cyrilzakka/clinical-trials huggingface dataset:
Neurosurgical Neuronavigation Using Resting State MRI and Machine Learning

This study is investigating the use of a computer algorithm to analyze scans of the brain before surgery to predict how a person's tumor will respond to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Must have a radiological diagnosis of a lesion in the brain with characteristics consistent with glioblastoma multiforme.
* Must be planning to undergo a pre-operative MRI.
* Must be at least 18 years old.
* Must be able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Contraindication to MRI.
* Inability to have clinical follow-up (e.g., patient is out of town and will do follow-up elsewhere).
Deep Learning Signature for Predicting Aggressive Histological Pattern in Resected Non-small Cell Lung Cancer

The purpose of this study is to evaluate the performance of a PET/ CT-based deep learning signature for predicting aggressive histological pattern in resected non-small cell lung cancer based on a multicenter prospective cohort.


Eligibility Criteria:
Inclusion Criteria:

(1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) Pathological confirmation of primary NSCLC; (3) Age ranging from 20-75 years; (4) Obtained written informed consent.

Exclusion Criteria:

(1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Participants who have received neoadjuvant therapy.
Stroke Therapy, Education, Prevention: Telemedicine Outpatient Initiative Trial

This study aims to determine whether patients who have had a stroke caused by a blockage of blood flow to the brain can have medical follow up after they leave the hospital in their home using a camera connected to a computer, also called telemedicine. Patients who have follow-up with telemedicine will be compared with patients following up in the usual way, by coming to clinic, and will have the same expectations for medical care and lifestyle changes like quitting smoking, exercising, and controlling their cholesterol. The study will try to show those stroke patients who live 75 miles or more from Oregon Health \& Science University (OHSU) and use a computer for follow up: 1) Will be able to complete the recommended visits using telemedicine in the home as well as those who come to clinic; 2) Will have blood pressures controlled at one year's time as well as those who follow up in the usual way by coming into clinic; 3) The patients followed with telemedicine will be as satisfied with the type of follow up they had as those followed in the usual way in the clinic. In the future, more patients who live at a distance from a major hospital might be able to get quality stroke care follow up using telemedicine if the study finds that telemedicine does meet these goals.


Eligibility Criteria:
Inclusion Criteria:

1. Age 21 and over.
2. Diagnosis of ischemic stroke or transient ischemic attack (TIA).
3. mRS≤3 or discharged home or inpatient rehabilitation with the intention to return home with reliable caregiver, regardless of mRS score.
4. Patient is willing and able to comply with all follow up visits for the protocol.
5. Patient available by phone.
6. Patient or caregiver must be able to operate an automated blood pressure cuff.
7. Patients living beyond a 75 mile radius must have private access to a computer to facilitate in-home telemedicine follow up visits.

Exclusion Criteria:

1. History of uncontrolled severe hypertension or refractory to medical management.
2. Severe liver impairment (AST or ALT \> 3x normal).
Dissemination of Prostate Cancer Screening to PCP's in African American Communities

The aims of this project are to adapt and extend the use of academic detailing to the dissemination of prostate cancer (CaP) screening findings to primary care physicians practicing in African American communities. The objectives of this study are:

1. To test the hypothesis that a community physician-based educational intervention (multi-component academic detailing, including an interactive, digitized, web-based program for informed decision-making about prostate cancer, and patient education materials designed for low literacy patients) will increase physician knowledge, positive attitudes/beliefs toward screening and screening options, and prostate cancer screening (using the digital rectal exam, and the serum prostate specific antigen test) at baseline, 6-, and 12-months post- randomization, compared to the rate observed in a service- as-usual control.

1A. To demonstrate the feasibility of disseminating the American Cancer Society guidelines for prostate cancer screening among primary care practitioners using multi-component academic detailing.

2. To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of PC screening guidelines to different physician subgroups.

The long term goal of this project is to increase prostate cancer screening among African American communities, thus decreasing cancer-related morbidity and mortality.

We will conduct a two-arm trial, recruiting, obtaining consent, then assigning 200 physicians' offices at random to one of two arms: intervention (multi-component academic detailing including an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients) or to a service-as-usual control arm. We will query 200 physicians about their PC knowledge, attitudes/beliefs toward screening and screening options, and PSA testing at baseline, 6, and 12months post-randomization, compared to the rate observed in a service-as-usual control. Physician counseling in cancer control will be verified by a chart review at baseline and at 12months post-randomization (N=750). The instruments will assess prostate cancer knowledge, attitudes and beliefs toward screening, and uptake of the PSA. The nested design uses the physician's office as the unit of randomization, and the office as the unit of analysis.

Eligibility Criteria:
Inclusion Criteria:

* Charts of male patients age 45 -75, (using the average age of death in this population) with at least one visit to the primary care provider over the last two years will be reviewed.

Exclusion Criteria:

Exclusion criteria will include:

* Diagnosis of cancer other than non-melanotic skin cancer.
Lifestyle, Eating, and Activity Patterns

The purpose of this research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention.

Previous observational and experimental research suggests that increased eating frequency is related to lower weight, body mass index (BMI)and body fatness. It is proposed that eating frequently during the day reduces overall energy consumed by preventing the development of excessive hunger. As elevated hunger increases the reinforcing value of food, and greater intake occurs when the reinforcing value of food increases, eating frequently during the day may be a dietary strategy that can aid with reducing energy intake and improving weight loss during a behavioral weight control program. Therefore, the purpose of this proposed research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention. Participants will be randomized to 1 of 2 conditions: 1) a condition in which participants will be given an eating frequency prescription to eat every 2 to 3 hours (Grazing); or 2) a condition in which participants will be given an eating frequency prescription of eating 3 meals per day (Three Meals). Both conditions will receive an identical dietary prescription, a low-calorie (1200 to 1500 kcals/d), low-fat (≤ 30% kcals from fat) diet and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week. Additionally, both conditions will receive an identical state-of-the-art, 6-month, behavioral weight loss program.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) between 27 and 45 kg/m2

Exclusion Criteria:

* report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
* report being unable to walk 1/4 mile without stopping
* report major psychological disease or organic brain syndromes
* report a diagnosis of type I or type II diabetes
* are currently participating in a weight loss program, are taking weight loss medication, have had surgery for weight loss, or have lost \> 5% of their body weight in the past 6 months
* are currently participating in a program that manipulates their eating habits
* intent to move outside of the East Tennessee area within the time frame of the intervention
* are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the intervention
* are unwilling to attend group intervention meetings, assessments, or complete a food diary for the duration of the study
APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

The goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women. The main questions it aims to answer are:

Does this dose and timing of aspirin reduce the risk of pre-eclampsia compared to standard recommendations? Does this dose and timing of aspirin reduce the risk of pregnancy loss compared to standard recommendations? Participants will begin taking at no later than 6 weeks 6 days gestational age, either 162mg of aspirin through delivery or placebo until 12 weeks and then 81mg of aspirin through delivery.


Eligibility Criteria:
Inclusion Criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Ability to take oral medication and be willing to adhere to the prescribed aspirin regimen.
4. Patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of LMP or ART date).
5. Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including:

   1. preeclampsia in a previous pregnancy,
   2. gestational diabetes in a previous pregnancy,
   3. any documentation of fetal growth restriction or low birth weight in a prior pregnancy,
   4. preterm birth in a previous pregnancy,
   5. known multifetal gestation at enrollment,
   6. chronic hypertension,
   7. pregestational diabetes,
   8. kidney disease,
   9. systemic lupus erythematosus,
   10. nulliparity,
   11. pre-pregnancy body mass index \>30,
   12. family history of preeclampsia (i.e., mother or sister),
   13. Black persons (due to social, not biological reasons),
   14. Maternal age 35 years or older,
   15. lower income (will be determined by qualification of public health insurance),
   16. conceived with fertility treatment (including in vitro fertilization, ovulation induction, or intrauterine insemination),
   17. history of one or more prior pregnancy losses \<20 weeks gestation,
   18. history of stillbirth in a prior pregnancy,
   19. An interval of greater than 10 years since the last pregnancy.

Exclusion Criteria

1. Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID);
2. Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia;
3. Clinical indication for chronic use of NSAIDS during pregnancy;
4. Medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcer.
5. Patients with pelvic pain or bleeding who require urgent care (i.e., active vaginal bleeding greater than or equal to expected menses, open cervical os suggesting active miscarriage or severe pain requiring evaluation for ectopic pregnancy)
Esophageal Manometry in Mechanically Ventilated Patients

Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.

In this study high resolution solid-state manometry technique was used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure.

Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.

In this study high resolution solid-state manometry technique was instead used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. The manometry catheter has 36 circumferential sensors at 1 cm intervals. Each sensor has 12 pressure-sensitive segments that add to the signal at that location. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure. Possible differences in tidal variations in esophageal pressure in different parts of the esophagus were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the critical care unit receiving mechanical ventilation or Patients anesthetized and undergoing surgery

Exclusion Criteria:

* Patients with a contraindication to insert a catheter in the esophagus for instance due to an operation.
LRRK2, GBA and Other Genetic Biomarkers in Eastern European (Ashkenazi) Jews With and Without Parkinson's Disease

Single site observational study focused on elucidating the genes and biochemical pathways involved in causing Parkinson disease.

This single site study, is enrolling Parkinson disease (PD) patients and their family members and is limited to participants of Ashkenazi (Eastern European) Jewish descent with GBA and LRRK2 mutations, or with 3 or more family members with PD. Follow-up will be for three years. Participants must be in the New York City area yearly and willing to come to Mount Sinai Downtown for yearly 2 hour study visits which include obtaining personal medical and family history information, blood, urine and spinal fluid samples, neurological exam and neuropsychiatric testing. De-identified data and samples will be securely stored at a central NIH-run repository for access by other researchers. Spinal fluid collection is encouraged but optional.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease patients and their family members and is limited to participants of Ashkenazi (Eastern European) Jewish descent with GBA and LRRK2 mutations, or with 3 or more family members with PD
* Participants must be local to the New York City area and willing to come to Mount Sinai Downtown for annual 2 hour study visits which include obtaining personal medical and family history information, blood, urine and spinal fluid samples, neurological exam and neuropsychiatric testing. Spinal fluid collection is encouraged but optional.

Exclusion Criteria:

-Patients who do not have Parkinson disease or family members of Ashkenazi (Eastern European) Jewish descent who either has a GBA or LRRK2 mutations OR who has 3 or more family members with PD.
Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy

Subtenonal anesthesia is a well-known technique of local anesthesia for patients undergoing pars plana vitrectomies. It was described to be efficient with respect to anesthesia of the eye and it showed less risks compared to retrobulbar or parabulbar anesthesia. Purpose of the study is to assess subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia.

Subtenonal anesthesia is a well-known technique of local anesthesia for patients undergoing pars plana vitrectomies. It was described to be efficient with respect to anesthesia of the eye and it showed less risks compared to retrobulbar or parabulbar anesthesia. Subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia, are probably different among patients with excessive indentation of the bulbus for retinal detachment repair, compared to patients undergoing vitrectomy with membrane peeling for epiretinal membranes or full thickness macular holes. Purpose of the study is to assess subjective pain scores of patients, that underwent vitrectomy with subtenonal anesthesia.

Eligibility Criteria:
Inclusion criteria

* Vitrectomy with subtenonal anesthesia in the time-period from 1.12.2022 to 31.8.2023
* Indication for surgery: retinal detachment, epiretinal membrane, or full thickness macular hole
* Questionnaire for subtenonal anesthesia was already answered by the patients
* Age 18 and older

Exclusion criteria

Any of the following will exclude a subject from the study:

* Surgery in general anesthesia
* Questionnaire missing or incomplete
A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)

This is a prospective pilot study to evaluate the usability and applicability of a self monitoring test of visual function with the handheld Health Management Tool (HMT) to remotely monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential change in disease status.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CNV secondary to AMD and not other causes in at least one eye identified by the investigator to be eligible for ranibizumab treatment
* Patients with a BCVA letter score in the study eye is 24 or better using an ETDRS chart measured at 4 meters distance

Exclusion Criteria:

* Patients with any concurrent ocular condition that may result in visual loss during the study
* Patients with past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
* Other protocol-defined inclusion/exclusion criteria may apply
Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption

To determine the effects of high cheese diets varying in carbohydrate content on markers of disease risk.

Summary of Proposed Research:

This project will involve four controlled 4 wk feeding periods in individuals with metabolic syndrome (currently 1/3 of US adults). After a 2 wk run-in period, 20 subjects will be fed one of three diets in a randomized and balanced order: a typical American High-Carb diet high in cheese (6 oz/day), a High-Carb diet low in cheese (0 oz/day), or a Moderate-Carb, high-cheese diet (6 oz/day), Low-Carb, high cheese where cheese displaces an isocaloric amount of carbohydrate. There will be a 2 wk washout period separating trials during which subjects consume their normal diet. Specific menus will be designed for each feeding phase and all food will be prepared for subjects. Testing will occur at baseline and after each feeding period. Measures of cholesterol beyond standard LDL- and HDL-cholesterol will be done by examining lipoprotein particle size, apolipoproteins, and fatty acid composition \[i.e., accumulation of saturated fat in blood and tissues, palmitoleic acid (highly linked to cardiovascular disease), and detection of phytanic acid (a uniquely bioactive fatty acid in dairy fat)\]. Changes in whole body and regional fat, including measures of visceral fat and liver fat, will be examined non-invasively by dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference (≥101.6 cm men, ≥88.9 cm women)
* Blood pressure (≥130/85 mm Hg) or current use of antihypertensive medication
* Fasting plasma glucose (≥100 mg/dL)
* Triglycerides (≥150 mg/dL)
* HDL-C (\<40 mg/dL men, \<50 mg/dL women)

Exclusion Criteria:

* Hypercholesterolemia
* Diabetes
* Liver, kidney or other metabolic or endocrine dysfunction, gastrointestinal disorders
* Regular smokers
* Lactose-intolerant
* Consume excessive amounts of alcohol (\>3 drinks/d)
* Have used cholesterol, diabetic, antibiotic or antifungal medications in the past 3 months
* Women who are pregnant or lactating
* Participants taking any probiotics or supplements known to affect serum lipid levels, inflammation, antioxidant status or the gut microbiota will be asked to discontinue use to allow for washout of any metabolic effects.
Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years

The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine antibiotic susceptibility.


Eligibility Criteria:
Inclusion Criteria:

* age less than 5 years

Exclusion Criteria:

* none
GutMe!: IBS and Collagen Protein Powder an Interventional Study

In this study we would like to understand how or if a food-based supplement affects gut symptoms such as bloating, stomach cramps and irregular bowel habits. Through using a digital symptom tracking app for a few weeks, you may just learn more about exactly what is triggering your symptoms!


Eligibility Criteria:
Inclusion Criteria:

* US based
* self report bloating

Exclusion Criteria:

* vegan or vegetarian diet
* suffering from any skin disorders
* kidney disease
* treated medical issues
* glutamine sensitivity
Assessment of Cyclofusion Capabilities of Normal Subjects and Patients With 3D Dynamic Random-dot Stereograms

With this study the investigator wants measure the individual cyclofusion competence from healthy subjects and patients suffering from Strabismus with a only binocularly visible threedimensional Landolt-C stimulus. For this the participant has to look at a 3-D monitor with shutter glasses. The participant is sitting in 2 meter distance in front of the monitor. On the monitor appears the Landolt-C stimulus as a dynamic Random-Dot Stimulus. As long as the participant can fuse the stimulus he will be able to see the Landolt C-ring threedimensional. The participant is then ask to tell in which direction the notch of the Landolt-C ring points out. Once a critical degree of cyclotorsion is reached the participant will no longer be able to see the Landolt C ring and the individual cyclofusion competence is reached.


Eligibility Criteria:
Inclusion Criteria:

* Visual acuity \>0,4; Stereopsis

Exclusion Criteria:

* Visual acuity \<0,4; no Stereopsis