cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes of Patients Treated with Open Surgical Repair for Complex Aortic Aneurysms

This is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).

Patients in need of OR for CAAs will be placed in this prospective, non-randomized, single center, data collection study. Choice of the prosthetic graft and configuration will be based on surgeon's preference and extent of the disease. OR will be performed by vascular surgeons at Mayo Clinic, Rochester, assuming no difference in surgical techniques.

Demographics, clinical presentation, preoperative clinical and imaging assessment, intraoperative information, length of ICU stay and hospitalization, early and late mortality, major adverse events (MAEs), reintervention, rupture and QoL at different postoperative time points (4 months, 1 year, 3 years and 5 years) will be recorded according to well-designed case report forms (CRFs) and SF-36 form. Follow-up information will be obtained from office visits or mailing questionnaires (SF-36 form and CAA-specific questionnaire).

Patients will be asked to fill out the SF-36 forms preoperatively, and along with the CAA-specific questionnaire at 4 months, 1 year, 3 years and 5 years post-operatively. Physician assistants or study coordinators will interview all patients prior to treatment (during office evaluation). The follow-up assessments will be conducted by questionnaires (SF-36 and CAA-specific questionnaire) and office visits as well. If no response in 6 weeks after sending out questionnaires at each time point, telephone interview will be followed.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing elective, emergent or urgent OR for CAAs, including:

1. Abdominal aortic aneurysms (AAA) not eligible for endovascular aneurysm repair (EVAR), including 1) Infrarenal AAA with complex aneurysm morphology 2) Short neck infrarenal AAA 3) Juxtarenal AAA 4) Suprarenal AAA
2. Thoracoabdominal aortic aneurysms (TAAA) (Type I - IV)
3. Chronic aortic dissections

Exclusion Criteria:

1. Patients who refuse to participate the study
2. Patients age \< 18 years
3. Pregnant breastfeeding patients
Detection of Krupple Like Factor -1(KLF1/ EKLF) DNA Mutations in Beta Thalassemia Patients

* Detection of KLF1 gene mutations in patients with beta thalassemia considering the alpha and beta molecular status of these patients.
* Study the relation between genotypic mutational status of KLF1 mutation with the level of Hb F and Hb A2 in the patients of beta thalassemia.

Thalassemias are inherited abnormalities in globin chain synthesis of hemoglobin and one of the most common single gene disorders in the world.

β-Thalassemia is caused by reduced (β+) or absent (β0) synthesis of the β-globin chains of haemoglobin. Three clinical and hematological conditions of increasing severity are recognized: the β-thalassemia trait, thalassemia intermedia and thalassemia major.

The Erythroid Kruppel-like factor (EKLF or KLF1) is a master regulator of terminal erythroid differentiation, controlling expression of many key pathways and structures including cell division, the cell membrane and cytoskeleton, heme and globin synthesis.

The KLF1 works as a key regulator of γ-globin to β-globin switch by up-regulation of PUM1 that binds to fetal γ globin mRNA impairing its stability and translation and by Bcl11a expression that represses γ-globin expression.

Previous studies reported that KLF1 mutations have been identified in a variety of erythroid conditions like hereditary persistence of fetal hemoglobin, Congenital dyserythropoietic anemia and borderline HbA2.

An Indian study on KLF1 gene variations found a marginal significance in the thalassemia intermedia group (14%) as against the thalassemia major group (2.0%).

Also, a case report on a Chinese family with twin brothers, both of whom had the same genotype of β0/β0, reported that KLF1 mutations have a role in modulating the phenotypic severity of β-thalassemia.

In our study, where there is high incidence of beta thalassemia in Egypt, we try to detect KLF1 mutations and its relation to clinical phenotype of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with β-thalassemia (intermedia and major) of both genders at any age

Exclusion Criteria:

* Patients with any other type of haemolytic anaemias.
* Patients on Hydroxyurea therapy
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis

One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia.

N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 50 years;
* pain visual analog scale (VAS) score\>4
* laparoscopic diagnosis of endometriosis (performed in the last three years),
* no assumption of any drugs (in particularly estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists)
* persistence of symptoms by at least one month

Exclusion Criteria:

* presence of other associated diseases
* assumption of drugs
* menopause
* pregnancy
* unable or unwilling to give written consent patients
* adverse reaction or hypersensitivity to active substance or excipients
Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

In the last decade, the number of dental implantations continuously increases. However, at the same time, the prevalence of peri-implantitis increases, too. Although both surgical and non-surgical interventions are available for the therapy, there is no efficient and satisfying therapy option resulting in an adequate improvement of this disease.

An innovative, low abrasive powder has been introduced for the therapy of periodontitis. However, the powder might be suitable for the peri-implantitis therapy, also, and could improve the effectiveness of the therapy. The usage of this powder in peri-implantitis patients has not been assessed in a clinical trial although the effectiveness in natural teeth has been demonstrated.

The aim of this prospective, randomised, multi-centre trial is to assess the effectiveness of the aforementioned powder in peri-implantitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate peri-implantitis
* age ≥18 years
* capacity to contract
* no subgingival debridement within the last six months
* informed consent

Exclusion Criteria:

* pregnancy
* subgingival debridement within the last six months
* bleeding tendency
* usage of antibiotics within the last three months
* insufficient restorations (including caries etc.)
* Diabetes mellitus
* smoker
* implantats with platform switch
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.

Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale.

In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness (PLMWI, PLM per hour). Subjects applied a single dose of treatment on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment

Exclusion Criteria:

* Patients with secondary RLS or clinically relevant concomitant diseases or medical conditions are excluded
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

To evaluate the toxicities of PPX/RT To evaluate neuro-cognitive functional assessments of patients with GBM receiving PPX/RT To obtain preliminary data in a randomized phase II study whether PPX/RT improves overall survival as compared to temozolomide /RT for patients with GBM without MGMT methylation to facilitate planning a phase III study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV)
* GBM must have unmethylated MGMT as determined by central laboratory
* Diagnosis of GBM must be made by biopsy or surgical excision, either partial or complete; as long as there is sufficient tissue to determine MGMT status
* No prior chemotherapy or radiation for brain tumor
* Must be able to tolerate brain MRIs.

  \*A diagnostic contrast-enhanced MRI must be performed postoperatively within 42 days prior to study registration.
* KPS \>60.
* Age \> 18
* Life expectancy of at least 3 months.
* Absolute neutrophil count \> 1500/mm3, Platelets \> 100,000/mm,
* Creatinine \< 2 x ULN
* ALT or AST \< 3 x upper limit of normal (ULN) and total bilirubin \< 1.5x ULN.
* Patients with a prior history of low grade glioma who did not receive prior radiation or chemotherapy with transformation to grade IV brain tumor are eligible.
* Women must be non-lactating, and surgically sterile, post-menopausal or have a negative serum pregnancy test and agree to use adequate birth control. Males must agree to use adequate birth control.
* Voluntary, signed informed consent.

Exclusion Criteria:

* Acute infection or other medical condition that would impair study treatment
* No other active invasive malignancy unless disease free for at least 3 years.
* Prior temozolomide or PPX.
* Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
* Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
* No diffuse leptomeningeal disease, or gliomatosis cerebri.
* Use of any other experimental chemotherapy drug within the 60 days prior to randomization and during the trial. (Use of a non-chemotherapy investigational agent must be approved by the Brown University Oncology Group)
Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project

Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.

Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This large quality improvement project will compare outcomes after standard perioperative practice with those after the implementation of a multi-modal evidence based care pathway, including standardized preoperative preparation, perioperative goal-directed fluid therapy (GFDT), multi-modal perioperative pain management, post operative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent colorectal surgery at Vanderbilt University Medical Center and whose data is stored in the perioperative data warehouse.

Exclusion Criteria:

* Age \<18 years
* Weight \<40 kg
Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI

Velopharyngeal insufficiency is defined as the inability of the soft palate to isolate the nasopharynx from the oropharynx. It is a frequent sequela in patients with a velopalatine cleft despite anatomical restoration of the soft palate by intravelar veloplasty at 6 months. If rehabilitation by a speech therapist is not successful, a pharyngoplasty can be discussed. In the last ten years, MRI was used in dynamic and static way, to analyzed velopharyngeal muscles, in particular Levator Veli Palatini. MRI could be used to identify the etiology of VPI in those patients, and thus allow personalized rehabilitation and surgical management. The aim of this study is to examine the differences in velopharyngeal motricity as well as velar muscles morphology, positioning, and symmetry of children with repaired cleft palate with different degrees of severity of velopharyngeal insufficiency (VPI), and children with labial cleft (noncleft palate anatomy).


Eligibility Criteria:
Inclusion Criteria:

* Children aged 7 to 12 years with Isolated cleft lip
* isolated velopalatal cleft
* Without a diagnosis of syndromic cleft or Pierre Robin sequence
* French speaking, and French is the native language
* Operated with a cheiloplasty (for cleft lip) or an intravelar Veloplasty (according to Sommerlad) at the Amiens University Hospital
* Whose follow-up is done at the Amiens University Hospital

Exclusion Criteria:

* Refusal of the parents and/or the patient
* With a contraindication to MRI
* Whose follow-up was initiated in another center and/or whose surgery was performed in another center
* Whose surgical schedule has not been followed
* Patient with severe neurological or neuropsychiatric disorders or Severe speech and language delay not related to the cleft anatomy
* Patients treated with fixed, non-removable orthodontic treatment.
Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology

The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with consciousness and muscle tone to a certain extent, and predict the shunt effect of PTH with disorders of consciousness.


Eligibility Criteria:
Inclusion Criteria:

Patients with disorder of consciousness in traumatic brain injury. The presence of hydrocephalus through image examination.

Exclusion Criteria:

Patients who cannot tolerate shunt surgery. Sedation maintained by greater than 0.15mg/kg/hour of midazolam or the infusion dose of propofol higher than 4mg/kg/hour.

Patients who are participating in drug research or other clinical trials.
Trajectories and Reactions of Users and Relatives Consulting French Youth Addiction Services

In France, the "Consultations Jeunes Consommateurs" (CJC) are the services specialized in the reception of young people for addiction problems. There are more than 500 CJCs throughout France. Depending on the situation, the CJC develops an early intervention strategy aimed either at reducing the risk of developing an addiction or at accelerating entry into appropriate care. The CJCs also meet with family members or professionals who may also independently request help or advice.

Set up by the State since 2004, the action of the CJCs has never been formally evaluated. Only descriptive studies, carried out by the French Observatory of Drugs and Drug Addiction (OFDT), have made it possible to better understand the profile of people who consult CJCs. However, no longitudinal study has yet been carried out to understand the factors associated with the overall evolution of users consulting CJCs, nor with the level of satisfaction of users and those around them. Such objectives are complex, due to the diversity of situations encountered in CJCs and the heterogeneity of the CJCs themselves.

This multicenter study will be open to 19 CJC (Consultations jeunes Consommateurs), based on a pre-selection by the partners of structures that are particularly willing to participate in the study (Fédération Addictions, Addictions-France).

However, other CJCs may be included depending on the progress of recruitment.

This recruitment of additional CJCs will be stratified to target a sample of CJCs representative of the CJCs on the metropolitan territory on the following characteristics:

* Region (13 major regions)
* Rural or urban area, as defined by INSEE
* Number of annual consultations

Eligibility Criteria:
Inclusion Criteria:

For users :

* First consultation in CJC
* From 12 to 25 years old

For caregivers :

* First consultation in CJC (with or without the youth) or second consultation if accompanying a user
* ≥ 18 ans

Exclusion Criteria:

* inability to reach by phone
* Insufficient french level
Evidence For Fusion In Spine With Orthoss®

This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).

This clinical investigation is a prospective, non-interventional, uncontrolled clinical trial, organized to generate clinical data on performance and safety of Orthoss® as a bone graft extender mixed with local bone at ratio of 1:1 and pedicle bone marrow aspirate in lumbar spondylodesis involving 1-2 levels. (Orthoss® is CE marked for this indication).

If you as a patient have a wear and tear disease of the spine, an operation serves to restore the stability of the spinal column. In order to promote a bony build-up of the lumbar spine segment (fusion), bone replacement material is used in your case as standard. The aim of this observational study is to determine fusion in order to address clinical performance of that bone replacement material.

Eligibility Criteria:
Inclusion Criteria:

* The patient (male or female) must be 18 years or older
* The patient must be a candidate diagnosed with either degenerative disc disease including 1-2 level (L4-L5 and/or L5-S1) or dysplasic spondylolisthesis (degree 1 or 2) or lumbar stenosis
* If the patient is of child-bearing potential, the patient confirms not to be pregnant
* The patient is able to comply with the clinical investigation-related procedures such as attending all follow-up procedures
* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent including the use of the anonymized data for scientific publication
* The patient will not participate in another clinical investigation during this clinical investigation

Exclusion Criteria:

* General contraindications for surgical treatment are present
* The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
* The patient is currently being treated with radiation, chemotherapy, immunosuppression or steroid therapy dose equivalent of more than 5mg prednisolon
* The patient is pregnant or nursing
* Women of childbearing age who are not using a highly effective method of birth control
* The patient has acute or chronic infection at the surgical site
* The patient has a known allergy to bovine bone material
* The patient has a medical history of alcohol or drug abuse within the last year prior to the screening examination
* Vulnerable population
* Patient is currently participating, or has participated in another clinical investigation within 6 months
Development of a Versatile Intra-operative On-screen Audiovisual Mentoring System Using TileproTM Program for Robotic Gastrectomy

Considering the development of gastric cancer surgery using da Vinci Robotic Surgical System, the development of educational program needs to be achieved in Korea and this institute. Moreover, because of the large number of gastrectomy including robotic surgery for gastric cancer treatment, the investigators can provide high quality of educational program using da Vinci System. Therefore, the investigators wanted to create an innovative real-time training module, which can provide an intraoperative step-by-step guide to robotic surgical procedures. This technological project was named as Advanced Robotic Multi-display Educational System (ARMES).

Considering the development of gastric cancer surgery using da Vinci Robotic Surgical System, the development of educational program needs to be achieved in Korea and this institute. Moreover, because of the large number of gastrectomy including robotic surgery for gastric cancer treatment, the investigators can provide high quality of educational program using da Vinci System. Therefore, the investigators wanted to create an innovative real-time training module, which can provide an intraoperative step-by-step guide to robotic surgical procedures. This technological project was named as Advanced Robotic Multi-display Educational System (ARMES).

The four-stages of ARMES development are as follows:

1. Standardization of the key steps of the selected procedure;
2. Preparation of well edited short video clips for each of the previously determined steps using our extensive library of videos of over 350 high quality robotic gastrectomies;
3. Production of a 3D animation of the key surgical steps;
4. Integration of the video segments into the da Vinci Robot system using TileproTM.

Through predetermined standardized segments of short operation video clips and 3D animation, the investigators are developing a versatile intra-operative on-screen audiovisual mentoring system using TileproTM program, which will improve surgeons' capabilities to perform complex robotic operations achieving quicker operation specific competency. It will help surgeons at initial state of robotic surgery in technical as well as oncological aspect for cancer surgery in detail and step-by-step. Finally this program can be applied to other robotic surgery and progressed to be a standard education program.

Eligibility Criteria:
Inclusion Criteria:

* Robotic surgery for primary early gastric cancer
* Distal gastrectomy with Billroth II anastomosis
* Age: 20\~80 years old

Exclusion Criteria:

* Other malignancy and inflammatory diseases
* Disease associated with bleeding tendency
* Previous major abdominal surgery
* Pregnancy
Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery

This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing colorectal surgery.

A former pilot study has shown that a preoperative relaxation program was effective in reducing preoperative anxiety. However the intervention was biased by concurrent pre-surgery education. Therefore this study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing colorectal surgery using a factorial design.

Eligibility Criteria:
Inclusion Criteria:

* referral for colorectal surgery
* preoperative anxiety at least 4/10 points on a numeric rating scale
* physical and mental capability to participant
* written informed consent

Exclusion Criteria:

* Emergency surgery
* known malignoma
* severe comorbidity
* severe psychological disorders
* immunosuppression
* coagulation disorders