bioihbjkbjnl/mcl2 huggingface dataset:
Estimation of Effective Dose 95 (ED95) of Intrathecal Isobaric 2-chloroprocaine (2-CP) Based on the Height (cm) of a Patient Undergoing Ambulatory Knee Arthroscopy
Condition: Knee Arthroscopy
Study type: Observational

Summary: 
      In ambulatory surgery, the choice of the local anesthetic used is essential. The ideal local
      anesthetic must allow a quick installation of the spinal block, a duration of the sensory
      block adapted to the surgery with a minimum of side effects. These side effects include
      bradycardia, hypotension and block failure during the intraoperative period; bladder
      retention, transient neurological disorders during the post-operative period. The achievement
      of kinetic objectives associated with a reduction in side effects is related to the choice of
      local anesthetic and the dose administered. However, there are interindividual
      pharmacokinetic variations that make it difficult to predict the effective dose and the
      unfortunate occurrence of side effects.

      In this context, the height of the patient is a criterion involved in the level, the duration
      of the sensitive motor block and therefore the side effects

      The local anesthetic of the amino ester family, isobaric 2-chloroprocaine (2-CP) has been
      successfully used for spinal anesthesia since several decades. With a short duration of
      action, it is preferred to other anesthetics for the short-term outpatient surgeries.
      However, the effective dose 95 (ED95) of intrathecal isobaric 2-CP is currently unknown.

      The purpose of this prospective study is to determine the ED95 of the spinal 2-CP using the
      continuous re-evaluation method (Continual Reassessment Method) (CRM) based on patient's
      height
    


Intervention name(s): Isobaric 2-chloroprocaine
Intervention type(s): Drug
Intervention description(s): The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
Other intervention name(s): Ampres 10mg/ml
Intervention MeSH terms: Chloroprocaine
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing ambulatory knee arthroscopy under the spinal anesthesia
      
Keywords: spinal anesthesia; Knee Arthroscopy; Chloroprocaine; Height; Effective Dose (ED95); Continual Reassessment Method (CRM)
Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed
      Newborns after spontaneous birth in comparison to cesarean section.

      This may have an influence on the risk of vertical HiV transmission.
    

Detailed description: 
      At birth maternal CD4+ t-cells from umbilical cord blood and placenta blood are measured by
      microchimerism-analysis.

      After 6 weeks the maternal CD4+ t-cells are measured in the blood of the babies blood.

      Additionally we look for HiV in maternal CD4+ t-cells.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section.
      
Biospecimen description: 
      Umbilical Cord blood Blood from peripheral vene
    
Keywords: Human Immunodeficiency Virus; Microchimerism; Maternal-Fetal Exchange; Gestation; HiV-vertical transmission
Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.
Condition: Postmenopause
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous
      regimen 17 b estradiol/trimegestone combination.
    


Intervention name(s): Trimegestone; 17b Estradiol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postmenopause
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
Condition: Barrett's Esophagus; Esophageal Cancer
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a cryoablation technique used to ablate human
      esophageal mucosa.
    

Detailed description: 
      The purpose of this study is to evaluate the histological results of a cryoablation technique
      used to ablate human esophageal mucosa. The performance and safety of the cryoablation
      technique will also be evaluated.
    

Intervention name(s): Cryoballoon Ablation
Intervention type(s): Device
Intervention description(s): Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." (K101825)
Other intervention name(s): CryoBalloon Ablation System; cryoablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophagectomy; Barrett's Esophagus
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional
      therapy using digital subtraction angiography（DSA） for nasopharyngeal carcinoma.
    

Detailed description: 
      By enrolling patients with nasopharyngeal carcinoma adapted to enrolled criteria, this study
      will document for the first time the safety and the short and long term efficacy of
      HepaSphere interventional therapy using digital subtraction angiography （DSA） for
      nasopharyngeal carcinoma.
    

Intervention name(s): interventional therapy
Intervention type(s): Procedure
Intervention description(s): nasopharyngeal carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal Carcinoma; HepaSphere
Lorazepam Sedation for Critically Ill Children
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This clinical trial is being performed under the Best Pharmaceuticals for Children Act,
      signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The
      purpose of this study is to make sure that lorazepam, when given to children who are very
      sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well
      as a drug called midazolam. Midazolam is already approved by the FDA for this use, but
      lorazepam is not, even though both drugs are commonly used for sedation.
    

Detailed description: 
      Lorazepam is used clinically for sedation of mechanically ventilated children, but has not
      been approved by the FDA for this indication in children. The purpose of this study, in
      response to the Written Request by FDA, is to determine the safety, efficacy, and dosage
      required for lorazepam compared with midazolam, which is approved by FDA for children for
      this indication.

      Study participants must be children who are critically ill and receiving mechanical
      ventilation who require sedation. Participants will be randomized to lorazepam (intermittent
      bolus or continuous infusion) or midazolam (continuous infusion). Sedation will be monitored
      using the COMFORT score. Blood will be drawn to measure lorazepam/midazolam plasma
      concentrations, and to measure the plasma concentrations of excipients (benzyl alcohol and
      glycols) in patients receiving lorazepam.
    

Intervention name(s): Lorazepam; Midazolam; Lorazepam CI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score; Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score; Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
Other intervention name(s): Ativan; Versed; Ativan
Intervention MeSH terms: Midazolam; Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lorazepam; Midazolam; Best Pharmaceuticals for Children Act; Critically ill; pediatrics; mechanical ventilation; sedation
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of
      SAR302503.

      Secondary Objective:

      To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with
      mild and moderate and hepatic impairment and in matched subjects with normal hepatic
      function.
    

Detailed description: 
      Study duration=17-35 days
    

Intervention name(s): SAR302503
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:capsule
Route of administration: oral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients
Condition: Wilson's Disease
MeSH terms: Hepatolenticular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients
      with Wilson's disease.
    

Detailed description: 
      An open, single-dose study to determine the pharmacokinetics, and safety of oral
      administration of trientine dihydrochloride in both children and adult patients with Wilson's
      Disease. Blood samples will be taken pre-dose and at 10 time-points post-dose to investigate
      the pharmacokinetic profile of trientine dihydrochloride up to 12 hours after intake of study
      medication in 20 patients.
    

Intervention name(s): trientine dihydrochloride
Intervention type(s): Drug
Intervention description(s): Patients will take their normal prescribed dose (x1) of trientine dihydrochloride 300mg
Intervention MeSH terms: Trientine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trientine; Pharmacokinetics
Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of sitagliptin on glucose variability
      both after meals and overnight in adult patients with type 1 diabetes.
    

Detailed description: 
      Improved post prandial glucose control with multiple daily injections of insulin in the DCCT
      study demonstrated significant reductions in microvascular complication. Similar to type 2
      diabetes, patients with type 1 diabetes have a paradoxical increase in glucagon after meals
      which contribute to worsening post prandial glucose control. This proposed study is designed
      to determine if altering the glucagon axis by giving sitagliptin can improve glucose control
      in patients with type 1 diabetes.
    

Intervention name(s): Sitagliptin; Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks; Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Type 1 diabetes; glucose variability
Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)
Condition: Hypophosphatasia (HPP)
MeSH terms: Hypophosphatasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP
      compared to a historical control group.
    

Detailed description: 
      Asfotase Alfa was formerly referred to as ENB-0040

      Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease
      characterized by defective bone mineralization and impaired phosphate and calcium regulation
      that can lead to progressive damage to multiple vital organs, including destruction and
      deformity of bones, profound muscle weakness, seizures, impaired renal function, and
      respiratory failure. There are no approved disease-modifying treatments for patients with
      this disease. There is also limited data available on the natural course of this disease over
      time, particularly in patients with the juvenile-onset form.

      Efficacy analyses were prospectively defined in the protocol with a comparison to historical
      controls. The historical control group came from patients whose characteristics matched as
      closely as possible the entry criteria for the trial. The control group included all patients
      who had x-rays within the age range defined by the inclusion criteria of this study (5 to 12
      years of age, inclusive, with open growth plates).

      The pre-specified plan for analysis was to combine the two asfotase alfa treated groups
      (asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg
      subcutaneous (SC) injection three times per week) and compare them to historical controls.
    

Intervention name(s): asfotase alfa; asfotase alfa
Intervention type(s): Biological; Biological
Intervention description(s): 2 mg/kg subcutaneous injection three times per week for 6 months.; 3 mg/kg subcutaneous injection three times per week for 6 months.
Other intervention name(s): Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein; sALP-Fc-D10; Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein; sALP-Fc-D10
Intervention MeSH terms: Immunoglobulin G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypophosphatasia; HPP; Bone Disease; Soft Bones; Low Alkaline Phosphatase; genetic metabolic disorder; alkaline phosphatase; tissue non-specific alkaline phosphatase; rickets; osteomalacia
The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational

Summary: 
      Thirteen hospitals in China will participate in the study, which aims to provide data on
      serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and
      estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes.

      We hypothesize that the study can be value in identifying and implementing strategies for
      risk reduction.
    

Detailed description: 
      Neonatal hyperbilirubinemia resulting in clinical jaundice is a common problem among infants,
      particularly during the first weeks of life.

      Information about the incidence and risk factors of neonatal jaundice is not available from
      China where is one of the highest countries of the incidence of severe neonatal
      hyperbilirubinemia.
    

Intervention name(s): Phototherapy
Intervention type(s): Procedure
Intervention description(s): The decision to use phototherapy conformed to the hour-specific threshold value for phototherapy presented by the American Academy of Pediatrics guidelines and was not at the discretion of the investigators.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Term or late-preterm newborn infants from Seventeen hospitals in China were recruited.
      
Keywords: Hyperbilirubinemia; Neonatal; Incidence; Risk factors
Clinical Profiles and Outcomes of Acute Aortic Dissection in the Chinese Patients
Condition: Aorta Thoracic Ascending Dissection; Dissection of Descending Aorta
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      Clinical profiles and outcomes of patients with acute aortic dissection have not yet been
      evaluated in China. The aim of this study is to establish clinical registry of acute aortic
      dissection in China and to analyze clinical features, managements and outcomes of Chinese
      patients with acute aortic dissection.
    

Detailed description: 
      In 1996, the Internation Registry of Acute Aortic Dissection(IRAD) was established to improve
      clinical diagnosis and treatment of acute aortic dissection. However, most patients from the
      IRAD are Caucasian. These data were not sufficient to reflect clinical profiles and outcomes
      of Chinese patients with acute aortic dissection. In China, little is known about clinical
      features, managements and outcomes of acute aortic dissection involving a large number of
      patients. The investigators established clinical multicenter registry of acute aortic
      dissection. Between January 2009 and February 2012, about 2000 were enrolled in the Chinese
      registry of acute aortic dissection(CRAD) database. The aim of this study is to analyze
      clinical profiles and outcomes of Chinese patients with acute aortic dissection.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Chinese population suffering acute aortic dissection
      
Keywords: Aortic dissection; Risk factor; Feature; Management; Outcome
Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine
      maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy
      with bevacizumab + paclitaxel in ER+HER2- advanced or metastatic breast cancer.
    

Detailed description: 
      This multicenter, randomized Phase II study of patients with advanced or metastatic estrogen
      receptor-positive human epidermal receptor type 2-negative breast cancer aims to compare two
      treatment strategies following induction therapy with 4-6 cycles of the combined use of
      weekly paclitaxel (wPTX) and bevacizumab (BV). In arm A, wPTX+BV is continued, while in arm
      B, wPTX is switched to maintenance endocrine therapy (hormone+BV) until disease progression,
      followed by wPTX+BV re-induction. The primary endpoint is time to failure of strategy, which
      is the time from randomization to a qualifying event (addition of a new agent not in the
      primary regimen, progressive disease during or after planned therapy, or death).
    

Intervention name(s): Paclitaxel; Bevacizumab; Letrozole; Anastrozole; Exemestane; Fulvestrant; Goserelin; leuprorelin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Taxol; Avastin; Femara; Arimidex; Aromasin; Faslodex; Zoladex; Leuplin
Intervention MeSH terms: Paclitaxel; Bevacizumab; Letrozole; Fulvestrant; Anastrozole; Exemestane; Goserelin; Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects
Condition: Prolapse, Vaginal; Paravaginal Cystocele
MeSH terms: Cystocele; Uterine Prolapse; Prolapse
Study type: Interventional

Summary: 
      this study designed To evaluate the efficacy and outcomes of laparoscopic approach for repair
      of paravaginal defects associated with anterior vaginal wall prolapse.
    

Detailed description: 
      This prospective interventional study. designed to evaluate the efficacy and outcomes of
      laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall
      prolapse .fifty participants with cystocele of lateral type offered laparoscopic paravaginal
      repair. the investigator used a 10mm laparoscope, with video camera, was introduced through
      the umbilical trocar. Another 5 mm in suprapubic area and two 10 mm trocars in right and left
      lateral abdominal sides were introduced. The larger trocar was needed to accommodate the
      passage of needles into the abdomen. Spacing of trocars sufficiently from each other was
      needed to facilitate laparoscopic suturing. Transperitoneal approach to retropubic space was
      used. Two to four polypropylene sutures were applied on each side. Sutures were tied with
      intracorporeal . The study evaluated the following outcomes Operative time, intra-operative
      blood loss, hospital stay , post-operative urinary symptoms, post-operative pain, fever,
      haematuria, post-operative vaginal wall prolapse .
    

Intervention name(s): laparoscopic paravaginal repair
Intervention type(s): Procedure
Intervention description(s): Using a 10mm laparoscope, with video camera, was introduced through the umbilical trocar. Another 5 mm in suprapubic area and two 10 mm trocars in right and left lateral abdominal sides were introduced. The larger trocar was needed to accommodate the passage of needles into the abdomen. Spacing of trocars sufficiently from each other was needed to facilitate laparoscopic suturing. Transperitoneal approach to retropubic space was used. Two to four polypropylene sutures were applied on each side. Sutures were tied with intracorporeal technique
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment