bioihbjkbjnl/mcl2 huggingface dataset:
VeClose Five Year Follow-Up Extension Study
Condition: Great Saphenous Vein (GSV) With Venous Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data
      from the patients enrolled in the VeClose study (NCT01807585).
    

Detailed description: 
      The VeClose Five Year Follow-up Extension Study will continue to assess the safety and
      efficacy of the VenaSeal Closure System for the long term effect on closure of the great
      saphenous vein by conducting a follow-up visit at five years post index procedure/enrollment
      in the VeClose study.
    

Intervention name(s): VenaSeal SCS; ClosureFast Radiofrequency Ablation (RFA); Roll-In (VenaSeal SCS)
Intervention type(s): Device; Device; Device
Intervention description(s): Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.; Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.; Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
Other intervention name(s): VenaSeal Sapheon Closure System; VSCS; ClosureFast; VenaSeal Sapheon Closure System; VSCS; Roll-in
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects currently enrolled in both arms of the VeClose Study (NCT01807585) will be
        assessed for eligibility to enroll in the VeClose Five Year Follow-up Extension Study. All
        subjects must meet the inclusion criteria and must not meet the exclusion criteria.
        Assessment of eligibility is based on data available to the investigator at the time of
        subject enrollment. The subject will be considered to be enrolled in the VeClose Five Year
        Follow-up Extension Study after the informed consent is signed/dated and all of the study
        eligibility criteria have been met.
      
Keywords: GSV
Study Evaluating the Clinical Benefit of SEROQUEL XR in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and
      Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects with
      Schizophrenia.
    


Intervention name(s): Quetiapine Fumarate Extended- Release
Intervention type(s): Drug
Intervention description(s): Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
Other intervention name(s): Seroquel XR®
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seroquel; schizophrenia; Extended Release
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body) and
      pharmacodynamics (the effect of the investigated drug on the body) of a single dose of
      long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of
      Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.
    


Intervention name(s): somapacitan; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order.
Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation.; Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.
Other intervention name(s): NNC0195-0092
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Innovative Probiotic Product With Antiallergic Properties
Condition: Atopic Dermatitis; Food Allergy; Effects of Probiotics
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Food Hypersensitivity
Study type: Interventional

Summary: 
      Allergic diseases are currently one of the most important problem in medicine. Research
      confirms that probiotics administered during the formation of the intestinal ecosystem and
      the maturation of the immune system can positively influence the development of antiallergic
      mechanisms. The aim of the present randomized, double-blind, placebo controlled study was to
      evaluate the efficacy of the mixture of probiotic Lactobacillus rhamnosus ŁOCK 0900,
      Lactobacillus rhamnosus ŁOCK 0908, and Lactobacillus casei ŁOCK 0919 in children up to the
      age 2 with atopic dermatitis and food allergy to cow's milk proteins. Children received the
      mixture of Lactobacillus strains for 3 months every day in the daily dose of a billion
      bacteria or a placebo (maltodextrin). Primary outcomes included the effects of probiotic
      treatment on the severity of symptoms assessed with SCORing atopic dermatitis (SCORAD) index.
      Secondary endpoints included assessment of total IgE and selected cytokine levels. Cytokines
      were evaluated in supernatants obtained from peripheral blood cultures of randomly selected
      20 patients from each group. The primary and secondary outcomes were assessed at 3 time
      points: at baseline, after the finishing the administration of probiotic/placebo, and after 9
      months of follow up.
    


Intervention name(s): Probiotic preparation; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The mixture of Lactobacillus rhamnosus ŁOCK 0900, Lactobacillus rhamnosus ŁOCK 0908 and Lactobacillus casei ŁOCK 0919 administered once a day at a dose of one billion for 3 months.; Maltodextrin comparable in color, texture and taste to the probiotic mixture administered once a day for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      The goal of this study is to evaluate basic usability and confirm expected safety and
      effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid
      sinus ostia in patients with chronic rhinosinusitis.
    

Detailed description: 
      A multicenter, single arm, prospective study conducted to assess the safety and effectiveness
      of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and
      sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).
    

Intervention name(s): Sinusys Dilation System
Intervention type(s): Device
Intervention description(s): Dilation of frontal recess and/or sphenoid sinus ostia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mental Training for Adults With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment; Aging
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study aims to determine the feasibility and acceptability of conducting a larger
      randomized clinical trial to test whether individuals with MCI can benefit from mental
      training programs.
    

Detailed description: 
      Half of participants will be randomized to a mindfulness group and half to a brain games and
      puzzles group as forms of mental training. Participants are adults with mild cognitive
      impairment. Participants will undergo neuropsychological testing, MRI scanning, and
      qualitative interviews to assess feasibility of conducting a larger randomized clinical trial
      in a population with mild cognitive impairment.
    

Intervention name(s): Mindfulness; Brain Games and Puzzles
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness meditation is a technique of sustained attention and focus, involving preventing the mind from wandering from the meditative object (i.e. breath or body sensations); Intervention will include the instruction and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.
Other intervention name(s): Meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mindfulness; Meditation; Imaging; MRI
Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This Pilot study will investigate the bioavailability in fasting women of 2 tablet
      formulations containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg.

      The Pilot study will be performed at a single site with 30 subjects. Participants will take 2
      tablets of the test product and reference product in 2 periods and 2 sequences (either test
      after reference or reference after test). There will be a washout of at least 14 days between
      each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Levonorgestrel and Ethinyl estradiol of 2 tablet formulations with Levonorgestrel 0.1 mg and
      Ethinyl estradiol 0.02 mg and to demonstrate bioequivalence of both formulations in terms of
      rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Level [Trademark], product of Biolab Sanus Farmaceutica Ltda.

      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus
      Reference Product) for the main pharmacokinetic parameters area under the plasma
      concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours
      (AUC0-72), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl
      estradiol will be determined.

      Participants will be confined in the study site for approximately 36 hours during each study
      period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic
      (PK) blood samples will be obtained. 16 blood samples will be taken up to 24 hours after the
      administration in each period. Participants will return to the site to provide additional
      blood samples at 48 h, and 72 h postdose.

      The washout period between the two study periods will be at least 14 days. The samples from
      each participant will be analyzed with 2 methods of high performance liquid
      chromatography-tandem mass spectrometry bioanalytical assays to quantify total Levonorgestrel
      and Ethinyl estradiol in plasma.

      The safety objective is to evaluate the tolerability of both formulations in women by
      collecting adverse events.
    

Intervention name(s): Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Test Product; Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference Product
Intervention type(s): Drug; Drug
Intervention description(s): Coated Tablets; Coated Tablets
Other intervention name(s): Investigational Medicinal Product; Level (Trademark)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury.
Condition: Hypogonadism; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Pituitary Diseases; Hypogonadism; Wounds and Injuries
Study type: Interventional

Summary: 
      There is evidence that has shown that serum testosterone levels are low in persons with
      chronic spinal cord injury (SCI). The question arises as to whether the defect in
      testosterone production is from the hypothalamic pituitary system (part of the brain that
      plays a role in testosterone release) or from the male testes. Studies to date are
      inconclusive. This study, will examine if persons with SCI has a normal hormonal regulation
      of the male hormone testosterone in comparison to persons who are able-bodied. This will help
      understand the physical and metabolic changes that occur in persons with SCI.
    

Detailed description: 
      Absolute or relative testosterone deficiency is associated with loss of lean body tissue and
      gain of fat, with associated adverse carbohydrate, lipid, and energy expenditure changes that
      increase the risk of cardiovascular disease. Impotence and infertility are common in patients
      with SCI. Of the many possible explanations of poor semen quality, one possible etiology is
      dysfunction of the hypothalamic-pituitary-testicular axis. Early reports have been
      inconclusive with regard to testicular function. These apparent discrepancies could, at least
      in part, be attributed to varying factors in population selection, including health and
      nutrition parameters, medication effects, and level and duration of injury, or to differences
      in methodology. Recently, two large population studies found a sizeable proportion of persons
      with SCI having testosterone deficiency. Huang et al. (1993) found significantly elevated
      luteinizing hormone (LH) responses to LH releasing hormone (LHRH) in subjects with SCI
      compared to controls. Of those studied with LHRH stimulation, 16/30 subjects with SCI had
      exaggerated LH responses and 6/30 had elevated follicular stimulation hormone (FSH)
      responses. Bulat et al., (1995) have shown that persons with tetraplegia tend to have
      increased gonadotropin release to standard provocative stimulation compared with able-bodied
      controls or those with paraplegia. In a preliminary report, testicular stimulation with
      standard doses of hCG for 2 days was similar in 10 subjects with SCI and 8 able-bodied
      controls.
    

Intervention name(s): Human chorionic gonadotropin (hCG); Luteinizing hormone releasing hormone (LHRH)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Chorionic Gonadotropin; Hormones; Prolactin Release-Inhibiting Factors
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hypogonadal; Hypothalamus; Pituitary; Spinal Cord Injury; Testes; Testosterone
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Abdominal
Study type: Interventional

Summary: 
      Background:Knee osteoarthritis is more common in patients with type-2 diabetes mellitus,
      however it is not known whether this effect is caused by diabetes itself or concominant
      abdominal obesity.

      Objectives:The aim of this study is to determine whether type-2 diabetes itself, independent
      of abdominal obesity, is a risk factor for femoral cartilage, knee osteoarthritis and poor
      quality of life.

      Design:A cross-sectional design. Settings:Training and research hospital in Turkey. Patients
      and Methods:Female patients was enrolled in this study and divided into two groups: according
      to presence or absence of diabetes. Later, both the patients with and without abdominal
      obesity was divided into two groups according the presence of diabetes.

      Main Outcome measures:Clinical parameters were visual analog-scale, gait speed and short
      form-36. Knee radiographs were evaluated according to Kellgren Lawrance-Scale. And
      ultrasonography parameters were the measurements of distal femoral cartilage thickness.

      Sample size:126
    


Intervention name(s): knee ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): The knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Both patients with and without diabetes mellitus was evaluated in terms of pain and ultrasonographic femoral cartilage thickness.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: knee osteoarthritis; type 2 diabetes
Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI)
      according to EIOS
    

Detailed description: 
      A total of 243 infertile couples underwent long GnRH agonist protocol in the ART unit,
      International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar
      University.

      Embryos which reached the two cell stage at 25-27 hr were classified as EC, and the remaining
      as Non Early Cleavage embryos (NEC). Embryos were assessed again at 64-68 hours post-ICSI for
      day three embryo morphology score (Loi et al.,2008). The best two or three embryos, according
      to day 3 embryo morphology were transferred. Each patient was given a score according to EIOS
      (female age, number of retrieved oocytes, number of EC embryos, number of good quality
      embryos and number of embryos transferred).
    

Intervention name(s): Edessy ICSI Outcome Embryo Score
Intervention type(s): Other
Intervention description(s): EIOS:
Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ICSI outcome
Study of Non Inferiority Bi-Profenid® 200mg Versus Bi-Profenid® 300mg Among Patients Presenting of the Post-traumatic or Rheumatologic Acute Affections of the Locomotor Apparatus (BIPROPAIN)
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x
      2 day in patients presenting with pain related to closed, benign, acute post-traumatic
      conditions of the motor system or acute, non-infectious rheumatologic conditions, by
      comparing, on the one hand, changes in resting pain intensity over the entire day, measured
      at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total
      intake over 5 days of concomitant analgesics.

      Secondary Objectives:

        -  To describe concomitant analgesic treatments

        -  To describe the time between baseline and use of a step I, II or III analgesic

        -  To evaluate patients pain relief using a Likert 4-class scale (complete or substantial
           relief, moderate relief slight relief and absence of relief) at D5

        -  To evaluate changes in intensity of pain when moving, over the entire day, measured at
           the end of the day using a numeric scale, over 5 days

        -  To evaluate the patients overall satisfaction at the end of treatment using a 4-point
           Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied,
           very unsatisfied)

        -  To evaluate the patients overall satisfaction at the end of the study using a 4-point
           Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied,
           very unsatisfied)

        -  To compare the safety of the two treatments
    


Intervention name(s): ketoprofen 100 mg; ketoprofen
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg b.i.d. for 5 days; 150 mg b.i.d. for 5 days
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mass Balance Study of KBP-5074 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite
      identification study in healthy male subjects.
    


Intervention name(s): KBP-5074
Intervention type(s): Drug
Intervention description(s): a single oral dose of [14C]-KBP-5074
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Male Subjects; KBP-5074
Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy
Condition: Pudendal Nerve
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic
      membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic
      prostatectomies.
    


Intervention name(s): Robotic Assisted Laparoscopic Prostatectomy; Application of Absorbable Hemostat; Application of dehydrated human amniotic membrane
Intervention type(s): Procedure; Other; Other
Intervention description(s): Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique; Application of Surgicel® SNoW Absorbable Hemostat by Johnson and Johnson on the neurovascular bundle after removal of the cancerous prostate.; Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.
Other intervention name(s): Surgicel® SNoW; AmnioFix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment