cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Biliary RFA of Malignant Bile Duct Obstruction

Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the duration of stent patency. RFA has showed promising results for malignant bile duct obstruction and increasing the duration of stent patency. The aim of our study was to evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.

Malignant bile duct obstructions are caused by many diseases arising from primary or metastatic disease in intrahepatic, extrahepatic or hilar locations. To relieve obstructive decompression and jaundice as a result of the obstruction, endoscopic stent placement is usually required. Compared with surgical intervention, stent insertion offers shorter hospitalization, lower overall cost and lower morbidity. Previous studies have shown the superiority of SEMSs over plastic stents for maintaining biliary drainage. However, SEMS can occlude due to epithelial hyperplasia, tumor in-/overgrowth, biofilm deposition and sludge formation. Studies have showed that the median SEMS patency is 120 days. Once bile duct obstruction reoccurs, it may lead to significant morbidity and mortality. Thus, long-term patency of the SEMS remains an unresolved issue.

Recently, endoscopic biliary radiofrequency ablation (RFA) have been used in patients suffering from inoperable malignant bile duct obstruction, and increasing the duration of stent patency. It delivers a high amount of thermal energy to target tissue with curative or palliative intent. The purpose of this study is to record information and evaluate the impact of radiofrequency ablation in improving the management of cholangiocarcinoma or malignant bile duct obstruction, and to compare the effects of SEMS plus RFA to SEMS alone.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
2. Inoperability by staging, comorbidities or patient wishes

Exclusion Criteria:

1. History of bleeding disorder or use of anticoagulation
2. prior cardiac pacemaker placement
3. Presence of serious dysfunction of heart, lung or kidney.
4. Presence of other malignancy
5. Pregnancy
6. Prior SEMS placement
7. Prior Billroth II or roux-en Y reconstruction
Rapid Analysis of Infections by Spectrometry of Exhaled Breath

To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18y at start of study
* One of the following diagnoses:

  * De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy
  * De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy
  * Aplastic anemia requiring ATG therapy
  * Any patient admitted for either autologous hematopoietic stem cell transplantation. Transplantation may not have been performed at time of enrolment.
  * Any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission.
* Written informed consent obtained from the patient

Exclusion Criteria:

* Hematological disease beyond the specified inclusion criteria
* Signs of active respiratory infection
* If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).
Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy

The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy. Investigators assume that Theophylline plus N-acetylcysteine is more effective than Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for elective coronary angiography or angioplasty and allocate them to each of the mentioned treatments from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* candidate of elective coronary angiography or angioplasty
* at least moderate risk for contrast induced nephropathy

Exclusion Criteria:

* unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
* unstable serum creatinine
* unstable hemodynamic
* intravascular administration of contrast material in the past month
* using theophylline or N-acetylcysteine in the past month,
* known hypersensitivity to theophylline or N-acetylcysteine
Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.


Eligibility Criteria:
Inclusion criteria:

1. All patients must sign an informed consent
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:

a post-bronchodilator forced expiratory flow in 1 second (FEV1) =\<30% of predicted normal and \<80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) \<70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years

Exclusion criteria:

* Patients with a significant disease other than COPD;
* Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
* Patients with a history of asthma or a total blood eosinophil count \>=600/mm3.
* Patients with any of the following conditions:

a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years

* Patients who have undergone thoracotomy with pulmonary resection
* Patients being treated with the following concomitant medications:

medications that prolong the QT/QTc interval oral Beta-adrenergics oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day

- Pregnant or nursing women
Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency

Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.

Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.

Eligibility Criteria:
Inclusion Criteria:

* pulmonary function: FEV1 \< 45 %, RV \> 150 %, TLC \> 100 %
* alpha1 antitrypsin deficiency (\< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0
* heterogenous emphysema

Exclusion Criteria:

* homogenous emphysema
* significant bronchiectasis
* severe concomitant diseases
* pregnancy
Social and Psychological Impacts of SARS-Cov-2 Pandemic Period in the Obese Population.

The population suffering from obesity is particularly at risk during this pandemic period. The Nouvelle Aquitaine region is not spared, since according to the regional epidemiological report of 7 May 2020, carried out by Santé Publique France, 39.2% of cases admitted to the intensive care unit in Nouvelle Aquitaine and presenting risk factors are overweight or obese.

Other risk factors, such as social-environmental factors, must be taken into consideration. Socio-demographic surveys in this area highlight the socio-economic and territorial inequalities that interfere with obesity issues. Similarly, the issues of stigmatisation and isolation seem to be at the heart of the question of how to deal with these people.

This is a prospective multicentre study. Participating patients will be recruited from the Specialised Obesity Centres (CHU and SSR, as well as patient associations) to fill in a questionnaire and take part in an interview (a varied panel representative of the target population in terms of place of residence, socio-professional category, sex and age).

The medical and paramedical staff involved in the partner CSOs and the patients' resources (identified by the patients' associations) will also be asked to participate in a semi-directive interview.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age.
* Be registered in an active file of the 3 partner CSOs.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients under protective measures or deprived of liberty:

  * pregnant or breastfeeding woman,
  * under guardianship,
  * under guardianship,
  * safeguard of justice,
  * incarcerated.
DF4 Master Study (Safety and Efficacy Study)

The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.


Eligibility Criteria:
Inclusion Criteria:

* Patient has provided written informed consent.
* Patient has standard ICD/CRT-D indication.
* Patient accepts Home Monitoring concept.
* Patient is able to attend the planned hospital follow-up visits.
* Patient has legal capacity and ability to consent.

Exclusion Criteria:

* Patient has a standard contra-indication for ICD/CRT-D therapy.
* Age \< 18 years
* Patient is pregnant or breastfeeding.
* Patient is expected to receive ventricular assist device or heart transplantation within the next 12 months.
* Life expectancy of less than 12 months.
* Participating in any other clinical study of an investigational cardiac drug or device.
Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain.

PURPOSE: This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously treated with radiation therapy to the brain.

OBJECTIVES:

Primary

* Determine the impact of donepezil hydrochloride on cognitive function in pediatric patients with primary brain tumors previously treated with cranial radiotherapy.

Secondary

* Assess health-related quality of life of patients treated with this drug.
* Assess function and quality of life of the families of patients treated with this drug.
* Determine the physiologic effects of radiotherapy on cerebrovascular hemodynamics in patients treated with this drug.
* Determine the toxicity of donepezil hydrochloride in these patients.

OUTLINE: This is a multicenter, pilot, open-label, controlled study.

Patients receive oral donepezil hydrochloride once daily or once every other day for up to 24 weeks in the absence of disease progression or unacceptable toxicity. After completion of 6 weeks of study therapy, patients are evaluated for toxicity. Patients experiencing no adverse effects from treatment may continue receiving donepezil hydrochloride at a higher dose for 18 more weeks.

Patients undergo measurement of cognitive function (by neurocognitive testing), behavioral adjustment and social competency (by parent-reported questionnaires), health-related quality of life (by child- and parent-reported questionnaires), and vascular dynamics (by transcranial Doppler ultrasound) at baseline and at weeks 12, 24, and 36. Family function and family quality of life are assessed at baseline and at week 24.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of primary brain tumor
* No type 2 neurofibromatosis
* Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
* Karnofsky or Lansky performance status 70-100%
* Fertile patients willing to use effective contraception
* Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3
* Stable weight within the past 6 months with no concern of weight loss
* Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated
* Able to speak English
* More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug

Exclusion Criteria:

* Stereotactic radiosurgery as sole treatment
* Evidence of disease progression by MRI
* Pregnant or nursing
* Attention-deficit/hyperactivity disorder before cancer diagnosis
* Uncontrolled seizures or uncontrolled endocrinopathies
* Uncontrolled comorbidities
* Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)
* Use of concurrent anticholinergic drugs
Image Quality of EOSedge for Radiographic Evaluation of Hip Implant

EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams.

The objective of the study is to evaluate the quality of the focused pelvis/hip X-ray images on EOSedge compared to those performed on DR (current practice) to perform a preoperative radiographic evaluation of hip implant, A sufficient image quality on focused X-ray images performed on EOSedge would allow (1) to avoid the passage on two different radiographic systems (saving time) (2) to reduce the patient's x-ray radiation dose


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Came to the imaging department to perform a preoperative assessment for hip replacement or revision

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient participating in an interventional study
* Patient unable to read and/or write
A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH

This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.

The total duration of the study will be up to 3 years. Eligible participants must complete all study assessments on the parent protocol before starting this study. All participants entering this study will receive danicopan as an add-on to a background C5i therapy. The only allowed C5i therapies are eculizumab and ravulizumab.

Eligibility Criteria:
Key Inclusion Criteria:

* All participants who completed their participation in an Alexion sponsored clinical study with danicopan as an add on to a C5i treatment.
* Patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
* Documentation of vaccination for Neisseria meningitidis: All participants must be revaccinated as per national vaccination guidelines or local practice for vaccination use with complement inhibitors.

Key Exclusion Criteria:

* Any medical condition (for example, cardiac, pulmonary, renal, oncologic, or psychiatric) that, in the opinion of the Investigator, might interfere with participation in the study, pose any added risk to the participant, or confound the assessment of the participant.
* Patient has been permanently discontinued from danicopan in the parent study for any reason other than enrollment into this LTE study.
* Female participants who are pregnant, breastfeeding, or intending to conceive during the course of the study.
Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands

Eligible subjects meeting the pathological profile will be recruited at the designated site by the study personnel. Following subject consent, the subjects will be evaluated for eligibility based on their health condition and history.

The ACR \| U.S. kit, in its original packaging, along with the ACR \| U.S. smartphone application will be provided to the subject in a simulated home- use environment. All subjects will be provided with a list of tasks to complete, including providing a urine sample and operating the ACR \| U.S. device on 2 mobile phones. After completing the test, the lay user will complete a post-test questionnaire. The study observer will also complete a questionnaire to collect information regarding the lay users' use of the ACR \| U.S.

The device use will be compared with identified risks to determine if the percentage of failures is acceptable. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Following the usability test performed by the lay user, the subjects' urine samples will be tested by the study staff using the comparator device. These results will be considered as the "true value".


Eligibility Criteria:
Inclusion Criteria:

* Males and Females 18-80 years of age.
* Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:

  * Diabetes Type I/Type II,
  * Hypertension,
  * any kidney disease,
  * other relevant conditions,
* or, subjects who are healthy or pregnant.
* Subject is familiar with the use of a smartphone.
* Subject is capable of comprehending and following instructions in English.
* Subject has facility with both hands.
* Subject is capable and willing to adhere to the study procedures.
* Subject is capable and willing to provide informed consent.

Exclusion Criteria:

* Subject has dementia.
* Subject has severe mental disorders.
* Subject cannot collect urine in a receptacle.
* Subject is visually impaired (cannot read the user manual).
* Any additional reason the study physician believes disqualifies the subject from participating in the study.
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP

The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP \>2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (\>4.5 mg/dL).

Patients who complete the TEN-02-301 study (PHREEDOM) may be eligible to enroll into TEN-02-401 (NORMALIZE).

Patients from the TEN-02-301 tenapanor arm will either receive only tenapanor or be given sevelamer in addition to tenapanor based on their sP. Patients from the TEN-02-301 sevelamer arm will be given tenapanor in addition to their sevelamer dose and the sevelamer dose will then be adjusted based on their sP following a protocol-specified dose titration schedule. Patients will be monitored for safety and efficacy with in-office and telephone visits for up to an additional 18 months.

Laboratory assessments will be measured at every visit (Weeks 1, 2, 3, 4, 6 and 8 and Months 3, 6, 9, 12, 15 and 18) using a central laboratory.

Safety assessments will be performed during the study and will include physical examinations, vital signs (blood pressure and pulse), body weights, clinical laboratory evaluations, 12-lead electrocardiograms (ECGs), and adverse event (AE) monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Must complete TEN-02-301 (PHREEDOM)

Exclusion Criteria:

1. Schedlued for kidney transplant
2. Life expectancy \<12 months
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).


Eligibility Criteria:
Inclusion Criteria:

* Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria
* Underwent allogeneic stem cell transplantation (allo-HCT)
* Karnofsky Performance Status score ≥ 60%.
* Evidence of myeloid and platelet engraftment.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

* Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD.
* Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP).
* Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization.
* cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence.
* Evidence of relapsed primary malignancy.
Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis

This study aims to quantify and follow the cumulative incidence of SARS-CoV-2 infection in the French population using serological tests and to assess the determinants of infection from Constances, E3N-E4N, ELFE-Epipage 2 and NutriNet-Santé cohorts.

The primary objective is to assess the cumulative incidence of infection in the general population using dried blood spot sampling.

The secondary objectives are:

* To identify factors associated with a positive SARS-CoV-2 infection (positive serology) and to characterize the durability of the serological response to SARS-CoV-2
* To identify associations of symptoms predictive of a SARS-CoV-2 infection
* To estimate the health care use associated with a SARS-CoV-2 infection
* To estimate the fraction of sub-clinical infections or infections not captured by the healthcare system;
* To study the acceptability of a mass anti-SARS-CoV-2 serological testing and the impact of its result, linked with social inequalities in health;
* To estimate the individual and collective impact of containment and other preventive measures on the risk of SARS-CoV-2 infection;
* To study the impact of social and territorial inequalities on seroprevalence levels.

Eligibility Criteria:
Inclusion Criteria:

* non applicable, already enrolled in the cohorts

Exclusion Criteria:

* non applicable