bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Intervention Among Men With Prostate Cancer Initiating Androgen Deprivation Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This research study is evaluating the impact and feasibility of a 12-week brisk walking and
      moderate strength training exercise intervention including a virtual component in men who are
      initiating androgen deprivation therapy (ADT) for prostate cancer
    

Detailed description: 
      Androgen deprivation therapy (ADT) is a key treatment of prostate cancer. While this therapy
      improves prostate cancer outcomes, ADT also has a variety of short- and long-term adverse
      effects, including increased body weight, loss of lean muscle mass, reductions in quality of
      life, and increased risk of cardiovascular disease. Studies have shown that among men with
      prostate cancer, physical activity is associated with improved outcomes, including a reduced
      risk of mortality, from prostate cancer and other causes. Our hypothesis is that physical
      activity will improve some of the physical and emotional side effects associated with ADT.
      Physical activity, such as brisk walking and moderate strength training, offers a lifestyle
      factor that may improve some of the side effects, and is low-cost and easy to do.

      The investigators are conducting this study to evaluate the impact and feasibility of a
      12-week moderate-intensity aerobic and strength training exercise intervention, including a
      virtual component. The intervention includes brisk walking and moderate strength training,
      and involves home-based exercises, in-person sessions with an oncology-trained exercise
      physiologist, optional group training sessions, and weekly training goals. Participants will
      have access to a personalized web-based platform called Postwire, which will include videos
      of training sessions, and will allow participants to easily communicate with the study staff
      and with other study participants.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Other
Intervention description(s): 12-week moderate-intensity aerobic and strength training exercise intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostate Cancer
Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
Condition: Acute; Myocardial Infarction, Complications; Cardiogenic Shock
MeSH terms: Myocardial Infarction; Shock, Cardiogenic; Infarction; Shock; Hypothermia
Study type: Interventional

Summary: 
      Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate
      whether induction of mild hypothermia in addition to primary percutaneous coronary
      intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic
      shock improves cardiac power index after 24 h.
    


Intervention name(s): Mild hypothermia
Intervention type(s): Procedure
Intervention description(s): Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiogenic shock; acute myocardial infarction; mild hypothermia
Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation
Condition: Type 2 Diabetes; Impaired Glucose Regulation
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Objective: To investigate the association between plasma transthyretin levels and risk of
      newly diagnosed type 2 diabetes mellitus (T2DM) and impaired glucose regulation (IGR) in a
      Chinese population.

      Design: We performed a case-control study, including 1,244 newly diagnosed T2DM patients, 837
      newly diagnosed IGR patients, and 1,244 individuals with normal glucose tolerance (NGT). The
      diagnostic criteria were recommended by World Health Organization in 1999. All cases were
      recruited from patients who, for the first time, received a diagnosis of T2DM in the
      Department of Endocrinology, Tongji Hospital, Tongji Medical College, Wuhan, China, from
      December 2010 to December 2016. Concomitantly, general population undergoing a routine health
      checkup in the same hospital were enrolled as controls. The inclusion criteria were age ≥ 30
      years, BMI < 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological
      treatment for hypertension and hyperlipidemia. Participants with clinically significant
      neurological, endocrinological, psychological or other systemic diseases, as well as acute
      illness or chronic inflammatory or infectious diseases, were excluded from the present study.
      Written informed consent was obtained from each participant. Besides, cases were stringently
      matched to controls in a 1:1 ratio, based on sex and age (± 3 years). All participants
      enrolled were of Han ethnicity, and gave a commitment of taking no medication known affecting
      glucose tolerance or insulin secretion before participating in the study. Fasting blood
      samples were collected in EDTA-anticoagulative tubes and separated for plasma within 1 h.
      Then plasma was kept at -80℃ prior to analyses. Plasma transthyretin levels were measured by
      BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.
    


Intervention name(s): Plasma transthyretin concentration
Intervention type(s): Other
Intervention description(s): Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All the participants enrolled were of Chinese Han ethnicity. They gave informed written
        consent to the study and did not take any medication known to affect glucose tolerance or
        insulin secretion before participation.
      
Keywords: transthyretin; type 2 diabetes; impaired glucose regulation
Effects of Limicol on LDL-cholesterol
Condition: Hypercholesteremia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The principal objective of this study is to investigate the effects of a novel food
      supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate
      hypercholesterolemia.
    


Intervention name(s): Limicol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 tablets / day during 4 months; 3 tablets / day during 4 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Delivery of Health Care; Cholesterol; LDL-cholesterol; Coronary artery disease; Red yeast rice; Plants extract; Cholesterol excess
Pharmacokinetics and Tolerability of Zavesca® (Miglustat) In Patients With Juvenile GM2 Gangliosidosis
Condition: Gangliosidoses GM2
MeSH terms: Gangliosidoses; Gangliosidoses, GM2; Tay-Sachs Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate the pharmacokinetics of Zavesca (miglustat,
      OGT918) when given as single and multiple doses in juvenile patients with GM2 gangliosidosis.
    

Detailed description: 
      The GM2 gangliosidoses are a group of neuro-degenerative lysosomal storage diseases resulting
      from accumulation of GM2 and related glycolipids in the central nervous system (CNS).
      Tay-Sachs and Sandhoff disease are two variants which are indistinguishable in clinical
      grounds. According to the onset and rate of disease progression, the condition can be
      categorized in infantile, juvenile and adult forms. This open-label, single-arm study is
      designed to assess the pharmacokinetics, safety and tolerability of miglustat in juvenile
      patients. Miglustat will be administered at a maximum dose of 600 mg/day, divided into three
      doses per day. The dose used for patients in this pediatric age range will be related to the
      patient's body surface area. The pharmacokinetics assessments for the study will be performed
      in-hospital during a 24 hour period, and will take place at the day one and at the month 3
      visits. The clinical (which includes safety and tolerability) assessments will be performed
      throughout the 24-month study period.
    

Intervention name(s): miglustat
Intervention type(s): Drug
Intervention description(s): Target dose of 320 mg/m^2/day (divided in 3 doses) will be based on the Body Surface Area (BSA). For children with a BSA > 1.3, 200 mg TID will be administered. For children with a BSA of 0.8-1.3, 100 mg TID will be administered.
Other intervention name(s): Zavesca
Intervention MeSH terms: Miglustat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; lysosomal storage diseases; Gangliosidoses GM2; Tay-Sachs disease; Sandhoff disease; Infantile GM2-activator deficiency; Miglustat
Oral Liposomal Glutathione Supplementation in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      This trial is designed to provide evidence of the efficacy of liposomal glutathione
      supplementation on healthy adults. The investigators anticipate that liposomal glutathione
      supplementation will enhance the levels of blood glutathione and improve the immune
      functions.
    

Detailed description: 
      This is a randomized study on healthy individuals. The study design includes the recruitment
      of 12 healthy male and female subjects (50-80 yr of age) randomized into 2 groups of 6 each
      (liposomal glutathione at 500 mg/day or liposomal glutathione at 1000 mg/day). Blood and
      urine samples will be obtained from all subjects at baseline. Eligible subjects will be
      required to have not have taken any high dose antioxidant supplements for at least 1 month
      prior to the study. Subjects will then begin supplementation according to the following
      schedule: Group A, liposomal glutathione (500 mg daily), Group B, liposomal glutathione (1000
      mg daily)

      Eligible participants who sign the informed consent will be randomly assigned to either low
      dose or high dose glutathione groups. Participants will be asked not to consume any other
      high-dose vitamin, multi-vitamin, or mineral supplements containing glutathione throughout
      the study in order to prevent variation in dose of supplemental liposomal glutathione between
      subjects. Participants are to limit their consumption of alcohol in the study to no more than
      5 oz. of alcohol per week. Supplementation will continue for 1 month with biological samples
      collected at 1, 2 and 4 weeks after baseline.

      Levels of glutathione will be measured in whole blood, erythrocytes, lymphocytes and plasma.
      The biomarkers of oxidative stress will include urinary 8-isoprostane and urinary
      8-hydroxydeoxyguanosine. Immune function biomarkers will be analyzed including lymphocyte
      proliferation and natural killer (NK) cell cytotoxicity.
    

Intervention name(s): Low dose oral liposomal glutathione supplementation; High dose oral liposomal glutathione supplementation
Intervention type(s): Other; Other
Intervention description(s): Low dose oral liposomal glutathione supplementation; High dose oral liposomal glutathione supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Aromatherapy Versus Gum Chewing on Preoperative Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Investigators hypothesized that the use of blend aromatherapy and gum chewing before surgery
      would reduce preoperative anxiety as assessed by the Speilberger State-Trait Anxiety
      Inventory (STAI) questionnaire and provide non pharmacological methods to decrease
      postoperative sore throat, postoperative nausea & vomiting and postoperative pain.
    

Detailed description: 
      A written informed consent will be taken from the patients.patients will be assigned randomly
      to three groups (30 subjects each) either with preoperative aromatherapy (Group A) or gum
      chewing (Group G) or control group (Group C) to assess the preoperative anxiety and
      postoperative sore throat, nausea & vomiting and pain control between the three studied
      groups.
    

Intervention name(s): Aromatherapy; Gum Chewing; Controlled
Intervention type(s): Other; Other; Other
Intervention description(s): Three drops of the designated blend aromatherapy (ginger & lavender) will be placed on a 2-inch by 2-inch impermeable, backed gauze pad and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes.; Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.; Patients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Pain Management in Arthtroscopic Shoulder Surgery
Condition: Arthroscopic Shoulder Surgery
Study type: Interventional

Summary: 
      It is compared that combined suprascapular and infraclavicular nerve blocks to interscalene
      nerve block for clinical outcomes after shoulder surgery
    

Detailed description: 
      In this study, the investigators planned to investigate postoperative pain, analgesic dosage,
      respiratory effects of the block and side effects of patients undergoing general anaesthesia
      after arthroscopic shoulder surgery under preoperative interscalene nerve block or
      suprascapular + infraclavicular nerve block.
    

Intervention name(s): Interscalene block; suprascapular and infraclavicular nerve block
Intervention type(s): Other; Other
Intervention description(s): 30 minutes before anaesthesia induction interscalene nerve block will be applied with ultrasound guidance with %0,25 bupivacain 20 cc .The sham block consisted of after patients were placed in the lateral decubitus position skin preparation, ultrasound scanning of the suprascapular region, and a dry-needling, all performed to preserve patient blinding in the ISB group patients.; 30 minutes before anaesthesia induction suprascapular with %0,25 bupivacain 10 cc .and infraclavicular nerve block with %0,25 bupivacain 10 cc will be applied with ultrasound guidance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine
Condition: Recurrent Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted
      depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)
    


Intervention name(s): Fluvoxamine
Intervention type(s): Drug
Intervention description(s): The subjects will be prescribed Fluvoxamine treatment for 24 weeks with dose 50-300 mg
Other intervention name(s): Fevarin®
Intervention MeSH terms: Fluvoxamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive function
A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to:

        -  1) Test the safety and tolerability of 2 different oral doses of SRT2104 in subjects
           with ulcerative colitis

        -  2) Determine the amount of SRT2104 measured from a single blood sample in addition to
           colon and/or rectal tissue samples (biopsies)

        -  3) Determine whether SRT2104 has any anti-inflammatory effect on the colon and/or rectum
           when taken orally for 8 weeks

        -  4) Determine whether SRT2104 causes any detectable changes to specific biomarkers. A
           biomarker is a biological marker (or substance such as a protein) that is used as an
           indicator of changes in a biological state that corresponds to the risk or progression
           of a disease.
    


Intervention name(s): SRT2104
Intervention type(s): Drug
Intervention description(s): SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 25mg or 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule. All subjects will be provided with one dosing bottle per day that contains two 25 mg or 250 mg SRT2104 capsules for oral ingestion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pain Perception With Tenaculum Placement
Condition: Pain
Study type: Interventional

Summary: 
      Randomized controlled trial that compares methods of tenaculum placement during intrauterine
      device insertion and their effect on pain. The two methods being compared are slow tenaculum
      placement versus tenaculum placement at time of cough. Subjects will be asked to rate their
      pain using visual analog scale. Primary outcome measured is pain at time of tenaculum
      placement. Secondary outcomes are overall pain with intrauterine device insertion and
      provider satisfaction with tenaculum placement.
    

Detailed description: 
      The two commonly described strategies for tenaculum placement, slow versus having the patient
      cough while the tenaculum is placed are utilized by providers based on preference and/or
      their previous training. There is no published study that compares these methods to one
      another. The investigators aim to compare these strategies, slow tenaculum placement versus
      the cough method, and their effects on pain at time of placement. 96 subjects will be
      randomized to each method. The subject will be asked to rate their pain using a 100-mm visual
      analog scale after speculum placement, after tenaculum is placed, and after completion of the
      procedure. The provider will be asked to rate their satisfaction with tenaculum placement on
      a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3:
      moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected
      using REDCap database.
    

Intervention name(s): Cough method for placement of tenaculum; Slow Tenaculum Placement of tenaculum
Intervention type(s): Other; Other
Intervention description(s): The intervention in this arm is the placement of tenaculum via cough method; The intervention in this arm is the placement of tenaculum via slow method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Bilateral Deficit Phenomenon, Functional and Dynamometric Assessment in Postmenopausal Women
Condition: Postmenopausal Syndrome; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Observational

Summary: 
      The bilateral deficit phenomenon (BLD) is defined as an inability of the neuromuscular system
      to generate maximal force when two homonymous limb operate simultaneously (bilateral
      contraction) with respect to the force developed when both limbs acts separately (unilateral
      contraction). From an applied perspective, movement patterns of bilateral homonymous limb are
      often developed during activities of day living, e.g. rising from a chair or opening a jar.
      The BLD can be considered an intrinsic property of the human neuromuscular system but could
      be enough important to constitute a performance-limiting factor for postmenopausal women that
      involves a degenerative loss of muscular strength. Therefore, a specific analysis of this
      phenomenon and its relation with activities of daily living, such as climbing a step and
      rising from a chair, is crucial for detecting variables of neuromuscular performance and
      develop strategies to minimize the loss of strength.
    

Detailed description: 
      -  20 postmenopausal women unexperience in strength training or resistance training,
           without musculoskeletal, neurological diseases, and cardiovascular limiting-diseases
           were recruited.

        -  Maximum strength of lower limbs during leg-press exercise was measured for future
           analysis.

        -  The force-time curves were measured during climbing a step and rising from a chair.

        -  A fragility phenotype test was applied to the subjects to determine frailty phenotype
           classification, including; weight loss of greater than 10 lbs in the past 12 months,
           maximal handgrip strength, time to walk 15-ft at usual pace, self-reported leisure time
           physical activity, and self-reported exhaustion.

        -  The anthropometric measurements were performed by dual energy X-ray absorptiometry.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Postmenopausal women not experienced in strength training or resistance, without
        musculoskeletal, neurological diseases, and cardiovascular limiting-factor.
      
Keywords: Musculoskeletal Physiological Phenomena; Postmenopause; Muscle Strength; Absorptiometry, Photon
Nasal Provocation Testing in Occupational Rhinitis
Condition: Allergic Rhinitis (Disorder)
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      In a previous study the investigators found that many bakery workers were sensitized to
      storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational
      allergen with clinical relevance has been questioned, and the investigators wanted to
      investigate whether a nasal provocation with a storage mite extract would trigger symptoms
      and objective signs of rhinitis in bakery workers and a control group.
    

Detailed description: 
      The investigations include allergy testing with skin prick testing, and measuring of specific
      Immunoglobulin E (IgE) in sera, answering a questionnaire, and symptom scoring before and
      after provocations. The participants will be investigated one day with a placebo, and another
      day with the allergen extract of either Acarus Siro or Lepidoglyphus Destructor. As a
      measurement of nasal patency we use the nasal peak inspiratory flow meter, but also clinical
      scoring of nasal secretion and blockage. Indices of inflammation (ECP and alfa-Macroglobulin)
      will be monitored in nasal lavage.
    

Intervention name(s): Storage mite allergen extracts
Intervention type(s): Biological
Intervention description(s): Nasal provocation with increasing doses of storage mite allergen extracts
Other intervention name(s): Acarus Siro; Lepidoglyphus Destructor
Intervention model: Single Group Assignment
Intervention model description: Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: rhinitis; allergy; occupational; storage mites; nasal lavage; challenge test; ECP; alfa2Macroglobuline