bioihbjkbjnl/mcl2 huggingface dataset:
Anesthetic Cost Analysis With Desflurane in Automated Gas Control Mode
Condition: Safety Issues
Study type: Observational

Summary: 
      Inhalation agents constitute the major part of anesthetic drug costs (20% - 25%) and a
      significant portion of the applied inhalation agents are thrown into the atmosphere through
      the waste gas system without being absorbed by the patient. The amount of waste gas is
      directly correlated to the fresh gas flow (FGF). Reducing the TGA during general anesthesia
      reduces the consumption of inhalant agents and contributes to the reduction of greenhouse gas
      pollution. Risks such as hypoxia, hypercapnia, inadequate depth of anesthesia and potential
      toxic gas accumulation were associated with low flow anesthesia, but the patient was provided
      with adequate safety by following pulse oximetry, capnography, FiO2 and anesthetic gas
      analysis. We aimed to perform anesthetic cost analysis and patient security in automated gas
      control mode (AGC).
    

Detailed description: 
      After the ethical approvel 60 adult patients scheduled for hepatectomy will be taken to
      study. Patients will be monitored after they are taken to the operating room (ECG, NIBP,
      SpO2, Body Temp, BIS, NIRS, PVI, PI, ORI). After the anesthesia induction and tarakeal
      entubation, first twenty patient will take 300 mL fresh gas flow with AGC mode (group 1),
      Second twenty patient will take 600 mL fresh gas flow with AGC mode (group 2), third twenty
      patient will take 600 mL fresh gas flow with manually. Hemodynamic and gas consumption data
      will be recorded. An operating room will be reserved for this study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing hepatectomy operation
      
Keywords: Low flow anesthesia; Desflurane; Cost analysis; Automated gas control
Treatment of Alcohol Dependence and Comorbid Bipolar Disorder
Condition: Alcohol Dependence; Bipolar Disorder; Depression; Mania; Psychosis
MeSH terms: Mania; Alcoholism; Depression; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will determine if individuals with co-occurring bipolar disorder and alcohol
      dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive
      performance if treated with lamotrigine plus their usual mood stabilizing medications
      relative to subjects treated with placebo plus usual mood stabilizing medications over a 16
      week period.
    


Intervention name(s): Lamotrigine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks; Placebo once daily for 12 weeks
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alcohol; Bipolar Disorder; Manic depression; Addiction; Alcoholism; Cognitive impairment; Executive function; Anxiety; Depression; Mania; Affective disorder; Psychosis; Carbohydrate deficient transferrin; Gammaglutamyltransferase; California Verbal Learning Test; Montgomery Asberg Depression Rating Scale; Young Mania Rating Scale; Timeline Follow Back
Mass Balance Study of FYU-981
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites
      of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.
    


Intervention name(s): 14C-FYU-981
Intervention type(s): Drug
Intervention description(s): 14C-FYU-981, (Oral single dosing)
Intervention MeSH terms: Dotinurad
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mass balance
Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation
Condition: Healthy
Study type: Interventional

Summary: 
      This is a placebo-controlled study conducted to investigates the safety and efficacy of
      products containing marine collagen peptide and CoQ10 in enhancing skin rejuvenation of
      Malaysian women. The study duration is 28 days and the skin assessment will be carried out at
      baseline, Day 14 and Day 28.The main questions it aims to answer are:

        1. The effect of product on skin hydration of women in Malaysia.

        2. The effect of product on skin elasticity of women in Malaysia.

        3. The effect of product on skin wrinkle of women in Malaysia.

        4. The skin brightening effect of product on Malaysian women.

        5. To observe any adverse effect occurrence with the consumption of the product.
    


Intervention name(s): Placebo; Product containing marine collagen peptide and Coenzyme Q10.
Intervention type(s): Other; Other
Intervention description(s): Product doesn't have active ingredients i.e. marine collagen peptide and Coenzyme Q10.; Product containing marine collagen peptide and Coenzyme Q10.
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of
      JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in
      healthy Japanese adult male participants in Part 2.
    

Detailed description: 
      This is a double-blind (neither physician nor participant knows the treatment that the
      participant receives), randomized (the study drug is assigned by chance), placebo-controlled
      study (placebo is an inactive substance that is compared with a drug to test whether the drug
      has a real effect in a clinical trial). The study consists of 2 Parts. In Part 1, three
      groups of healthy Japanese men and 3 groups of healthy Caucasian men will receive a single
      oral dose of JNJ-39439335 or placebo on Day 1. Each group will include 8 participants. The
      study duration of Part 1 for each participant is approximately 8 weeks: screening phase of up
      to 28 days prior to dose, treatment phase of 14 days, and a follow-up phase of 14 to16 days.
      In Part 2, three groups of healthy Japanese men will receive once-daily doses of either
      JNJ-39439335 or placebo for 21 days. Each group will include 12 participants. The study
      duration of Part 2 for each participant is approximately 11 weeks: screening phase of up to
      28 days prior to dose, treatment phase of 21 days, and a follow-up phase of approximately 28
      days. During the treatment phases, the participants will remain in the study unit. Blood
      samples and urine will be collected for drug concentration measurements and laboratory safety
      assessments.
    

Intervention name(s): JNJ-39439335 10 mg; JNJ-39439335 25 mg; JNJ-39439335 50 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.; Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.; Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.; Multiple (once daily for 21 days) oral doses of matching placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-39439335; Japanese; Caucasian; Male
Ball Exercises and Stereotypic Behavior in Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Autism spectrum disorder (ASD) is a neuro-behavioral disorder associated with repetitive
      movements. The role of physical therapist towards an autistic child is most neglected one.
      Therefore, the objective of this study was to see the effectiveness of different ball
      exercise on stereotypic behavior of children with ASD. Different ball exercises were
      implemented for 2 months, 3 sessions per week and every session consist of 35 minutes.
    


Intervention name(s): Ball Exercises
Intervention type(s): Procedure
Intervention description(s): Different ball exercises which include stability ball roll, stability ball hug, catching, throwing was performed. Along with these exercises, ball tapping exercise was also performed. Exercises were performed with 55 and 65 inch gym ball and a small regular plastic ball.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: ball exercises; physical therapy
Pregnancy & Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 (Study 38827)(P06056)(COMPLETED)
Condition: Pregnancy; Neonates
Study type: Observational

Summary: 
      The objective of this trial was to evaluate whether Org 36286 treatment for the induction of
      multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro
      fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant
      subjects and their offspring.
    

Detailed description: 
      This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal
      outcome of women who became pregnant during Trial 38826. For this trial, no study specific
      assessments were required, but information obtained in standard practice was used.
    

Intervention name(s): Org 36286; recFSH
Intervention type(s): Drug; Drug
Intervention description(s): single dose of 60, 120, or 180 μg Org 36286 (experimental group administered under protocol 38826); 150 IU recFSH daily (reference group administered under protocol 38826)
Other intervention name(s): Corifollitropin alfa; Follitropin Beta, Puregon®, Follistim®
Intervention MeSH terms: Follicle Stimulating Hormone
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38826 were
        enrolled in this trial.
      
Keywords: Neonatal outcome; Congenital malformations; In-Vitro Fertilization; Controlled ovarian stimulation; Follow-up
The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II
      patients were recruited for a randomised, placebo-controlled, double-blind study and were
      randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B;
      n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C; n=30).
      Scalp block was performed 5 min before head pinning. The primary outcome of the study was
      mean arterial pressure (MAP) and secondary outcomes were heart rate (HR), visual analogue
      scale (VAS) scores, additional intraoperative and postoperative drug use. Postoperative pain
      was evaluated using a 10-cm visual analogue scale (VAS).
    

Detailed description: 
      Following approval from the Research Ethics Committee of the Medical Faculty of Uludağ
      University, (the date and protocol number assigned by this ethics committee were March 4,
      2008 and 5/30, respectively),written informed consent was obtained from patients undergoing
      elective scheduled operations involving craniotomy during anaesthesia consultations. Ninety
      American Society of Anesthesiologists (ASA) Physical Status classification system I or II
      patients of either sex between 18-85 years of age were allocated to this randomised,
      prospective, placebo-controlled, double-blind study. The patients were randomly divided into
      three groups using a sealed-enveloped technique to receive either 20 ml of 0.5% bupivacaine
      (Group B (n=30)), 20 ml of 0.5% levobupivacaine (Group L (n=30)) or saline as a placebo
      (Group C (n=30)). Twenty-millilitre syringes for the block were prepared and numbered by a
      blinded assistant.
    

Intervention name(s): Levobupivacaine; Bupivacaine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): local injection; local injection; local injection
Other intervention name(s): chirocaine; marcaine; saline
Intervention MeSH terms: Bupivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: anaesthesia; local anaesthesia; hemodynamics; bupivacaine; levobupivacaine
Prosthetic Maintenance of Two Implant-Retained Overdentures Reinforced With PEKK Versus Co-Cr Frameworks
Condition: Completely Edentulous
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      The goal of this randomized clinical trial is to compare and assess the prosthetic
      maintenance of two implant-retained mandibular overdentures reinforced with PEKK and Co-Cr
      frameworks after twelve months. Twenty-four participants were randomly assigned to two
      groups: Group I received a mandibular implant-retained overdenture reinforced with a Co-Cr
      framework, while Group II received a mandibular implant-retained overdenture reinforced with
      a PEKK framework. Also, both groups were rehabilitated with a maxillary complete removable
      denture.
    

Detailed description: 
      Twenty-four participants with edentulous maxillary and mandibular ridges underwent meticulous
      selection, with two implants placed in the mandibular canine areas through a two-stage
      surgical technique facilitated by a radiographic and surgical stent. Following this, patients
      were provided with maxillary and mandibular complete removable dentures relined with soft
      liners. After the subsequent three-month osseointegration period, ball attachments were
      introduced. Patients were randomly allocated to two groups based on the type of prosthesis
      they received. Group I received mandibular implant-retained overdenture reinforced with the
      Co-Cr framework, while Group II received mandibular implant-retained overdenture reinforced
      with the PEKK framework, both groups received complete removable dentures for the maxillary
      arch. The assessment of prosthetic maintenance for mandibular implant-retained overdentures
      in both groups was conducted twelve months post-denture insertion.
    

Intervention name(s): Two implant -retained overdenture reinforced with Co-Cr framework; Two implant -retained overdenture reinforced with PEEK framework
Intervention type(s): Device; Device
Intervention description(s): The intervention is made from polymethylmethacrylate reinforced with cobalt chromium ( Co-Cr) framework.; The intervention is made from polymethylmethacrylate reinforced with Polyetherketoneketone ( PEEK) framework.
Other intervention name(s): implant retained overdenture; implant retained overdenture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental implants; Maintenance/standards; Overdenture
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Healthy Japanese Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of
      ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese
      male volunteers.
    


Intervention name(s): ACZ885
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Safety, tolerability, pharmacokinetics, pharmacodynamics, ACZ885, Japanese,
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of RV1729 for up to 28 Days
Condition: Asthma; Healthy Volunteers
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      RV1729 is a new medicine being developed for the potential treatment of asthma and smoking
      related lung disease (also known as chronic obstructive pulmonary disease - COPD).

      The objective of this study is to investigate the safety, tolerability and pharmacokinetics
      of single doses of RV1729 and repeat doses of RV1729 for up to 28 days.
    


Intervention name(s): RV1729 single dose; RV1729 matching placebo single dose; RV1729 14 day repeat dose; RV1729 matching placebo 14 day repeat dose; RV1729 28 day repeat dose; RV1729 matching placebo 28 day repeat dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Safety and tolerability of single dose; Safety and tolerability of single dose; Safety and tolerability of repeat doses; Safety and tolerability of repeat doses; Safety and tolerability of repeat doses; Safety and tolerability of repeat doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cold Plasma for the Reduction of Lymphoceles Following PLND
Condition: Lymphoceles Following Pelvic Lymph Node Dissection
MeSH terms: Lymphocele
Study type: Interventional

Summary: 
      This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based
      plasma technology in the reduction of lymphoceles following pelvic lymph node dissection
      (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be
      used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to
      prevent lymph leakage.
    

Detailed description: 
      Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy
      who have met the study inclusion criteria and who have also given informed consent will be
      enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection
      and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a
      follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is
      present. The occurrence rate of lymphoceles in this trial group will be compared to
      retrospective data from the principal investigator's practice and other published data to
      determine if the occurrence rate has been reduced.
    

Intervention name(s): J-Plasma
Intervention type(s): Device
Intervention description(s): Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.
Other intervention name(s): Cold plasma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: lymphocele; pelvic lymph node dissection; robotic assisted radical prostatectomy; PLND; RARP; prostatectomy; Patel
Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      (Food versus no food) crossover study to measure the effects of food on pharmacokinetics of
      TC-5214 (S-Mecamylamine) in healthy Subjects.
    

Detailed description: 
      Phase I, Open-label, Randomized, Single-dose, Two treatment (Fed Versus Fasted) Crossover
      Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in
      Healthy Subjects
    

Intervention name(s): TC-5214
Intervention type(s): Drug
Intervention description(s): Oral tablets, single 4mg dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy male; nonpregnant female; volunteers; pharmacokinetics; TC 5214; The effect of food on the pharmacokinetics of TC-5214
A Trial to Reduce Hepatitis C Among Injection Drug Users - 1
Condition: HCV Negative Status; HCV Risk Behavior
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the efficacy of a brief motivational intervention on
      the cumulative incidence of Hepatitis C.
    

Detailed description: 
      Injection drug users are at high risk for blood-borne viral infections during their first
      years of injecting when they are least likely to seek formal substance abuse treatment, and
      are likely to be practicing risky drug-use behaviors. Research has demonstrated that a brief
      motivational intervention that includes booster sessions and addresses drug and sex risks is
      effective in reducing HIV risk behaviors among injection drug users.

      Because Hepatitis C Virus is a bloodborne pathogen like HIV, and transmission occurs via
      similar behaviors, successful HIV prevention strategies should be robust in preventing HCV
      but need to be tested. Motivational interventions, which aim to elicit a goal and plan from
      the patient to reduce injection and sexual risk taking, are particularly suited to address
      behaviorally-based changes. Motivational interventions are individualized and tailored to the
      risks and concerns of the participant, but can be standardized and evaluated to make this
      technique applicable in a variety of settings. The occurrence of injection drug use in a
      population with traditionally poor linkage to primary care, an enormous burden of illness,
      and high HCV and other blood-borne pathogen transmission risk, supports the use of
      motivational interventions in this group.

      Comparison(s): Participants are assigned, in this 24 month longitudinal study, to an
      assessment-only condition or an assessment plus motivational intervention condition.
      Participants in the intervention condition receive up to 4 sessions of motivational
      interviewing during the first 6 months of the study.
    

Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis c; injection drug use