bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      People who follow a low-carbohydrate diet typically experience a decrease in triglycerides
      and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients
      may require lipid-lowering therapy. Statins may not be the most effective strategy for
      patients on this diet, since they typically consume a greater amount of saturated fat and
      cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We
      hypothesize that patients following a low carbohydrate diet would experience a significantly
      greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in
      the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg
      alone.
    


Intervention name(s): simvastatin 20 mg/ezetimibe
Intervention type(s): Drug
Intervention description(s): see protocol
Other intervention name(s): Low carb diet plus simvastatin 20 mg
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic Study of GSK2881078 and Study to Evaluate the Effect of CYP3A4 Inhibition on PK of GSK2881078
Condition: Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2881078 is a selective androgen receptor modulator (SARM) that is being evaluated for
      effects on muscle growth and strength in subjects with muscle wasting to improve their
      physical function. Part A of this study will evaluate the safety, efficacy and
      pharmacokinetics of GSK2881078 in healthy, older men and post-menopausal women who will take
      daily dosing for 28 days and be followed for a total of 70 days. Part B of this study will
      characterize the effect of Cytochrome P450 3A4 (CYP3A4) inhibition on the GSK2881078
      pharmacokinetics. Part B will only be conducted if safe and efficacious dose is identified in
      Part A. Part A will include healthy older males and post-menopausal females; and randomize
      approximately 60 subjects (about 15 per cohort [4 cohorts]) to complete approximately 48
      (about 12 per cohort). Part B will enroll one cohort of approximately 15 healthy male
      subjects to complete approximately 12. The study duration will be approximately 115 days for
      Part A and 122 days for Part B.
    


Intervention name(s): GSK2881078; Placebo; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK2881078 hot melt solutions, ranging in concentration from 0.05 mg/g to 50 mg/g, will be prepared by weighing drug substance directly into specific quantities of the hot melt vehicle solution. Subjects will be administered GSK2881078 (dose for Cohort 1: 0.75 mg for females and 1.5 mg for males) hot melt solution within capsule orally with water.; Subjects will be administered as hot melt vehicle placebo within capsule orally with water.; Subjects will be administered as two capsules of itraconazole 100 mg (200 mg) orally with water.
Intervention MeSH terms: Itraconazole; GSK2881078
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Itraconazole; GSK2881078; CYP3A4; Selective Androgen Receptor Modulator; Safety; Pharmacokinetics; Tolerability
Ultrasound Guided QLB III Versus Intrathecal Morphine for Analgesia After Cesarean Section
Condition: Block
Study type: Interventional
Phase: Phase 4

Summary: 
      Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after
      cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study
      is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional
      anesthetic technique that blocks the abdominal wall neural afferents, can provide at the same
      time better postoperative analgesia after CD with less side effects
    

Detailed description: 
      In this prospective double blinded randomized study,120 parturients undergoing cesarian
      delivery via a Pfannenstiel incision and who agreed to spinal anesthesia were randomly
      scheduled to receive either a SAM (group SAM, n=60) or a Quadratus lumborum block type 3
      (group QLB, n=60).Spinal anesthesia was initiated with hyperbaric Bupivacaïne 0.5% 10 mg,
      0,005 mg SUFENTANIL MEDIS and 0.1 mg morphine in the SAM group and with Bupivacaïne 0.5% 10
      mg, 0,005 mg SUFENTANIL MEDIS and 1 ml normal saline in group QLB.

      After surgery, bilateral QLB block type 3 was performed with the patient in lateral position
      using bupivacaine 0.25% , 20 mL on each side in group QLB and 20 ml normal saline in group
      SAM.

      Postoperative analgesia for the first 24 hours consisted of a patient controlled analgesia
      with IV morphine only. If necessary breakthrough pain was treated by 01 g paracetamol
      intravenously by the same doctor in charge of taking the values of the visual analogue scale.

      Patients were assessed postoperatively in the postanesthesia care unit (time 0 hours) and at
      2, 4, 6, 12 and 24 hours.

      Visual analogue scale (VAS) for pain at rest and during the palpation of the uterine globe
      was noted.

      The primary outcome measure was the total dose of morphine over 24 hours delivered by a
      patient-controlled analgesia system at predetermined intervals.

      Secondary outcomes were visual analogue scale (VAS) for pain at rest and on the palpation of
      the uterine globe ,heart rate, blood pressure, itching, nausea, pruritus, vomiting and
      sedation.
    

Intervention name(s): Morphine; Quadratus lumborum block
Intervention type(s): Drug; Drug
Intervention description(s): spinal morphine is done before cesarean section; a US Block QLB is done after surgery
Other intervention name(s): spinal morphine; QLB
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: quadratus lumborum block; cesarean section; spinal morphine; ultrasound guidance
Comparative Study:Topison (Mometasone Furoate) Versus Two Others Mometasone Furoates
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Atopic dermatitis is a chronic disease, with outbreaks, predominant in childhood, whose main
      symptom is pruritus of variable intensity and signs of cutaneous xerosis and eczematous
      pattern lesions.

      In this context, the present study aims to evaluate a comparative way of Topison drugs in
      reducing transepidermal water loss, improving skin hydration and comfort in participants with
      atopic dermatitis.
    

Detailed description: 
      Phase IV, national, single-center, comparative, double-blind, randomized clinical study with
      instrumental, clinical and subjective tests to compare mometasone cream puncture (Topison)
      versus two other mometasone cream punctures in participants with atopic dermatitis.

      60 research participants of both sexes will be required, aged 10 or over and under or equal
      to 60 years.

      Participants will be randomized into two groups, as follows:

      Group I: Use the drug Topison on one side of the upper limb and Mometasone Furoate 1mg / g
      Sanofi, Medley on the opposite side.

      Group II: Use the drug Topison on one side of the upper limb and Mometasone Furoate 1mg / g
      Aché on the opposite side.

      The side of the upper limb for the use of Topison or momofasone furoate Sanofi, Medley or
      Aché will be defined randomly.
    

Intervention name(s): Mometasone Furoate
Intervention type(s): Drug
Intervention description(s): mometasone furoate
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized into two groups, as follows:
Group I: Use the drug Topison on one side of the upper limb and Mometasone Furoate 1mg /g Sanofi,Medley on the opposite side.
Group II: Use the drug Topison on one side of the upper limb and Mometasone Furoate 1mg / g Ache on the opposite side.
The side of the upper limb for the use of Topison or momofasone furoate Sanofi,Medley or Aché will be defined randomly.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Topison; Atopic dermatitis; mometasone furoate
Oxidative Capacity and Exercise Tolerance in Ambulatory SMA
Condition: Spinal Muscular Atrophy Type 3; Mitochondrial Myopathy
MeSH terms: Muscular Diseases; Mitochondrial Myopathies; Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Observational

Summary: 
      This proposal will focus on (1) estimating oxidative capacity of specific muscle groups
      during exercise using near infrared spectroscopy and (2) describing body composition to
      better understand exercise capacity and mitochondrial function in ambulatory spinal muscular
      atrophy (SMA) patients and disease controls. It is a 6-month observational study including 14
      ambulatory SMA patients, 14 ambulatory patients with mitochondrial myopathy, and 14 healthy
      controls.
    

Detailed description: 
      Spinal Muscular Atrophy (SMA) is a progressive, recessively-inherited neuromuscular disease
      characterized by weakness and muscle atrophy due to the loss of spinal cord motor neurons.
      The results from this study would provide preliminary data, using non-invasive methods, on
      oxidative capacity in ambulatory SMA patients and disease controls to aid in the design of
      exercise intervention studies. Furthermore, this information would link previous laboratory
      and preclinical findings of mitochondrial depletion in SMA to the clinical condition and
      provide important information for future studies designed to improve oxidative capacity and
      fitness in SMA patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study sample will include 14 ambulatory SMA patients, 14 ambulatory mitochondrial
        myopathy patients, and 14 healthy controls.
      
Keywords: spinal muscular atrophy; oxidative capacity; exercise tolerance; mitochondrial myopathy; SMA; six minute walk test; neuromuscular disease; ambulation; exercise; mitochondria; cycle ergometry; near infrared spectroscopy
A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate night-driving performance in real-world driving
      conditions in participants with presbyopia treated with AGN-190584 versus vehicle. Adverse
      events and change in disease symptoms will be assessed.

      AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated
      with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle.

      This study consists of two parts. Part 1 consists of Visit 2 and Visit 3, and Part 2 consists
      of Visit 4 and Visit 5. Approximately half of the participants will receive AGN-190584 at
      Visit 2 through Visit 3 (Sequence 1 participants) and the remaining participants (Sequence 2
      participants) will receive AGN-190584 at Visit 4 through Visit 5. All participants will
      receive AGN-190584 at home as instructed. Approximately 54 adult participants with presbyopia
      will be enrolled AT 1 site in Australia.

      Treatment duration is expected to be no more than 71 days. In Part 1, at Visit 2 (Day 1) and
      at home as instructed for 7 to 14 days Sequence 1 participants will receive 1 eyedrop of
      AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each
      eye. All participants will have a driving assessment at Visit 3 (Day 8 to 15). In Part 2, at
      Visit 4 (Day 15 to 57) and at home as instructed for 7 to 14 days Sequence 2 participants
      will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1
      eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 5
      (Day 22 to 71).

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the course of the study at a
      hospital or clinic. The effects of the treatment will be checked by medical assessments,
      asking about side effects, and completing questionnaires.
    


Intervention name(s): AGN-190584
Intervention type(s): Drug
Intervention description(s): Topical eyedrop
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Presbyopia; AGN-190584
Effects of Breathing Patterns on Post-prandial Vascular Function
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of this study is investigate the effects of two different breathing styles on
      postprandial vascular function and oxidative stress markers. Participants will complete 2
      breathing conditions in random order.
    


Intervention name(s): Normal physiologic rate breathing; Slow breathing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2-minute breathing exercises will be completed every 15 minutes.; 2-minute breathing exercises will be completed every 15 minutes.
Intervention model: Single Group Assignment
Intervention model description: Each participant will complete 2 different sessions in random order.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breathing; Yogic breathing
The Relationship Between Serum PSA Levels and WBC, Delta Neutrophil Index (DNI) and Other Hematological Parameters
Condition: Prostate Infection; Prostate Disease; Prostate Cancer
MeSH terms: Prostatic Diseases
Study type: Observational [Patient Registry]

Summary: 
      Purpose:

      To find the correlation between hemogram parameters and Delta Neutrophil Index(DNI) and Serum
      PSA in patients presenting with the diagnosis of acute prostatitis.

      Material-Metod: Serum PSA levels and hemogram parameters of patients who came to the urology
      outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were
      collected retrospectively.
    

Detailed description: 
      Serum PSA levels and hemogram parameters of patients who came to the urology outpatient
      clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected
      retrospectively.

      WBC, neutrophil, lymphocyte, neutrophil-lymphocyte ratio, delta neutrophil index (DNI), PLT,
      RDW, and MPV values were determined in the Hemogram Parameters. Serum Total PSA and Free PSA
      values of the patients were also checked. Urine culture, urinary ultrasound, and antibiotic
      therapy
    

Intervention name(s): Serum PSA,Delta Neutrophil Index(DNI),WBC
Intervention type(s): Diagnostic Test
Intervention description(s): Urine culture, prostate volume
Other intervention name(s): MPV,NLR,RDW
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Adult male patients with acute prostatitis were included in the study.
      
Keywords: prostatit
The Effects of Decreasing the Lasix Dose on the Cardiorenal System
Condition: Heart Failure; Kidney Dysfunction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators' objective is to define the effects of decreasing the furosemide dose on
      heart, kidney and humoral function in people with compensated heart failure and kidney
      dysfunction and also in people with compensated heart failure without kidney dysfunction.
      Secondly, to define the humoral activation in both groups.
    

Detailed description: 
      The broad objective of this protocol is to advance our understanding of the
      pathophysiological mechanisms of human Cardiorenal Syndrome (CRS) with a specific emphasis
      upon the biological interaction between diuretic therapy, the
      renin-angiotensin-aldosterone-system (RAAS) and cyclic 3'-5'-guanosine monophosphate (cGMP)
      pathway.
    

Intervention name(s): Furosemide
Intervention type(s): Drug
Intervention description(s): Subjects received their clinically prescribed dose of furosemide for a 3 week stabilization period, then were assessed for cardiorenal and humoral function. Subjects then had a 50% reduction of the furosemide dose for a 3 week stabilization period, and were assessed for cardiorenal and humoral function again.
Other intervention name(s): Lasix
Intervention MeSH terms: Furosemide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heart failure; heart failure with and without kidney dysfunction
LifeFlow Fluid Study- Non- Critical Pediatric Patients Having a Trans Abdominal Ultrasound
Condition: Dehydration in Children; Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      This is an unblinded, randomized control study examining two fluid delivery modalities for
      non-critical female patients with a planned transabdominal pelvic ultrasound requiring
      intravenous fluid boluses.
    

Detailed description: 
      Subjects be identified during their clinical course in the ED and will be randomized to
      either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard
      of care). IV fluids will be provided until the subject notes the sensation of a full bladder,
      at which point, the standard of care clinical practice is to perform the ultrasound. The
      transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the
      ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound
      for virginal young women. All other clinical care is per standard of care. The only research
      component is the randomization and data collection.
    

Intervention name(s): LifeFlow
Intervention type(s): Device
Intervention description(s): The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Condition: Vitreous Hemorrhage; Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Vitreous Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of intravitreal bevacizumab injections for treatment of
      proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after
      previous full panretinal photocoagulation (PRP).
    

Detailed description: 
      The investigators will carry out a prospective study in patients with PDR and prior complete
      laser treatment who presented with new dense VH. All eyes will be treated with intravitreal
      injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular
      ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after
      first injection. Re-injection will be done in non-clearing and recurrent VH.
    

Intervention name(s): intravitreal injection of bevacizumab
Intervention type(s): Drug
Intervention description(s): intravitreal injection of bevacizumab
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bevacizumab,; proliferative diabetic retinopathy,; vitreous hemorrhage,
A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate whether the addition of Sitagliptin treatment provides a greater
      decrease in A1C levels compared to placebo in participants with inadequate glycemic control
      on sulfonylurea and metformin combination therapy.
    


Intervention name(s): Sitagliptin phosphate; Comparator: placebo to pioglitazone; Comparator: placebo to Sitagliptin; Comparator: pioglitazone; Glimepiride or gliclazide; Metformin; Pioglitazone rescue therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks; Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks; Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks; Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks; Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase A (Weeks 0-24): stable dose, as prescribed
by investigator, of metformin; Phase B (Weeks 24-
54): stable dose, as prescribed by investigator, of
metformin; Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.
Other intervention name(s): Januvia; Actos;; Actos
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Glimepiride; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus