bioihbjkbjnl/mcl2 huggingface dataset:
Obalon Balloon System Pivotal IDE (SMART) Trial
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This pivotal trial of the Obalon Balloon System is intended to generate safety and
      effectiveness data required to support a future marketing application. The trial has been
      designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition
      and lifestyle behavior modification program.

      Weight loss will be evaluated after the 6-month course to determine if a specific predefined
      superiority margin can be achieved in the device group compared to a sham-control group.
    


Intervention name(s): Obalon Intragastric Balloons; Sham Device; Nutrition and Lifestyle Program
Intervention type(s): Device; Device; Behavioral
Intervention description(s): Intragastric Balloon System to aid in portion control.; Sham Intragastric Balloon; Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Weight Loss; Obesity; BMI
Benefits of a Bolus Calculator in Pediatric Patients on Multiple Daily Insulin Injections
Condition: Poor Glycemic Control; Quality of Life
Study type: Interventional

Summary: 
      It it hypothesized that children and adolescents with type 1 diabetes, who are counting
      carbohydrates can achieve better metabolic control by concurrent use of the Accu-Chek Aviva
      Expert. Additionally, it is proposed that carbohydrate counting in combination with the the
      Accu-Chek Aviva Expert will lead to better quality of life as a result of fewer restrictions
      when eating and less variation in blood glucose.
    

Detailed description: 
      Carbohydrate (Carb) counting is a meal planning approach for patients with diabetes mellitus
      that focuses on carbohydrate as the primary nutrient affecting postprandial glycaemic
      response. In the early 1990's the Diabetes Control and Complications Trial (DCCT) used Carb
      counting as one of its education tools. More recently, short acting insulin analogues and
      insulin pumps have made the role of Carb counting important and popular. Carb counting can be
      used to estimate carbohydrate intake and adjust insulin around mixed meals and snacks using
      insulin to carbohydrate ratio. This effectively addresses the variable eating habits of most
      children and adolescents. Carb counting can make food planning more flexible and thus more
      acceptable for young patients with diabetes.

      Roche has recently launched the Accu-Chek Aviva Expert recently preliminary tested in
      adults4, being a blood glucose meter with integrated bolus calculator and memory function.
      This bolus calculator estimates the dose of insulin to be administrated on the basis of the
      following parameters: Current blood glucose, grams of carbohydrate, carbohydrate to insulin
      ratio, insulin sensitivity, target blood glucose and insulin action time.

      Hypothesis:

      It is hypothesized that paediatric patients in MDI therapy with suboptimal regulated diabetes
      will achieve better glycemic control by using Accu-Chek Aviva Expert rather than carbohydrate
      counting alone without the use of an external calculator.
    

Intervention name(s): accu chek Aviva Expert; Accu Chek Aviva Nano
Intervention type(s): Device; Device
Intervention description(s): This bolus calculator estimates the dose of insulin to be administrated on the basis of the following parameters: current blood glucose, grams of carbohydrate, carbohydrate to insulin ratio, insulin sensitivity, target blood glucose and quantity of insulin previously administered.; This meter is a normal glucometer without bolus calculator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Metabolic control; Quality of life
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Condition: Candidiasis, Vulvovaginal
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs
      Fluconazole for the treatment of severe vulvovaginal candidiasis
    

Detailed description: 
      The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg
      clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of
      150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The
      number of participants with adverse events as a measure of safety and tolerability.
    

Intervention name(s): Clotrimazole vaginal tablet; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4); 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Other intervention name(s): Canesten; Diflucan
Intervention MeSH terms: Fluconazole; Clotrimazole; Miconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Inflammatory Markers in Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      This is an investigation of inflammatory markers in women destined to develop preeclampsia.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study comprised 43 pregnant women who developed preeclampsia and 86 pregnant women who
        fulfilled a normotensive pregnancy.

        All women were of Caucasian origin, and were nulliparous.
      
Keywords: pre-eclampsia; inflammatory markers; serological biobank; To assess whether the inflammatory markers could be useful; in order to identify pregnant women at risk to; develop preeclampsia
The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Pathology
Condition: Cognitive Change; Memory; Disturbance, Mild; Emotional Regulation; Concentration Ability Impaired
Study type: Interventional

Summary: 
      This is a single-centre, single-blind, two-arms, controlled study to assess the efficacy and
      safety of food for special dietary use enriched with 5-hydroxytryptophan, L-theanine and
      Gamma-aminobutyric acid in generally healthy subjects with no cognitive disturbances
    


Intervention name(s): Food for special dietary use
Intervention type(s): Dietary Supplement
Intervention description(s): Food for special dietary use (spread) with modified ingredients' content will be included to the diet of 70 patients without significant organic pathology for 14 days receiving standard diet, modified by the inclusion of two portions of the spread, 20 grams each for breakfast and dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes
      and extent of elimination, mass balance, as well as safety and tolerability of
      [14C]BMS-986419 in healthy male participants.
    


Intervention name(s): [14C]BMS-986419
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Other intervention name(s): BMS-986419; EOAI4018683
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Metabolite profile; Radioactivity; BMS-986419; Healthy volunteer; Healthy participants
Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This study is a single-center, parallel-group, randomized controlled trial with the following
      objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in
      phacoemulsification surgery between modified and conventional 2.2mm microincision.
    

Detailed description: 
      2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a
      common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus
      age-related cataract. DMD is originated from the incision in the operation. How to construct
      the appropriate incision shape and size for reducing the occurrence of DMD is an important
      problem to be solved urgently in phacoemulsification surgery.

      The investigators found that enlarging the internal incision could increase the range of
      motion of surgical instruments and reduce the friction of instruments to incision.
      Therefore，the incidence of DMD would be reduced. The investigators developed this technique,
      modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase
      other incision related complications.

      In this trial, the investigators aim to compare modified and conventional 2.2mm incision with
      regard to safety and efficacy in reducing the incidence of DMD.
    

Intervention name(s): modified 2.2mm microincision; conventional 2.2mm microincision
Intervention type(s): Procedure; Procedure
Intervention description(s): enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification; conventional 2.2mm coaxial microincision phacoemulsification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Comparison of the Distance Between the Femoral Artery and Veins in Various Position in Malay Race Adult
Condition: Femoral Artery and Vein Distance; Anatomic
Study type: Observational

Summary: 
      The purpose of this study is to compare the distance between femoral artery and vein in frog
      position, abduction-exorotation position and anatomical position.
    

Detailed description: 
      The incidence of unintentional arterial puncture during cannulation of femoral vein was
      high(20-50%). The addition of knee flexion to abcudtion-exorotation position (frog position)
      have been shown to increase the cross sectional area of femoral vein. The purpose of this
      study is to compare the distance between femoral artery and vein in frog position,
      abduction-exorotation position and anatomical position.

      This study is an analytical observational study with cross sectional design within one grup
      with repeated measurement. The distance between artery and vein was measured in three
      position. The measurement was taken twice for each position. First picture was taken by one
      operator and one ultrasonography for all patient. Then another operator measured the
      distances with caliper feature on the ultrasonograph.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All Malay race adult seeking for medication in Ciptomangunkusumo Hospital who agree to
        participate in the study
      
Keywords: femoral artery; femoral vein; ultrasonography; Frog leg position; abduction-exorotation position
AGN-241751 in the Treatment of Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy at 1 day post initial oral dose of
      AGN-241751 compared with placebo in participants with Major Depressive Disorder (MDD).
    


Intervention name(s): AGN-241751; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AGN-241751 administered orally as a single tablet; Placebo administered orally as a single tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis
Condition: Renal Tubular Acidosis, Distal, With Hemolytic Anemia
MeSH terms: Acidosis, Renal Tubular; Anemia, Hemolytic; Acidosis
Study type: Observational

Summary: 
      This open-label, non-randomized, retrospective-prospective, non-interventional study will
      evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney
      disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12
      months at a dose to be determined by the investigator.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention was administered in this study.
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Patients 18 to 75 years old with stage III-IV chronic kidney disease not on dialysis
Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
Condition: STEMI
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in
      patients with ST-elevation myocardial infarction (STEMI) is safe and feasible
    

Detailed description: 
      A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential
      role of unloading with the Impella CP prior to revascularization in reducing infarct size.
      The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading
      with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate
      Arm: initiation of Impella CP unloading followed immediately by PPCI.

      Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System
      prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and
      feasible
    

Intervention name(s): Impella unloading prior to PPCI
Intervention type(s): Device
Intervention description(s): Impella unloading prior to PPCI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infarct Size; Impella; Unloading; Left Ventricle; PPCI; STEMI
Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk
Condition: Preterm Infants
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      OBJECTIVE. Neonatologists consider early feeding at the breast to be too tiring for preterm
      infants, although there is no evidence that this is actually the case. It is also not known
      whether the method of feeding affects energy expenditure. We hypothesized that resting energy
      expenditure (REE) would be higher after breastfeeding than after bottle feeding.

      PATIENTS AND METHODS. preterm ( >32 weeks GA) stable infants who are nourished entirely by
      their mothers' breast milk will be studied when fed expressed breast milk either by bottle or
      at the breast. REE will be measured for 20 minutes after feeding. Breast milk quantity is
      evaluated by pre- and post feeding weighing.
    

Detailed description: 
      Most VLBW infants cannot be fed at the breast upon birth, and expressed breast milk by
      gastric tube is thus recommended. Sucking skills mature at around 34 weeks when
      nipple-feeding is introduced. In the absence of evidence-based data to decide the best timing
      to introduce breastfeeding, many clinicians use empiric criteria, such as the infant's
      weight, gestational age, and the ability of infants to bottle feed as proxies of readiness to
      breastfeed. Despite some evidence of physiological benefits of preterm infants feeding at the
      breast, many neonatologists consider direct breastfeeding to be too fatiguing for preterm
      infants. It is not known, however, whether preterm infants who are breastfed expend more
      energy than bottle-fed infants
    

Intervention name(s): Way of Feeding - Breast feeding vs. Bottle feeding
Intervention type(s): Other
Intervention description(s): Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants born after 32 weeks of gestation, when they reached the corrected
        gestational age of 34 weeks or more.
      
Biospecimen description: 
      Maternal breast milk
    
Keywords: Metabolic rate; indirect calorimetry; oral feeding
Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block
Condition: Postoperative Analgesia; Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators compared between dexamethasone and dexmedetomidine when added to
      levobupivacaine in the quality and duration of ultrasound-guided interscalene block during
      shoulder arthroscopy.
    

Detailed description: 
      Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml
      levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H
      received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block.
      Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary
      outcome was the postoperative pain which was assessed by Visual analog score(VAS), the
      secondary outcomes were the onset and duration of sensory and motor block, the total amount
      of analgesic requirement, and blood cortisol level.
    

Intervention name(s): Saline; Dexamethasone Injection; Dexmedetomidine Hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 ml normal saline; 8 mg dexamethasone; 100 microgram dexmedetomidine
Other intervention name(s): normal saline; dexamethsone; dexmedetomidine
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Dexamethasone; Interscalene
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this long-term follow-up study was to evaluate the persistence of the cellular
      and the humoral immune response 4 years after the first dose of GSK Biologicals'
      investigational vaccine formulations containing HBsAg (used as a model antigen) and an
      adjuvant.
    

Detailed description: 
      Subjects in this long-term follow-up study were recruited among those subjects who completed
      the study 287615 (NCT00508833) and who were enrolled in specific groups. All subjects were
      vaccinated in the study 287615 (NCT00508833) according to a 0, 1, 10 month schedule. No new
      subjects were enrolled and no vaccine was administered in this long-term follow-up study.
      There was a single visit at Year 4 at which blood samples for immunogenicity assays were
      taken.
    

Intervention name(s): Blood Sampling
Intervention type(s): Procedure
Intervention description(s): Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HBsAg; Persistence of the immune response; Adjuvants
Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Doses of AZD2066 in Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive
      multiple-ascending panels are planned. Subjects will start with an initial single dose that
      is followed by a wash-out period of 48 hours to adequately define the single-dose
      pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended
      to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once
      daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to
      receive either AZD2066 or placebo.
    

Detailed description: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive
      multiple-ascending panels are planned. Subjects will start with an initial single dose that
      is followed by a wash-out period of 48 hours to adequately define the single-dose
      pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended
      to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once
      daily for 10 days. Furthermore, the study has been expanded to include two additional panels
      with increment of dose during the multiple dosing period (12 days) in order to obtain
      sufficient information on safety and tolerability of multiple dosing of AZD2066 in Japanese
      subjects at higher levels of exposure. Ten (10) subjects will be allocated to each dose panel
      and randomized to receive either AZD2066 or placebo.
    

Intervention name(s): AZD2066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16. Specific dose depends on dose panel.; Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; tolerability; pharmacokinetics; AZD2066; Japanese