cyrilzakka/clinical-trials huggingface dataset:
Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications

Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The common adverse events related to the eradication medications area as follows; Abdomen discomfort, pain, nausea, vomiting, diarrhea, bloating, urticaria, dizziness, headache, etc,. Various methods have been tried to reduce or prevent the adverse events related to the eradication medications. However, there is no established methods to reduce or prevent these events.

The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who underwent upper gastrointestinal endoscopy and were proven to have H. pylori infection either by using the rapid urease test, the 13 C-urea breath test (UBT), or histological examination.

Exclusion Criteria:

* Subjects who took medications as Proton pump inhibitor, Histamin-2 receptor antagonist and antibiotics,
* Subjects who underwent stomach resection
* Subjects less than 18 years of age
Registry of Pancreatic Exocrine Insufficiency.

A prospective, cross-sectional, observational study has been designed with the aim of the study is to evaluate the diagnosis and management of patients with pancreatic exocrine insufficiency secondary to different pancreatic diseases and conditions in clinical practice.

A registry has been develop to include patients older than 18 years diagnosed with pancreatic exocrine insufficiency, sho are willing to participate in the study and sign the informed consent.

Registry includes demographics, toxic habits,pharmacological therapies, underlying disease that causes pancreatic exocrine insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy.
* Willingness to participate in the study.

Exclusion Criteria:

* Patients with pancreatic diseases without PEI.
* Pregnancy
* Known allergy to oral pancreatic enzymes
* Any condition avoiding adequate clinical management of PEI.
* Patients who are not willing to participate in the study.
Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.


Eligibility Criteria:
Inclusion Criteria:

* T1c prostate cancer
* Gleason score ≤ 6 with no Gleason pattern of 4 or 5.
* Life expectancy ≥ 5 years.
* Single positive prostate biopsy core with ≤ 50% cancer
* PSA ≤ 10 ng/mL

Exclusion Criteria:

* Previous active treatment (such as surgery, brachytherapy, radiotherapy) for prostate cancer.
* Evidence of metastatic disease or previous positive bone scan.
* Previous hormonal therapy for prostate cancer.
* Use of certain concomitant medications, including 5 alpha reductase inhibitors (e.g. finasteride, dutasteride), androgen receptor blockers (e.g. flutamide, bicalutamide), immunosuppressants(such as Imuran™, Enbrel™, Remicade™, Humira™, etc.), anticoagulants(such as Coumadin™ or heparin), or chemotherapeutics.
* Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months.
* Pelvic irradiation.
* Urinary tract infection more than once in the past 12 months.
* Acute or chronic prostatitis in the past 12 months.
* Clinically significant renal or hepatic impairment.
* Bleeding disorder.
* Poorly controlled diabetes type 1 or type 2.
* Urinary retention in the previous 12 months.
* Self-catheterization for urinary retention.
* Post-void residual urine volume \> 200 mL.
* Prior significant rectal surgery or any rectal condition with rectal stenosis or fistula.
* History of alcohol or substance abuse or dependence within the past 2 years.
Metastatic Colorectal Cancer. Real-World Data Analysis.

The Treatment Choices, Duration and Outcomes in Patients with Ras Wild Type (RAS WT) Metastatic Colorectal Cancer (mCRC). Retrospective, Multi-Center, Real-World Data Analysis

In this study, with the given rationale is to reveal treatment approaches, survival data, side effect profile and their management in our country in RAS WT mCRC patients by means of the real-world data collection.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been histologically diagnosed with mCRC
2. Patients over the age of 18
3. Patients receiving at least a cycle systemic treatment for metastatic disease
4. RAS wild type patients
5. Patients who has demographic, histopathological and clinical information

Exclusion Criteria:

1. Patients diagnosed as mCRC but only referred to BSC
2. Patients with RAS mutation
3. Patients who were included in any clinical trial except standard treatments during their treatment
Implementing Virtual Reality in the Operating Room

"Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.

However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.

The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.

The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour."


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Patient admitted for total hip or knee replacement surgery.
* Patient undergoing anaesthetic management by loco-regional anaesthesia
* Affiliation to a French health insurance scheme or equivalent
* Patient who has given his non-opposition agreement

Exclusion Criteria:

* Patient with a neurological disorder (coma, dementia, confusion, photosensitive epilepsy)
* Patient with a severe psychiatric disorder
* Patients with severe deafness or visual impairment
* Language barrier
* Pregnant or breast-feeding women of childbearing age
* Refusal of patient involvement
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells

The purpose of this pilot study is to evaluate the addition of carvedilol with standard of care treatment to determine if it will improve progression-free survival in the front line setting in patients with glioblastoma multiforme (GBM). In addition, monitoring of circulating tumor cells (CTCs) by a real-time reverse transcriptase polymerase chain reaction (qRT-PCR) assay to correlate with the clinical findings.

This is a pilot study to assess efficacy of the addition of a non-selective beta-blocker to standard of care treatment in the front-line setting of glioblastoma multiforme. And to also evaluate the level of peripheral glioma circulating tumor cells via TeleomeScan assay to correlate disease response determined by neuro-imaging.

Peripheral blood samples will be collected at baseline, on day 1 of cycle 1 and then after on day 1 of cycle 4 and at the end of cycle 6 of adjuvant chemotherapy. in order to correlate the biological effects of treatment response. The investigators will evaluate the quantity of peripheral glioma circulating tumor cells and want to apply the information seen in the periphery to the status of the cancer on imaging studies.

Subjects will start oral carvedilol at 6.25 mg orally twice daily and will evaluate the patient and vital status if they tolerate this dose at 1-2 weeks after initiation. If tolerated well, will increase the dose to the maximum anticipation of 12.5 mg orally twice daily. Treatment will proceed for 6 cycles and carvedilol will stop at the end of 6 cycles. Patients will be monitored with neuroimaging prior before chemoradiotherapy, before adjuvant temozolomide and every 2 months on adjuvant temozolomide. Following the completion of 6 cycles of adjuvant therapy, patients will continue to receive neuroimaging on every 3 months' basis until disease progression based upon standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed WHO Grade IV Glioblastoma
* Subjects must have not received previous chemotherapy or radiation therapy for GBM
* Subjects must have systolic blood pressure greater than or equal to 90 and heart rate \>59
* Subjects who are on beta-blockers for other etiologies may enroll on study and switch therapy to carvedilol if deemed medical appropriate per treating physician

Exclusion Criteria:

* Subjects receiving any other investigational agents
* Subjects who have severe and uncontrolled asthma, COPD
* Systolic blood pressure \<90 mmHg or HR \<60 bpm without antihypertensive medications at baseline
* Subjects with uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Allergy to beta blockers
Pilot Clinical Study of the LRS ThermoSuit™ System in Post Arrest Patients

The purpose of this study is to determine if the Life Recovery Systems Thermosuit(R) System is able to quickly and conveniently cool patients who are comatose after resuscitation from cardiac arrest.

The primary purpose of this study is to clinically evaluate the use of a new cooling device (the LRS ThermoSuit(R) System) to cool patients who are comatose following resuscitation from cardiac arrest. This device cools by circulating cold water directly against the skin of the patient. Cooling to a state of mild hypothermia (32 to 34 degrees C, maintained for 12 to 24 hours) is recognized by the American Heart Association, European Resuscitation Council, and the Canadian Association of Emergency Care Physicians as a promising therapy for such patients, and is likely to be most effective if administered quickly following resuscitation. It is hypothesized that this new device will cool patients much more quickly than by historical means. Patients will be monitored for physiologic parameters such as body temperature during the cooling therapy, and will be tracked for neurological outcomes following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest prior to or during hospital admission, with restoration/return of spontaneous circulation (ROSC).
* Cardiac arrest of presumed cardiac origin.
* Initial (pre-resuscitation) cardiac rhythm of ventricular fibrillation, non-perfusing ventricular tachycardia, pulseless electrical activity, or asystole.
* Estimated or known age \> 18 years.
* Intubation, ventilation and placement of esophageal probe.
* Estimated time from collapse to the initiation of Advanced Cardiac Life Support (ACLS) \< 15 minutes and return of spontaneous circulation with defibrillation within 60 minutes of collapse.
* Persistent neurologic dysfunction i.e. comatose upon enrollment \[GCS ≤ 8\].

Exclusion Criteria:

* Height greater than 188 cm.
* Elbow-to-elbow width greater than 60 cm (as measured above the supine patient).
* Core temperature less than 34°C after ROSC (as measured at the tympanic membrane, esophagus, sub-lingual space, nasopharynx, or central blood vessel).
* Comatose state before the cardiac arrest due to the administration of drugs that depress the central nervous system.
* Known pregnancy.
* Response to verbal commands after ROSC (but before enrollment).
* Known terminal illness that preceded the arrest.
* Known enrollment in another study of a device, drug, or biologic.
* Major trauma or other co-morbidity requiring urgent surgery.
* Improving neurologic status.
* \> 8 hours since return of spontaneous circulation.
* Unknown time of arrest.
* Severe or known coagulopathy (with active bleeding).
* Hemodynamic instability despite vasopressors (SBP \< 90 mmHg or MAP \< 60 mmHg for \> 30 minutes after ROSC and before enrollment).
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis

OBJECTIVES:

I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

One group receives copolymer 1, a mixture of synthetic polypeptides composed of 4 amino acids, subcutaneously each day for 2 years.

The other group receives an injection of placebo daily for 2 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinically or laboratory-supported definite multiple sclerosis
* Neurologically stable for at least 30 days prior to entry Expanded Disability Status Scale score no greater than 5
* At least 2 documented relapses within 2 years prior to entry Onset of first relapse at least 1 year prior to randomization

--Prior/Concurrent Therapy--

* Biologic therapy: No prior copolymer 1
* Immunosuppressive therapy: No prior cytotoxic immunosuppressives, i.e.: Azathioprine Cyclophosphamide Cyclosporine At least 30 days since corticosteroids
* Radiotherapy: No prior lymphoid irradiation

--Patient Characteristics--

* Not HIV or HTLV-I seropositive No insulin-dependent diabetes mellitus No Lyme disease No requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs No pregnant or nursing women Adequate contraception required of fertile women
Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations

This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with Stanford staff. We hypothesize that the budesonide/formoterol combination improves the efficacy of budesonide alone.

The study was designed such that 30 participants would be consented/enrolled into the trial. The intervention would only be applied if the participant developed a viral illness that met eligibility criteria during the study period.

Only 10 of the 30 ppt. consented/enrolled developed a virus and were then treated according to study arm.

A more detailed description can be obtained by contacting Astra Zeneca

Eligibility Criteria:
Inclusion Criteria:

Subjects will be considered for inclusion in this study based on meeting all of the following criteria:

1. Male or female, aged 12 to 65 years
2. Subjects with mild to moderate asthma as determined by NHLBI 2007 guidelines
3. Subjects with exacerbation of their asthma symptoms by NHLBI 2007 guidelines
4. IgE level at study entry less than 50 IU/mL
5. Men and women of reproductive potential who document use of adequate contraception during the study and for 3 months after the conclusion of treatment with study drug/placebo
6. Historical documentation of asthma in the patient's medical record. The patient should have 6 months or more of asthma medication and management by a Stanford physician.
7. Women of childbearing potential who have a negative pregnancy test (urine or serum) at the time of study entry
8. Subject's guardians who are capable of understanding the purpose and risks of the study and who sign a statement of informed consent for the study

Exclusion Criteria:

Subjects will be ineligible for this study based on any one of the following criteria:

1. With a chronic or acute disease that might interfere with the evaluation of Symbicort or Pulmicort Flexhaler therapy
2. Pregnancy or lactation
3. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated)
4. History of infection with human immunodeficiency virus (HSC-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV)
5. Infections that require intravenous antibiotic therapy
6. Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine \>1.6 mg/dL; ALT or AST \> 1.5x the upper limit of normal; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry)
7. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry
8. Treatment with any investigational drugs or therapies within 2 weeks prior to study entry
9. Any use of oral, systemic corticosteroids within 2 weeks prior to study entry
Wound Biofilm Detection Kit Development: Validation of Grading System With Biofilm Severity

Chronic wound is a leading health issue in current health care system. Biofilm is a notorious risk factor of unhealed wound. Although biofilm-direct wound care has been a prevalent strategy of wound care currently, diagnosis of biofilm still remained as an unmet clinical need. Several advanced diagnostic tools of biofilm had been published in recent years, however, the evidence was still insufficient.

In this study, we will enroll patients with chronic wounds, collect the wound debris, quantify the biofilm and validate with the signals of advanced diagnostic tools for biofilm detection, hoping to transform the tools which could only tell us whether the biofilm is present or not, into the severity of biofilm infection. The two tested tools includes of MolecuLight i:X and wound blotting and Alcian blue biofilm detection kit.


Eligibility Criteria:
Inclusion Criteria:

* 1.Age 18 or older
* 2.Has an unhealed wound and is scheduled for debridement surgery
* 3.Patients who are receiving wound care at this hospital (Hsinchu branch) and are able to comply with follow-up wound monitoring

Exclusion Criteria:

* Does not consent to provide remaining tissue from wound treatment for in vitro analysis.
* Allergic to nylon components.
* Under 18 years of age.
Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds

Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.


Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.

Exclusion Criteria:

* Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation.
* Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time.

Allergy to acrylic products.
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients

The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in treatment-naive patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C genotype 1.

Exclusion Criteria:

* Patients that have previously received treatment with any interferon or interferon-based treatment for chronic hepatitis C.
* Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.
* Other causes of liver disease including autoimmune hepatitis.
* Transplant recipients receiving immune suppression therapy.
* Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core Immunoglobulin M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV Ab).
* Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, Child-Turcotte-Pugh (CTP) score \>6 or Model for End-stage Liver Disease (MELD) score \>8.
* Alcohol consumption of \>40 grams per day or an alcohol use pattern that will interfere with the study.
* Absolute neutrophil count \<1500 cells/mm3; platelet count \<135,000 cells/mm3; hemoglobin \<12 g/dL for women and \<13 g/dL for men; or serum creatinine concentration ≥1.5 times Upper Limit of Normal (ULN).
* Hypothyroidism or hyperthyroidism not effectively treated with medication.
* Hemoglobin A1C (HgbA1c) \>7.5 or history of diabetes mellitus.
* Body Mass Index (BMI) \>34.
* History or other clinical evidence of significant or unstable cardiac disease.
* History or other clinical evidence of chronic pulmonary disease associated with functional impairment.
* Serious or severe bacterial infection(s).
* Ulcerative or hemorrhagic/ischemic colitis.
* Pancreatitis.
* History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.
* History of uncontrolled severe seizure disorder.
* Requires concomitant theophylline or methadone.
* History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.
* History or other evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
* Hemoglobinopathies.
* History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or ribavirin tablets.