bioihbjkbjnl/mcl2 huggingface dataset:
Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers With 30kHz
Condition: Electrical Stimulation; Neuromodulation
Study type: Interventional

Summary: 
      High-frequency alternating currents of greater than 1 kHz applied on peripheral nerves has
      been used in animal studies to produce a motor nerve block. It has been evidenced that
      frequencies higher than 5 kHz are necessary to produce a complete peripheral nerve block in
      primates, whose nerve thickness is more similar to humans.
    

Detailed description: 
      The previous studies with transcutaneous and percutaneous HFAC, suggest high-frequency
      stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory
      threshold.

      However, the 30 kHz frequency has never been applied, and the hypothesis is that it can
      produce a greater blockage at the sensitive level and be a more comfortable application for
      the patient. The purpose of the present work is to determine if a greater blockage of the
      sensory component of the nerve occurs with this frequency and is to reduce the amount of
      current intensity needed using a percutaneous approach by apply two acupuncture needles near
      the nerve as electrodes.
    

Intervention name(s): 30 kHz stimulation (Myomed 932, Enraf-Nonius); Sham stimulation (Myomed 932, Enraf-Nonius)
Intervention type(s): Device; Device
Intervention description(s): A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 30 kHz. The stimulation intensity will be defined as that sufficient to produce a "strong but comfortable" sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands); Sham stimulation will be delivered at a frequency of 30 kHz only during the first 30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High-frequency alternating current; nerve block; somatosensory threshold; motor threshold; percutaneous electrical stimulation
Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis
Condition: Pregnancy Related; Cesarean Delivery Affecting Fetus; Fetus Fetus
Study type: Observational [Patient Registry]

Summary: 
      The primary aim of this randomised control trial is to assess the impact of pre-operative
      carbohydrate loading on thiol disulfide homeostasis when compared to standard care in
      elective cesarean section. Half of the participants will receive pre-operative carbohydrates
      and the other half will receive standard care.
    

Detailed description: 
      The concept of enhanced recovery after surgery (ERAS) has been gradually extended from
      surgery to the field of obstetrics. Carbohydrate loading before the surgery in obstetric
      patients reduce the incidence of nausea and vomiting and reduce insulin resistance. Although
      these effects of the preoperative carbohydrate loading has been studied, the thiol disulfide
      homeostasis effects after carbohydrate loading has not been investigated yet. Thiol-disulfide
      homeostasis (TDH) plays a critical role in the mechanisms of antioxidant defense,
      detoxification, apoptosis, regulation of enzyme activities, transcription, and cellular
      signal transduction. Since the newborns are very susceptible to harmfull effects of reactive
      oxygen species, the effect of carbohydrate loading on the reactive oxygen species gain
      importance.

      All mothers undergoing a planned caesarean section in the Karaman Training and Research
      Hospital will be invited to participate. Mothers will be divided into two groups. One group
      will receive standard care and the other group will receive a carbohydrate drink in addition
      to standard care.
    

Intervention name(s): Carbohydrate
Intervention type(s): Drug
Intervention description(s): Preoperative Carbohydrate Loading Drink
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The term pregnant patients admitted to Karaman Training and Research Hospital
Mindfullnes-Based Cognitive Therapy Effect
Condition: Mindfullnes-Based Cognitive Therapy and Adherence to Immunosuppressive Therapy
Study type: Interventional

Summary: 
      Objective: In this study, the effect of mindfulness-based cognitive therapy on compliance
      with immunosuppressive therapy in liver transplant patients was evaluated. Method: It was
      conducted the study in a randomized controlled type with n=120 participation of liver
      transplant recipients of a transplant hospital. It was applied mindfulness-based cognitive
      therapy to liver recipients in the experimental group.
    

Detailed description: 
      It was used simple random sampling method in assigning liver recipients to the experimental
      and control groups. Discharged liver transplant patients are informed about the use of
      immunosuppressive drugs and the drug is prescribed. Liver transplant patients drugs.
    

Intervention name(s): Mindfullnes-Based Cognitive Therapy
Intervention type(s): Behavioral
Intervention description(s): Mindfullnes-Based Cognitive Therapy Effect on Adherence to Immunosuppressive Therapy in Liver Transplant Recipients
Other intervention name(s): [Mindfulness]
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Experimental
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Liver Recipients; Transplantation; Mindfulness
Sternomental Displacement Test for Predicting Difficult Airway in Obese Patients
Condition: Difficult Airway Intubation
Study type: Observational

Summary: 
      Difficulties airway significantly contribute to the morbidity and mortality associated with
      anesthesia. Identifying situations and patients at risk for airway management problems is the
      key to optimal care and has been the focus of numerous publications. Although controversial,
      Body Mass Index (BMI) is considered as associated with difficult intubation in both and
      operating theaters. A modified measurement of SMD is obtained with the head in neutral
      position (SMD neutral), then the difference between SMD extension and SMD neutral was
      calculated and it was referred to as sternomental displacement (SMDD). SMDD was proved to be
      a good objective predictor for difficult laryngoscopy in adult patients, and its predictive
      ability was increased when combined with other tests as neck circumference (NC). To the best
      of our knowledge, the validity of the SMDD test was not previously assessed in obese
      patients.
    


Intervention name(s): Sterno-mental displacement test
Intervention type(s): Diagnostic Test
Intervention description(s): While the patient is in sitting position, (SMD neutral) will be is measured using tape as the distance between upper borders of the manubrium sterni to the mentum with the head in a neutral position. The (SMD extension) will be then measured in the same way with the head extended on the neck. The difference between SMD extension and SMD neutral will be then calculated as sternomental displacement (SMDD).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of either sex, aged between 18-60 years old, ASA physical status II & III with BMI
        > 30 Kg/m2
A Study With GLPG1972 in Osteoarthritis Subjects
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single
      center study, in three semi-sequential cohorts of 10 male and female subjects of
      nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Per
      cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with
      GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64
      years and 65-75 years) with a minimum of 2 of each sex per age group.
    


Intervention name(s): GLPG1972 cohort 1; GLPG1972 cohort 2; GLPG1972 cohort 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GLPG1972 dose 1 provided as oral tablets q.d.; GLPG1972 dose 2 provided as oral tablets q.d.; GLPG1972 dose 3 provided as oral tablets q.d.; Matching placebo provided as oral tablets q.d.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
IBSR Meditation Technique for Teachers' Burnout
Condition: Burnout, Professional
MeSH terms: Burnout, Professional; Burnout, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of Inquiry based stress reduction
      (IBSR) meditation technique on levels of burnout and wellbeing among teachers.
    

Detailed description: 
      Teachers' burnout is a well-known phenomenon with personal and professional implications. The
      current study investigates the effect of inquiry based stress reduction (IBSR) technique on
      burnout and well-being among teachers.
    

Intervention name(s): Inquiry Based Stress Reduction (IBSR)
Intervention type(s): Other
Intervention description(s): During a 12-week intervention program, participants will be encouraged to identify and inquire their stressful thoughts.All the sessions were standardized according to a training manual, and were assessed after each session for maintaining consistency in the program.
Other intervention name(s): The Work
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Burnout; Teachers; Meditation; IBSR; "The Work"; Byron Katie
Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.
Condition: Healthy; Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Single oral dose of study drug in two period(s) separated by a washout period of seven (07)
      days. Blood samples will be taken up to 24.0 hours post-dose.
    

Detailed description: 
      Test Product DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd.or
      Reference Product Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company
      Limited. will be administered to healthy male Pakistani volunteers with 240 mL ambient
      temperature water and blood samples will be taken up to 24 hours post dose for the
      calculation of Cmax, Tmax, AUC.
    

Intervention name(s): Dexlansoprazole; Dexlansoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Dexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm.; Dexlansoprazole capsule prepared by Takeda Pharmaceutical Company will be administered to this arm.
Other intervention name(s): DelanzoTMDR 60 mg capsule, hard; Dexilant® 60 mg capsule, hard
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single center, open-label, randomized, single-dose, two-period, two-way, cross-over study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study, Healthy Pakistani Population,; Dexlansoprazole Capsule
Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is single center, randomized, double-blind, placebo-controlled, single ascending dose
      study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food
      effect of BPN-14967 in healthy adult subjects.
    


Intervention name(s): BPN-14967; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BPN-14967 oral capsules; Oral capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aimed to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 on the
      Pharmacokinetics (PK) of five probe substrates for cytochrome P450 isozymes.

      The substrates used to monitor enzyme activity were oral warfarin (for CYP2C9), oral
      omeprazole (for CYP2C19), oral dextromethorphan (for CYP2D6), oral caffeine (for CYP1A2) and
      intravenous midazolam (for hepatic CYP3A)
    


Intervention name(s): BIRT 2584 XX; Warfarin sodium; Omeprazole; Dextromethorphan hydrobromide; Caffeine; Midazolam hydrochloride; Vitamin K1
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Coumadin®; Omeprazole-ratiopharm® NT; Hustenstiller-ratiopharm®; Coffeinum®; Dormicum®; Konakion®
Intervention MeSH terms: Vitamin K; Vitamin K 1; Midazolam; Dextromethorphan; Caffeine; Omeprazole; Warfarin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)
Condition: Smoking
Study type: Interventional

Summary: 
      The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile
      (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the
      PK profiles from a single use of a conventional cigarette (CC) and from a single use of
      nicotine nasal spray (NNS).
    


Intervention name(s): THS 2.2; CC; NNS
Intervention type(s): Other; Other; Other
Intervention description(s): Single use of the Tobacco Heating System 2.2 (THS 2.2); Single use of subject's own conventional cigarette (CC); Single administration of 1 mg of nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Smoking; Nicotine absorption; Modified risk tobacco product; Conventional cigarette; Nicotine replacement therapy; Nicotine nasal spray
The Effects of Body Contouring: Abdominoplasty and Liposuction
Condition: Subcutaneous Abdominal Fat; Abdominal Skin Elasticity; Rectus Muscle Diastasis; Unpleasant Body Contour
MeSH terms: Diastasis, Muscle
Study type: Interventional
Phase: Phase 4

Summary: 
      The data regarding the effects of aesthetic body contouring is insufficient. Poor results may
      related to preoperative psychological distress. Studies regarding eating disorder symptoms
      are lacking. Therefore studies using standardized and validated are needed. We decided to
      prospectively study quality of life, psychological distress, and eating disorder symptoms in
      body contouring (abdominoplasty or liposuction) patient populations. Used questionnaires are
      15D quality of life, Raitasalo's modification of the Beck Inventory, and the Eating Disorder
      Inventory. We hypothesize that aesthetic body contouring plastic surgery has notable quality
      of life effects.
    


Intervention name(s): Abdominoplasty and liposuction
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars
Condition: Acne Vulgaris; Atrophic Acne Scars
MeSH terms: Acne Vulgaris; Atrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using
      intra-individual comparison (right half-face versus left half-face).

      Participants with each half-face randomized to one of the two following treatments:

        -  Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte).

        -  Vehicle gel

      The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5%
      (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in
      moderate to severe acne participants.
    


Intervention name(s): ABPO Forte Gel; Vehicle gel
Intervention type(s): Drug; Drug
Intervention description(s): Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.; Participants applied placebo matched to ABPO Forte gel topically to the affected areas once daily for 24 weeks in Part 1 and 48 weeks in Part 2.
Other intervention name(s): TactuPump Forte
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: acne; scars
Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, pilot phase I trial studies the side effects of berberine chloride in
      treating patients with ulcerative colitis and who are in remission (a decrease in or
      disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer.
      Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention
      is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or
      coming back. The use of berberine chloride may keep colorectal cancer from forming in
      patients with ulcerative colitis.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the safety of berberine (berberine chloride) administered to participants
      with ulcerative colitis (UC) in clinical remission while receiving maintenance therapy with
      mesalamine.

      SECONDARY OBJECTIVES:

      I. Determine the molecular efficacy of berberine by examining the following biomarkers:

        -  Plasma-based measures of inflammation, including the blood C-reaction protein (CRP)
           level, erythrocyte sedimentation rate (ESR), and cytokines such as TNFa, IL-4, IL-6,
           IL-8 and IL-10 measured by enzyme-linked immunosorbent assay (ELISA).

        -  Tissue-based measures of inflammation, including TNFα, COX-2, and NF-kappa (κ)B by
           immunohistochemistry (IHC), and anti-cancer action, including antigen Ki-67 (Ki67) and
           activated caspase-3 by IHC, and deoxyribonucleic acid (DNA) methylation on SFRP1,
           TCERG1L FBN2, TFPI2 using the methylation-specific polymerase chain reaction (qMSP)
           strategy.

      II. Clinical efficacy: UC related symptoms will be measured using the Ulcerative Colitis
      Disease Activity Index (i.e. the Mayo score) (UCDAI).

      III. Histological analysis for inflammation: severity of histologic inflammation will be
      evaluated using the Geboes grading system.

      IV. Determine plasma concentration of berberine.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive berberine chloride orally (PO) thrice daily (TID) for 90 days in the
      absence of disease progression or unacceptable toxicity.

      ARM II: Participants receive placebo PO TID for 90 days in the absence of disease progression
      or unacceptable toxicity.

      After completion of study treatment, patients are follow-up for 30 days.
    

Intervention name(s): Berberine Chloride; Laboratory Biomarker Analysis; Placebo Administration
Intervention type(s): Drug; Other; Other
Intervention description(s): Given PO; Correlative studies; Given PO
Other intervention name(s): Berberine Chloride Dihydrate; Berberine Hydrochloride; Berberinum Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area
Condition: Moderate or Severe Submental Fullness
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the dosing interval, optimal dose, evaluate safety, and efficacy of AYP-101 S.C
      injection for the reduction of Submental Fat (SMF).
    

Detailed description: 
      This study is to determine the dosing interval, optimal dose, evaluate safety and efficacy of
      AYP-101 S.C injection for the reduction of SMF who wish improvement in the appearance of
      moderate to severe convexity or fullness associated with SMF in adults.
    

Intervention name(s): Polyene Phosphatidylcholine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.; Phosphate buffered saline placebo for injection
Other intervention name(s): AYP-101
Intervention MeSH terms: Polyene phosphatidylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Frequency Analysis of Raw EEG During Sevoflurane Anesthesia in Children Younger Than 2 Years Old
Condition: Anesthesia, General; Sevoflurane; Infant
Study type: Observational

Summary: 
      The purpose of this study is to analyze raw electroencephalogram in infants younger than 2
      years old undergoing general anesthesia using sevoflurane.
    

Detailed description: 
      After obtaining an informed consent from one of the parents, patients undergo routine
      anesthetic induction using sodium thiopental. Bispectral index and patient state index are
      both monitored simultaneously. Raw electroencephalogram data are transmitted and recorded via
      a dedicated equipment. Anesthesia is maintained using sevoflurane with end-tidal level of
      less than 2 minimum alveolar concentration (MAC) adjusted to age. Fentanyl of up to 1 mcg/kg
      can be administered in case of increased heart rate and mean blood pressure with a degree of
      30% of baseline.

      During anesthesia, patients' status of sedation is defined as 'maintenance of surgical state
      of anesthesia (MOSSA)' when the end-tidal concentration of sevoflurane is maintained between
      0.7 and 1.3 MAC and mean blood pressure and heart rate is between 80-120% of baseline.

      'Emergence' is defined as a 3-minute period in the middle of continuous decrease in end-tidal
      concentration of sevoflurane in the range of less than 0.7 MAC and finally reaching 0.2 MAC.

      Raw electroencephalogram waves are analyzed by distribution of power along frequency bands
      and compared according to the state of anesthesia or bispectral index / patient state index
      value.
    

Intervention name(s): BIS; PSi
Intervention type(s): Device; Device
Intervention description(s): Bispectral index monitoring; Patient state index monitoring
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients aged between 4 months and 2 years planned to undergo surgery under
        general anesthesia, whose American Society of Anesthesiologists physical status are 1 or 2
      
Keywords: Electroenphalography; Frequency analysis