cyrilzakka/clinical-trials huggingface dataset:
Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults

The investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. These patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. Especially the reduction in apnea-hypopnea index (AHI) will be evaluated. The quality of life and possible symptoms will be measured with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* age at least 16 during tonsillectomy
* preoperative obstructive sleep apnea and AHI (apnea-hypopnea index) \> 14
* tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (ICD-10 diagnostic codes G47.3, R06.5 or J35.1)
* in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate

Exclusion Criteria:

* AHI \< 14
* in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement
* other, evaluated by investigator
Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

Patients who need major head \& neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists in the optimal antibiotic regimen

Patients undergoing laryngeal oncologic surgery are at relatively high risk of developing complication.

Efficacy of cefazolin as a prophylactic antibiotic in head and neck surgery was reviewed in many researches \[6\] but considering the costs and morbidities of prolonged antibiotic regimen we have presented a prospective and randomized study in 90 patients comparing the efficacy of 2 day over 5 day protocols.

Eligibility Criteria:
Inclusion Criteria:e.

* Patients eligible to be included in this trial were those who histologically confirmed squamous cell carcinoma of larynx and hypopharynx and they were candidate of total or partial laryngectomy with or without neck dissection and with negative history of neck or laryngeal radiation were included in this study.

Exclusion Criteria:

* Patients having recurrences or another primary tumor, and those who underwent reconstruction with a flap were excluded from the study, because they had been submitted to prolonged antibiotic administration. Also cases with Diabet mellitus and Immune suppression or tumor types other than squamous cell carcinoma were excluded from the study.
* In addition, the following exclusion criteria were taken into account: pregnancy, hypersensitivity to penicillins or cephalosporins, patients who received a systemic antibiotic drug within one week prior to the planned procedure, those who had clinical or laboratory evidence of a preexisting infection or had serious systemic renal disease.
Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans

The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive therapy control group.


Eligibility Criteria:
Inclusion Criteria:

* PTSD related to OEF/OIF service

Exclusion Criteria:

* History of brain injury
Effect of Laser Acupuncture on Constipation in Patients With Advanced Cancer

Constipation is one of the most common complications in patients with advanced cancer.

The aim of this protocol designed as a double-blind randomized controlled trial is to investigate the efficacy of laser acupuncture (LA) therapy on constipation in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or older
* Principal diagnosis of advanced cancer
* Diagnosis of constipation
* Treat with laxatives for at least 1 week but still have symptoms of constipation

Exclusion Criteria:

* Intestinal obstruction
* Disturbance of consciousness
* Active gastrointestinal bleeding
* Active intraabdominal infection
* Local skin infection on the acupoints or limb amputees.
Stem Cell Transplantation for Children Affected With Osteopetrosis

Malignant infantile osteopetrosis (MIOP) is a rare fatal genetic disorder that is characterized by the bone's inability to regulate remodeling. The only curative therapy is hematopoietic stem cell transplantation. Stem cells provided from an HLA identical matched sibling donor is the standard of care, but not feasible for the majority of patients. In addition, due to the potentially rapid progression of this disease, the time to identify a suitable HLA matched unrelated donor is not optimal. Therefore this study is designed to test the hypothesis that children with osteopetrosis can properly engraft hematopoietic stem cells that are donated from a partially matched parental donor, or "haploidentical" stem cell donor that are processed on the investigational device, CliniMACS selection system.

The primary objective of this trial will be answered strictly by those patients enrolled who receive a haploidentical stem cell donor graft.

Patients with a matched sibling donor will be offered participation in this clinical trial and will receive a standard myeloablative conditioning regimen followed by the infusion of an unmanipulated bone marrow graft. However, data from these transplant recipients will be reported in a descriptive manner only.

Secondary Objectives in this trial include the following:

* To describe the outcome of children with MIOP who receive hematopoietic stem cells from a matched sibling donor or a haploidentical donor utilizing a uniform approach one year from transplant
* To estimate the fraction of children with MIOP who have a genetic defect correlating to the osteopetrosis phenotype
* To assess carrier-state of the genetic mutation in parents with an affected child
* To assess carrier-state of the genetic mutation in siblings of affected children
* To estimate the effect of age at the time of hematopoietic stem cell transplantation on the overall outcome of children with MIOP
* To describe the kinetics of select cytokine expression before and after transplantation

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of malignant osteopetrosis as documented by bone marrow biopsy and radiographic imaging
* A suitable hematopoietic stem cell donor is available

Exclusion Criteria:

* Participant has the Carbonic Anhydrase II (CAII) deficiency osteopetrosis variant
* Symptomatic cardiac disease or evidence of significant cardiac dysfunction by ECHO (shortening fraction \<30%)
* Creatinine clearance ≤ 40ml/min/1.73m\^2
* Bilirubin ≥ 3mg/dL
* SGPT ≥ 500 U/L
* Evidence of current severe infection which would preclude ablative chemotherapy or a successful transplantation
* Karnofsky or Lansky score \< 70 noting expected abnormalities
Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's Disease
* Patients with L-dopa induced dyskinesia for at least 3 months
* Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

Exclusion Criteria:

* History of severe allergy to food or drugs
* Very low or high body weight.
* Prior surgery for Parkinson's Disease
* Smokers Other protocol-defined inclusion/exclusion criteria may apply
Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence

A parallel-group, cluster-randomized, controlled trial designed to evaluate if hemodialysis patients benefit from BCT. The study includes two groups: usual care and pharmacist-led intervention groups.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years of age), chronic kidney disease patients on standard in-center hemodialysis for at least three months, patients receiving 4 hours per session, moderate to poor adherence to their therapeutic regimen according to End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) at the time of inclusion

Exclusion Criteria:

* Switching from hemodialysis to peritoneal dialysis, receiving transplantation during the research period, inability to communicate for any reason (cognitive impairment, hearing and visual loss, etc.), hemodialysis patients with viral hepatitis, and patient refusal to participate.
Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17

Anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. This study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia).

Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Eligibility Criteria:
* Children ages 2-17 years with fever and neutropenia.
* The expected duration of neutropenia should be 10 days and due to cytotoxic chemotherapy or aplastic anemia.
Evaluation of the Efficacy of the Sequencing Method by Gene-panel

In order to accelerate the identification of genes responsibles of PID, and to improve the diagnosis of PID, the research team would like to validate a rapid and targeted method of high-throughput sequencing, on 301 genes, known to be involved in PID.

The Primary Immuno-Deficiencies (PID) are a set of rare diseases (estimated incidence of 1/5000). Today, more than 320 PID are described, and for 301 of them, the genetic cause has been identified, which underlines the huge diversity of all PID.

The genetic diagnosis of PID is very important for the comprehension of PID physiopathology, their treatment and the genetic patient information.

The characterisation of the clinical and immunological phenotype of patients allowed to identify a known morbid gene in 30% of cases, but for other patients, the genetic cause remains unknown, due to, inter alia, the lack of efficient tools for genetic exploration.

In this context, each year, around 600 French and foreign patients are explored at the Necker hospital CEDI (Center for Immuno-Deficiencies Explorations), for whom are identified, in 30% of cases, a known genetic cause.

Their treatment and the diagnosis of these patients is slow, partially because these studies are dependants of research fundings. In addition, in the current practice, the investigators sometimes discover incidental findings via the non-targeted high throughput genetic analyzes.

The aim of the gene-panel is to improve the diagnosis procedures of these known diseases, by generalizing a rapid and targeted method of sequencing, on 301 genes, known to be involved in PID.

Eligibility Criteria:
Inclusion Criteria:

* Patient who need a genetic diagnosis of PID done at Necker's CEDI (Center for Immuno-Deficiencies Explorations), in the frame of an initial causal mutation identification
* Patient having signed an informed consent form (or parents for minor patients)
* Patient affiliated to National Health Care Insurance

Exclusion Criteria:

* Patient refusing to participate
* Patient under legal guardianship
* Patient that can't fulfill the study requirements, for any geographic, social or psychic reason
Diagnostic Efficacy of CNN in Predicting Intraoperative Complications and Postoperative Outcomes in SMILE

To evaluate the diagnostic efficiency of the neural network in predicting complications of Small Incision Lenticule Extraction in a multi-center cross-sectional study.

The primary cause of global visual impairment currently is refractive error, and Small Incision Lenticule Extraction (SMILE) using femtosecond laser for corneal stromal lenticule extraction can alter the refractive power. However, complications such as opaque bubble layer (OBL), negative pressure detachment, and black spots may arise during the SMILE laser scanning process due to individual differences in corneal characteristics, significantly affecting the normal course of surgery and postoperative recovery. Experienced docters can often predict intraoperative complications based on scan images, patient cooperation, and other factors, but the learning curve is relatively long. At present, artificial intelligence has achieved the accuracy comparable to human physicians in the interpretation of medical imaging of many different diseases.Previously, we have trained a deep convolutional neural network for predicting intraoperative complications in SMILE procedures. The current multi-center study is designed to evaluate the efficacy of the convolutional neural network based algorithm in predicting intraoperative complications and to assess its utility in the real world.

Eligibility Criteria:
Inclusion Criteria:

* A condition in which the spherical equivalent refractive error of an eye is ≤-0.50 D when ocular accommodation is relaxed;
* Age ≥18 years;
* Spherical equivalent (SE) ≥-10.0D;
* Corrected distance visual acuity (CDVA) ≥16/20;
* Stable myopia for at least 2 years;
* No contact lenses wearing for at least 2 weeks.

Exclusion Criteria:

* The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
* A history of eye surgery;
* The presence or history of systemic diseases.
Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of Type 2 Diabetes
* Stable dose of metformin for more than 8 weeks

Exclusion Criteria:

* Subjects with Addison's disease or Cushing's Syndrome
* Type 1 diabetes mellitus or secondary forms of diabetes
* Subjects with uncontrolled thyroid disease
* History of renal impairment
Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants

Lupus anticoagulants (are antiphospholipid antibodies (PSA), the screening of which is done by demonstrating prolongation of coagulation times corrected by the intake of phospholipids (PL).

Learned societies (ISTH, CLSI) thus recommend, for the research of LA, to carry out initially two screening tests with a low concentration in PL: a time of diluted Russell viper venom (DRVVT) as well as a time activated partial thromboplastin (TCA). If one of these screening tests is positive, it is recommended to perform a second confirmation test using the same principle (DRVVT or TCA) and containing a higher concentration of PL.

The current LA screening method at the Hematology Laboratory of Strasbourg University Hospital includes: a pair of DRVVT screening / confirmation (STA-Staclot DRVV Screen and Confirm, Diagnostica Stago, France) and a screening TCA (PTT-A , Diagnostica Stago, France).

This study aims to compare with the current method of the investigators a pair of TCA screening / confirmation (Cephen LS / Cephen, Hyphen Biomed, France).


Eligibility Criteria:
Inclusion criteria:

* Major subject
* blood sample already analyzed in the laboratory as part of the treatment by the reference method
* Patient who did not express his opposition to the reuse of his data and his blood sample for the technical study.

Exclusion criteria:

* Minor patient
* Patient under curatorship, guardianship or legal protection
* Patient who expressed his opposition to the use of his data
* Insufficient sample
Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma

This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.


Eligibility Criteria:
Inclusion Criteria:

1. newly diagnosed multiple myeloma;
2. age over 18 years, male or female;
3. glomerular filtration rate (eGFR) \< 40 mL/min
4. Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;
5. patients who completed at least one course of treatment were included in the safety observation;
6. Patients who completed at least 2 courses of treatment were included in the efficacy observation;

Exclusion Criteria:

1. acute and chronic renal insufficiency not caused by myeloma;
2. are receiving any other investigational drug or investigational medical device;
3. Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment;
4. patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;
V-Y Flap for Anal Stenosis

anal stenosis is a common complication after massive open hemorrhoidectomy. it interferes with the patient daily activities. Many interventions were described, but there is no standard treatment. Data were always lost about the best intervention. In this study we try to discover if V-Y advancement flap can effectively treat anal stenosis or not.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged ≥ 18years old with moderate to severe post- hemorrhoidectomy anal stenosis

Exclusion Criteria:

* pregant females
* patient with prior irridiation
* patient with T.B
* Patient with Crohn's disease
Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)

There exist already a few studies that have measured changes of brain metabolism pre and post Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all performed in a small number of patients and used different methodologies. It is therefore not surprising that these investigations provided inconsistent results, as reviewed previously {{23 Schmidt,E.Z. 2008}}.

In patients with treatment-refractory major depressive episodes, the investigators here therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur after treatment with ECT and (b) whether these correlate with the clinical amelioration of symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at the end of treatment.

Patients with a treatment refractory depression - defined as absent clinical improvement of depressive symptoms after at least two trials with antidepressants from different pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30 Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively asked for participation in this study. Patients had to be between 18 and 80 years old and to be physically healthy.


Eligibility Criteria:
Inclusion Criteria:

* clinical indication for ECT
* treatment refractory depressive episode
* age 18-85 y

Exclusion Criteria:

* addiction as a first diagnosis
* dementia
Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)

Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.

Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS).

Study design: Open-label, single-centre, randomized controlled trial pilot.

Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome.

Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin.

Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.


Eligibility Criteria:
Inclusion Criteria:

* Acute Coronary Syndrome
* Chronic Coronary Syndrome
* Successful PCI

Exclusion Criteria:

* Known allergy or contraindication for prasugrel, including Active pathological bleeding Severe liver disease (defined as Child Pugh class C)
* Current indication for oral anticoagulant therapy (OAC)
* Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)
* Pregnancy or breast-feeding women
* Participation in another trial with an investigational drug or device
* Recent or ongoing strong CYP3A4 inhibitor or inducer therapy (e.g. clarithromycin, ketoconazole, carbamazepine or rifampicin)
COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder

The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence.

It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later.

Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman, age\>18
* Diagnosis of cancer (solid tumor or hematology)
* Out patient or patient Under surveillance

Exclusion Criteria:

* Refusal to participate in the study
* Emergency, person deprived of liberty
* hospitalized patient