bioihbjkbjnl/mcl2 huggingface dataset:
Role of Pressure Bio Feedback in Management of Forward Head Posture for Computer Users at BUMDC
Condition: Forward Head Posture
Study type: Interventional

Summary: 
      Objective: The aim of present study is to explore the effectiveness of pressure bio feedback
      in treatment of occupational forward head posture on computer users.
    

Detailed description: 
      Material & Methods: This Randomized Control Trial was conducted in Bahria University College
      of Physical Therapy, Karachi. Ethical approval was prior taken from Institute Review Board.
      there were 32 participants selected randomly equally in experimental and control group. Both
      male and female were included with age of 25 to 55 years currently employees of Bahria
      University (BUMDC) having forward head posture or complaining neck pain were included.
      Exclusion was age less than 25 years, history of cervical trauma or surgery, any neurological
      conditions or cervical pathology. Experimental Group was given DCF exercises with Pressure
      Biofeedback Unit (PBU) and Control Group was given Conventional DCF Exercises. SPSS version
      23.0 was used for analysis.
    

Intervention name(s): pressure bio feedback
Intervention type(s): Device
Intervention description(s): The pressure biofeedback unit was placed between the plinth and the posterior aspect of the neck just below the occiput and inflated to a baseline of 20 mmHg. A trained physiotherapist was observing and correcting any substitution movements to ensure that all subjects could perform the exercises correctly. All exercise protocols and programs were taken from previously published studies8-10. A conventional DCF exercise protocol was performed three times a week for four weeks in both groups. The duration of the conventional DCF exercise protocol was 20-30 minutes, once a day in the control group, and 15-20 minutes, once a day in the experimental group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bio Feedback; Deep Cervical Flexor; Neck pain; Forward head posture; Neck Disability Index
Pain Management After Elective Shoulder Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative pain management plays an important role in elective shoulder surgery. The aim
      of this randomized quantitative study is to compare two frequently used postoperative pain
      regimes (hydromorphone versus piritramide) regarding onset and duration after the
      effectiveness of the single-shot interscalene block has diminished.
    


Intervention name(s): Hydromorphone Hcl 4Mg Tab; Piritramide 15mg s.c.
Intervention type(s): Drug; Drug
Intervention description(s): Hydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS > 5.; Dipidolor 15mg s.c. 2 times after surgery as basic medication. Dipidolor 7.5mg s.c. maximum 2 per 24h when NRS > 5.
Other intervention name(s): Hydal retard 4Mg; Dipidolor 15mg s.c.
Intervention MeSH terms: Hydromorphone; Pirinitramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Elective shoulder surgery, hydromorphone, piritramide
Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE)
Condition: Coronavirus Disease 2019
MeSH terms: COVID-19; Pneumonia; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the safety and efficacy of orally-administered M5049 in Coronavirus
      disease 2019 (COVID-19) pneumonia participants who are hospitalized but not on mechanical
      ventilation.
    


Intervention name(s): M5049; M5049; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received M5049 50 milligram (mg) orally twice daily for 14 days.; Participants received M5049 100 mg orally twice daily for 14 days.; Participants received placebo tablets matched to M5049 daily for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)
Study to Investigate Safety, Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD1704
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim for this study is to investigate the safety and tolerability of the AZD1704,
      first time in man.
    


Intervention name(s): AZD1704
Intervention type(s): Drug
Intervention description(s): One dose, by mouth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; tolerability
A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized, double-blind, placebo-controlled study is to estimate the
      effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality
      and strength at the proximal femur at one year.
    


Intervention name(s): ibandronate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): matching placebo
Other intervention name(s): Boniva
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoporosis; bisphosphonates; bone
Effects of Empowerment Program Integrated With Family Support on Maternal Self-esteem and Quality of Life Among Palestinian Pregnant Adolescents
Condition: Pregnant Adolescents
Study type: Interventional

Summary: 
      Adolescent pregnancy leads to increase risks and complications for the adolescent mother and
      her newborn. This study aims to examine the effects of empowerment program integrated with
      family support on maternal self-esteem and quality of life among Palestinian pregnant
      adolescents. A randomized controlled single-blind trial, pretest-posttest controlled group
      design will be conducted with 62 participants ( control group =31, experimental group = 31).
      Research instruments will include the instruments for data collection, instruments for
      research intervention, and control instruments for intervention evaluation. The instruments
      for data collection will be consists of a demographic data form, Maternal Self-Report
      Inventory (MSRI), and WHO quality of life-BREF (WHOQoL-BREF, 1997). The empowerment program
      integrated with family support will be the research intervention instruments and included
      five steps; step 1: building relationships and creating collaboration, step 2: discovering
      reality, step 3: critical reflection, step 4: taking charge, and step 5: holding on. Control
      instruments through Family Support Questionnaire (FSQ) will be used to evaluate the
      effectiveness of the intervention program. Data will be analyzed using mean and standard
      deviations, frequency distribution, percentage, and chi-square test, and t-test. This program
      is expected to guide nurses to empower pregnant adolescents in enhancing maternal self-esteem
      and improve their quality of life.
    


Intervention name(s): Empowered program integrated with family support
Intervention type(s): Other
Intervention description(s): The empowered program integrated with family support is an intervention consisted of five steps that will be given when pregnant adolescents on gestational age 32 or 33 weeks the second meeting will be when the pregnant adolescents on gestational age 34 or 35 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer
Condition: Recurrent Head and Neck Carcinoma
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head
      and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy,
      also known as internal radiation therapy, uses radioactive material placed directly into or
      near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry
      radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs
      131 into the wound bed after surgery may help treat microscopic cancer cells that may be in
      the tissue after surgical removal of the tumor.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Assess the impact of cesium 131 (cesium Cs 131) on recurrence rate, disease free survival
      and over all survival.

      SECONDARY OBJECTIVES:

      I. Assess complications associated with cesium 131 treatment in subjects with head and neck
      cancer.

      OUTLINE:

      Patients undergo brachytherapy using cesium Cs 131 during surgical resection.

      After completion of study treatment, patients are followed up at 30 days and then every 3
      months for 24 months.
    

Intervention name(s): Brachytherapy; Cesium-131; Conventional surgery
Intervention type(s): Radiation; Drug; Procedure
Intervention description(s): Undergo brachytherapy with Cesium-131; Undergo brachytherapy with Cesium-131; Undergo surgical resection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
Condition: Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged
      10-17 years diagnosed with heterozygous familial hypercholesterolemia.
    

Detailed description: 
      A study to evaluate the effect of 24 weeks of subcutaneous (SC) evolocumab compared with
      placebo, when added to standard of care, on percent change from baseline in low-density
      lipoprotein cholesterol (LDL-C) in pediatric subjects 10 to 17 years of age with heterozygous
      familial hypercholesterolemia (HeFH).
    

Intervention name(s): Evolocumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose of subcutaneous evolocumab every 4 weeks; Dose of subcutaneous placebo treatment every 4 weeks
Other intervention name(s): AMG 145; EvoMab
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Elevated Cholesterol; High Cholesterol; Heterozygous Familial Hypercholesterolemia; PCSK9 mutations; Paediatric; pediatric; Childhood Familial Hypercholesterolemia
Physical Fitness as Klotho Protein Stimulator.
Condition: Physical Activity; Aging
Study type: Interventional

Summary: 
      FIT-AGING will determine the effect of different exercise modalities on α-Klotho protein
      (primary outcome) in sedentary healthy adults. FIT-AGING also investigate the physiological
      consequences of activating Klotho gene (secondary outcomes).
    

Detailed description: 
      Aims: The plasma Klotho protein concentration (α-Klotho protein), which is considered a
      powerful biomarker of longevity, makes it an attractive target as an anti-aging therapy
      against functional decline, sarcopenic obesity, metabolic and cardiovascular diseases,
      osteoporosis, and neurodegenerative disorders. Physical exercise and physical fitness, could
      be α-Klotho protein activators through biochemical process. FIT-AGING will determine the
      effect of different exercise modalities on α-Klotho protein (primary outcome) in sedentary
      healthy adults. FIT-AGING also investigate the physiological consequences of activating
      Klotho gene (secondary outcomes).

      Methods: FIT-AGING will recruit 60 sedentary, healthy, adults (50% women) aged 40-65 years.
      Eligible participants will be randomly assigned to a non-exercise group to the usual control
      group (n=15), physical activity recommendation from American College of Sport Medicine, World
      Health Organization and American Heart Association group (n=15), High Intensity Interval
      Training group (n=15)) and Whole-Body Electromyostimulation group (n=15). Laboratory measures
      completed at baseline and 12 weeks later, include α-Klotho protein concentration, physical
      fitness (cardiorespiratory fitness, muscular strength), body composition, resting metabolic
      rate, hearth rate variability (HRV), health blood biomarkers, free-living physical activity,
      sleep habits reaction time, cognitive variables and health-related questionnaires. The
      investigators will also obtain dietary habits data and cardiovascular disease risk factors.
    

Intervention name(s): PAR; HIIT; WB-EMS
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical fitness; Klotho; Training; HIIT; WB-EMS
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the
      effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with
      lifelong PE.

      Men with self-reported lifelong PE (International Society for Sexual Medicine (ISSM)
      definition) and in stable heterosexual relationship will undergo a 4-week run-in period
      during which they will be asked to attempt intercourse at least 4 times. Men with IELT ≤ 1
      minute on at least 75% of attempts at intercourse during the no-treatment run-in period will
      be randomized for the double-blind phase of the study.

      In the double-blind phase of the study, men will be asked to take study drug 1 to 6 hours
      prior to sexual activity. Men and partners will be asked to attempt intercourse a minimum of
      8 times during the 8 week double-blind study treatment. The patient or partner will record
      the IELT on each occasion by use of a stopwatch.
    


Intervention name(s): IX-01 400 mg; Placebo; IX-01 800 mg; IX-01 1200 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IX-01 400 mg caplet; Placebo caplet(s); IX-01 800 mg (Two 400 mg caplets); IX-01 1200 mg (Three 400 mg caplets)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sex; Sexual Dysfunction; IX-01
Non-Invasive Reduction of Fat in the Inner Thighs
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the
      ZELTIQ CoolSculpting System.
    

Detailed description: 
      The Zeltiq CoolSculpting System, which reduces subcutaneous fat in specific areas of the
      body, will be studied for safety and efficacy when used in the inner thigh.
    

Intervention name(s): The Zeltiq CoolSculpting System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cryolipolysis; Fat Reduction
A Study of a Live Intranasal Influenza Vaccine in Children With Cancer
Condition: Cancer
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Eligible research subjects will be randomized to receive either FluMist or inactivated
      influenza vaccine then stratified by age and necessity to receive either one or two
      immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects
      requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed
      for 30 minutes following vaccination and given a diary card to record symptoms after each
      vaccination.
    

Detailed description: 
      The secondary objectives of this study are to:

        1. Describe the safety of FluMist and inactivated influenza vaccine.

        2. Describe the incidence and duration of viral replication following immunization with
           FluMist.

        3. To examine the association between immunization response (seroconversion or
           seroprotection) and baseline clinical factors (age, type of malignancy, absolute
           neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).
    

Intervention name(s): FluMist; Inactivated influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): FluMist is a live attenuated intranasal influenza vaccine; Inactivated influenza vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: FLuMIST; Inactivated influenza vaccine; Study of FluMist versus inactivated influenza vaccine in children with cancer
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
Condition: Coronary Artery Stenosis
MeSH terms: Coronary Stenosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to assess the safety and efficacy of Liposomal
      Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a
      population undergoing PCI with implantation of a bare metal stent.

      Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to
      placebo.
    

Detailed description: 
      This is a Phase II dose-finding, randomized, multi-center, prospective, double blind clinical
      study. Subjects undergoing percutaneous coronary intervention (PCI) with the Presillion™ CoCr
      bare metal stent will be randomized into three groups and administered (in a single dose
      intravenously (IV) through a peripheral venous catheter) either: low dose Liposomal
      Alendronate of 0.001 mg, high dose Liposomal Alendronate of 0.01 mg, or placebo (IV saline
      infusion) on a 1:1:1 basis.

      All subjects will undergo angiographic follow-up at 6 months and 110 subjects enrolled from
      pre-specified sites will undergo intravascular ultrasound (IVUS) at baseline and follow-up at
      6 months.
    

Intervention name(s): Liposomal Alendronate; Liposomal Alendronate; Saline infusion (placebo)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV in a single low dose during the index procedure (coronary stent implantation) over 2 hours; IV in a single high dose during the index procedure (coronary stent implantation) over 2 hours; IV saline infusion during the index procedure (coronary stent implantation) over 2 hours
Other intervention name(s): LA; LA; Saline
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Liposomal Alendronate; Percutaneous coronary intervention; Coronary stenting; de novo stenotic lesions; Native coronary arteries; Restenosis; Bare metal stent; Presillion CoCr coronary stent
Tryptophan Depletion in Acute Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the
      pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are
      currently the most widely used drugs for the treatment of depression. Patients with bipolar
      disorder (BD) who are treated for depression with SSRIs might develop mania, which is
      believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has
      been shown to induce transient depressive symptoms in remitted depressed patients treated
      with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have
      clinical effects. However, RTD was not studied in acutely manic patients and could
      theoretically have antimanic properties. In this double blind randomized placebo controlled
      study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated
      for its antimanic properties and potential use as augmentation to drug treatment in acute
      mania.
    


Intervention name(s): rapid tryptophan depletion
Intervention type(s): Other
Intervention description(s): Amino-acid mixture without tryptophan
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder; acute mania; tryptophan depletion; placebo controlled add-on; Bipolar disorder- manic type
Acceptable Pressure Range for Continuous Positive Airway Pressure(CPAP) Treatment
Condition: Obstructive Sleep Apnea of Adult
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Compliance of continuous positive airway pressure （CPAP） derived from auto-titration is
      similar to that derived from manual titration, although pressure derived from the former was
      usually 2-5 cmH2O higher than the latter. Therefore the Investigators hypothesize that
      accurate titration maybe not necessary for successful treatment of obstructive sleep apnea
      (OSA) as long as CPAP pressure was not lower than the minimal effective pressure.
    

Detailed description: 
      Study Design: A randomized, cross-over and double-blind study. Objective: To compare the
      pressure of 10 cmH2O and minimal effective pressure derived from manual titration on the
      effect of CPAP treatment in OSA. Methods: Patients with suspected OSA (age, body mass index
      and symptom) to be referred to a sleep centre were recruited. Patients with OSA confirmed by
      overnight full polysomnography (PSG) were invited to do standard overnight manual titration
      under PSG based on the Academy of Sleep Medicine (AASM) manual guidelines. Patients whose
      manual titration pressure lower than 10cmH2O and willing to participate in the study were
      invited to repeat two more nights (3th PSG and 4th PSG) under CPAP pressure at both 10cmH2O
      and the pressure derived from manual titration in random order. The sleep apnea-hypopnea
      index (AHI), obstructive sleep apnea index (OHI), arousal index (ArI), oxygen desaturation
      index (ODI), sleep structure, and treatment preference were to be observed.
    

Intervention name(s): CPAP at pressure of 10 cmH2O; CPAP at minimal effective pressure
Intervention type(s): Device; Device
Intervention description(s): Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography; Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OSA; CPAP; acceptable range