bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
Condition: aGVHD
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy and safety of combined ATG
      （antithymocyte globulin ） regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in
      matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).
    

Detailed description: 
      Transplantation with G-CSF （Granulocyte colony stimulating factor ）mobilized peripheral blood
      stem cell (PBSCT) has been a stable transplant setting with matched sibling donor
      transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in
      patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was
      associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with
      matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen
      with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of
      GVHD and improvement of long-term quality of life of the transplant recipients, which
      motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in
      MSD-PBSCT.
    

Intervention name(s): ATG; CsA; mycophenolate mofetil; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): rabbit ATG（Sanofi）; cyclosporine (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered.; From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.; short-term methotrexate
Other intervention name(s): Thymoglobuline; Neoral/Sandimmun; MMF（Novartis）; MTX(Pfizer)
Intervention MeSH terms: Mycophenolic Acid; Methotrexate; Thymoglobulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ATG; Matched sibling donor; peripheral blood stem cell transplantation
Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia
Condition: Ventilator Associated Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Interventional
Phase: Phase 4

Summary: 
      Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against
      Gram-negative and Gram-positive bacteria. This agent is often used as the last line of
      therapy for highly resistant Gram negative bacilli nosocomial infections. In common with
      other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that
      correlates with the therapeutic efficacy is the time that concentrations in the tissue and
      serum are above the MIC and administration by continuous infusion is the preferred mode of
      administration to maximize this parameter.

      However, in tropical countries, the stability of carbapenem antibiotics is an important
      consideration when considering continuous infusion. Therefore, prolonged infusion may be a
      useful mode of administration to maximize bactericidal activity. This study will demonstrate
      the stability of imipenem in clinical use at room temperature in tropical countries.
    


Intervention name(s): Imipenem; Imipenem
Intervention type(s): Drug; Drug
Intervention description(s): Each patient will receive a loading dose of 0.5 g 3 min infusion followed by 0.5 hr infusion of 0.5 g every 6 hr of imipenem at room temperature; Each patient will receive a loading dose of 0.5 g 3 min infusion followed by 4 hr infusion of 1 g every 8 hr of imipenem at room temperature
Other intervention name(s): Tienam; Tienam
Intervention MeSH terms: Imipenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patients with ventilator-associated pneumonia
The Role of Lactate in Viral and Bacterial Infection
Condition: Viral Infection; Bacterial Infections; Lactate Blood Increase
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Virus Diseases; Hyperlactatemia
Study type: Observational

Summary: 
      Acute upper respiratory tract infection(AURI) is common in children, and viral infection is
      the main cause. However, several children with viral infection are easy to suffer from
      secondary bacterial infection, and the mechanism is unclear.
    

Detailed description: 
      Lactate is an important molecule in the spread and metastasis of tumor by suppressing the
      innate immune response. As is known, the immune system is not mature in children and it is
      reverse related to the age of children. An reasonable hypothesis is that the lactate is a
      independent risk factor in the children with viral infection progress to bacterial infection.
      Here, our aim is to test the hypothesis.
    

Intervention name(s): viral infection; viral and bacterial infection
Intervention type(s): Other; Other
Intervention description(s): a child is infected by virus only; a child is infected by virus and progress to bacterial infection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The age of a child ranged from 0 to 18 is included in the present study, especially the
        first viral infection.
Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial
Condition: Depression in Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Depression; Depressive Disorder
Study type: Observational

Summary: 
      Minimal hepatic encephalopathy (MHE) is an important clinical variant of hepatic
      encephalopathy (HE), which occurs in up to 60-70% of patients with cirrhosis. The condition
      comprises a cognitive impairment, observed in patients with cirrhosis who have no clinical
      evidence of overt hepatic encephalopathy (OHE). It is associated with an increased incidence
      of road traffic accidents, reduced quality of life and it affects the ability to perform
      tasks of daily living. Successful treatment of hepatitis C has been reported to be associated
      with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and
      90% reduction in risk of liver transplantation. In addition, studies have shown that viral
      eradication may improve cognition when given interferon based regimens for HCV. With the
      available of safe, efficacious, all oral regimens for HCV, we plan to prospectively analyse
      the change in mood, depression and cognitive function in response to DAA therapy, in relation
      to outcomes of treatment.
    

Detailed description: 
      Investigations will be performed according to the Declaration of Helsinki and approval of the
      enrolment as well as the usage of patient blood samples for research purpose will be obtained
      from the institutional ethics committee, and written informed consent will be obtained from
      all patients.The primary analysis upon which the sample size consideration was based involved
      the comparison of the SVR subgroup and the subgroup of patients without SVR. For the sample
      size calculation, we a two-factorial design (time course × SVR) with the use of a two-way
      analysis of variance (ANOVA) analysis, a significance level of 5% and a statistical power of
      at least 80% to detect a medium effect size (d = 0.5) and thus to show a significant group
      difference. Based on this background, the optimal sample size is calculated to be a total of
      102 subjects. To consider asymmetric subgroups and to allow for a moderate dropout rate and
      additional calculations (secondary study objectives), we aim to include a total of at least
      150 study participants in each group with 25 healthy volunteers as controls.
    

Intervention name(s): Depression and Cognitive Tests
Intervention type(s): Other
Intervention description(s): Health Related Quality of Life, neurocognitive tests, PHES
Other intervention name(s): SF36
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Chronic hepatitis C Infection
      
Keywords: Neurocognition, Minimal hepatic encephalopathy, Direct antivirals, DAAs, Chronic hepatitis C
Methotrexate Adherence in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational [Patient Registry]

Summary: 
      This study was conducted for assessment of adherence of Rheumatoid Arthritis patients to
      Methotrexate as a gold standard drug for treatment of R.A. Moreover, evaluating the effect of
      drug adherence to patient quality of life.
    

Detailed description: 
      Rheumatoid arthritis one of most common autoimmune diseases. characterized by numerous
      complications which may affect patient quality of life. Hence, this review aim to search the
      relation between patient"s drug adherence and clinical health outcome. our review utilizing
      survey as a tool to collect needed data from rheumatoid patients. survey consisted of number
      of questions , participants were required to answer these questions. participation to this
      questionnaire was optional.
    

Intervention name(s): Rheumatoid Arthritis
Intervention type(s): Other
Intervention description(s): Rheumatoid Arthritis Disease (R.A)
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The survey participants were adults diagnosed as RA patients in accordance to 2010
        ACR/EULAR classification criteria.
Efficacy and Safety of Sodium Benzoate in the Management of Hyperammonemia in Infants, Children and Adolescent With Chronic Liver Disease.
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases; Hyperammonemia
Study type: Interventional

Summary: 
      Subject will be randomize in two groups. Group A will receive drug packets containing 2.5 gm
      sodium benzoate and 5 gm powdered table sugar for 5days.Since the dosage of Sodium Benzoate
      is Sta t250mg/Kg and then 250mg/Kg in next 24 hours, each patient would be given 750mg /kg
      stat and 750mg /kg in next 24 hours,keeping in view that 2/3 of powder used would be powdered
      sugar in the intervention arm. The dose of the powder used would be doubled in case of the
      ammonia level more than 300 mcg/dl. The drug will be prepared in sterile water and
      administered per orally or via the nasogastric tube. All the enrolled patients would be
      treated with SMT as per the recommendations of the EASL/AASLD 2014 guidelines of management
      of hepatic encephalopathy.

      Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is
      similar in appearance and taste as sodium benzoate.
    


Intervention name(s): Sodium Benzoate; Powdered table sugar as palcebo
Intervention type(s): Drug; Other
Intervention description(s): Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.; Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.
Intervention MeSH terms: Sodium Benzoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigating the Interactions of AZD0530 With Alcohol in Social Drinkers
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this alcohol-interaction pilot study is to provide information on the effect
      of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses,
      including stimulation, sedation, intoxication, body sway and physiological responses. The
      investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol
      related responses. This is a within subjects open label study in which the investigators plan
      to run 8 subjects to obtain 5 completers.
    

Detailed description: 
      The purpose of this alcohol-interaction pilot study is to provide information on the effect
      of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses,
      including stimulation, sedation, intoxication, body sway and physiological responses. The
      investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol
      related responses. This is a within subjects open label study in which the investigators plan
      to run 8 subjects to obtain 5 completers.

      Subjects will participate in two lab sessions, one prior to taking medication and one
      following 8-11 days of AZD0530. During each session, participants will receive successive
      doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80
      mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to
      the peak blood alcohol content (BAC) we have observed in prior research studies.Subjects will
      be monitored throughout the lab session and will receive a phone call two days following the
      2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any
      remaining side effects from the medication.

      Once it is determined that there is no change in the pharmacokinetics of alcohol or AZD0530,
      as well as no difference in behavioral or cognitive responses to alcohol in the presence of
      AZD0530, the investigators will begin the pilot study examining the effects of two doses of
      AZD0530 on behavioral measures related to alcohol self-administration following a fixed dose
      of alcohol in alcohol abusive or dependent heavy drinkers, and compare responses to those
      obtained from historical controls who were treated with placebo in Study 1. Subjects will be
      randomized to one of two doses of AZD0530 (50 mg/day or 125 mg/day) as a between subjects
      factor.
    

Intervention name(s): Saracatinib
Intervention type(s): Drug
Intervention description(s): Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session
Other intervention name(s): AZD0530
Intervention MeSH terms: Saracatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Polarity Therapy for American Indian Caregivers of Dementia Patients
Condition: Stress; Depression; Anxiety
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effectiveness of polarity therapy (PT), a
      complementary and alternative medicine treatment, in American Indian caregivers living in the
      Pacific Northwest.
    

Detailed description: 
      The caregivers of people with dementia experience high levels of stress and are at
      particularly high risk for physical and mental illness. Although stress and illness are
      serious problems among American Indian caregivers in the Northwest, few studies have
      concentrated on this population. PT is a treatment that involves awareness of one's energy
      field and touch therapy; it has been shown to provide several physiological, biological, and
      psychological benefits. This study will determine whether PT is more effective than respite
      from caregiving in reducing stress, anxiety, and depression and improving health function and
      overall quality of life in American Indian caregivers.

      Participants will be randomly assigned to receive either eight weekly sessions of PT or 3
      hours of weekly respite from caregiving for 8 weeks. At the beginning of the study and at
      Weeks 4 and 8, participants will complete questionnaires and self-report scales on stress,
      anxiety, depression, and quality of life. In addition, heart rate variability and levels of
      cortisol will be measured at study entry and Weeks 4 and 8.
    

Intervention name(s): Polarity therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Caregivers; Complementary Therapies
Experimental Study of Detection an Intentional Performance Degradation in Grip Strength
Condition: Pain
Study type: Observational

Summary: 
      In this study, the detection of the feigning weakness in grip strength is measured using
      different grip strength testing instruments. Patients with injury of the upper limb are
      compared to patients with injury of the lower limb as well as healthy controls.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        chronic pain patients patients with injury at the upper extremity healthy subjects
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of one
      or more doses of AP30663 for cardioversion in adult participants with AF.
    


Intervention name(s): AP30663; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administer by intravenous infusion.; Placebo matched to AP30663.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Egg White Supplementation in High-Intensity Functional Training
Condition: Exercise Training; Dietary Supplements
Study type: Interventional

Summary: 
      High-intensity functional training (HIFT), a new version of high-intensity interval training,
      has gained interest in recent years. HIFT is based on the CrossFit training template and
      includes multijoint movement patterns via both endurance and strengthening exercises.
      Research has shown positive effects of HIFT on body composition, cardiorespiratory fitness,
      and muscle performance of young individuals. The effectiveness of HIFT in higher ages and its
      protein requirements are less well documented. Protein requirements have been widely
      investigated in resistance training, where it has been found that protein supplementation may
      have additive beneficial effects on muscle strength and lean body mass. However, there is a
      research gap regarding the adaptations to HIFT when combined with protein supplementation.

      Thus, the aim of this research is to compare the effects of egg white supplementation, whey
      protein supplementation (as a positive comparator), and maltodextrin (a carbohydrate as
      placebo) on body composition, physical performance, and plasma amino acid profile in young
      and middle-aged trained individuals of both sexes who perform HIFT. Participants will take
      all three supplements for 6 weeks each, with 2 weeks of washout (no supplementation) in
      between, in random and counterbalanced order. Researchers will not know the supplementation
      status of the participants. Participants will receive 0.6 g of protein or placebo per kg body
      weight daily on top of isoenergetic dietary plans to avoid differences in energy intake that
      might compromise the validity of the study. The dietary plans will be individualized and will
      provided 1.0 g protein/kg body weight/day. The HIFT protocol will include multimodal patterns
      of movement, combining endurance and strengthening exercises with the use of equipment such
      as Total Resistance eXercise (TRX), Bosu, kettlebells, and barbells.

      Participants will undergo measurements of muscle strength, muscle endurance, aerobic
      capacity, and body composition at the beginning and end of the study, as well as during the
      two washout periods. Also, plasma amino acids, hematology, biochemistry, and hormones will be
      measured. Comparison of all these outcome measures between supplements will reveal whether
      protein supplementation is useful in HIFT.
    


Intervention name(s): Egg white; Whey protein; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Intake of egg white; Intake of whey protein; Intake of maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Phase II Clinical Trial of OCH-NCNP1
Condition: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the efficacy and safety of OCH-NCNP1 compared to placebo in
      subjects diagnosed with relapsing remitting multiple sclerosis (RRMS) and secondary
      progressive mltiple sclerosis (SPMS) .
    


Intervention name(s): OCH-NCNP1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OCH-NCNP1 3mg is supplied as granules and take orally once a week.; Placebo is supplied as granules and take orally once a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Non-invasive Methods of Lung Ventilation in Patients With Respiratory Failure After Cardiac Surgery
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Comparison of the effectiveness of three methods of non-invasive ventilation in patients with
      mild and moderate respiratory failure in the early postoperative period after cardiac surgery
    

Detailed description: 
      The study includes the comparison of the three methods of non-invasive ventilation:
      non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow
      nasal oxygenation) and non-invasive ventilation with a helmet in patients with mild and
      moderate respiratory failure in the early postoperative period after cardiac surgery. It
      assumes 90 randomized patients:30 patients in three study groups male and female aged 30 to
      60 years of age inclusive, with mild or moderate respiratory failure.The study will be
      randomized, single-center, prospective.
    

Intervention name(s): Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet
Intervention type(s): Procedure
Intervention description(s): Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet for tackling the problem of respiratory failure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment