bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the pathophysiological effects of a single dose methylprednisolone
      administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the
      effect on the endothelial glycocalyx shedding due to surgical trauma.

      Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will
      receive placebo.

      The investigators hypothesize that the group receiving methylprednisolone will experience
      reduction in glycocalyx degradation compared to the placebo-group, early after TKA.
    

Detailed description: 
      The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on
      postoperative pain, postoperative nausea and vomiting are well-documented.

      Postoperatively, activation and / or dysregulation of the inflammatory system influence on
      the endothelial glycocalyx. Damage of the vascular endothelia increases the risk of
      cardiovascular and thromboembolic complications.

      In animal studies glucocorticoids have been found to preserve the endothelial glycocalyx and
      the vascular barrier.

      The effect of glucocorticoids on human endothelial glycocalyx after surgery is unknown and
      calls for further investigation.

      This study is embedded in a primary study registrated as: NCT02319343

      For further details please view the EudraCT registration:

      EudraCT nr.: 2014-003395-23
    

Intervention name(s): Methylprednisolone; Isotonic Sodium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride; Placebo
Other intervention name(s): Solu-Medrol
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Glucocorticoid; Endothelial barrier; Glycocalyx; Knee arthroplasty, total
Bioequivalence Study on Vitamin C in Healthy Adults
Condition: Dietary Exposure
Study type: Interventional

Summary: 
      The objective of this exploratory pharmacokinetic research study is to demonstrate that both
      caplets and gummies provide an effective dose of ascorbic acid in healthy adults.
    

Detailed description: 
      This randomized, examiner-blind, cross-over study evaluates the bioequivalence of a gummy
      containing vitamin C relative to a caplet comparator product in healthy adults.
    

Intervention name(s): Vitamin C gummy; Vitamin C tablet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): vitamin C; vitamin C
Intervention MeSH terms: Vitamins; Ascorbic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Measure Absorption of Vitamin C in Blood
Early Intervention in Infants With Perinatal Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This current study proposes to analyze the feasibility and effects of the two most used
      therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in
      very young infants (less than one year) with perinatal stroke and with a high risk to develop
      hemiplegic CP.
    

Detailed description: 
      Perinatal stroke constitutes an acute presentation of encephalopathy; manifesting as seizure,
      altered mental status, and/or neurological deficit; between birth and the twenty-eight
      postnatal day for which a pattern of ischemic brain injury in an arterial distribution is
      evident by neuroimaging. Following perinatal stroke, approximately 60% of children develop
      cerebral palsy (usually presenting as spastic hemiplegia), 30-60% experience epilepsy, 25%
      show language delay, and up to 22% manifest behavioral problems.

      The current most predictive tools for early diagnosis of CP are a combination of brain
      MRI/cUS and a general movements (GM) assessment in the fidgety period (9). Asymmetry of
      fidgety GMs around 12 weeks post term can be the first clinical signs of hemiplegia.

      There are currently two intensive therapy approaches aiming at improving upper limb
      performance in adults and children (average age 8 years) with established hemiplegic CP:
      constraint induced movement therapy (CIMT) and Hand-arm bimanual intensive training (HABIT).
      Those current therapy approaches fundamentally comprise repeated practice of desired
      movements based on motor learning principles with the adult/ child as an active participant.

      Both therapies, in adults and in children with established hemiplegic CP (average age 8
      years) are effective and show similar improvements if the dosage of therapy is similar. In
      contrast, the feasibility and the effects of both therapy approaches at very young age (under
      age 1 year) is still unknown (22). Exploring these options to treat even before asymmetric
      hand use has appeared is interesting and promising enough since recent animal studies have
      demonstrated that there is a critical period of motor system plasticity, and that
      activity-dependent reorganization of the motor-projection pattern to the hand occurs before
      about 1 year of age
    

Intervention name(s): CIMT; HABIT; baby-massage
Intervention type(s): Other; Other; Other
Intervention description(s): Constraint-induced movement therapy; hand-arm bimanual intensive training; instructions for baby-massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: early intervention, infant
The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression.
Condition: Major Depression; Bipolar I Disorder; Bipolar II Disorder; Unipolar Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to find out if the medication known as ketamine can
      help the symptoms of depression. This drug is approved by the Food and Drug Administration
      (FDA) but the investigators will use it for a non-FDA approved reason (depression).
    

Detailed description: 
      The investigators will enroll 100 adults with treatment-resistant unipolar or bipolar major
      depression (TRD) across 7 clinical sites and provide three IV ketamine infusions (0.5 mg/kg,
      infused over 100 minutes) and measure their depressive symptom responses. Biomarkers will be
      developed using blood samples from study subjects, taken prior to (predictive biomarkers) and
      following ketamine treatment (change biomarkers). The investigators will begin by studying
      the predictive value of mechanistic target of rapamycin (mTOR) target engagement by ketamine
      using a white blood cell (WBC) assay for antidepressive response to ketamine (Aim 1);
      however, samples will be used to develop multiple blood-based biomarkers for ketamine
      antidepressive effects (Aim 2). The investigators will also examine the effect of combining
      multiple blood-based biomarkers for predicting antidepressive response to ketamine in adults
      with TRD (Aim 3).

      Baseline WBC markers of impaired cellular energy regulation will be associated with measures
      of clinical response to ketamine (predictive biomarker). Changes in WBC markers of impaired
      cellular energy regulation will be associated with clinical response to ketamine (change
      biomarker).
    

Intervention name(s): Ketamine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
Other intervention name(s): Ketalar
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Adult Primary and Preventive Practice (APPP) Study
Condition: Preventive Care
Study type: Interventional

Summary: 
      The study is a pre-post two round, randomized controlled study design of PCPs randomly
      assigned to a control or 1 of 2 intervention arms.
    


Intervention name(s): Educational materials on a new diagnostic service
Intervention type(s): Other
Intervention description(s): Educational materials on a new diagnostic service
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Absorption and Excretion Kinetics of the Bioactive Ingredients of Rice Bran Extract
Condition: Safety After Oral Intake; Pharmacokinetics After Oral Intake
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The oral absorption and urinary excretion kinetics of the bioactive ingredients from rice
      bran (gamma-oryzanol, tocotrienols, tocopherols and ferulic acid esters) after incorporation
      into an oat porridge (oat porridge) compared to unprocessed rice bran extract oil were
      investigated. The influence of the type of preparation (with water vs. milk) of porridge on
      the bioavailability of the bioactive compounds was compared. The study followed a single dose
      (2 g rice bran extract), randomized, three armed crossover study design with ≥1-week washout
      periods. Plasma and urine samples were collected at intervals up to 24 h after intake.
    


Intervention name(s): Rice bran extract; Porridge in water; Porridge in milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Pharmacokinetics; Rice bran extract; Vitamin E; Gamma-oryzanol; Ferulic acid
Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache
Condition: Postdural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache; Wounds and Injuries
Study type: Interventional

Summary: 
      Postdural puncture headache (PDPH) is defined, according to the International Headache
      Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15
      minutes after sitting or standing and improves within 15 minutes after lying.

      For preventing PDPH, there are some uncomfortable practices for patients (fluid
      supplementation and bed rest) and expensive for hospital (time spend for information and
      management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not
      effective in prevention of PDPH, "fluid supplementation" is not an advice based on any
      evidence but only on routine. By this trial, the investigators want to evaluate the
      scientific value of this advice, in the standard patient care.

      The primary objective of this study is to compare oral hyperhydration (2 liters during 2
      hours after lumbar puncture - the most common routine according to an internal pilot survey)
      versus no advice about the fluid intake to prevent the PDPH.

      The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.
    

Detailed description: 
      Postdural puncture headache (PDPH) is defined, according to the International Headache
      Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15
      minutes after sitting or standing and improves within 15 minutes after lying.

      For preventing PDPH, there are some uncomfortable practices for patients (fluid
      supplementation and bed rest) and expensive for hospital (time spend for information and
      management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not
      effective in prevention of PDPH, "fluid supplementation" is not an advice based on any
      evidence but only on routine. By this trial, the investigators want to evaluate the
      scientific value of this advice by non-inferiority study, in the standard patient care.

      The primary objective of this study is to compare oral hyperhydration (2 liters during 2
      hours after lumbar puncture - the most common routine according to an internal pilot survey)
      versus no advice about the fluid intake to prevent the PDPH. It will be evaluated on the
      occurrence of PDPH in both of the two groups The second objective is to observe the day of
      apparition of PDPH, between day 0 and day 5.
    

Intervention name(s): Lack of hyperhydration
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Spinal Puncture; Dural puncture; Nursing
ACRO Biocornea Clinical Trial in Taiwan
Condition: Corneal Ulcer
MeSH terms: Corneal Ulcer
Study type: Interventional

Summary: 
      The goal of this clinical trial is to investigate the safety and clinical performance of
      ABCcolla Collagen Ophthalmic Matrix used for anterior lamellar keratoplasty in patients
      suffering from corneal ulcer.

      Participants will undergo keratoplasty using the investigational product and be followed up
      for 24-week observation (total of 10 times).
    


Intervention name(s): Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix
Intervention type(s): Device
Intervention description(s): Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.
Other intervention name(s): ACRO Biocornea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Gut Hormone Analogue Y14 in Adult Subjects
Condition: Diabetes Mellitus; Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomised, placebo controlled Phase I study to investigate investigate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects.
    

Detailed description: 
      Objectives:

      Primary Objective

        -  To investigate the safety and tolerability of single doses of Y14 in overweight/obese
           but otherwise healthy male subjects.

        -  To investigate the safety and tolerability of multiple doses of Y14 in overweight/obese
           male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

      Secondary Objectives

        -  To assess the pharmacokinetic (PK) profile of single doses of Y14 in overweight/obese
           but otherwise healthy male subjects.

        -  To assess the PK profile of multiple ascending doses of Y14 in overweight/obese male
           subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

      Exploratory Objective

        -  To investigate the effects of multiple doses of Y14 on food consumption, body weight,
           enteropancreatic hormone changes and glucose tolerance in overweight/obese male subjects
           with normal glucose tolerance, Type 2 diabetes or prediabetes.
    

Intervention name(s): Y14; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gut hormone analogue; 0.9% saline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop
      tumor cells from dividing so they stop growing or die. Leucovorin may decrease side effects
      caused by high-dose methotrexate.

      PURPOSE: This phase II trial is studying how well giving high-dose methotrexate together with
      leucovorin works in treating patients with newly diagnosed glioblastoma multiforme.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response in patients with newly diagnosed glioblastoma multiforme treated
           with high-dose methotrexate and leucovorin calcium.

      Secondary

        -  Determine the acute toxicity of this regimen in these patients.

        -  Determine the duration of survival of patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive high-dose methotrexate IV over 4 hours on day 1 and oral or IV leucovorin
      calcium every 6 hours beginning on day 2 and continuing until blood methotrexate levels are
      acceptable. Treatment repeats every 14 days for up to 6 courses in the absence of disease
      progression or unacceptable toxicity.

      Patients then receive standard radiotherapy with or without chemotherapy. Patients with
      disease progression proceed to standard radiotherapy with or without chemotherapy upon
      stopping methotrexate therapy.

      Patients are followed at 30 days and then every 2 months for up to 2 years.

      PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.
    

Intervention name(s): leucovorin calcium; methotrexate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leucovorin; Methotrexate; Calcium; Levoleucovorin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
A Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the gastrointestinal behaviour of a novel weight loss
      device in vivo to further understand the device's mechanism of action in aiding weight loss.
    

Detailed description: 
      Gelesis100 is a new, experimental medical device which has been developed by Gelesis, Inc. to
      aid weight loss in overweight/obese patients by reducing the amount of food required to make
      them feel full. The device is contained in a capsule which is swallowed with water before a
      meal. Once swallowed, the capsule dissolves and the capsule contents hydrate and mix with the
      food in the stomach, creating a feeling of fullness.

      Four different treatments of up to 5 capsules each will be given to participants during this
      study. These will be a mixture of the Gelesis100 capsules and capsules which do not contain
      the device i.e., they are placebo (will contain sucrose [sugar])

      The study is designed to look at:

        -  The time it takes for the stomach to empty once receiving each treatment

        -  The time it takes for food and Gelesis100 to travel through the intestine

        -  The effects of Gelesis100 on the feeling of satiety (how full participants feel)

      In order to monitor gastrointestinal behavior, either a small amount of radioactive material
      will be added to a component of a standard lunch or to the water given with the treatment.
      The radiation emitted will then be detected as it travels through the GI tract by taking
      images using a device known as a gamma camera. The procedure is relatively easy and non-
      invasive.
    

Intervention name(s): Gelesis100; Placebo
Intervention type(s): Device; Other
Intervention description(s): Gelesis100 capsules; Sucrose (sugar) capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Changes in Sensory Perception During Hypnotic Relaxation
Condition: Healthy
Study type: Interventional

Summary: 
      Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory
      testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic
      susceptibility will be assessed before QST.

      QST data before and during hypnosis will be compared. Observed sensory changes will be
      evaluated in relation to the assessed hypnotic susceptibility
    

Detailed description: 
      Healthy volunteers will be recruited and tested regarding their hypnotic susceptibility with
      Harvard Group Scale. In a second session QST will be performed on the right hand.Then
      hypnosis will be induced with the fixation method. After that the hypnotherapist will ask
      them to focus their attention on imagining an individual situation of well-being and calmness
      the volunteers had described before hypnosis. Then QST will be performed a second time on the
      same location. Results be compared using student's ttest.
    

Intervention name(s): Hypnosis
Intervention type(s): Procedure
Intervention description(s): hypnotic Relaxation without specific analgesic suggestion
Other intervention name(s): hypnotic relaxation
Intervention MeSH terms: Hypnotics and Sedatives
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Combination of Cryosurgery and NK Immunotherapy for Advanced Kidney Cancer
Condition: Metastatic Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      advanced kidney cancer.
    

Detailed description: 
      By enrolling patients with kidney cancer adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of the combined
      therapy using cryosurgery and nature killer (NK) cells for advanced kidney cancer.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance); Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Cancer; Cryosurgery; NK Immunotherapy
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
Condition: Chronic Ischemic Symptomatic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow
      (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for
      revascularization.
    

Detailed description: 
      Several studies have demonstrated the short term safety, feasibility and efficacy of cell
      transplantation in patients with advanced heart failure. There are no data about the long
      term outcome.
    

Intervention name(s): Autologous bone marrow intracoronary infusion
Intervention type(s): Procedure
Intervention description(s): Percutaneous intracoronary mononuclear bone marrow cell infusion
Other intervention name(s): Intracoronary mononuclear bone marrow cell infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment