cyrilzakka/clinical-trials huggingface dataset:
WF and PR OCTA in Diabetic Retinopathy

Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.


Eligibility Criteria:
Participant-Related Inclusion Criteria:

I. All Diabetics (Groups A, B, C)

* Type 1 diabetes of at least 5 years duration or
* Type 2 diabetes of any duration II. Group B
* Able to return for follow-up over 3 years

Participant-Related Exclusion Criteria:

I. Group B

* Significant medical condition that would make long-term follow-up difficult II. Controls (Group D)
* Any medical problems associated with retinal vascular abnormalities (i.e., hypertension, systemic vasculitis, carotid insufficiency, etc.)

Eye-Related Inclusion Criteria:

I. Group A:

* Presence of active neovascularization, with or without prior treatment
* Presence of involuted fibrovascular proliferans

II. Group B:

* NPDR of any severity as defined by the International Clinical Diabetic Retinopathy Severity Scale

III. Groups C \& D:

* No evidence of diabetic retinopathy

IV. Group ME:

* Presence of center-involving macular edema requiring treatment

Eye-Related Exclusion Criteria: (Applies to study eye only. May be present in non-study eye.)

* Visual acuity worse than 20/200
* Inability to maintain stable fixation for OCT imaging
* History of major eye surgery (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery, etc.) within 90 days of enrollment
* History of another eye disease or condition that may alter retinal perfusion, permeability, or retinal anatomy
* Substantial media opacity (cataract, corneal scar, vitreous hemorrhage) that may interfere with study imaging
The Efficacy of Citalopram Treatment in Acute Stroke

We wish to conduct a prospective, randomized, double blind, placebo controlled multi center study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke.

Hypotheses:

SSRI treatment commenced in the acute phase of stroke (day 0-7) protects against new thromboembolic events and leads to better rehabilitation. 600 stroke patients will be randomized in a 1:1 ratio.

The treatment and follow up period is 6 months. During these 6 months there will be 2 clinical follow up visits, one telephone control and one visit to evaluate compliance regarding medication.

Design TALOS is an investigator-initiated, national multicenter randomized- and placebo-controlled, double blind trial testing citalopram in acute ischemic stroke.

Randomization Eligible patients will be randomized 1:1 to treatment with either citalopram or placebo. Treatment allocation is double-blinded based on computer-generated algorithm via a dedicated website. Patients whose treatment is stopped within 31 days after inclusion will be replaced.

Intervention and follow-up Patients randomized to citalopram will receive oral treatment with 20 mg tablets (10 mg if age ≥65 and/or reduced liver function) for 6 months with telephone contact after 2 weeks and 3 months and follow-up visits at 1 and 6 months. If patients develop depression dosage is initially doubled, followed by an additional control to evaluate effect and, if necessary, shifted to open-label antidepressant treatment. After 6 months, treatment will either stop or switch to open-label antidepressants at the discretion of the investigator.

Substudy 120 of patients will begin treatment within 12 hours after treatment with recombinant tissue plasminogen activator. These patients will receive a standard acute magnetic resonance imaging (MRI) with additional perfusion and angio sequences. The 24-hour control scan will be done using MRI instead of conventional CT.

Data monitoring When 300 patients have been included in the trial, an interim analysis will be performed. The unblinded results of this analysis will be reviewed by an independent data monitoring committee.

Eligibility Criteria:
Inclusion Criteria:

* First ever ischemic stroke
* Age 18 years or above

Exclusion Criteria:

* Hemorrhagic stroke
* Dementia or other neurodegenerative disease
* Antidepressant medical treatment within 6 months of admission
* Acute need for antidepressant treatment
* Drug abuse or other conditions that may indicate noncompliant behavior
* Liver failure (increased liver enzyme levels up to or more than 2 times upper limit)
* Renal failure (eGFR below 30 ml/min per 1.73m2)
* Hyponatremia (S-potassium below 130 mmol/l)
* Actively bleeding ulcer
* Fatal stroke or other severe co-morbidity that markedly decreases expected life span
* Prolonged corrected QT-interval (QTc above 480 ms)
* Ongoing treatment with drugs known to prolong the QTc interval
Early Goal Directed Sedation on Microcirculation in Septic Shock

The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients.

Recent studies suggest that early goal directed sedation might improve the outcome of critically ill patients. The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients with relative stable hemodynamics.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock patients despite early goal directed therapy
* Required sedation

Exclusion Criteria:

* Age\< 18
* Pregnancy
* Bradycardia (HR\<55bpm)
* Systolic blood pressure \< 80 mmHg / mean arterial pressure \< 50 mmHg on maximal support
* Death imminent
* Unlikely to survive 90 days
* Acute liver failure
* Dementia
* High-grade block in the absence of a functioning pacemaker.
Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.

OBJECTIVES:

* Determine the efficacy of arsenic trioxide in patients with metastatic stage IVA or IVB hormone-refractory prostate cancer.
* Determine the toxicity of this drug in this patient population.
* Assess, in a preliminary manner, the effect of this drug on pain control in these patients.
* Assess the potential value of serial quantitative prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA) mRNA determinations in RNA from peripheral blood mononuclear cells as surrogate markers of disease response in patients treated with this drug.
* Assess the pharmacokinetics and pharmacodynamics of this drug in these patients.
* Assess the feasibility of using pretreatment bone marrow evaluation of PSA and PMSA mRNA levels and pi class glutathione S-transferase expression (i.e., eliminate glutathione levels) as potential correlates of disease response in patients treated with this drug.

OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-5 and 8-12 for one course. Treatment continues as biweekly infusions for at least 14 additional weeks in the absence of disease progression, unacceptable toxicity, or excessive increase in serum prostate-specific antigen.

Pain is assessed at baseline and then before each biweekly treatment.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-24 months.

Eligibility Criteria:
Eligibility Criteria:

* Diagnosis of stage IVA or IVB hormone-refractory prostate cancer
* Obstructive uropathy and/or hydronephrosis allowed if adequate renal function and urinary drainage
* WBC at least 2,500/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL
* Bilirubin less than 2 mg/dL

Exclusion Criteria:

* No significant active infectious disease
* No grade 2 or greater peripheral neuropathy
* No other debilitating acute or chronic co-morbid medical, neurological, or psychiatric condition that would preclude study compliance
* No concurrent amphotericin B or other agent that prevents restoration of potassium or magnesium to normal levels and/or correction of QT interval to under 500 milliseconds
Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis

This study evaluates the effectiveness of Dupilumab in food allergic patients with moderate to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry.

The positive results of the dupilumab studies in AD, asthma and nasal polyposis with chronic sinusitis validate the fundamental role for IL-4 and IL-13 in the pathogenesis of these diseases, and add to the possibility that these cytokines are also critically involved in other related allergic/atopic (type 2 immune) diseases that are often co-morbidly associated with AD, such as food allergy.

Eligibility Criteria:
Inclusion Criteria:

1. AD patients with moderate to severe AD who are indicated for treatment with dupilumab
2. Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy allergic subjects, with a well-documented medical history of reactions after ingestion.Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy specific immunoglobulin E (IgE) level (Phadia CAP-system) higher than 0.35 kU/L or a skin prick test of at least 3 mm
3. Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting dose before the last dose
4. Signed Bioday informed consent from subjects

Exclusion Criteria:

1. Subjects reacting objectively to the placebo at screening.
2. Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable
Effect of Hyaluronic-acid on the Healing After Free Gingival Graft

This study evaluated the effect of topical hyaluronic acid (HA) application on free gingival graft (FGG) donor and recipient sites during the early wound healing period with laser Doppler flowmetry (LDF) and to investigate the effect of HA application on the dimensional change of the graft.Participants were randomly classified into the test group (TG) and control group (CG). HA was applied to both donor and recipient sites in 20 patients who formed the TG, whereas HA was not applied to the 20 patients who formed the CG.

The healing of a transplanted tissue depends on the formation of blood support between the donor and recipient sites.

Hyaluronic acid (HA) is a biomaterial that creates a favorable environment for wound healing due to its unique hydroscopic and viscoelastic properties, and it is important for wound healing activities.HA induces angiogenesis following degradation and improves the wound healing environment.HA supports a mechanism that induces proliferation of capillaries, and components produced after HA degradation increase vascularization.Laser Doppler flowmetry (LDF) technique is frequently used in the field of plastic surgery for monitoring microvascular blood flow to detect insufficient circulation in the skin transplants and flaps in the early period and to thereby prevent and predict possible surgical complications.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed inadequate attached gingiva

Exclusion Criteria:

* Smoking
Effect of 2% Lignocaine Solution in Pain During Removal of Nasal Pack

To evaluate the efficacy of rehydration of Merocel nasal packs with 2% Lignocaine on reducing pain and discomfort during nasal pack removal in patients undergoing septoplasty.

This study will be carried out in patients who have undergone septoplasty for deviated nasal septum under general anesthesia, and who are categorized as American Society of Anesthesiologists (ASA) grade I to II. Consent will be obtained from the patient for the same.

Septoplasty will be carried out under general anesthesia and in all patients Merocel nasal packs (expandable polyvinyl acetate nasal packing) that expand upon contact with fluid will be used.

The postoperative analgesia will include Ibuprofen 400mg + Paracetamol 500mg combination thrice daily and Ketorolac 30mg intravenous when needed. The packs will be removed on the second postoperative day, 48 hours after packing.

During nasal pack removal, the subjects will be randomly divided into 2 groups: the Lignocaine group (2% lignocaine HCl) and the Normal saline group (0.9% NaCl) using simple random sampling by lottery method. Subjects won't know which group they belong to and what medication they will be receiving. A 23-gauge needle will be used for direct application of the treatment to the Merocel, with care taken not to touch the patient.

In the Lignocaine group, 2.5 ml of 2% of lignocaine is diluted with 2.5 ml of distilled water, and the 5ml solution will be injected into the Merocel pack 15 minutes before removal of the pack. Nothing will be done to the opposite nostril, which would act as a control.

In the Normal saline group, 5 ml of normal saline was injected into the Merocel pack 15 minutes before removal of the pack. Nothing will be done to the opposite nostril.

All patients will be blinded to which group they belong and which solution was being kept in their pack.

All patients will be asked to evaluate the severity of pain during removal of nasal packing by Visual Analogue Scale (VAS) (range, 0-10; 0 = no pain and 10 = intolerable pain).

Adverse events such as vomiting and nausea will be recorded. These procedures will be done by the same team to minimize observer variations.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic deviated nasal septum undergone Septoplasty surgery with bilateral anterior nasal packing

Exclusion Criteria:

* History of previous nasal surgeries
* Nasal polyposis
* Allergic rhinitis
* Chronic sinusitis
* Patient with neurological and psychiatric disease
* Patient with sensitivity to anesthetic agent in study
* Patients unwilling to enroll in the study
Colonoscopy Endoguide in Specialist Practice

The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide.

The study will investigate whether the endoguide improves success rate and the patient's perception of pain.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided

Exclusion Criteria:

* Informed consent not provided or not possible to obtain
Black Garlic Nutraceuticals and Blood Pressure Control

Black garlic contains a series of allyl-sulfur compounds with the ability to modulate nitric oxide synthetase, angiotensin-converting enzyme system, and endothelial activation, which together could help better control blood pressure. The main objective of this study is to evaluate the effect on blood pressure and endothelial health of a daily intake of a black garlic supplement named ABG (registered mark), which has a higher concentration of black garlic bioactive compounds, in people with moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

- Clinical hypertension, medically treated with no more than 2 drugs

Exclusion Criteria:

* Body mass index above 35 kg/m2
* Fasting blood cholesterol levels below 115 mg/dL
* Fasting blood glucose levels above 126 mg/dL
* Taking anyone of the Angiotensin-converting enzyme inhibitors
* Anemia (hemoglobin below 13 g/dL in men and below 12 g/dL in women)
* Vitamin or nutraceutical intake in the last 30 days before the study enrollment
* Chronic gastrointestinal diseases
* Pregnancy and breastfeeding
* Garlic allergy
* Participation in another study 30 days before the study enrollment
Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).

This was a Phase IV open-label, multi-center, single-arm study in participants with newly diagnosed Philadelphia chromosome positive (Ph+) CML in chronic phase for who nilotinib is the appropriate treatment at the discretion of the investigator.

A screening period of 2 weeks was used to assess eligibility and to taper participants off disallowed medications. Participants whose eligibility was confirmed entered a 24 months treatment phase with nilotinib 300mg BID. Nilotinib was prescribed by the investigator according to the individual needs of the participants.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CML in chronic phase
* Patients must be previously untreated for CML with the exception of 6 months treatment with hydroxyurea and a maximum of 6 weeks treatment with imatinib
* Adequate end organ function
* Normal serum levels ≥ lower limit of normal (LLN) of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements, prior to the first dose of study medication.

Key Exclusion Criteria:

* Known impaired cardiac function like long QT syndrome, history of myocardial infarction or unstable angina in the past 12 months.
* Patients who are pregnant or breast feeding.

Other inclusion/exclusion criteria might apply
Dermacyd PH_DESILSTY_FL (Lactic Acid) - Photo Evaluation - Stay on Floral

Primary Objective:

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDESILSTYFL.

Secondary Objective:

None.


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin II and III Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 03 months before volunteers selection
* Use of Antihistamines 30 days before selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Use of photosensitivity drugs
* History of sensitivity or photosensitivity for topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Bending Adolescent Depression Trajectories Through Personalized Prevention

Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.

Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence. A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents. These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks. A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions. The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS. By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.

Eligibility Criteria:
Inclusion Criteria:

* Currently in the 6th to 11th grades
* Adolescent and parent must be English-speaking
* Parental consent and adolescent consent

Exclusion Criteria:

* Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
* Suicide attempt in the past week or significant suicidal ideation in the past week
* Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate
Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects

The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55 years (inclusive)
* Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight \> 50 kg

Exclusion Criteria:

* Women of child bearing potential
* Subjects positive for Hepatitis B, Hepatitis C, or HIV
* Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months