bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg)
      once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.
    


Intervention name(s): LY2940094; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics After Administration of Increasing Dose of BIBN 4096 BS in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing
      doses in healthy male and female volunteers
    


Intervention name(s): BIBN 4096 BS - in single rising doses; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olcegepant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Effects of Spirulina Supplementation on Overweight or Obese Adults
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      In this double-blind Randomized Controlled Clinical Trial investigators are going to study
      the effects of Spirulina supplementation on anthropometric measurements, lipid profile,
      appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese
      adults.
    

Detailed description: 
      A sample of 40 obese and overweight subjects will be recruited from Nutrition And Diet
      Therapy Clinic Of Shahid Beheshti Medical University.

      This study is a double-blind Randomized Controlled Clinical Trial, that subjects will be
      randomly allocated to spirulina or placebo group according to the Random permuted blocks
      within strata method based on BMI. Subjects will consume 2 g spirulina daily (4 tablets of
      500mg), whereas the control group are going to receive identical placebo tablets. Subjects
      are asked to maintain their usual physical activity level during the intervention period and
      also avoid taking any other supplements or medications without consulting the investigators.
      Intervention period is designed to be 12 weeks that has been determined sufficient to record
      changes of study parameters. At the beginning of the study and after 12 weeks of
      intervention, morning blood samples will be collected after 12 h of fasting. Anthropometric
      parameters will be also measured at the beginning, week 6 and after 12 weeks of intervention.
      Subjects will be followed through social network to ensure their compliance with the study.
      Furthermore, subjects in both spirulina and placebo groups received low calorie diet (-500 or
      -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat during the study period.
    

Intervention name(s): Spirulina; diet therapy
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 g(4* 500 mg tablets) daily intake of Spirulina Platensis; low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat
Other intervention name(s): Spiruvit; weight reduction diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; BMI; body weight
Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study will evaluate the acute effects of vibration (whole body vibration and local
      muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics
      linked to osteoarthritis development in individuals with anterior cruciate ligament
      reconstruction. Subjects will be randomly assigned to control (no vibration), whole body
      vibration, and local muscle vibration groups, and the aforementioned characteristics will be
      assessed prior to and following the respective interventions.
    

Detailed description: 
      Quadriceps muscle dysfunction and proprioceptive deficits following knee injuries alter
      walking gait biomechanics in manners that contribute to development of knee osteoarthritis.
      Current rehabilitation techniques are minimally effective for addressing these complications
      and preventing knee osteoarthritis. Anterior cruciate ligament reconstruction dramatically
      increases the risk of knee osteoarthritis, and represents an ideal model for evaluating novel
      rehabilitation techniques for preventing knee osteoarthritis.

      Direct (local muscle vibration) and indirect (whole body vibration) vibratory stimuli enhance
      quadriceps function and proprioception, and may improve rehabilitation and reduce the risk of
      knee osteoarthritis. The purpose of this investigation is to determine and compare the acute
      effects of whole body vibration and local muscle vibration on quadriceps function, knee
      proprioception, and gait biomechanics in individuals with anterior cruciate ligament
      reconstruction. The investigators hypothesize that vibratory stimuli will enhance quadriceps
      function, knee proprioception, and gait biomechanics in manners that would reduce the risk of
      developing knee osteoarthritis, and that whole body vibration and local muscle vibration will
      produce equivalent improvements in these characteristics.
    

Intervention name(s): Whole body vibration; Local muscle vibration
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: anterior cruciate ligament reconstruction
Plasma-based Colorectal Cancer Screening Research & Development
Condition: Colo-rectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The objective of this Clinical Sample Collection Study is to develop a biobank of
      appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages
      0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal
      cancer screening by colonoscopy, prior to bowel preparation.
    

Detailed description: 
      The objective of this Clinical Sample Collection Study is to develop a biobank of
      appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages
      0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal
      cancer screening by colonoscopy, prior to bowel preparation. Samples in the colorectal cancer
      biobank will be used to: 1) assess the clinical performance of novel biomarkers for
      colorectal cancer screening; 2) develop improved processing workflows for the Epi proColon®
      test; 3) develop an automated Epi BiSKit workflow.
    

Intervention name(s): Epi proColon
Intervention type(s): Diagnostic Test
Intervention description(s): Analysis of DNA methylation status for Septin9 and additional biomarkers
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women and Men age 45-84 reporting for screening colonoscopy (Group 2) or with known
        colorectal cancer, prior to intervention (Group 1).
      
Biospecimen description: 
      EDTA plasma samples
    
Keywords: plasma; cell-free DNA; DNA Methylation
Exercise Interventions for Improving Eye Control Post Strabismus Surgery
Condition: Strabismus
MeSH terms: Strabismus
Study type: Interventional

Summary: 
      The purpose of this study will be focused on the following issue:

      1. The aim of this study is to determine therapeutic effect of postoperative eye exercises on
      improving eye control after the strabismus surgery.

      HYPOTHESES:

      It will be hypothesized that:

      • Eye exercises have a positive effect on improving eye control post strabismus surgery.

      RESEARCH QUESTION:"

      • Do postoperative eye exercises improve eye control post strabismus surgery?
    

Detailed description: 
      Therapeutic procedures:

        -  Patient will be informed about measurement and treatment procedure before beginning of
           the treatment.

        -  Patient will be asked to follow physician instructions.

        -  Patients will be asked to avoid participation in any rehabilitation program prior to the
           study which may affect the result of the study.

        -  Measurement procedures will be applied for each patient.

        -  They will start the treatment program after 2 weeks of the surgery.

      The subjects will be divided into two groups (experimental group and control group) with
      equal numbers of patients in each group:

      Control group Participants within the control group will receive traditional care and
      medication following strabismus surgery.

      Experimental group Participants within the experimental group will receive physiotherapy
      exercises beside traditional care and medication after strabismus surgery. Physical therapy
      exercises will apply in the office and home. Office exercises will involve palming exercise,
      pencil push-ups, brock string exercise, thumb exercise (Near-distance jump), balance board
      exercise, Proprioceptors Neuromuscular Facilitating (PNF) exercise, occlusive therapy, eye
      hand coordination and computer therapy. Office exercises will be done two sessions per week
      for three months. Each session will be about 1 hour. Exercises will also perform at home from
      the first session including eye exercises in all directions, pencil push-ups, thumb exercise
      (Near-distance jump),brock string exercise, and dominant eye occlusion for 1 hour daily.
    

Intervention name(s): Exercise Interventions of Eye Muscles; Medication and eye glasses
Intervention type(s): Other; Drug
Intervention description(s): Application of eye exercise for improving eye control post strabismus surgery; medication and eye glasses used post strabismus surgery
Other intervention name(s): experimental; control
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
Condition: Human Epithelial Receptor (HER)-2 Positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN:
      trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast
      cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the
      non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes
      pharmacokinetics assessment.
    

Detailed description: 
      The study is based on the hypothesis of equivalence of BCD-022 (trastuzumab by JSC BIOCAD,
      Russia) in combination with paclitaxel used as the therapy of inoperable or metastatic
      HER2(+) breast cancer in comparison with Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland)
      in combination with paclitaxel. The objectives of the study is to evaluate efficacy, safety
      and pharmacokinetics of BCD-022 compared with reference trastuzumab by 1. overall response
      rate and other efficacy parameters; 2. incidence and severity of adverse events; 3. serum
      concentration after the first and multiple trastuzumab administration; 4. incidence and
      concentration of anti-trastuzumab antibodies.
    

Intervention name(s): Trastuzumab; Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 6 courses of trastuzumab in combination with paclitaxel. Trastuzumab will be administered at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations) as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).; Paclitaxel will be administered at a dose of 175 mg/m2 every 3 weeks (on Day 1 of each course) as 3 hour intravenous infusion (6 courses totally).
Other intervention name(s): BCD-022; Herceptin; Taxacad
Intervention MeSH terms: Paclitaxel; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: breast cancer; trastuzumab
Olanzapine for Nausea After Surgery
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic
      techniques have improved and pressure to reduce health-care costs has increased. While there
      are many benefits to recovering from surgery within the home, a significant disadvantage is
      the lack of rapid access to a healthcare provider when postoperative complications occur.
      Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent
      studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV) after
      ambulatory surgery, particularly in high-risk groups (female gender, age less than 50 years,
      history of PONV, opioid administration in the post-anesthesia care unit (PACU), and nausea in
      the PACU). Current practices known to reduce the risk of postoperative nausea and vomiting in
      the PACU, such as the avoidance of volatile anesthetics and the use of intraoperative
      ondansetron and steroids, have little effect on the risk of delayed PDNV. Novel strategies to
      prevent PDNV are needed. Orally administered olanzapine, which has been shown to decrease the
      incidence of chemotherapy-induced nausea and vomiting, demonstrates promise as a novel
      strategy for preventing PDNV. It has a long half-life, allowing for a single dose to be
      administered preoperatively. This study will evaluate whether there is a difference in the
      incidence and severity of PDNV between patients who receive oral olanzapine versus placebo
      prior to general anesthesia for ambulatory surgery.
    


Intervention name(s): Olanzapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg of olanzapine by mouth prior to anesthetic induction; placebo by mouth prior to anesthetic induction
Other intervention name(s): Zyprexa; 132539-06-1; Zyprexa Zydis; Olansek; Symbyax2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nausea; Vomiting
Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effects of desensitizing agents on the dental bleaching process, testing
      the hypothesis that they may control dental sensitivity.
    

Detailed description: 
      The objective of this double blind, randomized and controlled clinical study, was to evaluate
      the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low
      Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of
      bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model,
      where the hemiarcates were randomized and later allocated in one of the experimental groups:
      G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive
      control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser
      application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.
    

Intervention name(s): In-office dental bleaching; Low Level Laser Therapy; 5% potassium nitrate / 2% sodium fluoride gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.; It will be used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and apical region of the incisors, canines and premolars.; 5% potassium nitrate / 2% sodium fluoride gel will be applied for 10 minutes on the vestibular surface of all pre-bleached dental elements, following the manufacturer's protocol.
Other intervention name(s): 35% hydrogen peroxide; LLLT; desensitizing therapy
Intervention MeSH terms: Listerine; Hydrogen Peroxide; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Enemas Before Elective Cesarean Section
Condition: Complications After Cesarean Section
Study type: Interventional
Phase: Phase 2

Summary: 
      Enemas are not anymore used routinely before vaginal deliveries.The intention of this study
      is to elucidate whether there is a benefit in routine use of enema before cesarean section.
    


Intervention name(s): enema
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cesarean Section,; Enema
Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis
Condition: Blepharitis; Conjunctivitis; Keratitis
MeSH terms: Conjunctivitis; Keratitis; Blepharitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety and efficacy of antibiotic steroid combination compared with individual administration
      in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis
      and/or conjunctivitis).
    

Detailed description: 
      Antibiotic/steroid combination compared to individuals components 8 days of treatment.
    

Intervention name(s): Moxifloxacin and Dexamethasone combined; Moxifloxacin; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined; moxifloxacin 0,5% qid and; dexamethasone 0,1% qid
Other intervention name(s): vigadexa; maxidex and vigamox
Intervention MeSH terms: Moxifloxacin; Dexamethasone; Dexamethasone acetate; Norgestimate, ethinyl estradiol drug combination; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: moxifloxacin; dexamethasone; ocular inflammation; ocular infection
A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose
      via both intravenous and oral routes.
    


Intervention name(s): PF-06273588; PF-06273588
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous, 50 microgram, single dose; Oral solution, 50 microgram, single dose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Impact of Continuous Transcutaneous CO2 (TCCO2) Monitoring in Extremely Low Birth Weight (ELBW) Infants
Condition: ELBW - Extremely Low Birth Weight Infant; IVH- Intraventricular Hemorrhage
MeSH terms: Body Weight; Hemorrhage; Birth Weight
Study type: Observational

Summary: 
      An observational study comparing outcomes of Extremely Low Birth Weight (ELBW) infants that
      were monitored with non-invasive Transcutaneous CO2 (TCCO2) monitor to infants that were not
      monitored by TCCO2 monitor.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ELBW infants
Clinical Evaluation of Lithium Disilicate (e.Max) and Hybrid Nano-ceramic (Grandio) CAD/CAM Endocrowns
Condition: Personal Satisfaction
Study type: Interventional

Summary: 
      The purpose of this study is to compare marginal adaptation, fracture, retention, shade
      matching and patient satisfaction between lithium disilicate (e.max) and hybrid nano-ceramic
      (Grandio) CAD/CAM endocrowns.
    


Intervention name(s): Endocrown
Intervention type(s): Procedure
Intervention description(s): Endocrown
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lithium disilicate; hybrid ceramic
PEG-IFN Alfa-2b Plus Ribavirin for Treatment of Mexican naïve Patients With Chronic Hepatitis C Infected With Genotype 1 (Study P04511)(COMPLETED)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus
      weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1
      patients. All patients will receive peginterferon alfa-2b plus oral ribavirin for 12 weeks.
      At the end of this period, quantitative PCR will be used to determine the Early Viral
      Response (EVR) at this point of treatment. Total treatment duration will be 48 weeks for
      Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.
    


Intervention name(s): Peginterferon alfa-2b (SCH 054031); Ribavirin (SCH 018908)
Intervention type(s): Biological; Drug
Intervention description(s): All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.; All patients will receive peginterferon alfa-2b 1.5 ug/kg administered subcutaneously (SC) once weekly in combination with ribavirin (800-1200 mg/day) administered orally (PO) for a minimum period of 12 weeks. The total treatment duration will be as follows: 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.
Other intervention name(s): PegIntron; Rebetol
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment