bioihbjkbjnl/mcl2 huggingface dataset:
One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia.
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Observational

Summary: 
      Objective: Rezūm vapor ablation is a minimally invasive treatment for benign prostatic
      hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for
      tissue ablation. Although Rezūm is currently indicated for use in men with prostate sizes ≥30
      and ≤80 ml, it is unclear how effective Rezūm is for men in urinary retention. The
      investigators sought to determine whether Rezūm is effective in the treatment of
      catheter-dependent urinary retention secondary to BPH.
    

Detailed description: 
      The data of participants who underwent Rezūm operation with the diagnosis of BPH between 2021
      and 2023 were evaluated retrospectively. The investigators evaluated procedure details and
      evaluated pre- and post-Rezūm (including International Prostate Symptom Score (IPSS), IPSS
      quality of life (IPSS-QOL), prostate volumes, maximum flow (Qmax), post-void residual urine
      volume, IEEF-5, ejaculation dysfunction). The investigators examined variables at 6 and 12
      months).
    

Intervention name(s): REZUM
Intervention type(s): Device
Intervention description(s): The 3rd and 12th month follow-ups of the patients who underwent REZUM operation were evaluated.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        male patients with prostate symptoms
A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma, Basal Cell
Study type: Observational

Summary: 
      The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the
      skin's normal electric field and this abnormal electric field can be detected by the
      Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can
      provide useful data to guide in the diagnosis of skin disease.
    

Detailed description: 
      The Dermacorder is a non-invasive medical device that scans a probe over the skin about 200
      microns away from it and detects the electric field in the skin using capacitative coupling.
      Measurements of hundreds of malignant melanomas in mice indicated that these lesions generate
      an electric field that is easily detected. One previous clinical trial at the VA Medical
      Center in Hampton VA indicated an 80% reliability in predicting malignant lesions by their
      electric field. We have improved the Dermacorder over the past two years by enhancing its
      sensitivity and stability and must now determine if these improvements have improved its
      ability to detect malignant lesions. If the Dermacorder provides a reliable diagnosis of
      malignant lesions, its use could dramatically reduce the number of biopsies performed and
      this would significantly improve the quality of life for hundreds of thousands of Americans
      seeking the advice of dermatologists regarding suspicious lesions each year
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Males and females with multiple basal cell carcinomas
      
Keywords: Dermacorder; Electric field; basal cell carcinoma; Gorlin Syndrome
Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
Condition: Traumatic Brain Injury; Stroke
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of different
      dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day
      continuous infusion. The secondary objectives are to assess the pharmacokinetics (PK) of
      glyburide and blood glucose and serum insulin pharmacodynamic (PD) responses to glyburide.
    

Detailed description: 
      This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired
      by Biogen.
    

Intervention name(s): Glyburide for Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the Treatment Arm.; Administered as specified in the Treatment Arm.
Other intervention name(s): RP-1127; glibenclamide; glybenclamide
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vitamin/Mineral Supplement for Children and Adults With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesis is that a new, revised formulation of a vitamin/mineral
      supplement will result in:

        1. improvement of nutritional status in some children/adults with autism, and

        2. reduction of some of the symptoms of autism in some children
    

Detailed description: 
      The major goal of this study is to determine the effect of this vitamin/mineral supplement on
      levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies.
      The study design is a randomized, double-blind, placebo-controlled. Blood and urine
      measurements will be measured at the beginning of the study in children with autism and
      typical children. Then, the children with autism will be given the supplement or placebo for
      12 weeks, and then their blood and urine will be re-measured.
    

Intervention name(s): Multi-Vitamin/Mineral Supplement; Liquid Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): A broad-spectrum vitamin/mineral supplement designed for children and adults with autism; The placebo was formulated to look and taste like the intervention supplement. A small amount of beta-carotene was used for coloring. Natural cherry, citric acid, and a proprietary blend of natural flavors were used for flavoring to create a vitamin-like after-taste. Sucralose was used as a sweetener and the same preservatives were included (potassium sorbate, sodium benzoate).
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamins; Minerals
Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial was conducted in Russian Federation. This trial aimed for a comparison of the
      effect on glycemic control in subjects with type 2 diabetes of three different treatment
      regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in
      combination with metformin and treatment with oral anti-diabetic drugs.
    


Intervention name(s): biphasic insulin aspart
Intervention type(s): Drug
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)
Condition: Cardiovascular Disease and Lipoprotein(a)
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in
      patients with established cardiovascular disease (CVD).
    


Intervention name(s): Blood draw for Lp(a)
Intervention type(s): Diagnostic Test
Intervention description(s): Collect sample for Lipoprotein(a) testing
Other intervention name(s): In case retrospective laboratory data are not available, blood sampling will be performed to analyze Lp(a)
Intervention model: Single Group Assignment
Intervention model description: This is a multi-center cross-sectional epidemiological study to estimate the prevalence (%) of patients with elevated Lp(a) in patients with established CVD defined by their medical history. One study visit is planned for data collection. Relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period will be collected retrospectively. In case laboratory data are not available, blood sampling will be performed.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CVD, Lipoprotein (a),
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
Condition: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate the prostatic diffusion in significant
      concentration of ertapenem achieved after a pre-operative single administration.
    

Detailed description: 
      Ertapenem is an antibiotic belonging to carbapenems family and used in infections with
      Gram-negative bacilli with extended spectrum beta lactamase (ESBL). Its efficacy has been
      demonstrated in abdominal, soft tissue, pulmonary, skin and gynaecological infections.
      Recently it has been compared to ceftriaxone in urinary infections demonstrating his efficacy
      and tolerance.

      The purpose of this study is to assess its benefit in probabilistic strategy by demonstrating
      its prostatic diffusion in significant concentration when administrated in a pre-operative
      single injection.

      Patients were divided in two groups receiving a single injection of 1g of ertapenem 1h or 12h
      before endoscopic surgery of prostate hyperplasia.

      Concentration of ertapenem was measuring on blood sample and on chips resection of prostate
      during endoscopic surgery.

      To demonstrate the prostatic diffusion in significant amount of ertapenem, the prostatic
      concentration of ertapenem had to be higher than the minimal inhibitory concentration (MIC)
      for 40% of the time of injection interval.
    

Intervention name(s): Ertapenem
Intervention type(s): Drug
Intervention description(s): One single injection of 1g of ertapenem before surgery
Intervention MeSH terms: Ertapenem
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia
Assess the Safety and Immunogenicity of M-001 as A Standalone Influenza Vaccine and as A H5N1 Vaccine Primer in Adults
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      "Multimeric-001" (M-001) contains conserved, common linear influenza epitopes that activate
      both cellular and humoral arms of the immune system against a wide variety of influenza A and
      B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune
      responses to pandemic influenza vaccine in the adult population. The current clinical study
      was designed to assess M-001's standalone and priming action in subjects aged 18-60 years
      old.

      This is a Phase IIb study comprising 222 participants. Eligible subjects were randomized to
      receive two sequential intramuscular injection of 0.5mg or 1.0mg M-001 (treatment), or two
      placebo (saline) injection, before receiving the sub optimal dose of H5N1 pandemic vaccine.
    

Detailed description: 
      This is a multi-center, randomized, double blind active-controlled Phase 2b study. 222
      subjects will be randomized 1:1:1 into three groups to receive two sequential non-adjuvanted
      0.5 mg or 1.0mg intramuscular injection of M-001 (treatment), or two placebo (saline)
      injection, before receiving the Alum adjuvanted H5N1 vaccine at a sub optimal dose of 3mcg.
      Hemagglutinin inhibition (HAI) will be evaluated at baseline and 3 weeks after H5N1 whole
      virion inactivated pandemic influenza vaccination as a measure of M-001's ability to enhance
      the humoral response. Cell mediated immune (CMI) responses will also be evaluated at baseline
      and after immunization with M-001 as a measure of M-001's standalone immunogenicity. The
      subjects will monitored for safety throughout the study until day 180.
    

Intervention name(s): Multimeric 001 (M-001); H5N1 influenza vaccine; Saline
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Multimeric 001 is a recombinant protein comprising 9 conserved peptides from influenza A and B; Alum adjuvanted whole virion inactivated H5N1 vaccine produced by FluArt (Hungary); 0.9% NaCl in double distilled water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; vaccine; universal; peptide; prime; boost; HAI; CMI; UNISEC
Outcomes of Group Dance and Movement Training in Ambulatory MS Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      GroundWorks DanceTheater and Cleveland Clinic are partnering to create and offer an initial
      study of a dance movement-based community program for people with Multiple Sclerosis (MS).
      The program will address major needs in the MS community including social-emotional
      well-being, body awareness, and motor function. GroundWorks artists will use a variety of
      widely accepted movement-based practices with the goal of improving upper and lower body
      function and overall well-being. By partnering, GroundWorks and Cleveland Clinic hope to
      encourage more study of the benefits of dance movement-based programming in individuals
      affected by MS.
    

Detailed description: 
      GroundWorks DanceTheater and Cleveland Clinic are partnering to design and implement a pilot
      study of a dance movement-based community program for people with Multiple Sclerosis (MS).
      The program is aimed at addressing major needs in the MS community including social-emotional
      well-being, body awareness, and motor function. GroundWorks artists will use a variety of
      movement-based practices including personalized tasks and imagery, mirroring, and
      inscription, with the goal of improving upper and lower extremity function, and well-being.
      Cleveland Clinic will assist GroundWorks in the selection, monitoring, and testing of the
      participants. Cleveland Clinic will also take the lead with data management and analysis. By
      partnering, GroundWorks and Cleveland Clinic hope to create a promising program that will
      lead to further exploring the impact of dance movement-based programming in individuals
      affected by MS.
    

Intervention name(s): Group Dance and Movement Training
Intervention type(s): Other
Intervention description(s): Dance movement-based sessions including personalized tasks and imagery, mirroring, and inscription, plus warm-up and cool down practices to ensure physical safety
Intervention model: Single Group Assignment
Intervention model description: Uncontrolled pre-post intervention study. All participants will complete 14 1-hour dance intervention sessions together as a single group
Masking: None (Open Label)
Primary purpose: Other
Keywords: dance; movement
Melatonin for Pediatric Emergence Agitation
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      efficacy of melatonin premedication on emergence agitation in children undergoing
      herniorrhaphy surgeries
    

Detailed description: 
      Before administration of the oral premedication, each patient's baseline heart rate, mean
      systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will
      be recorded All the anesthetic and surgical techniques will be standardized. On arrival at
      the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse
      oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.

      Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is
      inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance
      done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational
      anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and
      atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery
      Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to
      the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of
      sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous
      eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration
      of stay in recovery and any side effects
    

Intervention name(s): Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg; Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg; Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg; Sevoflurane
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): will be administered 1 hour before arrival to operating room; will be administered 1 hour before arrival to operating room; will be administered 1 hour before arrival to operating room; for anaesthesia induction 3-8 MAC
Intervention MeSH terms: Sevoflurane; Melatonin; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: melatonin; emergence agitation
A Questionnaire Survey Study for Exploring Outcomes for Patients With Disc Herniation
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Observational

Summary: 
      Background: The selection of primary outcomes that reflect the real symptoms and conditions
      of patients is instrumental in clinical studies on the effectiveness of specific treatment
      modalities. This study aimed to explore the appropriate outcomes that reflect the real-world
      needs and concerns of patients with lumbar disc herniation (LDH) and provide a basis for
      designing related clinical trials.

      Methods and Findings: This cross-sectional nationwide web-based survey study was conducted in
      South Korea in November 2022. Patients who were diagnosed with LDH and had LDH-related
      radiating leg pain were enrolled. The questionnaire consisted of 5 parts: basic
      characteristics, disease onset, symptom and severity, priority symptoms for improvement, and
      important factors in treatment. Overall, 500 patients (100 patients from the each age group)
      were enrolled.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This is a survey study, and there were no intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All 19-69 patients who were diagnosed with LDH and had LDH-related radiating leg in Korea
Pre-Workout on Exercise Performance and Cognition
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of four different pre-workout beverages
      as compared to placebo on muscular strength and endurance, perceived energy and cognitive
      performance in healthy adult males.
    


Intervention name(s): Master Performance Blend Dose 1; Master Performance Blend Dose 2; Performance Energy Blend; Energy Blend; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Caffeine content: 200 mg; Caffeine content: 400 mg; Caffeine content: 175 mg; Caffeine content: 200 mg; Caffeine content: 0 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety and tolerability of romosozumab
      following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and
      postmenopausal women.
    


Intervention name(s): Romosozumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously or intravenously; Administered subcutaneously or intravenously
Other intervention name(s): AMG 785; EVENITY™
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amgen; First in Human; Postmenopausal; Phase 1
Therapeutic And Dietary Effects Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This study evaluates the dietary and therapeutic effect of supplement consisting of
      sublimated mare milk among patients with non-alcoholic steatohepatitis.
    

Detailed description: 
      Nonalcoholic steatohepatitis (NASH) is characterized by the liver damage in the form of fatty
      degeneration and hepatitis in people who do not abuse alcohol. The disease often develops in
      middle-aged women with excessive body weight, increased blood glucose and blood lipids, but
      can occur in all age groups and in both sexes. In most cases, the disease is asymptomatic.
      Laboratory data indicate an increase in the level of aminotransaminases. Ultrasound reveals
      hyperechoic tissue of the liver due to diffuse fatty infiltration. The degree of steatosis
      can also be estimated by a controlled attenuation parameter (CAP - Controlled Attenuation
      Parameter) in the fibroelastometry of liver tissue. It is also possible to verify the degree
      of fibrosis of liver tissue in its presence. Given that the mare's milk has therapeutic and
      dietary properties for various diseases of the internal organs, including liver diseases, the
      investigators decided to study its therapeutic effectiveness in NASH.

      In this clinical study, the effectiveness of mare's milk in NASH will be studied in
      comparison with control groups taking monotherapy with ursodeoxycholic acid (UDCA) and
      combined therapy (mare's milk and UDCA). Patients will receive a sublimated form of mare's
      milk in the appropriate dosage within 2 months, and the results of clinical laboratory and
      instrumental studies will be compared among themselves using statistical methods.
    

Intervention name(s): Sublimated mare's milk; Ursodeoxycholic Acid
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).; Ursodeoxycholic acid in the form of 250 mg capsule.
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-alcoholic Steatohepatitis; Mare milk; Immune markers