cyrilzakka/clinical-trials huggingface dataset:
Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Flaxseed may help protect normal cells from the side effects of radiation therapy.

PURPOSE: This randomized phase I trial is studying the side effects of flaxseed supplement in treating patients with locally advanced or metastatic non-small cell lung cancer undergoing chemotherapy and radiation therapy.

OBJECTIVES:

Primary

* To assess the feasibility of dietary flaxseed (FS) supplementation in patients undergoing definitive chemoradiotherapy for locally advanced or metastatic non-small cell lung cancer.
* To collect toxicity and tolerability data on dietary FS supplementation during definitive chemoradiotherapy.

Secondary

* To validate urinary and serum markers of oxidative stress and FS lignan levels as surrogates of the bioavailability of FS in these patients.
* To determine if a dose response to daily ingestion of 20 g or 40 g of FS can be observed in plasma lignan levels and urinary markers of oxidative stress.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients consume flaxseed muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
* Arm II: Patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.

Blood and urine samples are collected periodically for biomarker studies.

After completion of study treatment, patients are followed up for 1 month.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer

  * Locally advanced or metastatic disease
* Requires definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy

  * Total planned radiation dose to gross disease 60-80 Gy

PATIENT CHARACTERISTICS:

* No diagnosis of disease of the gastrointestinal (GI) system, liver, or kidneys that could result in altered metabolism or excretion of the study medication (e.g., history of major GI tract surgery, gastrectomy, gastrostomy, or bowel resection)
* No history of chronic GI disorders (e.g., ulcerative colitis, regional enteritis, or GI bleeding)
* No known hypersensitivity to flaxseed or any of its metabolites or to wheat products

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* See Patient Characteristics
* More than 14 days since prior and no concurrent investigational drugs
* More than 14 days since prior and no concurrent amifostine or Mucomyst (N-acetylcysteine)
* No prior thoracic radiotherapy
* No prior or other concurrent flaxseed, flax-containing products, soybeans, or soy-containing products
* No other concurrent dietary supplements, such as herbals or botanicals

  * Vitamins or multivitamins, including calcium and vitamin D, are allowed
Stereotactic Body Radiation Therapy (SBRT) for Lung Tumors

The purpose of this research study is to determine if Stereotactic Body Radiation Therapy(SBRT) is a good way to treat tumors near the thorax. Stereotactic Body Radiation Therapy (SBRT) is a general term for a group of techniques that are designed to deliver radiation therapy in a way that damages normal tissues less than conventional radiotherapy. The two features that distinguish SBRT from conventional therapy are procedures that decrease errors in patient positioning and technology that results in a radiation dose distribution that conforms more tightly to the tumor target. Patients will receive either 48 Gy or 60 Gy fractions depending on the type of tumor. The majority of patients will be treated in 1 week, Monday through Friday, with Wednesday off.

Stereotactic Body Radiotherapy (SBRT) for tumors in the thorax is a relatively new therapy in the United States, but has been used extensively in Japan for more than 10 years. This protocol seeks to enroll patients in three broad categories based on histology and clinical scenario: primary therapy for non-small-cell lung cancer (NSCLC), primary therapy to thoracic metastases, and retreatment of previously irradiated tumors or lung.

Primary lung tumors

Several studies have been published describing the utility of Stereotactic Body Radiotherapy (SBRT) for primary untreated lung tumors. In the United States, the most influential has been the experience of Robert Timmerman at the University of Indiana (7). They enrolled 37 patients in a dose escalation trial of SBRT for T1 N0 and T2 N0 patients with Non-small-cell lung cancer (NSCLC). The trial began with 24 Gy given in 3 fractions and escalated to 60 Gy given in 3 fractions. Dose limited toxicity (DLT) was defined as any grade 3 pulmonary, esophageal, cardiac, or pericardial toxicity, or any grade 4 toxicity that was ascribed to the protocol treatment using the Common Toxicity Criteria from the National Cancer Institute. The maximum tolerated dose (MTD) was defined at dose where less and 2 of 5 enrolled patients experienced DLT. The MTD was not determined by this trial as this criteria was not met in the enrolled patients. Of the 37 patients, 2 experienced Grade 3 toxicity. One patient experienced pneumonitis and other patient experienced hypoxemia. Both patients responded to therapy and made full recoveries. There were no long term complications reported from the treatment at a mean follow-up of 15 months.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in this protocol
* Patients of all ages are eligible
* All tumor types are eligible
* Patients with prior thoracic radiotherapy and/or surgery are eligible
* Tumor size ≤ 5 cm

Exclusion Criteria:

* The subject is eligible for surgical resection or prefers treatment on this protocol to surgical resection.
* Less than 1 year since original radiation to thorax for retreatment patients.
* More than 2 tumors requiring SBRT
* The patient cannot be positioned reproducibly due to pain or other factors
Assessment of Postop Hypospadias Pain

One of the most common pediatric urology procedures is hypospadias repair, a surgery to correct curvature of the penis and move the urethral meatus into the glans. A survey of pediatric urologists demonstrated that 72% of pediatric urologists prescribe opioid pain medication following the procedure. Using a validated questionnaire, the investigators aim to quantify how much opioid pain medication boys undergoing hypospadias repair require and if opioid pain medication can be eliminated from the routine postoperative medication regimen.

Postoperative pain scores, as measured by the Parents' Postoperative Pain Measure scale, will not be statistically different in boys who receive opioid pain medication postoperatively compared to boys who do not.

The long-term objectives of this study are to understand if pre and postoperative counseling and education along with proper surgical technique will result in less opioid prescriptions following hypospadias repair.

Children with suspected hypospadias will be seen and examined in clinic and offered surgery if appropriate. If the families elect for surgery, this will be performed by one of the investigators between 6-12 months of age. The surgical technique may vary among the investigators. Patients with severe hypospadias may require multiple surgeries for correction.

On the day of surgery, patients will be randomized to receive one of two pain medication regimens:

1. Acetaminophen (15 mg/kg) q6h and Ibuprofen (10 mg/kg) q6h
2. Acetaminophen q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h prn breakthrough pain for 10 doses Home dosing regimens will be started six hours after the last hospital dose of each medication. The families will be instructed as to when they can give oral medications at home. Lastly, families of both children in both groups will be instructed to contact the clinic or urologist on call if their children are experiencing uncontrolled pain. This may necessitate evaluation in person or adjustment of the current pain regimen. Any deviation from to prescribed pain regimen will be recorded for the study.

Patients will be contacted by phone at 1, 3, and 5 days postoperatively and given a validated questionnaire, the Parents' Postoperative Pain Measure scale, to objectively quantify how much discomfort boys in both groups experienced.

Eligibility Criteria:
Inclusion Criteria:

All boys undergoing hypospadias repair at our institution between June 2020 and June 2021

Exclusion Criteria:

Boys who have a contraindication to caudal block or Acetaminophen, Ketorolac, Ibuprofen, or Oxycodone use. Boys over 2 years of age.
Effect of Smokeless Tobacco on Anterior Segment

Observational, comparative, cross-sectional study

To evaluate the acute and chronic effects of smokeless tobacco (ST) on the anterior segment parameters using optical biometry. Observational, comparative, cross-sectional study Place and Duration of Study: Department of Ophthalmology, Kahramanmaras Sutcu Imam University.

The study included 53 right eyes of 53 subjects (study group), who used ST and 54 right eyes of 54 healthy subjects without ST (control group). Following a full ophthalmological examination, baseline measurements were taken with optical biometry and these measurements were repeated at 5, 30 and 60 mins after using ST.

Eligibility Criteria:
Inclusion Criteria:

* A subject who use ST
* A subject who was not using ST

Exclusion Criteria:

* Refractive disorder
* Systemic chronic disease (diabetes, hypertension, neurological, etc.)
* Ocular trauma
* Ocular surgery
* Glaucoma
* Optic disc abnormalities
* Congenital anomaly
Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens

The purpose of this study is to assess the safety and efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the optical correction of aphakia following cataract extraction.

A prospective, single-phase, non-randomized, open-label study to include patients with operable cataract of the human crystalline lens who have a potential post-operative best corrected visual acuity of 20/40 or better and no pre-existing progressive sight-threatening ocular disorders. Patients who are eligible per inclusion / exclusion criteria will undergo phacoemulsification cataract extraction and then implantation of the Hoya HMY Model YA-60BB posterior chamber intraocular lens. Each patient will be followed-up at specific time intervals to assess safety and effectiveness, for up to 36 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with cataract who are eligible for phacoemulsification cataract extraction of the lens through an incision of approximately 4 mm, and primary implantation of a posterior chamber intraocular lens.
2. Patients must have no pre-existing ocular conditions that preclude the ability of the treated eye to achieve BCVA of 20/40 or better after IOL implantation.
3. Patients must be at least 21 years of age.
4. Patients must sign a written informed consent form.
5. Patients must be able and willing to return for scheduled follow-up examinations after surgery throughout the 36 month study.

Exclusion Criteria:

1. Patients with a history of/or clinical signs of any of the following sight-threatening conditions:

   1. Previous Retinal Detachment or retinal pathology in operative eye, only
   2. Macular Degeneration in either eye
   3. Macular Edema in either eye
   4. Persistent Iritis/Uveitis in operative eye, only
2. Uncontrolled Glaucoma or under current treatment for glaucoma in either eye
3. Significant Corneal Disease in operative eye, only
4. Proliferative Diabetic Retinopathy in either eye
5. Patients who have had previous ocular surgery, of any kind, within the last 6 months or patients who have had previous ocular surgery at any time and who do not have potential BCVA after cataract extraction/IOL implantation of 20/40 or better
6. Patients who have best corrected vision worse than 20/200 in the fellow eye.
7. Patients with serious (i.e., life threatening) non-ophthalmic disease which may preclude study completion.
8. Patients who have undergone previous cataract extraction and intraocular lens implantation.
9. Patients unwilling or unable to sign the IRB-approved informed consent document for the study or who cannot or will not complete the study's examination schedule.
10. Patients who are currently enrolled in another clinical trial, or who exited a clinical trial within the last 30 days.
CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants

This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* recipients of a primary kidney transplant.

Exclusion Criteria:

* positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
* positive for hepatitis C virus, with moderate or severe liver disease;
* active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;
* need for maintenance corticosteroids for another condition.
Bilio-pancreatic Complications of Congenital Duodenal Obstructions

Congenital duodenal obstructions, often grouped under the term duodenal atresias, encompass a range of malformations of the duodenum that cause partial or complete obstruction. In the long term, the main complications described fall within the spectrum of digestive occlusions (anastomotic stenosis, obstruction due to adhesions, and duodenal dysmotility) and may require surgical revisions. Biliary and pancreatic complications, which are embryologically logical, are reported in the form of rare clinical cases. The aim of the research is to identify biliopancreatic complications following duodenal atresia surgery in order to characterize them, estimate their national frequency, and determine any potential iatrogenic risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent surgery for duodenal atresia in a pediatric surgery department participating in the study over the past 20 years,
* legal representatives did not object to data collection

Exclusion Criteria:

* Patients ≥ 16 years at the time of surgery.
* Objection from the legal representatives of the child or the adult patient to the collection and use of health data
Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's disease and related dementias and develop in the majority of dementia subjects. The presence of agitation in subjects with Alzheimer's disease places a significant burden not only on subjects and their caregivers but also on the healthcare system.

This is a trial designed to assess the safety and efficacy of flexible dosing of brexpiprazole in the treatment of subjects with agitation associated with dementia of the Alzheimer's type. The trial consists of a 12-week double-blind treatment period with a 30-day follow-up. The trial population will include male and female subjects between 55 and 90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are residing either in an institutionalized setting or in a non-institutionalized setting where the subject is not living alone.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 55 to 90 years of age, inclusive, at the time of informed consent.
* Subjects who are residing at their current location for at least 14 days before screening and are expected to remain at the same location for the duration of the trial.
* Subjects with diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA criteria.
* Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
* Subjects with onset of symptoms of agitation at least 2 weeks prior to the screening visit.
* Subjects with a total score greater than or equal to 4 on the agitation aggression item of the NPI-NH or NPI/NPI-NH at the screening and baseline visits.
* Subjects who require pharmacotherapy for the treatment of agitation per the investigator's judgement, after an evaluation of reversible factors (eg, pain, infection, polypharmacy) and a trial of nonpharmacological interventions.
* Subjects must have a previous MRI or CT scan of the brain, which was performed after the onset of symptoms of dementia, with findings consistent with the diagnosis of Alzheimer's disease.

Exclusion Criteria:

* Subjects with dementia or other memory impairment not due to Alzheimer's disease.
* Subjects with history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
* Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
* Subjects who have been diagnosed with an Axis I disorder (DSM-IV-TR criteria).
* Subjects with uncontrolled hypertension.
* Subjects with uncontrolled insulin-dependent diabetes mellitus (IDDM)
* Subjects with epilepsy or a history of seizures.
* Subjects considered in poor general health based on the investigator's judgment.
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption

The FeMicrobiome study will evaluate gut microbiome features and their relationships with dietary iron absorption in healthy adults. The investigators hypothesize that (1) the gut microbiota can be shaped by the heme and non-heme Fe content of the diet and that (2) this will influence individual variation in dietary Fe absorption.

Iron is an essential micronutrient ingested as either heme iron (from animal products) or non-heme iron (from both plant and animal sources). Humans have no regulatable means of eliminating absorbed iron, necessitating tight control of dietary iron absorption. Likewise, native microbes have evolved efficient iron sensing and utilization pathways to scavenge iron from the gastrointestinal environment, resulting in a competition for iron between the host and their microbiota. As growing numbers of Americans adopt plant-based diets, heme iron intakes are markedly reduced. This may shift the gut microbiome as some gut microbiota cannot independently synthesize heme and require host dietary heme sources to support their heme-dependent functions. Animal data have recently discovered that other gut microbiota respond to a low iron. To date, significant knowledge gaps exist on the interplay between dietary iron sources, native gut microbes, and iron utilization in humans. In the FeMicrobiome study, study investigators will recruit 120 adults who habitually ingest plant-based diets or habitually ingest diets containing animal protein (e.g., beef, pork, chicken, fish, and seafood). Iron absorption will be measured by using an in vivo, functional approach based on stable iron isotopes (i.e., 57Fe). Study participants will consume 57Fe (as ferrous sulfate) in the fasted state followed by two standardized meals. Two weeks after iron dosing, a blood sample will be collected from each participant and the amount of 57Fe incorporated into red blood cells will be measured using magnetic sector thermal ionization mass spectrometry. A stool sample will be collected near the time of 57Fe consumption. DNA will be extracted from this stool sample and sequenced using a high-depth shotgun metagenomic approach.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Age between 18- 40y
* Non-smoking
* Not currently taking vitamin, mineral, prebiotic, and probiotic supplements.
* Females: premenopausal and not pregnant or lactating
* No preexisting medical complications (such as eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis)
* Body mass index (BMI) between 18 - 27 kg/m2.

Exclusion Criteria:

* BMI \<18 or \> 27 kg/m2,
* Age \<18 y or \> 40y,
* Smoking
* Pregnancy, lactating
* Have gastrointestinal disorders/malabsorption diseases/hemoglobinopathies/dietary restrictions/steroid use/ medication use of medications known to impact iron status, iron utilization or inflammatory status
* Currently take vitamin, mineral, prebiotic, and probiotic supplements.
* Recently received antibiotic treatment
Study to Test the Blood to See if a New Medicine is Likely to Provide Pain Relief Similar to a Product Already Sold in Stores

This study is designed to assess bioequivalence between one test and one reference formulation used for temporary relief of pain. The results will help decide if the new medicine is likely to provide pain relief similar to the product being sold.

The study is a single dose, randomized, two-way crossover study in 32 healthy male and female volunteers, minimum of 14 of each gender. Two doses of study medication will be given as single doses on two separate treatment visits. A washout of at least 48 hours will separate the treatment visits. Each visit will include an overnight fast at the clinic and 19 blood samples drawn for pharmacokinetic analyses. Tolerability of the treatments will be evaluated in terms of reported and observed adverse events (AE).

Eligibility Criteria:
Inclusion Criteria:

* Healthy (per protocol-specified parameters) male or female subjects (14 of each gender) between the ages of 18 and 50 years, inclusive.
* Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco for at least 12 months before screening visit of this study.
* For females: if not postmenopausal, agrees to use a protocol-specified means of contraception or declared absence of sexual contact with a male partner during the study.
* For males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study.
* Body Mass Index (BMI) within protocol-specified parameters.
* A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.

Exclusion Criteria:

* Evidence or history of an acute or chronic medical or psychiatric condition, laboratory abnormality, or drug use that, in the judgment of the investigator or an authorized physician, may compromise subject safety or the interpretation of results.
* Females: Pregnant or breast-feeding
* Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
* History of regular alcohol consumption outside the protocol-specified allowances.
* Donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 mL.
* Relationship to persons involved directly with the conduct of the study, or their families.