bioihbjkbjnl/mcl2 huggingface dataset:
Red and Processed Meat Effects on the Metabolome and Microbiome
Condition: Controlled Feeding Trial; Healthy Eating Index; Red Meat; Meat
Study type: Interventional

Summary: 
      This controlled feeding trial will identify biomarkers in the metabolome and microbiome that
      may differ when consuming a healthy diet with or without red and processed meat.
    

Detailed description: 
      This is a randomized cross-over feeding trial to test whether red and processed meat
      consumption, in the context of a controlled diet based on HEI-2015, will cause shifts in the
      metabolome and the microbiome compared to a controlled HEI-2015 diet with no red or processed
      meat. Twenty healthy adult volunteers will consume two diets in random order: 1) Diet A is
      based on the Healthy Eating Index-2015 (HEI-2015) and includes no red or processed meat; 2)
      Diet B is based on the Healthy Eating Index-2015 and includes red and processed meat
      (HEI-2015-M) as some of the protein sources. Both diet periods last 21 days and an
      approximately 21-day washout period occurs between diets.
    

Intervention name(s): Randomized, cross-over controlled feeding trial testing a Healthy Eating Index 2015 (HEI-2015) diet with and without red and processed meat
Intervention type(s): Other
Intervention description(s): Healthy Eating Index-2015 (HEI-2015) with or without red/processed meat (HEI-2015-M)
Other intervention name(s): feeding trial, intervention, dietary, HEI-2015
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross-over
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Condition: Basal Cell Carcinoma; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Basal Cell
Study type: Observational

Summary: 
      The primary objective of this study is to (1) determine whether local injection of lidocaine
      used during Mohs surgery will elevate serum lidocaine concentrations to a level that could
      cause systemic symptoms and (2) determine whether sustained high levels of serum lidocaine
      occur after intralesional anesthesia on the face and neck. This study is a cross-sectional
      study of 10 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck
      requiring Mohs micrographic surgery. The study will consist of a brief questionnaire and
      blood draws during their Moh's surgical procedure.
    


Intervention name(s): Blood Draw
Intervention type(s): Procedure
Intervention description(s): Serum levels were measured
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study is a cross-sectional study of 20 subjects with basal cell carcinoma or squamous
        cell carcinoma of the face or neck requiring Mohs micrographic surgery.
      
Keywords: squamous cell carcinoma of the head or neck
SMART-IBD App Trial
Condition: Inflammatory Bowel Diseases; IBD; Crohn Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in
      improving medication adherence and self-management skills in adolescents with IBD. The
      investigators will conduct a randomized control trial to compare a sample of 15 youth (ages
      13-17) with IBD using an app that has educational content and medication reminders to 15
      youth in an attention control group. The length of the intervention will include one month of
      baseline adherence data collection, one month of intervention, and one month of
      post-treatment adherence data collection.
    


Intervention name(s): SMART-IBD
Intervention type(s): Behavioral
Intervention description(s): Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBD
Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs)
Condition: HIV Infection; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      The principal goal of this research project is to evaluate the natural history of HCV and
      liver disease and its treatment in HIV-infected persons who use drugs. Research procedures
      will focus on determining liver disease prevalence and severity within this population. This
      is an observational study without study specific interventions.
    

Detailed description: 
      The principal goal of this research project is to evaluate the natural history of HCV and
      liver disease and its treatment in HIV-infected persons who use drugs. The recent
      availability of a novel, non-invasive method of measuring HCV disease stage makes it possible
      to test the relationship of HCV disease stage and the management of coinfected IDUs with
      adequate precision. The investigators will apply the innovative technology, elastography
      (FibroScan®) to ask whether the marked differences in the final disease outcome, end-stage
      liver disease (ESLD), can be explained by a measure of liver stiffness as assessed by
      elastography (FibroScan®). While advances in non-invasive disease assessment are critical to
      HCV management, the greatest challenge to improving HCV treatment effectiveness in coinfected
      persons remains low rates of treatment uptake and adherence, even when freely accessible. In
      response to this glaring disparity, the investigators will test potent behavioral
      reinforcement interventions to improve the management of HCV disease by adapting a rigorously
      studied contingent behavioral incentives program to the treatment to coinfected IDUs.
      Hepatitis C Treatment Eligibility: To determine the population prevalence of significant
      liver disease in coinfected IDUs using an innovative, non-invasive methodology (transient
      elastography, FibroScan®) to measure liver stiffness. Liver Disease Staging: To test the
      hypothesis that liver stiffness, assessed by a novel, non-invasive methodology, is predictive
      of the development of ESLD, defined as hepatic decompensation, hepatocellular cancer, and
      liver-related death, in coinfected IDUs.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective observational cohort of HIV-infected persons receiving medical care
        at the Johns Hopkins Hospital. Participants are eligible if they are HCV antibody positive
        and use or have used drugs.
      
Biospecimen description: 
      Serum and plasma specimens are collected at regular intervals
    
Keywords: HIV; Human immunodeficiency virus; Acquired Immune Deficiency Syndrome Virus; AIDS virus; Immunodeficiency Virus, Human; Virus, Human Immunodeficiency; Hepatitis C; Hepatitis C, chronic; Hepatitis C virus; Hepatitis C antibodies; Hepatitis C antigens
Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases
Condition: Neoplasm Staging
Study type: Observational

Summary: 
      Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary
      tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios
      will be evaluated to create imaging protocols which are time efficient and diagnostically
      accurate.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with a proven or suspected oncological disease referred for a clinically indicated
        PET/CT with of without contrast media.
Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section
Condition: Cesarean Section; Dehiscence; Cesarean Wound; Dehiscence
Study type: Interventional

Summary: 
      This study compares the effect of two techniques of uterine closure, with or without
      endometrial suturing on isthmocele development after cesarean section.
    

Detailed description: 
      Cesarean section is the most common surgery performed on pregnant women. Poor healing of the
      incision of the uterus leads to isthmocele development. Long-term morbidities associated with
      isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style
      bleeding after menstruation. Many factors that may affect the healing of uterine scar have
      been studied in the literature (i.e. Double or single-layer closure, locked or unlocked
      closure, uterine retroflection). Suturing complete fold of the wound lips during the closure
      of the uterus may cause the endometrial layer to be embedded in the myometrium and to form
      niche tissue. The study hypothesized that isthmocele development can be reduced by suturing
      without enclosing the endometrium during uterine closure.
    

Intervention name(s): Closure of the uterus with endometrium at the time of cesarean; Closure of the uterus without endometrium at the time of cesarean
Intervention type(s): Procedure; Procedure
Intervention description(s): Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.; Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Closure of the hysterotomy at the time of primary cesarean section
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of 2 different dose levels
      of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly
      (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in
      healthy human immunodeficiency virus (HIV)-uninfected participants.
    

Detailed description: 
      This is a single-center, randomized (the study drug is assigned by chance),
      placebo-controlled (study in which the experimental treatment or procedure is compared to a
      pretend treatment with no drug in it to test if the drug has a real effect), and double-blind
      (neither physician nor participant knows the treatment that the participant receives) study.
      The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (participants
      will be vaccinated on Days 1 and 29), and a Follow-up Period (up to 48 weeks). All eligible
      participants will be randomly assigned to 1 of the 2 sequential cohorts (low dose cohort and
      high dose cohort). Participants in low dose cohort will receive 1 of the following
      treatments: low dose (50 microgram [mcg]) gp140 drug product (DP), low dose gp140 DP with
      adjuvant (aluminum phosphate), placebo matched to low dose DP; and participants in high dose
      cohort will receive 1 of the following treatments: high dose (250 mcg) gp140 DP, high dose
      gp140 DP with adjuvant, and placebo matched to high dose DP. There will be an interim safety
      review of safety/tolerability from low-dose cohort before the high-dose cohort receives study
      treatment. Total study duration will be 56 weeks per participant. Participants' safety will
      be monitored throughout the study.
    

Intervention name(s): gp140, 50 mcg; gp140, 50 mcg + Adjuvant; gp140, 250 mcg; gp140, 250 mcg + Adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Drug
Intervention description(s): Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.; The gp140 vaccine containing 50 mcg total protein mixed with 0.425 milligram (mg) aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.; The gp140 vaccine containing 250 mcg total protein will be administered intramuscularly on Day 1 and Day 29.; The gp140 vaccine containing 250 mcg total protein mixed with 0.425 mg aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.; Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy; Acquired Immuno-Deficiency Syndrome; Acquired Immunodeficiency Syndrome Virus; Glycoprotein; Adjuvant; Vaccine; Placebo
The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
Condition: Obesity; Overweight; Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Overweight; Weight Gain
Study type: Observational

Summary: 
      This study employs a cross-sectional design to profile the gut microbiome and urine
      metabolome in overweight/obese children with type 1 diabetes (T1D).
    

Detailed description: 
      The investigators will obtain stool and urine samples from subjects aged 7-17 years in 4
      groups:

        -  Group 1: Obese or overweight children within 3 years of diagnosis of T1D

        -  Group 2: Normal weight children within 3 years of diagnosis of T1D

        -  Group 3: Obese or overweight children without T1D

        -  Group 4: Normal weight children without T1D

      Type 1 diabetes will be defined according to American Diabetes Association criteria along
      with the presence of pancreatic autoantibodies (GAD65, ICA512, or insulin autoantibodies).
      Obese and overweight status will be defined by BMI >85th percentile for age and gender
      according to CDC criteria.

      All subjects will provide one-time stool and first morning urine sample. Overweight or obese
      subjects will additionally have a point of care blood glucose and hemoglobin A1c measurement
      to ensure that they do not have diabetes.

      The investigators will perform 16S rRNA sequencing of stool bacteria and mass spectrometry
      measurement of urine metabolites.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children aged 7-17 years with/without T1DM and with/without obese/overweight status in San
        Diego, California
      
Biospecimen description: 
      Stool Urine
Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT)
      toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid
      leukaemia.UCBT related mortality and morbidity were limiting factors for the development of
      this procedure in adults. Non myeloablative conditioning regimen showed promising results and
      prospective evaluation has to be developed to confirm these retrospective data.
    

Detailed description: 
      Individual meta-analysis is planned to compare geno-identical transplantation with
      myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.
    

Intervention name(s): Cord blood transplantation
Intervention type(s): Other
Intervention description(s): Umbilical cord blood transplantation after reduced intensity conditioning
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cord blood transplantation; Conditioning regimen; Acute myeloid leukaemia; SORROR comorbidity index; Quality of life; Innate immunity; Immune reconstitution post transplant; Umbilical Cord Blood Stem Cell Transplantation; Hematopoietic Stem Cell Transplantation
Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective was to investigate whether multiple-dose administration of ESL 800 mg
      once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.
    

Detailed description: 
      This was a single centre, two-way crossover, randomised, open-label study in 24 healthy
      volunteers. The volunteers will receive an oral single-dose of simvastatin 80 mg on two
      occasions - once administered alone and once after treatment with an oral once-daily dose of
      800 mg of ESL for 14 days -, separated by a washout period of 3 weeks or more
    

Intervention name(s): Eslicarbazepine acetate; Simvastatin
Intervention type(s): Drug; Drug
Other intervention name(s): Zebinix; Zocor
Intervention MeSH terms: Eslicarbazepine acetate; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eslicarbazepine acetate; simvastatin
Comparison Between D&C and Hysteroscopy in Management of AUB in Perimenopausal Women
Condition: Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The aim of this study is to compare dilatation and curettage with hysteroscopy in obtaining
      an accurate diagnosis of the etiology of abnormal uterine bleeding and outlining a mode of
      treatment-specific to the cause.
    

Detailed description: 
      Perimenopausal women complaining of abnormal uterine bleeding will be selected for assessment
      through detailed history taking, general and abdominal examination, local gynecological
      examination, transvaginal sonography (TVS) scanning and routine blood investigations.
      Eligible participants in our study will be those who complain of menorrhagia, metrorrhagia,
      polymenorrhoea or polymenorrhagia without local gynecological cause with failure of medical
      treatment for at least 3 months. All women participating in the study will be randomly
      allocated into two groups; dilatation and curettage (D&C) group and hysteroscopy group. For
      women in the D&C group, cervical dilatation and fractional endometrial curettage will be done
      under total intravenous (IV) anesthesia in operation theater and the curetting will be sent
      for histopathological examination. For women in the hysteroscopy group, hysteroscopy will be
      done under total IV anesthesia in operation theater hysteroscopic-guided curettings will also
      be taken and sent for histopathological examination.
    

Intervention name(s): D&C; Hysteroscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination; Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination
Other intervention name(s): Dilatation and curettage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Abnormal uterine bleeding; Dilatation and curettage; Hysteroscopy
Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy
Condition: Sedation; Tolerance; Anxiety; Satisfaction
Study type: Interventional

Summary: 
      The Flexible Bronchoscopy (FB) is a diagnostic and therapeutic procedure which is not usually
      tolerated by the patient. This makes the examination more difficult and a repetition of the
      examination, if necessary, resulting in a lower diagnostic performance.

      Furthermore, there is nowadays little information with a highly obvious level about the
      relationship between sedation and the patient´s satisfaction with the FB.

      Midazolam is one of the most commonly used sedatives at the beginning for its rapid onset
      property and brief duration of action with sedatives, anxiolytics and amnesia properties.

      The principal aim of our study is to analyse if the use of a local anaesthetic with midazolam
      whilst performing an FB improves the quality of examination in terms of tolerance for the
      patient. It would also be of interest to know if there is an improvement in the acceptance of
      a second or further FB and if this improves the satisfaction of the Bronchoscopist as far as
      the examination performed is concerned.
    

Detailed description: 
      PATIENTS AND METHODS:

      A randomized, prospective study has been carried out; double blind and controlled with
      placebo to be treated with midazolam. This included 152 patients, randomized into two groups:
      Group A - 79(51.9%) patients which received midazolam before the FB, and Group B - (49.1%)
      patients which received placebo. The patients were given a questionaire of 13 questions about
      different aspects of perception of the procedure after the respiratory endoscopy and another
      was given to the Bronchoscopist.

      RESULTS:

      Both groups started off with a similar assessment of fear and nervousness before the FB.
      Nevertheless, Group A gave a much higher score than Group B referring to variables related to
      symptoms and feeling. The patients´ cooperation was assessed by the Bronchoscopist in a
      similar way in both groups, although the length of the procedure and difficulty was higher in
      the group treated with placebo (Group B).
    

Intervention name(s): Midazolam; Physiological serum
Intervention type(s): Drug; Other
Intervention description(s): Sedation started by injecting a 4 ml drug bolus with midazolam (0.07-0.1 mg/kg dose). Supplemental doses of midazolam (2 mg) were administrated at an interval of >2 min to maintain conscious sedation; We started by injecting a 4 ml drug bolus and we ad supplemental doses (2 ml) to maintain the conscious sedation
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: sedation; midazolam; flexible bronchoscopy; tolerance
Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes.
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is, to investigate the effect of
      upper gastrointestinal disease on the pharmacokinetics (the exposure of the trial drug in the
      body) of oral semaglutide in subjects with type 2 diabetes.
    


Intervention name(s): semaglutide
Intervention type(s): Drug
Intervention description(s): All subjects will receive 3 mg oral semaglutide for five days followed by 7 mg oral semaglutide for five days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment