bioihbjkbjnl/mcl2 huggingface dataset:
Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy
Condition: Hemophilia
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional
      alterations (deficit of muscle strength, mobility and proprioception) (intra-articular
      alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue
      adhesions, relieve pain and reduce tissue sensitivity.

      Design. A randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a
      protocol by self-myofascial release with Foam Roller applied in patients with hemophilic
      ankle arthropathy.

      Patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study.
      Patients will be recruited in 5 centers, from different regions of Spain.

      Intervention: Each session will last approximately 15 minutes, with five physiotherapy
      sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the
      intervention, and after a follow-up period of 3 months. The treatment program includes 11
      exercises that must be administered bilaterally. A mobile application will be developed where
      each patient will be able to observe the exercises to be carried out.

      Measuring instruments and study variables: digital goniometer (ankle range of motion); visual
      analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint
      status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower
      limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). At the same
      time, the study will allow to determine joint bleeding caused by applied physiotherapy
      treatment.

      Expected results: To demonstrate the safety of this Physiotherapy technique in patients with
      hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is
      expected.
    


Intervention name(s): Self-Myofascial release
Intervention type(s): Other
Intervention description(s): The Self-Myofascial release protocol for the lower limbs using a Foam Roller will include: Self-Myofascial release of the plantar region using and Solid Ball Massage; release of the myofascial components of the back of the leg using a Foam Roller; release of the myofascial components of the anterior part of the leg using a Foam Roller; release of myofascial components of the hamstring region using a Foam Roller; release of the myofascial components of the adductor muscles using a Solid Ball Massage in a sitting position; release of the myofascial components of the abductor muscles using a Foam Roller in lateral decubitus; and release of the myofascial components of the pelvitrochanteric muscles using a Foam Roller in a sitting position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in
      subjects with type 1 diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.; A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
Other intervention name(s): NN1218
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
EDoF IOLs vs Monofocal IOL
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      prospective, comparative (3 arms), randomized, multicentric clinical trial
    


Intervention name(s): EDoF1; Monofocal; EDoF2
Intervention type(s): Device; Device; Device
Intervention description(s): extended depth of focus IOL - EDoF1; Monofocal IOL; Comparison EDoF2 IOL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the absorption, distribution, metabolism and
      excretion of an investigational medication used to treat chronic obstructive pulmonary
      disease (COPD). The study drug will be tested in 6 healthy normal males. Dosing will include
      a single dose of study drug administered via an IV Infusion and an Oral Dose. There will be a
      28 day washout period between each of the 2 dosing routes.
    

Detailed description: 
      This is an open-label, fixed-sequence, two-period study in up to 12 healthy male subjects.
      The present study is designed to fully characterize the rates and routes of elimination of TD
      4208 using radiolabeled drug administered via the oral and IV route. This study will provide
      information regarding the metabolic fate of TD 4208, the need for evaluation of potential
      drug-drug interactions, the need for studies in special populations and the absolute oral
      bioavailability of TD-4208. The results from this study will allow a comprehensive comparison
      between animal and human routes of elimination and metabolic profiles of TD 4208.

      This study will be conducted in a small number of healthy male subjects (up to n=12) to
      minimize the number of individuals exposed to radioactivity. Each subject will receive the
      following treatments: Treatment A (Period 1): 20 μg IV infusion of [14C] TD-4208 administered
      in a fasted state over 30 minutes. Treatment B (Period 2): 200 μg oral solution of [14C]
      TD-4208 administered in a fasted state. Blood, urine, feces, and vomitus (if applicable) will
      be collected until the subject is released during Periods 1 and 2. In Periods 1 and 2,
      subjects may remain in the clinical research unit for a maximum of 15 days. Between the
      dosing in periods 1 and 2, there will be washout intervals of at least 28 days.
    

Intervention name(s): TD-4208
Intervention type(s): Drug
Intervention description(s): One dose each of treatments A: [14C] TD-4208 20 μg IV administered in a fasted state over 30 minutes. B: [14C] TD-4208 200 μg oral solution administered in a fasted state.
Other intervention name(s): revefenacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD; ADME; Healthy Normal Males; Phase 1
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate
      on lung function, symptoms, and use of rescue medication in children with persistent asthma.
      Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone
      propionate will be inhaled at one dose level twice daily. The study duration consists of a
      baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide
      further data on safety and tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Child; Fluticasone propionate; Pediatric
Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4
Condition: Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone
      antibiotic. Cohorts of healthy adults (female and male) will participate in:

      single dose escalation study of increasing doses of MRX-4 given by mouth others will
      participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.

      other cohorts of subjects will participate in the study to evaluate the impact of concomitant
      food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4
    


Intervention name(s): Oral single doses of MRX-4; Oral multiple doses of MRX-4; MRX-4 co-administered with omeprazole; Oral single doses of placebo; Oral multiple doses of placebo; Placebo co-administered with omeprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral single escalating doses of MRX-4; Multiple ascending doses of MRX-4 given twice daily for 10 days; MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7; Single doses of placebo to match MRX-4; Oral placebo given twice daily for 10 days to match the oral MRX-4; Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Phase 1
Evaluation of the Effectiveness of Secukinumab in Patients With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      This study was a real-life study which was based on secondary data collection from the
      electronic or paper medical records from the Dermatology Clinics of the 14 University,
      Training & Research Hospitals in Turkey. Data were extracted between 02 September 2020 and 29
      April 2021.
    

Detailed description: 
      The study was a retrospective, multicenter, cohort study which was based on data collection
      at week 4,16 and 52 of secukinumab treatment of moderate to severe plaque psoriasis.

      The observational design of the study allowed data collection about secukinumab treatment
      patterns and clinical and demographic characteristics of plaque psoriasis patients treated
      with secukinumab for 52 weeks in Turkey. The adults included in the study were treated with
      secukinumab for 52 weeks. The adults with no available data of PASI scores at specific time
      points (4, 16 and 52 weeks) and no definite description of treatment cessation were excluded.
      The study population consisted of adults treated with secukinumab for 52 weeks and adults
      dropped out before 52 weeks with available data of PASI scores at 4, 16 and 52 weeks and
      definite description of treatment cessation.

      Retrospective data collection from secondary sources (hospital medical records) allowed time
      and cost saving since description of patients' characteristics, analyses of outcomes of
      interest and their determinants could be made in a short period of time.

      The study consisted of the following periods:

        -  The index date was the date of initiation of secukinumab

        -  The study (index) period was between 18 May 2018 to 31 May 2020

        -  The follow-up (post-index) period was 4,16 and 52 weeks post-index
    

Intervention name(s): Secukinumab
Intervention type(s): Other
Intervention description(s): Included all the patients treated with secukinumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consisted of adults diagnosed as chronic plaque psoriasis with no
        previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or
        IL-17RA, whose PASI score was ≥10 before initiation of secukinumab in whom secukinumab had
        been initiated for at least 52 weeks before data collection date.
      
Keywords: Secukinumab,; real life,; PASI,; effectiveness,; anti-IL17
Frozen Shoulder Treated by Energy Accumulator
Condition: Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      Frozen shoulder is a painful and disabling disorder of unclear cause, affecting middle-age
      people after their 5th decades. They suffer from annoying pain and limited shoulder mobility.
      Energy Accumulator provides a better way of relief through an integrative medicine concept.
    

Detailed description: 
      Frozen shoulder is common among middle-aged persons in the 5th and 6th decades. The pain can
      be acute or chronic. Patients feel stiffness over the shoulder, shown by restriction in range
      of motion. The etiology includes trauma, cervical disc degeneration, physical strain,
      psychosocial problems and even genetic factors. The predisposing factors include
      immobilization of the arm for a long time, rotator cuff or biceps tendinitis, tenosynovitis
      of the long head of the biceps, congenital deformity of the shoulder girdle, scapula-costal
      cementing, ligamentous injury, osteoarthritis, muscular fibrosis or nutritional deficiencies.
      The pathology is unclear but it is widely believed that it is related to inflammation in the
      joint and surrounding soft tissues which lead to fibrosis. Frozen Shoulder can be divided
      into Primary Frozen Shoulder which occurs spontaneously without other diseases; and Secondary
      Frozen Shoulder is associated with joint diseases, such as osteoarthritis or fractures.

      UKFROST was a multi-centre randomized clinical trial comparing 3 parallel groups (arms) of
      frozen shoulder patients treated 1) under anaesthesia + steroid injection 2) under
      anaesthesia + arthoscopy, and 3) physiotherapy + steriod injection..The large-scale study
      proves physiotherapy program beneficial to frozen shoulder patients, and, the effectiveness
      might further improve by introducing East-Meets-West component - Chinese Medicine.
    

Intervention name(s): Energy accumulator; Home exercise program
Intervention type(s): Device; Behavioral
Intervention description(s): All subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts. The course included 8 sessions of treatment, twice every week for 4 weeks. Each session lasted for 30-45 minutes. During heat therapy, the ceramic nozzle of the Energy Accumulator was lightly pressed in contact of the skin, without any contact medium, and moved slowly along the meridians with some circular movements.; Home exercises aimed at providing gentle mobilization at the shoulder and were capable of carrying out at home. Patients were requested to perform the movements on a daily basis within the first 4 weeks of treatment. Four movements were involved: Movement 1 - Pendular Exercise, Movement 2 - Circle Exercise, Movement 3 - Wall Climbing Exercise, and Movement 4 - Lie on bed and move both arms up and down.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Frozen Shoulder; Integrative Medicine; Energy Accumulator
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group
      study.

      The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared
      with valsartan therapy, on the efficiency of cardiac work in patients with NYHA II-III heart
      failure (HF) and reduced systolic function using 11C-acetate positron emission tomography
      (PET) and echocardiography.
    

Detailed description: 
      Subjects were randomized into valsartan or sacubitril/valsartan arms in a 1:1 ratio.
      Regardless of the treatment arm a subject is in, the study drug was up-titrated to the
      highest tolerated dose level during the scheduled study visits. The different strengths of
      the two study drugs were not identical in appearance so the possible dose modification(s)
      during the treatment period could not be performed in a blinded manner. Subjects started on
      valsartan 80 mg BID or sacubitril/valsartan 100 mg BID dose and there was only one scheduled
      up-titration visit after the randomization. Exception for this were the subjects that were on
      valsartan 160 mg BID dose during the run-in phase. These subjects were randomized directly to
      valsartan 160 mg BID or sacubitril/valsartan 100 mg BID. Subjects that were randomized to
      valsartan arm had similar visit after which they continued on the same dose. For subjects
      that were randomized from valsartan 160 mg BID to sacubitril/valsartan 100 mg BID the dose
      was up-titrated to 200 mg BID if clinically possible.

      The total duration for each patient was planned to be about 14 weeks but could be longer if
      required for scheduling purposes . The longest participation, from signing of ICF until end
      of study, was 26 weeks.
    

Intervention name(s): sacubitril/valsatran; valsartan; placebo to valsartan; placebo to sacubitril/valsartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sacubitril/valsatran 100 or 200 mg BID; Valsartan 80 or 160 mg BID; placebo to valsartan 80 or 160 BID; placebo to sacubitril/valsartan 100 or 200 mg BID
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart failure with reduced left ventricular ejection fraction; LVEF; Cardiac dysfunction; Heart muscle dysfunction; Left ventricular (LV) dilation; Left ventricular hypertrophy; HF; AHF; CHF; CCF; acute heart failure; chronic heart failure; congestive heart failure; congestive cardiac failure
Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure
Condition: Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Skin Diseases
Study type: Interventional

Summary: 
      It is an open-label physiological investigation of the allergic skin reactivity to
      epicutaneous allergen exposition in 20 allergic patients in two different skin conditions.
      The focus of the study is on the skin preparation/condition and not on the specific allergen
      or allergy, but for reasons of homogeneity a single allergic disease, birch pollen allergy
      was chosen as the basis for the testing. In order to evaluate the effects of the two
      different skin preparation techniques an intraindividual comparison of the skin reactivity in
      terms of the immediate phase I reaction to serial dilutions of birch pollen extracts was
      chosen. The serial dilution approach allows a dose dependent effect evaluation and comparison
      of the sensitivity. The differences will be explained mainly by the two different skin
      preparations allowing a quantitative comparison of these techniques.
    

Detailed description: 
      The Objective is the determination of the allergic skin reactivity to epicutaneoulsy applied
      birch pollen allergen extract after skin preparation (microporation by P.L.E.A.S.E.
      Professional) and standard skin prick test. By using the standard prick test the stratum
      corneum is overcome by a single puncture (1 mm).

      Micropores induced by P.L.E.A.S.E. Professional penetrate the stratum corneum less deep but
      with a higher density (five pores). It is therefore suggested that a skin preparation with
      micropores by P.L.E.A.S.E. Professional previously to the allergen contact may lead to a
      higher sensitivity. Less allergen might still elicit a skin reaction which won?t be seen by a
      conventional prick skin test. Whereas skin prick test may lead to true-negative (patient
      shows no allergic reaction on prick skin test but is an allergy sufferer in clinic),
      IgE-determination may lead to false-positives (patient is determined as allergy sufferer but
      has no clinical symptoms). So the sensitivity with micropores skin preparation by
      P.L.E.A.S.E. Professional could be a good compromise. The preparation of the skin with
      P.L.E.A.S.E. Professional leads to a better understanding of the influence of different types
      of skin injury patterns on the allergic skin reactivity. Namely, how important is the role of
      the exposed area, the depth of injury and the keratinocyte activation.

      This will be checked in a late phase reaction evaluation.
    

Intervention name(s): Microporation by P.L.E.A.S.E. Professional / Prick needle
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science