cyrilzakka/clinical-trials huggingface dataset:
Digital Therapeutic for Depression After Head Injury in Current and Former US Military Personnel

The Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx.

This trial is a single-blind, randomized, controlled interventional trial of current and former military personnel with symptoms of depression and a history of mTBI. The study will be conducted remotely.

Eligibility Criteria:
Inclusion Criteria:

* Be aged ≥ 18 to ≤ 65 years
* Be able to provide informed consent
* Diagnosed with mild TBI as defined by the Department of Veteran's Affairs and Department of Defense Clinical Practice
* Have a PHQ-9 score of ≥ 5 to 27, indicative of mild or greater depressive symptoms
* Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
* While participating in this study, be able to ensure that you have access to regular care for mental health and to speak with your provider as necessary

Exclusion Criteria:

* Report of starting pharmacological or non-pharmacological treatment for depression within the 3 months prior to trial enrollment
* Report a recent change in type or dose of antidepressant medications within 12 weeks prior to trial enrollment
* Report active psychotic or bipolar symptoms
* Active plan and/or intent of suicide or homicide
* In the opinion of the investigator, they have other considerations that may adversely affect patient safety, participation, or scientific validity of the data being collected
TopQ Cut-off Determination Study For 3D-OCT 1 Maestro and 3D OCT-2000

To determine optimal cut-off value for the TopQ cut-off on the Maestro and 3D OCT-2000.


Eligibility Criteria:
Inclusion Criteria:

* No known ocular pathologies

Exclusion Criteria:

* Any known ocular pathologies
The Aspirometer: A Noninvasive Tool for Detecting Aspiration Aim 3

This investigation evaluates the effectiveness of a device called the Aspirometer, which uses high resolution cervical auscultation (HRCA), in detecting when food or liquids enter the airway (aspiration) of the person swallowing, whether the person swallowing shows signs of aspiration (coughing) or not.

This aim of the project seeks to discriminate normal from abnormal airway protection and kinematic functions noninvasively via machine-learning analysis of Aspirometer/HRCA (high resolution cervical auscultation) signals, with similar accuracy as human judgment of VF. Hypothesis: Advanced data analytics can detect pathological airway protection in HRCA signal signatures with 90% accuracy when compared to a human expert's airway protection ratings from VF images. Analytical algorithms that can learn from data (e.g., Bayes' learning) will be used to infer about the continuum of abnormal airway protection during swallowing.

Eligibility Criteria:
Inclusion Criteria:

- referred by an attending physician as an inpatient, for a modified barium swallow examination due to suspected dysphagia and aspiration

Exclusion Criteria:

* tracheostomy
* pregnant
* unable to follow verbal commands
* anatomic disruption of head neck
* radiation therapy to head or neck
Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)

The present clinical trial will investigate the safety and efficacy of a sequential preoperative therapy with Epirubicin/Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2 overexpression primary breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Primary carcinoma of the breast, confirmed histologically by core biopsy (at least 3 core biopsy samples)
2. Tumor lesion of the breast with a palpable or a imagistic size ≥ 2 cm or inflammatory breast cancer
3. Known HER-2 status detected on core biopsy. HER-2 over expression is defined as DAKO HercepTest (3+) or DAKO HercepTest (2+) and FISH (+) (fluorescence-in-situ-hybridisation).
4. No distant metastatic disease, confirmed by chest x-ray, abdominal sonography and bone scan.
5. Female patients
6. Age ≥ 18 and ≤ 65 years
7. ECOG \< 2/WHO 0-1
8. Laboratory requirements GOT and Bilirubin \< 1.5x UNL Leukocytes \>= 3 G/l Neutrophile \> 1 G/l Thrombocytes \> 100 G/l Creatinine (Serum) \< 2.0 mg/dl.
9. Normal cardiac function, confirmed by cardiologist
10. No active hepatitis
11. Written informed consent for all study procedures
12. Patients must be available and compliant for treatment and follow-up

Exclusion Criteria:

1. Multicentricity in various quadrants (contact the study office)
2. CNS-metastases
3. Secondary malignancy, excluding basalioma of the skin or carcinoma in situ of the cervix that has received curative therapy
4. Patients with relevant hemodynamic cardial diseases
5. Patients with a left ventricular ejection fraction (LVEF) under the normal limit of the institution, confirmed by echocardiography or MUGA-Scan.
6. Uncontrolled, severe comorbidities
7. Patients with severe respiratory diseases and severe dyspnea and / or which need supportive oxygen
8. Previous anti-HER2-therapy
9. Patients receiving immunosuppressant therapy
10. Known allergy to medication containing cremophor
11. Hb \<10 g/dL, Neutrophile \<1.5 x109/L, Thrombocytes \<100 x109/L.
12. Total-Serum-Bilirubin \>1.5 x ULN (upper limit of normal) (except in patients with confirmed and documented Gilbert-Lereboullet-syndrome), ALT or AST \>2.5 x ULN (\>5 x ULN by liver metastases), Alkaline Phosphatase \>2.5 x ULN (\>4 x ULN by liver or bone metastases), Serumcreatinine \> 2 x ULN
13. Pregnancy, nursing (a negative pregnancy test must be documented, and safe anticontraceptive measures during pre- and postoperative treatment must be implemented)
14. Lack of signed informed consent after informing the patient
15. Lack of willingness to keep and disclose personal medical data as part of the study
Effect of a Vegan Diet Versus a Mediterranean Diet. Assessing Health Outcomes

This study aimed to evaluate the effect of a vegan diet (supplemented with vitamin B12) and an mediterranean diet on performance, cardiorespiratory fitness, metabolic health, immune status, and environmental impact in healthy adults.

OMNIVEG is a controlled crossover trial. Initially, registered dietitians conducted an assessment of participants' lifestyles in a preliminary session. Qualified nutritionists then developed personalized diets for each participant in accordance with the recommendations of the International Society of Sports Nutrition (ISSN). These diets followed specific guidelines, including a daily intake of 3-5 g of carbohydrates per kilogram of body weight, 1.4-2.0 g of protein per kilogram of body weight, and 0.5-1.5 g of fat per kilogram of body weight.

Both the mediterranean diet and vegan diets prescribed to the participants were isocaloric, with similar distributions of macronutrients. The primary difference between the two interventions was the source of food: the vegan diet exclusively comprised plant-based foods, while the omnivorous diet included foods of both animal and plant sources. In the case of the omnivorous diet, 60% of the total protein intake was derived from animal sources (mainly from fish, white meat, low-fat dairy and eggs).

As part of the vegan diet, participants were instructed to take 1000 µg of cyanocobalamin (a form of vitamin B12) twice a week from Harrison Sport Nutrition, Granada, Spain. This supplementation aimed to ensure adequate vitamin B12 intake, which is essential for individuals following a vegan diet.

Throughout the study period, participants were advised to maintain their initial physical exercise frequency and volume to maintain consistency and avoid confounding variables. To ensure standardized measurements, all tests were conducted in the same laboratory, employing identical testing devices, and supervised by the same group of researchers. This approach aimed to minimize experimental variability and improve the reliability of the study's results.

Eligibility Criteria:
Inclusion Criteria:

* Men.
* Aged between 18-40 years.
* Physically active according to the recommendations of the World Health Organization (WHO).
* Body Mass Index (BMI) between 18.5-24.9 kg/m2.
* No tobacco use.
* No or low alcohol consumption and no orthopedic limitations that would interfere with the performance of the study tests.

Exclusion Criteria:

* Chronic diseases that impair athletic performance (cardiovascular, metabolic, gastrointestinal, respiratory) within the last six months.
* Musculoskeletal disease within the last six months.
Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery

The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.

Colonic colonization by pathogenic Escherichia coli was determined when patients were operated on for colorectal cancer.

Several years later, the investigator investigate past and actual psychiatric disorder using the Mini International Neuropsychiatric Interview (MINI). Actual depression and anxiety scores are evaluated with Hamilton scales and personality traits are investigated using Personality Inventory for DSM-5 (PID-5).

Anxiety and depression scores, psychiatric diagnoses (MINI) and personality traits were compared in patients according to Escherichia coli presence/absence.

Eligibility Criteria:
Inclusion Criteria:

* patients operated on for colorectal cancer in the digestive surgery department of Clermont-Ferrand hospital
* patients older than 18 years,
* patients whose Escherichia coli colonization was analyzed after surgery
* patients which are always followed by the digestive surgery department.

Exclusion Criteria:

* Patients with dementia will not be included, according to the MMSE score:
* 22 if no grade
* 23 if study certificate or CAP or college without patent
* 25 if patent or school without the tray
* 26 or more when bin
Hydrogen Sulfide Detoxification and Butyrate Metabolism in Ulcerative Colitis

The purpose of this study is to evaluate the relation between sulphide detoxification and butyrate metabolism at the level of gene expression and enzyme activity in ulcerative colitis patients and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

- Ulcerative colitis patients: patients diagnosed with ulcerative colitis

Exclusion Criteria:

* Healthy controls: no diagnosis of inflammatory bowel diseases
* Intake of antibiotics in the last month before the study
Prostatic Artery Embolization for Benign Prostatic Hyperplasia

To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold standard surgical treatment- Transurethral Resection of Prostate (TURP).


Eligibility Criteria:
Inclusion Criteria:

1. Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS\>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living)
2. Urinary retention (related to BPH) leading to catheterization.
3. Refractory to medical treatment or patient is not willing to consider medical treatment
4. Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery.

Exclusion Criteria:

1. Mild symptoms (IPSS \<8)
2. Moderate to severe lower urinary tract symptoms (i.e. IPSS\>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living).
3. Suspected malignancy.
4. Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency.
5. Advanced atherosclerosis and unsuitable vascular access.
6. Allergy to intravenous contra
Scapular PNF and Activity Oriented Antiedema Proprioceptive Therapy on Shoulder Dysfunction Post Matectomy Lymphedema

Ninety -three female patients suffering from shoulder dysfunction after breast cancer-related arm lymphedema, will National Cancer Institute (Cairo university) be randomly distributed into three groups equal in number.

In this study the patients will be randomly assigned into three groups (Thirty - one patient for each group):

Group (A):

Thirty-one patients will receive: Scapular PNF technique, Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT).

Group (B):

Thirty-one patients will receive Scapular PNF technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT))

Group (C):

Thirty-one patients will receive Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) technique for the affected shoulder region plus conventional physiotherapy program in a form of (Complex decongestive therapy (CDT)

.

Eligibility Criteria:
Inclusion Criteria:

The subject selection will be according to the following criteria:

* Age range between 40-60 years.
* Only female patients will participate in the study.
* All female patients diagnosed as unilateral breast cancer.
* All Female patients operated on for BC with BCRL in stages I and II.
* All female patients suffering from shoulder dysfunction after breast cancer-related arm lymphedema.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

* Patients with health problems, diseases or dysfunctions that prevented them from participating in the intervention.
* Patients with bilateral lymphedema.
* Patients with previous primary lymphedema.
* Patients with metastasis.
* Patients whom staging was not possible due to atypical findings or poor image.
* Patients with active arm infection.
Comparative Pharmacokinetics (PK) Study of Efavirenz or Lopinavir/Ritonavir Between Older and Younger HIV-Infected Adults

HIV infected patients, aged \</= 35 years and aged \>/= 55 years, who are regularly taking either efavirenz (EFV) or lopinavir/ritonavir (Lop/r) as part of their antiretroviral regimen are being asked to spend 12 hours at the researchers' clinic (the ACS clinic at Jacobi Medical Center, Bronx, New York) for an intensive pharmacokinetic study in which 5 cc of blood will be drawn 9 times over a 12 hour period. Patients taking EFV will return for one additional blood draw the following day.

HIV infected patients, aged \</= 35 years and aged \>/= 55 years, who are regularly taking either efavirenz or lopinavir/ritonavir as part of their antiretroviral regimen are being asked to spend 12 hours at our clinic (the ACS clinic at Jacobi Medical Center, Bronx, NY) for an intensive pharmacokinetic study in which 5 cc of blood will be drawn 9 times over a 12 hour period. Patients taking EFV will return for one additional blood draw the following day.

Patients will be asked to come to the clinic at 7 am and bring their medication to the clinic. Blood will be drawn to obtain a trough level of either EFV or Lop/r after which the patient will be instructed to take their EFV or Lop/r. Then blood will be drawn 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours later. Patients on EFV will be asked to return the next morning for a 24 hour blood level.

The blood will be spun and the plasma frozen at - 70 C. The plasma samples, labelled with the patients' initials and the draw date, will be shipped to University of Alabama, Department of Pharmacology, where the drug levels will be measured.

Patients will be recruited from the ACS outpatient clinic. They will be identified by their providers.

Eligibility Criteria:
Inclusion Criteria:

* HIV+
* Taking lopinavir/ritonavir or efavirenz
* Age \</= 35 years or \>/= 55 years

Exclusion Criteria:

* Concurrent therapy with drugs that alter lopinavir/ritonavir levels.
* Other renal or kidney disease.
* Chronic hepatitis B or C
Cerebral Autoregulation Guiding Blood Pressure Management After Revascularization

This clinical trial aims to learn whether blood pressure (BP) guided by individualized cerebral autoregulation (CA) is safe and provides a better prognosis than a fixed target in patients with ischemic stroke after endovascular therapy. The BP of participants will be managed at least 48 hours after revascularization. Researchers will compare the CA-guided BP group with the fixed target BP group to mainly see if individualized BP could help more patients to have their neurological function improved at seven days.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke, undergone endovascular treatment within 24 hours of onset (time of stroke is the last known normal for wake-up stroke or with unknown onset time), with reaching the goal of mTICI grade 2b-3
* No functional disability before stroke (mRS 0-1)
* Angiography (CTA, MRA or DSA) before endovascular therapy confirmed occlusion of the internal carotid artery and/or the middle cerebral artery M1 to M2 segment, with consistent clinical symptoms.
* Informed consent is given by the patient or the legal representative.

Exclusion Criteria:

* Hemorrhagic transformation with mass effect (PH-2 type parenchymal hematoma) occurs during the operation.
* Coma, dilated pupils on one or both sides, dull or absent light reflex is noticed before randomization
* Dissection of aorta, common carotid artery, internal carotid artery, subclavian artery, intracranial artery; severe bilateral subclavian artery stenosis; contraindications of radial artery puncture were found before or during surgery.
* Shock.
* Severe cardiomyopathy with heart failure (EGFR ≤ 30% or NYHA Grade IV), acute myocardial infarction, or unstable angina.
* Possible infective endocarditis, infective embolism, or vasculitis.
* Participating in other clinical research involving drug or device intervention after endovascular therapy.
* Women who plan or are pregnant, or breastfeeding.
* Severe liver or kidney disease, malignant tumor with a life expectancy is less than 3 months.
* The 90-day follow-up is not expected to be completed.
Endothelial Cell Loss and Induced Astigmatism After Wound-directed and Wound-assisted IOL Injection

The purpose of this study is to determine if there is any difference in astigmatism (eye surface curvature) or corneal endothelial cell density (the inner cell lining of the eye surface) after two different methods for inserting a lens during cataract surgery.

Cataract surgery (removal of a cloudy lens) is currently performed through increasingly smaller incisions. Bimanual surgery, where two instruments are used to remove the lens, is performed through two 1.4 mm incisions. Typically, one of these incisions is enlarged to 2.2 or 2.4 mm in order that the IOL (artificial lens) can be inserted into the eye. Surgeons insert these lenses by placing a lens injector cartridge completely into the eye (wound-directed insertion) or by placing only the tip inside the incision (wound-assisted insertion). While wound-assisted insertion can be performed through slightly smaller incisions (2.2 mm versus 2.4 mm for wound-directed insertion), both methods of insertion cause some incision enlargement. There is some evidence that wound-assisted insertion can cause very short-term pressure within the eye to go up. Neither method is considered inferior or superior to the other, and the primary investigator (Dr. Kenneth Cohen) routinely uses both methods.

No studies have directly compared wound-healing characteristics between these two methods. We seek to compare differences in:

1. Surgically-induced astigmatism (changes in the corneal curvature from cataract surgery incisions.
2. Endothelial cell density loss. Endothelial cells line the inside surface of the cornea, and their overall density can be decreased by cataract surgery.
3. Best-corrected vision after surgery
4. Sizes of the incisions after lens injection

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients include those who undergo uncomplicated cataract extraction surgery and IOL implantation by KLC.

Exclusion Criteria: Patients who:

1. suffer from diabetes and have more than mild background diabetic retinopathy,
2. have a history of intraocular surgery,
3. have a history of ocular trauma,
4. have known pathology of the cornea,
5. have a history of intraocular inflammation,
6. are unable to understand English,
7. are decisionally impaired,
8. are currently incarcerated, or
9. are less than 18 years of age.

No exclusions will be made on the basis of gender, ethnicity, or race.
The Effect of Hinge Location on Corneal Sensation and Dry Eye After LASIK: A Systematic Review and Meta-analysis

The purpose of this study is to investigate the possible effect of hinge location on corneal sensation and dry eye syndrome after laser in situ keratomileusis (LASIK).

Dry eye symptoms are a frequent postoperative complication of laser in situ keratomileusis (LASIK). Although estimates of the incidence of dry eye syndrome vary widely, from 3% to 59%, almost all patients will have transient dry eye during the immediate postoperative period.Because of the variability in corneal innervation patterns, altering flap characteristics in LASIK may affect postoperative corneal sensation and dry-eye disease. Some studies have reported that postoperative corneal sensation may be higher and recovery faster in eyes with horizontal flaps (nasal- or temporal-hinge) than in eyes with vertical flaps (superior- hinge). However, some other studies have not established an association between corneal sensation and hinge position. This study reviewed the published literature and performed a meta-analysis aimed to investigate the effects of hinge location on corneal sensation and dry-eye symptoms after LASIK.

Eligibility Criteria:
Inclusion Criteria:

1. each trial should be a prospective randomized controlled clinical trial (RCT),
2. the age of patient population should be over 18 years

Exclusion Criteria:

1. non-randomized controlled trials
2. patients who had had a previous ophthalmic surgery or ocular surface disorders
3. the raw data was not completed