cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Three Medications to Treat Diarrhea in Adults.

A comparison of three medications to treat diarrhea in adults.

This single (investigator) blind, randomized, 3-arm, parallel-group study design was selected to show non-inferiority of loperamide/simeticone caplets compared to chewable tablets in a heterogeneous subject population aiming at validity of results and reducing bias. The study will also compare the loperamide/simeticone combinations versus a probiotic (Saccharomyces boulardii) in the treatment of acute diarrhea in adults. Probiotics have been used for acute infectious diarrhea to reduce the duration and severity of the illness.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age
* Acute diarrhea illness with symptoms onset within 48 hours of study entry
* Minimum of 3 unformed stools in 24 hours before study entry
* Most recent stool is unformed
* Abdominal discomfort/wind (intensity mild to severe) within 4 hours of study entry
* Women of childbearing potential must have a negative pregnancy test at screening
* Willing to adhere to the prohibitions and restrictions specified in this protocol
* Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Requiring hospital admission, parenteral hydration or antibiotic therapy Axillary temperature \>38.2°C or oral temperature \>38.6°C
* History or clinical evidence of gross blood or pus in stool in current illness
* Signs or symptoms of orthostatic hypotension
* Unable to take medication and fluids by mouth
* History of chronic gastrointestinal disease, hepatic or renal insufficiency, or other significant medical condition that could be aggravated by untreated acute diarrhea
* Immunodeficiency (e.g. those with acquired immunodeficiency syndrome \[AIDS\] or known human immunodeficiency virus \[HIV\] infection, or undergoing chemotherapy or radiotherapy)
* Intake of antibiotics, oral antifungals, quinidine or ritonavir within 7 days, antidiarrhoeal, promotility drugs (e.g., metoclopramide, domperidone), antiflatulents (e.g., simeticone, activated charcoal) or probiotics or bismuth salts within 48 hours, or any analgesic within 6 hours prior to study entry Hypersensitivity to loperamide, yeast, or any component of study formulations
* Pregnant or breast-feeding
* Unable to comply with the protocol requirements and schedule
* Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study
* Use of opiates (as 'recreational' drugs and as painkillers)
Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®

This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have been treated with placebo in phase 1/2a clinical trial of NEUROSTEM®
2. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative)

Exclusion Criteria:

1. History of stroke within 3 months prior to study enrollment
2. Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1
3. Severe kidney disorder (serum creatinine ≥1.5mg/dL) at Visit 1
4. Abnormal Laboratory findings at Visit 1

   * Hemoglobin \< 9.5 g/dL for male and \<9.0 g/dL for female
   * Total WBC Count \< 3000/mm3
   * Total Bilirubin \>= 3 mg/dL
5. Suspected active lung disease based on chest X-ray at Visit 1
6. Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of \< 137,000/mm3, PT ≥ 1.5 INR, or aPTT ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy)
7. Diagnosis of cancer (of any body system, including brain tumor)
8. Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)
9. Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above
GLPG0259 Solid Formulation Bioavailability and Food Effect

The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage formulation (with and without food)and an oral solution, and to assess its safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
Early Revalvulation After Fallot Repair Improves Clinical Outcome

Aim With this retrospective study, the investigators would like to evaluate and, if possible confirm, whether earlier revalvulation of the right ventricular outflow tract is better than late revalvulation. Up to now, no analysis is done to validate this policy change.

Patient selection All patients registered in the database of paediatric and congenital cardiology of the University Hospitals in Leuven, with sufficient follow-up data, and who underwent transannular patching at repair will be included in the study.

Methodology and statistical analysis All files will be reviewed for demographic, electrocardiographic, echocardiographic, and outcome data. Besides descriptive statistics, Cox regression will be performed to detect whether the time period between repair and revalvulation influences clinical outcome (defined as death, heart failure hospitalization, redo-revalvulation, implantation of automatic defibrillator, endocarditis).


Eligibility Criteria:
Inclusion Criteria:

* Tetralogy of Fallot patients repaired with transannulaire patch.

Exclusion Criteria:

* None.
Clinical Value of G-EYE Colonoscopy in Daily Practice for Adenoma Detection and Time for Polyp Removal

Colonoscopy parameters will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope

Colonoscopy parameters such as demographics, findings and procedural times will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope

Eligibility Criteria:
Inclusion Criteria:

- Indication for screening or surveillance colonoscopy based on the German guideline for colon cancer screening

Exclusion Criteria:

* Emergency procedure
* Patients with known inflammatory bowel diseases
* Patients with hereditary cancer syndromes
* Patients with acute colonic inflammation (e.g. diverticulitis, ischemic colitis)
* Patients after radiation of the abdomen or pelvis
* Patients with colonic surgery (except appendectomy)
* Patients with incomplete colonoscopy
* Patients with insufficient bowel preparation
Canakinumab in Patients With COVID-19 and Type 2 Diabetes

The purpose of this study is to evaluate whether Canakinumab has beneficial effects on patients with Type 2 diabetes mellitus and coronavirus disease 19 (COVID19).

Patients with a metabolic syndrome (overweight, diabetes, hypertension) have a particularly bad outcome if infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). This may be explained by an over-activation of the Interleukin-1 (IL-1) beta system. Metabolic stress (increased glucose and lipid levels) induces NOD-, LRR- and pyrin domain-containing protein 3 (NLRP3) -mediated IL-1beta secretion. SARS-CoV2 also activates NLRP3. Therefore, the study proposes that metabolic stress in patients with overweight and diabetes potentiates COVID-19 induced hyperinflammatory syndrome leading to excess mortality in these vulnerable patients. Canakinumab (Ilaris®) is a recombinant, human monoclonal antibody antagonizing IL-1beta by blocking IL-1beta activity. The aim of the study is to investigate the effect of canakinumab in type 2 diabetic patients with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Body mass index \> 25 kg/m² (overweight)
* Hospitalized with COVID-19

Exclusion Criteria:

* Suspected or known untreated active bacterial, fungal, viral, or parasitic infection with the exception of COVID-19
* Treatment with immunomodulators or immunosuppressant drugs, including but not limited to tocilizumab, tumor necrosis factor (TNF) inhibitors and anti-IL-17 agents within 5 half-lives or 30 days (whichever is longer) prior to randomization with the exception of anakinra which is excluded within 5 half-lives only. Note: Immunomodulators (topical or inhaled) for asthma and atopic dermatitis, and corticosteroids (any route of administration) such as dexamethasone are permitted.
* History of hypersensitivity to canakinumab or to biologic drugs
* Neutrophil count \<1000/mm3
* Pregnant or nursing (lactating) women
* Participation in another study with investigational drug within the 30 days preceding and during the present study-
Early Detection of Cardiac Affection in Patients of Wilson's Disease

Wilson disease (WD) is a rare autosomal recessive disorder caused by a genetic defect in ATP7B resulting in limited excretion of excess copper into the bile Pathological copper accumulation occurs in the entire body, with the liver and the brain being primarily affected

Wilson disease (WD) is a rare autosomal recessive disorder caused by a genetic defect in ATP7B resulting in limited excretion of excess copper into the bile. Pathological copper accumulation occurs in the entire body, with the liver and the brain being primarily affected. The pathological copper accumulation may induce toxic injury, including mitochondrial dysfunction or apoptosis . Exhausted hepatic copper storage capacity causes copper release into the bloodstream thus affecting other organs, in particular the brain. The neurotoxicity of copper primarily damages astrocytes, leading to a regional destruction of the blood-brain barrier with subsequent neurological symptoms. Asymptomatic cardiac arrhythmias are quite common in WD. Cardiomyopathy, autonomic dysfunction, and cardiac deaths due to copper accumulation in cardiac tissue have occasionally been reported in WD. Copper accumulation induces toxic effects in cardiomyocytes and the clinical consequences of these myocardial accumulations are poorly understood. Previous studies have mainly reported mild cardiac abnormalities including concentric hypertrophy, impaired left ventricular (LV) relaxation and minor electrocardiographic changes, mainly reported in the times before appropriate treatment was available. A longitudinal cohort study demonstrated a higher incidence of heart failure (HF) and atrial fibrillation in WD patients, indicating a potential adverse effect of copper on the heart. Cardiovascular magnetic resonance (CMR) allows for a non-invasive tissue characterization, specifically visualizing edema, fibrosis, and pathological infiltrations. CMR has been successfully used for diagnosis and therapy monitoring in other storage diseases such as myocardial iron overload and amyloidosis. Survival in patients with thalassemia major improved significantly after the introduction of CMR for identifying myocardial iron accumulation. Imaging regional fibrosis using CMR late gadolinium enhancement (LGE) and quantitative measurement of extracellular volume (ECV) provide independent prognostic markers in cardiac amyloidosis.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with Wilson's

Exclusion Criteria:

* Claustrophobia
* Refusal to share information
* Heart failure
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of non-CF bronchiectasis
* History of P. aeruginosa respiratory infections
* At least two pulmonary exacerbations treated with antibiotics in the previous year

Exclusion Criteria:

* Have a clinical diagnosis of CF
* Are pregnant
IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome

STUDY OBJECTIVE

To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS.

STUDY DESIGN

This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of GHIS such as Laron syndrome,
2. 2 - 18 years of age,
3. Height less than or equal to -3SD for age,
4. Pre-pubertal, defined as Tanner breast stage 1 or testis volume \<4mL

Exclusion Criteria:

1. Children in puberty,
2. Diagnosed malignancy,
3. A diagnosis of diabetes mellitus
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients

This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection complicated by cerebral edema, or complex spinal surgery including multi-level scoliosis correction, is a more effective way of monitoring fluid.

We hypothesize that the ability to assess volume status and fluid responsiveness with information gained from Edwards FloTrac/EV1000 system coupled with a goal-directed therapy fluid management algorithm can make a difference in patient outcomes. Our specific aims are:

* Demonstrate goal-directed therapy (GDT) in fluid management improves peri-operative fluid balance
* Demonstrate GDT improves pulmonary function and organ oxygenation
* Demonstrate GDT reduces necessary therapeutic interventions in the peri- operative period
* Demonstrate GDT reduces hypotensive episodes in the peri-operative period

Outcomes

We will study the consequences of goal-directed fluid therapy that employs use of dynamic indicators seen on FloTrac/EV1000 system by measuring the following:

* Pulmonary status

  * Time to extubation
  * Alveolar-arterial (A-a) gradient of oxygen
  * Requirements for supplemental oxygen
* Organ oxygenation

  * Serum lactate
  * Arterial blood gas values (pH, HCO3, CO2, O2)
* Length of stay (LOS)

  * In hospital, defined as time from operation start to eligibility for discharge from hospital according to surgeon in accordance with pre-define criteria
  * In ICU/PACU, defined as time from operation end to eligibility for discharge from intensive care according to attending intensivist in accordance with pre- define criteria
* Fluid Balance

  * Inputs and outputs (I/Os) of all measurable fluids (i.e. blood, crystalloid, colloid) in peri-operative period, through and including duration of intensive care or the next 24-48 hours after completion of surgery
  * Drugs administered for fluid management (i.e. mannitol, vasopressors)
  * Pre-operative and post-operative body weights and twice-daily weights via bed weights
* Hypotension

  * Number, duration and severity (i.e. minimum blood pressure) of hypotensive episode, defined as MAP \<65

Eligibility Criteria:
Inclusion Criteria:

* Neurosurgical patients with concerns for decreased intracranial compliance;
* Orthopedic spine patients;
* Patients scheduled to undergo neurosurgical interventions that include any of the following will be eligible: intracranial aneurysm repair; or, major spine surgery.

Exclusion Criteria:

* Patients with permanent cardiac arrhythmias;
* Patients with severe aortic regurgitation;
* Patients with intra-aortic balloon pump (IABP);
* Patients undergoing emergency surgery; and,
* Women who are pregnant and/or nursing will be excluded.
"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"

The main hypothesis of this study is that magnetic neuromodulation can be used to correct bladder overactivity. The investigators assume that the transvertebral magnetic stimulation can improve both the subjective state of patients evaluated through questionnaires and objective parameters evaluated through invasive and non-invasive urodynamic studies. This study will compare two protocols for magnetic stimulation of the sacral spine roots (S2-S3 segments). The investigators propose to find out the dependence of the therapeutic effect on the frequency of stimulation, the frequency of procedures and the duration of the treatment course.

The aim of the study is to test the hypothesis that the use of magnetic stimulation of the sacral spine roots (S2 - S3) in patients with idiopathic overactive bladder (OAB) will help reduce the clinical and urodynamic manifestations of bladder overactivity.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years;
2. Signed informed consent;
3. The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence;
4. The presence of detrusor overactivity patterns based on the results of the urodynamic study (UDI)

Exclusion Criteria:

1. The patient, who have been implanted devices that control physiological functions (a pacemaker, a device for deep brain stimulation and chronic epidural brain stimulation, a cochlear implant).
2. Convulsive attacks in the anamnesis;
3. Taking medications that may trigger the risk of seizures;
4. Pregnancy or suspicion on it;
5. The presence in the patient's body of metal elements or objects made with the use of ferromagnets (joint prostheses, eye prostheses, tattoos made using metal ink, surgical clips, staples and other metal suture materials, etc.)
6. Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
7. Pelvic organ prolapse (II-IV stages according to the POP-Q system)
8. The presence of urinary tract infection
9. The presence of tumors of the pelvic organs
Study of GL701 in Men With Systemic Lupus Erythematosus

Lupus flares and other symptoms associated with systemic lupus erythematosus (SLE) may be caused by a deficiency of dehydroepiandrosterone (DHEA). GL701 is an investigational new drug meant to enhance DHEA levels. This study is designed to evaluate both the safety and efficacy of GL701 in male lupus patients.


Eligibility Criteria:
Inclusion Criteria

* Patient must have a diagnosis of SLE \> 6 months according to the 1989 revised ACR criteria. Patient must meet at least four of the eleven ACR criteria for systemic lupus
* Patient must have a modified SLEDAI score \> 3 at both screening and qualifying visits (Appendix A-2)
* Patient must be treated for SLE with doses of prednisone \< 30 mg/day (including those on NO glucocorticoid therapy) unchanged for \> 6 weeks prior to study entry (including both screening and qualifying visits). Prednisone dose in patient's receiving alternate day therapy will be the mean daily prednisone dose
* Patient treated with azathioprine, methotrexate, or hydrochloroquine must be on a stable dose with no change in dose for at least 6 weeks preceding the study
* Patient must be able to read and speak English and willing to sign an informed consent in English

Exclusion Criteria

* Patient with a history of prostate cancer
* Patient with elevated Prostate Specific Antigen (PSA)
* Patient diagnosed with liver disease, defined as AST or ALT \> 3x the upper limit of normal
* Patient ingesting body building/anabolic steroids within the last 6 months preceding the study
* Patient with end stage renal disease or receiving hemodialysis treatment
* Patient with serum creatinine \> 2 mg/dl or creatinine clearance \< 60 ml/min
* Patient receiving treatment with ACTH within the 3 months preceding study entry
* Patient receiving androgens, immunoglobulins, cyclophosphamide, cyclosporin A, or other immunosuppressive agents, except azathioprine, methotrexate, and hydrochloroquine within the last 3 months
* Patient with known hypersensitivity to DHEA or the inactive ingredients used in the GL70l formulation (cornstarch, lactose, and magnesium stearate)
* Patient who participated in any prior DHEA study or administration of DHEA within the past 3 months
* Patient using any investigational agents within the longer of 30 days or 10 half-lives of the agent
* Patient with any condition which in the Investigator's or sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g.. alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease)
* Patient requires treatment/medication prohibited by protocol
* Patient with any serious EKG abnormality as determined by the Investigator
Effect of Hydrocortison on Post-ischemic Flow-mediated Dilation and on Thenar Oxygen Saturation in Human Septic Shock.

The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).

Two primary end points, considered as reflecting vasoreactivity will be assessed :

1. Flow-mediated dilation (FMD) of the brachial artery, measured by ultrasound imaging, expressed in mm or in percentage, will be calculated from artery diameters measured before and after a vascular occlusion test (cuff around arm or forearm).
2. recovery slope of thenar oxygen saturation (StO2), assessed by near infrared spectroscopy (NIRS), expressed in %/second, will be recorded after the vascular occlusion test.

The two primary end points (FMD and recovery slope of StO2)will be assessed at the following timepoints :

* baseline (before first injection of placebo or hydrocortison)
* 2 hours after first injection of placebo or hydrocortison
* 2 hours after second injection of placebo or hydrocortison (i.e. 8 hours after first injection)
* 4 to 6 hours after third injection
* 4 to 6 hours after fourth injection (optional)

Eligibility Criteria:
Inclusion Criteria:

* age over 18 yrs
* consent obtained
* septic shock (according to international definition)
* patient sedated and submitted to invasive mechanical ventilation
* no need for surgery expected within 24 hours after enrollment
* patient has received at least one dose of large spectrum antibiotics
* superior vena cava catheter in place
* patient carrying a thermodilution device for cardiac output measurement
* stable mean arterial pressure within 65-5 mmHg limits for at least 2 hours;

Exclusion Criteria:

* pregnancy
* age below 18 years
* patient treated with iv continuous epinephrine
* chronic occlusive arteriopathy of the upper limbs
* regular or recent treatment with glibenclamide or glipizide
* regular or recent treatment with steroids
* known surrenal insufficiency