bioihbjkbjnl/mcl2 huggingface dataset:
Magnetic Resonance Imaging in Subjects With Gouty Tophi
Condition: Hyperuricemia; Gout
MeSH terms: Hyperuricemia
Study type: Observational

Summary: 
      The purpose of this study is to determine the reproducibility of Magnetic Resonance Imaging
      (MRI) in the quantitative assessment of tophus volume.
    

Detailed description: 
      This is a multi-center, validation study of MRI in the quantitative assessment of gouty
      tophi. Subjects with palpable gouty tophi (confirmed by aspiration of the tophus) in select
      anatomical sites (foot, hand or elbow) will undergo pre- and post contrast MRI on two
      occasions separated by 5 to 10 days. This study will consist of up to 4 study visits.
    

Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): Subjects underwent MRI to evaluate tophi.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with palpable gouty tophi.
      
Biospecimen description: 
      None taken or retained.
    
Keywords: Gout; Tophus; MRI
Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor
Condition: Sjogren's Syndrome; Neonatal Systemic Lupus Erythematosus; Fetal Heart Block Complete
MeSH terms: Sjogren's Syndrome; Heart Block; Lupus Erythematosus, Systemic; Syndrome
Study type: Observational

Summary: 
      The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB
      (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to
      detect abnormal heart rates and rhythms in their babies before they are born.
    

Detailed description: 
      The study will enroll mothers during week 16-19 of gestation and will ask the mothers to use
      a hand-held Doppler monitor to listen to the baby's heart rate and rhythm twice daily from
      about week 16 to week 26 of the pregnancy. Pregnant mothers will be asked to keep a log of
      the heart rates and will undergo a fetal echocardiogram every 2 weeks during their study
      participation. In addition to these procedures, the study team will collect the mother's
      medical and obstetrical histories. Should irregular heart rhythms be detected at home, the
      mother will contact the investigator to be evaluated. After the baby is delivered, the study
      team will collect information about the baby's birth and heart rhythm evaluation
      (electrocardiogram).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include all pregnant women with positive SSA or SSA and SSB
        antibodies between the gestational ages of 16-19 weeks with no signs of antibody-mediated
        fetal cardiac disease on pre-enrollment fetal echocardiogram. Subjects who are more than 19
        weeks gestation will not be included. Subjects who have a fetus with an estimated fetal
        weight below the 10th percentile will also not be included.
      
Keywords: Neonatal Systemic lupus erythematosus; Sjogren's syndrome; Fetal Atrioventricular Block; Fetal Heart Block
Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to
      grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing.

      PURPOSE: This phase II trial is studying how well giving calcitriol together with
      mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the prostate-specific antigen (PSA) response rate, defined as the fraction of
           patients with 50% reduction in PSA level over 3 weeks' time, in patients with
           androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol,
           mitoxantrone, and prednisone.

      Secondary

        -  Determine the safety and tolerability of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral high dose pulse calcitriol on day 1, mitoxantrone IV on day 2, and oral
      prednisone on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence
      of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
    

Intervention name(s): calcitriol; mitoxantrone hydrochloride; prednisone
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention MeSH terms: Calcitriol; Prednisone; Mitoxantrone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent prostate cancer; stage IV prostate cancer
Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section
Condition: Early Skin-to-skin Contact
Study type: Interventional

Summary: 
      In the past decades frequency of cesarean section was increasing. Bonding or early
      skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery
      bonding/early SSC is already well-established. After cesarean section this important process
      starts after termination of operation. A Cochran review analyzed randomized studies and shows
      positive effects of early SSC. Possible concerns to adopt bonding in the operating room are
      beside organizational ones (change of established processes) also a different ambiance in the
      operating room (temperature, light, noise). In a prospective randomized trial, early SSC
      after cesarean section should be analyzed.

      Hypothesis

      Mothers, who have the chance to bond immediately after birth in the operating room, have
      lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels.
      Adaptation of the newborn is within the normal range. Early bonding has a further positive
      effect on breast feeding, maternal pain processing and mental health.
    


Intervention name(s): early SSC; late SSC
Intervention type(s): Procedure; Procedure
Intervention description(s): bonding straight after birth; bonding after termination of operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Tolerability of Asasantin in Healthy Female and Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the occurrence of dipyridamole associated headaches in healthy subjects using
      a titration scheme or not
    


Intervention name(s): Asasantin ER; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pain of Injection of Lipuro Propofol in Children Aged 1-7 Years
Condition: ASA 1-2 Requiring Intravenous Cannulation for General Anaesthesia
Study type: Interventional

Summary: 
      Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the
      pain of injection of the standard formulation
    


Intervention name(s): lipuro propofol; standard formulation propofol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Carvedilol for Psychostimulant Dependence
Condition: Cocaine Dependence; Cocaine Withdrawal
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine
      dependent participants.
    


Intervention name(s): controlled release carvedilol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper; Placebo
Other intervention name(s): Coreg CR
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine dependence; cocaine withdrawal
Corneal Oxygen Uptake With Apioc Contact Lenses
Condition: Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)
MeSH terms: Corneal Diseases
Study type: Interventional

Summary: 
      The purpose of this research is to determine if a new investigational contact lens shape
      allows the eye to get more oxygen.
    


Intervention name(s): Apioc Contact Lens
Intervention type(s): Device
Intervention description(s): Measurement of corneal oxygen uptake with contact lens wear.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
Trial With Allergic Rhinitis Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber
Condition: Rhinitis, Allergic, Seasonal; Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect
      versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber.
      GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in
      development by GSK for the treatment of allergic rhinitis, asthma and COPD.

      Subjects will be selected on the basis that they display a defined moderate response to the
      pre-determined dose used.

      This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients
      with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.

      12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal
      examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge
      assessments will also be performed at various time points throughout the study.
    


Intervention name(s): GSK256066
Intervention type(s): Drug
Intervention MeSH terms: 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Vienna Challenge Chamber; Seasonal Allergic Rhinitis; Inflammation
Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial
Condition: Head and Neck Neoplasms
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The Primary Objective is to evaluate the progression-free survival after treatment with
      docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus
      5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to
      evaluate and compare the clinical response rate both before and after radiotherapy, the local
      symptoms, the duration of response, the time to treatment failure, the survival, the toxicity
      and the quality of life in the 2 study groups.
    


Intervention name(s): DOCETAXEL; CISPLATIN; 5-FLUOROURACIL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous; Intravenous; Intravenous
Intervention MeSH terms: Docetaxel; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The co-administration of raltegravir with medicinal products that are knouwn to be potent
      UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once
      daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate
      therapeutic option in HIV-infected patients also receiving atazanavir-containing
      antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are
      recovered.
    

Detailed description: 
      Treatment adherence is crucial for the effectiveness of antiretroviral therapy, and, in an
      attempt to promote treatment adherence by the patients, once daily (QD) regimens are
      preferred rather than twice daily (BID) regimens.

      The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human
      immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients.

      Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase
      (UGT1A1)-mediated glucuronidation pathway. Thus, co-administration of raltegravir with
      medicinal products that are known to be potent UGT1A1 inhibitors, such as atazanavir, may
      increase plasma levels of raltegravir.

      Based on these data, it could be hypothesized that once daily raltegravir (800 mg QD) could
      be an appropriate therapeutic option in HIV-infected patients also receiving
      atazanavir-containing antiretroviral regimens. However, pharmacokinetic data supporting this
      hypothesis are lacking.
    

Intervention name(s): Addition of raltegravir 800 mg QD to HAART
Intervention type(s): Drug
Intervention description(s): Addition of raltegravir 800 mg QD to HAART
Other intervention name(s): HAART+RAL
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atazanavir; Raltegravir; once-daily; pharmacokinetics; HIV
Gestational Diabetes Mellitus and Neurodevelopment in Newborns
Condition: Diabetes, Gestational; Glucose Metabolism Disorders
MeSH terms: Diabetes, Gestational; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the feasibility of using a quantitative EEG method
      to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental
      deficits can be detected in newborns from mothers with gestational diabetes mellitus (GDM)
      compared to control newborns.

      The second purpose of this study is to determine whether cord blood concentration in
      docosahexaenoic acid (DHA), an omega-3 fatty acid, is similar in neonates of well-controlled
      mothers with gestational diabetes mellitus (GDM) compared to control mothers, and to evaluate
      whether this contributes to neonates neurodevelopment status.
    

Detailed description: 
      Maternal weight is measured close to delivery and BMI is calculated. Birth weight, length,
      head circumference, Apgar score and glycaemia are recorded at birth. An EEG are performed on
      the newborn within 48 hrs after birth.A maternal blood sample is collected at admission to
      measure maternal glycated hemoglobin (A1C). Cord blood samples are collected in the umbilical
      vein after delivery.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with singleton pregnancy were recruited in the Centre Hospitalier
        Universitaire de Sherbrooke (CHUS) at 24 - 28 weeks of gestation.
      
Biospecimen description: 
      cord blood plasma
    
Keywords: neurodevelopment; electroencephalography; gestational diabetes mellitus; omega 3 polyunsaturated fatty acids
Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)
Condition: Cocaine-related Disorder
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed whether AFQ056 had a beneficial effect by reducing cocaine use in Cocaine
      Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.
    

Detailed description: 
      This was a randomized, subject- and Investigator-blinded, parallel-group, placebo-controlled
      study in subjects with CUD. The study consisted of a 17-day screening period followed by a
      12-day baseline, a 98-day outpatient treatment period (14-day up-titration dose regimen
      followed by 84-day maintenance dose), and an End of Study evaluation visit approximately 14
      days after the last study drug administration. The total duration for each subject in the
      study was approximately 20 weeks including screening and baseline.
    

Intervention name(s): AFQ056; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg and 100 mg tablets taken orally; Matching placebo tablets taken orally BID
Other intervention name(s): mavoglurant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine Use Disorder; cocaine dependence,AFQ056,adult, cocaine use,CUD, drug abuse, drug addiction,
Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery
Condition: Burns Shock
MeSH terms: Shock; Burns
Study type: Observational

Summary: 
      To explore the effects and safety of human albumin in burn shock recovery, and then provide a
      theoretical basis for its rational use.
    

Detailed description: 
      A retrospective case-control study was conducted. Patients who admitted to the burn ward and
      needed fluid resuscitation during the period of January 2011 to December 2018 in our unit
      were identified. Patients were divided into two groups according to the severity of burns,
      the patients with a 20%<TBSA≤50% constituted the moderate and severe burn group, the patients
      with a TBSA>50% constituted the severest burn group, and then the patients who used albumin
      for resuscitation constituted the albumin group, the patients who did not use albumin
      constituted the control group. The primary outcome was mortality, and the secondary outcomes
      included hospital stay, ventilator supporting, fluid use, and complications.
    

Intervention name(s): Albumin
Intervention type(s): Drug
Intervention description(s): At least one dose of human albumin was used for the patients during hospitalization in the burn ward consisted the albumin group.
The patients who have no albumin use during their hospitalization in the burn ward consisted the control group.
Other intervention name(s): human albumin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who admitted to the burn ward of the Second Affiliated Hospital, School of
        Medicine, Zhejiang University and needed fluid resuscitation were identified during the
        period of January 2011 to December 2018.
      
Keywords: burns; shock; recovery; human albumin; effect
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl
Condition: Fentanyl Analgesia
Study type: Interventional

Summary: 
      CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after
      epidural injection. The objective of this investigation was to compare the analgesic effect
      of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.

      DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.

      METHODS: 29 patients were divided into two groups. During the postoperative period, in the
      presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in
      saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n =
      15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl
      intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL
      epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity
      was evaluated by numerical scale and plasma concentrations of Fentanyl were measured
      simultaneously.
    


Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): 100 mcg Fentanyl intravenous or epidural route
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Analgesia; Fentanyl; Orthopedic; Mechanism of action; Surgery
An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland
Condition: Prostatitis
MeSH terms: Prostatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of ELMIRONÂ® in the
      treatment of chronic non-bacterial inflammation of the prostate gland.
    

Detailed description: 
      The objective of this randomized, double-blind, placebo-controlled study is to determine the
      effectiveness and safety of ELMIRON® 100 mg three times per day for 12 weeks, as compared
      with placebo, in patients with chronic non-bacterial inflammation of the prostate gland.
      Safety evaluations will be assessed throughout the study. The hypothesis of the study is that
      ELMIRON® will be more effective than placebo, as based on the change in the total National
      Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline to the
      final visit (Week 12) and is generally well-tolerated. Patients will receive oral ELMIRON®
      100 mg three times per day orally or matching placebo three times per day for 12 weeks.
    

Intervention name(s): pentosan polysulfate sodium
Intervention type(s): Drug
Intervention MeSH terms: Pentosan Sulfuric Polyester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: prostatitis; Elmiron; pentosan polysulfate sodium