bioihbjkbjnl/mcl2 huggingface dataset:
Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool
      transplant" from a healthy individual to a C. difficile-infected recipient, and has long been
      a successful approach to recurrent/refractory C. difficile. The purpose of this project is to
      generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used
      repeatedly, particularly in those who do not have a healthy intimate partner or other related
      donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by
      the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a
      frozen inoculum administered by nasogastric tube vs administered by colonoscope.

      Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via
      either:

        -  colonoscopy

        -  NGT

      The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,
      systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.
      difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a
      normal bowel status for the individual. Secondary efficacy endpoints include weight,
      subjective well-being and relative clinical improvement per standardized questionnaire, and
      subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects
      will be monitored for clinical safety by history and standard exams and the follow-up
      questionnaire as well as followed closely by phone and in person.
    


Intervention name(s): Fecal Microbiota Transplant (FMT)
Intervention type(s): Drug
Intervention description(s): Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fecal Microbiota Transplant; Clostridium difficile; Diarrhea
Clinical Significance of Platelet Reactivity on Clopidogrel During Off-pump Coronary Artery Bypass
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Objective: To evaluate the early and late prognoses of patients according to platelet
      reactivity after clopidogrel administration and determine whether the measurement of platelet
      inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study
      design

        -  Prospective, observational, single-center study

        -  Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be
           enrolled.

        -  Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be
           measured by VerifyNow system.

        -  Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1
           year after surgery and subjects will be followed-up for 1 year about primary endpoint.

        -  Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and
           the cohort will be divided by the PRU cutoff value (low/high platelet reactivity
           groups).

        -  The primary and secondary endpoints will be compared between two groups
    


Intervention name(s): Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery
Intervention type(s): Drug
Intervention description(s): aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year
Intervention MeSH terms: Aspirin; Clopidogrel
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with indications for surgical myocardial revascularization
      
Biospecimen description: 
      Whole blood
    
Keywords: Platelet activity, CABG, off-pump surgery
A Study in Healthy Men to Test How Different Doses of BI 3032950 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics
      (PK) and pharmacodynamics (PD) of BI 3032950 in healthy male subjects following intravenous
      (Part A) or subcutaneous (Part B) administration of single rising doses.
    


Intervention name(s): BI 3032950; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 3032950; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Non-invasive Evaluation Program for TIPS and Follow Up Network
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal
Study type: Observational

Summary: 
      Evaluation of non-invasive prognostic parameters in patients receiving transjugular
      intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients
      are cared according to the local standardized follow up program. Clinical and laboratory data
      from standard patient care are evaluated for potential prognostic value.
    

Detailed description: 
      NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt
      (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a
      structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on
      clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All patients receiving TIPS according to guidelines
      
Biospecimen description: 
      serum, plasma, stool, DNA, PBMC, Buffi coat
    
Keywords: transjugular intrahepatic portosystemic shunt (TIPS); non-invasive assessments; Transthoracic echocardiography (TTE) with Speckle-tracking; Computer tomography scan (CT-scan); Magnetic resonance imaging (MRI); circulating biomarkers; Electroencephalography (EEG)
Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to
      8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort),
      and a midazolam drug-drug interaction phase (one cohort of 8 subjects).
    

Detailed description: 
      The single-dose phase initiates with ascending doses of an oral solution followed by a 3-way
      crossover food effect and bioavailability (capsule formulation) cohort. Serum IGF-1 levels
      and GHRH-analog stimulated GH levels will be assessed as pharmacodynamics measures.

      The first multiple-dose (7 days dosing) cohort will be initiated after the PK and safety data
      are available from the single-dose phase. Subsequent multiple-dose cohorts will have 10 days
      of dosing. Serum IGF-1 level and GH levels will be assessed as pharmacodynamics measures.

      The last cohort in the study is midazolam drug-drug interaction study. The dose will be
      selected based on review of all pharmacokinetic and safety data for the single-dose and
      multiple-dose cohorts completed. On Day 1, 8 subjects will receive a single oral 2 mg dose of
      midazolam. Starting on Day 3 through Day 8, subjects will receive daily doses of CRN00808. On
      Day 9, subjects will be administered CRN00808 and 2 mg midazolam together.
    

Intervention name(s): CRN00808; Placebo Oral Solution; Midazolam oral solution; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Investigational drug; Placebo; Midazolam as part of the drug-drug interaction arm of the study; Placebo
Intervention MeSH terms: Midazolam; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single and multiple-dose cohorts are placebo-controlled. The midazolam cohort does not have placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization
Condition: Central Venous Catheterization
Study type: Interventional

Summary: 
      To test the hypothesis that approaching the internal jugular vein with the needle bevel down
      would produce less injury to the vessel wall compared to the bevel up approach during central
      venous catheterization.
    


Intervention name(s): bevel direction during central venous catheterization; bevel direction during central venous catheterization
Intervention type(s): Device; Device
Intervention description(s): approaching the IJV with the needle bevel facing down; approaching the IJV with the needle bevel facing up
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: safety during central venous catheterization
A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of single
      ascending intravenous (IV) and subcutaneous (SC) doses of REGN7999 in healthy adult
      participants.

      The secondary objectives of the study are:

        -  To characterize the drug concentration profile of single doses of IV or SC REGN7999

        -  To assess the immunogenicity of single ascending SC or IV doses of REGN7999
    


Intervention name(s): REGN7999; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending IV or SC dose administered per protocol; Ascending IV or SC dose administered per protocol
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-menstruating; Transmembrane protease, serine 6 (TMPRSS6) antagonist; First in Human (FIH); Human monoclonal antibody (mAb)
Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)
Condition: Menopause
Study type: Interventional
Phase: Phase 4

Summary: 
      The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT
      regimen.
    


Intervention name(s): tibolone; low-dose estradiol/noresterone
Intervention type(s): Drug; Drug
Intervention description(s): uncoded tablets, at a dose of 2.5 mg per tablet; Subjects were to take 1 Livialâ tablet and 1 -matched Activelleâ placebo tablet, orally, once a day (preferably at the same time).; Activelleâ, estradiol (E2) 1 mg and norethisterone acetate (NETA) 0.5 mg per tablet, was supplied as uncoded tablets.
Subjects were to take 1 Activelleâ tablet and 1 Livialâ-matched placebo tablet, orally, once a day (preferably at the same time).
Other intervention name(s): Livial; Activelle®
Intervention MeSH terms: Tibolone; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Cantharidin in Molluscum Contagiosum
Condition: Molluscum Contagiosum, Skin Disease
MeSH terms: Molluscum Contagiosum; Skin Diseases
Study type: Interventional

Summary: 
      The University of North Carolina Department of Dermatology is conducting a clinical trial to
      evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a
      common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many
      flesh-colored bumps on the skin. It goes away on its own, though can last several months to
      several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is
      well tolerated by the majority of children.
    


Intervention name(s): cantharidin's vehicle; Cantharidin 0.7%
Intervention type(s): Drug; Drug
Intervention description(s): Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits.; Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events.
Intervention MeSH terms: Cantharidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling
Condition: Muscular Dystrophies
MeSH terms: Muscular Dystrophies
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, single-dose, 1-period study to compare EDG-5506 concentrations
      measured from venous and capillary blood sampling in healthy adult subjects.

      EDG-5506 is an investigational product designed to selectively modulate a fast skeletal
      muscle motor protein called myosin that is part of the contraction machinery of the
      damage-prone muscle fibers.
    

Detailed description: 
      Ten (10) healthy, adult male and female (of non-childbearing potential only) participants
      will be enrolled in the single-site study. Participants will receive a single oral dose of
      EDG-5506 on Day 1. Serial blood sampling will be collected pre-dose and up to 26 hours
      post-dose using venous blood sampling by venipuncture and capillary blood sampling by a
      capillary blood self-sampling device. On Day 3, participants will self-collect a capillary
      blood sample at home. The final on-site visit will be on Day 7 when a last blood sample will
      be collected using venous blood sampling by venipuncture and capillary blood sampling by a
      capillary blood self-sampling device.
    

Intervention name(s): EDG-5506
Intervention type(s): Drug
Intervention description(s): single oral dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
Condition: Growth Hormone Deficiency With Pituitary Anomalies
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin
      Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will
      include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of
      healthy control subjects.
    

Detailed description: 
      Trial subjects will be assigned to groups of descending likelihood of having AGHD:

      Group A, B, C: High, intermediate, and low likelihood of GHD, respectively; Group D: Healthy
      control subjects matching Group A subjects .

      The sequential order of the GHSTs for suspected AGHD subjects (Group A-C) will be determined
      by stratified randomization; healthy control subjects (Group D) will be tested in the same
      sequence as the matched Group A subjects.

      Serum concentrations of GH will be measured at pre-defined time points before and after GHST
      with macimorelin or insulin. A peak GH value below the GHST-specific cut-off value will be
      considered 'test positive'. The ITT will be considered as comparator (non-reference standard)
      to assess positive and negative agreement of both GHSTs, based on the predefined cut-off
      values.

      The following cut-off values for simulated GH levels were used for both GHST tests to be
      compared: macimorelin-GHST: GH: 2.8 ng/mL, ITT: GH: 5.1 ng/mL.

      Amendment no. 1 (repeatability extension): had been issued for selected sites in Europe to
      obtain exploratory data on the repeatability of the MAC in a subset of subjects (planned
      N=30, 10 per Group) that had completed the core study.
    

Intervention name(s): Macimorelin; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose; Insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose
Other intervention name(s): Macimorelin-GHST (MAC); Insulin Tolerance Test (ITT)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Adult Growth Hormone Deficiency
Reliability and Validity of CCISO for Diagnosis of Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Global Developmental Delay; Language Disorder
MeSH terms: Language Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      The investigators designed the Child-Caregiver Interaction Observation Scale（CCIOS）to assess
      social communication behaviors, stereotyped behaviors for children with autism spectrum
      disorder(ASD) via a 20-min video of interactions between a caregiver and a child. The
      original CCIOS coding scheme consists 23 items. The score range for each item is 0-4, with
      higher scores being indicative of more atypical behavior. The aim of the study is to
      determine items for inclusion in the final CCIOS coding scheme through exploration of item
      correlations, establish the cutoff score of CCIOS for ASD and evaluate the reliability and
      validity of CCIOS. The reliability evaluation include test-retest reliability and inter-rater
      reliability. DSM-5 criterion is used as the gold standard. Validity is assessed by
      determining the correlation and consistency between CCIOS and DSM-5 criterion.
    

Detailed description: 
      The investigators designed the Child-Caregiver Interaction Observation Scale（CCIOS）to assess
      social communication behaviors, stereotyped behaviors for children with autism spectrum
      disorder(ASD) via a 20-min video of interactions between a caregiver and a child. The
      original CCIOS coding scheme consists 23 items. The score range for each item is 0-4, with
      higher scores being indicative of more atypical behavior. The investigators conduct this
      study to determine items for inclusion in the final CCIOS coding scheme through exploration
      of item correlations, establish the cutoff score of CCIOS for ASD and evaluate the
      reliability and validity of CCIOS.

      It is of importance to accurately distinguish children with ASD from those with Global
      Developmental Delay (GDD) and Language Disorder (LD) without ASD, sometimes, it's very
      difficult in children with mental ages below 2 years. This differentiation has strong
      implications for treatment recommendations and may also inform long-term prognosis. In this
      study, The investigators planned to recruit 60 children with ASD and 60 children with GDD/LD
      aged from 18 months to 48 months. The reliability evaluation include test-retest reliability
      and inter-rater reliability. DSM-5 criterion is used as the gold standard. Validity is
      assessed by determining the correlation and consistency between CCIOS and DSM-5 criterion.
    

Intervention name(s): Do not take any interventions
Intervention type(s): Other
Intervention description(s): Do not take any interventions
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        ASD/GDD/LD children are from development behavior clinic
Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer
Condition: Recurrent Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure
      chemotherapy in women with recurrent ovarian cancer
    

Detailed description: 
      This study aims to investigate the therapeutic efficacy of PIPAC using doxorubicin and
      cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal
      carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate
      (CBR) according to RECIST criteria after three cycles of PIPAC with cisplatin and
      doxorubicin.
    

Intervention name(s): chemotherapy with doxorubicin and cisplatin
Intervention type(s): Drug
Intervention description(s): intraperitoneal chemotherapy applied as an aerosol and under pressure
Other intervention name(s): CISPLATIN Teva, Adrimedac
Intervention MeSH terms: Cisplatin; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian cancer, recurrent, chemotherapy, intraperitoneal