bioihbjkbjnl/mcl2 huggingface dataset:
Diabetes Resolution and Hormone Changes After BPDLL and LSG
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb
      (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.
    

Detailed description: 
      Twelve patients with diabetes mellitus type 2 (DM 2) and body mass index (BMI)> 50kg/m2) will
      undergo BPDLL and 12 twelve patients with DM 2 and BMI 40-50 kg/m2 will undergo LSG. The
      patients will be evaluated before and 1, 3 and 12 months after surgery with an oral glucose
      tolerance test. The investigators aim to investigate the effects of surgery on diabetes
      resolution, hypertension, dyslipidemia, and also on fasting, and glucose-stimulated insulin,
      glucagon, ghrelin, peptide-YY and glucagon-like peptide-1 (GLP-1) responses during during an
      oral glucose tolerance test (OGTT). Resolution of diabetes mellitus will be evaluated
      according to the criteria of American Diabetes Association with an OGTT. The effects on
      appetite and satiety will be also evaluated with the use of visual analog scores.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twelve patients with diabetes mellitus type 2 and BMI> 50kg/m2 will undergo BPDLL and 12
        patients with diabetes mellitus type 2 and BMI 40-50kg/m2 will undergo LSG
      
Keywords: biliopancreatic diversion; sleeve gastrectomy; diabetes mellitus; weight loss; ghrelin; PYY; GLP-1
Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects
Condition: Acute Stress Reaction
MeSH terms: Fractures, Stress; Stress Disorders, Traumatic, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of acutely dosed Neurexan using an
      experimental stress test called the Trier Social Stress Test
    

Detailed description: 
      An acute stress reaction is a biopsychological condition arising in response to an event
      which is individually regarded as emotionally stressful. The onset of a stress response is
      associated with specific physiological actions in the sympathetic nervous system, both
      directly and indirectly through the release of adrenaline and to a lesser extent
      noradrenaline from the medulla of the adrenal glands. These catecholamine hormones facilitate
      immediate physical reactions by triggering increases in heart rate and breathing,
      constricting blood vessels. The other major player in the acute stress response is the
      hypothalamic-pituitary-adrenal axis.

      Although stress has been described as a non-specific psychophysiological response to
      environmental stimuli, it is possible to discern specific bodily stress responses caused by
      specific emotional reactions to novel, ambivalent or uncontrollable situations and stimuli.
      For example, social stress induces elevated cortisol levels, particularly if the stressor is
      uncontrollable, unpredictable, and constitutes a social-evaluative threat due to the judgment
      of others such as in the Trier Social Stress Test. Usually, the TSST induces a two-fold
      increase in saliva cortisol with peaks around 10-20 min. after stress test termination. Also,
      an average increase in heart rates of around 20 beats per minute (bpm) is observed during the
      TSST. In addition, emotional states and feelings have been shown to be affected by this
      stress test, such as marked increases in stress perception,anxiety and emotional insecurity
      as well as decreases in mood, calmness and feeling awake.

      Preliminary results indicate that Neurexan® may improve coping abilities in stressful
      situations. This study aims to investigate the effect of Neurexan® on subjectively perceived
      nervousness and tension during an acute stressful situation and to characterize the efficacy
      profile of Neurexan®.
    

Intervention name(s): Neurexan®; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes; 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Other intervention name(s): Lactose monohydrate, magnesium stearate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute stress reaction; stress; stress perception; physiological stress response; Neurexan
A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men
Condition: Healthy Volunteers Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese
      men when it is given together with semaglutide. Participants will get NNC0480-0389 and
      semaglutide or 2 doses of placebo - which treatment participants get is decided by chance.
      NNC0480-0389 is a new medicine that has not been previously approved. It means that the
      medicine has not yet been approved by the health authorities. Semaglutide is a newly approved
      antidiabetic medicine that helps to lower blood sugar levels in patients with type 2
      diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389
      targets a different part of the system that regulates sugar levels in the body than
      semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more
      effectively lower sugar levels in the blood. Participants will get 2 injections of the study
      medicine. It will be injected with a needle into a skin fold on participants' stomach. The
      study will last for a maximum of 72 days. Participants will have 10 scheduled visits with the
      study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5
      nights).The study includes blood sampling.
    


Intervention name(s): NNC0480-0389; Placebo (NNC0480-0389); Semaglutide; Placebo (Semaglutide)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.; A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.; A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.; A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight
      non-small cell lung cancer.

      PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who
      have non-small cell lung cancer that cannot be surgically removed.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the safety of multiple endobronchial treatments with adenovirus p53
           bronchoalveolar lavage of a single lobe of the lung in patients with bronchoalveolar
           cell lung carcinoma.

        -  Evaluate expression of the p53 gene and induction of apoptosis in tumor and normal
           tissues exposed to the virus in these patients.

        -  Evaluate whether transbronchial administration of adenovirus p53 results in improved
           local tumor control in these patients.

      OUTLINE: This is a dose escalation study.

      Patients undergo biopsy and receive adenovirus p53 by bronchoalveolar lavage on days 1 and
      15. Patients repeat biopsy on days 3 and 28. If there is evidence of clinical benefit or
      response without significant toxicity, patients may receive a maximum of 3 courses. Treatment
      beyond 3 courses must be approved by protocol investigator.

      Cohorts of 3 patients are treated at escalating dose levels of adenovirus p53. Patients in
      each cohort are followed for dose limiting toxicity (DLT) for 2 weeks after completion of one
      course before dose escalation proceeds in subsequent cohorts. If 1 of 3 patients at a dose
      level experiences dose limiting toxicity (DLT), then 2 additional patients are entered at the
      same dose level. If more than 1 of 5 patients experience DLT, the previous dose is the
      maximum tolerated dose (MTD). An additional 10 patients are treated at the MTD.

      Patients are followed every 3 months for the first 2 years, every 6 months for the next 3
      years, and annually thereafter.

      PROJECTED ACCRUAL: There will be 15 patients accrued into this study over 1 year.
    

Intervention name(s): Ad5CMV-p53 gene
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; bronchoalveolar cell lung cancer
Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can
      involve brain and nervous system functions such as movement, learning, hearing, seeing, and
      thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these
      problems occur as the baby grows in the womb, but they can happen at any time during the
      first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem
      cells are known as a effective therapy.

      In this study the investigators evaluate the side effect of multiple intrathecal injection of
      bone marrow stem cell in patients with cerebral palsy.
    

Detailed description: 
      In this study,we evaluate the safety of multiple transplantation of bone marrow derived stem
      cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the
      study.first of all all the physical exam,laboratory test,EEG and MRI is done.after hospital
      admission,the patient underwent bone marrow transplantation.In laboratory,the cells are
      separated and prepared for injection.after 24hours the neurosurgeon inject the
      cells(intrathecal).the patient would be under observed for 48hours.If no allergic reaction or
      abnormal neurological symptoms accrued,patients can be discharged and would be followed up
      1,3 and 6months after injection.at the end of the 6months,the patients would receive second
      injection as same as the previous process.then they are followed at 1,3 immediate local and
      systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood
      pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter
      dysfunction,nausea,vomiting,head ache.EEG,MRI,GMFM66
    

Intervention name(s): stem cell intrathecal injection
Intervention type(s): Biological
Intervention description(s): Intrathecal injection of Bone marrow derived CD133 cells
Other intervention name(s): Stem cell transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy CD133 cells intrathecal injection
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Condition: Pediatric Cancer; Febrile Neutropenia; Oncology; Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia; Febrile Neutropenia
Study type: Observational

Summary: 
      In this pilot study the feasibility continous recording of vital signs in pediatric patients
      under chemotherapy for cancer, is studied.

      Vital signs and are recorded with two different wearable devices (WDs): Everion®, by
      Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland.
      Patients can choose if they want to wear one or both WDs during this study. Those opting to
      wear two WDs can choose if they want to wear them in parallel, or sequentially.

      Results from the two different WDs will be compared. Study duration for each participant is
      14 days per device.
    

Detailed description: 
      In a previous study (Bern 2019 WD Pilot, NcT04134429) the investigators found that continuous
      recording of vital signs with the Everion® is feasible in good quality across a wide age
      range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. However, the
      pre-defined criterion to claim feasibility was not formally reached and low compliance was
      the main reason identified.

      In this study the investigators want to assess the impact of measures aiming to increase
      compliance on feasibility for the Everion®.

      Second, the investigators want to assess the feasibility of a second device, made
      commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two
      different wearable devices will be compared. Study duration for each participant is 14 days
      per device.
    

Intervention name(s): Everion®; CORE®
Intervention type(s): Device; Device
Intervention description(s): The Everion® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.; The CORE® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients undergoing chemotherapy for cancer treated in the departments of
        pediatric oncology at the Children's university hosptials Bern or Basel.
      
Keywords: Wearable device; Everion®; CORE®; Continuous recording; Vital signs; Pediatric oncology
Comparison of Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome. Pregabalin is the only
      medication that has been approved to treat fibromyalgia in China. Currently, there has been a
      growing interest in the development of non-pharmacological therapies. Ba-Duan-Jin is an
      ancient Chinese exercise for health promotion yet easy to learn. Findings from our previous
      study showed an effectiveness and good safety of Ba-Duan-Jin in patients with fibromyalgia.
      This study is to evaluate the effectiveness comparison of Ba-Duan-Jin and pregabalin in
      managing fibromyalgia symptoms experienced by Chinese patients.
    


Intervention name(s): Ba-Duan-Jin; Pregabalin capsule
Intervention type(s): Other; Drug
Intervention description(s): Ba-Duan-Jin is a common form of "self-health-care" Qigong exercise that has been practiced by Chinese people for at least eight hundred years. It consists of eight sets of simple movements. By combining meditation with slow, graceful movements, deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear, previous clinical trials have demonstrated that Ba-Duan-Jin can improve sleep quality, physical health, and mental health in patients with various chronic diseases; Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.
Other intervention name(s): Baduanjin; Eight Brocades; Eight-Section Brocade
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eight Brocades; Ba-Duan-Jin; Baduanjin; Qigong; Pain
Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and the tolerability of the substitution
      of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable
      renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with
      tacrolimus and mycophenolate mofetil.
    


Intervention name(s): Mycophenolate sodium
Intervention type(s): Drug
Intervention description(s): Mycophenolate sodium
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney transplantation; conversion; mycophenolate mofetil; mycophenolate sodium,; tacrolimus
AZD8529 Single Ascending Dose Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate safety, tolerability, PK and PD effects of orally administered
      AZD8529 after single ascending doses
    


Intervention name(s): AZD8529; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Phase I
A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to assess the effect of repeated oral doses of
      Rifampicin on the pharmacokinetic profile of a single dose of Fluzoparib.

      The secondary objective of the study was to assess the safety of Fluzoparib given alone
      versus Fluzoparib coadministered with Rifampicin.
    


Intervention name(s): Fluzoparib; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): single dose on Day 1 and Day 12; QD on Day 5-14 for 10 days
Intervention MeSH terms: Rifampin; Fluzoparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy
Condition: Breast Cancer
Study type: Observational

Summary: 
      The purpose of this study is to develop a questionnaire to measure patient expectations of
      breast-conserving therapy (breast-conserving surgery and radiation). This questionnaire will
      assist both surgeons and patients by helping provide valuable information to patients about
      what to expect during and after surgery.
    


Intervention name(s): qualitative interviews with patients; questionnaires
Intervention type(s): Behavioral; Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MSKCC clinics
      
Keywords: Breast Conserving Therapy; Reported Outcomes Instrument; 16-325
Midazolam Versus Dexamethasone as an Adjuvant to Local Anesthetics in the Ultrasound Guided Hydrodissection of Median Nerve for Treatment of Carpal Tunnel Syndrome Patients
Condition: Pain Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      midazolam and dexamethasone both can counteract chronic pain. either via GABA mimetic action
      or via anti prostaglandins
    

Detailed description: 
      Entrapement syndrome - namely median nerve compression in carpal tunnel syndrome - causes
      chronic pain that can be refractory to medical treatment . Ultrasound guided hydrodissection
      is an option for alleviating pain . Recurrence is the main side effect of injection. We try
      in this research to prevent recurrence rate . Midazolam and dexamethasone both are used in
      chronic pain . Midazolm act by GABA mimetic action while dexamethasone act by decrease
      interleukin formation
    

Intervention name(s): Dexamethasone; Midazolam injection
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam; intracarpal injection of midazolam and bupivacaine 0.5%
Other intervention name(s): midazolam
Intervention MeSH terms: Dexamethasone; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups received hydrodissection sonar guided , one group received 50 mic/kg midazolam and the other received 8 mg dexamethasone
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Midazolam; median nerve; dexamethasone