cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer

The main objective of the project is to compare the effectiveness and efficiency of innovative care through the IsereADOM home-care service package versus standard care in the prevention of unplanned hospitalizations in patients with cancer treatment. In accordance with the recommendations of the French High Authority of Health (HAS), a cost-utility analysis (ACU) will be implemented

Specific management of cancer patients involves carrying out often heavy treatments (surgery, chemotherapy, radiotherapy, interventional radiology, etc.) during which close coaching is necessary. In spite of this adapted follow-up, the natural evolution of the disease and the management of treatment tolerance make these patients a frail population, sometimes isolated, for which admission to emergency services and admission to full hospitalization can be required.

This trial will use a service package at home named IsereADOM, currently in the development phase in the management of 4 types of populations:

* Retired persons with no proven loss of autonomy;
* Users with loss of autonomy at risk of falling;
* Cardiac insufficiency;
* Patients with cancer.

This service package is based on the identification of a person of proximity, called "sentinel referent". This person, in charge of monitoring the patient at his / her home, has access to various connected tools installed at the patient's home (scales, tensiometer ...) as well as computer solutions enabling the sharing of information with the different actors in the management of the patient.

In addition, the patient benefits from motivational coaching based on investigator's recommendation and telephone and internet information platforms.

Eligibility Criteria:
Inclusion Criteria:

* age \> or = 18 years old at the time of signature of informed consent form
* patient with solid or hematologic tumor under treatment for cancer at the time of inclusion
* Patient managed in a medical emergency context in the 2 weeks prior to inclusion
* Patient living in Isère department (area of coverage of experiment)
* ECOG Performance index \< or = 3
* patient with a life expectancy of 6 months or more
* patient with social security system
* patient able to read, write and understand French
* patient with signed informed consent

Exclusion Criteria:

* Patient included in clinical trial evaluating early stage therapeutic innovation with pharmacokinetic sampling
* Patients with follow-up in Hospitalization at Home at the end of the hospitalization for inclusion
* Patient without help "referent" in the entourage (spouse, family, friend ...)
* Patient residing in Elderly Accommodation (EHPAD) or in any other institution for dependent persons
* Patient who is homeless or living in a home that does not allow the installation of the necessary equipment
* Patient with severe cognitive impairment, defined by score at Mini Mental State Examination (MMSE)\< 23/30
* Patient unable to comply (or unwilling to comply) with follow-up of the study for the duration of participation
Use of Local Warming in Children Venipuncture

The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with Emla.


Eligibility Criteria:
Inclusion Criteria:

* age between 8 and 13 years
* Intravenous drug therapy prescribed by a physician
* no allergy to lidocaine
* no local skin disease
* absence of burns scars
* child and his/her family are native speaker of Italian
* BMI not lower than 10° centile for sex and age according to the CDC standards

Exclusion Criteria:

* age of child not included in the age range established for the study
* Intravenous drug therapy not needed
* Presence of an allergy to lidocaine products
* Skin disease
* Presence of burns scars
* The child or his/her family are not native speaker Italian
* BMI lower than 10° centile according to the CDC standards
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)

The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2.

The objective of the Postmarket Surveillance Plan is to assess safety and performance as used in postmarket clinical practice in the U.S.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has a documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils.
2. Patient is considered for treatment with coil embolization assisted by the Comaneci Device for wide-necked intracranial aneurysms with neck width ≤ 10 mm. A wide-necked intracranial aneurysm is defined by the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2.
3. A signed informed consent by the patient or legally authorized representative

Exclusion Criteria:

1. Patient with known hypersensitivity to nickel-titanium
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size\> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter \> 4cm before treatment.
2. Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
3. Age：18-70 years old.
4. ECOG status score ≤1;
5. WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥80×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.
6. Well-compliance and willing to keep in touch.
7. Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.

Exclusion Criteria:

1. After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
2. Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
3. Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
4. Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
5. Participate in other clinical trials.
6. Severe diseases of other important systems and organs.
7. Persons without disposing capacity.
8. Drug and/or alcohol abuse.
9. Unable or unwilling to sign informed consents.
10. Not eligible for the study judged by researchers.
S1 Transforaminal Injection and Vascular Incidence

Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15\~25%.

This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic approach.

Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional procedure that is effective in radicular pain conditions such as herniated interverebral disc, spinal stenosis and failed back surgery syndrome.

The incidence of inadvertent intravascular needle injection during lumbar transforaminal injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate is more frequent than at the lumbar level.

Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the risk of radiation exposure.

In this stidy, the investigators aimed to compare the incidence of intravascular injection rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid injection. In addition, the investigators also compared the procedure time and radiation exposure between two approach method.

Eligibility Criteria:
Inclusion Criteria:

* spinal stenosis
* herniated intervertebral disc
* failed back surgery syndrome

Exclusion Criteria:

* coagulopathy
* infection
Mirror Therapy for Impingement Syndrome

Background: Mirror therapy is an adjuvant treatment option based on shoulder impingement Syndrome Objective:To investigate the effect of mirror theraphy on shoulder impingement Syndrome Methods: The study included 62 participants, including cases in the intervention group (IG) (± years) and 20 cases in the control group (CG) (years) who met the selection criteria. IG received mirror theraphy with regular physiotherapy while CG received only regular physiotherapy. The patients were evaluated with the before treatment, immediately after treatment (post-treatment).


Eligibility Criteria:
Inclusion Criteria:

* Being aged 18-75 years
* Being diagnosed with shoulder impingement syndrome

Exclusion Criteria:

* Being uncooperative
* Having an additional systemic disease
* Having uncontrolled hypertension
* Presence of heart failure
* Having hearing or vision problems
* Having a balance disorder
* Diagnosis of heart disease and lung disease so advanced that exercise is contraindicated
* History of shoulder surgery
* Have any pathology that may cause referred pain (eg, cervical radiculopathy)
* Shoulder trauma, previous humeral fracture history
* Steroid injection to the shoulder joint or subacromial bursa in the last 6 months
Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

Patients with vocal hyperfunction will undergo standard of care voice therapy with ambulatory voice monitoring before therapy and after the first 3 voice therapy sessions. Biofeedback will be added to ambulatory monitoring after the 2nd voice therapy session only.

This study will use a single subject design to determine if adding ambulatory voice biofeedback to conventional voice therapy can result in faster carryover (generalization) of new vocal behaviors established during voice therapy to daily life. Here, ambulatory voice biofeedback will be based on objective measures that have subject-specific sensitivity to vocal hyperfunction. Hypothesis: The ambulatory voice biofeedback week (week 2) will result in higher generalization percentages when compared to baseline and the week prior to the initiation of biofeedback (week 1). This effect will be retained when the biofeedback is removed (week 3), thus it will be different than baseline and week 1, but not different than week 2.

Eligibility Criteria:
Inclusion Criteria:

* Patients with vocal fold nodules or muscle tension dysphonia undergoing voice therapy

Exclusion Criteria:

* If a patient's baseline ambulatory monitoring data is not at least 1 standard deviation away from a normative database in any measure, he/she will be excluded. Non-English speakers are excluded because prompts on the smartphone app are only available in English.
Niacin As Secondary Prevention Of Coronary Artery Disease (NASPOCAD)

Aim of the study is to show additional effects of the combined therapy of niacin and statins analyzing number and function of EPCs and other stem cell populations and adiponectin as well as hsCRP levels in patients with CAD.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old, male or female
* Have stable coronary artery disease (i.e. no acute event like myocardial infarction or PTCA less then 3 months ago)
* LDL \> 100 mg/dl
* HDL \< 50 mg/dl
* Triglycerides \< 400 mg/dl
* No Nicotine abuse for at least 3 months
* Statin-therapy for more than 4 weeks
* Give a written informed consent
* Have the ability to understand the requirements of the study, and agree and be able to return for the required assessments.

Exclusion Criteria:

* Women of childbearing potential, pregnancy or being lactating
* Current participation in another clinical trial
* Have other severe concurrent illness (e.g., active infection, malignancy)
* Have a history of alcohol or drug abuse within 3 months of admission or factors making follow-up difficult or unlikely.
* Have significant or unexplained liver dysfunction or chronic increased levels of transaminases (ALT, AST)
* Suffer from myopathy, active peptic disease or arterial bleeding
* Have a known hypersensitivity against niacin or statins
* Are actually treated with any of itraconazole, ketoconazole, HIV-Protease-Inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone.
* Actual therapy with ezetimibe
* Diabetes mellitus Type I
Evaluation of PrEP-30: a Demonstration Project of Pre-exposure Prophylaxis for MSM and Other High-risk Group Clients at the Thai Red Cross Anonymous Clinic

PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part of a combined HIV prevention program that includes risk-reduction counseling, regular HIV testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in Thailand.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. HIV test negative
3. Creatinine clearance \> 60 ml/min
4. No contraindication or allergy to PrEP medications (TDF/FTC)
5. At least one risk factor for HIV infection within the previous 6 months:

   * sex partner known to be HIV positive
   * works as commercial sex worker
   * use of PEP for sexual exposure
   * injection drug use
   * any STI (syphilis, gonorrhea, chlamydia)
   * \> 5 sex partners
   * inconsistent condom use with high-risk partners, including MSM, IDU

     * MSM: any insertive or receptive anal sex without condom
     * Women: any sex without condom with high-risk male partner (MSM, IDU, multiple female partners)
     * Heterosexual men: any sex without condom with high-risk female partner (commercial sex worker, IDU, multiple male partners)

Exclusion Criteria: -
Frailty Index as An Indicator Associated With Postoperative Adverse Outcomes In The Older Population

This study is a observational study in China, which aims to explore the predictive effect of preoperative frailty defined by the modified frailty index in predicting postoperative survival and complications in elderly patients.

The objectives of the study include:

1. To demonstrate that the frailty scale can predict short- and long-term survival after surgery in elderly surgical patients; 2 Demonstrated that frailty as defined by this scale is associated with postoperative complications in older patients

Traditionally, frailty has been described as the form of chronological age. Evaluating the patient's risks based solely on age is difficult, several other factors contribute to physiologic aging and determine functional reserve and response to the risk of postoperative complications. To meet the clinical demand for simpler frailty measurement tools, a simplified 5-index modified frailty index (mFI-5) has been proposed and validated in many literatures. However, there is a lack of evidence on the link between preoperative weakness and poor prognosis in elderly patients undergoing non cardiac surgery.

Therefore, the purpose of this study is to verify the prognostic value of mFI-5 for short-term and long-term adverse outcomes such as postoperative delirium, anxiety, depression, acute pain, and mortality in elderly non-cardiac surgery patients. Our hypothesis is that frailty may be highly correlated with postoperative mortality and adverse outcomes in elderly patients undergoing non-cardiac surgery, and that mFI-5 may be an effective risk prediction tool for decision-making and surgical planning.

Eligibility Criteria:
Inclusion Criteria:

(1) participants ≥ 65 years of age;

Exclusion Criteria:

1. lacked any covariate indicator or missing data for any confounder (such as demographic information, intraoperative surgery or anesthesia information);
2. ASA physical status Ⅴ;
3. Anesthesia other than general intravenous anesthesia or intravenous inhalation anesthesia;
4. Surgery time ≤ 60 min.
The Effect of a Mobile Application on Enhancing Pulmonary Rehabilitation After Lung Cancer Surgery

The goal of this clinical trial is to investigate the effect of a mobile application intervention on postoperative lung rehabilitation. The main purposes of this study are:

1. To understand the effectiveness of the pulmonary rehabilitation mobile application in improving lung function.
2. To assess the feasibility of the pulmonary rehabilitation mobile application in post-surgery rehabilitation care.

Researchers will compare the intervention group (using the pulmonary rehabilitation mobile application) to the usual care group to determine if the mobile application is effective in lung surgery rehabilitation.

Participants will join the study immediately after providing informed consent and will continue for up to 7 weeks post-surgery. Participants will be randomly allocated to either the intervention group or the control group. Both groups will receive regular pulmonary rehabilitation during their hospital stay (1 day before surgery and 2 to 3 days after surgery). Researchers will guide participants in the intervention group to use the mobile application for pulmonary rehabilitation exercises throughout the study period. Participants in the usual care group will receive health education and an exercise guide before discharge. Participants will undergo three study assessments: at baseline (within 1 week after enrollment), post-surgery (week 5), and at follow-up (week 8).


Eligibility Criteria:
Inclusion Criteria:

* age over 20 years
* primary diagnosis of lung cancer at any stage and type
* referral to lung cancer resection by thoracotomy or videothoracoscopy
* ability to understand and consent to the trial procedures
* conscious and cognition intact

Exclusion Criteria:

* included adjuvant treatments (chemotherapy or radiotherapy)
* previous history of thoracic surgery
* neurological and/or musculoskeletal comorbidities
* visual or hearing impairment
* acute respiratory illness
Effects of Three Warm-up Interventions at the Workplace Among Vineyard Workers - a Protocol Study

Background:

Physical activity programs at the workplace have shown positive results on physical capacities and pain for several years. Due to the duration of the training session, the need of instructor, and the need of a place to practice, these programs are commonly complex to implement. For this reason, many of companies, especially companies in manual sectors are turning to another solution, i.e warm-up intervention before work shift. These interventions present on paper numerous advantages such as short duration, no need to specifically allocate a place in companies and the possibility to perform exercises in working clothes... Surprisingly, while positive effects of warm-up interventions on pain, performance physical and psychological capacities, are expansively reported in sport context, effects of workplace warm-up intervention are lacking. Therefore, the aims of this study are (1) to implement such intervention among vineyard-workers, workers highly exposed to heavy physical workload and pain and (2) to assess their effects on physical (pain, strength, flexibility) and psychological (workload) functions and also on work-related outcomes (work performance, readiness to work)

Methods:

A cluster randomized study will be implemented among French vineyard workers. Four groups of 30 participants will be constituted; corresponding to four different conditions: (1) hybrid warm-up intervention (HWU); (2) dynamic warm-up intervention (DWU); (3) stretching warm-up intervention (SWU); (4) no warm-up intervention (NWU). A total of 120 vineyard-workers will be recruited to participate in the study.

Discussion:

The results will provide more evidence about the short-term effects of warm-up interventions at the workplace, and will provide more evidence on which warm-up modality is the most effective on pain, performance, physical and psychological capacities among vineyard workers.


Eligibility Criteria:
Inclusion Criteria:

* working full time
* having at least 1 year of employment in the company

Exclusion Criteria:

- not to present previous surgery in the low back region in the last 12 months
Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions

The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.

The main objective of this study is to compare a Drug-coated Ballon with Drug-eluting stent in the treatment of coronary arty lesions in STEMI patients in de novo coronary lesions.The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical criteria 1)over 18 years old 2)Angiographic confirmation of acute myocardial infarction 3)EKG prompts STEM basis 4)Sign informed consent
2. Angiographic criteria 1)In situ coronary artery disease 2)The reference diameter of the target vessel was 2.5-3.5 mm and the length was less than 28 mm 3)Visual examination showed that the diameter of lesions in criminals was narrower than or equal to 80%.

Exclusion Criteria:

1.Clinical criteria

1. LVEF\<30%
2. Killip grading is greater than 3
3. Significant abnormalities in hemorrhagic quality or known coagulation function
4. History of intracranial tumors, aneurysms, arteriovenous malformations or cerebral hemorrhage;There was a history of stroke or TIA in 6 months and gastrointestinal bleeding in 2 months.Major operations were performed within 6 weeks.Recent or known platelets \< 100,000/mm3 or hemoglobin \< 10 g/dL.
5. Planned elective surgery may lead to early discontinuation of ADP receptor antagonists
6. The expected survival time of patients with other systemic diseases, such as malignant tumors is less than 1 year 2.Angiographic criteria

1)Left main lesion 2)The grade of dissection is greater than or equal to grade C lesions. 3)Coronary artery bridge lesions 4)In-stent restenosis 5)Severe stenosis of non-criminal lesions requiring selective treatment