bioihbjkbjnl/mcl2 huggingface dataset:
Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
Condition: Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V; Lipidoses; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the
      effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A
      coadministered with simvastatin) will be superior to atorvastatin on decreasing the low
      denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio
      for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg
      MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg
      MK-0524B versus 80 mg atorvastatin.
    


Intervention name(s): MK-0524A; Atorvastatin; Simvastatin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Lipitor; Zocor
Intervention MeSH terms: Atorvastatin; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction
Condition: Intrauterine Growth Restriction
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 2

Summary: 
      Intrauterine growth restriction is a common and complex obstetric problem. Intrauterine
      growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine
      growth restriction is diagnosed antenatal; however, some of these fetuses, especially if
      unscreened during pregnancy, may be detected only in the neonatal period. It is very
      important for obstetricians and perinatologists to identify growth restricted fetuses,
      because this fetal condition is associated with significant perinatal morbidity and
      mortality.

      Omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon
      atom from the end of the carbon chain. The fatty acids have two ends, the carboxylic acid
      end, which is considered the beginning of the chain, thus "alpha", and the methyl end, which
      is considered the "tail" of the chain, thus "omega." Omega3 improve fetal wellbeing by two
      mechanisms: Firstly, maternal and docosahexaenoic acid supplementation during pregnancy and
      lactation normalizes intrauterine growth restriction induced changes in adipose deposition
      and visceral PPARγ expression. Secondly, maternal docosahexaenoic acid supplementation
      increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin
      receptors. Novel findings suggest that maternal docosahexaenoic acid supplementation
      normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic
      function in intrauterine growth restriction
    


Intervention name(s): Low dose aspirin; Omega 3
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Mictalase® After ThuLEP
Condition: BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      In this single-center, prospective, randomized, open label, phase-III study, patients with
      indication to Thulium Laser Enucleation of Prostate were enrolled. The report conformed to
      CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group
      A: patients who were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5
      days, then once a day for other 10 days; Group B: patients who did not receive the
      suppositories ("controls"). Study endpoints were evaluated at 15 and 30 days postoperation.
      Primary endpoint included evaluation of effects of the suppository on irritative symptoms by
      administering International Prostate Symptom Score (IPSS) with Quality of Life (QoL)
      questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections
      by performance of urinalysis with urine culture.
    


Intervention name(s): Phenolmicin P3 and Bosexil suppository
Intervention type(s): Device
Intervention description(s): The suppository we herein investigated includes different active principles, namely: Bosexil®, that is a vegetal extract derived from the resin of the Boswellia serrata, a plant native to India. It has already been published that the Boswellic acids contained show anti-inflammatory and antioxidant properties in a variety of inflammatory diseases whose physio-pathological pathways are shared with those of prostatitis; phenolmicin P3 is a polyphenolic extract derived from beehive propolis, that also demonstrated anti-inflammatory and antioxidant properties in preclinical reports. It has also been reported to have the ability to create a microenvironment hostile to the reproduction of pathogenic bacteria.
Other intervention name(s): Mictalase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: benign prostatic hyperplasia; BPH; laser enucleation; ThuLEP; LUTS; urinary tract infections
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)
Condition: Adult Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates the efficacy and tolerability of an intensified induction and
      consolidation therapy. Thereafter patients receive individualised treatment stratified
      according to relapse risk with stem cell transplantation for patients with high and very high
      risk of relapse. Patients with standard risk receive further consolidation and reinduction
      chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and
      one year the decision on intensification or discontinuation of therapy is made based on the
      results of MRD evaluation.
    


Intervention name(s): Cyclophosphamide; Dexamethasone; Vincristine; Daunorubicin; Asparaginase; Methotrexate; Cytarabine; Mercaptopurine; G-CSF; Vindesine; Etoposide; Prednisolone; Adriamycin; Thioguanine; Teniposide; CNS irradiation; Mediastinal Irradiation; Stem cell transplantation (SCT); Idarubicin; Fludarabine; Cladribine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure; Drug; Drug; Drug
Intervention description(s): Cytostatic drug; Antileukemic drug; Cytostatic drug; Cytostatic drug; Cytostatic drug; Cytostatic drug; Cytostatic drug; Cytostatic drug; Growth factor; Cytostatic drug; Cytostatic drug; Antileukemic drug; Cytostatic drug; Cytostatic drug; Cytostatic drug; Cytostatic drug; Irradiation; Stem cell transplantation; Cytostatic drug; Cytostatic drug; Cytostatic drug
Other intervention name(s): Pegylated Asparaginase; Etoposide Phosphate
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisolone; Cyclophosphamide; Methotrexate; Fludarabine; Etoposide; Etoposide phosphate; Vincristine; Doxorubicin; Daunorubicin; Asparaginase; Mercaptopurine; Idarubicin; Thioguanine; Cladribine; Vindesine; Teniposide; Pegaspargase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALL; Treatment; de novo; Minimal residual disease; Adult
Effect of Food on Peposertib PK
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate the effect of food on the Pharmacokinetic (PK) of a single dose of
      peposertib administered as film-coated tablet under fed and fasted conditions. Furthermore,
      the PK profile of peposertib administered as an oral suspension of disintegrated tablets and
      as film-coated tablets will be compared under fasted conditions to evaluate the relative
      bioavailability in healthy participants.
    


Intervention name(s): Peposertib; Peposertib
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of Peposertib tablet under fasting (Treatment A) or fed (Treatment B) conditions.; Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.
Other intervention name(s): MSC2490484A; M3814; MSC2490484A; M3814
Intervention MeSH terms: Peposertib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Peposertib; Pharmacokinetics; Relative Bioavailability
Biological Specifications for Denture Designs
Condition: Tooth Loss
MeSH terms: Tooth Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary term goal of these research efforts has been to enhance the functional status,
      comfort and quality of life of edentulous patients by evaluating clinical procedures, denture
      designs and adjunctive therapies based upon a clear understanding of: (1) oral functional
      impairments caused by the loss of teeth and subsequent tissue changes; (2) neurophysiological
      mechanisms associated with oral functions; (3) metabolism of oral tissues; and (4)
      interactions between biological and psychological processes and denture characteristics. The
      primary purpose of the proposed clinical outcome study is to compare the relative efficacies
      of three different combinations of implant-supported maxillary and mandibular prostheses with
      traditional complete dentures for edentulous patients. Completion of this study will
      determine the relative cost-effectiveness of the implant-supported denture treatments for use
      in the general population of edentulous patients.
    


Intervention name(s): Implant-supported denture
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dental implant
Thoracic Epidural Reduces Risks of Increased Left Ventricular Mass Index During Coronary Artery Bypass Graft Surgery
Condition: Ischemia Coronary Artery Origin
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Increased left ventricular mass index (LVMI) results from aortic valve lesions as an adaptive
      mechanism to help limit systolic wall stress and preserve ejection fraction (EF). This study
      Aim to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV
      function in patients undergoing aortic valve replacement (AVR) alone or in addition to
      coronary artery bypass graft (CABG). It Designs as A prospective randomized controlled
      comparative study in which eighty patients received either general anesthesia ( control group
      n=40) or with high thoracic epidural analgesia(HTEA group n=40). Each group subdivided to
      normal (LVM) (n=20)or increased(LVM) group(n=20), all submitted to (AVR) alone or in addition
      to (CABG).
    

Detailed description: 
      Background: Increased left ventricular mass index (LVMI) results from aortic valve lesions as
      an adaptive mechanism to help limit systolic wall stress and preserve ejection fraction (EF).

      Aim: to investigate the effects of sympathetic blockade by HTEA on systolic and diastolic LV
      function in patients undergoing aortic valve replacement (AVR) alone or in addition to
      coronary artery bypass graft (CABG).

      Design: A prospective randomized controlled comparative study. Methods: Eighty patients
      received either general anesthesia ( control group n=40) or with high thoracic epidural
      analgesia(HTEA group n=40). Each group subdivided to normal (LVM) (n=20)or increased(LVM)
      group(n=20), all submitted to (AVR) alone or in addition to (CABG).Perioperative heart rate
      (HR), mean arterial blood pressure (MAP), incidence of ischemic ECG, LV systolic and
      diastolic function changes were measured till 48 h, postoperatively.

      Patients were subjected to ambulatory Holter monitoring, Hemodynamic measures, intraoperative
      transesophageal echocardiography (iTEE) and postoperative Trans Thoracic Echocardiography
      (TTE) to assess myocardial ischemia and Left ventricular systolic/diastolic function.
    

Intervention name(s): thoracic epidural
Intervention type(s): Device
Intervention description(s): high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG
Other intervention name(s): high thoracic epidural anesthesia (HTEA) combined with GA; transesophageal and transthoracic echocardiography; Holter ECG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Epidural.; ventricular mass; Aortic valve; coronary bypass
Safety, Tolerability, PK & Efficacy of V81444 in Volunteers With Attention Deficit/ Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to evaluate the safety, tolerability, effectiveness,
      and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD.
      Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and
      eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood
      samples will be taken throughout the study for PK analysis.
    


Intervention name(s): V81444; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14; Capsules to match V81444 twice daily for 13 days and once on Day 14
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit/ Hyperactivity Disorder
Brain Effects of Escitalopram and Citalopram Using fMRI
Condition: Antidepressant Activity in Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake
      inhibitors that alter blood flow to the amygdala and other brain structures involved in
      regulating mood. Escitalopram consists of S-citalopram while citalopram contains both
      S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may
      block the effects of S-citalopram. The hypothesis being tested is that because of the
      antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood
      circuit than racemic citalopram when equal doses of S-citalopram are administered. The study
      design consists of a two week medication period followed by blood oxygen level dependent
      (BOLD) functional magnetic resonance imaging (fMRI) while viewing affective visual stimuli.
    


Intervention name(s): Escitalopram; Citalopram; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One week of escitalopram taken orally at 10 mg followed by one week at 20 mg daily.; One week of citalopram taken orally at 20 mg followed by one week at 40 mg daily.; Two weeks of placebo taken orally.
Other intervention name(s): Lexapro; Celexa
Intervention MeSH terms: Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Citalopram; Escitalopram; Celexa; Lexapro; fMRI; antidepressant; healthy volunteers
Effect of Ketoconazole on Biliary Excretion of AZD0837
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an explorative study and the scientific question to be investigated is if the biliary
      excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by
      co-administration with ketoconazole
    


Intervention name(s): AZD0837; Ketoconazole; ketoconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral solution, dosing through the Loc-I-Gut catheter, single dose; tablets, orally, once daily for 3 days; dissolved tablets, dosing through the Loc-I-Gut catheter, single dose
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics
A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Condition: Geographic Atrophy
MeSH terms: Geographic Atrophy; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled
      study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections
      administered monthly or every other month in patients with geographic atrophy.
    


Intervention name(s): FCFD4514S; sham
Intervention type(s): Drug; Drug
Intervention description(s): Repeating intravitreal injection; Repeating sham injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Simulation of Perinatal Grief. (SPG)
Condition: Perinatal Death; Perinatal Grief; Teaching Innovation
MeSH terms: Perinatal Death
Study type: Interventional

Summary: 
      A proposal for teaching innovation is proposed with the topic of "perinatal grief" very
      little studied and taught in degrees such as medicine, nursing and psychology, with
      scientific evidence demonstrating a knowledge deficit on the part of healthcare
      professionals.
    

Detailed description: 
      A proposal for teaching innovation is proposed with the topic of "perinatal grief" very
      little studied and taught in degrees such as medicine, nursing and psychology, with
      scientific evidence demonstrating a knowledge deficit on the part of healthcare
      professionals. With the aim of improving this knowledge and the communication skills of the
      students who are taught, the objective is to introduce perinatal grief so that the level of
      knowledge on this topic increases and also increases their communication abilities in this
      aspect, being a very difficult topic to cover if you do not have training. To carry out
      teaching innovation, it is proposed, in addition to a master class to impart theoretical
      knowledge, to innovate by carrying out clinical simulation among students and through a
      questionnaire to evaluate whether this type of technique is effective for the acquisition of
      knowledge, skills to provide support. , improve self-awareness and also assess student
      satisfaction.
    

Intervention name(s): Educative intervention
Intervention type(s): Other
Intervention description(s): an activity for simulation-based learning First, a theoretical session was carried out in order to acquire theoretical knowledge, skills to provide support for perinatal grief, and improve self-awareness. Prior to this, a pre-questionnaire was carried out in order to previously evaluate these aspects.
Subsequently, a first session was held to make contact with the simulation, teach the scenarios, material, etc. After this, two questionnaires were passed: one related to the acquisition of knowledge, skills to provide support, self-awareness and another on the students' satisfaction with the simulation.
Other intervention name(s): Formative intervention
Intervention model: Single Group Assignment
Intervention model description: This is an activity for simulation-based learning.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Perinatal Death; Grief; Teaching Innovation; Clinical simulation
Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users
Condition: Menstruation Disturbances
MeSH terms: Hemorrhage; Menstruation Disturbances
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal
      bleeding in women who are using the Etonogestrel contraceptive implant.
    

Detailed description: 
      Nearly all of the 3 million unintended pregnancies in the United States each year result from
      inconsistent or non-use of contraception. Increasing use of the most effective methods of
      contraception will reduce unintended pregnancies and their social, medical and economic
      consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective
      at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that
      make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM)
      used most commonly for adjuvant treatment of breast cancer, has previously been shown to
      dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant
      (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG
      implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients
      and physicians a valuable option for management of progestin-induced irregular bleeding. This
      research project will test the effectiveness of tamoxifen taken on an as-needed basis to
      treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective
      treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG
      implant, increase its use and reduce unintended pregnancies. This is the first project to
      evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG contraceptive
      implant.
    

Intervention name(s): Tamoxifen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 7 day course of tamoxifen during an episode of irregular vaginal bleeding; 7 day course of placebo during an episode of irregular vaginal bleeding
Other intervention name(s): Nolvadex
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Contraceptive implant; Irregular vaginal bleeding; Etonogestrel implant