cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation

The purpose of this study is to evaluate the safety and effectiveness of a once-daily medication, fenofibrate (Lofibra), to prevent ischemic cholangiography (IC) in persons who were transplanted with livers donated after circulatory death (DCD).

In this prospective pilot study, we aim to evaluate 1) the tolerability and safety, 2) the efficacy of 12 weeks once-daily fenofibrate in reducing IC incidence after DCD liver transplantation, 3) assess the association between serum markers of cholestasis and development of IC.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone Donation after Circulatory Death (DCD) liver transplantation (LT).
* At least one serum alkaline phosphatase level \>2.5x upper limit of normal between post-LT days 21-60 (inclusive).

Exclusion criteria:

* LT performed for primary sclerosing cholangitis or primary biliary cholangitis.
* Untreated hepatic artery compromise (e.g thrombosis, stenosis)
* Untreated biliary anastomotic stricture or bile leak between days 0-60 after LT
* Renal dysfunction defined as baseline glomerular filtration rate \< 30 ml/min.
* Previously known intolerance or allergy to fenofibrate.
* Other clinically significant comorbid condition, including psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment.
Acceptability Study on Oral Nutrition Supplement (ONS)

Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.


Eligibility Criteria:
Inclusion:

* Male and female patients
* ≥ 18 years of age
* Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days
* Patient is able and willing to provide written informed consent

Exclusion:

* Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients
* Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine)
* Patients who express general dislike to two or more of the four flavours
* Severely impaired gastrointestinal function or complete failure
* Severe metabolic or circulatory disorders
* Acute disease
* Unstable vital functions
* Necessity of total parenteral nutrition or more than 50% Parenteral Nutrition in combined therapy
* Simultaneous participation in another interventional study
* Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
* Pregnancy
* Emergencies
Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

Patients who have concussions exhibit an array of symptoms, also known as post-concussive symptoms, including headaches, feeling slowed down or foggy and difficulty with concentration. This study aims to determine if cranial osteopathy can provide additional or expedited symptom relief when accompanying current conventional treatments. The patients will be identified through routine clinical contact. If patients are found to be eligible and agree to participate, they receive a single session of cranial osteopathy in addition to their usual care through the concussion program.


Eligibility Criteria:
Inclusion Criteria:

* Concussion occurred within 8 weeks
* Age greater or equal to 14 years
* Complains of post-concussive symptoms with a symptom score of \>10 on PCSS

Exclusion Criteria:

* Concussion occurred \> 8 weeks
* Age less than 14 years
* Surgery of the cervical and/or thoracic spine within the last 3 months
* Currently receiving or has received workers compensation within the last 3 months
* Currently or potentially become involved in litigation related to the injury
* Received osteopathic craniosacral treatments within the last 3 months
* History of hydrocephalus, current infection or active tumor
* Active or marked depression, anxiety or psychosis
PPI and Mindfulness App for Parents of Children with a NDD

An app based on positive psychology and mindfulness to support the mental well-being of parents of children with a Neurodevelopmental Disorder (NDD) was developed and will be evaluated on effectiveness.

This pragmatic randomized controlled trial aims to assess the effectiveness of the Adappt app, an app developed to support the mental well-being of parents of children with a neurodevelopmental disorder (NDD), such as autism and ADHD. This app was developed since research has shown that these parents experience higher stress levels than parents of typically developing children. Furthermore, the app was developed in collaboration with parents of children with a NDD, mental health care professionals and scientists in Europe.

Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years
2. parent of one or more children (\< 18 years) diagnosed with or suspected of a NDD
3. having access to internet
4. in possession of an e-mail address,
5. in possession of a smartphone or tablet
6. willing to use the digital intervention for a month, daily for approximately 15 minutes a day.

Exclusion Criteria:

1. presence of severe anxiety symptoms
2. presence of moderately severe to severe depressive symptoms
3. being in treatment for mental health issues (the parent self)
Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet

The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.

This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HIV infection
* Patients that will be treated with Kaletra tablets independent from their participation in this study

Exclusion Criteria:

* Hypersensitivity against Kaletra or other ingredients
* Severe liver insufficiency
* No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
* Patients who received more than 1 protease inhibitor during their therapy history
10-Years Follow-up of the EXAMINATION Trial

The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at 5-year. However, very-long term follow-up is unknown. The study had an independent Clinical event Committee (CEC). All events were adjudicated by an independent clinical committee, according to the Academic Research Consortium 1.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were enrolled in the EXAMINATION trial (NCT00828087).

Exclusion Criteria:

* None.
Central Venous Oxygen Saturation and Carbone Dioxide (CO2)-Derived Indices in the Critically:

The optimal management of shock states requires a precise evaluation of several parameters, clinical, biological, hemodynamic, and echocardiographic. Among these, parameters that measure O2 and CO2 consumption are of a great interest, especially PCO2 arteriovenous gradient (PCO2 gap) and O2 arteriovenous difference \[D(a-v) O2\]. The PCO2 gap best correlates with cardiac output while the PCO2gap/D(a-v)O2 ratio would be earlier and more specific than blood lactate assay in assessing tissue hypoperfusion secondary to shock.

The PCO2 gap and the PCO2gap/D (a-v) O2 ratio have been evaluated from gas measurements of venous blood collected from the pulmonary artery and from the superior vena cava area. However, in some patients the placement of a catheter in the superior vena cava is difficult or even impossible due to thrombosis, vascular occlusions and other reasons... In these cases, the inferior vena cava is used for drugs infusion, nutrition and possibly samples. Gasometric samples in lower cellar territory have not yet been validated and may not be correlated with measurements in upper cellar territory. It is therefore useful for current practice to validate samples in lower cellar territory and demonstrate their correlation with measurements made in upper cellar territory.

During an observation period, in patients with catheters in the superior and inferior vena cava for therapeutic indications (renal replacement therapy,...), the investigators systematically took gas measurements at the femoral and jugular sites. the investigators used these data to assess the correlation of PCO2 gap measurements and carbon dioxide-derived indices according to the harvest site : jugular and femoral venous.


Eligibility Criteria:
Inclusion criteria:

- All consecutive critically ill patients who had an arterial catheter and a venous catheter in the superior and inferior vena cava were included.

Exclusion criteria:

* An age under 18
* Pregnancy
* Legally protected adults
Drug-coated Balloon Treatment in Coronary Lesions

This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions

The treatment of coronary lesions triggers processes in vessel walls with different characteristics depending on the revascularization strategy, post-traumatic healing following plain balloon angioplasty triggers vessel recoil and neointimal overgrowth, bare metal or drug eluting stent implantation results in neointimal cell proliferation, scar tissue formation, and ultimately, the generation of neoatherosclerosis Drug-coated balloons(DCBs) were presented two decades ago as an alternative to plain-balloon inﬂation or subsequent stent implantation in order to overcome in-stent restenosis.Recently, there has been growing evidence that DCBs can also be used off-label to treat de novo lesions in small vessels Therefore, the aim of this study is to evaluate efﬁcacy and safety of drug-coated balloons angioplasty for treatment of de novo and in-stent restenosis lesions

Eligibility Criteria:
Inclusion Criteria:

Eligible patients are those with lesions in the coronary vessel tree who will be planned to be treated with drug coated balloon.

Exclusion Criteria:

1. Severe renal impairment ( Cr.Cl. \< 45 ml/min ).
2. Sever heart failure or liver cell failure .
3. Patients with contraindications to coronary angiography or invasive procedures.
4. Known allergy or intolerance to the medications or devices commonly used during PCI procedures.
5. Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol.
6. Pregnant or lactating women.
Cancer Anesthesia and Frailty

Subjects undergoing cancer related surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori - Milano will be consecutively recruited. Data regarding presence of co-morbidities, frailty, cancer staging, and inflammatory status (CRP protein measurement) will be collected preoperatively. Intra-operative data collection will comprehend type and duration of surgery, kind of anesthesia, complications. In-hospital mortality will be considered as the primary endpoint, while secondary outcome measures will be duration of hospital stay and admission to intensive care.

A prospective data collection of pre-intra and postoperative variables will be collected in a cohort of subjects undergoing cancer relate surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

BEFORE SURGERY Subjects will be stratified before surgery according to the following three main clusters: 1) Systemic inflammation: baseline levels of C Reactive Protein; 2) Cancer staging: TNM will be taken into account, together with the type of cancer, previous radio or chemo therapy, and planned/performed surgical procedure; 3) Frailty: subjects will be stratified according to their overall status, taking into account elements of frailty. Co-existing diseases such as diabetes, hypertension, cardiac heart failure, acute myocardial infarction, chronic obstructive disease/asthma, kidney or liver disease (past or present) will be considered. Functional status will be assessed by means of ASA, ECOG status and Possum scores. Frailty will be explored using the mFI and G8 score, the WHO scale, and considering age. Absolute BMI and loss of weight will be used to assess malnutrition.

DURING SURGERY Duration and type of surgery, kind of anesthesia and intra-operative complications will be considered.

AFTER SURGERY Hospital mortality, length of stay, and admission to intensive care will be considered as outcome measures. Major complications, such as myocardial infarction, arrhythmia, cardio circulatory arrest, shock, stroke, pulmonary embolism, kidney failure, delirium, pneumonia or SSI will also be considered.

Eligibility Criteria:
Inclusion Criteria: Subjects undergoing cancer related surgery at the Fondazione IRCSS Istituto Nazionale dei Tumori, Milano

Exclusion Criteria: Day case surgery
Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer

This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.

Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis
2. No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.
3. Performance status 0-2
4. Must meet criteria for acceptable lab values as outlined in the protocol.
5. Peripheral neuropathy must be greater than or equal to 1
6. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

1. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80
Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography

The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an endoscopic retrograde cholangiography (ERC).

During endoscopic retrograde cholangiography (ERC), deep medical sedation of the patient is routinely perform. Since ERC is a complex examination and in addition sometimes several intervention steps are necessary (bougienage, dilatation, brush cytology, specimen collection, insertion of plastic and metal stent prostheses), the sedation time is almost always \> 30min, in many cases even up to one hour or longer. These patients are at risk for developing hypothermia (drop in core body temperature below 36 degrees Celsius).

It is well known from anesthesiologic research that even moderate perioperative hypothermia, however, can have potentially serious complications. These include increased mortality, cardiac complications such as arrhythmias and infarctions, coagulation disorders, and increased transfusion requirements and wound infections. Changes in serum concentrations of potassium and peripheral vasoconstriction with decrease in subcutaneous partial pressure of oxygen are also clinically important side effects of perioperative hypothermia.

However, the current 2014 German S3 guideline "Sedation in gastrointestinal endoscopy" does not mention peri- or intra-interventional temperature measurement or temperature management.

The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an ERC. From the description of various clinical endpoints, we seek to obtain sufficient evidence to support routine use of such a system in ERC examinations. This study has the potential to set the new standard for modern sedation during ERC interventions that recognizes the risk of hypothermia and identifies a strategy to avoid it.

For this purpose, we will use a device, that is already routinely used in all operation rooms in Germany, the so-called warm air device "Twinwarm, Generation III". This device has a valid CE mark and will be used according to its purpose "pre-, intra- and postoperative maintenance of the normothermic body temperature of the patient". The device will be used strictly in accordance with the existing in-house SOP "Heat Management" of 04/2021 of the Department of Anesthesiology and Intensive Care Medicine of Hannover Medical School (MHH).

Eligibility Criteria:
Inclusion criteria:

* Indication to receive repeat (≥ 2 expected interventions) endoscopic retrograde cholangiography (ERC) (The following underlying conditions may be considered as indications for repeat ERC to be performed:
* Primary sclerosing cholangitis (PSC)
* Ischemic type biliary lesion (ITBL) after liver transplantation (LTX)
* Anastomotic stenosis after LTX
* Secondary sclerosing cholangitis (SSC))
* necessary intravenous medical sedation is expected to be required \>30min (female and male, age ≥ 18 years).

Exclusion Criteria:

* Patients \< 18 years
* Pregnant women
A Trial Of SU14813 In Patients With Advanced Solid Malignancies

The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function

Exclusion Criteria:

* Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment
* Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.
New Variants Involved in Taybi-Linder Syndrome

Taybi-Linder syndrome (TALS, OMIM 210710) is a rare autosomal recessive disorder belonging to the group of microcephalic osteodysplastic primordial dwarfisms (MOPD). This syndrome is characterized by short stature, skeletal anomalies, severe microcephaly with brain malformations and facial dysmorphism, and is caused by mutations in RNU4ATAC. Although RNU4ATAC-associated TALS is a recognizable phenotype, an atypical presentation is sometimes observed, thus expanding the clinical spectrum (TALS-like phenotype).

This study aims to identify new variants involved in Taybi-Linder syndrome and associated phenotypes (i.e.TALS-like).

This non interventional study will be performed on patients with no proven mutation of RNU4ATAC and their blood relatives (19 samples total) by high throughput sequencing and genetic analysis of already collected deoxyribonucleic acid samples.

Altogether, such a study will allow a better understanding of the molecular mechanisms responsible for the Taybi-Linder syndrome and Taybi-Linder syndrome-like phenotypes as well as the pathophysiology of these devastating forms of microcephalic dwarfism.


Eligibility Criteria:
Inclusion Criteria:

* foetus or young children diagnosed with a Taybi-Linder or Taybi-Linder like syndrome, with no RNU4ATAC mutation (index case)
* aged 20 weeks pregnant to 18 years old
* parents or sibling of the index cases, with informed consent for the analysis of both their DNA sample and the one of the index case.

Exclusion Criteria:

* no informed consent for the use of genetic samples for medical research
Intravenous Insulin in Patients With Diabetes After Percutaneous Coronary Intervention (PCI)

The purpose of this study is to evaluate the effects of intravenous insulin/24 hours to normalize glycemia upon markers of oxidative stress (protein oxidation and total antioxidant defense) and inflammation (C-reactive protein (CRP) and sCD40L) in diabetic patients submitted to PCI with stent.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetes Mellitus submitted to Percutaneous Coronary Intervention with Stent bare metal
* Age: 18-80 years old

Exclusion Criteria:

* Restenosis
* Drug elution stent
* Acute coronary syndrome at last 30 days
* Use anti inflammatory, antibiotic, vitamin E
* Inflammatory disease or oncologic
Can Village Health Volunteers/Workers Working As Male-Female Pairs Improve the Use of Postnatal Care Services in the Lao People's Democratic Republic

The study aims to assess the effectiveness of male-female VHV/Ws working in pairs on women's uptake of second PNC visits in rural Sepone, Lao PDR.

Methods A quasi-experimental cluster study will be conducted between July 2024 and October 2026 in 37 selected sites from two districts in southern Lao PDR. In 19 selected intervention villages in the Sepone district, female-male VHV/Ws pairs will promote postpartum services, whereas, in 18 similar control villages in the Vilabuly district, VHV/Ws will work as individuals.


Eligibility Criteria:
Inclusion Criteria:

* Women who gave birth within six weeks and twelve months before the study's baseline and end-line surveys.

Exclusion Criteria:

* Women whose births resulted in a loss,
* Women who do consent to participate in the surveys
* Women who face a language barrier with surveyors will not be enrolled.