cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Efficacy of Ocular Dipyridamole in the Treatment of Dry Eye Symptomology in Subjects With Pterygium

Subjects with pterygium and associated dry eye symptoms (DES) are randomized into an active cohort (receiving ocular administration of Dipyridamole) or placebo cohort (ocular administration of vehicle). Monthly follow up is conducted for 12 months. Testing conducted at follow up will assess dry eye / pterygium symptoms and endpoints and review the efficacy of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent.
* Ineligible or refused surgical excision, or had recurrence of pterygium following surgical excision
* Able to follow the study instructions, including application of the study product
* Agreement not to change the type of lubricating eye drops used (if any) during their participation in the study.
* Assessed as having at least pterygium stage 0-1 (pinguecula) based on Johnston, Williams \& Sheppard's classification for pterygium
* Concomitant dry eye symptoms, as determined by one or more of the following Subject interview (modified Ocular Surface Disease Index test), Tearing, Itch / foreign body sensation, Positive Fluorescein test, Positive TBUT test, Positive Tear meniscus test

Exclusion Criteria:

* Inability to provide informed consent
* Dry eye due to other factors
* Known lacrimal obstruction
* Contact lens wearers
* Non-corrected refraction
* Allergy or sensitivity to dipyridamole or excipients
* Use of dipyridamole in the last 6 months
* Other eye conditions (i.e. active ocular infection, herpes keratitis in last 6 months, corneal disorder abnormality excluding pterygium, history of ocular acne rosacea, blepharitis) which would impact results
* Diagnosis of ALS (Amyotrophic lateral sclerosis)
* Existing conditions which are contraindicated or precaution in use of dipyridamole or excipients
* Use of eye drops (other than ocular lubricants)
* Pregnant or breastfeeding
* Inability to apply the medical product or follow the study procedures
* Anything that the PI thinks would impact the trial
Efficacy Comparison of 2 Low-dose Atropine Eye Drops in Vietnamese Children Myopia Management

The goal of this clinical trial is to compare the efficacy of 2 low-dose atropine drops (0,01%; 0,05%) in Vietnamese children. The main questions it aims to answer are:

1. How is the difference in efficacy among 3 groups: atropine 0,01% vs 0,05% vs spectacles?
2. How is the difference in side effects among 3 groups: atropine 0,01% vs 0,05% vs spectacles?
3. How is the difference in rebound phenomena between 2 atropine groups?

The study is prospective, comparative, open label. Participants are Vietnamese children. Prescribing drops : 1 drops/eye/night/ 12 months Wash-out: 12 months The atropine drops in this study are commercially available.

Eligibility Criteria:
Inclusion Criteria:

* myopic 2 eyes (SE above from -0.75 D, astigmatism below -1.50D)
* 8 - 13 years old
* Vietnamese, speaking Vietnamese
* BCVA from 8/10 each eye

Exclusion Criteria:

* Using any contact lens in less than 3 months
* Other eye diseases than myopia
* History of eye trauma, surgeries
* Having chronic systemic diseases or having medications affecting eye.
* Having contraindications of atropine drops
* Pre-known allergies to atropine drops
* Undergoing another myopia control treatments
Ancillary T Cell Based Studies in SPIROMICS

The long-term objectives of this ancillary application are to characterize a subpopulation of smokers with auto-reactive T cell response, to validate immunodiagnostic assays that could detect emphysema, and to find molecular signatures for pathogenic T cell development in a well-characterized cohort participating in SPIROMICS (UCSF center).

One of the major medical challenges facing us is that susceptibility to smoking-induced lung diseases varies greatly and essentially precludes our ability to predict which smokers will develop emphysema. Because the SPIROMICS study is designed to phenotype a large and heterogeneous group of smokers, we have chosen this cohort to identify the subpopulation who have auto-reactive T cells, as this may represent a contributing mechanism in the development of emphysema, which may need alternative therapies, and may represent a group of patients who will have progressive disease despite smoking cessation. In Aim 1, we will prospectively determine the presence of auto-reactive T cell responses as determined by increased cytokine release in 180 ever-smokers with and without emphysema; in Aim 2 we will focus on the longitudinal aspect of the factors that could predispose development of auto-reactive T cells in the population at risk. These studies form the prerequisite basis for developing additional novel immune-based diagnostic and therapeutic strategies in human emphysema. The short-term objectives outlined here are based on our preliminary data, and provide the necessary platform that will be used to answer the following urgent questions: i) in a distinct prospective cohort of ever smokers, can auto-reactive T cells predict the presence of radiographic emphysema? ii) Can we identify unique and persistent transcriptional signature(s) that are associated with autoimmune emphysema? The observational and longitudinal design of SPIROMICS allows for detailed assessment of the association between emphysema as the primary clinical endpoints and could validate the novel T cell specific immunodiagnostic potential that has been developed in our laboratory. We propose to explore the role of autoimmunity as a contributing mechanism in the development of emphysema with the additional aim of bringing current technologies to bear on clinical and future diagnostic tests. PUBLIC HEALTH RELEVANCE: We have discovered specific autoreactive T cells in ever-smokers with emphysema and there is growing evidence linking these particular effector cells with the pathophysiology of smoking related lung disease. Our proposed studies are important because they will provide new diagnostic and prognostic assays (e.g. gamma-6-Spot, based on Th1 and Th17 cytokines) in ever-smokers who have, or are at risk of developing emphysema.

Eligibility Criteria:
Inclusion Criteria:

* Over 4o, former or active smokers

Exclusion Criteria:

* HIV infection, chronic hepatitis B and C, immune suppressive medications.
Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible according to the following criteria:

1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
2. Subjects who are \> 18 years year old.
3. Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
4. Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
5. Symptomatic neuroma confirmed by pain relief following a 10min ±2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as any reduction in VAS questionnaire score.
6. Subjects with history of pain in the area of the end-neuroma for at least 6-months.
7. Subjects with a positive Tinel's sign.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation:

1. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
2. Subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation or subjects who are not using appropriate birth control.
3. Subjects who have had historical radiotherapy in the area of the end-neuroma.
4. Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
5. Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
6. Subjects is involved in another pain study.
7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32\[15/85 D/L\] Lactide-Ԑ-Caprolactone) (PLCL).
8. Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.
9. Insufficient soft tissue at the end-neuroma site to cover the investigational device.
10. Immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.
Expanded Access to ABBV-787

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-787 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

- The participant must not be eligible for an ABBV-787 clinical trial.
Enoxaparin in Acute Venous Thromboembolic Disease

Study objectives :

* To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors

Exclusion Criteria:

* Patients with a history of heparin or warfarin treatment longer than 24 hours,
* Patients requiring thrombolytic treatment,
* Patients having thrombophilia diagnosis,
* Patients with prior deep vein thrombosis or pulmonary emboli evidence,
* Patients with familial bleeding disorder,
* Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month
* Patients with renal failure (serum creatinine concentration \> 180 mmol/L or \> 2.03 mg/dL),
* Patients with severe hepatic failure
* Patients with history of allergy against heparin and protamine,
* Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment,
* Patients participating in another clinical study within the last 4 months
* Patients who are pregnant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)

A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 to 80 years with Type 2 Diabetes who are on a stable dose of antidiabetic medication for at least 3 months

Exclusion Criteria:

* Patients taking Cholestin, niacin (\>50 mg/day), fibrate therapy, hormonal contraceptives, intermittent Hormone Replacement Therapy, or certain corticosteroids
* Patients with any of the following conditions: active liver disease or kidney disease, poorly controlled high blood pressure, active peptic ulcer, or other heart or blood diseases
* Patients with abnormal laboratory results from a blood test that will be given before starting the study
Ovarian Reserve in Premenopausal Breast Cancer

This is a translational, mutlicentre study. The aim of this study is to determine whether pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.

It is proposed that levels of AMH and inhibin A and B measured will give an indication of the residual ovarian reserve in women with breast cancer treated with chemotherapy. In addition, AMH might give an indication of the possible efficacy of GNRH agonists in fertility preservation and the effect on ovarian follicular reserve using different adjuvant chemotherapy regimens. Those likely to be offered GNRH agonists are younger women with no children and a wish to have some in the future. Older women who have completed their families are less likely to be offered a GNRH agonist.

Eligibility Criteria:
Inclusion Criteria:

1. Documented histological diagnosis of invasive breast cancer
2. Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)\*
3. Female patients aged between 18 and 50 years
4. Premenopausal status as defined by a hormone profile within the pre-menopausal range as defined by local lab

   OR The patient's last menstrual period had to be within the last 180 days

   OR An IUD is used for contraception.
5. Ability to provide written informed consent

   * Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible

Exclusion Criteria:

1. Patients with hypothalamic/pituitary disorder
2. History of ovarian tumour
3. Current pregnancy
Candida Albicans in Periodontal and Endodontic Lesions in Diabetic and Normoglycemic Patients

Pulpal and periodontal tissues are closely related and have similar microbiota that cross-contamination between the pulp and periodontal tissues.The aim of this study was to investigate the prevalence of isolated Candida albicans from periodontal endodontic lesions in diabetic and normoglycemic patients and their virulence in different atmospheric conditions. A case-control study was conducted on 15 patients with type 2 diabetes mellitus (G1) and 15 non-diabetics (G2), with periodontal endodontic lesions. Samples of root canals and periodontal pockets were plated on CHROMagar for later identification by polymerase chain reaction (PCR) and virulence test.

This case-control study was conducted on thirty patients (15 patients with type 2 diabetes mellitus and 15 normoglycemics) with clinical and radiographic diagnosis of a periodontal endodontic lesion. To assess the glycemic control of the patients were measured the plasma glucose level and glycosylated hemoglobin concentrations (HbA1c). All patients were initially submitted to examination to verify the clinical periodontal parameters (plaque index, probing bleeding, probing depth, clinical attachment level and gingival recession) and pulp sensitivity testing. The study included patients who presented periodontal pockets involving the apical region of the tooth and pulp necrosis (periodontal endodontic lesion). Exclusion criteria were: use of antibiotics in the last six months, pregnancy, smoking, other systemic diseases, clinical signs of oral candidiasis, and patients who did not sign a free and clarified consent term.

Sample collection Collection from the root canal was performed after access, rubber dam isolation, disinfection of the surgical field with 5.25% sodium hypochlorite, and neutralization with 5% sodium thiosulfato, with 3 sterile paper points remaining in the root canal for one minute. Sampling of the periodontal pocket was made at the deepest site through 3 sterile paper points, inserted one by one for one minute. The material collected from the periodontal pocket and the root canal was inoculated in Eppendorf tubes containing 1 ml of reduced transport fluid (RTF). Next, samples from each site were diluted and plated on the medium Saboraund Dextrose Agar plus Chloramphenicol and chromogenic medium (CHROMagar Candida ®, BioMerieux, Paris, France) and incubated at 37° C for 48h in a reduced oxygen atmosphere (10% CO2 and 90% air). The green colonies that grew on CHROMagar plates were chosen at random and stored in glycerol at 20° C for later identification by PCR.

Eligibility Criteria:
Inclusion Criteria:

-patients who presented periodontal pockets involving the apical region of the tooth and pulp necrosis (periodontal endodontic lesion).

Exclusion Criteria:

* use of antibiotics in the last six months,
* pregnancy,
* smoking,
* other systemic diseases,
* clinical signs of oral candidiasis
* patients who did not sign a free and clarified consent term.
Blood Coagulation Abnormalities in COVID-19 (Corona Virus Disease-19) Patients

The role of the coagulation parameters in predicting the severity of COVID-19 disease will be assessed

In COVID-19 patients the coagulation parameters Prothrombin concentration (PC), Activated Partial Thromboplastin Time (aPTT), D Dimer, Antithrombin III (ATIII) and Fibrinogen are measured and correlation with disease severity is to be investigated

Eligibility Criteria:
Inclusion Criteria:

● Confirmed cases with COVID 19

Exclusion Criteria:

● Known history of blood coagulopathy disorder
Improving Syncope Risk Stratification in Older Adults

Syncope (temporary loss of consciousness) is a frequent reason for an emergency department (ED) visit among older adults. The current ED evaluation of syncope frequently leads to hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of this protocol is to improve risk prediction for syncope. Improved risk prediction will inform the design of interventions to safely reduce unnecessary health service use.

This is a multi-center, prospective, observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting). The primary outcome is a composite of 30-day cardiac death and serious cardiac events.

Study Aims and Hypotheses are:

Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic tests.

H1: Current patterns of care representing a diversity of practice settings and patient populations are costly with low clinical benefit.

Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death and serious cardiac outcomes after unexplained syncope.

H2: Explicit criteria including contemporary cardiac biomarkers will improve risk stratification compared to unstructured physician assessment and published risk models.

Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to existing care for unexplained syncope.

H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating unexplained syncope in older adults.


Eligibility Criteria:
Inclusion Criteria:

1. age≥60 years; AND
2. a complaint of syncope or near-syncope. Syncope is defined as a transient loss of consciousness (LOC), associated with loss of postural tone, with immediate, spontaneous, and complete recovery. Near-syncope is the sensation of imminent syncope without loss of consciousness.

Exclusion Criteria:

* Seizure as presumptive cause of LOC
* Stroke or transient ischemic attack as presumptive cause of LOC
* LOC AFTER head trauma Confusion from baseline mental status
* Intoxicated (alcohol or other drugs)
* Medical or electrical intervention to restore consciousness
* Hypoglycemia as presumptive cause of LOC
* inability to provide follow-up information, including patients who do not speak English (or Spanish, if applicable for study site), lack phone access, or lack a permanent address
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent
Gated and Non-Gated Dynamic PET/CT Imaging

The goal of this study is to see how the images collected during the first hour compare with the routine images collected as part of the clinical scan.


Eligibility Criteria:
Inclusion Criteria Main Cohort:

* 18 years of age or older
* Scheduled to undergo a clinical PET/CT scan with any clinically prescribed radiotracer for known or suspected malignancy (pathologic confirmation not required)
* Able to provide informed consent

Inclusion Criteria Repeatability Cohort:

* 18 years of age or older
* Scheduled to undergo a clinical PET/CT FDG or 68Ga- DOTA-0-Tyr3-Octreotate (DOTATATE) for known or suspected malignancy (pathologic confirmation not required)
* Able to provide informed consent

Exclusion Criteria:

-Younger than 18 years of age
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patient is currently receiving Prograf® based immunosuppressive therapy for liver transplantation.
* Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable

Exclusion Criteria:

* Patient has previously received an organ transplant other than a liver
* Patient is currently receiving sirolimus immunosuppression therapy.