bioihbjkbjnl/mcl2 huggingface dataset:
A Safety/Tolerance Phase, Ascending Single Dose Study to Evaluate the Safety and Tolerability of G3P-01, a Food-Grade Pectic Product, in Healthy Volunteers
Condition: Gastrointestinal Discomfort; Performance Status
Study type: Interventional

Summary: 
      This is an interventional, open-label study to evaluate the safety, tolerability and PK of
      escalating single doses of G3P-01 in 10 healthy adult subjects. All participants will receive
      G3P-01 in sequential, escalating doses of 50mg (Period 1), 500mg (Period 2), 1,000mg (Period
      3), and 2,000mg (Period 4). A wash out period of at least 7 days will occur between doses in
      each sequential treatment period. Subjects will be admitted Day 1 and stay overnight until
      the morning of Day 2 for each treatment period. There will be a follow up call 14 days (+/- 2
      days) following the last dose of the IP.
    


Intervention name(s): G3P-01
Intervention type(s): Dietary Supplement
Intervention description(s): G3P-01 is a food-grade pectic product derived from squash.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastrointestinal; Performance
MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)
Condition: Rhinitis Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical study evaluates the efficacy and safety of MK0476 in adult patients with
      allergic rhinitis.
    


Intervention name(s): MK0476, montelukast sodium / Duration of Treatment: 2 Weeks; Comparator: placebo / Duration of Treatment: 2 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Human Behavioral Pharmacology Laboratory (HBPL) Study of Varenicline's Impact on Cocaine and Alcohol Craving
Condition: Alcohol Dependence; Cocaine Dependence
MeSH terms: Alcoholism; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II within-subjects double-blind placebo-controlled human laboratory study.
      The purpose of the study is to determine the efficacy of varenicline (Chantix) for reducing
      cue-induced cocaine and alcohol craving.
    


Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline, oral target dose of 1.0 mg BID, one week titration.; Placebo
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of an Oral Nutritional Supplement
Condition: Gastro-intestinal Tolerance
Study type: Interventional

Summary: 
      The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional
      supplement containing a new protein blend in healthy elderly subjects.
    


Intervention name(s): Study Oral Nutritional Supplement
Intervention type(s): Other
Intervention description(s): Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Study of Single-dose ALXN2050 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and
      investigator blind, sponsor open) placebo-controlled, single-ascending dose study of
      ACH-0145228 (ALXN2050) conducted in healthy adult participants.
    


Intervention name(s): ALXN2050; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder-in-capsule (PIC).; PIC.
Other intervention name(s): ACH-0145228 (formerly); ACH-5228
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Factor D Inhibitor; Complement; ALXN2050; ACH-0145228; Pharmacokinetics; Pharmacodynamics; Safety
Pro-2-Cool Device Clinical Study
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      This study is being conducted to quantify the clinical safety and efficacy of head and neck
      cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents
      participating in sporting activities.
    

Detailed description: 
      This is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that
      will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30
      patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment
      and control arm combined) for a total of up to 260 patients overall in both phases. The pilot
      study will serve as an opportunity to assess the protocol and make adjustments, if necessary.
      In addition, descriptive statistics including effect size will be calculated and the safety
      of the device will be assessed at the conclusion of the pilot study.

      Subjects will be assigned to study arm based on a block randomization schedule generated a
      priori.

      The study sponsor believes that the device and therapeutic treatment that will be evaluated
      in this study is a non-significant risk (NSR) to the subjects.
    

Intervention name(s): TecTraum device
Intervention type(s): Device
Intervention description(s): A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.
Other intervention name(s): Pro-2-Cool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Concussion; TBI; mTBI
Stem Cell Therapy to Improve Myocardial Function in Patients With Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The purpose of the study is to compare the efficiency of a sorted subpopulation of
      CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of
      patients with acute myocardial infarction and a low left ventricular ejection fraction.
    

Detailed description: 
      Aim is to compare the efficiency of sorted subpopulation of CD34+/CXCR4+ cells and unselected
      bone-marrow-derived progenitor cells in treatment of patients with acute myocardial
      infarction and low left ventricular ejection fraction. The subpopulation of CD34+/CXCR4+
      cells most likely contains the tissue-specific stem cells likely to be involved in myocardial
      salvage/regeneration after ischemic injury. This approach is novel and original, because so
      far no study identified the type of cells that actually contribute to stem cell-induced
      improvement in myocardial function in patients with AMI which were treated with unselected
      population of cells. The REGENT trial (prospective, randomized, multicentre trial comparing
      unselected BM mononuclear cells and sorted CD34/CXCR4+ cells in patients with myocardial
      infarction and low left ventricular ejection fraction) successfully treated with primary
      percutaneous coronary angioplasty within 12 hours after the onset of chest pain. The cells
      are delivered by intracoronary infusion. Efficiency is assessed by cardiac magnetic resonance
      imaging, echocardiography and left ventricular angiography.
    

Intervention name(s): Autologous bone marrow-derived stem cells
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stem cells; acute myocardial infarction; regeneration; left ventricular ejection fraction
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      Among existing surgical techniques, spinal fusion is considered as the gold standard to treat
      a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis,
      with regard to pain reduction and functional improvement. However, pseudarthrosis and failure
      to relieve low back pain are unfortunately still frequent, irrespective of the type of
      procedures and grafts used by the surgeon.

      The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a
      proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.
    


Intervention name(s): ALLOB® cells with ceramic scaffold
Intervention type(s): Drug
Intervention description(s): Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Fusion; Lumbar Interbody Fusion; Degenerative Disc Disease; Cell Therapy; Bone Graft
Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not
      yet known if celecoxib is more effective than no treatment before surgery for prostate
      cancer.

      PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before
      surgery to remove the prostate in treating patients who have localized prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare biomarker modulation (prostaglandin levels) in tissue samples of patients with
           localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by
           prostatectomy.

        -  Compare the effect of these regimens on angiogenic factors within the prostate in these
           patients.

        -  Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these
           patients.

        -  Compare the toxicity profiles of these regimens in these patients.

        -  Compare the compliance of patients treated with these regimens.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral neoadjuvant celecoxib twice daily.

        -  Arm II: Patients receive oral neoadjuvant placebo twice daily. Treatment in both arms
           continues for at least 4 weeks followed by prostatectomy.

      Patients are followed within 1 month and then at 3 months.

      PROJECTED ACCRUAL: A total of 60-70 patients (at least 30 per arm) will be accrued for this
      study.
    

Intervention name(s): celecoxib; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.; Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
Other intervention name(s): celebrex
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; adenocarcinoma of the prostate
A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control
Condition: Acute Lower Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      prulifloxacin is not inferior to levofloxacin hydrochloride in treating acute uncomplicated
      lower urinary tract infection in chinese
    


Intervention name(s): prulifloxacin; Levofloxacin; Prulifloxacin Placebo; Levofloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Levofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days.; Placebo of prulifloxacin film-coated tablet without active components.; Placebo of levofloxacin hydrochloride tablet without active components.
Intervention MeSH terms: Levofloxacin; Ofloxacin; Prulifloxacin; Fluoroquinolones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
Condition: Venous Thromboembolism
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out whether rivaroxaban is safe to use in children and
      how long it stays in the body. Safety will be assessed by looking at the incidence and types
      of bleeding events. There will also be a check for worsening of blood clots.
    


Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939)
Intervention type(s): Drug
Intervention description(s): With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant
Intervention MeSH terms: Rivaroxaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric
Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries
Condition: Cesarean Scar Niche; Cesarean Wound; Dehiscence; Cesarean Section; Dehiscence
MeSH terms: Emergencies
Study type: Observational [Patient Registry]

Summary: 
      This study was designed to evaluate the scar characteristics following scheduled and
      emergency cesarean deliveries.
    

Detailed description: 
      design and settings: This study is a descriptive, cross-sectional and multicenter study
      conducted at Tanta and Benha Universities, Egypt in the period from August, 1, 2018 to
      December, 31, 2018.

      Patients:

      Eligibility: Nine hundred patients were selected carefully according to inclusion and
      exclusion criteria. The inclusion criteria were: (i) Primipara having prior cesarean delivery
      whether scheduled or emergency (ii) Term delivery ≥ 37 weeks of gestation (iii) Multipara
      having the last delivery by cesarean either scheduled or emergency (iv) The interval
      following cesarean delivery to be 6 months at least and (v) Double-layer repair of uterus and
      (vi) Cesarean by pfannensteil incisions. The exclusion criteria were: (i) Repeat cesarean
      sections (ii) Preterm delivery (iii) Associated placental abnormalities (iv) Single-layer
      repair of uterus and (v) Refusal to participate.

      Allocations: This study is not a clinical trial so allocation is made based on
      characteristics of patients and eligibility to be allocated in either scheduled cesarean
      group or emergency cesarean group. The allocation was not equal based on the percentage of
      patients in either group. The scheduled cesarean group included 580 cases while the emergency
      cesarean group included 320 cases from both universities.

      Intervention: Cesarean scar assessment included both uterine scar and cutaneous scar. The
      uterine scar was assessed by transvaginal 3D ultrasound. The used device in both universities
      was DC-30 device of Mindray Company. All ultrasound examinations were conducted by third
      author in this study. Cutaneous scar was assessed by surgery department represented by the
      fourth author in this study. The uterine scar in both groups was examined for distance from
      internal os, length, thickness, volume, vasculature and presence of any defects. Cutaneous
      scar was examined for distance from symphysis pubis, length, shape, any depressed areas, any
      defects (hernia orifice), sinus and presence of keloid or hypertrophic scar.
    

Intervention name(s): Ultrasound assessement of uterine scar
Intervention type(s): Radiation
Intervention description(s): 3D ultrasound assessment of scar characteristics
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All patients will be selected according to inclusion and exclusion criteria.
Treatment of Severe Male Infertility - Predictive Factors (Imaging)
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Observational

Summary: 
      Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential
      differences depending on the outcome, ie. sperm recovery in consequent microdissection
      testicular sperm extraction (MD-TESE).
    

Detailed description: 
      Sperm recovery rate in non-obstructive azoospermia (NOA) men is 43% in Turku University
      Hospital, depending on the diagnosis leading to NOA. To date, there are no known parameters
      known to differentiate between successful and unsuccessful sperm recovery.

      MRI is performed on men prior to the operation, and the objective is to compare the
      functional parameters assessed by magnetic resonance imaging between the group of men with
      positive and the men with negative sperm recovery in testicular microdissection sperm
      extraction (MD-TESE).
    

Intervention name(s): MRI
Intervention type(s): Diagnostic Test
Intervention description(s): Pelvis MRI
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Azoospermic men scheduled for MD-TESE
      
Keywords: Azospermia; Micro Dissection Testicular Sperm Extraction; Male infertility; Testis; MRI
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The Automated Insulin Delivery (AID) System is an investigational insulin delivery device
      being developed for use for participants with diabetes. The purpose of this study is to
      assess the safety of the AID system and to test whether the AID System functions as designed.
      The study will last about 3 months with up to 6 days of inpatient time.
    


Intervention name(s): AID System; Insulin Lispro
Intervention type(s): Device; Drug
Intervention description(s): AID system; Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Other intervention name(s): LY8888AU; LY275585
Intervention MeSH terms: Insulin Lispro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male
      and/or female subjects, to estimate the effect of steady state lersivirine on the steady
      state pharmacokinetics of abacavir/lamivudine.
    


Intervention name(s): Abacavir/Lamivudine; Abacavir/Lamivudine; Lersivirine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Abacavir/Lamivudine 600/300 mg QD for 5 days; Abacavir/Lamivudine 600/300 mg QD for 10 days; Lersivirine 750 mg QD for 10 days
Intervention MeSH terms: Lamivudine; Abacavir; Dideoxynucleosides
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lersivirine; UK-453; 061; NNRTI; Abacavir; Lamivudine; Combivir; Pharmacokinetics; Drug Interaction; HIV; AIDS
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Condition: Keratitis; Corneal Ulcer
MeSH terms: Corneal Ulcer; Keratitis; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
    


Intervention name(s): T4020; Vehicle
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART
Condition: Human Immunodeficiency Virus; HIV
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to study the kinetics (study of the rate of change) of immune
      recovery quality and function in stored plasma blood samples of treatment-naive (not
      previously treated with antiretroviral drugs) patients with advanced human immunodeficiency
      virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active
      antiretroviral therapy (HAART) regimen.
    

Detailed description: 
      This is an ex-vivo study (study which takes place outside the organism and records immune
      parameters from stored blood and cells of a defined population without any intervention by
      the researcher) to evaluate the kinetics (study of the rate of change) of immune recovery
      quality and function in stored plasma blood samples of treatment-naive (not previously
      treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV)
      infection starting a Darunavir/Ritonavir (DRV/r)- or Efavirenz (EFV)-based highly active
      antiretroviral therapy (HAART) regimen. In previously stored plasma blood samples, the role
      of DRV/r compared with EFV in reducing T-lymphocyte activation, DRV/r compared with EFV in
      recovering T-lymphocyte immune phenotype in peripheral blood and thymic production, and DRV/r
      compared with EFV in recovering T-lymphocyte function (functional immunity) will be studied.
      Blood samples will be analyzed before (baseline) and up to 48 weeks after initiating HAART.

      Each patient will receive orally administered (given by mouth) regimens of either
      Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina or Efavirenz (EFV) +
      Tenofovir/Emtricitabina.
    

Intervention name(s): Darunavir/Ritonavir (DRV/r); Efavirenz (EFV)
Intervention type(s): Drug; Drug
Intervention description(s): Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen; Efavirenz (EFV) + Tenofovir/Emtricitabina regimen
Intervention MeSH terms: Ritonavir; Darunavir; Efavirenz
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Antiretroviral treatment-naive patients with advanced HIV infection starting a
        Darunavir/Ritonavir - or Efavirenz-based HAART regimen. Patients with advanced HIV
        infection are defined by a treatment-naïve CD4+ cell count >50 to <250 cells/mm3.
      
Keywords: Human Immunodeficiency Virus; HIV; Highly Active Antiretroviral Therapy; HAART; Darunavir; Ritonavir; Efavirenz; Kinetics; Immunological Recovery