bioihbjkbjnl/mcl2 huggingface dataset:
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for
      treatment of newly diagnosed AML patients, younger than 66 years.

      Trial is based on:

        -  INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).

        -  CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC
           (HDAC)

        -  INTENSIFICATION: Allo-BMT, ASCT

        -  MAINTENANCE: AraC

           a) Primary endpoints:

        -  Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.

        -  RFS, DFS and OS.

           b) Secondary endpoints:

        -  Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression
           and monitoring.

        -  Evaluation of prognostic clinical relevance of biological features at onset.

        -  Feasibility and outcome of consolidation with BMT.
    


Intervention name(s): FLAIMy - Fluda, Ida, Ara-C, Mylotarg
Intervention type(s): Drug
Intervention description(s): FLUDARABINE: 25 mg/m2/day, 250 FS in 30', start h 9 - 1, 2, 3, 4, 5
ARABINOSYL-CYTOSINE (Cytarabine): 2 g/m2/day, 500 FS in 3 h, start h 13 - 1, 2, 3, 4, 5
IDARUBICIN: 10 mg/m2/day, 100 FS in 1 h, start h 16 - 1, 3, 5
GEMTUZUMAB OZOGAMICIN (Mylotarg): 5 mg, single dose 500 FS in 4 h - 6
Intervention MeSH terms: Gemtuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induction chemotherapy; Fludarabine; Gemtuzumab Ozogamicin
Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A total of 201 participants with chronic HCV GT4 infection were allocated into two groups.
      One group participants were treated with SOF plus RBV (24 weeks). The second group was
      treated with SOF plus SMV (12 weeks).
    

Detailed description: 
      A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection
      were allocated into two groups based on the type of the regimen used. All eligible
      participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group
      1), or SOF plus daily oral SMV (12 weeks; group 2).
    

Intervention name(s): Sofosbuvir + Simeprevir + Ribavirin
Intervention type(s): Drug
Other intervention name(s): Olysio is a trade name of simeprevir; Sovaldi is a trade name of sofosbuvir
Intervention MeSH terms: Ribavirin; Sofosbuvir; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Egyptian patients; HCV GT4; Naive; Ribavirin; Simeprevir; Sofosbuvir; Experinced
The Role Of Local Anesthetics in the Management of Adverse Effects Associated With Intrauterine Device Application
Condition: IUD; Contraception; Pain
Study type: Observational

Summary: 
      Patients who visited our family planning clinic and opted for IUD application for
      contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who
      matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the
      study group and 41 patients who only received IUDs were included in the control group. All
      patients received copper IUDs and none of them were on additional hormonal treatment. Before
      the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1%
      procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations. Following
      IUD insertion, another 6ml of 1% procaine was injected into the Frankenhauser ganglia
      bilaterally. A final dose of 8ml of 1% procaine was injected into the abdominal trigger
      points and intracutaneously into the L4-S4 dermatomes as quaddles.
    


Intervention name(s): with NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )
Intervention type(s): Other
Intervention description(s): Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations.
Other intervention name(s): without NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Women with underlying chronic diseases which could cause chronic pelvic pain such as
        endometriosis and which makes them prone to infections such as diabetes mellitus were
        excluded from the study. Furthermore, women by whom a complication had arised during the
        IUD insertion, such as uterine perforation, were also excluded from the study.
A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions
Condition: Ischemia; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      One of the purpose of this study is to assess the preliminary safety and feasibility,and to
      provide related information and evidence for the design of the further pivotal randomized
      control trial.the other purpose is to assess the performace of the stent delivery system.
    

Detailed description: 
      1. Single-center, prospective, pilot study

        2. De novo,coronary artery, single vessel and single lesion

        3. Sample size = 45

        4. Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years

        5. Randomization 2:1 Angio and OCT scheduled follow-up in the hospital

        6. Follow-up Angio and OCT randomized 30 patients for 4-month and 15 patiens for 12-month
    

Intervention name(s): EXCEL-Ⅱ
Intervention type(s): Device
Intervention description(s): A PILOT First-In-Man Study to evaluate safety and efficacy of the EXCEL-Ⅱ with New Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions
Other intervention name(s): CREDIT-Ⅰ
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MACE; TVR; MI; TLF; Death
Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      Social anxiety disorder among youth is highly prevalent and causes significant impairment in
      the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective
      treatment, research suggests that many young people with this disorder do not have access to
      good-quality CBT. Internet-delivered CBT could be an effective method to increase
      availability of evidence-based treatments for youth with social anxiety disorder. The primary
      objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth
      (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized
      controlled trial with N = 101 participants. Participants will be randomized to either the
      active treatment arm (guided ICBT) or to a control condition (guided internet-delivered
      support and counseling). Follow-ups will be conducted at 3 and 12 months after
      post-assessment.
    


Intervention name(s): Cognitive Behavior Therapy; Support and Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms; Guided Internet-delivered support and counseling includes educative material about social anxiety and health related issues such as physical activity, nutritious diet, sleep habits etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social anxiety disorder; Cognitive Behavior Therapy; Internet-delivered treatments; Children and adolescents; Randomized controlled trial
Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease
Condition: Parkinson Disease; Apathy
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The objective of this study is to describe the evolution of hypodopaminergic syndrome in
      patients with Parkinson's disease.
    

Detailed description: 
      All patients to be included have been clinically described in the early phase of their
      disease, before instauration of dopaminergic treatment, in the context of a former study
      ("Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667") between june
      2012 and june 2016.

      3 to 5 years after this study, those patients who started dopaminergic treatment will be
      evaluated again.

      The objective of this study, which takes place 3 to 5 year after the initial evaluation, is
      to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome.

      Secondary objectives are the evolution of other parameters including pain, personality and
      behavior. All parameters measured have been determined of each patient in the Honeymoon
      study.
    

Intervention name(s): Starkstein scale of Apathy
Intervention type(s): Other
Intervention description(s): The degree of apathy will be evaluated with the "Starkstein scale of Apathy"
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinon's disease who participated in "Non Motors Aspects in De Novo
        Parkinson's Disease (Honeymoon)" NCT02786667 between june 2012 and june 2016
      
Keywords: non motor symptoms
Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      As the principal objective of this study is to evaluate the efficacy and safety of the
      treatment measuring the changes in a symptom score, the patient will be asked to fill in a
      patient diary. This diary will evaluate the week before the patient comes back to receive the
      treatment. Nose (sneeze, blockage and running), eye (itching, redness and swelling) and chest
      (breathlessness, wheeze, chest tightness), are scored on a scale from The patient will be
      instructed to daily assess each one of the symptoms, recording them on an individual symptoms
      follow-up diary.
    

Detailed description: 
      The study drug is a sublingual immunotherapy (vaccine) with allergenic extract of grass
      pollen (Lolium perenne (50%) + Cynodon dactylon (50%)). Sublingual immunotherapy has been
      available on the European market to treat patients with allergic rhinoconjunctivitis
      (itching, sneezing, stuffy nose, runny nose) for many years. In this study it will be used as
      drops under the tongue. At the beginning of the study, you will be given a card that
      documents that you are taking part. Please carry this with you at all times, in case
      treatment is necessary at another location. The drops will be given at two doses. The drops
      are held under the tongue for 2 minutes prior to swallowing.Sublingual Immunotherapy has been
      shown to be safe and effective in reducing the symptoms of allergic rhinoconjunctivitis
      (nasal allergy and allergy of the eyes).
    

Intervention name(s): Grass pollen allergenic extract (L. perenne-C. dactylon ); Grass pollen allergenic extract (L. perenne-C. dactylon ); placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Sublingual. 2 drops/daily 1000 DPP/ml 2 years; Sublingual. 2 drops/daily 10000 DPP/ml 2 years; Sublingual. 2 drops/daily 2 years
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinoconjunctivitis,; Immunotherapy
Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating
Condition: Binge-Eating Disorder; Eating Disorders; Obesity; Diabetes Type 2; Adolescent Behavior
MeSH terms: Diabetes Mellitus, Type 2; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      The aim of the present study was to specifically screen obese diabetic adolescent female
      individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst
      identified individuals, and this led to assessing the impact of binge eating disorders on
      glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.
    

Detailed description: 
      Challenges in eating for diabetic adolescents can be categorized as eating disorders (ED) and
      disordered eating symptoms (DES). Binge-eating disorder (BED) is defined as recurrent
      episodes of binge eating at least once a week over a three-month time period and it is
      accompanied by feeling the lack of control and marked distress over one's eating behaviour.
      The aim of the present study was to specifically screen obese diabetic adolescent female
      individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst
      identified individuals, and this led to assessing the impact of binge eating disorders on
      glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.
    

Intervention name(s): BED Questionnaire
Intervention type(s): Diagnostic Test
Intervention description(s): BED Questionnaire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Systolic Hypertension in the Elderly Program (SHEP)
Condition: Cardiovascular Diseases; Cerebrovascular Disorders; Heart Diseases; Hypertension
MeSH terms: Cerebrovascular Disorders; Hypertension; Cardiovascular Diseases; Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to assess whether long-term administration of antihypertensive
      therapy to elderly subjects with isolated systolic hypertension reduced the combined
      incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the
      effect of long-term antihypertensive therapy on mortality from any cause in elderly people
      with isolated systolic hypertension; possible adverse effects of chronic use of
      antihypertensive drug treatment in this population; the effect of therapy on indices of
      quality-of-life; the natural history of isolated systolic hypertension in the placebo
      population.
    

Detailed description: 
      BACKGROUND:

      More than 3 million persons in the United States over the age of 60 have isolated systolic
      hypertension. They face an excess risk (2-3 fold) of stroke, other cardiovascular disease and
      death. Population-based data show that the prevalence rises from approximately 8 percent in
      the age group 60-69 years to approximately 20 percent over the age of 80. Based on available
      data, an annual stroke rate of 2.0 percent has been estimated in this population. The
      full-scale clinical trial followed a pilot study conducted from 1980 to 1983. Recruitment in
      the trial began in March 1985 and was finished in January 1988. Follow-up ended in February
      1991. Data analysis continued through October 1996.

      DESIGN NARRATIVE:

      A randomized, double-blind trial in which 2,365 subjects were assigned to active treatment
      and 2,371 to placebo. For the active treatment group, a stepped-care regimen was used which
      included chlorthalidone 12.5 or 25 mg/day, and as needed, addition of atenolol 25 or 50
      mg/day or reserpine, 0.05 or 0.10 mg/day. Treatment goal was to reduce systolic blood
      pressure by at least 20 mm Hg from baseline and to below 160 mm Hg with minimal amounts of
      study medication. The primary endpoint was the incidence of fatal and non-fatal stroke.
      Secondary endpoints were cardiovascular and coronary morbidity and mortality, all-cause
      mortality, and quality-of-life measures.
    

Intervention name(s): chlorthalidone; atenolol; reserpine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Atenolol; Chlorthalidone; Reserpine
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of an HIV-1 gp41
      MPER-656 liposome vaccine in healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome
      vaccine in healthy, HIV-uninfected adults.

      Participants will be randomly assigned to four groups. Participants in Group 1 (Treatment 1)
      will receive 500 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6. Participants in
      Group 1 (Control 1) will receive placebo at Months 0, 2, and 6. Participants in Group 2
      (Treatment 2) will receive 2000 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6.
      Participants in Group 2 (Control 2) will receive placebo at Months 0, 2, and 6. Study staff
      will review safety data from Group 1 before deciding whether to enroll Group 2.

      Participants will attend several study visits through Month 12. Visits may include physical
      examinations, blood and urine collection, HIV testing, risk reduction counseling, and
      questionnaires. Study staff will contact participants at Month 18 for follow-up health
      monitoring.

      As of May 2020, vaccinations were discontinued for all participants.
    

Intervention name(s): MPER-656 Liposome Vaccine; Placebo for MPER-656 Liposome Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Administered by intramuscular injection; Administered by intramuscular injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Commuter Air Pollution Intervention Study
Condition: Cognitive Function; Cardiopulmonary Function; Saliva Stress Hormones; Air Pollution Exposure; Lung Inflammation
MeSH terms: Pneumonia; Inflammation
Study type: Interventional

Summary: 
      Traffic related air pollution is a well-recognised and much studied contributor to smog and
      is linked to a number of adverse health outcomes. Although traffic pollutants can travel long
      distances, exposure to the highest levels of the raw emissions can occur closest to the
      source; e.g. in a car in dense traffic conditions. Time spent in-vehicle may contribute up to
      half of commuters' daily exposure to certain air pollutants. Most new cars now have or allow
      for a cabin air filter, but it is not known how well cabin air filtration can reduce exposure
      to traffic-related air pollution.

      This intervention study will measure commuters' exposure to air pollutants in rush hour
      traffic. It will evaluate the impact of this exposure on stress hormones in saliva, and short
      term cardiopulmonary health indicators such as blood pressure, heart rate variability and
      respiratory inflammation. It will also look at effects on cognition (mental processing and
      judgement) in this real world environment where any deficit could be important to safety. In
      addition, the study will examine whether cabin air filtration can reduce the exposure to
      traffic related air pollutants and result in improvements in short term cardiopulmonary and
      cognitive function. This research will contribute to our understanding of how this
      environment contributes to Canadians' overall air pollution exposure as well as the potential
      health impacts. It will also test a potentially valuable and economical means of reducing
      exposure to traffic related air pollution in a commuting environment. The study may also
      guide the future implementation of the use of cabin filters as an exposure reduction
      intervention.

      Overall Project Objectives:

      Can cabin air filtration effectively reduce exposure to traffic related air pollution? Does
      commuter exposure to air pollution affect short term stress, and cardiopulmonary and
      cognitive function? Can cabin air filtration mitigate the health effects of commuters'
      exposure to air pollution?
    


Intervention name(s): Cabin Air Filtration; Placebo
Intervention type(s): Device; Other
Intervention description(s): No Cabin Air Filtration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Cabin Air Filtration; Particulate Matter; Commuter Exposure; Traffic Related Air Pollution
Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect
      on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male
      volunteers.
    

Detailed description: 
      The number of patient is twenty-four.Patients were randomly assigned either
      DP-R202(Sarpogrelate HCL 300mg, qd) under fasting condition or DP-R202(Sarpogrelate HCL
      300mg, qd) after eating foods.
    

Intervention name(s): High fat meal
Intervention type(s): Dietary Supplement
Intervention description(s): offer high fat-meal in the morning before drug intake.
Other intervention name(s): Other Names:; DP-R202 : DP11002-3
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)