cyrilzakka/clinical-trials huggingface dataset:
Ultrasonography Guided Brain Lesions Resection:

1. Evaluate the clinical value of intraoperative ultrasonography as a real-time guidance
2. Combination of data of MRI Tractography and intra operative ultrasonography will be useful in good localization of lesions or not .
3. Maximal safe resection .

Accurate pre and intraoperative localization of Brain lesions is a challenge in neurosurgery specially deep intra cerebral lesions. Stereotaxy and neuronavigator played a major role in preoperative and intraoperative evaluation of exact location of intra cerebral lesions, the main drawbacks of using steriotaxy and neuronavigator that they are time consuming, complicated and expensive.(1) Nowadays we use MRI Tractography as preoperative imaging to localize lesions and there relation to neural tracts specially in eloquent brain areas, and also intraoperative ultrasonography Which act as a real-time, unexpansive and relatively simple tool for intraoperative visualization of the lesion's location, size, extent and its relationship with the surrounding tissue, also it can reveal the lesion's blood supply, it can measure the rate and direction of arterial blood flow.(2,3,4) Intraoperative ultrasonic imaging was first applied as a real-time navigation system in neurosurgery in 1980. (5) In this research we will combine the use of preoperative MRI tractography with intra operative ultrasonography in accurate localization of brain lesions and its relation with important tracts and if this combination will be beneficial and add to the safety of excision of lesions or not.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed to have Intracranial lesions Patients with recurrent lesions

Exclusion Criteria:

* Patients who are unfit for surgery Patients who have multifocal lesions
An Environmental Intervention to Encourage Healthy Food Choices

The primary objective of this study is to test effectiveness of an environmental intervention designed to encourage healthy food intake during meals. It is hypothesized that fruit, vegetable, whole grain, lean protein, and low-fat dairy consumption will increase during the intervention. It is also hypothesized that nutrition knowledge, attitudes, and behaviors will change as a result of the intervention. The findings from this study will provide insight into the applicability of this intervention in military dining facilities.

Previous studies attempting to increase consumption of healthy foods in military dining facilities have had mixed results, and alternative approaches need to be considered. The present intervention was designed with the results of previous studies in mind, and as such, does not focus on labeling only healthy food choices. Instead, the present intervention aims to encourage consumption of nutritionally well-balanced meals using an environmental cue in military dining facilities.

Eligibility Criteria:
Inclusion Criteria:

* Military member or government civilian employee
* Normally eat in military dining facility at least 1 day per week.

Exclusion Criteria:

* N/A
Machine Learning in the ICU: Predicting Mortality in Bloodstream Infections (ICU:Intensive Care Unit)

Using our own patient data, our study aimed to predict mortality that can develop in Carbapenem-resistant Gram-negative bacilli bloodstream infections with a machine learning-based model.

In the intensive care unit, patients with bloodstream infections, both with and without mortality, will be examined retrospectively in two subgroups for comparison.

Carbapenems are one of the last-resort antibiotics used to treat severe infections caused by multi-drug resistant Gram-negative pathogens. Infections with Carbapenem-resistant Gram-negative bacilli (CR-GNB) have become widespread in the past decade, posing serious threats to public health. Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Acinetobacter baumannii (CRAB), and Carbapenem-resistant Pseudomonas aeruginosa (CRPA) top the priority list of antibiotic-resistant bacteria worldwide. CR-GNB causes a broad spectrum of infections, including bacteremia, urinary tract infections, pneumonia, and intra-abdominal infections. Carbapenem-resistant bloodstream infections are a significant cause of morbidity and mortality, and therapeutic options in treatment are extremely limited. By evaluating risk factors in patients monitored in the intensive care unit, scoring systems that can predict prognosis reduce mortality risk by ensuring the early application of effective antibiotics and timely hemodynamic support that are currently in use.

With the accumulation of big data and advancements in data storage techniques, innovative and pragmatic machine learning methods that have entered our lives demonstrate good prediction performance in the medical field. Machine learning-based models developed to predict mortality in patients monitored in the intensive care unit are available in the literature and provide an opportunity for earlier intervention in patients.

Using our own patient data, In the intensive care unit, patients with bloodstream infections, both with and without mortality, will be examined retrospectively in two subgroups for comparison. The investigators aim to predict mortality that can develop in Carbapenem-resistant Gram-negative bacilli bloodstream infections with a machine learning-based model.

Eligibility Criteria:
Inclusion Criteria:

* In our study, patients who were monitored in our hospital's tertiary Intensive Care Unit between June 2017 and June 2023 and developed bloodstream infections with Carbapenem-resistant Enterobacteriaceae, Carbapenem-resistant Acinetobacter baumannii and Carbapenem-resistant Pseudomonas aeruginosa will be retrospectively included.

Exclusion Criteria:

* Patients under the age of 18 and those with infections other than bloodstream infections will not be included.
Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure

BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures

This is a multi-centered, randomized trial in patients receiving lung biopsies. Patients will be randomized to either receive or not receive a Bio-Seal Biopsy Track Plug after a lung biopsy per standard hospital protocol. This study is designed to demonstrate safety and efficacy of the Bio-Seal Biopsy Track Plug in reducing pneumothorax rates post lung biopsy.

Eligibility Criteria:
Inclusion Criteria:

* The patient must meet all medical conditions for lung biopsy;
* The patient must be at least 18 years of age;
* The patient, or legal representative, must understand and provide written consent for the procedure;
* The patient has a non-calcified, radiologically suspicious opacity or lung nodule, including a metastatic lung module, or mass of at least 1.0 cm in size; as determined by CT scan equipped with measurement software. Suspicious nodules observed by CT scan are defined as non-calcified masses with convex borders, not known to be stable. Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray that are suspicious by radiographic or clinical means and require biopsy.

Exclusion Criteria:

* Patients with radiological findings of bullous emphysema located in the area of the anticipated biopsy and biopsy needle track;
* Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;
* Female patients who are pregnant. Note: patients of childbearing potential must have a serum or urine pregnancy test no more than one week prior to the biopsy procedure, and be instructed not to have unprotected sexual intercourse after the test until the biopsy procedure is completed.
* Patients who are uncooperative or cannot follow instructions.
* Patients who are currently enrolled in another IDE or IND clinical investigation that has not completed the required follow-up period.
A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer

This study will evaluate the disease free survival rate of a combination of capecitabine \[Xeloda\] and oxaliplatin (XELOX) with trastuzumab \[Herceptin\] in patients with resectable gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor. If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in every cycle. The anticipated time on study drug will be 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age
* Locally advanced resectable HER2-positive gastric or esophagogastric junction adenocarcinoma (Sievert types I, II, III)
* Measurable (RECIST criteria) or assessable disease
* ECOG performance 0-2
* Life expectancy of 12 weeks or more

Exclusion Criteria:

* Immeasurable lesion as the only evidence of disease
* Previous chemotherapy or radiotherapy for gastric neoplasm or some kind of previous surgical resection of the tumor (except diagnostic laparoscopy)
* Concomitant heart disease
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)


Eligibility Criteria:
Key Inclusion Criteria:

* Previously treated recurrent CLL
* Measurable lymphadenopathy
* Requires therapy for CLL
* Has experienced CLL progression \< 36 months since the completion of the last prior therapy

Key Exclusion Criteria:

* Recent history of a major non-CLL malignancy
* Evidence of an ongoing infection
* CLL refractory to bendamustine
* Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Investigation of Mechanisms of Action in Superpower Glass

The following study aims to understand the mechanism of action at work in a novel artificial intelligence (AI) tool that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This study will examine 2 versions of software on the Google Glass based wearable intervention system. Participants will receive 1 of 2 versions of the software and use the device at home for 4 weeks. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that both mechanisms under investigation will contribute to social gains in children over the 4 week period of use.


Eligibility Criteria:
Inclusion Criteria:

* Parent of a child with a professional diagnosis of autism who is at least 18 years old.
* Child with autism is 4-8 years old
* Parent/Guardian is able to drive to Stanford University for 2 in lab appointments.(Lives within driving distance of Stanford University).

Exclusion Criteria:

* Parent/Guardian unable to speak and read in English.
* Child with autism receives Social Communication Questionnaire score\>15
A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients

Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on skin basal cell carcinomas in Gorlin's syndrome patients.

Following a 21-day screening period, patients were exposed to multiple doses of topically applied LDE225 twice daily for 4 weeks in a double-blind manner. The patients returned weekly for visits where each BCC was clinically evaluated and digital photographs taken. Local safety and tolerability was also assessed. After the last application of treatment, biopsies were taken from treated (both vehicle and LDE225) BCCs (three per patient) for histology, biomarker evaluation and for pharmacokinetics (skin exposure). In addition, a biopsy from LDE225-treated uninvolved perilesional skin was taken for pharmacokinetic evaluation. In total, 4 biopsies were taken: 2 for histology and biomarker and 2 for PK.

Part II of this study consisted of a 21-day screening period, a baseline period (directly before commencing the treatment period) and a treatment period of 6 or 9 weeks, depending on randomization. A clinical assessment was performed on site on the last treatment day and if a full clinical response had been observed, approximately 3 weeks after the last treatment an excision of the BCC(s) would have been performed. The study completion visit occurred either 1 week after the excision (when this visit was planned) or 1 week after the last treatment. For a subset of patients, skin biopsies were collected on the last treatment day and an excision of a BCC was also performed at that same visit.


Eligibility Criteria:
Inclusion Criteria:

- Patients with multiple basal cell carcinomas and Gorlin syndrome, or patients with multiple basal cell carcinomas and a mutation in the PTCH1 gene at chromosome 9q22.3

Exclusion Criteria:

* Previous treatment of the BCC's that are selected for treatment.
* Any systemic treatment which is known to affect BCCs esp. cytostatic treatments, retinoids and photodynamic treatments.

Other protocol defined Incl./Excl. criteria may apply.
Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder

This study evaluates whether whole blood transferred through the new POLFA needle assembly meets supernatant hemoglobin acceptability standards.

The POLFA needle is part of the set's PPD (personal protection device) sampling port assembly that facilitates safer blood transfer between the collection set (i.e., the diversion pouch) and a Vacutainer® for the purpose of viral testing or other testing of the whole blood. The POLFA needle assembly was developed as a means to reduce costs while maintaining functionality, quality and safety. Since the overall functionality of the POLFA needle was designed to be equal to the currently approved Kawasumi needle, a change to the overall device safety and use profile is neither anticipated nor intended.

This trial will serve to generate data sufficient to demonstrate that blood transferred through the POLFA needle results in plasma hemoglobin levels below 100mg/dL.

Eligibility Criteria:
Eligibility Criteria:

* Study donor must be ≥ 18 years of age.
* Study donor must weigh ≥ 110 pounds.
* Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral).
* Study donor's hemoglobin must be ≥12.5 g/dL.
* Study donor's hematocrit must be ≥ 38%.
* Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR).
* Study donor's most recent single RBC unit donation must have been ≥56 days prior to study donation.
* Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study donation.
* Study donor must have consented to study participation by reviewing and having expressed understanding the site-respective IRB-approved informed consent form prior to undergoing any study related procedures.
* Study donors must agree to report adverse events from the time of signing the informed consent to twenty-four hours following the end of their active study involvement.
* Study donors must not have experienced any of the following:

Physical trauma consistent with associated coagulopathy within the last 30 days, Surgery within the last 30 days, Known history of hypercoagulopathy (i.e., Factor V Leiden, Prothrombin G20210A, idiopathic venous thrombotic events, etc.).

* Female study donors must not be pregnant, expected to be pregnant or breastfeeding.

Exclusion Criteria - any individual not meeting the above criteria.
Why do People With Low Back Pain Fear and Avoid Lifting?

The investigators' main focus of this trial will be to investigate

* why people with low back pain perceive lifting (with a bent back) as harmful.
* whether general measures of pain-related fear are associated with task-specific measures of perceived harmfulness
* why people with low back pain avoid lifting (with a bent back) This will be investigated using self-report (i.e., questionnaires)


Eligibility Criteria:
Inclusion Criteria:

* low back pain \>3 months

Exclusion Criteria:

* healthy persons
* low back pain \<3 months
Evaluation of Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma

The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled trial comparing primary surgery versus primary chemotherapy followed by surgery in patients with a resectable signet ring cell gastric adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the stomach or the oesogastric junction of type III of Siewert classification,histologically proven with the presence of signet ring cells (according to WHO 2000 classification) or diffuse form (according to Lauren classification) on pre-therapeutic biopsies
* tumoural stage IB, II or III (according to UICC-AJCC 2009)
* patient judged resectable in a curative intent on inclusion
* absence of distant metastasis
* absence of peritoneal carcinomatosis during pre-treatment explorative laparoscopy
* WHO performance status 2 or less
* age over 18 or under 80 years
* weight loss at the time of inclusion \< 15%
* neutrophilic polynuclears more than 1500/mm3
* platelets more than 100000/mm3
* creatinine clearance more than 50 ml/min
* serum-albumin more than 30 gram/l
* bilirubin less than 1,5 normal
* prothrombin rate over 80%
* absence of prior treatment with chemotherapy or radiotherapy for gastric cancer
* absence of kniwn child B or C cirrhosis
* left ventricular ejection fraction more than 50% before epirubicin treatment
* extension check-up performed within 4 weeks of inclusion
* signed written informed consent given by the patient

Exclusion Criteria:

* no corresponding to the inclusion criteria
* another malignant tumour treated for curative purposes during the past 5 years excepted basocellular skin carcinoma or in situ uterine cervix cancer
* allergy to the active substance or one of the excipients in the study drugs
* pregnancy or breast-feeding
* any other concommitant treatment, immunotherapy or hormonal therapy
* history of abdominal or chest radiotherapy
* any evolving disorder which is not under control (liver failure, kidney failure, respiratory failure, evolving heart failure or myocardial necrosis during the past 6 months)
* patients who cannot be regularly monitored
Staff Absenteeism and Delivery of Healthcare Services During the COVID-19 Pandemic

Work attendance of more than 700 hospital workers was evaluated. The assessment of the number of medical services that were performed was based on monthly reports prepared for the national payer of health services.

A retrospective analysis of above-mentioned data, covering the period January-April 2019 and January-April 2020, was carried out. The evaluation of the staff's absence included all workers employed under an employment contract: 713 workers in 2019 and 747 workers in 2020. The variable number of employees was a result of the employment dynamics in the subsequent 2 years, due to variable quantity of healthcare services that were contracted with the national payer and changes in the form of employment of some hospital workers.Three types of analyses were carried out: global analysis, analysis taking into account division into specific professions and the analysis of absence in different hospital organizational units/areas. The absences due to medical reasons, holidays or childcare were analyzed together. The analysis of performing the contracted tasks was shown in relative values ( %). The analysis included the structure of contracted services dividing them into: Orthopedics (alloplasty and others), rehabilitation (person-day), rheumatology (drug trials and others). Considering the rehabilitation unit, it was subdivided into inpatient and outpatient wards due to temporary closure of the outpatient ward.

Eligibility Criteria:
Inclusion Criteria:

all workers employed under an employment contract Exclusion Criteria: not applicable
Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair. Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty

Cleft palate is one of the most common congenital abnormalities of the orofacial region throughout the world. This condition can cause facial deformity, feeding problems, frequent middle ear infections, dental defects, speech abnormalities and emotional problems . Early surgical repair of this congenital anomaly prevents the psychological and functional problems associated with the deformity . Patients may develop various complications after primary palatoplasty including palatal fistula and velopharyngeal insufficiency (VPI) which are relatively common .

The main goal of cleft palate repair is to achieve normal speech and adequate velopharyngeal function with minimal effect on facial growth. The primary objective in the surgical repair of a cleft palate is the development of normal speech. Speech quality remains the most important standard for assessing clinical outcomes and the success of surgical procedures. Many surgical techniques for palate correction have been described determining the most effective technique for the surgical repair of palatal clefts continues to cause controversy .

The incidence of VPI post cleft palate repair is 20-30% of patients . If there is significant velopharyngeal dysfunction during normal speech development, many children learn to compensate for the lack of intraoral pressure. They produce a hoarse voice because of vocal fold adduction and sudden release. Compared with the adductor vocal fold palsy .


Eligibility Criteria:
Inclusion Criteria:

* •children more than 3 years old

  * Type of cleft: isolated cleft palate

Exclusion Criteri

* Complicated cases by fistula or redo,
* Missed follow up; less than 6 months.
Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure drug, also called an anticonvulsant.

Cognitive symptoms are not currently well-managed in Veterans with schizophrenia, leading to substantially diminished quality of life. Improved treatment strategies clearly are needed. Recent studies suggest taht an overactive hippocampus is associated with cognitive deficits in the illness. Based on findings that the anti-epileptic drug levetiracetam (LEV) reduces hippocampal activity and improves cognition in other clinical populations while being safe and well-tolerated, this study will examine the effects of the drug on hippocampal activity and cognition in Veterans with schizophrenia. In this crossover design, participants will take LEV for 4 weeks and placebo pills for 4 weeks, but will not know the order in which they are taking them.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Good general health
* Normal vital signs (blood pressure, pulse, respiration)

Exclusion Criteria:

* Substance abuse
* Significant neurological disorders
* Significant head trauma/injury
* Pregnancy
* MRI-specific exclusion criteria, e.g.,:

  * claustrophobia
  * weight\>400 lbs
  * metal in the body