bioihbjkbjnl/mcl2 huggingface dataset:
Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Effective post-surgical pain management is a crucial component of a patient's postoperative
      course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative
      analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse
      reaction risks. The colorectal, orthopedic and general surgery literatures have reported on
      an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute
      post-operative pain; however, literature regarding this medication specific to Urogynecology
      and Gynecology is limited.

      The investigators propose a prospective, randomized, double blind, trial with 120 subjects
      recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic
      to study postsurgical pain control after posterior repair. There will be two arms in the
      study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with
      Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing
      posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of
      plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.

      The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a
      visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have
      acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available
      for pain control regardless of assignment, which is the usual postoperative pain control
      regimen. The investigators hypothesize a 30% difference in post-operative pain measurements
      between the two groups.

      Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3
      and any post-operative voiding and defecatory dysfunction, comparing the two groups
    


Intervention name(s): Exparel plus plain bupivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy; 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
Other intervention name(s): extended release liposomal bupivacaine plus marcaine; marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
Condition: Hypertension; Blood Pressure, High
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if there is greater blood pressure reduction using
      ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.
    


Intervention name(s): Ramipril and hydrochlorothiazide
Intervention type(s): Drug
Intervention MeSH terms: Hydrochlorothiazide; Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hypertension; High Blood Pressure; Diuretic; Angiotensin converting enzyme inhibitor; Ambulatory blood pressure monitoring
Reproductive Hormones And Pre-Clinical Cardiovascular Disease (CVD) In Women
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      Heart disease is not just the number one killer of women, it is also a leading cause of
      disability. While it is generally believed that heart disease in women is a disease of old
      age, the stark reality is that heart disease is responsible for more deaths than breast
      cancer AT ALL AGES. Also, when young women develop heart disease, they are more likely to die
      or become disabled than their male peers. Identifying women at risk for heart disease is an
      important step toward reducing the impact of this disease.

      Although women can develop heart disease at any age, most women show signs and symptoms of
      disease about 10 years after men. For years, it has been thought that the reason for this lag
      is that women's hearts are protected by estrogen, and that when women go through menopause
      and lose their natural estrogen, they also lose their protection from heart disease. It has
      been assumed that if estrogen is replaced then protection will continue. These assumptions
      have not been proven. In fact, three large, randomized trials have shown no benefit from
      hormone replacement therapy in women known to have heart disease, and in fact have shown that
      hormone replacement may be harmful.

      To better understand the role of hormones and heart disease, the investigators propose to
      look at markers of heart disease in healthy women and compare this to their natural hormone
      levels. One of the markers known to be related to heart disease is carotid artery
      intima-medial thickness (c-IMT) which can be measured by creating an ultrasound picture of an
      artery in the neck. The investgators will use c-IMT scans and serum blood samples from women
      in the NIH-sponsored Los Angeles Atherosclerosis Study (LAAS), a large epidemiologic study
      that followed participants for 8 years. The proposed study will use risk factor information,
      serum samples and c-IMT scans collected from the female participants (about 269 women) over
      the 8 years of follow-up. The total sample size is 269 subjects, each of whom donated 3 blood
      specimens for the LAAS study. This research will examine those specimens (800 in total). It
      will also measure other markers of heart disease, including inflammation (hsCRP) and diabetes
      (insulin and glucose). All information has been obtained and there will be no need to collect
      additional information from participants nor additional blood specimens.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Women in LAAS Study
      
Keywords: Reproductive Hormones
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this phase III study is to compare the efficacy and safety of the
      fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether
      lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa
      and South East Asia.
    

Detailed description: 
      This is a multi-centre, comparative, randomised, (double-blind, double-dummy),
      parallel-group, non-inferiority study comparing the efficacy and safety of the fixed
      combination of PA with that of AL in the treatment of acute, uncomplicated P. falciparum
      malaria. The study population will include 1269 patients, comprising male and female children
      (≥20 kg body weight) and adults recruited from study sites in Africa and South East Asia.

      Patients will be randomised to receive either oral PA (180:60mg tablets) once a day plus
      AL-placebo (twice a day) for 3 consecutive days (Days 0, 1, and 2) or AL twice a day plus
      PA-placebo (once a day) for 3 consecutive days (Days 0, 1, and 2) in a 2:1 ratio. The dose
      range of PA covered by this regimen is 7.2:2.4 mg/kg to 13.8:4.6 mg/kg, respectively, which
      has been shown to be effective and safe in Phase I and II studies. Posology will be based on
      body weight ranges for both the PA and AL regimens.

      Patients will be confined to the study facility for ≥4 days (Days 0, 1, 2, and 3) and remain
      near the study site for ≥7 days, or once fever and parasite clearance has been confirmed for
      ≥24 hours - whichever occurs later.

      The primary efficacy end point for the study is the proportion of patients with PCR-corrected
      adequate clinical and parasitological response (ACPR) on Day 28. Scheduled follow-up visits
      will continue until completion of the study at Day 42. In the case of adverse events reported
      and unresolved at Day 42, patients will be followed up for a further 30 days, or until
      resolution of the event.
    

Intervention name(s): Pyronaridine artesunate; Coartem® (artemether lumefantrine)
Intervention type(s): Drug; Drug
Intervention description(s): Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2); AL (20:120mg tablets) twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)
Other intervention name(s): Pyramax; Coartem
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Pyronaridine; Pyronaridine tetraphosphate, artesunate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: malaria; antimalarial; artemisinin based combination therapy (ACT); P. falciparum; pyronaridine artesunate (Pyramax)
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules
Condition: Thyroid Nodule; Thyroid Diseases; Thyroid Gland; Node
MeSH terms: Thyroid Nodule; Thyroid Diseases
Study type: Interventional

Summary: 
      The study aimed to determine the best intervention between Core biopsy and Fine needle
      aspiration in diagnosis of thyroid malignancy.
    


Intervention name(s): FNB; Core biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): Fine needle aspiration from the nodules; Core biopsy from thyroid nodules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Thyroid nodule; Core needle biopsy; FNB
Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Our overall goal is to determine the effect of Phentermine and Topiramate ER on gastric
      emptying, gastric accommodation, satiety, and satiation in obese participants.
    

Detailed description: 
      Investigators propose a randomized controlled trial of combination phentermine topiramate ER
      versus placebo given orally for 10-15 days.

      At visit 1 subjects had a brief interview, body measurements, and completed 4 questionnaires
      to rule out any gastrointestinal or significant psychological distress.

      At visit 2 subjects did a satiation/nutrient drink test. They drank a nutrient drink until
      they reached the maximum volume that could be tolerated, symptoms were recorded and blood
      samples taken at 4 times. They were randomized to one of the arms, and received a 5 day
      supply of study medication or placebo. The dosing of the study drug was phentermine 3.75 mg /
      topiramate 23 mg days 1-5.

      At visit 3 subjects returned to pick up a nine day supply of study medication or placebo. The
      dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.

      At visit 4 subjects underwent imaging to measure the volume of their stomach with an external
      camera that revolved around abdomen while they were lying on a table. Stomach volume was
      checked during fasting, starting 10 min after an intravenous injection of a radioactive
      material. The subjects ingested more of the liquid nutrient drink and 2 more images were
      obtained over 30 minutes. On the same day, subjects participated in an all you can eat meal,
      starting 4 hours after the ingestion of the liquid nutrient drink.

      At visit 5 subjects repeated the satiation/nutrient drink test. They drank a nutrient drink
      until they reached the maximum volume that could be tolerated, symptoms were recorded and
      blood samples taken at 4 times.

      At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given
      a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small
      amount of radioactive substance. At the completion of the meal, subjects stood in front of a
      special camera and pictures were taken at specific intervals.
    

Intervention name(s): Phentermine-Topiramate ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.; Placebo pills matched the study drug in appearance for the 2 dose levels.
Other intervention name(s): Qsymia
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; BMI; Incretin; Satiety; Phentermine; Topiramate
Postoperative Pain After Root Canal Preparation Using Different Engine-driven Systems
Condition: Asymptomatic Molar Teeth With Periapical Lesions
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      A hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical
      lesion were included. For each patient, teeth were prepared with Reciproc Blue or Protaper
      Universal instruments. Each tooth was obturated with gutta-percha and resin-based sealer
      using single cone technique for mesial roots and for distal roots single cone and cold
      lateral compaction technique. Root canal treatment was performed in a single visit.
      Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours
      and 7 days after obturation.
    

Detailed description: 
      The aim of this study was to compare the effect of root canal preparation techniques on the
      occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar
      teeth with periapical lesions.A hundred twenty patients who had an asymptomatic mandibular
      molar teeth with periapical lesion were included. For each patient, teeth were prepared with
      Reciproc Blue or Protaper Universal instruments. Each tooth was obturated with gutta-percha
      and resin-based sealer using single cone technique for mesial roots and for distal roots
      single cone and cold lateral compaction technique. Root canal treatment was performed in a
      single visit. Postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24,
      48, 72 hours and 7 days after obturation.For the comparison of pain scores between the tested
      instrumentation systems, the Mann Whitney test was used. Differences between postoperative
      pain intencity for each instrumentation technique, at different time intervals, were assessed
      by the Friedman test. For the association of pain and an analgesic intake with gender, the
      chi-square test was performed. For the association of pain with age and an analgesic intake
      were calculated using Mann Whitney test. A P value < .05 or less was considered significant.
    

Intervention name(s): Protaper Universal instruments; Reciproc Blue instruments
Intervention type(s): Other; Other
Intervention description(s): Root canal treatment using Protaper Universal instruments; Root canal treatment using Reciproc Blue instruments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: one-visit root canal treatment,; engine-driven instruments,; asymptomatic molar teeth wtih periapical lesions
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of
      age) and after the complete 2, 4, 11 months schedule when co-administered with
      DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)
    

Detailed description: 
      Total anticipated: 300 subjects (150/group). 2-dose group - 10-valent pneumococcal vaccine +
      DTPa combined vaccine (2, 4, 11 months); Comparator group - 10-valent pneumococcal vaccine
      (2, 3, 4, 11 months) + DTPa combined vaccine (2, 4, 11 months). The Protocol Posting has been
      updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Intervention name(s): GSK Biologicals' 10-valent pneumococcal conjugate vaccine.; Infanrix hexa.; Infanrix-IPV/Hib.
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 3 or 4 doses (2-4-11 or 2-3-4-11 months of age schedule).; Intramuscular injection, 3 doses (2-4-11 months of age schedule).; Intramuscular injection, 3 doses (2-4-11 months of age schedule).
Other intervention name(s): DTPa-HBV-IPV/Hib; DTPa-IPV/Hib
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary vaccination; Pneumococcal disease; Safety; Booster vaccination; Immunogenicity; Pneumococcal vaccine; Dose comparison
Human Papillomavirus (HPV) Infection in Pregnancy
Condition: Papillomavirus Infections; Pregnancy Complications
MeSH terms: Infections; Papillomavirus Infections; Pregnancy Complications
Study type: Observational

Summary: 
      The purpose of this study is to determine if maternal infection with human papillomavirus
      (HPV) is associated with pregnancy complications including spontaneous preterm delivery
      (sPTD), severe preeclampsia (PE), and poor fetal growth.
    


Observational model: Cohort
Time perspective: Prospective
Keywords: HPV; Pregnancy
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO
Condition: ARDS; Acute Lung Injury; Extracorporeal Membrane Oxygenation; Respiratory Distress Syndrome; Respiratory Tract Diseases; Lung Diseases; Lung Injury, Acute
MeSH terms: Lung Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Lung Injury; Acute Lung Injury; Respiratory Tract Diseases; Wounds and Injuries
Study type: Interventional

Summary: 
      The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory
      failure, presented in 10% of all intensive care patients and carrying a high mortality rate.
      Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe
      ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not
      clearly defined at the moment.
    

Detailed description: 
      The aim of this study is to assess the effect of a rigorous low breathing frequency and
      ultra-low tidal volume ventilation strategy on clinical outcome, compared to standard
      ventilator settings following the recent guidelines in patients with severe ARDS treated with
      ECMO.

      The hypothesis is that a low breathing frequency and ultra-low tidal volume ventilation
      strategy is more protective for the ARDS challenged lung and reduces the duration of
      mechanical ventilation and so increases the ventilator free days in patients with severe ARDS
      treated with ECMO.
    

Intervention name(s): Ultra-protective ventilator settings; Standard ventilator settings
Intervention type(s): Other; Other
Intervention description(s): 4-5 Breaths per minute; 14-16 cmH2O Positive endexpiratory pressure (PEEP) (adjust PEEP to 23 < Plateau pressure < 25 cmH2O); 23-25 cmH2O Plateau pressure (adjust to not exceed Tidal volume > 4 mL/kg Predicted body weight (PBW)); < 4mL/kg PBW Tidal volume; 1:5 Inspiration:Expiration (I:E); 12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of 2 groups
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ARDS, ECMO, Ventilation
Study Of Factors Favoring The Onset Of Novo Atrial Fibrillation In The Immediate Aftermath Of Coronary Artery Bypass Surgery
Condition: Coronary Artery Bypass Graft With or Without ECC
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Before la surgery:

      Transthoracic cardiac echography will be done systematically, to measure among other things
      the size of the left atrium.

      During surgery:

      Surgery under extracorporeal circulation: tissue samples will be harvested from the right
      atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before
      declamping of the aorta (T1= post-ischemia sample).

      Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG
      (T0) and a second sample after CABG (T1).

      In parallel with the harvesting of cardiac tissue, blood samples will be taken at different
      times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the
      anesthetists.

      After the surgery:

      Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an
      observation notebook. The biological samples will be analysed immediately and the biological
      data obtained will be recorded in the observation notebook.
    


Intervention name(s): Tissue samples from the right atrium; Blood samples
Intervention type(s): Other; Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Coronary artery bypass graft with or without extracorporeal circulation