bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
Condition: Muckle Wells Syndrome
MeSH terms: Cellulitis; Eosinophilia; Cryopyrin-Associated Periodic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to provide efficacy and safety data for ACZ885 (a fully human
      anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection
      subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.

      Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.

      Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of
      ACZ885 compared to placebo.

      Part III is an open-label, active treatment period where patients will receive ACZ885 every 8
      weeks after withdrawal or completion of Part II.
    


Intervention name(s): ACZ885; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Muckle-Wells Syndrome; children; systemic autoinflammatory disease; CIAS-1 gene; NALP-3; ACZ885; human monoclonal anti-human interleukin-1beta (IL-1beta); antibody; autosomal dominant; familial autoinflammatory syndrome
Study to Evaluate a Probiotic in Healthy Subjects With a History of Abdominal Discomfort and Bloating
Condition: Abdominal Discomfort; Bloating
Study type: Interventional

Summary: 
      This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a
      probiotic for abdominal discomfort and bloating in healthy subjects.
    

Detailed description: 
      This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, 6-week
      study of a probiotic for abdominal discomfort and bloating in healthy subjects.
    

Intervention name(s): B. infantis 35624; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): B. infantis 35624 in white capsules; white placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: abdominal discomfort and bloating
Imiquimod 5% Cream in the Treatment of External Genital or Perianal Warts in HIV+ Patients
Condition: Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 4

Summary: 
      Imiquimod 5% cream in the treatment of external genital or perianal warts in HIV+ patients
    

Detailed description: 
      To evaluate the percentage of HIV+ subjects successfully treated with HAART, with total
      clearance (100%) of baseline external genital or perianal warts within 16 weeks of treatment
      with imiquimod 5% cream.
    

Intervention name(s): Imiquimod 5% cream
Intervention type(s): Drug
Intervention description(s): Subjects were treated with imiquimod (one sachet/20 cm2), three applications per week, for up to 16 weeks, or fewer in the case of total clearance of initial warts. At the visit at the end of treatment, a second scraping of the lesion area was carried out to determine the sub-type of HPV.
Intervention MeSH terms: Imiquimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: external genital and perianal warts
Responsiveness of Quantitative Musculoskeletal Ultrasound Measures on the Healing of Achilles Tendon
Condition: Achilles Tendinopathy
MeSH terms: Tendinopathy
Study type: Observational

Summary: 
      To this day, the most accepted treatment for the Achilles tendinopathy (AT) remains the
      exercise program to strengthen the plantar flexor muscles. The eccentric exercises protocol
      proposed by Alfredson is the most popular and recommended one by the rehabilitation
      professionals. Currently, the response to interventions is measured almost exclusively by
      clinical data, especially using questionnaires, since the Quantitative Ultrasound (QUS) is
      rarely used. In fact, the thickness of the Achilles tendon, which is generally the only
      measure noted when using musculoskeletal ultrasound on AT, does not allow the clinician to
      confirm an improvement following an eccentric exercise program if the tendon is thinner,
      especially in adults with chronic AT. No scientific evidence indicates whether there is an
      improvement in the biological integrity of the Achilles tendon following the completion of
      Alfredson's eccentric strengthening protocol. This is why it seems relevant to use the
      pre-established minimal biomarker data set obtained with the QUS in order to study the
      variation of these data in response to a rehabilitation intervention and to verify how these
      variations influence clinical data.
    

Detailed description: 
      A comprehensive clinical evaluation (questionnaires, clinical examination and ultrasound
      imaging) will be completed immediately before the intervention (pre), immediately after the
      intervention (post), and three months after the intervention (follow-up).
    

Intervention name(s): Eccentric strengthening exercises of the Achilles tendon
Intervention type(s): Other
Intervention description(s): This exercise will require the completion of slow active eccentric plantar flexion exercises with the forefoot positioned over the edge of a step. These exercises will be repeated twice daily (three sets of 15 repetitions with the knee in extension and three sets of 15 repetitions with the knee in flexion) during a three-month period. The amount of loading will be calibrated and progressed on a weekly basis by the physiotherapist according the participant's perceived effort and pain intensity.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be recruited from patients with symptoms consistent with AT in the middle
        third of the Achilles tendon for at least six weeks. They will be recruited from physical
        therapy clinics, sports medicine clinic, sports teams and athletic clubs.
Evaluation of the Change of Penile Corpus Cavernosum After Caudal Block Using Ultrasonography in Children
Condition: Pediatric Urologic Surgeries
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the change of penile corpus cavernosum after caudal
      block using ultrasonography in pediatric patient.
    


Intervention name(s): urologic surgery and caudal block
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pediatric patients who need urologic surgery and caudal block
Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Condition: Erosive Reflux Disease
MeSH terms: Dyssomnias; Parasomnias; Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the nighttime heartburn and sleep disturbance improvement effect
      of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
    

Detailed description: 
      This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study.
      Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg,
      esomeprazole 40mg)
    

Intervention name(s): Tegoprazan; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Tegoprazan 50mg tablet; Esomeprazole 40mg tablet
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
      sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x
      300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose
      pharmacokinetic parameters for baseline corrected total L-thyroxine and non-baseline
      corrected total L-triiodothyronine were calculated using noncompartmental techniques.
    


Intervention name(s): Levothyroxine Sodium Tablets 300 μg; Synthroid® Tablets 300 μg
Intervention type(s): Drug; Drug
Intervention description(s): 2x300mcg, single dose fasting; 2x300mcg, single dose fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Comparision of M-TAPA Versus TAPB After Laparoscopic Cholecystectomy
Condition: Postoperative Pain, Acute
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      This randomized controlled study is designed to evaluate the postoperative analgesic effect
      of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial
      approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators
      hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control
      than the US-guided subcostal transversus abdominis plane block (TAPB).
    

Detailed description: 
      Patients (Age>18 years) undergoing elective laparoscopic cholecystectomy are randomly
      allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30)
      using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator
      evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and
      patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before
      discharge. The primary outcome is pain severity evaluated by a NRS at 12hours
      postoperatively.
    

Intervention name(s): Type of interfascial plane block
Intervention type(s): Procedure
Intervention description(s): In the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way.
In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cholecystectomy; thoracoabdominal nerves block; transversus abdominis plane block; interfascial plane block; regional analgesia
The Effect of Breakfast With Different Macronutrient Composition on PYY, Ghrelin, GLP-1,Glucose Level, VAS for Hunger, VAS for Satiety and Ad Libitum Intake 4 Hours After Breakfast in Obese Women
Condition: PYY; Ghrelin; Appetite; Gut Hormones; Obesity; Protein Consumption
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Gut hormones, such as PYY and ghrelin, are associated with appetite control and obesity.
      Protein is thought to be the most satieting nutrient and could affect production of several
      gut hormones. This study's objective is to find the effect of breakfast with different
      protein composition on PYY, ghrelin, and ad libitum intake four hours after breakfast.

      The research methodology was used a clinical trial with 22 obese women participants. Subjects
      were given three types of breakfast: low protein consumption (12.4% protein), medium protein
      (23.5% protein), and high protein (40,6% protein). PYY and ghrelin level were measured at 0,
      15, 60, 120, and 180 minutes after breakfast. Ad libitum meal was given four hours after
      breakfast and measured after.
    


Intervention name(s): diet with different composition
Intervention type(s): Behavioral
Intervention description(s): Participants should not eat within the last 10 hours. Participants could drink mineral water up to 2 hours before intervention. Breakfast given is a milk-based formula which has to be finished within 15 minutes, and subjects could only consume 600 mL of mineral water within the next 4 hours after intervention. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure ghrelin and PYY level. Breakfast given is adjusted to participants' energy requirement. Energy requirement is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Different composition of protein, carbohydrate and fat were given to each arm depends on their group.
After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: PYY; ghrelin; ad libitum intake; high protein diet; moderately protein diet; low protein diet; breakfast; obesity
Graded Motor Imagery in Elbow Limitation
Condition: Elbow Fracture; Limitation, Mobility; Pain, Postoperative; Upper Extremity Problem
MeSH terms: Pain, Postoperative; Mobility Limitation; Elbow Fractures
Study type: Interventional

Summary: 
      This randomized-controlled trial aims to investigate the efficacy of Graded Motor Imagery
      (GMI) on function, pain, and range of motion (ROM) in patients with a posttraumatic stiff
      elbow.
    

Detailed description: 
      To investigate the efficacy of GMI on function, pain, and ROM in elbow limitation, voluntary
      patients with elbow limitation, aged between 20-55 years will be randomly divided into two
      groups: GMI group and standard rehabilitation (SR) group. Interventions will be applied for
      12 sessions. The patients will be assessed before, after six-week treatment and six-week
      follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog
      Scale (VAS). Pain pressure threshold of the elbow and soft tissue around the elbow will be
      evaluated by digital pressure algometry. ROM will be assessed with a digital goniometer.
      Isometric muscle strength will be measured with a handheld dynamometer of elbow flexors and
      extensors. Grip strength will also be assessed. Recognise™ will be used for assessing the
      right-left discrimination. The functional status and kinesiophobia will be evaluated by
      Disabilities Arm, Shoulder and Hand (DASH) and Tampa Scale for Kinesiophobia, respectively.
      The Global Rating of Change will be used to evaluate patient satisfaction. The Vividness of
      Movement Imagery Questionnaire 2 (VMIQ-2) will be used for evaluating the individuals'
      ability to mental imaginary.
    

Intervention name(s): Graded Motor Imagery; Standard Rehabilitation; Home Exercise Program; Cold Application
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The first stage of GMI includes laterality reconstruction. Patients will view and determine if the various images of body parts to image portrays the right or left side. The second stage targets activation of the primary motor cortex by imagine moving the involved body part. The final stage involves that the patient watches the unaffected body part moving in a mirror to "trick" the brain into thinking the affected body part is actually moving in a pain-free way. This will be applied for 6 weeks.; Shoulder, elbow and wrist AROM exercises. Elbow flexion and extension, and wrist flexion and extension stretching exercises. Elbow and wrist strengthening exercises. Grip strengthening exercises. This will be applied for 6 weeks.; Proprioception exercises for the elbow. Scapulothoracic strengthening exercises. This will be applied for 6 weeks.; Cold application around the elbow joint for 15 minutes in every session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Imagery; Mirror Neurons; Immobilization; Exercise; Rehabilitation
Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD
Condition: COPD
Study type: Interventional

Summary: 
      The study team proposes a two-arm pilot study randomizing participants with COPD who smoke
      combustible cigarettes (CC) to counseling + NRT (standard of care) or counseling +
      e-cigarettes.
    

Detailed description: 
      Globally, chronic obstructive pulmonary disease (COPD) is projected to be the third largest
      cause of death by 2030 and in the US over 16 million people have COPD. Smokers are four and a
      half times more likely to develop COPD than non-smokers, with the likelihood of COPD
      increasing progressively with the duration and intensity of smoking. Among those with COPD,
      smoking cessation is the most effective means of slowing the decline of lung function and
      overall disease progression. Patients at all stages of COPD benefit from quitting smoking.
      Over 90% of COPD deaths occur in current smokers, however 47.1% of people with COPD continue
      to smoke. Electronic cigarettes (E-cigarettes) could help people reduce the harm of
      combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or
      quitting CC completely by addressing both nicotine and behavioral dependence. Although there
      are associated health risks, all available evidence indicates that E-cigarettes are safer
      than CC. Unlike CC, e-cigarettes are not associated with coronary heart disease or myocardial
      infarction. The purpose of this mixed methods study is to identify barriers and facilitators,
      as well as to assess preliminary effectiveness of e-cigarettes as a harm reduction strategy
      among people with COPD.
    

Intervention name(s): E-cigarette (EC); Nicotine Replacement Therapy (NRT); Smoking Harm Reduction Counseling Sessions
Intervention type(s): Other; Other; Behavioral
Intervention description(s): NJOY Daily E-cigarettes are self-contained and non-refillable. Each DAILY provides approximately 300 puffs, comparable to a full pack of cigarettes.; Participants in the NRT arm will receive 21 mg nicotine patch (for those with CPD >= 20) or 14 mg nicotine patch (for those with CPD < 20) + 4 mg nicotine gum. CPD stands for Cigarettes Per Day.; Counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects know to contribute to smoking among people with COPD (e.g., tips on dealing with depression)
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: E-cigarettes
Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy,
      such as gemcitabine, work in different ways to stop the growth of cancer cells, either by
      killing the cells or by stopping them from dividing. Bortezomib may help gemcitabine work
      better by making cancer cells more sensitive to the drug.

      PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine
      works in treating patients with relapsed mantle cell lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy (response rate) of bortezomib and gemcitabine hydrochloride in
           patients with relapsed mantle cell lymphoma.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the time to progression and duration of response in patients treated with this
           regimen.

      OUTLINE: This is a nonrandomized, multicenter study.

      Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over
      30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed at 4 weeks and then every 3 months
      thereafter until relapse/progression.
    

Intervention name(s): bortezomib; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks; 1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks
Intervention MeSH terms: Gemcitabine; Bortezomib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent mantle cell lymphoma
IL-6 as a Biomarker for Personalized Treatment of PR
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Several studies have shown the relevance of the IL6 level before treatment or after 6 months,
      as a predictive biomarker for the persistence of remission. The IL6 assay is now routinely
      available using the instruments available at the Montpellier University Hospital and with
      reagents provided by the ROCHE Laboratory. Moreover medical practices should incorporate this
      parameter. However, relevant threshold shlould be defined before being able to integrate
      biomarkers such as IL6 for monitoring bDMARDs in an algorithm.

      The medical staff of Clinical Immunology Unit has decided to include the dosage of IL-6
      during a routine biological assessment during patient visit to follow the new EULAR
      recommendations . This measument will be perfom in addition to the CRP and biochemical
      parameters on subjects with active RA or in remission upon the introduction of biological
      treatments or JAKi or during remission after at least 6 months of treatment. From March to
      July 2021, 200 patients will beenrolled and will benefit of this assessement. The
      investigators will retrospectively define clinical correlations with serum IL6 levels in
      order to define a threshold. In the second stage, a decisional algorithm based on the results
      of this project will be create. This will allow an improvement of the medical practices
      thanks to the integrationof of serum IL6 dosage as a standard during patients visits. The
      IL-6 assay will be performed on the e801 module of the Cobas lines (Roche Diagnostics)
      currently in place in the Biochemistry and Hormonology laboratory. The Elecsys® IL-6 - Roche
      Diagnostics test, high sensitivity, is an electrochemiluminescence immunoassay.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with active RA (DAS28> 3.6) who have failed methotrexate treatement and with a
        standard medical care for which an indication for biotherapy is retained.

        Subjects with remission of RA (DAS28<2.6) for which a biotherapy delay (anti-TNF or
        anti-IL6R or JAKi) is proposed.
      
Keywords: IL-6; Biomarker