bioihbjkbjnl/mcl2 huggingface dataset:
A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to evaluate the safety and effectiveness of a new oral
      antibiotic called SMT19969 in treating C. difficile Infection (CDI).
    


Intervention name(s): SMT19969; Vancomycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vancomycin; Ridinilazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CDAD; Clostridium Difficile
Botswana Pediatric Respiratory Disease and Bloodstream Infection Study
Condition: HIV Infections; Respiratory Tract Diseases; Sepsis
MeSH terms: Infections; Communicable Diseases; HIV Infections; Sepsis; Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      The purpose of this study is to learn about lower respiratory tract and bloodstream diseases
      among infants born to HIV positive mothers in Botswana. Study factors include how commonly
      infants get these diseases, the causes, and outcomes. The study will also try to measure the
      protective effect, if any, of breast feeding on respiratory disease illness and deaths.
    


Intervention name(s): blood draws, etc.
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        LIVEBORN INFANT IN THE MASHI PMTCT TRIAL
      
Keywords: HIV infected mothers; Infants at risk of HIV-infection; Infant lower respiratory tract disease; Infant bloodstream infection
Temporal Trends of Thrombolysis Treatment in Chinese Acute Ischemic Stroke (AIS) Patients From 2007-2017: Analysis of China National Stroke Registry (CNSR) I, II, and III; CTP-Draft Review Performed;
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      The present study is to be conducted based on the AIS patient data collected from CNSR I, II,
      and III.

      The primary objectives are:

        -  To investigate the temporal changes in the proportion of intravenous recombinant
           plasminogen activator (IV rtPA) treatment from 2007 to 2017 among Intravenous
           Thrombolytics (IVT) eligible patients (patient groups B and B') and overall AIS patients
           (patient group A) in China;

        -  To investigate the temporal changes in IV rtPA treatment time intervals from 2007 to
           2017 among IV rtPA treated patients (patient groups C and C') in China.

      The secondary objectives are:

      - To describe the demographic and clinical characteristics of the IV rtPA treated patients
      (patient groups C and C'), IVT eligible patients (patient groups B and B') and the overall
      AIS patients (patient group A) from 2007 to 2017 from the CNSR I to III.
    


Intervention name(s): IV rtPA (intravenous recombinant plasminogen activator)
Intervention type(s): Drug
Intervention description(s): intravenous injection
Intervention MeSH terms: Plasminogen
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All eligible patients from the CNSR I to III will be included. Patient groups include the
        overall AIS patients (patient group A), IVT eligible patients (patient groups B and B'),
        and IV rtPA treated patients (patient groups C and C').
Sex Steroids and the Serotonin Transporter
Condition: Transsexualism
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to prove the influence of the sex steroid hormones estrogen,
      progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron
      emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT
      binding will be quantified before and after hormone therapy underwent by 10 male-to-female
      (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level,
      long-term administration of opsite sex steroid hormones in transsexuals provide the unique
      opportunity to investigate the influence of sex steroid hormones on the serotonergic system.
      Since the serotonin transporter serves as a primary target molecule for antidepressant
      treatment, the results of the study will be of benefit for the assessment of the clinical
      relevance of estrogen and testosterone as modulatory and neuroactive agents.
    


Intervention name(s): Testolactone undecanoate; Lynestrenol; Cyproterone Acetate; Estradiol; 5-alpha reductase inhibitor
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 4ml i.m.; 2/day; 50mg per day; 100 microgram TTS twice a week; 1mg daily
Other intervention name(s): Nebido®; Orgametril®; Androcur®; Estradot®; Finasterid®
Intervention MeSH terms: Cyproterone Acetate; Testolactone; Lynestrenol; Estradiol; Cyproterone; 5-alpha Reductase Inhibitors
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Serotonin Transporter; Hormone therapy; Gender Dysphoria; Transsexualism
Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative pain management in children is still standing as a problem to solve. Effect of
      quadratus lumborum block has been shown to be a promising technique to overcome postoperative
      pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new
      defined relatively safer and easier regional anesthesia technique which could be used for
      this purpose. Primary aim of this double blinded randomized controlled trial is to compare
      the analgesic efficacy of this two block techniques in this group of pediatric patients.
    


Intervention name(s): Erector Spinae Plane Block; Quadratus Lumborum Block; Bupivacaine (Block Drug)
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Erector Spinae Plane block will be administered under general anesthesia before the surgery; Quadratus Lumborum Block will be administered under general anesthesia before the surgery; 0,25% Bupivacaine was used 0,5ml/kg (max. 20cc) for block performances
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pediatric Surgery; Postoperative Pain; Erector spinae plane block; quadratus lumborum block
Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers
Condition: Obesity; Type 2 Diabetes; Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      Childhood obesity is a critical global public health concern. Breastfeeding is the ideal
      choice for infant nutrition. However, rapid and excess weight gain during infancy predicts
      later, even among breastfed infants. This risk is higher if mothers are obese and/or
      diabetic. Composition of bioactive components of breast milk may differ based between mothers
      who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are
      associated with overall increases in inflammation and oxidative stress, but how breast milk
      composition is affected remains unknown. The investigators overarching goal is to determine
      how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how
      differences in composition may impact infant growth and fat development. The investigators
      are undertaking a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and
      20 Type 2 Diabetic mothers and their infants over the first 4 months of life. The
      investigators will track infant weight and fat gain and monitor maternal glucose control. The
      investigators will also collect breast milk samples over the first 4 months and measure
      concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and
      nutrient composition in milk. The investigators predict that concentrations of
      growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and
      markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast
      milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers'
      breast milk. The investigators expect these differences will be most pronounced in the first
      2 weeks after birth. The investigators also predict that breast milk concentrations of these
      biomarkers will be associated with infant fat gain. What the investigators find will help
      understand how early infant nutrition and growth may affect that child's later risk of
      obesity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit pregnant women in the Denver Colorado area who plan to deliver their infant
        at the University of Colorado Hospital, and plan to exclusively breastfeed their infant for
        at least 5 months.
      
Biospecimen description: 
      Human Milk, Plasma, Urine and Stool
    
Keywords: human milk; infant growth; obesity; diabetes; breastfeeding
Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the
      treatment of endometriosis
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Visanne (SH T00660AA , BAY86-5258)
Intervention type(s): Drug
Intervention description(s): Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Uroflow Measurements in Healthy Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      The goal of this study to determine normal values for certain urinary measurements in order
      to better understand voiding dysfunction in women.
    

Detailed description: 
      see above
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Urogynecology clinic
      
Keywords: Urogynecology
Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be performed as an open-label, randomised, single-dose, two-sequence,
      four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be
      randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once
      or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period.
      The length of admission will be 7 days in each period.
    


Intervention name(s): T80/A5 mg FDC tablet; T80/A5 mg FDC tablet; H12.5 mg tablet; T80/A5/H12.5 ng FDC tablet; H12.5 mf tablet; T80/A5/H12.5 mg FDC tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet; A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet; A HCTZ 12.5 mg tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
Condition: Renal Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This sequential study will assess the efficacy and safety of multiple doses of intravenous
      (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum
      starting dose for maintenance treatment of anemia in children with chronic kidney disease on
      hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin
      alfa during the screening period, after which they will receive IV MIRCERA monthly, at a
      starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on
      the response achieved, another group may be selected to receive a higher or a lower dose.
    


Intervention name(s): Methoxy Polyethylene Glycol-Epoetin Beta
Intervention type(s): Drug
Intervention description(s): Will be administered IV, every 4 weeks.
Other intervention name(s): MIRCERA; RO0503821
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study is to analyse if corifollitropin alfa, an agent for
      prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day
      2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.
    

Detailed description: 
      Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating
      activity. It offers novel and effective treatment option for potential normal responder
      patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro
      fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily
      rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised
      trial, we want to evaluate whether this agent can be clinically used when started on day 4 of
      the cycle.
    

Intervention name(s): corifollitropin alfa
Intervention type(s): Drug
Intervention description(s): long acting FSH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ICSI; GnRH antagonist; corifollitropin alfa
Tirofiban and Enoxaparin in High Risk Coronary Intervention
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients undergoing coronary angioplasty are frequently treated with new drugs that stop
      blood platelets working and so improve the success of the procedure. Individual patients may
      vary in the dose of the drug required. New platelet tests have been developed which can be
      performed near the patient and possibly immediately tell the doctor the degree of platelet
      inhibition achieved so that the dose can be adjusted accordingly. This study aims to
      investigate if these platelet tests indicate if new anticoagulants are more effective at
      inhibiting platelet function than the traditional anticoagulants. The study will demonstrate
      if these newer drugs improve blood flow through the heart muscle and thereby provide better
      long term outcomes for patients undergoing percutaneous intervention.
    

Detailed description: 
      Objectives: The study assessed the benefit of high bolus dose tirofiban with enoxaparin
      compared to unfractionated heparin.

      Introduction: The benefit of the use of glycoprotein IIb/IIa inhibitors with low molecular
      weight heparins in high risk patients undergoing percutaneous intervention (PCI) over
      traditional unfractionated heparin (UFH) is debated. Methods; The study is a prospective
      single center open-label trial of patients with high-risk acute coronary syndrome treated
      with PCI who were randomised to anticoagulation with UFH or enoxaparin with 'high dose' (25
      mcg/kg bolus) tirofiban This study measured a panel of platelet activation markers,
      inflammatory biomarkers and thrombus generation between the two groups.
    

Intervention name(s): Enoxaparin; Tirofiban; unfractionated heparin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Enoxaparin was administered at the commencement of PCI at a dose of 0.75 mg/kg
Intervention MeSH terms: Heparin; Enoxaparin; Calcium heparin; Tirofiban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enoxaparin; tirofiban; percutaneous intervention; platelet inhibition; CD40L; Mac-1; prothrombin fragment 1+2.
ANAIS Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access®
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      Prospective, single-arm, multi-center study to assess the safety and performance of the ANA
      5F Advanced Neurovascular Access®, in combination with a stent retriever in patients with
      acute ischemic stroke.
    

Detailed description: 
      ANA 5F Advanced Neurovascular Access®: distal access catheter system designed to assist in
      neurovascular procedures by facilitating the insertion and guidance of other devices (i.e.
      retrieval devices and intravascular catheters) and temporarily restricting blood flow at the
      target position.

      The objective of this study is to confirm the safety and performance of the ANA 5F device to
      be used as a tool to facilitate the Solitaire stent retriever placement and provide temporary
      restriction of blood flow in stroke patients undergoing neurothrombectomy for an acute large
      vessel occlusion (LVO) treated 24 hours from symptom onset (last time the subject was seen
      well).

      Population: Up to 30 Participants with Acute Ischemic Stroke (AIS), indicated for treatment
      with ANA 5F device in combination with Solitaire stent retriever, whose stroke is
      attributable to an occlusion of a large artery in the neurovasculature.
    

Intervention name(s): Neurothrombectomy
Intervention type(s): Device
Intervention description(s): The ANA 5F device is intended to be inserted, be navigated to the neurovascular anatomy inside an outer catheter and be used as a conduit for insertion and guidance of intravascular catheters and retrieval devices into a selected blood vessel. The funnel is deployed by retracting the conduit catheter and is intended, when deployed, to provide temporary vascular flow restriction.
The device is indicated for the introduction of interventional devices into the neuro vasculature, during interventions for restoring blood flow in patients experiencing acute ischemic stroke due to large vessel occlusion.
Other intervention name(s): Mechanical thrombectomy (MT)
Intervention model: Single Group Assignment
Intervention model description: Patients with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AIS
Methyl-Donors and EpiGenetics in The Gambia
Condition: Aberrant DNA Methylation
Study type: Observational

Summary: 
      Accumulating evidence suggests that early-life nutrition can affect metabolism and thus
      increase the risk of disease in adulthood (e.g. type II diabetes and obesity). One possible
      mechanism to explain these effects is epigenetic variation at critical periods of
      development. Epigenetic variation describes non-inherited permanent alterations to an
      individuals DNA.

      Recent work in mouse models has demonstrated that maternal nutritional status can affect such
      epigenetic processes such as DNA methylation and gene expression during embryonic
      development, with profound effects on outcomes. The investigators aim to study these
      processes in humans for the first time. The investigators will exploit the "experiment of
      nature" setting in The Gambia, i.e. fluctuation in diet according to season. During the
      'hungry' season diets are known to be depleted in nutrients required for epigenetic gene
      regulation. Nutritional biomarkers in blood as well as the dietary intake will be measured in
      pregnant women according to season. A blood sample will also be taken from babies born to
      these women to determine whether there is a direct effect of diet on mothers' nutritional
      status and hence variation in DNA methylation patterns in their babies by season.
    


Intervention name(s): season, dietary intake
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women of reproductive age in rural Gambia and their infants
      
Biospecimen description: 
      blood, buccal swab, hair follicles
    
Keywords: season of conception; maternal nutritional status; infant DNA methylation