bioihbjkbjnl/mcl2 huggingface dataset:
Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia
Condition: Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The objective is to evaluate the clinical effectiveness and safety of PAE in treating
      patients with BPH.
    

Detailed description: 
      Benign prostatic hyperplasia (BPH), non-malignant enlargement of the prostate, is a common
      condition among elderly men with a prevalence increasing with age. When sufficiently large,
      the hyperplastic nodules compress the urethral canal to cause obstruction of the urethra and
      interfere the normal flow of urine, leading to symptoms of urinary hesitancy, frequent
      urination, increased risk of urinary tract infections and urinary retention. While medication
      is often prescribed as the first treatment option, it often does not adequately restore
      normal urine flow. Many patients being treated with medication may not achieve sustained
      improvement in symptoms, or they may stop taking the medication because of side effects,
      therefore other forms of treatments may be necessary. Although surgery with transurethral
      resection of prostate (TURP) is a benchmark for BPH treatment, it involves insertion of an
      endoscope is inserted through the penis, and removal of the prostate piece by piece. While
      considered a safe technique with a mortality rate below 0.25%, it is not without adverse
      events. The most frequent complications are ejaculatory disorders (up to 80%), early urinary
      incontinence (30 to 40%), acute urinary retention caused by blood clots (2 to 5%), sexual
      impotence (up to 5%), and the need for blood transfusions (0.4 to 7%). Patients who have
      undergone TURP require surgical retreatment for lower urinary tract symptoms in 3 to 14.5% of
      cases. Others include infection and urethral stricture. Therefore TURP is only recommended
      for complicated or severe BPH due to its adverse effects. Prostatic artery embolization (PAE)
      is a potentially promising, minimally invasive alternative procedure for BPH. Results from
      early studies showed that PAE might be a safe and effective treatment for BPH.
    

Intervention name(s): Prostate artery embolization (PAE)
Intervention type(s): Procedure
Intervention description(s): Right femoral arterial puncture is performed under local anesthesia. The blood supply to the prostate is mapped by angiography of the iliac vessels and the prostate arteries. Microcatheters are used for super-selective catheterization of the right and left inferior vesicle arteries. Embolization is performed with a microcatheter to deliver microspheres of 300 micron diameter. The microsphere mixture is slowly injected under fluoroscopic guidance. The endpoint of embolization is flow stasis in the prostatic vessels with prostatic gland opacification, without reflux of the mixture to undesired arteries.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and
      liquid S95014 formulations during the induction phase after a single IV dose in newly
      diagnosed paediatric patients with ALL
    


Intervention name(s): Lyophilized S95014; Liquid S95014
Intervention type(s): Drug; Drug
Intervention description(s): Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.; Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oncology / Haematology; Phase II; Acute Lymphoblastic Leukemia; Parallel group; Pegaspargase; Pharmacokinetics comparability; Lyophilized pegaspargase; Liquid pegaspargase; Pegaspargase formulation; Randomized, open-label
Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride
      administered by intrathecal delivery.
    

Detailed description: 
      This is an open-label, single-arm safety study to evaluate the safety of hydromorphone
      hydrochloride given by continuous intrathecal infusion using an implantable pump device. This
      study will enroll both subjects on a current opioid intrathecal medication as well as naïve
      subjects now current on intrathecal opioid medications. All subjects currently on intrathecal
      opioid treatment will be converted from their current intrathecal therapy to intrathecal
      hydromorphone hydrochloride according to standard medical practice. After an optimal dose for
      pain relief is achieved, subjects will remain on therapy for a total of 12 months or until
      discontinuation from the study. During this continuous dosing period, dose adjustments (up or
      down) are permitted to manage pain or side effects provided a maximum dose of 10 mg/day is
      not exceeded. Subjects will be assessed for pain intensity using a visual analog scale of
      pain intensity (VASPI) instrument at each study visit.

      Subjects will be evaluated for side effects and clinical complications associated with the
      use of intrathecal hydromorphone. Events will be classified by intrathecal drugs used and
      concentrations.
    

Intervention name(s): Hydromorphone Hydrochloride; Programmable Implantable pump
Intervention type(s): Drug; Device
Intervention description(s): Opioid for chronic pain; Device: Programmable Implantable pump
Programmable Implantable pump delivering intrathecal hydromorphone
Other intervention name(s): Hydromorphone; Opioid
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hydromorphone Hydrochloride; Hydromorphone; Pain; Chronic Pain; Implantable Pump; Pump; Intrathecal
Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients
Condition: Pain; Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      We are doing this study to find out what happens to acetaminophen in the body after it is
      given to children through the vein. Children's bodies may handle drugs differently than
      adults. Understanding how long the drug stays in the body and how the drug is changed or
      metabolized by the body (called pharmacokinetics) is an important step in learning what the
      best dose of acetaminophen for children should be. We are also interested in learning about
      the safety of this medication when given to children.
    

Detailed description: 
      A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study,
      of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and
      Safety in Acute Pain and Fever
    

Intervention name(s): IV Acetaminophen; IV Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)
Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen; This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age)
Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen
Other intervention name(s): APAP; IV APAP; APAP; IV APAP
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
Condition: Exertional Heat Stroke
MeSH terms: Heat Stroke; Sunstroke
Study type: Interventional
Phase: Phase 3

Summary: 
      A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat
      stroke (EHS) compared to current Standard of Care (SOC) for EHS.
    

Detailed description: 
      Following triage and primary assessment in the emergency medical facility, subjects will be
      randomized to 1 of 2 treatment arms, SOC plus Ryanodex or SOC only. Subjects will be dosed
      and followed for up to 6 hours post-randomization. Current SOC is limited to body cooling and
      supportive measures.
    

Intervention name(s): Ryanodex and Standard of Care; Standard of Care
Intervention type(s): Drug; Other
Intervention description(s): Ryanodex to be administered as a rapid IV push; Body cooling measures and supportive measures
Other intervention name(s): Ryanodex and SOC; SOC
Intervention MeSH terms: Dantrolene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ryanodex (dantrolene sodium) for injectable suspension plus Standard of Care
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      To evaluate the impact of low FODMAP diet on Health related Quality of life in children with
      Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric
      Hospital at Ain Shams University
    

Detailed description: 
      Single blinded randomized two-arm intervention study in which 42 patients with irritable
      bowel syndrome were enrolled to study the effect of LOW FODMAP diet ( intervention group) on
      their gastrointestinal symptoms and their quality of life another group of 42 patients of IBS
      were enrolled as a control group who were received general diet instructions and they
      followed the NICE guide lines for IBS management
    

Intervention name(s): low fodmap diet; NICE guidelines for IBS
Intervention type(s): Other; Other
Intervention description(s): elimination of high fodmap diet - High FODMAP diet: ice cream, soft cheese , yoghurt, cabbage , cauliflower, green bean, garlic, okra, onions, snow peas, broccoli, avocado , apple, mango , dates, watermelon, legumes , pulses, wheat , pasta , artificial sweeteners; follow NICE guidelines for IBS :have regular meals and take time to eat. avoid missing meals or leaving long gaps between eating. drink at least 8 cups of fluid per day, especially water or other non-caffeinated drinks, for example herbal teas.
restrict tea and coffee to 3 cups per day. reduce intake of alcohol and fizzy drinks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Trial of Buprenorphine/Naloxone for Opiate Dependence - 2
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone
      sublingual tablet formulation as an office-based therapy for opiate dependence treatment.
    


Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Primary purpose: Treatment
Keywords: opiate dependence
Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to show that individuals treated with Fampridine-SR tablets are
      significantly more likely to have consistent improvements in their walking than those treated
      with placebo tablets.
    

Detailed description: 
      Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central
      nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal
      cord, providing communication between the brain and the arms and legs. In people with MS, the
      fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates,
      causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience
      periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of
      coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the
      ability to think and/or remember. These periods of illness may come (exacerbations) and go
      (remissions). Fampridine-SR is an experimental drug that has been reported to possibly
      improve muscle strength and walking ability for some people with MS. This study will evaluate
      the effects and possible risks of taking Fampridine-SR in MS patients
    

Intervention name(s): Fampridine-SR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 10 mg, twice daily, 9 weeks; placebo (sugar pill)
Other intervention name(s): 4-aminopyridine
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; MS; walking; leg strength; demyelination
A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day)
      administered to Japanese patients with early Parkinson's disease.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3
      study to evaluate the efficacy and safety of TVP-1012 in Japanese participants with early
      Parkinson's disease.

      The study period consisted of a 28-week trial period. The participants who fulfill the
      inclusion criteria and not meeting any of the exclusion criteria were enrolled, and
      randomized in a 1:1 ratio to either the 1 mg of TVP-1012 or the placebo group. In each
      treatment group, participants received either 1 mg of TVP-1012 or placebo once daily in a
      double-blinded manner.
    

Intervention name(s): TVP-1012; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TVP-1012 1mg Tablets; Placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage
Condition: Postoperative Pain; Postoperative Complications; Gingival Recession
MeSH terms: Gingival Recession; Postoperative Complications
Study type: Interventional

Summary: 
      This study evaluates postoperative morbidity of patients that undergo free gingival graft
      harvesting from palate with or without use of autogenous PRF (Platelet Rich Fibrin) membranes
      to cover the donor site.In the Test Group venous blood sampling was done in order to prepare
      PRF membranes used to cover the donor site, whereas in Control Group hemostatic agents with
      oxidized and regenerated cellulosa were used.
    


Intervention name(s): Platelet rich fibrin ( PRF); hemostatic agents with oxidized and regenerated cellulosa
Intervention type(s): Biological; Drug
Intervention description(s): Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.
At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site.; In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0).
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Connective tissue graft; Platelet concentrates; PRF; Mucogingival surgery
Placebo and Active Controlled Study to Compare the Antipyretic Efficacy of Aspirin® in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin
Condition: Respiratory Tract Infections; Fever
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is addressed to patients suffering from an acute febrile upper respiratory tract
      infection suspected to be of viral origin. The purpose of this study is to determine the
      antipyretic efficacy (reduction of fever by lowering the body temperature from a raised
      state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of
      Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo
      (comparator medication without an active substance). Despite of its common use for fever
      treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin
      are sparse. Therefore, the purpose of this study is to collect such data.
    


Intervention name(s): Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid (Aspirin, BAYE4465); Paracetamol; Paracetamol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol; Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol; Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid; Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid; 2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose
Intervention MeSH terms: Aspirin; Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upper Respiratory Tract Infections
Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is an open label, non randomized, uncontrolled, multicenter, single arm observational
      study. In this study, the enrolled subjects will be treated with Rebif human serum albumin
      (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc),
      thrice in a week (tiw) for 24 months.
    


Intervention name(s): Rebif (Interferon beta-1a)
Intervention type(s): Drug
Intervention description(s): Rebif will be administered at a dose of 44 mcg, sc, tiw.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects diagnosed with RMS and who are treatment naïve or on other disease modifying drugs
        (DMDs) will be enrolled into the study.
      
Keywords: Relapsing Multiple Sclerosis; Interferon beta-1a; Rebif®; Morisky Green Levine Medication Adherence Scale
Whole Grain and Fiber Addition Study
Condition: Healthy
Study type: Interventional

Summary: 
      The human gut microbiota is the complex community of bacteria that reside within the human
      gastrointestinal tract. This community plays an important role in supporting normal immune
      function and digestion. Disruption of the microbial communities within the gastrointestinal
      tract, sometimes termed "dysbiosis" is linked to a wide range of human diseases, including
      obesity, metabolic syndrome, malnutrition, and cancer. Stability of the microbiome is thought
      to be important for human health, however the factors that drive microbiome community
      stability are poorly understood.

      Within the gastrointestinal tract, the microbiota is constantly exposed to complex mixtures
      of foods and the products of digestion. Importantly, changes in diet have been shown to
      rapidly induce shifts in microbial community composition. These compositional shifts can also
      affect microbial production of bioactive metabolites, which may be one mechanism to explain
      how the microbiome impacts host physiology and disease.

      Fiber is often considered to be one of the largest contributors to microbial compositional
      shifts that follow dietary interventions. Fiber resists digestion and persists through the
      gastrointestinal tract to reach the large intestine where it can be metabolized by bacteria.
      The end products of this metabolism are the short chain fatty acids (SCFAs), acetate and
      butyrate, which are often associated with beneficial health outcomes. Fibrous foods are also
      a source of polyphenols and other phenolic compounds that may be used by microbes in the
      production of secondary metabolites or freed from the food matrix by microbial enzymes.

      The purpose of this study is to: 1) to investigate the impact of high fiber, whole grain and
      bran cereal on microbiome stability, and 2) to explore the microbial contribution to
      polyphenol metabolism from whole grain in healthy individuals.
    


Intervention name(s): Fiber cereal
Intervention type(s): Other
Intervention description(s): Whole grain and bran cereal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science