bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effectiveness of Resistance Training in Patients With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional

Summary: 
      The aim of this study was to assess the effectiveness of resistance training in improving
      functional capacity, muscle strength, quality of life and disease activity in patients with
      PSA.
    

Detailed description: 
      The IG patients performed resistance exercises for the following muscles group: upper limbs,
      lower limbs and trunk. It was used a machine "leg extension" for the training on the lower
      limbs. For upper limbs we used a pulley triceps machine and front pull in addition to free
      weights (dumbbells).

      In order to perform the exercise program the study followed all the recommendations
      established by the American College of Sports Medicine (ACSM) (Ratamess et al., 2009). It was
      carried out two exercises for major muscle groups and one exercise for small muscles. The
      exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of
      the exercises were 60% of one-maximum repetition (1RM).

      The exercise program involved pectoral exercises: crucifix and seat supine; biceps:
      alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead;
      quadriceps: leg extensor and finally gluteo: standing hips extension.

      Control Group (CG) The control group was kept in a waiting list while continued with the
      standard pharmacological treatment during all the study. The patients were instructed to
      maintain their daily activities and to avoid any other non-pharmacological treatment. The
      exercise program was offered to the control group in the end of the study.
    

Intervention name(s): Resistance exercise; Waiting list for the exercises
Intervention type(s): Other; Other
Intervention description(s): Underwent resistance exercise twice a week, for twelve weeks. The IG patients performed resistance exercises for the following muscles group: upper limbs, lower limbs and trunk.
It was carried out two exercises for major muscle groups and one exercise for small muscles. The exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of the exercises were 60% of one-maximum repetition (1RM).
The exercise program involved pectoral exercises: crucifix and seat supine; biceps: alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead; quadriceps: leg extensor and finally gluteo: standing hips extension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Physical exercise; Psoriatic arthritis; Quality of life
Long-term Follow-up After Surgical Treatment for GERD (Gastroesophageal Reflux Disease)
Condition: Patient Satisfaction; Relapse; Dysphagia; Bloating
MeSH terms: Deglutition Disorders; Recurrence
Study type: Observational

Summary: 
      10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal
      Symptom Rating Scale) and two reflux specific questionnaires.
    

Detailed description: 
      Long-term follow up with questionnaires after surgery with laparoscopic 270 degrees posterial
      partial fundoplication vs total fundoplication for the treatment of gastroesophageal reflux
      disease.

      Quality of Life SF-36; physical and mental component scores. GSRS, five dimensions of
      abdominal symptoms; reflux, abdominal pain, indigestion, obstipation and diarrhea.

      Reflux specificquestionnaries on various issues of reflux disease and frequency issues about
      reflux disease problems.
    

Intervention name(s): 10 years follow up
Intervention type(s): Other
Intervention description(s): Questionnaires
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Gastroesophageal Reflux Disease
Pulmonary Vasculopathy Under Second-line Therapy of Chronic Myeloid Leukemia
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Observational

Summary: 
      Chronic myelogenous leukemia (CML) is a chronic myeloproliferative disorder characterized by
      a translocation between chromosome 9 and 22, leading to a pathogenic tyrosine kinase signal
      transduction protein. CML can be treated with tyrosine kinase inhibitors (TKIs), which
      inhibit BCR/ABL kinase, such as imatinib. In about 20% of CML patients who are treated by
      imatinib, a complete cytogenetic response cannot be achieved. The other two novel TKIs
      (dasatinib and nilotinib), achieve higher rates of complete cytogenetic response and they are
      proposed as second-line therapy for imatinib-resistant patients or for those who do not
      tolerate imatinib. Dasatinib inhibits BCR/ABL kinase in about >300 times in vitro in more
      than imatinib and also inhibits several other kinases, including the Src family. Src tyrosine
      kinase is crucial for potassium channel function in human pulmonary arteries. Imatinib and
      nilotinib do not inhibit the Src.

      Incident cases of precapillary PH have been reported in patients who have CML treated with
      the dasatinib. Improvements were usually observed after withdrawal of dasatinib.

      This study is designed to identify incident cases of dasatinib-associated PH and describe
      pulmonary vascular changes induced by dasatinib. As comparison population will be patients
      who receive another second-line TKI (nilotinib).
    

Detailed description: 
      Doppler echocardiography at rest will be performed in each patient. Patients without exercise
      capacity limitation an exercise test (Doppler echocardiography with spiroergometry) will be
      performed. Patients who show elevated SPAP at rest or during exercise (in this study SPAP ≥
      40 mmHg) or with reduced exercise capacity (peak VO2 < 75%) a right heart catheterization
      (RHC) will be suggested. Additionally for the evaluation of exercise capacity a 6 MWD will be
      performed. This work- up of patients allows clinical and hemodynamic evaluation.
    

Intervention name(s): Echo, exercise echo, and if indicated, right heart catheter
Intervention type(s): Other
Intervention description(s): routine echocardiography and special measurements of the right heart are performed at rest and during exercise
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with chronic myeloid leukemia under second-line therapy with dasatinib or
        nilotinib,
      
Biospecimen description: 
      Samples with DNA will be retained for later examinations at the Biobank, in case that the
      patient agrees (extra patient information). The blood samples are taken only during routine
      tests.
    
Keywords: Pulmonary hypertension; chronic myeloid leukemia; dasatinib; nilotinib
GSK1349572 Hepatic Impairment Study
Condition: Healthy Subjects; Hepatic Impairment; Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1349572 is an integrase inhibitor that is currently in clinical development for the
      treatment of human immunodeficiency virus (HIV) infection. GSK1349572 is metabolized
      primarily by uridine diphosphate glucuronosyltransferase (UGT)1A1 with a minor role of
      Cytochrome P450 (CYP)3A. Hepatic impairment could potentially alter the clearance and plasma
      protein binding of GSK1349572. This study will evaluate the single dose pharmacokinetics and
      safety of GSK1349572 in healthy subjects and in subjects with mild or moderate hepatic
      impairment based on Child-Pugh category.

      This is a single-dose, open-label, parallel group, two-part, adaptive study in adult males
      and females with mild or moderate hepatic impairment and matched, healthy control subjects
      with normal hepatic function. Healthy control subjects (16) will be matched for gender, age,
      and BMI to the subjects in the mild (8) or moderate (8) hepatic impairment category. In Part
      1, approximately 8 subjects with moderate hepatic impairment (cohort 1) and 8 matched,
      control subjects (cohort 2) will each receive GSK1349572 50 mg as a single dose in the fasted
      state followed by pharmacokinetic sampling for total concentrations of GSK1349572 in plasma.
      Free (unbound) plasma concentrations of GSK1349572 will also be evaluated at sparse, selected
      time points. If the geometric mean total plasma area under the concentration curve (AUC) of
      GSK1349572 is increased by > 2-fold in moderately impaired subjects compared to matched
      controls, Part 2 will be conducted to evaluate GSK1349572 pharmacokinetics in another group
      of subjects with mild impairment (8, cohort 3) and matched, control subjects (8, cohort 4).
      Vital signs, electrocardiograms (ECGs), and adverse events will be monitored throughout the
      study. A follow-up visit will occur 7-10 days after the dose of study drug.
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship
    

Intervention name(s): GSK1349572
Intervention type(s): Drug
Intervention description(s): All subjects will receive a single dose of GSK1349572 50 mg. GSK1349572 is an experimental drug in the integrase inhibitor class being developed for the treatment of HIV infection. GSK1349572 is not approved by the FDA.
Intervention MeSH terms: Dolutegravir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare subject response to liquid vs. tablet formulations,
      to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate
      if dose response curve for tablet is equal to liquid form."
    

Detailed description: 
      1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of
      liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet =
      to liquid form
    

Intervention name(s): Buprenorphine formulation: liquid vs. tablet
Intervention type(s): Drug
Intervention description(s): random assignment to liquid buprenorphine or tablet buprenorphine
Other intervention name(s): Subutex; Suboxone
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid dependence
Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis
Study type: Observational

Summary: 
      The objective of this study is to evaluate the correlation of the calculated portosystemic
      pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the
      EchoTip® Insight™ and indirect portal vein pressure measurements using the interventional
      radiology based hepatic venous pressure gradient (HVPG) procedure.
    


Intervention name(s): EchoTip® Insight™
Intervention type(s): Device
Intervention description(s): Patients will undergo procedure where HVPG is obtained under mild sedation, next the patients will undergo anesthesia and mechanical intubation where HVPG measurements will be obtained simultaneously with the EchoTip Insight measurement. For patients receiving a transjugular intrahepatic portosystemic shunt (TIPS), direct portal vein pressure measurements will be obtained by the EchoTip® Insight™ and compared to the transjugular direct portal vein measurement obtained during the interventional radiology (IR) procedure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cirrhosis who have been referred for a HVPG procedure.
      
Keywords: Portal Pressure Measurement; Portal Pressure Gradient; Hepatic Vein Pressure Gradient; Liver Diseases; Portal Hypertension; Intractable ascites; End Stage Liver Disease
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of a study drug known as LY3209590
      in Japanese participants with type 2 diabetes. Side effects and tolerability will be
      documented. Blood samples will be taken to compare how the body handles the drug and how it
      affects blood sugar levels. The study will last about four weeks, not including screening.
      Screening is required within 4 weeks before the start of the study.
    


Intervention name(s): LY3209590; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35
      mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with
      that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company,
      Inc., following a single oral dose (2 * 0.4 mg/35 mcg chewable tablets) in healthy female
      adult volunteers administered under fasting conditions.
    


Intervention name(s): Norethindrone/Ethinyl Estradiol; Ovcon® 35 Fe
Intervention type(s): Drug; Drug
Intervention description(s): 0.4 mg/35 mcg Chewable Tablets; 0.4 mg/35 mcg Chewable Tablets
Other intervention name(s): Zeosa®; Femcon® Fe; Norethindrone/Ethinyl Estradiol (generic name)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Subjects
Dronabinol Treatment for Marijuana Addiction
Condition: Marijuana Abuse
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana
      addiction and withdrawal.
    

Detailed description: 
      Marijuana addiction is associated with significant withdrawal symptoms, including anxiety,
      irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the
      effectiveness of dronabinol in reducing withdrawal symptoms.

      During this twelve-week, double-blind, placebo-controlled study, study visits will occur
      twice each week. During study visits, participants will receive either placebo or medication.
      Throughout the study, all participants will receive individualized psychotherapy sessions. At
      each study visit, vital signs, self-report ratings, and urine samples will be collected.
      Participants will have a follow-up evaluation at month 6.
    

Intervention name(s): Dronabinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dronabinol; placebo
Other intervention name(s): Marinol
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabis dependence; dronabinol; treatment
Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
Condition: Non-insulin-dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase IIIb, randomised, double blind, placebo controlled, study in patients with
      type 2 diabetes mellitus and coexisting vascular disease or hypertension. The total duration
      of the study will be approximately 60 weeks. The aim of this study is to examine the
      potential beneficial effects of rosiglitazone on carotid atheroma in patients with type 2
      diabetes mellitus and coexisting vascular disease or hypertension. It is hypothesised that
      treatment with rosiglitazone will lead to an decrease in plaque size. In addition, it is
      hoped that rosiglitazone will have a positive effect on plaque composition and stability.
    


Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: diabetes rosiglitazone plaque
Wound Powder for Pressure Ulcers at End-of-life
Condition: Pressure Ulcer; Wounds
MeSH terms: Pressure Ulcer; Ulcer; Death; Wounds and Injuries
Study type: Interventional

Summary: 
      This study will test a special powder for ulcers caused by a variety of conditions such as
      pressure that sometimes happen when a person is at the end of life. The powder will be
      applied to these ulcers to see if it helps with pain, odor and drainage (leakage). People who
      are being cared for by hospice or palliative care organizations will be invited to be in the
      study. The study will also find out if the powder is easy to use by caregivers as well as
      improving the comfort and quality of life of the person who has the ulcer.
    

Detailed description: 
      Aim 1. In a comparative 2-group design, we will evaluate and compare the feasibility of the
      intervention through assessment in both settings (home-based and inpatient) on:

        1. Adherence to RGN107 protocol by licensed care providers and/or family or other
           caregivers providing wound care; measures include implementation of procedures,
           frequency of dressing changes.

        2. Reach, enrollment, disenrollment, acceptability, satisfaction; measures include
           difficulties with recruitment and enrollment, side effects such as burning, peri-wound
           skin irritation.

        3. Usability issues such as powder ability to stick to wound and ease of use of applying
           powder.

      Aim 2. Estimate variability of outcome measurements and effect sizes and investigate the
      presence of a preliminary "signal" of clinical efficacy in two groups of hospice/home
      health/residential individuals receiving RGN107 in:

        1. Physical wound symptoms outcomes, specifically pain, odor and exudate.

        2. Quality of life of individuals receiving and caregivers using RGN107.
    

Intervention name(s): Wound powder application
Intervention type(s): Other
Intervention description(s): Powder application to wound per protocol.
Other intervention name(s): RGN107; MittiHeal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: wound; palliative care; hospice; pressure ulcers
Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation,
      compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young
      children with persistent symptoms of asthma.
    

Detailed description: 
      Asthma is a chronic disease which is estimated to affect over 25 million people both in the
      US and Europe(i.e. approximately 10% of the total population).There is evidence that over the
      last 20 years prevalence has considerably increased, especially among children. The diagnosis
      of asthma in children may be difficult, largely because episodic wheezing and cough are among
      the common symptoms encountered in childhood illnesses, particularly in children under 3
      years old.Although in these young children there is the possibility of over treatment, the
      episodes of wheezing may be reduced in intensity by the effective use of anti-inflammatory
      medications and bronchodilators rather than antibiotics. At present, pharmacological therapy
      is used to treat reversible airway obstruction, inflammation and hyperreactivity in both
      children and adults. Medications include preventive treatments in forms of
      antinflammatory/antiallergic agents (e.g. glucocorticosteroids, leukotriene antagonists,
      cromolyn sodium) and reliever treatments, in form of bronchodilators (e.g. β-adrenergic
      agonists, anticholinergics). Comparisons: Beclomethasone suspension for nebulisation (400 mcg
      U.D.V.) plus as needed salbutamol compared to placebo plus as needed salbutamol and to as
      needed salbutamol/beclomethasone fixed combination.
    

Intervention name(s): Beclomethasone dipropionate; Beclomethasone dipropionate/Salbutamol combination; Salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Beclomethasone; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Young Children; Corticosteroids; Beclomethasone; Salbutamol; Beclomethasone/Salbutamol fixed combination; Suspension for nebulisation