bioihbjkbjnl/mcl2 huggingface dataset:
Exenatide and Weight Loss for Diabetes Prevention
Condition: Pre Diabetes; Insulin Resistance
MeSH terms: Diabetes Mellitus; Insulin Resistance; Prediabetic State
Study type: Interventional
Phase: Phase 1

Summary: 
      Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients
      with type 2 diabetes, has been associated with restoration of the first-phase insulin
      response when administered intravenously to patients with type 2 diabetes. In longer clinical
      trials, it is associated with progressive decreases in body weight, and improvement in the
      dyslipidemia that characterizes insulin resistance, although insulin resistance was not
      quantified. The investigators will seek to determine whether exenatide would have similar
      effects in individuals who were not diabetic. in particular, the drug effect on beta cell
      function and insulin sensitivity would be subject to less confounding by changes in blood
      glucose in the prediabetic population, allowing for clearer evaluation of the physiological
      effects of the drug on these metabolic endpoints. The investigators will compare 2 groups of
      prediabetic insulin resistant individuals, all on a weight loss diet and one group on
      exenatide and the other on placebo. The investigators will evaluate restoration of first
      phase insulin response, potential glucose lowering effects, including both reversal of
      prediabetes and hypoglycemia, and improvement in insulin resistance.
    


Intervention name(s): Exenatide 5 and 10 mcg 2 times a day; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: prediabetes; exenatide; weight loss; insulin resistance; acute insulin response; insulin secretion
Safety and Protective Efficacy of Pb(PfCS@UIS4)
Condition: Malaria,Falciparum; Plasmodium Falciparum; Plasmodium Berghei; Controlled Human Malaria Infection (CHMI)
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is
      one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that
      immunization of humans with P. berghei will induce a cross-species immune response without
      the risk of a breakthrough infection. To further increase the potential for protective
      efficacy, the P. falciparum circumsporozoite (CS)- protein gene has been integrated in the P.
      berghei parasite, generating a genetically modified P. berghei parasite, abbreviated as
      Pb(PfCS@UIS4).
    


Intervention name(s): Pb(PfCS@UIS4)-infected mosquitoes; Challenge infection P. falciparum
Intervention type(s): Biological; Other
Intervention description(s): Pb(PfCS@UIS4)-infected mosquitoes; Challenge infection with bites of five infected Pf mosquitoes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      The aim of this study is to determine the effectiveness of three different treatment methods
      which consists spinal decompression, deep friction massage and exercise. The patients were
      separated three groups Group one received non-surgical spinal decompression therapy, group
      two received non-surgical spinal decompression, lumbar stabilization exercises and manual
      therapy, group three received manual therapy and lumbar stabilization exercises. All groups
      completed 15 sessions of therapy. In each session, pain severity was assessed with numeric
      analog scale, straight leg raise test applied and the degree of the hip flexion where the
      patient reported pain were recorded, respectively. Static, dynamic muscle strength-endurance
      tests were applied before the treatment sessions started, after the treatment sessions ended,
      six weeks after and three months after the study. Oswestry Disability Scale (ODI), Back
      Performance Scale (BPS), Lanss Neuropathic pain Questionnaire, Fear-Avoidance-Beliefs
      Questionnaire (FABQ) and McGill Pain Questionnaire were applied before the treatment sessions
      started, after the treatment sessions ended and three months after the study. Gradient of
      disc height and thickness of the herniation were assessed segmentally with magnetic resonance
      imagination (MRI) before the study and three months after the study.
    


Intervention name(s): non -surgical spinal decompression therapy; deep friction massage,; electrotherapy; exercise
Intervention type(s): Other; Other; Other; Other
Intervention description(s): it is a kind of traction therapy, it has an special traction design which can provide intermittent traction as to herniation levels.; deep friction massage is a kind of massage targeting deep muscles for decreasing pain and increasing function; electrotherapy is consist of hot pack, ultrasound and TENS. electrotherapy agents were help decreasing pain, increasing metabolism of tissues.; special lumbar stabilization exercises were applied in advanced protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; deep friction massage; spinal decompression; non-surgical spinal decompression
Inspiratory Muscle Training in Patients With Interstitial Lung Disease
Condition: Interstitial Fibrosis; Pulmonary Disease; Interstitial Lung Disease; Sarcoidosis; Idiopathic Pulmonary Fibrosis; Pneumonia, Interstitial
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Respiratory Aspiration; Lung Diseases, Interstitial; Sarcoidosis; Fibrosis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of inspiratory muscle training program in
      inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional
      capacity and quality of life in patients with interstitial lung disease. Patients are
      evaluated before the inspiratory muscle training and after 8 weeks of training.
    

Detailed description: 
      Inspiratory Muscle Training has been described as an effective intervention and contribute to
      the improvement of inspiratory muscle function and breathlessness in patients with chronic
      lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle
      endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of
      life in patients with interstitial lung disease. It is a quasi-experimental study. Patients
      with interstitial lung disease are recruited from interstitial disease ambulatory. In each
      session patients performs two times 30 breaths with a minute rest between them. The load is
      set according with 50% of actual PImax, the Borg score should be between 4 and 6, otherwise
      the load will decrease (if Borg more than 6) or increase (if Borg less than 4). New PImax is
      measured weekly and the new load is defined following the same protocol for 8 weeks. Patients
      are evaluated before the inspiratory muscle training and after 8 weeks of training.
    

Intervention name(s): Inspiratory muscle training
Intervention type(s): Other
Intervention description(s): Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).
Intervention model: Single Group Assignment
Intervention model description: Quasi-experimental
Masking: None (Open Label)
Primary purpose: Other
Keywords: Inspiratory muscle training; Interstitial lung disease; Inspiratory muscle endurance; Breathless
A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose study in healthy male volunteers to investigate the effect of high
      doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT
      interval
    


Intervention name(s): NXL104; Ceftaroline; Placebo Infusion; Ceftazidime; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV Solution; IV Solution; IV Saline; IV Solution; Tablet (1)
Intervention MeSH terms: Moxifloxacin; Ceftazidime; Ceftaroline fosamil; Avibactam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: NXL104; CAZ104; Ceftazidime; CXL104; Ceftaroline; Healthy Male Volunteers; Phase 1; OT; Single Dose Study
Microalbuminuria and Allopurinol in Type 1 Diabetes
Condition: Type 1 Diabetes; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to determine if lowering serum uric acid by means of allopurinol in the
      course of kidney disease may be effective in preventing or improving albuminuria and renal
      function in Type 1 Diabetic patients. The study is a double blinded, randomised,
      placebo-controlled cross-over clinical trial.
    


Intervention name(s): Allopurinol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Type 1 diabetes; Diabetic nephropathy; Albuminuria; Allopurinol
Phamacological Reversal of Airway Instability During Sedation
Condition: Upper Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Interventional

Summary: 
      The investigators are attempting to demonstrate a decrease in the frequency and severity of
      sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological
      pre-treatment in this pilot project and then eventually to understand the mechanisms behind
      this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep
      in Obstructed Sleep Apnea (OSA) patients, have not been systematically studied during
      sedation in either normal subjects or OSA patients. The agent to be assessed in this study in
      physostigmine versus placebo.
    

Detailed description: 
      One of the most serious side effects of drugs administered for sedation is untoward
      respiratory events. The relative prevalence of such events is thought to be high, occurring
      in up to 41% of patients in some cohorts. Many specific drugs and combinations have been
      recommended for moderate sedation, particularly when provided by a non-anesthesiologist. The
      use of an opioid and a benzodiazepine is the most frequent combination, partly because the
      availability of antagonists for both drugs may make a "rescue" easier. However, this
      combination results in frequent respiratory arrhythmias (combinations of obstructions, pauses
      and changes in respiratory patterns).There has not been a comprehensive study of the
      mechanisms underlying the disruptions of respiratory rhythm caused by agents commonly used
      for moderate sedation. This specific research, and the line of research it opens, has the
      potential to make the administration of anxiolytics and analgesics safer for patients at high
      risk for respiratory events.
    

Intervention name(s): Physostigmine; Oxygen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Physostigmine is a centrally acting acetylcholinesterase inhibitor that has been proposed as a treatment for sleep disordered breathing. It is currently FDA approved and used commonly by Anesthesiologists in the post anesthetic setting to reverse confusion caused by central anticholinergic medication effects.; The administration of nasal cannula-administered oxygen at a flow rate of 2 liters/minute is commonly performed during clinical sedation practice. Thus, this experiment employed its use to compare respiratory effects of oxygen versus room air.; The administration of placebo versus physostigmine was untertaken in the same sedation conditions on the alternate day in each subject (and with both room air and oxygen)
Other intervention name(s): Antilirium; Normal Saline
Intervention MeSH terms: Physostigmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Breathing; Sedation
Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma; Lymphoma, B-Cell; Lymphoma, Low-Grade
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the antitumor effect and safety of the product
      for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Zevalin (SH L 749 , BAY86-5128); Zevalin (SH L 749 , BAY86-5128)
Intervention type(s): Drug; Drug
Intervention description(s): 0,3mCi/kg; 0,4mCi/kg
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antigen; CD20
Meditation and Opioid Consumption in Total Joint Replacement Patients Undergo Primary Total Hip and Knee Replacement
Condition: Arthropathy of Knee; Osteo Arthritis Knee; Osteonecrosis; Meditation; Knee Osteoarthritis; Knee Disease; Knee Injuries; Opioid Use; Opioid Dependence; Opioid Use Disorder
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteonecrosis; Opioid-Related Disorders; Knee Injuries
Study type: Interventional

Summary: 
      The main purpose of this study is to look at whether meditation techniques can help reduce
      pain and opioid use after surgery.
    

Detailed description: 
      Background: The Center for Disease Control identified prescription drug abuse as one of the
      top 5 current health threats in the US. Orthopedic Surgeons rank among the top 3 prescribers
      of opioid analgesics. Opioids are commonly used following total knee arthroplasty. Peri-
      operative protocols have been developed to reduce opioid intake however complications related
      to opioid analgesics remain problematic resulting in increased morbidity and mortality. There
      is a pressing need for non-narcotic adjuncts that can minimize /eliminate the use of opioids
      following elective total knee arthroplasty (TKA). Mind-body techniques including mindful
      medication (MM) have been demonstrated to reduce pain in acute and chronic disease states.

      Purpose: To determine whether mindful meditation, in conjunction with standard analgesic
      protocols, can impact opioid consumption, pain and function following elective primary TKA.

      Methods: a prospective, randomized control trial was conducted in patients aged 18-99 with
      degenerative joint disease of the knee presenting for primary TKA. Controls received standard
      perioperative analgesia. In additional to standard analgesia, study patients performed
      Isha-Krya meditation peri-operatively for 2 weeks followed by 4 weeks post operatively.
      Outcome measures: opioid consumption, time to discontinue opioids, Pain by Visual Analog
      Score (VAS), Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) Global
      Health Short Form, Knee injury and Osteoarthritis Outcome Score (KOOS)
    

Intervention name(s): Mindful meditation
Intervention type(s): Behavioral
Intervention description(s): Adding mindful meditation to pre- and post-operative care for patients who are having a TKA
Other intervention name(s): meditation; Isha Kriya meditation; Sadhguru meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized to 2 groups. The Meditation group or the Control group. The meditation group was asked to meditate 2 times a day, for 2 weeks preoperatively and for 30 days post operatively
Masking: None (Open Label)
Primary purpose: Prevention
Envarsus XR in Lung Transplant
Condition: Lung Transplant
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients undergoing a lung transplant will be enrolled. All patients will undergo lung
      transplantation with standard post-operative management, including triple immunosuppression.
      As soon as the patient is deemed appropriate to take medications via the oral route, they
      will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's
      standard of care.
    

Detailed description: 
      Lung transplantation will be performed per standard-of-care techniques. All post-transplant
      management, including initial triple immunosuppression, will be carried out per standard of
      care. Once the patient is able to take medications via the oral route, they will be converted
      to Envarsus XR, which will be maintained for the first year post-lung transplant.
    

Intervention name(s): Extended-Release Tacrolimus; Immediate-Release Tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.; Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
Other intervention name(s): Envarsus XR; Prograf
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During IL-6 vs. TNF Antibody Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The present study will investigative the physiological effects of the cytokines interleukin-6
      (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with
      rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will
      decrease the cardiac and metabolic adaptations to exercise training compared to the
      inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised
      exercise training intervention study.
    

Detailed description: 
      80 patients with rheumatoid arthritis who are being treated with either interleukin-6
      receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four
      months prior to enrollment will be recruited and undergo baseline testing, including
      examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography,
      cardiac MRI.

      After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF
      inhibitor treatment.will be randomly allocated into one group receiving standard of care
      (control group) or a group performing supervised high-intensity interval training three times
      a week over a period of 12 weeks. The randomization procedure involves a computer-generated
      block randomization schedule in a ratio of 1:1 stratified by sex by an independent person.
      Following the 12-week intervention period, all groups will complete a series of follow-up
      tests (as baseline testing).
    

Intervention name(s): Exercise; No exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supervised high-intensity interval training for 12 weeks three times per week. The supervision may be physical or online supervision; Control group, therefore no supervised exercise regime
Other intervention name(s): High intensity interval training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Cardiac adaptations; Metabolic adaptations; High intensity interval training
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence
      of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
    


Intervention name(s): biphasic insulin aspart 50
Intervention type(s): Drug
Intervention description(s): A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment