bioihbjkbjnl/mcl2 huggingface dataset:
Combined Spinal-Epidural Temperature and Duration of Action
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have
      a shorter period of pain relief than that maintained at room temperature. The temperature of
      the dose of medication will be measure with an infrared thermometer immediately prior (within
      5 minutes) to administration.
    

Detailed description: 
      Subjects will receive a combined spinal epidural medication as per standard of care to treat
      their labor pain; however, they will be randomized to receive either a dose maintained at
      room temperature (60-75 degrees F) or one maintained in a refrigerator (~<43 degrees F).
      Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage
      and fetal heart rate every 15 minutes until the subject requests additional pain medication
      to treat their labor pain.
    

Intervention name(s): combined spinal epidural
Intervention type(s): Drug
Intervention description(s): Combined Spinal Epidural
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Combined spinal epidural duration; labor pain
Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus
Condition: Obesity; Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to explore the mode of action of topiramate in the treatment of
      obese and diabetic patients by testing association between genetic variations within
      candidate genes or chromosomes (thread like structure found in cell which carries genes) and
      the clinical outcomes.
    

Detailed description: 
      This pharmacogenomics (effect of genetic variation on drug response) study will analyze
      genetic variations in the DNA extracted from blood samples collected from patients who were
      randomized (assigned to treatments by chance) in 1 of 3 previous topiramate studies on
      obesity and diabetes. The study consist of a screening telephone contact, a single visit to
      the study site for a blood sample collection (10 ml of whole blood) for genetic analyses, and
      a 24-hour post-sample adverse event reporting period. The total duration of the study is 24
      hours from the time of the blood sample collection. Safety will be monitored up to 24 hours
      after blood sample collection. No study medication was administered.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No treatment was given to the patients as this is an observational study.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The patients from previous topiramate obesity and diabetes studies (PRI/TOP-INT-31 or
        PRI/TOP-INT-33 or a subset of patients with diabetes mellitus who were randomized within
        the PRI/TOP-INT-34 study at sites that also participated in the PRI/TOP-INT-31 study).
      
Biospecimen description: 
      Whole blood
    
Keywords: Obesity; Type 2 Diabetes Mellitus; Topiramate; Pharmacogenomics; DNA Polymorphism
Corticosteroid Prophylaxis on the Cardiopulmonary Bypass-Induced Systemic Inflammatory Response
Condition: Heart Valve Diseases; Systemic Inflammatory Response Syndrome
MeSH terms: Heart Valve Diseases; Systemic Inflammatory Response Syndrome
Study type: Interventional

Summary: 
      To observe the effect of glucocorticoid on the dynamic changes of monocyte subsets in the
      peripheral blood of valve disease patients undergoing cardiopulmonary bypass perioperatively.
    

Detailed description: 
      Systemic inflammatory response syndrome (SIRS) is a common major complication of
      cardiopulmonary bypass. "Emergency Hematopoiesis" is the pathological process induced by the
      inflammation. The investigators previously confirmed that emergency hematopoiesis induced by
      cardiopulmonary bypass led to dynamic changes of quantities of monocyte subsets, there is a
      significant increase in the number of two monocyte subsets: 1) CD14highCD16+ monocyte with
      strong immunomodulatory activity; 2) CD14lowCD16- monocyte with potential ability of
      proliferation and differentiation. Therefore, a new hypothesis risen: "the change of the
      function and the number of monocyte subsets induced by emergency hematopoiesis play an
      important role for SIRS occurrence after cardiopulmonary bypass, correcting emergency
      hematopoiesis is a new breakthrough in the prevention and treatment of SIRS." To identify the
      mechanism of function changed in different monocyte subsets during the pathogenesis of SIRS,
      the research intended to target perioperative-period patients with heart valve replacement,
      monitor dynamically the number and phenotype of peripheral blood monocyte subsets by flow
      cytometry; sort out of different monocyte subsets for cell culture in vitro, observe the
      ability of proliferation and differentiation and effects between monocyte subsets and T
      lymphocyte; investigate the mechanism of immune function changes with antibody-blocking and
      compartment culture in patients; observe the impact of glucocorticoid treatment on the
      emergency hematopoiesis, offer new objects for evaluation of immune status in patients and
      provide new evidence for anti-inflammatory therapy .

      Patients should be follow the protocol of cardiopulmonary bypass according to normal hospital
      routine practice.

      A total of 30 patients will be enrolled in this clinical trial.
    

Intervention name(s): Corticosteroid
Intervention type(s): Drug
Intervention description(s): 500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.
Other intervention name(s): Solu-Medrol
Intervention MeSH terms: Methylprednisolone Hemisuccinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: monocyte; cardiopulmonary bypass; cardiac surgery
Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis
Condition: Chronic Pancreatitis; Depression; Quality of Life; Chronic Pain
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Chronic Pain; Depression; Depressive Disorder
Study type: Observational

Summary: 
      Chronic pancreatitis (CP) is associated with recurrent intractable abdominal pain, pancreatic
      exocrine insufficiency and endocrine dysfunction. Very few studies had evaluated the quality
      of life in CP, and even a fewer have assessed the mental status in these patients.

      In the current study, we proposed to evaluate the the relationship between pain, quality of
      life and depression status in two large independent cohorts of patients with CP. We also
      proposed to evaluate the brain metabolites in the right and left anterior cingulate cortex,
      basal ganglia, hippocampus and prefrontal cortex using magnetic resonance spectroscopy. We
      further proposed to evaluate the pasta metabolites and look for associations with the mental
      state. Finally, we proposed to evaluate how CP related education of the patients could impact
      on their mental status and response to interventions on pain.
    


Intervention name(s): Patient education about chronic pancreatitis.
Intervention type(s): Other
Intervention description(s): Patients in the second cohort were educated about their disease phenotype in a structured and personalised manner that included their disease course, symptoms, imaging, treatment option and possible long-term outcomes and prognosis. This was followed by answering all the queries of the patient and their caregivers.
The patients were advised to visit the Pancreas clinic after 3-months for re-evaluation of the clinical, psychological and metabolic parameters.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population constitutes of patients with chronic pancreatic of at least 3 years
        duration. They are a composite with or without depression. Rationale for taking a lag time
        of at least 3 years was to allow development of the complications of the disease.
      
Biospecimen description: 
      Plasma samples
A Trial to Study the Influence of Growth Factors on Bone Marrow and Hepatic Regeneration in Patients With Decompensated Cirrhosis.
Condition: Decompensated Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      This will be a randomized double blind study which will be conducted on patients admitted to
      Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having
      any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline.

      60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30
      patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will
      receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1
      year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd
      day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice
      a week for 2 months.

      Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3
      months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).
    


Intervention name(s): G-CSF+Erythropoetin; G-CSF
Intervention type(s): Drug; Drug
Intervention MeSH terms: Epoetin Alfa; Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Media Images, Alcohol and Tobacco to Youth
Condition: Healthy
Study type: Observational

Summary: 
      The main objective is to assess the relationships between French teenagers' attitudes and
      beliefs towards alcohol and tobacco products and the degree to which they watch and relate to
      television series and music videos.
    

Detailed description: 
      The research extends existing research conducted by Cristel A. Russell to assess the
      relationships between French teenagers' attitudes and beliefs towards alcohol and tobacco
      products and the degree to which they watch and relate to television series and music videos.
      We test whether the consumption of media (TV series and music video) are related to French
      youth's perceptions of the consequences related to the use of alcohol and/or tobacco and
      ultimately their intentions and behaviors. To do so, an online questionnaire will be passed.
      Teenagers will be recruited through a private research firm, Cint. Because the study focuses
      on teenagers (14-17 y.o), parental consent to participate to the study will be obtained prior
      to the teenager's one.
    

Intervention name(s): Investigation
Intervention type(s): Other
Intervention description(s): Investigation of relationships between French teenagers' attitudes and beliefs towards alcohol and tobacco products and the degree to which they watch and relate to television series and music videos
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tennagers aged between 14 and 17 years
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be
      used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation
      in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial
      fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.
    

Detailed description: 
      The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower
      electrode-tissue interface temperature, combined with the anatomical guidance of
      electroanatomical mapping should allow:

        1. Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of
           pulmonary vein stenosis;

        2. Creation of continuous, transmural linear left atrial lesions with the same or lower
           risk of thromboembolism;

        3. These two factors will eliminate documented episodes of symptomatic sustained AF in
           patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month);

        4. Patients with interruption of the vagal response (sinus bradycardia or AV block) during
           stimulation at the sites of left atrial autonomic ganglionated plexi (GP) will have
           lower recurrence of atrial fibrillation.
    

Intervention name(s): GP ablation + PV isolation
Intervention type(s): Device
Intervention description(s): All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
Other intervention name(s): Navi-Star ThermoCool Catheter, Biosense-Webster Inc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Catheter Ablation; Atrial Fibrillation
Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Arrhythmia, Cardiac
MeSH terms: Arrhythmias, Cardiac; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Observational

Summary: 
      Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be
      recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along
      with a control group of twenty-one individuals with normal glucose tolerance matched for age,
      gender, and body mass index. Patients with type 2 diabetes will be scheduled for a three-week
      run-in period with LR and CGM prior to participation in Part 1. Only patients with a
      well-functioning loop-recorder and who can comply with CGM will be included. Patients with
      type 2 diabetes will continue in part 2 of the study, a one year observational study
      employing CGM and LR and clinical examination after 1, 3, 6, 9, and 12 months and an extended
      observation period of 2 years employing LR and clinical examination.
    


Intervention name(s): Combined hyper- and hypoglycaemic clamp; Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA); Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)
Intervention type(s): Other; Device; Device
Intervention description(s): During the entire clamp, participants will be monitored by ECG, pulse oximetry, and blood pressure and plasma glucose will be measured bedside every fifth minute. Additionally, patients with type 2 diabetes will be monitored by a loop recorder (LR) and a continuous glucose monitor (CGM). Comparison of LR and CGM recordings with the recordings obtained by ECG Holter monitor and blood sampling will be used for validation of the method used in Part 2 of the study. Blood samples will be drawn and analysed for changes in electrolytes, insulin, glucagon, catecholamines and cortisone. A cardiac haemodynamic evaluation will be performed by echocardiography at baseline, hyperglycaemia, and hypoglycaemia.; Implantation of a loop-recorder; Monitoring with a continuous glucose monitor
Intervention MeSH terms: Hypoglycemic Agents
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patiens with insulin-treated type 2 diabetes with complications and healthy controls
Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers
Condition: Chemotherapy-Induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple
      Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and
      pharmacokinetics of single-dose and multiple-dose oral administration of the investigational
      product, EC-18 (study drug) in healthy adult male volunteers.
    

Detailed description: 
      In vitro and in vivo efficacy studies and clinical trials have shown that EC-18 has a mode of
      action of improving neutropenia by promoting neutrophil production from hematopoietic stem
      cells and at the same time, efficiently controlling STAT6/Complement 3(C3), suggesting its
      potential to be developed as an orally administered new drug for treatment of neutropenia
      resulting from decreased neutrophils caused by administration of an anticancer agent.

      This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple
      Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and
      pharmacokinetics of single-dose and multiple-dose oral administration of the investigational
      product, EC-18 (study drug) in healthy adult male volunteers.
    

Intervention name(s): EC-18; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EC-18 Soft-capsule (500mg/1 capsule); Placebo with same shape and size
Other intervention name(s): EC18 Soft-capsule; Placebo for EC-18 (Sofe-capsule)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EC-18; Hematology; Cancer; Neutropenia
Semen Analysis and Insight Into Male Infertility
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Observational

Summary: 
      Semen analysis is the cornerstone for the valuation of the male partner in the infertile
      couples. This test has been standardized throughout the world through the World Health
      Organization (WHO) since the1970s by producing, editing, updating, and disseminating a semen
      analysis manual and guidelines.
    

Detailed description: 
      A retrospective study to assess the frequency of male factor infertility in the last years.
    

Intervention name(s): semen fluid analysis
Intervention type(s): Diagnostic Test
Intervention description(s): semen fluid analysis
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        infertile males
      
Keywords: Infertility;; male; semen
A Study of the Effect of Oats on Post Prandial Glucose Response
Condition: Normoglycemic; Normal Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat
      β-glucan on post-prandial glycemic response in healthy adult participants.
    

Detailed description: 
      The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment
      intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan)
      periods separated by about 5-7 days washout period. Normoglycemic (<5.6 mmol/L) males and
      females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be
      recruited.

      Each participant will receive each of the following breakfast foods in a random order: 1) oat
      meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta
      glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to
      consume one of the breakfast foods during each visit.

      Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of
      treatments will be measured by visual analogue scales (VAS).

      Glucose measurements: Capillary blood will be collected during each visit by finger prick.
      Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first
      bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI)
      guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters .

      Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the
      first two weeks of their menstrual cycle (follicular phase), once per week.

      During the wash-out days (5 - 7 days between each phase), participants can go about their
      daily activities unrestricted with the following exception: no strenuous activity or alcohol
      consumption on the days before the clinic visit. The investigators will ask that participants
      go to sleep at the same time on the days before the sessions.
    

Intervention name(s): Oatmeal
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Oatmeal; Beta glucan; Postprandial Glycemic Response; Blood Glucose
A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)
Condition: Healthy Females
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect
      of multiple dose PF-06651600 on single dose OC PK in healthy female subjects. Subjects will
      be randomized to 1 of 2 treatment sequences.
    


Intervention name(s): PF-06651600; Ethinyl estradiol (EE) and levonogestrel (LN)
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg by mouth (PO) Once daily (QD) for 11 days; Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Other intervention name(s): Oral contraceptive
Intervention MeSH terms: Ethinyl Estradiol; Contraceptive Agents; Contraceptives, Oral; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: female; post-menopausal; healthy; oral contraceptive