bioihbjkbjnl/mcl2 huggingface dataset:
Norepinephrine Consumption After Prophylactic Ondansetron
Condition: Maternal Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of prophylactic ondansetron on the incidence of spinal
      hypotension and vasopressor consumption in caesarean section patients using norepinephrine
      treatment. Half of participants receive ondansetron before spinal anesthesia while the other
      half receive saline.
    

Detailed description: 
      Spinal hypotension in cesarean section patients can occur vigorously and may lead to
      cardiovascular collapse. If doesn't treated precipitously, It can cause maternal hypotension,
      nausea and vomiting and fetal acidosis. Recently norepinephrine has been proposed for the
      prevention and treatment of spinal hypotension with less tendency to decrease HR and CO. It
      has been reported that ondansetron can be used for prophylaxis and treatment of nausea and
      vomiting, may also reduce the vasopressor requirement in patients undergoing caesarean
      section with spinal anesthesia. The aim of the present study is to assess the effect of
      prophylactic ondansetron on norepinephrine consumption and incidence of spinal hypotension,
      and side effects such as maternal nausea, vomiting and bradycardia.
    

Intervention name(s): Ondansetron; Saline
Intervention type(s): Drug; Drug
Intervention description(s): After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.; After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Perinatal Depression Treatment and Child Development
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to examine whether the successful perinatal depression
      intervention among mothers (Thinking Healthy Programme, THP) has led to improved
      developmental outcomes in the children 6 years later. Economic and human resources aspects of
      the intervention will also be evaluated to determine overall societal benefits from
      investment in such a program, feasibility of scaling up the intervention and its
      sustainability in the long-term. The primary hypothesis is that children of mothers who
      participated in the THP will have better cognitive outcomes and socio-emotional functioning
      when compared to children of mothers randomized to the control group.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population includes children of women who participated in the Thinking Healthy
        Programme and children of women who were eligible for participation in the Thinking Healthy
        Programme but who screened negative for depression at the time.
      
Keywords: Depression; Cognitive Behavior Therapy; Child Development
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
Condition: Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot, prospective, randomized, open-label clinical trial. During the study,
      pregnant women will be randomized (1:1) to receive co-administration of a single
      intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a
      single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria
      toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the
      vaccines (IIV followed by Tdap ~ 21 days later). Vaccines will be administered by licensed
      study personnel.

      Prior Tdap/Td/TT and influenza vaccine history will be verified by medical record review when
      possible.

      Injection-site (local) and systemic reaction data will be assessed on vaccination day and
      during the 7 days following vaccination using either identical web-based or paper diaries,
      depending on study participant preference.

      Maternal serum samples will be collected for antibody titers relevant to the Tdap and
      Influenza at time points that include: prior to vaccination(s), ~21 days post vaccination(s),
      and at delivery. Additionally, cord blood serum will be analyzed for the same antibody
      titers.

      Pregnant women will be followed with comprehensive obstetric and neonatal outcomes obtained
      from medical record review.
    


Intervention name(s): Tetanus, Diphtheria, and Pertussis Vaccine; 2016-2017 Quadrivalent Inactivated Influenza Vaccine; 2017-2018 Quadrivalent Inactivated Influenza Vaccine
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Tdap; Flu vaccine; 2016-2017 Flu vaccine; Flu vaccine; 2017-2018 Flu vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tdap vaccine; Flu vaccine; vaccines in pregnancy; immunizations in pregnancy; Whooping Cough; Pertussis; Influenza
Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy
Condition: Obesity; Obesity, Morbid; Obesity; Endocrine; Bariatric Surgery Candidate
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in
      gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways
      and is a complex regulator of food intake as well as lipid and glucose metabolism. This study
      aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization
      (GMD) for the management of obesity and its related comorbidities.
    

Detailed description: 
      Endoscopic approaches to obesity may help fulfill the unmet need of over half the US adult
      population that would benefit from therapy for obesity but are not receiving it. Endoscopic
      approaches to obesity have the potential to be more efficacious than antiobesity medications
      and have a lower risk-cost profile compared with bariatric surgery.

      Endoscopic approaches to obesity need to be increasingly modeled on the proposed mechanisms
      contributing to the benefits of bariatric surgery.

      The investigators seek to decipher if the gastric mucosa is an independent regulator of food
      intake, body weight, lipid and glucose metabolism and serum gut hormones. The investigators
      also wish to ascertain if selective devitalization of the gastric mucosa, without alteration
      in gastric volume, will improve obesity related comorbidities.

      This study will be divided into 3 phases. The purpose of completing the 3 phases is to
      develop a minimally invasive weight loss technique that is effective, safe and ready for more
      rigorous assessment via a future randomized control trial.

      Objectives:

      Overall:

      To assess the efficacy and safety of gastric mucosal devitalization for the management of
      obesity and its related comorbidities

      Phase 1:

      On an ex vivo specimen, identify the optimal color of the tissue indicating that the gastric
      mucosa has been sufficiently treated such that selective mucosal devitalization has occurred.
    

Intervention name(s): Gastric mucosal devitalization
Intervention type(s): Procedure
Intervention description(s): During routine laparoscopic sleeve gastrectomy surgery, once the greater curvature of the stomach is excised as per normal surgical technique, the investigators will take the specimen out and perform an ablation ex-vivo, with the intention of performing selective mucosal devitalization. This specimen will then be transported to pathology lab for analysis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Mucosal Devitalization; Obesity; Endoscopic Bariatric Therapies; Bariatric surgery
Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia
Condition: Antenatal Management of the Fetal Gastrointestinal Atresia
MeSH terms: Intestinal Atresia
Study type: Observational

Summary: 
      Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts
      obstetric and neonatal outcomes.

      Methods- This was a retrospective cohort study at a single center. The study population
      comprised 51 consecutive pregnancies, including 29 mothers (57%) and their fetuses affected
      by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and
      their babies with postnatally diagnosed fetal esophageal or intestinal atresia.
    

Detailed description: 
      Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts
      obstetric and neonatal outcomes.

      Methods- This was a retrospective cohort study at a single center. The study population
      comprised 51 consecutive participants, including 29 mothers (57%) and their fetuses affected
      by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and
      their babies with postnatally diagnosed fetal esophageal or intestinal atresia.
    

Intervention name(s): scheduled delivery at a tertiary center
Intervention type(s): Procedure
Intervention description(s): Neonatal units in French hospitals are classified in three levels. The intention is for infants requiring high level care to receive it in a tertiary neonatal unit within the same network when appropriate. In case of known fetal gastro-intestinal artesia, the prenatal care includes obstetric consultation and level 3 ultrasound scheduled every four weeks at our unit until the end of the pregnancy, antenatal consultations with a specialized multidisciplinary team, and an antenatal visit of the birth center to reduce the parental anxiety.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        51 mother-baby pairs
Endothelial Dysfunction in Obese Children
Condition: Obesity; Atherosclerosis
MeSH terms: Atherosclerosis; Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to objectify the effect of diet and exercise on early markers of
      atherosclerosis in obese children.
    

Detailed description: 
      The favorable responses of combined treatment strategies, consisting of exercise training and
      proper diet change, for childhood and adolescent obesity on vascular health are poorly
      understood. The overall objective of this research project is to investigate the underlying
      pathophysiological mechanisms that mediate these beneficial effects.

      Particularly, the following aims are set forth:

        1. To establish the effect of a combined lifestyle intervention, i.e. an individualized
           exercise training and caloric restriction program, on vascular function (primary
           endpoint) and structure in a substantial population of obese adolescents.

        2. To characterize causal pathways between obesity and endothelial dysfunction with focus
           on classical risk factors, oxidative and inflammatory stress, metabolic adaptations,
           bone marrow derived progenitor cells, and blood microparticles.

      This research knowledge will be instrumental for risk stratification and clinical management
      aimed to improve endothelial function by limiting damage and reinforcing regenerative
      mechanisms in obese adolescents.
    

Intervention name(s): Exercise training; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance; Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; cardiovascular risk factors; exercise training; endothelial function; endothelium; endothelial progenitor cells
Influence of a Single Dose Dexamethasone on the Time Course of Neuromuscular Blockade of Rocuronium
Condition: Neuromuscular Block, Dexamethasone; Neuromuscular Block, Recovery
Study type: Observational

Summary: 
      The aim of the present study is to compare the time course of a neuromuscular block in
      patients receiving dexamethasone 8 mg in order to reduce postoperative nausea or vomiting
      several hours before surgery with patients receiving the drug immediately before induction of
      anaesthesia and patients without a dexamethasone prophylaxis. The primary end point is the
      time from start of injection of rocuronium until recovery to a train of four ratio (TOF
      ratio) of 0.9.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients of a primary care clinic undergoing elective gynecologic abdominal surgery
Evaluating the Influence of Showing Patients Their Predicted Teeth Alignment on Their Expectations and Satisfaction
Condition: Crowding, Tooth
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Patients who have moderate crowding will be treated in this study. The efficacy of showing
      the predicted alignment of patient's teeth at the end of orthodontic treatment previously to
      treatment on their expectations from orthodontic treatment and their satisfaction with their
      teeth alignment will be assessed.
    

Detailed description: 
      It is known that most patients expect that orthodontic treatment will improve their
      appearance which increases their confidence and self-esteem level.

      The ability to approach patient's expectations to reality is crucial to making them
      reasonable and to improve patient's satisfaction with treatment outcomes.
    

Intervention name(s): Fixed orthodontic appliances
Intervention type(s): Device
Intervention description(s): Visual presentation of patient's predicted teeth alignment at the end of orthodontic treatment:
Presenting predicted teeth alignment after orthodontic treatment to patients before treatment starts, by using photos and videos of dental digital set-up.
Predicted teeth alignment can be described as: well-leveled and aligned patient's dental arches, well engaged posterior teeth and normal frontal teeth relationships.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crowding; Simulation; Prediction; Expectation; Satisfaction; Three-dimensional set up
Effects of Training Intensity on the CHD Risk Factors in Postmenopausal Women
Condition: Cardiovascular Diseases; Coronary Disease
MeSH terms: Cardiovascular Diseases; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this research is to find out whether training at different exercise
      intensities reduces the risk of developing cardiovascular disease (CVD) to a different
      extent. Heart attacks and stroke are the leading cause of death in older women. Reduced
      variability of the heart rate and increased dips and swings in blood pressure are risks
      factors that predict the chance of developing CVD as are increased levels of clotting protein
      fibrinogen and plasminogen activator inhibitor 1, and high levels of LDL-cholesterol
      (>160mg/dl). We will be measuring all of these risk factors and any changes in your body fat
      level before you start training and after 15 and 30 weeks of training in the form of walking.
      At the present time the effects of exercise intensity on these factors are not well
      understood. This study will add to the basic understanding of these issues and allow us to
      recommend to postmenopausal women optimal exercise intensities to lose body fat and reduce
      the risk of developing CVD.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: exercise
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, Phase 1, randomized, open-label, single-dose, 3 treatment, 3-period,
      6-sequence, crossover study designed to compare the PK of SMP-100 dissolved in water for oral
      administration with SMP-100 tablets under fasting conditions, and to evaluate the effect of
      food on the bioavailability of SMP-100 tablets in healthy subjects.
    

Detailed description: 
      SMP-100 is a novel serotonin receptor 3 (5-HT3) partial agonist. The compound is under
      development in an oral dosage form for the treatment of diarrhea-predominant irritable bowel
      syndrome (IBS-d). The study drug also has the potential to treat chemotherapy induced nausea
      and emesis and diarrhea due to carcinoid syndrome.

      A single ascending dose (SAD) and multiple ascending dose (MAD) clinical study (study number
      SMP-100-101) evaluating the safety, tolerability, and PK profile of orally administered
      SMP-100 in healthy volunteers is ongoing. Regarding safety, there have been no clinically
      relevant abnormal vital signs, ECGs, laboratory results or SAEs.

      In each period, subjects will receive a single 4 mg dose of SMP-100 on Day 1 (Period 1), Day
      4 (Period 2), and Day 7 (Period 3), under fasting or fed conditions, followed by 48 hours of
      PK and safety assessments.

      The study will include a screening visit from Day -28 to Day -2. Eligible subjects will be
      admitted to the clinical site on Day -1 and will be confined until completion of the
      assessments on Day 9. There will be a washout period of at least 72 hours between doses.

      Primary objectives:

        -  To compare the PK of SMP-100 dissolved in water for oral administration with SMP-100
           tablets under fasting conditions, following a single dose in healthy subjects.

        -  To evaluate the effect of a high-fat, high-calorie meal on the bioavailability of
           SMP-100 tablets, following a single dose in healthy subjects.

      Secondary objective:

      • To evaluate the safety and tolerability of two SMP-100 oral formulations when administered
      to healthy subjects.
    

Intervention name(s): SMP-100
Intervention type(s): Drug
Intervention description(s): In each period, subjects will receive a single dose of SMP-100 on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3), under fasting or fed conditions, followed by 48 hours of PK and safety assessments.
Other intervention name(s): ALB-137391(a); CSTI-300; SMP-100 oral solution; SMP-100 tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults
Condition: Dysmenorrhea; Pelvic Pain
MeSH terms: Pelvic Pain; Dysmenorrhea
Study type: Observational

Summary: 
      The aim of this study is to determine the prevalence of menstrual cycle related pain
      complains in adolescents and young adults.
    

Detailed description: 
      An internet questionnaire with 12 items was used:

      Adolescents

        -  start of menstruation

        -  characteristics of menstrual cycle

        -  pain related to menstrual cycle (questions based on well-known pain-complaints related
           to the presence of endometriosis)

        -  analgetics

        -  influence on school carrier

        -  influence on social life

      Young adults

        -  idem as for adolescents

        -  influence of pain on an eventual sexual relationship
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        3rd year high school girls and 1st year university young females having a routine visit to
        the school doctor or student doctor.
      
Keywords: adolescents; young adults; dysmenorrhea; pelvic pain
Inferior Vena Cava Index in Patients Undergoing Liver Resection
Condition: Liver Neoplasms
MeSH terms: Liver Neoplasms
Study type: Observational

Summary: 
      The aim of this study was to evaluate whether IVC index measured intraoperatively was
      affected by fluid administration and could add any helpful information about the hemodynamics
      during hepatic resection. In addition, the investigators evaluated whether IVC index was
      somehow correlated with the risk of postoperative complication.
    


Intervention name(s): IVC diameters evaluation by intraoperative ultrasound
Intervention type(s): Other
Intervention description(s): Out of consecutive patients who underwent hepatectomy for primary and secondary liver tumors, patients in whom IVC diameters were intraoperatively measured for clinical reasons were retrospectively selected and analyzed
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients underwent liver resection for primary and secondary liver disease
Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients
Condition: HIV
Study type: Interventional

Summary: 
      The primary objective is to assess the effect of short-term diet modification on the
      microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy
      (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative
      controls in the United States.
    

Detailed description: 
      This is a randomized clinical trial. Fifty (50) Antiretroviral therapy (ART)-treated Human
      immunodeficiency virus (HIV) positive participants, 24 HIV negative controls matched for age
      and sex, and 24 HIV negative controls from a population at high risk for contracting HIV will
      be recruited into 3 cohorts. All participants will undergo a 4 week diet modification and
      will be randomly assigned to receive either an Agrarian diet or a Western-type diet. For the
      first 2 weeks, food will be provided to the participant, followed by an additional 2 weeks
      where participants will be provided a diet menu with recipes to prepare themselves. There
      will be 4 study visits and participation will last for up to 2 months.
    

Intervention name(s): Agrarian Diet; Western-type Diet
Intervention type(s): Other; Other
Intervention description(s): A diet higher in carbohydrates and lower in fats and sugars; A diet higher in fats and lower in carbohydrates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gut microbiota composition