bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical
      patients during the first 24 hours after a surgical procedure. The incidence of postoperative
      nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in
      high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of
      this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a
      triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV
      in patients undergoing craniotomies under general anesthesia.
    

Detailed description: 
      At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg
      IV and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were
      transferred to the surgical intensive care unit (SICU) or post anesthesia care unit as
      clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to
      subjects with PONV symptoms. PONV was assessed and collected every 24 hours for 5 days via
      direct interview and/or medical charts review.
    

Intervention name(s): Palonosetron 0.075 mg IV; Dexamethasone 10 mg IV; Promethazine 25 mg IV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.; At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.; At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
Other intervention name(s): Aloxi; Decadron; Phenergan
Intervention MeSH terms: Promethazine; Diphenhydramine; Dexamethasone; Palonosetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Palonosetron; Craniotomy; Nausea; Vomiting
Developing Self-Management Interventions After HCT
Condition: Hematopoietic Stem Cell Transplant (HSCT)
Study type: Observational

Summary: 
      This is a prospective, longitudinal, observational trial to evaluate quality of life in
      hematopoietic stem cell transplant survivors.
    

Detailed description: 
      Hematopoietic stem cell transplant (HSCT) survival rates continue to increase as treatment
      protocols improve. However, HSCT survivors face many mental, emotional, and physical
      challenges that threaten quality of life (QOL), which, according to the American Society of
      Clinical Oncology, is the most important treatment outcome next to survival. Psychoneurologic
      symptoms (PNS) significantly diminish QOL after HSCT. PNS often co-occur and may be
      associated with inflammation related to perturbations of the gut microbiota. This project
      will track the interplay among these factors in 50 adult survivors of HSCT to lay the
      groundwork for a targeted dietary self-management intervention to mitigate PN symptoms.This
      is to be achieved by elucidating the complex bio-behavioral mechanisms of distressing
      symptoms in HCT patients such as neurocognitive dysfunction, fatigue, anxiety, depression and
      pain, inflammation (cytokines and C-reactive protein), gut microbiota [(GM) richness and
      diversity] and diet (macronutrients: carbohydrates, fats and proteins).
    

Intervention name(s): PNS Tracking
Intervention type(s): Other
Intervention description(s): Through blood and stool samples the study team will track the interplay among PNS as they relate to diminished QOL. Symptoms tracked include neurocognitive dysfunction, fatigue, anxiety, depression and pain, inflammation (cytokines and C-reactive protein), gut microbiota [(GM) richness and diversity] and diet (macronutrients: carbohydrates, fats and proteins).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hematopoietic Stem Cell Transplant (HSCT) Survivors. Survival rates continue to increase as
        treatment protocols improve; by 2030, an estimated half-million HSCT recipients in the
        United States will be long-term survivors. However, HSCT survivors continue to face many
        mental, emotional, and physical challenges that threaten QOL, which, according to the
        American Society of Clinical Oncology, is the most important treatment outcome next to
        survival. Therefore, a prospective, observational design to longitudinally examine these
        factors in 50 adult (at least 18 years of age) survivors of HSCT to lay the groundwork for
        the future development of a targeted dietary self-management intervention to mitigate PN
        symptoms in this growing group of HSCT survivors is being planned.
      
Biospecimen description: 
      Microbiome: Stool, Cytokines and C-Reactive Protein: Blood.
    
Keywords: psychoneurological symptoms (PNS); quality of life (QOL); hematopoietic stem cell transplant (HSCT); microbiota gut-brain axis; inflammation
A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine
Condition: Group B Streptococcus (GBS) Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at the body's immune response to a GBS vaccine 2 years after the orginal
      vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody
      levels.
    


Intervention name(s): Group B streptococcus (GBS) vaccine
Intervention type(s): Biological
Intervention description(s): No vaccine will be administered in this study. Only one study visit is required.
Subjects will return to the clinic for a single visit at 24 months (± 3 months) after the last injection administered in the V98P2 study.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Group B streptococcus; GBS; Vaccine
The Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for Chemotherapy
Condition: Stem Cell Transplantation, Hematopoietic
Study type: Interventional

Summary: 
      The purpose of this randomized trial will evaluate whether providing clinicians with daily
      reports from a well-validated, standardized, patient-centered electronic symptom survey tool
      (PRO-CTCAE) improves symptom burden in patients undergoing high-dose chemotherapy. Adult
      inpatients at UNC undergoing high-dose chemotherapy for preparative chemotherapy prior to
      stem cell infusion. Participants will be randomized into one of two arms: (1) a control arm
      with standard of care daily clinician interviews or (2) standard of care plus daily
      electronic symptom surveys, the results of which will be sent to clinicians electronically.
    

Detailed description: 
      The primary objective of the study is to compare peak symptom burden between the two study
      arms (autologous transplant vs. allogeneic transplant). Peak symptom burden will also be
      compared between the two study arms within both subgroups of patients (myeloablative vs.
      reduced intensity conditioning). Secondary outcomes that will also be compared between the
      two arms include: changes in patient-reported quality of life, time to supportive care
      treatment changes, length of hospital stay, thirty day readmission rate after discharge, days
      alive and out of the hospital in the 100 days since admission, and overall survival.
      Additionally, measures of physical activity will be captured through physiological monitoring
      in order to explore associations with patient-reported symptom measures. Patient and
      clinician satisfaction will also be evaluated.

      In this study, the investigators will use an electronic survey to assess 16 patient-reported
      symptoms to calculate a symptom score that may range from 0-61 each day. This symptom score
      represents the symptom burden for the patient on that particular day. Symptom burden is
      anticipated to peak between days 7 and 14, so the investigators will define peak symptom
      burden as the average of the symptom scores on days 7, 10 and 14. In both arms, symptoms will
      be assessed on these days in order to compare peak burden.
    

Intervention name(s): Electronic symptom survey; Blinded Electronic Symptom Survey
Intervention type(s): Other; Other
Intervention description(s): Standard of care plus daily electronic symptom surveys, the results of which are sent to clinicians electronically.; Standard of care daily clinician interviews with blinded symptom surveys
Other intervention name(s): Online Daily Symptom Survey
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Pulmonary Rehabilitation, Dyspnoea and Emotional Cognition in COPD
Condition: COPD; Dyspnea; Rehabilitation; Tobacco Use; Emotional Disturbances
MeSH terms: Dyspnea; Affective Symptoms
Study type: Observational

Summary: 
      To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial
      emotions recognition and smile production, by improving the emotional dimension of dyspnoea
      in patients with chronic obstructive pulmonary disease (COPD).To evaluate whether pulmonary
      rehabilitation improves emotional cognition, using facial emotions recognition and smile
      production, by improving the emotional dimension of dyspnoea in patients with chronic
      obstructive pulmonary disease (COPD).
    

Detailed description: 
      The aim of the study will be to evaluate the effect of pulmonary rehabilitation on dyspnoea
      emotional component and on emotional cognition. It will add a better understanding of the
      mechanisms of pulmonary rehabilitation on dyspnoea.

      Patients with COPD will be included before starting a pulmonary rehabilitation and be
      evaluated with questionnaires (including the Multidimensional Dyspnea Profile, and quality of
      life questionnaires), emotional cognition (at rest and right after an endurance test, using
      some short movies sequences and pictures of faces expressing some well defined emotions) and
      smile production analysis.

      After having followed a pulmonary rehabilitation, the same evaluation will be realised and
      results will be compared before and after the intervention.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients admitted for a pulmonary rehabilitation
Comparison of Laryngeal Masks in Urethral Cystoscopic Surgery Operations: a Prospective Randomized Clinical Study
Condition: Ureteral Calculi
MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional

Summary: 
      The use of Laryngeal masks are increased.This study aimed to compare lma pro seal and baska
      -mask in urethral retrograde sistoscopy operations.
    

Detailed description: 
      The use of Laryngeal masks are increased. Aimed to compare lma pro seal and baska -mask in
      urologic retrograde sistoscopy operations. ASA 1-2 80 subjects who is undergoing elective URS
      operations were enrolled in this prospective randomized clinical study. The demographic and
      airway characteristics of patients preoperatively and lam insertion times, nasogastric
      insertion times number of intubation attempts, fiberoptic grades from the lam, expired tidal
      volume, oropharyngeal leak pressures, peak and mean airway pressures preoperatively, minor
      complications like sore throat, hoarseness, dysphagia were recorded at the postoperative care
      unit.
    

Intervention name(s): proseal; baska-mask
Intervention type(s): Device; Device
Intervention description(s): laryngeal mask proseal; laryngeal mask baska-mask
Other intervention name(s): laryngeal mask; laryngeal mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: baska-mask; proseal; urs
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to
      assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of
      aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic
      Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive
      aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks
    

Detailed description: 
      Screening Phase: up to 42 days (consisting of a Screening Visit (V1), a washout period and
      Interim Screening Visit (V1a) when applicable, and a Baseline Visit (V2). The Screening Phase
      will serve multiple purposes: to allow for appropriate washout of prohibited medications; to
      allow for review of screening data; to establish a pre-treatment baseline of key outcome
      measures.

      Treatment Phase: The duration of the treatment is 8 weeks. The purpose of the treatment phase
      is to evaluate the efficacy, safety, tolerability and steady-state plasma trough
      concentration of aripiprazole in the treatment of serious behavioral problems in children and
      adolescents with a diagnosis of Autistic Disorder..

      Safety Follow-up Phase: All subjects will be followed up for safety (adverse events) at Day
      16 after the last medication via telephone.
    

Intervention name(s): Aripiprazole Oral Solution; Placebo Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole 2~15 mg/day (2~15 mL/day); Placebo 2~15 mg/day (2~15 mL/day)
Other intervention name(s): Abilify; Aripiprazole; Placebo
Intervention MeSH terms: Aripiprazole; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autistic; Aripiprazole Oral Solution
Identifying Expression Markers of Cumulus Cells to Identify Oocyte Developmental Potential Through a Maturation Analysis
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The aim of the study is to analyze the expression of genes and microRNAs potentially involved
      in oocyte competence in follicles of different sizes (<17mm and ≥17mm) at the time of oocyte
      pick-up.
    

Detailed description: 
      In ART, one of the major obstacles encountered in some patients is the wide variation in the
      follicular size at the oocyte pick-up day and consequently, the number of available mature
      oocytes and the number of competent embryos for implantation. The follicular size at the day
      of oocyte pick-up reflects the synchronicity of the individual follicular responsiveness to
      FSH.

      For successful preimplantation development of an embryo, the oocyte must contain all
      necessary maternal factors. Two of these factors are specific mRNA transcripts (GDF9, PTX3,
      HAS2, PTGS2, TNFAIP6) and microRNA (miR-224).

      For each Cumulus Oocyte Complex, the evaluation of embryo development and morphokinetics will
      be correlated with the expression and implantation data to identify a quantitative biomarker
      to predict the embryo with the highest chance of implantation in patients.

      Experimental Design:

        1. - Collection of Cumulus Oocyte Complex (COC) from patients

        2. - Separation of oocytes according to the size of the follicule they have been retrieved
           from (<17mm; ≥17mm)

        3. - Isolation of mRNA from both groups of cumulus cells

        4. - Expression studies, qRT-PCR (GDF9, PTX3, HAS2, PTGS2, TNFAIP6)

        5. - Analysis of miR-224, a negative regulator of cumulus expansion via PTX3

        6. - Time-lapse culture & evaluation of morphokinetics
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile couples applying to the clinic for assisted reproductive technologies
      
Biospecimen description: 
      Cumulus cells from each oocyte of every enrolled patient will be collected and mRNA & miRNA
      extraction will be performed.
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and
      ticagrelor under steady state conditions; to investigate the effect of staggered
      administration of ticagrelor loading dose on dabigatran exposure (in Part II)
    


Intervention name(s): dabigatran etexilate; dabigatran etexilate; ticagrelor; ticagrelor; ticagrelor; dabigatran etexilate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): multiple doses of dabigatran; medium dose dabigatran; loading dose of ticagrelor; multiple doses of ticagrelor; loading dose of ticagrelor; single dose of dabigatran
Intervention MeSH terms: Dabigatran; Ticagrelor
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study researchers want to learn how quickly patients suffering from allergic rhinitis
      (also known as hay fever) can expect symptom relief after using Azelastine Hydrochloride
      0.15% Nasal Spray.

      This study plans to enrol about 80 male or female participants in the age of 18 to 65 years
      suffering from an allergic rhinitis to ragweed pollen for at least 2 years. In a first phase
      participants will be exposed to ragweed pollen in a special study room to ensure they will be
      adequately symptomatic when they progress into the treatment phase of the study. In a second
      phase study participants will be divided in 2 groups. After exposure to ragweed pollen one
      group will receive Azelastine Hydrochloride 0.15% Nasal Spray and the other group will
      receive placebo (a nasal spray which does not contain any active drug substance). In the
      third phase of study the treatment will be switched: participants who received in the
      previous study Azelastine Hydrochloride 0.15% Nasal Spray will receive the nasal spray
      without any active drug substance and the other group will receive Azelastine Hydrochloride
      0.15% Nasal Spray. During the second and third study phase the researchers will examine
      thoroughly over 4 hours the change of nasal symptoms such as runny nose, itchy nose, sneezing
      and nasal congestion after participants received the nasal spray.
    


Intervention name(s): Azelastine hydrochloride (BAYR9258); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, metered-spray solution, 2 sprays per nostril, 205.5 mcg/spray, intranasal administration.; Single dose of Azelastine hydrochloride-matched placebo, metered-spray solution, 2 sprays per nostril, intranasal administration.
Intervention MeSH terms: Azelastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus
      (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of
      pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of
      insulin resistance. Dietary supplementation of inositol improves insulin resistance in
      patients with GDM.
    

Detailed description: 
      Methods: A randomized double-blind study was carried out in women with GDM. Patients were
      randomly exposed to inositol and placebo. Increase of BMI, blood glucose at 75 grams oral
      glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were
      correlated to inositol exposure.
    

Intervention name(s): Inositol
Intervention type(s): Dietary Supplement
Intervention description(s): inositol exposure in early GDM
Intervention MeSH terms: Inositol
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pregnant women presenting random fasting glucose during the first half of pregnancy above
        92 mg%
      
Keywords: inositol; gestational diabetes mellitus; obstetric adverse outcomes
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of FB825 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      immunogenicity of single-ascending IV doses of FB825
    


Intervention name(s): FB825; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection; Solution containing no active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective is to investigate the efficacy, safety and pharmacokinetics of three different
      doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes
      mellitus with insufficient glycemic control. In addition an open-label metformin arm will be
      assessed
    


Intervention name(s): BI 10773; placebo; metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Empagliflozin
Intervention model: Parallel Assignment
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in
      patients with seasonal or perennial allergic rhinitis to investigate the safety,
      tolerability, and pharmacokinetics (PK) of MEMP1972A.
    


Intervention name(s): MEMP1972A; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Repeating ascending dose; Repeating ascending dose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment