cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

All Subjects

* Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 65 years, inclusive ('healthy' is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests).
* Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight \>50 kg (\>110 lbs).

Subjects with Normal Renal Function (Group 1)

* Normal renal function (CLcr =\>90 mL/min) during the screening period.
* Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10 kg), gender, and race according to protocol.

Subjects with Severe Renal Impairment (Groups 2)

* Good general health commensurate with the population with chronic kidney disease.
* Severe renal impairment (CLcr\<30 mL/min) during the screening period.

Exclusion Criteria:

All Subjects

* Renal allograft recipients.
* Any condition possibly affecting drug absorption.
* 12 lead ECG demonstrating QTc \>470 msec at screening.
* Urinary incontinence without catheterization.
* A positive urine drug screen.
* History of regular alcohol consumption.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
* Pregnant or nursing females; females of childbearing potential, including those with tubal ligation.
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Subjects with Severe Renal Impairment (Groups 2)

* Subjects with any significant hepatic, cardiac or pulmonary disease (apart from stable ischemic heart disease), or subjects who are clinically nephrotic.
* Subjects requiring hemodialysis.
* Subjects with strict fluid restriction (ie, \<1500 mL/24 hours).
* Significant bleeding diathesis which could preclude multiple venipuncture.
* Use of food or drugs that are CYP3A4 inhibitors and inducers.
* Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of trial medication
* Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer

RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.

OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.

Phase I

* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II.

Phase II

* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed nasopharyngeal cancer

  * Stage II-IVB
  * Newly diagnosed
* No distant metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* WBC at least 3,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL

Hepatic

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
* AST no greater than 2.5 times ULN

Renal

* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* Calcium no greater than 11.5 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Medically able to tolerate a definitive course of radiotherapy and the necessary immobilization
* No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for this diagnosis
* More than 3 years since other prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy for this diagnosis
* More than 3 years since other prior radiotherapy
* No prior radiotherapy to the head and neck region

Surgery

* Not specified
HRCT, CT Cisternography and MR Cisternography in Assessment of CSF Rhinorrhea

To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.

CSF rhinorrhea is defined as passage of CSF from the subarachnoid space through osseous and dural defect at skull base into the nasal cavity.

Causes of CSF rhinorrhea are classified into traumatic (including iatrogenic) and non traumatic (including spontaneous leak).

Patients are presented by variable symptoms including clear nasal discharge, headache or with complications like meningitis or even brain abscess, so closure of the defect is of great importance with required accurate localization of the defect and its dimensions.

CSF rhinorrhea can be also classified into active when with active dripping or inactive when dripping is intermittent.

Different imaging modalities have been employed to localize and characterize skull base defects responsible for CSF leakage including computed tomography (CT), CT cisternography (CTC), magnetic resonance imaging (MRI), MR cisternography (MRC) and radionuclide cisternography (RNC). However, there is still no gold standard imaging modality.

High resolution computed tomography (HRCT) provides accurate bone details, but difficult to differentiate para nasal sinus secretions from CSF leak. contrast enhancing CT cisternography has an advantage of definite proof of CSF leak and definite anatomical localization of the bony defect, but side effects like headache and meningeal irritation may occur.

Magnetic resonance imaging (MRI) with 3D- constructive interference in steady state (3D-CISS) (MR cisternography) instead of the invasive CT cisternography shows CSF as a bright signal without intra thecal contrast injection. Also MRI provides intra cranial details, but it lacks of bony details.

In the present prospective study, we will assess the use of HRCT, CTC and MRC imaging modalities in definite diagnosis and localization of active CSF leak.

Eligibility Criteria:
Inclusion Criteria:

* (1) patients with active traumatic or non traumatic CSF leakage.
* (2) patients with adequate organ function.

Exclusion Criteria:

* (1) Patients known to have contrast hypersensitivity. (2) Patients with any general contraindication to MRI as presence of para magnetic substance as pacemakers or with claustrophobia.

  (3) Patients with contraindication to lumbar puncture:
  * Infection near the puncture site, fever, sepsis.
  * New focal neurological signs or seizures.
  * Increased intra cranial tension.
  * Space occupying lesion.
  * Vertebral deformity, retropulsion, severe vertebral osteoarthritis or degenerative disc disease renders procedures more technically difficult.
  * Coagulopathy.
  * Patient refusal.
Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes

The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.

This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).

Eligibility Criteria:
Inclusion Criteria:

* Self-described Haitian immigrant aged 21 and older
* Known diagnosis of type 2 diabetes for at least one year
* Have lived in the US for at least one year
* Have an HbA1c of 7.5%
* Willing and able to participate in an individual interview

Exclusion Criteria:

* Having a diagnosis of type 1 diabetes
* Unable to comprehend, consent and or fully participate in the study
Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children

assess the effect of dental educational program on oral hygiene among institutionalized hearing impaired and mute children in Cairo, Egypt.

* Evaluate participants satisfaction regarding the dental educational program(learning teeth brushing technique)
* Measure the oral hygiene index simplified to the participants at a different follow up periods for assessing the effect of the dental educational program on oral hygiene.

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 6-12 years with mixed dentition.
* Institutionalized Deaf children in Cairo, Egypt.

Exclusion Criteria:

* Children above the age of 12 years and below the age of 6 years
* Patient un able to give informed consent
* Patient suffering from any other type of disability such as (mental retardation, physically and mentally handicapped, .etc.)
* Medically compromised patient
* Patient who were absent in the day of examination
Combining Language Therapy With rTMS in Aphasia

With the present RCT, the investigators aimed at finding an optimal protocol for the neurorehabilitation of chronic post-stroke aphasia by combining two promising methods, ILAT (Intensive language action therapy) and 1-Hz rTMS to the right-hemispheric homologue of the anterior language area of Broca (pars triangularis), thus taking advantage of recent research in speech and language sciences, neurorehabilitation and brain research.

New neuromodulation technologies, such as transcranial magnetic stimulation (TMS), are promising tools for neurorehabilitation, aphasia therapy included. Combined with behavioral techniques, Intensive Language-Action Therapy (ILAT), TMS could substantially amplify the beneficial effect of such behavioral therapy alone.

In this randomized study of 17 subjects with post-stroke aphasia in the chronic stage will be studied the combined effect of ILAT and 1-Hz placebo-controlled navigated repetitive TMS (rTMS) to the right-hemispheric inferior frontal cortex (pars triangularis). Participant will be randomized to groups A and B. Participants in group A will receive a 2-week period of rTMS during naming training where they name pictures every ten second displayed on the screen, followed by 2-weeks of rTMS and naming combined with ILAT. Those in group B will receive the same behavioral therapy but TMS is replaced by sham stimulation.

Language performance will be measured before, during and after the interventions for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75 years
* presence of a single clinically documented stroke
* chronic stage (at least 12 months post-stroke)
* aphasia documented using the WAB test
* no recurring utterances or severe global (total) aphasia
* residual ability to understand simple task instructions
* availability of information about medication
* right-handedness
* native speakers of Finnish.

Exclusion Criteria:

* severe global (total) aphasia (Boston naming test less 3 points)
* neglect, agnosia, severe vision impairment or hearing loss
* severe attention or memory deficits
* left-handedness
* cardiac pacemaker or other stimulators
* diagnosis of severe diabetes or severe depression
* additional neurological diagnoses
* other interventions, including speech therapy, in the same time period
SHIFT: Studying HIV Immunology After Fecal Transplant

SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on stable antiretroviral therapy (ART).

This study is designed to test the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV infected individuals on stable antiretroviral therapy (ART). Additionally, the study will examine potential effects of FMT on HIV immune activation, which has been linked to HIV disease progression.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women ages 18 - 75 years.
2. HIV-1 positive:
3. Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion Criteria:

1. Patients with a history of significant allergy to tree nuts, peanuts, shellfish, and/or eggs, vancomycin, levofloxacin, or metronidazole, chocolate/cocoa or gelatin; or unwillingness to ingest gelatin (in placebo capsules)
2. Use of investigational therapies or investigational vaccines within 90 days prior to study entry
3. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
4. History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.
5. History of positive HBsAg within 48 weeks prior to study entry
6. Liver cirrhosis, history of C. difficile infection, history of inflammatory bowel disease, bariatric surgery, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy.
7. Current diagnosis of diabetes
8. BMI \>35
9. Either breastfeeding or pregnant within 24 weeks prior to study entry
10. Tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment)
11. Use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry.
12. Use of probiotics and prebiotics (supplements and products) within 30 days of the study. Yogurt with live cultures is allowed.
13. Diagnosed bacterial enteric infection within 30 days prior to study entry.
14. Acute diarrhea within 30 days of study entry.
15. Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.
Flipped Classroom for Weight Management

This study is a 24-week, single-arm trial investigating the feasibility of a flipped classroom behavioral intervention for weight management. The investigators will recruit up to 30 adults ages 18+ with a body mass index greater than or equal to 25 kg/m2 to participate in weekly, 1-hour group weight management education delivered remotely via Zoom with a trained health educator. Participants will receive a dietary prescription of 1200-1500 calories/day (5 portion-controlled meals and 5+ servings of fruits and vegetables) and exercise prescription of 150-300 minutes exercise/week. Additionally, participants will be asked to self-monitor diet and exercise adherence weekly. Feasibility outcomes will be collected at baseline, 12-weeks, and 24-weeks.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index greater than or equal to 25
* Age 18 to 75 years
* Wireless internet connection in the home
* Ability to engage in moderate to vigorous intensity exercise

Exclusion Criteria:

* Unable to commit to weekly group education
* Food allergy/intolerance that would hinder ability to adhere to dietary prescription
CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of CS-7017 in combination with erlotinib.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) Non-small Cell Lung Cancer (NSCLC)
* Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy
* Male or female ≥ 18 years of age
* Anticipation of more than 3 months survival
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
* Adequate organ and bone marrow function

Exclusion Criteria:

* Prior Tyrosine Kinase Inhibitor (TKI) therapy
* Anticipation of need for a major surgical procedure or radiation therapy during the study
* Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
* Treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of treatment
* History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I Congestive Heart Failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe Chronic-Obstructive Pulmonary Disease (COPD) or asthma)
* Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
* Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
* Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBsAg)-, hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)-positive or receiving antiretroviral therapy
* Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
* Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
* Treatment with Thiazolidinedione(TZDs) within 4 weeks prior to start of study treatment
* History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
* Poorly-controlled blood pressure as judged by the Investigator
Brown Seaweed Extract on Glycemic Control and Body Weight

The overall goal of this study is to investigate the effects of a daily dietary supplement of brown seaweed (2 capsules of InSea2®) on body weight, glycemic control and insulin secretion in overweight prediabetic men and women in association with a moderate weight loss intervention.

Diets that produce lower glucose and insulin responses may reduce diabetes and cardiovascular risk. They may also facilitate weight control by promoting satiety, insulin sensitivity and optimal insulin secretion after a meal. Food ingredients may indeed reduce postprandial glucose and insulin response through an inhibition of α-amylase and α-glucosidase activity that may slow down the absorption of carbohydrates. InSea2® is a unique combination of polyphenolic extracts of brown algae (Ascophyllum nodosum and Fucus vesiculosus) which has been shown to inhibit the action of α-amylase and α-glucosidase. Preliminary data in healthy men and women have demonstrated a reducing effect on plasma insulin of a single intake of InSea2® consumed with a high-carbohydrate meal.

The main objective is to evaluate the effects of a daily dietary supplement of 500 mg (2 capsules) of brown algae extract powder (InSea2®) on body weight and blood glucose homeostasis (glucose, insulin, c-peptide) measured in the fasting state and during a 2-hour oral glucose tolerance test (OGTT) in overweight prediabetic men and women.

The secondary objectives are to assess the contribution of a daily consumption of this supplement (InSea2®) on weight loss when associated with a daily caloric restriction of 500 kcal due to individualized nutritional intervention on markers of lipid profile, blood pressure, inflammation, oxidative stress and gut barrier integrity.

The investigators expect that InSea2® lowers body weight and blood glucose homeostasis (glucose, insulin or C-peptide, as marker of insulin secretion, in the fasting state or during a 2-hour oral glucose tolerance test) in association with metabolic and inflammatory markers in the context of moderate weight loss in overweight prediabetic human subjects.

Eligibility Criteria:
Inclusion Criteria:

* overweight (BMI \> 25; waist circumference ≥ 80cm for women and ≥ 94 cm for men)
* fasting insulin (≥ 60 pmol/L)
* Impaired fasting glycemia with or without impaired glucose tolerance
* HbA1c between 5.6 and 6.4
* non-smoking
* stable weight in the past 3 months

Exclusion Criteria:

* diabetes
* chronic disease (thyroid dysfunction, hepatic or gastrointestinal disorder, uncontrolled hypertension)
* taking drugs that could affect glucose or lipid metabolism or weight and appetite
* taking dietary supplements (protein powders, fish oil, omega-3 or any marine supplements) or natural health products that could affect glucose, lipid, weight or appetite
* major surgery 3 months prior to the study
* pregnancy
* fish, seafood or iodine allergy