cyrilzakka/clinical-trials huggingface dataset:
Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

A geriatric assessment is becoming increasingly important in the treatment of patients with a percutaneous aortic valve replacement due to their comorbidities. The aim of this multimodal therapy concept is to examine the influence on the postoperative outcome. In addition to a comprehensive assessment of the individual frailty score, the subjective condition before and after TAVI is also evaluated using a standardized questionnaire ("Minnesota living with heart failure questionnaire").


Eligibility Criteria:
Inclusion Criteria:

* all patients with indication for TAVI according to the current guidelines

Exclusion Criteria:

* no indication for TAVI, indication for cardiac surgery, mentally disabled patients, patients with endocarditis or life expectancy of less than 2 years
Establishment of a Method for Extraction and Quantification of Gingival Tissue Nicotine y

establishment of a method for extraction and quantification of gingival tissue nicotine in relation to conventional tobacco biomarkers: a pilot study

The study aim to establish a method for extraction and quantification of gingival tissue nicotine. Additionnaly, the relationship between the nicotine tissue intoxication with others smoking indicators will be evaluated as mentionned in the following PICO question:

* P: Smoker patients
* I: Biopsie of gingival tissue
* C: Non-smoker patient
* O: nicotine dependence test (FTND), salivary cotinine, fibroblast nicotine, number of cigarette consumed per day (NCC) and the pack-year (PY)

Eligibility Criteria:
Inclusion Criteria:

* non smokers
* smokers

Exclusion Criteria:

* not able to have biopsie
Role of Fibrocytes in Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by both bronchial inflammation and remodelling.

Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the number of eosinophils can be also increased during exacerbation.

Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of COPD and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.


Eligibility Criteria:
Inclusion Criteria:

* Patients: diagnostic of Chronic obstructive pulmonary disease (COPD) exacerbation.
* Control group: subjects without any history of lung disease and with normal lung function testing. Subjects will be separated in 2 sub-groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
* Written informed consent

Exclusion Criteria:

* Subject without any social security or health insurance
* Asthma, lung fibrosis or idiopathic pulmonary hypertension
* Chronic viral infections (hepatitis, HIV)
A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain

The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.

The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik GmbH, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D) It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fiberoptic guidance. Similarly As in to the LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes placement up to a size of 18 Fr.

The iLTS-D comes in one size. According to the depth of insertion, this device is equivalent to size 4 for patients 175patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm. The iLTS-D is provided by the manufacturer with a compatible 7.5mm ETT and with a plastic stabilizer for removal of the device.

The current randomized study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients under general anesthesia

Eligibility Criteria:
Inclusion Criteria:

American Society Anesthesiology I and II

Exclusion Criteria:

Difficult intubation, Cervical pathology
Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)

The purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA).

This is a 8-week, double-blind, randomized, placebo-controlled study, the patients with CVA will be randomized to experimental or placebo control group.

During the screening period, eligible patients will be evaluated by cough symptom score and LCQ life quality score. After 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and LCQ life quality score respectively. Adverse events will also be captured at every visit.

Eligibility Criteria:
Inclusion Criteria:

* male or female patients,18-75 years old;
* cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom;
* without wheeze and fever;
* without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years;
* without rales from lung;
* no obvious abnormalities from chest X-ray;
* bronchial provocation test: positive.

Exclusion Criteria:

* patients with chronic pulmonary disease;
* patients who are allergic to ß2 receptor agonist;
* patients taking ß2 receptor agonist for long time;
* severe heart, renal and hepatic disease;
* unable to comply with the protocol;
* pregnant, breast feeding, and childbearing potential women;
* patients improper to the trial according to the investigators' judgment.
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients

This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis therapy for at least 12 weeks before screening;
* receiving IV epoetin for at least 8 weeks before screening.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.
Placental Growth and Adverse Pregnancy Outcomes

The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.

The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed for measurement of placental volumes during pregnancy. It may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. Furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. The investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.

Eligibility Criteria:
Inclusion Criteria:

* All singleton gestations presenting for Sequential Screen testing at HUP
* patients competent to provide verbal informed consent

Exclusion Criteria:

* Multiple gestations
* patients not competent to provide informed consent
* patients found to be too late for the Sequential Screen
* pregnancy losses 20 weeks gestation
* major fetal anomalies
* patient delivering outside of the UPHS
Telmisartan Versus Ramipril After Acute Coronary Syndrome

The purpose of this study is to compare the antinflammatory and endothelial progenitor cell (EPC) mobilizing effect of Ramipril and Telmisartan in patients presenting with acute coronary syndrome


Eligibility Criteria:
Inclusion Criteria:

* Biochemical evidence of myocardial infarction as indicated by elevation of cTnT,
* presence of ECG ischemic changes,
* angiographic evidence of a primary coronary event, such as plaque erosion and/or rupture, fissuring, or dissection at coronary angiography,
* successful coronary revascularization of at least one culprit coronary vessel.

Exclusion Criteria:

* Age\>80 years, current ACE inhibitor or ARB treatment,
* ejection fraction \<35%, infarction secondary to ischemia due to an imbalance of O2 supply and demand,
* ECG abnormalities that could affect the recognition of ST segment shift,
* recent or chronic infective or inflammatory diseases,
* malignancy, and myocardial infarction,
* surgery or trauma in the previous month.
A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis

In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Non-operated histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx (except the posterior wall) and lymph node metastases from the unknown primary tumor (CUP)
* Stage T1-4; Tx N+ for the CUP
* Multidisciplinary Group of Head and Neck Tumors at Ghent University Hospital decision of radical radiotherapy (±concurrent chemotherapy)
* Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* Age \< 18 years
* Pregnant or lactating women
* Active infection or fistula in the oral/oropharyngeal mucosa
* Previous cancer of the oral cavity and the oropharynx
* Prior head-and-neck radiotherapy
* Expectation of non-compliance with the study protocol
* Known allergy for topical anesthetics (Xylocaïne)
Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction?

This study aims to identify factors influencing the time span and success of reperfusion after a mechanical thrombectomy in the acute phase of cerebral infarction, and in particular the effect of intra-venous thrombolysis.

Mechanical thrombectomy (MT), associated with standard IV thrombolysis (IVT) treatment, is effective during the acute phase of cerebral infarction with proximal occlusion of the anterior circulation in reducing disability at three months. MT-only treatment has only been assessed retrospectively in subgroups of controlled studies, with a significant difference in favour of the treatment. These results have led to a discussion about the benefits of MT without IVT in cases of proximal occlusion or carotid terminus occlusion. Recent data are in favour of a better prognosis for patients benefiting from a combined procedure. The impact of IVT on the implementation of MT is widely disputed, in particular the speed of execution, which could be enhanced by IVT. The factors influencing the time span and success of reperfusion after an MT are still not well-known, IVT in particular. The investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.

The investigators carried out a retrospective study based on data gathered prospectively by the Franche-Comté Stroke Registry. The investigators also considered other factors which could have affected the duration of the procedure or the rate of satisfactory revascularisation, including location of infarct, thrombus size and stroke aetiology.

Hypothesis: the investigators have made the assumption that IVT could have an effect on the success of MT by shortening the duration of the procedure and increasing the likelihood of satisfactory revascularisation.

Eligibility Criteria:
Inclusion Criteria:

* acute phase of cerebral infarction
* all patients who had undergone an arteriography for cerebral infarction prior to mechanical thrombectomy at CHRU Besançon
* from 1st January 2015 to 31st December 2016

Exclusion Criteria:

* Patients whose procedures were interrupted (puncture failure, catheterisation of the common or internal carotid artery failure)
* Patients whose arteries were recanalised during the diagnostic arteriography
Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression

This study will determine whether there are age-related differences in the body systems controlling sleep and stress hormone patterns. This study will also determine whether the differences in sleep and hormone patterns between depressed adolescents and adults are associated with differences in their response to antidepressant treatment.

Adolescent depression is a serious public health concern that may lead to functional disability and death. The problems associated with the condition may continue into adulthood; therefore, early identification and effective treatment of adolescent depression is critical. Studies indicate that depressed adolescents experience greater variations in sleep and hormone patterns than depressed adults. These variations may influence responses to antidepressant treatment. This study will examine the mechanisms underlying developmental differences in sleep and hormone patterns to develop a strategy for identifying adolescents and adults who could benefit from antidepressant treatment.

This study will last approximately 10 weeks. At study start, participants will wear an activity monitor on their wrist and keep track of their nightly sleep schedule to establish baseline measures. This will continue for 2 weeks. During the second week of wearing this watch the participant will be asked to come in for a sleep study. This study will consist of two initial nights in the sleep lab and then two more nights in the lab a week later. Participants will be able to leave during the day. Upon completing the sleep assessment, participants will receive bupropion twice daily for 8 weeks. Upon completion of this 8-week treatment, participants will be interviewed to assess the effectiveness of the treatment. One follow-up meeting will occur 6 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder and/or dysthymic disorder

Exclusion Criteria:

* Current treatment with antidepressant drugs
* Major medical illness
* Diagnosis of anorexia nervosa or manic-depressive illness
* Pregnancy
Parastomal Reinforcement With Strattice

The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.


Eligibility Criteria:
Inclusion Criteria:

* adults
* need for permanent ileostomy or colostomy

Exclusion Criteria:

* history of hernia at new ostomy site
* has previously implanted surgical mesh at site of planned ostomy
* requires a temporary ostomy
* has need for multiple ostomies
* is receiving chronic immunosuppression therapy, has MELD score of \> 17, has severe COPD, systemic infection, or known collagen disorder
* is bedridden or otherwise non-ambulatory
Genetic Study of Antithyroid Drugs Associated Agranulocytosis

Thionamides, the antithyroid drugs, have been widely used to treat hyperthyroidism1. Side effects are found in 1% - 5% of the patients1. One of the most serious side effect is agranulocytosis, which occurs in 0.1% - 0.3 % of the patients1. This might lead to severe infection and sometimes mortality. The underlying mechanism is unclear. An immune phenomenon may be involved because the antigranulocyte antibodies or lymphocyte sensitized to antithyroid drugs are found in these patients6,7. The recognition of major histocompatibility complex class II peptide complexes by T lymphocytes is central to the development of immune response. According to a report in 1996, the HLA DRB1\*08032 allele is strongly associated with susceptibility to methimazole-induced agranulocytosis20.

Recently, there are new techniques for genetics study. We aimed to identify the associated genetic change of the agranulocytosis side effect of antithyroid drugs. First, we will look at the classical human Leukocyte Antigen (HLA) loci, such as HLA-A, -B, -C, -DR, -DQ and -DP. If no significant change is found in the above genes, we will consider whole exon sequencing with next-generation sequencing, Statistic analysis will include appropriate linkage analysis, association study, variation data analysis, pathway analysis. If we can identify the genetic change and perform genetic examinations before prescription, we can avoid the happening of severe side effects.


Eligibility Criteria:
Inclusion Criteria:

* patients with absolute neutrophil count lower than 500/mm3 caused by anti-thyroid drugs

Exclusion Criteria:

* Patients who is younger than 20 years old or older than 85 years old
MINDFUL-OBOT: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

The goal of this pilot study is to test the Mindful Recovery OBOT Care Continuum (M-ROCC) model in primary care office-based opioid treatment (OBOT). M-ROCC features integration of evidence-based mindfulness training with weekly group-based opioid treatment. Primary outcomes include (1) Feasibility measured by implementation of the curriculum into two CHA primary care sites and attendance at weekly sessions; (2) Acceptance via self-report and qualitative interviews. Secondary outcomes include anxiety reduction.

The primary objective of this study is to conduct a single-arm pilot study in order to refine a Mindfulness-Based Intervention for the Opioid Use Disorder (OUD) treatment in primary care, called the Mindful Recovery OUD Care Continuum (M-ROCC). Study investigators will conduct qualitative interviews, assess opioid use, preliminary pre/post measures for participants participating in the pilot study. Additional aims of the pilot study is manual refinement and pilot testing assessment batteries to prepare for a multi-site RCT.

The study will focus on demonstrating feasibility and acceptability of the M-ROCC continuum.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Current CHA patient with a CHA primary care provider
3. Diagnosis of opioid use disorder prescribed buprenorphine/naloxone
4. Sufficient English fluency to understand procedures and questionnaires
5. \<90 days of complete abstinence from illicit opioids, cocaine, benzodiazepines, AND alcohol (excluding cannabis/nicotine)
6. Ability to provide informed consent.

Exclusion Criteria:

1. Psychosis
2. Mania
3. Thought disorder
4. Schizophrenia or Schizoaffective disorder
5. Acute suicidality with plan
6. Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) \<24 OR the inability to complete consent quiz and baseline assessments.
7. Current participation in another CHA research study
8. Expected hospitalization in next 6 months, including second and third trimester pregnancy at screening.
Effect of Self-affirmation Versus Back Massage on Psychological Distress and Fear of Birth Among Primigravid Women in Third Trimester

Based on the literature review, care must be emphasized on aspects of self-strengthening or self-affirmation to reduce stress and fear and equip women with the ability to manage stress and fear due to negative thoughts. Accordingly, the present study aimed to investigate and compare the effects of self-affirmation versus back massage on psychological distress and fear of birth among primigravid women in third trimester.


Eligibility Criteria:
Inclusion Criteria:

* • Pregnant women aged 20-35 years.

  * Primigravida women.
  * Read \&write.
  * During third trimester of pregnancy.
  * Free from any medical, obstetric, gynecological and other psychological risk factors and /or conditions
  * With normal course of pregnancy.
  * Attend regular antenatal care visits.
  * With intact back skin and free from burn, wound or any scar, injury, inflammation and allergy.
Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean

An open-label, single-dose, three-treatment, three-period study to investigate the effect of SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in healthy male Korean.


Eligibility Criteria:
Inclusion Criteria:

* Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures

Exclusion Criteria:

* A subject with history of allergies including study drug (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.

Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Patients scheduled for an outpatient screening or surveillance colonoscopy.

Exclusion Criteria:

* Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding).
* Patients requiring deep ileal intubation.
* Patients with inflammatory bowel disease.
* Patients with radiotherapy-induced colitis or other severe colitis.
* Patients with colonic strictures.
* Patients with acute diverticulitis.
* Patients with large bowel obstruction.
* Patients scheduled for therapeutic colonoscopy (e.g., planned endoscopic mucosal resection for known polyps).
* Patients scheduled for assessment of a known colonic lesion.
* Patients with a known history of hereditary polyposis syndrome or untreated colon cancer.
* Patients with a history of colon resection.
* Patients on continuous anti-thrombotic therapy
* Pregnancy.
* Patients who are ineligible for colonoscopy due to medical or psychiatric conditions.
* Patients who are vulnerable or unable to consent