bioihbjkbjnl/mcl2 huggingface dataset:
Subarachnoid or Infiltration for Hemorrhoidectomy
Condition: Hemorrhoid
MeSH terms: Hemorrhoids
Study type: Interventional

Summary: 
      There will be compared the postoperative analgesic effect of infiltration or spinal block for
      hemorrhoidectomy
    

Detailed description: 
      This is a prospective, randomized study, including 40 patients between 18 and 60 years, of
      both genders, ASA 1 or 2.

      Patients in group 1 (n = 20) will be submitted to spinal block and group 2 (n = 20) to
      infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The
      infiltration will be performed with 10 ml of 0.5% bupivacaine with epinephrine on each side.

      Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 15 minutes,
      relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes
      until reached the criteria for discharge, muscle strength of the lower limbs every 30
      minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine
      output, nausea and vomiting), time to hospital discharge, and duration of analgesia. Adverse
      effects and complications will be noted.
    

Intervention name(s): Infiltration; Spinal block; Bupivacaine; 10 mg of hyperbaric 0.5% bupivacaine
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): injection of local anesthetic, associated with general anesthesia; injection of anesthetic; 10ml 0.5% bupivacaine.; Spinal punction and injection of local anesthetic
Other intervention name(s): Local Infiltration; subarachnoidal block; Local infiltration; spinal anesthesia
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infiltration; hemorrhoidectomy; Postoperative pain
High Dose of Vitamin C on Mechanically Ventilated Septic Patients in Intensive Care Unit
Condition: Ventilator Associated Pneumonia ( VAP); Sepsis
MeSH terms: Sepsis; Pneumonia, Ventilator-Associated
Study type: Interventional

Summary: 
      Prospective, Randomized clinical trial study will be carried out in intensive care unit in
      Ain Shams University Hospitals on 40 forty septic patients admitted to ICU and mechanically
      ventilated.
    

Detailed description: 
      This study will be carried out in intensive care unit in Ain Shams University Hospitals ,
      Cairo,Egypt on 40 patients admitted to ICU that are septic patients and mechanically
      ventilated which will be recruited into the study . After approval from ethical committee, an
      informed consent will be obtained from relatives of all patients. All data of patients will
      be confidential with secret codes and private file for each patient. Each patient's relative
      will receive an explanation for the purpose of the study. The study design will be
      prospective , randomized clinical trial.

      Methodology:

      All patients will be subjected to:

        1. Complete history taking.

        2. Full clinical examination

        3. Evaluation and monitoring of(pulse oximetry , ECG, NIBP, temperature)

        4. CBC , Blood gas (for determination of (PaO2/FiO2), Blood cultures,serum Creatinine and
           total bilirubin were recorded daily for the first 7 days.

        5. Severity scores by calculating Acute physiology and chronic health evaluation (APACHE
           II)score
    

Intervention name(s): Vitamin C
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded ,Prospective, Randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Vitamin C; Sepsis; Intensive care unit; Mechanically ventilation; VAP
Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC)
      injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean
      percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK)
      profile. The study is designed to evaluate the efficacy and tolerability of setmelanotide
      administered once or twice daily. The study drug (setmelanotide and placebo) will be
      administered in a blinded fashion.
    


Intervention name(s): Setmelanotide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): RM-493
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Overweight
Study to Detect Oral Administration of Budesonide in Women.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims at identifying analysis strategies to detect oral administration of
      Budesonide in women; in order for them to be used by the accredited laboratories of the Worl
      Anti-Doping Agency (WADA).
    

Detailed description: 
      This clinical trial aims at studying the budesonide metabolism of women. The objective is to
      identify analysis strategies to detect oral administration of Budesonide in women. In order
      to use them in the accredited laboratories of the Worl Anti-Doping Agency (WADA).

      This study will also help with defining the referential levels of this way of administration.
      Also, it will be used to test the safety and tolerability of the medication used.

      For this, will be collected at precise times after the oral administration of the medication,
      the concentrations in urines of the metabolite o budesonide : the 6bêta-hydroxy-budesonide,
      of budesonide itself, of other metabolites. These concentrations will be compare to the ones
      in the basal samples of subject's urines.
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention description(s): Patients will be given, on an empty stomach since a minimum of 10 hours, a single dose of 3 mg of Budesonide, in the form of Entocord® capsuls. After that, they will remain under medical control for at least an hour, and then will be back home with instructions to collect urine samples at defined times, during 4 days.
Other intervention name(s): Entocord® modified release capsule, 3 mg single-dose
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Intervention model description: Healthy women, aged between 18 and 45 years old, weighing between 50 and 75 kg and with BMI included between 19 and 27 kg/m².
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: doping
The Effect of Yoga and Stabilization Exercise in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Identification of the effects of yoga, stabilization exercise and home exercise approaches on
      pain, function,stress and quality of life in individuals with low back pain.
    

Detailed description: 
      44 patients participating in the study were divided three groups. The patients in the
      stabilization exercise group were instructed to perform hotpack, Trans-cutaneous Electric
      Nerve Stimulation (TENS) and spinal stabilization exercises, the patients in the yoga group
      were instructed to perform yoga program consisting of breathing, relaxation and flexibility
      exercises. The patients in the home exercise group were instructed to perform stabilization
      exercise. The severity of the pain evaluated through visual analog scale, functional status
      and quality of life evaluated through Oswestry Disability Index(ODI), Nottingham Health
      Profile (NHP), respectively. Assessments were repeated before and after the treatment.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): All exercises programs applied three sessions per week, totally six week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise, pain, yoga
Effects of Vitamin D Supplementation on Immune Function in Infants
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Current study shows that vitamin D deficiency might affect human's immune function. Although
      breast milk is the best food of infants, however the vitamin D content in breast milk is low.
      Thus, breastfeeding infants are at high risk of vitamin D deficiency.Children's development
      and health are always the most important issues for parents. However, high prevalence of
      allergy in infants in Taiwan were not only with environmental factor which may also relate to
      their nutritional status. The aim of this study was to enroll breastfeeding infant at age of
      4 month, and provide vitamin D supplement 10 μg daily until 6 month, to discuss the effects
      of vitamin D supplementation on immune function in infants.
    

Detailed description: 
      Study plan to enroll breastfeeding infant at age of 4 month, and provide vitamin D (vitD)
      supplement 10 μg daily until 6 month. we also enroll 6 month-old infant as control group.

      All infants collected 5 ml artery blood and measured vitD nutritional status and immune
      function. Blood analysis contain complete blood count (CBC), differential count (DC), serum
      calcium, serum Parathyroid hormone (PTH), serum 25(OH)D3, serum total immunoglobulinE (IgE)
      and cell phagocytosis.

      Peripheral blood mononuclear cell (PBMC) in blood was separated and cultured with complete
      medium contain 10% fetal bovine serum (CM10), or with different mitogens, include
      lipopolysaccharide (LPS), phorbol 12-myristate 13-acetate and ionomycin (PI) and house dust
      mite extract (HDM). PBMC are incubated at 37 ℃, 5% CO2 for 48 hours, and determined the
      expression of B cell with IgE receptor CD21 and CD23 and T regulatory cell with transcription
      factor Foxp3 by flow cytometry. All data were analyzed with SPSS 20.0. Infant sex and feeding
      type were analyzed by chi-square analysis. Difference between vitD supplement group and
      control group were analyzed by student's t test. Relationship between 25(OH)D3 and Calcium or
      PTH were analyzed by pearson correlation analysis. There was a significant difference when
      p-value was less than 0.05.
    

Intervention name(s): vitamin D
Intervention type(s): Other
Intervention description(s): vitamin D supplement 10 μg daily for 2 months
Other intervention name(s): Baby Ddrops® Liquid Vitamin D3 Vitamin Supplement
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 months old or 6 months old breastfeeding infants
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitamin D, immune, infants, breastfeeding
Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects
Condition: Incontinence
Study type: Interventional
Phase: Phase 1

Summary: 
      THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic
      agonist (pilocarpine).
    

Detailed description: 
      Because of the limitations of taking two medications separated by a period of time to
      minimise these adverse events, two novel formulations were developed to improve compliance
      and ease of administration. This study will evaluate these formulations in terms of their
      pharmacokinetic profiles and effects on SSF. In addition, the effects of this combination and
      its entities on urine frequency and safety/tolerability will be assessed.
    

Intervention name(s): Tolterodine; Pilocarpine; THVD-201; THVD-201; placebo capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Comparison of different dosages of drug; Comparison of different dosages of drug; Comparison of different dosages of drug; Comparison of different dosages of drug; Comparison of different dosages of drug
Intervention MeSH terms: Tolterodine Tartrate; Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tolterodine; Over active Bladder (OAB); Incontinence
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study was to assess the safety and tolerability of multiple doses
      of ASP8062 or placebo alone and in combination with a single dose of morphine.

      This study also assessed the potential for pharmacokinetic interaction between ASP8062 and
      morphine.
    

Detailed description: 
      Participants were screened for up to 28 days prior to first investigational product
      administration. Eligible participants were admitted to the clinical unit on day -1 and were
      residential for a single period of 17 days/16 nights.

      Participants were discharged from the clinical unit on day 16 on the condition that all
      required assessments had been performed and that there were no medical reasons for a longer
      stay in the clinical unit.
    

Intervention name(s): ASP8082; morphine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Opioid Use Disorder; pharmacokinetic; ASP8062; morphine
Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
Condition: Polio
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of different
      sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.
    


Intervention name(s): Sabin IPV+ bOPV+ bOPV; Sabin IPV + Sabin IPV + bOPV; Sabin IPV + Sabin IPV + Sabin IPV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.; Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.; Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunogenicity; Safety; Sabin IPV; bOPV
Stabilometry and Plantar Pressures Changes After Dry Needling in Flexor Digitoum Brevis.
Condition: Healthy; Foot; Dry Needling
Study type: Interventional

Summary: 
      The aim of this clinical trial is to check the effects of dry needling in the Flexor
      digitorum Brevis .
    

Detailed description: 
      Fiveteen healthy subjects wil be recruited for a quasi-experimental study. Participants will
      be from 18 to 40 years old, not obese. Participants will be measured before and after
      bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure
      stabilometry variables and static footprint. The footprint variables will be divided in
      bilateral rear foot, bilateral midfoot, bilateral fore foot.

      Measures. Stabilometry will be measured by displacement of the center of pressures in X and Y
      with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with
      eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with
      eyes open and closed, and COP speed. Two trials will be recorded for each condition and the
      order of the conditions will be randomized across subjects, eyes open and eyes closed. Foot
      plantar pressure and surface area of two static footprints will be measured during bipedal
      standing. Static plantar pressure will be evaluated by means of maximum pressure, medium
      pressure and surface area of each aspect of the foot (rearfoot, midfoot, and fore foot).
    

Intervention name(s): Dry needling
Intervention type(s): Other
Intervention description(s): Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
Intervention model: Single Group Assignment
Intervention model description: Pretest posttest of bilateral Flexor digitorum Brevis dry neddling intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stabilometry; Platform; Dry needling; trigger point
The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects
Condition: Pharmacological Action (PA)
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To examine whether Ritalin has analgesic properties in healthy subjects.

        2. To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a
           broader, non-specific effect on high mental functions.
    


Intervention name(s): methylphenidate hydrochloride; Sugar pill (placebo)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ritalin; methylphenidate hydrochloride; experimental pain
Pediatric Transcranial Static Magnetic Field Stimulation to Improve Motor Learning
Condition: Healthy; Pediatrics
Study type: Interventional
Phase: Phase 1

Summary: 
      Non-invasive brain stimulation (NIBS) is a safe, painless way to improve brain function. It
      is used for many conditions, including to help children with disabilities. However, it can be
      challenging to apply NIBS in very young children and infants. A new, simple form of NIBS
      called transcranial static magnetic field stimulation (tSMS) is a promising tool for early
      brain stimulation. tSMS in adults has been shown to be safe, tolerable and have the desired
      effects on brain activity when applied to the motor cortex of the brain. However, how tSMS
      affects on motor function is not understood. This research will use tSMS to target the motor
      cortex which is responsible for voluntary movement. The study will determine if tSMS can
      improve motor learning in healthy children. It is hypothesized that application of tSMS on
      the right motor cortex will decrease excitability of the motor cortex and will lead to
      improved motor learning in the right hand. tSMS has the potential to become a safe,
      inexpensive, home-based way to enhance personalized rehabilitation for disabled children.
    


Intervention name(s): Transcranial Static Magnetic Field Stimulation (tSMS); Sham Transcranial Static Magnetic Field Stimulation (tSMS)
Intervention type(s): Device; Device
Intervention description(s): tSMS consists of a small compact cylindrical neodynium magnet (S-45-30-N, Supermagnete) with an estimated strength of up to 0.5 Tesla and a size of 30 mm x 45 mm.; Sham tSMS consists of a small compact metal cylinder, identical in appearance to the real tSMS device.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive all 3 treatment arms (Right M1 tSMS, Left M1 tSMS, sham tSMS) in a randomized order.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate PEMF Therapy on Experimentally Inducted Pain in Subjects With Painful Peripheral Diabetic Neuropathy
Condition: Painful Peripheral Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional

Summary: 
      Evaluate the effectiveness of the Provant Therapy System compared to sham on pain sensitivity
      and nervous system response to various qualities of experimentally induced pain in the upper
      and lower extremities of subjects with painful peripheral diabetic neuropathy.
    

Detailed description: 
      This is a multi-center, randomized, double-blind, sham-controlled crossover clinical trial
      conducted on subjects with painful peripheral diabetic neuropathy. Eligible subjects will
      include those between 22 and 80 years of age with Type 2 diabetes having persistent pain,
      numbness, tingling, and/or burning in at least one foot. Pain threshold, tolerance to thermal
      stimuli and pressure response to the induced pain stimuli will be measured at three time
      points using five standardized experimental pain measures: baseline, after a single 30 minute
      treatment with active PEMF or sham treatment and after a second 30 minute treatment with
      active PEMF or sham treatment. Eligible subjects with painful peripheral diabetic neuropathy
      will undergo Diabetic Screening (Nerve Conduction Velocity, Skin Perfusion Pressure,
      Ankle-Brachial Index, and Vibratory Testing) in the index foot prior to randomization.
      Following the Diabetic Screening tests, subjects will return to the research center for the
      Enrollment/Randomization Visit and complete measures of pain by completing the Brief Pain
      Inventory (BPI) and functional assessments. Subjects will then be randomly assigned to one of
      the two groups; control (sham) or experimental (active) device by a research assistant
      blinded to the device status. Patients will also be randomly assigned to the sequence order
      of experimental induced pain tests. The ischemic pain testing (SMET) will always be conducted
      last. Patients will return to the research center within 7 days after the
      Enrollment/Randomization Visit where they will be crossed over to the other treatment
      assignment and be randomly assigned to the sequence order of experimental induced pain tests
      on the same extremity as previously randomized.
    

Intervention name(s): Provant
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment