cyrilzakka/clinical-trials huggingface dataset:
Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg

Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind Treatment Phase and Open-Label Treatment Phase.

Screening: Eligibility of subjects will be evaluated following informed consent signature. Screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory tests) and confirmation of eligibility following Rome III Diagnostic questionnaire will be performed.

Run-In: Subjects will enter a 2-week Run-In Phase during which IBS Symptoms and Stool Characteristics will be recorded. At the end of the Run-In Phase, data collected over the last week will be reviewed. Upon confirmation of IBS-D severity status, subjects may be randomized.

Double-Blind Treatment: Subjects will take study medication (either LACTEOL® 340 mg or Placebo) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed. HAD score will be assessed at the end of the double blind treatment.

Open-Label Treatment: All study completers will be eligible for a second 28 day Open-Label Treatment in the event that IBS-D symptoms remain or recur within the month following the end of Double-Blind Treatment. Subjects will take the study medication (LACTEOL® 340 mg) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed.

Eligibility Criteria:
Inclusion Criteria:

* IBS-D diagnosis using the Rome III questionnaire
* IBS Symptoms Severity Scale (IBS-SSS) score ranging between 100 and 400
* Bristol Stool Form Scale score exceeding two (\> 2) but less than seven (\< 7)
* Stable diet
* Mental and legal ability to sign informed consent

Exclusion Criteria:

* Diagnosis of Inflammatory Bowel Disease (IBD)
* Chronic use of systemic steroids
* Diagnosis of autoimmune Diseases or Disorders
* Invasive abdominal surgery
* Use of antibiotics prior to screening
* Allergy to active substance or any other ingredient in LACTEOL® 340 mg
* Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance
* Diagnosis of exocrine pancreatic insufficiency
* Use of any experimental drug within the 30 days prior to screening
Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding

Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital admission, and has significant associated morbidity and mortality, especially in the elderly. The most common causes of acute UGIH are nonvariceal. Although up 70% of non-variceal bleeds settle with conservative measures, endoscopic therapy is the established method for treating those bleeds for which this is not sufficient. Despite advances and increased expertise in managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained unchanged for several years.

EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in non-variceal upper gastrointestinal bleeding. This is a multicenter, prospective, randomized study.

Patients with upper GI bleeding who need endoscopic hemostasis will be enrolled in this study. When there is a upper GI bleeding with active bleeding or stigmata on the lesions, endoscopic hemostasis will be done.

After randomization, patients in both group will undergo endoscopic hemostasis with epinephrine injection therapy. In the study group, Endo-clot will be applied after epinephrine injection therapy. In the control group, hemoclip will be applied after epinephrine injection therapy. The efficacy of Endo-Clot and hemoclip will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 19 years old
2. Patients with hematemesis, hematochezia, melena, suspected upper gastrointestinal bleeding
3. Inpatients who were consulted gastroenterologist for management of upper gastrointestinal bleeding
4. Patients who are planned to undergo EGD for management of upper gastrointestinal bleeding

Exclusion Criteria:

1. Patients who had diagnosed esophageal cancer or stomach cancer
2. Patients who are suspected variceal bleeding, had medical history of liver cirrhosis, hepatocellular carcinoma
3. Coagulation disorder (hemophilia, ITP,,)
4. Post-procedure bleeding (EGD biopsy, EMR, ESD, stent insertion..)
5. Patients who cannot undergo EGD because of anatomical problem, unconsciousness.
6. Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
Glycemic Relapse Prevention: Maintenance Dose Assessment

This purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse.

Recent large randomized controlled trials have proven that tight glycemic control reduces the microvascular and macrovascular complications of diabetes. Reduction of these complications also leads to a great cost savings to healthcare and society. However, it has been difficult to translate the success of these large randomized control trials to everyday practice. A recent cross-sectional analysis of 95 clinicians revealed only 40.5% of type 2 diabetes patients had a glycated hemoglobin (HbA1c) less than 7%. The disparity of care between the large trials and a primary care office is largely due to the difference in resources available in the typical medical office. Practical, sustainable ways of maintaining tight glycemic control are needed in everyday practice.

While diabetes improvement programs are successful in acutely lowering HbA1c the long-term effectiveness of these programs is disappointing. Approximately 40% of those who return to routine care after completing an intensive diabetes improvement program experience a relapse in their glycemic control within one year. Some proportion of the relapse is likely due to a patient's inability to maintain adherence to key self-care behaviors - diet, exercise, self-monitoring of blood glucose and medication regimen.

The purpose of this study is to better understand prevention of glycemic relapse. The primary aim of this study is to assess the relative effectiveness of three management approaches, varying in frequency, for preventing glycemic relapse after glycemic control has been achieved through participation in an intensive diabetes improvement program. This study will determine the optimal frequency of intervention needed to prevent glycemic relapse in patients with type 2 diabetes. The authors hypothesize that high intensity intervention will lead to a decrease in glycemic relapse in a dose dependent fashion.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Recent control obtain (HbA1c\<8%) after diabetes improvement program
* Receives care in primary care clinic

Exclusion Criteria:

* pregnant
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study

This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.

A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic paroxysmal AF suitable for AF ablation
* Age \> 18 years old
* Informed consent to participate in this study.

Exclusion Criteria:

* Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
* Unable to undergo general anaesthesia for AF ablation.
* Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
* Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
* Previous thoracic surgery.
* Participation in a conflicting study.
* Potential participants who are mentally incapacitated and cannot consent or comply with follow-up
* Pregnancy
* Other cardiac rhythm disorders
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)

The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.


Eligibility Criteria:
Inclusion Criteria:

* Male and female of at least 19 years old
* Patient with functional dyspepsia met the ROME III criteria

Exclusion Criteria:

* Patients with previous gastrointestinal surgery
* Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
* Patients with history of gastrointestinal cancer
Randomized Study of Fluoxetine in Children and Adolescents With Autism

OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism.

II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.

III. Compare the baseline compulsive severity and treatment outcome in these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. All patients receive oral placebo daily during week 0.

Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8. Patients then crossover to receive treatment on the other arm during weeks 12-20.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Meets diagnostic criteria for autism

--Prior/Concurrent Therapy--

Other:

* At least 3 months since prior electroconvulsive therapy
* At least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity
* At least 2 weeks since prior monoamine oxidase inhibitors
* At least 6 weeks since prior long acting phenothiazines
* At least 1 week since prior other psychotropic drugs
* No prior fluoxetine of 20 mg/day for 6 weeks
* At least 6 weeks since prior fluoxetine
* No concurrent use of terfenadine (Seldane) or astemizole (Hismanal)
* No concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted)
* Prior participation in another serotonin reuptake inhibitor trial allowed

--Patient Characteristics--

Hematopoietic: No significant hematopoietic disease

Hepatic: No prior or concurrent liver disease

Renal: No prior or concurrent kidney disease

Cardiovascular:

* No significant cardiovascular disease
* No abnormal EKG

Neurological:

* No prior seizure disorder or high risk development of seizures
* No prior cerebrovascular disease
* No prior brain trauma

Other:

* Not pregnant or nursing
* Negative pregnancy test
* No unstable major medical illness or systemic disease
* No moderate or severe mental retardation and motor deficits (IQ less than 50)
* No family history of bipolar disorder
* No prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders)
* No significant autoaggressive behavior or serious suicidal risk
* No prior or concurrent gastrointestinal conditions
* No unstable endocrine disease (e.g., hypo or hyperthyroidism)
* No prior or concurrent malignancy
* Must be able to tolerate tapering of psychoactive medication
* No history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors
* No history of severe personality disorder or noncompliance
RCT Ventralex vs Onlay Mesh in Incisional Hernias

A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias

Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities.

Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.

Eligibility Criteria:
Inclusion Criteria:

* Hernia defect 1-4 cm
* Incisional hernia or recurrent hernia after previous primary hernia repair
* BMI \<35
* Age 18-100 years

Exclusion Criteria:

* Defect size\>4 cm
* Ongoing pregnancy
* BMI\>35
* Primary hernia
Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

The prevalence of onychomycosis among diabetic patients is still a debated question as well as the best way to diagnose the disease. We conducted a prospective study to assess the prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of this disease and to assess the reliability of the diagnosis of onychomycosis.

From December 2000 to January 2005, we followed 100 successive diabetic patients, type 1 and type 2, suffering from (DN). At baseline we assessed age, gender, medical history and medications, foot insensitivity defined by a vibration perception threshold (VPT) \>25 volts and onychomycosis by clinical diagnosis.

Multiple samples of the most affected nail, often the big toe, were taken. A potassium hydroxide (KOH) test was done by 2 independent and blinded investigators and a culture in a laboratory (lab) specialized in mycology.

Pictures of the nails and particularly of the sampled nail were taken. Apart from the laboratory results, two independent and blinded dermatologists gave their diagnosis looking at the pictures.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were: presence of diabetes mellitus, type 1 or type 2, age between 18 and 80 years, neuropathy demonstrated by a VPT (Vibration Perception Threshold) \>25 volts tested with a neurothesiometer (Horwell Scientific, London, UK) and a clinical diagnosis of onychomycosis.

Exclusion Criteria:

* Exclusion criteria were a history of psoriasis, systemic antifungal therapy during the year preceding the enrolment, immunosuppression either by disease or treatment induced.
Linguistic Characteristics of Suicidal Patients in the Emergency Department

The purpose of this study is to determine whether patients who have a high risk for serious suicide behavior will demonstrate a speech pattern that has a relationship to language patterns found in suicide notes.

In an average week the CCHMC Emergency Department (ED) evaluates 40 patients with suicidal behavior. Currently, there is no systematic method for assessment of suicide risk in these patients and often, emergency department staff are required to make judgments about the disposition of these patients without a full understanding of the patient's risk for another serious suicide attempt. This pilot project involves experts in child psychiatry, biomedical informatics, and emergency medicine to collect pilot data for developing a method to estimate the risk of serious suicidal behavior based on computational linguistics.

Eligibility Criteria:
Inclusion Criteria for Suicidal Subjects:

* Subjects age 13 years 0 months to 17 years, 11 months old
* Admission to CCHMC ED, psychiatric units, or medical units with suicidal behavior or attempt
* The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent.
* English is spoken as the primary language in the home

Inclusion Criteria for Non-Suicidal Subjects:

* Subjects age 13 years 0 months to 17 years, 11 months old
* Admission to CCHMC ED with no current or no history of suicide ideation/attempt/gesture
* No past or current history of a major mood disorder
* No history of death by suicide in first-degree relatives
* The patient and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent.
* English is spoken as the primary language in the home

Exclusion Criteria for Suicidal Subjects:

* Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol
* Level of consciousness precludes consent and research assessments
* Unable to assent because of severe mental retardation or incapacitating psychosis

Exclusion Criteria for Non-Suicidal Subjects:

* Any current or past suicide attempts
* Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol.
Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure

To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.

To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients who have undergone radial intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Patient and/or patient's legal representative and/or impartial witness has/have been informed of the nature of the study and agrees to its provision and has provided written informed consent as approved by the Ethics Committee of the investigative site.
3. Iatrogenic puncture
4. Patient who want to undergo radial intervention.
5. All puncture size must be less than 2.5cm.

Exclusion Criteria:

1. Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.).
2. Patients with known sensitivity to chitosan (shellfish) used in this study.
3. Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring Immediate suturing.
4. Patient is currently participating in an investigational drug or dressing study that has not yet completed its primary endpoint interferes with procedure and assessments in this trial.
5. Pregnant women.
6. Patients with hemorrhagic shock.
7. Patient having hemoglobin \< 9 g/dl.
Identifying Changes in Blood (Potential Biomarkers) in Individuals With Drug-Induced Liver Injury

The purpose of this study is to try to develop new blood tests that may help doctors identify if a drug is hurting a person's liver.

Our hypothesis is that there are liver-specific particles, called mRNA, that are identifiable in a person's blood sample during liver injury caused by some drugs. The purpose of this study is to try to develop new blood tests that may help doctors identify if a drug is hurting a person's liver, perhaps early in the process before significant injury or illness have occurred.

Eligibility Criteria:
Inclusion Criteria:

* ALT \> 200 IU/L at presentation to UNC Hospitals
* Drug induced liver injury considered likely by admitting medical staff
Functional Residual Capacity During Different Levels of High-flow in Preterm Infants

Although there is a widespread use of HighFlow therapy around the world, there is still uncertainty about the most appropriate initial HighFlow level after nasal continuous positive airway pressure therapy. Higher levels might produce excessive and harmful intra-alveolar pressures exceeding those reached during nasal continuous positive airway pressure therapy. Low levels may not generate sufficient distending pressures, which may result in a loss of functional residual capacity and an increased risk of respiratory failure. Therefore, the aim of this study is to assess the effect of different HighFlow levels on the functional residual capacity and to compare these findings to the functional residual capacity during nasal continuous positive airway pressure therapy.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent by one or both parents or legal guardians as documented by signature
* 30 - 35 weeks postmenstrual age
* Respiratory support with nCPAP PEEP 5mbar and FiO2 \< 0.30
* \> 72 hours old

Exclusion Criteria:

* Inability of the parents to understand the study concept or procedures due to cognitive or linguistic reasons
* Congenital malformations adversely affecting lung aeration or pulmonary perfusion (e.g. congenital heart or lung defects)