bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom
      scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on
      placebo.
    

Detailed description: 
      This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST
      vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two
      years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR
      symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching,
      sneezing, and post-nasal drip.
    

Intervention name(s): Placebo; STAHIST
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, one BID; STAHIST in tablet form dosed one BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2; SAR; STAHIST
Acupressure and Stress Resilience
Condition: Post-traumatic Stress Disorder (PTSD); Mild Traumatic Brain Injury (mTBI)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The current study will assess the efficacy of acupressure, a type of complementary and
      alternative medicine (CAM) in the Veteran population. Veterans with co-occurring mild
      traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) will be consented and
      randomly assigned to either an active or placebo acupressure treatment series of 8 sessions.
      The investigators will determine if acupressure affects aspects of day-to-day function, such
      as memory, sleep, mood, psychiatric health and stress resilience. This information will help
      identify potential treatment strategies to improve quality of life and overall function in
      this particular Veteran population.
    


Intervention name(s): Active Acupressure Treatment; Placebo Acupressure Treatment
Intervention type(s): Other; Other
Intervention description(s): Participant will receive 8 active acupressure treatments.; Participants will receive 8 placebo acupressure treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy
      (HRP) performed at home compared with the standard polysomnography (PSG) in children with
      clinically suspected Obstructive Sleep Apnea (OSA).
    

Detailed description: 
      AIMS: To assess the diagnostic validity and cost-effectiveness of a home respiratory
      polygraphy (HRP) performed at home compared with the standard polysomnography (PSG) in
      children with clinically suspected Obstructive Sleep Apnea (OSA).

      METHODOLOGY: DESIGN: Randomized, prospective, multicenter, double blind and crossover trial.
      The study will include 320 children, 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) clinic
      history; b) Anthropometric variables: weight, height, body mass index, neck circumference and
      percentile; c) Chervin questionnaire, quality of life and clinical questionnaires and
      comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Quantitative unbiased
      proteinic urine analysis and g) 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 ROC curves; 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 by participating
      hospitals according the Cohen Kappa method, 4) A diagnosis paradigm based on proteinic
      defined variables and 5) A cost-effectiveness analysis of the different diagnostic and
      therapeutic procedures will be performed.
    

Intervention name(s): Home Respiratory Polygraphy (HRP); Standard Polysomnography (PSG); Home Respiratory Polygraphy (HRP); Standard Polysomnography (PSG)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Randomizing to start with home respiratory polygraphy; Randomizing to start with Standard Polysomnography (PSG); Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP); 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: Child obstructive sleep apnea; Home Respiratory Polygraphy; Diagnosis; Validity; Polysomnography
Galectin Role in Periodontal Disease
Condition: Gingivitis; Periodontitis
MeSH terms: Gingivitis; Periodontitis
Study type: Interventional

Summary: 
      This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1
      and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to
      periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers
      and/or therapeutic targets for periodontitis, in addition to revealing their possible role in
      the periodontal disease.

      45 systemically healthy participants were enrolled in this investigation, equally subdivided
      into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control
      group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque
      index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups
      (before and after non-surgical treatment for periodontitis group) using enzyme linked
      immune-sorbent assay (ELISA) kit.
    


Intervention name(s): GCF sample collection; non-surgical periodontal treatment
Intervention type(s): Diagnostic Test; Procedure
Intervention description(s): collecting GCF from deepest sites by paper points; performing scaling and root planning using ultrasonic device and manual curettes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the 1 month safety and tolerability after multiple
      oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin
    


Intervention name(s): AZD1656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tolerable dose given twice daily; Tolerable dose given twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type II Diabetes
Women's Activity and Lifestyle Study in Connecticut
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 3

Summary: 
      Despite an increase in longevity, surviving ovarian cancer often brings an array of
      unpleasant side effects and compromises in QOL. Our proposed trial will be the first study to
      test whether exercise compared with attention control has a beneficial impact on quality of
      life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique and
      important role for exercise in ovarian cancer care given that physical and functional aspects
      of QOL are often the most compromised in ovarian cancer patients.
    

Detailed description: 
      Currently, the American Cancer Society recommends a physically active lifestyle for cancer
      survivors to increase disease-free survival from cancer and other chronic diseases, and to
      improve quality of life. Studies of a strong benefit of physical activity on improving QOL
      following other types of cancer treatment, e.g., breast cancer, are well documented in the
      literature; yet very few studies of physical activity and QOL after a diagnosis of ovarian
      cancer have been published. Therefore, clinical trials of exercise on common physical and
      psychological consequences of ovarian cancer and its treatments are warranted.

      The primary aims of our study are to examine, in 230 women who have completed treatment for
      Stage I-IV ovarian cancer, the impact of a moderate-intensity aerobic exercise intervention
      vs. attention control on:

        -  Quality of Life

        -  Body Composition (weight, BMI, total and % body fat, waist and hip circumference)

        -  Hormones possibly associated with physical activity and ovarian cancer prognosis
           (insulin, IGF-I, IGF-II, IGF binding protein-3, CRP, leptin, estrone, estradiol, free
           estradiol, and sex-hormone binding globulin, osteopontin, MIF, prolactin, and CA-125)

        -  Cardiorespiratory Fitness - an objective measure of functional capacity and adherence to
           exercise.

      Hypotheses: Women randomized to exercise will experience improvements in quality of life,
      body composition, hormone levels, and cardiorespiratory fitness compared to women randomized
      to usual care.

      Our trial could suggest a unique and important role for exercise in ovarian cancer care given
      that physical and functional aspects of QOL are often the most compromised in ovarian cancer
      patients.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: exercise; physical activity; ovarian cancer; quality of life; fatigue; weight
Effectiveness of Acupuncture for Depressed Patients Not Taking Antidepressant Medications
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Acupuncture is a popular complementary/alternative therapy that has been in use for thousands
      of years for the treatment of various medical and psychiatric conditions, including Major
      Depressive Disorder (MDD). In this study, the investigators applied the investigators
      acupuncture-treatment-for-depression protocol, based on Traditional Chinese Medicine (TCM)
      principles for treating MDD, to depressed patients not taking any antidepressant medications
      (a protocol that the investigators previously piloted as a medication augmentation therapy
      for partial responders with MDD).

      The investigators specifically investigated the efficacy, safety, and tolerability of this
      TCM-based protocol for such patients, as well as potential differences in outcomes between
      weekly vs. twice-weekly treatment. The investigators hypothesized that acupuncture
      monotherapy would be associated with a response rate of at least 50%, which the investigators
      defined as a decrease in depressive symptoms from the beginning to the end of the study of
      50% or more, and that the response would be greater among patients who received acupuncture 2
      times per week (vs. 1 time per week). The investigators also hypothesized that acupuncture
      would be associated with minimal side effects.
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): 5 specific body acupoints (HT-7 and LI-4 on the hands bilaterally, and ST-36, SP-6, and LR-3 on the legs bilaterally) with gentle manual tonification every 10 min. Two acupoints along the midline of the head, GV-20 and GV-24.5 (Yintang), were also used with a 2 Hz current applied from GV-20 (-) to GV24.5 (+).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupuncture; Antidepressant; Monotherapy; Depression; Alternative treatments
Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial
Condition: Frozen Shoulder; 432 Hertz Frequency Music; Manual Therapy; Exercise
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The goal of this clinical trial is to determine the effect of listening to music during the
      treatment of frozen shoulder on pain, normal range of motion, functional activity status and
      quality of life.Upon recruitment, the subjects were randomly assigned to one of four
      treatment groups: Group 1 received Music + Mobilization + Exercise, Group 2 received Music +
      Exercise, Group 3 received Mobilization + Exercise, and Group 4 received Exercise only.
    

Detailed description: 
      Forty individuals diagnosed with frozen shoulder were randomly allocated into four distinct
      treatment groups. Each participant received a total of eighteen treatment sessions,
      administered three days per week. Pain levels, range of motion of the shoulder joint,
      functional status, general health condition, and quality of life were measured and recorded
      for each participant both before and after the treatment.
    

Intervention name(s): 432 Hertz frequency music; TENS; Mobilization; Exercises; Hotpack
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 432 Hertz frequency music was played to patients through headphones during hotpack and TENS applications.; The TENS treatment was conducted using a double-channel TENS device equipped with four electrodes. The electrodes were placed around the painful area to ensure targeted stimulation. Each session lasted for 30 minutes, during which the TENS device operated at a high frequency range of 60-120 Hz. To achieve the desired analgesic effect, a short transition time of 20-120 microseconds was employed.; Electrophysiological agents were administered to the affected shoulder joint area before initiating mobilization. The Cyriax mobilization techniques targeted the scapula, clavicular, and GH joints, considering their biomechanical interaction and the specific dysfunction of each patient.; The combined utilization of exercises targeting the glenohumeral (GH) joint, scapulothoracic (ST) region, and stretching has demonstrated significant effectiveness in ameliorating range of motion and alleviating pain during the treatment of Frozen Shoulder (FS). These exercises were closely supervised and administered by the physiotherapist in each session. Furthermore, a home exercise program was provided to the patients, consisting of exercises for posture, thera band, and finger ladder. They were instructed to perform 10-15 repetitions of these exercises twice a day independently.; Each group of patients received a 20-minute hot pack application to the scapula and shoulder circumference.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Frozen Shoulder; 432 Hertz Frequency Music; Manual Therapy
To Evaluate the Pharmacokinetics and Safety of AD-208
Condition: Androgenetic Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate pharmacokinetics and safety of AD-208.
    

Detailed description: 
      The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers
      are evaluated as compared to Avodart Soft Capsule 0.5mg.
    

Intervention name(s): AD-208; Avodart Soft Capsule 0.5mg
Intervention type(s): Drug; Drug
Intervention description(s): Dutasteride 0.2mg; Dutasteride 0.5mg
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition
Condition: Undernutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the improvement in nutritional status, especially
      in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the
      circulating cytokine levels, after providing extra protein and energy contents to
      community-dwelling older adults at risk of undernutrition.
    

Detailed description: 
      Sixty of aged over 65 years, living independently in the community for elderly people,
      nondiabetic subjects with serum prealbumin of under 30 mg/dL and BMI under 25 kg/m2 were
      recruited. The subjects were followed for a 2-week pre-intervention period, followed by an
      intervention period, which they received 2 cartons of liquid oral nutritional supplementation
      daily for 2 weeks.
    

Intervention name(s): Pre-intervention; Liquid nutritional supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): First 2-weeks : keeping routine dietary habit; Pre-intervention period was followed by an intervention period, during which consumed twice-daily 200 mL cartons of oral liquid nutritional supplementation (total 400 mL daily, containing 16 g protein, 12 g fat and 60 g carbohydrate and providing 400 kcal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
Condition: Wound Infection
MeSH terms: Wound Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      Following closure of surgical incisions, wounds may develop redness, swelling, and drainage
      which may result in increased pain and infection. This study will test to hypothesis that
      using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness,
      swelling, and infections in a group of patients undergoing a mediastinotomy incision used for
      open heart surgical procedures.
    


Intervention name(s): Vicryl Suture; 3M TM S Surgical Skin Closure System
Intervention type(s): Procedure; Device
Intervention description(s): A 4-0 vicryl suture will be used to close the subcuticular layer; These steri-strips will be applied to close the skin in this cohort of patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sutures
Arterial Calcifications in Nocturnal Hemodialysis and Renal Transplantation Versus Conventional Dialysis
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Observational

Summary: 
      Objective:

        1. To assess whether nocturnal hemodialysis and renal transplantation are associated with
           less progression of coronary arterial calcification, compared with conventional
           hemodialysis and peritoneal dialysis;

        2. To identify the risk factors for coronary arterial calcification in dialysis and
           transplant patients, and to assess a possible interaction with treatment modality.
    

Detailed description: 
      To assess whether nocturnal hemodialysis and renal transplantation are associated with less
      progression of coronary arterial calcification, compared with conventional hemodialysis and
      peritoneal dialysis; To identify the risk factors for coronary arterial calcification in
      dialysis and transplant patients, and to assess a possible interaction with treatment
      modality.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ESRD
      
Biospecimen description: 
      1x 4,5 ml citrate plasma

      1x 10 ml EDTA plasma
    
Keywords: cardiovascular disease; endstage renal disease
Exercise Induced Bronchoconstriction (0476-359)
Condition: Asthma, Exercise-induced
MeSH terms: Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 1

Summary: 
      Exercise-induced bronchoconstriction (EIB) is a condition where airways tighten when you
      exercise and may cause coughing, wheezing, or shortness of breath. In many patients, this
      condition can cause lung function to drop making it harder to breath. An instrument called a
      spirometer is commonly used to measure lung function. This traditional means of assessing
      lung function in asthma is limited in its ability to provide information as to where in the
      lung the tightness is. Hyperpolarized helium magnetic resonance imaging (3He MRI) is a novel
      way to see the where air is going in the lungs using an MRI and special gas. The ability to
      see where the air can and cannot reach in the lungs may help show more accurately if a
      medication is working to make the asthma better. The purpose of this study is to examine
      patients with EIB in order to see if 3He MRI provides a better way to measure lung function.
      Patients will be given either montelukast sodium, a drug to improve the ability to breath
      with EIB, or placebo and then put on a treadmill to induce an occurrence of airway
      constriction. The patient's lung function will be measured more than once using both the
      spirometer and the 3He MRI.
    


Intervention name(s): montelukast sodium; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose, before exercise challenge, of montelukast 10mg; 7 week duration.; single oral dose, before exercise challenge, of Pbo; 7 week duration.
Other intervention name(s): MK0476; Singulair®
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether there is a difference in proportion of
      patients with resolution of heartburn and other symptoms related to gastroesophageal reflux
      disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects
      with Erosive Esophagitis (EE) and those without EE.
    


Intervention name(s): Esomeprazole
Intervention type(s): Drug
Intervention MeSH terms: Esomeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment