cyrilzakka/clinical-trials huggingface dataset:
Storytelling to Promote Living Donor Kidney Transplant

This study will examine the effectiveness of first-person storytelling in encouraging patients with end-stage renal disease to pursue Living Donor Kidney Transplant (LDKT). The Living Donation Storytelling Library LDSP is a library of videos from donors and recipients sharing their transplant stories, serving as a narrative-based transplant education resource. This study will investigate if exposure to the LDSP changes patient readiness and motivation to pursue LDKT to ultimately increase the number of donor inquiries and donor evaluations. This study will also test if the LDSP serves as a health-literate and culturally safe education approach that can effectively support racialized communities who have a disproportionately higher need for LDKT.

Background: In Canada, racialized communities are 50 to 75 percent less likely to be referred for living donor kidney transplant (LDKT), identify donors, complete evaluation, and receive transplant in comparison to white patients. Several narrative-based transplant education interventions have proven to be effective in increasing LDKT pursuit among Black patients in America. However, these education interventions are labour- and time-intensive and fail to reach the general public outside the location of transplant education. Efficacy of interpersonal education interventions have also yet to be evaluated in Canadian minority populations, predominantly comprised of South Asian, East Asian and Indigenous communities.

Objective: The aim of this study is to examine the effectiveness of a narrative-based LKDT education intervention, the Living Donation Storytelling Library, in increasing transplant knowledge, health literacy, and recruitment of living donors. Secondarily, this study aims to compare hereterogeneity in viewer responses across race and gender to identify potential targeted narrative interventions for LKDT education.

Method: Two-arm randomized control trial with 80 prospective living donor kidney transplant recipients at Vancouver General Hospital in collaboration with Houston Methodist Hospital and Weill Cornell Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Waitlisted and newly referred kidney transplant candidates at the Vancouver Kidney Transplant Program
* 18 years of age or older
* Able to provide informed consent
* English literate

Exclusion Criteria:

* Inability to understand English and provide informed consent
* Transplant candidates excluded from transplantation based on clinical criteria or other contraindications for transplant
* Unwilling to disclose information on race or ethnicity
Arterial Stiffness in Type I Diabetes Mellitus

Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of 65 children with Type I diabetes mellitus. This prospective, crossover study will help determine if there is an acute increase in arterial stiffness in children with Type I diabetes mellitus who do not give extra insulin to cover a meal. This will give more support to show why it is so critical to bolus every time they eat and to bolus on time to decrease cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving insulin before a meal compared to not giving insulin before a meal will be associated with lower arterial stiffness in children with type I diabetes.

The subject will fast overnight (nothing to eat or drink for at least 8 hours). The subject will be asked to drink a mixed meal replacement drink (Boost) and will be randomized (like flipping a coin) to bolus insulin for the "meal" or to not bolus insulin using their standard insulin dose. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement.

Stiffness of the blood vessel of the wrist will be determined using radial tonometry. Radial tonometry is safe and does not hurt. A pen like probe is placed on the blood vessel of the wrist. When the machine reads a good wave form the computer will calculate the stiffness of the blood vessel. This test will be done along with the glucose checks; before drinking the meal replacement drink, and 1 and 2 hours after drinking the meal replacement drink.

During the next study visit, the subject will repeat the exact same study described above. However, this time they will receive the other insulin assignment they were assigned during the first study (either bolus or no bolus).

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes based on clinical history
* Basal-bolus insulin regimen
* Duration of diabetes greater than 1 year
* Blood glucose 65-200 mg/dL fasting

Exclusion Criteria:

* Use of metformin or any other hypoglycemic agents besides insulin
* Use of anti-hypertensives
* Caffeine or smoking within the past 24 hours
Contingency Management for Alcohol Use Disorders

Contingency management (CM) treatments are highly efficacious in improving outcomes of substance abusing patients. However, CM has rarely been applied to individuals with alcohol use disorders, primarily because of technological limitations in monitoring drinking. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to continuously monitor alcohol consumption 24 hours a day for 7 days per week. The purpose of this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx. In total, 120 alcohol abusing or dependent patients initiating outpatient treatment at community-based clinics will be randomly assigned to one of two conditions: standard care, or standard care plus CM with reinforcement based on results of SCRAMx readings. Compared with standard care, it is expected that CM will result in fewer drinking days and longer durations of continuous non-drinking days.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* current diagnosis of alcohol use disorder and self report of recent alcohol use
* pass an informed consent quiz
* agree to wear a SCRAMx monitor for 12 weeks
* have a standard SCRAMx compatible phone line in their home or agree to attend the clinic weekly for brief research visits/downloads
* agree to sign an off-campus property transfer form and return SCRAMx equipment

Exclusion Criteria:

* serious, uncontrolled psychiatric illness
* in recovery from pathological gambling
* have an unstable address
* intend to participate in activities incompatible with SCRAMx over the next 3 months
* are wearing SCRAMx for legal purposes
Effect of High Protein Diet in Stroke Patients With Low Muscle Mass

Our prior studies demonstrated that dehydration was a predictor for poor outcome in stroke and Blood urea nitrogen/Cr ratio-based saline hydration therapy in patients with acute ischemic stroke may increase the rate of favorable clinical outcome with functional independence at 3 months after stroke. However, dehydration is likely to be only a part of representation in poor nutrition status and physical fragility for a stroke patient.

Our prior study found that acute stroke patients admitted to neurological intensive care unit with low urinary creatinine excretion rate (CER), a marker of muscle mass, was associated with poor outcome at 6 months after stroke. An animal study suggested inadequate food and water intake determine mortality following stroke in mice and nutritional support reduced the 14-day mortality rate from 59% to 15%. A study also showed that high protein intake was associated with a better outcome in previous cardiovascular events.

We will calculate CER based on published equation. Based on our prior study, acute stroke patients with their CER\<1500 mg/day will be enrolled. A randomized controlled trial will be conducted and patients will be randomly assigned to high protein diet or normal protein diet for at least 2 weeks. We plan to enroll 300 patients, with 150 patients in ach group, during 3-year study period. We will consult dietitians for arrangement of their diet. We assume that patients receiving high protein diet will have higher opportunity to walk independently (modified Rankin Scale 0-1) at 3 month after stroke.


Eligibility Criteria:
Inclusion Criteria:

1. acute ischemic stroke during hospitalization
2. eGFR \>30
3. urine albumin creatinine ratio \< 30 mg/g
4. urinary creatinine excretion rate (CER) \< 1500g/day

Exclusion Criteria:

1. chronic kidney disease stage 4 or 5 (i.e. eGFR \< 30)
2. proteinuria (protein 1+ or more in urine routine)
3. known impairment of functional status (mRS ≥ 2) prior to the index stroke
4. refuse to participate in this study.
Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)

Ataxia Telangiectasia (AT) is an autosomal recessive inherited condition caused by mutations in the ATM gene1. Patients suffer from neuro-degenerative problems, usually commencing in the second year of life, and affecting predominantly the cerebellum. They also develop the characteristic superficial telangiectases. Between 60 and 80% of affected children are immunodeficient. This is associated with deficiency of immunoglobulin A (IgA ) 2, of IgG23 and of antibody responses to pneumococcal polysaccharides4. Patients suffer recurrent sino-pulmonary infections but a recent study suggests poor correlation between immune status and immunological parameters5. If uncontrolled, recurrent pulmonary infections can contribute to the development of chronic lung disease and bronchiectasis. Preventative management includes continuous prophylactic antibiotic treatment in some with the need for replacement immunoglobulin therapy in only a small proportion of cases. Antibiotics have been reasonably effective in this situation but the emergence of resistance amongst community acquired pneumococcal isolates is a cause for concern. Appropriate immunisation strategies may also have a role.

This study is designed to look at antibody responses in a one versus two dose regimen in a cohort of AT patients recruited through the AT Society a national charitable organisation involved in providing support to families with this condition and in fostering education and research in the field.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of AT
Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery

We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical postoperative complication. Anastomotic leakage severely compromises the recovery after surgery. It increases the overall burden of patients and hospital resources. Postoperative mortality is higher in patients with anastomotic leakage.

Human albumin is routinely administered after surgery with a unproven hypothesis that the human albumin is beneficial to prevent anastomotic leakage. We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed gastric cancer
* Patients who underwent radical gastrectomy

Exclusion Criteria:

* Patient who did not undergo gastrectomy
Imatinib Dose Escalation to 800 mg/Day in Korean Patients With Metastatic or Unresectable GIST Harboring KIT Exon 9 Mutation: KENEDI

KIT exon 9 mutants had poorer survival compared with KIT exon 11 mutants when they were treated with the same dose of imatinib, 400 mg per day, and that patients with KIT exon 9 mutation had better progression-free survival with imatinib treatment at an escalated dose, 800 mg per day, than with imatinib treatment at a dose of 400 mg per day.10,11 Based on the results, imatinib 800 mg per day is now considered the standard dose for the treatment of patients with metastatic or unresectable GIST showing KIT exon 9 mutation in Western countries.

According to our previous prospective phase II study of imatinib 400 mg per day in metastatic or unresectable GIST, hematologic and non-hematologic toxicities were more frequent in Korean patients compared to the Western studies.7 It may be caused by relatively higher exposure to imatinib per body surface area in Korean patients than in Western population because the weight and height of Korean patients are relatively smaller than Western people. So, we plan to start imatinib at 400 mg per day and then sequentially escalate the doses of imatinib in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Histologically confirmed metastatic or unresectable GIST with CD117(+), DOG-1 (+), or KIT mutation
* ECOG PS(Eastern Cooperative Oncology Group Performance Status) 0\~2
* Primary mutation at KIT exon 9
* Imatinib treatment for less than 4 weeks from the first dose at 400 mg per day
* No prior use of tyrosine kinase inhibitors ((but, patients who have recurrence 6 months after completion of adjuvant imatinib at a dose of 400 mg per day can be enrolled in this study)
* At least one evaluable disease by RECIST v1.0
* Resolution of all toxic effects of prior treatments (chemotherapy, surgery, RFA(radiofrequency ablation), radiotherapy, and/or TACE)
* Adequate bone marrow function as defined by platelets ≥ 75 x 109/L and neutrophils ≥ 1.5 x 109/L (within 1 week prior to the first dose of imatinib at 400 mg per day)
* Adequate renal function, with serum creatinine \< 1.5 x ULN (within 1 week prior to the first dose of imatinib at 400 mg per day)
* Adequate hepatic function with serum total bilirubin \< 1.5 x ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x UNL in the presence of liver metastases (within 1 week prior to the first dose of imatinib at 400 mg per day)
* No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer except where treated with curative intent \> 5 years previously without evidence of relapse
* Provision of a signed written informed consent

Exclusion Criteria:

* Severe co-morbid illness and/or active infections
* Pregnant or lactating women
* History of other malignancies except basal cell carcinoma and carcinoma in situ of uterine cervix
* CNS metastasis
* Clinically significant bleeding in GI tract
* GI obstruction or malabsorption
* Known hypersensitivity to imatinib
Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty

The purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications.

A current research debate is whether glenosphere size has a significant clinical impact on a patient's range of motion (ROM) following RSA. Some researchers have shown an association between increased glenosphere size and improved ROM, but no study has determined the absolute minimal motion differences that would be recognizable or beneficial by patients. This is mostly attributable to limitations such as small sample sizes as well as the fact that shoulder dynamics are multifactorial in nature. Most studies have shown an increased ROM with larger glenosphere sizes.1 Because smaller patients are often times female and receive smaller implants, female patients may be more susceptible to limited ROM. The purpose of this study is to determine if a larger glenosphere allows for greater ROM in female patients undergoing RSA.

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear for which the patient has elected to undergo reverse shoulder arthroplasty
* No history of prior shoulder arthroplasty
* Consent to study participation by signing the informed consent and the Protected Health Information (PHI) form (Attachment B and C)
* Ability to speak, read and write English

Exclusion Criteria:

* Male sex
* Any impairment that would prevent answering the surveys
* No children or adolescents under the age of 18 years old
* No prisoners, pregnant women, or mentally disabled persons
* No Workers' Compensation cases
Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children With Cancer

This study investigates parents' attitudes and beliefs on the risks of opioid use in children with cancer. Pain is the common symptom reported by pediatric cancer patients. Opioids are the mainstay in the treatment of cancer-related pain. Despite an almost universal desire to prevent or mitigate pain in their children, parents exhibit complex behaviors from withholding prescribed opioids entirely to giving less than the prescribed analgesic dose of opioid to discontinuing despite ongoing pain. Information gathered from this study may help address a crucial knowledge gap in researchers' understanding of parental attitudes and beliefs regarding the risks associated with opioid use in children and adolescents.

PRIMARY OBJECTIVE:

I. To determine parents' level of concern regarding the use of opioids for pain in their children.

SECONDARY OBJECTIVES:

I. To explore differences in parents' level of concern regarding the use of opioids for pain in their children as well as level of concern for side effect of opioids between the opioid subgroup and non-opioid subgroup.

II. To explore differences in other parental attitudes and beliefs between the opioid subgroup and the non-opioid subgroup.

III. For each concern, associations between:

IIIa. Level of concern regarding the use of opioids and the age and disease of the child.

IIIb. Level of concern regarding the use of opioids and parental history of addiction.

IIIc. Level of concern regarding the use of opioids and a family history of addiction.

OUTLINE:

Parents complete survey over 20 minutes. Patients' medical records are reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Parents must be at least 18 years old
* The parent must be able to understand, read, write, and speak English
* The parent must provide verbal informed consent
* The child of the parents must be 18 years old or younger
* The child must have a diagnosis of cancer

Exclusion Criteria:

A non-cancer diagnosis (neurofibromatosis, Li-Fraumeni syndrome for example).
Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye

The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient between 18 and 80 years of age and in good general health condition.
* Signed written informed consent.
* Existence of moderate to severe DES symptoms defined as Break-up time (TBUT) ≤ 10 s (mean of 3 consecutive measurements) and OSDI questionnaire ≥ 20.

Exclusion Criteria:

* Contraindication for the use of the products (e.g. hypersensitivity to the constituents of the test products) or any study procedure.
* Concomitant or previous participation in a clinical investigation within the last 3 months.
* Concomitant therapies/manipulations that affect either the tear film, tear secretion or ocular surface integrity or would alter the effect of the devices being evaluated.
* Concurrent (systemic) DES-associated diseases that are not on a stable therapy since at least 1 month (therapy not expected to change)
* Glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected to change)
* Any diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation
* Pregnant or lactating females.
* Participants of childbearing age who do not use adequate methods of birth control.
* Subjects unable to understand the informed consent or having a high probability of noncompliance to the study procedures and/or non-completion of the study according to investigator's judgment (e.g. illiteracy, insufficient knowledge of local language).
* Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.
The Stony Brook University Calm-Mom Study

The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress. The Stress Managment and Resiliency Training Program (SMART-Mom program), an 8-session Cognitive Behavior Therapy (CBT) based mind body program and the Mama Support Program, an 8-session social support group program. Sixty pregnant women (\<20 weeks Estimated Gestational Age) will be screened and either enrolled in the online SMART Mom Program or the Mama Support Program. Outcomes, including maternal perceived stress, depression, and anxiety will be assessed at post-treatment, three, and six months post program completion. Potential impact on infant health outcomes will be assessed via post-delivery electronic medical record review.

Aim 1: The investigators will conduct a randomized clinical trial (RCT; n=60) to assess the feasibility, acceptability and preliminary efficacy of the Stress Management and Resillency Training program (SMART Pregnancy) delivered online versus a time and attention matched prenatal support group (Mama Support). It is expected that SMART-pregnancy participants will demonstrate high levels of treatment engagement and adherence. It is predicted that participants in the SMART-Pregnancy condition will demonstrate improvements in emotional distress and stress regulation (as indexed by hair cortisol concentrations) at post-treatment and 3 month follow-up. Aim 2: The investigators will conduct a postnatal chart review to explore secondary treatment benefits including pre-and postnatal maternal health and birth outcomes.

Eligibility Criteria:
Inclusion Criteria:

* \<21 weeks pregnant with medically confirmed viability
* Speak, read and write in English fluently,
* Endorse elevated levels of prenatal maternal stress (PNMS; i.e., New Prenatal Distress Questionnaire Score \> 19).

Exclusion Criteria:

* Current enrollment in individual or group psychotherapy
* Current un-managed serious mental illness including bipolar disorder and psychosis
* History of previous suicide attempt
* Inappropriate for participation in group therapy format as determined by study director
Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks

Use of higher energy doses (120-150 J) may not offer additional benefits and higher success rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial fibrillation cardioversion. In this prospective open-label randomized trial consecutive patients with AF and candidate to AF electrical cardioversion will be randomized to receive 100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each group to anterolateral or postero-anteriore placement of defibrillator electrodes.

Open-label randomized trial to assess the efficacy of alternative initial biphasic shocks (100 versus 120 J) for cardioversion of atrial fibrillation including alternative option for electrode placement (anterolateral or postero-anterior in each group).

Eligibility Criteria:
Inclusion Criteria:

* Adult (Age\>18 years)
* Candidate to Cardioversion for recent onset, persistent atrial fibrillation (\>48 hours but \< 12 months)
* Informed Consent

Exclusion Criteria:

* Atrial Flutter or other arrythmias