bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Condition: Acute Myeloid Leukemia (AML) Relapse
MeSH terms: Leukemia, Myeloid, Acute; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation
      study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem
      cell transplantation (alloHSCT).
    

Detailed description: 
      The aim of the study is to determine a recommended dose for F16IL2 in combination with BI
      836858 in AML relapse after alloHSCT and investigating safety and tolerability of the
      combination regimen.

      Dose escalation will be guided by a Bayesian logistic regression model (BLRM) with overdose
      control that will be fitted to binary toxicity outcomes. The estimate of parameters will be
      updated as data are accumulated using the BLRM. At the end of the dose escalation phase, the
      probability of toxicity at each dose combination level will be calculated to determine an
      estimate of the MTD. Once the MTD or a biological active dose has been defined, additional
      patients (up to 10) will be treated with F16IL2 and BI 836858 dosed at this dose combination
      in order to confirm the safety profile of the combination.
    

Intervention name(s): F16IL2; BI 836858
Intervention type(s): Drug; Drug
Intervention description(s): F16IL2 dose escalation with provisional doses of 10, 20 and 30 Mio IU on Day 1, 8, 15 and 22 of each cycle through a rate-controlled intravenous infusion of 3 hours; BI 836858 dose escalation with provisional doses of 10, 20, 40, 80 and 160 mg on days 3, 10, 17 and 24 of each cycle through a rate-controlled intravenous infusion up to 5 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Frailty on Balance, Activities of Daily, and Exercise Capacity in COPD
Condition: COPD; Frailty
MeSH terms: Frailty
Study type: Observational

Summary: 
      The investigators aim to demonstrate whether balance, cognition and activities of daily
      living have changed in COPD patients with and without frailty.
    

Detailed description: 
      COPD is a common, preventable and treatable disease characterized by progressive respiratory
      symptoms and airflow limitation. Frailty defines a clinical syndrome characterized by
      multiple system effects, leading to decreased functional reserve and increased sensitivity to
      dependence or mortality following minor stress events. Inflammation, lack of physical
      activity, reduced exercise efficiency and maximum oxygen uptake may contribute to the
      development of frailty in patients with COPD. Balance, cognition and activities of daily
      living are associated with COPD.

      This study will evaluate the effect of frailty on balance, cognition and activities of daily
      living in patients with COPD.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals who are diagnosed with COPD at Hacettepe University and who are referred to the
        Cardiopulmonary Rehabilitation Unit for physiotherapy also who are willing to participate
        in the study will be included in the study.
      
Keywords: COPD; Frailty; Balance; Cognition; Activities of Daily Living
Determination of Iron Absorption Mechanism From Ferrous Fumarate With GOS
Condition: Low Iron Stores
Study type: Interventional

Summary: 
      The aim is to investigate the mechanism by which galacto-oligosaccharide acutely increases
      iron absorption by using stable isotope appearance curves. This will allow the evaluation of
      changes in serum iron isotopes over the first few hours after administration of the iron
      supplement and provides information where and in what amount iron absorption takes place in
      the GI-tract.
    

Detailed description: 
      Iron is an important mineral in our body and fulfills essential functions such as for example
      oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and
      widespread nutritional disorder in the world according to WHO. Common iron supplements all
      have their limitations in terms of availability and compatibility. Prebiotic fibers, such as
      galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria.
      Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby
      decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of
      minerals such as calcium and magnesium and they have been proposed to potentially improve
      iron absorption.

      In a recent iron absorption study in adult women with low iron stores in the laboratory of
      human nutrition ETH zurich, it was found that 15 g of GOS given with an iron supplement in
      the form of iron fumarate acutely increased iron absorption when given with water and a bread
      based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to
      the study, the aim of the current study is to investigate the mechanism by which GOS acutely
      increases iron absorption by using stable isotope appearance curves. This will allow the
      evaluation of changes in serum iron isotopes over the first few hours after administration of
      the iron supplement and provides information where and in what amount iron absorption takes
      place in the GI-tract.
    

Intervention name(s): nutritional iron (14 mg) supplement in form of ferrous fumarate; ferrous fumarate + 15 g GOS
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): nutritional iron (14 mg) supplement in form of ferrous fumarate; nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g GOS)
Intervention MeSH terms: Ferrous fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Low iron stores; Prebiotics; Galacto-oligosaccharides
Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification
Condition: Neck Pain
MeSH terms: Musculoskeletal Pain; Neck Pain
Study type: Observational

Summary: 
      Chronic pain is commonly defined as any pain which lasts more than 12 weeks. Chronic
      non-specific neck pain (CNSNP) has no specific underlying disease causing the pain. There are
      neurophysiological factors that may modulate pain response and perception in the central
      nervous system, producing sensory changes such as the presence of temporal summation (TS) and
      pressure, cold or heat hyperalgesia. TS describes the progressive increase in reported pain
      intensity as a function of repeated noxious stimulation (e.g. thermal, electrical or
      mechanical). TS and hyperalgesia are measured through quantitative sensory tests (QST) where
      pain pressure thresholds (PPT) are measured with an algometer. The current evidence show that
      PPTs are significantly lower compared to healthy subjects and the association between PPTs,
      pain intensity and disability are inconsistent. Further, there are psychosocial factors
      (catastrophizing, kinesiophobia, stress…) that may influence the pain experience. This
      psychosocial factors associated with chronic pain are not systematically collected in the QST
      literature complicating the interpretation of data. The objectives of this study are 1) to
      determine disability, sensory (TS and PPTs) and psychosocial changes (kinesiophobia,
      catastrophizing, sleep quality, life quality, stress and anxiety) in the natural evolution or
      in the result of physiotherapy treatment in CNSNP individuals, 2) to study the correlations
      between disability, psychosocial and sensory factors and 3) to observe if there is a
      homogeneity between the subjects.
    


Intervention name(s): No intervention. Observational study
Intervention type(s): Other
Intervention description(s): Observational study
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study was divided into 2 groups: individuals with Chronic Non-Specific Neck Pain and
        healthy controls.
      
Keywords: chronic non-specific neck pain; musculoskeletal pain; psychosocial factors; sensory characteristics; pressure pain thresholds; temporal summation
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute
      and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the
      prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period.
      The prostate is localized and the plan is reoptimized as needed prior to each treatment.
    

Detailed description: 
      This protocol requires radiation treatments to be performed with a stereotactic technique
      with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or
      use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.
    

Intervention name(s): SBRT Prostate
Intervention type(s): Radiation
Intervention description(s): Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Other intervention name(s): Stereotactic body radiation therapy; External beam radiation therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CaP; SBRT; Prostate; ExacTrac; Calypso; IMRT; Radiation; Cancer of Prostate; Prostatic Neoplasms
Do Handgrip Strength and Dexterity Predict of Respiratory Function ?
Condition: Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases
Study type: Observational

Summary: 
      Dysfunction due to weakness in respiratory muscles is one of the biggest problem that causes
      mortality and morbidity in neuromuscular diseases.Since the NMD have a crucial life-threading
      natural progression, many clinicians and researchers are trying to working out to increase
      life span and/or quality of life with medical and rehabilitative approaches.The relationship
      between upper extremity functions and respiratory functions in pediatric neuromuscular
      patients is still not clear. The clinician working with children with neuromuscular disease
      should be aware of the effects of muscle weakness and cognitive dysfunction on the
      respiratory system. Symptoms can be insidious and cause progressive loss of function,
      respiratory failure, and even death
    

Detailed description: 
      Background:Neuromuscular diseases are acquired or hereditary diseases that affect the
      function of the muscles in our body caused by the nerves not sending information to your
      muscles and/or problems with the muscles not working properly.

      Objective:The aim of our study is to discover more cost-effective and practical tools to
      predict respiratory function losses that may be a significant problem in children with
      neuromuscular disease.

      Methods: Hand grip strength and dexterity of children with neuromuscular disease were
      measured using the dynamometer and the nine-hole-peg-test respectively. The Vignos and Brooke
      Upper Extremity Functional Scales were used to evaluate functional status for patient
      recruitment.Respiratory function parameters:forced vital capacity (FVC), forced expiratory
      volume in one second (FEV1) and peak expiratory flow(PEF) were evaluated with spirometry.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Our study was carried out with 30 patients between the ages of 6-18 who were followed up
        with a diagnosis of neuromuscular disease.
Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home
      respiratory polygraphy (HRP).
    

Detailed description: 
      To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home
      respiratory polygraphy (HRP), performed at home compared with the standard polysomnography
      (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA).

      METHODOLOGY: DESIGN: Randomized, prospective, multicenter, and crossover trial. The study
      will include 240 adults, both sexes, with clinical suspicion of obstructive sleep apnea
      (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep
      units, the following questionnaires and measurements will be performed: a) clinical history;
      b) Anthropometric variables: weight, height, body mass index, neck circumference and
      percentile; c)Epworth sleepiness scale; OSA questionnaire, quality of life and clinical
      questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f)
      Cost-effectiveness variables.

      ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of
      results according to the different apnea-hypopnea index by using the Receiver Operating
      Characteristic (ROC) curve; 2) The concordance of the diagnosis and treatment decisions when
      using clinical findings and data from PSG or HRP at home; 3) All data will be analyzed
      independently; 4) A cost-effectiveness analysis of the different diagnostic and therapeutic
      procedures will be performed.
    

Intervention name(s): Home Respiratory Polygraphy (APNIA); Standard Polysomnography (PSG); Home Respiratory Polygraphy (APNIA); Standard Polysomnography (PSG)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Randomizing to start with home respiratory polygraphy (APNIA); Randomizing to start with Standard Polysomnography (PSG); Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA); Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Other intervention name(s): Validity; Validity; Effectiveness; Effectiveness
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Home Respiratory Polygraphy; Standard Polysomnography; Validity; Cost-effectiveness
Elastic Band Resistance Exercise on Glycated Haemoglobin and Muscle Strength, Balance, and Physical Function in Patients With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis
Condition: Elastic Band Resistance Exercise With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Whether elastic band resistance exercise (EBRE) as a home-based rehabilitation routine can
      control the glycated heamoglobin (HbA1c) level and improve the muscle strength, dynamic
      balance, and physical function in older patients with comorbid T2DM and knee OA?
    

Detailed description: 
      Design: Randomised controlled trial. Participants: Seventy patients diagnosed with T2DM
      together with knee OA. Intervention: Patients in the experimental and control group were
      instructed by clinical staff to perform home-based exercises and followed up through phone
      calls. The experimental group performed exercises using an elastic resistance band with 10
      repetitions/set × 5 sets/day × 3 days/week. The control group underwent active joint
      range-of-motion exercises and isometric contraction exercises. The intervention regimens
      lasted 12 weeks.
    

Intervention name(s): Elastic Band Resistance Exercise; active joint range-of-motion exercises and isometric contraction exercises
Intervention type(s): Other; Other
Intervention description(s): Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set × 5 sets/day × 3 days/week.; The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Design: Randomised controlled trial. Participants: Seventy patients diagnosed with T2DM together with knee OA. Intervention: Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set × 5 sets/day × 3 days/week. The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: home-based exercise, resistance band, cartilage degeneration, glycated haemoglobin control, diabetes mellitus
Phase III Study of ASP2151 in Herpes Zoster Patients
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with
      valaciclovir (VACV) 3000 mg in patients with herpes zoster.
    

Detailed description: 
      A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy
      and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in
      patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined
      as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study
      treatment" to demonstrate the non-inferiority of ASP2151 to VACV. The safety will be
      evaluated based on adverse events, laboratory tests, vital signs, and ECGs.
    

Intervention name(s): ASP2151; valaciclovir
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg once daily or 400 mg once daily; 1000 mg three times daily
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms
Condition: Brain Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm; Aneurysm, Ruptured
Study type: Observational [Patient Registry]

Summary: 
      An observational non-randomized, multi-center, prospective assessment of the clinical utility
      of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms
      deemed appropriate for endovascular treatment. The population being treated in this Registry
      is a subset of the CE marked indication.
    

Detailed description: 
      All eligible subjects presenting to the participating Registry Center will be considered for
      entry into the Registry. Up to 70 evaluable subjects meeting the Registry entry criteria will
      be enrolled.

      An intermediary analysis will be performed when the first forty (40) subjects reaching the
      planned one month follow-up.

      subjects will be followed per Institution's standard of care.
    

Intervention name(s): WEB Aneurysm Embolization System
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The decision to use a WEB device to treat the patient has been made before and
        independently of the decision to include the patient in this Registry
      
Keywords: Endovascular; Brain aneurysm; Ruptured aneurysm
Effect of Acetazolamide on Cognition in Patients With Respiratory Disease at Altitude
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, placebo controlled trial evaluating the effect of acetazolamide on cognition in
      lowlanders with chronic obstructive pulmonary disease travelling from 760 m to 3200 m.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of acetazolamide (375 mg per day) vs. placebo on visuomotor learning performance at altitude
      (Tuja Ashu, 3200 m). Randomization to acetazolamide or placebo will be carried out after
      baseline measurements in Bishkek (760 m).

      Visuomotor learning performance will be tested by Motor Task Manager (MTM). The MTM requires
      the subjects to reach visual targets with a hand-held cursor. During progression of the test,
      the movement direction from the cursor on the computer screen will increasingly differ from
      the direction of the hand movement, forcing the unaware subject to implicitly adapt to the
      imposed cursor rotation. This test assesses a subjects ability to visuomotor adaption,
      perception and attention. Furthermore, as the task will be performed in the evening and after
      sleep in the next morning, the investigators will be able to assess overnight improvement of
      implicit learned skills.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cognition; visuomotor learning; airway disease; altitude; prevention; acetazolamide