bioihbjkbjnl/mcl2 huggingface dataset:
Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes
Condition: Healthy; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      GLP-1 is a hormone made by the body that promotes the production of insulin in response to
      GLP-1 is produced within the islets expressing prohormone convertase 1/3eating. However,
      there is increasing evidence that this hormone might help support the body's ability to
      produce insulin when diabetes develops. The purpose of this study is to determine the effect
      of endogenous GLP-1 secretion on insulin secretion in people with and without type 2
      diabetes.
    

Detailed description: 
      Accumulating evidence suggests that in rodents and humans GLP-1 is synthesized within islets
      and may act locally in a paracrine fashion. Indeed, mice with genetic loss of intra-islet
      GLP-1 exhibit decreased insulin secretion and impaired response to metabolic stressors.
      'Pancreatic' GLP-1 may contribute to the effects of DPP-4 inhibitors in rodents and humans.
      Antagonism of GLP1R with exendin-9,39 during fasting impairs the islet cell response to an
      I.V. glucose challenge. Islet GLP-1 content is increased in T2DM and in islets from
      non-diabetic humans exposed to hyperglycemia and Free Fatty Acids. These observations imply
      that paracrine GLP-1 secretion supports islet function in the presence of glucolipotoxicity.
      In this experiment we will examine the role of endogenous GLP-1 secretion in people with and
      without T2DM and during β-cell stress induced by FFA elevation.
    

Intervention name(s): Saline; Exendin-9,39; Saline + Intralipid/Heparin; Exendin-9,39 + Intralipid/Heparin
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Saline infused during the study; Exendin-9,39 infused during the study; Saline infused during acute insulin resistance; Exendin-9,39 infused during acute insulin resistance
Intervention MeSH terms: Heparin; Calcium heparin; Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS
Condition: Vitreoretinal Surgeries; Postoperative Nausea and Vomiting; Postoperative Pain
MeSH terms: Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The aim of this randomized trial is to assess the efficacy of preemptive analgesia using
      paracetamol or metamizole or both of them under SPI-guided anaesthesia for vitreoretinal
      surgery (VRS), presence of PONV (postoperative nausea and vomiting) and oculocardiac reflex
      (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring
      pain perception postoperatively.

      Patients will receive general anaesthesia combined with either preemptive analgesia using
      preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of
      1,0 g of acetaminophen or both of them together.
    

Detailed description: 
      Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular
      block are routine in modern anaesthesia, whereas monitoring of analgesia still requires
      further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable
      showing the nociception-antinociception balance into abovementioned parameters constituting a
      novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia
      (AoA) or tailor-made anaesthesia.

      Different options of preemptive analgesia are used to decrease the postoperative pain
      perception as well as diminish the rate of PONV by deceasing intraoperative consumption of
      intravenous narcotic analgesics
    

Intervention name(s): Metamizol; paracetamol; paracetamol and metamizole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram; in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram; in group PM patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram and paracetamol in a dose of 1 gram
Other intervention name(s): Pyralgin
Intervention MeSH terms: Acetaminophen; Dipyrone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Surgical Pleth Index (SPI); General Anaesthesia (GA),; Numerical Rating Scale (NRS); Adequacy of Anaesthesia (AoA); Oculocardiac reflex (OCR); paracetamol; metamizole
Spatial Orientation and Vestibular Function
Condition: Vestibular Perception; Damaged Vestibular System
Study type: Interventional

Summary: 
      Spatial orientation is achieved through central integration of various sensory inputs and
      prior knowledge in a statistically optimal way based on the reliability of the different
      signals. When upright, the subjective visual vertical (SVV) is accurate and precise in
      healthy human subjects. However, when roll-tilted, both systematic physiologic, roll-angle
      dependent errors (termed A- und E-effect) and a decrease in precision of SVV estimates have
      been described. In case of a sudden unilateral vestibular deficit (UVD) a significant
      imbalance between the two vestibular organs occurs at the level of the vestibular nuclei,
      disrupting the percept of vertical. The most frequent cause for such a unilateral vestibular
      deficit is an inflammation of the vestibular nerve by viral infection, termed vestibular
      neuritis (VN). While in the acute stage these patients are usually immobilized due to the
      severity of symptoms, recovery is overall good and most patients return to their daily
      activities within a few weeks. Central compensation is considered the most important
      contributor to recovery in these patients, while recovery of the damaged vestibular nerve
      occurs only in a minority of cases. While acute VN presents with sudden UVD, bilateral
      vestibular deficits (BVD) typically evolve more slowly and re-sult in distinct complaints.

      The percept of vertical can be quantified by assessing the subjective visual vertical or SVV,
      which is usually done by letting subjects adjust a luminous line along perceived direction of
      gravity. Modifications of this paradigm which are independent from retinal input are e.g.
      adjustments of a rod along perceived vertical in complete darkness (termed subjective haptic
      vertical or SHV) and self-alignments along perceived vertical (subjective postural vertical
      or SPV) and perceived horizontal (subjective postural horizontal or SPH) in complete
      darkness. Previous research has proposed no unified percept of vertical as errors assessed in
      different domains (visual, haptic, postural) were diverging in patients with acute UVD. While
      errors were profound for the SVV, the SPV remained accurate.

      Here the investigators aim to quantify verticality perception in patients with either acute
      or chronic UVD and patients with BVD both in upright and roll-tilted positions. Specifically,
      the investigators will use different paradigms to address the ques-tion whether there is a
      unified percept of vertical and how a bias in this percept changes over time.
    


Intervention name(s): vestibular stimulation
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety of Polyphenon E in Multiple Sclerosis Pilot Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label 6 month study. All subjects will be treated with Polyphenon E
      (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be
      safety. Secondary outcomes are the change in NAA levels over 6 months as measured by
      MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E
      will protect neurons and thus increase NAA levels.
    

Detailed description: 
      Additional clinical data include changes in EDSS, MS functional composite and cognitive
      testing.
    

Intervention name(s): Polyphenon E
Intervention type(s): Drug
Intervention description(s): Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.
Other intervention name(s): EGCG; Green tea extract
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; safety; open label; Polyphenon E; EGCG; NAA; N-acetyl-aspartate; MRI
Telmisartan/Hydrochlorothiazide (HCTZ) Fixed Dose Combination Compared to Its Monocomponents in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose
      combination in comparison to the single unit formulations
    


Intervention name(s): BIBR 277 SE and HCTZ; BIBR 277 SE; HCTZ
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A - fixed dose combination; Treatment B - Monocomponent; Treatment B -Monocomponent
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Volatile Organic Compounds in Cystic Fibrosis
Condition: Cystic Fibrosis; Pseudomonas Aeruginosa
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This experiment is designed to test the effectiveness of a new electronic nose device, which
      allows a non-invasive breath test for markers of lower respiratory tract infection, which may
      predict the probability of bacterial organisms in the lower respiratory tract. It consists
      of:

        -  A breath collection apparatus for collection of volatile organic compounds in breath
           onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample
           of room air.

        -  Analysis of the volatile organic compounds in breath and room air by short acoustic
           wave/gas chromatography.

        -  Interpretation of the volatile organic compounds with a proprietary algorithm in order
           to predict the probability of lower respiratory tract colonization and infection.

      This study will test the hypothesis that the investigators can identify the presence of
      Pseudomonas aeruginosa by sampling the "head space" above culture media of sputum provided by
      patients with cystic fibrosis. This study will test the additional hypothesis that the
      investigators can identify the presence of Pseudomonas aeruginosa by sampling exhaled breath
      from the patient providing the sputum.
    


Intervention name(s): Cystic Fibrosis patients
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be selected from Dr. Landon's primary care clinic.
      
Keywords: Cystic Fibrosis; Pseudomonas aeruginosa; Volatile Organic Compounds; Electronic nose; Gas Chromatography
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

        -  To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo
           in children suffering from acute diarrhoea and treated for 7 days.

      Secondary objective:

        -  To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
    


Intervention name(s): Spores of Bacillus Clausii Probiotic Strain
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors
Condition: HER2-positive Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, phase II，multi-center study to evaluate the efficacy, safety and
      tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors.
    

Detailed description: 
      KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping
      epitopes of HER2, leading to a dual HER2 signal blockade.KN046 is a PD-L1 - CTLA-4 bispecific
      antibody. The study composes of two stages. The first stage plans to enroll HER2-positive
      solid tumors. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with
      KN046 at 5 mg/kg Q3W at the first stage.A SMC meeting will decide whether to proceed to the
      nest stage.
    

Intervention name(s): KN026 combination
Intervention type(s): Drug
Intervention description(s): 30 mg/kg Q3W KN026+ 5 mg/kg Q3W KN046
Other intervention name(s): IO therapy
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: KN026 and KN046; HER2-Positive Solid Tumor
Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury
Condition: Traumatic Brain Injury; Brain Concussion; Head Injury; Dizziness
MeSH terms: Vertigo; Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Brain Concussion; Dizziness; Wounds and Injuries
Study type: Interventional

Summary: 
      The main aim of this study is to evaluate the effect of vestibular rehabilitation and balance
      training on patients with dizziness and balance problems after traumatic brain injury.
    

Detailed description: 
      8 000 to 10 000 persons are admitted to hospitals in Norway with traumatic brain injury
      (TBI)annually. Dizziness and balance problems have an incidence of 30-80% in this population.

      Studies show that dizziness and imbalance has the potential to restrict several aspects of
      personal and social life.

      Vestibular rehabilitation (VR) is an accepted and effective treatment for dizziness and
      imbalance. However there is lack of evidence/knowledge about its effect on TBI patients.

      The study is designed as a randomized controlled trial study (RCT). Patients aged 16-60
      admitted to Oslo University Hospital with TBI and symptoms of dizziness and imbalance are
      included 8 weeks after the injury.

      The intervention and control group will receive multidisciplinary assessment and evaluation.
      The intervention group will in addition receive group training and a home exercise program by
      physiotherapists. The intervention will consist of a individually adapted Vestibular
      Rehabilitation and balance program.

      The main outcome measurement is the Dizziness Handicap Inventory (DHI). The study has several
      other self-report and performance based outcome measures. The outcome measures will be
      performed before and after the intervention and 6 months after the injury.
    

Intervention name(s): Multidisciplinary evaluation and VR; Multidisciplinary evaluation
Intervention type(s): Other; Other
Intervention description(s): Multidisciplinary assessment and evaluation and VR - Vestibular rehabilitation and balance training. Individually adjusted exercises in groups twice a week for two months. Home exercise program.; Multidisciplinary assessment and evaluation.
Other intervention name(s): Multidisciplinary evaluation and Vestibular rehabilitation; Multidisciplinary assessment and evaluation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic brain injury; Dizziness; Vestibular rehabilitation; Balance rehabilitation
Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in
      relief of acute postoperative pain and in reduction of analgesics consumption on demand and
      their side effects in patients after ambulatory knee arthroscopy
    


Intervention name(s): Auricular acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute pain; postoperative pain; auricular acupuncture
Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease
Condition: Hypotension, Orthostatic; Parkinson Disease; Autonomic Failure; Cognitive Impairment
MeSH terms: Parkinson Disease; Pure Autonomic Failure; Hypotension, Orthostatic; Hypotension
Study type: Interventional

Summary: 
      Study on orthostatic Hypotension in Parkinson's disease
    

Detailed description: 
      Orthostatic hypotension (OH) in Parkinson's disease (PD) may not only be related to dizziness
      or light headedness but to deficits in attention, visual, and verbal memory. Would a
      successful treatment of OH which includes physiotherapy significantly improve OH and these
      cognitive deficits? By means of a randomized cross-over trial, we want to measure and compare
      the effects of OH therapy on orthostatic tolerance, as well as on attention, visuo-spatial
      working memory, and verbal memory in patients with PD. If confirmed, therapy of orthostatic
      hypotension would provide a sound and simple approach to improve those cognitive deficits
      originating from orthostatic hypotension.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): Ambulatory leg-muscle oriented physiotherapy (2 x 45 minutes per week for at least 8 weeks) at Aachen University Hospital. Daily protocol of leg muscle training, exercises, sufficient fluid intake of 2liter/day, pressure stockings.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of the experimental medication
      BMS-986256 in healthy participants.
    


Intervention name(s): BMS-986256; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction
Condition: Diabetes Mellitus; Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine whether exercise has further beneficial effects on
      improving cardiovascular risk factors such as hypertension, high cholesterol level or
      diabetes mellitus, when added to the standard program of health check followed by life style
      recommendations.
    

Detailed description: 
      Multiple risk factors contribute to the causation of atherosclerotic cardiovascular disease.
      Past studies indicate that exercise exerts its protective effects on the disease through
      actions on multiple cardiovascular risk factors simultaneously; however, the studies focused
      on the effect of exercise predominantly on subjects with a single risk factor. Does exercise
      differentially act on various risk factors in the same subject? Do subjects with multiple
      risk factors respond differently to exercise than those predominantly with a single risk
      factor do? To our knowledge, this is the first large-scale study to test the efficacy of
      exercise on subjects with multiple risk factors. Exercise in fitness clubs has uniquely
      fitting features for middle to older aged people with multiple risk factors: access is
      relatively easy because there are usually many clubs throughout the city; the control of
      exercise intensity or heart rate is made precise, rendering exercise safer when treadmills or
      bicycles are used as a mainstay of aerobic exercise as in this study; and cardiac arrest, the
      most feared complication of exercise, will be most likely to be properly handled since in
      recent years the installment of automated external defibrillators has been increasingly
      popular in many clubs.

      Comparison: Exercise vs. standard care comparison is to be made only for the first 6-month
      period. The second 6-month period is for follow-up and other purposes.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Exercise; Fitness Club; Randomized Controlled Trial; Cardiovascular Risk Factor; Overweight; Inactivity
Safety and Efficiency of γδ T Cell Against Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing
      surgery, for example, cryosurgery going to be investigated.
    

Detailed description: 
      Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the
      patient will be separated from peripheral blood. After making them potential cancer killer γδ
      T Cell, they will be infused to the patients as an immunotherapy treatment NOTE: Originally,
      our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand
      Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of
      cancer patients could not be effectively expanded, including cell number, cell purity and
      cell function could not meet the requirements of reinfusion. Meanwhile, those patients could
      not tolerate 100ml of blood drawing for culture every 2 ~ 3 weeks.

      Therefore, we submitted new clinical study application to the ethical committee of the Fuda
      Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous
      protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted
      allogeneic cells instead of autologous in our subsequentially clinical study.
    

Intervention name(s): Cryosurgery , IRE surgery ,surgery; γδ T cells; γδ T cells/ Surgery
Intervention type(s): Procedure; Biological; Other
Intervention description(s): surgery will be used in local tumor; γδ T cells will be used against; Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Immunotherapy, γδ T Cell, Breast Cancer