bioihbjkbjnl/mcl2 huggingface dataset:
Buzzy® Application in Pain
Condition: Healthy
Study type: Interventional

Summary: 
      The research was conducted as a randomized controlled experiment to investigate the effect of
      Buzzy® on pain level during the measles-rubella-mumps (MMR) vaccine injection in 12-month-old
      infants. This study was done with infants meeting the sampling criteria (buzzy group: 30,
      control group: 30) on November 2018-May 2019 in Istanbul Bakirkoy 9 Family Health Center.
    

Detailed description: 
      To determine the effect of Buzzy® application on pain, which is a combination of cold and
      vibration, during measles-rubella-mumps (MMR) vaccine injection administration on
      12-month-old infants. The study is a randomized contrlled experimental research. The research
      sample is composed of 60 infants (buzzy:30, control:30) who are 12-month-old injected MMR
      vaccine at Bakırköy No. 9 Family Health Center between November 2018-May 2019. As a data
      collection tool Data Collection Form, FLACC Pain Scale and Buzzy® device have been used.
      While Buzzy® was applied on infants in the trial group before, during and after the vaccine
      injection, the infants in the control group were applied routine vaccine injection. The pain
      response of the infants was evaluated by the nurse and the parent before, during and after
      the vaccine injection and the physiological parameters were evaluated by the nurse before and
      after the vaccine injection.
    

Intervention name(s): Buzzy
Intervention type(s): Device
Intervention description(s): Buzzy ® device (Buzzy ® Mini Healthcare) has been used to reduce pain by using local cold application and vibration effect. Buzzy ® was developed by Dr. Amy Baxter in 2009. The size of the Buzzy ® device measures 2⅞ꞌꞌ x 1⅞ꞌꞌ x ⅞ꞌꞌ (7,2 cm x 4,8 cm x 2,2 cm). It is a bee-shaped device made of hard plastic with a vibrating motor (2 settings - fixed and pulsed), powered by a 2AAA battery. There are 4 ice packages and elastic fastening strap. On the part where the device touches the skin, there is an ice package in the shape of a wing. When the button on the device is pressed, it vibrates.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pain; Vaccination; Baby; Buzzy; Pediatric nurse
Effects of Inspiratory Muscle Training in Elders
Condition: Muscular Atrophy; Sensitivity Training Groups; Aging
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      Aging causes anatomical and physiological changes in the respiratory system and respiratory
      muscle strength with decline in its maximum function. This study aimed to evaluate the
      effects of inspiratory muscle training on respiratory muscle strength, thickness of the
      diaphragm and diaphragmatic mobility in older women. The investigators' hypothesis is that
      inspiratory muscle training improves respiratory muscle strength, the thickness of the
      diaphragm and diaphragmatic mobility in older women.
    


Intervention name(s): Inspiratory muscle training; Training sham
Intervention type(s): Other; Other
Intervention description(s): Conducting fake training with the aim of blind the control group
Other intervention name(s): respiratory muscle training
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Breathing exercises; Aged
Mesalazine Oral Suspension in Active Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis
    

Detailed description: 
      This is an open-label, monocentric exploratory phase IIa pilot study, which serves to
      evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension
      for the treatment of active eosinophilic esophagitis (EoE).
    

Intervention name(s): Mesalamine Oral Product
Intervention type(s): Drug
Intervention description(s): Mesalamine oral suspension for oral use
Other intervention name(s): 5-ASA
Intervention MeSH terms: Mesalamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal dysfunction, esophageal inflammation
Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Atrophy
Study type: Observational

Summary: 
      Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing
      the progression of whole brain atrophy. Whole brain atrophy rates will be measured through
      magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis
      (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy
      controls. The primary outcome will be whole brain atrophy rate measured as the percent change
      in brain volume (PBVC) over a two-year period.

      Primary hypothesis:

      The investigators hypothesize that long term (>2 years) NTZ therapy will slow the rate of
      whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change
      in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a
      true "disease activity free" state).
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Relapsing Multiple Sclerosis and Healthy Controls
Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging.
Condition: Aging
Study type: Interventional

Summary: 
      To assess the impact of lifestylel changes upon measures of wellness and aging, in particular
      weight change, fitness measures, and cognitive performance. The hypothesis was that aerobic
      exercise would improve mental performance and measures of fitness.
    

Detailed description: 
      A 10-week, randomized control study conducted in a wellness center in St. Petersburg,
      Florida. Adults age 21-65, exercising less than 3 days/week. 56 subjects were randomized to a
      control or an intervention group. Subjects followed a diet with >30 grams of fiber and <16
      grams of saturated fat daily, and were taught to reach 70-85% of their maximum heart rate 5-6
      days/week, and to perform strength training 3 days/week, plus were asked to participate in
      10-20 minutes of stress management activities daily. The study was designed to determine body
      composition, maximal aerobic capacity (VO2 max), total cholesterol/high-density lipoprotein
      (TC/HDL), and cognition.

      Specific aspects ofcognitive performance were noted to increase with increasing levels of
      aerobic activity, but not with strength training, dietary fiber change, or stress managment.

      Having established that the treatment group would exercise at different levels of intensity,
      additional subjects were recruited, and the cognitive performance of no exercise, moderate
      aerobic exercise, and frequent aerobic exercise could be compared with specific domains of
      cognitive performance: memory, psychomotor speed, reaction time, attention, and cognitive
      flexibility. The St Anthony's Institutional Review Board approved this research project.
    

Intervention name(s): Aerobic exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Aging; Wellness; Aerobic exercise; Prevention
Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)
Condition: Fibromyalgia (FM); Chronic Fatigue Syndrome (CFS)
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      Fibromyalgia (FM)and Chronic Fatigue Syndrome (CFS) are complex diseases often presenting
      overlapping symptomatology. Manual therapy (MT) protocols report benefits for pain treatment
      of FM, but the underlying mechanisms for patient improvement remain unknown.

      The main goal of this study is to assess the molecular changes associating to mechanical and
      additional MT triggers, possibly involved in patient symptom improvement.
    

Detailed description: 
      Patients with Fibromyalgia as primary diagnosis assessed by the 1990 & 2010 ACR (American
      College of Rheumatology) criteria, presenting or not comorbid CFS, according to the Canadian
      and International CFS criteria, age 40-75 and BMI<35 (N=40), will be subjected to
      physiotherapy treatment consisting on 8 sessions of manual therapy (twice weekly) of 25
      minutes including pressure maneuvers of about 4,5 N by a single operator (Collegiate
      Physiotherapist). Blood samples (10-20mls/participant) will be obtained before and after
      first treatment, and after fourth and last treatment to determine molecular blood changes
      associated to the physiotherapy protocol applied. PBMC (Peripheral Blood Molecular Cells)
      transcriptome before and after treatments (RNAseq) will be studied towards identifying
      treatment-associated differential expression, mechanomiR profiles included. Patient health
      status with treatment will be monitored by FIQ, MFI and SF-36 questionnaires, in addition to
      an anonymized satisfaction questionnaire to register potential undesired secondary effects.
    

Intervention name(s): Manual Therapy
Intervention type(s): Procedure
Intervention description(s): 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N
Other intervention name(s): Physiotherapy treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Manual Therapy; Physiotherapy; Fibromyalgia (FM); Chronic Fatigue Syndrome (CFS); RNAseq; microRNA; mechanomiR
A Phase 4 Post-marketing Study of Intramuscular Injections of BLB-750 in Healthy Adult Subjects
Condition: Pandemic Influenza Prevention
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of two intramuscular
      vaccinations with BLB-750 in healthy Japanese adults.
    

Detailed description: 
      The drug being tested in this study is called BLB-750 that is a vaccine for pandemic
      influenza infection. This study will evaluate immunogenicity and safety of two intramuscular
      vaccinations with BLB-750 at 3-week intervals in healthy Japanese adults. The study will
      enroll 55 participants. BLB-750 will be administered in opened manner:

      - Two intramuscular vaccinations of BLB-750 at 3-week intervals, 0.5 mL

      This trial will be conducted in Japan. The overall time to participate in this study will be
      43 days, starting on the day of first vaccination. Participants will make multiple visits to
      the clinic, including 21 days after the first vaccination and 21 days after the second
      vaccination.
    

Intervention name(s): BLB-750 Vaccine (Qinghai RG strain)
Intervention type(s): Biological
Intervention description(s): BLB-750 Injection
Other intervention name(s): Cell-Culture Influenza Vaccine H5N1 "Takeda"
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study on the Pharmacokinetic Effect of Itraconazole on SHR0302 Tablets in Healthy Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of oral itraconazole on the pharmacokinetics of SHR0302 in healthy
      subjects.

      To evaluate the safety and tolerability of oral SHR0302 and itraconazole monotherapy and
      combination use in healthy subjects.
    


Intervention name(s): itraconazole、 SHR0302 tablets
Intervention type(s): Drug
Intervention description(s): Itraconazole 7 times and SHR0302 tablets twice. On the 8th day of this, itraconazole and SHR0302 tablets were taken simultaneously.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Intervention model description: itraconazole and SHR0302 tablets are used in combination
Masking: None (Open Label)
Primary purpose: Basic Science
Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
Condition: Inguinal Hernia; Hernia
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not
      been studied. In this multicenter trial the patients are allocated to surgery using TEP
      (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively
      up to one month. Immediate and late complications are also analyzed.
    

Detailed description: 
      Patient characteristics are recorded before surgery. The adult patients with inguinal hernia
      are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open
      Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times
      using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical
      complications and use of pain killers are carefully recorded. Clinical examination is
      performed if necessary.
    

Intervention name(s): Tep surgery for inguinal hernia; Lichtenstein
Intervention type(s): Procedure; Procedure
Intervention description(s): TEP surgery; Lichtenstein surgery for inguinal hernia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus combination
      chemotherapy in treating patients with limited-stage small cell lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of thoracic radiation using an
      accelerated boost with concurrent chemotherapy in patients with small cell lung cancer. II.
      Evaluate the response rate and overall survival in these patients. III. Reduce the toxic
      effects of treatment to esophagus and lungs.

      OUTLINE: This is a radiation dose escalation study. Patients are sequentially accrued to one
      of four radiation dose levels. Dose level 1: Patients receive radiotherapy 5 days a week for
      4 weeks followed by radiation boost given daily for 2 days, then twice daily for 3 days
      during week 5. (Closed to accrual 6/98) Dose level 2: Patients receive radiotherapy 5 days a
      week for 4 weeks followed by radiation boost given twice daily for 5 days during week 5.
      (Closed to accrual 9/24/99) Dose level 3: Patients receive radiotherapy 5 days a week for 18
      days followed by radiation boost given in the evenings on days 19 and 20, then twice daily
      for 5 days during week 5. (Closed to accrual 5/5/00) Dose level 4: Patients receive
      radiotherapy 5 days a week for 16 days followed by radiation boost given in the evenings on
      days 17-20, then twice daily for 5 days during week 5. The fifth dose level is the same as
      the first dose level. (Closed to accrual 3/19/99) Cohorts of 5 patients are entered at each
      radiation dose level. If one patient experiences nonhematologic dose limiting toxicity (DLT),
      5 additional patients are treated at that level. If no further DLT occurs, escalation to the
      next arm proceeds. Patients receive cisplatin IV plus etoposide IV on day 1 of radiotherapy
      and oral etoposide on days 2 and 3 every 3 weeks for 4 courses. Patients are followed every 3
      months for 1 year, every 6 months for 2 years and then annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10
      months.
    

Intervention name(s): cisplatin; etoposide; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Etoposide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: limited stage small cell lung cancer
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Condition: HIV Infections; Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is
      effective in reducing fatigue in adults with HIV/AIDS.
    

Detailed description: 
      Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities
      and serving as a significant barrier to working among those whose health is otherwise stable
      or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability
      and diminished quality of life. It may be caused by ARVs or by the virus itself. A related
      study tested whether modafinil, of which armodafinil is an r-isomer, could reduce fatigue in
      HIV/AIDS patients. Armodafinil, believed to have a longer duration and greater effect than
      modafinil, will be tested on the same criteria.

      Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4
      weeks. Participants randomized to active medication and who show improvements in symptoms
      will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16
      weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks.
      For these participants, the study duration is 20 weeks. Participants who did not benefit from
      armodafinil will receive alternate treatment options. All participants will have weekly study
      visits for the first 4 weeks of the study and biweekly visits for the remainder of the study.
      At each visit, participants will complete various tasks to determine cognitive function, and
      self-report scales will be used to determine symptoms of depression and fatigue. After
      completion of 16 weeks, participants responding to armodafinil will be transitioned to the
      publicly available modafinil over the course of 2 weeks.
    

Intervention name(s): Armodafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.; Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy
Other intervention name(s): Nuvigil; Sugar pill
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; AIDS; Armodafinil; Depression
Permeability Enhancement to Reduce Chronic Inflammation
Condition: End Stage Renal Disease; Inflammation
MeSH terms: Kidney Failure, Chronic; Inflammation
Study type: Interventional

Summary: 
      Chronic dialysis patients with end stage renal disease have an increased mortality rate as
      compared to the age matched healthy population. It is known that chronic inflammation
      contributes to the high incidence of cardiovascular events in chronic dialysis patients.
      Dialyzers made by membranes with increased pore size (high cut-off Dialyzer HCO1100) may be
      beneficial in the elimination of inflammatory mediators and may improve the inflammatory
      status. Hypothesis: In this study it will be investigated whether the treatment with HCO1100
      will improve the inflammatory status of chronic dialysis patients.
    


Intervention name(s): HCO1100; P210H
Intervention type(s): Device; Device
Intervention description(s): Dialysis; Dialysis
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammation; dialysis
Study of REGN3500 and Dupilumab in Patients With Asthma
Condition: Asthma, Allergic
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with
      placebo, on changes in inflammatory gene expression signatures in sputum induced after a
      bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after
      treatment initiation compared with those at screening.
    


Intervention name(s): REGN3500; Dupilumab; Placebo; Fluticasone propionate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous (IV) use; Subcutaneous (SC) use; Matching placebo; Inhalation use
Other intervention name(s): Dupixent
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Accelerating Post-exercise Muscle Glycogen Resynthesis in Humans: Impact of Combined Nutrient Intake and Intermittent Pneumatic Compression or Heat Therapy
Condition: Muscle Recovery; Muscle Soreness; Glycogen Depletion
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      To determine if modalities designed to improve blood flow combined with post-exercise
      nutrient intake will improve replenishment of muscle glycogen better than nutrient intake
      alone. A secondary objective is to compare the effectiveness of heat therapy and intermittent
      pneumatic compression on glycogen replenishment.
    


Intervention name(s): Compression sleeve; Heat therapy; Glycogen-depleting exercise session; Nutrient Intake (beverage); Skeletal muscle biopsy
Intervention type(s): Device; Device; Other; Other; Procedure
Intervention description(s): From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour; Custom leg garment with one leg heated by circulating hot water approx 40 degrees C, the other leg approx 32 degrees C (thermoneutral) for 1 hour; Prolonged intermittent high intensity running (LIST protocol); Post-exercise, all participants will receive a beverage containing 1.0 g/kg carbohydrate and 0.3 g/kg protein from the mixture of Gatorade Recover Protein Shake and Gatorade Thirst Quencher; Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique
Other intervention name(s): IPC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: muscle glycogen; glycogen replenishment; muscle recovery; intermittent pneumatic compression; IPC; heat therapy