bioihbjkbjnl/mcl2 huggingface dataset:
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Condition: Induction of Labor
Study type: Interventional

Summary: 
      The purpose of this study is to compare between single balloon catheter and double balloon
      catheter for ripening the cervix among pregnant with unfavorable cervix.
    


Intervention name(s): Foley catheter; Atad catheter
Intervention type(s): Device; Device
Intervention description(s): Single balloon catheter; Double balloon catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induction of labor; Ripening; Single balloon catheter; Double balloon catheter
LEAP2 Kinetics in Healthy Individuals
Condition: Obesity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study aims to investigate the kinetics of the naturally occurring peptide liver-enriched
      antimicrobial peptide 2 (LEAP-2) in healthy volunteers. The overall objective is to
      investigate the physiological importance of LEAP-2 in healthy subjects.
    

Detailed description: 
      In a recent study, the molecular phenotype of enteroendocrine cells in the small intestine
      before and after Roux-en-Y Gastric Bypass (RYGB) surgery in obese individuals was examined.
      Enteroendocrine cells were identified and isolated from intestinal biopsies and analysed for
      differentially expressed genes by Illumina High Throughput RNA-sequencing. It was discovered
      that the gene encoding liver-enriched antimicrobial peptide 2 (LEAP2), a naturally occurring
      peptide in humans, was significantly upregulated compared to baseline expression.
      Interestingly, LEAP2 was recently shown to antagonize ghrelin function in response to feeding
      in mice. Moreover, the mature murine LEAP2 peptide is identical in mice and humans. Thus,
      LEAP2 has been identified as an endogenous peptide that may be able to alter feeding
      behaviour and maintenance of glucose levels during calorie restriction.

      This study aims to investigate the kinetics of exogenous LEAP2 in healthy subjects.
    

Intervention name(s): Liver-enriched antimicrobial peptide 2
Intervention type(s): Biological
Intervention description(s): IV infusion of LEAP2, 2 hours
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Intervention model: Single Group Assignment
Intervention model description: The study is designed as a clinical study involving one experimental study day.
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill
Condition: Muscle Soreness; Muscle Fatigue; Oxidative Stress; Inflammation
MeSH terms: Myalgia; Inflammation
Study type: Interventional

Summary: 
      This study assesses the effect of molecular hydrogen inhalation in healthy males on muscle
      soreness, fatigue, oxidative stress, and inflammation following eccentric muscle contraction
      during downhill walking on the treadmill.
    

Detailed description: 
      The main aim of this randomized, double-blind, placebo-controlled crossover study is to
      assess the effect of molecular hydrogen inhalation on recovery after downhill walking with an
      additional load of 15% of body mass on the treadmill with a negative slope of -15% at a speed
      of 6.5 km/h for 90 min. The study includes 12 participants, healthy males aged 20-35 years.
      The study consists of two experimental sessions, one using molecular hydrogen inhalation and
      the other using placebo inhalation. Randomization is performed using a computer random
      generator. Molecular hydrogen is colourless, odourless, and tasteless, so it cannot be
      distinguished from placebo by the human senses. The washout period between sessions is set at
      four weeks. One week before each session, participants are asked to follow diet and physical
      activity rules. Variables measured during the 48 h recovery are as follow: creatine kinase
      level, perceived muscle soreness, reactive strength index, malondialdehydes level, and
      interleukin-6 level. The following variables are also measured during exercise: heart rate,
      ventilation and gas exchange, and blood lactate level. Analysis of variance for repeated
      measures and Fisher's post hoc tests are used for statistical analysis. The significance
      level is set at 0.05.
    

Intervention name(s): Molecular hydrogen; Placebo
Intervention type(s): Other; Other
Intervention description(s): Hydrogen gas, purity >99.9%, flow rate 300 ml/min.; Ambient air, flow rate 300 ml/min.
Other intervention name(s): i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic; i300 Placebo Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      The purpose of this study is:

        1. To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC)
           screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV
           carriers between age 40 and 70 years);

        2. To establish the cost-effectiveness of the screening tests;

        3. To compare tumor sizes, resection rates, and survival rates up to 18 months between
           those who were screened by HS-AFP those of a historical control group that was not
           screened.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HBV carriers between age 40 and 70 years
      
Keywords: HBV carriers
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine the pharmacokinetic (PK) profile of
      multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple
      sclerosis (RRMS). The secondary objectives are as follows: to characterize the
      pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to
      explore the safety and tolerability of multiple doses of natalizumab in the pediatric
      population.
    


Intervention name(s): Natalizumab
Intervention type(s): Biological
Intervention description(s): As specified in the treatment arm
Other intervention name(s): Tysabri; BG00002
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric
IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient
Condition: Ibuprofen; Ketorolac; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to assess the Efficacy of IV Ibuprofen and Ketorolac in the
      Management of Postoperative Pain in obese patients Following abdominal cancer surgery.
    

Detailed description: 
      Colorectal cancer is the third most common cancer in the world, after lung and breast cancer,
      and the 4th most reported cause of cancer death, reporting about 8.0 % of all cancer deaths
      According to the WHO, Egypt was ranked the 18th regarding the prevalence of obesity, and
      Deaths attributable to non-communicable diseases represent about 71% of the total mortality
      burden.Data obtained from the past 25 years suggest that the obesity is a cause of nearly 14%
      of cancer deaths in men and up to 20% of cancer deaths in women. Most of cases experience
      moderate to severe pain after colorectal surgery, So effective and individualized analgesia
      required after colorectal surgery, as pain response to surgery is not predicted.

      Opioids are an effective analgesic for moderate to severe pain, although their efficacy is
      limited by adverse effects including respiratory depression, failure to reduce pain caused by
      tissue inflammation, nausea, emesis, drowsiness, moderate sedation, pruritus, urinary
      retention and ileus.

      Regional anesthesia can be an alternative to opioids but according to multiple studies it was
      associated with technical difficulties and higher failure rates in obese patients. Ibuprofen
      is a nonselective inhibitor of cyclooxygenases (COX) enzymes, the inhibition ratio of COX-1
      to COX 2 of Ibuprofen is 2,5:1 that has a low risk of bleeding or gastrointestinal problems,
      while other NSAID as for example ketorolac have an inhibition ratio of 330:1 for COX-1 to
      COX-2 , reason for a high risk of side effects , therefore its use is controversial in most
      of perioperative settings. ketorolac 10 and 20 mg and ibuprofen 400 mg have the same
      analgesic effect that was significant by hour 1 and persisted for 5-6 hours for each active
      medication.
    

Intervention name(s): IV ibuprofen; IV ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): Group 1 will receive IV ibuprofen 400mg \ 6 hours the first dose will be administrated immediately post operative.; Group 2 will receive 20 mg IV ketorolac\ 6 hours the first dose will be administrated immediately post operative
Intervention MeSH terms: Ibuprofen; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
Condition: Healthy
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine
      regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic
      gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and
      transgender individuals having sex with cis-gender men and/or transgender individuals.
    

Detailed description: 
      Human immunodeficiency virus type 1 (HIV-1) is a retrovirus that, if left untreated, can
      progress to acquired immunodeficiency syndrome (AIDS), a condition in which the immune system
      is severely compromised, leading to life-threatening conditions. Ad26.Mos4.HIV is a
      tetravalent vaccine composed of Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and
      Ad26.Mos2S.Env. Clade C and Mosaic gp140 HIV bivalent vaccine contains: Clade C gp140, HIV-1
      Env gp140 of Clade C, Mosaic gp140, HIV-1 Env gp140, and aluminum phosphate adjuvant.
      Evidences showed that a combination of vaccination with Ad26.Mos.HIV followed by Ad26.Mos.HIV
      together with Clade C gp140 protein in aluminum phosphate adjuvant led to highest level of
      protection observed so far with this vaccine concept. Study comprises of a screening period
      of 45 days, a 12-month vaccination period and a follow-up period of at least 18 months after
      fourth vaccination (until Month 30) in participants who remain HIV-1 negative or up to 6
      months after diagnosis of HIV-1 infection in participants who become HIV-1 infected.
      Participants who completed their Month 30 visit will be followed for HIV infection,
      medically-attended adverse event (MAAEs) and serious adverse events until the end of study
      (Month 30). Primary analysis of vaccine efficacy will evaluate the number of HIV-1 infections
      in the vaccine group compared to number of HIV-1 infections in the placebo group between
      Month 7 and Month X (with 24<=X<=30) in per-protocol population.
    

Intervention name(s): Ad26.Mos4.HIV; Clade C and Mosaic gp140 HIV bivalent vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.; Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.; Participants will receive matching placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial
Condition: ıntrapartum Haemorrhage; Postpartum Haemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesis in this study is that administration of rectal and sublingual
      misoprostol decreases intrapartum and postpartum haemorrhage.
    


Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of high fat meal and increased gastric pH
      on BMS-663068 bioavailability
    


Intervention name(s): BMS-663068
Intervention type(s): Drug
Intervention description(s): BMS-663068
Intervention MeSH terms: Fostemsavir
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Other
Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
Condition: Hemianopia; Stroke
MeSH terms: Stroke; Hemianopsia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this Study is to determine whether non-invasive transcranial direct current
      stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual
      Cortex.
    

Detailed description: 
      Visual field defects after posterior cerebral artery stroke can be improved by vision
      restoration training (VRT), but when combined with transcranial direct current stimulation
      (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic
      stage. Because it is possible that such therapy may be more effective during the early
      recovery phase after the stroke and can reach patients during the rehabilitation phase,
      investigators wished to explore the applicability, efficacy and safety of early intervention
      with a combined tDCS/VRT treatment.

      Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of
      combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion
      was the pre-post change in perimetric detection thresholds in percent. The results were
      compared to 7 age and stroke lesion matched controls of our patient data pool who received
      standard rehabilitation.
    

Intervention name(s): tDCS; Standard rehabilitation
Intervention type(s): Device; Behavioral
Intervention description(s): Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes; Standard rehabilitation procedures involving PC-based training of saccades and visual exploration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled,
      multicenter study designed to evaluate the safety and tolerability of efalizumab administered
      subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque
      psoriasis who are candidates for systemic therapy.
    


Intervention name(s): Raptiva (efalizumab)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Moderate Plaque Psoriasis; Severe Plaque Psoriasis; Topical
A Novel Method of Non-invasive Ventilation in Children
Condition: Apnea
Study type: Observational

Summary: 
      The purpose of this study is to quantify the tidal volume generated by the pressure release
      immediately following the application of pressure to the chest.
    

Detailed description: 
      Airway management in the pediatric population differs from the adult population because of
      differences in their respiratory physiology and anatomy. For example the oxygen consumption
      is about three times higher in children as compared to adults; therefore, if there is a
      problem ventilating a child there is a higher impact on oxygen delivery and oxygen reserve.
      Current guidelines recommend that in respiratory emergencies where one "cannot ventilate and
      cannot intubate" that a cricothyroidectomy (insertion of a needle through the cricothyroid
      membrane in the neck) be performed. This procedure is very invasive and difficult to perform,
      especially in a small child. Since timing and simplicity are essential to successful airway
      management it is hypothesized that the investigators could utilize the physiological
      principles behind breathing to ventilate these children using the release of applied pressure
      to their chest. During, inspiration, the vertical and transverse dimensions of the thorax are
      increased, generating a negative pressure between the intrapleural space and the chest wall,
      allowing for air to be drawn into the lungs. As children have a very compliant rib cage one
      of the theoretical ways to improve lung inflation is to apply external pressure on the chest.
      The intrathoracic pressure increases above atmospheric pressure and air preferentially flows
      out of the lungs according to the pressure gradient. When the pressure is released and the
      chest recoils passively, a negative intrathoracic pressure is generated, which allows for air
      to flow into the lungs according to the pressure gradient created. If a sufficient tidal
      volume is generated by the release of pressure from the chest this could potentially become a
      simple, non-invasive, life-saving technique in children with difficult airways. By adapting
      the principles described above, it is possible that tidal volume and therefore, gas exchange
      can take place on release of the pressure applied to the chest.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective, cohort study with a sample size of approximately 100 pediatric
        patients. The population will be stratified equally into the following age groups: neonate
        (0-28 days or 44 post-conceptual weeks), infants (>1-12 months), toddlers (>12months-3
        years), children (>3-8 years), pre-teen (>8-13 years) and adolescent (>13 years).
      
Keywords: Tidal Volume; Pediatric; Difficult airway; Ventilation; Airway management
Leptin and Endothelial Function
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial was to determine if injections of leptin would improve vascular
      function in normal-weight, healthy volunteers.
    

Detailed description: 
      The researchers plan to enroll a total of 15 non-obese (BMI < 27 kg/m2) otherwise healthy
      adults into a randomized, double-blinded, cross-over study of the impact of recombinant
      methionyl human leptin 0.2 mg/kg SC, hereafter called rL, (Amgen Inc, Thousand Oaks, Calif)
      versus placebo SC (sorbitol and sodium acetate, pH 4.0 of same volume) in 15 non-obese
      adults. Subjects will have baseline vascular studies performed by brachial artery
      ultrasonography-flow-mediated dilatation and nitroglycerin mediated dilatation and blood
      drawn for measures of leptin levels. They will then receive rL SC or placebo SC (randomized
      order). They will then have vascular studies performed and blood levels drawn every 2 hours
      for 6 hours total. After completion of day 1, patients will return 1-4 weeks later and repeat
      the protocol crossed-over to the alternate intervention (rL or placebo).
    

Intervention name(s): leptin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Image Narrative With College Students
Condition: Depression, Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      The PI developed the Image Narrative Intervention (INI) based on the research using visual
      images in which visual images and narratives were found to support trauma survivors in
      narrating their experiences and in meaning making. The proposed study is the first study to
      test the therapeutic effect of the INI program. The investigators propose to assess, both
      qualitatively and quantitatively, the feasibility and preliminary effect of the INI through a
      pilot randomized control trial (RCT) design with a wait list control.
    

Detailed description: 
      AIM 1. To understand the unique experiences of emerging adult college students during the
      Covid-19 pandemic (especially around the themes of the self, relationships with others, and
      the future).

      AIM 2. To evaluate the feasibility of the INI for emerging adult college students during the
      Covid-19 pandemic, both quantitatively and qualitatively.

      AIM 3. To evaluate the preliminary efficacy of the INI on distress, PTG, Quality of Life and
      Meaning-Making.
    

Intervention name(s): Image Narrative
Intervention type(s): Behavioral
Intervention description(s): Each participant will take part in a 5-week program of weekly 1-hour telehealth sessions with the PI or a social work PhD student facilitator trained in the INI by the PI.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; college students; posttraumatic growth; meaning making; quality of life