cyrilzakka/clinical-trials huggingface dataset:
KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) currently affecting one person in a thousand in France. It can lead to numerous digestive complications such as fistulas, abscesses or stenosis. Despite numerous therapeutic advances, the rate of patients requiring surgery remains very high, with approximately 50% requiring at least one surgical intervention at 10 years after disease diagnosis. However, surgical treatment is not curative, the postoperative recurrence rate being very high, from 65 to-90% endoscopic recurrence at 1 year. The ileocolonic anastomosis is the main site of postoperative recurrence currently defined by a Rutgeerts score (≥i2) 6 months after surgery. In 2003, Kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (Kono-S anastomosis). The study showed no decrease in endoscopic recurrence rate at 1 year (83% vs 79%), but a significant decrease in surgical recurrence rate at 5 years (15% vs 0%). Recently, a randomized Italian monocenter study showed a significant decrease in endoscopic recurrence rate at 6 and 18 months (22.2% versus 62.8% and 25% versus 67.4%), as well as a decrease in clinical recurrence. The limitations of this study are its monocentric nature and the lack of centralization of the endoscopic analysis to assess the primary endpoint. This surgical technique has been performed in some centers for ileocolonic Crohn's surgery since 2020. Nevertheless, the level of evidence remains too low to establish practice recommendations. The KOALA study will be the first prospective, multicenter, randomized study comparing KONO-S anastomosis and conventional anastomosis for ileocolonicresection of Crohn's disease, with blinded and centralized evaluation of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥ 18 years and ≤75 years
* With Crohn's disease.
* Requiring a first ileocolonic resection: fistulizing, abscessed, or stenosing disease or disease refractory to medical treatment.
* Affiliated to the French social security system.

Exclusion Criteria:

* Previous ileocolonic resection
* Contraindication to postoperative endoscopy.
* Anastomosis with a planned defunctioning protective stoma.
* Emergency surgery (peritonitis).
* Lack of consent to the study.
* Pregnant patients.
* Refusal to participate or inability to provide informed consent.
* Patient under legal protection (individuals under guardianship by court order)
Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy

The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.

The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* adult patients diagnosed with cancer
* patients who use smart phone

Exclusion Criteria:

* patients with cancer with comorbidity
Bifurcation ABSORB OCT Trial

The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive subjects with and without fenestration towards the side branch.

Patients included in this study will be divided into three different cohorts:

* Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.
* Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.
* Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.

All patients will also have telephone FU at 30 days, 12, 24 and 36 months.

Inclusion of patients in the BISORB OCT trial stopped in November 2016 after safety concerns of the ABSORB BVS were reported. BISORB OCT included 3 patients, which were all included in the Academic Medical Center


Eligibility Criteria:
Inclusion Criteria:

* Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded).
* Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography.
* Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure,as approved by the appropriate Ethics Committee.

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject is presenting with a STEMI
* Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
* Subject has known hypersensitivity or contraindication to contrast, aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
* Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) \<60mL/min/1.73m2 or serum creatinine level of \>2.5mg/dL or subject on dialysis)
* Subject with a limited life expectancy less than one year.
* Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or subject unable to read or write.
Hypertension, Ethnicity and Exercise Trial

The main aim of this study is to investigate the acute effects of a single bout of isometric handgrip exercise (IHG) and a single bout of aerobic endurance exercise (AEX) on blood pressure, both immediately after exercise and during the subsequent activities of daily living in patients with high-normal to grade 1 hypertension of South-Asian or African descent living in Suriname.


Eligibility Criteria:
Inclusion Criteria:

* • Age 18 - 65 years

  * Patients with high- normal BP (SBP: 130 - 139 mmHg or and DBP: 85 - 89 mmHg) or stage I hypertension (SBP: 140 - 159 mmHg or DBP: 90 - 99 mmHg) according to the ESC/ESH guidelines \[15\]
  * Asian or African descent
  * Do not meet the level of physical activity recommended by the WHO based on self-report \[15\]
  * Non-medicated patients or patients using a maximum of 2 antihypertensive drugs

Exclusion Criteria:

* • Functional or mental limitation limiting the correct execution of an exercise bout

  * History of ischemic stroke, autonomic neuropathy, cardiovascular, renal, or pulmonary disease by self-report
  * Diabetes type I or II
  * Pregnancy
  * The presence of exercise induced signs of myocardial ischemia or complex ventricular arrhythmia during CPET
  * Patients using three or more antihypertensive drugs or patients with resistant hypertension
Evaluation of Sarcopenia in Patients Receiving Home Health Care

The aim in the study is to evaluate the presence of sarcopenia in patients receiving home health care; To evaluate the relationship between sarcopenia and age, disease duration, and cause of immobility. In the literature review, a limited number of studies evaluating sarcopenia in home health patients were found.

Home Health Service is the provision of health services needed by immobile and chronic disease patients in the home environment. The purpose of this service is not to diagnose the patient, but rather to follow up, implement and educate the treatment of the diagnosed patient.

The aim of the study is to evaluate the presence of sarcopenia in patients receiving home health care; To evaluate the relationship between sarcopenia and age, disease duration, and cause of immobility. In the literature review, a limited number of studies evaluating sarcopenia in home health patients were found.

Eligibility Criteria:
Inclusion Criteria:

1. Receiving home health care
2. Being at the mental and physical activity level to be able to perform and complete the tests
3. Being 18-85 years old

Exclusion Criteria:

1) Patients who cannot cooperate
Impact of Preoperative Midazolam on Outcome of Elderly Patients

We aim to assess, if placebo compared to preoperative administration of midazolam in elderly patients is equal in regard to the global postoperative patient satisfaction

Generalised premedication with benzodiazepines in all surgical patients has become questionable, regarding the risk-benefit assessment and the lack of evidence for this practice. Particularly, in elderly patients (≥65 years), a higher risk for adverse events is described.

Patients will be randomly assigned to one of the following two study groups. Preoperatively, group 1 will receive midazolam and group 2 will receive placebo.

Anaesthesia will be performed according to the clinical routine.

All possible side effects are described in the SmPC for midazolam. For the placebo-group, we do not expect any harm, as in the case of strong preoperative anxiety or agitation, additional midazolam application may occur on behalf of the attending anaesthesist at any time.

The sample size was calculated based on detecting a minimum of 5 unit difference in the primary outcome variable overall patient satisfaction measured with the EVAN-G. Setting a type 1 error of 0.05, a power of 0.8 and assuming the standard deviation of EVAN-G to be 14 units, 248 patients per group are needed to detect a 5 unit difference.

Considering a drop-out of 10% and a screening failure of 10%, we decided to include 614 patients in total.

The hypothesis of the study is that global patient satisfaction after surgery in elderly patients is similar after preoperative placebo application compared to midazolam application.

Eligibility Criteria:
Inclusion Criteria:

1. 1. Only legally competent patients
2. Written informed consent prior to study participation
3. 65-80 years
4. Elective surgery
5. Expected surgery duration ≥ 30 minutes
6. Planned general or combined regional and general anaesthesia
7. Planned extubation at the end of surgery

Exclusion Criteria:

1. Age \> 80 years
2. Age \< 65 years
3. Non-fluency in German language
4. Alcohol and/ or drugs abuse
5. Chronic benzodiazepine treatment
6. Intracranial surgery
7. Local and stand by anaesthesia or solely regional anaesthesia
8. Monitored anaesthesia care
9. Cardiac surgery
10. Ambulatory surgery
11. Repeated surgery
12. Contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy)
13. Allergy against any component of the Placebo (lactose monohydrate, cellulose powder, magnesium stearate, microcrystalline cellulose) or investigational drug (midazolam, lactose) or the capsules (gelatine, E171 titanium dioxide, E132 indigotine).
14. Expected benzodiazepine requirement after surgery
15. Expected continuous mandatory ventilation after surgery
16. Patients who explicitly request anxiolytic premedication
17. Patients with severe neurological or psychiatric disorders
18. Refusal of study participation by the patient
19. Parallel participation in interventional clinical studies within the last 30 days
Intrinsic Respiratory Rate Assessment During Mechanical Ventilation to Accelerate Spontaneous Breathing and Extubation

The goal of this study is to identify patients with reverse triggering who's the potential to breath spontaneously is hidden because of the ventilator management strategy by performing a simple 30sec-test with includes reducing the support from the ventilator. The findings will provide clear advice to doctors on how to better care for these patients.

This will be a pilot randomized clinical trial including 70 adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering. The study will be conducted in two ICUs: 1) St. Michael's Hospital, Toronto Canada and 2) Toronto Western Hospital, Toronto, Canada.

The objective of this study is to investigate the impact of assessing intrinsic respiratory rate in mechanically ventilated patients with reverse triggering on the facilitation of transition to spontaneous breathing and successful extubation.

Patients will be excluded if under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph\<7.25 at the time of study procedure.

Patients will be screened every morning from 8:00 am to 9:00 am all the patients under controlled ventilation to detect the presence of reverse triggering by looking at the screen on the ventilator (2-5 min observation). The research team (research MDs, physiotherapists and respiratory therapists) is very well trained at detecting reverse triggering. Patients will then be randomized to standard of care or intervention using a deferred consent model.

* Control group: standard care.
* Intervention group: The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.

If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:

- It will be indicated that the patient tolerated 5 min of pressure support ventilation and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering.

Exclusion Criteria:

* under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph\<7.25) at the time of study procedure.
Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial

The goal of this clinical trial is to compare in patients undergoing thoracic procedures the lung inflammatory response in on one-lung ventilation and two-lung ventilation strategies The main question to answer is:

• Lung inflammation differs when comparing one to two-lung ventilation strategies during the procedure? Participants will be divided in the classic one lung ventilation or two lung ventilation (using pneumothorax with CO2) and different biomarkers of lung inflammation will be measured after procedures.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of pleural or mediastinal pathology that requires diagnostic or therapeutic surgical intervention;
* Written consent to participate

Exclusion Criteria:

* Pregnant women;
* Patients on mechanical ventilation prior to the procedure;
* Patients classified by the American Society of Anesthesiology (ASA) as class 4;
* Patients with subpulmonary or diaphragmatic pathologies, where it is believed that the two pulmonary technique is superior;
* Impossibility of using a double-lumen tube or difficult intubation;
* Patient does not support one-lung ventilation;
* Patient with previous lung resection surgery
Postoperative Cognitive Dysfunction After Propofol Anesthesia for Noncardiac Surgery

Background: Postoperative cognitive dysfunction (POCD) in elderly patients after noncardiac surgery is a common problem.

Therefore,this study was designed to assess POCD after closed-loop coadministration of propofol and remifentanil guided by bispectral index in comparison to intravenous anesthesia in elderly patients undergoing major noncardiac surgery. Methods: After approval of the local ethical committee was obtained, 204 patients (American Society of Anesthesiologists physical status I-III; age, \> 55 yr) undergoing surgery (duration, \> 1 h) were enrolled into this pospective randomized monocenter study. Patients received anesthesia 3 days after using a neuropsychological test battery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I-III;
* undergoing surgery (duration, \> 1 h)

Exclusion Criteria:

-
Comparative Effectiveness of IIMR Versus CDSMP

The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population.

The proposed study will be the first to compare two commonly used but substantially different, evidence-based self-management interventions. Integrated Illness Management and Recovery (I-IMR), is an individually-tailored, 16-session, integrated program combining both physical and mental health self-management specifically developed for people with SMI. In contrast, the Stanford Chronic Disease Self-Management Program (CDSMP) is a group-based, 6-session, chronic disease self-management program largely focused on physical health self-management alone. I-IMR is delivered by community mental health providers or by community outreach workers, while CDSMP is co-delivered by two peers or by a health professional and a peer. Both programs have been widely recommended, disseminated, and used. The proposed parent study will randomize people with serious mental illness to I-IMR (n=300) and CDSMP (n=300).

Eligibility Criteria:
Inclusion Criteria:

* Serious Mental Illness (diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic depression with moderate impairment in functioning) receiving services at Centerstone(KY and TN)
* Diagnosis of a chronic medical condition increasing risk of early mortality from cardiovascular or respiratory disease (e.g., diabetes, hyperlipidemia, hypertension, COPD, heart failure, tobacco dependence, obesity), and at least 1 ER visit or hospitalization within the past year or judgment by the treatment team of substantial need for illness self-management training.

Exclusion Criteria:

* Consumers who do not speak English
* Consumers with either no, or a well-controlled medical condition will not be included
* Individuals residing in a nursing home or other institution
* Evidence of significant cognitive impairment as indicated by a Mini Mental Status Examination score \<24, will be excluded

Eligibility for the COVID -related substudy is dependent on enrollment and participation in the parent project.
Clinical Validation of the New Print on Focus DAILIES Toric

The purpose of this study is to validate the improvements to the inversion indicator.

This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
* Willing and able to wear study lenses in both eyes in the available parameters.
* Light-eyed subjects.
* Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
* Optimal or acceptable fit in each eye at time of dispensing.
* Willing to wear the study lenses at least 8 hours a day, 5 days a week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment for this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* RGP contact lens wearer.
* Other protocol-defined exclusion criteria may apply.
Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer

This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
* Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
* Tumor involvement of at least one axillary lymph node
* Absence of any clinical or radiological evidence of local or metastatic disease
* Premenopausal or postmenopausal women aged 18-75 years old
* Adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3)
* Adequate liver (bilirubin \<1.0 times upper limit of normal and SGOT/SGPT \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl)
* Adequate cardiac function (LVEF\>50%)
* Written informed consent

Exclusion Criteria:

* Positive pregnancy test.
* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
* Previous history of other invasive malignancy other than non-melanomatous skin cancer.