cyrilzakka/clinical-trials huggingface dataset:
Clopidogrel Reloading in Patients With NSTEACS Undergoing Percutaneous Coronary Intervention on Chronic Clopidogrel Therapy

Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention.

The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* chronic (\> 10 days) therapy with clopidogrel (75 mg/day)
* non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography

Exclusion Criteria:

* primary percutaneous coronary intervention (PCI) for acute ST-segment elevation acute myocardial infarction
* platelet count \< 70 × 10\^9/L
* high bleeding risk
* coronary bypass grafting in the previous 3 months
Extended Spectrum Betalactamase Producing Bacteria; Epidemiology and Treatment in Non-hospitalized Patients

This project aims at investigating the duration of human fecal carriage of bacteria harboring plasmid-borne resistance genes expressing Extended Spectrum beta-lactamases (ESBL), risk factors for infections with such bacteria and persistence, mobility and spread of ESBL in the environment and within households. It also aims to compare different methods of detecting ESBL carriage and treat patients with urinary tract infection caused by these bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>=18 of age with a urine culture yielding E. coli or K. pneumoniae \>10.000 colony forming units/mL.

Exclusion Criteria:

* Patients who have lived in Norway for \<1 year
* Patients who are unable to answer a questionaire
* Patients who have been infected with an ESBL producing bacteria before
* Patients who have been admitted to a hospital or a long term care facility for \>24 hours during the past 31 days.
Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)

The links between low LDL-C levels and psychologic symptoms (psychotic disorders, mood disorders, aggressivity, suicidal risk, etc.) and cognitive deficits (mainly executing functioning) are debated. The PARTITION study aims at estimating the prevalence of hypobetalipoproteinemia (HBL), defined as a LDL-C level ≤ 0,50 g/L, in a psychiatric population.

Some forms of hypobetalipoproteinemia (HBL) are associated with a longevity syndrome and cardiovascular protection due to prolonged exposure to low levels of LDL-C. However, while LDL-C reduction has been studied extensively for its beneficial effect on cardiovascular risk, other studies have reported that low levels of LDL-C (either spontaneous or artificially occurring with low-fat diets or lipid-lowering drugs) may be associated with psychiatric symptoms (psychotic or mood disorders, aggression, suicidal attempts, etc.) or altered cognitive performance (particularly executive functioning). These studies have led to contradictory results, and the possible link between low LDL-C levels and psychiatric symptoms remains highly controversial so far.

The PARTITION study aims at estimating the prevalence of hypobetalipoproteinemia (HBL), defined as a LDL-C level ≤ 0,50 g/L, in a psychiatric population. Moreover, the study includes the characterization of psychiatric disorders as well as psychological and personal characteristics associated with HBL. The evolutionary profile of patients with and without HBL will be studied. Genetic characteristics and biomarkers of HBL will also be studied.

Eligibility Criteria:
Inclusion Criteria:

All patients hospitalized in one of the full-time adult psychiatric departments of Nantes University Hospital may be included, without maximum age limit.

Minors and patients under guardianship and tutorship may be included, taking into account the study population and the low risks and constraints of the study

Exclusion Criteria:

* minors under 15 years
* pregnant or nursing woman;
* simultaneous participation in another interventional research on a drug;
* not mastering the reading and writing of the French language well enough
PVI Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries

Intraoperative fluid given according to BMI in group B and according to pulse oximeter- derived pleth variability index(MASIMO RAINBOW PULSE CO OXIMETRY) in group G. Comparison of haemodynamics, urine output,blood lactate levels, blood sugar, flap sugar and coagulation profile between the two groups.

A sample size of 80 taken and computer generated random allocation done to divide the patients in two groups(40 each). Head and neck onco surgery patients undergoing resection and reconstruction with radial artery free flap and antero lateral thigh free flap of duration 4-6 hours taken for surgery.

Group B to receive intravenous fluid according to body weight stating at the rate 6-8 ml/kg/hr.

Group G to receive intravenous fluid according to Pleth variability index value(4-11).Blood loss up to 10% replacement by colloids.

Comparison of following parameters:

Demography, haemodynamics,urine output .blood lactate, ph, oxygenation index ,thromboelastography (TEG), blood sugar, flap sugar .

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing radial and anterolateral free flap

Exclusion Criteria:

* Duration of surgery \> 6hrs
* BMI \> 30
* Patients on anti platelet drugs
* Patient refusal
The Effect of Reading a Pictorial Storybook on Children's Fear, Anxiety and Emotional Symptoms Before Dental Treatment

The aim of this study was to determine the effect of reading a picture storybook on children's fear, anxiety and emotional symptoms before dental treatment.

In children with receiving dental treatment will be randomly divided into two groups: picture storybook group and control. Interventions will be applied for only 1 times. While the illustrated storybook is read to the experimental group, no intervention will be applied to the control group. The children will be assessed before, during and after. Fear, anxiety and emotional symptoms due to dental treatment procedure will be evaluated using the Children's Emotional Indicator Scale, Child Anxiety Scale-Stateness and Children's Fear Scale.

Eligibility Criteria:
Inclusion Criteria:

* No audiovisual impairment,
* Being open to communication and
* Must be accompanied by a parent.

Exclusion Criteria:

* Having special needs,
* Having an audio-visual impairment,
* Learning difficulties or mental retardation and
* Children whose parents do not agree to participate in the study.
Repeatability and Reproducibility of the ArcScan Insight 100 VHF Digital Ultrasound

The purpose of this study is to evaluate the repeatability and reproducibility of corneal (including corneal, epithelial, stromal, and LASIK flap thickness) and anterior segment measurements using the ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.

Very high-frequency (VHF) digital ultrasound was first used in 1993 to obtain images of the cornea (the window at the front of the eye) and anterior segment (the space behind the cornea including the iris and the lens). A commercially available instrument, called the Artemis 2, has been used in routine clinical practice since 2001. The Artemis 2 was CE approved as well as having FDA approval (the US equivalent of the CE mark).

The ArcScan Insight 100 VHF digital ultrasound scanner is a new instrument so does not yet have a CE mark. However, the ArcScan Insight 100 is an upgraded version of the Artemis 2, so any differences are improvements to components, but the measurement method remains essentially the same.

The aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) of the ArcScan Insight 100 device for measuring corneal and anterior segment parameters.

Eligibility Criteria:
INCLUSION CRITERIA Only patients who are medically suitable for corneal refractive surgery can be included in the study.

As general inclusion criteria the following aspects are defined:

* Subjects should be 21 years of age or older.
* Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
* Patient will be able to understand the patient information and willing to sign an informed consent.

For the repeatability and reproducibility phase using normal eyes of the study:

* Eyes with no ocular pathology
* Eyes with no previous ocular or corneal surgery

For the repeatability and reproducibility phase using post-LASIK eyes of the study:

• Eyes between 3 and 9 months after LASIK or SMILE

For the comparison of ArcScan Insight 100 VHF digital ultrasound with RTVue OCT

• Either eyes before or after corneal refractive surgery

EXCLUSION CRITERIA

* Previous ocular or corneal surgery (for normal eyes)
* Patient not being able to tolerate local or topical anesthesia
* Patient has active conjunctivitis or any active ocular infection or inflammation
* Patient has a corneal ulcer
* Patient has an open wound on the corneal epithelium
* Patient has compromised epithelium (e.g. ≥Grade 3 superficial punctate keratitis)
* Pregnancy
Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome

Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic Syndrome (ATP III)
* Moderate to severe OSA

Exclusion Criteria:

* Smokers
* Patients under chronic use of medications
* Neurological diseases
* Coronary artery disease
* Acute heart failure
* Chronic renal failure (GFR \< 30 ml/min)
* Chronic obstructive pulmonary disease
* Mild OSA and patients with BMI over 40 kg/m2.
Using Conversation Maps to Reinforce Self-Care

Many people with type 2 diabetes are not able to keep their blood glucose in good control. Improving blood glucose control and maintaining that improvement is important for diabetes patients because doing so delays the onset and progression of severe complications of diabetes. Although educational programs may be helpful, their effect is not always long-lasting. This project is studying whether the Conversation Maps program (an interactive diabetes education program) reinforces diabetes education and information and thus helps type 2 diabetes patients take better care of their diabetes and blood glucose levels. Half of the patients will attend the Conversation Maps program and half of the patients will attend an educational program about blood pressure and cholesterol. Also, all patients will come in for 4 or 5 appointments to complete surveys and other tests and have their blood drawn. The group of patients who attend the Conversation Maps program will be compared to the group of patients who attend the blood pressure and cholesterol program to see if the educational programs helped diabetes patients to improve their diabetes control and quality of life and to maintain that improvement over time.


Eligibility Criteria:
Inclusion Criteria:

* Ages 25-75 years
* Diagnosis of type 2 diabetes mellitus
* Two A1c levels ≥7.0 % (above ADA target)
* 2 years since initial diagnosis. This will provide a minimum of two-years experience with diabetes treatment. Also, excluding those who are newly diagnosed will prevent improvement due to newly prescribed medications from confounding study results.
* Attended one of Joslin's group education programs or comparable 3-hour (or more) educational programs and/or appointments

Exclusion Criteria:

* Severe complications of diabetes including renal disease (microalbumin \>300 ug/mg), severe peripheral diabetic neuropathy and/or severe peripheral vascular disease, symptomatic severe autonomic neuropathy, that may place participants at risk when increasing activity levels.
* Proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included.
* Current or planned pregnancy
* A1c levels less than 7.0% (normal range 4.0 - 6.0%) and A1c levels greater than 14%.
* A history of severe, unstable myocardial infarction, congestive heart failure or other severe cardiac disease, or severe hypertension (systolic ≥160 mmHg or diastolic ≥ 90 mmHg) (increased risk when mildly increasing physical activity).
* A diagnosis of bipolar disorder, schizophrenia, mental retardation, organic mental disorder, and alcohol or drug abuse will be excluded, as well as patients currently undergoing psychiatric treatment. These exclusions are being made to avoid confounds due to concurrent changes in mental status and the effects of ongoing psychiatric treatment.
* Used Conversation Maps as an educational tool
* Started a new diabetes medication (pills or insulin) in past three months
Sources of Variability in Peak Expiratory Flow

To provide information necessary for the development of standards for peak expiratory flow (PEF) test performance in populations studies.

BACKGROUND:

While PEF has routinely been applied in the diagnosis and management of asthma, scientists were finding new applications for PEF as both a clinical and epidemiologic tool for following individuals with pulmonary diseases, studying the natural history of chronic obstructive pulmonary disease, and evaluating the impact of environmental exposures on lung function. Yet the standardization of the PEF measurement lagged behind its application.

The little attention paid to the performance characteristics of the PEF maneuver contrasted sharply with the efforts to standardize measurement procedures for FEV1 and FVC. The American Thoracic Society devoted a great deal of attention to studying these measures and published guidelines for the standardization of their measurement. These guidelines included detailed protocols for calibrating equipment, administering the tests, determining reproducibility, and interpreting results.

The research provided data on the optimal number of trials per test session, the difference between a PEF performed during a full forced expiratory effort and that resulting from a short blast, the impact of test supervision on test performance, and the reproducibility of the PEF measurement.

DESIGN NARRATIVE:

A baseline survey of ventilatory function was performed using spirometry. PEF was measured daily with a mini-Wright Peak Flow Meter over a period of several weeks in a study of 201 normals (staff, faculty and graduate students at the University of Massachusetts Lowell). Serial PEF data were collected on a group of mild asthmatics identified in a local occupational medicine clinic. Finally, performance characteristics were examined in serial PEF data from two existing occupational cohort studies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma

In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.


Eligibility Criteria:
Inclusion Criteria:

* must have metastatic breast cancer
* must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
* must have measurable or evaluable disease
* ECOG of 0-1
* patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
* must have adequate organ function
* must be at least 19 years of age
* peripheral neuropathy less than or equal to grade 1
* must have voluntarily signed informed consent
* patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled

Exclusion Criteria:

* patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
* patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
* known uncontrolled existing coagulopathy
* patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
* use of other investigational agents in the last 28 days
* pregnant or lactating women
* patients who are known HIV positive
* patients with life expectancy of less than 3 months
* sexually active patients unwilling to practice reliable contraception during the study
A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as compared to IV administered migalastat HCl in healthy volunteers. The data from this study will help us understand how migalastat works in the body and will help us determine what would be an effective dose in future studies with migalastat hydrochloride.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 45 years of age.
* Body weight range ≥ 50 kg ≤ 100 kg and BMI within the range 18.5 - 29.9 kg/m2.
* Healthy as determined by a responsible and experienced physician, based on a medial evaluation.
* Male and female subjects of childbearing potential agree to adhere to the contraception requirements.
* Capable of giving written informed consent.

Exclusion Criteria:

* History of sensitivity to migalastat HCl or related iminosugars (eg, miglitol, miglustat), or other significant drug allergy.
* Past medical history, or physical examination findings, of clinically significant abnormalities that may put the subject at risk or interfere with outcome variables.
* Positive pre-study drug/alcohol screen.
* Pregnant or lactating females.
* The subject has participated in a clinical trial and has received an investigational product within 60 days prior to the first dosing day in the current study.
Evaluation of Effectiveness of Nutritional Counseling in Patients After Stroke

Stroke is the leading cause of disability worldwide and the leading cause of death in Brazil. It is estimated that about 18 million people will have a stroke in 2015 and approximately one third of these resulting in death. The factors most important modifiable risk for stroke include high blood pressure (hypertension), diabetes, smoking, dyslipidemia, sedentary lifestyle and obesity. Acting on these risk factors can be reduced by 88% the risk of another stroke. Healthy eating is among the changes in lifestyle that are recommended for prevention and treatment of one of the main risk factors for stroke. Studies show that the adoption of the DASH diet can significantly reduce blood pressure and the result is even more significant in hypertensive patients, making this diet a new alternative in the prevention and treatment of hypertension and consequently stroke. Compliance therapy is a determining factor for success in the treatment of chronic diseases. Adherence to long-term treatment in developed countries is around 50% and in developing countries the rates are even lower. The aim of this study is to evaluate the effectiveness of nutritional counseling in an adapted DASH style diet on body weight, glycemic control, blood pressure values and improved lipid profile compared to the usual diet without nutritional counseling in patients with stroke within the last 3 months. The hypothesis is that nutritional counseling with an adapted DASH style diet reduces cardiovascular risk factors compared with the usual diet without nutritional counseling in patients with stroke within 3 months. The stroke patients will be selected in the hospitalization or in the outpatient clinic of Hospital de Clínicas de Porto Alegre in a period up to 3 months after ischemic stroke. The patients will be randomized to one of the 2 groups. In the first visit they will be submitted to a social class and international physical activity questionnaire and they will be submitted to a food frequency questionnaire, measures of weight, height, waist circumference, hip and neck, blood pressure and cholesterol and glucose measurements at the baseline, 30 days and 3, 6, 9 and 12 months. The main endpoints will be the change in the body weight, blood glucose, blood pressure values and lipid profile.

The study will be followed by a evaluation of other endpoints: new stroke, myocardial infarction or cardiovascular death.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic Stroke up to 3 months
* Modified Rankin Score \< 4

Exclusion Criteria:

* Aphasia
* Enteral diet
* Unavailability to follow up the study
Erector Spinae Plane Block for Acute Back Pain in the Emergency Department

The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are:

1. Does the ESPB reduce short-term pain in participants with low back pain?
2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain?

Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain.

Participants will:

Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.

Exclusion Criteria:

* Do not speak English or Spanish as a primary language
* Are incarcerated
* Have a known pregnancy
* Are allergic to amide-type local anesthetics
* Are unable to tolerate positioning for the procedure
* Have a critical illness precluding the ability to perform the procedure.