cyrilzakka/clinical-trials huggingface dataset:
Using Induced-Pluripotent Stem Cells to Model Cancer Therapy-Related Adverse Events

This study is being done to find out if patient blood samples can be used to perform individualized modeling of cancer therapy-related side effects.

PRIMARY OBJECTIVES:

I. Generate induced pluripotent stem cells (iPSC's) from patients receiving cancer treatment.

II. Differentiate patient iPSC's into cardiomyocytes and/or neurons or other cell types that may be relevant to modeling cancer therapy-related adverse effects, such as cardiotoxicity and neurotoxicity.

III. Use patient specific iPSC-derived cells to:

IIIa. Model cancer therapy-related toxicities; IIIb. Better understand the mechanisms of toxicities; IIIc. Determine if patient specific genetic variants are causative of toxicities; IIId. Screen novel protective therapies for cancer therapy-related toxicities.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* \* Any patient \>= 18 years of age

  * Planned or receiving any potentially toxic cancer therapy including but not limited to chemotherapy, targeted and immunotherapies

Exclusion Criteria:

* Inability on the part of the patient to understand the informed consent or be compliant with the protocol
Pendulum D2D Glucose Control for Adults With Type 2 Diabetes

The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agents to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes.

A high prevalence of gastrointestinal (GI) symptoms exist in both type 1 and type 2 diabetes that affect the quality of life negatively and substantially, although the underlying pathophysiology and relationship with glycemic control remain unclear. The current study aims to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes mellitus who are already on a stable dose of metformin alone and/or alongside other oral or injectable anti-hyperglycemic agents (sulfonylurea agents, DPPIV inhibitor,Glucagon-like peptide (GLP)-1 agonist, sodium-glucose cotransporter (SGLT)-2 inhibitor and/or insulin) and with present GI symptoms. The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agent and an HbA1C between 6.5% and 9.5%. The study will be 8 weeks in duration (2 weeks baseline and 6 weeks product intervention), with an option to continue to 6 months for those willing to continue taking the dietary supplement. As the study is observational and the data are to be used to for the purpose of evaluating improvement in GI symptoms during the intervention with Pendulum T2D there is no specific method to determine sample size.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≤ 45 kg/m2.
* Subjects with type 2 diabetes that are on a stable dose of one or more injectable or oral antihyperglycemia agents for at least 8 weeks prior to screening.
* HbA1c ≥ 6.5 % and ≤ 9.5% obtained at the screening visit.
* Subjects with any gastrointestinal symptoms including but not limited to heartburn, indigestion, diarrhea, constipation.
* Must be willing and be able to give written informed consent.

Exclusion Criteria:

* Type 1 diabetes
* Pregnant, nursing or planning pregnancy
* Planning elective surgery in the next 8 weeks
* Current or planned use of steroids, orally or injected
* Diagnosis of irritable bowel disease , diverticulitis, other significant GI illness
* Co-existing severe health condition, such as active cancer or unstable cardiovascular disease/congestive heart failure.
* Severe allergy to tape or any component of the CGM device
Evaluation of an Acceptance and Commitment Therapy-Based Narrative Intervention for Individuals Taking Antidepressants

This study aims to compare the efficacy of LifeStories on depression symptomatology compared to antidepressant treatment alone, in addition to examining the effect of the intervention on health-related quality of life. Participants will be randomly assigned to either an online ACT-based narrative intervention (Lifestories) or the waitlist control condition (antidepressant treatment alone). It is hypothesized that participants who receive the LifeStories will result in decreased depression and increased quality of life, general functioning and decreased psychological inflexibility compared to the waitlist group.

The purpose of this study is to test the efficacy of an online, self-guided ACT-based narrative intervention for adults currently taking antidepressant medication. To test the effects of LifeStories on depression severity, quality of life, general functioning and psychological inflexibility, the investigators will conduct a randomized controlled trial with two conditions (LifeStories and waitlist control) using a sample of 90 adults currently taking antidepressant medication. Interested individuals will complete a screening survey to determine eligibility. After being informed about the study and potential risks, eligible participants who provide informed consent will be asked to complete a baseline survey. Participants will then be randomized to LifeStories or a waitlist control conditions, each lasting 4 weeks. Those in the waitlist group will be asked to not use other self-help websites or books for four weeks, after which they will be given weekly access to LifeStories modules. Participants in both groups will be asked to complete a midtreatment survey 2 weeks after baseline, and a posttreatment survey 4 weeks after baseline (i.e. after completing the 4-week video intervention for those in the active condition).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Currently residing in the United States
3. Currently taking antidepressant medication prescribed by a primary care provider (PCP)
4. Meets criteria for at least moderate depression on the 9-item Patient Health Questionnaire
5. Fluent in English
6. Reliable access to an internet browser, and internet speed that is sufficient for streaming online videos

Exclusion Criteria:

1. Change in medication regimen in past 6 weeks
2. Presently seeing a mental health specialist (e.g. psychologist, psychiatrist, counselor, social worker)
Mother and Infant Study Cohort (MISC)-

This study aims to explore breastfeeding and complementary feeding practices of mothers in the United Arab Emirates (UAE) and its relation to the early life determinants of obesity and non-communicable diseases (NCDs). This research study will follow a prospective cohort approach. Two hundred and fifty mother-infant pairs will be followed for 18 months.

The hypothesis of this research study is that exclusive breastfeeding of the infant will provide potential protective effect against cardiometabolic risk factors. This study will also hypothesize that mothers who exclusively breastfeed their newborns would experience greater postpartum weight and body fat loss than mothers who are not breastfeeding.

United Arab Emirates(UAE) is facing two critical situations: high incidence of obesity and chronic diseases and suboptimal infant feeding practices as reported by the Ministry of Health in the UAE. So early identification of preventive markers of cardiometabolic risk factors in breast milk is important for developing early intervention strategies to optimize health care for individuals and communities especially in countries suffering from high rates of obesity and chronic diseases such as the UAE.

The purpose of this study is to prospectively follow up with the mothers and their infants (from 0-18months of infants age). It will explore breastfeeding and complementary feeding practices of mothers in UAE and its relation to the early life determinants of obesity and non-communicable diseases (NCDs). It will examine the components of human milk which might offer a protective benefit against obesity and its health consequences in infancy. It will also evaluate the feeding practices of the mothers and her nutritional status and relates it to their infants' growth and development.

It is expected that this research study will fill an important knowledge gap in the understanding of the feeding practices of mothers and its relation to early-life determinants of obesity and other chronic diseases in the UAE.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women:

  * Emirate nationality or Arab expatriate
  * Age: 19-40 years
  * Singleton pregnancy
  * Within the third trimester of pregnancy (27-42 weeks of gestation)
  * Free of chronic diseases (diabetes, hypertension, kidney disease, cancer, or other chronic diseases), autoimmune disorders, or infections with the human immunodeficiency virus, or hepatitis in preconception

Exclusion Criteria:

* Multiple pregnancies (pregnant with two or more fetuses)
* High-risk pregnancy or pre-eclampsia
* History of chronic diseases
* Preterm (\<37 weeks of gestation) or late-term (\>42 weeks of gestation) infants
* Congenital diseases or any health condition that could deter breastfeeding
Alabama Veterans Rural Health Initiative

The purpose of the Alabama Veterans Rural Health Initiative is to better understand access and barriers to health care and to enhance veteran enrollment or engagement in health care services of veterans residing in rural areas. It describes an intervention that is adaptable for use by other VA facilities that serve veterans in rural settings, and importantly, this study will improve our understanding of barriers to care and evaluate a method for enhancing access to care. The anticipated impact is that more veterans in rural areas who were previously under-utilizing VA services will receive and attend a health care appointment. This gain may improve preventative and primary care health care and reduce long term health care morbidity, expense and burden. This study may also identify previously unknown barriers to care that can be surmounted by innovative access and health care delivery approaches.

The primary objective is to evaluate an innovative approach for enhanced enrollment and engagement outreach intervention (EEE intervention) for rural veterans in VA health care services. This study entails a two-cell design, addressing this objective with a prospective, randomized controlled multi-site clinical trial that evaluates an active intervention compared to administrative outreach (AO, control condition) on whether or not a rurally-residing veteran obtains and attends a VA appointment.

Access, enrollment, and engagement with primary and specialty health care services present significant challenges for rural populations worldwide. The Alabama Veterans Rural Health Initiative evaluated an innovative outreach intervention combining motivational interviewing, patient navigation, and health services education to promote utilization of the United States Veterans Administration Healthcare System (VA) by veterans who live in rural locations.

Eligibility Criteria:
Inclusion Criteria:

* Veterans who live in rural Alabama counties who have either never enrolled or have previously enrolled but have not accessed a VA in 2 years or more
* Signed informed consent
* Any race, social class or ethnicity

Exclusion Criteria:

* Pending active legal charges or current/expected incarceration
Predicting Inflammatory Skin Disease Response to IL-23 Blockade

This study examines the effect of IL-23 blockade with Tildrakizumab on the immune cells of psoriatic skin lesions.

This is a one-arm, open-label study to examine the effect of Tildrakizumab. Tildrakizumab is a FDA-approved medication for the treatment of cutaneous psoriasis. This study will examine how Tildrakizumab affects immune cells within psoriatic skin lesions. Fifteen subjects with moderate to severe psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict Tildrakizumab treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age at clinic visit.
* Documentation of moderate-severe psoriasis or atypical psoriasis.
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Tuberculosis, active serious infection, active systemic malignancy,
* Received a systemic medication for psoriasis within 3 months of study screening
Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of COVID-19.

Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also looking for to evaluate associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.

An association between the presence of previous cardiovascular disease and adverse prognosis has been demonstrated in patients with COVID-19 (coronavirus disease-19), presenting increases of up to 5-10 times in mortality.

As an initial process, the SARS-CoV-2 virus, anchored in the transmembrane angiotensin-converting enzyme 2 (ECA2), penetrates host cells, including endothelial cells, pericytes and macrophages, in addition to type II pneumocytes.

Cellular invasion results in massive release of several pro-inflammatory cytokines ("cytokine storm"), such as IL-1β, IFN-1 and IL-6, by the cells of the immune system. In turn, cytokines increase the process of vascular inflammation and the expression of leukocyte-vascular endothelium adhesion proteins, which results in endothelial activation accompanied by a pro-coagulant and pro-adhesive phenotype - between leukocytes, platelets, red blood cells and vascular endothelium - characteristic of the dysfunctional endothelium in the microcirculation, which results in severe changes in the microvascular flow and, as a result, in tissue perfusion.

It is also worth noting that the patients most vulnerable to the development of complications are those with pre-existing endothelial dysfunction, associated with several risk factors such as male gender and smoking, and comorbidities such as hypertension, diabetes and obesity, all of which are associated with poor prognosis in COVID -19.

Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also evaluating associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.

Eligibility Criteria:
* Age\> 18 years admitted to the hospital
* SARS-CoV-2 positive real-time PCR molecular test

Exclusion Criteria:

* Presence of non-COVID infection with systemic and microbiologically documented repercussions.
MomHeartHealth: Reducing Cardiovascular Risk

This single-site research study will pilot-test a context-specific cardiovascular disease (CVD) risk prevention program, Mom♥Health, using two childhood centers at Family Health Centers (FHC) at NYU Langone as platforms for maternal engagement.


Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as a woman
* Is a primary caregiver of child(ren) ≤ 5 years (biological, adopted, fostered) and the child(ren) attends one of the designated childhood centers at FHC at NYU Langone;
* Is between 21-49 years of age
* Is English/Spanish/Mandarin speaking
* Has the capacity and willingness to provide consent

Exclusion Criteria:

* Significant cognitive impairment (evident during screening)
* Current participation in another behavioral clinical trial
Muscle Training Effectiveness in the Degree of Dyspnea and Aerobic Capacity in COPD

Objective: To estimate the effectiveness of muscle training, the degree of dyspnea and aerobic capacity in patients over 50 with COPD, in a health care institution provider in Antioquia.

Question: What is the effectiveness of muscle training, in the degree of dyspnea and aerobic capacity in COPD patients over 50 years, in a health service institution provider in the department of Antioquia?

Hypothesis: Muscle training causes changes in the degree of dyspnea and aerobic capacity, other than the breathing exercises and relaxation

Design: Randomized clinical trial with allocation and blinding of the autcomes assesor.

Participants: COPD patients stage II and II, male and female, over 50 years old, who are attending to a community health service provider in the department of Antioquia.

Intervention: A physiotherapeutic intervention using PNF technique was applied to the experimental physiotherapy group versus Yoga sessions applied to the other group. Twelve weeks protocol performing three sessions per week.

Outcome measures: Dyspnea degree and aerobic capacity was measured using the MMRC scale and the six minute walking test respectively at the begining and the end of the study.

Chronic obstructive pulmonary disease (COPD) is defined by GOLD (The Global Initiative for Chronic Obstructive Lung Disease) as a disease process characterized by progressive airflow limitation associated with an abnormal inflammatory response of the lungs to particles or harmful gases and is not fully reversible. This restriction generates an expiratory flow of air entrapment resulting hyperinflation, coupled with the effects that systemic, structural changes occur in skeletal muscles which leads to greater fatigue causing dyspnea. Consequently, patients with COPD require participation of accessory muscles of respiration, which should have a dual function during activities involving the upper limbs, to supply the ventilatory requirements and movements of the shoulder girdle, which increases dyspnea carrying the patient to stop their activities, leading to physical deconditioning and progressively decreasing aerobic capacity. This demonstrates the need to improve the resistance of the upper limb muscles in these patients, thus contributing to a reduction in the degree of dyspnea and improved their aerobic capacity. The investigators propose a study aimed at determining the effectiveness of muscle training in the degree of dyspnea and aerobic capacity in COPD.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 50 years with a diagnosis of COPD stage II and III according to GOLD classification, performed spirometry
* Patients who manifest dyspnea on MRC
* Patients SGSS affiliates.
* COPD controlled, verified medical history
* Voluntary participation in informed consent

Exclusion Criteria:

* Higher mental functions altered
* Degenerative musculoskeletal diseases (acute state)
* Multisystem disease not controlled
* Perform a current fitness program
Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery

A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer.

The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

An interim analysis will be made after 40 included patients in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have undergone surgery for rectal cancer (sphincter saving surgery, low anterior resection)
* Adult ≥ 18 years old
* Have scoring major LARS (according to the Low anterior resection syndrome score)

Exclusion Criteria:

* stoma
* recurrent disease
* Another colorectal surgery
* Inflammatory bowel disease (IBD)
Patients With Renal Impairment Undergoing CT

The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.


Eligibility Criteria:
Inclusion Criteria:

* referred for MDCT of liver or peripheral CTA
* stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min

Exclusion Criteria:

* unstable renal function
* required prophylactic drugs to receive contrast (other than hydration)
* uncontrolled diabetes
* currently on dialysis
Team-Based Goals and Incentives for Community-Based Health Workers to Promote Maternal and Child Health in Bihar, India

This study is designed to evaluate the impact of team-based goals and performance-based incentives for community-based health workers on health-promoting behaviors among women related to reproductive, maternal, newborn and child health and nutrition in Bihar, India.

The intervention was funded by the Bill and Melinda Gates Foundation (BMGF) and implemented from 2012 to 2014. Health sub-centers in the catchment areas of five blocks (sub-districts) of the district of Bengusarai were randomly assigned to treatment or control arms (38 sub-centers were assigned to each). Data were collected in the Intervention and Control areas from mothers of infants 0-12 months at baseline and at 2.5-year follow-up, to assess the intervention's effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess outcome effects in this quasi experimental study.

The TBGI intervention was implemented in areas where the BMGF-funded Ananya program (official title: Bihar Family Health Initiative) was also being implemented. Thus, the impact is of the \[TBGI intervention + Ananya\] versus \[Ananya alone\]. The Ananya program was developed and implemented via a partnership of BMGF and the Government of Bihar. The ultimate purpose of Ananya was to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to improve maternal and neonatal care and health behaviors, and thus survival. It was implemented from 2012 to 2014. Eight focal districts in western and central Bihar received Ananya, while 30 districts did not.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of infants 0-12 months residing in the catchment area of the subcenters (public health facilities)

Exclusion Criteria:

-