cyrilzakka/clinical-trials huggingface dataset:
Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients

The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.

Implantable cardioverter defibrillator (ICD) are an important and effective treatment in patients at risk of sudden cardiac death. In order to allow for a more continuous follow-up and reduced complication rates of patients with ICD, new devices including remote-monitoring (home-monitoring) features of patients with ICD have been developed. BIOTRONIK Home Monitoring service enables the doctors to safely follow up their patients with implanted cardioverter-defibrillators in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient follow-up and cost-savings for the health care payer.

The objective of the current study is to investigate the cost-effectiveness and effectiveness of home-monitoring compared to standard care.

Eligibility Criteria:
Inclusion Criteria:

* The patient is willing/able to undergo the study protocol appointments and procedures/questionnaires
* Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines

Exclusion Criteria:

* Age \< 18 and \> 80 years
* Expected non-compliance
* Known drug or alcohol abuse
* Life expectancy \< 1 year
* NYHA classification IV
* Participation in another clinical study
* Participation in another telemonitoring concept
* Pregnant or breast-feeding woman
* Uncontrolled hypertension
* No mobile phone use possible in patient residence
Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions

Aim of Study:

To determine the optimal duration of voice rest following phonosurgery for patients who undergo phonosurgery due to benign vocal cord lesions IE: vocal fold nodules, cysts, polyps, granulomas, leukoplakia, and subepithelial edema.

Optimal Duration of Voice Rest Voice Following Phonosurgery for benign vocal lesions: Prospective Randomized Study

Background:

Phonosurgery is performed in order to improve voice quality in patients with various vocal fold pathologies including nodules, cysts, polyps, granulomas, leukoplakia, and subepithelial edema. It is customary to order the patients voice rest following vocal fold surgery, however, according to the current literature, it is not well known how long patients should remain in voice rest following phonosurgery (regardless of the type of benign lesion) in order to achieve the best voice quality results. In the literature, there is one preliminary study that shows that when voice quality was assessed at 15 days post-surgery, patients with voice rest of 10 days had better voice outcomes compared to patients with 5 days voice rest(1). A contradicting study, that measured voice outcomes in patients at 1, 3, and 6 months post-operatively, shows that a short voice rest of 3 days lead to better voice results compared to a 7 days voice rest(2).

The aim of our study is to determine the optimal duration (3 versus 7 days) of voice rest following phonosurgery for patients who undergo phonosurgery due to benign vocal cord lesions in order to achieve better voice quality post-operatively. In this study, patients will be randomly assigned into one of 2 different groups of voice rest durations: either 3 or 7 days following surgery. Patients will undergo pre and post (at 1, 3 and 6 months) operative voice testing. Voice quality testing will include: perceptual voice analysis using the GRABS (grade, roughness, asthenia, breathiness, and strain) scale, Voice Handicap Index-10 (VHI) questionnaire, measurement of maximum phonation time (MPT), and computerized voice analysis including voice intensity, fundamental frequency (F0), jitter, shimmer, and dysphonia severity index (DSI).

Eligibility Criteria:
Inclusion Criteria:

* • Patients who undergo phonosurgery for benign vocal fold lesions.

  * Adults (18-90years).
  * Patients who can provide and give informed consent.

Exclusion Criteria:

* • Patients without a complete medical record

  * Patients who are unable or unwilling to give informed consent
  * Patients younger than 18 years of age or older then 90 years
  * Patients who are pregnant
Effect of Post-operative Brace on Pain and Patient Outcomes Following Hip Arthroscopy for FAIS

The routine application of hip brace following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) has no proven clinical benefits. This study will investigate whether the application of hip brace affects the post-operative course and patient reported outcomes in patients undergoing hip arthroscopy for FAIS.


Eligibility Criteria:
Inclusion Criteria:

* Patient age of 18 years or older
* Patients with femoroacetabular impingement syndrome (FAIS) and who are candidates for surgical treatment with hip arthroscopy

Exclusion Criteria:

* Patient age \< 18 years
* Patients with FAIS who are not surgical candidates (surgical therapy is not indicated)
* Patients with previous, ipsilateral hip procedures
Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).

This study is currently available in Canada only.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
* ER-positive and/or PR-positive tumor based on local laboratory results
* HER2-negative tumor based on local laboratory results
* Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)

Exclusion Criteria:

* Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor
Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy

Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain, especially around the umbilical port is dominating the first postoperative week. Single Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative incisional pain and improve cosmetic results, but results are not convincing and the risk of formation of an umbilical trocar-site hernia is not properly investigated.

This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC vs. conventional 4-port laparoscopic cholesystectomy.

Methods This is a cohort registry study with prospective questionnaire and clinical follow-up on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a conventional laparoscopic cholecystectomy (consecutively from one month before and after SILC. They are matched for age, gender, date of operation, and surgeons skills (database from intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation (operation for a umbilical hernia or clinical hernia).

The H0 hypothesis is that there is not difference between SILC and conventional.

Exclusion criteria are: death, operation for acute cholecystitis. The included patients will be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia, and perioperative data that we do not have in the database. Futhermore those patients who suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis. Furthermore we patients are asked to report if they have chronic pain and/or discomfort.


Eligibility Criteria:
Inclusion Criteria:

* SILC 1/1-2009-1/6-2011 and matched controls consecutively from the cholecystectomy-database having a lap. chol. one month before and one month after the SILC group.

Exclusion Criteria:

* death in the follow-up time
* an abdominal operation before la.chol/SILC with midline incision
* an abdominal operation after la.chol/SILC with midline incision
* primary operation for acute cholecystitis
Immune Response After Leptospirosis Infection

Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira) growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas aera, and especially in Reunion Island, as compared to metropoly, it is considered as a major public health issue.

An important inter-individual variability in humoral immune response suggests that vaccination should be recommended in exposed subjects.

This cohort study aimed to determine if subjects that have been infected by leptospirosis for 1 to 7 years still remain immunized, and then do not need vaccination.

Every year more than 500 000 severe forms of leptospirosis are diagnosed in Reunion Island. The risk of mucocutaneous contact with contaminated media remains important due to highly aqueous environment.

Cured subjects that have been infected for 1, 2, 3, 4, 5, 6 or 7 years will be enrolled. The qualitative and quantitative humoral immune response to leptospirosis infection will also be evaluated to determine whether they still get protective immunization. Leptospirosis immunization will be evaluated using micro-agglutination test.

Graded immune responses related to the severity and the length of the infection will also be investigated.

Finally, 3 methods used for leptospirosis diagnosis will be compared. It is expected from this study to evaluate the appropriate conditions in which new vaccination could be required to prevent further leptospirosis infection in cured subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed for leptospirosis by polymerase chain reaction measured in Reunion Island Hospital between 209-2015
* with social security issue

Exclusion Criteria:

* Leptospirosis diagnosis not confirmed by polymerase chain reaction
* subject exhibiting immunodepressive status (cancers, transplantation, immune deficit, blood disorders)
* under medication: corticoids, immunosuppressor, chemiotherapy
Effectiveness of Modified-free Gingival Graft for Treatment of Localized Gingival Recession Defects

The aim of the present study is to evaluate, whether use of the modified free gingival graft (mod-FGG) technique improves treatment outcomes after surgical root coverage at mandibular incisors with gingival recession defects.

Gingival recession defects (GRD), defined as displacement of the gingival margin apical to the cemento-enamel junction, are frequent clinical findings in the general population.

The major indications for root coverage procedures are improved esthetics, reduction of root hypersensitivity and the increase of the dimensions of keratinized tissue in order to facilitate infection control and prevent further progression of gingival recession defects. Numerous surgical techniques for root coverage have been suggested, with different degrees of success as assessed by the proportion of complete root coverage. The scientific evidence has revealed that mandibular incisors were associated with the least favourable outcomes when compared to other teeth. The lower success rate and lower predictability of root coverage procedures at lower incisors, teeth with the highest frequency of GRDs, may be related to the unfavorable anatomic conditions including marginal frenum attachment, high muscle pull and a shallow vestibule. These features are frequently encountered in the anterior area of the mandible, while they are rare in the maxillary anterior region.

The so-called "Free Gingival Graft" (FGG) was shown to be the most effective procedure for gingival augmentation at sites with minimal amount of keratinized tissue. Great variability in terms of proportion of root coverage (range: 11% to 87%; mean: 63%) has been reported when applying this technique, however. One of the challenges may be the inadequate blood supply to the portion of the FGG placed on the exposed root surface. A modified version of the FGG technique (mod-FGG) has been proposed, aiming to improve the vascularity of the recipient site over the denuded root surface. However, there is to date no scientific evidence whether the mod-FGG provides better clinical results than the conventional FGG.

The hypothesis of the study is that the mod-FGG will improve predictability and treatment outcomes for root coverage at mandibular incisors.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Periodontally and systemically healthy
* Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
* Thin phenotype
* Probing pocket depth (PPD) ≤3 mm
* Absence of excessive tooth mobility
* Absence of cervical composite restorations or non-carious cervical lesions
* Shallow vestibule

Exclusion Criteria:

* Pregnancy
* Smoking
* Alcoholism
* Para-functional habits
* Poor oral hygiene
* Excessive crowding or misalignment of teeth
Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque

The objective of this exploratory study is to analyse in humans any qualitative changes of carotid artery atherosclerotic plaque under the influence of plant sterols consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patient, men and women, aged between 40 to 75 ans (limits included) willing to participate to the study and have signed informed consent for its participation in the study
* Displaying a non serious chirurgical indication of clinical asymptomatic carotid stenosis defined by:

  * atherosclerotic stenosis of 60 to 75% on one on the two carotid junction (external carotid excluded) according to criteria from NASCET
  * without constituted or transitory recent cerebral vascular accident. The discovery of an ischaemic after-effect on a systematic scanner is not a criterion of exclusion
* Subject with normal body weight or in over weight (Body Mass Index ranged between 19 and 30 kg/m2, \[limits included\])
* Subject willing to follow dietary recommendations advised during hypercholesterolemia (according to AFSSAPS' recommendations)
* Subject with social insurance or equivalent.

Exclusion Criteria:

* Subject who, according to AFSSAPS' recommendations, should received a hypocholesterolemic therapy before the end of the study.
* Subject with a history of diabetes
* Subject with cardiac disease such as unstable angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft surgery, or moderate or severe congestive heart failure within the last 6 months.
* Subject with plasma triglyceride levels higher than 2,5 g/l \[limit included\],
* Subject taking any drugs known to affect the evaluation of studied parameters
* Subject with severe or acute disease that could affect the results of the study or subject safety
* Subject with regular consumption of phytosterol enriched foods products during the study.
* Subject with any other medical condition or laboratory abnormality prior to recruitment that in the opinion of the principal investigator could affect subject safety or render unlikely trial to be conducted to the end.
* For women: pregnancy or breast feeding or subject likely to be pregnant during the study.
* For women: subject likely to modify their hormonal therapy during the study
* Subject in exclusion period after its participation in an other clinical trial
Artificial Intelligence to StrategiCally Enhance Pulmonary Embolism Response Team Activation

Pulmonary embolism (PE) remains a high mortality and morbidity disease state. The investigators have previously shown that use of a Pulmonary Embolism Response Team (PERT) can improve overall readmission, bleeding, and mortality outcomes. Unfortunately, PERT may still be underutilized from a national standpoint and may not be readily available in underserved areas.

The use of artificial intelligence (AI) may help streamline and systematically ensure unbiased mechanism for activation of PERT for discussion of patients with siginficant clot burden and hemodynamic abnormalities. AI algorithms have been FDA approved for use of triage of the PE patient. The institutional PERT program will adapt the use of an AI algorithm for activation as routine care; the efficiency of activation will be compared to our retrospective historical comparison for efficiency and appropriateness of activation.

The active phase of the study is designed to further differentiate between patients who are considered to be intermediate-high risk category but yet do not clearly qualify for invasive therapy (catheter-directed therapy, systemic thrombolysis, or invasive hemodynamic support). These patients will undergo walking test to further understand noninvasive hemodynamic compromise and undergo 2:1 randomization to early-invasive strategy versus mtranditional medical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients obtaining a CT at University Hospitals found to have a pulmonary embolism with evidence of right ventricular strain (RV:LV \> 0.9) along with an abnormal vital sign (HR \> 110 bpm, RR \> 30/min, SBP \< 100 mmHg, or O2 saturation \< 90%)
* Patients undergoing PERT discussion as deemed appropriate by the provider

Exclusion Criteria:

* Age \<18
* Pregnant patients. Women of childbearing age will be asked if they are pregnant before enrollment. No formal pregnancy test will be performed as a part of this study. If a patient does require invasive intervention, as part of the routine procedure for cardiac catheterization laboratory, women of childbearing age will either undergo pregnancy testing or opt-out per their own discretion
* Patients unable to perform 6MWT (e.g., lack of one or both legs) will not be included in the randomization. They will be included in the observation for routine treatment
Safety and Performance of New 1-piece Ostomy Product

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and signed letter of authority form.
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the bags themselves.
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Currently use a 1-piece flat ostomy appliance with open bag.
7. Use minimum 1 ostomy appliance every second day.
8. Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
9. Must be able to use a custom cut ostomy appliance.
10. Accept to test three 1-piece ostomy appliances in the investigation.
11. Negative result of a pregnancy test for women of childbearing age (only DK).

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.
6. Currently using ostomy belt.
7. Currently using extended wear product.
8. Known hypersensitivity towards any of the test products
9. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse) -
Randomized Clinical Trial to Assess the Efficacy and Safety of Concomitant Use of Rifampicin and Efavirenz 600 X 800mg

Rifampicin is a potent inducer of the CYP450 and decrease the plasmatic concentration of NNRTI and Protease Inhibitors. In our study we are going to compare the 600 an 800mg doses of efavirenz concomitant of rifampicin use to treat tuberculosis. The hypothesis is that the 800 mg dose would be more adequate than the 600mg

The study consist in a open label randomized clinical trial comparing efavirenz 600mg QID versus efavirenz 800mg QID in patients with tuberculosis (treated with regimens including rifampicin) and AIDS diagnosis. The total duration of the study is 6 months for each patient. All eligible patient will be treated with a fist line regimen for tuberculosis according to Brazilian guidelines: rifampicin (600mg QID); isoniazid (400mg QID) e pyrazinamide (2g QID) during 6 months for a weight of 45 kg or more and adapted doses for persons with less than 45 kg. For patients with previous history of TB therapy etambutol 1.200mg QID will be added to the regimen.

Both groups will receive nucleoside reverse transcriptase inhibitors (NRTI)and a non nucleoside transcriptase inhibitor (NNRTI) to treat HIV. The ITRN of first choice will be zidovudine and lamivudine association. Patients presenting contra indication for the use of those drugs will receive others NRTI. The NNRTI is efavirenz (800 or 600mg).

Antiretrovirals will be initiated 30 days after stable TB therapy. In case of adverse events during TB therapy that lead to treatment interruption, the study drugs will be delayed until the 30th day after triple therapy for TB. During HIV therapy NRTI can be changed in case of intolerance

Eligibility Criteria:
Inclusion Criteria:

* Adults with tuberculosis diagnosis, HIV positive.
* Agreement to avoid not allowed drugs during the trial, agreement to participate in the study (informed consent)

Exclusion Criteria:

* Active liver disease
* Pregnancy or breast feeding
* CD4 counts \>350