cyrilzakka/clinical-trials huggingface dataset:
The Relationship of Initial Liver Profile and Outcome After Transplantation

Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one or more bile ducts probably caused by inadequate blood flow or a failure of biliary epithelium to regenerate. It typically presents weeks to months after liver transplantation, is often refractory to treatment and can result in a requirement for re-transplantation. Although IC is more common following DCD liver transplantation, it is otherwise very difficult to predict and the underlying pathogenesis is poorly understood. The aim of this study is to correlate microRNA (miRNA) levels and markers of senescence in liver and bile duct biopsies taken during liver transplantation with the incidence of IC following liver transplantation.

Study population

Tissue from all deceased adult liver transplant grafts will be collected. The test samples will be selected from procedures were the liver transplant recipient has developed IC. The control samples will include tissues from procedures were the transplant recipient had an uncomplicated outcome. There will be matching of test samples and control samples based on a range of clinical factors.

Consent

Standard consent for organ donation documentation has a general consent to research section. Due to the small risk of damage to blood vessels when taking samples the liver transplant recipient will also be consented for these procedures to take place.

Tissue sampling

Liver and bile duct samples from each graft will be obtained at various different time points during liver transplant procedures.

Processing of specimens

Following removal of the specimens, samples will be divided then added to RNAlater (Life Technologies, Paisley, UK), 10% formaldehyde or will be snap frozen. At a later time point samples will be analysed.

Definition of ischemic cholangiopathy

IC will be defined as strictures, dilatations, or irregularities of the intra- or extrahepatic bile ducts of the liver graft. Isolated strictures at the bile duct anastomosis will be excluded. The diagnosis will be based on at least one adequate imaging study of the biliary tree, after exclusion of hepatic artery thrombosis by Doppler ultrasound, computed tomography or conventional angiography.

Eligibility Criteria:
Inclusion Criteria:

* All deceased adult liver transplant donors (\>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh

Exclusion Criteria:

* Paediatric liver transplant donors (\<16 years of age).
Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis

This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of psoriatic arthritis

Exclusion Criteria:

* Patients with arthritis or ankylosing spondyitis
* Drug-induced psoriasis
* Male or female patients who plan to conceive during the time course of the study, or for 6 months after the administration of the second dose.
* Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
* Previous use of immunosuppressive agents eg cyclosporine, without the necessary wash-out period
* History of severe allergy to food or drugs
* Positive TB test. Other protocol-defined inclusion/exclusion criteria may apply
Adaptation of Linehan's Biosocial Model to Emotional Dysregulation in Autism Spectrum Disorder

Linehan's biosocial model conceptualizes the factors at play in the development of emotional dysregulation (ED), that is, difficulty regulating one's emotions, in borderline personality disorder (BPD). The model explains ED as the result of the interaction between the person's biological emotional vulnerability and their exposure to early invalidating experiences from those around them. Recently, ED has been shown to be prevalent in autism spectrum disorder (ASD). The objective of the study is to propose an adaptation of Linehan's model to the specificities of ASD to conceptualize the factors contributing to ED in the context of this disorder. To do this, the investigators will carry out a narrative literature review, as well as an illustrative case conceptualization based on the proposed model.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (≥18 years old)
* Having been diagnosed with ASD without intellectual disability
* Presenting severe ED with self-harming behaviors and/or suicidal behaviors

Exclusion Criteria:

- Subjects not meeting the study eligibility criteria
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.

The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
* Failure of first-line platinum-based chemotherapy

Exclusion Criteria:

* Mixed small cell or non-small-cell histology
* Bronchoalveolar carcinoma
* Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
* Prior treatment with docetaxel
Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis

* Intra-abdominal pressure(IAP) is defined as a steady state pressure of the abdominal cavity
* many studies have proved IAP as a prognostic factor that elevated IAP influences hemodynamics and multiple organs dysfunction
* In previous studies, most of them was based on the septic patients of medical diseases. And it is rare about sepsis of surgical diseases such as traumatized or postoperative patients
* We hypothesized that intra-abdominal hypertension may affect clinical course such as length of stay of intensive care unit, weaning of mechanical ventilation, proceeding of enteral feeding and mortality
* Our study was aimed to investigate prevalence of IAH and risk factors and to analyze clinical course and prognosis influenced by IAH in surgical patients with severe sepsis

* Inclusion criteria older than 18 diagnosed as severe sepsis agreed on informed consent
* Exclusion criteria refused to participate in the study traumatic injuries on urethra or bladder open abdomen status
* Definition of severe sepsis organ failure more than one organ with sepsis arterial blood lactate concentration of at least 4mmol/L hypotension with a systolic blood pressure lower than 90mmHg
* Definition of intra-abdominal hypertension intra-abdominal pressure more than 12mmHg
* Measurement of IAP measuring via three lument urinary catheter measuring after filling with 25ml normal saline measuring in supine position at level of mid-axillary line on iliac crest measuring three times a day during ICU stay

Eligibility Criteria:
Inclusion Criteria:

* older than 18-year
* agreed on informed consent
* diagnosed with severe sepsis

Exclusion Criteria:

* traumatic injuries on urethra or bladder
* open abdomen status
Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID)

This is a prospective, open-lable Phase II clinical trial (ORCHID study) evaluating the effectiveness and safety of oral vinorelbine or capecitabine combined with trastuzumab as adjuvant treatment for patients with lymph node negative, HER-2 positive and small tumor size breast cancer


Eligibility Criteria:
Inclusion Criteria:

1. women aged 18-70 years old;
2. T ≤1cm and negative lymph node confirmed by histopathology after early breast cancer surgery
3. HER2 positive confirmed by histopathology after early breast cancer surgery（HER2-positive breast cancer defined as a positive in situ hybridization test or an Immunohistochemistry (IHC) status of 3+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) , or Silver in situ hybridization (SISH)) test is required by local laboratory testing.)
4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN，and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula).
6. Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.

Exclusion Criteria:

1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy）;
2. Has bilateral breast cancer;
3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
4. Has metastic (Stage 4) breast cancer;
5. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
6. Patients participating in other clinical trials at the same time;
7. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
8. Has severe or uncontrolled infection;
9. Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders;
10. the researchers judged patients to be unsuitable for the study.
Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs

The aim of this observational study is to analyze the short- and long-term outcome after surgical implantation of the Codubix® Ribs prosthesis in a descriptive and non-statistical way.

An intact thoracic wall is essential for maintaining organ and respiratory function and upper extremity mobility, and therefore may require surgical intervention if portions of the thoracic wall have been destroyed or removed. Thoracic wall reconstruction is typically needed for cancers originating in or invading the chest wall or for large defects resulting from surgery that removes multiple ribs or the sternum. Less commonly, it is required due to malformations, infections, radiation injuries, or trauma to maintain respiratory function, protect internal organs, and avoid cosmetic defects.

There are several synthetic, metallic, and biologic materials on the market for thoracic wall reconstruction, each with its advantages and disadvantages, and none has proven superior to the others, often being chosen based on the surgeon's experience and preference. Codubix® Ribs, a knitted prosthesis made of polypropylene and polyester yarn, has been used since 2018 for thoracic wall reconstruction due to its high strength, low weight, and non-reactive properties. Moreover, it is radiolucent, easily adjustable to the chest wall's curvature, and maintain enough stiffness to not require additional materials, even for large defects. Although well-established in neurosurgery, its use in thoracic surgery is relatively new and not yet extensively reviewed in literature.

The primary objective is to evaluate the postoperative outcomes after thoracic wall reconstruction with Codubix® Ribs examining mobility, stability, aesthetic outcome and pain. The secondary objectives are to evaluate specific indications for chest wall resection found in the participants and in-hospital complications during the hospital stay.

The results of this study, summarizing our experiences with the relatively unknown prosthesis Codubix Ribs, aim to provide valuable insights and contribute to the broader knowledge base of the medical community regarding effective thoracic wall reconstruction materials.

Eligibility Criteria:
Inclusion Criteria:

* Patients that received full thickness resection of the thoracic wall and reconstruction using Codubix® Ribs
* Patients of all co-morbidities and gender
* Patients that signed written informed consent according to ICH-GCP regulations prior to initiation of any protocol-specific follow-up events
* Patients of age \>18 years at the time of informed consent

Exclusion Criteria:

* Patients who have not signed hospital's general consent form for the use of their health-related data for scientific purposes will not be included into the project.
* Patients that received thoracic wall reconstruction with other materials than Codubix® Ribs
* Inability to follow procedures or insufficient knowledge of language
* Inability to give consent
Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation

Diabetic cardiomyopathy( DCM) is a major complication of diabetes and is a common cardiovascular complication independent of coronary artery disease and hypertension．Trial to assess of myocardial injury in recipients of simultaneous pancreas and kidney transplantation by nuclear magnetic T２ mapping technology.

1. Evaluate the changes of myocardial injury before and after SPK by cardiac magnetic resonance imaging (CMR),
2. Evaluate the value of SPK in the repair of myocardial injury by comparing with the single renal transplant in recipients with diabetic nephropathy.

Eligibility Criteria:
Inclusion Criteria:

1. patients with type 2 diabetes were treated with SPK; 2.No definite history of cardiovascular diseases (such as congenital heart disease, coronary heart disease, cardiomyopathy or valvular heart disease, etc.); 3. Preoperative hemodialysis 4. No history of heart failure

Exclusion Criteria:

1. Contraindications in cardiac magnetic resonance imaging；2.poorly controlled hypertension；3.CMR examination revealed marked hypertrophy of the left ventricular myocardium
A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization

A study comparing a 10 cm catheter with a 7 cm catheter in a group of female patients who, on a routine bases, empty their bladder using urinary catheters, by measuring residual urine after intermittent catheterization.

The study personnel will conduct three bladder scans after each catheterization in order to obtain the mean residual urine volume. Each patient will catheterize herself two times with each product, i.e. a total of four catheterizations.

Diagnosis and BMI will be collected at visit 1 to assess whether the residual urine volume differs between these subgroups.

The hypothesis that the mean residual volumes were equal when using the 7 and the 10 centimeter catheters was tested by means of the Wilcoxon signed rank test.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent
* Female subjects aged 18 years and over
* Experienced users of CIC with a minimum of one month of use
* Practice CIC a minimum of 1 time per day
* Practice CIC with female catheters with a maximum length of 20 cm
* Perform self-catheterization
* Sufficient hand function to be able to open and handle catheter packages
* Use catheters with Ch 10, 12 or 14

Exclusion Criteria:

* Pregnancy
* Ongoing symptomatic UTI
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
* Previous enrolment or randomisation of treatment in the present study
* Participation in another clinical study during the study period
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)

This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.


Eligibility Criteria:
Inclusion Criteria:

* Signed a current IRB/IEC-approved informed consent form
* Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
* On a stable regimen of antiparkinson's medications , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
* Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)
* Able to understand and complete a standardized PD home diary, following training

Exclusion Criteria:

* History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
* History of seizures or stroke/TIA within 2 years of screening
* History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
* Estimated GFR \< 50 mL/min/1.73m2
* Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening
* If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose
* If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment
* Treatment with an investigational drug or device within 30 days prior to screening
* Treatment with an investigational biologic within 6 months prior to screening
Fibrinogen Early In Severe Trauma studY

* Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients
* Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
* Hypo/dysfibrinogenaemia plays an important role in TIC
* Early replacement of fibrinogen may improve outcomes
* Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
* The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
* Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
* It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
* Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
* Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay
* No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients
* Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm
* It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation)
* Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate
* It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible


Eligibility Criteria:
Inclusion Criteria:

1. Adult affected by Trauma (\>18yrs) and
2. Judged to have significant haemorrhage or
3. Predicted to require significant transfusion with ABC Score ≥ 2 or by treating clinician judgement

Exclusion Criteria:

1. Injury judged incompatible with survival
2. Pregnancy
3. Known objection to blood products
4. Previous Fibrinogen replacement this admission
5. Pre-Trauma Centre fibrinogen replacement
6. Participation in competing study
Elevated Serum HDL in Four Generations of a Nashville Family

The purpose of this study is to determine the genetic basis of one family's hereditary hyper-HDL-emia using multiple modalities such as linkage analysis and gene array.

HDL, or good cholesterol, has been shown to protect against heart attack and stroke. How HDL works as a protective agent is not well understood. There is a family that has 4 generations of living members with high HDL level. In the study, after consent is obtained, we will obtain 2 tablespoons of blood from all the family members in order to study their cholesterol levels and to obtain DNA in order to determine if there is a pattern of inheritance for this trait. We will also have them fill out a questionnaire about their medical history, diet and activity level as all of these can affect their HDL levels. In addition we will obtain additional blood (about 2 tablespoons) for plasma, white blood cells and also perform a biopsy to obtain skin cells from a matched pair of family members with and without the trait in order to determine which genes might be turned on and off because of this trait. We also wish to study other families who have members with high HDL cholesterol as well. These individuals will be identified from a core database.

Eligibility Criteria:
Inclusion Criteria:

* 26 living members of a family with HDL levels greater than 90mg/dl and several of whom will act as related age matched controls.
* The investigators will also identify individuals in a lipid core database with HDL's of greater than 90mg/dl who have normal or low LDL and triglyceride levels and determine if they have normal or low LDL and triglyceride levels and determine if they have family members (parents or siblings) who also have high HDL cholesterol.

Exclusion Criteria:

* Individuals who are not a member of the study family and individuals with high HDL's and elevated LDL and/or triglycerides.