bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Moderate Physical Activity on Diabetic Adhesive Capsulitis: A Randomized Clinical Trial
Condition: Adhesive Capsulitis of Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The study is designed to determine the effects of moderate physical activity on adhesive
      capsulitis in patients with uncontrolled diabetes mellitus.
    

Detailed description: 
      This study aims to investigate the effect of additional Physical activity programmes in
      patients with Diabetic Frozen Shoulder (DFS).

      Physical activity can help people with diabetes achieve a variety of goals, including
      increased cardiorespiratory fitness, increased vigour, improved glycemic control, decreased
      insulin resistance, improved lipid profile, blood pressure (BP) reduction and maintenance of
      weight loss Frozen shoulder syndrome, also known as adhesive capsulitis, is a clinical entity
      that refers to a stiff and painful shoulder causing major functional impairment. It affects
      women more than men, and is mostly associated with diabetes mellitus as a systemic condition.
      . Frozen shoulder may be either primary idiopathic or secondary to a systemic disease, such
      as diabetes mellitus.

      The adoption and maintenance of physical activity are critical for blood glucose management
      and overall health in individuals with diabetes. In this Position Statement, we provide a
      clinically oriented review and evidence based recommendations regarding physical activity and
      exercise in people with type 2 diabetes.
    

Intervention name(s): Moderate Physical Activity + Conventional Physical Therapy; Conventional Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): Hot pack and TENS for 10 minutes at the affected shoulder. Passive shoulder mobilizations were performed initially at pain free range in anterior, posterior, and inferior direction (10 reps x 1 set).
Shoulder rolls, pendulum stretch, cross body arm stretch and towel stretch (10 reps x 1 set) were actively performed by the patient with-in limits of pain Moderate physical activity on treadmill, brisk walk was performed 5 days a week for 30 minutes at 4 mph speed (3-6 METs) with warm up for a 5 minutes at low speed and then at the end speed was also decreased for a 5 minutes; Hot pack and TENS for 10 minutes at the affected shoulder. Passive shoulder mobilizations were performed initially at pain free range in anterior, posterior, and inferior direction (10 reps x 1 set).
Shoulder rolls, pendulum stretch, cross body arm stretch and towel stretch (10 reps x 1 set) were actively performed by the patient with-in limits of pain
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups with randomization. Assignment; treadmill walking
Masking: Single (Participant)
Primary purpose: Other
Molecular Subtyping for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer Resectable
MeSH terms: Adenocarcinoma
Study type: Observational

Summary: 
      Pancreatic adenocarcinoma (PAAD) patients following surgeries are prone to relapse shortly,
      while it is not well understood by current biomarkers. Given the potential associations of
      human leukocyte antigen class I (HLA-I) genotype with oncogenic mutational profile and
      immunotherapy efficacy, we aimed to assess whether differential HLA-I genotype could predict
      the postoperative outcomes in resected PAAD patients.
    


Intervention name(s): Multigene panel for next-generation sequencing
Intervention type(s): Device
Intervention description(s): HLA-I genotyping based on next-generation sequencing for prognosis evaluation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Radically resected patients with pancreatic adenocarcinoma
      
Biospecimen description: 
      Matched blood cells and tumor tissues
    
Keywords: human leukocyte antigen class I; supertypes; recurrence
Effect of PUR003 on Asthma
Condition: Asthma; Lung Diseases; Bronchial Diseases
MeSH terms: Asthma; Lung Diseases; Bronchial Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.

      Study objectives are to :

        1. to evaluate the safety of PUR003 in subjects with asthma, and

        2. to evaluate the efficacy of PUR003 in assisting the treatment of asthma.
    


Intervention name(s): PUR003; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PUR003 for inhalation; Normal saline for inhalation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; bronchial diseases; lung diseases; bronchitis; respiratory tract diseases
A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to evaluate the efficacy and tolerability of the
      phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of
      subjects with erectile dysfunction of different aetiologies and severity, who have not been
      previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity; Matching Placebo
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; PDE5 inhibitors
Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
Condition: Acquired Aplastic Anaemia
MeSH terms: Anemia; Anemia, Aplastic
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG,
      Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired
      severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who
      are transfusion dependent. To compare the response rate of the combination of rabbit ATG
      (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of
      matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®)
      and CSA; obtained from the EBMT database (comparative study).
    


Intervention name(s): Rabbit ATG, Thymoglobuline (Genzyme)
Intervention type(s): Drug
Intervention description(s): Rabbit ATG, Thymoglobuline® (Genzyme) 1.5 vials/10kg (3.75mg/kg) daily for 5 days given as an intravenous infusion over 12-18 hours.
Ciclosporin (CSA) 5mg/kg/day orally from day +1 for a minimum of 6 months
Intervention MeSH terms: Thymoglobulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN)
Condition: Secondary Prevention; Stroke; Ischemic Heart Disease; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      To investigate the risk of major bleeding (including gastrointestinal and intracranial
      bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical
      practice
    

Detailed description: 
      These will be based on population-based cohorts using data from a primary care database in
      the UK: The Health Improvement Network (THIN) and will serve to make a clinically meaningful
      benefit-risk assessment regarding major bleeding consequences of ASA exposure in general
      population.
    

Intervention name(s): Acetylsalicylic Acid (Aspirin, BAYE4465); Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs
Intervention type(s): Drug; Drug
Intervention description(s): Low-dose ASA for secondary prevention of cardiovascular events; Secondary prevention of cardiovascular events
Intervention MeSH terms: Aspirin; Anticoagulants; Clopidogrel
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        THIN is a computerized medical research database that contains systematically recorded data
        on more than 3 million UK primary care patients. It is representative of this population
        with regard to age, sex, and geographic distribution, and has been validated for use in
        pharmacoepidemiological and epidemiological research in multiple studies 13. Participating
        Primary Care Physicians (PCPs) record prospectively data as part of their routine patient
        care, including demographics and life style factors (e.g. alcohol use, body mass index
        (BMI) and smoking status), consultation rates, referrals, hospital admissions, laboratory
        test results, diagnoses, prescriptions ordered by the PCPs, and a free text section, and
        send their data anonymously to THIN for use in research projects.
      
Keywords: Low-dose Acetylsalicylic Acid,; Bleeding,; The Health Improvement Network (THIN),; Cardiovascular; Secondary prevention of cardiovascular events
Stress and Medication Effects on Cocaine Cue Reactivity
Condition: Cocaine Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Stressful situations and cues associated with cocaine can lead to craving in cocaine
      dependent individuals. The purpose of this study is to determine whether guanfacine or
      modafinil are effective in reducing stress and cue induced craving in cocaine dependent
      individuals.
    

Detailed description: 
      Stress and cocaine cues produce craving and ultimately relapse in cocaine dependent
      individuals. This is a randomized, double-blind, placebo-controlled study evaluating the
      effects of either guanfacine (Tenex) or modafinil (Provigil) on stress and cue induced
      craving in cocaine dependent individuals. Cocaine dependence will be assessed in adults (ages
      18-65) as defined by DSM-IV criteria. If the subject signs the consent form, meets the study
      criteria and does not meet the exclusion criteria they will be included in the study.
      Subjects will report to the General Clinical Research Center (GCRC) at the Medical University
      of South Carolina (MUSC), for an outpatient visit and will receive their first dose of study
      medication. The following day subjects will return to the GCRC and admitted for the duration
      of the study (two days and one night). There will be a one-week and a one-month follow-up
      visit. Subjects will be randomly assigned to one of two treatment groups (guanfacine or
      placebo). Each subject will also be randomly assigned to either a stress or no-stress
      subgroup. On the test day (day 3) subjects in the stress group will be asked to perform a
      speech and a math problem in front of an audience (Trier Social Stress Test, TSST), while the
      no-stress group will be asked to sit quietly and read. Following these tasks, each subject
      will be exposed to neutral (control) cues and immediately afterwards the subjects will be
      exposed to cocaine cues (cocaine paraphernalia). Craving/mood, physiological activity, and
      endocrine responses, will be assessed at pre-set intervals throughout the testing procedure.
      The cue reactivity protocol will be repeated on the one-week follow-up visit.
    

Intervention name(s): Guanfacine; Modafinil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Guanfacine; Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Cocaine Addiction; Cocaine Dependence
The Effect of rhDNase on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether rhDNase treatment improves ventilation inhomogeneity as
      assessed by lung clearance index (LCI) in patients with cystic fibrosis (CF).
    

Detailed description: 
      Life expectancy in CF patients has greatly increased due to improved clinical care. While
      this is certainly beneficial to CF patients, it has made it more difficult to assess the
      effect of therapeutic interventions. Currently, FEV1 remains the primary outcome parameter
      for most clinical trials, but many CF patients have normal pulmonary function and the annual
      rate of decline is now less than 2 %. Therefore, additional parameters are needed that are
      more sensitive to define abnormalities in CF patients and that can be used in therapeutic
      trials.

      Gas mixing techniques have been shown to be sensitive parameters to define abnormalities in
      patients with cystic fibrosis, but it is unclear how useful this technique is to detect
      changes after a therapeutic intervention. Abnormalities in gas clearance from the lung are
      largely due to retention of inhaled gases due to mucous obstruction in the lower airways and
      can be assessed with the lung clearance index (LCI). Interventions that improve mucous
      accumulation are expected to improve lung clearance as assessed by this technique. RhDNase
      has been demonstrated to improve lung function and reduce pulmonary exacerbations in patients
      with cystic fibrosis due to improved mucus clearance.

      Lung clearance index (LCI) has been shown to be more sensitive than spirometry in detecting
      abnormalities in CF patients. Clear cut-offs have been found which can differentiate normal
      patients from even newly diagnosed CF patients. However, little is known about how LCI may
      change with treatment.
    

Intervention name(s): rhDNAse; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 2.5 mg rhDNase will be dispensed in 2.5 ml vials and administered once a day for 28 days. Treatment will be administered by inhalation.; 2.5 mg of the placebo will be dispensed in 2.5 ml vials and administered once a day over 28 days. Treatment will be administered by inhalation.
Other intervention name(s): Brand Name: Pulmozyme
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Cystic Fibrosis; Lung Clearance Index; rhDNAse
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Immunologic Deficiency Syndromes; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the safety and immunogenicity of the Dengue vaccine in a
      population of special interest, such as HIV-positive adults previously exposed to dengue.

      Primary Objective:

        -  To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults
           previously exposed to dengue.

      Secondary Objectives:

        -  To describe the humoral immune response to each dengue serotype at baseline and after
           each injection of CYD dengue vaccine in HIV-positive adults previously exposed to
           dengue.

        -  To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously
           exposed to dengue.

        -  To describe changes in CD4 count and HIV RNA viral load after each injection of CYD
           dengue vaccine in HIV-positive adults previously exposed to dengue.

      Observational Objective:

        -  To describe the FV (YF, Dengue, Zika) serological status in the study population at
           baseline.
    

Detailed description: 
      Eligible subjects will be randomized in a 2:1 ratio into 1 of 2 groups to receive 3
      injections of either CYD dengue vaccine or placebo at 0, 6, and 12 months. The enrollment of
      subjects will be carried out in two steps, including an early safety data review before the
      second step. The duration of each subject's participation in the study will be approximately
      18 months.
    

Intervention name(s): CYD Dengue Vaccine; Placebo (NaCl 0.9%) vaccine group
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively; 0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; Human Immunodeficiency Virus; CYD Dengue Vaccine
Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      Hypotheses:

        1. Preschool children with autism spectrum disorders (ASDs) who undergo ABA treatment only
           will demonstrate significantly better outcomes compared to an age and severity matched
           control group without ABA treatment.

        2. Preschool children with ASDs who undergo ABA in combination with risperidone will
           demonstrate significantly better outcomes compared to age and severity matched children
           who are receiving ABA alone.

        3. Young age, cognitive development and attentional abilities at baseline will be
           predictive of good socio-emotional and neuropsychological outcomes after ABA treatment.

        4. At baseline, children with ASDs will show significantly lower performances on measures
           of cognitive, neuropsychological, and socio-emotional functioning than age-matched
           typically developing controls.
    


Intervention name(s): Risperidone; ABA
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Autism, Applied Behavioral Analysis, Risperidone
Safety Study of Two Oral Formulations of MGCD265 Administered in Healthy Subjects in the Fasting State
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study two MGCD265 oral formulations at dose level of 100 mg are administered to
      healthy male and female subjects under fasting conditions.
    

Detailed description: 
      The objective of this study is to compare the rate and extent of absorption of two MGCD265
      oral formulations at a dose level of 100 mg administered to healthy male and female subjects
      under fasting conditions.
    

Intervention name(s): MGCD265
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: c-Met; VEGFR; Ron; Cancer; Tumor; Safety; Phase 1
Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the
      GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy
      elderly population aged 18-45 years of age.
    

Detailed description: 
      The safety profile of the PhtD vaccine will be assessed in comparison to a comparator vaccine
      (Pneumovax 23TM). In order to further increase the immune response to vaccination, a novel
      adjuvant system will also be examined.
    

Intervention name(s): PhtD vaccine with/without adjuvant; Pneumovax 23TM; NaCl
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.; One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.; One dose administered intramuscularly in the deltoid region of the right arm at month 2.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Safety; Pneumococcal Infections; Immunogenicity; PhtD vaccine; Healthy adults; Reactogenicity
Prevention of Reduced Employability With an Expert System With Telephone, Motivational Interviews Supporting Self-management
Condition: Employability
Study type: Observational

Summary: 
      The purpose of the study is to determine which factors on a personal, social and contextual
      level will help rehabilitation patients on returning to or continuing to work as well as to
      stay employable.
    

Detailed description: 
      For most people work is an integral part of their life which not only secures their life
      standards, but also forms the basis for social participation and personal growth. If
      someone's workability is limited as a result of health problems, medical rehabilitation can
      often help to regain strength and capabilities, and to continue to work in a productive way
      and remain healthy. In cooperation with the Deutsche Rentenversicherung Oldenburg-Bremen
      health psychologists at Jacobs University Bremen are investigating what contributes to the
      success of such medical rehabilitation treatments.

      The focus is to understand which measures are helping people during and subsequently to their
      treatment in the clinic.Therefore voluntary participants will be asked to fill out a
      questionnaire when arriving at the rehabilitation facility and will subsequently invited to
      participate in two motivational telephone interviews after six and 12 months. Personal,
      social and contextual factors, measures and offers, as well as goals, plans and behaviors,
      will be taken into consideration to evaluate the effectiveness of medical rehabilitation on
      returning to or continuing to work.
    

Intervention name(s): medical rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Participants who will take part in the study are asked to fill out a questionnaire when arriving at the rehabilitation clinic and will be invited to participate in two motivational telephone interviews after six and 12 months.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In the study insurants of the Deutsche Rentenversicherung Oldenburg-Bremen with a granted
        medical rehabilitation treatment will be asked to fill out a questionnaire when arriving at
        the rehabilitation clinic as well as to take part in two subsequent telephone interviews
        after 6 and 12 months.
      
Keywords: Return to work, state of subjective health, medical rehabilitation, motivational interviewing