bioihbjkbjnl/mcl2 huggingface dataset:
Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell Transplantation
Condition: Acute Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      350 patients with early leukemias were assigned to receive peripheral blood or bone marrow
      transplantation; the occurrence of acute and chronic graft versus host disease, survival,
      transplantation-related mortality, and relapse rates were compared.
    

Detailed description: 
      The trial was designed to investigate the safety and outcome of allogeneic
      filgrastim-mobilized PBPCT compared with allogeneic BMT in patients with standard-risk
      leukemia. A total of 350 patients between 18 and 55 years of age with acute leukemias in
      remission or chronic myelogenous leukemia in first chronic phase were randomized to receive
      either filgrastim-mobilized peripheral blood progenitor cells or bone marrow cells from
      HLA-identical sibling donors after standard high-dose chemoradiotherapy. The study was
      approved by the ethics committees of all participating centers, and all patients and donors
      gave informed consent before any study-related procedure was performed. Donor-recipient pairs
      were randomized to undergo either BMT or PBPCT. Randomization was carried out centrally at
      the International Institute for Drug Development (id2), Brussels, Belgium, and used the
      minimization method to allocate donor and recipient to allogeneic BMT or PBPCT. The
      randomization strata were as follows: diagnosis (chronic myeloid leukemia [CML] vs other
      diseases), sex mismatch of donor and recipient, and whether the donor was female and
      nulliparous. Follow-up visits were scheduled for 6, 12, 24, and 36 months after the date of
      transplantation.

      Neutrophil and platelet recovery occurred significantly faster after transplantation of
      peripheral blood progenitor cells than after bone marrow transplantation. Acute graft versus
      host disease of grades II-IV was significantly more frequent in recipients of peripheral
      blood progenitor cells than in recipients of marrow cells The cumulative incidence of chronic
      graft versus host disease was higher with peripheral blood progenitor cells than with bone
      marrow cells
    

Intervention name(s): Bone marrow transplantation; Peripheral blood stem cell transplantation
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received bone marrow transplantation; Patients received filgrastim-mobilized peripheral blood stem cell transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allogeneic transplantation; Leukemia; GvHD; MDS
Multiple Dose Japanese Bridging Study
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of multiple oral daily
      doses of BMS-708163 in healthy young male subjects
    


Intervention name(s): BMS-708163; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, Oral, 125 mg, once daily, 14 days; Capsules, Oral, 0 mg, once daily, 14 days
Other intervention name(s): (GAMMA SECRETASE inhibitor)
Intervention MeSH terms: BMS 708163; Gamma Secretase Inhibitors and Modulators
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effect of Short-term Oxygen During CPET in HFpEF
Condition: Heart Failure, Diastolic (HFpEF)
MeSH terms: Heart Failure; Heart Failure, Diastolic
Study type: Interventional

Summary: 
      In a randomized, sham-controlled crossover trial the investigators will test whether
      supplemental oxygen given during cardiopulmonary exercise testing will improve exercise
      performance and physiological parameters in patients with heart failure with preserved
      ejection fraction.
    


Intervention name(s): Oxygen application; Sham room air
Intervention type(s): Procedure; Procedure
Intervention description(s): Oxygen application Supplemental oxygen via mask; Room air will be applied via mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Human Repeated Insult Patch Test
Condition: Dermatitis; Allergy; Contact Allergy
MeSH terms: Dermatitis; Dermatitis, Allergic Contact; Hypersensitivity
Study type: Interventional

Summary: 
      Repeated insult patch test on healthy males and females to determine potential contact
      irritation or contact allergy in the skin
    


Intervention name(s): NeoMatriX Collagen Dressing
Intervention type(s): Device
Intervention description(s): Collagen wound dressing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of Displaced Radial Neck Combined With Olecranon Fractures
Condition: Child
MeSH terms: Olecranon Fracture
Study type: Observational

Summary: 
      This study aimed to evaluate the outcomes of using absorbable rods and Kirschner Wires
      technique for severe displaced radial neck fractures combined with olecranon fractures in
      children.
    

Detailed description: 
      The most common fracture in children is the elbow fracture, and the three most common elbow
      fractures are supracondylar, lateral condylar, and medial epicondylar fractures. Elbow
      fractures are easy to diagnose and the treatment modalities are studied often. However,
      proximal radius fractures, which include radial neck and head fractures, remain challenging
      to diagnose and manage. In addition, proximal radius fractures are often combined with other
      fractures, most commonly, an olecranon fracture. Most radial neck fractures can be treated
      conservatively if the displacement is less than 3 mm and the angle is less than 30º. However,
      for severe Judet type III and type IV radial neck fractures, surgery is inevitable.

      This study focused on radial neck fractures combined with an olecranon fracture. In this
      study, absorbable rods were used for fixation of radial head fractures, and with no need for
      removal of the inner fixation, we performed anatomy reduction via the same incision with
      direct vision of the olecranon, and we were able to fix the fractures with Kirschner wires
      (K-wires). In this retrospective study, we aimed to evaluate a treatment method for severe
      displaced radial neck combined with olecranon fractures in children using a Boyd incision,
      absorbable rods, and K-wires.
    

Intervention name(s): Absorbable Rods and Kirschner Wires
Intervention type(s): Procedure
Intervention description(s): A Boyd incision was applied in all patients; olecranon fractures were reduced first and fixed with Kirschner wires. Then, the displaced radial neck fractures were reduced and fixed using absorbable rods.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Medical records of patients who attended our hospital between Jan 2012 and Dec 2016 were
        retrospectively reviewed.
      
Keywords: Kirschner wires; Absorbable rods; Radial neck fracture; Olecranon fracture
Tongue Depressor-related Tongue Swelling
Condition: Children, Only; Adenoidal Hypertrophy; Adenoid Disease - Chronic; Complication; Side Effect
MeSH terms: Hypertrophy
Study type: Observational

Summary: 
      This study aimed to detect tongue swelling induced by the pressure exerted by tongue
      depressor; swelling detection was made through tongue surface area measurement using
      ultrasonography (USG) in pediatric patients who underwent adenoidectomy surgeries.
    

Detailed description: 
      The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect
      the occurrence of tongue swelling through USG examination and to educate clinicians about the
      association between subacute tongue swelling and tongue depressor in pediatric patients.
    

Intervention name(s): Ultrasonography imaging
Intervention type(s): Diagnostic Test
Intervention description(s): This study aimed to measure the tongue surface areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue surface areas.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 16 years or younger who were to undergo adenoidectomy surgery were eligible
        for inclusion in this group. Informed consent was obtained from the parents of all the
        patients with a clinical diagnosis of chronic adenoiditis and adenoid hypertrophy (except
        tonsillectomy surgeries) and were to undergo adenoidectomy surgery.
      
Keywords: children; tongue disease; ultrasonography; enlarge tongue; adenoid
Pharmacokinetics of Two Different Persantin® Sugar Coated Tablets in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability of the proposed formulation of PERSANTIN®
      compared to the present commercial formulation.
    


Intervention name(s): Persantin® new formulation; Persantin® commercial formulation
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dipyridamole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of the Happy Grow Program on Parental Self-confidence: A Randomized, Controlled Open-label Study
Condition: Responsive Parenting
Study type: Interventional

Summary: 
      This is a randomized, controlled education-based interventional study without any
      investigational product. Study subjects are randomized to the intervention or control groups
      with a follow-up period of 12 weeks. 250 toddlers between ages 24 and 28 months with
      first-time primary caregiver (mother or father) from low to mid-income families in Indonesia
      will be enrolled.
    

Detailed description: 
      Extensive scientific literature demonstrates that childhood happiness can be nurtured through
      positive and responsive parenting strategies, and is associated with optimal child
      development and is a predictor of future happiness.

      The Grow Happy program is a translation of scientific literature into parent-friendly
      educational materials and actionable tips and advice aimed at improving parental knowledge
      and child happiness through parenting techniques and play.

      Although the Grow Happy Program is scientifically validated, it has yet to be clinically
      tested. It is hypothesized that the Grow Happy program will improve mothers' knowledge and
      self-confidence related to parenting behaviors that promote happiness and optimal child
      development.
    

Intervention name(s): Education based; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The interventional materials will be provided digitally for 12 weeks, with the monthly theme featured from the educational Grow Happy book and related tips and videos that will be released weekly.; At enrollment, subject will be provided with the Mother and Child booklet, which is the Indonesian standard of care for parenting guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, controlled education-based interventional study without any investigational product. Study subjects are randomized to the intervention or control groups with a follow-up period of 12 weeks.
Masking: None (Open Label)
Primary purpose: Other
Reference Population for Speckle Tracking Imaging
Condition: Left Ventricular Function
Study type: Observational

Summary: 
      The SCAR study uses a software program entitled QLAB, a proprietory program, developed by
      Philips Healthcare (Philips Healthcare, Andover, MA). Literature on two-dimensional speckle
      tracking imaging (2DSTE) is growing, but data relevant to the population in the SCAR study is
      minimal. Accumulation of data relevant for a population of subjects will provide a set of
      normal values for interpretation of 2DSTE and minimize any influences from differences in
      data produced from different companies. This data may also assist other researchers
      investigate other cardiac diseases and abnormalities.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal healthy males and females
      
Keywords: speckle tracking echocardiography; database
Compare the Clinical Efficacy of Prototype Toothpastes
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival
      inflammation.
    


Intervention name(s): Fluoride; Triclosan, fluoride; Metal salt
Intervention type(s): Drug; Drug; Other
Intervention description(s): Brush twice daily; Brush twice daily; Brush twice daily
Other intervention name(s): Colgate Winterfresh Gel; Colgate Total toothpaste; New toothpaste formula being evaluated.
Intervention MeSH terms: Listerine; Triclosan; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a phase I, open label, three period, fixed sequence crossover study to
      evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of
      Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening
      visit within 30 days prior to the first dose of study drug, three treatment periods, and a
      follow-up visit 7-14 days after the last dose of study drug. There is no washout between
      treatment periods.
    


Intervention name(s): DTG; CBZ
Intervention type(s): Drug; Drug
Intervention description(s): DTG will be supplied as 50 mg tablet to be administered orally; CBZ will be supplied as 100 mg and 200 mg extended release tablet to be administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: healthy volunteers; drug interaction; carbamazepine; Dolutegravir; pharmacokinetics
Comparison of the Effectiveness of Yoga and Exercise in Female Patients With Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      In this study, yoga, aerobic exercise, resistance exercise training in female individuals
      with fibromyalgia syndrome; It was aimed to compare their effectiveness on fatigue, quality
      of life and pain.
    

Detailed description: 
      The study was planned as a randomized controlled study. Participants will be divided into 3
      groups by simple randomization method. groups will be named as aerobic, yoga and resistance
      exercise groups. 12-week exercise protocols will be applied to all participants. Participants
      before and after treatment; The Fibromyalgia Impact Questionnaire, the McGill Pain
      Questionnaire for pain assessment, the Chalder Fatigue Scale to assess their fatigue level,
      will be filled in by the participants before and after the study. The data obtained will be
      statistically analyzed.
    

Intervention name(s): aerobic; resistant; yoga
Intervention type(s): Other; Other; Other
Intervention description(s): We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; includes activities such as walking, cycling, jogging, aerobic dancing, swimming.
An average of 50 minutes of exercise per day will be required, 3 days a week.; Resistance exercises are the whole of the exercises in which effort is made against the weight and the weight is lifted. Exercises with therabands, dumbbells or body weight will be given. The exercises will be done 2 days a week for an average of 30-40 minutes.; Yoga is basically breathing exercises, warm-up exercises, relaxation, It is a session consisting of movements and relaxation exercises.movements are performed by standing in a fixed posture for 15 seconds to 2 minutes in a certain posture, they are postures for both strengthening, stretching and balance. Yoga practice will be done 2 days a week for an average of 40 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Aerobic exercises, resistant exercises and yoga
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: women; sleep; tiredness
A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this protocol is to determine the single-dose pharmacokinetics and
      immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended
      pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion
      through the inclusion of placebo controls at each dose level.
    


Intervention name(s): Abatacept
Intervention type(s): Drug
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Effect of Omega-3 Supplementation on Child Behavior Problems
Condition: Antisocial; Aggressive; Externalizing Behavior Problems; Internalizing Behavior Problems
MeSH terms: Aggression; Problem Behavior
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary purpose of this study was to assess the effectiveness of omega-3 supplementation
      on behavior problems in children.
    

Detailed description: 
      This study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on
      behavior problems in children. All behavior problem outcomes were assessed, although the
      primary focus was on antisocial and aggressive behavior.
    

Intervention name(s): omega-3
Intervention type(s): Dietary Supplement
Intervention description(s): 200 ml fruit drink containing omega-3
Other intervention name(s): Smartfish
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized controlled trial; omega-3; nutrition; behavior problems; externalizing; internalizing; antisocial; aggressive
Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.
Condition: Sleep; Sleep Deprivation; Insulin Resistance; Type 2 Diabetes
MeSH terms: Sleep Deprivation; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The use of energy from food changes when people sleep. However, it is still not known if
      differences in the amount of nighttime sleep have an effect on the amount of energy that
      people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to
      perform their daily activities. This study is being done to test the hypothesis that the
      daily use of energy in people who have a history of type 2 diabetes in their family will be
      different after they have slept short hours for 16 days in comparison to when they have slept
      longer hours for 16 days.
    

Detailed description: 
      Study participants will complete two 16-day inpatient stays in the sleep laboratory of the
      University of Chicago Clinical Resource Center that will be scheduled at least 4 weeks apart.
      Bedtime duration will be set at 5.5 hours per night during one of these stays and at 8.5
      hours per night during the other. No daytime naps will be allowed. Study participants will be
      served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. On
      weekdays all participants will engage in simulated "office work" in the sleep laboratory.
      During the rest of the time participants will maintain their usual indoor and outdoor
      activities as much as possible within the limits of the University of Chicago campus. At the
      beginning of each inpatient stay, study participants will drink a glass of water containing
      harmless non-radioactive dense forms of oxygen and hydrogen, small amounts of which are found
      in natural water. Several urine samples will be collected before and after the participants
      drink the water and again 14 days later in order to measure the amount of energy that was
      used by them during this time. At the end of each stay participants will also undergo
      measurements of their body composition (lean tissue, bone and fat) and their metabolic rate
      at rest and after a standard meal, and will complete tests to determine how much insulin does
      their body produce in response to an intravenous glucose infusion and how effective is the
      action of the sugar-processing hormone, insulin, in their body when it is infused
      intravenously together with glucose over a period of several hours.
    

Intervention name(s): 5.5-hour bedtime; 8.5-hour bedtime
Intervention type(s): Other; Other
Intervention description(s): 16 days with sleep allowed only during a 5.5-hour bedtime period at night; 16 days with sleep allowed only during a 8.5-hour bedtime period at night
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: short sleep duration; energy expenditure; insulin secretion; insulin action; lipid turnover; free fatty acids
A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, multi-center, single-dose, parallel group study to determine the
      pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted
      male and female adult subjects with varying degrees of hepatic function. The study will be
      conducted based on the Child-Pugh classification of hepatic impairment. The anticipated
      duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying
      degrees of hepatic function and up to 12 healthy control volunteers.
    


Intervention name(s): cobimetinib
Intervention type(s): Drug
Intervention description(s): single oral 10-mg dose of cobimetinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)