cyrilzakka/clinical-trials huggingface dataset:
Stress-Echography in Hereditary Haemorrhagic Telangiectasia Patient with Hepatic Involvement

The hepatic involvement of HHT (Hereditary Haemorrhagic Telangiectasia) disease is characterised by the formation of arterio-sus-hepatic shunts which lead to dilatation of the hepatic artery and may result in high output heart failure. This evolves silently for long-standing period from left ventricular cavities dilatation to advanced heart failure with post-capillary pulmonary hypertension (PH) (more rarely pre-capillary), and its evolution is poorly understood. The specific treatment options for HHT disease are either the use of anti-angiogenic therapy (bevacizumab) or liver transplantation. As rest echocardiography can only detect advanced cases or heart failure with rest PH, the investigators speculate that exercise echocardiography can provide additional information in patients without rest PH. The hypothesis is that an exaggerated pulmonary pressure increase during exercise may precede the occurrence of rest PH in the course of the disease. It could identify patients with substantial heart failure at an earlier stage and may facilitate the access to liver transplantation. These parameters have never been studied in this context and it seems interesting to evaluate them in this pilot study.

The investigators hypothesise that HHT (Hereditary Haemorrhagic Telangiectasia) patients with hepatic involvement and cardiac high output will have significantly greater and/or earlier elevation of exercise pulmonary arterial pressures than those with normal cardiac output.


Eligibility Criteria:
Inclusion Criteria:

* HHT patient \> 18 yo
* Hepatic involvement (hepatic artery diameter \> 6mm)
* Patient having received the information and signed the informed consent form
* Patient affiliated to a social security scheme or beneficiaries of a similar scheme

Exclusion Criteria:

* Haemoglobin \< 90 g/L
* Active Infection
* Atrial Fibrillation permanent or persistent
* Known cardiopathy
* Pregnant or breastfeeding woman (by questioning)
* Adult subject to a legal protection measure (guardianship)
* Participation in another clinical trial that may interfere with the proposed trial (investigator judgment)
* Patient physically unable to pedal
* Patient with Pulmonary arteriovenous malformations awaiting embolization
* Patient treated with beta-blockers

Secondary Exclusion Criteria verified on rest ultrasound

* PAH (Pulmonary Arterial Hypertension) at rest (Vmax \> 2.8 m/sec)
* Inability to obtain a stream of IT at rest
* Patient with atrial fibrillation (AF)
Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)

The purpose of this study is to refine and pilot an intervention using the Nicotine Metabolite Ratio (NMR) to inform the selection of pharmacologic treatment to increase smoking abstinence among Alaska Native and American Indian people. This is a single-arm pilot trial to assess and improve acceptability and feasibility.


Eligibility Criteria:
Inclusion Criteria:

(Patients)

* Alaska Native or American Indian person by self-report
* eligible for or already receiving services at Southcentral Foundation (SCF)
* age 18 years or older
* daily smoking in the past 30-days
* if other nicotine or tobacco products are used, cigarettes are main product used
* planning to schedule an appointment with the Quit Tobacco Program to seek smoking cessation treatment in the next 30 days
* willing to make a quit attempt within 30 days of enrollment in the Quit Tobacco Program
* willing to have a blood test to inform their treatment
* willing to try a pharmacologic treatment
* willing to provide a saliva sample
* has phone service
* has access to broadband internet on mobile phone at home, work, or other location
* has an Android or iPhone mobile phone compatible with the Smokerlyzer app

(Staff)

- Staff participants of qualitative interviews to assess acceptability and feasibility of the intervention must be a health care professional at Southcentral Foundation (SCF), involved in the care of one of the participants of the study, that is their care team staff; including but not limited to: primary care providers, tobacco treatment specialists/health educators, pharmacists, nurse case managers, behavioral health consultants, certified medical assistants, and lab technicians.

Exclusion Criteria:

(Patients)

* Participated in the prior study phase
* participated in a cessation program during the past 3 months
* their provider has not approved varenicline in their referral to the Quit Tobacco Program
* has history of serious hypersensitivity or skin reactions to varenicline
* has bleeding disorder or is currently receiving cancer treatment
* questionable capacity or impaired decision-making capacity
Follow-up Data of Patients Treated With XIGRIS® in France

The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.

The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.

The objectives of the study as defined by the specific requirements of Transparency Commission are as follows:

* To describe the characteristics of the patients treated with Xigris®

  * socio-demographic characteristics,
  * clinical profile
* To determine the conditions of use of Xigris®

  * To describe previous treatments,
  * To observe delay before Xigris® initiation,
  * To describe dose, duration of treatment,
  * To study the concomitant treatments and the associated treatments
* To describe the clinical evolution of the patients

  * To observe mortality after 1 month
  * To describe reasons of death

Eligibility Criteria:
Patients are eligible to be included in the study if they meet the following criteria

* Patients treated with Xigris® during the study period in intensive care units in France
* Patients with a minimum age of 18 years
* Patients who are presenting in the normal course of care
Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon

This study evaluates the face validity and cultural acceptability of the Faces Pain Scale - Revised in pediatric patients treated at Mbingo Baptist Hospital, Northwest Province, Cameroon. Participants from the four major language/cultural groups evaluated at the hospital with a complaint of pain will trial the Faces Pain Scale - Revised and then undergo cognitive interviewing to assess comprehension and clinical accuracy.

Twelve to fifteen pediatric patients complaining of pain from each of the four primary language groups treated at Mbingo Baptist Hospital (Grammar English, Pidgin English, French, and Fulfulde) will be enrolled in the study. Each patient enrolled will trial the Faces Pain Scale - Revised (FPS-R) in his or her native tongue, before receiving standard analgesic treatment as ordered by the provider caring for the patient. One to two hours post analgesia, the patient will be reassessed and the FPS-R will be repeated. After completion of the second FPS-R, an audio-recorded cognitive interview will be performed by trained study personnel. These recordings will be transcribed into English and analyzed on a question-by-question basis to evaluate for themes pertaining to comprehension and understanding, ease of use, and reliability, within the different language groups. Enrollment in the study does not alter the routine pain management offered or received by patients. Rather, the FPS-R will be utilized on patients who are complaining of pain and who will be allocated to receive analgesia regardless of study enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Children's Ward
* Complaint of pain

Exclusion Criteria:

* Coma
* Traumatic brain injury
* Glasgow Coma Scale (GCS) \< 13
* Cognitive delay
* Narcotic/opioid dependency
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

Exclusion Criteria:

* Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization
Evaluation of the Impact of the Modification of Antibiotic Susceptibility Testing on Antibiotic Prescriptions

As of 2019, the CA-SFM (Comité de l'Antibiogramme de la Société Française de Microbiologie) recommends that the letter "I" or the term "intermediate" on antibiotic antibiograms. Instead, it is recommended that the term "sensible à forte posologie" or "SFP". These recommendations have been in place since 21/01/2022 at Nancy University Hospital.

Pseudomonas aeruginosa is the bacterium most affected by this change, as it has a high proportion of "high dosage" antibiotics.

Staphylococcus aureus is the most widely isolated bacterium, and also impacted by the change in antibiotic susceptibility testing.

The aim of this change in recommendations is to guarantee the efficacy of the proposed molecules.

Main objective Evaluate the impact of the change in antibiogram recommendations in samples positive for Pseudomonas aeruginosa and Staphylococcus aureus on antibiotic therapy (prescribed dosage)

Secondary objectives

* Evaluate the impact of changing the way antibiograms in Pseudomonas aeruginosa and Staphylococcus aureus on antibiotic therapy (molecule prescribed).
* Evaluate the impact of changing the way antibiograms on antibiotic therapy (molecule and dosage prescribed), depending on the strain identified (Pseudomonas aeruginosa or Staphylococcus aureus).
* Describe the impact of changing antibiograms in Pseudomonas aeruginosa and Staphylococcus aureus on antibiotic therapy (molecule and dosage prescribed) by department.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with a positive monobacterial P. aeruginosa or S.aureus resulting in an antibiotic susceptibility test between 01/03/2021 and 31/08/2021 (AVANT period) and between 01/03/2022 and 31/08/2022 (AFTER period)

Exclusion Criteria:

* patients from the maternity unit / the Centre Chirurgical Emile Gallé (CCEG) / dialysis department (UF 1094)
* patients with sample results that did not result in a prescription of antibiotics documented and duplicate samples relating to the same pathology and the same documented treatment
* patient opposed to research
RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing

The purpose of this research study is to:

1. assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention.
2. test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).
3. assess treatment retention rates in patients completing the RETAIN intervention.
4. test the impact of RETAIN on knowledge about HCV/HIV
5. test the impact of RETAIN on interest in being tested for HCV/HIV

The pre-post study of RETAIN will: 1) assess the acceptability of RETAIN as measured by participant feedback about the intervention; 2) test the impact of RETAIN on knowledge about MAT, as measured by the MAT Knowledge Assessment; 3) assess MAT retention rates in patients completing the RETAIN intervention; 4) test the impact of RETAIN on knowledge about HCV/ HIV; 5) test the impact of RETAIN on interest in being tested for HCV/HIV.

The acceptability of RETAIN will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. The average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. Pre-/post-changes in the percent of correct knowledge assessment items (i.e., about MAT and HCV/HIV) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The 3- and 6-month retention rates for RETAIN participants will be compared, using Fisher's exact tests, to the overall treatment retention rates at 3- and 6- months for the UC Health MAT clinics as determined by the retrospective chart review.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Starting MAT with methadone or suboxone or in MAT for less than 2 weeks;

   Exclusion Criteria:
3. Does not sign the "short form" consent form
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)

The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). Clinical trials are needed to isolate the effects of vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk. The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease risk.


Eligibility Criteria:
Inclusion Criteria:

* Age 8 to 17 years
* BMI less than 85th percentile for age and gender
* Subject and parent/guardian understands the study protocol and agrees to comply with it
* Informed Consent Form signed by the parent/guardian and assent signed by the subject

Exclusion Criteria:

* Subjects using vitamin supplements containing vitamin k
* Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
* Subjects presenting chronic degenerative and/or inflammatory diseases
* Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
* Subjects receiving corticosteroid treatment
* Subjects using oral anticoagulants
* Subjects with a history of soy allergy
* Subjects who have participated in a clinical study more recently than one month before the current study
The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy

This is a randomized controlled clinical study. The investigators screen of eligible patients, randomized divide into the following two groups: corticosteroids + azathioprine group, corticosteroids + leflunomide group. The investigators treat the enrolled patients, estimate efficacy and observed the side effects according to the requirements of program. The investigators establish a clinical database for recording patients date and statistical analysis. Evaluation of short-term and long-term efficacy of thymectomized myasthenia gravis patients in the different group prove that what kind of treatment can improve the cure rate. The investigators will evaluate the acute toxicity (gastrointestinal side effects, liver and kidney dysfunction) and long-term toxicity (immune dysfunction, gonadal suppression) when the investigators apply these therapy in the treatment of different clinical types of myasthenia gravis.


Eligibility Criteria:
Inclusion Criteria:

1. 12 to 65 years；
2. Myasthenia gravis:

   1. Patients who are diagnosed as generalized or ocular myasthenia gravis
   2. have experienced extended thymectomy (including thymic hyperplasia and thymoma)， no significant complications in 6 months after operation , and does not received any immunosuppressants or glucocorticoids treatments.
   3. do not applied in plasmapheresis or immunoglobulins treatment during 3 months .
   4. women of child-bearing period do not have a plan of pregnant for at least 3 year.
   5. Written consent of the patient, after informing

Exclusion Criteria:

1. The liver , kidney or glycometabolic function is abnormal
2. Seriously complications, such as infection or symptom in central nervous system,
3. The patients who suffering from malignancy or a history of malignancy, a variety of sexually transmitted diseases and HIV infection, tuberculosis infection, and other condition which need to prohibit the use of immunosuppressive patients.
4. Be allergic to leflunomide, azathioprine
5. Pregnant or suckling period woman
6. Accompanied with mental disorders and have difficult to communication
7. Experienced myasthenia crisis in 3 months.
8. suffering from clear cardiopulmonary functional and brain abnormalities
9. Have a history of refractory hypertension or peptic ulcer .
10. One of the white blood cells, hemoglobin, and platelet count obvious abnormalities
Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

To evaluate the safety and effectiveness of cell therapy using Precision Cells to treat Advanced Gastric Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Gastric Cancer.

A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~65 years old, male or female;
2. Life expectancy≥6 months;
3. ECOG score: 0-3;
4. Advanced Malignancies (gastric cancer) were diagnosed by pathological or clinical physicians;
5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x 10\*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level；
7. Signed informed consent；8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

1. Expected Overall survival \< 6 months;
2. Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months.
3. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
4. Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
A Trial to Assess the Impact of Ascorbic Acid on Cardiac Surgeries Outcomes and Complications''

this study is evaluating the safety and efficacy of ascorbic acid as a drug that can decrease inflammatory complications post surgical in addition to its impact on decreasing risk of arrhythmia and total opioid administration post operative

The study will include two arm of patients who are scheduled for elective cardiac surgery, either coronary artery bypass grafting (CABG) or Valvular replacement First arm: Patients will take 2 g orally ascorbic acid effervescent tablets the night before cardiac surgery, then 1 g twice daily for 5 days after surgery in addition to their traditional medical care. Second arm: will not be given ascorbic acid , instead a placebo 9orange carbonated beverage) will be used, and will be given the rest of traditional medical care provided to the first arm. Inflammatory markers C- reactive protein (CRP), erythrocyte sedimentation rate (ESR) and differential total leukocytic count (TLC), serum urea and creatinine, ALT, AST, CK-mb, CK-Total, aPTT, INR, Hemoglobin, platelet count, will be assessed on day 0, 1,2,4,6 postoperative in both arms.

Eligibility Criteria:
Inclusion Criteria:

* Elective Cardiac surgery
* American Society of Anesthesiologists physical status class I-III

Exclusion Criteria:

* Allergy to ascorbic acid
* Asthma
* COPD
* Allergy to opioids
* Previous history of chemical dependence
* Prior cardiac surgery
* Known hyperoxaluria
* History of renal calculi
* History of allergic or hypersensitivity reaction to ascorbic acid products
* Currently taking 1 g or more of ascorbic acid supplementation daily
Facilitated Release of Endogenous Enterokines

The overall objective is to develop therapy for obesity and diabetes that is as effective as gastric bypass surgery but without the cost and safety concerns.

Gastric bypass leads to rapid, sustained diabetes remission in the majority of patients who undergo this procedure and is also highly effective therapy for obesity. However, currently \<1% of medically-eligible patients undergo this or other bariatric operations due to cost and safety concerns. The approach is based on data suggesting that the benefit of gastric bypass is largely due to anatomical rearrangement of the intestine which leads to accelerated delivery of nutrients to the jejunum. This rerouting of nutrients stimulates the release of multiple neural, hormonal and enterokine responses that are associated with appetite suppression and improved glucose control. In this pilot proposal the question under investigation is whether repeated rapid delivery of a mixed meal directly to the jejunum can promote weight loss and glucose control.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes on oral antidiabetic medication
* BMI greater than or equal to 30kg/m2
* A1C less than 9%

Exclusion Criteria:

* Use of any of the following medications: dipeptide-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide) or medication that could alter glucose tolerance (e.g. steroids)
* Contraindication to tube (e.g. Prior upper gastrointestinal bleed, or history of easy bleeding, altered foregut anatomy due to obstruction or surgery)
* Known cardiovascular disease other than controlled hypertension.
* Pregnancy or unwilling to take contraception
* Active esophagitis
* Known hiatal hernia
* Active gastric ulcer and/or duodenal ulcers,
* Previous restrictive surgery of the gastrointestinal tract
* Crohn's disease
* Active cancer
* History of gastrointestinal hemorrhage
* Known upper gastrointestinal lesions with potential to bleed
* Use of NSAIDs or anticoagulants
* Psychiatric disorders other than mild depression
* Likely inability to adhere to study protocol including alcohol or drug dependent patients
* Type I diabetes,
* Liver, kidney or multi-organ dysfunction.
* Known eating disorders
* Inability to attend scheduled or unanticipated study visits
* Known prior abdominal problems or operations that could lead to adhesions or strictures and that could prevent the spontaneous passage of a 10 French jejunal tube if it were to dislodge distally.