bioihbjkbjnl/mcl2 huggingface dataset:
Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if natalizumab in combination with Glatiramer
      Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with
      relapsing-remitting Multiple Sclerosis (MS).
    


Intervention name(s): Natalizumab; Natalizumab; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.; Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.; Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Other intervention name(s): Tysabri; Tysabri
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; MS
Effect of High Protein Diet in Stroke Patients With Low Muscle Mass
Condition: Ischemic Stroke; Diet, Healthy; Muscle Loss
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      Our prior studies demonstrated that dehydration was a predictor for poor outcome in stroke
      and Blood urea nitrogen/Cr ratio-based saline hydration therapy in patients with acute
      ischemic stroke may increase the rate of favorable clinical outcome with functional
      independence at 3 months after stroke. However, dehydration is likely to be only a part of
      representation in poor nutrition status and physical fragility for a stroke patient.

      Our prior study found that acute stroke patients admitted to neurological intensive care unit
      with low urinary creatinine excretion rate (CER), a marker of muscle mass, was associated
      with poor outcome at 6 months after stroke. An animal study suggested inadequate food and
      water intake determine mortality following stroke in mice and nutritional support reduced the
      14-day mortality rate from 59% to 15%. A study also showed that high protein intake was
      associated with a better outcome in previous cardiovascular events.

      We will calculate CER based on published equation. Based on our prior study, acute stroke
      patients with their CER<1500 mg/day will be enrolled. A randomized controlled trial will be
      conducted and patients will be randomly assigned to high protein diet or normal protein diet
      for at least 2 weeks. We plan to enroll 300 patients, with 150 patients in ach group, during
      3-year study period. We will consult dietitians for arrangement of their diet. We assume that
      patients receiving high protein diet will have higher opportunity to walk independently
      (modified Rankin Scale 0-1) at 3 month after stroke.
    


Intervention name(s): high protein diet; normal protein diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): receive 1.8g protein/kg; receive 1g protein/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
An Open-label Trial of 48-week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of Chronic Hepatitis B Patients With HBeAg Seroconversion on Nucleot(s)Ide Analogue Therapy
Condition: Chronic Hepaititis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, single-arm, open-label study on the virological response of chronic
      HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on
      nucleos(t)ide analogue (NA) treatment. The primary endpoint of this study is to investigate
      the sustained response (HBeAg seroconversion with HBV DNA <2000 IU/ml) to peginterferon at 24
      weeks after the end of treatment.
    

Detailed description: 
      Chronic hepatitis B is the commonest cause of liver cirrhosis and hepatocellular carcinoma in
      Hong Kong. Treatment with interferon and nucleos(t)ide analogues (NA) can reduce the risk of
      HCC. NA is the commonest used medication in Hong Kong. However, most patients require
      long-term treatment and premature drug cessation may lead to hepatitis relapse.

      Under the current regional guidelines, patients who have positive hepatitis B e antigen
      (HBeAg) treated by NA can consider stopping treatment if HBeAg seroconversion has developed
      for at least 12 months. However, up to 30-50% of patients may develop virological relapse
      and/or HBeAg reversion after cessation of treatment. On the other hand, interferon-based
      treatment has a much more durable response. HBeAg seroconversion is maintained in 80% of
      patients after successful treatment with peginterferon. Upon long-term follow-up,
      peginterferon-treated patients are also more likely to achieve hepatitis B surface antigen
      (HBsAg) seroclearance, a condition closest to a cure of chronic hepatitis B.
    

Intervention name(s): Pegyinterferon-alfa-2a
Intervention type(s): Drug
Intervention description(s): Pegyinterferon-alfa-2a 180mcq weekly for 48 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Clinical Monitoring Software on Symptoms in Patients With Chronic Low Back Pain
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim of this randomised controlled trial is to compare the effectiveness of two different
      telerehabilitation assessment methods in patients with chronic low back pain. The control
      group will receive a video exercise-based rehabilitation protocol with telerehabilitation.
      The intervention group will be followed up with the same protocol plus symptom monitoring
      software called PhysioAnalyst which provides visual feedback. The evaluation of outcome
      measures will be performed on the control group through the PhysioAnalist programme without
      visual feedback and on the intervention group through the PhysioAnalist programme with visual
      feedback.
    

Detailed description: 
      Individuals with chronic low back pain will be divided into 2 groups by randomisation
      software (https://ctrandomization.cancer.gov/tool/). The control group will be given video
      exercises on the online platform. Initial, interim and final evaluations will be performed by
      filling in the patient-reported outcome measures through the PhysioAnalyst programme without
      patient feedback. The intervention group will be given the video exercise programme on the
      same online platform. Initial, intermediate and final assessments will be performed with our
      self-developed PhysioAnalyst software using visual feedback tools. The video exercises given
      to the participants will include Williams, McKenzie exercises and core strengthening
      exercises. Visual Analogue Scale pain score, Nottingham Health Profile, Pain Catastrophising
      Scale, Oswestry Disability Index, Telehealth Usability Questionnaire, Telemedicine
      Satisfaction Questionnaire, Exercise Adherence Rating Scale will be applied.
    

Intervention name(s): Symptom monitoring software via visual feedback
Intervention type(s): Other
Intervention description(s): With PhysioAnalyst software, individuals are evaluated using clinical tools (questionnaire, scale). These evaluations provide visual feedback to individuals in the form of tables and graphs. In this way, patients can observe the changes in their clinical status.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pain Management in Laparoscopic Appendectomy
Condition: Post Operative Pain; Appendicitis Acute; Surgery
MeSH terms: Appendicitis; Pain, Postoperative
Study type: Interventional

Summary: 
      Laparoscopic appendectomy causes postoperative pain. The primary objective of this
      prospective randomized controlled study is to compare the effect of ultrasound (US)-guided
      quadratus lumborum block (QLB) on 24-hour cumulative opioid requirements with transversus
      abdominis plane (TAP) block.
    

Detailed description: 
      168 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo laparoscopic
      appendectomy, were randomized and divided into two groups. 32 patients were dropout for
      different reasons.(68 patients in each of the TAP block and QLB block groups). TAP block was
      performed for TAP group and QLB block was performed for QLB group. Postoperative analgesia
      was provided by intravenous tramadol hydrochloride using a patient-controlled analgesia
      device. 24-hour total tramadol hydrochloride consumption was primary outcome
      measure.Postoperative numeric rating scale values were the secondary outcome measure.
    

Intervention name(s): Transversus abdominis plane block; Quadratus Lumborum Block
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators performed transversus abdominis plane block to that patient group for postoperative analgesia; The investigators performed quadratus lumborum block to that patient group for postoperative analgesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Postoperative pain; Laparoscopic appendectomy; Transversus abdominis plane block; Quadratus Lumborum Block; Local anesthetic
Investigating the Effectiveness of Exercise Coaching on the Physical Activity Behavior of Physically Inactive Employees.
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate if and how a physical activity counselor can
      offer an added value in exercise promotion in physically inactive employees. We will explore
      if the physical activity counselor in the workplace setting can motivate sedentary employees
      to engage into systematic participation in sports and/or exercise by means of a short term
      coaching of 12 weeks. We aim to include 300 employees in the physical activity coaching
      process.
    

Detailed description: 
      Being physically active on a regular basis has many health benefits. Nevertheless, the
      majority of the Belgian population doesn't reach the recommended amount and intensity of
      physical activity to profit from these health benefits. A physical activity counselor can
      possibly play a crucial role for these physically inactive individuals. He/she can design an
      individualized exercise program to stimulate the person to become lifelong physical active.
      Research has shown that exercise promotion at work can result in a lower absenteeism,
      prevention of burn-out and a positive corporate identity.
    

Intervention name(s): physical activity coaching
Intervention type(s): Behavioral
Intervention description(s): After measuring physical actity, physical fitness level, anthropometric and psychosocial variables a personalized 12 week physical activity program is made (=baseline). The intervention consisted of two face-to-face counselling sessions at the start of the intervention, short contacts by e-mail or telephone at weeks 3, 6 and 9, and two face-to-face counselling sessions at the end of the intervention. Employees exercise on their own. After 12 weeks and 6 months all measures are repeated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical activity counselor; Workplace intervention; Active and healthy lifestyle
Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a
      range of doses of investigational product and pioglitazone, compared to placebo, administered
      as monotherapy over 12 weeks in treatment naive patients with T2DM
    


Intervention name(s): GSK189075; pioglitazone; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Experimental Drug; Active Control; Placebo Comparator
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pioglitazone; HbA1c; Diabetes mellitus
Levetiracetam for Painful Polyneuropathy
Condition: Painful Polyneuropathy
MeSH terms: Polyneuropathies; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Polyneuropathy of different etiologies is often associated with pain. The standard treatment
      of this pain is anticonvulsants or antidepressants, but none of these treatment are effective
      or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the
      hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised,
      double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000
      mg/day on pain in polyneuropathy
    


Intervention name(s): levetiracetam
Intervention type(s): Drug
Intervention description(s): Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: polyneuropathy; neuropathic pain; levetiracetam
Effect of Coherent Breathing on Elderly Quality of Life
Condition: Stable Diabetes Mellitus; Geriatrics; Hypertension
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will be carried out on sixty elderlies of both gender with ages ranges from 60 to
      70 years old. The participants will receive Inspiratory muscle trainer and/or Coherent
      breathing exercise three times per week for 12 weeks.
    


Intervention name(s): Coherent Breathing Exercise; Inspiratory muscle training
Intervention type(s): Other; Device
Intervention description(s): Step 1: Focus on your natural breathing and count the time of your inhale and exhale.
Step 2: Sit in a comfortable position to practice the coherent breathing technique. Gently place one hand on your stomach.
Step 3: Inhale for four seconds and then exhale for four seconds. Repeat this for one minute.
Step 4: Repeat the above step but lengthen your inhales and exhale for five seconds.
Step 5: Repeat the above step but extend the breaths to six seconds. Once you're able to do this for five minutes, gradually work your way up to 20 minutes.
During this breathing exercise, keep your hand on your stomach. Using diaphragmatic breathing can help you feel your breaths.; The patient was in the comfortable sitting position and then put the nose clip on the patient's nose
After setting the maximum training; the user recognized the load at which they could effectively execute ten breaths at greatest resistance relying upon the patient's pace of apparent effort.
Training was begun with a load at low intensity 20-30% of the patient maximum 10 repetition method using inspiratory muscle training (IMT) device.
Progress slowly and monitor carefully.
As the inspiratory muscle became stronger the inspiratory load was progressed to 50% of maximum effort over 3 weeks as tolerated.
Patient took full breath in (maximal and deep inspiration) then longer and slow expiration. Continue this breathing pattern for 10-20 breath.
Repeated step (5), 4-6 times or about 10-15minutes with rest in between 30 seconds.
The session was repeated three times per week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
4th Generation Chimeric Antigen Receptor T Cells Targeting Glypican-3
Condition: Advanced Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I Clinical Study of 4th generation Chimeric Antigen Receptor T Cells Targeting
      Glypican-3 ( CAR-GPC3 T Cells) in Patients with Advanced Hepatocellular Carcinoma
    

Detailed description: 
      This is a phase I open-label, single and multiple infusion, dose escalation/cohort expansion
      study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of CAR-GPC3 T
      cells, infused intravenously in subjects who have been diagnosed with GPC3 positive advanced
      hepatocellular carcinoma and refractory or intolerant to current standard systemic treatment.

      Primary objectives:

      •To evaluate the safety and tolerability of CAR-GPC3 T cells infused intravenously at
      escalating doses in patients with advanced hepatocellular carcinoma.

      Secondary objectives:

        -  To evaluate the cellular pharmacokinetics of CAR-GPC3 T cells

        -  To evaluate the overall safety and tolerability of infusion of CAR-GPC3 T cells

        -  To investigate the preliminary efficacy of CAR-GPC3 T cells in the treatment of advanced
           hepatocellular carcinoma
    

Intervention name(s): CAR-GPC3 T Cells
Intervention type(s): Drug
Intervention description(s): Pretreatment with fludarabine and cyclophosphamide CAR-GPC3 T Cells infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced hepatocellular Carcinoma; CAR-T; GPC3
Exercise Device in Total Knee Arthroplasty
Condition: Total Knee Arthroplasty; Total Knee Replacement
Study type: Interventional

Summary: 
      Total knee arthroplasty is performed in patients with advanced stages of osteoarthritis who
      can not respond to conservative treatment, in order to reduce pain, increase range of motion,
      and improve function and quality of life. Continuous passive motion device continues to be
      used in many clinics, although it has been shown that there is no effect in total knee
      arthroplasty rehabilitation. The aim of the study was to assess the clinical effects of the
      knee exercise device on pain, ROM and function and quality of life in total knee arthroplasty
      rehabilitation.
    

Detailed description: 
      Volunteers with total knee arthroplasty according to the criteria of inclusion, who will be
      operated in Istanbul University Istanbul Medical Faculty Orthopedics and Traumatology
      Department will be included this study. Participants will be randomly allocated 2 groups:
      easy-flex group and traditional exercise group. Exercise group will be treated with the
      traditional exercise program and the Easy-Flex group will be treated with the Easy-Flex
      device in addition to the traditional exercise program.
    

Intervention name(s): Easy-Flex; Exercise
Intervention type(s): Device; Other
Intervention description(s): The Easy-Flex device will be used to increase knee flexion and extension ROM.; After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee prosthesis; Physiotherapy; Range of motion
A Clinical Study to Investigate How Safe and Tolerable the Study Drug MT-2990 is and How MT-2990 is Taken up by the Body in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and
      immunogenicity of MT-2990 in healthy male subjects.
    


Intervention name(s): MT-2990; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single IV dose of MT-2990; Subjects will receive a single IV dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
Condition: Malignant Pleural Mesotherioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive
      patients with Malignant Pleural Mesothelioma.
    


Intervention name(s): Pemetrexed; Cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pemetrexed
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of
      different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.
    

Detailed description: 
      Clarification regarding injection volumes for the different study groups:

      Subjects will be randomized to Group A or Group B (1:1).

        -  Group A: 0,63ml NaCl will be used to reconstitute toxin in the vial. 0,05mL will be
           injected (equal to a dose of 10s.U.)

        -  Group B: 1,25ml NaCl will be used to reconstitute toxin in the vial. 0,1 mL will be
           injected (equal to a dose of 10s.U.).

      The two different reconstitution volumes (each containing a dose of 10s.U. botulinum toxin A)
      will be compared as described under objectives.
    

Intervention name(s): Azzalure
Intervention type(s): Drug
Other intervention name(s): botulinum toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Probiotics in the Treatment of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Some evidences have shown that probiotics are effective in the treatment of irritable bowel
      syndrome. Because few evidences are available in our population, we investigated if
      probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol
      which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.
    


Intervention name(s): Lactol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The Symbiotic Lactol® (Bioplus Life Sciences Pvt.) was applied 3 times a day for 3 months. Lactol is composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol.; Placebo pill was applied 3 times a day for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; Functional gastrointestinal disorders; Gut flora; Probiotics