cyrilzakka/clinical-trials huggingface dataset:
EyeBOX Concussion Study and Registry

The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.


Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent or assent along with guardian consent.
2. Have sustained a suspected direct or indirect force to the head with or without documented loss of consciousness, memory loss, alteration in consciousness or neurologic deficits. Only individuals presenting for initial evaluation of concussion may be enrolled, however longitudinal assessments may be conducted on enrolled subjects.
3. Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.

Exclusion Criteria:

1. Have penetrating trauma.
2. Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
3. Either of the following conditions, immediately related to the incident head trauma: loss of consciousness exceeding 30 minutes or best available GCS score less than 13 within 24 hours.
4. Be blind (no light perception), have missing or non-functional eyes.
5. Be unable to open their eyes.
6. Have a history of unresolved strabismus, diplopia, amblyopia.
7. Have a history of unresolved cranial nerve III, IV, or VI palsy.
8. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
9. Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
10. Have a prior history of unresolved ocular-motor dysfunctions.
11. Be intoxicated.
Imgatuzumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma

This study will evaluate the anti-tumor activity, safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of imgatuzumab, a monoclonal antibody against epidermal growth factor receptor (EGFR) with enhanced antibody-dependent cellular cytotoxicity (ADCC) in patients with advanced cutaneous squamous cell carcinoma (CSCC). Quality of life of patients treated with imgatuzumab will also be assessed.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed diagnosis of CSCC
* CSCC of advanced stage
* Males or females at least 18 years of age at the time of consent
* Signed informed consent provided prior to any study procedures
* Ability to and willing to understand informed consent and comply with protocol requirements and procedures
* No more than two prior lines of systemic treatment for advanced disease
* Patients must have at least one lesion that is considered as measurable according to the Study Response Criteria
* Eastern Cooperative Oncology Group performance status 0 or 1
* Adequate function of bone marrow, liver, kidneys
* Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at Screening

Key Exclusion Criteria:

* Prior systemic treatment for advanced disease with any anti-EGFR agent
* Active central nervous system metastasis
* Systemic anti-cancer therapy within five half-lives or two weeks, whichever is shorter, prior to first dose of the study drug
* Persistent toxicities from previous systemic anti-neoplastic treatments
* Wide-field radiotherapy within four weeks, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within two weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
* Major surgery within four weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
* Active infection requiring therapy
* Concomitant use of systemic steroids at dose of \>10 mg of prednisone or its equivalent per day
* Known or suspected allergy/hypersensitivity to the study drug or any component of the study drug, other monoclonal antibodies, premedication medicines
* Concurrent participation in another investigational therapeutic clinical trial
* Pregnant or breast-feeding females
* Mental or medical conditions that prevent the patient from giving informed consent or participating in the trial
* Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study

Note: Other protocol defined Inclusion/Exclusion criteria apply.
The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study

The aim this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk.

Undertake a retrospective observational cohort study of patients admitted to intensive care units between 2006 and 2023.

Study Participants: Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023.

Objectives:

To determine the short and long-term cardiovascular consequences of critical illness and identify in-ICU factors that affect them.

To identify the risk factors for new-onset atrial fibrillation/flutter occurring during critical illness.

To study the association between poor cardiovascular function during critical illness and long-term cardiovascular disease.

This study will provide new knowledge about the associations between baseline cardiovascular risk, the disease resulting in ICU admission and therapies / events on ICU with subsequent major adverse cardiac events (MACE), to allow the ongoing risk of these events to be determined. If clinicans can idetnify who is at risk, then risk factors can potentially be modified .

Eligibility Criteria:
Inclusion Criteria:

* Aged 16 years or above.
* Admitted to an intensive care unit at a study site from 2006 onwards

Exclusion Criteria:

* Patients that have informed their participating site that they do not wish their electronic records would be used for future research
* Patients who inform us directly that they don't wish their records used in this research study
Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea

Patients with Obstructive Sleep Apnea Syndrome (OSAS) will evidence higher levels of salivary cortisol and alpha-amylase levels prior to use of placebo and continuous positive airway pressure (CPAP) and will evidence a decrease in these levels after consistent use of continuous positive airway pressure (CPAP) therapy as compared to placebo. Their level of sleepiness will also decrease with the use of CPAP therapy and will correlate with the levels of salivary cortisol and alpha-amylase in relation to their subjective sleepiness scale, Psychomotor Vigilance Test (PVT), and pupillometry.

It has been shown that there is an inconsistent response in serum cortisol levels in patients with Obstructive Sleep Apnea Syndrome (OSAS), but it is undetermined whether a change in hormone level was not seen due to compliance issues in these long-term studies. These investigators will be employing compliance monitoring continuous positive airway pressure (CPAP) machines and also assessing "sleepiness" before and after therapy. Sleepiness is the dependent variable in our study and will be measured subjectively using sleepiness scales and objectively using Psychomotor Vigilance Test (PVT) and an autonomic measure using pupillometry prior, during and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Male and female
* Between ages 18 and 90
* Undergo a Polysomnography (PSG) with evidence of any sleep disordered breathing including snoring, mild/moderate/severe sleep apnea, and/or restless legs

Exclusion Criteria:

* Ages 17 and under
* Pregnant women
Imaging Biomarkers of FOG Response to DBS

For this study, we are recruiting 54 individuals with Parkinson's Disease and Freezing of Gait (FOG) who are planning to undergo Deep Brain Stimulation (DBS). The objective of this study is to better understand the FOG response to DBS. Prior to DBS study participants will undergo a MRI scan, behavioral assessment related to walking, a cognitive evaluation, and assessment of other Parkinson's disease symptoms. Following DBS participants will repeat these assessments at multiple timepoints over the period of one year. Overall, participants will complete a total of 7 visits over a period of approximately 1 year.

The long-term goal of this research is to develop an individualized approach for the treatment of Freezing of Gait (FOG) with Deep Brain Stimulation (DBS). In pursuit of this goal we have preliminary findings which show that: 1) effective subthalamic nucleus DBS (STN-DBS) activates the globus pallidus interna (GPi) and decreases cortical activation in Parkinson's Disease (PD), 2) structural connectivity to the GPi, supplemental motor area (SMA) and primary motor cortex (M1) is associated with DBS response in FOG, and 3) decreased microstructural integrity of the GPi is associated with decreased dopa-response in FOG. We propose a conceptual framework whereby engaging a specific FOG response network depends on the structural integrity of the network, as well as lead placement and stimulation parameters. We propose to recruit 54 PwF identified as appropriate STN-DBS candidates to undergo a prospective longitudinal imaging and behavioral study of FOG response to STN-DBS. Baseline behavioral assessments will characterize FOG behavior, severity, subtype, as well as the cognitive profile, non-FOG motor severity and other demographics of the enrolled patients that may contribute to DBS response. Baseline imaging will utilize advanced diffusion MRI metrics to determine which brain areas are structurally connected to the stimulation target and their structural integrity. Post-operative assessments will include behavioral measures of FOG response and imaging measures of neural response to stimulation. Pre- and post-operative data will be used to evaluate the association between structural integrity, connectivity and behavioral response.

Eligibility Criteria:
Inclusion Criteria:

1. \>40 years of age.
2. diagnosis of PD based on UK Brain Bank diagnostic criteria.
3. presence of FOG, defined as a score of 1 on part 1 of the nFOGQ and confirmed by objective evaluation (a score of 1 represents a positive response of having experienced such an episode over the last month).
4. clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery.

Exclusion Criteria:

1. a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities).
2. inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices.
3. contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants.
4. implantation of non-3 T MRI-compatible DBS devices.
ASAN Medical Center Aortic Valve Replacement Registry

This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.

All TAVR and SAVR cases will be enrolled retrospectively and prospectively.

This registry includes sub group analysis named STRATEGY AS(Role of Sarcopenia and frailTy in pRedicting outcomes After TranscathEter or surGical aortic valve replacement in elderlY patients with Aortic Stenosis: A prospective cohort study). For this sub group analysis, all enrolled subjects will have following tests : EQ-5D, KCCQ-12(Kansas City Cardiomyopathy Questionnaire), ADL(Activities of daily living), IADL(Instrumental. Activities of Daily Living), Nagi \& Rosow-Breslau self-reported items, Previous fall events since 6 months (initial) or last visit(F/U), IPAQ(The International Physical Activity Questionnaires), Social frailty screening, CES-D(Center for Epidemiologic Studies Depression Scale), MNA-SF(Mini Nutritional Assessment - Short Form),SPPB score (Short Physical Performance Battery, usual gait speed, balance, chairstand), Multi-task gait test (counting7, animal, motor, motor\&counting7), Grip strength, Bioimpedance analysis, Muscle tone at thigh and calf, UEF (Upper extremities function).

Eligibility Criteria:
Inclusion Criteria:

* All successful transcatheter aortic valve replacement or surgical aortic valve replacement
* Written consent

Exclusion Criteria

* Infective endocarditis
Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects

Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects

Pharmacokinetic (PK) parameters, Pharmacodynamics

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged 18-45 years (inclusive);-
2. With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG;
3. Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.

Exclusion Criteria:

1. Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial
2. Subjects with history of or current malignancy;
3. Participant who the researchers believe that there are volunteers who are not suitable for
Patient-Centered Smartphone-Based Diabetes Care

The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS). This study was aimed to test the feasibility of the PSDCS.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* HbA1c levels ≥ 6.5%

Exclusion Criteria:

* severe diabetic complication including severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy, chronic kidney disease stage 4-5, severe diabetic neuropathy, history of diabetic foot, history of angina pectoris, myocardial infarction, and cerebrovascular disease, and peripheral arterial disease
* type 1 diabetes
* insulin therapy other than insulin glargine
* subjects with insulin pump
* history of drug addiction
* history of psychotic disorder
* pregnancy
Effect of Obesity Among COVID-19 Patients in Critical Care Settings

A novel human coronavirus that is now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (formerly called HCoV-19) emerged in Wuhan, China, in late 2019 and is now causing a pandemic. Human-to-human transmission is primarily achieved through close contact of respiratory droplets, direct contact with the infected individuals, or by contact with contaminated objects and surfaces. As a new chapter in human life opens up, the world seems to be divided into two parts pre- and post-COVID-19 era. Body mass index (BMI) is widely used to define obesity and overweight in adults. A BMI between 25 and 30 indicates overweight and above 30 indicates obesity. It is important to note that the levels of the inflammatory cytokines found in obese people are significantly higher than those in lean people, but they are still lower than those in individuals with infection or trauma. Obesity-mediated alterations in the airways and immune system are extremely important at the present moment considering SARS-Cov-2 infection. This study is designed to determine the effect of overweight and obesity with outcomes of patients with moderate to severe COVID-19 infection in critical care setting. Also, to see outcomes of assisted ventilation in obese patients.

This may help in establishing strong association of obesity with COVID-19 in our part of the world. This may open new treatment strategies for COVID-19 by treating obesity as an essential risk factor.

This Prospective Cohort Study study will be conducted in COVID-19 Intensive care unit, Services hospital Lahore. it will be completed in 3 months after approval of proposal taking 100 patients using Non Probability Purposive sampling.

After ethical approval, research will be started and patients will be recruited from ICU according to inclusion and exclusion criteria. Patients will be randomized to two groups Group A with normal BMI and Group B having over weight and obese patients. They will be given standard treatment as practiced and outcome will be measured in terms of recovery from disease or death. Duration of stay in hospital, progression of disease, O2 requirement, improvement in biochemical profile and radiology or occurrence of complications.

Data will be put in SPSS version 25 and analysis will be done.

Eligibility Criteria:
Inclusion Criteria:

1. All Patients presented to ICU with PCR positive for Covid-19 .
2. Both genders included.
3. Age range 18 to 80 years.
4. Patients fulfilling Criteria for moderate to severe disease.
5. Conscious patient on initial presentation.
6. BMI range from 18-\> 40.

Exclusion Criteria:

1. Unable to provide free informed consent.
2. Pregnant females.
3. Gross ascites, amputation or other conditions making BMI measurement unreliable.
Efficacy of Melanostop Peeling for Improvement of Melasma

Participants with face melasma will receive 4 Melanostop peel treatments containing 20% azelaic acid, 10% resorcinol and 6% phytic acid. Peels will be performed at 2-week interval. They will also receive a facial tonic and cream for at home use, containing brightening ingredients: vitamin C, niacinamide, alpha arbutin, kojic acid. They will also receive sunscreen protection cream with SPF 50, protecting against UVA, UVB, HEV and IR. Products for at home use will be used twice a day, every day. Measurements will be made at baseline, on the day of the forth peel treatment and 4 weeks after the last peel. Measured parameters will be: mMASI score, VisioFace photography analysis, melasma area measurements, and melanin index, ΔE, CIELab colour measurements with Cortex SkinLab Combo (Cortex Technology Asp, Denmark).


Eligibility Criteria:
Inclusion Criteria:

* Adult women aged between 20-50 years old.
* Melasma on the face
* Fitzpatrick phototypes I-IV
* Presenting facial melasma
* In good health condition

Exclusion Criteria:

* Breastfeeding and pregnancy
* Women presenting oral herpes
* Other skin diseases, arthritis, diabetes, diseases of thyroid gland
* Any known allergies to ingredients of the products used in the study
* Systemic or topical use of corticosteroids in the previous 6 months
* Antiaging or lightening cosmetic/estetic procedures in the last 2 months (for example: laser or IPL treatments, chemical peels,..)
* Taking drugs for skin lightening in the previous 2 months
* Smoking
* Lesions of unknown origin
* Oral or topical use of isotretinoin in the previous 6 months
* Active bacterial, viral or fungal infections of the skin
* Presence of keloid scars
* Immunodeficiency
* Moderate to severe acne
* Planned change in hormonal contraception or taking drugs that have an affect on hormonal balance during the course of the study
* Unrealistic expectations
* Refusal to use sunscreen protection and complying with instructions
Nebulized Epoprostenol (FLOLAN) and Phenylephrine on One Lung Ventilation (OLV)

This is a pilot study of a new use of Epoprostenol via inhalation (Epoprostenol is approved for intravenous use). The purpose of this study is to administered inhaled Epoprostenol and intravenous Phenylephrine to improve arterial oxygen tension during one-lung anesthesia either with volatile anesthesia (Sevoflurane) or with intravenous anesthesia (Propofol).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing esophagectomy via video assisted thoracoscopy surgery or open thoracotomy.
* Patients greater than eighteen years old that have the capacity to provide consent.
* Patients who weigh 89kg or less.
* Patients with a preoperative platelet count \> 100,000mm3

Exclusion Criteria:

* Contraindication or allergy to any of the study drugs e.g. epoprostenol, phenylephrine, sevoflurane or propofol.
* Spirometry: Force expiratory Volume (FEV1) less than 80% predicted for age. Patients with spirometry indicative of obstructive lung disease are less likely to develop hypoxemia during OLV compared to patients with normal spirometry . These patients are likely to have a smaller treatment effect if any.
* A history of a bleeding diathesis.
* Use of a platelet inhibitor within the last seven days e.g. Aspirin, clopidogrel
Feasibility Trial to Evaluate the Ability of the SuMO Tissue Access and Resection System

This feasibility trial will evaluate the ability of the SuMO Tissue Access and Resection System (Apollo Endosurgery, Austin, Texas). The SuMO System utilizes balloons to create a submucosal pocket and electrosurgical cutting device to resect the mucosa. The SuMO elevates the tissue from the underlying muscularis using a balloon to distend the submucosa, similar to what is currently performed with injectable saline in a standard EMR. After dissection of the lesion, a separate cutting device will be utilized to resect the tissue by cutting around the border of the targeted tissue. If needed, a standard loop snare will be used to complete the mucosal resection.

The subject will already be scheduled for segmental colectomy or gastrectomy.

The colectomy or gastrectomy specimen will be prepared on a side table for an ex vivo endoscopic procedure. The ends of the stomach or colon, if not already stapled closed will be ligated to allow for insufflation. The endoscope will be placed into the excised organ and the SuMO System devices will be deployed away from any areas of excised pathologic tissue, so as not to disrupt the pathologist's evaluation of the excised tissue. The specimen will then be opened and grossly examined for the actual completeness of the submucosal pocket and resection. Mucosal and muscular wall disruptions will be assessed. Again, no interference in the underlying pathology will be performed. If sufficient specimen is present, the SuMO procedure may be repeated on the same specimen.

Following the performance of the EMR by the SUMO balloon system on the ex vivo colon specimen, both the resected piece of tissue and the site of resection will be evaluated pathologically by H and E staining. Specifically, the depth of resection in the ex vivo colon specimen will be determined. In addition, the level of dissection on the removed piece of mucosa will also be identified.

During this procedure still images or a video recording maybe captured, however all images will be taken of the removed specimen. There will not be any patient identifiers on any of the images or DVD's taken during the procedure.

No clinical follow up is required, as the treated area will have already been resected and there is no risk to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age
* Established indication for open or laparoscopic or colon resection or gastrectomy
* Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form

Exclusion Criteria:

* Subjects that are minors or prisoners
* Subjects who would have difficulty comprehending or complying with the requirements of the study
* Subjects who fail to give informed consent