bioihbjkbjnl/mcl2 huggingface dataset:
Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial
Condition: Fatigue; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Fatigue
Study type: Interventional

Summary: 
      Aim: To study if a person-centered physical therapy intervention program contributes to
      diminished fatigue in people with Rheumatoid Arthritis (RA).
    

Detailed description: 
      The effect of person-centered physical therapy on fatigue related variables in peoples with
      Rheumatoid Arthritis- Randomized controlled trial Aim: To study if a person-centered physical
      therapy intervention program contributes to diminished fatigue in people with RA.

      Hypothesis: That the person-centered treatment program diminishes fatigue and its
      consequences on daily life.

      Design: A controlled randomized interventional trial, assessing effectiveness of
      intervention.

      Methods:

      Selection: Seventy persons with diagnosis of RA and fatigue over 50 (0-100) will be recruited
      from the rheumatology clinic at Sahlgrenska University Hospital. Participants are randomized
      to an intervention group or a waiting list control group.

      Intervention: The 12-week intervention period begins with an individual person-centered
      meeting to develop an individualized feasible self-care plan for the participant with extra
      focus on health-enhancing physical activity, stress management (relaxation exercise training
      and modified mindfulness techniques) and balance in daily life. A written consent, aiming to
      increase coherence, is signed. The participants will be asked to keep a journal about their
      strategies and reflections. Follow up meetings and contacts will be planned according to
      personal preferences.

      Procedure: The participants are invited to a clinical examination before and after the
      12-week intervention and at 6-month follow-up, assessing demographic data, disease activity,
      inflammation parameters, physical capacity and questionnaires of health status in RA. Primary
      outcome are questionnaires of single item- and multidimensional fatigue.

      Analysis: Effects of the interventions will be analyzed using non-parametric statistics for
      between-group changes over time. Within-group changes over time will be analyzed for each
      group.

      Expected results. New knowledge of fatigue is of importance for improvement of overall health
      of people with RA, as fatigue influences all aspects of their life, both private life and
      employment, thus decreasing the quality of life.
    

Intervention name(s): Person-centered physical therapy intervention program
Intervention type(s): Behavioral
Intervention description(s): Comparison of person-centered physical therapy and control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fatigue; Rheumatoid Arthritis; Physical Therapy; Person-Centred Care
Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an
      open-label extension (OLE) in adolescents (≥12 to <18 years) with EoE.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an
      open-label extension (OLE) in adolescents (≥12 to <18 years) with EoE that will evaluate the
      efficacy and safety of APT-1011 3 mg administered HS for the induction of response to
      treatment (histologic and symptomatic) over 12 weeks.

      At Week 12, subjects may move into the open-label single arm study of APT-1011 3 mg hora
      somni (HS; at bedtime). All subjects who do not move into the open-label study will return at
      Week 14 for a 2-week off-treatment follow-up.
    

Intervention name(s): APT-1011; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.; Placebo orally disintegrating tablet
Other intervention name(s): fluticasone propionate; PBO
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: APT-1011; Esophagitis; Eosinophilic Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the use of the next generation applicator
      and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives
      include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and
      safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant,
      and to assess participant expectations and satisfaction with the Radiopaque Implant.
    


Intervention name(s): Radiopaque Etonogestrel Implant
Intervention type(s): Drug
Intervention description(s): One implant inserted for a 3-year treatment period
Other intervention name(s): SCH 900415
Intervention MeSH terms: Etonogestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Myocellular Signalling in Skeletal Muscle
Condition: Exercise; Insulin Sensitivity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The study will investigate myocellular signalling in skeletal muscle after
      insulin-stimulation and exercise in healthy young men
    


Intervention name(s): Insulin; Exercise
Intervention type(s): Drug; Other
Intervention description(s): 2 h insulin clamp; Cycling exercise
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Improving the Safety of Oral Immunotherapy for Cow's Milk Allergy
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity
Study type: Interventional

Summary: 
      Allergy to cow's milk is the most common food allergy affecting children. There is currently
      no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted to
      induce desensitisation using small daily doses of cow's milk, predominantly by the oral route
      (oral immunotherapy, OIT). Although this therapy works for some people, its effects are not
      generally long lasting and it is associated with significant side effects during protocol,
      including potentially life-threatening allergic reactions.

      Pilot data suggests that sublingual immunotherapy (SLIT, where allergen is held under the
      tongue, rather than swallowed) can also induce a degree of desensitisation, but with fewer
      adverse events. However, the degree of desensitisation induced appears to be lower than that
      with oral immunotherapy.

      The investigators wish to determine whether a sublingual pretreatment phase can improve the
      safety of conventional OIT in cow's milk allergy.
    


Intervention name(s): SLIT to cow's milk; Low dose OIT; Conventional OIT to cow's milk
Intervention type(s): Other; Other; Other
Intervention description(s): Sublingual immunotherapy; Oral Immunotherapy (low dose); Oral Immunotherapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cow's milk allergy; Desensitisation; Safety
CKD-828 (40/5mg) Pharmacokinetic Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828
      (Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.
    


Intervention name(s): CKD-828; Combination Therapy
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Telmisartan 40mg + S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily; Drug: Telmisartan 40mg Tablet, Oral, Once Daily
Drug: S-amlodipine 5mg Tablet, Oral, Once Daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-828; Hypertension; Primary Hypertension; Healthy Volunteer; S-Amlodipine; Telmisartan; Amlodipine; Pharmacokinetic; Phase 1
Acceptability and Tolerance Study of New Oral Nutritional Supplement
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      -  To evaluate tolerance and acceptability of AYMES ROME in patients requiring
           supplementary oral nutritional support compared with currently available alternatives.

        -  To obtain data to support a submission to Advisory Committee on Borderline Substances
           (ACBS) for AYMES ROME (to allow for prescription in the community at National Health
           Service (NHS) expense).
    

Detailed description: 
      To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary
      oral nutritional support compared with currently available alternatives, measuring outcomes
      of GI effects, Compliance, product preference,convenience etc.

      To obtain data to support an ACBS submissions for AYMES ROME (to allow for prescription in
      the community at NHS expense).
    

Intervention name(s): AYMES ROME
Intervention type(s): Dietary Supplement
Intervention description(s): AYMES Rome is a powder, designed to be mixed with 250 ml water to make up a juice style ONS. When made up AYMES Rome provides 300 kcal (1 kcal / ml) and 10.7 g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old
Condition: Tetanus; Diphtheria; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to generate additional safety and immunogenicity data to support the
      registration of the product in Japan.

      Primary objectives:

        -  To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of
           diphtheria and tetanus booster response rate (proportion of subjects with booster
           responses) and seroprotection rate (percentage of subjects with antitoxin concentrations
           ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents
           11-12 years of age.

        -  To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in
           terms of booster response rate (proportion of subjects with booster responses) at 28
           days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.

      Secondary objectives:

        -  To further evaluate the immune response of the study vaccines against diphtheria,
           tetanus and pertussis antigens.

        -  To assess the safety of the study vaccines after one injection in Japanese adolescents
           11-12 years of age.
    

Detailed description: 
      Study participants will receive either a single dose of SP306 vaccine intramuscularly or a
      dose of DT vaccine subcutaneously. They will be monitored after vaccination for immediate
      adverse events (AEs) solicited injection site and systemic reactions and unsolicited AEs
      including serious adverse events throughout the study period, approximately 28 days (+7
      days).
    

Intervention name(s): Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed; Diphtheria and Tetanus toxoids adsorbed
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, intramuscularly.; 0.1 mL, Subcutaneously
Other intervention name(s): Adacel; SP306 (in Japan); DT vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tetanus; Diphtheria; Pertussis; TdaP vaccine; DT vaccine
Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds
Condition: Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes
      the effectiveness of clinical trials for the treatment of difficult to heal wounds and
      security.
    


Intervention name(s): TB4
Intervention type(s): Biological
Intervention description(s): Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TB4; Difficult to heal
Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs
Condition: Obesity, Morbid; Bariatric Surgery Candidate
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass (RYGB)
      bariatric surgery, drug bioavailability after the surgery can be altered. Therefore,
      post-operative dose adjustment in these patients can be required.

      The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass
      (LRYGB) surgery on drug pharmacokinetics and cytochrome P450 (CYP) mediated metabolism using
      a cocktail of nine CYP probe drugs.

      The cocktail covers nine main CYP enzymes: melatonin (CYP1A2), nicotine (CYP2A6), bupropion
      (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4),
      dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1), midazolam (CYP3A4).

      The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity
      of CYPs are evaluated before and one year after LRYGB. In the study, the patients
      administering drug cocktail before surgery and 1 year after LRYGB are served as their own
      controls.
    


Intervention name(s): cocktail of nine CYP probe drugs
Intervention type(s): Drug
Intervention description(s): Two equally loaded capsules containing:
Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone (62.5 mg) Midazolam (1.85 mg) Dextromethorphan (30 mg) as an oral solution was administered separately after the capsules.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia
Condition: PONV
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the quality of perioperative antiemesis of palonosetron and
      ondansetron in patients undergoing cesarean section
    

Detailed description: 
      Perioperative nausea and vomiting (PONV) related to spinal block anesthesia are common events
      and unpleasant for pregnant women. Its incidence can reach 80% in high-risk patients, and
      remains high despite the emergence of new antiemetic drugs.

      Episodes untreated can result in prolonged stay in post-anesthetic care unit (PACU) and
      rehospitalization which can result in significant increase in overall costs of health care.

      The purpose of the prophylaxis of PONV is therefore decrease its incidence, the stress of the
      patient, improve the quality and safety of surgical procedure and reduce hospital costs.

      Antagonists of the 5-hydroxytryptamine 3 subtype receptor have been widely used and effective
      against PONV due to its efficacy and a favorable side-effect profile. Palonosetron is a new
      and potent drug generation5 second-HT antagonist with improved profile that acts longer.
      Recent studies where it was compared to ondansetron and palonosetron in high-risk patients in
      head and neck surgery and laparoscopic surgery is disclosed palonosetron far superior to
      ondansetron especially 2-24 hours after surgery. But there are no studies on caesareans
      comparing the two drugs.

      This prospective, randomized, double-blind, placebo controlled, was designed to evaluate the
      efficacy of palonosetron compared with ondansetron and placebo for the prevention of nausea
      and vomiting in patients undergoing cesarean delivery under spinal anesthesia.
    

Intervention name(s): Placebo; Ondansetron; Palonosetron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive regular spinal anesthesia; Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping; Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping
Other intervention name(s): Saline
Intervention MeSH terms: Ondansetron; Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: PONV; Palonosetron; Ondansetron; Cesarean section
Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration
Condition: Opioid Induced Swallowing Disorders
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine weather remifentanil induced swallowing
      difficulties increase risk for pulmonary aspiration.
    

Detailed description: 
      Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical
      procedures and as pain relief in icu-patients when the patient is spontaneously breathing and
      the airway is not secured by endotracheal intubation. In these circumstances inability to
      clear the pharynx by swallowing may increase risk for aspiration.In a previous study ( not
      yet published) we showed that remifentanil induce subjective swallowing difficulties in
      healthy volunteers and the aim of this study is to determine weather remifentanil infusion in
      healthy non-intubated volunteers increase risk for pulmonary aspiration. To assess this
      question we are going to study 14 volunteers who are randomised to receive remifentanil
      infusion with target concentration 3 ng/ml during 60 minutes at one occasion and an equal
      amount of saline at the other. Radioactive Technetium colloid solution is parallelly infused
      through a pliable catheter transnasally. After remifentanil infusion is stopped the
      transnasal catheter is removed and the volunteer is asked to swallow water to clear the
      remaining radioactivity from upper gastrointestinal tract. Thereafter lung scanning with a
      gamma camera is performed. Through which mechanism remifentanil cause swallowing difficulties
      is not known.To determine weather remifentanil induce general muscle weakness in volunteers
      measurements of grip strength using Jamar dynamometer are performed before, during and 15
      minutes after remifentanil infusion.
    

Intervention name(s): Remifentanil; Placebo; Technetium; Dynamometer (Jamar)
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min); Infusion fluid, solution 9 mg/ml ( hydrogenic solution ); 37-40 MBq( effective dose 0,7 mSv) 99Tc albumin colloid in a volume of 6 ml, infusion velocity 0,1 ml/min via a transnasal catheter; portable hydraulic hand dynamometer to assess grip strength.
Other intervention name(s): Ultiva; ATC-code: N01AH06; Saline; ACT-code: B05XA03; Nanocol; ACT-code: V09DB01; Jamar dynamometer
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: swallowing difficulties; remifentanil; pulmonary aspiration; scintigraphy
A Study to Characterize the Phenotype in Patients With Morton's Neuroma and to Explore the Effect of Local Administration of Xylocaine (Lidocaine)
Condition: Morton's Neuroma
MeSH terms: Neuroma; Morton Neuroma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To characterize the phenotype in patients with Morton's neuroma and to explore the effect of
      local administration of Xylocaine (lidocaine)
    

Detailed description: 
      A randomised, double-blind, placebo-controlled, three-way cross-over single center study to
      characterize the phenotype in patients with Morton's Neuroma and to explore the effect of
      local administration of Xylocaine (lidocaine)
    

Intervention name(s): Xylocaine; Xylocaine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 mg/mL solution for injection; 10 mg/mL solution for injection; solution for injection
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Morton's neuroma, QST measurements
Intranasal Insulin Treatment in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal
      insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia
      subjects to examine insulin's effect on psychopathology and cognition. In addition, the study
      will examine insulin's effects on weight, food intake, resting energy expenditure, and body
      composition.
    

Detailed description: 
      The specific aims include:

      Primary aims

        1. Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving
           cognitive deficits in patients with schizophrenia.

        2. Examine the efficacy of intranasal regular insulin in improving negative symptoms and
           positive symptoms of schizophrenia.

      Secondary aims

        1. Examine intranasal insulin's effects on weight, food intake and resting energy
           expenditure.

        2. Examine intranasal insulin's effects on body composition, waist circumference, and
           waist/hip ratio.
    

Intervention name(s): Insulin or Placebo
Intervention type(s): Drug
Intervention description(s): intranasal, 40IU, 4 times daily
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognition, psychopathology