bioihbjkbjnl/mcl2 huggingface dataset:
S-1 and and Gemcitabine vs Gemcitabine Alone as Adjuvant Chemotherapy for Patients With Resected Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, open-label, controlled study that will compare the efficacy of
      S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients
      with surgically resected pancreatic adenocarcinoma.
    


Intervention name(s): S-1, Gemcitabine
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of Rectus Sheath Block to Control Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block
      (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.
    

Detailed description: 
      Prospective, randomized study.Forty patients with American Society of Anaesthesiologists
      (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups
      and are administered general anesthesia and before the beginning of surgery ultrasound guided
      RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the
      loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M,
      respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of
      morphine and 30 minutes lockout interval is set up postoperatively in both groups.
    

Intervention name(s): ultrasound guided rectus sheath block; Morphine
Intervention type(s): Procedure; Drug
Intervention description(s): the application of rectus sheath block with ultrasound guidance
Other intervention name(s): US guided rectus sheath block
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laparotomy; levobupivacaine; patient controlled analgesia
Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy
Condition: Drug Resistant Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional

Summary: 
      Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug
      resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams
      University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs
      AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at
      base line and after 6 months of treatment.
    

Detailed description: 
      The Aim of this work was to study the effect of Magnesium as add on therapy on clinical
      seizure control in drug resistant idiopathic epilepsy and IQ.
    

Intervention name(s): Magnesium; Placebo - Concentrate
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Oral magnesium; Placebo will be given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Children; IQ; Idiopathic epilepsy; Magnesium supplementation; Seizure control; Chalfont score
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Condition: Smoking Cessation
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety
      for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total
      of 52 weeks of cardiovascular safety data collection.
    

Detailed description: 
      This study is an extension protocol for study A3051123. No treatment is provided during this
      study. This study is to monitor for cardiovascular events 28 weeks after completion of
      A3051123. This study is an extension protocol for study A3051123. No treatment is provided
      during this study. This study is to monitor for cardiovascular events 28 weeks after
      completion of A3051123.
    

Intervention name(s): placebo; varenicline tartrate; bupropion hydrochloride; Nicotine Replacement Therapy Patch
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): All dosing to have taken place per study A3051123; All dosing to have taken place per study A3051123; All dosing to have taken place per study A3051123; All dosing to have taken place per study A3051123
Other intervention name(s): Chantix; Champix; Zyban; NRT
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: smoking cessation; psychiatric disease; cardiovascular events
Use of Tranexamic Acid in the Total Knee Arthroplasty.
Condition: Knee Osteoarthritis; Blood Loss; Blood Transfusion
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Tranexamic acid is a medication used to treat or prevent excessive blood loss during surgery.
      Previous studies have shown tranexamic acid (TXA) reduces blood loss and post-operative blood
      transfusion rate without significant complications. In addition, many meta-analyses have
      confirmed these results. This study also aims to determine how safe and effective tranexamic
      acid treatment is for different patients undergoing primary total knee arthroplasty.
    

Detailed description: 
      Tranexamic acid (TXA) is used to control both intraoperative (IO) and postoperative (PO)
      bleeding during various surgical procedures. Moreover, TXA was found to indirectly reduce
      post-surgery infection rates and decrease hemorrhage-related mortality in trauma patients.
      This study aims to determine how safe and effective tranexamic acid treatment is for patients
      undergoing primary total knee arthroplasty. The study is a prospective, randomized,
      triple-blinded, placebo-controlled study. Ninety participants were enrolled between July 2021
      and September 2022 and followed up with every patient for six months.

      The study was done in Damascus, Syria. Participants were randomly assigned following simple
      randomization procedures (computerized random numbers) to 1 of 2 groups. The allocation was
      put into concealed envelopes independent of the surgeon and the author, and the randomization
      was performed by a research fellow who was not involved in patient care. Participants who
      went unilateral primary TKA and did not use TXA, just IV normal saline (0.9% sodium
      chloride), formed the control group. In contrast, the intervention group comprised
      participants who went primary unilateral TKA and used two-dose intravenous tranexamic acid
      that was applied as follows: 10mg/kg of Tranexamic Acid in 100 Milliliters（ml) normal saline
      (0.9% sodium chloride), the first dose 15 minutes before the tourniquet deflation and the
      second dose at 180 minutes after the first dosage.
    

Intervention name(s): Tranexamic Acid 100 MG/ML; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Tranexamic Acid: 100 MG/ML Solution for injection; 0.9% sodium chloride normal saline
Other intervention name(s): TXA; NS
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tranexamic acid; total knee arthroplasty; blood loss; complication
HTEMS Treatment of Diabetic Polyneuropathy
Condition: Diabetic Polyneuropathy
MeSH terms: Polyneuropathies; Diabetic Neuropathies
Study type: Interventional

Summary: 
      So far, there are no sufficient pharmacologic therapies for the treatment of diabetic
      neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation
      (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.
    

Detailed description: 
      Patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized
      controlled trial. Each intervention will be administered for a period of at least 30 min on
      at leat 5 days in a week. Health impairments will be assessed using the neuropathy symptom
      score (NSS) before, during and after intervention.
    

Intervention name(s): HTEMS; Placebo
Intervention type(s): Device; Device
Intervention description(s): high-tone external muscle stimulation; Placebo stimulation
Other intervention name(s): HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany); Placebo treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; neuropathy; pain; HTEMS
Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The study assesses PK and safety of other drugs, such as some antibiotics, proton pump
      inhibitors, statins, and combined oral contraceptives when co-administered with Elpida®
    

Detailed description: 
      This study evaluates the drug-drug interaction of Elpida® and other drugs (Rifampin,
      Rifabutin, Clarithromycin, Omeprazole, Atorvastatin and combinations of Levonorgestrel and
      Ethinylestradiol) according to changes in the PK parameters of the study substances in their
      single co-administration in healthy subjects
    

Intervention name(s): Elpida®; Rifampin; Rifabutin; Clarithromycin; Omeprazole; Atorvastatin; Levonorgestrel+Ethinylestradiol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Elpida® capsules, 20mg; Rifampin capsules, 150mg; Rifabutin capsules, 150mg; Clarithromycin Film-coated tablets, 250mg; Omeprazole Film-coated tablets 20mg; Atorvastatin Film-coated tablets, 80mg; Levonorgestrel 150 μg + Ethinylestradiol 30 μg, Film-coated tablets
Other intervention name(s): elsulfavirine; VM1500; VM-1500
Intervention MeSH terms: Clarithromycin; Rifampin; Rifabutin; Elsulfavirine; Omeprazole; Atorvastatin; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1
Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder
Condition: Alcohol Dependence; Posttraumatic Stress Disorder
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to test if provision of an effective psychotherapy for
      Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol
      dependent patients with PTSD and if it is associated with better treatment outcomes compared
      to an active control condition.
    


Intervention name(s): Trauma-focused exposure therapy; Motivational enhancement + trauma-focused exposure therapy; Healthy lifestyles sessions
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): cognitive behavioral therapy for PTSD; Cognitive behavioral therapy for PTSD
Other intervention name(s): Prolonged exposure; Trauma-focused motivational enhancement therapy; Prolonged Exposure; Motivational Interviewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome
Condition: Secons Stage of Labor
Study type: Interventional

Summary: 
      The use of fundal pressure in management of the second stage of labor is controversial. The
      aim of this study is both to evaluate the effectiveness of fundal pressure in shortening the
      second stage of labor and to examine the related neonatal and maternal outcomes.
    

Detailed description: 
      Patients will be randomly allocated to two groups by using a computer-generated random number
      chart: Kristeller maneuver intervention (study) group (n=140) and control group (n=140).
      Umbilical artery blood gas will obtained to assess the newborn's acid-base status. The
      umbilical artery levels of creatinine kinase, creatinine kinase with myocardial specific
      isoform, aspartate amino transferase, alanine amino transferase, lactate dehydrogenase and
      lactic acid will be measured. Length of episiotomy and length of vagina will be measured at
      45 degrees from the midline. Each patient's vaginal laceration, cervical laceration, length
      of episiotomy and vagina before and after delivery and duration of the second stage of labor
      in minutes will be recorded. Neonatal information will include: infant birth weight, apgar
      scores, babies requiring pediatric help, and admission of neonatal intensive care units.
    

Intervention name(s): KRISTELLER
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Kristeller maneuver; Second stage of labor;; Perineal laceration; Obstetrical outcome;; Neonatal outcome
Study of Safety, Blood Levels and Brain Receptor Occupancy of GSK598809 Using PET Imaging in Health Males.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how much of a new drug, GSK598809 binds to specific
      proteins in the brain and how much stays in the blood over a range of different doses.
    


Intervention name(s): GSK598809, using [11C]-(+)-PHNO
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PET scan; Health Males
SHCP in 4-H Using Teenagers as Teachers
Condition: Nutrition Knowledge; Vegetable Preferences; Youth Engagement; Civic Responsibility
Study type: Interventional

Summary: 
      In close collaboration with the Nevada County 4-H Youth Development Program, the Shaping
      Healthy Choices Program was implemented utilizing 4-H teenagers as cross-age teachers for
      younger youth. The 4-H Youth Development Program is an education program of the University of
      California Cooperative Extension that emphasizes learning citizenship, leadership, and life
      skills. The program creates positive opportunities for youth to learn, develop skills, and
      become engaged in their local communities. This is accomplished with combined efforts of
      youth, volunteer leaders, and University staff and faculty through a fun, hands-on learning
      approach to non-formal education. As a requirement to participate in the program, all youth
      had to enroll in 4-H for the 2016-2017 year. Teenagers were initially trained in
      inquiry-based and experiential learning techniques before facilitating the program. Teenage
      teachers collectively lead classroom education, garden activities, and cooking
      demonstrations. Additionally, teenage teachers, UC Cooperative Extension staff, and UC Davis
      students organized and implemented a community health fair for elementary-aged children.

      Measurements were taken on nutrition knowledge, vegetables preferences, civic responsibility,
      program fidelity, and self-efficacy for teaching nutrition. A parent interview was also
      conducted to gauge parental engagement and perception of whether their child had behavior
      changes while participating in the program. Preliminary findings from the parent interview
      show that children were more likely to support and engage in healthy eating practices
      throughout their involvement than they had before the program. Children also have expressed
      interests in continuing their participation in subsequent years. All other data for this
      intervention are currently undergoing analyses.
    


Intervention name(s): Teenagers as cross-age SHCP teachers for younger youth
Intervention type(s): Behavioral
Intervention description(s): Implementation of the SHCP using teenagers as cross-age teachers for younger youth
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Anti-oxidant, Anti-aging and Wellbeing Effects of a Novel Nutraceutical Formulation (HealthSpan)
Condition: Aging; Well Aging; Oxidative Stress
Study type: Interventional

Summary: 
      The study was designed as a randomized, placebo-controlled trial with follow-up at 3 months.
      The study is in accordance with the Declaration of Helsinki and was approved by the
      Institutional Bioethical Committee of the National Hellenic Research Foundation. All the
      study participants received informative material, filled a questionnaire regarding the
      self-assessment of their health status and nutritional habits, and signed their written
      informed consent. In total, excluding the participants that did not return for the follow-up
      (dropouts), 122 apparently healthy volunteers of age 29-85 were followed, with 43 of them
      being randomly assigned in the placebo subgroup and 79 receiving the composition of the
      present invention.
    

Detailed description: 
      The study was designed as a randomized, placebo-controlled trial with follow-up at 3 months.
      The study is in accordance with the Declaration of Helsinki and was approved by the
      Institutional Bioethical Committee of the National Hellenic Research Foundation. All the
      study participants received informative material, filled a questionnaire regarding the
      self-assessment of their health status and nutritional habits, and signed their written
      informed consent. Patients eligible for the inclusion criteria were randomized into two
      groups: the group of healthy adult volunteers that received a capsule with the active
      formulation and those the received the placebo (a capsule with only the carrier substance
      magnesium stearate) In total, excluding the participants that did not return for the
      follow-up (dropouts), 122 apparently healthy volunteers of age 29-85 were followed, with 43
      of them being randomly assigned in the placebo subgroup and 79 receiving the composition of
      the present invention.
    

Intervention name(s): HealthSpan; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention was conducted on a group of healthy volunteers of age 29-85 with a once-daily administration of the oral capsule containing the active ingredients, for three consecutive months.; The intervention was conducted on a group of healthy volunteers of age 29-85 with a once-daily administration of the placebo, for three consecutive months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nutraceuticals; dietary supplements; antioxidant defense; proteostasis; well-being
Study of the Effects of ITCA 650 on Gastric Emptying and Interaction of ITCA 650 on 4 Commonly Studied Drugs
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Fixed-Sequence, Open-label Study in Healthy Subjects to Estimate the Effects of
      ITCA 650 on Gastric Emptying and on the Absorption Pharmacokinetics of Each of 4 Commonly
      Studied DDI Probe Compounds.
    

Detailed description: 
      Acetaminophen will be use to assess the effect of ITCA 650 on the rate of gastric emptying.

      Interactions between ITCA 650 and the medications lisinopril, digoxin, atorvastatin, and
      warfarin will also be studied.
    

Intervention name(s): ITCA 650 20/60 mcg/day; Acetaminophen; Atorvastatin; Lisinopril; Warfarin; Digoxin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ITCA 650 osmotic mini pump delivering exenatide 20 mcg/day for 14 days, followed by ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day.; Oral acetaminophen 1000 mg on Day 1 and Day 27; Oral atorvastatin 40 mg on Day 2 and Day 28; Oral lisinopril 20 mg on Day 2 and Day 28; Oral warfarin 25 mg on Day 2 and Day 28; Oral digoxin 0.5 mg on Day 2 and Day 28
Intervention MeSH terms: Acetaminophen; Exenatide; Digoxin; Lisinopril; Warfarin; Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adult; Male; Female; Volunteers
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
Condition: Anemia; Chronic Kidney Disease; Chronic Renal Failure; Cancer
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum
      pharmacologically active dose of peginesatide in Healthy Volunteers.
    

Detailed description: 
      This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis
      stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer
      participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was
      randomly assigned to receive a single dose of peginesatide or placebo, respectively,
      administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by
      cohort. The study was conducted at a single clinical center.
    

Intervention name(s): Placebo; peginesatide
Intervention type(s): Drug; Drug
Other intervention name(s): Omontys; Hematide; AF37702 Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: anemia; chronic kidney disease; CKD; chronic renal failure; CRF; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide™; hemoglobin; Hb; Hgb; Omontys; peginesatide; red blood cell; red blood cell production