bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Outcomes After Dry Needling on Cervical Muscles, and Quality of Life, in Patients With Fibromyalgia Syndrome.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Objectives: The purpose of the current randomized clinical trial is to compare the
      effectiveness of dry needling versus myofascial release therapy on myofascial trigger points
      (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and
      depression in patients with fibromyalgia syndrome (FMS).
    

Detailed description: 
      Design: A single-blind randomized controlled trial will be conducted on patients with FMS.

      Methods: Sixty-four subjects with FMS will be randomly assigned to an experimental group
      receiving dry needling therapy, or to a control group for myofascial release therapy in the
      trigger points active or latent in the following pairs of muscles: occipital, splenius
      capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and
      multifidus. Myofascial trigger points, quality of life, impact of fibromyalgia symptoms,
      quality of sleep, intensity of pain, anxiety levels, state of depression, impact of fatigue
      will be recorded at baseline and after four weeks of treatment.
    

Intervention name(s): Dry Needling Therapy; Myofascial Release Therapy
Intervention type(s): Other; Other
Intervention description(s): Dry needling procedures will be performed in the following pairs of muscles in the same intervention: occipital, splenius capitis, sternocleidomastoid (Clavicular branch TrPs 1, 2 and 3; sternal branch TrPs 1, 2, 3 and 4), scalene (anterior TrPs 1, and 2; medial TrP (Trigger Point) 1; posterior TrP 1), trapezius (upper TrPs 1, and 2; middle TrPs 5, 6 and 7; lower TrPs 3, and 4), supraspinatus (central point; myotendinous union; tendon insertion), infraspinatus (medial/superior; lateral/superior; lateral scapular side; medial scapular side), and multifidus (level C6).; Patients will develope a myofascial therapy protocol, administered in the following order in the same intervention: deep fascia release in temporal region, suboccipital release, compression-decompression of temporomandibular joint, global release of cervicodorsal fascia, release of pectoral region, diaphragm release (transverse slide), and transverse diaphragmatic plane.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Quality of Life; Fatigue; Anxiety; Physical Therapy Modalities; Pain
Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate
Condition: Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images
Study type: Observational

Summary: 
      This is a non-interventional pilot study with the following objectives:

        -  Establish scalable methodology for collection of retinal images, blood pressure (BP) and
           laboratory-based assessments

        -  Compare the results of a machine-learning algorithm in predicting BP, glycated
           haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR) from digital retinal
           images with clinical and laboratory-based measures

        -  Determine the required sample size needed to support a future study to fully validate
           the machine-learning algorithm
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants have to be more than 35 years, able to provide written consent and meet the
        following inclusion criteria:

          -  With or without DM (at least 50% of participants will have an HbA1c ≥ 6.5%* and/or a
             known diagnosis of DM)

          -  Male or female (at least 40% of participants must be male, and at least 40% must be
             female)
      
Keywords: - Machine learning; retinal images; blood pressure; glycated haemoglobin; glomerular filtration rate
Dexmedetomidine Added to Bupivacaine Versus Bupivacaine inTransincisionalU/S Guided Quadratus Lumborum Block in Open Renal Surgeries , A New Technique
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the addition of dexmedetomidine to bupivacaine versus
      bupivacaine only in anterior QLblock(transincisional) , where the local anesthetic will be
      applied before wound closure at the end of surgery through the wound . in combination with
      general anesthesia in elective open renal surgery with regard to Postoperative pain
      control,hemodynamic stability, and adverse effects.
    


Intervention name(s): Dexmedetomidine +bupivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): patients will receive combined general anesthesia and Quadratuslumborum block( transincisional ie before wound closure)with 19 mL of bupivacaine 0.20%plus 1 mic/kg of dexmedetomidine, total volume 20 ml; patients will receive combined general anesthesia and quadratus lumborum block (transincisional) with 20 ml of bupivacaine 0.20% .
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Testosterone vs Placebo in Testicular Cancer Survivors
Condition: Metabolic Syndrome; Testicular Cancer; Leydig Cell Failure in Adult
MeSH terms: Testicular Neoplasms; Metabolic Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The overall purpose of the study is to evaluate the effect of 12 months testosterone
      replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in
      order to reduce the risk of cardiovascular disease.

      The primary study objective is to evaluate changes in insulin sensitivity. The secondary
      study objective is to evaluate changes in the prevalence of metabolic syndrome, body
      composition, systemic inflammation and symptoms of testosterone deficiency.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled intervention study,
      designed to evaluate the effect of testosterone replacement therapy in testicular cancer
      survivors with mild Leydig Cell Insufficiency.

      70 subjects will be randomized to receive either testosterone replacement therapy or placebo.
      The subjects will be invited for an information meeting where informed consent is signed. If
      a subject is suitable for participation in the trial, subject will be randomized to
      testosterone replacement therapy or placebo and baseline investigations will be performed.
      Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of
      testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of
      the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at
      the end of treatment (52 weeks) and three months after completion of treatment (week 64).
    

Intervention name(s): Testosterone; Placebos
Intervention type(s): Drug; Drug
Other intervention name(s): Tostran
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients
      with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD
      001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in
      combination with carboplatin, paclitaxel and bevacizumab
    

Detailed description: 
      This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001
      is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as
      carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced
      (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced
      disease
    

Intervention name(s): RAD001
Intervention type(s): Drug
Intervention description(s): 5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other intervention name(s): Everolimus
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non Small Cell Lung Cancer; NSCLC; Advanced Lung Cancer; RAD; RAD001; chemotherapy; carboplatin; paclitaxel; bevacizumab
Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome
Condition: Neonatal Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Syndrome
Study type: Interventional

Summary: 
      In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth
      would decrease the incidence of intubation or death in twin infants when compared to nCPAP.
    

Detailed description: 
      After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another
      nIPPV.
    

Intervention name(s): nIPPV; nCPAP
Intervention type(s): Device; Device
Intervention description(s): one of the twins was randomly allocated to nIPPV; another of the twins was allocated to nCPAP
Other intervention name(s): nIPPV:Nasal Intermittent Positive Pressure Ventilation; nCPAP:Nasal Continuous Positive Airway Pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Nasal Intermittent Positive-Pressure Ventilation; Nasal Continuous Positive Airway Pressure; twin; respiratory distress syndrome
Outcomes for Manual Lymphatic Drainage
Condition: Total Knee Arthroplasty
MeSH terms: Kinesiophobia
Study type: Interventional

Summary: 
      In this context, the purpose of our study is to investigate the effect of MLD(manual
      lymphatic drainage) technique applied in addition to the standard postoperative
      rehabilitation protocol on pain, kinesophobia and quality of life in early periods in
      patients undergoing primary TKA(total knee arthroplasty) surgery. Our hypothesis is that the
      addition of the MLD technique to the standard postoperative rehabilitation protocol will
      improve the early clinical outcomes of patients undergoing primary TKA. In the future
      perspective, we anticipate that the data obtained as a result of our study will make a
      significant contribution to the relevant literature on the early and mid-term ameliorative
      effects of MLD on postoperative pain, kinesiophobia and quality of life, which will be
      possibly applied in addition to standard postoperative rehabilitation protocols in patients
      undergoing primary TKA.
    


Intervention name(s): exercise and manual lymphatic drainage; exercise
Intervention type(s): Other; Other
Intervention description(s): MLD will be launched with simple neck application. Hemodynamics of blood and lower extremity motoring will be increased by combining active bilateral shoulder-twisting with breathing after effleurage. Cervical lymph nodes will be stimulated. Back-up treatment will be applied for the abdominal area. Suction power in the ductus thoracicus will be increased with breathing exercises. Ventral drainage will be applied to the lower extremity in accordance with the surgery of the patient.; range of motion and walking exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Manual Lymph Drainage; Kinesiophobia; Pain; Quality of Life
A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine the side effects related to LY3493269 given as a
      single injection to healthy participants. Blood tests will be performed to check how much
      LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each
      enrolled participant will receive a single dose of LY3493269 or placebo. The study will last
      up to approximately 71 days for each participant, including screening.
    


Intervention name(s): LY3493269 - SC; Placebo - SC; LY3493269 - IV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.
Condition: Pulpotomies Primary Teeth; Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth
Study type: Interventional

Summary: 
      assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary
      molars with carious pulp exposure in comparison to Formocresol.
    


Intervention name(s): MedCem MTA pulpotomies in primary teeth.
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulpotomy; MTA; primary teeth; formocresol
Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory
      agent, will improve the clinical condition of patients with rheumatoid arthritis who still
      have active joint inflammation despite taking methotrexate for at least 6 months.
    

Detailed description: 
      This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled,
      dose-finding study in which patients with active RA despite receiving methotrexate for at
      least 6 months (at unchanged doses for >=2 months) will be randomized to the addition of
      either CF101 0.1 mg, CF101 1 mg, or placebo given orally q12h for 12 weeks. Screening
      examinations will occur within 1 month prior to dosing. Washout of other disease-modifying
      antirheumatic drugs (DMARDs) (with the exception of hydroxychloroquine), including biological
      agents, will occur prior to dosing; if washout is necessary, patients must re-qualify for
      inclusion following the washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and
      corticosteroids must be stable for >=1 month prior to dosing and remain so during protocol
      participation. Disease activity will be assessed using swollen and tender joint counts,
      physician and patient global assessments (by visual analog scale, VAS), patient reported pain
      (by VAS), a Health Assessment Questionnaire (HAQ) Disability Index (DI), Westergren
      erythrocyte sedimentation rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP)
      levels. Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8,
      and 12.
    

Intervention name(s): CF101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): orally q12h; orally q12h
Other intervention name(s): IB-MECA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Oral Isotretinoin for Photoaging: Results of a Randomized Controlled Phase II Trial
Condition: Photoaging; Epidermal p53 Expression
MeSH terms: Skin Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical and histological randomized controlled phase II trial to evaluate the efficacy and
      safety of oral isotretinoin for treating photoaging was performed with 32 menopausal or
      sterilized women aged 40-55y. The subjects were included in two randomly selected groups: A-
      21 women received 20mg oral isotretinoin 3x week, moisturizer, sunscreen SPF 60 during three
      months; B- 11 women received only same moisturizer/sunscreen.
    

Detailed description: 
      Clinical assessment ranging from -2=very bad to +2=very good for all patients. Also,
      profilometry, corneometer and skin elasticity tests in periocular regions and left forearm;
      skin biopsy on left forearm before/after treatment in B and in 10 randomly selected patients
      from A. Microscopic evaluation of corneal layer and epidermal thickness, dermal elastosis,
      new collagen and p53 epidermal expression performed by quantitative digital image analysis.
      Blind evaluations (group/time) conducted by two independent observers.

      Clinical evaluation results showed no alterations (0) or slight improvement (+1) for all
      patients; profilometry, corneometer and skin elasticity measurements presented a significant
      difference in pre and post treatment values (p=0,001 to 0,028) with no differences between
      A/B. Regarding histological findings and p53 expression no previous differences between
      groups before the treatment were observed (p>0,1).Quantitative microscopic digital analysis
      demonstrated no differences between groups at the end of the study for the majority of
      variables. However, slight but significant difference between A/B subjects was found for p53
      with major expression reduction for those treated with oral isotretinoin [0,66±0,31 vs
      0,94±0,34 respectively (p=0,04)]. The main side effects were cheilitis in 15 patients (75%)
      and xerophthalmia in 5 (25%). No significant alterations occurred in biochemical tests.
    

Intervention name(s): oral isotretinoin and Mexoryl SX / XL; Mexoryl XL / SX
Intervention type(s): Drug; Drug
Intervention description(s): 20mg, 3/week,continuously for three months; 11 subjects used only the same moisturizer and SPF 60 sunscreen
Other intervention name(s): isotretinoin; mexoryl; mexoryl
Intervention MeSH terms: Isotretinoin; Terephthalylidene dicamphor sulfonic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: photoaging; isotretinoin; profilometry; digital analysis
Environmental Exposures, Genetics, and Exhaled Nitric Oxide in Pediatric Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is one of the most common childhood diseases. It is chronic and often severely
      disabling. The amount of nitric oxide that is exhaled while breathing increases with airway
      inflammation, a symptom of asthma. This study will examine the results from a previous study,
      the Cincinnati Asthma Prevention (CAP) study, to evaluate the effects of environmental and
      genetic factors on exhaled nitric oxide (eNO) levels and to determine the relationship
      between eNO and asthma severity.
    

Detailed description: 
      Nitric oxide is a naturally occurring gas that plays a role in many body functions. Levels of
      eNO increase with airway inflammation, a symptom of asthma. Researchers have proposed using
      eNO as a noninvasive measure to guide physicians in the treatment and medical management of
      asthma in children. However, more information about eNO is needed before this can happen.
      This study will perform a secondary analysis of the results from its parent study, the CAP
      study, which evaluated the effectiveness of preventing asthma in children who had been
      exposed to environmental tobacco smoke.

      This study will not enroll any new participants. Previously collected data from the CAP study
      will be reevaluated in this study to determine the longitudinal effects of environmental and
      genetic factors on eNO levels. In addition, the data will be evaluated to determine the
      relationship between eNO levels and asthma severity. No new data will be collected in this
      study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cincinnati area children with asthma
      
Biospecimen description: 
      Blood and urine
    
Keywords: Exhaled Nitric Oxide; Asthma; Tobacco Smoke; Allergen
Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children
Condition: Salter-Harris Type I; Salter-Harris Type 2; Radius Fractures; Forearm Fracture
MeSH terms: Fractures, Bone; Radius Fractures
Study type: Interventional

Summary: 
      The standard treatment for children with closed reduction of displaced distal forearm
      fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm
      immobilization with combicast in children 4-16 years might be sufficient.
    

Detailed description: 
      Children with distal radial or forearm fractures needing closed reduction are eligible for
      this study. By drawing lots either an immobilization with an upper arm or forearm combicast
      will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be
      performed to check the rate of displacement, consolidation time, wearing comfort and movement
      of the elbow joint after taking off the cast.
    

Intervention name(s): combi cast
Intervention type(s): Device
Intervention description(s): upper arm or forearm combi cast
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: one Group with upper arm cast one Group with forearm cast
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cast, fracture, immobilization, displacement, child
Study of VX-770 and Rifampin in Healthy Male Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the effects of multiple doses of rifampin on the
      single-dose pharmacokinetics of VX 770.
    

Detailed description: 
      This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to
      investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone
      or with rifampin.

      All enrolled subjects will receive the same treatments and undergo the same procedures. In
      Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will
      receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.
    

Intervention name(s): VX-770; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.; In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment