cyrilzakka/clinical-trials huggingface dataset:
Faith-Based African American Cancer Survivorship Storytelling

The purpose of this research study is to evaluate the feasibility and acceptability of an intervention (viewing of video recordings) designed to reduce psychological distress among African Americans during treatment for cancer. This knowledge will inform a larger test of an intervention.

This study addresses a need to integrate spirituality with cancer care as requested among African Americans. In the PI's research with African Americans, a dominant mental health promoting strategy used in response to a cancer diagnosis is the use of religious stories and songs. African Americans have a strong cultural history of relying on religious stories and songs to overcome oppression and mental suffering encountered in their lived experience. If successful, the findings from this preliminary study will contribute to the evidence that spirituality is important to cancer care and to achieving optimal patient outcomes among this medically underserved population. More importantly, the infusion of spirituality in cancer care has to potential to reduce the high levels of psychological distress experienced among African Americans and FCG's; to enable them to become more engaged in their cancer care and in supportive family relationships; and, ultimately to improve the overall quality of life for African American cancer patients and FCGs. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period. The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn.

Eligibility Criteria:
Inclusion Criteria for Patients:

* Age 30-89 years
* Newly diagnosed with any stage cancer
* Treatment plans to include weekly outpatient chemotherapy
* Previously screened and with greater than 0 level of psychological distress
* Willingness to participate in all study activities including data collection
* Willing to identify a family caregiver (FCG) (immediate or extended family member) to also participate

Exclusion Criteria for Patients:

* Have completed surgery with no plans for chemotherapy
* Find conversations around religion or spirituality emotionally upsetting
* Have completed more than half of prescribed chemotherapy treatments
* In hospice care
* Not able to provide informed consent

Inclusion Criteria for Family Caregiver:

* Immediate or extended family member of the patient
* 18 years of age or older
* Able to provide informed consent
* Willing to participate in study activities, including data collection

Exclusion Criteria for Family Caregiver:

* Find conversations around religion or spirituality emotionally upsetting
Comparative Treatment Study in Patients With Lower Ureteral Stones

We wish to determine the best treatment for expulsion of lower ureteral stones. Which of the three major treatment protocols is the best treatment of conservative management of ureteral stones?

The study will include 60 patients with lower ureteral stones. The patients will be divided into three groups. The first group will be administered Alfuzosin (10 mg). The second group will be administered a combination of Alfuzosin (10 mg)and Rowatinex (Pinene 31%, Camphene 15%, Anetol 4%, Borneol 10%, Cineol 3%, Fenchenol 4%, Olive Oil 33%). The third group will be administered Rowatinex.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lower ureter (urinary calculi) up to 8mm
* Must be able to swallow tablets

Exclusion Criteria:

* Sensitivity to Alfuzosin and Rowatinex
* Pregnant and breastfeeding women
* Single kidney
* Obstructing stone
* Renal failure creatinine up to 1.8 mg/dl
* Patients using various alpha blockers
* Liver failure
* Fever higher than 38 C
* UTI
* Syncope or hypotension
* Patients treated with PDE5
* Patients treated with inhibitor CYP3A4
* Patients refusing participation
A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection

To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus


Eligibility Criteria:
Inclusion Criteria:

* End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
* Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
* Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study

Exclusion Criteria:

* Receiving or having previously received an organ transplant other than a kidney
* Cold ischemia time of the donor kidney \> 30 hours
* Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
* Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
* Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
* Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
* Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Pregnant woman or breast-feeding mother
* Subject or donor known to be HIV positive
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
* Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully
* Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

Acute cellular rejection is relatively common after liver transplantation, typically does not affect graft survival, and is not associated with the development of chronic rejection. Acute cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated when compared to baseline. The only means of differentiating acute rejection from other liver pathologies is with a liver biopsy. However, even with this invasive diagnostic procedure, it may be difficult to distinguish acute rejection from another disease process, such as injury caused by the hepatitis C virus (HCV) from the native liver. This study will evaluate whether certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver transplant recipient can be used to determine if the transplanted liver is being rejected by the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific for acute rejection and informative of the severity of HCV recurrence could allow for modulation of immunosuppression therapy and treat the clinical condition without the need for invasive liver biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Specimens derived from subjects enrolled in the ITN030ST study.
* Availability of adequate biopsy specimens with corresponding blood and/or serum collected within a 10 day window of a for-cause or protocol biopsy.

Exclusion Criteria:

* Withdrawal of consent for the ITN030ST study.
* Absence of consent in the ITN030ST study for the collection and storage of samples of blood and tissue for future research studies.
Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction in Gynecological Cancers

Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers

Guidelines for the management of patients with Malignant Bowel Obstruction(MBO) are not available and as such, there remains an urgent need for a collaborative approach to streamline patient care and optimize use of hospital resources. This study will focus on management of MBO in advanced gynecological cancers.If patients with MBO can be effectively managed in an ambulatory setting, this may improve quality and consistency of patient care, and help reduce volume and duration of bed occupancy.

Eligibility Criteria:
Inclusion Criteria:

Histologically and /or cytologically confirmed gynecological cancer, including ovarian, fallopian tube, endometrial, cervical or primary peritoneal cancer Deemed to be at risk of developing or have a clinical diagnosis of MBO as defined using the following criteria: clinical evidence of bowel obstruction (history/physical/radiological examination; and bowel obstruction beyond the ligament of Treitz.

Exclusion Criteria:

There are no specified exclusion criteria for this study
Effect of Transcutaneous Nerve Stimulation on Primary Motor Cortex to Modulate Cortical Excitability and Hemodynamic Response During Implicit Motor Learning: A TMS and NIRS Study

Noninvasive brain stimulation was recently gradually be emphasized. The electrical current applied on scalp can effective modulate cortical excitability. Forms of Stimulation included transcranial direct current stimulation(tDCS) and transcranial alternating stimulation(tACS). tDCS had been proved the effect of cortical excitability modulation. The polarization effect of direct current stimulation can modulation specific brain area and enhance motor performance. tACS was still controversial about the effect on cortical excitability. Previous study show that the frequency dependent excitatory or inhibitory effect on cortex. The possible mechanism was to affect brain oscillation status by provided different frequency of stimulation. Transcutaneous nerve stimulation (TENS) was common used on management of chronic pain. Peripheral nerve stimulation can enhance pain or sensory evoked potential was noted. Effect of low frequency TENS on central nervous is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Health Adult
Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism

The investigational enVista IOL, Model MX60Tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism.

The investigational enVista Toric IOL, Model MX60T, and the currently approved Model MX60, are identical with the exception of the addition of toric optics and axis marks on the posterior optic surface for the correction of astigmatism on the Model MX60T. Both lenses have an aspheric biconvex optic with a modified C haptic monoblock, single-piece design. The design and material of both the MX60 and MX60T allow them to be folded and inserted through small incisions to minimize the possibility of surgically induced astigmatism (SIA).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinically significant cataract in the study eye that is considered amenable to treatment with standard phacoemulsification cataract extraction.
* Subjects must require a lens power from 16.0 D to 27.0 D in the study eye.
* Subjects must be willing to discontinue contact lens wear for the duration of the study and, demonstrate stability prior to biometry and surgery in the study eye.
* Subjects must have a best corrected distance visual acuity (BCDVA) projected to be better than 20/30 after toric IOL implantation in the study eye.
* Subjects must have predicted postoperative corneal astigmatism between 0.90D and 2.40D in the study eye, as determined by the Toric Calculator.
* Subjects must have a minimum preoperative corneal astigmatism of 0.90 D in the study eye.
* Subjects must have a dilated preoperative pupil size greater than or equal to 5.0 mm in the study eye.

Exclusion Criteria:

* Subjects who have had previous intraocular or corneal surgery in the study eye.
* Subjects with any clinically significant ocular pathology which would be expected to reduce potential BCDVA to 20/30 or worse in the study eye during the course of the study.
* Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery.
* Subjects with associated ocular conditions which could affect the stability of the IOL in the study eye.
* Subjects with a traumatic cataract in the study eye.
* Subjects with uncontrolled glaucoma in the study eye.
* Subjects with clinically significant irregular corneal astigmatism in the study eye, as determined by the medical judgment of the Investigator.
* Subjects with clinically significant corneal pathology potentially affecting topography of either eye.
* Subjects with any ocular condition that could prevent the possibility of a visual outcome better than 20/30 in the study eye.
* Subjects with a difference of greater than 0.50D of corneal astigmatism as measured with the IOL Master and the topographer in the study eye using vector analysis.
* Subjects with an anterior chamber depth \<2mm in the study eye.
* Subjects with potential BCDVA of 20/200 or worse in the fellow eye.
Brain Uptake and Safety With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers

Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects with Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* The subject meets National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for clinically probable AD and Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for dementia of Alzheimer's type.
* The subject meets Petersen criteria for amnestic MCI.
* The subject has no evidence of cognitive impairment by medical history.

Exclusion Criteria:

* The subject may not be able to complete the study as judged by the investigator.
* The subject has received ionising radiation exposure from clinical trials in the last 12 months or has participated in any other clinical study within 30 days of study entry.
* The subject has known allergies to \[18F\]AH110690 or \[11C\]PIB or their constituents.
* The subject is pregnant or breast-feeding.
* The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records.
* The subject has a contraindication for MRI (including, but not limited to, claustrophobia, pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant).
* The subject has a history of head injury with loss of consciousness.
A Transplant or Cancer Resilience Intervention

The overall aim of this protocol is to examine patient and care-giver outcomes and acceptance of a new 6 week intervention in Arizona for our transplant and cancer patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes, that has been approved as a pilot clinical program at Mayo Clinic in Arizona.

Transplant medicine and cancer are major strategic foci of Mayo Clinic. At Mayo Clinic, we are often challenged to respond adequately to the high levels of stress encountered by our transplant patients and their care-givers. The overall aim of this project is to pilot a 6 session intervention in Arizona for our transplant and cancer patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes. Demonstration of a feasible and effective program will allow us to offer similar programs at all three sites. This program has potential to better meet our transplant patients' needs, improve outcomes, and set us apart from other transplant programs who do not offer this intervention for patients and caregivers. Psychiatry already has a good collaboration with transplant medicine, with psychiatry screening transplant patients and following a large subset of patients. Many of the referrals to psychiatry post-transplant have to do with difficulty managing stress or break-down in care-giver support. The proposed program would address this unmet need with a more comprehensive intervention than is currently available at the Mayo Clinic. The role of this pilot program is to:

* Explore the feasibility of routinely offering a resilience intervention involving mindfulness based stress reduction to our solid organ and stem-cell transplant and cancer patients and their care-givers.
* Pilot a mindfulness-based group treatment for stress reduction to assess its impact, using standardized rating tools, on transplant patient stress-levels, sleep quality, anxiety, depression, medical outcomes, and health-care utilization
* Examine patient and care-giver acceptance/adherence and satisfaction
* Understand the resources both in terms of staffing and fees required to offer this as a clinical program in the future
* Explore the reimbursement options for covering the program's expenses.

Eligibility Criteria:
Inclusion Criteria:

* Patient listed for liver, heart, kidney, or bone marrow transplant
* Patient who has received a liver, heart, kidney, or bone marrow transplant
* Caregiver of transplant patient
* patient with diagnosis of cancer, either active or in remission
* supportive care partner of cancer patient

Exclusion Criteria

* Suicidal
* Severe cognitive impairment
* psychotic
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease

The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.


Eligibility Criteria:
Inclusion Criteria:

Part 1: Observational Stage

* The infant is less than or equal to (\<=) 4 months of age at enrollment and asymptomatic for acute respiratory illness (ARI)-like symptoms requiring medical intervention at the time of consent to participate in the study
* At least 1 parent/caregiver must be able to use the respiratory syncytial virus (RSV) mobile application (App) at home via his/her own Android/iOS electronic device (compatible with RSV mobile App)
* The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

Part 2: Interventional Stage

* The infant is 28 days and if prematurely born infant (that is \[i.e.\], less than \[\<\] 37 weeks and 0 days of gestation at birth) is at least 3 months postnatal age
* The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay
* The participant weighs more than 2.4 kilogram (kg)
* The participant has an acute respiratory illness as evaluated by the investigator
* Except for the RSV-related illness, the participant must be medically stable in case of allowed co-morbid conditions
* The participant must have been assessed per local public health practice and considered not to have SARS-CoV-2 infection during this respiratory infection

Exclusion Criteria:

Part 1: Observational Stage

* The participant has any physical abnormality which limits the ability to collect regular nasal specimens
* The participant is receiving chronic home oxygen therapy at enrollment (applicable to both parts)

Part 2: Interventional Stage

* The participant is \<3 months postnatal age at screening and was born prematurely (i.e., \<37 weeks and 0 days of gestation) or if the participant weights \<2.4 kg
* The participant has a QT interval with Fridericia's correction (QTcF) greater than (\>) 450 milliseconds per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate Electrocardiogram (ECG) recording during screening
* The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition or medical therapy
* The participant has had any of: a) Confirmed SARS-CoV-2 infection (test positive) during the four weeks prior to randomization, or b) Close contact with a person with Coronavirus Disease 2019 (COVID-19) (test confirmed or suspected SARS-CoV-2 infection) within 14 days prior to randomization
Impact of Beta-lactams on the Microbiota and Relative Fecal Abundance of Mulltidrug Resistant Bacteria

The global spread of ESBL-producing enterobacteria (EBLSE) poses a real public health problem. The exposure of patients to antibiotic therapy leads to an increase in resistant bacterial populations within the digestive flora. As a result, the diagnosis of digestive colonization by EBLSE is an event that has become common in hospitalized patients in intensive care / intensive care under high pressure antibiotics. The aim of this work is to study the impact of beta-lactams frequently prescribed on the microbiota and the emergence of multiresistant bacteria in the digestive flora and to evaluate, in colonized patients, the factors associated with the occurrence of an infectious episode. In particular, the impact of the relative fecal abundance of ESBL enterobacteriaceae on the occurrence of this event will be studied.

Among enterobacteria, the production of ESBL is the first cause of multi-resistance. The consequences of multidrug-resistant enterobacterial infections predominantly represented by ESBLs are currently well known, both from the individual point of view (increase in mortality and length of hospital stay) and collective (increase in costs of care). Data from the literature reveal an increased risk of ESBL bacteremia in patients with rectal carriage of ESBL-producing enterobacteria. It therefore appears necessary in known patients with ESBL-producing enterobacteria to evaluate the impact of different antibiotics (beta-lactams) on the modification of flora, the increase of faecal abundance in multidrug-resistant bacteria such as E. coli ESBL and evaluate the factors associated with infections in these patients.

Eligibility Criteria:
Inclusion Criteria:

* age\> 18
* ICU admitted patient
* rectal colonization of Enterobacteria
* accepting participation
* with medical insurance

Exclusion Criteria:

* patient without bacterial colonization
* under antibiotics more than 24hours
* without medical insurance
Liver Transplantation for Unresectable GIST Liver Metastases

Liver Transplantation for Unresectable GIST Liver Metastases


Eligibility Criteria:
Inclusion Criteria:

* GIST diagnosis (c-Kit, CD34, DOG-1)
* Imatinib-sensitive mutation
* Non-resectable liver metastases
* Abscence of extrahepatic disease
* Period greater than two years between primary tumor and metastases diagnosis