bioihbjkbjnl/mcl2 huggingface dataset:
GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study
Condition: Asthma; Respiratory
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Breathing retraining supervised by a physiotherapist will result in improvements in the
      quality of life and asthma control of patients treated for asthma in the community with
      symptoms suggestive of dysfunctional breathing.

      To investigate the effects of breathing retraining on clinical and physiological parameters
      of asthma control, to identify the characteristics of patients who benefit, to perform a
      health economic evaluation.
    

Detailed description: 
      Objectives:

        -  To assess the effect of breathing retraining on asthma-related health status, asthma
           control and objective indices of asthma severity (bronchial hyper-reactivity (BHR),
           sputum eosinophilia and nitric oxide production) in patients with symptomatic asthma.

        -  To compare the relationship between symptoms of dysfunctional breathing (Nijmegen
           Questionnaire screening score), changes in asthma-related health status and other
           parameters resulting from breathing retraining

        -  To explore the relationship between dysfunctional breathing, baseline asthma symptoms,
           treatment and asthma-related quality of life.

        -  To estimate the cost effectiveness of the breathing retraining intervention
    

Intervention name(s): Physiotherapist
Intervention type(s): Other
Intervention description(s): Physiotherapist administered breathing retraining programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      In this study, the safety, acceptance and metabolic effects in infants receiving a novel low
      glycaemic index follow-on formula will be investigated.

      After 4 week intervention period, metabolic response after feeding is significantly different
      between a follow-on formula containing low glycaemic carbohydrate and a conventional
      follow-on formula containing higher glycaemic carbohydrates.
    


Intervention name(s): Modified infant follow-on formula; Standard infant follow-on formula
Intervention type(s): Other; Other
Intervention description(s): The modified infant follow-on formula has a different carbohydrate pattern than the standard formula; Infants are fed a commercial follow-on formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Fully formula fed
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn whether Saxagliptin added to
      thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2
      diabetic subjects who are not sufficiently controlled with TZD alone
    

Detailed description: 
      All subjects will participate in a lead-in period, and qualifying subjects will continue into
      a short-term randomized treatment period. Subjects who complete the short-term period will be
      eligible to enter the long term extension period. Also, subjects in the short-term period who
      have an elevated blood sugar that requires additional medication for blood sugar control will
      be eligible to enter the long-term treatment extension period where they will receive
      metformin (defined as rescue medication) added onto their blinded study medication
    

Intervention name(s): Saxagliptin; Saxagliptin; Placebo; pioglitazone; rosiglitazone; metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT); Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT); Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT); Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT); Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT); Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Other intervention name(s): BMS-477118; BMS-477118
Intervention MeSH terms: Metformin; Pioglitazone; Rosiglitazone; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gut Microbiome Based Analysis of High Protein High Fat Diet
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this study was to determine body mass reduction and microbiota composition change
      after the weight loss diet (50 % fat, 25 % proteins and 25 % carbohydrates).
    

Detailed description: 
      For high fat group a total of 19 overweight/obese participants (14 females, 5 males, aged 25
      to 43) with BMI of 28.9-44.4 kg/m2 were assigned to low-calorie low-carbohydrate high-fat
      weight loss diet for 4 weeks.

      As a control group, 58 subjects (39 females, 20 males, aged 24 to 55 years) were recruited
      and divided into 3 groups based on BMI: 18-25, 25-30, 30-39 kg/m2 (N=33, N=16, N=9,
      respectively).

      Inclusion criteria for participants included no previous history of gastrointestinal (GI)
      disease, no reported antibiotic use in preceding 3 months, or taking any medication known to
      alter bowel motility, no history of food allergies and not taking medications.

      Before the study all participants were informed about the study and participants were signed
      a written consent.

      At day 0 baseline samples and data were collected (faecal sample, Bristol score and bowel
      habits, food diary about the period of at least three days before faecal sampling, body
      weight). After collection of baseline samples subjects in the high fat group started diet
      plan for 4 weeks while control group contiunued their habitual diet. After the 4 week
      intervention period samples and data were collected again (faecal sample, Bristol score and
      bowel habits, food diary about the period of at least three days before faecal sampling, body
      weight).
    

Intervention name(s): High fat diet
Intervention type(s): Other
Intervention description(s): 50 % fat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: microbiome; ribosomal sequencing; obesity; bifidobacteria; Collinsella
Relationship of Mindfulness, Artistic Activities and Quality of Life
Condition: Quality of Life
Study type: Observational

Summary: 
      Methods: This study has the descriptive-correlational method and the statistical population
      was all artistic females of Bojnord city in 2018. In this study, 200 women of carpet weavers
      were selected by cluster random sampling. Participants filled out researcher-made
      questionnaires on how to do artistic activities, mindfulness, and quality of life. Data were
      analyzed using the Pearson correlation coefficient and hierarchical regression (moderator).
    


Intervention name(s): descriptive
Intervention type(s): Other
Intervention description(s): correlation
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population consisted of women working in workshops of carpet weaving in Bojnourd
        in 2018 that were selected by cluster sampling from 5 workshops.
Nicotinic Modulation of the Default Network
Condition: Magnetic Resonance Imaging; Cognition; Nicotine; Mecamylamine
Study type: Interventional

Summary: 
      Many disorders where attentional problems are a hallmark, such as Alzheimer's disease and
      schizophrenia, display abnormal regulation of the so-called default network of resting brain
      function that maintains internally directed thought when the mind is free to wander. There is
      indication that nicotine may improve attention by aiding the deactivation of the default
      network, and this mechanism may be of therapeutic benefit for the above disease states. The
      current project aims at providing a proof of concept by demonstrating that nicotinic drugs
      modulate default network function. The nicotinic agonist nicotine is hypothesized to improve
      attention by facilitating the down-regulation of default network activity, and the nicotinic
      antagonist mecamylamine is hypothesized to impair attention by impeding the down-regulation
      of default network activity during attentional task performance.
    

Detailed description: 
      This study only enrolls healthy non-smokers. Participants perform attention tasks while
      undergoing functional Magnetic Resonance Imaging on three separate days. Across the three
      days, three difference conditions are tested in a double-blind manner, in randomized order.
      In all test sessions, participants receive a skin patch and swallow a capsule. In one
      session, both are a placebo. In another, the patch is a low-dose nicotine patch, and the
      capsule is a placebo. In another session, the patch is a placebo and the capsule contains a
      low dose of mecamylamine.
    

Intervention name(s): Placebo; Nicotine; Mecamylamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants are administered a placebo patch and a placebo capsule; Participants are administered a nicotine patch (7 mg/24 hrs) and a placebo capsule; Participants are administered a placebo patch and a capsule containing 7.5 mg of mecamylamine
Other intervention name(s): Nicotine CQ
Intervention MeSH terms: Mecamylamine; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: nicotine; mecamylamine; attention; default network; fMRI
Therapeutic Lactose to Support Vaginal Microbiota
Condition: Bacterial Vaginoses
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      The aim of the study was to investigate whether the administration of a vaginal tablet
      containing lactose can modulate the bacterial flora of women with bacterial vaginosis (BV).

      Design: Double-blind, placebo-controlled randomised trial.

      Setting: Women with BV who responded to advertisements in local newspapers and on posters at
      the Institutions for Education in Health Science in Eastern Jutland, Denmark. These
      individuals were supplemented with patients enrolled at a gynaecological clinic.

      Participants: Forty women with BV diagnosed through the Amsel test. By randomisation, 20 were
      assigned to receive lactose tablets, and 20 were assigned to receive placebo tablets.

      Interventions: Twice daily application of one lactose tablet or placebo tablet for 7 days.
    


Intervention name(s): Lactose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg; Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study describes a controlled randomized clinical trial to evaluate the efficacy of bone
      marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy
      and cardiac failure class III or NYHA.
    


Intervention name(s): intramyocardial bone marrow stem cells implantation
Intervention type(s): Procedure
Intervention description(s): Control group: the patients will be monitored with regular medical visits. Echocardiography: baseline,3,6,9 months. Cardiac NMR at baseline, 3 and 9 months.
Interventional group: Bone-marrow was collected from in the anterior-superior iliac crest and mononuclear stem cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5ml), in the anterior, lateral, posterior and apical faces of the LV ((average 9.6±2.6 x 10[7] cells). After the procedure, the patients were kept in the p.o. for a minimum period of 24hrs. They were released from the hospital in a period that varied from 5-7 days.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiomyopathy; stem cell; cardiac failure
Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
Condition: Anemia; Chronic Kidney Disease; Chronic Renal Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety, pharmacodynamics (PD), and
      pharmacokinetics (PK) of multiple subcutaneous injections of peginesatide in participants
      with chronic kidney disease (CKD) not on dialysis who had not received erythropoiesis
      stimulating agent (ESA) treatment.
    

Detailed description: 
      This was a Phase 2, dose finding study designed to evaluate peginesatide treatment of
      participants with CKD not on ESA treatment. The objective was to determine the range of doses
      of peginesatide administered subcutaneously once every 4 weeks (Q4W) that increased and
      maintained hemoglobin at 11 to 13 g/dL.
    

Intervention name(s): peginesatide
Intervention type(s): Drug
Other intervention name(s): Omontys; Hematide; AF37702 Injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anemia; chronic kidney disease; CKD; chronic renal failure; CRF; dialysis; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide™; hemoglobin; Hb; Hgb; Omontys; peginesatide; red blood cell; red blood cell production
Meperidine for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.
Condition: Patients Undergoing Diagnostic EGD
Study type: Interventional

Summary: 
      Our pilot results showed that meperidine reduce patient discomfort during EGD
      (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative
      agents. So the investigators target the use of meperidine on patients expected to have poor
      tolerance in this study, which includ young females with high anxiety level and patients with
      prior poor tolerance. The investigators test the hypothesis that meperidine improves
      tolerance and alleviates discomfort for patients expected to have poor tolerance during
      diagnostic EGD.
    


Intervention name(s): placebo; Meperidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Meperidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: EGD; tolerance; discomfort
A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose
      of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in
      matched participants with normal renal function.
    


Intervention name(s): Odalasvir
Intervention type(s): Drug
Intervention description(s): Participants will receive odalasvir 25 mg tablet, orally.
Intervention MeSH terms: Odalasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Double Regional Anesthesia in Video Assisted Thoracoscopy
Condition: Video Assisted Thoracoscopy; Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Monocentric, randomized, controlled, single-blind study who's aim is to demonstrate the
      efficacy of the association of paravertebral block and serratus plane block with
      paravertebral block alone
    


Intervention name(s): Serratus plane block and paravertebral block; paravertebral block
Intervention type(s): Drug; Drug
Intervention description(s): Single Administration of 20 mL of ropivacaine for Serratus plane block (Intra-muscular injection) followed by a single administration of 20 ml ropivacaine for paravertebral block (T4 inter-vertebral injection); Single Administration of 20 ml of ropivacaine for paravertebral block (T4 inter-vertebral injection)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Sleep Plus Eating Routines for Weight Loss
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study will test the effectiveness of two different approaches for preparing
      overweight/obese individuals for weight loss: 1)providing important information about weight
      control, including dispelling common myths; or 2) developing a consistent sleep and eating
      routine to prepare for the challenges of a weight control intervention.
    


Intervention name(s): Weight Loss Education; Sleep and Eating Routine
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight loss
Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus
      subjects continuing to administer insulin in multiple dose injections. Evaluate the
      educational materials and time required for training subjects naïve to continuous
      subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation
      for a large multi-center clinical trial
    

Detailed description: 
      Many subjects with Type 1 diabetes continue to manage their disease utilizing multiple daily
      injections, but despite frequent blood glucose checks, are unable to control their glycemic
      variability or lower their A1C levels. The MiniMed Paradigm REAL-Time System transmits sensor
      glucose values to the insulin pump every 5 minutes, allowing users to view their current
      glucose values as well as glycemic excursions and trends over a 24-hour period. The System
      will also alert users of high and low glucose levels, allowing subjects and their clinicians
      to make carefully monitored modifications to therapy. Additionally, data can be uploaded from
      the monitor into a personal computer, allowing the subject and clinician to see a complete
      picture of trends over time.

      Subjects learning this technology would require a new approach to training if they were to
      master operation of an insulin pump, make effective use of the sensor technology and
      understand the complete picture provided by the software component. Subjects will be trained
      to first use the insulin pump, add the sensor and then utilize the software and the
      effectiveness of the training methods and timing will be measured using questionnaires
      designed to evaluate understanding of the device, Self Efficacy and User Acceptance. The
      group wearing the System will also be compared to subjects that continue on their current MDI
      therapy over a 15-week time period.
    

Intervention name(s): MiniMed Paradigm REAL-Time System
Intervention type(s): Device
Intervention description(s): MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink
Other intervention name(s): Medtronic MiniMed Paradigm insulin infusion pump (MMT-722); Transmitter (MMT-7701); Subcutaneous glucose sensor (MMT-7002); Medtronic CareLink Diabetes Management System (MMT-7334); Paradigm Link Glucose Meter (HMS-322200A)
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Potential Biochemical Diagnosis Criteria and Therapeutic Effect Indexes: Sex Hormone Binding Globulin Levels and Free Androgen Index in Blood of Patients With Polycystic Ovary Syndrome
Condition: The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;; At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;; 534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs;; The Investigators Monitored Basic Indexes in Blood of All the Subjects in This Suvey,and Also Monitored Indexes of 579 Patients After Treatment.
MeSH terms: Infertility
Study type: Observational

Summary: 
      To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic
      indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）.
      Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic
      effect indicatrixes of women with PCOS.
    


Intervention name(s): Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Clomiphene; Enclomiphene; Zuclomiphene; Menotropins; Cyproterone acetate, ethinyl estradiol drug combination
Observational model: Case-Control
Sampling method: Probability Sample
Study population: 
        The investigators collected 534 PCOS patients as the case group, 580 infertile women with
        normally ovulatory cycle as the control groupand.The patients of the case group aged from
        20 to 42 years old, the average age was 27.87 years old, and the standard deviation of ages
        was 3.75 years old. And patients' ovulation in the case group was normal, as control group,
        aged from 20 to 43 years old, the average age was 28.18 years old; the standard deviation
        of ages was 3.99 years old.Also the investigators also collected 579 patients as the
        treatment group,who aged from 20 to 39 years, the average age was 27.93 years old, the
        standard deviation of ages was 3.70 years old.