cyrilzakka/clinical-trials huggingface dataset:
Drug Nephrotoxicity Amelioration by N-acetylcysteine

When treating individuals with febrile neutropenia, amphotericin B (AmB-d) is one of the most effective treatments against often fatal systemic fungal infections.Nephrotoxicity from amphotericin B can develop with an incidence of up to 80.This emphasizes the value of nephroprotectant agent use.Because of N-acetylcysteine's antioxidant, antiapoptotic, vasodilator properties and its therapeutic effects on contrast nephropathy. Acetylcysteine's impact on amphotericin B-induced nephrotoxicity in cancer patients is assessed.

Severe fungal infections continue to be a significant source of morbidity and mortality in haematology units despite recent therapeutic advancements. The first anti-fungal medication that was successful against systemic mycoses was characterised as the traditional amphotericin B in the middle of the 1950s.AMB remains the treatment of choice for many serious fungal infections in vulnerable hosts owing to its excellent spectrum of activity and its low resistance rates. To date, it continues to be the agent with the widest spectrum of action and the lowest resistance potential of any known antifungal agent.In spite of clinical effectiveness, AmB treatment is associated with a range of acute and chronic adverse reactions . Nephrotoxicity and consequent electrolytes imbalances have been demonstrated as the most clinically significant adverse reaction of AmB that can restrict its clinical utility. Up to 80 % of AmB recipients during the first two weeks of treatment may develop some degree of reversible kidney injury . In addition, nearly 15 % of these patients may require dialysis which can lead to prolongation of hospital stay, increased total treatment costs, and mortality .

N-acetylcysteine, a drug with vasodilating, antiapoptotic, and anti-oxidant features, has been found to diminish the nephrotoxicity of cisplatin , cyclosporine and gentamicin . The results of two experimental studies in rats have suggested that N-acetylcysteine can mitigate GFR reduction as well as renal tubular apoptosis caused by AmB .

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years.
* Patients who have indication for systemic (injection) for conventional amphotericin at least 7 days.

Exclusion Criteria:

* documented acute kidney injury defined by an increase in serum creatinine ‡ 0.3 mg/dl within 48 h, or an increase in serum creatinine by ‡ 1.5 times baseline within the prior 7 days, or urine volume \<0.5 ml/kg/h for 6 h
* documented chronic kidney disease (clearance creatinine below 60 ml/min/1.73 m2 calculated by the abbreviated Modification of Diet in Renal Disease equation), history of peritoneal or hemodialysis for \> 3 months
* sepsis
* Severe hemorrhage(Blood loss \> 3 litres)
* Patient with cardiac or chronic liver disease history of receiving AmB by any administration route within the recent 14 days known allergy to either amphotericin b or N-acetylcysteine.
* receiving any formulation of NAC within the last week.
* unable to tolerate oral intake.
Strength Training on Pancreatic Cancer

The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss in both ears due to autoimmune inner ear disease (AIED).

Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated community approach to treatment with AEDs would have community units served by these volunteer non-medical responders who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD).

Eligibility Criteria:
Inclusion Criteria:

* patients with pancreatic carcinomas after surgery (resection or exploration)
* given consent

Exclusion Criteria:

* acute infection
* pain
* no mobility or ability for walking or standing
* severe neurological disorders (apoplex, morbus Parkinson, paresis of the lower extremeties)
* severe cardiac or cardiovascular diseases (z.B. heart insufficiency NYHA III, myocardial infarction \<3 months)
* rhytmical disorders, that contraindicate ergospirometric examinations
* cardiac therapy with digitalis pharmacy
* unclear syncopes
* severe pulmonal insufficiency
* renal insufficiency (GFR \< 30% at Krea \>3 mg/dl)
* synchronous participation in an other clinical trial
Stress, Inflammation and Immune Response Pilot Study- Aim 3

The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time.

Aim 1- Characterizing the immune response after acute stress and glucose consumption Aim 2- Temporal mapping of the modulation of immune cell function via meditation Aim 3-Influence of meditative practice on lupus patients Aim 4-Influence of meditative practice on healthy subjects

Current Clinicaltrials.gov record, will be focused on Aim-3 only. Aim-3 will test whether meditation alters neutrophil function and inflammation in patients with lupus. Study team will investigate whether patient neutrophils have altered NET formation, phagocytosis, ROS signaling and migration after ABMP. Innate immune function via analysis of monocytes by flow cytometry will also be analyzed. Other immune cell responses including CD8 T cells will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Lupus diagnosis according to \>4 ACR 1987 criteria or \>4 SLICC 2012 criteria or a diagnosis confirmed by a board-certified rheumatologist
* Capacity to provide informed consent and ability to speak and read English
* BMI under 35
* Must have access to an iOS or android smartphone to allow daily use of an app

Exclusion Criteria:

* Currently participating in another clinical trial with intervention. Participation in observational clinical trials is not grounds for exclusion.
* History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinological (diabetes), neurologic, rheumatologic, or gastrointestinal disease)
* Acute illness or evidence of clinically significant active infection
* Pregnant, breast feeding or less than 6 months post-partum
* Taking prescribed psychotropic or central nervous system altering medications
* History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder, epilepsy or seizures
* Individuals who are currently undergoing a depressive episode. Can include those who are under treatment and not depressed currently.
* Excluded based upon the screening visit
* Use of nicotine
* Significant previous training or significant current practice in meditation
* Completed Mindfulness Based Stress Reduction (MBSR) in the past
* Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include))
* Significant daily practice with other mind-body techniques
* Daily Yoga or Tai Chi Practice - exclude
* Other daily practice - judgment
Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Primary objective is to estimate the overall response rate (ORR) and the complete response rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable disease, no prior chemotherapy, immunotherapy or radiotherapy except for 1 cycle of CHOP-like chemotherapy.

Exclusion Criteria:

* Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral neuropathy, history of myocardial infarction in last 6 months, or patients who are Hepatitis B Surface Antigen positive.
Parkinson's Disease Therapy Using Cell Technology

Treatment of patients with Parkinson's disease using mesenchymal stem cells is a perspective method to influence on the pathogenesis of the disease. At the same time, this is a complex and still insufficiently explored process. Autologous mesenchymal stem cells will be transplanted to 30 patients with Parkinson's disease. The results of the effectiveness of the combined and intravenous routes of mesenchymal stem cells administration on the motor and non-motor symptoms in these patients will be evaluated and compared with the results of control group that received placebo therapy


Eligibility Criteria:
Inclusion Criteria:

1. A reliable diagnosis of Parkinson's disease, according to the diagnostic criteria developed by the Brain Bank of the Society for Parkinson's disease of Great Britain (UK Brain Bank Criteria, 1992).
2. Stage of the disease according to Hen-Yar: 1.5 - 3.0 stage.
3. Rapidly progressive type with a change in the stages of Parkinson's disease in no more than 4 years.
4. A good response to levodopa treatment: a positive dopamine test for assessing motor functions by a total score of section 3 of the UPDRS scale in the on- and off-period (not less than 30%).
5. The duration of the disease is not more than 8 years with the absence of motor fluctuations and dyskinesias.
6. The age of patients is up to 65 years

Exclusion Criteria:

e and parkinsonism-plus. 2. Severe concomitant diseases (congestive heart failure, myocardial infarction, pneumonia, decompensated diabetes mellitus, cachexia, etc.).

3. Autoimmune diseases, a tendency to bleeding, a history of sepsis. 4. Oncological diseases. 5. The presence of acute or exacerbation of the chronic inflammatory process of the sinuses or oral cavity.

6. A positive result for HIV, hepatitis B (HBV), hepatitis C (HCV), syphilis (RW).

7. Cognitive deficit. 8. Mental disorders - hallucinations, behavior disorders. 9. Depression of a pronounced degree (not more than 19 points on the Hamilton scale).

10. Alcoholism, drug addiction, criminal liability in the patient's history. 11. Pregnancy, lactation.
Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on Alcohol-induced Liver Disease in adults for 8 weeks.

Previous studies have indicated that Fermented Protaetia brevitarsis seulensis powder may have the ability to improve liver function in adults with alcohol-induced liver disease. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on liver function in adults with alcohol-induced liver disease; the safety of the compound are also evaluate. The Investigators examine gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 4,000 mg of Fermented Protaetia brevitarsis seulensis powder or a placebo each day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of viral hepatitis or cancer
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks
Evaluating the Impact of Patient Photographs for Preventing Wrong-Patient Errors

This is a multi-site, 4-arm randomized controlled trial to test the effectiveness of patient photographs displayed in electronic health record (EHR) systems to prevent wrong-patient order errors. The study will be conducted at several academic medical centers that utilize two different EHR systems. Because EHR systems have different functionality for displaying patient photographs, two different study designs will be employed. In Allscripts EHR, a 2-arm randomized trial will be conducted in which providers are randomized to view order verification alerts with versus without patient photographs when placing electronic orders. In Epic EHR, a 2x2 factorial trial will be conducted in which providers are randomized to one of four conditions: 1) no photograph; 2) photograph displayed in the banner only; 3) photograph displayed in a verification alert only; or 4) photograph displayed in the banner and verification alert. The main hypothesis of this study is that displaying patient photographs in the EHR will significantly reduce the frequency of wrong-patient order errors, providing health systems with the evidence needed to adopt this safety practice.

Although Computerized provider order entry (CPOE) systems are associated with a reduction in medical errors, when orders are placed electronically certain types of errors, including placing orders on the wrong patient, may occur more frequently. The danger of wrong-patient electronic orders was highlighted by one hospital's report of over 5,000 wrong patient orders in 1 year. With the growing use of electronic health records (EHRs), an effective method to minimize wrong-patient orders is needed. One study showed that patient photographs displayed in EHR systems decreased wrong-patient orders from 12 to 3 per year after patient photographs were implemented. While encouraging, this study was limited due to its small sample size, compared outcomes of the intervention participants to outcomes of a comparison group similar in demographics but may have differed in ways that were not measured in the study (quasi-experimental design), and reliance on voluntary reporting of errors by providers, which is known to be unreliable and greatly underestimate the actual error rate. This research proposes to use an automated and reliable measure of wrong-patient errors instead of voluntary reporting will demonstrate that patient photographs can significantly prevent wrong-patient orders.

Eligibility Criteria:
Inclusion Criteria:

* All patients for whom an order was placed in the study period.
* All providers with the authority to place electronic orders and who placed electronic orders during the study period.

Exclusion Criteria:

* None
Prenatal Surgical Repair of Fetal Myelomeningocele

The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one corresponding to the anatomical defect (as defined by the last upper normal vertebra before the defect).

The purpose of this study is to introduce in France an innovative technique for prenatal repair of myelomeningocele until now developed only on the American continent.

Spina bifida (SB) represents one of the most severe congenital malformation of the central nervous system and amenable to prenatal diagnosis. In the past 20 years, prenatal repair of SB has become an established technique.

The PRIUM study will include 10 cases of fetuses with prenatal diagnosis of SB and for whom the maternal willing will be to continue the pregnancy. A surgical prenatal repair of the defect will be planed at 19-25+6 weeks gestation following maternal laparotomy and hysterotomy under maternal general anesthesia. The delivery will be planed at 36 weeks'. Postnatal evaluation of the neonates will be scheduled at birth, 1 month, 12 months and 36 months of age. Those data will be matched to controls who have underwent a conventional postnatal repair of the SB

Eligibility Criteria:
Inclusion Criteria:

* patient of majority age, with an assumption by health insurance, understanding and speaking French
* A term between 19 and 25 +6 weeks gestational age (not for control)
* Single-Pregnancy
* Normal fetal karyotype
* Myelomeningocele with higher-level defect between S1 and T1
* Placenta not low-inserted or not covering
* Fault-isolated ultrasound reference

Exclusion Criteria:

* Age under 18 years
* Patient foreigner who understands not French
* Multiple Pregnancy
* Low Placenta inserted or covering
* Severe kyphosis
* Placental abruption
* Fetal malformation unrelated to the existence of myelomeningocele (the existence of a malposition of one or both feet do not represent an exclusion criterion)
* Increased risk of preterm birth: a history of preterm delivery before 37 weeks gestational age, cervical length \<26 mm before 26 weeks gestational age (not for control)
* Bleeding active between 20 and 26 weeks gestational age (not for control)
* Maternal obesity with BMI\> 35 (not for control)
* History of uterine surgery involving the anterior surface of the uterus (not for control)
* Maternal contradiction in surgery or general anesthesia (not for control)
"MyPlan" - Individualized Planned Eating Patterns for Adolescents With Type 1 Diabetes

The purpose of this study is to test the acceptability and effectiveness of an individualized eating strategy as part of diabetes self-management to improve glycemic levels among youth with type 1 diabetes (T1D) and suboptimal glycemic management. Investigators will assess participant acceptability of and adherence to a 6-month individualized eating strategy ("MyPlan") characterized by approximate day-to-day consistency in the frequency and timing of meals and snacks and distribution of carbohydrate throughout the day. Within-individual change in glycemic levels between baseline and 6-months of the study will also be compared. The goal of the study is to inform the design of a future randomized clinical trial to test the addition of the MyPlan eating strategy to ongoing diabetes clinical care among youth with T1D.

This is a pilot, single-arm clinical trial to assess whether "MyPlan" is an acceptable and effective dietary strategy to be included in future fully powered trials aimed at optimizing diabetes outcomes in youth with T1D. Youth and guardian dyads will be enrolled for a total of 6 months, during which time dyads will be counseled to follow an individualized eating pattern ("MyPlan") defined by five eating behavior goals: 3-4 meals per day and 1-2 optional snacks; eating occasions no less than 2 hours or greater than 4 hours apart; target carbohydrate ranges for each eating occasion; no post-dinner snacking; eating occasion within 1-2 hours of waking. The plan, including the eating behavior goals, will be tailored to youth and family routines and preferences. Registered dieticians will support participant adherence to the plan via telehealth counseling sessions on a weekly basis for the first 2 months followed by bi-weekly sessions for 4 months. Investigators will assess a) acceptability of the eating pattern and counseling strategy according to youth and guardians; b) youth adherence to the five eating behavior targets; c) change in youth glycemic levels between baseline and 6-months.

Eligibility Criteria:
Inclusion Criteria:

* Youth 12-17 years old
* History of T1D of at least one year
* HbA1c 7.5-11%
* Guardian willing to also participate
* English as preferred language

Exclusion Criteria:

* Youth with other metabolic disorders, unstable thyroid disease, diagnosed eating disorders, prohibitively strict dietary restrictions, or those with other serious condition that renders participation inappropriate.
* Females who are pregnant, breast feeding, planning to become pregnant during the study period or delivered a baby in the last 12 months.
* Unwillingness to follow a personalized eating plan for 6 months or complete MyFitnessPal logs at least 3 days/week throughout the study.
CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who Are Undergoing Radiation Therapy

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Multiple CT scans may improve the accuracy of radiation therapy for prostate cancer.

PURPOSE: Phase I trial to study the effectiveness of multiple CT scans in guiding the treatment of patients who have prostate cancer and are undergoing radiation therapy.

OBJECTIVES:

* Compare the accuracy of radiotherapy delivery using multiple CT scans to guide patient positioning vs the standard portal image guided procedure in patients with prostate cancer undergoing external beam radiotherapy.
* Determine the reduction in the proportion of patients with large target positioning errors using the CT-guided procedure.
* Determine organ motion and setup errors over the course of radiotherapy in order to develop efficient clinical intervention strategies in these patients.

OUTLINE: Patients undergo radiotherapy over 9 weeks. Patients undergo a CT scan immediately prior to receiving radiotherapy on treatment days 3-8 and then weekly thereafter. On 3 different days, patients also undergo CT scan immediately after radiotherapy. If the CT scans indicate a correction that exceeds the action level currently in effect, then beginning with the next treatment, the patient's position with respect to the radiation field is adjusted.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing external beam intensity-modulated radiotherapy for prostate cancer
* Able to maintain treatment position for about 40 minutes

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* Not specified