bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in
      children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who
      are in remission.
    


Intervention name(s): MMX Mesalamine/Mesalazine (Low Dose); MMX Mesalamine/Mesalazine (High Dose)
Intervention type(s): Drug; Drug
Intervention description(s): Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (>) 23 kg to <= 35 kg; 1800 mg/day for participants weighing > 35 kg to <= 50 kg; 2400 mg/day for participants weighing > 50 kg to <= 90 kg.; Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to <= 23 kg; 2400 mg/day for participants weighing > 23 kg to <= 35 kg; 3600 mg/day for participants weighing > 35 kg to <= 50 kg; 4800 mg/day for participants weighing > 50 kg to <= 90 kg.
Other intervention name(s): Lialda; Mezavant; Mezavant; Lialda
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild; Moderate
Improving Functions in MTBI Patients With Headache by rTMS
Condition: TBI (Traumatic Brain Injury)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Headache
Study type: Interventional

Summary: 
      Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild
      traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most
      debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely
      clear. Recently, the use of non-invasive brain stimulation such as repetitive transcranial
      magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable
      chronic central pain conditions including headaches. This study aims to 1) assess the effect
      of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the
      neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS
      with function magnetic resonance imaging (fMRI).
    

Detailed description: 
      This study will only be conducted at the Veterans Affair hospital in San Diego.
    

Intervention name(s): Transcranial Magnetic Stimulation; Sham Transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.; Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
Condition: Brain and Central Nervous System Tumors; Radiation Toxicity
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such
      as thinking, attention, concentration, and memory) and may improve quality of life in
      patients who have undergone radiation therapy to the brain.

      PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving
      neurocognitive function in patients who have undergone radiation therapy for primary brain
      tumor or brain metastases.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the effect of donepezil or EGb761 on neurocognitive function in patients who
           underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months
           before study registration.

      Secondary

        -  Determine the toxicity of these drugs in these patients.

        -  Determine the quality of life of patients treated with these drugs.

        -  Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy
           in patients treated with these drugs.

      OUTLINE: This is an open-label, multicenter study.

        -  Group 1 (closed to accrual 10/09/03): Patients receive oral donepezil once daily for 24
           weeks.

        -  Group 2: Patients receive oral EGb761 three times daily for 24 weeks. In both groups
           (group 1 closed to accrual 10/09/03), treatment continues in the absence of unacceptable
           toxicity.

      In both groups (group 1 closed to accrual 10/09/03), quality of life and neurocognitive
      assessment is performed at baseline and at weeks 6 (group 1 only), 12, 24, and 30.

      Patients are followed at 6 weeks.

      PROJECTED ACCRUAL: A total of 70 patients (35 per treatment group) will be accrued for this
      study within 9.5 months. (Group 1 closed to accrual 10/09/03)
    

Intervention name(s): EGb761; donepezil hydrochloride; cognitive assessment
Intervention type(s): Dietary Supplement; Drug; Procedure
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Supportive Care
Keywords: radiation toxicity; adult mixed glioma; adult central nervous system germ cell tumor; adult brain stem glioma; adult craniopharyngioma; adult medulloblastoma; adult meningioma; adult choroid plexus tumor; adult tumors metastatic to brain; adult anaplastic oligodendroglioma; adult anaplastic astrocytoma; adult pilocytic astrocytoma; adult subependymoma; adult meningeal hemangiopericytoma; adult ependymoblastoma; adult anaplastic ependymoma; adult pineoblastoma; adult pineocytoma; adult myxopapillary ependymoma; adult glioblastoma; adult grade III meningioma; adult oligodendroglioma; adult giant cell glioblastoma; adult gliosarcoma; adult ependymoma
Effect of Hypoxia Exercise on Erythrocyte Aggregability
Condition: Hypoxia; Training
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Pathological erythrocyte aggregation reduces capillary perfusion and oxygen transfer to
      tissue. The aggregation is determined by opposing forces, the repulsive force between cells,
      cell-to-cell adhesion induced by plasma fibrinogen, and the disaggregating shear force
      generated by blood flow. The investigators investigate how hypoxic exercise affects
      intrinsic/extrinsic factors of aggregation. Sixty sedentary males were randomly assigned into
      either hypoxic (HE; FiO2=15%, n=20) or normoxic (NE; FiO2=21%, n=20) training groups for 30
      min·d-1, 5 d·wk-1 for 6 weeks at 60% of maximum work rate or to a control group (CTL; n=20).
      A hypoxia exercise test (HET, FiO2=12%) was performed before and after the intervention. The
      erythrocyte aggregation, binding affinity of fibrinogen and membrane biomarkers were
      determined by an ektacytometry and flow cytometry, respectively.
    

Detailed description: 
      The aim of this study is to clarify the effects of exercise training with and without hypoxia
      on the erythrocyte aggregation, further providing a feasible strategy for developing an
      appropriate exercise regimen that improves cardiopulmonary fitness and minimizes the risk of
      hemorheological disorders. This study evaluated the distinct effects of hypoxic exercise
      training (HE) and normaxia exercise training (NE) for 6 weeks on the following issue: (1)
      intrinsic/extrinsic erythrocyte aggregation, (2) binding affinity of fibrinogen to
      erythrocyte, (3) erythrocyte turnover rate and (4) characteristic of mature erythrocytes in
      blood, under hypoxic exercise test (HET) (100W under air 12% O2 condition) in healthy
      sedentary men.
    

Intervention name(s): Normoxic exercise; Hypoxic exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Trained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax)for 30 minutes per day, 5 days per week for 6 weeks; Trained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax)for 30 minutes per day, 5 days per week for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erythrocyte; Aggregation
IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics
Condition: Hysterectomy; Surgery
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
    

Detailed description: 
      A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
      Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical
      System with Firefly® Fluorescent Imaging
    

Intervention name(s): IS-001; da Vinci® Si/Xi Surgical System
Intervention type(s): Drug; Device
Intervention description(s): 10mg, 20mg or 40 mg IV IS-001 drug administered during surgery; robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients
Condition: Hypercholesterolemia; Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      This 8 weeks, prospective, single center, randomized, open-label, parallel-group,
      non-inferiority study was performed from October 2015 to April 2018. This study as designed
      to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin,
      ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with
      primary hypercholesterolemia and complex dyslipidemia.
    


Intervention name(s): CRESTOR, reference formulation of rosuvastatin; ROVASRO, generic formulation of rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Use of ROVASRO for hypercholesterolemia; Use of CRESTOR for hypercholesterolemia
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 10mg of the generic formulation (rosuvastatin, ROVASRO®) versus 10mg of the reference formulation (rosuvastatin, CRESTOR®)
Masking: None (Open Label)
Primary purpose: Treatment
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall purpose of the study is to assess the efficacy of three different doses of BI
      655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus
      nephritis in order to characterize the dose-response relationship within the therapeutic
      range, and select the target dose for phase III development.
    


Intervention name(s): BI 655064 dose 1; BI 655064 dose 2; BI 655064 dose 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
TVT-SECUR as an Office-based Procedure
Condition: Urinary Incontinence; Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This is a pilot study to assess the feasibility and success of performing the TVT-Secur in
      the office setting. Endpoints would be success, complications, and patient and physician
      acceptance of the procedure. Success would be assessed by validated questionnaires.

      This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure
      done in the office under local anesthesia. They will be followed for a period of 3 years.
    

Detailed description: 
      The study will include 50 patients who would meet the inclusion/exclusion criteria and who
      sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting
      from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women
      who no longer intend to bear children and who do not require any other concomitant surgery.
    

Intervention name(s): Gynecare TVT-SECUR system
Intervention type(s): Device
Intervention description(s): All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Other intervention name(s): TVT-S; Mid-urethral sling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: urinary incontinence; stress urinary incontinence; mid-urethral slings; Tension-free vaginal taping; TVT
Efficacy and Safety of Sirolimus to Vascular Anomalies
Condition: Vascular Anomaly
MeSH terms: Vascular Malformations; Congenital Abnormalities
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of Sirolimus in complicated vascular anomalies in Chinese
      children
    

Detailed description: 
      Vascular anomalies are composed of vascular tumors and vascular malformations. The prognosis
      of vascular anomalies is significantly variable. Most of them had a benign course. However,
      complicated vascular anomalies can lead to disfigurement, organ disfunction and
      life-threatening with significant morbidity and mortality. Traditional treatments, including
      steroids, vincristine, cyclophosphamide and surgery, had limited response to complicated
      vascular anomalies. In the past few years, the inhibitor of the mammalian target of rapamycin
      (mTOR) signaling pathway-sirolimus has emerged as a treatment for severe vascular anomalies.
      Besides, preclinical studies also showed that the Phosphoinositide 3-kinase (PI3K)/protein
      kinase B (Akt)/mTOR pathway play an important role in the development of vascular tumors and
      vascular malformations. However, the exact efficacious rate and complications of sirolimus
      are still unknow in china because of the lack of large scale of prospective studies.
      Therefore, it's important to perform this prospective study to determine the safety and
      efficacy of sirolimus in the treatment of Chinese children with complicated vascular
      anomalies, and this study will also make contributions to the diagnoses and treatments of
      vascular anomalies.
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention description(s): Sirolimus was initiated at a dosage of 0.8 mg/m2 administered twice daily. Subsequently, the sirolimus dosage was adjusted monthly to achieve trough levels between 10 and 15 ng/mL.
Other intervention name(s): Rapamycin
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sirolimus; Vascular anomalies
A Study of HMPL-689 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of a single dose of
      HMPL-689 in healthy volunteers To determine the pharmacokinetic profile of single oral doses
      of HMPL-689 in healthy volunteers
    

Detailed description: 
      Subjects will receive a single dose of HMPL-689 or matching placebo during Day 1. The planned
      dose levels are: 1, 2.5, 5, 10, 20, 25 and 30 mg (about 7 cohorts of 8 subjects). In each
      dose cohort, 8 subjects will be randomized to receive HMPL-689 (6 subjects) or placebo (2
      subjects) under fed condition with a standard meal.

      For the first dose Cohort (1 mg), a sentinel group of 2 subjects (1 HMPL-689 and 1 placebo)
      will be dosed 24 hours prior to the planned dosing of the remaining six subjects. The
      decision of dose escalation or study termination will be made jointly by the principal
      investigator and the sponsor based on the clinical data (safety, tolerability, available PK
      data and clinical laboratory values). Any dose level may be repeated, reduced or split into 2
      doses if deemed appropriate by the Principal Investigator and Sponsor's medical Expert.
    

Intervention name(s): HMPL-689; HMPL-689 placebo
Intervention type(s): Drug; Drug
Intervention description(s): selective PI3Kδ inhibitor; placebo of HMPL-689
Other intervention name(s): Huchison Medipharma; Huchison Medipharma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Surveillance Monitoring on General Wards
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Observational

Summary: 
      This is a study to determine if surveillance monitoring of general ward patients can reduce
      cardio-pulmonary arrest while maintaining an acceptable false alarms rate for nursing
      workload.
    

Detailed description: 
      The investigators placed a wired monitoring system (pulse oximetry, heart rate and
      respiratory rate) on every patient who arrived on a subject general post surgical ward who
      assented to wear the system. this was the Masimo PSNET system using the Radical 87 monitor
      and an acoustic respiratory sensor along with a Masimo pulse oximetry probe. Patients were
      monitored for a minimum of 48 hrs. Heart Rate (HR) parameters were set between 45-130,
      Respiratory rate was set between 6-20 and pulse oximetrry was 85-100%. Nurses documented in
      the Electronic Medical Record (EMR) any alarms they responded to as to whether they were
      false (vital sign not out of range when rechecked) or true and what the response was.
      Responses ranged from nurse managed to notification of primary service to Rapid Response
      Activation to Code team activation as well as transfer to a higher level of care (operating
      room or Intensive Care Unit (ICU)/IMC. Patient and Nursing satisfaction surveys were
      collected.
    

Intervention name(s): No intervention
Intervention type(s): Device
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Post-surgical patients on a general hospital ward
Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the excretion balance, metabolic profile and the
      routes of excretion of [14C]PF-04991532 in healthy adult male subjects.
    


Intervention name(s): PF-04991532
Intervention type(s): Drug
Intervention description(s): a single oral dose of [14C]PF-04991532 (450 mg/100 uCi suspension)
Intervention MeSH terms: 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: diabetes mellitus; ADME
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      Huahui Health is developing a treatment for Hepatitis B virus. This study is designed to
      evaluate the safety and tolerability of HH-006, a hepatitis virus neutralizing monoclonal
      antibody in healthy volunteers, and to determine its pharmacokinetic profile and
      immunogenicity.
    

Detailed description: 
      This is a double-blind, placebo-controlled, Phase Ia study aimed to evaluate the safety and
      tolerability of HH-006 after single ascending doses given as subcutaneous injections.
    

Intervention name(s): HH-006; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Different dose levels of HH-006; Different dose levels of placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial Investigating the Effect of Oral Semaglutide Compared With Placebo on Postprandial Glucose and Triglyceride Metabolism, Energy Intake, Appetite Sensations and Gastric Emptying in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the effect of oral
      semaglutide compared with placebo on postprandial glucose and triglyceride metabolism, energy
      intake, appetite sensations and gastric emptying in subjects with Type 2 diabetes
    


Intervention name(s): semaglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration once-daily.; Oral administration once-daily.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin 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: 
      Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy
      on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in
      patients with type 2 diabetes inadequately controlled with metformin.
    


Intervention name(s): Vildagliptin AM; vildagliptin pm; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; vildagliptin; Hemoglobin A1c