bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Donor-recipient ABO Matching on Haploidentical Stem Cell Transplantation
Condition: Hematological Malignancies; Haploidentical Stem Cell Transplantation
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Observational

Summary: 
      the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell
      haploidentical hematopoietic stem cell transplantation
    

Detailed description: 
      The impact of donor-recipient ABO compatibility on transplant outcomes had been evaluated in
      different transplant settings, but had shown different results. The investigators set out to
      investigate the impact of ABO incompatibility on post-transplant outcomes, engraftment
      kinetics and blood product requirements, transfusion independence, the incidence of poor
      graft function (PGF) in anti-T-lymphocyte globulin (ATG) based haplo-SCT with PBSC grafts.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention, just observation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with malignant hematological diseases plan to receive allogeneic peripheral blood
        stem cell transplantation
      
Keywords: haploidentical stem cell transplantation; hematological malignancies; ABO incompatibility
Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
Condition: Squamous Cell Carcinoma of Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To evaluate the overall response rate (including complete response and partial response) of
      subjects treated with combination therapy docetaxel and cisplatin followed by the
      chemoradiotherapy in patients with locally advanced head and neck cancer

      Secondary Objective:

      To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed
      by the chemoradiotherapy in patients with locally advanced head and neck cancer
    

Detailed description: 
      The treatment duration for each patient will be around six months. Patients included in the
      study will be treated with induction regimen followed by chemo radiotherapy. Within the
      induction period there are three cycles (Docetaxel + Cisplatin) every 21 days, with follow-up
      post-induction at day 21 after cycle three. This is followed by chemoradiotherapy consisting
      of radiotherapy for six weeks and cisplatin every week for four weeks. The post-consolidation
      follow up is at eight weeks after end of chemoradiotherapy.
    

Intervention name(s): Cisplatin; DOCETAXEL XRP6976; Dexamethasone; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution Route of administration: intravenous; Pharmaceutical form:solution Route of administration: intravenous; Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:solution Route of administration: intravenous
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Docetaxel; BB 1101
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aerobic Exercises and Postural Stabilization Exercises in Fibromyalgia Syndrome
Condition: Fibromyalgia Syndrome; Physiotherapy; Rehabilitation
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      Fibromyalgia Syndrome (FMS) is a chronic rheumatic disease characterized by a wide range of
      symptoms such as widespread muscle pain, fatigue, sleep disturbances, anxiety-depression,
      impaired balance, falling risk, poor physical condition, cognitive dysfunction, and irritable
      bowel syndrome.

      The aim of the study; It is a comparison of the effectiveness of aerobic exercises and
      postural stabilization exercises that are structured to reduce the pain severity, fatigue,
      sleep problems and anxiety-depression levels of patients who are being followed up with a
      diagnosis of FMS, and to increase the duration of physical activity and quality of life.
    


Intervention name(s): aerobic exercise; postural stabilization exercises
Intervention type(s): Other; Other
Intervention description(s): Structured aerobic exercises (Each session will consist of 50 minutes and will be divided into three parts: 5 minutes of warm-up exercises, 40 minutes of aerobic exercises, 5 minutes of cool down exercises) will be taught in the first session.; Structured postural stabilization exercises (strengthening exercises, balance-coordination exercises, flexibility exercises) will be taught in the first session.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerobic Exercise; Postural Control; Fibromyalgia
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
Condition: Opioid-Related Disorders; Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study was to assess the efficacy of induction treatment with
      buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with
      buprenorphine only. The hypothesis is that starting directly on OX219 works equally well
      (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on
      Day 3.
    

Detailed description: 
      This was a prospective, randomized, multicenter, blinded, parallel-group, active-controlled,
      non-inferiority study conducted at 13 sites within the US. Eligible patients participated in
      8 treatment visits on Days 1, 2, 3, 4, 8, 15, 22, and 29. Effectiveness of treatment was
      assessed as follows:

        -  Retention in treatment at Day 3

        -  Clinician and patient assessments of opioid withdrawal symptoms

        -  Assessment opioid cravings
    

Intervention name(s): Buprenorphine/naloxone sublingual tablets; Buprenorphine
Intervention type(s): Drug; Drug
Intervention description(s): Advanced-formulation buprenorphine/naloxone sublingual tablets; Buprenorphine sublingual tablets
Other intervention name(s): Zubsolv; OX219; Generic buprenorphine
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: opioid dependence, buprenorphine/naloxone, sublingual
Pulse Oximeter Hypoxia
Condition: Oximetry
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The aim of this project is to test the accuracy of pulse oximeters (devices intended to
      measure oxygen saturation in blood noninvasively) during mild, moderate and severe hypoxia (a
      lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2
      saturations from 100 to down to 70%. This is done by comparing the reading of the pulse
      oximeter during brief, steady state hypoxia with a gold-standard measurement of blood
      oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample
      processed in a laboratory.
    


Intervention name(s): MyHomeDoc
Intervention type(s): Device
Intervention description(s): MyHomeDoc device SpO2 measurements and parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: myhomedoc; pulse oximetry; oximeter
Heart Focused Movement Effects on Cardiometabolic Risk
Condition: Cardiometabolic Risk Factors
Study type: Interventional

Summary: 
      This study is designed as a two-group parallel randomized controlled trial (N=50) to test
      effects of 8-weeks of Qigong/Tai Chi (QTC) intervention compared to QTC plus HRVB on HRV
      parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., BMI,
      waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional
      regulation, eating behaviors, and cognitive performance).
    

Detailed description: 
      Heart rate variability biofeedback (HRVB) will be investigated as a target to optimize
      Qigong/Tai Chi (QTC) practices based on the expectation that learning to, and practicing
      changing heart rate variability (HRV) using HRVB, in addition to QTC, will result in higher
      levels of HRV and coherence than just the QTC alone. This study is designed as a two-group
      parallel randomized controlled trial to test effects of QTC compared to QTC plus HRVB on HRV
      parameters (primary), and cardiometabolic risk factors and sequelae (secondary). Fifty
      participants will be recruited and randomized to one of these groups and receive daily text
      prompts for 8 weeks to practice (using video links) Tai Chi Easy for 10-30 minutes (length of
      practice, the participants' choice). Half of the participants randomized to the HRVB
      enhancement will also be coached to practice HRVB to achieve coherence in their heart beat
      rhythms prior to practice (QTC plus HRVB group). Data collection at baseline and post
      intervention will assess body mass index (BMI, waist circumference/percent body fat, sleep
      quality, stress, eating behaviors, emotion regulation, mood (depression and anxiety),
      cognitive performance and changes in HRV parameters (high frequency power and coherence).
    

Intervention name(s): Qigong/Tai Chi; Heart rate variability biofeedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will engage in 8 weeks of gentle movement/mindfulness videos provided in a daily text prompt, asking that this be practices most days of the week. A choice of practice video links will be provided, ranging from 10-30 minutes in length, and later confirmation texts will be employed to document if practiced, and what length was chosen.; Randomized participants will be coached to practice a breathing technique that focuses attention on the sensations in the heart area, slowing and deepening the breath, and activating through memory or imagery a positive emotion. This practice is used along with a feedback device that provides information on achievement of the heart rate variability target, "coherence" that represents a neurocardiac state associated with vagal tone, or balance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Moxonidine Effects on Neuropeptide Y
Condition: Obesity; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatment with monotherapy of moxonidine 0.6 mg daily in treatment-naïve subjects with mild
      or moderate hypertension
    

Detailed description: 
      Treatment with 0.6 mg moxonidine daily in treatment-naïve subjects with mild or moderate
      hypertension according to guidelines (Stage 1: Systolic Blood Pressure =140-159 mmHg,
      Diastolic Blood Pressure =90-99 mmHg, and Stage 2: systolic blood pressure=160-179 mmHg,
      diastolic blood pressure=100-109 mmHg) that require monotherapy and reevaluation after 12
      weeks
    

Intervention name(s): Moxonidine
Intervention type(s): Drug
Intervention description(s): 0.6 mg moxonidine daily
Intervention MeSH terms: Moxonidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; obesity; Neuropeptide Y; moxonidine
Comparison of the Effects of Balance-proprioception and Aerobic Exercises on Functional Status and Strength Parameters in Patients With Fibromyalgia.
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      In this study, it was aimed to examine the effects of aerobic exercise and
      balance-proprioception exercises on pain, functionality and strength parameters of
      fibromyalgia patients and to compare the two exercise types.
    

Detailed description: 
      In the study planned to evaluate the effect of aerobic and balance-proprioception exercises
      on the symptoms of the disease and the superiority of the two exercise models in patients
      with fibromyalgia syndrom (FMS), 62 women who meet the inclusion criteria will be randomly
      divided into two groups. Aerobic exercise group (n = 26) and balance-proprioception exercise
      group (n = 26) will be applied for 3 weeks a week, 6 days a week under the supervision of a
      physiotherapist in the exercise laboratory of the Istanbul Medical Faculty Sports Medicine
      Department. Pain (VAS), functional status (FİQ) and knee extension muscle strength (Cybex
      isokinetic dynamometer) will be evaluated before and after the program. Cognitive status will
      be evaluated with standardized Mini Mental Test only before the program.
    

Intervention name(s): therapeutic exercises
Intervention type(s): Other
Intervention description(s): Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia, aerobic exercise, balance, proprioception, pain, strength
Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers
Condition: Rheumatoid Arthritis; Giant Cell Arteritis
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, two period trial where participants will be given either of 3 Tocilizumab
      product on Day 1 during period 1 and either one of the remaining 2 Tocilizumab products on
      Day 1 period 2. There will be at least 6 weeks (42 days) of wash out between subsequent two
      period dosing. The maximum flexibility allowed between subsequent periods will be up to 9
      weeks (63 days).

      Names of the 3 tocilizumab products are DRL_TC, RP and RMP. So if a participant receives
      DRL_TC on Day 1 Period 1 then he/she will either receive RP/RMP on Day 1 Period 2.
    

Detailed description: 
      The study will be conducted at 4 sites (2 in New Zealand, 1 in Australia and 1 in India) The
      three pairwise product comparisons (DRL_TC vs. RP; DRL_TC vs RMP and RP vs. RMP)will be
      performed in parallel. Each comparison will be separately considered. Study subjectswill be
      randomly assigned in a 1:1:1 ratio to one of the comparisons and within eachcomparison
      subjects will be randomized in a 1:1 ratio to one of the two possible productsequences The
      total duration of the individual subject study participation will be at least 12weeks. Dosing
      for period 1 will be on on day 1 followed by washout out period of upto 9weeks. Dosing for
      Period 2 will be on Day 1.

      Subjects who complete the study and are found to be positive for anti-drug antibodies (ADA)on
      Day 29 and/or Day 43 period 2, will be followed up every 90 days for immunogenicitysampling
      up to approximately one year post Period II dosing, or until two consecutive sampleshave been
      negative for ADA, whichever is earlier. Early dropouts will be tested forimmunogenicity at
      the time of EOS and if they are positive for ADAs they will be followed-up ifpossible at 90
      days intervals starting from the last received dose (either Period I or Period II) ina
      similar manner.

      300 NHV (Normal Healthy Volunteers) will be included in the study as justified under
      samplesize justification. After the data of these 300 volunteers become available a blinded
      samplesize re-estimation (BSSR) will be performed to reconfirm the statistical assumptions of
      thestudy design and depending upon the outcome of the BSSR, study may be stopped or thesample
      size may be increased, as needed to attain the required statistical power.
    

Intervention name(s): Tocilizumab Prefilled Syringe
Intervention type(s): Drug
Intervention description(s): 0.9ml Subcutaneous pre-filled syringes containing 162mg of Tocilizumab.
Other intervention name(s): Actemra; RoActemra
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessing the Functional and Psychosocial Impact of Strabismus in Asian Children Using the AS-20 and IXTQ Questionnaires
Condition: Strabismus
MeSH terms: Strabismus
Study type: Observational

Summary: 
      Studies suggest that strabismus has a negative impact on a person's self-image, interpersonal
      relationships, emotional and psychosocial state (4-15). There are, however, few such studies
      based in Asia, and the functional and psycho-social impact of disease is often neglected in
      our management of strabismus in Singapore. The aim of this pilot study is to measure
      quality-of-life (QOL) among strabismic children in Singapore so as to better understand the
      functional and psychosocial issues faced by these children in their daily living. The
      investigators also hope to evaluate the performance of the Intermittent Exotropia
      Questionnaire (IXTQ) (2) and Adult Strabismus Quality of Life Questionnaire (AS-20) (1) and
      to determine if differences between child and parental perceptions exist.

      60 children with strabismus presenting to the KKWCH Eye Centre and their parents will be
      invited to participate in the study and answer questions in 2 Pediatric Eye Disease
      Investigator Group (PEDIG)-validated questionnaires (i.e. the IXTQ and AS-20). 30 children
      aged 5-7 years will answer the 12-question IXTQ (5-7 years), while 30 children aged 8-16
      years will answer the 12-question IXTQ (8-16 years) and the 20-question AS-20 questionnaires.
      Their parents will answer the self-administered IXTQ child-proxy (12 questions), IXTQ
      parental (17 questions) and modified AS20 child-proxy questionnaires (20 questions). For
      comparison, 60 aged-matched children without strabismus or amblyopia (30 aged 5-7 years, and
      30 aged 8-16) and their parents will also be invited to answer similar questionnaires
      (controls).

      Results will be analysed question-by-question and then by composite score, and comparison
      will be made between child and parental-proxy measures, as well as with scores obtained from
      myopic children. It is hoped, that from this study, we will be able to assess the usefulness
      of the IXTQ and AS-20 instruments as measures of QOL in strabismic children, and to assess
      the feasibility of its use in a larger study looking at the impact of strabismus and its
      treatment in Singaporean children.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with strabismus
Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy
Condition: Diabetes Mellitus, Type 2; Neuropathy
MeSH terms: Diabetic Neuropathies; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effects of modified otago exercises on joint
      position sense, balance and physical fitness parameters in individuals with diabetic
      neuropathy. In addition aim of to examine the effects of exercise on metabolic variables and
      to gain exercise awareness in diabetic individuals.
    


Intervention name(s): Exercise Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): The exercise group will be informed about diabetes and diabetes complications. A total of 16 sessions of 8 weeks, modified otago exercises will be applied individually by the research physiotherapist.Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program).; The control group will be informed about diabetes and diabetes complications. Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Otago Exercise; Joint Position Sense; Balance; Physical Fitness
Anisometropia Amblyopia Improved by Perceptual Learning and Patching
Condition: Anisometropic Amblypia
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effects of perceptual learning with patching on improving visual acuity and
      contrast sensitivity in payient with anisometropic amblyopia.
    

Detailed description: 
      Patients with anisometropic amblyopia were randomized to patching or perceptual learning
      group. Corrected amblyopic logMAR visual acuity and contrast sensitivity function were
      measured at four-weekly intervals until visual acuity stabilized or amblyopia resolved.
      Improvement in visual acuity, contrast sensitivity, and the resolution of amblyopia were
      compared between groups.
    

Intervention name(s): computer program and patching
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: perceptual learning; occlusion therapy
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the single-dose effectiveness of two bronchodilator
      inhalers given at two dose levels in pediatric asthma patients.
    


Intervention name(s): Bronchodilator
Intervention type(s): Drug
Intervention MeSH terms: Bronchodilator Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
The Minimum Effective Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block
Condition: Minimum Effective Concentration of Local Anesthetic
Study type: Interventional

Summary: 
      The aim of this study is to determine the minimum effective concentration of local anesthetic
      (ropivacaine 40mL) required to produce an effective double-injection USG-SCB for surgical
      anesthesia in 90% of patients (MEC90) in young group (18-40 years) and in middle aged group
      (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the
      shoulder.
    

Detailed description: 
      The study is based on biased coin design, and the concentration of LA for the next patient is
      determined by the result of the last one. In the case of block failure, the concentration
      will be increased by 0.025%. Conversely, block success will result in either a reduction in
      concentration by 0.025% (probability 11%) or no change in concentration (probability 89%). A
      blinded assistant will assess sensory and motor blockade in each nerve territory ( the
      median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after
      completion of the block. Finally, MEC90 is calculated by isotonic regression.
    

Intervention name(s): brachial plexus block
Intervention type(s): Other
Intervention description(s): brachial plexus block with ropivacaine 40ml
Other intervention name(s): ultrasound guided supraclavicular block
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: minimum effective concentration; ropivacaine; ultrasound-guided supraclavicular block