bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Interventional
Phase: Phase 2

Summary: 
      Although conventional hemodialysis removes waste products and corrects fluid imbalance, it
      does not replace critical absorptive, metabolic, endocrine, and immunologic functions
      performed by healthy renal tubule cells. This trial involving patients with acute renal
      failure evaluates the efficacy and safety of an extracorporeal renal assist device (RAD)
      containing human renal tubule cells connected to a conventional hemodialysis circuit. It is
      hypothesized that short-term (72-h) use of this cell therapeutic device will improve survival
      of ARF patients compared to patients receiving only conventional continuous renal replacement
      therapy.
    

Detailed description: 
      Acute Renal Failure (ARF) is a severe inflammatory disease state often accompanied by
      Multi-Organ Failure (MOF) and Systemic Inflammatory Response Syndrome (SIRS). ARF is
      precipitated by many factors and is most often linked to the loss of kidney tubule cell
      function. Patients with ARF are treated in the intensive care units of hospitals, and
      recovery of renal function is vitally important to their survival. Current therapy for ARF
      involves conventional kidney support with continuous renal replacement therapies (CRRT).
      Despite advances in treating patients with CRRT, ARF has an extremely high mortality rate
      (55-70%) and requires extensive hospital stays, predominantly in the ICU. The RAD is designed
      to both treat ARF with MOF and/or SIRs and facilitate the natural recovery of a patient's own
      kidney function. The RAD is intended for use for short periods of time in conventional
      extracorporeal therapeutic systems that are already available in the hospital. The RAD
      therapy operates outside the body and is designed to mimic the structure and function of the
      natural kidney. In this manner it is intended to replace the missing metabolic, endocrine,
      and immunologic functions of the kidney and allow time for the patient's own kidneys to
      resume normal functions.
    

Intervention name(s): Renal tubule assist device
Intervention type(s): Device
Intervention description(s): Standard hemofiltration cartridge containing nonautologous human renal tubule cells, connected to conventional continuous venovenous hemodialysis circuit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute renal failure; Bioartificial kidney; Cell therapy; Hemofiltration; Septic shock
Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Observational

Summary: 
      OBJECTIVES: I. Determine whether release of endogenous growth hormone (GH)-releasing hormone
      is involved in GH responses to clonidine, pyridostigmine, levodopa, arginine, GH-releasing
      peptide, insulin-induced hypoglycemia, and exercise in patients with acromegaly.

      II. Determine whether endogenous GH-releasing hormone influences the maintenance of GH
      hypersecretion.
    

Detailed description: 
      PROTOCOL OUTLINE: Growth hormone-releasing hormone antagonist (GHRH-A) is administered to
      volunteers and followed with 1 of these challenges: insulin, clonidine, pyridostigmine,
      arginine, levodopa, growth hormone-releasing peptide, or exercise. Tests are repeated with
      normal saline as the control; the order of administration (control vs. pharmacologic
      stimulation) is randomly assigned.

      Patients receive GHRH-A (dose determined in volunteer study), thyrotropin-releasing hormone,
      and growth-releasing hormone.

      All stimulation tests follow an overnight fast.
    

Keywords: acromegaly; endocrine disorders; rare disease
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine the safety and tolerability of PH100, a purified
      phlorotannins from a brown alga Ecklonia cava and the pharmacokinetics of its major compounds
      8,8'-bieckol, dieckol, and phlorofucofuroeckol A (PFF-A), after single, ascending, oral doses
      of PH100 Capsules (over-encapsulated tablets) in healthy adult volunteers.
    

Detailed description: 
      This was a single-center, randomized, double-blind, placebo-controlled, single ascending dose
      study in healthy volunteers in which subjects received either placebo or a 100 mg, 200 mg,
      400 mg, 800 mg, 1200 mg, or 1600 mg dose of PH100 capsules (over-encapsulated tablets
      containing purified Ecklonia cava phlorotannins as an active ingredient) in escalating dose
      groups (six cohorts). A total of 48 subjects were enrolled. Each cohort comprised eight
      subjects. Within each cohort, six subjects received PH100 and two subjects received placebo.
      The first cohort was dosed as a single group with PH100 (100 mg) or placebo. The subsequent
      five cohorts were dosed sequentially with 200 mg, 400 mg, 800 mg, 1200 mg, and 1600 mg of
      PH100 or placebo. Safety and pharmacokinetic data were collected and evaluated following each
      cohort. Dose escalation occurred after review of the safety and pharmacokinetic data from the
      preceding cohort(s). Doses were administered with subjects in the fasted condition.
    

Intervention name(s): Placebo; PH100 100mg; PH100 200mg; PH100 400mg; PH100 800mg; PH100 1200mg; PH100 1600mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1~8 Placebo capsule(s) corresponding to each PH100 dose; 1 x 100 mg PH100 oral capsule; 1 x 200 mg PH100 oral capsule; 2 x 200 mg PH100 oral capsules; 4 x 200 mg PH100 oral capsules; 6 x 200 mg PH100 oral capsules; 8 x 200 mg PH100 oral capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single-center, randomized, double-blind, placebo-controlled, single ascending dose study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; PH100; Ecklonia cava; Phlorotannin
Postpartum Weight Loss and Exercise (PRIDE)
Condition: Gestational Diabetes; Glucose Intolerance
MeSH terms: Diabetes, Gestational; Glucose Intolerance; Weight Loss
Study type: Interventional

Summary: 
      The overall objective of this pilot project is to test in 50 women with a history of
      gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month
      intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year
      after delivery.
    

Detailed description: 
      The objective is in comparison to a group of women not enrolled in the lifestyle
      intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss
      through increased physical activity and dietary modification in women with a history of GDM
      will:

        1. decrease body weight and

        2. reduce the rate of metabolic abnormalities, 12 months after delivery
    

Intervention name(s): Non-intervention group; Face to face; Telehelath Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A pedometer and written material on a healthy lifestyle.; Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.; Participants will speak to Trestletree personnel once a week via phone.
Other intervention name(s): Placebo; Trestletree
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Women; Postpartum; GDM
Endogenous vs. Exogenous Ketone Bodies
Condition: Healthy
Study type: Interventional

Summary: 
      Aim of the study is to compare the origin of ketone bodies: endogenous ketone bodies due to
      36 hours fasting or 24 hours of ketogenic diet vs. exogenous ketone bodies as supplements
      additional to normal diet.

      Secondary aim of the study is to validate the new metabolic chambers.
    

Detailed description: 
      Each study week starts with a 3-day run-in period with controlled diet at home and ends with
      a test-meal (breakfast) in the lab and following food record over the rest of the day at
      home.

        1. week: physical activity level (PAL) 1.3, 3 intervention days in the metabolic chamber:
           ad libitum energy intake, washout day, isocaloric diet, 36 hours fasting

        2. week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber:
           isocaloric diet, 36 hours fasting

        3. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:
           ad libitum energy intake, 36 hours fasting

        4. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:
           isocaloric diet, ketogenic diet (isocaloric)

        5. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:
           isocaloric diet, isocaloric diet + ketone body supplements (isocaloric)
    

Intervention name(s): Beta-Hydroxybutyrate as Ca-Mg-salt, active; ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active; fasting, active; fasting, inactive
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.; 24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.; 36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.; 36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.
The same intervention is reproduced one week later.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: all subjects are undergoing each intervention
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ketone bodies; appetite control; macronutrient oxidation; metabolic chamber; exogenous ketones
Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      the aim of the study is to compare between two non-surgical methods of treatment of
      peri-implantitis by using debridement and placing an healing abutment with electomagnetic
      field (MED-Magdent Miniaturized Device) in the test group and Sham healing abutment in the
      control group ( Sham MED).
    

Detailed description: 
      Dental Implants are common alternative for replacement at the time of tooth loss. The two
      common methods for treatment implant with inflammation include surgical and global
      non-surgical treatment.

      The non-surgical treatment includes soft tissue debridement with various tools which
      including manual, ultrasonic rotators, lasers and delayed release devices.

      Using an electromagnetic field to induce bony healing in fractures and around implants is
      being investigated for studies and was found to be effective and safe. The electric field
      lowers osteoclasts activity, speeds up osteoid construction and stimulates creation blood
      vessels development. Forty patients who will attend to the department of periodontology at
      Rambam health care campus, at the School ofpostgraduate Dentistry, which will meet the
      research criteria, will be recruited. All patients will exhibit a moderate-onset gum
      infection around one of the implants.
    

Intervention name(s): Magdent Cap MED; Sham MED
Intervention type(s): Device; Device
Intervention description(s): Magdent is intended to be used for accelaration of soft tissue and bone healing; Sham MED is intended to be used for soft tissue healing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Long-term Follow-up for Growth and Development of Pediatric Patients From CRAD001M2301
Condition: Growth and Development
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of CRAD001M2305 is to report the long-term effects of everolimus
      treatment on height, weight and sexual development (using Tanner Stages) in children and
      adolescents with Tuberous Sclerosis Complex (TSC)-associated with Subependymal Giant Cell
      Astrocytoma (SEGA). The study will monitor the growth and development of pediatric patients
      with TSC-associated SEGA, previously enrolled in CRAD001M2301 until they reach Tanner Stage
      V, or until age 16 for females or 17 for males whichever occurs first.
    

Detailed description: 
      CRAD001M2305 is a prospective, multi-center phase IIIb/IV study. This study will investigate
      if the physical and sexual development of pediatric patients is affected by previous or
      ongoing treatment with everolimus. The study will monitor the growth and development of
      pediatric patients with TSC-associated SEGA, previously enrolled in CRAD001M2301 until they
      reach Tanner Stage V, or until age 16 for females or 17 for males whichever occurs first.
      Continued treatment with everolimus is at investigator discretion and is not required for
      participation in CRAD001M2305. Growth (height, weight), and sexual development (Tanner
      Stages, sex hormone levels, age at menarche, thelarche (females) and adrenarche (males)), and
      brain development (assessed by TAND Checklist, dates of brain MRI) of patients participating
      in this long-term follow-up study will be followed at annual visits to the site until
      patients achieve Tanner Stage V or age 16 (females), age 17 (males) whichever occurs first.
      Adverse events, concomitant medication, appearance of menarche, will be monitored and data
      collected every 3 months ("3-monthly"). Unless clinically indicated these 3-monthly visits
      can be performed per telephone.
    

Intervention name(s): Everolimus; Envirolimus drug class as prescribed by Physician
Intervention type(s): Drug; Drug
Intervention description(s): Blood sample and Tanner Stage assessment; At the discretion of the investigator, patients may be treated with commercially available everolimus, as per local product information/ standard of care.
Intervention MeSH terms: Everolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: TSC-associated SEGA,; height,; weight,; Tanner Stage,; growth development,; everolimus,; RAD001
Tanglewood Trail Walking Program in Rural Kentucky 2020
Condition: Dietary Habits
Study type: Interventional

Summary: 
      The Tanglewood Trail Walking Program is a well established community health initiative that
      encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market
      each Saturday. The study aims to determine if walking to the market with a community health
      coach results in healthier options being selected at the market when compared to the driving
      group.
    

Detailed description: 
      In the summer of 2017, community members of Whitesburg, KY were recruited to join the
      Tanglewood Trail Walking Program to the Whitesburg farmers market. Each Saturday,
      participants reported whether or not they walked the 1 mile trail to the farmers market and
      they reported which fruits and vegetables they purchased. Participants completed
      questionnaires about fruit and vegetable consumption and physical activity. Participants also
      provided physical and biological measurements. The ClinicalTrials.gov record for the original
      trial in 2017 is NCT03495648.
    

Intervention name(s): walking group led by a community organizer
Intervention type(s): Behavioral
Intervention description(s): Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: farmers market; Appalachia; physical activity; fruit and vegetable voucher program
Tofacitinib as a GC Sparing Agent for Polymyalgia Rheumatica
Condition: Polymyalgia Rheumatica; Effect of Drug; Safety Issues
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Glucocorticoids are the cornerstone treatment for polymyalgia rheumatica but induce adverse
      events. The efficacy of the candidate drug Tofacitinib has not yet been demonstrated in
      controlled studies. The aim of the study is to investigate the efficacy and safety of
      Tofacitinib as a glucocorticoid sparing agent in patients with polymyalgia rheumatica.
    

Detailed description: 
      A two-stage, phase 2 clinical trial was conducted to test whether tofacitinib would take into
      effect as a glucocorticoid sparing agent in patients with polymyalgia rheumatica. Tofacitinib
      was given at the dose of 10mg daily through the 24 weeks. Patients were to receive prednisone
      in a dosage of 15mg daily (or equivalent oral GCs) at baseline and tapered to 2.5mg or less
      daily within 20 weeks. The primary endpoint was the response to treatment, defined as the
      achievement of sustained low disease activity (PMR-AS<7) with GC independence
      (prednisone≤2.5mg daily or equivalent oral GCs) for 4 weeks from week 20.

      The trial will be conducted following a two-stage Simon minimax design. After 8 participants
      have completed their 24-week follow up there will be an interim analysis. If there are 3 or
      more failures out of these 8 then the trial will stop with the conclusion that the study of
      Tofacitinib should be abandoned. If there are fewer than 3 failures then the study will
      continue until a further 6 participants have received treatment, giving a total sample size
      of 14. If amongst these 14 participants there are 4 or more failures then it will be
      concluded that further study of Tofacitinib should be abandoned. If further study of the drug
      is not abandoned at either the interim of the final analysis, then a recommendation to
      conduct a comparative, randomized phase III trial will be made.
    

Intervention name(s): Tofacitinib 5 MG
Intervention type(s): Drug
Intervention description(s): Oral tofacitinib at the dose of 5mg twice a day was given for 24 weeks. Prednisone (or equivalent oral GCs) of 15 mg daily at baseline willed be tapered to 2.5 mg or less within 20 weeks. Unless specifically considered by patients and physicians, the GC will be tapered followed the predefined taper regimen depending on the response to treatment judged by PMR-AS. The PMR-AS will be determined every two weeks; if<10 the daily GC dosage was decreased by 2.5mg; if>17, the GC daily dosage was increased to the previous dosage; if 10≤PMR-AS≤17, the GC daily dosage was maintained at the previous stable dose.
Other intervention name(s): Prednisone
Intervention MeSH terms: Prednisone; Tofacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Observational

Summary: 
      The current study will assess the real - life effectiveness of adalimumab in the management
      of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis
      (PsA).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Offices of community rheumatologists & dermatologists
      
Keywords: Assessing Effectiveness in Psoriatic Arthritis
Haemodynamic Effect of Dexmedetomidine
Condition: Haemodynamic Effects of Dexmedetomidine
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart
      rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic
      vascular resistance increases. The indication for the drug is to produce sedation during
      surgical procedures and in ICU patients.

      The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure
      and heart rate variability during drug infusion) depend on pre-drug autonomic system
      activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement
      before drug injection and during drug infusion. Heart rate and blood pressure measured before
      and during drug infusion will be analysed.

      HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug
      injection and during its infusion. 5 minutes intervals will be analysed , using Frequency
      Domain Measures of HRV. Surgical procedure will start after measurement have been taken.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): 1 mcg/kg over 10 minutes, followed by a maintenance infusion titrated to achieve desired clinical effect - Richmond Agitation Scale between 0 and (-) 3. Holter ECG recording before start of infusion and during infusion for 25 minutes.
Other intervention name(s): Dexdor; Precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: dexmedetomidine; heart rate; heart rate variability
Chronic Obstructive Pulmonary Disease Markers and Prognosis
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The study aim is to verify the association between the changes in markers of disease and
      patient´s prognosis in chronic obstructive pulmonary disease.
    

Detailed description: 
      In a previous study, 133 COPD patients were followed-up during the period of one-year.
      Analyses of the association between baseline characteristic and the occurence of disease
      exacerbation was performed. In this study, the patients included in the previous research
      will be contacted and invited to participate in a complete evaluation after a three-year
      period. The association of the changes in dyspnea perception, spirometry variables, body
      composition, quality of life and exercise tolerance measures with disease prognostic will be
      studied.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pulmonary outpatient clinic
      
Keywords: COPD; Survival; Exacerbation; Disease markers