bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison Between Two Oral Hypoglycemics - Metformin and Glybenclamide for the Treatment of Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Rationale Gestational diabetes mellitus (GDM) complicates 5-7% of pregnancies. Major hazards
      include macrosomia, polyhydramnios, labor trauma and neonatal hypoglycemia. The ADA and ACOG
      recommend glucose control in order to reduce the incidence of hyperglycemia induced
      complications. Glucose control can be achieved using diet and life style changes. Insulin is
      initiated in women who fail to obtain glucose control with diet alone. During the past 11
      years oral hypoglycemic drugs have been tested and proven to be efficacious and safe.

      Objectives

        1. To compare the efficacy and safety of glybenclamide vs. metformin in the treatment of
           women diagnosed with GDM

        2. To evaluate the improvement in glycemic control after the addition of a second oral
           hypoglycemic drug after failure of the first

      Hypothesis GDM is one of the major conditions contributing to obstetrical complications and
      prenatal morbidity. Improving glycemic control, by means of improving compliance and patient
      satisfaction, will decrease obstetrical complications, maternal and neonatal morbidity and
      have positive long term health implications.

      Study design Prospective, randomized, open label

      Study population Women between the ages 18-45, diagnosed with GDM will be recruited. GDM will
      be defined by a pathological OGTT (according to Carpenter and Coustan criteria) performed at
      or after 13 weeks of gestation.

      Study period From recruitment until discharge of the newborn baby after delivery

      Study protocol Women will be randomized at recruitment. Demographic and obstetrical data will
      be collected. Average glucose levels during the previous two weeks, estimated fetal weight
      and amniotic fluid index, and lab exams reflecting glycemic control will be noted. Women will
      provide daily glucose levels via fax or mail once a week. Glycemic control will be evaluated
      by a daily chart, including 7 measurements: 3 preprandial, 3 postprandial and a 7th
      measurement at 10 pm. Women will be invited to a monthly follow-up, which will include a
      sonographic evaluation of fetal weight and amniotic fluid, and lab exams. Follow-up protocol
      after 38 w of gestation will be according to our ward's protocol. The study was approved by
      the local Helsinki committee.

      Time table Duration: two years
    


Intervention name(s): metformin; glybenclamide
Intervention type(s): Drug; Drug
Intervention description(s): metformin up to 2550mg per day.; glybenclamide up to 20mg per day.
Intervention MeSH terms: Metformin; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.
Condition: Candidiasis
MeSH terms: Candidiasis; Candidemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to investigate the safety and efficacy of voriconazole for the treatment of
      candidemia in critically ill non-neutropenic patients
    


Intervention name(s): VFENDÂ® I.V., Oral; Conventional amphotericin B; Diflucan IV, oral
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure
Condition: High-grade Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      This is a pilot study to test the short-term effectiveness of an alternative treatment
      approach for precancerous cells of the cervix. The study will also explore whether this new
      treatment is feasible to perform and if it is acceptable to patients.
    

Detailed description: 
      Standard treatment for precancerous cells of the cervix is called electrosurgical excision
      procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved
      equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the
      visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual
      symptoms will be monitored as well as the patient's thoughts and recommendations of the
      procedure. The total amount of time of study participation is six months.
    

Intervention name(s): Focal LEEP
Intervention type(s): Procedure
Intervention description(s): Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical neoplasia; cervix; high-grade dysplasia; LEEP (loop electrosurgical excision procedure); precancerous cells; colposcopy
Modelling Interface Pressure Applied by Superimposed Compression Bandages
Condition: Risk of Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      The aim of the study is to measure and model interface pressure applied on the lower leg of
      patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex
      16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher). The patient specific model should better
      predict the interface pressure distribution than Laplace's Law.
    

Detailed description: 
      The measurement of the patients' legs shapes will be performed thanks to an optical scanner.
      The patients' posterior part of the calf will be submitted to a localized compression test,
      in order to characterize the soft tissue mechanical properties of both legs.

      Pressure measurements, applied by the different bandages, will be taken at the height of
      measurement points B1 and C on the lateral and medial sides of the leg in supine, sitting and
      standing positions, on both legs.

      2 single bandages (Biflex 16 (Thuasne) and Rosidal K (Lohmann & Rauscher)) and their
      different combinations will be applied on the patient's legs.

      The order of bandage application for each patient is randomized, but is the same for both
      legs. The order of the leg (right or left) on which the bandages are applied is randomized.
    

Intervention name(s): Compression bandages application and interface pressure measurements
Intervention type(s): Other
Intervention description(s): Bandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Compression bandages
Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite
Condition: Lack or Loss Appetite Nonorganic Origin
Study type: Interventional
Phase: Phase 3

Summary: 
      Lack of appetite is one of the most common reasons for visits to pediatric clinics.The
      symptoms usually manifest after weaning when they are introduced into the diet of infant
      foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and B
      and also vitamins complex.
    

Detailed description: 
      Study Design:

        -  Multicenter

        -  Phase III

        -  Randomized

        -  Double Blind

        -  Prospective and Comparative

        -  Experiment duration: 30 days

        -  3 visits (day 0, day 15 and day 30)

        -  Increased appetite

        -  Adverse event
    

Intervention name(s): Apevitin BC; Vitamin B Complex + Vitamin C
Intervention type(s): Drug; Drug
Intervention description(s): 3.5 to 5 ml 3 times a daily; 3.5 to 5 ml 3 times a daily
Intervention MeSH terms: Vitamins; Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD8233 After Multiple Dose Administration in Subjects With Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study to assess the safety, tolerability and pharmacokinetics (PK), and
      pharmacodynamics (PD) of AZD8233, following subcutaneous (SC) administration of multiple
      ascending doses (MAD) of AZD8233 in subjects with confirmed dyslipidemia with or without type
      2 diabetes.
    

Detailed description: 
      This study is a Phase 1, randomized, single-blind, placebo-controlled, multiple dose group
      design in up to 33 male or female subjects with dyslipidemia with or without Type 2 diabetes
      and performed at multiple study centers. The planned number of cohorts is 3 but up to 5
      cohorts may be included if the Safety Review Committee (SRC) considers it necessary. The 3
      multiple dose levels of SC AZD8233 planned are:

        -  Cohort 1: Dose 1 (starting dose).

        -  Cohort 2: Dose 2 (provisional dose).

        -  Cohort 3: Dose 3 (provisional dose). Within each of these cohorts, 8 subjects will be
           randomized to receive AZD8233 and 3 subjects randomized to receive placebo. Cohorts 2
           and 3 may be run in parallel if Cohort 3 is a lower dose. If Cohort 3 is a higher dose,
           the cohorts will be run sequentially. At any time, the dose levels may be adapted by the
           SRC based on emerging data. The expected duration of each patient in this study is up to
           28 weeks with a maximum of 17 visits. Screening will be completed between Days -28 and
           -1. Each subject will receive single doses of AZD8233 or placebo on Days 1, 8, 29, and
           57. The treatment period will consist of 58 days (up to Visit 9), followed by a
           follow-up period (up to Visit 17).

      Following review of data, the SRC may decide to adjust the following for subsequent cohorts:

        -  The timing and amount of the loading dose.

        -  The length of the stay at the study site, the timing and number of assessments and/or
           samples.

        -  As decided by the SRC, blood and urine samples collected in the study may be used to
           address any of the other pre-specified study objectives.

        -  Each subject will be followed up for 16 weeks post last dose.
    

Intervention name(s): AZD8233 subcutaneous injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Randomized subjects will receive SC dose of AZD8233 (dose 1, dose 2, and dose 3) injection.; Randomized subjects will receive SC dose of placebo injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Multiple Ascending Dose; AZD8233; Safety; Tolerability; PK; PD
Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
Condition: Crow's Feet Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy and safety of Botulax® in treatment of crow's feet line
    

Detailed description: 
      1. Allocation: Randomized

        2. Masking: Double Blind
    

Intervention name(s): Botulinum toxin type A; Botulinum toxin type A
Intervention type(s): Drug; Drug
Intervention description(s): Experimental; Active Comparator
Other intervention name(s): Botulax; Botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.
Condition: Symblepharon; Dry Eye; Ocular Surface Disease; Transplantation
MeSH terms: Stevens-Johnson Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate salivary gland and labial mucous membrane
      transplantation in patients with severe symblepharon and dry eye secondary to Stevens-Johnson
      Syndrome (SJS).
    

Detailed description: 
      This study was performed to evaluate the use of salivary gland and labial mucous membrane
      transplantation in patients with severe symblepharon and dry eye secondary to SJS. Labial
      mucous membrane and salivary gland transplantation showed to be a good option in the
      treatment of severe symblepharon and dry eye secondary to SJS. labial mucous membrane,
      salivary glands, symblepharon, entropion, transplantation, graft.
    

Intervention name(s): Salivary Gland and Labial Mucous Membrane Transplantation
Intervention type(s): Procedure
Intervention description(s): Minor salivary glands (SG) will be obtain "en block" from the same donor site, at the inferior or superior labial mucous membrane, above the orbicularis oris muscle to correct lubrication. The thin split thickness graft of mucous membrane will be suture to the sclera with absorbable sutures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Labial mucous membrane; symblepharon; dry eye; Stevens -Johnson syndrome; salivary gland; ocular surface disease; transplantation
Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies how well dolcanatide works in preventing colorectal cancer in
      healthy participants. Dolcanatide is similar to a natural hormone released into the
      intestine. It is thought that people who have low levels of the hormone are more likely to
      get colon cancer. It may be possible to prevent colon cancer by giving a drug that is similar
      to the hormone, such as dolcanatide.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To identify the ability of dolcanatide (SP333), when administered as a single daily dose
      of 27 mg x 7 days, to induce a direct pharmacological effect on cGMP levels, based on biopsy
      samples from the rectum obtained pre- and post-intervention, as compared to placebo.

      SECONDARY OBJECTIVES:

      I. To assess the pharmacodynamic (PD) response rate between arms (dolcanatide versus
      placebo).

      II. To confirm the safety and tolerability of dolcanatide, as compared to placebo.

      OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM A: Participants receive dolcanatide orally (PO) once daily (QD) for 7 days.

      ARM B: Participants receive placebo PO QD for 7 days.

      After completion of study, participants are followed up at 21 and 51 days.
    

Intervention name(s): Dolcanatide; Laboratory Biomarker Analysis; Placebo Administration; Questionnaire Administration
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Given PO; Correlative studies; Given PO; Ancillary studies
Other intervention name(s): SP 333; SP-333; SP333
Intervention MeSH terms: Dolcanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Propofol and Sevoflurane for Catheter-Related Bladder Discomfort
Condition: Catheter Site Discomfort; Complications; Anesthesia; Urinary Bladder Neoplasms
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      The investigators want to evaluate the efficacy of the propofol and sevoflurane for the
      prevention of catheter-related bladder discomfort.
    

Detailed description: 
      The mechanism of catheter-related bladder discomfort is thought to be related to the
      muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent.
      Propofol and desflurane are known to block the muscarinic receptor in different ways.

      The investigators want to evaluate the efficacy of the propofol and sevoflurane for the
      prevention of catheter-related bladder discomfort.
    

Intervention name(s): Propofol; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Propofol will be administered.; Sevoflurane will be administered.
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions
Condition: Pharmacokinetic Parameters
Study type: Interventional

Summary: 
      Background: The current study is a randomized, open-label, two-period, two-sequence, two-way
      crossover pharmacokinetic study in healthy Jordanian subjects to evaluate the
      pharmacokinetics and bioequivalence profile of two formulations of empagliflozin 10-mg under
      fasting and fed conditions administered orally.; (2) Methods: The plasma concentrations of
      empagliflozin were determined using High-performance liquid chromatography- Mass
      Spectrometry/ Mass Spectrometry (HPLC-MS/MS) method. This study included 26 subjects, 26 in
      each fasting and fed group.
    


Intervention name(s): Empagliflozin 10 mg Tab
Intervention type(s): Drug
Intervention description(s): The Empagliflozin 10 mg Tab were administered orally. The plasma concentrations of empagliflozin were determined using an HPLC-MS/MS method. Tolerability and safety were assessed throughout the study. This study included 26 subjects, 26 in each fasting and fed group.
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with
      Diabetic Gastroparesis (KIGA-DG)
    

Detailed description: 
      Patients are invited to participate in a research study of Kuvan® (sapropterin
      dihydrochloride). We hope to learn whether treatment with Kuvan® is safe and effective in
      improving the ability of the stomach to relax after eating and improving the symptoms of
      diabetic gastroparesis. Women are selected as a possible participant in this study because
      they have diabetes and moderate to severe gastroparesis (meaning stomach empties slowly).
    

Intervention name(s): sapropterin dihydrochloride
Intervention type(s): Drug
Intervention description(s): sapropterin dihydrochloride: 10mg/kg/day
Other intervention name(s): KUVAN
Intervention MeSH terms: Verapamil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria
Condition: Type 2 Diabetes Mellitus and Microalbuminuria
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the efficacy and safety on daily oral doses of TAK-272 5
      mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by
      randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine
      the clinical dose of TAK-272.
    

Detailed description: 
      The drug being tested in this study is called TAK-272. This study evaluated the dose-response
      relationship of the efficacy and safety of TAK-272 in participants with type 2 diabetes
      mellitus and microalbuminuria.

      The study enrolled 415 patients. Participants were randomly assigned to one of the 6
      treatment groups:

        -  TAK-272 5 mg

        -  TAK-272 20 mg

        -  TAK-272 40 mg

        -  TAK-272 80 mg

        -  Candesartan cilexetil 8 mg

        -  Placebo (dummy inactive pill) for TAK-272 or Candesartan cilexetil - this was a tablet
           that looks like the study drug but had no active ingredient

      All participants were administered tablets, orally at the same time each day for 12 weeks in
      double-blind manner. Participants were administered TAK-272 placebo 4 tablets and Candesartan
      cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and
      follow-up period (Week 12-14).

      This multi-center trial was conducted in Japan. The overall time to participate in this study
      is 22 weeks including 2 weeks of follow-up assessment period after last dose of study drug.
      Participants made multiple visits to the clinic during these periods.
    

Intervention name(s): TAK-272; TAK-272 Placebo; Candesartan cilexetil; Candesartan cilexetil Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-272 tablets; TAK-272 placebo-matching tablets; Candesartan cilexetil tablets; Candesartan cilexetil placebo-matching tablets
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Imarikiren hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacological therapy
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
Condition: Invasive Ductal Breast Cancer; Carcinoma Breast Stage I
MeSH terms: Breast Neoplasms; Carcinoma, Ductal, Breast
Study type: Interventional

Summary: 
      The overall objective of this study is to determine the feasibility and tolerability of
      single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when
      administered at the time of breast conserving surgery for patients with early stage breast
      cancer.
    

Detailed description: 
      Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation
      of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the
      patient, are evaluated using questionnaire.

      Local recurrence is evaluated under the same imaging protocol used for Whole breast
      radiation.
    

Intervention name(s): Intraoperative Electron Radiotherapy
Intervention type(s): Radiation
Intervention description(s): Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stage I Breast Carcinoma