cyrilzakka/clinical-trials huggingface dataset:
Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease

Patient found to be malnourished after the nutritional evaluation would be randomized in the two groups of the study. The control group would receive standard nutritional counseling from a trained dietician where as those in the intervention group would be given 120 gm of a polymeric nutritional supplement providing around 500 Kcal per day over and above the standard nutritional counseling from a trained dietician. Both the groups would receive standard medical treatment. The polymeric nutrient supplement would be taken by the patients in this arm for a period of 6 months.

Patients with ALD (Alcoholic Liver Disease) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations, upper GI endoscopic findings and radiological investigations, patients would also be screened for the assessment of nutritional status. Patient found to be malnourished after the nutritional evaluation would be randomized in the two groups of the study. The control group would receive standard nutritional counseling from a trained dietician where as those in the intervention group would be given 120 gm of a polymeric nutritional supplement providing around 500 Kcal per day over and above the standard nutritional counseling from a trained dietician. Both the groups would receive standard medical treatment. The polymeric nutrient supplement would be taken by the patients in this arm for a period of 6 months. A record would be kept for the medications taken by the patients.

All the patients would be followed up at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after inclusion. Clinical, nutritional and biological data were collected at each visit. All these patients would receive standard treatment of cirrhosis consisting of withdrawal from alcohol along with symptomatic treatment including B vitamins, diuretics, salt restriction, lactulose, beta blockers, and antibiotics after bacteriological samples if needed. All patients would receive endoscopic surveillance for portal hypertension. An adequate prophylaxis by ligation or beta blockers would be performed as needed. The patients with a past history of spontaneous bacterial peritonitis will receive antibiotic prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive malnourished patients with ALD aged between 18 to 65 years of either gender would be enrolled.
* Abstinence of three months.

Exclusion Criteria:

* Severe alcoholic hepatitis
* Uncontrolled complication of the cirrhosis (variceal bleeding, infection, etc.),
* Hepatocellular carcinoma
* Ongoing corticosteroid treatment
* Co morbidities e.g. chronic renal insufficiency \& Acquired immunodeficiency syndrome.
* Refusal to participate in the trial
Comparing "salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in with Relapsing Prostate Cancer

Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT.

Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact.

In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA \>0.2 \<2.0 ng/mL, and increasing measured twice.
* Multidisciplinary conference (MDK) decision to offer the patient SRT
* Signed Informed Consent

Exclusion Criteria:

* Patients previously treated for prostate cancer with biochemical recurrence
* Previous treatment with androgen deprivation therapy (ADT) after surgery
* Previous pelvic radiotherapy
* Patients with positive lymph nodes at surgery
Thrombin Generation in Liver Transplant Surgery

This is a prospective observational study of 100 patients undergoing liver transplantation at a single centre. Thrombin generation and kinetics will be assessed using a novel point-of-care device, and compared to conventional measures of hemostasis as well as viscoelastic tests to pinpoint specific coagulation deficits and identify potential therapeutic targets. The clinical course of patients will be followed for major bleeding and transfusion outcomes.

Liver transplantation is the only curative option for end stage liver disease, but is associated with high morbidity and mortality. End stage liver disease is known to be accompanied by dysregulated coagulation, which is further exacerbated in the immediate perioperative period by transplantation, leading to both coagulopathic bleeding and thrombosis. Altered thrombin generation is thought to play a key role in the predisposition of these patients for both severe coagulopathic hemorrhage and life-threatening thromboembolic complications. Despite this, thrombin generation during the immediate transplant period in patients with end-stage liver disease is poorly characterized, in part because it is not well reflected by conventional measures of coagulation. This study aims to characterize changes in thrombin generation capacity pre, intra- and post-transplant utilizing a novel point-of-care thrombin generation assay. Other specific aims of the study are to identify risk factors for patients with impaired thrombin generation and will assess the association of impaired thrombin generation with overall clinical bleeding risk. The overarching goal of this work is to develop a point-of-care-testing guided algorithm addressing dysregulated thrombin formation that improves coagulation management without increasing the risk of thromboembolic complications. Ultimately, this line of research will improve the outcomes of liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (\> 18 years of age) proceeding to imminent (within 24 hours) liver transplantation surgery at Toronto General Hospital will be offered participation.
* Patients should have end stage liver disease necessitating transplantation. All etiologies of end stage liver disease will be accepted.

Exclusion Criteria:

- Patients who are unable to consent to the study or who refuse participation will be excluded.
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS

The aim of this study is to validate uHear™, an iOS-based tool, as a screening tool to detect significant hearing impairment as part of a comprehensive geriatric assessment in patients aged 70 years and older. The pass or fail screening cut-off is defined as having two or more consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5 - 2.0 kHz.


Eligibility Criteria:
Inclusion Criteria:

* Patients should have reached the age of 70 or more at enrolment
* Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible
* Patients should be fluent in Dutch or French
* Patients must receive their primary oncology care in the participating hospital
* Patients should be cognitively capable of performing the audiology assessment
* Patients should be scheduled to receive a CGA
* Patients should have signed informed consent

Exclusion Criteria:

* Patients who do not match the above inclusion criteria
* Patients presenting with clinically diagnosed Meniere's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss
* Patients who already have a hearing aid or a previously diagnosed hearing loss
Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil

Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil

Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil in three study populations: \<65 year healthy, 65 and older healthy, and Alzheimer's disease.

Each subject attends for 4 study days, receiving incrementally larger MCT doses at each visit for 0g, to 14g, to 28g to 42g.

Eligibility Criteria:
Inclusion Criteria:

* adult, healthy or with AD

Exclusion Criteria:

* unable to attend all study days
* coconut allergy
* Diabetes
Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising.

Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or more.
* Term singleton pregnancy (38 - 38+6 weeks gestation).
* Planned for elective transverse lower segment caesarean section with an indication.

Exclusion Criteria:

* Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.
* Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol.
* Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study.
* Pregnancies with known foetal malformation/s or chromosomal aberration.
Resilient, Empowered, Active Living: REAL Diabetes Study

This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assessment, principles of an evidence-based occupational therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. The study will randomize 80 young adults with diabetes to receive either the six-month REAL intervention or an attention control condition. Blinded data collectors will assess glycemic control, diabetes self-care behaviors and quality of life outcomes, as well as potential intervention mediators, before and after the six-month intervention. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention.

The study's specific aims and hypotheses are as follows:

Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care.

Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants.

Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT).

Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants.

Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in potential mediators of the intervention: habit strength, problem solving, activity participation, self-efficacy and diabetes knowledge as compared to baseline.

Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 or type 2 diabetes mellitus for a minimum of 12 months
* Most recent A1C ≥8.0%
* Fluent in English or Spanish
* Reachable by telephone or text message
* Willing to participate in study activities
* Reside in Los Angeles County with no plans to relocate

Exclusion Criteria:

* Pregnant or planning to become pregnant
* Cognitive impairment or severe disability limiting life expectancy
* Participated in lifestyle intervention targeting diabetes within past 12 months
* Participated in formative research related to intervention development.
IA or PE - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases

In this prospective controlled monocentric observational study, we assessed safety and efficacy of therapy with IA or PE in patients with neurological autoimmune diseases. In the subgroup analysis of MS patients also the EDSS was evaluated. In addition, we investigated possible pathomechanisms, such as cytokine alterations under therapy.

Plasma exchange (PE) and immunoadsorption (IA) are first- or second line treatment options in patients with neurological autoimmune disease, including multiple sclerosis, neuromyelitis optica, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré-Syndrom) or autoimmune encephalitis. This prospective controlled monocentric observational study of patients treated with either tryptophan IA or PE in cases of autoimmune neurological therapy refractory disease was performed between 2016 and 2019. The main outcome parameter for efficiency was clinical improvement after completion of treatment with PE/IA. Symptoms were assessed before the first and after the last IA/PE. In total, all patients receive 5 treatments. As patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* autoimmune neurological therapy refractory disease

Exclusion Criteria:

* Intake of Angiotensin-converting-enzyme inhibitors (ACE inhibitors) because of allergic reactions by using tryptophan adsorber
* contraindication for any anticoagulation
* contraindication for treatment with citrate dextrose anticoagulation
Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children

The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC infusion over the first hour, and additional SC rehydration could be continued as clinically indicated. The preferred anatomic site for the SC infusion was the anterior thigh, unless there was an overriding preference for an alternate site.

The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum of 72 hours. The investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other assessments of effectiveness and safety were made directly during the rehydration period and ED stay, and by telephone on Days 3 and 7 after discharge from the ED.

Eligibility Criteria:
Inclusion Criteria:

* Child, 2 months to 10 years of age
* Body weight less than 42 kg
* Presenting at emergency department with mild to moderate dehydration (Gorelick dehydration classification: presence of 1 to 6 \[of possible 10\] moderate or severe signs and symptoms) requiring parenteral rehydration

Exclusion Criteria:

* In shock or life-threatening situation (other than dehydration)
* Severe dehydration
* Requires intravenous (IV) therapy for another indication
* Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection)
* Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment
* Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site
* Reason for hospital admission or extended emergency department stay other than dehydration
* Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX
* Hyponatremia or hypernatremia
* Hypokalemia
* Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments
* Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results
* Participated in study of any investigational drug or device within 30 days prior to this study
TaVNS for Acute Intracerebral Hemorrhage

This study aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with acute intracerebral hemorrhage (ICH). The taVNS intervention will be delivered using the BS-TVNS800-1 transcutaneous electrical stimulation therapy device (KERFUN, Shanxi, China). A total of 186 patients will be randomly assigned in a 1:1 ratio to either the taVNS group or the sham-taVNS group. The primary outcome is the relative volume of perihematoma edema assessed on day 10-14 after randomization. Adverse events associated with taVNS therapy will be systematically evaluated to assess its safety profile.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with spontaneous supratentorial intracerebral hemorrhage.
2. Age between 18 and 80 years.
3. Onset within 72 hours.
4. Hematoma volume between 5 and 40 mL.
5. Glasgow Coma Scale (GCS) score greater than 8.
6. Written informed consent obtained from the patient or their legal representative.

Exclusion Criteria:

1. Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related).
2. Primary intraventricular hemorrhage.
3. Parenchymal hemorrhage that ruptures into the ventricles, with blood completely filling one lateral ventricle, the third ventricle, the fourth ventricle or more than half of both lateral ventricles.
4. Progressive neurological or other severe diseases.
5. Planned surgical treatment within 24 hours.
6. Pre-existing disability caused by previous illnesses: Modified Rankin Scale (mRS) score ≥ 3.
7. Patients with severe cardiomyopathy, heart failure, pacemaker implantation, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or other severe arrhythmias.
8. Severe pulmonary disease, liver disease, renal insufficiency (glomerular filtration rate \< 30 mL/min), active gastrointestinal bleeding, or malignant tumors with an expected survival of less than 3 months.
9. Patients with hyperthyroidism, hypothyroidism, syncope, epilepsy, multiple sclerosis, Parkinson's disease, multiple system atrophy, or other known disorders affecting autonomic nervous function.
10. Use of medications that interfere with autonomic function (e.g., beta-blockers, theophylline, tricyclic antidepressants, or steroids) within 7 days before screening.
11. Patients who cannot tolerate taVNS.
12. Congenital or acquired ear abnormalities preventing taVNS treatment.
13. Inability to comply with 10 days of treatment.
14. Pregnancy or within 30 days of delivery.
15. Participation in another interventional clinical trial.
16. Inability to obtain written informed consent from the participant or their legal representative.
Prevention of Nosocomial Bacteremia Among Zambian Neonates

The purpose of this study is to estimate the burden of disease, identify risk factors associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the investigators propose to study the impact of a novel package of infection control interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center in sub-Saharan Africa.

The study is an18 month prospective quasi-experimental evaluation of nosocomial bacteremia and mortality among hospitalized neonates and will consist of a 6-month baseline period to capture the incidence and all-cause mortality of nosocomial BSIs, a 1-month implementation period of low-cost infection control strategies (including alcohol-based hand rub \[AHR\], 2% chlorhexidine gluconate \[CHG\], hospital staff education and text message-based reminders of infection control recommendation) and an 11-month intervention period.

All neonates admitted to the neonatal intensive care unit (NICU) of the University Teaching Hospital (UTH) in Lusaka, Zambia during the study period will be eligible for study enrollment. This study will determine the capacity of an innovative bundle of low cost, simple and locally available interventions that leverage new technologies and expand application of highly effective interventions in order to reduce the incidence of nosocomial bacteremia among NICU patients in a developing country setting.

Eligibility Criteria:
Inclusion Criteria:

* Neonates admitted to the study site NICU during the study period (including both "inborn" and "outborn" neonates)

Exclusion Criteria:

* Neonates without documented birth date
* Parent or guardian unavailable or unwilling to provide consent