Condition: Progesterone Supplementation in Women Undergoing ART
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety of Progesterone Vaginal Ring (PVR) in women
      undergoing fresh embryo transfer (ART).
    


Intervention name(s): Progesterone vaginal ring
Intervention type(s): Drug
Intervention description(s): A flexible, non-degradable PVR containing progesterone in micronized formulation and dispersed evenly throughout the ring.
Intervention MeSH terms: Progesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Progesterone vaginal ring (PVR); Vaginal progesterone ring; Assisted reproductive technology (ART); Infertility
Pulmonary Artery Involvement in Takayasu's Arteritis
Condition: Takayasu Arteritis; Pulmonary Artery Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to analyze the clinical manifestations, imaging features, and
      prognosis-related factors of pulmonary artery (PA) involvement in Takayasu's arteritis (TA),
      and to explore the early clinical features of PA involvement in TA patients.
    

Detailed description: 
      Takayasu's arteritis patients with pulmonary artery involvement were enrolled into this
      study. The demographic information of the patients (age, sex, course of disease), symptoms at
      their admissions (cough, hemoptysis, dyspnea, palpitations, fever), laboratory examinations
      (blood lab routines, erythrocyte sedimentation rate, C-reactive protein), and imaging
      examinations (vascular ultrasonography, computed tomographic angiography, echocardiography,
      chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were collected by
      reviewing the cases. The prognostic information was collected by telephone follow-up. The
      follow-up end point was December 2015.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Takayasu's arteritis patients with pulmonary artery involvement
      
Biospecimen description: 
      serum
    
Keywords: Takayasu Arteritis; Pulmonary artery hypertension
Pre-Implementation Study of Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
Condition: Thoracic Surgery
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      The purpose of the LCCC 2202 is to evaluate the barriers and facilitators to implementing
      perioperative "ePRO monitoring". This study will inform a future hybrid effectiveness study
      (LCCC 2141:Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes
      (ePROS). Eligible thoracic surgery patients will be enrolled to ePRO monitoring using
      web-based or telephone surveys. Patients will be asked to self-report symptoms for remote
      monitoring by their care team. Patients will be approached for a semi-structured interview to
      understand the barriers and facilitators to ePRO use.
    

Detailed description: 
      This is a single-site, non-randomized study in patients receiving major thoracic surgery,
      which commonly involves chest wall incisions and overnight admission Eligible patients will
      be approached at any time point between their preoperative clinic visit and up to 30 days
      after discharge from the hospital. Approximately 60 patients will be enrolled in the study.
      Patients will complete symptom surveys via email or telephone. Concerning symptoms will
      generate alerts for the clinical care team who will follow their usual protocols for the
      management of symptoms. Patients will be purposively selected and invited to participate in a
      semi-structured interview to understand their experience using ePRO. Interviews will continue
      until 30 complete interviews are obtained and/or thematic saturation is reached.
    

Intervention name(s): Patient-reported outcomes monitoring
Intervention type(s): Behavioral
Intervention description(s): o Patient-reported outcomes will be collected from patients through web or telephone and alerts sent to providers.
Other intervention name(s): Survey
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects scheduled thoracic surgery at UNC Chapel Hill Hospital.
      
Keywords: Electronic Patient-Reported Outcome
CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation
Condition: CD19+ Malignancies: Relapse Post-allogeneic Transplant
MeSH terms: Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical
      standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels
      planned.

      Patients will be followed up regularly during the interventional phase of the study until 12
      months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually
      for years 2 and 3.
    

Detailed description: 
      Patients will receive escalating doses of 4G7-CARD T-cells (after pre-conditioning with
      Fludarabine and Cyclophosphamide), paralleling clinical standard of care with unmanipulated
      donor lymphocytes. Intra-patient dose escalation will proceed at intervals of not less than 8
      weeks, dependent on development of toxicity or evidence of efficacy and confirmation by the
      Trial Management Group.

      Three dose cohorts levels are planned, and dosing will be according to total CD3+ T- cell
      dose as this correlates with toxicity in the unmanipualated donor lymphocyte setting:

        -  Dose Level 1: 1x10^6 CD3+ T-cells/kg (starting dose for all patients)

        -  Dose Level 2: 3x10^6 CD3+ T-cells/kg

        -  Dose Level 3: 1x10^7 CD3+ T-cells/kg

      The inter-patient dosing for the first 3 patients was at least 28 days, following TMG
      confirmation.

      Patients will be followed up regularly during the interventional phase of the study until 12
      months post-final 4G7-CARD T-cell infusion. During the long term follow up phase of the study
      (years 2-3 post-final 4G7-CARD T-cell infusion) patients will be followed-up annually for
      overall survival, disease status and safety.

      All patients will enter long term follow up until 3 years post-final 4G7-CARD T-cell
      infusion.
    

Intervention name(s): Infusion of modified CAR19 T-cells (4G7-CARD T-cells)
Intervention type(s): Genetic
Intervention description(s): The original stem cells donor (or if not available the patient) will undergo unstimulated leucapheresis for generation of the Advanced Therapy Interventional Medicinal Product (ATIMP) 4G7-CARD T-cells. Escalating doses of the ATIMP will then be infused to the patient depending on outcome and any experienced side effects.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CD19+; allogeneic transplant; relapse