bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Three Different Doses of Intrathecal Ketamine
Condition: Ketamine Causing Adverse Effects in Therapeutic Use
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the postoperative analgesic effect of three different
      doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee
      arthroscopy.
    

Detailed description: 
      A meta-analysis of adult human randomized controlled studies that compared single dose
      perioperative intrathecal ketamine plus intrathecal bupivacaine to bupivacaine alone in
      spinal anesthesia suggests that there is a benefit to using intrathecal ketamine as an
      adjunct to bupivacaine in multimodal analgesia. However, there are still knowledge and
      experience gaps regarding neuraxial ketamine dosing in this regard.

      Aim of the study:

      The aim of this study is to compare the postoperative analgesic effect of three different
      doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee
      arthroscopy.
    

Intervention name(s): Ketamine 0.1 mg; Ketamine 0.2 mg; Ketamine 0.3 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg; will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg; will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
S-Equol in Alzheimer's Disease (SEAD) Trial
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if S-equol could benefit persons with Alzheimer's
      Disease (AD).
    

Detailed description: 
      Alzheimer's disease (AD) is a progressive brain disorder which causes memory and thinking
      problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of
      your cells that produces energy) might be linked to symptoms of AD. Some studies have shown
      that patients with Alzheimer's disease have reduced mitochondrial activity or have fewer
      mitochondria present in neurons. In this study, it is believed that by targeting
      mitochondria, we might learn more about its influence on AD symptoms.

      Mitochondria have a receptor site for estrogen (a hormone) called estrogen receptor β (ERβ).
      When estrogen attaches to this site, it promotes mitochondrial function. Studies have also
      suggested ERβ stimulation can cause cells to create new mitochondria. More mitochondria, or
      increased activity of existing mitochondria, in the cell might have an impact on patients
      with Alzheimer's disease. One way to measure this increase in function is to look for the
      presence of an enzyme called COX in your blood. If a drug increases mitochondrial function,
      there will be an increase in COX concentration in the bloodstream.

      By doing this study we hope to learn if S-equol, a compound that acts like estrogen in the
      body, causes such an increase in mitochondrial activity. We also hope to determine the
      tolerability of a therapeutic dose of S-equol. It is our goal to advance the understanding of
      AD, particularly in women.
    

Intervention name(s): S -Equol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.; The placebo has no active ingredients but is made to look like the study drug.
Other intervention name(s): AUS-131
Intervention MeSH terms: Equol
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: S-equol; COX activity
Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving
Condition: Addiction Opiate
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      the study aim is to compare betwenn the effect of mindfulness based relapse prevention and
      other evidence based psychotherapy interventions regaring substance craving.
    

Detailed description: 
      In this prospective study, the population included opioid-dependent men (aged 18-50 years),
      some of them were admitted to El Maamora hospital and others were attendees in NA. To conduct
      this research, considering the drop-out rate, the list of 60 persons applying for treatment
      was prepared based on inclusion and exclusion criteria.

      Then, three groups of 20 were randomly selected and placed in three intervention groups,
      group one received CBT, group two received MBRP, and group three received twelve-step
      therapy.

      The subjects were assigned randomly to the treatment condition via a computer-generated
      random number with the aid of trained staff at the clinic blindly.

      All participants completed the measurement scales immediately after detoxification (pre-test)
      and after the end of therapeutic sessions (post-test).
    

Intervention name(s): cognitive behavioral therapy,mindfulness based relapse prevention,twelve-step therapy
Intervention type(s): Behavioral
Intervention description(s): In cognitive-behavioral therapy, participants learned that thoughts and emotions contribute to behavior, and responses to thoughts and emotions can be controlled.
in mindfulness-based relapse prevention, participants learned to focus on the present moment experience including craving with an attitude of acceptance and non-judging.
In twelve-step therapy, participants learned principles of acceptance, gratitude, forgiveness, tolerance, patience, humility, and honesty together with participation in different healthy ways to enrich life.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Standard cognitive behavioral therapy comprises approaches directed toward modifying dysfunctional thinking and behavior discussed through 8 sessions.
mindfulness based relapse prevention is an 8-week therapy program based on:
Attention to present moment experience, even if it includes craving or negative emotion.
An accepting attitude towards this experience letting it be exactly as it is, without judging it or reacting to it.
This group therapy was facilitated by an ex-addict working in El Maamora hospital.
12-step therapy was based on strengthening conscious contact with God and awakening spirituality through prayer and meditation.
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Peptide YY (PYY)in Inhibiting Food Intake.
Condition: Obesity
Study type: Interventional

Summary: 
      12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of
      PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4
      escalating doses PYY3-36 on 5 different test days within one week. The patients will be
      tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum
      energy intake, blood pressure and blood sampling will be performed during the test day.
    


Intervention name(s): peripheral Peptide YY administration
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
High-dose Vitamin D Supplementation for ADT-induced Side Effects
Condition: Prostatic Neoplasms; Bone Mineral Density Quantitative Trait Locus 3
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of a high-dose vitamin D supplementation
      regimen in reducing androgen deprivation therapy (ADT)-related side effects in older prostate
      cancer patients on ADT. The proposed study is a randomized, double-blind, 2-arm, controlled
      clinical trial that will accrue 76 prostate cancer patients without severe bone loss, aged 60
      and older, beginning ADT, and scheduled to receive at least 6 months more of ADT.
      Participants will be randomized to: 1) weekly high-dose vitamin D3 (50,000 IU) or 2) vitamin
      D placebo only for a period of 24 weeks. Both groups will also receive a daily multivitamin
      and calcium supplement.
    

Detailed description: 
      The investigators hypothesize high-dose vitamin D supplementation will reduce androgen
      deprivation therapy (ADT)-related side effects including ADT-induced bone loss, decreased
      muscle mass, falls, reduced muscle strength, and diminished physical performance in older
      prostate cancer patients. The vitamin D supplementation is aimed at reducing fracture risk by
      maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and
      increasing muscle mass. Both vitamin D and exercise are efficacious in maintaining proper
      bone health and muscle mass among the general population, but little research has been done
      on prostate cancer patients and survivors. Vitamin D could reduce fracture risk among
      prostate cancer survivors.
    

Intervention name(s): vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 50,000IU/week of vitamin D3
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: prostate cancer; bone density; vitamin D; micronutrients; pharmacologic actions
Study of the Renal Perfusion in Healthy Volunteers and Renal Transplant Recipients During an Orthostatic Stress
Condition: Safe Volunteers; Kidney Transplant Recipients
Study type: Interventional

Summary: 
      Autonomic nervous system contributes to the regulation of renal blood flow, affected by
      upright posture. Kidney transplantation implies sympathetic denervation. The aim of this
      study is to compare the renal vascular response in volunteers and renal graft recipients to
      an orthostatic stress induced by a head-up tilt test. Renal peripheral resistances are
      assessed by echo Doppler. The sympathetic nervous system activity is evaluated by plasma
      concentrations of catecholamine before and after the head-up tilt test.
    


Intervention name(s): tilt test
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIGB), may carry
      radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such
      as irinotecan and vincristine, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Giving iodine I 131 MIGB
      together with irinotecan and vincristine may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 MIGB
      when given together with irinotecan and vincristine in treating young patients with resistant
      or relapsed high-risk neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the maximum tolerated dose (MTD) of iodine I 131 metaiodobenzylguanidine
           when given in combination with fixed-dose irinotecan hydrochloride and vincristine in
           young patients with refractory or relapsed high-risk neuroblastoma.

        -  To determine the dose-limiting toxicities of iodine I 131 metaiodobenzylguanidine when
           combined with fixed-dose irinotecan hydrochloride and vincristine.

      Secondary

        -  To determine if there is a therapeutic response to this regimen.

      OUTLINE: This is a multicenter, dose-escalation study of iodine I 131 metaiodobenzylguanidine
      (^131I-MIBG).

      Patients receive ^131I-MIBG IV over 1½-2 hours on day 1, vincristine IV on days 0 and 7, and
      irinotecan hydrochloride IV over 1 hour on days 0-4 and 7-11. Treatment repeats every 56 days
      in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 1 year and then
      every 6 months thereafter.
    

Intervention name(s): irinotecan hydrochloride; vincristine sulfate; iobenguane I 131
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Irinotecan; Vincristine; 3-Iodobenzylguanidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent neuroblastoma
The Implantable Cardioverter-defibrillators (ICD)/Device Expectations, Adaptations, and Successes Study
Condition: Depression; Anxiety; Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The introduction of pacemakers and implantable cardioverter-defibrillators (ICDs) has
      substantially changed the medical and surgical management of patients with cardiac rhythm
      disease. In the case of patients with ICDs, these devices are programmed to deliver a strong
      electrical shocks. In adults, multiple studies have suggested that patients at risk of
      receiving shocks from their device have an increased prevalence of anxiety and depression.
      Very few studies have looked at this question in children. We propose to evaluate a cohort of
      patients age 6 to 20 with ICDs, compared to a cohort of patients with pacemakers, assessing
      each group for the presence of depressive and anxiety disorders, including post-traumatic
      stress disorder (PTSD).
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients at participating center with pacemakers and ICDs who fit inclusion/exclusion
        criteria.
      
Keywords: Pacemaker; Implantable cardioverter-defibrillator
Honey Dressing - A Preventive Procedure for Post-Surgical Site Infection.
Condition: Wound Infection; Wound Dehiscence; Wound Bleeding; Wound Surgical
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Wounds and Injuries; Surgical Wound
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this clinical trial is to compare the wound healing in the participants who
      underwent the clean surgical procedure, by applying honey dressing and common Iodine solution
      dressing, participants will have no other co-morbidities like Diabetes, Anemia, etc. which
      can make the results biased. The main questions it aims to answer are:

        -  Do the iodine solutions are enough to counter the infections caused by resistant strains
           of bacteria?

        -  What is the efficacy and efficiency of honey dressing in wound care?

      Participants will be tasked to

        -  Ensure strict follow-up in the hospital dressing room

        -  Half of the participants will apply common iodine solution dressing and the other half
           will be applied honey dressing.

      Researchers will compare Iodine dressing (Control group) with Honey dressing (Experimental
      group) to see if Honey dressing is better in the prevention of post-surgery wound infection
      and if it is cost-efficient and its efficacy.
    


Intervention name(s): Honey Dressing; Iodine Dressing
Intervention type(s): Biological; Drug
Intervention description(s): Honey Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed.; Iodine Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed.
Other intervention name(s): Iodine solution dressing
Intervention MeSH terms: Iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
Condition: Chronic Hepatitis C; Renal Impairment
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of
      combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic
      (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with
      end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal
      impairment. Both groups were compared to healthy matched controls.
    


Intervention name(s): Grazoprevir; Elbasvir
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg oral tablet administered once a day for 10 days; 50 mg oral tablet administered once a day for 10 days
Intervention MeSH terms: Grazoprevir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy
Condition: Hypogonadotrophic Hypogonadism
MeSH terms: Insulin Resistance; Hypogonadism; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study searched for answers to two questions

        1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with
           congenital hypogonadotropic hypogonadism?

        2. What is the effect of testosterone replacement therapy on endothelial dysfunction,
           inflammation and insulin resistance?
    


Intervention name(s): Testosterone 250mg injection; Testosteron 50 mg transdermal gel
Intervention type(s): Drug; Drug
Intervention description(s): The testosterone 250mg ester intramuscular injections performed in three weeks; 50mg testosterone gel implemented on every night
Other intervention name(s): Sustanon 250 mg amp.; Testogel 50mg transdermal gel
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypogonadism; Endothelial dysfunction; Insulin resistance; Inflammation; Testosterone replacement therapy
A Study to Evaluate Whether Food Has an Effect on the Uptake of Solifenacin and Tamsulosin When Administered in a Combination Tablet
Condition: EC905; Pharmacokinetics; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of food (low and high fat breakfast vs. fasting) on the
      pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and
      tamsulosin administered as combination tablet EC905. Also to evaluate the safety and
      tolerability of single doses of EC905 in young, healthy male subjects, when administered
      under fed (low and high fat) or fasting conditions.
    

Detailed description: 
      Subjects are admitted to the clinic on Day -1 and receive a single dose of the combination
      tablet EC905 on the first day of 3 periods, under three conditions (high fat breakfast, low
      fat breakfast, and fasting) in order to evaluate the effect of food.

      Blood sampling for pharmacokinetic (PK) assessment is performed on the dosing day and for 11
      days after dosing in each period. This 11-day on-site period is repeated three times so that
      all subjects are dosed under all conditions. Each period is separated by 7 days off site.

      Subjects return for an End of Study Visit (ESV) at least 7 days after the last 11 day on-site
      period, or after withdrawal.

      On Day 1 of each of 3 periods, subjects are given a single dose of EC905 under three
      conditions (high fat breakfast, low fat breakfast and fasting) in order to evaluate the
      effect of food on the PK of solifenacin and tamsulosin HCl. The aim is to show the absence of
      a food effect after a low fat breakfast vs. fasting conditions, and to evaluate the food
      effect after a high fat breakfast vs. fasting conditions.

      Subjects are randomized to one of 6 possible sequences of fasted or fed conditions.

      Screening takes place from Day -21 to Day -1. They are admitted to the clinic on Day -1.
      Blood sampling for PK assessment is performed from Day 1 to Day 11 of each period. This 11
      day on-site period is repeated three times in order to allow all subjects to be dosed under
      fed (low and high fat) and fasting conditions.

      The 11 day on-site periods are separated by 7-day off site periods; subjects are checked for
      eligibility again one day prior to the start of a new dosing day.

      Safety assessments are performed throughout the investigational period. Subjects return for
      an ESV at least 7 days after the last 11 day on-site period, or after withdrawal.
    

Intervention name(s): EC905
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): Vesomni; VesiFlow; Urizia
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Combination tablet EC905; Omnic OCAS®; Vesicare®; Food effect; Vesomni; VesiFlow; Urizia
Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets
      administered once-daily compared to Prograf capsules administered twice-daily after kidney
      transplantation.
    

Detailed description: 
      This is a 2-arm , parallel group, prospective, double-blind, double-dummy,
      multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily
      in comparison to Prograf capsules twice-daily after kidney transplantation.
    

Intervention name(s): LCP-Tacro tablets; Prograf
Intervention type(s): Drug; Drug
Intervention description(s): Tacrolimus; Tacrolimus
Other intervention name(s): Prograf; Prograf Capsules twice daily
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment