cyrilzakka/clinical-trials huggingface dataset:
Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients

The primary objective of this study is to determine the effectiveness of home digital blood pressure monitoring in aiding providers to maintain blood pressure within a therapeutic range in type B aortic dissection patients upon discharge from the hospital.

Patients admitted to the Cleveland Clinic Main Campus with a diagnosis of type B aortic dissection or intramural hematoma who do not receive a surgical intervention during their index hospitalization, or planned intervention on follow up, and are discharged on medical therapy consisting of strict heart rate control and BP control will be included in the study. They will be either randomized to standard therapy to measure BP at home (standard of care) or intervention arm consisting of Withings Wireless Blood Pressure Monitor, which will transmit BP recordings from smartphone to MyChart/EPIC (test arm). All patients will first receive a 24 hour ambulatory monitor regardless of treatment assignment to establish baseline BP pattern. Following this patients randomized to intervention arm will utilize their Withings Blood Pressure Monitor. Providers on the study team will then adjust the patient's hypertensive medications to ensure their BP is below a systolic goal of 120 mmHg utilizing downloaded recordings available in the electronic medical record.

The primary clinical endpoint is the change in mean 24 hour systolic blood pressure between the start of the study and the end of the study period (4-week period). Secondary outcomes will include the number of patients able to achieve a therapeutic systolic blood pressure of 120 mmHg with both mean BP cuff and in office visit at end of 4 week period, increase in size as measured by computed tomography (CT) scan of the aorta, hospitalization or emergency room (ER) visits for symptoms from dissection or uncontrolled hypertension, hospitalization or ER visits for hypotension, all-cause mortality, and need for surgical intervention (open or endovascular).

Eligibility Criteria:
Inclusion Criteria:

* Patients discharged from Cleveland Clinic Main Campus with principal diagnosis of type B aortic dissection (defined as distal from left subclavian artery) who do not receive a surgical intervention during their hospitalization
* Arm Circumference of 9-17 inches

Exclusion Criteria:

* Patients who do not have a smart phone
High Intensity PreHab Before Major Abdominal Surgery

The risk for major cardiac cardiovascular events (MACE) within the first 30 day after surgery is nit only associated to the patient relate risk factors but also to the kind of surgery. Surgical interventions can be distinguished infield risk (MACE \<1%), moderate risk (MACE 1-5%) and high risk (MACE \> 5%). In addition with patient related risk factors it can raise to values of 40%.

The preoperative aerobic fitness \[oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) \<11 mL/kg/min\] has been shown of particularly interest in identifying patients at increased risk of postoperative complications. In the last decade major interest was put in the question whether a preoperative personalised physical training may have beneficial effect on the preoperative fitness and on the occurrence of postoperative complications. In some small studies this benefit has been shown for abdominal and thoracic surgery.

However some of those studies are controversially discussed because of missing randomisation and methodical issues. Also most of the studies needs a four week training period. This may lead to ethical and logostical problems oncologic patients.

The aim of this study is to assess the effect of a personalised, high intensity trains program of two weeks on the preoperative fitness.

The risk for major cardiac cardiovascular events (MACE) within the first 30 day after surgery is nit only associated to the patient relate risk factors but also to the kind of surgery. Surgical interventions can be distinguished infield risk (MACE \<1%), moderate risk (MACE 1-5%) and high risk (MACE \> 5%). In addition with patient related risk factors it can raise to values of 40%.

The preoperative aerobic fitness \[oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) \<11 mL/kg/min\] has been shown of particularly interest in identifying patients at increased risk of postoperative complications. In the last decade major interest was put in the question whether a preoperative personalised physical training may have beneficial effect on the preoperative fitness and on the occurrence of postoperative complications. In some small studies this benefit has been shown for abdominal and thoracic surgery.

However some of those studies are controversially discussed because of missing randomisation and methodical issues. Also most of the studies needs a four week training period. This may lead to ethical and logostical problems oncologic patients.

The aim of this study is to assess the effect of a personalised, high intensity trains program of two weeks on the preoperative fitness.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* BMI 18 - 35kg/m2
* Signed informed consent
* Elective abdominal surgery with moderate to high risk

Exclusion Criteria:

* Pregnancy of lactation
* Major trauma or massive haemorrhage with the last two weeks
* Inclusion of the patient in a interventional study
* Contraindication for preoperative fitness training or ergometry
* Transplantation surgery
Stereotactic Radiation in Patients With Small Cell Lung Cancer and 1-10 Brain Metastases

This research study is studying stereotactic radiation (focused/pinpoint radiation that targets each individual tumor but not the surrounding brain) instead of whole-brain radiation (radiation targeting the entire brain) as a possible treatment for patients with small cell lung cancer and 1-10 brain metastases.

The intervention involved in this study is:

-Stereotactic (focused, pinpoint) radiation

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment, in this case stereotactic radiation, to learn whether this treatment works in treating a specific disease. "Investigational" means that the treatment is being studied.

In patients with a limited number of brain metastases (spread of a cancer that started outside of the brain to the brain itself) the standard radiation option is stereotactic radiation, which involves using a high dose of radiation that only targets the specific metastases that are visible on imaging of the brain, not the whole brain itself. However, studies evaluating the role of stereotactic radiation to treat brain metastases generally excluded patients with small cell lung cancer. Therefore, among patients with small cell lung cancer and brain metastases, the typical treatment that has been offered is whole brain radiation. However, whole brain radiation has deleterious associated side effects including significant fatigue and permanent memory/attention problems. The investigators are studying whether stereotactic radiation can be effectively utilized for patients with small cell lung cancer and brain metastases in order to avoid such side effects.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a biopsy-proven tumor consistent with small cell lung cancer and intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible. Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study.
* 1-10 definitive intracranial lesions must be present on MRI of the brain.
* Age \>=18 years at diagnosis of brain metastases.

Exclusion Criteria:

* Participants who have undergone prior radiation for brain metastases.
* Participants who have received prophylactic cranial radiation for prevention of brain metastases
* Participants who cannot receive gadolinium
* Participants with stage IV-V chronic kidney disease or end stage renal disease
* Participants with widespread, definitive leptomeningeal disease
* Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
* Participants with \>6 definitive lesions consistent with brain metastases
* Participants with inadequate mental capacity to complete quality of life questionnaires
Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy

The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS) causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing spasticity and the spastic syndrome in selected cases of patients with cerebral palsy

PROJECT Lateral Cord Stimulation was thought by the author to be employed in patients with spastic cerebral palsy with the aim to improve tonus, motor function and speech.

Nevertheless, as it has been demonstrated as acting on the basic phenomena related with spasticity, it's to say the propagated spinal responses, its use could be extended to other forms of spastic disease, like spastic limbs post stroke, brain congenital malformations producing spasticity and motor disorders as the main signs, post anoxic encephalopathy, etc.

In this preliminary clinical trial, classed as phase 3, our sample must be very limited to assure stable conditions for statistical significance, hence our group is going to be circumscribed to certain conditions and pathology.

In the future, as long the method could spread its use, the extension on indications in other pathological conditions is advisable thus, its possibilities of marketing could be enlarged with its use in a broader spectrum of spastic patients.

Calculated risks are similar to those related with the ancient surgical technique called "Scoville"technique, currently employed time ago for cervical discectomy (6) Investigational plan The purpose of this clinical trial is to release spasticity and by this means improve the condition of patients with spastic cerebral palsy by extradural lateral cord electrical stimulation, by using currently employed electrodes and neurostimulators Those devices are already FDA approved and currently used for Dorsal Column Stimulation with the objective to treat chronic Pain and spasticity (Spasmodic Torticollis).

Eligibility Criteria:
Inclusion Criteria:

* Aged sixteen or older
* Spastic Cerebral Palsy with stable condition
* Motor disability unilateral or predominantly unilateral.
* Troubles of speech clinically evident.
* Normal or Slightly sub-normal I.Q
* No psychiatric disorders.

Exclusion Criteria:

* Severe cardiac or respiratory troubles
* Fixed abnormal postures (except if previously corrected by orthopedic surgery)
* Chronic recurrent bronchial or pulmonary infections
* Chronic recurrent urinary infections
* Severe osteoporosis on affected limbs
* Chronic skin ulcerations.
Comparison of Two Physical Activity Interventions in Individuals With Multiple Sclerosis

This study will examine the effectiveness of aquatic therapy on a range of MS-related symptoms such as cognition, mood, fatigue and quality of life (QOL).

Aim 1. Examine the impact of aquatic exercise on cognitive abilities. The proposed study will test the hypotheses that, compared to the wait-list control group, the treatment group will demonstrate significantly greater improvements in cognitive outcomes, specifically: processing speed, executive functioning, working memory and long-term memory.

Aim 2. The current study will examine the impact of an aquatic exercise on fatigue, mood, wellness, QOL and physical functioning. Specifically the investigators predict that aquatic exercise will lead to improvements in: 1.Fatigue 2. Health related QOL 3. Depression/anxiety 4. Self-efficacy 5. Physical Functioning (i.e. gait and walking).

Aim 3: Examine the long-term effects of aquatic exercise on all outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MS.
* between the ages of 18-65.
* read and speak English fluently.

Exclusion Criteria:

* history of significant substance abuse.
* history of neurological disease other than MS (for example, stroke, epilepsy, or brain injury).
* history of significant psychiatric illness (for example, bipolar disorder or schizophrenia).
* has engaged in more than 30 minutes of moderate to strenuous exercise per week during the past six months.
PCC and Fibrinogen Compared With FFP in PPH

The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). The original protocol included the use of HES and the recruitment of patients was postponed while waiting the final decision by EMA. All HES solutions were abandoned at our institution in September and an amendment was made to change the protocol. HES solution are replaced by the use of hyperoncotic (20%) albumin.

Forty patients are randomized to receive either PCC and fibrinogen concentrate (PCC group) or FFP (and fibrinogen if needed) (FFP group), 20 patients in each group. Patients in the PCC group receive 15 IU/kg of PCC concentrate and 2 g of fibrinogen concentrate. Patients in the FFP group receive 4 units of FFP. In both groups, additional fibrinogen is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm.

Baseline blood samples will be drawn at study inclusion when the (on-going) blood loss exceeds 1500 ml. The next samples will be drawn at 45 min (or immediately after the administration of the study drug if later). Otherwise, the management protocol strictly follows the local PPH guideline.

The primary endpoint is the amount of blood loss within the first 6 and 24 hours after delivery. Secondary endpoints include the difference/similarity in the laboratory determinations (ia coagulation screen, PFA-100, CAT and ROTEM).

Eligibility Criteria:
Inclusion Criteria:

Women who have delivered vaginally or by caesarean section with a PPH of 2000 ml (the amount of blood loss: in addition to the suctioned blood, sponges, wraps, swabs, etc. are carefully weighed)

Exclusion Criteria:

Women with a history of bleeding tendency or hepatic or renal insufficiency, or PPH exceeding 3000 ml because in that case the initial need for fibrinogen may be even more
Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.

Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%.

This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Cervical cancer FIGO stage IIB-IVA
* Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
* ECOG performance status 0-2
* No history of other cancer except basal cell carcinoma
* Adequate bone marrow function (WBC \> or = 3,000/mm3, granulocytes \> or = 1,500/mm3, platelet count \> or = 100,000/mm3)
* Bilirubin \< 1.5 folds, SGOT/ SGPT \< 1.5 folds of normal limit, creatinine clearance \> or = 40 mg/dl
* Consent to participate

Exclusion Criteria:

* Para-aortic lymph node enlargement \> 1 cm or suspicious for cancer metastasis from CT or MRI
* Adnexal mass from physical examination or imaging study
* Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
* Pregnancy or lactation
Using Multimedia Technologies to Disseminate an HIV Prevention

This RCT will randomly assign 40 of the CBOs to receive the Multimedia intervention and training package (Multimedia)and the other 40 to receive the original, manualized Connect intervention and training package (Traditional). The technology transfer process involves all agencies receiving four days of training and two planned technical assistance conference calls, by study investigative staff, in the first four months following training. Telephone assessments completed by up to 6 staff at each agency will measure primary outcomes, mediating, moderating and process measure variables at baseline, 6, 12 and 18 months post-technology transfer. The primary outcome of the study is adoptions of the Connect intervention. The unit of analysis is the CBO.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, CBOs must have reported that they

* had 501c3 status;
* provided at least a minimum level of direct contact HIV prevention services to clientele; and
* that their target population for services included heterosexual men and women.

Exclusion Criteria:

-
Head to Head Trial of Mailed Cologuard to Mailed FIT

The objective of this study is to measure the comparative effectiveness of mailed outreach of two stool based tests, multi-target stool DNA (Cologuard) and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.

Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 12 months of randomization will be measured as the primary outcome, in addition to secondary outcomes of Cologuard or FIT positivity rate measured within 12 months of randomization, and follow-up colonoscopy uptake and CRC incidence, measured within 24 months of randomization.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health
* ≥1 UCSD Health System health visit within the last year
* Resides in San Diego or Imperial County
* Currently not up to date with CRC screening
* Insured by private, public or other health insurance.

Exclusion Criteria:

* Up-to-date with screening
* Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer.
* Prior history of colectomy
* Lack of health insurance
Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
* Has a history of treatment with NSAIDs with positive therapeutic benefit
* Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
* Females who are able to have children must have negative urine pregnancy tests

Exclusion Criteria:

* Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
* History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
* Requires joint replacement
First Impressions and Attractiveness Levels of Smiling Individuals With and Without a Mask

Evaluation on the effects of smiling on first impressions and attractiveness with and without wearing a facial surgical mask.


Eligibility Criteria:
Inclusion Criteria:

1. Models who are males and females of ages 21-39.
2. Live and random raters who are males and females of ages 18-39.
3. Models and raters that understand the purpose and aspects of the study, freely sign the consent and complete the required visit.
4. Models and raters must all be able to understand English fluently.

Exclusion Criteria:

1. Model participants younger than 21 or older than 40 will not be included.
2. Live and random rater participants younger than 18 and older than 40 will not be included.
3. Models with unusual hair styles or colors
4. Facial piercing other than ears
5. Facial and/or neck scaring or tattooing
6. Models and raters that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required visit will also be excluded.
Can Quantitative Ultrasound be Used for the Evaluation of Bone Health in Adolescents and Adults With Cystic Fibrosis

Measurement of bone density of Cystic Fibrosis patients with two techniques and correlation to serum bone parameters, use of steroids, lung function and nutritional status.

Measurement of bone density of Cystic Fibrosis patients with two techniques and correlation to serum bone parameters, use of steroids, lung function and nutritional status.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Cystic Fibrosis

Exclusion Criteria:

-
Effect of Low-Glycemic Index Mediterranean Diet on AGEs

Advanced glycation end products (AGE) result from a chemical reaction between the carbonyl group of reducing sugar and the nucleophilic NH2 of a free amino acid or a protein; lysine and arginine being the main reactive amino acids on proteins. Following this first step, a molecular rearrangement occurs, rearrangement of Amadori resulting to the formation of Maillard products.

Specialized receptors (RAGE, Galectin 3...) bind AGE. The binding to the receptor causes the formation of free radicals, which have a deleterious effect because they are powerful oxidizing agents, but also play the role of intracellular messenger, altering the cell functions.

This role is especially true at the level of endothelial cells as the attachment of AGE to RAGE receptor causes an increase in vascular permeability. AGE binding to endothelium RAGE and to monocytes-macrophages, led to the production of cytokines, growth factors, to the expression of adhesion molecules, and the production of procoagulant activity. Increased permeability, facilitation of leukocyte migration, the production of reactive oxygen species, cytokines and VEGF suggest that the AGE could be an element of a cascade of reactions responsible for the diabetic angiopathy and vascular damages observed during aging and chronic renal failure. Recently, It's been proposed that balanced diets can limit the deleterious effect of AGE. For these reasons, the interest in preventive approaches complementary or alternative to cholesterol reduction should be one of the main objectives of cardiovascular research in the years to come. Already in the '70s the very low incidence of atherosclerotic diseases in Mediterranean countries (Greece and Southern Italy) and the importance of the "dietary factor" in such protection were noticed. Diets for people in these countries are, among other components, very rich in oleic acid, the main constituent of olive oil, with about 29% of daily caloric intake derived from monounsaturated fatty acids. Aim of this trial is to estimate the effect of a Low Glycemic Index Mediterranean Diet on AGE products.

Eligibility Criteria:
Inclusion Criteria:

* Subject enrolled in the Nutriep cohort assembled in 2005-2007

Exclusion Criteria:

* Not enrolled in the Nutriep cohort
* Pregnancy