bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of a Vitamin E Supplement in Normal Volunteers and Those With Both Allergy and Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Gamma tocopherol (gt) is a naturally occurring form of vitamin E that is found in many foods,
      and is also commercially available as a vitamin supplement. The purpose of this Phase 1
      research study is to see if two doses of gt, 600mg and 1200mg, are safe (do not cause
      gastrointestinal distress or other problems), and can cause changes in your blood levels of
      gt and other antioxidants. This study will also examine if there is a difference in response
      between asthmatic and non-asthmatic adults when taking the same dose of gt. Phase 1 research
      studies like this one are not intended to be a treatment, but are a scientific investigation.
    

Detailed description: 
      This is designed as an open label study of the effect of 600 mg and 1200mg gamma tocopherol
      (gt), orally administered daily for 8 days, on serum antioxidant levels in asthmatics and
      healthy volunteers. Each course of gamma tocopherol will be followed by a 7-8 day wash out
      period and serum testing to ensure that blood levels are back to baseline prior to starting
      the next course. The gamma tocopherol will be obtained from Yasoo Health Inc and contains
      623mg gt per 830 mg gelatin capsule.

      Allergy skin testing to a battery of allergens common to the region will be performed to
      determine the state of atopy both prior to drug administration and after the 8 day course.
      Allergic volunteers will be asked to abstain from taking any antihistamines during the 3 days
      prior to the skin testing. Repeat allergy testing will not be performed on subjects unable to
      hold antihistamines for health reasons, or on non-allergic volunteers who demonstrate no
      response to baseline testing. Spirometry will be performed to determine the current level of
      lung function. Subjects will be asked to refrain from taking vitamin supplements,
      non-steroidal anti-inflammatory medications and other dietary supplements.
    

Intervention name(s): Vitamin E supplement rich in gamma tocopherol
Intervention type(s): Drug
Intervention description(s): daily dose of Vitamin E supplement rich in gamma tocopherol
Other intervention name(s): Maxi-Gamma
Intervention MeSH terms: Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; gamma-Tocopherol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: vitamin E; gamma tocopherol; moderate to severe asthma; healthy subjects
The Use of Statins for Myocardial Death Prevention
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The administration of high dose HMG-CoA reductase inhibitors (Statins) to patients with acute
      ST-elevation MI (hypoxia/ischemia) who are treated with primary PCI (reoxygenation/
      reperfusion) will protect their cardiomyocytes from death and thus preserve LV ejection
      fraction.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): Oral Atorvastatin
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Acute ST Elevation Myocardial Infarction
Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Condition: Bursitis
MeSH terms: Bursitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety and efficacy of methylprednisolone infiltration in anserine
      bursitis treatment
    


Intervention name(s): EXPERIMENTAL; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days; Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
Other intervention name(s): DEPOMEDROL
Intervention MeSH terms: Methylprednisolone Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anserine bursitis
Integrated Supported Employment in Mainland China
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      In this randomized controlled trial, the researchers investigated the effectiveness of
      integrated supported employment (ISE) as compared with individual placement and support (IPS)
      and traditional vocational rehabilitation (TVR) for people with schizophrenia in mainland
      China.
    

Detailed description: 
      One hundred and sixty-two participants with schizophrenia were randomly assigned to ISE (n =
      54), IPS (n = 54), and or TVR (n = 54). Blinded assessments of employment status, job tenure,
      and psychological outcomes were conducted at admission, completion of the 3-mo program, and
      follow-up at 7, 11, and 15 mo.
    

Intervention name(s): Integrated Supported Employment
Intervention type(s): Other
Intervention description(s): vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multi-center Dynamic Investigation and Research on Nutritional Status of Inpatients
Condition: Nutrition
Study type: Observational

Summary: 
      we use the tools of SGA and NRS2002 to understand the nutritional status of Chinese Han
      inpatients during hospitalization and discharge, and to dynamically analyze the changes in
      the process of internal medicine and surgery in many general hospitals across Zhejiang
      Province.
    

Detailed description: 
      his study was conducted in parallel in a number of Grade-A hospitals across the country.

      The researchers used SGA and NRS2002 and other data measurement tools to collect patient
      information.

        1. General survey: initials, age, height, weight, gender, birthday, nationality;

        2. Admission and discharge diagnosis: primary diagnosis and secondary diagnosis;

        3. Laboratory indicators at admission and discharge: white blood cell, lymphocyte count,
           hemoglobin, platelet; Liver function (ALT and TBIL); kidney function (BUN and CR);
           protein (total protein, albumin and Prealbumin); blood lipids (cholesterol and
           triglycerides), etc.: The above results are subject to laboratory examinations within 3
           days of hospitalization and discharge, and collect as complete as possible;

        4. Anthropometric indicators at admission and discharge: hand grip, calf circumference or
           upper arm circumference, etc.

        5. Comprehensive evaluation tools at admission and discharge: subjective comprehensive
           nutritional assessment (SGA) and nutritional risk screening (NRS2002);

        6. Description of nutritional support during hospitalization: no nutritional support, pure
           enteral nutrition support, pure parenteral nutrition support, enteral + parenteral
           nutrition support;

        7. Clinical outcome indicators at discharge: 30-day hospitalization mortality, total
           complications, infection complications, length of stay, total medical expenses, etc.
    

Intervention name(s): Apply SGA and NRS2002
Intervention type(s): Other
Intervention description(s): Special researchers appointed by the research unit apply SGA and NRS2002 and other data measurement tools to collect patient information
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients in the hospital
      
Biospecimen description: 
      1. Newly hospitalized patients ≥ 18 years old;

        2. The length of hospital stay is 7-30 days;

        3. Those who have not undergone surgery before 8 o'clock the next day;

        4. Consciousness;

        5. Willing to accept the assessment and sign the informed consent form.
    
Keywords: SGA NRS2002 nutrition
Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial is to evaluate the utility of noninvasive
      markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic
      Fatty Liver Disease (NAFLD) by ultrasound.

      The primary objective is to determine the effectiveness of noninvasive markers for detect of
      advanced fibrosis in patients with diagnosis of fatty liver disease.

      The secondary objectives are:

        -  To determine the increase in health care with the specialist (gastroenterologist or
           endocrinologist).

        -  To determine which noninvasive evaluation strategy favors any treatment of fatty liver
           disease.
    


Intervention name(s): Electronic detailed information; NAFLD Score; Transient elastography
Intervention type(s): Other; Other; Other
Intervention description(s): Electronic detailed information about non alcoholic fatty liver disease.; diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854; Transient elastography values greater than 8 kPa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Hepatic fibrosis; Steatosis; Noninvasive markers.
A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to
      cirrhosis patients with ascites despite having received treatment with conventional diuretics
      and the change in body weight from baseline at the time of the final administration will be
      compared between the two groups.
    


Intervention name(s): OPC-41061; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days; Once-daily oral administration of placebo after breakfast for 7 days
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cirrhosis; ascites; Tolvaptan; OPC-41061
Ingestion of Beta-alanine Effects in Well-trained Tennis Players
Condition: Beta-alanine; Placebo
Study type: Interventional

Summary: 
      Beta-alanine is considered as ergogenic aids with good to strong evidence for improving
      sports performance in specific sports context scenarios. However, most of the studies has
      been realized in endurance, with limited evidence in intermittent sports, especially in
      racket sports. Thus, the aim of this study was to explore the effects of 4-weeks ingestion of
      beta-alanine on neuromuscular performance in well-trained tennis players.
    

Detailed description: 
      Fourteen tennis players (23.3 ±3.7 years) between 50-250 national tennis ranking participated
      in this study. Participants were randomly divided into two groups that realized a
      neuromuscular battery after beta-alanine (4.8 gr/daily during 4-weeks) or placebo (i.e.,
      fructose) (4.8 grams/daily during 4-weeks). Before and after the supplementation period
      tennis performed a neuromuscular test battery in a tennis court consisted in different test
      such as; serve velocity, countermovement jump, isometric handgrip strength, 10-m sprint,
      modified 5-0-5 agility test and repeated sprint ability. After 48 h of the realization of
      neuromuscular test battery, tennis players performed VO2max consumption test (i.e.,
      treadmill).
    

Intervention name(s): Beta-alanine supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): In a randomized order, two groups (n=7) was randomly assigned to beta-alanine and placebo during a 4-weeks period
Other intervention name(s): Placebo supplementation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial
      in subjects with type 1 diabetes mellitus.

      Each subject will be administered individualised single subcutaneous doses of BioChaperone
      Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin®
      Normal) immediately before ingesting a standardised mixed meal.

      Following trial drug administration, PK and PD assessments will be carried until 6 hours
      after start of the standardized test meal.

      The total trial duration for an individual subject will be up to 11 weeks.
    


Intervention name(s): BioChaperone Human Insulin (HinsBet®); Insulin Lispro (Humalog®); Regular human insulin (Huminsulin® Normal)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake; Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake; Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Cerebrospinal Fluid (CSF) Biomarkers Alzheimer's Disease (AD) and Non-AD Dementias
Condition: Alzheimer's Disease; Dementias
MeSH terms: Alzheimer Disease; Dementia
Study type: Observational

Summary: 
      To establish a cutoff value using a ratio of CSF tau to Aβ42 (tau/Aβ42) for distinguishing
      patients wth mild to moderate Alzheimer's disease (AD) from health elderly control subjects.
      The investigators hypothesize that a cutoff can be found that has at least 80% sensitivity
      and 60% specificity.
    

Detailed description: 
      This study will enroll 50 AD subjects, 50 normal controls and approximately 20 subjects with
      non-AD dementia. There will be 2 visits (up to 30 days apart), and a telephone follow-up
      visit.

      This protocol does not include treatment of subjects. Lumbar puncture and phlebotomy are
      routine clinical tasks and are associated with a low level of risk. All adverse events will
      be documented and reviewed by the PI.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Duke Memory Disorders Clinic
      
Biospecimen description: 
      Blood, urine and cerebral spinal fluid.
    
Keywords: non-AD dementias; healthy elderly controls
An Observational Study of GP Verbal Reminders Upon Cervical Screening
Condition: HPV-Related Cervical Carcinoma; Physician-Patient Relations
Study type: Observational [Patient Registry]

Summary: 
      Cervical cancer screening is offered to all women in the United Kingdom (UK) between the ages
      of 24.5 and 64 years of age. The majority of screening is performed in primary care and the
      rate remains stubbornly below 80%, despite an automated national invitation system. This
      study is designed to assess the effectiveness of a physician invitation during a telephone or
      face-to-face primary care appointment upon non responders of automated invitations, to
      increase the uptake of cervical screening.
    

Detailed description: 
      It is estimated that between 800 and 2,000 deaths a year are now prevented due to the
      effectiveness of the UK's national cervical screening programme and mortality rates have
      dropped by over 75% since the 1970s. These statistics corroborate the importance of the
      screening programme in reducing mortality from cervical cancer. Cervical screening rates in
      the UK remains stubbornly below 80% and interventions are needed to attract the 20% who are
      missing out on screening. This prospective observational study is designed to measure the
      impact of a physician intervention in a usual healthcare environment, amongst a heterogeneous
      patient population to yield replicable real-world results. The intervention arm will receive
      a physician intervention to inform them of their overdue screening status, remind them of the
      importance of cervical screening and guide them to book a screening appointment. The
      screening rate in the intervention arm will be compared to a control made up of patients seen
      by other clinicians and receiving unstructured reminders. The results will assist physicians
      in deciding whether a structured intervention is anymore effective than the unstructured
      advice currently given at improving screening rates in the non responder population.
    

Intervention name(s): Cervical Screening Reminder
Intervention type(s): Behavioral
Intervention description(s): Verbal reminder and if seen face-to-face, a written appointment booking slip.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients registered at the Gill Medical Centre, who have a cervix, are eligible for
        cervical screening and have been non responders to the automated national invitation. These
        patients are opportunistically recruited when they are consulted by the principal
        investigator.
      
Keywords: Cervical Screening; Primary health care; Physician intervention
Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy
Condition: Myopic Traction Maculopathy
MeSH terms: Myopia; Macular Degeneration
Study type: Observational

Summary: 
      The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular
      retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent
      vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to
      evaluate ultrastructure with electron microscopy.
    


Intervention name(s): Vitrectomy with internal limiting membrane peeling
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who underwent vitrectomy with internal limiting membrane peeling for myopic
        traction maculopathy
      
Biospecimen description: 
      Excised internal limiting membrane during the surgical treatment for myopic traction
      maculopathy
    
Keywords: Myopic traction maculopathy
Postoperative Epidural Analgesia in Spine Fusion Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL +
      Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and
      mobilization maneuvers.
    


Intervention name(s): 0.125% Bupivacaine HCL @ 4-5 ml/h; 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h; 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fentanyl; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative; spine surgery
Use of Low-level Laser Therapy (808nm) to Muscle Fatigue Resistance
Condition: Healthy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The study hypothesis is a improved muscle fatigue resistance induced by low-level laser
      therapy applied between sets of intense exercises.
    


Intervention name(s): Low-level laser therapy (808nm); isokinetic exercise; Placebo low-level laser therapy
Intervention type(s): Device; Other; Device
Intervention description(s): Use of low-level laser therapy(LLLT)or placebo-LLLT applied on quadriceps femoris muscles between sets of isokinetic knee flexion-extension exercise
Other intervention name(s): Low-level laser therapy;; Placebo low-level laser theraphy; Laser device (808nm; 100mW; DMC®, Brazil).; Isokinetic knee flexion-extension exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low-level laser therapy; Muscle fatigue resistance
A Safety Study of ARRY-300 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per
      subject), designed to test the safety of investigational study drug ARRY-300 in healthy
      subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.
    


Intervention name(s): ARRY-300, MEK inhibitor; oral; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose, escalating; matching placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Adequacy of Perioperative Cefuroxime Dosage According to the BMI
Condition: Obesity; Drug
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was
      increased if the BMI was over 30kg/m*m and as well over 50kg/m*m. Drug levels were measured
      in blood and tissue.
    

Detailed description: 
      Cefuroxime is an often used antibiotic for surgery antibiotic prophylaxis to avoid surgical
      wound infection. In this study the dosage of cefuroxime was adjusted to the BMI:

      less than 30kg/m*m: 1,5g 31-50kg/m*m: 3,0g more than 50kg/m*m: 4,5g

      Cefuroxime was applicated 30 to 60 minutes before the begin of surgery. Drug Levels in blood
      and fat tissue were measured at skin cut (30-60 minutes after application of Cefuroxime), 45
      minutes after skin cut (75-105 minutes after minutes after application of Cefuroxime) and at
      the end of surgery (up to 150 minutes after application of Cefuroxime) .

      The hypothesis of this study is that adequate drug levels are reached in all groups.
    

Intervention name(s): Cefuroxime 1,5g; Cefuroxime 3g; Cefuroxime 4,5g
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients with BMI of <30kg/m*m: 1,5 g Cefuroxime; Patients with BMI of 30-50kg/m*m: 3g Cefuroxime; Patients with BMI of >50kg/m*m: 4,5 g Cefuroxime
Intervention MeSH terms: Cefuroxime; Cefuroxime axetil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: BMI: <30kg/m*m: 1,5g, 31-50kg/m*m: 3,0g, >50kg/m*m: 4,5g
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Surgery; Obesity; Drug; Antibiotics; Cefuroxime