bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
Condition: Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases
Study type: Interventional

Summary: 
      Monocenter study to determine and evaluate the optimal amount of humidification doses
      delivered by the On-Demand humidification system in neuromuscular patients requiring home
      mechanical ventilation. The patient's perception will be monitored with subjective as well as
      with objective measurements of the optimum comfortable on-demand humidification doses.
    


Intervention name(s): On Demand Humidification system Mark 2
Intervention type(s): Device
Intervention description(s): The on demand humidification humidifier is set up to alternate between periods of humidification and no humidification totaling 6 periods of 30 minutes duration each. Thus, the test will consist of 3 cycles of disabled humidification and enabled humidification. Each cycle will be with a different humidification setting to assess which setting is most comfortable. In the second phase, the patient will be treated with the dose they had the best experience with in the first test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Comparison of Two Freezing Techniques
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine the best way to freeze eggs in order to preserve
      the fertility potential of young women.
    

Detailed description: 
      Human egg freezing is rapidly becoming a vital tool in Assisted Reproductive Technology.
      Candidates for egg freezing include women without partners who wish to preserve their
      fertility; cancer patients at risk of losing fertility from chemotherapy; and donor egg
      recipients. While in the past, egg freezing has not been as successful as embryo freezing in
      producing live births, recent experience in several centers has demonstrated significant
      improvement, with pregnancy rates comparable to those achieved with frozen embryos. The
      purpose of this study is to determine the best method to freeze eggs. We shall be seeking
      volunteers from the egg donor program, since young, fertile donors represent the best model
      to study the effect of egg freezing.

      We plan to enroll 12 recipients and 6 donors in this study. Each egg donor will go through a
      stringent screening process (medical, genetic and psychological). Eggs retrieved from all
      donors will be split in half: one half will be frozen by the slow freeze method, and the
      other half by vitrification. Each of the six donors will be paired with two recipients; each
      recipient will be assigned half the total eggs frozen. For each recipient, half of the eggs
      will come from the slow freeze group and the other half will come from vitrification.

      When the recipient's uterine lining is deemed ready (following estrogen treatment and
      ultrasound monitoring), thawing will be performed on eggs frozen by either the slow freeze or
      the vitrification method. The thaw process will be randomized between the two types of
      freezing. One sperm will be injected into each egg that survived the freeze. Fertilization
      and embryo development will be recorded. Ideally, two embryos will be transferred into the
      recipient's uterus. Pregnancy will be determined by a blood test and followed by serial blood
      tests and ultrasound.

      The study will determine which freezing method yields better survival and pregnancy rates.
    

Intervention name(s): oocyte freezing
Intervention type(s): Procedure
Intervention description(s): retrieved oocytes from the donor will be split in half and frozen by both existing egg freezing methods: slow freezing and vitrification. The recipients will then be randomized as to which group of eggs will be thawed out for their first attempt at achieving a pregnancy.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: oocyte freezing; vitrification; slow freeze; fertility preservation
A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c)
      level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day
      (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic
      control on oral antidiabetic drugs (OADs).
    

Detailed description: 
      A multicenter, non-randomized, open-label, post-marketing clinical study. The target
      population of the study is type 2 diabetic patients who have failed to achieve adequate
      glycemic control on OADs. The study consists of 4 periods: Lead-in Period (2 to 4 weeks),
      Study Period I (16 weeks), Study Period II (16 weeks), and Study Period III (16 weeks). The
      regimen of lispro mix 50/50 injection will be changed every 16 weeks based on the HbA1c
      level. During Study Period I, all the subjects will be given a once daily (QD) injection of
      lispro mix 50/50. During Study Period II, the regimen of lispro mix 50/50 injection will be
      changed to twice daily (BID) if the HbA1c level at Week 16 is 6.5% or above, and QD injection
      will be continued if the value is below 6.5%. During Study Period III, if the HbA1c level at
      Week 32 is 6.5% or above, the subjects on BID treatment during the previous period (Study
      Period II) will receive three times daily (TID) injections of insulin.
    

Intervention name(s): Lispro Mix 50/50
Intervention type(s): Drug
Intervention description(s): Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control.
Other intervention name(s): LY275585; Humalog Mix50
Intervention MeSH terms: Isophane insulin, insulin lispro drug combination 50:50
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
Condition: Hypobaric Hypoxia; Cognitive Deterioration; Emergency Medicine; Resuscitation; Stress Physiology
MeSH terms: Emergencies; Hypoxia
Study type: Interventional

Summary: 
      The study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance
      (H0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at
      3000 meters above sea level = cognitive performance at 5000 meters above sea level).

      Before participating in the study, each participant will respond to a questionnaire related
      to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria
      evaluation.

      On day 0, after the interview and signed informed consent, the participant will undergo a
      medical examination that will include a general objective examination. Participants will
      participate in a training on the emergency and safety procedures of the hypobaric hypoxia
      facility, as well as a refresh on cardiopulmonary resuscitation procedure.

      During the following two days (day 1 and 2) the study protocol will be executed (one test per
      day). The study protocol envisages:

        -  a basal cognitive test battery

        -  blind ascent in the hypobaric chamber to simulated altitude

        -  cognitive test battery

        -  5 minutes of recorded chest compressions on dummies

        -  cognitive test battery

        -  blind descent in the hypobaric chamber.

      During the stay in the hypobaric hypoxic facility, each participant will be monitored in real
      time with the Equivital© medical monitoring device.

      Before and after the stay in the hypobaric hypoxic facility, a saliva sample will be
      collected, and psychological tests administered.
    


Intervention name(s): Altitude exposure in climate chamber
Intervention type(s): Other
Intervention description(s): Altitude exposure in a climate chamber will consist of hypobaric hypoxia similar to the conditions found at 3000m asl and 5000m asl.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-over
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)
Condition: Edentulous; Teeth Replacement; Bounded Edentulous Space
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      The result of the study will demonstrate that the functional activity of maxillofacial area
      with edentulous posterior bounded spaces recovers more effectively in patients treated with
      restorations on implants comparing to patients treated with fixed dentures.
    

Detailed description: 
      All patients will be provided with electromyographic research before denture treatment, in a
      month and three months after the termination of treatment.
    

Intervention name(s): EMG befor denture treatment; EMG in a month after termination of treatment; EMG in a 3 months after termination of treatment
Intervention type(s): Procedure; Procedure; Procedure
Other intervention name(s): electromyographia; electromyographia; electromyographia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Acute Transcranial Bright Light on Anxiety Symptoms
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine if transcranially administered bright light has
      acute effect on anxiety symptoms.
    

Detailed description: 
      Subjects (n=30) with anxiety symptoms will be recruited into the study. To be included into
      the study, subjects have to get at least seven points in BAI(Becks Anxiety Inventory). At the
      beginning of the study subject will be randomly assigned to 12 minutes of acute transcranial
      bright light or placebo exposure group. Anxiety symptoms will be measured using Spielberger
      State-Trait Anxiety Inventory (STAI, form Y1)self-rating questionnaire just before and 10 and
      110 minutes after the experiment.
    

Intervention name(s): Transcranial bright light device; Transcranial sham device
Intervention type(s): Device; Device
Other intervention name(s): Valkee npt 1100; Valkee npt 1100
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
Condition: HIV Infections; HIV-1
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each
      volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers
      will receive investigational product for a total of 42 days.
    


Intervention name(s): dapivirine (TMC120) vaginal gel
Intervention type(s): Drug
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV seronegativity
Safety and Immunogenicity of a Nipah Virus Vaccine
Condition: Nipah Virus Infection
MeSH terms: Henipavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to
      assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus
      soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will
      also be explored.
    

Detailed description: 
      This is a randomized, placebo-controlled, observer-blind, phase 1 trial in healthy male and
      non-pregnant female adults 18 through 49 years of age designed to assess the safety and
      immunogenicity of three ascending doses of HeV-sG-V. Different dosing regimens and number of
      doses will also be explored.

      The study plans to accrue eligible subjects into three successive dosage escalation cohorts
      consisting of 12, 72, and 108 subjects, respectively (total of 192 subjects). The three
      HeV-sG-V dosages will be 10 mcg, 30 mcg, and 100 mcg.

      In the first cohort, subjects will receive two doses of the investigational product (IP) at
      28-day intervals. Subjects will be randomized in a 5:1 ratio, with 10 receiving two doses of
      HeV-sG-V (10 mcg dosage) and two subjects will receive placebo.

      In the second cohort, subjects will be randomized in a 5:5:2 ratio with 30 receiving a 30 mcg
      dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29), 30
      receiving a 30 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit
      2 (Day 8), while 12 subjects will receive placebo at each of the same visits.

      The third cohort will be randomized in a 5:5:5:3 ratio so that 30 subjects are assigned to
      each of three different regimens consisting of a 100 mcg dosage of HeV-sG-V and placebo
      administered as three doses, HeV-sG-V on Visit 1 (Day 1) with placebo on Visits 2 and 3 (Days
      8 and 29), or HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29), or
      HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8), while the
      remaining 18 will receive a dose of placebo at each of the same visits.
    

Intervention name(s): HeV-sG-V; Normal Saline Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A Hendra virus soluble glycoprotein vaccine formulated in phosphate buffer and adjuvanted with aluminum hydroxide. Placebo is normal saline.; 0.9% Saline
Other intervention name(s): Nipah Vaccine, HenipaVaxTM; Placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ascending dose study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Nipah, Vaccine, Henipah
Clinical Trial to Compare the Pharmacokinetics and Pharmacodynamics After Oral Administration of Glucophage and HL-018
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics
      and safety after oral administration of Glucophage with those after oral administration of
      HL-018 in healthy male volunteers
    


Intervention name(s): Glucophage 500mg; HL-018 500mg; No administration of Drug
Intervention type(s): Drug; Drug; Other
Intervention description(s): Single Oral Dose of; Single Oral Dose of
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: healthy volunteers
Effects of Low Fat Milk Consumption on Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study aimed to investigate the effects of low-fat milk consumption on metabolic
      parameters and biomarkers related to inflammation, oxidative stress, and endothelial function
      in Korean adults with metabolic syndrome.
    

Detailed description: 
      A randomized, controlled, parallel, dietary intervention study was designed. Subjects with
      metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the low-fat milk group,
      which were instructed to consume 2 packs of low-fat milk per day (200 mL twice daily) for 6
      weeks, and the control group was instructed to maintain their habitual diet. Metabolic
      markers were evaluated at baseline and at the end of the study.
    

Intervention name(s): Low-fat milk group
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: low-fat milk; metabolic syndrome; lipid profile; inflammation; oxidative stress; endothelial function
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
Condition: Kidney Transplantation; Graft Rejection
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to compare the safety and efficacy of three immunosuppressive
      treatment regimens following a kidney transplant.
    


Intervention name(s): Everolimus; Mycophenolic Acid (MPA); Cyclosporine A (CsA); Basiliximab; Corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral, bis in diem/twice a day (bid); 2 oral capsules of mycophenolic acid 360mg administered bid; CsA dose adjustments were based on CsA trough levels (C0).; All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was to be given within 2 hours prior to transplant surgery and the second dose was to be administered on day 4, or each dose could have been administered according to local practice.; Oral corticosteroids were administered according to local practice during the trial. At the same center, all patients were to follow the same steroid administration protocol.
Other intervention name(s): Certican, Zotress; Myfortic; Neoral; Simulect
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplantation, kidney, and organ transplant; Renal transplant rejection
Influence of Vasculary Inflammation on Development of Diabetes
Condition: Coronary Artery Disease(CAD)
MeSH terms: Coronary Artery Disease; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if patients with coronary heart disease have
      higher risk to develop diabetes mellitus among the following two years.

      The examination of biomarkers taken from blood and fat issue shall provide which factors
      could be responsible for development of diabetes mellitus.
    


Intervention name(s): biopsy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution
Condition: Occlusion
Study type: Interventional

Summary: 
      evaluation of occlusal force distribution was carried out with the aid of T-Scan device
      (Tekscan Inc., South Boston, MA, USA) for mandibular complete dentures before and after
      relining with long term soft liner for controlled type 2 diabetic patients.
    

Detailed description: 
      A crossover clinical study was carried out with previously constructed and used conventional
      complete dentures before relining with soft denture liners and then with the same dentures
      after relining with soft denture liners. The study sample included 50 males completely
      edentulous contributors, All patients were controlled type 2 diabetes during the study
      period. All selected patients had previously constructed and used conventional heat cured
      acrylic resin complete dentures for not less than two years with history of retention and
      stability problems of mandibular dentures. Mandibular complete dentures had received the
      essential prosthetic adjustments aiming to achieve optimal retention, maximum stability and
      the necessary occlusal contacts. The first occlusal parameters were recorded before denture
      relining. Relining of mandibular dentures was performed and Patients were comfortably using
      their relined mandibular complete dentures for at least three months and the retention and
      stability of the conventional dentures were assessed before second recording of occlusal
      parameter. The evaluation of occlusal force distribution was carried out with the aid of
      T-Scan device (Tekscan Inc., South Boston, MA, USA). The first record was recorded before
      denture relining and the second record was three months after denture relining
    

Intervention name(s): relining of mandibular complete denture
Intervention type(s): Procedure
Intervention description(s): Relining of mandibular dentures was performed by reducing one mm of the denture fitting surfaces and borders to make a right-angled border. apply two separate layers of Mucopren adhesive upon the vestibular surface of the mandibular denture and allow each layer to dry for about 40 seconds. then, the lower denture was inserted and molded in patient mouths; while biting in centric occlusion with the opposing maxillary complete dentures.
Intervention model: Single Group Assignment
Intervention model description: occlusal load distribution was measured by T scan system before and after mandibular complete denture relining with soft denture liner
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: complete dentures; relining; occlusal force; T scan system