cyrilzakka/clinical-trials huggingface dataset:
Implementation and Evaluation of an Activity Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer

Implementation and Evaluation of an Activity Based Program to Improve Quality of Life, Pain and Fatigue Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction, decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods Quality of Life, Pain and Fatigue surveys).

This research study will focus on developing and implementing two one-week activity camps in the summer of 2016 for women diagnosed with cancer. One camp will be held in West Philadelphia and another in Camden, New Jersey, both of which have been identified as underserved areas for health access. The focus of this programming is to allow women to engage in activities they may not be engaged in since the diagnosis of cancer and to provide them with opportunities to socially interact and communicate with individuals who may have encountered the same difficulties as them. Quality of life, pain and fatigue information will be collected before, during and after implementation of the activity program. The main objective is to demonstrate improved life satisfaction, decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods and geographical locations through Quality of Life, Pain and Fatigue surveys). The intended sample size is 57 women.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with cancer
* Age of 21 of older
* Clearance from their MD to participate in the activity program

Exclusion Criteria:

* None
Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees

Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roasting degrees. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo.

The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.

Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roast levels. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo.

The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at different roast levels.

After medical examination and approval, subjects will be randomly assigned to one of the four coffee treatments. Each study period correspond to the ingestion of one the treatments and study periods are separated by a one week washout period. Blood will be taken as a time course for 24h while urine will be collected for 30h. Investigators are also blinded with respect to the dose and the treatment given to the subjects.

Eligibility Criteria:
Inclusion Criteria:

* 20 - 60 years, male and female
* healthy as determined by the medical questionnaire and the medical visit
* normal weight: BMI 19 - 25
* Coffee drinkers with an average consumption of 2-5 cups per day
* having given informed consent

Exclusion Criteria:

* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer
* food allergy
* Have had a major gastrointestinal surgery
* Difficulty to swallow
* Have a regular consumption of medication
* Have taken antibiotic therapy within the last 6 months
* Alcohol consumption \> 2 units a day
* Smokers \> 5 cigarettes a day
* Have given blood within the last 3 weeks before the start of the study
* Volunteers who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial during the last 3 weeks
An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data

The pathological variants of IgA nephropathy identified by the Oxford classification may be related to the clinical data at presentation and follow-up, including proteinuria and renal function. This study is aimed to identify the potential relationship between pathological variants and clinical data in IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* biopsy-proven IgA nephropathy;

Exclusion Criteria:
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)

To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \>2500m on pulmonary artery pressure (PAP) and other hemodynamics.

This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA \>2500 (PVD_HA) will have PAP and other hemodynamics assessed by echocardiography and blood gases near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-90 years old of both genders,
* Residence \> 2500m of altitude
* diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) \>20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
* Patients stable on therapy
* New York Heart Association (NYHA) functional class I-III
* Provided written informed consent to participate in the study.

Exclusion Criteria:

* Age \<18 years or \>80 years
* unstable condition
* Patients who cannot follow the study investigations, patient permanently living \< 2500m.
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, severe smokers (\>20 cigarettes/day)
* Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulse-oximetry (SpO2) \<80% on ambient air.
* Patients with chronic mountain sickness (Hemoglobin \> 19 g/dl in women, \>21 g/dl in men)
* Patient with a non-corrected ventricular septum defect
* Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)
Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease

in this study the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction

in this study the patients that have morbid obesity concomitant GERD will managed by sleeve gastrectomy plus cruroplasty then stripe from the momentum is fashioned and is raped around the gastroesophageal junction

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures
Pharmacoinvasive Strategy vs. Primary PCI in STEMI: A Prospective Registry in a Large Geographical Area

For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking, especially in developing countries.

The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area.

For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. The optimal choice between primary percutaneous coronary intervention (PPCI) and intravenous thrombolytic agents depends upon the timeliness of effective delivery, as well as the total ischemic time. While PPCI is widespread available in the USA and Europe, limited resources and lack of infrastructure means that patients with STEMI in low- and middle-income countries (LMICs) receive significantly less reperfusion therapy, and when they do, they are more prone to receive thrombolytic agents.

Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking. The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area.

PHASE-Mx study is a prospective, real-world registry including patients with STEMI finally treated at a large cardiovascular center. In brief, patients aged 18-99 years old with the diagnosis of STEMI whom received either PI or PPCI during the first 12 hours since symptom onset were included. Patients could have a first medical contact directly at the study center or in one of other 60 hospitals along the STEMI network. Patients with a discharge diagnosis other than STEMI were excluded. Four of the investigators recorded the study data at admission and during hospital stay. Main efficacy outcome will be the composite of cardiovascular death, cardiogenic shock, reinfarction or stroke. Main safety outcome will include rates of major bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-99 years old, with the diagnosis of STEMI whom received either PI or PPCI during the first 12 hours since symptom onset. Patients could have a first medical contact directly at the study center or in one of other 60 hospitals along the STEMI network.

Exclusion Criteria:

* Patients with a discharge diagnosis other than STEMI.
Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.

This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults (≥18 yrs)
* Stable health status
* Provide informed consent
* Access to direct phone service (NOT a pay phone or a common-use phone service)
* Eligible females must have a negative pregnancy test

Exclusion Criteria:

* Febrile illness (\>38.0°C oral temperature)
* High blood pressure (≥140/90 mmHg)
* Significant acute or chronic
* Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
* Immunosuppressive condition (confirmed or suspected)
* Renal impairment
* Hepatic dysfunction
* Complicated insulin-dependent diabetes mellitus
* Unstable cardiopulmonary disease
* Blood dyscrasias
* Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
* History of demyelinating disease
* Active neurological disorder
* Significant alcohol or drug abuse
* Significant coagulation disorder (prophylactic antiplatelet medications allowed)
* Influenza vaccine administrated within 6 months prior to study vaccination
* Administration of any other vaccine from 30 days prior to the end of the study
* Use of non-registered drug within 30 days prior to study vaccination
* Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
* History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
* Pregnant or nursing female subjects
* Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)
Post-Market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Liver Surgery

The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female patient ≥ 18 years old
* Subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent
* Patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent
* Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up.

Main Exclusion Criteria:

* Known allergy or hypersensitivity to any component of the investigational treatment PuraStat®
* Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding
* Concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints
A Retrospective Review of DEXTENZA 0.4 mg inseRt Following Corneal Transplant or Cataract Surgery

A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal transplant or Cataract surgery

A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert, placed within the lower or upper eye lid canaliculus in conjunction with topical steroid Prior to or Following Corneal transplant or Cataract surgery

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Patients who received DEXTENZA insertion perioperatively.

Exclusion Criteria:

* Any patient who did not receive DEXTENZA insertion
Worksite Wellness Within Long-term Care Facilities

The goal of this proposed study is to test the feasibility and preliminary efficacy of worksite wellness program designed to reduce worker stress (job and personal) and improve cardiovascular disease among long-term care workers. We also aim to test if increasing wellness behaviors in staff will translate to increased wellness behaviors in residents due to positive role modeling.

This is a cluster randomized control trial (staff n=246 and resident n=180) implemented in six long-term care worksites. Three sites will be randomized to the WHHIP-PLUS \& FFC and three sites will be randomized to the education-only.

The intervention occurs over 12 months and measures will be collected at three timepoints. We will test treatment fidelity as well as if our intervention improves Life's Simple 7 scores and reduces stress levels among long-term care workers and increases physical activity among residents.

Eligibility Criteria:
Staff inclusion criteria:

18 years or older; Able to understand and speak English; Employed by the facility; Passed the evaluation to sign consent

Resident inclusion criteria:

55 years or older; Able to understand and speak English; Resident of the facility; Passed the evaluation to sign consent

No exclusion criteria for staff or residents
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation

The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.

This study investigated the effects of ivacaftor in participants with cystic fibrosis (CF) \>=12 years of age with a forced expiratory volume in 1 second (FEV1) \>=40 percent (%) predicted. This study was conducted in 2 parts.

* Part A of this study was a randomized, double-blind, placebo-controlled, parallel-group evaluation of participants with CF who were aged 12 years or older and were homozygous for the F508del-CFTR mutation.
* Part B of this study was an open-label extension of Part A, enrolling participants who completed Part A and met pre-specified endpoint criteria, and explored the safety and efficacy of ivacaftor over long-term treatment in participants with CF aged 12 years or older who were homozygous for the F508del-CFTR mutation.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cystic fibrosis (CF) and homozygous for F508del-CFTR mutation
* Forced expiratory volume in 1 second (FEV1) of at least 40% of predicted normal for age, gender, and height
* Willing to use at least 2 highly effective birth control methods during the study
* No clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator
* Able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator

Exclusion Criteria:

* History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject
* Acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of Day 1 of the study
* History of alcohol, medication or illicit drug abuse within one year prior to Day 1
* Abnormal liver function \>=3 x the upper limit of normal
* Abnormal renal function at Screening
* History of solid organ or hematological transplantation
* Pregnant or breast-feeding (for women)
* Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to screening
* Previous participation in a VX-809 study
* Used inhaled hypertonic saline treatment
* Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP3A4)
Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

16-week, open-label, multi-center pilot study. Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of either: 1) ≥ 2 OAs (Cohort A), 2) basal insulin ± OAs (Cohort B), or 3) basal-bolus insulin ± OAs (Cohort C) will initiate basal-bolus therapy with an insulin pump using a rapid-acting insulin analog.


Eligibility Criteria:
Inclusion Criteria:

1. Is 18 to 75 years of age, inclusive;
2. Has a clinical diagnosis of type 2 diabetes mellitus;
3. Is anti-glutamic acid decarboxylase (GAD) antibody negative;
4. Has an A1C ≥ 7.0% and ≤ 10.5%;
5. Has a body mass index (BMI) ≥ 25 kg/m2 and ≤ 40 kg/m2;
6. Is treated with either ≥ 2 oral antidiabetic agents (OA) or basal insulin ± OA(s) or basal-bolus insulin ± OA(s) for at least 3 months (Subjects may also be treated with exenatide \[Byetta\] or pramlintide \[Symlin\].
7. If on concomitant metformin, has serum creatinine \< 1.5 mg/dL (male) or \<1.4 mg/dL (female);
8. If female, has a negative urine pregnancy test

Exclusion Criteria:

1. Has experienced recurrent severe hypoglycemia (\> 2 episodes) requiring assistance during the past 6 months;
2. Has clinical cardiovascular disease (CVD) as evidenced by prior myocardial infarction, stroke, arterial revascularization and/or angina with ischemic changes on ECG at rest, changes on graded exercise test, or positive cardiac imaging test results;
3. Has abnormalities on the screening (Visit 1) 12-lead ECG that are deemed by the investigator to be clinically significant;
4. Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route or potent inhaled,intrapulmonary, intranasal, or topical steroids that are known to have a high rate of systemic absorption;
5. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be non-compliant;
6. Has any significant medical condition, laboratory findings, or medical history that in the investigator's opinion may affect successful completion of the study and/or personal well-being;
Chest Compression and Cerebral Oxygenation During Cardiopulmonary Resuscitation

In recent years, monitorizations during Cardiopulmonary Resuscitation (CPR) are inadequate to show the sufficiency of cerebral oxygenation. During CPR, insufficient chest compressions have critical importance for neurological results and life quality after the return of spontaneous circulation (ROSC).

The Near-Infrared Spectroscopy (NIRS), which is used in measuring the cerebral tissue oxygenation is one of the latest technologies that allow the measurement of brain oxygen saturation. With this study, the issue of whether sufficient cerebral oxygenation is provided during CPR applied to patients that have Cardiac Arrest (CA) will be investigated, and the effect of CPR on the patient prognosis after ROSC will be examined. In this study, the aim is to investigate whether sufficient oxygenation is provided in synchronization with chest compressions during CPR; and to test the regional brain tissue saturation with rSO2 measurement, and the prognosis with Full Outline of UnResponsiveness (FOUR) Score in patients with ROSC.

Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing cardiac arrest in intensive care unit

Exclusion Criteria:

1. Head injury and intracranial bleeding
2. Cerebral ischemic vascular event
3. Pulmonary diseases that may affect blood-oxygen levels
4. Below the age of 18