bioihbjkbjnl/mcl2 huggingface dataset:
Thermogenic Effect of Ginger
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The main objective of the study is to evaluate the thermogenic effect of ginger.
    

Detailed description: 
      Healthy and eutrophic women will receive capsules of 200 mg of ginger extract (5% active
      ingredient) or placebo (cellulose), along with a standardized breakfast, with a minimum seven
      days washout period.
    

Intervention name(s): Extract of ginger; Placebo (Cellulose)
Intervention type(s): Other; Other
Intervention description(s): The volunteers will receive two capsules containing 200mg of extract of ginger with 5% of gingerols (20 mg). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.; The volunteers will receive two capsules containing cellulose (placebo). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Thermic Effect of Food; Energy Expenditure; Ginger
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells. It is not yet known whether
      monoclonal antibody therapy is effective in treating kidney cancer.

      PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how
      well it works in treating patients who have undergone surgery for nonmetastatic primary
      kidney cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the disease-free and overall survival of patients with primary clear cell renal
           cell carcinoma at high risk for recurrence treated with chimeric monoclonal antibody
           cG250 (WX-G250) vs placebo in an adjuvant setting.

      Secondary

        -  Evaluate the safety of these drugs in these patients.

        -  Assess the quality of life of patients treated with this drug.

        -  Perform pharmacokinetic analysis of WX-G250.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to risk criteria and participating centers (US vs Non-US). Patients
      are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes
           once weekly for 24 weeks.

        -  Arm II: Patients receive placebo IV over 15 minutes once weekly for 24 weeks. In both
           arms, treatment continues in the absence of disease progression or unacceptable
           toxicity.

      Blood samples are collected for pharmacokinetic analysis.

      Quality of life is assessed at baseline, at weeks 12 and 24 during treatment, and then at 6
      months after completion of study treatment.

      Patients are followed every 3 months during years 1 and 2, every 6 months during years 3 and
      4, and then annually during year 5 and thereafter.

      PROJECTED ACCRUAL: A total of 864 patients out of the expected 856 (428 per treatment arm)
      were accrued for this trial.
    

Intervention name(s): girentuximab; placebo
Intervention type(s): Biological; Other
Intervention description(s): Given IV; Given IV
Other intervention name(s): Rencarex®, cG250 and WX-G250
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: clear cell renal cell carcinoma; stage I renal cell cancer; stage II renal cell cancer; stage III renal cell cancer; stage IV renal cell cancer
Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution
Condition: Observation of Neuromuscular Block; Disease (or Disorder); Gynecological
MeSH terms: Disease
Study type: Interventional

Summary: 
      The authors would like to investigate the blocking characteristics, surgical quality and side
      effects of intrathecal levobupivacaine whether there are any differences between the
      hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block
      level than the urological surgeries.
    

Detailed description: 
      The investigators study in the similar patients, give the same intervention except the
      baricity of levobupivacaine. The investigators record the level of sensory block and modified
      Bromage score for motor blockade.
    

Intervention name(s): isobaric levobupivacaine; hyperbaric levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 0.42% either isobaric levobupivacaine 3 ml spinal injection once; 0.42% hyperbaric levobupivacaine 3 ml spinal injection once
Other intervention name(s): Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway; Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: abdominal incision; hyperbaric; isobaric; levobupivacaine; spinal anaesthesia
St. John's Wort Photodynamic Therapy
Condition: Acne
Study type: Interventional

Summary: 
      The investigators aimed to evaluated the efficacy and safety of SJW-PDT compared to
      indole-3-acetic acid (IAA)-PDT in the treatment of acne. The investigators also investigated
      the skin rejuvenating effects of SJW-PDT.
    


Intervention name(s): PDT
Intervention type(s): Procedure
Intervention description(s): A 630 nm red light and a 520 nm green light of the light-emitting diode (LED) device (Nouvo-GB®) with an intensity of 35 mW⁄cm2 was simultaneously illuminated for 10 minutes (a total light dose of 21 J/cm2). Participants received a total of four treatments at 1-week intervals and were followed up 1 and 4 weeks after the last treatment.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: a double-blind split-face randomized controlled design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional
Phase: Phase 3

Summary: 
      OMS103HP is being developed for improvement in knee function following ACL reconstruction.
      Secondary benefits being evaluated include reduced postoperative pain, improvement in knee
      motion and earlier return to work.
    

Detailed description: 
      The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic
      surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma
      initiates an acute inflammatory response, including swelling and pain, that leads to
      restricted joint motion and loss of function. Because of the dynamic nature, complexity and
      redundancy of the chemical mediators of inflammation and pain and their pathways, no
      currently available single drug has sufficiently broad spectrum of activity to effectively
      inhibit the inflammatory process. OMS103 provides a multicomponent approach to controlling
      the inflammation induced by arthroscopic surgery. It delivers three active ingredients, each
      with distinct pharmacological activities, directly to the site of surgical procedures to
      preemptively block the inflammatory cascade induced by surgical trauma.
    

Intervention name(s): OMS103HP; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours; Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; Musculoskeletal System; Ligament; ACL reconstruction
Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring
Condition: Early Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      There are clinical usefulness issues associated with bispectral index (BIS) for sedation of
      endoscopic submucosal dissection (ESD). However, the clinical usefulness of BIS for deep
      sedation is incompletely described. The purpose of this study is to show that BIS-guided
      sedation is safe and useful clinically and may provide stable sedation status to physicians
      and patients.
    


Intervention name(s): BIS sensor attachment; no- BIS sensor attachment
Intervention type(s): Device; Drug
Intervention description(s): For double blind method, BIS sensors were attached to all patients, but only BIS-group was measured by the value. BIS monitor was pushed back toward the anesthesiologist so that the physician could not see it. 3 L/min of oxygen was delivered by a nasal cannula to all patients throughout the procedure. Blood pressure was recorded every 5 minutes and heart rate, peripheral oxygen saturation were measured continuously. For induction of sedation, propofol 1 mg/Kg and lidocaine 30mg was administered throughout IV line and immediately followed by continuous infusion of propofol 0.04-0.06 mg/Kg/min and remifentanil 0.05 mcg/Kg/min. The evaluation of sedation depth using OAA/S was performed at 1 minute after propofol administration, endoscopy insertion, submucosal inflation by 1:100000 epinephrine with indigocarmine, initial submucosal dissection and when the patient had restlessness or coughing additively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: propofol, endoscopy, bispectral index
Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Examine adrenal cortical function and the incidence of adrenal dysfunction in children
      with septic shock.

      II. Examine the mortality, length of stay in the PICU, and incidence of multiorgan failure in
      children with adrenal dysfunction and septic shock.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Patients undergo a corticotropin stimulation test within 8 hours of admission to the PICU.
      Blood samples for plasma cortisol and corticotropin levels are drawn at time 0 followed by
      corticotropin 1-24 IV. Additional cortisol levels are drawn at 30 and 60 minutes.
      Corticotropin is measured by immunoradiometric assay and cortisol is measured by
      radioimmunoassay. Mean arterial blood pressure, heart rate, and respiratory rate are recorded
      at baseline and at 60 minutes.

      Patients receive routine management for septic shock and multiple organ system failure.
    

Intervention name(s): corticotropin
Intervention type(s): Drug
Intervention MeSH terms: Adrenocorticotropic Hormone
Primary purpose: Diagnostic
Keywords: immunologic disorders and infectious disorders; rare disease; sepsis; septic shock
Stroke, Measurement and Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The main aim of the study was to investigate the effects of transcranial laser stimulation
      together with neuromuscular electrical stimulation (NMES) in post-stroke patients.
    

Detailed description: 
      Post-stroke sequelae includes loss functions, such as cognitive and sensory-motor which lead
      to emotional and social problems, reducing quality of life and well-being. The main aim of
      the study was to investigate the effects of transcranial laser stimulation together with
      neuromuscular electrical stimulation (NMES) in post-stroke patients. The clinical trial
      showed improvement of cognitive function, pain relief, greater manual dexterity, enhancement
      of physical and social-emotional health which lead to better quality of life and well-being.
      There was also increased temperature in the treated regions with laser and NMES. Therefore,
      transcranial laser stimulation associated with NMES can be an important therapeutic resource
      for rehabilitation after stroke.
    

Intervention name(s): transcranial laser stimulation associated with NMES; Placebo
Intervention type(s): Device; Other
Intervention description(s): The cluster was applied on the skin covering the head. NMES of the paretic limbs was programmed to generate, alternately, ankle dorsiflexion and wrist extension.
The NMES was started, after 5 minutes the transcranial laser stimulation (active or placebo-treatment) was started. Then, the therapies were combined. After finishing the transcranial laser stimulation (active or placebo-treatment), the NMES was continued until completing 30 minutes.; The transcranial laser was applied identically for all groups, but the null dose was used in the placebo group. NMES of the paretic limbs was programmed to generate, alternately, ankle dorsiflexion and wrist extension.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized and placebo-controlled.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Stroke; Photobiomodulation; Electrical Stimulation
ABSK091 Food Effect Study in Healthy Subjects
Condition: Health, Subjective; Food-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, a single oral dose of the tablet formulation administered under fed conditions
      will be compared to administration under fasted conditions to assess the effects of a
      high-fat meal on the rate and extent of absorption and exposure.

      Study ABSK091-101 is a single-center, Phase 1, open-label, randomized, two-period,
      two-sequence, and crossover study in healthy subjects.
    


Intervention name(s): ABSK091 tablet
Intervention type(s): Drug
Intervention description(s): ABSK091 tablet which is being developed for the treatment of patients with advanced solid tumors
Other intervention name(s): AZD4547 tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In this study, a single oral dose of the tablet formulation administered under fed conditions will be compared to administration under fasted conditions to assess the effects of high-fat meal on the rate and extent of absorption and exposure.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade
      versus Movi Prep for outpatient colonoscopy.
    

Detailed description: 
      Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the
      bowel regimen in cleansing the colon
    

Intervention name(s): comparing 2 drugs on their effect on the bowel preparation for colonoscopy
Intervention type(s): Drug
Intervention description(s): the effects of the drug on the colon preparation for colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: Miralax with gatorade and dulcolax; Movi pre; Patient satisfaction and efficacy
Trial of Adjuvant Chemotherapy for Gastric Cancer
Condition: Stomach Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with
      early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine
      compared to mitomycin plus doxifluridine in resected advanced gastric cancer.
    

Detailed description: 
      Stomach cancer is the most common cancer in Korea and one of the major health problems
      worldwide. The most effective treatment for gastric cancer is curative surgical resection of
      primary tumor. However, a substantial number of patients eventually die of recurrences after
      curative resection. A number of randomized trials investigating the role of adjuvant
      chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still
      controversial and varied between Western and Asian trials. Meta-analysis of Western trials
      didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely,
      some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative
      resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected
      gastric cancer compared to no treatment.

      This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with
      early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine
      compared to mitomycin plus doxifluridine.
    

Intervention name(s): cisplatin, mitomycin-C, doxifluridine
Intervention type(s): Drug
Intervention description(s): Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)
Intervention MeSH terms: Mitomycins; Mitomycin; Doxifluridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stomach cancer; adjuvant chemotherapy; mitomycin; cisplatin; doxifluridine
Alcohol-Containing Products' Effect on Breathalyzer Results in Healthy Adults Without Acute Intoxication
Condition: Alcohol Drinking; Intoxication Alcohol
MeSH terms: Alcoholic Intoxication; Alcohol Drinking
Study type: Observational

Summary: 
      This study is a prospective, controlled study in healthy volunteers all of whom are
      residents, medical students, faculty physicians, or emergency department nursing and
      ancillary staff.
    

Detailed description: 
      The breathalyzer, BACtrack S80 Breathalyzer, will be calibrated per manufacturer's
      recommendations before each reading will be taken. Participants will administer the
      breathalyzer test on themselves. They will be instructed on how to hold and blow into the
      breathalyzer machine. Participants will then be instructed to wash his or her hands and an
      initial breathalyzer reading will be taken and will serve as the control prior to the
      application of each product. Participants with a result >0 will be excluded from the study.
      Participants will apply the alcohol-containing product to his or her hands and a second
      breathalyzer reading will be obtained immediately after application. If the second
      breathalyzer result is >0, a third breathalyzer reading will be obtained after the product
      has dried appropriately on the participant's hands (approximately 1 minute after initial
      application). A minimum of two breathalyzer readings will be obtained from each participant
      per product application. If the second breathalyzer reading is >0, a third breathalyzer will
      be obtained from that participant.
    

Intervention name(s): BACtrack S80 Breathalyzer
Intervention type(s): Device
Intervention description(s): The breathalyzer, BACtrack S80 Breathalyzer, will be calibrated per manufacturer's recommendations before each reading will be taken. Participants will administer the breathalyzer test on themselves. They will be instructed on how to hold and blow into the breathalyzer machine.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A maximum of 50 healthy individuals between the ages of 18 and 75 who are willing to
        participate and able to verbally consent for this study. Volunteers will include residents,
        medical students, faculty physicians, or emergency department nursing and ancillary staff.
        Demographics collected for each participant will include age and gender.
Effect of Manual Therapy and Inmediately Application of Plantar Orthoses
Condition: Ankle Injuries and Disorders
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      Limitation of ankle dorsiflexion is directly related to pronated foot. For its treatment,
      plantar orthoses and manual therapy are used. There is a lack of evidence on their
      combination, as to when the cast should be taken after manipulation. Our hypothesis proposes
      that it is more effective to cast immediately after manipulation.
    

Detailed description: 
      The popularity of long-distance running has increased because it can be practised in many
      settings, the low cost and the links to prevention of health problems. In running between
      19-79% of runners may suffer a running-related overuse injury each year. Pronated feet have
      been identified as a risk factor for lower limb overuse injury, and several studies have
      found that ankle dorsiflexion limitation is related to pronated feet.

      There is a lack of evidence on their combination, as to when the cast should be taken after
      manipulation. Our hypothesis proposes that it is more effective to cast immediately after
      manipulation.

      The main objective is to compare the effect of manipulation with motion (MWM) performed
      immediately prior to casting for plantar orthoses (PO) with the effect of manipulation with
      motion performed one week prior to casting for plantar orthoses on ankle dorsiflexion (ankle
      DF) and foot pronation in runners with hyper pronator feet secondary to a limited ankle DF.

      This study's population will be composed by at least 16 individuals per group, both male and
      female, with ages among 18 and 45.

      They will be randomised into two groups; group A, which will undergo MWM and have the moulds
      taken in phenolic foam immediately after the manipulation. The other group will be group B,
      which will undergo the MWM, and the moulds will be taken one week after the manipulation.
    

Intervention name(s): MWM (Mobilization with movement); Plantar orthoses
Intervention type(s): Procedure; Device
Intervention description(s): This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.; Procedure: MWM All participants will undergo MWM. This manipulation is intended to improve ankle dorsiflexion. One session of 3 sets of 20 slow ankle dorsiflexion's separated by 10 seconds of rest will be performed.
Procedure: Plantar orthoses The moulds will be taken immediately after the manipulation. The PO will be made of resin (0.8mm +1.2mm), 2mm hard EVA heel stabiliser, 3mm semi-hard EVA cover. The PO should be worn for 3 months to obtain the results of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ankle; plantar orthoses