bioihbjkbjnl/mcl2 huggingface dataset:
Blood Transfusions in Thalassemia Patients, Complications and Adverse Effects
Condition: Thalassemia; Sickle Cell Anemia
MeSH terms: Thalassemia; Anemia, Sickle Cell
Study type: Observational

Summary: 
      Patients suffering from Thalassemia or another hemoglobinopathies required regular blood
      transfusions. The complications and adverse effects of blood transfusions can be classified
      as immediate and late. Among the immediate effects the most common are allergic reactions and
      fever, besides congestive heart failure in patients with cardiomyopathy. The late effects are
      mostly related to blood transmitted infections like HIV or Hepatitis C infections.

      The purpose of this study is to summarize the data of those complications in a cohort of 100
      patients receiving regular blood transfusion.
    

Detailed description: 
      About 100 patients aged several months to 50 years are treated in the Pediatric Hematology
      Unit, most of those patients receive blood transfusions monthly. The adverse reactions were
      routinely recorded during each transfusion. All the patients were also screened annually for
      the incidence of blood transmitted infections principally HIV and Hepatitis C. All those
      records will be systematically screened and all the immediate or late adverse reactions and
      complications related to blood transfusions will be summarized.

      A second goal of this study will be to control the staff strictness related to the ministry
      of health protocol dealing to blood transfusions.
    

Intervention name(s): Clinical medical record summary
Intervention type(s): Other
Intervention description(s): Summary of immediate and late adverse effects of blood transfusions
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients receiving blood transfusions due to chronic hematologic disorders
      
Keywords: Blood transfusions; Adverse events; Hepatitis C; HIV
A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.
Condition: Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; Healthy Subjects; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single
      ascending dose sequential group study in healthy male subjects. The objectives are to study
      the safety, tolerability, pharmacokinetics and effects on glucose homeostasis
      (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid
      receptor modulator (SGRM). The study will also assess the safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high
      doses of AZD9567 and placebo.
    

Detailed description: 
      This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single
      ascending dose sequential group study in healthy male subjects. The objectives are to study
      the safety, tolerability, pharmacokinetics and effects on glucose homeostasis
      (pharmacodynamics) of AZD9567. Additional exploratory variables (Inflammation biomarkers, ECG
      modelling and taste assessment) will also be evaluated. The study will also assess the
      safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg
      in comparison with high doses of AZD9567 and placebo. The study will be conducted at a single
      study centre with a planned number of subjects of up to 72 healthy males, aged 18 to 55
      years.
    

Intervention name(s): AZD9567 Monohydrat; Placebo oral suspension/ Placebo capsule; Prednisolone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD9567 oral suspension 0.5 to 10 mg/ml; Matching placebo; Prednisolone 60mg oral capsules (12 capsules of 5 mg each).
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: AZD9567; Healthy subjects; Phase 1; placebo controlled; single ascending dose; Pharmacokinetics; Pharmacodynamics; Rheumatoid Arthritis
Improving Representative Payeeship for People With Psychiatric Disabilities and Their Families
Condition: Schizophrenia; Bipolar Disorder; Major Depressive Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      Representative payees, mostly family members, manage Social Security Administration funds of
      more than one million people with psychiatric disabilities. Although studies show payeeship
      can be used coercively, foster dependency, reduce work incentives, lead to family conflict
      and even violence, there has been little systematic research on how to lower these
      significant barriers to community integration.

      The investigators' long term goal is to promote recovery among adults with psychiatric
      disabilities who have payees by reducing downsides associated with what has been called "the
      nation's largest guardianship system." The investigators' objective in the current
      application is to evaluate a pilot-tested, stakeholder-informed intervention that is grounded
      in principles of psychiatric rehabilitation and encourages consumers with psychiatric
      disabilities and their family members to collaborate within the representative payee
      arrangement.
    

Detailed description: 
      To do this, we will test the Steps for Achieving Financial Empowerment (SAFE) intervention by
      randomly assigning N=200 consumer-family payee dyads into one of two groups: (a) the SAFE
      intervention (n=100); or (b) a "usual care" control (n=100). The SAFE is a brief, 5 component
      educational intervention that aims to facilitate a cooperative consumer-payee relationship,
      increase accurate knowledge about representative payeeship, promote collaborative money
      management and effective budgeting, and prepare mutually developed plans for carrying out the
      payeeship in the future.

      We will interview people with psychiatric disabilities and their family payees at baseline
      and six-months. This study aims to examine the effects of the SAFE intervention on community
      participation, employment, and family support of adults with psychiatric disabilities who
      have family representative payees. Our central hypothesis, based on strong preliminary data,
      is that the SAFE will benefit consumers by enhancing autonomy, boosting motivation to work,
      and reducing family conflict.
    

Intervention name(s): Steps for Achieving Financial Empowerment (SAFE)
Intervention type(s): Behavioral
Intervention description(s): The SAFE is a brief, 5-component intervention that aims to facilitate a cooperative consumer-payee relationship, increase accurate knowledge about representative payeeship, promote collaborative money management and effective budgeting, and prepare mutually developed plans for carrying out the payeeship in the future.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate
      in the treatment of postoperative pain in different pediatric age groups following
      multiple-dose administration.

      To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.

      To compare plasma concentration of morphine sulfate in each age group of pediatric subjects
      with adult plasma morphine sulfate concentrations.
    


Intervention name(s): Morphine Sulfate
Intervention type(s): Drug
Other intervention name(s): Morphine Sulfate Oral Solution; Morphine Sulfate Tablet
Intervention MeSH terms: Morphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Observational Study to Investigate the Effects of Rapid Transmeridian Travel
Condition: Jet Lag Disorder
MeSH terms: Jet Lag Syndrome
Study type: Observational

Summary: 
      Observational study to investigate circadian rhythm patterns
    


Intervention name(s): Transmeridian travel across multiple time zones
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
PE PREMIER CHINA CLINICAL TRIAL
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM
      Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of
      Atherosclerotic Lesion(s)
    

Detailed description: 
      To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM
      Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with
      atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries
      ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)
    

Intervention name(s): Percutaneous coronary intervention PROMUS PREMIER
Intervention type(s): Device
Intervention description(s): PROMUS PREMIER
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Disease
Allo vs Hypomethylating/Best Supportive Care in MDS (BMTCTN1102)
Condition: MDS
MeSH terms: Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed as a multicenter trial, with biological assignment to one of two study
      arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation
      (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.
    

Detailed description: 
      Background: MDS is a clonal disorder of hematopoietic precursors and stem cells, which may
      evolve to a terminal phase resembling acute leukemia. A subject of clinical urgency for
      researchers, clinicians, patients, and health care underwriters such as Medicare, is the role
      of allogeneic hematopoietic cell transplantation (alloHCT) in the treatment of older patients
      with higher risk myelodysplastic syndromes (MDS). The use of reduced intensity conditioning
      (RIC) regimens has extended HCT to the care of older patients with acute myelogenous leukemia
      (AML) and lymphoma and a number of retrospective and phase II trials for patients with MDS
      now show the curative potential of RIC alloHCT in selected patients.

      This protocol is designed to evaluate the relative benefits of RIC alloHCT compared to
      non-transplant therapies focusing on overall survival. This will be done by having patients
      biologically assigned to the alloHCT arm or the hypomethylating therapy/best supportive care
      arm and following them for survival at 3 years.
    

Intervention name(s): Allogeneic Hematopoietic Cell Transplant; Hypomethylating Therapy / Best Supportive Care
Intervention type(s): Procedure; Procedure
Intervention description(s): Bone marrow or peripheral blood stem cell transplant.from a fully matched related (6/6) or unrelated (8/8) donor. The specific transplant treatment regimen will be at the discretion of the treating physician but is required to be reduced-intensity.; The specific non-transplant treatment regimen will be at the discretion of the treating physician.
Other intervention name(s): RIC alloHCT; Non-transplant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arms will enroll and have data collected on them simultaneously.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myelodysplastic Syndrome
Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian
      Federation
    

Detailed description: 
      Awareness about the disease in Russia is extremely low both among doctors and especially
      among patients. To date there are no data on the prevalence of the disease in Russia. This is
      the first study to show patient profile, main trigger factors and concomitant diseases among
      patients with Irritable Bowel Syndrome (IBS) in Russia. Also treatment characteristics for
      these patients in Russia will be measured. This study fills a lack of scientific data about
      prevalence of IBS and additional information.
    

Intervention name(s): IBS
Intervention type(s): Other
Intervention description(s): No intervention, description of routine practice only
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult subjects, male and female, aged from 18 up to 50 years with symptoms potentially
        indicative of IBS according to ROME IV criteria
      
Keywords: IBS; Irritable Bowel Syndrome; spasmolytics; mebeverine; Duspatalin
Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men
Condition: Anal Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ
Study type: Observational

Summary: 
      The goals of this application are to assess the usefulness of biomarkers, including p16
      proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV)
      types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying
      HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by
      anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it
      will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months,
      and perform HRA and biomarkers on all clients at baseline and every 12 months. Information
      from this study would inform AIN screening and follow up approaches in HIV-positive and
      HIV-negative MSM in both resource-limited and resource-rich settings.
    

Detailed description: 
      The goals of this application are to assess the usefulness of biomarkers, including p16
      proteins, MCM proteins, high-risk HPV types, and E6 and E7 mRNA/oncoproteins, as adjunct
      tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the
      characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals,
      in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives
      and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at
      baseline and every 12 months. Information from this study would inform AIN screening and
      follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and
      resource-rich settings.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        MSM with HIV negative and positive in Thailand
      
Keywords: Histological HGAIN; detected biomarkers; MSM population; HPV subtypes; AIN study; HIV-positive and HIV-negative MSM; anal cytology and biomarkers; likelihood of AIN development at month 12 and yearly thereafter
"Safeguard Your Smile" an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior
Condition: Gingivitis; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      The purpose of the investigators' study is to assess effectiveness of community based oral
      health literacy intervention promoting positive oral hygiene self-care behavior among
      Montreal's Punjabi immigrants.
    

Detailed description: 
      There will be 140 participants in this study who will be randomly allocated into either
      intervention group (70) or control group (70).The intervention group will receive one hour
      long "Safeguard Your Smile" intervention and control group will receive no intervention and
      only a conventional pamphlet. Data will be collected at baseline and after 3 months using
      three research instruments. i) Oral hygiene self-care knowledge and oral hygiene self-care
      behavior will be assessed using self administered questionnaire. ii) Using Loe and Sillness
      indices, plaque and gingival index scores will be measured. iii) And oral health literacy of
      participants will be measured with the TS-REALD tool.The data analysis will include
      descriptive statistics and frequency tables will be provided for both baseline and endpoint
      data of the both groups. Continuous variables will be summarized with mean, standard
      deviation and range and for the categorical variables; frequency counts and percentage of
      subjects within each category will be provided. An array of data analysis including t-test,
      correlations and logistic regression will be performed assessing effectiveness of the
      Safeguard Your Smile intervention.
    

Intervention name(s): Safeguard Your Smile an oral health literacy intervention
Intervention type(s): Behavioral
Intervention description(s): Safeguard Your Smile intervention will consist of following five components:
i) Reviewing photonovel (educational booklet) with participants to help them understand adequate oral hygiene self-care behavior. ii) Demonstrating adequate tooth brushing, flossing and tongue cleaning (frequency, duration and technique) on dentoform iii) Helping participants to make a concrete plan (specifying when where and how will they perform oral hygiene self-care behavior and a coping plan). Also, to identify a prompt/cue that would act as a reminder. iv) Assigning a task to participants to daily check-mark their behavioral progress on a calendar provided in the photonovel for the next three months. v) Follow up by making three phone calls to each participant of the intervention group once a month.
Intervention MeSH terms: Fenbendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oral health literacy intervention; oral hygiene behavior
Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
Condition: Acidosis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acidosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The
      study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease
      and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug
      dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug
      dosing (TRC101 or placebo) continued for 14 days once daily (QD).

      The maximum study duration per subject was anticipated to be up to 42 days.
    


Intervention name(s): Placebo; TRC101
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension; oral suspension
Other intervention name(s): Veverimer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: metabolic acidosis; serum bicarbonate; kidney disease
Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to see if apricitabine or tipranavir affect the levels of each other
      in the blood (pharmacokinetic interaction) when they are dosed together.
    

Detailed description: 
      Apricitabine is a new NRTI in development for treatment of drug resistant HIV. Tipranavir is
      a recently licensed protease inhibitor for treatment of drug resistant HIV. Tipranavir
      affects the plasma concentration of some other drugs when they are used together with
      tipranavir. This study will examine whether the pharmacokinetics of apricitabine are changed
      when it is dosed together with tipranavir compared to apricitabine alone. Also, the
      pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and
      when it is dosed together with apricitabine. Information on the safety and tolerability of
      the two drugs when dosed together will also be obtained.
    

Intervention name(s): apricitabine
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Human Immunodeficiency Virus; anti-retroviral therapy; nucleoside analogue; reverse transcriptase; apricitabine; tipranavir; bioequivalence; drug-drug interaction; pharmacokinetics
Double-blinded, Randomized, Placebo-controlled Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection
Condition: Recurrent Urinary Tract Infection in Adult Women
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Recurrence
Study type: Interventional

Summary: 
      Urinary tract infections (UTIs) are the most common bacterial infections in women, with about
      50% of women experiencing at least one UTI in their lifetime.

      The main pharmacological treatments of cystitis usually involve the use of antibiotics, in
      particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation
      and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase
      inhibitors.
    

Detailed description: 
      This is a double-blinded, randomized, placebo-controlled, parallel-group study evaluating the
      effect of the probiotic on recurrent urinary tract infection (UTI) in adult women recently
      treated for UTI.

      Primary objective The primary objective is to evaluate the effect of oral supplementation
      with probiotic on the frequency of UTI during six months from start of intervention in adult
      women with recurrent UTI.
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blinded, randomized, placebo-controlled, parallel-group
Masking: Single (Investigator)
Primary purpose: Prevention