bioihbjkbjnl/mcl2 huggingface dataset:
Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT
Condition: Hematological Neoplasms; Recurrence
MeSH terms: Hematologic Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with
      hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation
      (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years,
      without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).

      Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon
      alpha-2b (Peg Intron®; Schering-Plough) 1~1.5ug/kg qw, until occurrence of grade II or higher
      grade of acute GVHD, or no response to treatment after 8 doses of treatments.
    

Detailed description: 
      Eligible patients were age 14 to 60 years with molecular, hematological or radiography
      relapsed hematological malignancies post allogeneic hematopoietic stem cell transplantation.

      Molecular relapse was defined as reappearance or 1 log increase of molecular markers or
      decreasing donor chimerism by more than 5%; Hematological relapse was defined as reappearance
      of blast in bone marrow smear by more than 5%; radiography relapse was defined as enlargement
      of lymph nodes by more than 25% or infiltration of tumor cells in other sites.

      Patients were excluded if they need immunosuppressant treatment for ongoing grade II～IV acute
      GVHD or moderate to severe chronic GVHD.

      Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®;
      Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until
      occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8
      doses of treatments. Patients were followed up every week. Physical exams and blood tests
      including complete blood count (CBC), chemical were performed every week. Disease status
      evaluation was performed every month.

      Number of subjects: 50 Single center, one group, prospective.
    

Intervention name(s): Peg interferon alfa-2b
Intervention type(s): Drug
Intervention description(s): Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments.
Other intervention name(s): PEG INTRON®
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematological Neoplasms; recurrence; Hematopoietic Stem Cell Transplantation; peginterferon alfa-2b; Graft vs Host Disease
SMS Reminders for Positive FOBT Follow-up
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      A randomized controlled trial to examine the effect of 3 mobile telephone text message
      reminders on followup colonoscopy 120 days after a positive fecal occult blood test among
      Meuhedet members aged 50-74 who tested positive in 2016.
    

Detailed description: 
      Background: Fecal occult blood tests are recommended by the US Preventive Services Task Force
      as a screening method for colorectal cancer, but they are only effective if positive results
      are followed by colonoscopy. Surprisingly, a large proportion of patients with a positive
      result do not follow this recommendation.

      Objective: To examine the effectiveness of a short message service in increasing adherence to
      colonoscopy follow-up after a positive fecal occult blood test.

      Methods: This randomized controlled trial was conducted with patients who had positive
      colorectal cancer screening results. Randomization was stratified by residential district and
      socioeconomic status. Subjects in the control group (n = 238) received routine care that
      included an alert to the physician regarding the positive Fecal occult blood test result. The
      intervention group (n = 232) received routine care and three short message service reminders
      to visit their primary care physician. Adherence to colonoscopy was measured 120 days from
      the positive result. All patient information, including test results and colonoscopy
      completion, were obtained from their computerized medical records. Physicians of the study
      patients completed an attitude survey regarding FOBT as a screening test for colorectal
      cancer. The intervention and control groups were compared using chi-squared for discrete
      variables. Logistic regression was used to calculate odds ratios and 95% confidence intervals
      for performing colonoscopy within 120 days, adjusting for potential confounders of age,
      gender, socioeconomic status, district, ethnicity, intervention group and physician's
      attitude.
    

Intervention name(s): SMS
Intervention type(s): Behavioral
Intervention description(s): Text reminders to mobile telephone
Other intervention name(s): mobile text reminder
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomisation into Intervention and control groups. Text message sent to Intervention group. No intervention in control group
Masking: Double (Participant, Care Provider)
Primary purpose: Screening
A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)
Condition: Muscle Anabolism
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the use of fractional synthetic rate as an early biomarker of
      muscle anabolism (muscle build-up).
    


Intervention name(s): Comparator: Testosterone 300 mg, intramuscular injection; Comparator: Testosterone 100 mg, Intramuscular injection; Comparator: Placebo given by Intramuscular Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.
Day 1 & 7 - Testosterone 300 mg, Intramuscular injection.; Day 1 & 7- Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.
Day 1 & 7 - Testosterone 100 mg, Intramuscular injection.; Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.
Day 1 & 7 - Placebo given as intramuscular injection.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Males with low-normal serum total testosterone levels.
Relaxation Response Training to Treat Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Interventions such as Relaxation Response appear to have widespread effects on physiology.
      Endothelial function, changes in genomic expression, several biomarkers have been associated
      with chronic stress and cardiovascular dysfunction, and there is some suggestion that
      elicitation of the Relaxation Response may lead to improvement in-or normalization of-these
      factors. By studying the impact of the Relaxation Response on endothelial function, genomic
      expression and biomarkers among subjects with hypertension, it may be possible to better
      understand the biologic underpinnings of Relaxation Response-type interventions. Furthermore,
      with a greater understanding of the physiologic mechanisms by which the Relaxation Response
      works, it may be possible to better target other symptoms and conditions that can be
      effectively treated by such an intervention.
    


Intervention name(s): Relaxation Response; Relaxation Response
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Relaxation Response is a type of relaxation. The goal of the Relaxation Response is to consciously elicit a reaction opposite in direction to the stress response.; Relaxation Response is a type of relaxation. This is a technique that elicits a state that is opposite to the stress response.
Other intervention name(s): Meditation; Meditation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Stage 1 hypertension
One-Day Versus Three-Day Bowel Preparation for Colonoscopy in Children
Condition: Bowel Preparation; Pediatric Colonoscopy
Study type: Observational

Summary: 
      This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day
      bowel preparation in a pediatric population. Limited data is available in this regard, and
      this study supports the use of a one-day bowel preparation, as this is both safe and
      effective.
    

Detailed description: 
      Colonoscopy in children and young adults is performed by gastroenterologists for a variety of
      indications, including but not limited to evaluation of rectal bleeding, chronic diarrhea,
      family history of polyposis syndromes and surveillance for colon cancer in patients with
      inflammatory bowel disease. A successful bowel preparation that enables clear visualization
      of the intestinal mucosa is essential to diagnose and treat the underlying pathology.
      Currently, gastroenterologists use a variety of colon cleansing preparations, but
      Polyethylene Glycol (PEG) 3350 given for three to four days appears to be standard. Though it
      is well tolerated, safe and effective the duration of preparation may cause disruption to the
      routine and missed school days. To date, there is limited data that shows efficacy of a
      shorter duration of bowel preparation with PEG. This study aims to compare the efficacy and
      safety of a one-day preparation with that of a three-day preparation with PEG 3350 as
      preparation for colonoscopy in children and young adults.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children between 2 and 21 years of age undergoing elective colonoscopy were enrolled into
        the study.
      
Keywords: Pediatric Colonoscopy; Bowel Preparation; Safety; Tolerability
Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels
Condition: Heart Arrest; Sport Injury; Inflammatory Response; Oxidative Stress
MeSH terms: Heart Arrest; Athletic Injuries
Study type: Observational

Summary: 
      Prospective observational study to determine predictors that related to cardiac troponin I
      (cTnI) release, malondialdehyde (MDA) and high sensitivity C Reactive Protein (hs-CRP) after
      Tour de Borobudur (TdB) 2017
    

Detailed description: 
      Eligible Criteria:

        1. minimum sample size of 80 men, non-athlete, participants of TdB

        2. Classified into two groups: 160kms cycling and 100kms cycling participation

        3. 25-55 years old

        4. voluntary participate in the research

        5. eligible in pre participatory physical examination and ECG test by the doctor

        6. have no history of the previous acute coronary syndrome (ACS)

      Measurements:

      Interview for determining predictors of sports participation history, medical history, family
      medical history and Rate of Perceived Exertion Measurement and examination to determine:
      anthropometry parameters, clinical conditions (Systolic BP, Diastolic BP, hemoglobin levels,
      T-cholesterol and HDL-C levels, the intensity in cycling activities (mileage, velocity,
      duration, and time for resting), hemodynamic responses (average and maximum heart rate,
      Karvonen Index), and Hydration status

      Other outcome measurements; pre and post-TdB 2017 measurements of cTnI, MDA, and hs-CRP
    

Intervention name(s): 140kms cycling
Intervention type(s): Other
Intervention description(s): Main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms, and 240kms (investigator did not give any treatment/intervention, just observed the cycling touring event)
Other intervention name(s): medical history; sports participation history; clinical appearance; lipid profile status
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        participants of Tour de Borobudur Indonesia 2017
      
Keywords: troponin-I; hs-CRP; Malondialdehyde; predictors
A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to assess next-day driving performance following evening administrations of
      ACT-541468 in middle-aged and elderly subjects
    


Intervention name(s): ACT-541468; Zopiclone 7.5 mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Film-coated tablet for oral use at a dose strength of 50 mg.; Over-encapsulated to maintain blinding.; Matching to maintain blinding.
Intervention MeSH terms: Zopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4-way cross-over study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Role of Endothelin-1 in Flow-mediated Dilatation
Condition: Healthy Conditions
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Endothelial dysfunction of conduit arteries contributes to the increased morbidity and
      cardiovascular mortality in patients with essential hypertension and appears increasingly as
      an independent therapeutic target. We have shown previously that besides a decrease in the
      availability of NO and other endothelium-derived vasodilators factors, the
      epoxyeicosatrienoic acids, an increase in the vasoconstrictor endothelin-1 (ET-1) may play a
      role in the pathophysiology of this endothelial dysfunction. Indeed, the local concentrations
      of endothelin-1 during the endothelium-dependent dilation of the radial artery in response to
      a sustained increase in blood flow decreased significantly in healthy volunteers controls but
      not in hypertensive patients. This lack of adaptation of the endothelinergic system could be
      due to a decreased clearance of endothelin-1 by endothelial ETB receptors, potentiating the
      vasoconstrictor action of endothelin-1 mediated by ETA receptor activation at the muscular
      level. However, to validate this hypothesis , it is needed to demonstrate the physiological
      role of ETA receptor and ETB in sustained flow-mediated dilatation of conduit arteries.
    


Intervention name(s): BQ-788 and/or BQ-123
Intervention type(s): Drug
Intervention MeSH terms: BQ 788
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Endothelin, endothelium, flow-mediated dilatation
A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011
Condition: Acute Radiation Syndrome
MeSH terms: Radiation Injuries; Acute Radiation Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is designed to evaluate the safety, tolerability, pharmacokinetic and
      pharmacodynamic of KMRC011 injection in healthy adult volunteers.
    


Intervention name(s): KMRC011 5μg or Placebo; KMRC011 10μg or Placebo; KMRC011 15μg or Placebo; KMRC011 20μg or Placebo; KMRC011 25μg or Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml; Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml; Intramuscular Injection of KMRC011 15μg or Placebo(Normal Saline) 0.3ml; Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.4ml; Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.5ml
Other intervention name(s): Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies
Condition: Alzheimer's Disease (AD); Progressive Supranuclear Palsy (PSP); Cortical Basal Syndrome (CBS); Frontal Temporal Dementia (FTD)
MeSH terms: Alzheimer Disease; Supranuclear Palsy, Progressive; Tauopathies
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this imaging trial is to characterize [18F]MNI-815, a PET radioligand for
      imaging Tau.
    


Intervention name(s): [18F]MNI-815 (MNI-815)
Intervention type(s): Drug
Intervention description(s): All enrolled subjects will undergo an [18F]MNI-815 PET imaging visit. As a part of the screening visit, subjects will undergo [18F]florbetaben (FBB) PET imaging to determine if they have significant amyloid deposition.
Other intervention name(s): [18F]MNI-815; FBB; [18F]Florbetaben
Intervention model: Single Group Assignment
Masking: None (Open Label)
Intrauterine Contraception (IUC) After Medical Abortion
Condition: IUC Insertion After Medical Abortion
Study type: Interventional

Summary: 
      Today a large proportion of early abortions are medical, in accordance to the woman's choice.
      The main objective of the present study was to compare, in a randomised fashion, initiation
      of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion
      with regard to expulsions and safety.
    


Intervention name(s): Timing of IUC insertion
Intervention type(s): Other
Intervention description(s): Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment while patients randomised to delayed insertion had the IUC insertion at about 3 to 4 weeks after mifepristone.
Other intervention name(s): Women were free to chose the type of IUC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Copper IUD; LNG-IUS; intrauterine contraception; medical abortion; postabortion contraception
CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
Condition: Arterial Occlusive Diseases
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100
      mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in
      patients receiving a below knee bypass graft for the treatment of PAD.

      Secondary objectives:

      Comparison, between the two treatment groups, of :

        -  Primary patency,

        -  Assisted primary patency,

        -  Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.

        -  Ankle Brachial Pressure Index (ABPI) changes from baseline
    


Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the plasma concentration-time profile of voriconazole in adults
      receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to
      assess the safety profile of voriconazole during the treatment period.
    


Intervention name(s): voriconazole
Intervention type(s): Drug
Intervention description(s): 6 mg/kg IV q12h on Day 1, and 4 mg/kg IV q12h on Days 2-7, then switch to 200 mg oral tablet q12h on Days 8-14.
Other intervention name(s): Vfend
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics and safety of voriconazole intravenous oral adults
In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp
Condition: Pruritus of the Scalp
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a
      dermatologist and by the subjects themselves after four weeks of regular product use.

      Additional objective of this clinical in-use study was to evaluate the cosmetic features and
      the acceptance of the product by means of a questionnaire at the end of the 4-week treatment
      period.
    


Intervention name(s): WO 5101 Shampoo for Scalp and Hair
Intervention type(s): Other
Intervention description(s): Wash the hair at least three times a week for a period of four weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: itchy scalp; chronic pruritus
Assessement of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin
Condition: Healthy Volunteers
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The study is aimed to assess the soothing effect of a food supplement composed of Coriander
      Seed Oil (CSO) in terms of reducing skin redness and skin discomfort (stinging feeling) on
      sensitive and reactive skin.
    

Detailed description: 
      A double blind, parallel groups, placebo-controlled study is carried out on 80 female
      subjects aged between 18 and 65 years old with sensitive and reactive skin.

      The study foresees 56 days of products intake. Evaluations of the parameters under study are
      performed at baseline, after 14, 28 and 56 days of products consumption.
    

Intervention name(s): Coriander Seed Oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The study foresees the intake of 1 capsule per day during 56 days; The study foresees the intake of 1 capsule per day during 56 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment