cyrilzakka/clinical-trials huggingface dataset:
Re-engaging Patients With Hepatitis C Into Care

Aims:

To evaluate the impact of a letter, phone call and incentive in re-engaging patients with hepatitis C care.

Outcomes of interest:

Primary outcome of interest:

- Attendance for assessment of liver disease within 4 months of being sent invitation letter.

Secondary outcomes of interest:

- Commencing treatment within 6 months of being sent invitation letter.

Methods:

Patient identification:

The local copy of the Scottish Hepatitis C database holds data regarding patients referred to secondary care for treatment of their hepatitis C, and holds ethics approval for research on treatment and patient outcomes. This will be used to identify patients with hepatitis C infection that is untreated, treatment has been unsuccessful, or the patient has been treated but the outcome is unknown (due to non attendance for blood tests). The database has been cross checked with virus lab results, to ensure infection status is up to date. Finally, the patient data has been checked by NHS GG\&C information team, to exclude patients who are deceased, or whom are no longer resident in NHS greater Glasgow and Clyde based on updated details obtained from SCIstore.

Inclusion criteria:

Patients (16 years and over) who have previously engaged with Hepatitis C services in Glasgow but who are either untreated, have been treated unsuccessfully, or have been treated but have not attended for blood tests to check for treatment success.

Exclusion criteria:

Patients with HIV. Patients no longer resident within NHS Greater Glasgow and Clyde area.

Allocation to contact groups:

Patients will be randomly distributed into 3 groups:

1. Letter: Will be sent letter 1 (appendix)
2. Letter plus telephone call: will be sent letter 2 (appendix) and be followed up with a telephone call from the treatment centre if no contact has been received after 4 weeks
3. Letter plus incentive: will be sent letter 3 (appendix)

Process:

Patient letters will be sent out by GG\&C public health. For all 3 groups the letter will be sent with the small Hepatitis C Scotland booklet "Hepatitis C treatments have changed".

Letters will identify include the telephone number for the identified treatment centre which will be either, the last known treatment centre or a more local treatment centre were appropriate based on current residence.

Primary and secondary outcomes measures will be collected via the Scottish Hepatitis C database.

Lay Summary:

This study will test whether a letter alone, a letter plus follow up phone call or a letter with offer of incentive, will be most effective in re-engaging patients who are known to have hepatitis C but not yet received treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or older
* Known hepatitis C infection which is either:
* untreated
* treated but the outcome of treatment unknown

Exclusion Criteria:

* Known HIV infection
* No longer resident within NHS Greater Glasgow and Clyde area
Passive Leg Raising and Fluid Responsiveness

In the Intensive Care the Passive Leg Raising (PLR) test is a validated instrument to predict fluid responsiveness. In this study the investigators will try to prove the similarity of PLR test with a pillow and the PLR test with the patients bed in 45 degrees.

PLR test with pillow PLR test with bed to avoid a difference in results by the order of the measurements, the order of PLR testing is random.

Eligibility Criteria:
Inclusion Criteria:

* admission on Intensive Care
* clinical signs as; mean arterial pressure \< 60, lactate \> 2.0 mmol/L

Exclusion Criteria:

* age \< 18
Search for New Genetic Mutations Major Effect in Crohn's Disease

This study highlight genetics mutations with major effect in Crohn's Disease (CD) by WES in individuals affected and healthy individuals from EPIMAD Inserm InVS registry families.

The EPIMAD Registry covers a large area of Northern France (9 millions inhabitants) and collects all incident CD cases and data from CD multiplex families (families with 3 or more CD affected patients) in the Nord the Pas de Calais the Somme and the Seine Maritime. If the investigators could demonstrate that most CD cases from multiplex families were related to high frequency of NOD2 gene mutations, the investigators found some CD multiplex families without any NOD2 gene involvement. Thus in these families high prevalence of CD cases may rely on other major genetic susceptibility variant(s) that remain to be determined.

this clinical research Whole Exome Sequencing protocol, aiming to highlight genetics mutations with major effect in CD has been initiated.

This study is a familial genetic study with intra-familial controls. The genetics analyses are:

* Ascertain of no significant NOD2 mutation in the family members by Sanger DNA sequencing
* WES (CD patients and family controls unaffected subjects)
* Genotyping of all mutations found, case control and segregation analyses to validate their implication in CD.

Eligibility Criteria:
Inclusion Criteria:

* Crohn disease subject
* EPIMAD family with, at least, 3 Crohn disease subjects

Exclusion Criteria:

* Pregnant or lactating women
Intracellular and Renal/Myocardial Tissue Concentrations of Cyclosporine A (CsA) and Rejection Frequency Following Transplantation

The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

Secondary objectives are to investigate associations between intralymphocyte concentrations and whole-blood concentrations of CsA, renal tissue concentrations and nephrotoxicity, heart tissue concentrations and cardiotoxicity with CsA based immunosuppressive therapy in transplanted patients. In addition, this study aims to validate the use of quinine as a probe for determination of CYP3A4 activity in transplanted patients as well as proteomic-based urine analyses as a screening tool for acute rejection episodes in transplanted patients.

Eligibility Criteria:
Inclusion Criteria:

1. Renal or heart transplant recipients scheduled to receive CsA as part of their immunosuppressive therapy at the time of transplantation.
2. 18 years of age or older.
3. Signed informed consent.

Exclusion Criteria:

1. Known contraindications for renal or heart biopsies, respectively, at the time of inclusion.
2. Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, erythromycin, clarithromycin.
Modafinil for the Treatment of Cocaine Dependence - 1

The purpose of this study is to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

This is a double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have DSM-IV diagnosis of cocaine dependence as determined by SCID.
* Must be seeking treatment for cocaine dependence.
* Must be able to understand and provide written informed consent.

Exclusion Criteria:

* Please contact the study site for more information.
Self-proning and Repositioning in COVID-19 Outpatients at Risk of Complicated Illness

The rapid development of safe and effective COVID-19 treatment is a global health priority. Numerous studies evaluating therapies for this disease are currently underway, but the majority of these are in hospitalized patients with severe illness. Consequently, there is an urgent need to identify therapies that prevent mild COVID-19 cases in the community from becoming more severe. "Proning" or lying face down in bed has been shown to improve breathing and oxygen levels in COVID-19 patients, reducing the need for breathing tubes and ventilators and increasing survival. The current study will investigate whether proning and repositioning (lying on one's side or sitting up) can prevent mild cases of COVID-19 from becoming more severe resulting in fewer hospitalizations and death. A randomized controlled trial will be used to reduce the risk of bias when testing this intervention. Unvaccinated or partially vaccinated adult patients with a positive COVID-19 test willing to participate and well enough to be treated outside the hospital will be randomly assigned to one of two groups: a home-proning intervention group with instructions and daily reminders to prone and reposition during the day and at night, and a standard care group. Our goal is to assess whether home-proning/repositioning leads to fewer hospitalizations and death when compared with standard care. We'll also compare recovery time, use of antibiotics and follow up emergency department visits between these two groups. The current pilot study will assess the feasibility of a larger investigation or "main trial", meaning it will be small scale test of methods and procedures to be used on a larger scale.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Positive SARS-CoV-2 PCR test
3. Presence of two or more of the following criteria:

   1. Age\>55 years
   2. Fever by history or at presentation
   3. Cough
   4. Dyspnea/shortness of breath
   5. Fatigue necessitating daytime bed rest
   6. One or more of the following medical conditions:

      * Hypertension
      * Diabetes
      * Cardiovascular disease
      * Chronic lung disease
      * Chronic kidney disease
      * Obesity (BMI≥30kg/m2)
   7. Tachycardia \> 110 bpm
   8. Oxygen saturation \<94%
   9. One or more of the following laboratory abnormalities:

      * Lymphocytes \<1500/microL
      * ESR \> 100 mm/h
      * CRP \> 10 mg/L
      * D-Dimer \> 1000 ng/mL
      * LDH \> 240 U/L
   10. Bilateral infiltrates or ground glass opacities on chest x-ray or CT scan
4. Socially and medically fit for discharge
5. Access to a smartphone

Exclusion Criteria:

1. Pregnancy \>20/40 weeks
2. Body mass index (BMI) \>40 kg/m2.
3. Skeletal deformities that interfere with proning
4. Developmental delay or cognitive impairment that would preclude patient cooperation
5. Other contraindications to proning including any of the following: recent abdominal surgery, active vomiting, acute intoxication.
6. Unlikely to adhere to the proning protocol according to the treating physician's judgment
7. Fully vaccinated for COVID-19
Neonatal Screening of Biotinidase Deficiency: Genotype-phenotype Correlation and Clinical Follow-up

Retro-prospective, single-centre, observational study conducted at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy.

The study involves children born in Emilia-Romagna region, Italy, from January 2016 to December 2020 with biotinidase deficiency identified through Neontal Screening at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy. The primary aim of this study is to assess the incidence of biotinidase decificiency in this cohort of patients and the possible correlation between the genotype and the biochemical and clinical phenotype of this cohort of patients.

The study consists of the retrospective collection and analysis of clinical, biochemical and genetic data of pediatric patients who were taken in charge for Biotinidase Deficiency at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy, following Neonatal Screening positivity.

For this cohort of patients, a clinical evaluation is planned annually after the diagnosis of Biotinidase Deficiency for the identification of possible long-term complications. A clinical follow-up of at least 36 months is expected.

According to clinical practice, parents of pediatric patients with Biotinidase Deficiency identified through Neonatal Screening will undergo molecular genetic analysis for specific familial mutations of the BTD gene, but will not be followed up.

Eligibility Criteria:
INCLUSION CRITERIA:

FOR PEDIATRIC PATIENTS

* Neonatal Screening test result of Residual biotinidase Enzyme Activity \<50% carried out from January 2016 to December 2019 at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy;
* Neonatal Screening test result of Residual biotinidase Enzyme Activity \<30% carried out from January 2020 to December 2020 at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy;
* Obtaining informed consent from parents or legal guardian of pediatric patients.

FOR PARENTS

* Being a parent of a paediatric patient enrolled in the study;
* Availability of parental data;
* Obtaining informed consent.

EXCLUSION CRITERIA:

* Subjects with known chromosomal abnormalities or complex syndromes.
Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus

In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.

To achieve the goal of elimination of hepatitis C in 2030 as set forward by the world health organization (WHO) a main group requiring treatment are subjects co-infected with HIV. These subjects offer a particular challenge as they are receiving ART which frequently interferes with hepatitis treatment. The number of pills they are already taking also limits the compliance of these patients.

In order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular ART medicine being used by the patient - a multi-center study of 200 co-infected patients has been designed.

The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.

The study is one of the pilots being run for hepatitis C elimination in Iran.

Eligibility Criteria:
Inclusion Criteria:

* Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
* Positive human immunodeficiency virus test

Exclusion Criteria:

* Heart rate \< 50/min,
* Taking amiodarone
* Renal failure
Etiological DiagnOsis of caRdiac Diseases Based on echoCardiograpHIc Images and Clinical Data.

Research hypothesis - Recent studies have shown that high-dimensional descriptors of the cardiac function can be efficiently exploited to characterize targeted pathologies. In this project, the investigators hypothesize that echocardiograms possess a wealth of information that is currently under-exploited and that, combined with relevant patient data, will allow the development of robust and accurate digital tools for etiological diagnosis.

Objectives - Based on key advances recently obtained in image analysis, notably by members of the consortium, the objective of this project is to develop rigorous and explainable cardiac disease prediction models from echocardiography based on the transformer paradigm (AI). The strength of this study lies in the development of a strong AI framework to model the complex interactions between high-quality image-based measurements extracted from echocardiograms and relevant patient data to automatically predict etiological diagnosis of cardiac diseases


Eligibility Criteria:
Inclusion Criteria:

* Patients with transthoracic echocardiography with satisfactory image quality (sufficient echogenicity)

Exclusion Criteria:

* Minor patients
* Patients under curatorship or guardianship
Medication Adherence Intervention in Chronic Recurrent Multifocal Osteomyelitis (CRMO)

This project aims to quantify and evaluate rates of non-adherence and barriers to medication adherence in pediatric patients with CRMO followed at Seattle Children's Hospital's robust CRMO program, which is the only clinical program in the Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region. This will be a stepped-wedge cluster-randomized trial, in which participants will be randomly assigned to one of two groups -- one which receives educational materials at the end of their first clinic visit, and the other which receives educational materials at the end of their second clinic visit. All participants will be given baseline surveys at the start of their first clinic visit, as well as follow-up surveys at the start of their second and third clinic visits. These surveys aim to evaluate rates of non-adherence and qualitative barriers to adherence, as well as efficacy of educational interventions in improving adherence rates.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CRMO
* Receives clinical care at Seattle Children's Hospital
* On one or more scheduled prescription medications

Exclusion Criteria:

-
Effectiveness of an mHealth Colorectal Cancer Screening Intervention

The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC) can increase the percentage of patients who receive colorectal cancer screening. The mCRC intervention will include a tablet-based patient education program, clinic protocols to facilitate the ordering of CRC screening tests, and electronic messaging with patients to promote screening. The investigators hypothesize that participants randomized to mCRC will be more likely to complete screening compared with those randomized to the control arm of the study. Additionally, the investigators hypothesize mCRC will increase several intermediate outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict completion of screening. Lastly, the investigators hypothesize the mCRC intervention will add little to the overall cost of screening.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking patients aged 50 - 74 years
* Scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit
* Due for colorectal cancer screening

Exclusion Criteria:

* A personal history of CRC
* Specific CRC risk factors, including: First degree relative with CRC; Personal history of adenomatous polyps; Recent blood in stools
* Obvious physical or mental disability that would prevent participant from interacting with a tablet device.
* Receipt of treatment for cancer (excluding non-melanoma skin cancers) within the last 6 months.
Evaluation of Blood Gas Syringes

To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.

This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Willing and able to independently sign an English Informed Consent
3. Have adequate veins for sampling blood from both right and left upper extremities

Exclusion Criteria:

1. Currently taking anti-coagulation medication
2. Have a known bloodborne disease or bleeding tendency
3. Have a known fear or adverse reaction to needles or blood
4. Women who are pregnant or nursing
Role of Bronchoscopy in Early Lung Cancer Screening of High Risk Population

The purpose of this study is to determine the diagnostic yield of early lung cancer in high risk population, who smokes or has other risk factors, by different bronchoscopy,. Furthermore, another purpose is to determine whether the different bronchoscopy are significant different in diagnosing early lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient is over 40 years in age and is a heavy cigarette smoker.(smoking index is over 400)
* Patient has been coughing irritably for 2-3 weeks with a failed treatment and without obvious causes.
* The nature of cough changes in a patient who has chronic respiratory disease.
* Patient has blood-stained sputum persistently or repeatedly without obvious causes.

Patient will be included if accorded with any item of above.

Exclusion Criteria:

* Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
* Patient has uncontrollable hypertension (SBP \> 180mmHg).
* Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
* Patient has blood coagulation disorders (PT\>2 times the upper limit of normal(ULN) or Platelet(PLT)\<50000/ul）.
* Patient has severe dyspnea.
* Patient is allergic to local anesthetic.
* Patient is unable to provide informed consent.
* Patient is not an appropriate candidate for or is unable to tolerate flexible bronchoscopy procedures.
* Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints.
* Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
* Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
* Patient has pulmonary lesions suspected to be cancer from CT images.
* Female patient of childbearing potential has a positive result from a pregnancy test.