bioihbjkbjnl/mcl2 huggingface dataset:
Response Inhibition Training for Children With Williams Syndrome
Condition: Williams Syndrome
MeSH terms: Williams Syndrome; Syndrome
Study type: Interventional

Summary: 
      The investigators will conduct a pilot study investigating the effectiveness of a
      computerized response inhibition training program at reducing the response inhibition
      difficulties often seen in children with Williams syndrome ages 10-17. The investigators
      hypothesize that after completing the training program, children with Williams syndrome will
      show improvement on computerized measures of response inhibition and on parent measures of
      impulsivity.
    

Detailed description: 
      Behavioral characteristics of individuals with Williams syndrome include eagerness to
      approach and interact with others (including strangers), repeated questions especially about
      upcoming events, and difficulties with attention, impulsivity, and inhibition. There is very
      little systematic research about the kinds of interventions that are most useful for children
      with Williams syndrome to support optimal psychosocial functioning, and of the effectiveness
      of such interventions. We will conduct a pilot study of a potential intervention to address
      the response inhibition difficulties associated with Williams syndrome. The investigators
      will examine the utility of an online, web-based computerized cognitive retraining program
      aimed at addressing impulsivity and inhibition difficulties in 20 children, ages 10-17, with
      WS. The engaging training program has shown some utility in other populations, including
      children with tic disorders and trichotillomania. The investigators will examine the
      acceptability and feasibility of the treatment approach, as well as its impact on performance
      on experimental measures of impulsivity and on everyday psychosocial functioning as rated by
      parents; this study will consist of a small-scale pilot Randomized Clinical Trial with wait
      list. Through this novel work, we hope to develop and tune this approach for optimal outcomes
      and to demonstrate the promise of this intervention to address common challenges of people
      with Williams syndrome in the area of inhibition.
    

Intervention name(s): Response Inhibition Training
Intervention type(s): Behavioral
Intervention description(s): Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Response Inhibition, Williams Syndrome
Neurodynamic Interventions for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      A randomized, parallel-group, clinical trial will be conducted to compare the immediate
      effects of the inclusion of a neurodynamic intervention into a multimodal physiotherapy
      program on pressure pain sensitivity, pain and manual dexterity in patients with multiple
      sclerosis
    


Intervention name(s): Physical Therapy; Physical Therapy plus Neurodynamic
Intervention type(s): Other; Other
Intervention description(s): Patients will receive 5 session of multimodal physiotherapy treatment of 30min duration including low-load strength exercises, soft tissue mobilization and muscle-tendon stretching exercises twice per week.; Patients will receive 5 session of multimodal physiotherapy treatment of 30min duration including low-load strength exercises, soft tissue mobilization and muscle-tendon stretching exercises twice per week. In addition, they will also receive bilateral nerve slider neurodynamic interventions targeting the median, ulnar and radial nerves.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neurodynamics; pain
Kinesio Tape Application With EDF Technique on Active Trigger Points of Upper Trapezius Muscle
Condition: Myofascial Pain Syndrome; Myofascial Trigger Point Pain
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      In this double-blinded, prospective randomized sham controlled multi centered study, the aim
      was to investigate the efficacy of EDF technique on pain intensity, number of active TrPs,
      cervical ROM and disability levels in patients with MPS on upper trapezius (UT) muscle.180
      patients were randomly allocated to kinesio taping (KT) group or sham group. Applications
      were done two times 1 week apart. VAS-pain scores, disability scores , cervical ROM angles
      and number of trigger points were evaluated as outcome parameters. Vas-pain scores and number
      of trigger points were assessed at baseline, after 1 week and after 2 weeks (at the end of
      the study). Cervical ROM angles and disability (measured by Neck Pain Disability Scale) were
      assessed at baseline and at the end of the study. Both groups received home exercise program.
      As a result application of KT with EDF technique to the UT muscle provided a significant
      improvement in pain level, disability, number of active TrPs and cervical ROM angles and
      found superior to sham application.
    

Detailed description: 
      In order to determine the sample size, power analysis was performed using the G*Power Version
      3.1.9.2 program. Effect size of 1.26 was set up for the VAS pain score changes between groups
      as per the previous study. For power calculations, a confidence level (α) of 0.05 and a power
      level of 0.95 was assumed. Fifteen patients per group in each center was required. 15
      patients were randomized to two groups in each center by numbered envelopes method. The group
      1 and group 2 notes were put into to the closed envelopes separately, and each patient
      randomly chose an envelope and gave it to a physician who was not the researcher. One
      researcher evaluated the patient and then collected the data, and the second researcher who
      was certified as KT practitioner applied the KT. Both patients and the researcher who
      recorded the data were blinded to treatment allocation.
    

Intervention name(s): Kinesio tape; Sham Kinesio Tape
Intervention type(s): Device; Device
Intervention description(s): The Kinesio Tex Gold FP (Kinesio Tex Tape, Kinesio Holding Corporation, Albuquerque, NM, USA) was used. It was waterproof, porous and adhesive, had a width of 5 cm and a thickness of 0.5 mm. The same brand of tape was used in both groups.; The Kinesio Tex Gold FP (Kinesio Tex Tape, Kinesio Holding Corporation, Albuquerque, NM, USA) was used. It was waterproof, porous and adhesive, had a width of 5 cm and a thickness of 0.5 mm. The same brand of tape was used in both groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Inpatient Diabetes on Corticosteroids
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite a significant problem with out-of-control glucose levels in patients with diabetes
      receiving corticosteroids for a variety of illnesses, there are no published protocols
      addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators
      propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin
      for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed
      to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's
      usual insulin regimen and timed to correspond to the corticosteroid dosing regimen.
      Investigators will prospectively enroll eligible consented patients with diabetes who are
      receiving corticosteroids as part of their treatment in a large county hospital, will
      randomize them to intervention or control groups, and will monitor their glucose levels
      during their inpatient stay. The protocol will demonstrate improved control of glucose levels
      with minimal risk of hypoglycemia, and will provide a practical and readily implementable
      protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
    

Detailed description: 
      As above.
    

Intervention name(s): NPH; Correction Factor
Intervention type(s): Drug; Drug
Intervention description(s): NPH given per study table based on steroid dose and patient weight in kg.; Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Other intervention name(s): NPH Lilly Insulin; Rapid acting regular insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: corticosteroid; diabetes; insulin
A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate
Condition: Rheumatoid Arthritis; Pharmacokinetics of ASP2408
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with
      Rheumatoid Arthritis (RA) on Methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of
      ASP2408.
    

Detailed description: 
      This is an ascending dose frequency study. There are two cohorts of active and placebo
      patients. The first cohort is dosed every 4 weeks for a total of 3 doses. The second cohort
      is dosed every two weeks for a total of 3 doses.
    

Intervention name(s): ASP2408; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; subcutaneous injection
Intervention MeSH terms: ASP2408
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Rheumatoid Arthritis; ASP2408; methotrexate
Intestinal Microbiota and Thyroid Cancer
Condition: Microbiota
MeSH terms: Thyroid Neoplasms
Study type: Observational

Summary: 
      Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the
      fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States
      has increased by an average of 3% per year over the past 4 decades. Much progress has been
      made in exploring the etiology and pathogenesis of thyroid cancer, while the exact etiology
      remains unknown, TC is thought to arise from interactions between genetic susceptibility
      factors, epigenetic effects, and various environmental factors. Besides the improvement of
      diagnosis, TC increasing incidence emphasize that other important factors such as the
      environment play an important role in disease pathogenesis. While microbiota as an
      environment factor to some cancers accept widespread attention, if microbiota also as a risk
      factor for TC, it is worthy to be considered.
    

Detailed description: 
      Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the
      fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States
      has increased by an average of 3% per year over the past 4 decades. According to the China
      National Cancer Registry data in 2015 (3), there were estimated 90,000 new TC cases in China,
      and its incidence has risen sharply. Much progress has been made in exploring the etiology
      and pathogenesis of thyroid cancer, while the exact etiology remains unknown, TC is thought
      to arise from interactions between genetic susceptibility factors, epigenetic effects, and
      various environmental factors. Besides the improvement of diagnosis, TC increasing incidence
      emphasize that other important factors such as the environment play an important role in
      disease pathogenesis. While microbiota as an environment factor to some cancers accept
      widespread attention, if microbiota also as a risk factor for TC, it is worthy to be
      considered.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All patients were included according to the inclusion and exclusion criteria
      
Keywords: Gut microbiota; 16S rRNA gene; Thyroid cancer; Metabonomics
Comparison Of Isometric And Isokinetic Strength Training Effects On Physical Performance In Athletes With Knee Pain
Condition: Knee Injuries
MeSH terms: Knee Injuries
Study type: Interventional

Summary: 
      Frequent sports events causing more injuries in athletes causing decline in their
      performance. Injuries around knee joint are common. Strength training of hamstring and
      quadriceps are effective tool in rehabilitation. The multi-speeds and multi-angles strength
      training plans were used to see the effects on symptoms and performance in athletes.
    

Detailed description: 
      A total of 69 athletes with knee pain were recruited and randomly divided into two groups. 50
      athletes completed the training programs, 25 in each group. Data was also collected from
      healthy athletes for normative values. International Knee Documentation Committee subjective
      knee evaluation form was used to report the athlete's knee condition and severity of symptoms
      including pain. Biodex isokinetic system was used for isokinetic and isometric strength
      trainings and kinetic data collection. Physical performance of an athlete was assessed by
      components of fitness through two commonly used tests: Illinois agility run test and vertical
      jump test. The athletic single leg stability test was used to assess the stability of
      athletes on Biodex Balance System.
    

Intervention name(s): isometric strength training and isokinetic strength training
Intervention type(s): Other
Intervention description(s): Isokinetic strength program included strength training at 5 different velocities from slow to fast. Participants were trained on speed of 30°/sec, 90°/sec, 150°/sec, 210°/sec and 270°/sec. Flexion and extension movements were completed with 5 repetitions at each speed.
Participants of isometric strength training group performed isometric contractions at 30°, 45° and 60° of knee flexion with five repetitions at each angle for both hamstring and quadriceps.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Athletes were randomly assigned into two groups: Isometric (ISOM) and Isokinetic (ISOK). A coin was flipped at start of data collection for the first patient to be assigned odd number and included in isometric group. Later on odd and even numbered patients were included in specific group. Additionally, data was collected from healthy athletes doing their training at Pakistan Sports Board, called healthy control group. Due to ethical constraints knee pain athletes were not included as control subjects
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Isokinetic, Isometric, Agility; Athletic Single Leg Stability,; Vertical Jump Biodex, Knee Pain
Intraoperative Monitoring of the Pelvic Autonomic Nerves
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is
      the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for
      diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying
      degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal
      cancer despite potentially nerve-sparing total mesorectal excision (TME).

      The study will examine the impact of a newly developed continuous monitoring device for
      preservation of urogenital function in patients with TME for rectal cancer. 188 patients will
      be included in the prospective, randomized, single-blind, parallel group multi-centre trial
      including two arms (TME with and without intraoperative continuous monitoring of pelvic
      autonomic nerves). The primary efficacy endpoint is the change in urinary function measured
      by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions
      measured as secondary endpoints. The application of the continuous intraoperative
      neuromonitoring device could enhance the objective intraoperative confirmation of pelvic
      nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes
      the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An
      enormous reduction of treatment costs is to be expected.
    


Intervention name(s): TME; TME; Neuromonitoring
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Total mesorectal excision; Total mesorectal excision; Intraoperative neuromonitoring of pelvic autonomic nerves.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Rectal cancer; total mesorectal excision; pelvic autonomic nerve preservation; neurostimulation; urogenital function; quality of life
A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients
Condition: Pruritis
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 4

Summary: 
      Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There
      may be many different reasons for the pruritis. Efforts to treat the problem have not been
      very effective.

      Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D
      plays an important role in the skin and is effective in treatment of certain skin conditions
      that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients.

      The objective of the investigators study is to determine the effect of supplementation with
      oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.
    

Detailed description: 
      Vitamin D2 is a fat soluble steroid hormone precursor which must be hydroxylated in the liver
      and kidney respectively to make the active form 1-25-Vitamin D. This active metabolite and
      related analogs have been synthesized and are frequently used in the treatment of
      hyperparathyroidism in patients with chronic kidney disease. However the active metabolite
      may not be back metabolized to the precursor forms which may have functions in other organs
      including the skin. Supplementation of hemodialysis patients with oral vitamin D forms would
      provide a source of precursors for use throughout the body.
    

Intervention name(s): 50,000 Units Ergocalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50,000 Units oral ergocalciferol to be given once weekly; oral placebo once weekly
Intervention MeSH terms: Ergocalciferols; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pruritis in hemodialysis patients; 25-Vitamin D in chronic kidney disease
Photobiomodulation Therapy in Exercise Capacity Assessed by 6MST in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) is characterized by dyspnea, as well as
      musculoskeletal and systemic manifestations. Photobiomodulation therapy (PBMT) with use of
      low-level laser therapy (LLLT) and/or light emitting diode therapy (LEDT) is an
      electrophysical intervention that has been found to minimize or delay muscle fatigue. The aim
      of this study is to evaluate the acute effect of PBMT with combined use of lasers diodes,
      light emitting diodes (LEDs), on muscle performance, exercise tolerance and metabolic
      variables during the 6-minute stepper test (6MST) in patients with COPD. Twenty-one patients
      with COPD will completed the 6MST protocol over 2 weeks, with 1 session per week. PBMT or
      placebo (PL) will be performed before each 6MST (17 sites on each lower limb, with a dose of
      30 J per site, using a cluster of 12 diodes: 4 × 905 nm super-pulsed laser diodes, 4 × 875 nm
      infrared LEDs, and 4 × 640 nm red LEDs; Multi Radiance Medical™, Solon - OH, USA). Patients
      will be randomized into two groups before the test according to the treatment they will
      receive. Assessments will be performed before the start of each protocol. The primary
      outcomes are oxygen uptake and number of steps, and the secondary outcome are perceived
      exertion (dyspnea and fatigue in the lower limbs).
    

Detailed description: 
      All patients will have a diagnosis of COPD according to the global initiative for chronic
      obstructive lung disease (GOLD) criteria. The patients will be at a stable phase of the
      disease, indicated by a lack of change in medical therapy (including oral steroids) or an
      exacerbation of symptoms in the preceding 4 weeks. Patients with other known severe chronic
      diseases, including cardiac, neuromuscular, or orthopedic disorders, will be excluded.
    

Intervention name(s): Photobiomodulation Therapy (PBMT)
Intervention type(s): Device
Intervention description(s): Phototherapy device - Multi Radiance Medical™ (Solon, OH, EUA)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomization will be held by drawing lots, which we use to determine whether the active combination of superpulsed lasers, LEDs, comprising the PBMT or the placebo will be given during the first session. During the second session, participants will receive the opposite treatment compared to their first session. Randomization labels will be created using a randomization table at a central office where a series of sealed, opaque, and numbered envelopes ensured confidentiality.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being performed in order to learn more about the safety and tolerability of
      AZD1386. AZD1386 is primary intended for treatment of chronic pain.
    


Intervention name(s): AZD1386; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L; Oral admin. of doses at 11 days through a 12 days period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MAD; Multiple ascending dose; Chronic pain; pain