cyrilzakka/clinical-trials huggingface dataset:
A Novel Scoring System for Predicting the Success of PCI in Patients With CTO

The investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. The investigators reviewed the clinical and angiographic records of 432 patients with 459 CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success.

Chronic total occlusions (CTO) accounting for about 15-20% of coronary artery lesions can be challenging and only 10-15% of patients undergo successful percutaneous coronary intervention (PCI) .Thanks to the technological and device advances, the marked improvement of PCI success rates could be seen. However, in contrast to non-CTO lesions, these procedures are accompanied by longer procedure time, contrast and radiation burden, and higher complication rates. The possibility to predict which CTOs are more likely to be treated successfully is still of utmost importance for patient selection. Several scores have been proposed to predict the procedural success rate, such as J-CTO, CL-Score, Progress-Score et al , J-CTO is widely accepted. But Karatasakis et al.showed that these scores performed moderately in predicting technical outcome, while ignoring many factors such as stumpless lesion which may exert an influence on the procedural success. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success.

Eligibility Criteria:
Inclusion Criteria:

1. complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
2. presence of angina or angina-equivalent symptoms ; undergo coronary intervention;

Exclusion Criteria:

-
A Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor

This is a phase II single center, open-label, single arm study of palbociclib treatment in patients with recurrent or metastatic advanced TETs after failure of one or more cytotoxic chemotherapy regimens. Patients will receive oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.

Patients will continue to receive Palbociclib until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever occurs first.

Disease assessments will be performed every 8 weeks (±7 days) from the date of initiation of treatment. Each assessment will be performed as scheduled according to the calendar regardless of any dosing delay to prevent the introduction of bias into the assessment of efficacy. Tumor assessments will be performed until radiographically and/or clinically (ie, for photographed or palpable lesions) documented progressive disease (PD) as per RECIST v.1.1, initiation of new anticancer therapy, or discontinuation of patient from overall study participation (eg, death, patient's request, lost to follow-up), whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven thymic epithelial tumor (TET) patients
2. Be ≥18 years of age on day of signing informed consent.
3. Documented progressive disease according to RECIST v1.1 following receipt of at least one cytotoxic chemotherapy regimen administered for inoperable or metastatic disease.
4. Measurable disease as defined per RECIST v 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated sited after completion of therapy is clearly documented.
5. Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue \[block preferred, or 10 unstained slides\]), which will be used for retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
6. ECOG performance status of 0 to 2

Exclusion Criteria:

1. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
2. Inability to swallow capsules.
3. Prior treatment with any CDK4/6 inhibitor.
Gasless Single-port Laparoscopic-assisted Radical Resection for Rectal Carcinoma

This project aims to investigate the safety and effectiveness of gasless single-port laparoscopic-assisted radical resection (GSLR) in the treatment of rectal carcinoma.

The gasless single-port laparoscopic-assisted surgery (GSLS) is associated with rapid recovery and shorter postoperative hospital stay and no pneumoperitoneum complications occur after the operation. To our knowledge, there have been no reports about GSLS applied to the treatment of gastrointestinal cancer in the world. To explore the safety and effectiveness of GSLS in rectal cancer patients, this project plans to evaluate the operation time, cardio-pulmonary function, postoperative pain, immunologic function and restoration of bowel function after the operation.

Eligibility Criteria:
Inclusion Criteria:

* Rectal carcinoma;The distance between tumor and anal verge is 5-15cm; The primary tumor can radical resect.

Exclusion Criteria:

* Neoadjuvant therapy;Surgical contraindication.
Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans

A recent study with rats showed that electrical stimulation of the vagus nerve (VNS) facilitates extinction of fear (Pena, Engineer, \& McIntyre, Biological Psychiatry, 2013). The hypothesized mechanism is that VNS both enhances memory consolidation (by increasing noradrenergic neurotransmission) and reduces anxiety (thus: preventing fear responses to the CS which may re-consolidate the fear memory). The effect was only apparent when VNS occurred during exposure of the fear conditioned stimulus (CS), and not when stimulation was given immediately following exposure. These results may have implications for the treatment of anxiety disorders in humans. However, until recently, the only means to investigate the effects of VNS on human fear learning would have required the invasive implantation of vagus nerve stimulators. This has fortunately changed, as a non-invasive transcutaneous VNS device has been approved for use in the E.U. for the treatment of psychological disorders.

This study proposes to use a t-VNS to investigate its effects on fear learning and extinction in (healthy) humans. Previous research has only investigated the effects it has on human mood and memory. The results obtained suggest that it reduces negative affect and enhances memory, findings which are consistent with those reported for rats. It is thus reasonable to expect that t-VNS will facilitate the extinction of fear in humans.

The present study aims to answer the following research questions:

Does t-VNS during extinction training:

1. accelerates extinction curves
2. reduces spontaneous recovery of previously extinguished fear
3. reduce re-acquisition of fear
4. reduce generalization of fear to other stimuli that resemble the CS+?
5. facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?


Eligibility Criteria:
Inclusion Criteria:

* healthy men and women aged 16 - 50 years

Exclusion Criteria:

* current or past psychiatric or neurological disorder
* use of psychopharmaca
* use of medication that affects autonomic nervous functioning (e.g., bèta-blockers)
* current cardiac or respiratory disorder
* pregnancy
Open Vs. Endoscopic Transversus Abdominis Release Trial

This study aims to comparatively evaluate the early and long-term results of open and endoscopic TAR procedure for large midline incisional ventral hernias.

Minimally invasive (endoscopic) transversus abdominis release (TAR) - new technique for the treatment of patients with large incisional ventral hernia. Term "endoscopic" TAR combines two minimally invasive (laparosopic or extraperitoneal (eTEP) approaches. These techniques have demonstrated significant advantages compared with open TAR in several retrospective studies. There are currently no randomized trials comparing open and endoscopic TAR operations for incisional ventral hernia repair.This study aims to comparatively evaluate the early and long-term results of open and endoscopic TAR procedure for large midline incisional ventral hernias.

The sample size was determined based on a previously conducted retrospective pilot study comparing the results of open and endoscopic TAR procedures for midline incisional ventral hernia repair. The retrospective study included 133 patients with midline incisional ventral hernias who were underwent Rives-Stoppa hernia repair in combination with bilateral posterior component separation with transversus abdominis release via open (open TAR) or endoscopic (eTAR) technique in Moscow City Hospital №1 from January 2018 to December 2022. All patients were included in the study, starting from the moment of endoscopic TAR technique was introduced into the clinic. At the same time, the learning curve for the open TAR had already been reached at that time; more than 20 open TAR interventions were performed in the clinic in 2016-2017. The average hospitalization time in open TAR group was 6.7 ± 2.14 days. In endoscopic TAR group the average hospitalization time after surgery was 5.2 ± 1.65 bed days. After achieving the learning curve (20 operations) for the endoscopic TAR procedure technique average hospitalization period after surgery was 4.8 ± 1.47 days. Thus, a decrease in the duration of hospitalization in endoscopic TAR group after reaching the learning curve was noted by 28.4%. This fact, based on a retrospective pilot study, allows the investigators to assume as a hypothesis for this RCT a reduction in the duration of hospitalization during endoscopic TAR by at least 30% as a guideline for calculating the power of the study. Thus, assuming a Type I error probability α of 0.05 and a Type 2 error probability β of 0.20, it would require a total sample size of 36 patients (18 patients in each group).

Eligibility Criteria:
Inclusion Criteria:

* midline incisional hernia
* defect width from 8 till 12 cm
* ASA I-III class
* able to give informed consent
* elective hernia repair
* considered eligible for minimally invasive ventral hernia repair

Exclusion Criteria:

* primary ventral hernia
* lateral hernia with/without midline
* refuse to give informed consent
Effects of LY450139, on the Progression of Alzheimer's Disease as Compared With Placebo

Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some patients. In this trial, patients who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all patients could eventually receive active drug. Each patient's participation could last approximately 2 years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study.

Preliminary results from this study (LFBC) (and another similar study LFAN \[NCT00594568\]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination score of 16 through 26 at visit 1
* Modified Hachinski Ischemia Scale score of less than or equal to 4
* Geriatric Depression Scale score of less than or equal to 6
* A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
* If female, must be without menstruation for a least 12 consecutive months or have had both ovaries removed.

Exclusion Criteria:

* Is not capable of swallowing whole oral medication
* Has serious or unstable illnesses
* Does not have a reliable caregiver
* Chronic alcohol and/or drug abuse within the past 5 years
* Has ever had a active vaccination for AD
Reuse of Polyp Traps, a Way to Approach Sustainability

The environmental impact of healthcare practice in the context of climate change is in the spotlight. Digestive endoscopy units are the third hospital unit that generates the most waste and environmental impact. For this reason, scientific societies advice studying and adopting more sustainable clinical practices, reconsidering current protocols for reprocessing and disinfection of single-use material. One of the devices, widely used and which generates a large amount of waste, is the polyp trap. It allows an easy recovery of the polyps removed during endoscopy. This device is discarded after a single use in some centers, and reused after washing and disinfection in others. Manufacturers recommend the single-use of the device, even there is no scientific evidence to support this action. In the investigators endoscopy unit, 3800 polyp traps are used yearly. The investigators hypothesis is that reusing the polyp catcher has similar safety to disposal after a single use, with better environmental and economic results. Objectives: To evaluate the safety of the reused and discarded after a single-use polyp trap. The investigators will assess 1) the post-colonoscopy infection rate and 2) the reliability of the anatomopathological study, 3) CO2 emissions and 4) costs of each practice. Methodology: A non-inferiority study will be carried out by observing the usual clinical practice of different centers and collecting data that suggest infection, cross-sampling and general complications. The results will be easily applicable in endoscopy units and will serve as a basis for future studies with other more controversial devices.


Eligibility Criteria:
Inclusion Criteria:

* All patients who undergo an elective colonoscopy will be recruited for the study.

  * Written informed consent to participate in the study and willingness to be contacted by telephone for follow-up.

Exclusion Criteria:

* Patients who complete the colonoscopy without a polypectomy.
* Patients who complete the colonoscopy without the use of a polyp trap.
Weight-bearing Recommendation After Replacement of the Hip or Knee Joint

Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of consensus regarding postoperative treatment, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices. In particular, there are no evidence-based recommendations on the amount of weight that the patient should be advised to bear on the operated leg after the operation.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis for diagnosis of osteoarthritis or femoral head necrosis

Exclusion Criteria:

* A history of septic arthritis,
* Hip fracture,
* Intraoperative complications,
* History of implant surgery on the joint to be operated on,
* Rheumatoid arthritis,
* Amputations,
* Inability to complete the questionnaires because of cognitive or language difficulties.
Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance

Recent updates of the guidelines on polyp surveillance of the American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) increasingly focus on size of polyps as an important indicator of malignant transformation to colorectal cancer (CRC). However, the interobserver variability in polyp size assessment between optical diagnosis of endoscopists and pathologists is considerable. This may lead to incorrect surveillance intervals in patients at risk for developing colorectal cancer, which may increase the risk of post-colonoscopy CRC (PCCRC). This study aims to assess the precision of a new laser-based measurement system (AccuMeasure, VTM Technologies Ltd.) for polyps during colonoscopy.

Objective: The main objective is to compare the precision of polyp size measurement by AccuMeasure to biopsy forceps assisted measurement. Secondary objectives are to assess: Time needed for measurement and learning curve, endoscopists advised surveillance intervals based on both measurement methods, and safety.

Study design: Multicenter, randomized, parallel group, endoscopist blinded study, including the measurement of 138 polyps during standard colonoscopy. With a polyp detection rate of approximately 40%1, this results in up to 345 patients/colonoscopies to be included. Enrollment will conclude once 138 polyps are included in the study.

Study population: All adult patients with screening or surveillance colonoscopies will be asked for informed consent. Polyps smaller than 25mm found during colonoscopy are considered eligible for inclusion. Up to 3 polyps per patient can be included in this study.

Intervention: Optical assessment will be performed upon identification of the polyp. Then, measurement with AccuMeasure and biopsy forceps will be performed in a randomized order. The endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements.

Eligibility Criteria:
Inclusion Criteria:

* • Adult patients (\>18 years)

  * Scheduled for screening, surveillance, or diagnostic colonoscopy
  * Polyps of all forms ≤ 25mm as assessed by the endoscopist

Exclusion Criteria:

* • Therapeutic colonoscopy;

  * Inflammatory bowel disease (IBD);
  * American Society of Anesthesiologists (ASA) score of \>3;
  * Inadequately corrected anticoagulation disorder or anticoagulation medication use;
  * Inability to provide informed consent;
  * Inadequate bowel preparation (Boston bowel preparation scale score \[BBPS\] \<2 per segment);
  * No polyps identified during colonoscopy or only small (\<5mm) hyperplastic rectal polyps;
  * Intraprocedural complications, not caused by the study device.
Evaluating the Impact of Behavioral Nudges on Student Hand-washing in Elementary Schools in the Philippines

This study evaluates the impact of school-based behavioral "nudges" installed in toilets and handwashing facilities on handwashing behavior among students in the Philippines. Nudges include: visible signage crafted to trigger behavioral motivators for handwashing; colorful pathway overlaid with footprints leading from the toilet to the handwashing station; sticker of a pair of eyes placed above the handwashing station; soap dish with an arrow beside it on the sink or counter to remind children to wash their hands with soap. The study's main hypothesis is that behavioral nudges will increase the percentage of students who wash their hands with water and soap after toilet use by 7 percentage points or more among schools where nudges were installed compared to control schools without nudges. The study is taking place in public primary schools in Zamboanga Del Norte, Philippines between October 2019 and May 2020.

The impact of the behavioral nudge intervention will be evaluated using a cluster randomized controlled trial (RCT). The investigators will randomly select 132 Department of Education (DepEd) schools across Zamboanga Del Norte province to comprise the study sample. 66 schools will be assigned to the treatment group, and 66 schools to the control group. Treatment schools will receive the behavioral nudge intervention, while control group will not. Both treatment and control schools will receive DepEd's national WASH in Schools (WinS) policy. WinS promotes "correct hygiene and sanitation practices among school children and a clean environment in and around schools" and includes initiatives related to infrastructure, knowledge, and behavior change, but does not include other programs with an explicit focus on handwashing promotion.

Four months after installing nudges, enumerators will conduct structured observations in study schools, observing whether pupils wash their hands with soap, wash without soap, or do not wash, after they have used classroom toilets. This will be used to estimate the causal impact of the nudges intervention on rates of independent handwashing with water and soap after toilet use.

Eligibility Criteria:
Inclusion criteria:

* Water for handwashing is available at the school for at least certain days of the week
* The overall pupil to toilet ratio equals 100 or lower
* School has at least one individual handwashing station or group handwashing station
* School is situated in a district deemed safe by DepEd
* School does not have any planned WASH programming in the upcoming 2019-20 school year beyond standard WinS activities

Exclusion Criteria:

* Water for handwashing is not available at the school for all days of the week
* The overall pupil to toilet ratio equals over 100
* School does not have either an individual handwashing station nor a group handwashing station
* School is situated in a district deemed unsafe by DepEd
* School has at least one planned WASH programming in the upcoming 2019-20 school year beyond standard WinS activities
A Prospective Observational Study of Sepsis

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with high morbidity and mortality. Sepsis3 gives sepsis a broad definition, reflecting the heterogeneity of the disease. So we need a precise treatment with a stratification of patient prognosis in order to reduce mortality in patients with sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who met the Sepsis3 diagnostic criteria.

Exclusion Criteria:

* Absence of laboratory test items (blood routine examination, coagulation function, liver function, biochemistry, urine routine examination, urine renal function, urine protein, etc.) \>20%.
* Admission in ICU less than 48 hours.
* Patient with psychiatric disorders.
* Under 18 years of age.