bioihbjkbjnl/mcl2 huggingface dataset:
TAP Block vs LAWI for Analgesia Post-cesarean Section
Condition: Obstetric Pain; Obstetric Anesthesia Problems
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Adequate pain control after cesarean delivery is a significant concern both for parturients
      and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound
      infiltration with anesthetics are alternatives for reducing the severity of pain, total
      analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are
      superior to placebo; however, it is unknown which provides better analgesia after cesarean
      delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the
      TAP block would decrease postoperative pain and postoperative cumulative opioid consumption
      at 24 hours
    


Intervention name(s): Transversus Abdominis Plane Block; Local anesthetic wound infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.; 40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: transversus abdominis plane. VAS; visual analogue score; wound infiltration; cesarean section; postoperative pain; analgesia
Biological Potency of the Cat Epithelial Allergenic Extracts
Condition: Cat Allergy (Disorder)
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this clinical trial is to quantify the loss of in vivo biological
      potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the
      native allergenic extract (N).
    

Detailed description: 
      This is an open-label, non-randomized phase II clinical trial.

      Three different concentrations of three different cat epithelial allergenic extracts,
      together with a positive and negative control, using 10 mg/ml histamine dihydrochloride and a
      glycerated phenol saline solution, respectively, will be tested in every subject on the volar
      surface of the forearm.
    

Intervention name(s): 1 (Dose Response Skin Prick Tests)
Intervention type(s): Biological
Intervention description(s): 3 different cat epithelium allergenic extracts at 3 different concentrations, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Immunotherapy; Subcutaneous immunotherapy; Skin Prick Test; Dose Response Prick Test
Three Anxiolytic Drugs Used in Third Molar Surgery
Condition: Dental Anxiety; Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina
      mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of
      asymptomatic, impacted mandibular third molars.
    

Detailed description: 
      In this research, characterized as a randomized, double-blind, parallel study, 200 healthy
      volunteered patients aging 18 or older will be distributed into 4 groups (n=50) as follows:
      Group I - 500mg Erythrina mulungu; Group II - placebo; Group III ; 100 mg Passiflora
      incarnata; Group IV - 15 mg midazolam. All treatments will be administered p.o. 1 hour
      randomly prior to the surgical procedures. The level of anxiety will be assessed through
      questionnaires and physical parameters, such as blood pressure, heart rate and oxygen
      concentration in three periods: at baseline, right before the surgical procedures and after 7
      days. Data will be collected, tabulated and analyzed by the following statistical tests:
      chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's exact test with significance
      level of 5%.
    

Intervention name(s): Mulungu; Placebo; Passiflora incarnata; midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 500 mg/single dose/1 hour before dental surgery; 500 mg/single dose/1 hour before dental surgery; 100 mg/single dose/1 hour before dental surgery; 15 mg/single dose/1 hour before dental surgery
Other intervention name(s): Mulungu Matusa, Erytrina mulungu; Dormonid
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Third molar surgery; Blood pressure; Heart rate; Oxygen saturation
Subclinical Cardiovascular Disease in Psoriatic Disease
Condition: Cardiovascular Diseases; Myocardial Infarction; Atherosclerotic Cardiovascular Disease; Thrombotic Vascular Disease
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Vascular Diseases; Atherosclerosis; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will look at how chronic inflammation seen in psoriatic disease translates into
      the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk.
      The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic
      disease and measures of vascular function. 2) Evaluate the association between moderate to
      severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional
      medications used in cardiovascular disease (CVD) prevention such as aspirin and statins
      affect vascular function and thrombotic risk in those with moderate to severe psoriatic
      disease.
    

Detailed description: 
      Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable
      risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of
      CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate
      who to treat with primary prevention measures but do not take into account patient-specific
      disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which
      predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of
      atherosclerotic heart disease and myocardial infarctions compared to matched controls.
    

Intervention name(s): Aspirin and/or Atorvastatin
Intervention type(s): Drug
Intervention description(s): This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
Intervention MeSH terms: Aspirin; Atorvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiovascular disease; CVD
Comparison of Different Fluence Settings for Yellow Subthreshold Laser Treatment in Diabetic Macular Edema
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Observational

Summary: 
      To assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC))
      compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave
      (CW) laser
    

Detailed description: 
      Test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and
      perform laser with various DC (5%, 15%, cw) as per the group.

      Focal to Mas+ confluent burns to areas of diffuse leakage
    

Intervention name(s): Laser
Intervention type(s): Procedure
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Asian
Kinematics in Posterior Cruciate Retaining and Bi-Cruciate Retaining Total Knee Replacements
Condition: Arthroplasty, Replacement, Knee; Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Observational

Summary: 
      The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who
      were implanted with the Smith & Nephew Journey II posterior cruciate retaining (PCR) total
      knee arthroplasty (TKA) or Journey II bi-cruciate retaining (BCR) TKA. CMR has previously
      collected data for the Smith & Nephew BCS TKA and compared these kinematics data to those of
      normal knees.
    

Detailed description: 
      The objective for this study is to analyze the in vivo kinematics for subjects implanted with
      either a Journey II PCR or BCR TKA and compare those patterns to subjects having a normal
      knee from our previous study and to those patterns from subjects having a Smith & Nephew
      Journey II BCS TKA.
    

Intervention name(s): Journey II posterior cruciate retaining total knee arthroplasty; Journey II posterior bi-cruciate retaining total knee arthroplasty
Intervention type(s): Device; Device
Other intervention name(s): Journey II PCR TKA; Journey II BCR TKA
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients implanted with a Smith & Nephew Journey II posterior cruciate retaining (PCR) or a
        Smith & Nephew Journey II bi-cruciate retaining (BCR) total knee arthroplasty (TKA)
        implanted by Dr. Harold E. Cates.
      
Keywords: total knee arthroplasty
Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of
      exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six
      months the pharmacological treatment will be associated to rehabilitation treatment.

      The main hypothesis is that GH can improve motor function of patients with traumatic spinal
      cord injury below the lesion level. The hypothesis is based on possible effects of GH at
      muscle and synaptic level. GH can also promote axonal growth and regeneration.

      Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by
      third parties and blinding in the analysis of data (triple-blind design).

      Duration of intervention and monitoring: 364 days.

      Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale
      (motor score)
    


Intervention name(s): GH; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year; Administration of a subcutaneously injected daily dose of placebo for 1 year
Other intervention name(s): Genotonorm; Provided by the Genotonorm producer (Pfizer)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Growth Hormone; Trauma; Incomplete; ASIA
Intrathecal Mg in Gynecologic Laparoscopic Surgeries.
Condition: Gynecologic Laparoscopic Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg
      sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative
      pain in gynecologic laparoscopic surgeries.
    

Detailed description: 
      The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg
      sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction
      and postoperative pain in gynecologic laparoscopic surgeries.
    

Intervention name(s): intrathecal Mg sulfate.; intrathecal bupivacaine 15 mg.
Intervention type(s): Drug; Drug
Intervention description(s): intrathecal Mg sulfate 50 mg.; intrathecal bupivacaine 15 mg.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Escalating Doses of GSK1325756 Solution for Infusion, and Absolute Bioavailability Relative of an Oral Dose, in Healthy Adult Subjects
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be the first time GSK1325756 Solution for Infusion formulation that has been
      administered to humans. Prior studies have been performed with oral GSK1325756. The primary
      objectives of this study are to obtain information on the safety, tolerability, and
      pharmacokinetics (PK) of single and twice daily intravenous (IV) administration of GSK1325756
      in healthy subjects. In Part A, single, escalating doses will be given in the same cohort of
      subjects after a seven day washout. In addition, the study will evaluate the absolute
      bioavailability of a single dose of the current oral tablet formulation as compared to the IV
      formulation in Part A. In Part B, twice daily (BID) intravenous dose administration will be
      given for 5 days (9 total doses) in two separate cohorts of subjects. Data from this study
      will provide understanding of the safety, tolerability, and PK of intravenously administered
      GSK1325756 twice daily to guide dose selection in future clinical studies in patients with
      viral respiratory tract infections
    


Intervention name(s): GSK1325756 Solution; GSK1325756 Solution Matching Placebo; GSK1325756 Tablet; GSK1325756 Tablet Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Solution containing 2 mg/mL GSK1325756 in sterile water for injection, to be administered intravenously.; Solution containing sterile water for injection matching GSK1325756 solution, to be administered intravenously.; A white film coated tablet containing 50 mg GSK1325756 to be administered orally.; A white film coated tablet matching GSK1325756 tablet, to be administered orally.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK1325756; Safety; Bioavailability; Pharmacokinetics
Spices Inhibit the Formation and Absorption of Malondialdehyde From Hamburger Meat
Condition: NIDDM
Study type: Interventional

Summary: 
      Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly,
      in response to biotic or abiotic stresses such as infections, wounding, UV irradiation,
      exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that
      the molecular basis for the protective action of polyphenols in plants is their antioxidant
      and free radical scavenging properties. These numerous phenolic compounds are major
      biologically active components of spices, aromas, essential oils, and traditional medicines.
      In order to investigate the impact of spice polyphenols on postprandial cytotoxic lipid
      peroxidation products (MDA) levels in humans, the investigators propose to achieve the
      following specific aims using a randomized crossover study design:

        1. To determine the effect of a ground beef patty meal with and without spices on
           postprandial levels of plasma malondialdehyde (MDA).

        2. To determine the effect of a ground beef patty meal with and without a spice blend on
           MDA accumulation in urine.

      This study will determine whether spice polyphenols exert a beneficial effect by inhibition
      of the absorption of MDA. These findings may help to explain the potentially harmful effects
      of oxidizable fats found in foods and the important benefit of dietary polyphenols in
      ameliorating this potentially harmful effect.
    

Detailed description: 
      10 male subjects with type 2 diabetes mellitus who will be recruited based on inclusion and
      exclusion criteria. The study will be carried out in accordance with the guidelines of the
      Human Subjects Protection Committee of the University of California, Los Angeles. All
      subjects will give written informed consent before the study begins. After the screening
      visit, each subject will come to the Center for Human Nutrition on two 1-day test phases
      separated by at least one week. At each of phases, subjects will consume, in a random order,
      two different test meals consisting of either: a) a ground dark meat beef patty seasoned with
      salt only, or b) a ground dark meat beef patty seasoned with a spice mixture and salt. The
      subjects will be asked to avoid eating meat, poultry, or fish products for 3 days before the
      day of each of the two experimental phases
    

Intervention name(s): Hamburger meat patty with salt; Hamburger meat patty with spice blend
Intervention type(s): Other; Other
Intervention description(s): hamburger meat cooked with salt; hamburger meat cooked with spice mixture
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: MDA; Spice
Antibody and Safety Study of 6 Doses of NicVAX in Smokers
Condition: Smoking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for
      anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule
      so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether
      changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating
      antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1
      adds a 6th dose at week 26, and extends follow-up through week 52.
    


Intervention name(s): 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
Intervention type(s): Biological
Intervention description(s): 1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)
Other intervention name(s): NicVAX
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nicotine; Vaccine; Immunogenicity; Tobacco; Habits
Airway Management With Supraglottic Devices in Unruptured Intracranial Aneurysms
Condition: Airway Management
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      Endovascular techniques for the treatment of intracranial aneurysms are growing.
    

Detailed description: 
      Retrospective analysis of the investigators experience in the last 8 years with the airway
      management in endovascular therapy for unruptured aneurysms. A total of 206 participants will
      be included from 2010 to 2018. Airway management (anticipated difficult airway, need for LM
      repositioning, orotracheal intubation because of failed laryngeal mask insertion, airway
      complication), intraoperative monitoring, aneurism size and location, intraoperative and
      perioperative complications will be registered.

      Statistics will be compared between groups with t test or x test, as appropriate.
    

Intervention name(s): supraglottic device
Intervention type(s): Device
Intervention description(s): airway management will be collected
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent endovascular treatment for unruptured aneurysm in the past 8 years
        in our institution
      
Keywords: supraglottic devices
A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip
Condition: Chronic Pain
MeSH terms: Osteoarthritis; Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness of multiple doses of once daily
      tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe
      pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the
      treatment of patients with moderate to severe pain due to OA.
    

Detailed description: 
      Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions
      including: obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short
      elimination half-life of tramadol IR necessitates every 4-6 hour dosing to maintain optimal
      levels of analgesia in chronic pain. The study medication in this study is a once-daily,
      extended-release tramadol formulation. This is a 12-week multi-center, double-blind,
      randomized, dose-ranging, parallel-group, fixed-dose, placebo-controlled study. Patients with
      OA Functional Class I-III of the knee or hip (index joint) are eligible for participation, if
      appropriate criteria are met. During a 2-7 day washout period, the use of all analgesic
      medications will be discontinued. Eligible patients experiencing moderate to severe pain
      (<=40 mm on a 100 mm visual analog scale) in the index joint to be evaluated and who meet all
      other study criteria will enter in a 2-week,double-blind titration period. During this
      period, patients will be randomly assigned to receive treatment with tramadol HCl ER 100 mg,
      200 mg, 300 mg, 400 mg or placebo, once a day. Patients will be titrated to their assigned
      dose between study days 1 - 15 and will continue at that dose for the remainder of the study
      (Week 12). Efficacy and safety evaluations will be collected at study visits occurring at
      Weeks 1, 2, 3, 6, 9 and 12 or at early termination. Study medication will be discontinued at
      Week 12 and patients will return after 1 week for a post-treatment visit (Week 13). Patients
      with unmanageable pain or with unacceptable side effects will be discontinued from the study
      and alternate analgesic therapy initiated, as appropriate.
    

Intervention name(s): Tramadol HCl ER
Intervention type(s): Drug
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: osteoarthritis pain; knee; hip; extended-release analgesia; opioid