bioihbjkbjnl/mcl2 huggingface dataset:
Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity
Condition: Spinal Deformity
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal
      deformity.
    

Detailed description: 
      1. Identify disease burden associated with adult spinal deformity (ASD) using quality
           adjusted life year (QALY) analysis.

        2. Identify disease burden of specific demographic and radiographic features associated
           with ASD.

        3. Compare disease burden of ASD to other musculoskeletal and non-musculoskeletal diseases.

        4. Identify efficacy of specific nonoperative treatment modalities to treat ASD and
           identify specific clinical and radiographic features of ASD responsive to nonoperative
           treatment modalities.

        5. Compare QALY and ICER values for different ASD nonoperative treatment modalities to
           previously established QALY and ICER for values for operative and nonoperative treatment
           modalities for degenerative hip and knee disease, coronary artery disease, insulin
           dependent diabetes, and hypertension.

        6. Evaluate the cost and work hours associated with data collection and minimum 85% patient
           follow up.

        7. Evaluate patient characteristics associated with poor patient compliance for study
           follow up including demographic, radiographic and HRQOL values and for reasons for
           cross-over to operative treatment for ASD.

        8. Establish standardized data collection methodology for economic based outcome studies
           based upon patient demographics and HRQOL values.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult spinal deformity patients
      
Keywords: Scoliosis; Kyphosis; Sagittal plane deformity
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and bioequivalence of
      amlodipine besylate formulations under fed conditions.
    

Detailed description: 
      This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of
      Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy
      volunteers with a washout period of 14 days.
    

Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention description(s): Amlodipine Tablets, 10 mg
Other intervention name(s): Norvasc 10 mg tablets of Pfizer, Inc.,
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Amlodipine Besylate
This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      1265162 in healthy male subjects following inhalative administration of single rising doses.

      Secondary objective is the exploration of the pharmacokinetics (PK) of BI 1265162 after
      single dosing.
    

Detailed description: 
      To investigate safety, tolerability and pharmacokinetics of BI 1265162 in man.
    

Intervention name(s): BI 1265162; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single rising dose groups; Single rising dose groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels of Patients With Periodontal Disease
Condition: Chronic Periodontitis, Generalized; Gingivitis
MeSH terms: Gingivitis; Leukemia; Periodontitis; Periodontal Diseases; Chronic Periodontitis
Study type: Interventional

Summary: 
      This study aims to determine Oncostatin M (OSM), Leukemia inhibitory factor (LIF), and
      Interleukin-11 (IL-11) levels in gingival crevicular fluid (GCF), saliva, and serum in
      periodontally healthy individuals and those with gingivitis and chronic periodontitis before
      and after periodontal treatment and to evaluate the relationship between these cytokine
      levels and clinical periodontal parameters.
    


Intervention name(s): Initial Periodontal Therapy
Intervention type(s): Procedure
Intervention description(s): Oral hygiene education, including the use of toothbrushes and dental floss and/or interproximal brushes, was given to them. After one week Chronic Periodontitis group received nonsurgical periodontal therapy consisting of scaling and root planing (quadrant by quadrant) using manual scalers and curettes under local anesthesia. No antibiotics or any medications were prescribed during the treatment. Periodontal treatment was performed by the same investigator
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Chronic Periodontitis; Gingival Crevicular Fluid; Leukemia Inhibitory Factor; Oncostatin M; Interleukin-11; Periodontal Therapy; Gingivitis
LIFEHOUSE: Description of the Tent Bucket -Immune Support
Condition: Immune Response
Study type: Interventional

Summary: 
      This immune support program will be an extension to the existing LIFEHOUSE program. Essential
      employees in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe Springs, CA, will
      be offered complimentary supplementation with commercially available nutritional supplements
      supportive of immune health for several months. The outcome will be measured via blood
      parameters and questionnaire responses.
    

Detailed description: 
      This program, as a component of the LIFEHOUSE program, will consist of data collection during
      a period of supplementation with commercially available nutritional supplements supportive of
      immune health. Employees, in Gig Harbor, WA; Colonial Heights, VA; Lenexa, KS, and Santa Fe
      Springs, CA, will be offered the opportunity to participate.

      The nutritional and inflammatory status will be captured via fingerstick biomarkers.
      Participants will receive in-home testing kits including instructions regarding the
      applicable fingerstick blood collections. Fingerstick testing will include 25-Hydroxy Vitamin
      D3 (25-OH D3) and high sensitivity c-reactive protein (hs-CRP) measurements at baseline, 1,
      and 2 (phase 1), or at baseline 1,2, 3, and 6 months intervals (phase 2).

      Participants will also be asked to complete applicable questionnaires (QNs) electronically
      monthly using standard software programs for questionnaire completion.

      This will include the Medical Outcome Study (MOS) Short Form (SF) -36 (baseline and monthly)
      and Health Status QNs including questions on compliance, wellbeing, lifestyle (exercise,
      shifts worked, medications and supplements, and diet) (baseline and monthly).
    

Intervention name(s): Vit.D3 5000 IU, Immune Active
Intervention type(s): Dietary Supplement
Intervention description(s): The subjects will receive monthly (for either 3 or 6 months):
Vit.D3 5000 and Immune Active. The first phase includes 3 months of treatment and the second phase includes 6 months of treatment.
An in-home Vit.D/ hs-CRP test kit and asked to self-administer a blood collection via fingerstick and return the kits for analysis within a few days.
Two online questionnaires each month and asked to fill them out within a few days. It will either be the Medical Outcomes Study (MOS) Short Form (SF)-36 and the Health Status Baseline or Health Status Follow-up Questionnaire.
Other intervention name(s): Test kits- Vit.D and hs-CRP blood measurements; Questionnaires
Intervention model: Single Group Assignment
Intervention model description: A single-arm cohort intervention study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Nutritional Supplements; Vitamin (Vit.) D3; hs-CRP; Inflammation; Employee wellness program
Preventive Treatment of Groin Pain in Football
Condition: Healthy
Study type: Interventional

Summary: 
      Groin pain represents a common issue in football. Currently, there are no prevention
      protocols demonstrating real effectiveness. We aimed to investigate the possible positive
      effect of a prevention program for groin pain.Forty-two élite male athletes belonging to a
      youth academy of a professional football club were recruited in this prospective, randomized,
      controlled, single-blind, study.
    


Intervention name(s): preventive treatment group
Intervention type(s): Other
Intervention description(s): each athlete belonging to the preventive treatment group performed the protocol of preventive treatment 2 times a week, before or after the training session for five months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Groin injuries, soccer, athletes, pain, muscle strength
SleepPOSAtive Trial
Condition: Obstructive Sleep Apnea of Child
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This is a randomized crossover trial of children diagnosed with positional obstructive sleep
      apnea (POSA) on a baseline polysomnogram (PSG). Participants will undergo two further PSGs in
      random order over 4 weeks to assess the efficacy of a positional sleep therapy belt compared
      to a control for treating POSA.
    

Detailed description: 
      Obstructive sleep apnea (OSA) is highly prevalent, and the gold standard therapy is
      continuous positive airway pressure (CPAP) for persistent OSA. Although CPAP is highly
      efficacious, long-term effectiveness is limited by poor adherence rates. Given the burden of
      untreated OSA in children, novel alternative therapies that are effective, acceptable and
      comfortable are urgently required.

      OSA is characterized by recurrent obstruction of the upper airway associated with
      intermittent hypoxia and chronic sleep deprivation. OSA occurs in 1-4% of healthy children
      and in up to 80% of children with medical complexity (e.g. Down syndrome). It has significant
      health, societal, and economic impacts. CPAP is the gold standard therapy for persistent OSA
      but is poorly tolerated.

      There is distinct clinical phenotype of OSA characterized by the predominance of obstructions
      in supine position, as measured by the obstructive apnea-hypopnea index (OAHI) on
      polysomnography (PSG). Up to half of children with OSA meet criteria for this phenotype which
      is termed positional OSA. Positional sleep belts that prevent children from adopting supine
      position may be beneficial for treating OSA but have not yet been studied in children.

      The primary aim of this study is to assess the efficacy of a body positional sleep belt for
      the treatment of moderate to severe positional OSA in a paediatric population. This is a
      randomized crossover trial of children aged 4-18 years diagnosed with positional OSA.
      Participants will undergo two PSGs in random order over 4 weeks with a control and positional
      device therapy to assess treatment efficacy. Perceived comfort will be evaluated with
      surveys.

      This novel research addresses a critical knowledge gap regarding the rigorous evaluation of
      alternative therapies beyond CPAP for managing OSA. Positional therapy has the potential to
      change clinical practice as an effective, cost-efficient, and non-invasive treatment option
      for children with positional OSA, particularly for children intolerant of CPAP.
    

Intervention name(s): Positional Sleep Belt; Control
Intervention type(s): Device; Device
Intervention description(s): Rematee Positional Sleep Belt; Control Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (Pharmetrics)
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Observational

Summary: 
      Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom
      burden is limited in commercially insured adult patients. Additionally, limited information
      exists on economic burden of adverse events associated with treatments for
      advanced/metastatic renal cell carcinoma. An objective of the current study is to estimate
      the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US
      "real-world" setting. Another objective is to quantify the economic burden of severe adverse
      events with agents used in management of first line advanced/metastatic RCC (sunitinib,
      sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective cohort design.
      Analyses of health insurance claims data from a large commercially insured population will be
      employed in the current study. Study subjects will consist of all persons, aged ≥18 years,
      with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons
      will be identified based in part on case-ascertainment algorithms. Analyses will be directed
      at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as
      symptom burden and costs of common severe adverse events associated with treatments used in
      management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).
    


Intervention name(s): Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)
Intervention type(s): Drug
Intervention description(s): Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels.
Other intervention name(s): VOTRIENT™ (pazopanib); SUTENT® (sunitinib malate); AVASTIN® (bevacizumab); NEXAVAR® (sorafenib)
Intervention MeSH terms: Bevacizumab; Sunitinib; Sorafenib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study subjects will be selected from a source population consisting of all persons in the
        PharMetrics database with one or more days of eligibility for comprehensive health benefits
        between January 1, 2000 and December 31, 2009.
      
Keywords: retrospective database analysis; economic burden
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075
      dose(s) effective to reverse prolongation of blood coagulation time by dabigatran
    


Intervention name(s): BI 655075; BI 655075; Placebo; BI 655075; Placebo; Placebo; Placebo; BI 655075
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Stretching Exercises on Symptoms of Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      The purpose of this study was to assess the effect of active stretching exercises on reducing
      pain and the quality of life during menstrual cycle in young adult females.
    

Detailed description: 
      Thirty females with primary dysmenorrhea, aging between 18 to 23 years with BMI of 20-29.9
      kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were
      randomly assigned into three equal groups; two interventions groups (supervised and
      non-supervised active stretching exercise program) and one control group. The intervention
      group A practiced a 30 to 45-minute supervised active stretching program three times a week
      for four weeks, while the other intervention group B practiced non-supervised active
      stretching home program and the control group C . Visual Analog Scale (VAS) was used to
      measure pain intensity, and Verbal Multidimensional System (VMS) for measuring menstruation
      characteristics and the effect of pain on quality of life, before (pre) as well as after
      (post) 4 weeks at the end of the study .
    

Intervention name(s): supervised stretching exercises; non-supervised active stretching home program
Intervention type(s): Other; Other
Intervention description(s): 30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations; non supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations
Other intervention name(s): home program stretching exercises; home program of stretching exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the sedating (causing sleepiness) effects
      of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize,
      remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.
    

Detailed description: 
      To compare the treatment effects of risperidone and quetiapine on cognitive function, using
      measures commonly believed to be affected by sedation and at doses typically used in clinical
      settings in stable bipolar I outpatients.One-half of patients are randomized to treatment
      sequence risperidone-quetiapine (R-Q), and the other one-half to quetiapine-risperidone
      (Q-R). Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before
      testing and placebo with breakfast on the day of testing. After a 6 - 14 day washout period
      they receive 100 mg quetiapine with dinner the night before their second day of testing and
      100 mg with breakfast the day of testing.

      Those randomized to Q-R receive the same treatments, but in reverse order. Patients
      randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and
      placebo with breakfast on the day of testing. After a 6-14 day washout period they receive
      100 mg quetiapine with dinner the night before their second day of testing and 100 mg with
      breakfast the day of testing. Those randomized to Q-R receive the same treatments, but in
      reverse order.
    

Intervention name(s): risperidone; quetiapine
Intervention type(s): Drug
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: Bipolar I Disorder; risperidone; quetiapine; sedation; cognition
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries; Tendon Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal
      stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with
      supraspinatus partial thickness tear by ultrasonographic guided injection.
    

Detailed description: 
      Injection volume depends on the size of lesion on ultrasound examination. And all injection
      will be done under ultrasound guidance. Double blind Randomized placebo controlled study will
      be done with following 3 groups. Each group will have 8 people, so, the total patients will
      be 24 people.

        1. Stem cell treatment group : stem cell 0.5cc (Total: 10 million cells) + Fibrin glue
           0.5cc + range of motion exercise

        2. Active control (fibrin glue) group : Normal saline 0.5cc + Fibrin glue 0.5cc + range of
           motion exercise

        3. Control (normal saline) group : Normal saline 0.5cc + Normal saline 0.5cc + range of
           motion exercise

      The investigators will compare the efficacy difference with VAS(visual analog scale, primary
      outcome), ASES(American Shoulder and Elbow Surgeons) Score, UCLA(University of California,
      Los Angles) Shoulder Score, DASH(The Disabilities of the Arm, Shoulder and Hand) Score and
      change of tear size compared to the baseline image assessed by MRI. These measurement will be
      done at 6 and 12 weeks after injections and long-term follow-up will be also planned to 6
      months, 12months and 24 months except for the evaluation of the tear size which will be done
      at baseline, 3 months and 24 months after the intervention.
    

Intervention name(s): allogenic adipose stem cell injection; fibrin glue/normal saline injection; normal saline injection
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.; Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise; Total 1cc of normal saline injection and range of motion exercise
Other intervention name(s): experimental group; active control group; placebo group
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adipose derived mesenchymal stem cell; allogeneic stem cell; Rotator cuff tear