bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries
Condition: Coronary Occlusion
MeSH terms: Coronary Occlusion
Study type: Interventional

Summary: 
      The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety
      and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary
      arteries.
    


Intervention name(s): CiTop(tm) Guidewire
Intervention type(s): Device
Intervention description(s): CiTop(tm)6 Guidewire
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CTO; Chronic Total Occlusion; Revascularization
Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
Condition: Myopia; Hyperopia
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      Open label, 1-week daily disposable, dispensing study
    

Detailed description: 
      Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when
      refitted with ocufilcon D asphere for 1 week of daily disposable wear.
    

Intervention name(s): filcon IV 1; ocufilcon D
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Impact of GH Measurements on GHD Diagnosis
Condition: Growth Hormone Deficiency
Study type: Observational

Summary: 
      Human growth hormone (hGH) provocation test is an essential tool to assess growth hormone
      deficiency in children and young adults. It is important to have a robust and reliable method
      to determine the hGH peak of stimulation. This work aimed to compare three common automated
      immunoassays for hGH measurements and to assess whether there are still result-related
      differences influencing clinical decision.
    

Detailed description: 
      The investigators analysed GH provocative test of 41 young patients (median age: 12 years)
      from Pediatric Department of Montpellier Hospital, (26 boys and 15 girls), admitted for
      follow-up or for suspicion of growth hormone deficiency. Serum GH of peak concentrations were
      compared using three automated immunoanalyses : COBAS 8000 e602 (ROCHE Diagnostics), IDS-iSYS
      (IDS immunodiagnostic systems) and Liaison XL (Diasorin S.A.).
    

Intervention name(s): GH provocation tst
Intervention type(s): Other
Intervention description(s): All patients underwent insulin-induced hypoglycaemia stimulation test also called insulin tolerance test (ITT), considered the 'gold standard' test for GHD diagnosis. Following insulin administration by venipuncture (1UI/mL), levels of hGH and glucose were monitored on serum and fluoride tube plasma, respectively, at intervals of 0, 30, 45, 60 and 90 minutes (T0, T30, T45, T60 and T90).
Other intervention name(s): reliquens of serum samples from GH provocation test
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        From April to November 2019, forty-one young patients (26 boys and 15 girls) from the
        Paediatric Department of Montpellier Hospital were included in this study. They were mainly
        admitted for suspicion (short stature or growth retardation) or follow-up of GHD in pre-and
        pubertal age (median age= 12).
      
Biospecimen description: 
      serum
    
Keywords: growth hormone deficiency; immunoanalysis; hGH provocation test; diagnosis
Evaluation of the Glycemic Index in 4 Dairy Beverages.
Condition: Glycemic Index; Cognitive Performance
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the glycemic index and glycemic load of 4 chocolate
      milk drinks.
    

Detailed description: 
      Subjects will make a total of 5 visits. Four visits where they will drink a chocolate
      milkshake at each visit. In the other visit they will take glucose, as a comparator product.

      Due to the low amount of sugars in the shakes, subjects will drink the equivalent of 25g of
      glucose.

      At each visit subjects will have to come fasting, and samples will be collected at 9
      different times.
    

Intervention name(s): Experimental product; Control product
Intervention type(s): Other; Other
Intervention description(s): Chocolate milk shakes; Glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in
      combination with zidovudine (AZT) in HIV-infected infants.

      PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the
      safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in
      log10 RNA, of the two study arms.

      Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and
      rapid decline of CD4 count and immunologic function. Combination therapy may be preferred
      over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is
      little information on ddI monotherapy in young infants less than 90 days and no information
      on the use of combination therapy in this population.
    

Detailed description: 
      Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and
      rapid decline of CD4 count and immunologic function. Combination therapy may be preferred
      over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is
      little information on ddI monotherapy in young infants less than 90 days and no information
      on the use of combination therapy in this population.

      In Part A, a cohort of patients younger than 28 days (was less than 120 days; amended
      6/20/95) of age receives open-label ddI monotherapy for 1 week before initiation of AZT/ddI
      combination therapy. After pharmacokinetic data are obtained, an additional cohort of
      patients receives ddI at a higher dose. An age-adjusted dose for ddI is determined for use in
      Part B. (NOTE: As of 2/13/95, Part A has completed accrued for infants 29 to 120 days of
      age.) Part B patients less than 90 days of age (was less than 180 days of age; amended
      6/20/95) are randomized, on a double-blind basis, to receive ddI or AZT/ddI. All patients
      continue treatment until 12 months after the last patient on Part B is enrolled. PER
      AMENDMENT 4/8/97: Part A of this protocol is closed with accrual objectives met. Part B of
      the study will remain open for patient accrual until 6/2/97. Part B is designed as a 2-arm,
      randomized, double-blind study to assess safety, toxicity and tolerability as well as
      anti-HIV activity of ddI or AZT/ddI.
    

Intervention name(s): Zidovudine; Didanosine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Didanosine
Masking: Double
Primary purpose: Treatment
Keywords: Didanosine; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine
Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 Study
Condition: FLU
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza
      Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To
      evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in
      healthy children aged up to 35 months; to evaluate the safety and tolerability of a single
      0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.
    


Intervention name(s): Influenza Trivalent Inactivated Vaccines; Influenza Trivalent Inactivated Vaccines
Intervention type(s): Biological; Biological
Intervention description(s): This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm.; This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; vaccines; children
Use of Pancreatic Enzymes in Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with short bowel syndrome have a high mortality rate that is mainly attributed to
      complications from central lines and long-term intravenous (IV) nutrition. There are few
      medical therapies to date that improve gut absorption in patients with short bowel syndrome.
      The primary objective of this study is to evaluate if absorption from the GI tract improves
      in subjects with short bowel syndrome following therapy with pancreatic enzymes.
    

Detailed description: 
      This is an interventional study of subjects with short bowel syndrome to determine if enteral
      absorption improves following therapy with pancreatic enzymes. The study will assess enteral
      absorption and nutritional status at baseline through a series of stool tests, blood tests,
      and anthropometric measurements. Following approximately ten days of therapy with pancreatic
      enzymes, the study will reassess enteral absorption.
    

Intervention name(s): Pancreatic Enzyme
Intervention type(s): Drug
Intervention description(s): All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.
Other intervention name(s): Creon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic enzymes
Pulmonary Hypertension: Assessment of Cell Therapy
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to establish the safety of autologous progenitor cell-based gene
      therapy of heNOS in patients with severe Pulmonary Arterial Hypertension(PAH) refractory to
      conventional treatment.
    

Detailed description: 
      This is a two centre, phase I clinical trial. A total of 18 patients will be studied using an
      open-label, dose escaling protocol; three patients will be entered into each of the five
      dosing panels. An additional three patients will be entered into the final dose panel to
      establish safety at the maximum tolerated dose.
    

Intervention name(s): eNOS transfected EPCs will be delivered via a PA line
Intervention type(s): Biological
Intervention description(s): incremental dosing over 3 days
Other intervention name(s): eNOS transfect EPCs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pulmonary Arterial Hypertension (PAH)
Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy
Condition: Malignant Tumor
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      To investigate gene expression profile and immunological associated analysis relating to
      immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.
    

Detailed description: 
      1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine
           induced killer cells (CIK) .

        2. Venous blood (4 ml) is collected from each subject and placed into tubes containing
           Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are
           sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until
           processing.

        3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。

        4. Estimate Immunotherapy response, time to disease progression, survival rates and
           clinical benefit response on patients. Response is assessed using Response Evaluation
           Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide
           the cancers into two groups: sensitive and non-sensitive to immunotherapy.

        5. Compare the gene expression profile between different immunotherapy response groups to
           explore the mechanism that predict the DC-CIK immunotherapy response.
    

Intervention name(s): DC-CIK Immunotherapy
Intervention type(s): Biological
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
Condition: Post-Menopausal Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on
      parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral
      density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly,
      and measurements will be taken at baseline, and at intervals over 2 years. The anticipated
      time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
    


Intervention name(s): ibandronate [Bonviva/Boniva]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150mg po monthly for 2 years; po monthly for 2 years
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin
      levels in IBD patients in clinical remission. During the study fecal calprotectin levels will
      be measured every 3 months and clinical flares will be registered.
    


Intervention name(s): Eicosapentaenoic acid; Medium chain fatty acid (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of Eicosapentaenoic acid for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured. The effect of Eicosapentaenoic acid on fecal calprotectin level will be monitored. Clinical relapses will be considered during the study.; 30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of medium chain fatty acids for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured.
Other intervention name(s): ALFA TM (S.L.A. Pharma A.G. Switzerland)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY3050258 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This
      study will evaluate the safety and how well the body tolerates LY3050258. It will last
      approximately 14 weeks with a 2 week follow-up appointment after the last treatment with
      study drug.
    


Intervention name(s): LY3050258; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Music During Carotid Endarterectomy
Condition: Anxiety State
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that music listening during carotid
      endarterectomy administered the cervical plexus block will cause less anxiety, less pain, and
      greater patient satisfaction.
    

Detailed description: 
      Patients who decided to participate in the study were randomized by means of a
      computer-generated randomization order into 2 groups: Music Group (Group M) and Operating
      Room (OR) Noise Group (Group O). Randomization was independently carried out in both centers.

      Preoperative and postoperative State Trait Anxiety Inventory (STAI) scores, intraoperative
      STAI responses, preoperative and postoperative numerical rating scale scores for anxiety,
      pain scores and hemodynamic parameters were recorded.
    

Intervention name(s): music; operating room noise
Intervention type(s): Other; Other
Intervention description(s): effect of music on anxiety scores; effect of operating room noise on anxiety scores
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several
      studies examined the effect of light-filters on contrast and colour vision. However, the
      study outcomes were varying. The present study investigated the effect of two light-filtering
      IOL on colour perception and contrast acuity using highly sensitive measurement methods.
    

Detailed description: 
      Prospective, randomized, double-masked study with intraindividual comparison. Implantation of
      a Polylens Y30 IOL in one eye and an Orange Series Model PC 440 Y in the contralateral eye.
    

Intervention name(s): Polylens Y30 intraocular lens; Orange Series Model PC 440 Y intraocular lens
Intervention type(s): Procedure; Procedure
Intervention description(s): cataract surgery; cataract surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: intraocular lens; light filtering intraocular lens; contrast acuity; color vision
Ameparomo Capsules 250 mg Drug Use Investigation
Condition: Intestinal Amebiasis
MeSH terms: Amebiasis; Dysentery, Amebic
Study type: Observational

Summary: 
      This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg
      under actual medical practice.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Sites of infection department, internal medicine, and other relevant departments.
Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Premature luteinization in patients undergoing IUI can occur in up to 24% of cycles. These
      patients, according to recent data, have a lower pregnancy rate than controls. The
      possibility to avoid premature luteinization with GnRH antagonist may restore the chances of
      achieving a pregnancy in these women.
    

Detailed description: 
      The purpose of this study was to investigate whether a subset of patients benefits from GnRHa
      administration during IUI. PL was tested for in patients who were undergoing artificial
      insemination procedures, and the effect of GnRHa on PR in patients who
    

Intervention name(s): Ganirelix
Intervention type(s): Drug
Intervention description(s): Ganirelix 0.25mg s.c every 24 h starting stimulation day 6
Other intervention name(s): Orgalutran
Intervention MeSH terms: Ganirelix
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women with patent tubes who were undergoing IUI due to infertily of unknown origin.
      
Keywords: GnRH antagonist; IUI
Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of ascending multiple oral
      doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.
    

Detailed description: 
      This is a phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple
      ascending dose trial in 3 sequential cohorts of elderly subjects (age 70 to 85 years old)
      with MDD. Brexpiprazole will be administered as an adjunct treatment to the current
      antidepressant therapy that the subject is receiving. Total individual subject duration is
      expected to be no more than 119 days (a 30-day screening period, a 14-day washout period, up
      to 45-day in-clinic treatment period, and a 30-day follow-up after the last dose of trial
      medication).
    

Intervention name(s): Brexpiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): up to 3mg oral dose once daily
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder (MDD)