bioihbjkbjnl/mcl2 huggingface dataset:
Measuring Fear of Physical Activity in Patients With Heart Failure
Condition: Chronic Heart Failure; Fear of Physical Activity
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The study's aims are twofold: First, to examine physiological correlates of fear of physical
      activity (PA) and second, to examine correlates between fear of PA and interoceptive
      abilities in patients with chronic heart failure and healthy persons. Patients' fear of PA
      will be assessed via the "Fear of Activity in Situations - Heart Failure" (FActS-HF)
      questionnaire. The patient group will be split into two subgroups: One with high fear of PA
      and the second with low fear of PA based on FActS-HF scores. Fear of PA will be assessed via
      an adapted version of FActS-HF in a sample of healthy persons (control group). Each member of
      the high-fear-of-PA group will be individually age- and sex-matched with one member of the
      low-fear-of-PA group and control group. The participants of all three groups undergo the same
      experimental trials.

      Aim 1: The "startle paradigm" will be used to investigate the physiological component of fear
      of PA. The startle paradigm is based on empirical observations that the startle reflex is
      larger after the priming with unpleasant stimuli and inhibited after the priming with
      pleasant stimuli. The participants will be primed with various words including those words
      associated with physical activity that are expected to be unpleasant in patients with high
      fear of PA. The startle reflex will be triggered by air puffs on the eyes (startle probes)
      and measured via facial electromyography (EMG). We assume that startle responses primed with
      PA related words are stronger in patients with high fear of PA compared to the other groups.

      Aim 2: Interoceptive accuracy will be assessed via the "Schandry test" and interoceptive
      awareness will be assessed via the "Multidimensional Assessment of Interoceptive Awareness"
      (MAIA) questionnaire. During the Schandry test the participants will be instructed to
      subjectively count their heart rate without any aid or tools. The heart rate will be
      objectively measured at the same time via ECG. A high congruence of the objective and
      subjective results indicates a high interoception ability, and is assumed to be correlated
      with fear of physical activity. Additionally, we expect the MAIA and FActS scores to be
      correlated.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of adult patients with diagnosed chronic heart failure of
        all underlying diagnoses. Patients have to be outpatients at time of study participation.
        They will be recruited in primary care clinics, and heart failure outpatient clinics in
        Germany. For the control group healthy volunteers without a chronic heart failure are
        recruited.
Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
      Combining thalidomide with chemotherapy may kill more tumor cells and be an effective
      treatment for stage IIIB or stage IV non-small cell lung cancer.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
      thalidomide in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate and duration of response in patients with stage IIIB or IV
           non-small cell lung cancer treated with carboplatin, irinotecan, and thalidomide.

        -  Determine the progression-free and overall survival of patients treated with this
           regimen.

        -  Evaluate the toxicity profile of this regimen in these patients.

      OUTLINE: Patients receive carboplatin IV over 30 minutes on day 1 and irinotecan IV over 90
      minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression
      or unacceptable toxicity. Patients with stable or responsive disease receive up to 6 courses
      of therapy. Patients also receive oral thalidomide once daily beginning on day 1 and
      continuing until disease progression.

      Patients are followed every 3 months until disease progression and then every 6 months
      thereafter.

      PROJECTED ACCRUAL: A total of 39-70 patients will be accrued for this study within 14 months.
    

Intervention name(s): carboplatin; irinotecan hydrochloride; thalidomide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Thalidomide; Carboplatin; Irinotecan
Primary purpose: Treatment
Keywords: squamous cell lung cancer; large cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer
Effects of Enriched Gardens in Nursing Home Residents With Dementia
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional

Summary: 
      Comparing the effect of the frequentation of an enriched garden vs sensory conventional
      garden by nursing home residents with Alzheimer disease. The effects will be evaluated as
      regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal
      stance and UpandGo Test)
    

Detailed description: 
      The cluster controlled trial is conducted over a six months period after recruitment of
      residents from 4 different nursing homes in France. The participants are distributed into 3
      groups. One group does not receive incentive from carers to visit any garden, the second
      group receives incentives to visit regularly a conventional sensory garden and the third
      group receive incentives from carers to visit regularly an enriched garden. The study is
      conducted over a period of 6 months. All participants are giving consent to the study. They
      will be evaluated before and after over 4 different tests. MMSE (Mini Mental Status
      Examination) for cognitive impairment, ADL (Activity for day Living) for functional autonomy,
      TUG (Test up and Go) and Unipodal Stance for prevention of falls.
    

Intervention name(s): INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN
Intervention type(s): Other
Intervention description(s): Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Alzheimer; Enriched garden; Enriched environment; Dementia; Cognitive impairment; Functional autonomy
Endoscopic Harvesting in Coronary Artery Bypass Grafting.
Condition: Coronary Bypass Stenosis; Graft Infection
Study type: Interventional

Summary: 
      This is a retrospective data collection looking at patients who received either an endoscopic
      vessel harvesting procedure versus the conventional open procedure. Besides looking at cost
      variables in the 2 groups, other outcomes of interest include length of hospital stay, rates
      of infection, medication use, re-admissions and compilations.
    

Detailed description: 
      Since April 2018, the study database has been updated with all patients (currently there are
      340 patients per group) and variables - both reflecting effectiveness of the procedure and
      cost. Preoperative variables being captured include comorbidity factors and variables
      relating to the Society of Thoracic Surgery (STS) score , which is a pre-procedure assessment
      of surgical risk.

      The postoperative data collection includes a variety of complications and comorbidities the
      patient could experience during their hospital stay. These variables will provide us with
      information regarding procedure effectiveness, patient recovery and further costs associated
      with the procedure. Medications and antibiotics provided during the stay are also being
      captured. Total hospital costs will include any costs associated with ward stay, separated
      per level of care: Intensive Care Unit (ICU), Cardiac Surgical Unit (CSU), and regular ward.

      The two follow up periods are 30 days and 6 months. Both look at the same effectiveness
      variables, any emergency room (ER) visits, re-admissions, and their respective reasons.
      Quality of life will be obtained by looking at the number of complications the patient
      experienced during these periods. The frequency of home care services provided to each
      patient, if any, are also being tracked. Cost calculations will be done by obtaining the
      time, length and number of visits to the ER, re-admissions and clinic visits.
    

Intervention name(s): Medtronic endoscope
Intervention type(s): Device
Intervention description(s): The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
Condition: Tibial Fractures
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Interventional

Summary: 
      Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern.
      Children have thickened periosteum compared with adults, which therefore may impart stability
      to the fracture without the need for additional immobilization. The goal of the study is to
      evaluate whether or not there is a difference in children treated with and without cast
      immobilization in regards to time to ambulation; perceived pain; difficulty in dressing &
      bathing; radiographic displacement or angulation; and time missed from work or daycare. Our
      null hypothesis is that there will be no difference in clinical or radiographic outcomes
      between the groups.
    


Intervention name(s): Short leg cast; No Immobilization
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: toddler's fracture; tibial fracture; children
Study of Wound Packing After Superficial Skin Abscess Drainage
Condition: Abscess; Skin Diseases, Infectious; Boils; Furuncle; Carbuncle; Folliculitis; Cellulitis; Wounds
MeSH terms: Communicable Diseases; Infections; Abscess; Cellulitis; Skin Diseases, Infectious; Carbuncle; Skin Diseases; Folliculitis; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Superficial skin and soft tissue abscess are frequently managed by opening them up with a
      procedure called "incision and drainage". It is routine practice in the United States to
      place packing material inside the abscess cavity after opening them up, in order to promote
      better wound healing and limit abscess recurrence. However, this practice has never been
      systematically studied or proven to decrease complications or improve healing. Patients with
      wound packing usually return to the emergency room or practice setting for multiple "wound
      checks" and dressing/packing changes which lead to missed days from work or school and
      utilization of healthcare resources. This procedure can often be painful and may even require
      conscious sedation (and the risks entailed) especially in children. With rates of superficial
      skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it
      is important to determine whether packing wounds is necessary or even advantageous to
      patients.

      This study is the first to systematically evaluate the efficacy of wound packing after
      superficial skin or soft tissue abscess incision and drainage in children. The investigators
      will be evaluating wound healing, complications, recurrence and pain associated with packing
      both short and long term. In addition, the investigators will also be evaluating the utility
      of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess
      cavity. This test may be useful to determine whether incision and drainage is necessary for
      an individual who has a skin infection that is suspicious for an abscess.
    


Intervention name(s): Wound packing; NoPacking
Intervention type(s): Procedure; Procedure
Intervention description(s): 1/4" non-iodoform packing loosely placed inside abscess cavity.; This is a routine incision and drainage procedure but without the use of packing. Sterile gauze dressing will be placed over the abscess cavity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized; clinical trial; ultrasound; prospective; abscess; packing; incision and drainage; superficial soft tissue infection
Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention
Condition: Emergence Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with
      physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery
      under general anesthesia using Sevoflurane inhalation agents, in investigator institution
      during February-May 2019.. There were 64 children obtained by consecutive sampling, who
      underwent eye surgery in investigator institution during February-May 2019. The subjects then
      grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from
      Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events.
      Data analysis using Chi Square test and Mann-Whitney test.
    

Detailed description: 
      There were 64 children obtained by consecutive sampling, The subjects then grouped into
      dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events,
      recovery time, and post-premedication desaturation events.
    

Intervention name(s): Intranasal dexmedetomidine; Intranasal Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction; subject will receive premedication with intranasal midazolam thirty minutes before induction
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: emergence, delirium, dexmedetomidine, midazolam, pediatric
Effects of Cranberry Extractive on the Lipid Profiles in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Cranberry, containing flavonoids, is effective on improvement of lipid profiles in
      non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid
      profiles in type 2 diabetic patients using oral antidiabetic drugs.
    

Detailed description: 
      Hypercholesterolemia is a notorious risk factor for cardiovascular disease. It had been
      reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein
      (HDL) cholesterol levels in non-diabetic subjects. Although characteristics of diabetic
      dyslipidemia are low HDL and high triglyceride, the benefits of concentrated powder of
      cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet
      control alone. To the best of our knowledge, the effect of cranberry on lipid profiles in
      type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially
      total to HDL cholesterol ratio which is important in predicting cardiovascular diseases in
      Asian and/or diabetic population. Furthermore, cranberry has anti-oxidative effect which is
      associated with reduction of oxidized low-density lipoprotein (ox-LDL) cholesterol in
      non-diabetes. Therefore, we conducted a placebo-controlled, double-blind, randomized study to
      assess the effect of cranberry on lipid profiles in type 2 diabetes.
    

Intervention name(s): cranberry
Intervention type(s): Dietary Supplement
Intervention description(s): cranberry extractive in powder product (by Triarco Industries, Inc. NJ, USA) and encapsulated in dose of 500mg/capsule (by Topo digital tech co., Taiwan). By one capsule after each of three meals per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cranberry; total to HDL cholesterol ratio; type 2 diabetes
Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective
      in treating the behavioral symptoms of Fragile X Syndrome.
    


Intervention name(s): AFQ056; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AFQ056, was provided as hard gelatin capsules, 25mg and 100 mg oral dosage strengths, identical in appearance were used; Placebo medication identical in appearance to active medication was provided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fragile X Syndrome; Martin-Bell Syndrome; Genetic Diseases; X-Linked
Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone
Condition: Pemphigus Vulgaris
MeSH terms: Pemphigus
Study type: Interventional
Phase: Phase 2

Summary: 
      Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease
      with unknown etiology that affects mucosa and skin of patients with significant morbidity and
      mortality.

      The treatment back-bone is based on prednisolone administration. There are controversies on
      the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid
      sparing drugs. For others, they are disease modifying drugs.

      The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in
      new cases of pemphigus vulgaris treated with prednisolone.
    

Detailed description: 
      The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in
      new cases of pemphigus vulgaris treated with prednisolone.

      Official Title: Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Azathioprine
      in New Cases of Pemphigus Vulgaris Receiving Prednisolone

      Randomized Double Blind Controlled Trial of Azathioprine versus Placebo in new cases of
      Pemphigus Vulgaris treated with Prednisolone

      Study Type: Interventional

      Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Controlled,
      Parallel Assignment, Safety/Efficacy Study

      Condition Intervention Phase Pemphigus Vulgaris Drug: Azathioprine Drug: Prednisolone Other:
      Placebo Phase II
    

Intervention name(s): Azathioprine; Prednisone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): It is given in a consistent dosage of 2.5 mg/kg/day throughout the study; Oral corticosteroid initiated at 2 mg/kg/day dosage. Dosage may be tapered primarily by 1/3 total dosage if no new blister, then 5 mg every three days to reach the daily dosage of 30 mg then tapered by 1.25 mg every week to reach daily dosage of 20 mg/day, then tapered by 1.25 mg every two weeks to reach daily dosage of 10 mg, then tapered by 1.25 mg monthly to reach daily dosage of 7.5 mg and continue this dosage for six months then tapered to 5 mg/day if no new lesions are observed as determined by clinical assessment of the investigator.; Placebo given in place of Azathioprine 2.5 mg/kg/day throughout the study
Other intervention name(s): Imuran; Meticorten ®; Deltasone®; Orasone®; Vehicle
Intervention MeSH terms: Prednisone; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pemphigus Vulgaris; Azathioprine; Prednisone
Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults
Condition: Influenza; Orthomyxoviridae Infection; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the
      trivalent inactivated split virion influenza vaccine when administered by intradermal route
      with that of the current pharmaceutical presentation administered by intramuscular route.

      Primary Objective:

      To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated
      split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57
      years.

      Secondary Objective:

      To evaluate the safety profile during the 21-day period following each vaccination in each
      study group
    

Detailed description: 
      This is an open (for the administration route) and double-blind (only for the two dosages
      administered at year 0 by using the investigational administration route) randomized trial
      conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections
      at 1-year interval.
    

Intervention name(s): Inactivated, split-virion influenza vaccine; Inactivated, split-virion influenza vaccine; Inactivated, split-virion influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.1 mL, ID. 1 injection/year for 3 years; 0.1 mL, ID. 1 injection/year for 3 years.; 0.5 mL, IM. 1 injection/year for 3 years
Other intervention name(s): Vaxigrip®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviridae Infection; Inactivated, Split-virion influenza vaccine; Intradermal injection; Adults.