bioihbjkbjnl/mcl2 huggingface dataset:
Home-Based Exercise Training in Older Adults During the COVID-19 Pandemic
Condition: Physical Inactivity; Aging; COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The physical fitness and functionality of older adults are affected during the COVID-19
      Pandemic. Regular exercise programs are effective in physical fitness and functioning in
      older adults. Individualized and supervised exercise programs for older adults in a safe
      environment can improve physical fitness and functionality. This study aims to examine the
      effect of home-based and exercise training on physical fitness and functionality in sedentary
      older adults during the COVID-19 pandemic.
    

Detailed description: 
      Purpose: This study aims to examine the effect of home-based supervised exercise programs on
      physical fitness and functionality in sedentary older adults during the Covid-19 pandemic.

      Methods: The older adults participating in the study are divided into two groups as exercise
      group and the control group. Individual exercise training is applied to the exercise group
      for eight weeks, three days a week, and 45 minutes a day. This exercise training consists of
      a program that includes strengthening, flexibility, aerobic, and balance exercises. The
      control group is given only of stretching and breathing exercises. Individuals are evaluated
      using the Berg Balance Scale, Timed Up and Go Test, Senior Fitness Test, and Tinetti Falling
      Efficacy Scale before starting the study and at the end of the eight weeks.
    

Intervention name(s): Supervised Home Based Exercise Training; Unsupervised stretching and breathing exercises
Intervention type(s): Other; Other
Intervention description(s): Exercise program was prepared based on WHO, American College of Sports Medicine (ACSM), Geriatrics Physiotherapists Association and Otago exercise program for the exercise group. The older adults are given individual supervised exercise training in their own homes for eight weeks, 3 days a week and 45 minutes a day, by a physiotherapist according to social distance rules. This exercise training consists of a program that includes strengthening, flexibility, aerobic and balance exercises. Each exercise is started with eight repetitions and each week will be increased by two repetitions. In case of fatigue, a rest is given. Brochures are also be prepared for the exercises. Before each session, individuals performed warm-up exercises for 5 minutes. At the end of the session, individuals performed cooling exercises.; Individuals in the control group are performing stretching exercises for proximal extremity muscles for 15 minutes 3 times a week for eight weeks. The participants also perform breathing exercises for 5 minutes a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Exercise; Physical Fitness; Functionality; Older adults
A Study of Topical XG004 in Participants With Osteoarthritis of the Knee
Condition: Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This is phase 1 placebo controlled study to evaluate the safety, tolerability and
      pharmacokinetics of XG004 applied topically in participants with osteoarthritis of the knee
    

Detailed description: 
      The study will consist of a 4-week Screening period, an 7-day Treatment period and a 7-day
      Safety follow-up period that will be conducted by telephone for each Cohort.

      Up to 32 participants with OA of the knee will be enrolled into 6 cohorts sequentially and
      assigned treatment on a 3:1 (XG004: placebo) ratio.
    

Intervention name(s): XG004; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): XG004 gel in two concentrations (5% and 10%) will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee.; Placebo gel will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neuromyelitis Optica (NMO) & Cetirizine
Condition: Neuromyelitis Optica
MeSH terms: Neuromyelitis Optica
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system.
      Patients have relapses (also known as attacks) which are often quite severe and leave them
      with significant disability. Without treatment, within 5 years 50% of NMO patients are blind
      in one or both eyes or require walking assistance (cane, walker or wheelchair).

      NMO has only been relatively recently described and is fairly rare. Most NMO patients' immune
      systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in certain
      cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they trigger a
      cascade of events involving the immune system which eventually leads to damage to the nervous
      system. This ultimately leads to disability, some of which is permanent.

      Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4
      antibody. However, recent experiments in animal models of NMO have shown the importance of
      what happens inside the central nervous system after the antibody binds to the nervous system
      cell. Specifically, researchers have noted the importance of a specific cell type,
      eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they
      could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular
      over-the-counter allergy medicine.

      Cetirizine is already known to be safe and well-tolerated in the general population. In this
      study, the researchers plan to add cetirizine on to patients' current NMO treatment. The
      researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO
      patients have less relapses and therefore less disability over the course of the year
      following initiation of treatment. The researchers also plan to study how cetirizine changes
      the immunological profile in NMO patients by examining blood and cerebrospinal fluid.
    

Detailed description: 
      The researchers hypothesize that cetirizine, an allergy medication that acts as an
      eosinophil-stabilizer, will decrease the relapse rate when added to current standard therapy
      in patients with neuromyelitis optica.

      Medication compliance will be assessed by the research coordinator at each visit through
      discussion with the patient and pill counting.
    

Intervention name(s): cetirizine
Intervention type(s): Drug
Other intervention name(s): Zyrtec
Intervention MeSH terms: Cetirizine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromyelitis Optica; Cetirizine
Etiology of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in Japan
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this prospective, epidemiological, cohort study is to evaluate the lung
      microbiome in stable-state chronic obstructive pulmonary disease (COPD) in Japanese
      participants
    


Intervention name(s): Prospective observational cohort study
Intervention type(s): Other
Intervention description(s): Prospective observational cohort study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will enroll participants with a recorded clinical diagnosis of COPD, ACOS or
        chronic bronchitis (CB), who have airflow limitation indicative of COPD according to Global
        Initiative for Chronic Obstructive Lung Disease and a recent history of lower respiratory
        tract infection (LRTI).
      
Keywords: Asthma-COPD overlap syndrome; Acute exacerbations of chronic obstructive pulmonary disease; Acute Exacerbation and Respiratory Infections in COPD-Japan; Chronic bronchitis; Chronic obstructive pulmonary disease; Exacerbation; Microbiome; Quantitative polymerase chain reaction (qPCR); 16S ribosomal Ribonucleic acid (16S rRNA); Metagenomic analysis; Sputum
Feasibility of ReSpace™ Hydrogel to Establish a Stable Cervical-rectal Space
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, 5 subjects will be enrolled and the cumulative D2cc dose for rectum during
      brachytherapy will be recorded as the primary outcome measures.
    

Detailed description: 
      This is a phase I prospective study of 5 patients to determine if PEG hydrogel (ReSpace™)
      reduces the radiation dose delivered to the rectum during radiation therapy for cervical
      cancer by increasing the space between the cervix and the anterior rectal wall. In the other
      word, the purpose of this study is to assess whether the use of ReSpace™ hydrogel results in
      a reduction of radiation exposure to the anterior rectum.
    

Intervention name(s): ReSpace™
Intervention type(s): Device
Intervention description(s): All of the subjects will be injected with ReSpace™ hydrogel.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical Cancer; hydrogel spacer
Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine
Condition: Renal Dialysis
Study type: Interventional

Summary: 
      The aim of this clinical trial will be to verify the feasibility of using an impeller system
      instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and
      a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer.
    


Intervention name(s): Convergence Dialyzer
Intervention type(s): Device
Intervention description(s): The Convergence dialyzer with design changes made to FX Coral 600 dialyzer will be tested together with Sidecar. In the dialyzer is integrated centrifugal-flow blood pump.The centrifugal-flow blood pump replaces the peristaltic roller pump of the extracorporeal circuit which pumps blood from patient to the dialyzer and from dialyzer to the patient. The centrifugal-flow blood pump is designed to transport blood from the patient to the dialyzer, and after purification, return the blood to patient.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
A Study of Oraxol in Subjects With Cutaneous Angiosarcoma
Condition: Angiosarcoma of Skin
MeSH terms: Hemangiosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a non-blinded, multi-center, open-label, phase 2 study to evaluate the activity,
      safety, and tolerability of Oraxol in subjects with cutaneous angiosarcoma.
    

Detailed description: 
      Oraxol will be administered once daily for 3 consecutive days every week during the Treatment
      Period from Weeks 1 through 25.

      Subjects who do not have documented disease progression by the end of the Treatment Period
      will be eligible to receive therapy in the Treatment Extension Period; Oraxol may be
      administered from Week 26 onwards.
    

Intervention name(s): Oraxol
Intervention type(s): Drug
Intervention description(s): oral paclitaxel will be supplied in capsules and oral HM30181A-US in tablets
Other intervention name(s): oral HM30181A + oral paclitaxel
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after
      receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may
      help doctors identify biomarkers related to cancer and help doctors predict how patients will
      respond to treatment.

      PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing
      implant radiation therapy and luteinizing hormone-releasing hormone agonist therapy in
      patients with stage I or stage II prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To analyze biopsy results at 36 months after permanent iodine I 125 implantation therapy
           and luteinizing hormone-releasing hormone (LHRH) agonist therapy for patients with
           untreated intermediate-risk prostate cancer.

      OUTLINE: Patients received luteinizing hormone releasing-hormone (LHRH) agonist therapy and
      permanent iodine I 125 implantation on protocol JUSMH-BRI-GU05-01.

      Patients undergo blood sample collection and tissue biopsy for biomarker/laboratory analysis
      at 36 months after receiving brachytherapy and releasing-hormone agonist therapy. PSA levels
      and biopsy results are compared.
    

Intervention name(s): biopsy
Intervention type(s): Other
Intervention description(s): Conduct prostatic needle biopsy at 36-39 months-after brachy therapy. Basic method is by transectal ultra-sound-guided systematic biopsy,; systematic sextant biopsy which involves samples from both seminal vesicles is adopted as much as possible.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Previously enrolled on protocol JUSMH-BRI-GU05-01 and 36 month after treatement of
        brachytherapy.
      
Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
The Effect of Web-based Mindfulness-based Stress Reduction Program on Pregnant Women
Condition: Anxiety; Pregnancy Related
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Pregnancy is a period in which physiological and psychological changes are experienced and
      discomforts related to these changes are observed, and comfort is affected for the pregnant.
      However, fetal health concern refers to the concern of the expectant mother about the health
      of her developing fetus. Mindfulness is a non-judgmental and accepting focus of one's
      attention on what is happening right now. A total of 96 pregnant women (48 experimental, 48
      control) are planned to be included in the study. Data will be collected with the "Personal
      Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory
      (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied
      by the researcher to the pregnant women in the experimental group.
    

Detailed description: 
      Women experience intense physiological, psychological and social changes during pregnancy and
      postpartum period. Pregnancy and postpartum period can be a difficult process for some women
      due to biological and environmental factors. Mindfulness-based approaches have been used in
      solving both physical and mental problems in pregnant women and very positive results have
      been obtained. The aim of this study, which is carried out to determine the effect of
      mindfulness on prenatal comfort and fetal anxiety levels in pregnant women, is aimed at
      creating intervention programs compatible with the antenatal period and contributing to the
      improvement of pregnancy outcomes. A total of 96 pregnant women (48 experimental, 48 control)
      are planned to be included in the study. Data will be collected with the "Personal
      Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory
      (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied
      by the researcher to the pregnant women in the
    

Intervention name(s): Mindfullness Based Stress Reduction (MBSR) intervention
Intervention type(s): Behavioral
Intervention description(s): Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prenatal Comfort; MBSR
Bioequivalence Study of Aripiprazole From Apipe 10 mg Orally Disintegrating Tablets (Man. by: P&C Labs (Pellets & CR Products), Egypt) Versus Abilify 10 mg Orodispersible Tablets (Otsuka Pharmaceutical Netherlands B.V., Netherlands)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover bioequivalence study to determine the
      bioequivalence of Aripiprazole from Apipe 10 mg orally disintegrating tablets (Man. by: P&C
      Labs (Pellets&CR Products), Egypt) versus Abilify 10 mg orodispersible tablets (Otsuka
      Pharmaceutical Netherlands B.V., Netherlands ) in Healthy Human Volunteers Under Fasting
      Condition
    

Detailed description: 
      Healthy male volunteers, 45-55 years of age, selected from the Egyptian population fulfilling
      the selection criteria. 24 subjects will participate in the study. All dosed subject samples
      will be analyzed and their data will be included in the final study report 18 blood samples
      will be drawn in each period. The total volume of blood will not exceed 200 ml throughout the
      whole study. 0.00, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00,
      8.00, 12.00, 24.00, 48.00, 72.00 hours.

      Primary Pharmacokinetic Parameters: Cmax, Truncated AUC0→72 Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax and Truncated AUC0→72 for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Truncated
      AUC0→72 and Cmax to be within 80.00-125.00%.
    

Intervention name(s): Apipe (Aripiprazole10 mg); Abilify (Aripiprazole10 mg)
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Reference drug
Other intervention name(s): Abilify; Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach,
      duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of
      action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper
      gastrointestinal tract in man.
    

Detailed description: 
      Twelve healthy volunteers will undergo antroduodenojejunal manometry. Baseline recording with
      infusion of saline for 1 hour is compared with infusion of GLP-1 0.7 and 1.2 pmol per kg
      minute for another 1 hour. Plasma GLP-1 and GLP-2 is measured by RIA. Responses to GLP-1 will
      be measured after food intake as prandial response to GLP-1. The outcome will be evaluated as
      change in motility index from baseline to meal-stimulated conditions and during influence of
      GLP-1. Further in vitro studies of gastrointestinal muscle strips, precontracted with
      bethanechol or electric field stimulation, are planned to investigate the response to GLP-1
      or GLP-1 analogue ROSE-010. GLP-1 and GLP-2 receptor immunoreactivity is localized by
      immunohistochemistry. Receptor mediated mechanisms are studied with GLP-1 receptor blocker
      exendin(9-39)amide, nitro-monomethyl arginine to block nitric oxide synthase and tetrodotoxin
      to block sodium channels and nerve conduction.
    

Intervention name(s): GLP-1; Intravenous saline
Intervention type(s): Biological; Biological
Intervention description(s): Intravenous infusion of GLP-1; Control
Other intervention name(s): Glucagon-like peptide-1
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Irritable bowel syndrome; Functional dyspepsia; Gastric emptying; Gastrointestinal peptide hormones
Bioavailability Study of BIA 5-453
Condition: Hypertension; Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453
      under fasted and fed conditions.
    

Detailed description: 
      This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male
      volunteers. Subjects received a single oral 200 mg dose of BIA 5-453 following a standard
      meal in one period, and following at least 10 hours of fasting in another period. Treatment
      periods were separated by a washout interval of 2 weeks or more.
    

Intervention name(s): BIA 5-453
Intervention type(s): Drug
Intervention description(s): BIA 5-453 capsules 50 mg. Route of administration: Oral. In one period subjects received 4 capsules of 50 mg of BIA 5-453 after a fasting of at least 10 hours, and in the other period subjects were dosed with 4 capsules of 50 mg of BIA 5-453 after a standard high-fat and high-calorie meal
Other intervention name(s): Etamicastat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)
Condition: Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.
MeSH terms: Chronic Pain; Cancer Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objectives:

        -  To determine non-inferiority of FITpatch with regard to efficacy compared to standard
           opioid treatment

        -  To assess the safety of FITpatch compared to standard opioid treatment

      Secondary objectives:

        -  To assess the intake of oral morphine as rescue analgesic to FITpatch compared to
           standard opioid treatment

        -  To assess Quality of life reported with FITpatch compared to standard opioid treatment
    


Intervention name(s): Fentanyl (Matrifen)
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment