cyrilzakka/clinical-trials huggingface dataset:
Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on impulsivity.

Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control subjects.

Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk taking (as measured by the Balloon Analogue Risk Task) and on the preference for small immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To compare subjects with alcohol use disorder and healthy control subjects on these tasks.

Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary study outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps delivered in the Balloon Analogue Risk Task

Study Design: Randomized, placebo control, cross-over, single-dose


Eligibility Criteria:
Inclusion Criteria:

* 30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20),
* 30 sex and age-matched healthy controls,
* over 18, informed consent.

Exclusion Criteria:

* opiate-treatment,
* contra-indications for Nalmefene and/or Baclofen,
* unstable psychiatric disorder,
* pregnancy,
* acute withdrawal syndrome.
Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers

This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).


Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic leg ulcers evolving for more than 6 months
* Patient to receive skin pellet transplant
* Chronic wound area between 10 and 30 cm²

Exclusion Criteria:

* Patient without health insurance,
* Pregnant womens,
* Smoking patient,
* Chronic wound area \>30 cm²
Pharmacokinetics of Afamelanotide in EPP Patients

The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.


Eligibility Criteria:
Inclusion Criteria:

* EPP patients aged between 12 and 70 years
* BMI between 15 and 30 kg/m2
* \>50 kg

Exclusion Criteria:

* Any personal or direct family history of melanoma
* Any significant history of allergy and/or sensitivity to any of the contents of study drug product or lignocaine or other local anaesthetics if used
* Any significant illness during the four weeks before the study screening period
* Any evidence of hepatic or renal impairment
A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis

Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria consists of all patients suffering from HD at an age of less than 13 years old, and HD is confirmed by postoperative pathological examination, barium enema and anorectal manometry.

Exclusion Criteria:

* Age\> 13 years old
* Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or can not thrive.
* Patients are complicated with congenital gastrointestinal malformations (such as anal stenosis, intestinal atresia stenosis), metabolic and endocrine diseases caused by organic constipation and functional constipation in children.
* Children are complicated with liver, kidney dysfunction, blood disorders, immune deficiency diseases and significant ECG abnormalities.
* Children have taken oral antibiotics, microecological modulator, yogurt, other gastrointestinal motility drugs which can affect the gut flora.
* Drug allergies, or allergic diseases..
* Poor compliance with oral probiotics treatment.
Adaptive MR-guided SBRT for Localized Prostate Cancer

The purpose of this study is to evaluate a technical feasibility of MR-guided SBRT fraction dose adaptation for low-risk, intermediate-risk and low-volume metastatic prostate cancer. .

Hypofractionated SBRT to 36.25 Gy in 5 fractions (fraction dose 7.25 Gy) for low- and intermediate risk prostate cancer is standard of care. Using higher fraction doses that might be beneficial for disease control is not safe in all patients, unless adaptive treatment is performed. In this clinical trial the feasibility of online MR-guided SBRT fraction dose adaptation (between 7 and 8 Gy) for prostate cancer will be investigated. A fraction dose to the planning target volume (PTV) will be adapted to organs-at-risk (OAR) geometry (position, shape and volume) on online planning MRI scans of the treatment day ("geometry-of-the-day"). Thus the investigators hope to maximize treatment individualization.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent according to Swiss law and ICH/GCP regulations before any trial specific procedures;
* Males;
* Histologically confirmed adenocarcinoma of the prostate;
* Low (Grade group 1 \[Gleason score ≤6\], clinical stage T1-2a N0 M0, and PSA \< 10 ng/ml) and intermediate (Grade group 2-3 \[Gleason score 7\], clinical stage T2b-2c N0 M0, PSA 10-20 ng/ml) risk prostate cancer with indications for SBRT with curative intent;
* Newly diagnosed low-volume metastatic prostate cancer with indications for SBRT, in whom metastatic disease was confirmed on a bone scintigraphic scan and soft-tissue imaging done within 3 months of starting androgen deprivation therapy (ADT);
* IPSS \<15;
* Age: ≥ 18 years old;
* Karnofsky performance status ≥70;
* Patients able to tolerate long (approximately 60 minutes) treatment time;
* Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.

Exclusion Criteria:

* Previous radical treatment for prostate cancer - either radiation therapy (external or brachytherapy), surgery, TUR-P, cryosurgery, or HIFU;
* Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia;
* Lack of safe contraception;
* Known or suspected non-compliance, drug or alcohol abuse;
* Inability to follow the procedures of the trial, e.g. due to language problems of the participant;
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
Neuromed- Integrated Health Life Platform and Biobank

This project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the Neuromed Group clinics, associated with a biobanks of biological fluids and human tissues and a biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.

There is a need for a change of vision in health care that could become a key innovation point for digital medicine in the future, a sort of Copernican revolution: the starting point is no longer the disease, but the patient around whom pathologies and risk factors rotate, not as distinct and uniquely defined entities, but as communicating and interconnected possibilities that define their form only in relation to the individual, his genome, his personality, his habits of life and the environment in which he lives. From these interactions, a personalized, dynamic, integrated, and continuous diagnostic and therapeutic pathway is created that accompanies the person not only in the stage of the disease but also in the previous and subsequent phases, becoming a way of life oriented towards the health of the person rather than a way to cure a disease.

An Integrated Health Life Platform enables you to develop an interactive healthcare health model among all actors who manage the health of the person, healthcare professionals in the area, and hospitals, caregivers, and community through the integration of remote monitoring of data with A virtual community.

The platform is thought not as a pure aggregation of data, but as a digital hub centered on the patient, with his (clinical and personal) data, but also the environment in which he lives, his behaviors, accessibility to services and The relationships that come to them and from them. The platform aims to effectively integrate self management, personalization of the path, and co-production of health, demonstrating that these three key dimensions of care are mutually reinforcing.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Older than 18 years
* Cardiovascular disease
* neurodegenerative disease
* Cancer
* Pregnancy

Exclusion Criteria:

* Inability to understand and to want
* Refusal to sign the informed consent
Effects of Whole Food, Plant-Based Nutrition on Chronic Kidney Disease With Proteinuria

This study will test the hypothesis that lifestyle intervention consisting of a whole food, plant-based (WFPB) diet and group education will favorably impact outcomes germane to individuals with chronic kidney disease (CKD) stage 3b and 4, including blood pressure control, amount of proteinuria (protein in the urine), and preservation of glomerular filtration rate (GFR). In addition, this study will assess weight and body composition, diabetic control in subjects with diabetes as well as CKD, and quality of life. Safety of a WFPB diet in subjects with CKD will be tested with respect to the development of elevated serum potassium and phosphorus, hypoalbuminemia (low blood protein), hypotension (low blood pressure), and hypoglycemia (low blood sugar). An exploratory aim is to test the effects of a WFPB diet on the microbiome of subjects by collecting and analyzing stool samples.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Subjects with CKD 3b and 4 (as determined by an estimated glomerular filtration rate of ≥ 15 ml/min but ≤ 45 ml/min for at least three months)
* Subjects with proteinuria documented at least twice with the most recent test within the last 6 months as determined by:

  * Urine albumin excretion rate of \> 300 mg/day or urine albumin to creatinine ratio of \> 300 mg/g of creatinine
  * Urine protein excretion rate of \> 500 mg/day or urine protein to creatinine ratio of \> 0.5 g/g of creatinine
* If using angiotensin converting enzyme inhibitor, angiotensin receptor blockers and/or aldosterone antagonists, on a stable dose of for greater than one month
* Fluent in English language
* Able and willing to comply with the testing and group education schedules
* Able and willing to comply with a whole-food, plant-based diet
* Able and willing to give informed consent

Exclusion Criteria:

* Any kidney disease requiring immunosuppressive therapy
* Pregnancy or intent to become pregnant in the next 12 months
* Life expectancy \< 12 months
* History of solid organ transplant or anticipated solid organ transplant in next 12 months
* History of hyperkalemia: Two potassium measurements \> 5.1 Meq/L within the last three months, or history of any intervention for hyperkalemia in the last 6 months
* Subjects with malabsorptive syndromes
* Subjects with history of bariatric surgery or planned bariatric surgery in the next 12 months
* Subjects on warfarin
* Subjects with current eating disorders
* Subjects with tobacco or illicit substance use
* Subjects with alcohol use of \> 7 drinks per week
* Allergy or intolerance of a plant-based or plant-derived food (gluten, soy, etc.)
* Following a vegan diet in the six months prior to consent
* Major surgery within 60 days prior to consent
Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED)

Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensulizole.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age
* Have Fitzpatrick skin types I, II, or III
* In good general health based on a medical history review
* Be free of any acute or chronic illness/disease that might interfere with or increase risk of study participation
* Be able to cooperate with the investigator and research staff
* Be willing to have the test materials applied according to the protocol
* Be capable of understanding and provide written informed consent

Exclusion Criteria:

* Subjects with a history of adverse effects upon sun exposure
* Subjects currently taking any medication that may alter the sunlight response or is a known photosensitizer
* Subjects with a history of any form of cancer, lupus, psoriasis, rosacea, porphyria cutanea tarda, connective tissue disease, diabetes or any disease that would increase the risks associated with study participation
* Subjects with an abnormal sensitivity to any sunscreen agent
* Females who indicate that they are pregnant or nursing an infant during the period of the study
* Subjects with excessive hair, blemishes, nevi, warts, moles, scars, sunburn, suntan or uneven pigmentation in the test areas
* Subjects who have been administered an investigations drug or have participated in another SPF or PFA study within 30 days prior to this study
* Subjects who are allergic to latex or latex products
* Subjects who have any conditions that would make study participation inappropriate as determined by the investigator
Impact of Telomere Biology and Sperm DNA Fragmentation on Embryonic Development

The proposed project we intend to assess the implication of the telomeric pathway in male infertility. To get this, several analyzes will be carried out: 1. Determination of the TL by means of two methods: Q-FISH and PCR. 2. Determination of sperm DNA fragmentation by tunnel technique. 3. Assess sperm maturation.

Finally, the correlations between age, normality or not of the seminogram, LT, Short telomers (ST) accumulation, DNA fragmentation levels, sperm maturation and fertility, blastocyst development, and pregnancy rates will be established in search of cut-off points that can give a forecast of man´s fertility who consults on this subject.

To carry out the project, men who come to the clinic in the context of a couple fertility study and who do not have a known cause that justifies their infertility will be recruited. A clinical history will be made, and an informed consent will be given to them for their participation in the project (Annex Consents). Semen samples will be obtained on the day of oocyte fertilization and the unused part of the sample is recovered for Sperm LT determination, ST accumulation, sperm DNA fragmentation and sperm maturation.

Eligibility Criteria:
Inclusion Criteria:

* Men of any age who come to IVI Madrid in the context of a couple's infertility study and who present normozoospermia or semenograms with sperm count \>10mill/ml, \>25% progressive motility and \> 1% normal morphology.

Exclusion Criteria:

* Males who have suffered any acute illness in the three months prior to inclusion in the study.
* Males with any known chronic disease or genetic alteration.
Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease

The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure with New York Heart Association (NYHA) Classification II or III
* Chronic kidney disease
* Cardiac ejection fraction \<40%
* On heart failure therapy including an ACEI or ARB, and a BB
* Willing to understand and comply with study procedures and provide written informed consent.

Exclusion Criteria:

* Hospitalization within 4 weeks of baseline visit
* History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
* Current or anticipated dialysis during study
* In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe
* Drug or alcohol abuse
Organizational Factors Influencing Practice Improvement in Community Based Care

Purpose of the Study:

The Richmond Behavioral Health Authority's Substance Abuse Services Division and Virginia Commonwealth University's Institute for Drug and Alcohol Studies are working on an important research study to improve the quality of substance use disorder treatment services offered by RBHA and its contracted services providers. Specifically, this preliminary research will provide the information needed to conduct a planned series of program-specific interventions, designed to increase the adoption of evidence-based practices (EBPs) within specific programs. A major goal of the study is to better understand what factors influence the adoption of EBPs, and what adoption strategies work best for which types of staff, which types of programs, and under what conditions.

Description of Staff Involvement:

In this study, staff will be asked to complete questionnaires about themselves, their workplaces, and their perceptions about the services their organization provides. Some of these questionnaires will be given to staff when they first enter the study, and others may be given to staff before and about 9 months after a 3-day Practice Improvement Workshop (please note that each agency may or may not be selected to complete the workshop).

Description of Client Involvement:

Clients at each participating site will be asked to complete a brief survey about the services they receive at that site. This survey will occur at the initial timepoint, and at several later timepoints. This survey is confidential and anonymous.


Eligibility Criteria:
Inclusion Criteria:

* Substance abuse staff members (who work with adults) working at Richmond Behavioral Health Authority (RBHA) and its contracted providers
* Clients seen at RBHA and its contracted providers during specific periods, who are at least 18 years of age

Exclusion Criteria:

* Being under 18 years of age
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study

The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit from the device. The HEAL-HF protocol will compare the outcomes of conventionally placed CRT devices with magnetically placed CRT devices by assessing hemodynamic parameters during the magnetic placement of the left ventricular (LV) lead.

Baseline information will be obtained including QoL, 6-minute walk, and echo measurements. The patient will be randomized to receive a conventionally-placed LV lead or randomized to receive a magnetically-placed LV lead. The magnetic group will have acute hemodynamics assessed during the procedure to evaluate the best response of the left ventricle during pacing. Patients will be followed for 6 months with a re-evaluation of the baseline tests to assess the change in HF symptoms. Adverse events will also be recorded during the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic cardiomyopathy
* Ejection Fraction (EF) \<= 35%
* QRS duration \>= 120 msec
* Standard heart failure (HF) oral medications for at least 1 month
* Evidence of mechanical dyssynchrony
* NYHA Class III or IV

Exclusion Criteria:

* Persistent or chronic atrial fibrillation (AF)
* Hemodynamically unstable or uncontrolled arrhythmias
* Unstable angina
* Aortic valve (AV) insufficiency or stenosis
* Mitral valve (MV) regurgitation \> 2+
* Active infection
* Contraindications for heparin
* Dependence on atrial pacing
0.01% Hypochlorous Acid in the Treatment of Blepharitis

This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older.
2. Anterior or mixed (anterior + posterior) blepharitis.
3. Similar clinical condition of both eyes.
4. A negative urine pregnancy test result for women of childbearing potential
5. Normal lid position and closure
6. Ability to understand and provide informed consent to participate in this study
7. Willingness to follow study instructions and likely to complete all required visits.

Exclusion Criteria:

1. Any ocular surface disease other than blepharitis.
2. Known allergy to hypochlorous acid or boric acid.
3. Eye surgery in the last 6 months.
4. History of Stevens-Johnson syndrome or ocular pemphigoid
5. Ocular trauma in the last 6 months.
6. Use of contact lenses in the last 6 months.
7. Pregnancy or lactation.
8. Daily use of makeup on lashes.
9. Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
10. Pregnant or lactating women
11. Signs of current infection, including fever and current treatment with antibiotics
12. Liver, renal, or hematologic disease
13. The use of any other investigational drug
Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue

There are to date no studies available that have examined the effects of CAP on tumor tissue in patients. The aim of this study is to investigate these effects in patients undergoing surgery for peritoneal metastases. Tumor nodules will be treated with different durations and intensities of CAP before being surgically removed. The resected nodules will be analyzed for tumor vitality.


Eligibility Criteria:
Inclusion criteria:

* Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origin. Potential cancer types include ovarian cancer, colorectal cancer, and malignant peritoneal mesothelioma
* Written informed consent
* Age ≥ 18 years.
Covering of the Abdominal Wall in Laparotomies: Differences in Surgical Site Infections Between an Approved Abdominal 3M™ Steri-Drape™ Wound Edge Protector and Standard Woven Swabs at Technische Universität München

BaFo is a prospective, double-blinded randomized controlled clinical trial that assesses the numbers of surgical site infections in two different techniques of covering the abdominal wall in laparotomies. Standard covering with woven swabs is compared to a novel, approved 3M™ Steri-Drape™ Wound Edge Protector.


Eligibility Criteria:
Inclusion Criteria:

* Ability to sign the informed consent
* Patients older than 18 years
* Abdominal operations with longitudinal / cross section with clean wounds, clean-contaminated wounds or contaminated wounds (cdc-definitions of surgical wound infections)

Exclusion Criteria:

* Pregnant or lactating women
* Revision Operations
* Operations with dirty or infected wounds (CDC definition of surgical wound infections)
* Laparoscopic operations
* Small operations without longitudinal- / cross-section e.g. appendectomy