cyrilzakka/clinical-trials huggingface dataset:
NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement

Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in ischemic optic neuropathy. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* age 40 years or older
* must understand and sign the informed consent
* must be medically able to undergo ophthalmic surgery for the NT-501 device insertion and possible removal, as well as the testing required.
* diagnosis of ischemic optic neuropathy characterized by (a) non-arteritic subtype, including a normal ESR and CRP; (b) syndrome of acute unilateral visual loss with documented optic nerve head edema but without significant pain; (c) a relative afferent papillary defect in the affected eye, and a decrease of best-corrected visual acuity to 20/40 or worse in the affected eye, and detectable loss on visual field testing consistent with nerve fiber visual field defect but retaining measurable residual visual field preservation.

Exclusion Criteria:

* other corneal, lens, optic nerve or retinal disease causing vision loss,
* blind in one eye
* requirement of acyclovir and/or related products during study
* receiving systemic steroids or other immunosuppressive medications.
* pregnant or lactating.
* considered immunodeficient or has a known history of human immunodeficiency virus (HIV)
* on chemotherapy, or a history of malignancy, UNLESS it was treated successfully 2 years prior to inclusion in the trial.
Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome

The purpose of this study is to determine whether Lovastatin, Minocycline and the combination Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X individuals.


Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of fragile X syndrome
* The participant must be accompanied his parent, legal tutor or legal representative.
* Identify a caregiver who spends at least six hours per day with the participant (may be the parent, legal tutor, legal representative or an other person).
* IQ \< 70
* ABC-C score \> 20
* CGI-Severity score ≥ 4

Exclusion Criteria:

* Pregnant or breastfeeding participants
* Previous intolerance/allergy to statins, minocycline or tetracyclines
* Participants who have taken lovastatin or minocycline in the last 12 weeks
* Personal history of myopathy, myalgia or high creatine kinase (CK) levels
* Renal disease / liver disease / disturbed hepatorenal tests
* Participants taking more than three psychoactive medications (except anticonvulsants)
* Untreated or uncontrolled hypothyroidism
* Any other active medical condition
* Modification of psychoactive treatment in the last 6 weeks prior to randomization
* Participants under the age of 13 years who have incomplete formation of the crown of their teeth (except possibly their 3rd molars) as shown by panorex
* Concomitant use of prohibited drugs

  * Prohibited drugs include other hypolipemic including gemfibrozil (or other fibrates) and niacin (nicotinic acid), angiotensin converting enzyme (ACE), cyclosporine, danazol, amiodarone, verapamil and inhibitors P450 (CYP3A4) (itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, inhibitors of HIV protease and nefazodone).
Clinical Data Collection for the Closed Loop Development for the Type 2 Diabetes Treatment - DT2_1

The objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.

T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.

Type 1 diabetes (T1D) requires a complete and immediate substitution of pancreatic insulin secretion. Currently, patients need to be involved in managing their disease by deciding how much insulin to administer based on the results of glucose monitoring. Artificial intelligence, thanks to a self-learning algorithm, enables the automation and customization of insulin administration. These devices, known as closed loops, bring real benefit to the patients included in the studies, by improving glycemic balance, by decreasing the number of hypo- and hyperglycemia but also by decreasing the mental load associated with the disease, improving their quality of life.

These very significant benefits in the T1D treatment open the possibility of obtaining similar benefits in the T2D treated by the basal-bolus type insulin regimen. This study aims to develop a specific algorithm of T2D to meet its particular characteristics.

The objective of this study is to collect the evolution of blood glucose levels in T2D patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.

Eligibility Criteria:
Inclusion Criteria:

* Patient with T2D treated with insulin pump for at least 6 months
* Patient with a body mass index (BMI) between 27 and 40 kg/m2
* Patient treated with a total daily dose of insulin between 40 and 300 U/24 h
* Patient with CGM
* Patient with Social security or beneficiary
* Patient able to read and understand the procedure, and able to express consent for the study protocol

Exclusion Criteria:

* Patient with T1D
* Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
* Persons referred to in articles L.1121-5 to L.1121-8 of the CSP (corresponds to all the protected persons: pregnant woman (checked by the dosage of β-human chorionic gonadotropin for any woman wishing to participate in the protocol and in childbearing age 60 years), parturient, mother breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
The Gaps-in-Noise Test: Gap Detection Thresholds in Normal-Hearing Young Adults

The aim of this study was to establish parameters for the Gaps-in-Noise test in normal-hearing young adults. One hundred subjects (50 males and 50 females) received an audiological evaluation to rule out hearing loss and auditory processing disorder. The Gaps-in-Noise test was then conducted on all subjects. The mean gap detection threshold was 4.19 msec. A psychometric function by gap duration was constructed, revealing that the percentage of correct responses was less than or equal to 5% for a gap duration of 2 msec, 10-30% for a gap duration of 3 msec, 60-70% for a gap duration of 4 msec, and over 96% for gap durations of 5 msec or longer. The results suggest that the data obtained can be applied as reference values for future testing. In the subjects evaluated, the Gaps-in-Noise test proved to be consistent with low variability.


Eligibility Criteria:
Inclusion Criteria:

Subject inclusion criteria were:

* all of the subjects have to have auditory thresholds lower than 20 dB HL at all of the frequencies evaluated (octave frequencies between 0.25 to 8 kHz), bilaterally;
* type A tympanometric curves with presented ipsilateral and contralateral acoustic reflexes;
* 95% or higher correct responses for each ear in the dichotic digit test.

Subject inclusion criteria also included negative histories for audiologic, otologic, head trauma, and neurologic involvement.

Exclusion Criteria:

* Hearing loss;
* Auditory processing disorder;
* Histories of audiologic, otologic, head trauma, and neurologic involvement.
Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status

Older adults typically do not drink later in the day to avoid the necessity of interrupting sleep to urinate. Sometimes they also limit ingestion of fluids to avoid the need to urinate when engaged in certain activities such as traveling or attending an event. Therefore, beverages that have greater fluid retention in the body leading to a more sustained positive hydration status could be advantageous in such situations. The composition of a beverage as well as other factors such as volume ingested and metabolism of components can affect the retention of the fluid in the body. Age may be another factor. The beverage hydration index (BHI), first described in 2016, was used to indicate the hydration response to thirteen well-known beverages in young male adults. The current study assesses the BHI of four beverages and how that response is affected by age following the standardized protocol. The four beverages have been chosen for inclusion in this study because they have been used by older adults to prevent dehydration.

Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles, as well as measures of liver and renal function. The subjects are assigned to one of two groups based upon age.

Subjects participate in five experimental trials, one for each of the five beverages. The beverages are commercially-available and contain ingredients that are generally recognized as safe (GRAS). The order of the beverages is randomized. The list of ingredients on the bottle containing the beverage is obscured. The trials are identical and separated by at least five days. For each experiment, baseline measurements are conducted. Then the subjects consume one liter of the test beverage over thirty minutes. Additional measurements are performed thirty minutes post ingestion and then every hour for four hours post ingestion.

This study yields two BHI numbers for each beverage, one number for each study-group. The BHI numbers are indicative of the amount of fluid remaining in the body four hours after consumption of the beverage. The BHI number is inversely related to the amount of urine produced over the four hours. A greater BHI number indicates better fluid retention and maintenance of plasma volume.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years or ≥60 years

Exclusion Criteria:

* cardiovascular, renal, or digestive diseases
* pregnancy
* breastfeeding
* smoking and/or use of nicotine-containing products
* illegal/recreational drug use
* medications that alter fluid balance (e.g., diuretics)
* allergy to Latex
* men with prostate issues that interfere with urination.
Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19

Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.

SARS-CoV-2 infection has been associated with coagulation disorders and increased risk of venous thromboembolism (VTE). The aim of the study is to determine the cumulative incidence of VTE in critically ill patients with COVID-19 and its impact on prognosis.

Methods Cohort study of critically ill patients due to COVID-19. A bilateral venous compression (CUS) ultrasound screening of the lower extremities was performed during a cut-off period in 2 intensive care units of university hospitals in Spain. Asymptomatic and symptomatic VTE were registered: pulmonary embolism (PE) (diagnosed by CT-angiography) and deep venous thrombosis (DVT). The characteristics of the patients, results of their blood tests and their evolution after 7 days of follow-up were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe COVID-19 pneumonia admitted to the intensive care unit

Exclusion Criteria:

* Treatment with Extracorporeal membrane oxygenation (ECMO)
* Pregnant or postpartum women
* Under 18 years old
Mandible and Sub-mandible Using the 1440nm Wavelength Laser and Hand Piece

The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to provide clinical outcome data for treatment of the mandibular and submandibular areas specifically for skin tightening and laser lipolysis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male or female subjects 18-65 years of age
* Presents for treatment of their unwanted skin laxity and fat in the mandibular and submandibular areas for an improved aesthetic appearance and is willing to undergo laser treatment
* Understands/accepts obligation not to receive any other procedures in the mid-face to sub-mandibular areas through 3 months follow up visit
* Understands/accepts the obligation and is logistically able to present for all scheduled follow up visits
* Is capable of understanding the consent form and able to provide written consent to participate in the study and any other practice consents for anesthesia and surgical procedures
* Understands/accepts obligation to have facial photographs taken
* Understands/accepts may be asked to consent to having a two 2mm biopsies in an inconspicuous place such as behind the ear
* Agrees to maintain present diet and exercise program

Exclusion Criteria:

* Has had any procedure in the mid-face to sub-mandibular areas in the last six months
* Has a history of thrombophlebitis, history of coagulation disorders or using anticoagulant medications
* Has a significant systemic illness or immunity disorder or localized condition affecting treatment area
* Is female and pregnant, was pregnant or given birth within the last three months, is currently breast feeding, or planning a pregnancy during the course of the study
* Has known history of allergic reactions to local anesthesia
* Has any other medical condition, that, in the investigator's opinion would interfere with the subject's participation in the study
* Is susceptible to light induced seizures or history of seizures
* Has a history of keloid formation
* Has therapies or medications which may interfere with the treatment (including medications causing photosensitivity
* Has a BMI above 30
Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)

We aim to determine if Colchicine improves short-term outcomes in hospitalized coronavirus disease-19 (COVID-19) patients with cardiac manifestations of disease.

Myocardial injury has been described in up to 30% of COVID-19 infected patients, and portends a poor prognosis with currently no known treatment. Colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been FDA approved for the treatment of inflammatory disorders including gout and familial Mediterranean Fever. Trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. We extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized COVID-19 patients with evidence of cardiac injury.

This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)

Eligibility Criteria:
Inclusion Criteria:

* Men and Women ≥ 18 years of age
* Covid-19 Positive
* Hospitalized patients able to provide informed consent
* Cardiac injury (as evidenced by any of the following)

  1. Elevated troponin level
  2. Elevated BNP level
  3. New ischemic or arrhythmogenic ECG/telemetry changes
  4. New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram

Exclusion Criteria:

* Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:

  1. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
  2. Hormone method with a barrier method
  3. Two barrier methods
  4. If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
* History of severe hematologic or neuromuscular disorder
* Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport inhibitor
* Severe renal impairment with concomitant hepatic impairment
* Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment
MyoStrain CMR Testing of Ischemia With Low Levels of Stress

This prospective, observational study evaluates the accuracy of stress testing with the MyoStrain SENC CMR Imaging System to detect myocardial ischemia and viability in patients with suspected coronary artery disease using low levels of stress.

This prospective, single center study evaluates the MyoStrain SENC CMR Imaging System for the detection of myocardial ischemia and viability during conventional Cardiac Magnetic Resonance (CMR) wall motion stress testing. Patients with known or suspected coronary artery disease and scheduled for cardiac catheterization will be consented for inclusion in the study and evaluated during stress testing with low dose Dobutamine as the stressor agent. Data obtained with the MyoStrain SENC CMR Imaging System will be for observational purposes and will not be used to alter patient management.

Eligibility Criteria:
Inclusion Criteria:

* Known or suspected Coronary Artery Disease
* Symptoms potentially due to CAD; stable angina
* Positive imaging stress test or negative stress test but typical angina or anginal equivalent
* Negative Troponin with unstable angina
* Invasive coronary angiography planned within 3 months of CMR
* Provided written consent

Exclusion Criteria:

* Pregnancy
* Contraindication to Magnetic Resonance Imaging
* Prior allergy to Dobutamine
* Severe aortic stenosis
* Hypertrophic Cardiomyopathy
* Clinically significant Ventricular Tachycardia that would prohibit Dobutamine administration
Observational Registry on Acute Coronary Syndromes in Campania

This registry aims to collect data related to management of patients affected by acute coronary syndromes and hospitalized in the Campania Region of Italy


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for acute coronary syndromes

Exclusion Criteria:

* Refuse to provide informed consent for study enrollment
Effect of Location of Tetanic Stimuli on Photoplethysmogram Under General Anesthesia

The effect of the location of tetanic stimulus on photoplethysmography signals will be studied in patients under general anesthesia.

A 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations (Ulnar nerve, Facial nerve, Posterior Tibial nerve) in a random order in patients who are under general anesthesia. Tetanic stimuli are used routinely during general anesthesia to assess effectiveness of neuromuscular blockade. These tetanic stimuli are noxious stimuli that elicit a stress response which can be quantified using photoplethysmography. This study investigates if the magnitude of the tetanus induced stress response is dependent on the location of the tetanic stimulus as measured by photoplethysmography.

Eligibility Criteria:
Inclusion Criteria:

* Surgical patients
* Undergoing general anesthesia
* Able to consent in english
* 18 years of age or older

Exclusion Criteria:

* Under 18 years of age
* unable to consent in english
* receiving regional anesthesia
Women's Health Communication Study

The central goal of this randomized, controlled pilot study is to examine the feasibility, acceptability, and preliminary effects of an educational intervention (called "Starting the Conversation"; STC) on patient communication about sexual health in gynecologic cancer and other patient health outcomes. Approximately 30 women with a diagnosis of gynecologic cancer will be randomized to either participate in either the Starting the Conversation (STC) condition, consisting of an educational video, workbook, and list of resources on sexual and menopausal health, or to a control condition offering the resource guide only. Patients will be asked to review intervention materials prior to their next clinic visit with their gynecologic cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any stage (I-IV) gynecologic cancer (uterine, ovarian, cervical, vaginal/vulvar, fallopian tube, peritoneal)
* Receiving any treatment for gynecologic cancer or have completed acute treatment \< 10 years ago
* Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)

Exclusion Criteria:

* Not able to speak English
* Eastern Cooperative Oncology Group (ECOG) Performance status score \> 2
* Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.