cyrilzakka/clinical-trials huggingface dataset:
ALK Digital Pathology Outcome Predition, Multi Institutional, Restrospective Study

The Goal of this observational study is to develop an AI-driven pathologic image analysis-based classifier that can identify patients unlikely to significantly benefit from the currently utilized first-line ALK inhibitors (advanced-generation ALK inhibitors). Our goal is a classifier with final ROC-AUC value of 0.75.

This is a retrospective study. All data have been collected at different time points during the patients' routine visits at the hospital.

1. Collection of a retrospective set of ALK positive patients with advanced NSCLC that have received an advanced-generation ALK inhibitor treatment as the first ALK inhibitor (i.e. alectinib, lorlatinib, brigatinib or ceritinib): collection of the clinical data, pathologic data, response to treatment and scans H\&E images
2. Image analysis of the scanned H\&E images, development of a classifier of the data to identify responders vs. non-responders.

Image analysis and AI development will be carried out at the Sheba Medical Center, in-house development. The clinical data will be analyzed, tagging study samples as belonging to a responder (R), vs. a non-responder (NR). For the purpose of this study, a NR will be defined as a patient that has progressed or died on an ALK inhibitor treatment within the first year of treatment.

The study cases will be randomly split to three: a training cohort, a validation cohort and a test cohort. The cohorts will be stratified by the response to treatment (i.e. equal proportion of R vs. NR cases in each cohort). Next, scanned images will be processed and analyzed. Slides analysis would be done using python using the pytorch packages. Further statistical analysis will be done with R statistical programming.

At first the whole slide image (WSI) is divided into thousands of tiles. These are examined by a convolutional neural network (CNN) to extract tile level features. We will be using Resnet, a common deep learning model used for computer vision as the CNN. The CNN will be trained with multiple instance learning (MIL) at the tile level and later the predicted scores will be aggregated for the WSI level . The final model will be conducted on the slides, to distinguish between R vs. NR. The classifier will be developed on the training cohort, modified if required following processing of the validation cohort and finally tested for efficacy on the test cohort. Cross-Validations techniques will also be used.

We aim to use this technique in order identify a sub-group of ALK positive patients that might be candidates for more aggressive treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years;
* Patient with an oncologic disease;
* ALK positive patients with advanced NSCLC that have received an advanced-generation ALK inhibitor treatment as the first ALK inhibitor (i.e. alectinib, lorlatinib, brigatinib or ceritinib)

Exclusion Criteria:

* Absence of information on the last oncologic treatment received;
* Patient without a general or specific consent for this study
Artificially Sweetened Beverage Feeding Study

The aims of the study are to conduct a pre- and post- two week feeding study of artificial sweetened beverage consumption in middle-aged women. The study will also compare metabolic profiles before and after artificially sweetened beverage consumption.

The aims of the study are to:

1. To conduct a pre- and post- two week feeding study of Artificially Sweetened Beverage (ASB) in women.
2. To assess the general levels of ASB consumption.
3. To compare metabolic profiles before and after beverage consumption

Eligibility Criteria:
Inclusion Criteria:

• Healthy women

Exclusion Criteria:

• Having a history of diabetes or cardiovascular disease and any other health or chronic condition that precludes participation in the study.
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block

Breast cancer is the most common malignancy in women. Modified radical mastectomy, a surgical procedure in the treatment of breast cancer, is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and inadequately treated acute pain can trigger chronic pain syndrome. Therefore, thoracic paravertebral block and thoracic epidural block are effective in postoperative analgesia. However, the use of these blocks is limited due to complications. In recent years, less invasive blocks, such as pectoral nerve block (PECS I-II), Serratus anterior plane block (SAPB), Erector spinae plane block (ESPB), and Serratus Posterior Superior intercostal Plane Block (SPSİPB) have been applied. In this study, it was aimed to compare the analgesic effectiveness of ESPB and SPSİPB applications in patients undergoing breast surgery.

Postoperative pain will be assessed during resting and coughing with a visual analog scale (0-10 cm) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 4, 8, 12, and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Those aged 18-65
* Those with ASA scores I-II-III
* Those with a body mass index (BMI) between 18-35
* Patients who will undergo breast surgery

Exclusion Criteria:

* Those under the age of 18 and over the age of 65
* Those with ASA score IV and above
* Those with a history of allergy to the drugs to be blocked
* Those with a history of bleeding diathesis
* Patients with infection in the area to be blocked
* Those with a BMI below 18 and above 35
* Patients who underwent surgery under emergency conditions
Definition, Quantification, and Utility of Biomarkers of Repetitive Brain Injury in Predicting Concussion and Other Long-Term Injury Risks in Patients With Atrial Fibrillation (Concussion AF)

This is a prospective clinical study designed to evaluate biomarkers of brain injury and dementia incidence and moderate cognitive decline rates in moderate- to high-risk atrial fibrillation patients that undergo standard of care atrial fibrillation management.

A written informed consent will be obtained from atrial fibrillation patients seen at Intermountain Medical Center who meet the study eligibility criteria. Following the baseline visit for obtaining informed consent and conduct of baseline procedures, subjects will be required to return to clinic at 6, 12, 18 and 24 months after enrollment. Cognitive testing will be performed at baseline and repeated at 24 months. As much as possible, the study follow-up visits will be scheduled at the same time as the patients' regular visits for clinical care.

Six questionnaires will be administered at the baseline visit and repeated at the 24-month visit. At the time of cognitive assessment, the following will be completed, if not already performed as part of usual standard of care: complete blood count, protime/INR, basic metabolic profile, review of cardiac medications, and review of adverse events and hospitalizations. Additional serum tests will be performed on all subjects at enrollment and at the 24-month visit. Biomarkers will be drawn at specific intervals (baseline, 6, 12, 18, and 24 months) then on an as needed basis (within 7 days) when treatments for atrial fibrillation that may increase brain injury risk occur.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 65 to ≤ 95 years of age
2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
3. AF documented by electrocardiogram, ambulatory event monitor, telemetry, or medical records within 12 months of enrollment
4. Ability to complete a mini-mental status evaluation
5. Ability to independently comprehend and complete a quality of life and dementia questionnaires
6. Willing and able to comply with the follow-up visits, tests, and schedule of evaluations

Exclusion Criteria:

1. Have a history of any form of dementia
2. Have a life expectancy less than 24 months
3. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
4. Other conditions that in the opinion of the Principal Investigator and/or Sub-Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial
5. The Principal Investigator and/or Sub-Investigator(s) determine(s) that the subject is not eligible for participation in this research study
ROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week

To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of post-menopausal osteoporosis. Open, non-controlled, multi-center study.


Eligibility Criteria:
Inclusion criteria :

* Postmenopausal ambulatory women
* Established osteoporosis

Exclusion criteria:

* History of cancer: basal cell or squamous cell carcinoma-documented 6-month remission,
* Diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Stellate Ganglion Block Can Cause Enhanced Recovery After Coronary Arteries Bypass Grafting Surgery

The effects of SGB on the cardiovascular system remain controversial since the cardiac sympathetic nerves pass through the stellate ganglion. SGB is expected to have an ameliorative effect on impaired coronary circulation and cardiac function and thus to be well suited to the treatment of angina pectoris and myocardial infarction

investigators chose left SGB being safer with regards conductivity changes when compared to right SGB, in the present study investigators are trying to examine and compare whether coronary reperfusion in patients undergoing coronary artery bypass grafting who were subject to ultrasound guided left Stellate ganglion block (SGB ) performed in the induction of anesthesia could decrease post cardiopulmonary bypass ischemic changes, pulmonary hypertension and right ventricular dysfunction leading to enhanced recovery.

Place of work: Ain shams university hospitals cardiovascular surgery academy, Cairo, Egypt.

Number and selection of participants:

40 participants, 20 in each group (2 groups).

Eligibility Criteria:
Inclusion Criteria:

Ischemic heart disease patients age above 18 years

Exclusion Criteria:

allergy to LA, severe COPD
To Determine the Food Effect and Bioavailability of Three Formulations of Veliparib in Subjects With Solid Tumors

Compare the bioavailability of three veliparib formulations in subjects with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy.
2. In the opinion of the Investigator, life expectancy is 12 weeks or greater.
3. Subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (CNS) disease progression as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI) within 21 days prior to the first dose of study drug.
4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
5. Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.

Exclusion Criteria:

1. The subject is unable to swallow capsules or has nausea or vomiting.
2. Female subject is pregnant or breast-feeding.
3. Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome).
4. History of gastric surgery, vagotomy, bowel resection (except for left hemicolectomy) or any surgical procedure that might interfere with gastrointestinal motility, potentiometric hydrogen ion concentration (pH) or absorption.
5. Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

   * Known seizure disorder that is uncontrolled over the past month
   * Active uncontrolled infection
   * Unstable angina pectoris or cardiac arrhythmia
   * Psychiatric illness/social situation that would limit compliance with study requirements
Influence of "Espresso" on Adsorption of Myo-inositol

Neural Tube Defects (NTDs) are multifactorial (genetic/environmental) diseases that arise from failure of embryonic neural tube closure. Several studies have demonstrated that periconceptional administration of folic acid can prevent approximately 70% of all NTDs cases. The finding of several NTDs cases in a single family, despite prophylactic therapy with folic acid, suggested that a proportion of human NTDs are folate-resistant. So far, no preventive therapy for folate-resistant NTDs is available. Studies performed on folate-resistant NTDs animal models have shown that inositol is effective in preventing NTDs occurrence. Preliminary results in patients with at least two previous pregnancies affected by NTDs, despite folic acid supplementation, indicate that periconceptional treatment with 500 mg/day of inositol (three months before conception and two months after) is able to prevent NTDs recurrence in humans.

Recently, caffeine intake (more than 10 mg/day) has been associated with an increased risk of NTDs, especially for subgroups of people that carry genetic variants for enzymes involved in caffeine metabolism.

The teratogenic effects of caffeine are known since the 70s. Indeed, gynecologists suggest to pregnant women to avoid/reduce caffeine intake. It is still unknown, however, whether pre-conception caffeine intake interferes with prophylactic therapy for NTDs.

In the proposed study, we aim to evaluate the effect of "espresso" consumption (corresponding to about 100 mg caffeine) on the pharmacokinetics of oral administered myo-inositol (MI), in order to highlight any possible negative effects of caffeine on MI adsorption and excretion before conception.

The study will consist of two phases and will be carried on twelve healthy volunteers. During phase 1, volunteers will be kept for 15 days under inositol-poor diet; at the end of this period, 20 g of MI will be administrated in a single dose. Basal levels of serum and urinary concentration will be evaluated before MI administration (t0); subsequently, sampling will be performed 2, 4, 6 and 8 hours after MI administration. Phase 2 will consist of 15 additional days of inositol-poor diet: basal levels of MI will be again measured before MI administration. In phase 2, MI administration will be concomitant to caffeine exposure through single"espresso" consumption. Samples will be collected at the same time points as in phase 1.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18 to 24

Exclusion Criteria:

* on going pregnancies
* pharmacological treatment in the last 2 weeks
* chronic diseases
* Diabetes
Impact of Draining Significant Effusion on Gas Exchange and Lung Mechanics in Patient Under Mechanical Ventilation

Patients with acute respiratory failure (ARF) who were receiving mechanical ventilator support, had significant pleural effusion (both transudates and exudates) and drainage plan were evaluated. Decision to drain, timing and duration of drainage were made by primary physician according to the intensive care unit (ICU) protocols.The estimated amount of effusion (mL) was calculated as the maximum pleura-lung distance (mm) x 20 and significant effusion is accepted as ≥ 800 mL according to thoracic ultrasonography (USG) performed by the intensivist. The amount of effusion drained, mechanical ventilator parameters, arterial blood gas results and hemodynamic data were recorded before, at the 1st hour and at the end of drainage up to 30 days after drainage.


Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation due to acute respiratory failure
* Estimated effusion \> 800 ml according to USG
* Have drainage plan according to ICU protocols decided by primary physician

Exclusion Criteria:

* Have absolute drainage indication (empyema, hemothorax or chylothorax)
* predicted duration of mechanical ventilation less than 72 hours
* contraindications to drainage,
* underlying disease, which prevents lung expansion (chest deformity, central atelectasis)
* malignant effusions
Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease

The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately to severe inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Crohn's disease or ulcerative colitis

Exclusion Criteria:

* Tuberculosis infection
* Allergy to CT-P13
Workstation Pilot Study

This is a pilot study to assess the feasibility of using treadmill desks (Workstations) within a Louisiana office workplace and to determine the effects of walking while working in overweight or obese, sedentary individuals.

Eligible participants will be randomized by chance to the WorkStation Intervention Group or to a Usual Working Condition Group.

The WorkStation Intervention Group will be asked to walk for up to 1.5 hours per day during the work week of Monday through Friday on the treadmill. Participants will complete two sessions per day for up to 45 minutes per session, tracking time and speed.

Usual Working Condition Group will be asked to continue working in usual environment and accustomed manner.

Regardless of which group the participants are assigned to, the participants will be asked to complete baseline and follow up assessment visits. Months 3 and 6 for approximately 1 hour for Body measurements (height, weight and waist circumference), body fat percent, gait speed, questionnaires, and accelerometry.

Eligibility Criteria:
Inclusion Criteria:

* Males or females
* BMI ≥ 25 kg/m2
* Willing to give informed consent
* Willing to accept randomization to group assignment and willing to follow the protocol for the group to which they have been assigned
* Willing to maintain fulltime employment at the company for the next 6 months
* Willing to receive frequent contacts and communication from study staff over the next 6 months

Exclusion Criteria:

* Current participation in other Pennington Biomedical research studies
* BMI \< 25 kg/m2
* Type 1 diabetes
* Average step count of ≥ 7,500 steps/day
* Self-reporting exercising \> 20 minutes on 3 or more days/wk, within the past 6 months
* Unable to walk 45 minutes continuously without taking a rest
* Unable to walk without the use of an assistive device, such as a cane or walker
* Have had a cardiovascular event (stroke or heart attack) in the past 6 months
* Have a pacemaker or any other internal electrical medical device
* Have been diagnosed with Schizophrenia or bipolar disorder
* Have any condition that would limit participation in a physical activity program
* Women who are pregnant, have been pregnant in the last 6 months, or are breastfeeding
* Actively participating in a weight loss program
* Plan to move out of the study area within the next 6 months or plan to be away from work for more than 4 weeks in the next 6 months
* Have another member of household participating in the study
* Have any condition, which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study
Evaluation of the Effectiveness of Infrared LED Photobiomodulation in Children With Sleep Bruxism

Sleep bruxism is a masticatory muscle activity characterized as rhythmic (phasic) or non-rhythmic (tonic). The literature reports the prevalence rates, diverse etiologies and different types of treatment. In children and adolescents, etiological factors, such as breathing pattern and sleep quality, have recently been addressed in studies investigating sleep bruxism. While studies have also reported psychological factors as a causal factor, this aspect requires further research. There are also divergences in opinion regarding the form of treatment. New therapies for adults, such as botulinum toxin, have been investigated, but such techniques are not applicable for individuals in the growth and development phase. Thus, photobiomodulation therapy has piqued the interest of researchers, as this noninvasive method has demonstrated positive results in problems related to muscle tissues. This document describes the protocol for a proposed study to evaluate morphological and psychosocial aspects in children and adolescents with awake bruxism and their responses to photobiomodulation therapy with infrared LED.


Eligibility Criteria:
Inclusion Criteria:

* mixed dentition phase (permanent incisors and molars erupted)
* established permanent dentition.

Exclusion Criteria:

* dental caries
* using medications, such as anti-inflammatory agents, muscle relaxants, corticoids, anticonvulsants and antidepressants
* those with chronic diseases that affect muscles or motor coordination
* those who do not cooperate during the evaluation
Open Label Study of Long Term Safety Evaluation of Alirocumab

Primary Objective:

To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).

Secondary Objectives:

* To evaluate the long-term efficacy of alirocumab on lipid parameters.
* To evaluate the long-term immunogenicity of alirocumab.

The maximum study duration will be 176 weeks per participant.

Eligibility Criteria:
Inclusion criteria:

Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).

Exclusion criteria:

Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe

Magnetic resonance (MR) spectroscopic techniques are to be developed to obtain the best data possible at 3 Tesla (3T) for the prostate.


Eligibility Criteria:
Inclusion Criteria:

* Subject 18 years of age and over