bioihbjkbjnl/mcl2 huggingface dataset:
Interventional Study on the Impact of the Hypnosis Used as Sedation or Relaxation in the Breast Oncologic Surgery
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aims of the study are to compare the recovering period between a group of patients with
      conventional sedation, a group using hypnosis as sedation during the surgery and a third
      group using hypnosis as a relaxation method and preparation but enjoying a classic sedation
      for their surgery.

      Comparaison of pain ( different types of pain), consumption of pain killers ,anxiety and
      fatigue on day0,1, 8 after surgery and every. 3 months during the first 2 years of follow up.

      Comparisons are also performed in substudies defined by treatments modalités. Inflammatory
      parameters s ( CRP_ C reactive protein, NLR- ( neutrophils to lymphocyte ratio) are measured
      on Day 0, 1, 8 and also salivary Immunoglobulins and different endocannabinoids.
    

Detailed description: 
      Hypnosis has already demonstrated benefits among breast cancer patients undergoing oncologic
      surgery. Different side effects were measured during the post operative period and at each
      follow up visit by physicians in order to carefully compare side effects in the 3 armes of
      patients..

      Our hypothesis was that hypnosis sedation generates less perioperative inflammatory reaction.

      A substudy of 50 patients was also dedicated to the investigation ofsalivary immunoglobulins
      and dosage of differents endocannabinoids
    

Intervention name(s): General anesthesia; Hypnosis sedation; General anesthesia with preoperative session of hypnosis
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Patients will undergo oncologic breast surgery on general anesthesia.; Patients will undergo oncologic breast surgery on hypnosis sedation.; Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.
Intervention MeSH terms: Anesthetics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of JNJ-42847922 (Seltorexant) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the absolute bioavailability of seltorexant in
      healthy participants following a single oral dose of seltorexant and an intravenous (IV)
      infusion dose of 14C-seltorexant.
    


Intervention name(s): Seltorexant
Intervention type(s): Drug
Intervention description(s): Seltorexant will be administered orally as a tablet and as an intravenous infusion of 14C-seltorexant.
Other intervention name(s): JNJ-42847922
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel
      syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).
    

Detailed description: 
      1. A randomized controlled trial

        2. Moxibustion treatment, sham control

        3. To observe the safety and efficacy of moxibustion treatment versus placebo control

        4. Evaluation by intestinal microbial structural and diversity changes using 16S rDNA
           sequencing

        5. Evaluation by structural MRI and resting state-functional MRI

        6. Evaluation by ERP
    

Intervention name(s): moxibustion; Sham moxibustion
Intervention type(s): Device; Device
Intervention description(s): Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral). using mild-warm moxibustion，the surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.; Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral); using sham mild-warm moxibustion，the surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moxibustion; irritable bowel syndrome; Magnetic Resonance Imaging
Defective Atypical Protein Kinase C (PKC) Activation in Diabetes and Metabolic Syndrome
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The investigators are examining the activation of insulin signaling factors in skeletal
      muscles of human diabetics. The investigators are characterizing the defects in signaling,
      and are examining the effects of anti-diabetic agents and exercise on signaling to glucose
      transport biochemical machinery and whole body glucose disposal.
    

Detailed description: 
      We have provided clear evidence that insulin activation of all three signaling components,
      Viz., IRS-1-dependent PI 3-Kinase, atypical protein kinase C (aPKC) and PKB/Akt is defective
      in diabetic muscle. These defects are best seen when insulin activation is conducted at both
      half-maximal and maximal stimulation. Moreover, whereas previous studies had shown that
      treatment with metformin (Met) alone improves aPKC activation, or that treatment with
      thiazolidinedione (TZD) alone produces increases in activation of IRS-1/PI3K and aPKC when
      evaluated at maximal insulin stimulation, we have recently found that combined treatment with
      Met plus TZD for 6 weeks provokes marked increases in insulin effects on all three signaling
      factors at both half-maximal and maximal insulin stimulation. This work is being prepared for
      submission for publication.

      We have also evaluated the improvement in insulin signaling in diabetic muscle 4 hours after
      acute endurance (one-legged) exercise and found that the responsiveness of aPKC to the lipid
      PI3K-derived activator, PIP3, was improved. Also increased was the activation by insulin of
      IRS-2-dependent PI3K, ERK1/2, and downstream protein synthesis machinery, viz., p70S6 kinase
      and eukaryotic elongation factor eEF2. These effects of exercise would be expected to enhance
      glucose transport and utilization by muscle, and promote protein synthesis, i.e., an anabolic
      response.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        type 2 diabetes controlled by diet or oral agents and comparable non-diabetic control
        subjects
      
Biospecimen description: 
      Muscle biopsies taken before and after insulin stimulation in euglycemic clamp studies
    
Keywords: Diabetic
Which is a Better Breakfast? Egg or Cereal?
Condition: Hunger; Satiety
Study type: Observational

Summary: 
      Which is a better breakfast? Egg or cereal?
    

Detailed description: 
      Which breakfast has the most beneficial effect on blood glucose and insulin, blood hormones
      and blood pressure, egg or cereal breakfast? Over a seven week period the participant will
      take part in eating breakfast of either egg breakfast or cereal breakfast which will be
      monitored. Blood samples will be taken before participants eat and different times throughout
      until after Lunch on day 1 and day 7. Questionnaires will be given to determine satiety
      (feeling of fullness) and hunger before and after breakfast and lunch. After a two week
      period participants will return for another week of the same procedure and tests that was
      followed from Day 1 though day 7 listed. However, this time participants will be eating the
      second of the two breakfasts whichever one they did not have for the first test period.
    

Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        In the community area of Baton Rouge, LA area exclusively random process to guarantee that
        each participant or population has specified chance of selection.
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Participants in this study will be randomized to receive either oral vitamin D pills OR
      ultraviolet light treatment. The investigators will compare how these two methods of raising
      vitamin D levels will affect cholesterol levels.
    

Detailed description: 
      Potential subjects will be screened for eligibility, including serum 25(OH)D levels <20ng/ml.
      Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000
      units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks.
      Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be
      measured monthly. For participants with levels <35 ng/ml, additional doses of oral vitamin D3
      or UV radiation will be administered.

      A subset of participants from both groups will participate in a skin biopsy cohort, where
      skin biopsies are obtained before and after 8 weeks of treatment.
    

Intervention name(s): Oral Vitamin D3; Ultraviolet Light
Intervention type(s): Dietary Supplement; Radiation
Intervention description(s): 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed; 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of AZD0530 (Saracatinib) in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Alzheimer's disease is a devastating neurodegenerative disorder, for which there is currently
      no effective treatment to slow or halt progression. Beta amyloid peptide accumulates in the
      brains of those with Alzheimer's, and is thought to play a major role in triggering the
      dementia. The investigators recently characterized a molecular pathway by which ß-amyloid
      damages neurons, and showed that the protein termed Fyn kinase is crucial. Our data suggest
      that blocking Fyn will have a significant therapeutic benefit for Alzheimer's. Astra Zeneca
      has developed a blocker of Fyn and related kinases (AZD0530) for the treatment of cancer.
      Chronic AZD0530 administration is well tolerated in humans, and the investigators propose to
      test its potential as a novel Alzheimer's disease modifying therapy. This study will assess
      the safety and tolerability of AZD0530 in patients with Alzheimer's disease.
    


Intervention name(s): saracatinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral drug given to experimental group; Placebo given to placebo group
Other intervention name(s): AZD0530
Intervention MeSH terms: Saracatinib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch
Condition: Chronic Liver Disease; Liver Fibrosis; Liver Steatoses
MeSH terms: Liver Diseases; Liver Cirrhosis; Fatty Liver; Fibrosis
Study type: Interventional

Summary: 
      This study is aimed to compare the results and operating characteristics of liver stiffness
      measurement with the use of Fibroscan (EchoSens, France) and iLivTouch (Wuxi Hisky Medical
      Technologies Co., China) in patients with chronic liver diseases.
    

Detailed description: 
      This is prospective comparative trial to assess diagnostic characteristics of non-invasive
      methods of liver fibrosis and steatosis assessment based on the measurement of liver
      stiffness. The null hypothesis is that novel device, iLivTouch FT100/FT200 and standard probe
      allows to obtain similar results of liver stiffness and controlled attenuation parameter
      compared to FibroScan 530 and probes M+ and XL+ in patients with chronic liver diseases.
      According to the study protocol, standard examination will be performed to eligible subjects
      on the same day with the use of both devices. At least 10 measurements will be performed with
      the use of each device to each subject after overnight fasting. The medians of liver
      stiffness and controlled attenuation parameter measurements, their interquartile range,
      success rate of measurements and related interpretations of the results (grades of liver
      fibrosis and steatosis) will be compared. To assess the variability of the results,
      demographic data (age, biological sex, ethnicity) will be collected; weight and height of the
      subjects will be measured on the day of examination. Medical history of the subjects will be
      examined to extract data, confirming the presence of chronic liver diseases and ensure
      eligibility.
    

Intervention name(s): iLivTouch
Intervention type(s): Diagnostic Test
Intervention description(s): Eligible subjects will undergo liver stiffness and controlled attenuation parameters examination with two devices on the same day
Other intervention name(s): FibroScan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ilivtouch; fibroscan; liver stiffness measurement; controlled attenuation parameter; non-alcoholic fatty liver disease; liver steatosis
Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients
Condition: Anemia; Inflammation; Malnutrition
MeSH terms: Malnutrition; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The response of Continuous Erythropoietic Receptor Activator (CERA) with different dose
      interval and the survey for influence factors:

      We aim to evaluate a better clinical response which can be achieved by different dosing
      interval of a fixed dose of CERA. We expect this study can determine the dosing schedule with
      better clinical response to CERA and identify the associated factors predicting the
      cost-effectiveness of CERA in maintenance hemodialysis (HD) patients in Taiwan.
    

Detailed description: 
      We included HD patients with stable hematocrit (between 30~36%) under intravenous
      administration of CERA 100 μg once monthly for two months. Then they were shifted to receive
      CERA 50μg twice monthly for anther two months and finally they were shifted back to receive
      CERA 100 μg once monthly again for additional two months. Then we measured and compared the
      erythropoietic response (hematocrit, hemoglobin), profiles of iron status as well as
      nutritional status and inflammatory markers among the study subjects every two months for a
      total of 6 months. Those who had bleeding or received surgery or blood transfusion were
      excluded.
    

Intervention name(s): CERA
Intervention type(s): Drug
Intervention description(s): changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA
Other intervention name(s): Full name: Continuous Erythropoietic Receptor Activator; Abbreviation : CERA; Generic name: Methoxy polyethylene glycol-epoetin beta; Brand name：Mircera®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malnutrition, inflammation, and anemia (MIA) syndrome,; hemodialysis,; erythropoietin stimulating agent (ESA),; cost-effectiveness,; pharmacokinetics,; endothelial dysfunction
A Study Exploring the Use of Challenge Agents in Healthy Volunteers - Intervention Specific Appendix
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to characterize the disruption of intestinal barrier as a result
      of indomethacin challenge in healthy volunteers using an orally administered
      lactulose-mannitol test.
    


Intervention name(s): Indomethacin; Lactulose-mannitol
Intervention type(s): Drug; Diagnostic Test
Intervention description(s): Indomethacin capsules will be administered orally.; Lactulose-mannitol solution will be administered orally.
Intervention MeSH terms: Indomethacin; Mannitol; Lactulose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with
      pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite
      dual therapy with metformin and a sulfonylurea.
    

Detailed description: 
      This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria:
      type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to
      their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for
      > 10 weeks. > 20 years old; A1C:> 7.0 % and < 11% Exclusion criteria: insulin use within 12
      weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone,
      impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase (ALT) or
      aspartate aminotransferase levels (AST) > 2.5 times the upper limit of normal (ULN), current
      or prepare to pregnancy and lactation.

      Primary Purpose:

      compare the change in hemoglobin A1c and the proportion of patients achieving A1C < 7%
      between the 2 groups

      Secondary Purposes:

        1. Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP)

        2. Homeostasis model assessment-β cell function(HOMA-β) will be calculated to assess
           changes in β-cell function and HOMA-insulin resistance(HOMA-IR)to assess changes in
           insulin resistance

        3. Body weight change, proportion of side effects
    

Intervention name(s): Sitagliptin; pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): add sitagliptin100mg/d to pre-study OADs; add pioglitazone 30mg/d to pre-study OADs
Other intervention name(s): Januvia; actos
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sitagliptin; pioglitazone; type 2 diabetes
Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study.
Condition: Beta-Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to compare the effectiveness and safety of two hemoglobin F
      inducer. This is single centered interventional pilot study is to compare the efficacy and
      safety parameters in beta thalassemia patients. As this is a pilot study, the investigator
      took a small number of patients. The Sample size was calculated by the World health
      organization sample size calculator. After screening 39 patients and 24 patients were
      eligible for enrollment in this study.

      The main objective was to evaluate safety of both drugs in genetic disorder like thalassemia.
      for safety evaluation, hematological parameters were evaluated that includes total bilirubin
      , indirect bilirubin, Serum Glutamate Pyruvate Transaminase, serum glutamic-oxaloacetic
      transaminase, urea, creatinine and lactate dehydrogenase were monitored . Moreover to
      evaluate the efficacy of drug, hematological parameters that includes hemoglobin, red blood
      cells , nucleated red blood cells , reticulocytes count, Red blood cells indices ( mean
      corpuscular hemoglobin, mean corpuscular volume and mean corpuscular hemoglobin
      concentration) , white blood cells and platelets were done. Another important parameters to
      evaluate the efficacy of hemoglobin F inducer is transfusion frequency.

      Test were done at baseline and after completion of study means after 06 months.
    


Intervention name(s): Thalidomide 100mg; Hydroxyurea
Intervention type(s): Drug; Drug
Intervention description(s): Thalidomide is available in capsulated form in the strength of 100 mg and 50 mg. It was given according to the weight of the patient. Due to somnolence, it was advised to give at night only.; Hydroxyurea is available in capsulated form under the brand of hydrea. Its available strength is 500 mg . Dosing depends upon weight of patient, that is 15mg/kg/day. so patients unable to take full capsule due to low weight, was advised to take hydroxyurea syrup.
Intervention MeSH terms: Thalidomide; Hydroxyurea
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were divided into 2 groups, one received hydroxyurea second group received thalidomide.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thalidomide,; hydroxyurea; hemoglobin F inducers; beta thalassemia
Measurement of Age and Sex Related Changes in Nasal Tip Support Using Digital Newton Meter
Condition: Nasal Valve Incompetence; Alar Collapse
MeSH terms: Shock
Study type: Observational

Summary: 
      Background:

      It is predicted that the nasal tip support will decrease with aging due to weakening of
      cartilage and connective tissues. However, there is no consensus on the age at which this
      change began. It is quite difficult to evaluate the nasal tip support, while the ideal nasal
      tip support pressure is also not known. The aim of this study is to determine the nasal tip
      support pressure alterations in various age groups, by measuring nasal tip support with a
      Newton meter, according to age and gender.

      Methods:

      This prospective clinical study was conducted between January 2019 and April 2019 at a
      tertiary health facility. Nasal tip resistances in 4 different age groups, as 20-29, 30-39,
      40-64 and 65 years and older, were measured with a digital Newton meter. A total number of
      159 patients with a minimum of 36 patients in each age group were included in the study.
      Nasal tip resistance measurements were compared among nasal tip displacement distances of
      2mm, 3mm and 4mm, according to age groups and gender.
    


Intervention name(s): measurement of nasal tip support in different age groups.
Intervention type(s): Diagnostic Test
Intervention description(s): Nasal tip resistances , were measured in all age groups with a digital Newton meter.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Four groups were formed as 20-29, 30-39, 40-64 and 65 years and older
      
Keywords: Nasal tip; Tip support; Rhinoplasty; Nasal cartilage; Age