cyrilzakka/clinical-trials huggingface dataset:
Sirolimus for Cowden Syndrome With Colon Polyposis

Colon polyposis (the presence of multiple colon polyps) is very common with Cowden syndrome, as over 60% of patients have 50 or more polyps. In a previous clinical trial, some participants had reduction in the number of colon polyps with the use of the medication sirolimus for a very short time period. This study is investigating sirolimus and its effect on the number of colon polyps in patients with Cowden syndrome and polyposis over a 1 year period.

PTEN is a tumor suppressor gene that regulates the cell cycle through the phosphoinositide 3-kinase (PI3K)/Akt/mTOR pathway. When germline mutations in PTEN occur, the result is Cowden syndrome (or less commonly one of several related disorders collectively called the PTEN hamartoma tumor syndrome). This is characterized by the growth of hamartomas and a high risk of cancer in multiple organ systems. This includes colon polyps in 92.5% of Cowden syndrome patients and 64% with an estimated 50 or more polyps. Although outcomes of this are under reported, series suggest 20-38% of patients will receive colectomy.

Current clinical practice for Cowden syndrome is based on close surveillance for the development of cancers. Sirolimus (also known as rapamycin) is a specific inhibitor of mTOR that is FDA-approved for immunosuppression and use in several types of cancers as chemotherapy. It has also been used successfully in other hamartomatous syndromes including lymphangioleiomyomatosis. There is also a completed pilot clinical trial for adults with Cowden syndrome in which some had reduction in the number of colon polyps with the use of the medication sirolimus for a very short time period.

This will be an open-label pilot trial to determine whether sirolimus reduces colon polyp burden in Cowden syndrome. Sirolimus will be administered for one year. Colonoscopy with polyp estimation will be performed at trial entrance and at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Cowden syndrome or other PTEN hamartoma tumor syndrome spectrum disorder
* Confirmed pathogenic or likely pathogenic PTEN germline mutation on genetic testing
* Previous colonoscopy with colon polyposis. This is defined for the study as either too many polyps to remove endoscopically as judged by the performing physician at the last colonoscopy or findings indicating at least an InSIGHT stage 1 score (over 20 polyps).
* Age 18 or greater
* Capacity to consent to study

Exclusion Criteria:

* Pregnancy or plans for pregnancy while on treatment or within 3 months of stopping treatment (for both women and men)
* Chronic kidney disease
* Chronic renal disease
* History of colon cancer or colon adenoma with high grade dysplasia
* History of colectomy
Follow-up Study to Investigate Long Term Effect of Supplementing Pre- and Probiotics in Children Born by C-Section

This study investigate the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section.

This is an extension of investigation on the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section from an earlier completed study.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the Julius SN study until 16 weeks of age
* Written informed consent from parent(s) or legally acceptable representatives

Exclusion Criteria:

* Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.
Long-term Effect of Steroid on Metabolic Diseases in Asthmatics

The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:

i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.

ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).

iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.

iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications.


Eligibility Criteria:
A. Inclusion criteria i. Adult asthmatics (over 18 years) who have maintained inhaled corticosteroid with or without systemic corticosteroid for more than 12 months before the index date in our Medical Center.

ii. At least 1 asthma diagnosis within 1 year before the first corticosteroid exposure date by asthma specialists at Ajou University Medical Center (AUMC, Suwon, South Korea) with informed consent.

iii. A high cumulative dose is defined as the dose of corticosteroids above the mean cumulative dose of corticosteroids prescribed during 1 year.

iv. The equivalent dose will use for calculating the mean cumulative dose of each inhaled corticosteroid inhaler or systemic corticosteroid prescribed.

v. Prescriptions within 365 days from the first prescription will be assumed to be continuous, and the cohort end date will be defined as the end of the continuous drug exposure.

B. Exclusion criteria i. Patients younger than 18 years ii. Patients younger than 50 years and males in high-risk population cohorts iii. Patients with osteoporosis or osteoporosis-related major fracture outcomes (pathological fracture due to osteoporosis, closed fracture of the femur, pelvis, and vertebral column) before the index date iv. Patients with corticosteroid-related outcomes (diabetes mellitus, hypertension, hyperlipidemia) before the index date (for secondary endpoint).
Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders

Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy

An open-label, prospective evaluation of the efficacy of vitamin D supplementation starting 1 month before and continuing for the duration of combination therapy with pegylated interferon alpha (2a or 2b) plus ribavirin in patients with chronic viral hepatitis C genotype 1 or 4, nonresponders to a first antiviral therapy.Vitamin D supplementation is started one month before antiviral therapy in order to introduce pegylated interferon plus ribavirin in patients with optimal vitamin D status

Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis C Genotype 1 or 4
* Hypovitaminosis D defined by a value \<30 ng / ml
* Patient non responder to previous antiviral combination therapy of Pegylated Interferon and Ribavirin defined by a decrease in viral load \<2 log at week 12 of the first course (Peg/RBV)
* Patient who received at least 80% of the optimal dose of Pegylated Interferon and Ribavirin according to current recommendations
* Patient for which the investigating physician decided to initiate treatment for hepatitis C combination therapy

Exclusion Criteria:

* Decompensated liver disease: Child-Pugh B\> 8 or one of the following criteria: bilirubin\> 35 micromol/L, TP \<50%, ascites, recurrent encephalopathy
* Positive serology for HBV and HIV
* Alcohol consumption exceeding 50 g/day
* Chronic intake of vitamin D
* Thrombocytopenia \<50 000/mm ³, neutropenia \<750/mm ³, hemoglobin \<11 g/dL
* Pregnant women
Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?

There is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.


Eligibility Criteria:
Inclusion Criteria:

* All patients
* ≥65 yrs
* Admitted to the hospitalist Medicine Service

Exclusion Criteria:

* Patients who have pre-existing, pan-institutional (e.g. to be applied at nursing homes and hospitals) orders of no CPR and/or no mechanical ventilation will be screened (demographic and outcomes data collected) but NOT randomized.
* Patients already receiving critical care on admission will also be excluded
Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration

The purpose of this study is to evaluating whether autologous Concentrate Growth Factors(CGF) is safe and/or effective to accelerating skin regeneration and soft tissue expansion.


Eligibility Criteria:
Inclusion Criteria:

* Age of 14 to 65 years;
* Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
* Persistent high level of expander internal pressure;
* Need for further skin expansion;

Exclusion Criteria:

* • Not fit for soft tissue expansion treatment;

  * Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
  * Significant renal, cardiovascular, hepatic and psychiatric diseases;
  * Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
  * BMI \>30;
  * History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
  * History of allogenic bone marrow transplantation;
  * Long history of smoking;
  * Evidence of malignant diseases or unwillingness to participate.
Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation

The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined.

Constipation is a major problem in elderly institutionalised patients. Non-pharmacological treatments are proposed as primary management of constipation, but institutionalised patients are not likely to be able to increase either the intake of dietary fibre or fluid and their physical activity is low.

The latest agent widely used for the treatment of constipation is polyethylene glycol (PEG). PEG is classified into the group of osmotic laxatives. It is minimally absorbed from the gastrointestinal tract and not metabolised by colonic bacteria.

Most of the PEG products at the market contain electrolytes and have a salty and unpleasant taste which may affect the compliance of using them. A PEG solution without electrolytes has been developed and used for some years in various countries. Now we will compare the efficacy and safety of PEG solutions with or without electrolytes and their acceptability in the use for constipation in institutionalised patients.

Eligibility Criteria:
Inclusion Criteria:

* Isotonic PEG treatment for constipation at the stable dose for at least 2 weeks before the run-in period

Exclusion Criteria:

* Other medical treatment for constipation than isotonic PEG or plantago ovata seeds
* Severe dementia
The Cardiovascular Effects of Air Pollution: the Role of Nitric Oxide

Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality. The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these detrimental vascular is unclear, but is thought to be via oxidative stress and altered bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of endogenous nitric oxide (NO) in the adverse vascular responses observed following exposure to diesel exhaust.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Use of regular medication (except oral contraceptive pill)
* Current smokers
* Significant occupational exposure to air pollution
* Intercurrent illness
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates

Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.

UVC insertion has benefits and potential complications such as infection, intestinal necrosis, thrombosis, ascites, hydrothorax, cardiac tamponade, cardiac arrhythmias, pleural effusion, pericarditis and pericardial effusion. The complications may be due to insertion of catheter in an inappropriate location. Imaging procedures such as plain thoracoabdominal x-ray is needed after catheter insertion to specify the location of the catheter tip. In addition to preventing complications, insertion of umbilical venous catheter in an appropriate location is essential for umbilical catheterisation effectiveness. There are different methods to determine the length of catheter which must be inserted in umbilical vessels. The UVC formulae are based on either body surface measurement such as Dunn method, Umbilical to Intermammary Distance (UIMD), Umbilical to Nipple Distance (UN)-1 and birthweight based formula method such as Shukla and Modified Shukla. Shukla and UN-1 Methods have been widely used in the world. However, the accuracy of these two methods in estimating the length of umbilical venous catheter has not still demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* All term and preterm newborns requiring UVC insertion will be included in the study.

Exclusion Criteria:

* All neonates with major congenital malformations that interferes with the placement of the UVC will be excluded.
A Study of ALS-008176 in Infants Hospitalized With RSV

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)


Eligibility Criteria:
Inclusion Criteria:

* Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the time of hospital admission, or \<28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness

Exclusion Criteria:

* Prematurity
* Receiving invasive endotracheal mechanical ventilation
* Poorly functioning gastrointestinal tract
* Anticipated to be discharged from the hospital in \<24 hours from the time of randomization
* Prior exposure to palivizumab
Telehealth Approach to Enhancing Glycemic Control

This study evaluates whether the use of a Continuous Glucose Monitoring (CGM) device combined with a Remote Patient Monitoring (RPM) program can improve blood sugar control and reduce hospital visits among patients with poorly controlled diabetes who have recently been discharged from the hospital.

The study, led by White Plains Hospital (WPH) Cares, will follow 208 patients for 90 days after their discharge. Half of the participants will receive standard care, while the other half will receive a Dexcom G7 CGM device along with support from trained nurses who will monitor their glucose readings daily. The goal is to determine whether this approach helps lower Hemoglobin A1c (HbA1c) levels, reduces hospital readmissions, and improves overall health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Discharged Home from the WPH Inpatient Setting A1c \>= 8.0 within 90 days of discharge \>= 18 Years of Age Lives within Westchester County

Exclusion Criteria:

* \<18 Years of Age Patient With Documented Cognitive Impairment or Decisional Incapacity Pregnant or Plans to Become Pregnant in 6 Months Discharge Disposition of Short-term or Long-term Care Facility, Assisted Living Facility, Group Home, Against Medical Advice/Eloped, or Home Hospice Patient or Caregiver Unable to Check Glucose at Home Using a Home Glucometer Lives Outside Westchester County
Derazantinib and Atezolizumab in Patients With Urothelial Cancer

The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract
* Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or progressing disease
* Documented central FGFR genetic aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions) (Note; Substudy 2 started with patients requiring an FGFR GA, but this requirement was removed from the protocol later on)
* Measurable disease, as defined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Adequate organ functions as indicated by Screening visit local laboratory values

Exclusion Criteria:

* Receipt of prior cancer treatment within specific interval periods
* Concurrent evidence of any clinically significant corneal or retinal disorder
* History of clinically significant cardiac disorders
* Known CNS metastases
* Concurrent uncontrolled or active infection with human immunodeficiency virus
* Active hepatitis B or chronic hepatitis B without current antiviral therapy
* Active hepatitis C
* Active tuberculosis
* Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration
Posttraumatic Hypopituitarism - Incidence, Predictors and Test Validity

The purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and to identify predisposing factors in order to establish a rational responsible socioeconomic screening program.


Eligibility Criteria:
Inclusion Criteria:

* International Classification of Diseases (ICD) 10 code S06.0-06.9
* Age 18 - 65 years at time of traumatic brain injury
* Duration of hospitalization \> 24 hours.

Exclusion Criteria:

* Known pituitary disease
* Clinically significant liver or renal disease
* Breast-feeding
* Pregnancy
* Alcohol or drug abuse
JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers

This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall. The JetTouch Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected into the bladder without using a needle. It is hoped that this method will provide a reliable and consistent method to deliver drugs into the bladder wall.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.

Exclusion Criteria:

* Unable or unwilling to sign Informed Consent Form or comply with study requirements
* Non-English speaking
* Currently enrolled in another clinical trial
* Undergone treatments given into the bladder in the past 4 weeks
* Female subject and has a positive urine pregnancy test at the time of screening/procedure or intends to become pregnant while enrolled
* Female subject and is currently breast feeding
* Female subject and has given birth in past 6 months
* Current or history of chronic urinary tract infections
* Current or history of chronic hematuria
* Current or history of bladder cancer
* History of major surgery in the last 6 months
* Current or history of bleeding disorders
* Currently taking anticoagulants
* Taking aspirin and is unable to discontinue treatment for 2 weeks prior to bladder injection
* Taking NSAIDS and is unable to discontinue 48 hours prior to bladder injection
* Platelet count, prothrombin time/INR (PT/INR) and partial thromboplastin time (PTT) outside the normal limits of the laboratories established reference ranges
* Current or history of any of the following: neurogenic bladder, radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi
* Known hypersensitivity to any of the agents used in the injection (FLEXLINE-Bladder® Attachment material, lidocaine, saline, Indigo Carmine dye or Ciprofloxacin)
* Current or history of any medical condition that in the opinion of the Investigator would make them an unsuitable candidate for this study.
Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

The purpose of this study is to evaluate the PK properties in fed and fasted men and women.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged between 18 and 65 years (inclusive)
2. Able to give signed informed consent
3. BMI 27-45 kg/m2, inclusive
4. Eligible male and female subjects must agree not to participate in a conception process.
5. Considered to be in stable health in the opinion of the Investigator.

Exclusion Criteria:

1. Prior participation in any study of lorcaserin.
2. Clinically significant new illness in the 1 month before screening
3. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
4. History of any of the following cardiovascular conditions:

   * Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 6 months of screening;
   * Cardiac arrhythmia requiring medical or surgical treatment within 6 months of screening
   * Unstable angina
   * History of pulmonary artery hypertension
5. Positive result of HIV, hepatitis B or hepatitis C screens
6. Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
7. Initiation of a new prescription medication within 1 month prior to screening.
8. Recent history (within 2 years prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
9. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
10. Use of SSRIs,SNRIs, and other medications must meet the washout period.