cyrilzakka/clinical-trials huggingface dataset:
Mobile Health (mHealth) App for Safe Opioid Use

A key driver of the current opioid overdose epidemic is the misuse of legitimately prescribed opioid medications. Patient education through use of mobile technology may help to increase knowledge of appropriate use of opioid medications; however, knowledge does not always translate into behavior modification. Therefore, there is a need for more research into patient-facing technology that can increase both knowledge and behaviors consistent with appropriate opioid use. These needs have been amplified by the severe acute respiratory syndrome coronavirus-2 (COVID-19) pandemic, which has exposed healthcare disparities, heightened the risk for mental and behavioral health disorders, and dramatically increased reliance on telehealth technologies. It is critically important that telehealth solutions be accessible and user-friendly for all consumers, particularly members of underserved communities with limited digital health literacy. This feasibility study will develop a mobile health app to improve appropriate use of opioid medications among patients with a prescription to treat non-cancer pain. The study will use focus groups with consumers and providers to determine the content and features to be included in the app and will test the feasibility of implementing a contingency management approach (i.e., rewards system) with the app using a randomized control trial. The key outcome of interest is confirmation of the design and operating specifications of the app, including the use of contingency management. Secondary outcomes of interest are the overall rating of the app and an increase in knowledge among users regarding the safe use, storage, and disposal of opioid medications.


Eligibility Criteria:
Inclusion Criteria:

* Has current prescription for opioid medication
* Any ethnic group
* Served through the following programs of partnering organization: primary medical care, transgender medical care, HIV and sexually transmitted infection (STI) screening and counseling, LGBTQ services, pre-exposure prophylaxis and post exposure prophylaxis services, health education, clinical research, case management, psychosocial services, nutrition counseling, treatment adherence
* Owns an Android-base smartphone

Exclusion Criteria:

* Unable to provide informed consent
* Pregnant women
* Currently being treated for/history of mental health or substance use disorder
Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.

To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.

The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.

Eligibility Criteria:
Inclusion Criteria:

* Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
* Prior treatment with \>= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
* Age 18 years or older
* ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
* Central foveal thickness \>275 microns or presence of cystic edema on OCT studies.
* For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.
* Ability to provide written informed consent • Capable of complying with study protocol

Exclusion Criteria:

* History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
* Intraocular injection of steroid medication within prior 4 months
* Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
* Previous laser photocoagulation within 4 months of study
* Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
* Patients who are pregnant.
* Unwilling or unable to follow or comply with all study related procedures.
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

Patients were randomized in a 1:1:1 ratio to placebo, apremilast 20 mg BID and apremilast 30 mg BID. The duration of the study was approximately 5 years. The double blind period (when patients nor the physician knew whether placebo or apremilast was taken) was 24 weeks. At Week 16, participants who did not have either a ≥ 20% improvement or a ≥ 1 unit improvement from baseline in at least two of the four SpondyloArthritis international Society (ASAS) domains were entered in "early escape" from their current treatment in a double-blinded manner. However, such participants were permitted to continue in the study. At Week 24, participants may have entered a long-term extension phase for up to an additional 4.5 years (236 weeks). At "second escape" (at Week 24), apremilast 20 mg BID treated participants transitioned to receive double-blinded apremilast 30 mg BID and remained on double-blinded apremilast 30 mg BID because they continued to improve with a longer duration of treatment. After Week 24 and during the early portion of the long-term extension through Week 52, all participants continued on either double-blinded apremilast 20 mg BID or 30 mg BID treatment. After all participants had completed Week 52 or had terminated early from the study and the 52-week data base was locked, apremilast 20 mg BID or 30 mg BID treatment was provided.

Eligibility Criteria:
Inclusion Criteria:

* Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain and stiffness, which improves with exercise, but is not relieved by rest for more than 3 months prior to screening. At the completion of screening procedures, a documented diagnosis of definite active AS, as defined by the modified New York criteria (1984) whereby both criteria, at least 1 radiographic criterion and at least 1 clinical criterion, must be met
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is ≥ 4
* Total back pain is ≥ 4
* On stable dose of AS medication (or lack of medication) prior to randomization and through week 24

Exclusion Criteria:

- Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for AS
DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open angle glaucoma or ocular hypertension
* Provided signed, written informed consent
* 20 years of age and older
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)

The objective of this research work is two-fold: (i) to conduct a systematic literature review to identify surrogate endpoints in this specific drug class (review registered in the PROSPERO database) and (ii) to assess the surrogate properties of candidate surrogate endpoints in the specific context of melanoma cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients included in phase III randomized clinical trials (RCT)
* Metastatic melanoma

Exclusion Criteria:

* N/A
A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years

This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults 18 to 49 years of age.
2. Healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study.
3. Negative serum pregnancy test for all female subjects who are of childbearing potential.

Exclusion Criteria:

1. Baseline laboratory test results outside of the normal reference range considered clinically significant.
2. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) associated with a vaccine.
3. History of culture-proven invasive disease caused by S pneumoniae.
4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
5. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12 months before investigational product administration, or planned receipt through study participation.
6. Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study participation and for at least 6 months after the last dose of investigational product.
Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling

The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with genodermatosis (i.e, keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses) and a desire to have children, with if applicable his or her partner with a desire to have children
* Patients with clinically and molecularly confirmed variant of a genodermatosis
* Health care professionals involved with the care of genodermatology patients (e.g. clinical geneticists, dermatologists)

Exclusion Criteria:

* Not being able to communicate verbally in Dutch or English
Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

Topical steroids are used as treatment for non-retractile foreskin in children for decades, but, there are disagreement among physicians about the optimum potency of the agent used. This study is designed to determine any difference in the beneficial effects of mild versus potent topical corticosteroids in treatment of non-retractile foreskin in children.


Eligibility Criteria:
Inclusion Criteria:

* Children 2-16 with non-retractile foreskin

Exclusion Criteria:

* Balanitis xerotica obliterans, balanitis, \<2yrs
Prospective Evaluation of Volatile Sedation After Heart Valve Surgery

Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids.

The study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.


Eligibility Criteria:
Inclusion Criteria:

* Valve reconstruction or valve replacement
* Must be capable to giving written consent

Exclusion Criteria:

* Intolerance to volatile anaesthetics (e.g. malignant hyperthermia)
* Severe obstructive pulmonary disease
* Extended aortic arch or ascending aorta surgery
* Age \<18 years
Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia

Mastectomy triggers stress and inflammation responses due to tissue trauma. Surgical stress will increase levels of hormones (adrenocorticotropic hormone, cortisol, antidiuretic hormone, epinephrine, norepinephrine, and dopamine) and inflammatory cytokines (Tumor Necrotic Factor-α, interleukin-1, interleukin-2, and interleukin-6) in the body. This causes insulin resistance, gluconeogenesis, and glycolysis, and impaired insulin secretion, which results in hyperglycemia due to intraoperative stress. Intraoperative hyperglycemia increases postoperative complications and mortality. Inhibition of hyperglycemia due to operative stress and stress hormones with good anesthetic management in improving patient outcomes.

The choice of opioid type plays an important role in suppressing the perioperative stress and inflammatory response. Opioids are an alternative, besides the use of regional anesthetic techniques which have been proven to suppress the perioperative stress response. Fentanyl is one of the phenylpiperidine synthetic opioids. Large doses of fentanyl can reduce stress responses but also increase side effects, such as hemodynamic instability and decrease T-cell function.

Remifentanil provides unique pharmacokinetic benefits through nonspecific esterase enzyme metabolism, so it has a very fast onset and half-life. In addition, remifentanil also provides benefits in reducing the production of interleukin 6 cytokines (IL-6) and tumor necrosis factor α (TNF-α) and inhibits neutrophil migration through the endothelial layer.

The stress response to stress and inflammation is directly proportional to the dose of remifentanil given. It is reported that remifentanil can suppress cortisol response according to increasing dose.

Winterhalter et al. and Lee et al. reported that remifentanil is better at suppressing the stress response than fentanyl. On the other hand, Bell et al. showed no difference in cortisol and hemodynamic levels between the two groups.

The goal of this study is to see if remifentanil provides less increase in serum epinephrine level, norepinephrine level, platelet to lymphocyte ratio (PLR), lymphocyte to monocyte ratio (LMR), and blood glucose level at one-hour and 24-hours postoperative in patients undergoing mastectomy surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a mastectomy under general anesthesia
* Patients aged 30-65 years old
* ASA physical status: I-II

Exclusion Criteria:

* Refusal to be included in the study
* History of opioid allergies
* Long-term use of steroids
* Patients on β blockers medication
* History of diabetes, autoimmune disease, or heart disease
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)

The mechanism for increased androgen production in women with polycystic ovary syndrome (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal women. To test this hypothesis, the investigators propose to conduct a dose-response study in which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH surrogate, will be assessed in PCOS and normal women.

Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research Center (GCRC) for study on 5 occasions. All subjects will receive an intravenous injection of hCG dose of 1, 10, 25, 100, and 250 micrograms, each of which will be given on one of 5 different days each separated by at least two weeks at 8 AM. Blood samples will be obtained at t -0.5, 0, and 24 hours after injection. All visits to the GCRC will be done as out patients. The total amount of blood withdrawn will be about 35 teaspoons. For normal control subjects this will be over a period of about 4-6 months and for PCOS subjects this will be over a period of about 6-10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Normal CBC (Hemoglobin must be at least 11mg/dl)
* Normal renal and liver function tests
* Normal vital signs including normal blood pressure

Exclusion Criteria:

* No oral contraceptives
* No insulin lowering drugs
* No anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
* No medications that will influence androgen metabolism or clearance
* No medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconozole, etc)
* No use of clomiphene citrate within 3 months prior to study
Phase 1 Study of HBN-1

Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management in adult patients who have experienced out-of-hospital-cardiac arrest. HBN-1 will be administered IV as a loading dose infusion followed by a 12-hour maintenance infusion.

Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management in adult patients who have experienced out-of-hospital-cardiac arrest.

HBN-1 will be administered as an IV solution according to a weight-based escalating loading dose infusion rate scheme involving three sequential cohorts with a loading dose of HBN 1 administered over 60 minutes (Cohort A), 45 minutes (Cohort B), or 30 minutes (Cohort C). For all cohorts, the loading dose will be followed by a 12-hour maintenance infusion of HBN-1.

Dosing cohorts will include a minimum of 6 subjects randomized in a 2:1 ratio of HBN-1 plus standard of care versus standard of care alone. Individual cohorts may be expanded to up to a maximum of 12 subjects . If the cohort is expanded, the additional subjects will receive HBN-1 + SOC.

During the loading dose and maintenance infusion, physical exam, temperature, assessment of shivering, ECG, vital signs, clinical laboratory, blood alcohol level, and neurologic status will be monitored.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40 to 80 years, inclusive
2. Documented diagnosis of OHCA with ventricular tachycardia/fibrillation, asystole or pulseless electrical activity
3. Return of spontaneous circulation within 50 minutes of the event
4. FOUR Motor Score \<4
5. Maximum estimated weight not to exceed 100 kg

Exclusion Criteria:

1. Return of spontaneous circulation \>8 hours
2. Known history of prior cardiac arrest, alcohol, or substance abuse or dependence
3. Presumed etiology of cardiac arrest is trauma, hemorrhage, or sepsis
4. Comfort measures only or anticipated withdrawal of life-support within 24 hours
5. Is within a protected population group (eg, pregnant or breastfeeding or incarcerated persons)
6. Has history or evidence of significant hepatic dysfunction (Sequential Organ Failure Assessment Hepatic score \>2)
7. Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end-stage chronic illness with no reasonable expectation of survival to hospital discharge
8. Is able to obey to verbal commands
9. Is receiving IV vasopressin or lidocaine hydrochloride
Maternal EED and Aflatoxin Birth Outcomes Study Uganda

This prospective cohort study focuses on the relationship between maternal environmental enteric dysfunction (EED) and maternal aflatoxin B1 exposure and birth outcomes, particularly infant anthropometry and gestational age, in Mukono, Uganda.

The problem of stunting, which has long-term health and economic consequences both at the individual and population level, persists in low and middle income countries (LMICs). It has been recognized that an estimated 20% of stunting begins in-utero. Although poor maternal nutrition during pregnancy is often blamed, it has been hypothesized that maternal EED status and maternal aflatoxin exposure during pregnancy may also play a role. However, to date, there have been no studies which have attempted to show the association between EED in pregnant women and negative birth outcomes. Furthermore, few studies have examined the association between maternal aflatoxin exposure during pregnancy and negative birth outcomes.

In this prospective cohort study, pregnant women were enrolled at their first prenatal visit and birth outcome data was assessed within 48 hours of delivery. EED was measured via lactulose: mannitol (L:M) ratios and serum concentrations of antibodies to the bacterial components flagellin and lipopolysaccharide (LPS). Aflatoxin exposure was assessed by measuring the serum concentration of AFB1-lysine adduct from a blood sample taken at enrollment. Data on covariates were obtained from two surveys, one at enrollment and one three weeks prior to participant's estimated date of delivery.

The specific aims of this study were as follows:

1. To evaluate the relationship between markers of EED in pregnancy and negative birth outcomes, including low birth weight, stunting at birth, small head circumference, and premature delivery.
2. To evaluate the relationship aflatoxin B1 exposure in pregnancy and negative birth outcomes, including low birth weight, stunting at birth, small head circumference, and premature delivery.

Eligibility Criteria:
Inclusion Criteria:

* Carrying a singleton pregnancy
* 18-45 years old
* Residing within 10 kilometers of Mukono Town

Exclusion Criteria:

* Younger than 18 years old or older than 45 years old
* HIV-positive (verified via routine rapid HIV test conducted at first prenatal visit)
* Severely malnourished (defined as BMI \<16.0 kg/m\^2)
* Severely anemic (defined as Hb \<7 g/dl)
* Planning to move away from Mukono District prior to delivery