cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops

The objective of the study is to demonstrate a change in osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears lubricating drops.

Symptomatic dry eye subjects exhibited a significantly higher tear osmolarity than observed in normal subjects, this is thought to relate to the inherent tear film instability of dry eye disease. Lubricating eye drops are frequently prescribed to relieve the symptoms of dry eye.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 21 years of age and has full legal capacity to volunteer;
2. Has read and signed the information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye;
5. Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye or a osmolarity reading of at least 308 (in worse eye) and at least an 8 point difference between the two eyes.

Exclusion Criteria:

1. Has taken part in another research study within the last 30 days;
2. Planned contact lens wear during the course of the study;
3. Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
4. Any subject that violates the washout period by using eye drops during the 72hrs washout period;
5. Has any known ocular disease\* including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
6. Restasis use can be included if they have been on it for at least 3 months and are stable.Used Restasis (or similar topical medication) within the last 6 months;
7. Has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable;
8. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary);
9. Use of systemic anti-histamines, as long as they have been on them continuously for at least 1 month. Use of medications such as: Systemic Antihistamine (e.g., Allegra®, Benadryl®, Claritin®, Dimetapp®, Unisom®, Zyrtec®, etc.), Isotretinoin (e.g., Accutane®, Roaccutane®, Amnesteem®, Claravis®, Isotroin®, Sotret®) or similar medications;
10. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
11. Has undergone ocular surgery(LASIK, Cataract, etc)within the last year;

    * For purposes of this study, ocular conditions that are typically associated with dry eye status, such as meibomian gland dysfunction, mild (i.e. not considered clinically relevant) blepharitis, corneal and conjunctival staining are not considered an exclusion.
Protocol-guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms

This program will seek to implement a quality improvement program to improve the care of Veterans with TIA or minor stroke at 6 Veteran Health Administration Hospitals. The investigators will evaluate the implementation and effectiveness of the quality improvement program.

Aim 1. To develop a quality improvement program to improve the care of Veterans with TIA or minor stroke that can be deployed nationwide. The program will include multiple components: a reporting system that is based on validated electronic quality measures (eCQMs) that will allow staff to monitor the time-sensitive processes of care and outcomes of their population of Veterans with TIA or minor stroke; clinical protocols to improve the timeliness and completeness of care; professional education materials; and clinical note templates for use by nursing and pharmacy staff. Lessons learned at the individual sites engaged in the quality improvement program will be shared across sites by use of a web-based platform and a virtual collaborative. We will assess end user's assessment of the program and its core elements.

Aim 2. To evaluate the effectiveness of the Aim 1 QI intervention program for Veterans with TIA or minor stroke against usual care. Teams at the 6 intervention sites will be given the quality improvement program components. The primary effectiveness outcome is the proportion of Veterans who received all of the guideline-concordant processes of care for which they are eligible referred to as the "Without-Fail" care rate.

Aim 3. To evaluate the implementation of the QI intervention program across the 6 participating sites. The two primary implementation outcomes will be the number of implementation activities completed during the one-year active implementation period and the final level of team organization (defined as the Group Organization (GO Score)) for improving TIA care at the end of the 12-month active implementation period.

Secondary Aim To evaluate the sustainability of the program. Sustainability will be evaluated over a one-year period that begins immediately after the one-year active implementation period. We will compare the Without-Fail rate in the sustainability period to the baseline period and the post-implementation period.

Eligibility Criteria:
Inclusion Criteria:

* This program will seek VA hospitals that are self-designated as either a VHA Primary Stroke Center or a Limited Hours Stroke Facility or Supporting Stroke Center.
* Eligibility for staff interviews is based on involvement in the QI intervention and willingness to participate.

Exclusion Criteria:

* Unwilling to participate
Minocycline's Effects on Alcohol Responses in Humans

This is a double-blind, placebo-controlled, outpatient study with a between-groups design. Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or 400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3 outpatient visits for medication administration, dispensing of take-home doses and monitoring of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will have 2 laboratory sessions where alcohol or placebo will be administered intravenously using a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc) method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple outcome measures including subjective, motor, cognitive measurement and plasma cytokine levels.


Eligibility Criteria:
Inclusion Criteria:

1. Male and females, between the ages of 21 and 50;
2. Heavy social drinkers who are defined as consuming ≥10 standard alcoholic drinks per week with one to five weekly "binge" drinking episodes, (5 plus drinks per occasion for men; 4 plus drinks for women). No maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for AUD will be excluded from the study;
3. No current drug use disorder of any drugs of abuse (except alcohol and tobacco);
4. No current medical problems and normal ECG; 5) For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

1. Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
2. History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
3. Liver function tests (ALT or AST) greater than 3 times normal;
4. Allergy to minocycline or other tetracyclines;
5. Participants who at any appointment have a Clinical Institute Withdrawal Assessment Scale (CIWA) \[36, 37\] score of 4 or greater, or who report any history of alcohol withdrawal within the past 6 months.
Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy and sargramostim in treating patients who have non-small cell lung cancer.

OBJECTIVES:

* Determine whether a specific T-cell response can be induced in patients with stage IB-IV non-small cell lung cancer treated with mutant K-ras peptide vaccine (limited to the specific K-ras peptide mutation in their tumors) and sargramostim (GM-CSF).
* Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive sargramostim (GM-CSF) intradermally (ID) on days 1-10 beginning a maximum of 6 months after complete surgical resection. Patients receive mutant K-ras peptide vaccine (limited to the specific K-ras mutation in their tumors) ID on day 7. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 and 12 weeks.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven stage IB-IV non-small cell lung cancer

  * Non-squamous cell histology only
  * Must have undergone curative surgery within the past 6 months and must be free of recurrence
  * Tumor must demonstrate a specific K-ras mutation at codon 12 for which a vaccine preparation is available

PATIENT CHARACTERISTICS:

Age:

* Over 17

Performance status:

* Karnofsky 70-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* No New York Heart Association class III or IV heart disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent medical condition that would preclude compliance or immunologic response to study treatment
* No other serious concurrent medical condition
* No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the uterine cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 3 weeks since prior postoperative chemotherapy and recovered

Endocrine therapy:

* No concurrent systemic steroids
* Concurrent inhaled steroids allowed

Radiotherapy:

* No prior radiotherapy to spleen
* At least 3 weeks since prior postoperative radiotherapy and recovered

Surgery:

* See Disease Characteristics
* No prior splenectomy

Other:

* No concurrent immunosuppressive drugs or antiinflammatory drugs
Evaluating the Effectiveness of a Cognitive Behavioral Intervention (CBI)

This is a Phase III, randomized, one-center, three arm parallel group, open label and single blind clinical study to evaluate the effectiveness of a cognitive behavioral intervention (CBI) adjunctive to a smart powered toothbrush on the oral health of adolescents.

This is a Phase III, randomized, one-center, three arm parallel group, open label and single blind clinical study to evaluate the effectiveness of a cognitive behavioral intervention (CBI) adjunctive to a smart powered toothbrush on the oral health of adolescents. Outcomes briefly summarized include the plaque score, gingival score and a survey of knowledge, attitudes and procedures measured at 1,3 and 6 months

Participating subjects will be randomized to one of the following products:

TEST GROUP I A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush CONTROL GROUP I A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush CONTROL GROUP II A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle toothbrush

Eligibility Criteria:
Inclusion Criteria:

Students are enrolled in participating high schools Caregivers give informed consent Student gives assent

Exclusion Criteria:

* Having a prosthetic heart valve
* Having a history of previously having infective endocarditis
* Having had joint replacement surgery
* Children on blood thinner medication such as Coumadin or Rivaroxaban
* Children who are currently receiving chemotherapy
* Children who have received organ transplants of any type
* Children with Leukemia
FOXP1 Syndrome: The Seaver Autism Center for Research and Treatment is Characterizing FOXP1-related Neurodevelopmental Disorders Using Genetic, Medical, and Neuropsychological Measures.

FOXP1, also known as Forkhead-box Protein P1, is a transcription factor protein belonging to the FOX gene family. Disruptions in the FOXP1 gene cause a phenotype characterized by global developmental delay, speech deficits, mild dysmorphic features, and traits of autism spectrum disorder. This study seeks to characterize FOXP1-related neurodevelopmental disorders using a number of genetic, medical and neuropsychological measures.

Subjects with a variant in the FOXP1 gene will be asked to complete a battery of developmental, behavioral and medical assessments to better characterize gene-related neurodevelopmental deficits. This series of assessments takes place over the course of a three-day period. It includes the Autism Diagnostic Observation Schedule (ADOS), parent interviews regarding developmental history and behavior, a psychiatric evaluation, a neurology assessment, as well as a clinical genetic evaluation that includes a physical and vitals exam. Affected individuals, as well as biologically related siblings, will also undergo a series of sensory assessments, including a research EEG, visual evoked potential, and an eyetracking assessment. Family members present for the visit will also be asked to provide a blood and/or saliva sample for research genetics.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must have a documented variant affecting the FOXP1 gene that the research team determines to be likely or definitely pathogenic.
* Eligible participants must be at least 2 years of age.

Exclusion Criteria:

* none
Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI)

The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histological/cytological confirmed diagnosis of Gastrointestinal malignancy, except pancreatic cancer
* Eligible for 5FU/LV or FOLFIRI chemotherapy
* ECOG 0-1
* Able to swallow and tolerate tablets
* Life expectancy of 3 months

Exclusion Criteria:

* Unwilling to use acceptable method to avoid pregnancy of partner/self for the entire study period and up to 4 weeks after last dose
* Women who are pregnant or breastfeeding
* Pancreatic cancer
* Known brain metastasis, evidence of leptomeningeal disease
* History of thrombo-embolic disease
* Hemorrhage/bleeding events
* Uncontrolled or significant cardiovascular disease
* Any 3 or more of the following risk factors: arterial thrombosis , smoking, hypercholesterolemia, hypertension, obesity (BMS\>30) and diabetes
* Pre-existing thyroid abnormality, not maintained with medication
* QTC (Fridericia) \>450 msec on two consecutive ECG's
* Subjects with concomitant second malignancies ( except adequately treated non-melanoma skin, in situ carcinoma of bladder, cervix or breast, early prostate cancer)
* Any major surgery within 4 weeks of study drug administration
* Increased levels of both D-Dimer and Prothrombin fragment 1 +2
* Arm B and C only-positive UGT1A1 genotype of TA7/TA7
* History of allergy of brivanib or drug class
* History of severe reactions to fluoropyrimidine therapy or irinotecan
* Prior therapy with brivanib
Evaluation of Metoprolol Pharmacokinetics in Patients Receiving Hi Flux Hemodialysis

The current study will evaluate the plasma pharmacokinetics of metoprolol in a cohort of 8 adult volunteers who are receiving regular hemodialysis treatment (HD) 3 days a week for 4 hours each day and have been taking a total daily dose of 25-200 mg of metoprolol succinate for \>30 days as part of their usual care. Blood sampling will occur over 10 hours, with frequent sampling during HD and in the 4 hours after termination of HD treatment. The 8 subjects will all receive their prescribed dose (25-200 mg total daily dose) 2 hours prior to HD treatment. The pre-HD sample will also be sent for pharmacogenomics genotyping. Safety and pharmacodynamic assessments (blood pressure (BP) and heart rate (HR) assessments) will be performed throughout the study. Axiom Precision Medicine Research Array (Affymetrix, Santa Clara, CA) will be used to evaluate genotype of CYP2D6. CYP2D6 phenotype will be evaluated using the ratio of parent drug to metabolite. Non-compartmental analyses will be performed to compare maximum concentrations (Cmax), time to maximum concentration and area under the curve from time 0 to the last measurable sample (AUClast) between the two phases. Compartmental analyses will be performed to construct a model to explain time-dependent changes in metoprolol clearance. Monte Carlo simulations will be performed to compare metoprolol pharmacokinetic profiles on and off HD.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Indwelling tunneled catheter, AVF, AVG that is currently used for hemodialysis
3. Receiving in-center hemodialysis 3 days a week for 3-4.5 hours each treatment
4. Taking a total daily dose of 25-200 mg metoprolol succinate as prescribed by their physician
5. Hemoglobin ≥ 9.5 g/dL on most recent laboratory assessment prior to study

Exclusion Criteria:

1. Any condition that would not allow for arm BP to be taken
2. Hemoglobin \< 9.5 g/dL on most recent lab prior to study
3. Patient is on a CYP2D6 inhibitor (most common in HD population amiodarone, bupropion, cinacalcet, diphenhydramine, fluoxetine, paroxetine)
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life

National, prospective, multicentre observational study designed for eligible patients treated with Inflectra.

Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.
* Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis Patients (or their legal representatives) who have received information (verbally and in writing) about the study and agreed to take part in it.
* Patients who have given their agreement for their clinical data and their medical file to be accessed by signing the information leaflet.

Exclusion Criteria:

* Patients who refuse access to their medical file for collection of: their medical data
* Patients not treated with Inflectra™.
* Patients treated with Inflectra™ for psoriasis.
* Patients with a past history of hypersensitivity to infliximab, to other murine proteins or to one of the excipients in Inflectra™.
* Patients with tuberculosis or any other severe infection such as sepsis, abscess or opportunistic infection .
* Patients with moderate to severe heart failure (NYHA III/IV)
Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.


Eligibility Criteria:
Inclusion:

* Must be scheduled for a segmental colectomy via open laparotomy with general anesthesia
* Subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met
* Subjects must meet the American Society of Anesthesiologists physical status I, II or III

Exclusion:

* Subjects who are scheduled for laparoscopic surgery for the segmental colectomy
* Subjects with a recent history (\<1 year prior to randomization) of abdominal radiation therapy; Subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions)
* Subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (NSAIDs)
Airway Inflammatory Profile Among Cleaning Workers From Different Workplaces

There are consistent evidences through epidemiologic studies in different places, reinforced by occupational asthma records studies, that cleaning workers have a high risk in developing asthma. These risk determinants are not totally known. The air around the worker may have some higher and lower molecular weight with different concentration peaks from removed dust of the cleaning process and volatile substances from cleaning products. Cleaning activities may occur in different places. Although the relationship between rhinitis and asthma is already established, there are not many studies about occupational rhinitis-related work place. This study aimed to investigate airway inflammation and respiratory symptoms of cleaning workers from different workplaces.

Were recruited to participate in the study individuals from four different workplaces: Hospital; University; Housekeeper and Control (office workers). The research was performed in Cacoal city, Rondonia, Brazil. Smokers (active), pregnant, lactating, and individuals at continuing therapy for treating disorders of the airways were excluded.

Clinical profile and respiratory symptoms employees evaluation were performed using the European Community Respiratory Health Survey for occupational diseases evaluation (ECRHS), and the International Study of Asthma and Allergies in Childhood (ISAAC) - Asthma module.

Nasal swab was collected for evaluation of upper airways inflammation, according to Ronchetti et al protocol, using a sterile swab that was moistened with 1mL saline solution; both nostrils were scraped using this swab. Twenty minutes after this, laminas were stained using May-Grunwald-Giemsa to eosinophils, neutrophils, lymphocytes, macrophages and epithelial cells identification. Cells were analyzed using a Nikon E600 optical microscope (Nikon, Canada), of 1.000 x magnitude. Whenever possible a total of 200 cells were counted in two slides.

Statistical analysis were performed using Anova variance (Kruskal-Wallis) and Dunn's test for comparisons between groups. To evaluate the association between the qualitative variables we used the chi-square, Statistical software Sigma Plot 12.0 and SPSS 21.0. The confidence interval was 95% (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Cleaning workers from different workplaces
* Non-cleaning workers (control group)
* People legally capable (over 18 years old)
* Must be able to nasal swab collection and answer questionnaires
* Sign the informed consent form

Exclusion Criteria:

* Smokers (active)
* Pregnant (women)
* Lactating (women)
* Not accept the informed consent form
* Individuals at continuing therapy for airways treating disorders