cyrilzakka/clinical-trials huggingface dataset:
Empowering Cessation ACS South Region

Sexual and/or gender minority (SGM) people face a disproportionate burden of cancer risk, and tobacco use is a key modifiable risk factor. SGM tobacco-related disparities are especially pronounced in places with high levels of stigma against SGM people. This community-engaged and remotely-delivered Research Scholar Grant project will evaluate an empowerment-based smoking cessation intervention tailored for SGM people in high-stigma places. In partnership with Freedom Oklahoma (OK) and a Community Advisory Board from Arkansas (AR) and Texas (TX) this projects aims to: (1) Adapt SGM-serving volunteer activities from the Oklahoma intervention pilot study for delivery in nearby states; (2) Test intervention efficacy among SGM adults in OK, AR, and TX; (3) Identify treatment mechanisms.


Eligibility Criteria:
Exclusion criteria:

* Currently using other smoking cessation treatments.
* Unable or unwilling to use Nicotine Replacement Therapy (NRT)
* Serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler Psychological Distress (PD) Scale-6 19)

Inclusion criteria will be:

1. ≥ 18 years old
2. sexual and/or gender minority-identified (SGM) (see definition below)
3. living in Oklahoma, Texas, or Arkansas (verified by address)
4. a current cigarette smoker (see definition)
5. willing to quit smoking within 30 days of enrollment (see definition)
6. ability to read and speak English 'well' or 'very well'
7. ≥ weekly internet access
8. willing and able to participate in SGM-serving volunteer activities.
9. own a smartphone

Sexual minority identity will be indicated by selecting any non-heterosexual response option(s) from: Heterosexual (Straight); Gay or Lesbian; Bisexual; Something else (please state)." Participants will indicate the sex assigned on their birth certificate (i.e., natal sex). Gender minority identity will be indicated by "Trans male/Trans man;" "Trans female/Trans woman;" "Gender queer/Gender non-conforming;" "Different identity (please state)" or a binary identity (male or female) non-concordant with natal sex.

Current cigarette smoking will be indicated by ≥100 lifetime cigarettes and currently smoking cigarettes "every day" or "some days".

High SGM stigma states are defined as the 22 states wherein ˂60% of the population 'thinks that homosexuality should be accepted'. High SGM stigma municipalities are defined as one of the 246 U.S. municipalities (out of the 496 scored from all U.S. states) that scored below the median (71) on the HRC Municipal Equality Index.

Willingness to quit smoking will be assessed with a single item: "Are you willing to quit smoking cigarettes within 30 days after enrolling in this study? (yes/no)". To be classified as 'ready to quit smoking,' participants will report readiness to quit in the next 30 days and at least 1 past-year quit attempt (i.e., in the "Preparation" stage of change).
Corneal Tissue Inlay for Keratoconus

This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.

The objective of this study is to evaluate the outcomes of placing preserved corneal tissue within the corneal stroma in keratoconus patients as a means of enhancing thickness, stability, and optical conformation.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age, male or female, of any race
* Provide written informed consent and sign a HIPAA form
* Willingness and ability to follow all instructions and comply with schedule for follow-up visits
* For females: Must not be pregnant
* Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus.

Exclusion Criteria:

* Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
* If female, pregnant
* Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme
* Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications For example: a history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.)
* A history of delayed corneal healing in the eye to be treated
* Have used an investigational drug or device within 30 days of the study
Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D

The prevalence of vitamin D deficiency increases as kidney function declines. As a result, many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown that vitamin D supplementation may improve many aspects of poor health such as heart disease and inflammatory markers. The objectives of this study are to determine how supplementing dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels can be maintained after a 6 month treatment course, and to examine the effect of ergocalciferol on biomarkers of inflammation and vascular health.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Activated vitamin D administration
* On chronic hemodialysis for ≥ 6 months
* Use of a synthetic biocompatible dialysis membrane
* 25-hydroxyvitamin D levels \< 30 ng/mL
* Corrected serum calcium \< 10.2 mg/dL
* Serum phosphate \< 7 mg/dL
* Iron replete (Ferritin \> 200 ng/mL and transferrin saturation \> 20%)

Exclusion Criteria:

* Current participation in any other investigational drug trial
* Vitamin D deficiency due to a heredity disorder
* Liver disease or failure
* Current or past treatment with ergocalciferol or cholecalciferol ≥ 2000 IU per day (within the past 6 months)
* Treatment with calcimimetics or bisphosphonates within the last 3 months
* Treatment with anti-epileptics or other medications that can effect vitamin D metabolism
* Malnutrition (serum albumin \< 2.5 mg/dL)
* Pregnancy, positive pregnancy test or breastfeeding
* Malignancy or other significant inflammatory disease
* HIV/AIDS
Low-Cost Contingency Management for Hispanic Outpatients - 3

The purpose of this study is to evaluate the effectiveness of a lower-cost contingency management (CM) procedure in Hispanic substance abusing outpatients. Thirty individuals meeting DSM-IV criteria for substance dependence receive one of two conditions: (a) standard treatment, or (b) standard treatment plus prize CM. Using a cross-over design, CM is implemented in a community-based outpatient clinic and compared with non-CM in the same clinic. The participating clinic is randomly assigned to receive either the CM or non-CM phase first; 15 weeks after the final participant in one phase is enrolled, a one-week washout period occurs, followed by a switch to the other phase. Patients initiating outpatient treatment during the non-CM phase receive standard treatment and submit urine and breath samples 2/week during Weeks 1-6 and 1/week during Weeks 7-12. Patients initiating treatment during the CM phase also receive standard treatment and the same breath and urine monitoring. In addition, they earn the opportunity to win prizes for coming to treatment and for submitting negative breath and urine samples. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.


Eligibility Criteria:
Inclusion criteria:

* age \> 18 years
* current DSM-IV substance dependence.

Exclusion criteria:

* have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
* have dementia (\<23 on the Mini Mental State Exam; Folstein et al. 1975)
* DSM-IV diagnosis of pathological gambling
* plans to move from the Hartford are within 9 months.
Safety Study of ADV-specific T-cells in Paediatric Patients Post Allo-HSCT

Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune response post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral therapy without toxicity or increasing the occurrence of Graft Versus Host Disease. This is a Phase I/IIa open-label safety study, assessing the effects of administering adenovirus-specific T-cells (Cytovir ADV) to paediatric patients post haematopoietic stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

Patients:

1. Age 16 years or younger
2. Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor
3. The subject (or legally acceptable representative) must give informed consent (and assent for subjects ≥ 12 years). All subjects will have a parent or guardian provide informed consent and the subject will provide witnessed verbal assent
4. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG.

Donors

1. Meets requirements of Directive 2004/23/EC as amended and the UK statutory instruments pursuant therein
2. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG
3. Passed medical assessment for stem cell donation
4. HdADV seropositive
5. Signed informed consent
6. Age 16 years or older

Exclusion Criteria:

Patients

1. Pregnant or lactating females
2. Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
3. Human Immunodeficiency Virus (HIV) infection

Donors

1. Pregnant or lactating females
2. (assessed prior to apheresis) Platelets \< 50x109/L
The Heartland Study

The Heartland Study is a prospective, observational study that will enroll up to 2,600 pregnant participants across the Heartland States in the U.S..

The objective of the Heartland Study is to address major knowledge gaps concerning the health effects of herbicides on maternal and infant health. The study is being conducted to evaluate the associations between environmental exposures to herbicides during and after pregnancy and reproductive health outcomes. The study is measuring multiple biomarkers of herbicide exposure among pregnant Midwesterners and their partners to evaluate associations with pregnancy and childbirth outcomes, epigenetic biomarkers of exposure, and child development.

During Phase 1 of the Study, newly pregnant mothers will be enrolled less than or equal to 20 weeks + 6 days gestation and followed through to the end of pregnancy. Prenatal urine and buccal (cheek) samples will be collected to measure urinary herbicide exposure levels and to identify herbicide induced epigenetic biomarkers. Pregnancy outcomes and fetal health will be documented and analyzed to further investigate potential effects of fetal exposure. Indirect measures such as food and beverage consumption, workplace and household related chemical exposures, substance use, residential proximity to agricultural fields, and socioeconomic factors will be captured from questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant persons ages 18 or older at time of consent who are ≤20+6 weeks pregnant. Best clinical estimate of gestational age will be utilized for recruitment purposes. Enrollment in the first trimester (≤ 13 + 6) is preferred, but anyone ≤ 20 +6 is permitted.
* Living in one of the 13 Heartland Study region states at the time of enrollment (Arkansas, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, or Wisconsin) Optional inclusion of the putative biological father

Exclusion Criteria:

* Participants who are not fluent in and/or do not fully understand, read, write, or speak the English language.
* Other inability to provide informed consent to participate
Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly

The CIRCLE study is a single-center prospective observational study that enrolled individuals with cerebral small vessel disease (SVD), while free of known dementia or stroke (both cerebral infarction and hemorrhage). The patients will receive neuropsychological testing, retinal digital images and multimodal magnetic resonance imaging (MRI). Blood samples will also be collected. Recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and brain atrophy will be evaluated on both baseline and follow-up brain MRIs. The investigators will explore the predictors of preogression of SVD and cognitive deficits.

Cerebral small vessel disease (SVD) is commonly detected in elderly individuals, and patients with stroke or neurodegenerative disease. Features seen on neuroimaging include recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and brain atrophy. Previous studies indicated that SVD was associated with an increased risk of stroke and stroke recurrence, cognitive deficits, physical disabilities, and mortality. However the pathogenesis of SVD is largely unknown. Little is known about how SVD lesions contribute to neurological or cognitive symptoms, and the association with risk factors. Recent data sugessted concomitant SVDs and retinopathy is associated with a profile of vascular cognitive impairment. In this study, the investigators try to explore the new pathological mechanism of SVD, the new predictors for SVD progression, and the association with cognitive Impairment, based on digital retinal images and brain multimodal imaging technique.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥40y; no upper limit)
* Free of known dementia or stroke (both cerebral infarction and hemorrhage)

Exclusion Criteria:

* Any MRI contraindications
* Serious head injury (resulting to loss of consciousness) or received intracranial surgery
* Suffering from cancer
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Adult patients (≥ 18 years old) with chronic renal anemia
* Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528\[NCT00048048\], BA16285\[NCT00048035\], BA16286\[NCT00364832\], BA16736\[NCT00077597\], BA16738\[NCT00081471\], BA16739\[NCT00077610\], BA16740\[NCT00077623\], BA17283\[NCT00077766\] and BA17284\[NCT00081484\]
* Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
* Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) \< 10%

Exclusion Criteria:

* Poorly controlled hypertension
* History of epileptic seizure
* Pure red cell aplasia
* Chronic congestive heart failure \[New York Heart Association (NYHA) IV\]
* High likelihood of early withdrawal or interruption of the study
* Active malignant disease (except non-melanoma skin cancer)
* Life expectancy less than 12 months
* Pregnancy or breast-feeding
The Effectiveness of Double Incision Technique in Uterus Preserving Surgery for Placenta Percreta

Placenta percreta is a life-threatening condition that patients are under risk of massive bleeding. It readily necessitates very complicated surgery even leads to mortality. Cesarean hysterectomy is the procedure that is acknowledged worldwide, however, recent studies discussing conservative treatment with segmental resections were published. Fetal extraction and segmental resection could be performed from same (single uterine incision) or two different (double uterine incision) incisions. In this study, the investigators aimed to evaluate the effectiveness and the results of double uterine incision.


Eligibility Criteria:
Inclusion Criteria:

* Intraoperatively and pathologically confirmed diagnosis of placenta percreta

Exclusion Criteria:

-
Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation

The objective of this EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor
* Confirmed presence of a KRASG12C mutation
* Ineligible for an ongoing clinical trial of MRTX849
* No available or not eligible for standard of care treatment
* Adequate organ function
* CNS Metastases (within set parameters) are allowed
* ECOG performance status of ≤ 2

Exclusion Criteria:

* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of MRTX849 treatment or result in inability to swallow
* Prior therapy targeting a KRAS G12C mutation
* Other active cancer
Clinical Signs and Symptoms of Anemia in Patients Over 75 Years

Anemia is a common pathology in geriatrics. According to the World Health Organization it affects 23.9% of subjects over 60 years in the world, and 8% of patients over 60 years in Europe. A prevalence that increases with the age and twice in individuals over 85 years.


Eligibility Criteria:
Inclusion criteria:

* Adult over 75 years old, male or female

Exclusion criteria:

* Transfusion within 3 months, acute anemia / deglobulisation
BELIEVE Study: Nesiritide and Post Myocardial Infarction Left Ventricular Modeling

This study is being done to determine the effects (good and bad) of intravenous infusion of a human brain natriuretic peptide (BNP), Natrecor (nesiritide), a hormone produced by the heart in persons who have just suffered a heart attack. The human BNP, Natrecor (nesiritide) has been approved by the United States Food and Drug Administration (FDA) to be given intravenously for the management of acute heart failure. It is unknown if human BNP may have good effects on the pumping function of the heart after a heart attack.

During the 72 hours of intravenous (IV) nesiritide infusion, if the systolic blood pressure decreases to less than 90 mmHg for 5 minutes, the coronary care unit (CCU) sx will be notified and if the systolic blood pressure has not increased to \> or equal to 90 mmHg within 45 minutes, the nesiritide infusion will be stopped. All patients will receive other medical therapy as determined appropriate by the physician except for angiotensin converting enzyme inhibitor (ACEI), which will be started 24 hours after IV nesiritide. Lisinopril will be started 24 hours after the start of IV nesiritide at an initial dose of 2.5 mg and to be titrated up by the participants' physician according to their clinical status. The window for the lisinopril doses would be +/- 1 hour.

Patients with any signs or symptoms of post revascularization ischemia will be discontinued from the study.

Blood for the measurement of renin, angiotensin II (Ang II), aldosterone (Aldo), endothelin (ET)-1, norepinephrine, atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), cGMP, C reactive protein, tumor necrosis factor (TNF)-alpha, matrix metalloproteinase (MMP)-2 and tissue inhibitor of metalloproteinase (TIMP)-2 will be drawn before the initiation of IV nesiritide, six hours into the infusion before the initiation of ACEI and just before completion of the 72 hour infusion. The window for the blood draw for the six hour time point would be +/- 1 hour and the 72 hour time point would be +/-1 hour or just prior to discharge but not less than 66 hours.

MUGA will be performed within 24 hours after the initiation of the IV nesiritide to assess systolic and diastolic volumes and LV ejection fraction (EF).

Follow up at 4 weeks:

All patients, whether they complete the entire 72 hours of the nesiritide infusion or not, will return 1 month later for a repeat MUGA and blood draw for the neurohumoral profiling and pregnancy test if required by nuclear cardiology. The visit window for the one month return would be 30 to 40 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ST elevation myocardial infarction of at least \> 2mV ST elevation in two or more anterior precordial leads, with successful revascularization (Thrombolysis in Myocardial Infarction \[TIMI\] grade 3 flow) of the lesion within 24 hours of chest pain as documented by coronary angiogram.
Finding Patterns In Clinical Trial Experiences of Patients With Eczema

Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited.

Eczema clinical trial patients help us identify these factors by sharing trial experiences during the course of the observational medical study.

This study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. The collected data will then be used to benefit future eczema patients who are considering participating in a clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with eczema
* Patient is 18 years old
* Patient has self-identified as planning to enroll in an observational clinical study

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Patient is pregnant
* Inability to perform regular electronic reporting