bioihbjkbjnl/mcl2 huggingface dataset:
Intraoperative Analgesia Based on ANI
Condition: Pain Monitoring; Pain Assessment; Opioid Consumption
Study type: Observational [Patient Registry]

Summary: 
      Osteoarthritis of the knee joint is common and total knee arthroplasty (TKA) is performed in
      patients with advanced joint degeneration, no response to conservative treatments, severe
      pain and joint instability. Severe pain levels between 4 and 8 in visual analog pain scale
      (VAS) scores have been reported in the postoperative period. Multimodal analgesia is
      considered to be the best option for pain control after total knee arthroplasty. Multimodal
      analgesia is defined as the combined use of different analgesia techniques such as neuraxial
      analgesia, peripheral nerve blocks, patient-controlled analgesia and different analgesic
      drugs. For this purpose, peripheral nerve blocks are effectively applied as a component of
      multimodal analgesia. Thus, side effects such as nausea, vomiting, pruritus and sedation that
      may occur due to opioid use are reduced. At the same time, in addition to providing effective
      analgesia, peripheral blocks contribute to early initiation of rehabilitation of the knee
      joint, early ambulation, reduction of pulmonary complications and early discharge from the
      hospital.

      Recently, objective methods such as skin vasomotor reflex analysis, pupilometry, pulse
      plethysmographic signals and analgesia nociceptive index (ANI) have been used to standardize
      the need for intraoperative analgesia in patients under general anesthesia. Among these
      methods, ANI is a non-invasive method that provides continuous measurement of parasympathetic
      tone, which is a part of the autonomic nervous system. Electrodes are placed on the chest
      wall on both sides of the heart and the patient is monitored.

      The investigators aimed to compare the analgesia nociception index (ANI) and the conventional
      method to determine perioperative analgesic needs in patients undergoing total knee
      arthroplasty under general anesthesia with femoral nerve block.
    


Intervention name(s): Analgesia nociception index
Intervention type(s): Device
Intervention description(s): a device to assess patient's pain during surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18-75 years old, ASA I-II-III risk group, undergo knee operation under general anesthesia
      
Keywords: Analgesia nociception index; opioid consumption; Pain management
A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
Condition: Clostridium Difficile Associated Diarrhea (CDAD)
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single
      oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males
      and females.
    


Intervention name(s): Surotomycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules; A single oral dose of placebo for surotomycin in hard gelatin capsules
Other intervention name(s): CB-183,315
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting Study
Condition: Healthy
Study type: Interventional

Summary: 
      This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg
      delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent
      to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy
      Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of
      Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of Wyeth
      Pharmaceuticals Inc., USA in healthy, adult, human, male subjects under fasting
      conditions.condition.
    

Detailed description: 
      The study was an open-label, balanced, randomized, two-treatment, two-period, two-sequence,
      single-dose, crossover, bioequivalence under fasting condition.

      A washout period of 04 days was enforced between the administrations of study drugs in each
      period.. At study check-in, the subjects reported to the clinical site at least 36 hours
      prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample
      collections were obtained within 90 minutes prior to dosing (0 hour) and after dose
      administration at periodic interval up to 24.00 hour in each period. A total number of blood
      draws during the study were fifty-four (54) and the total volume of blood drawn did not
      exceed 274 mL.

      Following an overnight fast of at least 10 hour, a single oral dose of Pantoprazole sodium
      delayed release tablets 40 mg of either test or reference drug product was administered
      during each period of the study, along with 240 mL of drinking water at ambient temperature
      under low light condition and under supervision of trained study personnel. Both test and
      reference drug products were administered to all the study subjects one in each period
    

Intervention name(s): Pantoprazole; Pantoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Pantoprazole 40mg Delayed release tablets (Test Product); Protonix® Delayed Release 40 mg tablets (Reference product)
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series
      in Healthy Infants
    


Intervention name(s): 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase
      inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction
      and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled,
      parallel-group study to assess the impact of dutasteride treatment on sexual function as well
      as subject satisfaction with hair growth and quality of life in men with AGA. This study will
      consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks,
      and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of
      double-blind, placebo controlled treatment and 24 weeks of open-label treatment with
      dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a
      change in erectile function at the end of treatment.
    


Intervention name(s): Dutasteride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of dutasteride to be administered orally.; Dutasteride matching placebo will be supplied as capsules to be administered orally.
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: quality of life; safety; sexual function; male pattern hair loss (MPHL); Androgenic alopecia (AGA); dutasteride; satisfaction with hair growth
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      There has been an increased interest in the association between ADHD and sleep disorders over
      the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been
      identified in ADHD children regardless of whether or not they are receiving stimulant
      therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD
      associated insomnia.
    

Detailed description: 
      The study is being conducted in the United States. It consists of 3 segments:

        -  Segment A: 2 to 21 day screening period

        -  Segment B: 8-week double-blind treatment period

        -  Segment C: 1-week follow-up period

      Subjects will have a polysomnography in a sleep lab two times during the study (at baseline
      and between visit 4-5) and also be required to wear an actigraphy monitoring tool. There will
      be several questionnaires completed throughout the study: CGI-child, CGI-parent/legal
      guardian, ADHD Rating Scale-IV, and the Pediatric Daytime Sleepiness Scale.
    

Intervention name(s): Zolpidem (SL800750)
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Child Psychology; Pediatric Psychology; Insomnia; Sleeplessness
Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab
      (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute
      Myeloid Leukemia (AML) in first complete remission
    


Intervention name(s): IPH2102 at 0.1 mg/kg; IPH2102 at 1 mg/kg; Placebo (normal saline solution)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): every 3 months; every 4 weeks; every 4 weeks
Other intervention name(s): lirilumab/BMS986015; lirilumab/BMS986015; normal saline solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability of Fatty Acids From Krill Oil and Krill Meal and Fatty Acids From Fish Oil in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare the acute bioavailability of two different krill oil
      products called krill oil and krill meal in comparison to fish oil product.
    


Intervention name(s): Krill oil; Krill meal; Fish oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Krill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration; Krill meal, granular meal from Antarctic krill, per oral, targeted daily n-3 PUFA dose of 1 700 mg, single administration; Fish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pelvic Binder vs. Pelvic C-clamp for Bleeding Control
Condition: Pelvic Ring Fracture; Pelvic Bleeding; Polytrauma
MeSH terms: Hemorrhage; Fractures, Bone; Multiple Trauma
Study type: Observational

Summary: 
      Pelvic ring fractures carry a high risk for severe bleeding. Expecially bleeding from the
      posterior ring might result in a fatal course. Different types of external emergency
      stabilization (EES) are available for the posterior pelvic ring, namely the non-invasive
      pelvic binder or the invasive pelvic c-clamp. Which stabilization technique is superior, has
      not been investigated yet.
    

Detailed description: 
      Severe bleeding is the major cause of death in unstable pelvic ring fractures. Therefore, a
      quick and efficient emergency stabilization and bleeding control is inevitable. The pelvic
      C-clamp and the pelvic binder are efficient tools for temporary bleeding control, especially
      for the posterior pelvic ring. However, whether these disadvantages make up for a more
      efficient bleeding control, still needs to be discussed in the guidelines of the emergency
      management of pelvic ring fractures.

      Patients with a type-C pelvic ring fracture were identified from the German Pelvic Registry
      (GPR). The patients were divided into three groups of 40 patients: 1. group without emergency
      stabilization, 2. group treated with pelvic binder and 3. group treated with pelvic C-clamp.
      The patients were matched according to the following parameters: age, gender, initial RR and
      HB level. The complication rates and mortality rates were compared between the groups,
      especially regarding bleeding control, as measured by the amount of transfused blood
      products. Furthermore, the subjective efficacy of the treatment was assessed. Finally, the
      time until established bleeding control was compared.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a Type-C pelvic ring fracture and an abdominal ISS >8 are identified from the
        German Pelvic Registry.

        Cases in which the external emergency stabilization was not specified were left included.
        The remaining cases were divided into the different treatment groups:

          1. Patients who received no external emergency stabilization.

          2. Patients who were treated with a pelvic binder.

          3. Patients who were treated with a C-clamp.

        Age, gender, the initial HB level and the initial blood pressure were used to match the
        cases of the three groups.
      
Keywords: Pelvic binder; Pelvic C-clamp; Pelvic ring fracture; Fatal pelvic bleeging; Emergency stabilization
G7 Acetabular System vs. Exceed ABT Acetabular System in THA
Condition: Osteoarthritis Arthritis; Rheumatoid Arthritis
MeSH terms: Arthritis; Osteoarthritis
Study type: Interventional

Summary: 
      Evaluate the safety and effectiveness of patients who received G7 Acetabular system in
      conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem
      compared to patients who received the Exceed ABT Acetabular system with the same combination
    

Detailed description: 
      This study will be a multi-center randomized controlled study. Eligible patients will be
      randomly assigned to receive a combination of G7 Acetabular system with CoC articulation and
      Taperloc Complete Microplasty stem or Exceed ABT Acetabular system with CoC articulation and
      Taperloc Complete Microplasty stem. Patient demographics, preoperative clinical outcomes,
      operative information, postoperative clinical outcome, radiographic assessment, incidence of
      squeaking, incidence of dislocation, implant survivorship and adverse events will be
      collected prospectively.
    

Intervention name(s): G7; Exceed ABT
Intervention type(s): Device; Device
Intervention description(s): The Biomet G7™ Acetabular System has been designed to provide more options to surgeons for treatment of patients needing total hip arthroplasty, while concurrently simplifying the surgical process with well-designed, modular components and corresponding instruments. The G7™ Acetabular System includes three liner types; ArComXL highly-crosslinked or E-1 Vitamin E-infused polyethylnene and a Biolox Delta (Ceramtec, Plochingen, Germany) ceramic liner.; The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: G7 Acetabular System
Diabetes Prevention in Clinical Practice.
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      We randomize individuals with impaired glucose tolerance to one of three arms for degree of
      physical activity: 1. Continue with your current life style; 2. Ordinary life activities for
      increased physical activity; 3. Scheduled group activities for changed behavior. The overall
      aim is to focus on change of physical activity and to keep other life style activities more
      or less unchanged (diet, smoking, etc) and the effect on metabolic variables.
    


Intervention name(s): Low intensity intervention; High intensity intervention.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): We administer, a pedometer and the participants receive a prescription on physical exercise.; We schedule group sessions for changes in behavior e.g. type of physical activity to prefer, barriers for change of life style etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; insulin resistance; exercise
A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in
      healthy volunteers
    


Intervention name(s): 100mcg; 500mcg; 1000mcg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100mcg '719; 500mcg '719; 1000mcg '719; Placebo '719
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; New formulation
Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Condition: Major Depressive Disorder With Mixed Features
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with
      mixed features.This clinical study is designed to test how well Lurasidone works to treat
      major depressive disorder with mixed features.
    


Intervention name(s): Lurasidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20, 40, 60 mg, flexible dose, once daily PM 6 weeks; Placebo
Other intervention name(s): Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; Lurasidone; Latuda
Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture
Condition: Aphakia Due to Trauma; Eye; Rupture, Traumatic, With Loss of Intraocular Tissue; Aniridia
MeSH terms: Aphakia; Aniridia; Rupture
Study type: Observational

Summary: 
      Purpose: To assess long-term outcomes of implantation of black diaphragmintraocular lens (BD
      IOL) in postraumatic aniridia and aphakia due to eye rupture.

      METHODS: This is retrospective consecutive case series of 14 eyes with post-traumatic
      complete aniridia and aphakia treated withscleral fixation of BD IOL with. Measurements
      included ophthalmological comorbidities, best corrected visual acuity (BCVA), complications,
      and postoperative interventions. The average postoperative follow-up period was 36 months.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive patients
      
Keywords: aphakia; black diaphragmintraocular lens; eye rupture; aniridia
Comparative Effect of Theipoental and Propofol in IVF Outcome
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the aim is to compare the effect of the type of anaesthetic drug used during
      oocyte retrieval on fertilization rates of oocytes retrieved after ovarian stimulation for
      in-vitro fertilization.
    


Intervention name(s): Propofol; Thiopental
Intervention type(s): Drug; Drug
Intervention description(s): Propofol intravenous infusion for introduction and maintance of anaesthesia at doses 3-5mg depending on the total time needed for completion of oocyte retrieval; Patients will receive thiopental in addition to fentanyl for introduction and maintanance of anaesthesia at doses 7mg. IF required patients will receive a repeat dose of 1-3mg of thiopental depending on the totla time needed to complete oocyte retrieval
Intervention MeSH terms: Thiopental; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment