bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Single Administration in Healthy Male Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerability, pharmacokinetics and
      immunogenicity of MEDI9929 following administration of single ascending doses in healthy male
      Japanese subjects.
    

Detailed description: 
      This is a Phase I, single centre, randomised, single-blind, placebo-controlled, single
      ascending dose parallel study in healthy male Japanese subjects. Up to 3 dose levels of
      MEDI9929 will be investigated.

      Primary object is to assess the safety and tolerability of single ascending subcutaneous (SC)
      doses of MEDI9929 in healthy male Japanese subjects. Secondary objectives are to characterize
      the pharmacokinetics (PK) of MEDI9929 in healthy male Japanese subjects and to evaluate the
      immunogenicity (IM) of MEDI9929 in healthy male Japanese subjects.

      Up to 24 healthy subjects aged 20 to 45 years will participate in a maximum of 3 cohorts.

      Eight subjects will participate in each cohort. Subjects will be randomized in a 3:1 ratio
      (active: placebo) and will receive a single dose of either MEDI9929 or placebo. Each subject
      will only participate in one cohort.

      The first cohort will receive Dose 1 MEDI9929 (n=6) or placebo (n=2), the second cohort will
      receive Dose 2 MEDI9929 (n=6) or placebo (n=2), and the third cohort will receive Dose 3
      MEDI9929 (n=6) or placebo (n=2).

      Following a screening period of a maximum of 28 days, subjects will stay at the study
      facility for eight nights starting from the day before dosing (Day -1) to Day 8. The follow
      up period after the dosing will be 84 days (112 days for cohort 3). Subjects will receive a
      single dose of MEDI9929 or placebo subcutaneously on Day 1 and safety monitoring and serial
      collection of blood samples for PK evaluation will be followed throughout the study period.
    

Intervention name(s): MEDI9929; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo; 1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: safety, tolerability, pharmacokinetics,immunogenicity, MEDI9929, Japanese
Factors Affecting the Prognosis of Patients With Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Observational

Summary: 
      Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has
      been overcome the epithelial ovarian cancer because of the change of life style to western
      style recently. Most patients with endometrial cancer are stage I & II, the most histology is
      still "endometrioid adenocarcinoma" (type I endometrial cancer). In statistics, advanced
      stage (FIGO stage III and IV) is approximately 16% of all cases.

      Most patients has good outcome of endometrial cancer because their surgical stage is belonged
      to "early stage". However, the recurrence, distant metastases and mortality are high if the
      diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking
      operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy.
      Whether the adjuvant therapy can cure the disease of not is still controversial.

      Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic
      modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy
      and radiation therapy or sequential "sandwich" therapy were ever used for such group patients
      in each medical center. But the case number is insufficient and limited to show the survival
      or progression free benefit during the statistics. Besides, the surgical procedures and
      adjuvant therapy for early endometrial cancer is still remained to be determined. The
      investigators are also interested to analyze the factors affecting their survival.

      The investigators will perform a retrospective study to review the data of patients with
      endometrial cancer in Department of Obstetrics & Gynecology in Far Eastern Memorial Hospital.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the cases with endometrial cancer
Hyperopic LASIK With Crosslinking Versus Standard LASIK
Condition: Hyperopia
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      Analysis corneal and refractive stability of hyperopic laser-assisted in situ keratomileusis
      (LASIK) with and without concurrent prophylactic high-fluence cross-linking (CXL).
    

Detailed description: 
      Interventional prospective consecutive comparative case control series of cases; 50 eyes of
      25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic
      astigmatism underwent customized LASIK with concurrent prophylactic high-fluence
      cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases
      with hyperopia +1 diopter to +6 diopters or hyperopic astigmatism up to 4 diopters were
      included in the study. Patients with previous intraocular or corneal surgery, active corneal
      disease were excluded from the study.

      Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical
      equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric
      measurements and spherical aberrations at 4 mm and maximum pupil and their evolution along 6
      months postoperatively.
    

Intervention name(s): LASIK
Intervention type(s): Procedure
Intervention description(s): LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional prospective consecutive comparative case control series of cases; 50 eyes of 25 patients with mean age 35.7 ± 12.4 (Range 18-61years) with hyperopia or hyperopic astigmatism underwent customized LASIK with concurrent prophylactic high-fluence cross-linking in right eye (group 1) and customized LASIK only in left eye (group 2). Cases with hyperopia +1D to +6D or hyperopic astigmatism up to 4D were included in the study. Patients with previous intraocular or corneal surgery, active corneal disease were excluded from the study.
Main outcome measures were uncorrected visual acuity (UCVA), manifest refractive spherical equivalent (MRSE), cycloplegic refractive spherical equivalent (CRSE), keratometric measurments and spherical aberrations at 4 mm and maximum pupilnand their ecolution along 6 months postoperatively.
Masking: None (Open Label)
Primary purpose: Other
MGB/OAGB Versus RYGB After Failed Sleeve
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number
      of data documents that some patients have to be surgical revised due to weight regain or
      gastro-esophageal reflux disease.

      This study elaborates weather Roux-en-Y gastric bypass (RYGB) or Mini/One anastomosis gastric
      bypass (MGB/OAGB) is a better second step procedure after failed sleeve gastrectomy.
    

Detailed description: 
      All patients who underwent RYGB or MGB/OAGB between October 2014 and December 2016 after
      failed sleeve gastrectomy will be recorded and analyzed in relation to weight loss, intra-
      and postoperative complications (Clavien-Dindo) and postoperative morbidity up to one year
      follow-up.
    

Intervention name(s): Roux en Y gastric bypass; Mini/One anastomosis gastric bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb); Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)
Other intervention name(s): RNYGB; MGB/OAGB
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity Surgery; Failed Sleeve Gastrectomy; Roux-en-Y gastric bypass; Mini/One anastomosis gastric bypass
Water Method Colonoscopy in Patients With Prior Surgery
Condition: Intubation; Surgery; Adenoma; Pain
MeSH terms: Adenoma
Study type: Observational

Summary: 
      Water method with water exchange has been shown to reduce medication requirement and pain
      experienced during colonoscopy. It increases the success rate of cecal intubation in sedated
      and unsedated patients undergoing screening colonoscopy. Exchange of water during scope
      insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion
      of air from the colon during insertion by omission of air insufflations and suction removal
      of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy
      insertion in average patients and may enhance the success of difficult colonoscopy.

      Prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the
      probable adhesion may change the anatomy and increase the discomfort of patients. We
      postulate that these patients may benefit from using the water method for colonoscopy. In
      this proposal we test the hypothesis that compared with conventional air insufflations the
      water method with water exchange significantly enhances the success rate of cecal intubation
      in patients with prior abdominal or pelvic surgery.

      The aim of the study is to compare the outcome of colonoscopy using the water method versus
      the conventional air method in patients with prior abdominal or pelvic surgery. The primary
      outcome is cecal intubation success rate. The secondary outcomes include cecal intubation
      time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma
      detection rate.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with prior abdominal or pelvic surgery undergoing unsedated colonoscopy will be
        recruited in this study.
      
Keywords: colonoscopy; water; surgery; unsedated
What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?
Condition: Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized study was designed to compare the 2 year clinical and functional results with
      the STARR procedure using a new curved cutter stapler or the same operation done with 2
      traditional circular staplers.
    

Detailed description: 
      From January to November 2006, 80 women were selected, with clinical examination,
      constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned
      to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers
      PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation
      with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were
      followed up with clinical examination, constipation score, and perineography.
    

Intervention name(s): starr
Intervention type(s): Procedure
Intervention description(s): stapled transanal rectal resection
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ODS; stapled transanal rectal resection
Effects of Recoverben® on Recovery After Exhaustive Exercise
Condition: Healthy Volunteers; Muscle Fatigue; Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The aim of the study is to investigate a pre and post workout supplementation (15 days) with
      Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects
      will be investigated with 400mg Recoverben® and compared to placebo.
    

Detailed description: 
      The aim of the study is to investigate a pre and post workout supplementation (15 days) with
      Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects
      will be investigated with 400mg Recoverben® and compared to placebo.

      Targeted parameter will be determined at the beginning of the study and after
      supplementation, each. Parameter include maximal strength (MVC), muscle soreness (VAS), pain
      sensitivity (Algometry) and biomarkers (CK, IL-6, glutathione peroxidase).
    

Intervention name(s): Aloysia citriodora extract; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules with 200mg - daily dosage 400mg; 2 capsules with 200mg - daily dosage 400mg
Other intervention name(s): Recoverben®; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Recovery; Muscle soreness; Lemon Verbena
Safety and Efficacy of Therapeutic Anticoagulation With Tinzaparin During Pregnancy Via Weight-based Dosing
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of therapeutic
      anticoagulation with tinzaparin during pregnancy via weight-based dosing.
    

Detailed description: 
      Physicians in the Calgary Health Region are using tinzaparin (predominantly) and other low
      molecular weight heparins (LMWHs) for the treatment venous thromboembolism (VTE) in
      pregnancy. The most recent anticoagulation guidelines from American College of Chest
      Physicians (ACCP) suggest that heparin levels (anti-Factor-Xa activity levels) may be done
      periodically through pregnancy to determine the need to adjust the dose of LMWH as pregnancy
      progresses. This monitoring is widely practiced. There is no clear consensus in the
      literature, however, with some experts suggesting that initial and subsequent dosing may be
      done based on weight alone (as is done in the non-pregnant population). Given the multiple
      physiologic changes which occur to drug metabolism during pregnancy, this bears further
      evaluation. To date, there is very limited data on weight-adjusted dosing of LMWH in
      pregnancy. This study is therefore designed to determine if dosing of tinzaparin during
      pregnancy based on weight, with periodic weight-based adjustments, will result in adequate
      therapeutic anticoagulation.
    

Intervention name(s): Tinzaparin
Intervention type(s): Drug
Intervention description(s): LMWH (tinzaparin-Innohep, Leo Pharma A/S) 175 anti-factor Xa units per kilogram of body weight sub-cutaneously once daily.
Treatment will be done for the duration of the pregnancy.
Other intervention name(s): innohep
Intervention MeSH terms: Tinzaparin; Heparin, Low-Molecular-Weight; Dalteparin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: anticoagulation; pregnancy
Efficacy and Safety of an Electronic Nicotine Delivery Device (E-Cigarette) Without Nicotine Cartridges
Condition: Healthy Smokers; Smoking Cessation
Study type: Observational

Summary: 
      The study's major aim is to investigate the ability of a commercial Electronic Nicotine
      Delivery Device (E-Cigarette) to induce long-term smoking reduction/abstinence in smokers
      unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and
      cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe. The
      study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and
      adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette -
      "NO nicotine" cartridges). The primary hypothesis is that the E-Cigarette is a safe device
      that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal
      symptoms and cravings independently from nicotine delivery.
    

Detailed description: 
      The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed
      for the purpose of nicotine delivery to the respiratory system where nor tobacco nor
      combustion are necessary for its operation. For these reasons, it is possible that this
      product may be safer than cigarettes. Marketing claims also include that they can be useful
      smoking cessation aids. Although E-Cigarette may produce lung delivery of nicotine similar to
      that of tobacco cigarettes and reproduces the gesture component associated with tobacco
      smoking, very little is known about the effect of E-Cigarette on the smoking habits of
      regular tobacco smokers. Therefore, we designed a prospective observational study consisting
      of 8 office-based visits (a baseline visit and a 2, 4, 6, 8, 10, and 12-weeks and a final
      visit at 24-weeks) to monitor possible modifications in the smoking habits of a group of well
      characterized regular smokers experimenting the e-cigarette focusing on long-term smoking
      reduction/abstinence, changes in withdrawal symptoms/cravings and adverse events.
      Specifically, 100 smokers will be given "Categoria" electronic cigarette loaded without
      nicotine ("NO nicotine" cartridges) and followed up for a total of 24 weeks.</
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Regular smokers from Catania in Italy recruited following the placement of an advertisement
        in a local newspaper.
      
Keywords: electronic cigarette; nicotine; smoking cessation; smoking reduction
A Phase I Study of the Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this pilot study is to determine the within-subject pharmacokinetic
      (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat
      administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed
      commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to
      plan and support the design of a subsequent bioequivalence study.
    

Detailed description: 
      This will be a single-site, single-dose, randomized, open-label, two-treatment, two-sequence,
      four-period replicated crossover study in healthy adult subjects. The study will comprise a
      screening period, four treatment periods with a 7-day washout between dosing in each period,
      and a safety follow-up visit.
    

Intervention name(s): Eliglustat, common blend proposed commercial formulation; Eliglustat, Phase 3 capsule formulation
Intervention type(s): Drug; Drug
Intervention description(s): All participants will receive a single oral 150-mg dose of the common blend proposed commercial formulation of eliglustat, administered as one 150-mg strength capsule (Treatment T), on 2 separate dosing occasions.; All participants will receive a single oral 150-mg dose of the Phase 3 capsule formulation of eliglustat, administered as three 50-mg strength capsules (Treatment R), on 2 separate dosing occasions.
Other intervention name(s): Genz-112638; Genz-112638
Intervention MeSH terms: Eliglustat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genz-112638
Racial Differences: Nitric Oxide(NO) and Endothelin-1(ET-1) in Preeclampsia (PreE)
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      The goal of this study is to examine the activation of markers of endothelial and
      cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this
      study will hopefully provide enough information to determine a link between race, the advent
      of high risk pregnancies and cardiovascular markers. With this information it might be
      possible to intervene with approved pharmacological treatments.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women delivering babies at the University of MS Medical Center
      
Biospecimen description: 
      Placental Tissue
Effect of Vitamin D Supplementation on Inflammatory Markers
Condition: Vitamin D Deficiency; Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Previous studies have shown that improving vitamin D status among the elderly may lead to an
      improvement in some inflammatory markers, especially with patients with type 2 diabetes. The
      aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in
      patients having type 2 diabetes.
    

Detailed description: 
      Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one
      of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an
      elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as
      tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to
      insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled,
      double blind study is to examine the effect of vitamin D supplementation on some inflammatory
      markers in older Lebanese patients having type 2 diabetes.
    

Intervention name(s): cholecalciferol (Euro-Pharm International, Canada); Placebo tablet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months; The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitamin D, type 2 diabetes, inflammation