cyrilzakka/clinical-trials huggingface dataset:
Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease

Two recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.


Eligibility Criteria:
Inclusion Criteria:

* acquired penile curvature of \> 30 degrees and \< 90 degrees associated with palpable penile plaque on physical examination
* onset of curvature within 18 months prior to signing consent form
* serum TT \< 500 ng/dl at the screening visit

Exclusion Criteria:

* prior history of treatment for PD that includes intra-lesional injections, topical creams, or surgery
* prior treatment with oral therapy at least 2 weeks prior to signing consent form (e.g. Potaba, Vitamin E, colchicines) will be acceptable for inclusion
* prior history of treatment for testosterone deficiency
* presence of dense calcified plaque by US or plain radiograph
* taking the medication Coumadin
* hypersensitivity to testosterone, stearic acid, or polyvinyl pyrolidone (the constituents of Testopel)
* unable to achieve adequate erection with penile injection to access degree of curvature
* undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy.
* prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with human immunodeficiency virus, or psychiatric disorders including major depression, schizophrenia, bipolar disease
* history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
* PSA \> 4.0 ng/dL at the screening visit, unless prostate cancer has been excluded to the investigator's satisfaction
* clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
* received any other investigational drug within 30 days
Search for a Recanalization of the Sylvian Artery Electro-Physiological Biomarker

Early recanalization is a major prognostic factor in vascular accidents ischemic brain injury (AIC). The acute phase therapies of AIC aim to recanalization by intravenous thrombolysis and/or mechanical thrombectomy. Recanalization is identified immediately during thrombectomy by per-procedural arteriography. For the thrombolysis, only a performed MRI will validate the recanalization. This "proof of concept" study aims to identify an Electro-Encephalographic biomarker (EEG) of the recanalization in real time, the EEG being easy to set up. This biomarker will be sought during recanalization certified by thrombectomy in order to identify the window time for which the biomarker must be sought on the EEG. During this study, the identified EEG biomarker can be used to validate the recanalization during the intravenous thrombolysis in future studies


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Presenting a cerebral infarction with proximal occlusion of the sylvian artery requiring thrombectomy
* No objection to participation in the study

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient benefiting from legal protection
* Absence of affiliation to a social protection scheme
* Recent cranial surgery not allowing the installation of a scalp EEG
Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.

Low levels of zinc are associated with an increased risk of HIV-related death and opportunistic infections in HIV infected individuals. Drug users are especially susceptible to zinc deficiency. The purpose of this trial is to evaluate the effectiveness of zinc therapy in preventing immune failure in HIV infected individuals who abuse drugs.

This trial will last 30 months. Participants will be randomly assigned to receive either zinc supplements or placebo. Male participants will receive 15 mg of zinc and female participants will receive 12 mg of zinc. Clinical and laboratory study visits will occur at 3 or 6 month intervals throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Drug User
* Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml

Exclusion Criteria:

* Currently participating in an another clinical trial
* Blood selenium level less than 85 mcg/L
* Pregnant or intends to become pregnant
Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism

Dexmedetomidine's Sedative Effect on Diabetic Patient

Dexmedetomidine is a high selective α2 agonist,its sedative and analgesia feature is acclaimed. The pathogenesis of type 2 diabetes mellitus is associated with α2 excessive adrenaline receptors expression. This study is to evaluate whether the use of dexmedetomidine is helpful to Diabetic Patient through its antisympathetic effect

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 60
* Selective epigastrium surgery
* In

Exclusion Criteria:

* American Society of Anesthesiology (ASA) Physical Status\>3
* Duration of operation \>3 hours
* Hypovolemia,sinus bradycardia,atrioventricular block,severe hepatic and renal dysfunction,severe cardiac insufficiency
Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

The purpose of this study is to collect a large amount of data that may assist in addressing the gap in knowledge of understanding pupillometer readings using a pupillometer device.

The aim of this project is to establish normative values for pupillometer data. Measures of central tendency will be developed for the variables provided by automated pupillary exams, which will provide an enhanced understanding of clinically appropriate pupil values for size, reactivity, and neurological pupil index.

Data will be collected on patients in the intensive care units at the selected hospitals on patients who have been assigned, by the attending physician, to have regular pupillary assessments, and in whom staff nurses are performing pupillary assessments with the pupillometer. While a sample size estimate would be considered inappropriate for registry development, power analysis techniques were used to examine the potential of this registry to generate adequate information to begin to fully describe normative data for pupillary exams. Using the assumption that the desire is to understand neurological pupil index (NPi) and size differences within 0.1, and that the spread of data would be approximately normally distributed, a minimum of 3,250 observations is required (alpha = 0.05, beta = 0.80). It must, however, be repeated that this is simply a rough estimate. The registry data generated will, in fact, be the source of data from which future studies will be powered.

Eligibility Criteria:
Inclusion Criteria:

* Data will be collected on patients admitted to enrolling hospitals who have been assigned, by the attending physician, to have regular pupillary assessments, and in whom staff nurses are performing pupillary assessments with the pupillometer.

Exclusion Criteria:

* Out-patients
* Patients that do not have orders for regular pupillary assessments
Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation

To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH.

* Determine if there is aa reduction in PIH in patients treated with three (3) monthly sessions of fractionated 1927-nm non ablative thulium laser
* Determine if there is efficacy of post-procedure clobetasol propionate 0.05% ointment in the management of PIH
* Determine the histological and molecular changes that occur with laser and laser plus topical steroid treatment compared to untreated skin

The design of the study consists of a total of six visits including one initial screening visit within 107-127 days depending on the scheduling of your screening and subsequent visits. Assessments such as visual examination, photography, Investigatory Global Assessment (IGA) of pigmentation and erythema; Colorimetry; and Diffuse Reflectance Spectroscopy of the intended treatment area will be conducted at Visits 1-5. Optional biopsies will be taken at various time points.

Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 and older
* Patient with skin phototypes IV-VI
* Patient able to understand requirements of the study and risks involved
* Patient able to sign a consent form
* Patient to have discontinued all oral medications used to treat pigmentary abnormalities and all topical medications, except for sunscreen, used to treat pigmentary abnormalities on the buttocks one month prior to treatment

Exclusion Criteria:

* A patient who has skin dyspigmentation, birth marks, tattoos, or other skin findings at baseline on either buttock that may obscure study results
* A patient who is lactating, pregnant, or planning to become pregnant
CardioMEMS HF System OUS Post Market Study

The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with New York Heart Association (NYHA) Class III Heart Failure in a commercial setting.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from subject
2. ≥ 18 years of age
3. Diagnosis of NYHA Class III Heart Failure
4. At least 1 HF hospitalization within 12 months of Baseline visit
5. Subjects with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB.
6. Subjects with a BMI ≤ 35. Subjects with BMI \>35 will require their chest circumference to be measured at the axillary level, if \> 65 inches the patient will not be eligible for the study.
7. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)
8. Subjects willing and able to comply with the follow-up requirements of the study

Exclusion Criteria:

1. Subjects with an active infection
2. Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
3. Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
5. Subjects with Cardiac Resynchronization Device (CRT) implanted \< 3 months prior to enrollment
6. Subjects with a Glomerular Filtration Rate (GFR) \< 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
7. Subjects with congenital heart disease or mechanical right heart valve(s)
8. Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
9. Subjects with known coagulation disorders
10. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).
Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.

This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP \>= 21 mmHG).
* Visual acuity \>= 20/200.

Exclusion Criteria:

* Closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
* Hystory of ALT within 3 months prior to the baseline visit.
* History of any ocular filtering surgical intervention.
* Ocular surgery or inflammation/infection within 3 months prior to the baseline visit.
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care

The purpose of the study is to rigorously evaluate Next4You, an innovative, fully mobile program featuring 6 content modules, each containing 8-10 microlessons intended to reduce rates of unintended pregnancy and sexually transmitted infections (STI) and increase essential knowledge, attitudes, and skills among young people aged 16-19 currently in the foster care system in California.

Next4You will be tested using a randomized controlled trial (RCT) involving approximately 500-600 young people ages 16-19 with former or current experience in the California foster care system. Participants will complete an online screener that will assess eligibility (age, foster youth status, county of residence, English proficiency, and access to a device that is Wi-Fi or cellular enabled). Participants will be randomly assigned to receive access to the Next4You mobile platform and its microlessons and resources or a control website containing various health promotion materials. Participants in both conditions will have four consecutive weeks to explore the content on the platform (defined as the implementation period). Self-reported survey data related to attitudes, knowledge, and behavior around romantic relationships and sexual behavior are collected at baseline, as well as 3 months and 9 months after the intervention ends.

Eligibility Criteria:
Inclusion Criteria: Age, foster youth status, county of residence, English proficiency, access to a digital device that is Wi-Fi and/or cellular enabled -

Exclusion Criteria:

-
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)


Eligibility Criteria:
Inclusion Criteria:

* Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the Study Eye at Screening
* BCVA ETDRS score between 78 and 25 letters (Snellen equivalent \~20/32 and 20/320) inclusive, in the Study Eye at screening and reconfirmed at Day 1.
* Capable of giving signed informed consent.

Exclusion Criteria:

* BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular)
* Fibrosis or atrophy of \>50% of the lesion size and/or involving the foveal center of the Study Eye at Screening
Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis

Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.


Eligibility Criteria:
Inclusion Criteria:

* 16-65 years old individuals with probable of definite AIH according to the revised AIH criteria.
* Willing and able to participate in the study

Exclusion Criteria:

* Non-consenting patients
* decompensated cirrhosis, i.e. clinical ascites, hepatic encephalopathy, history of variceal bleeding
* Presence of serious concomitant cardiovascular, pulmonary or renal condition
* Presence of active malignant disorder
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.


Eligibility Criteria:
Key Inclusion Criteria:

* HCV RNA ≥ 10\^4 IU/mL at screening
* HCV genotype 1, 2, 3, 4, 5, 6
* Cirrhosis determination, a fibroscan or liver biopsy may be required
* HIV-1 infection
* Use of protocol specified method(s) of contraception
* Screening laboratory values within defined thresholds

Key Exclusion Criteria:

* Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
* Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
* Screening ECG with clinically significant abnormalities
* Pregnant or nursing female or male with pregnant female partner
* Infection with hepatitis B virus (HBV)
* Use of any prohibited concomitant medications as described in the protocol
* Chronic use of systemically administered immunosuppressive agents

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Effects of Breathing Exercises on Fear of COVID-19, Anxiety, Sleep and Quality of Life During the COVID-19 Pandemic

It has been reported that in the first stages of the pandemic, a significant portion of the general population experienced psychological problems such as anxiety, depression and post-traumatic disorders. These problems persist today. A balanced diet, physical activity participation and relaxation techniques are recommended for preventing such problems. In studies conducted before the pandemic, it is reported that breathing exercises have positive effects on anxiety, sleep and quality of life in both patients and healthy individuals. Aim of this study is to investigate the effects of breathing exercises applied via teleconference on fear of COVID-19, anxiety, sleep and quality of life in healthy adult population.


Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in the study
* having a smart phone that can be used for teleconferencing purposes

Exclusion Criteria:

* have had COVID-19
* hospital admission for suspected COVID-19 in the past week
* having acute respiratory tract infection
* having any diagnosed chronic respiratory, cardiovascular, metabolic or neurological diseases
Cornea Ectasia Excimer Laser Treatment

To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

Background To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia performed with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years) affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were evaluated preoperatively and 6 months postoperatively using corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

- keratoconus with moderate severity (Amsler-Krumeich stage I-II)

Exclusion Criteria:

* concomitant ocular disease
* concomitant systemic disease
* corneal opacities
Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer

The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Since higher doses of radiation are used each day, the total number of treatment days needed to complete this type of radiation is only five instead of the 45-48 treatments currently used. Treatment takes place every other day and is complete after 2 weeks. If the patient decides to get this treatment, they will come in for 5 treatments. This is different from the 48 treatments they would get normally.


Eligibility Criteria:
Inclusion Criteria:

Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.

* Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
* Low risk patients will be defined as:

  * PSA \< or = to 10 ng/ml and
  * Gleason score = 6 and
  * Clinical Stage \< or = to T2a
* Intermediate risk patients will be defined as:

  * PSA 10-20 ng/ml or
  * Gleason score = 7 or
  * Clinical stage T2b/T2c

Additionally, patients will be required to meet the following criteria:

* Age \> or = to 18
* KPS \> or = to 70
* Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
* Prostate size \< or = to 60 cc
* International Prostate Symptom Score \< or = to 15

Exclusion Criteria:

* Prior androgen deprivation therapy for prostate cancer

  * Elective pelvic lymph node irradiation
  * KPS \< 70
  * Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
  * Presence of distant metastasis as determined by:

    o alkaline phosphatase \> or = to ULN or
  * whole body bone scan positive for osseous metastases
  * Prior history of transurethral resection of the prostate
  * Prior history of chronic prostatitis
  * Prior history of urethral stricture
  * Prior history of pelvic irradiation
  * History of inflammatory bowel disease
  * Unable to give informed consent
  * Unable to complete quality of life questionnaires Abnormal complete blood count. Any of the following

    * Platelet count less than 75,000/ml
    * Hb level less than 10 gm/dl
    * WBC less than 3.5/ml
  * Abnormal renal function tests (creatinine \> 1.5)
Mindfulness Training for Senior Leaders

The overarching goal of the project is to investigate if a mindfulness-based attention training (MBAT) program contextualized for Military Senior Leaders (SLs) might benefit SLs in three key domains: (1) cognitive abilities, (2) psychological well-being and self-reported physical health, and (3) strategic leadership skills and ability. The MBAT-SL program will be tested by the training cohorts and compared to the wait-list control cohorts who will receive the training after a no-training interval.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are between 18 and 65 years of age.
2. Individuals who are fluent English speakers.
3. Individuals who are active-duty service members
4. Individuals who are willing and able to consent to participate in the study.
5. Individuals who participated in the courses provided by the Army War College (AWC).

Exclusion Criteria:

1. Individuals who have been hospitalized for psychological/mental health issues within the last month