cyrilzakka/clinical-trials huggingface dataset:
Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3

This study is to determine whether sleep disorders contribute to impaired quality of life and mobility in patients with Bronchiolitis Obliterans syndrome and whether non invasive positive airways pressure ventilation can improve sleep, quality of life and mobility in this patient group.

Patients with Bronchiolitis Obliterans syndrome (BOS) 2 \& 3 (25) will be matched 1:2 BOS 0 patients with similar demographics such as age, gender, BMI, time post transplant and renal dysfunction.Patients fitting inclusion/exclusion criteria once they have given informed consent will complete questionnaires on quality of life (QOL), any sleep issues they may have and be assessed by a doctor. Data from standard blood tests, respiratory function tests and physio assessments of daytime activity, mobility and muscle strength will be collected. All participants will undergo an overnight sleep study. If a sleep disorder is identified the participant will be offered appropriate treatment. All assessments with the exception of the sleep study will be repeated at 6 and 12 months post sleep study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 2 \& 3
* Comparative group -Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 0
* Identified possible sleep related disorder

Exclusion Criteria:

* Subjects who do not provide informed consent
* Subjects unable to understand the study and related procedures
* Patients with a life expectancy of less than 6 months
Intestinal Permeability in Response to Treatment in Eosinophilic Esophagitis Patients

Do patient's with eosinophilic esophagitis have increased small intestinal permeability and if this changes in response to topically administered esophageal steroids?

Eosinophilic esophagitis is an allergy mediated disease in which antigens exposed to the gastrointestinal tract trigger a combined immediate hypersensitivity.

The investigators anticipate that patients with active eosinophilic esophagitis will have increased intestinal permeability on urine collection of sugars. The investigators are not sure whether these findings will be found in patients who have been successfully treated with topical esophageal steroids. Improvement in intestinal permeability would be perceived as indicating that esophageal disease drives the intestinal permeability. Lack of improvement would indicate that eosinophilic esophagitis is a more systemic disease in which increased small bowel permeability is a marker or perhaps important driver of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 18 and 80 with Eosinophilic Esophagitis diagnosed by compatible symptoms, endoscopic findings, histology and lack of response to proton pump inhibitors or negative pH study.

Exclusion:

* Vulnerable populations, such as those with diminished mental acuity, will be excluded.
* Patients allergic to Lactulose
* Women who are pregnant or lactating.
Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence

In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled trial to evaluate an active choice intervention with and without social comparison feedback to increase physician statin prescribing rates for eligible patients.

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Strong evidence indicates that statin medications can reduce the risk of CVD and for those with CVD statins have been shown to reduce mortality. Despite this evidence, statins are under-prescribed. In this study, the investigators will test the effectiveness of nudges targeted to physicians using active choice and social comparisons feedback to increasing the rate at which statin medications are prescribed to patients eligible based on national practice guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a primary care physician at University of Pennsylvania Health System
* Patient meets 2013 AHA/ACC guidelines for statin therapy but no record of a statin prescription in the electronic health record

Exclusion Criteria:

* Patient has an allergy or adverse reaction to statins documented in the electronic health record
* Patient has glomerular filtration rate less than 30 mL/min
* Physicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin
Interoception and Sense of Movement in the Patient With Multiple Sclerosis

To evaluate the effectiveness of an experimental rehabilitative protocol with specific tasks for the improvement of body awareness and the motor scheme in the patient with multiple sclerosis (EDSS \<2.5).

Primary outcome: improvement of the interoception (awareness of the body) and of the related motor capacity Secondary outcomes: improvement of balance and postural self-correction control

Multiple sclerosis (MS) is a chronically progressive, disabling, autoimmune disease that affects the central nervous system causing a wide spectrum of sensory, motor, and neuropsychiatric signs and symptoms. In the great part of patients with MS, there is a cognitive deficit that can start already in the early stages of the disease. Disability related to the disease is usually investigated through the Expanded Disability Status Scale (EDSS), however, the scale does not evaluate some very disabling aspects of the disease such as diplopia, fatigue and the impact of cognitive disorders.

The posture and postural self-correction are dependent on the image that anyone have of his own body and on the perception of it in the space, both internal and external. In multiple sclerosis proprioception and interoception are often altered due to motor and cognitive impairment.

The investigators propose a rehabilitative protocol that combine postural rehabilitation with specific visual-spatial tasks, relaxation sessions with self-awareness improvement and cognitive rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* BMI\<30
* Diagnosis of multiple sclerosis for less than 10 years
* Course of relapsing remitting type
* Relapse-free for at least 30 days
* EDSS score \<2,5
* FDA-approved disease-modifying therapy for at least 6 months
* MMSE\>24
* Public health guidelines for participating in physical activity

Exclusion Criteria:

* Other concurrent neurological and psychiatric diseases (like schizophrenia, bipolar disorder I or II and substance abuse disorders)
* Oncological diseases
* Cardiovascular disease, pacemaker carrier
* Diabetes
* Rheumatological diseases
* Scoliosis \>20° Cobb
* Previous surgery on the spine
* Pregnancy
* Other physiotherapy in progress
IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus

Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial.

Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.

Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial.

The current study hypothesizes that IVI-guided PCI will be superior with respect to target vessel failure (TVF), including cardiac death, target-vessel myocardial infarction (TVMI), or clinically-driven TVR when compared with angiography-guided PCI in patients with diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 \~ 80 years old,
2. Confirmed diabetes mellitus
3. Indications for undergoing percutaneous coronary intervention using a drug-eluting stent (Invasive or quantitative fractional flow reserve (QFR or FFR) \<0.80)
4. Silent angina, stable angina, unstable angina, or Non-ST-elevation myocardial infarction

Exclusion Criteria:

1. Cardiogenic shock
2. Previous coronary artery bypass graft (CABG)
3. Left ventricular ejection fraction \< 30%
4. Requiring oral anticoagulation medications
5. Any planned surgery within 12 months
6. Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2
7. Platelet count \< 100,000 mm3
8. Contraindication to study medications or metal
9. Women of childbearing potential
10. Life expectancy \< 1 year
11. Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)
Continuous Glucose Monitoring in Critically Ill

The goal of this clinical research study is to learn if The Guardian® blood-sugar monitoring device can be used reliably in patients with high blood sugar who are receiving care in the ICU. Researchers will compare blood-sugar measurements from the study device with blood-sugar measurements from the standard "fingerstick" method of blood-sugar testing. This is being done to see if the new device can accurately measure blood sugar.

The Study Device:

The Guardian® blood-sugar monitoring device is designed to automatically record blood sugar levels many times per hour, without requiring multiple fingersticks. It uses a blood sugar "sensor" (an electronic measuring device) that is about the size of a beeper. The sensor is attached to a small catheter that has a small needle in it. Once the catheter is inserted in the skin, the needle is removed right away.

Use of Study Device:

If you agree to take part in this study, while you are in the ICU, the catheter and needle part of the study device will be inserted under the skin of your abdomen or thigh. The device will automatically measure your blood sugar every 10 seconds so the data can be reviewed by the research staff. The needle will be removed right away. The catheter must be changed every 3 days (+/- 3 days) by the research staff. You will have the study device in place for 15 days (or until you leave the ICU, whichever comes first).

Standard Monitoring of Blood Sugar Levels:

While you are on study, your blood sugar will also be monitored according to the standard of care. This will be in the form of having your blood sugar checked by using a small needle to prick the tip of your finger every hour or more, as necessary.

The blood sugar measurements from the study device will not be used in any way to affect any decisions about your blood sugar monitoring or care.

Length of Study Participation:

After the study device is removed from your body for the last time (after 15 days or when you leave the ICU), you will be considered off study. If intolerable side effects occur, or an infection occurs that seems to have been caused by the study device, you will be taken off study early.

This is an investigational study. The study device is commercially available and FDA approved for monitoring blood sugar levels for outpatient (outside of the hospital) use. Using the device in patients who are in the hospital is considered experimental. At this time, it is only being used in this way in research.

Up to 60 patients will take part in this multicenter study. Up to 25 will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in any of our University of Texas collaborative intensive care units.
2. Critically ill patients on an insulin infusion protocol

Exclusion Criteria:

1. Patients or their legal representatives who do not consent
2. Patients with large areas of skin affected so as not to allow implantation of device.
3. Patients \< 18 years of age
Onlay Versus Sublay Mesh in Incisional Hernia

Onlay versus Sublay Mesh hernioplasty in management of incisional Hernia Comparative prospective study (Short term outcomes)

Comparison between Short term outcomes (advantages and disadvantages) of sublay and onlay techniques in management of incisional hernia regarding :

* Short term complications (superficial skin infection, seroma formation , recurrence and chronic abdominal discomfort.)
* operative time , hospital stay , difficulty of technique.

Eligibility Criteria:
Inclusion Criteria:

* Surgically Fit patients
* Patients presented with incisional Hernias
* Age between 18 to 60 years
* Cicatrized incisional hernia involving both muscle cutting and muscle splitting incisions

Exclusion Criteria:

* Surgically unfit patients
* Irreducible, obstructed, strangulated hernias
* Other Ventral hernias that not related to surgical incision.
* Huge hernias with wide abdominal wall defect and retracted abdominal wall muscles.
The AMARA (As Much As Reasonably Achievable) Study

Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose \>200Gy by the partition model. The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors. In addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by MIM Software Inc) based on 90Y-PET/CT imaging.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 yr
* Both sexes eligible for study
* Patients with primary or secondary liver tumors
* Liver dominant disease
* At least one lesion greater than 5.0 cm in maximum diameter
* Life-expectancy \> 3 months
* FLR \>40% or greater than 500mls
* Must be able to tolerate pre-treatment CT scan , DSA and 99mTc-MAA infusion and imaging with SPECT/CT scan
* Able to schedule and tolerate post-treatment Y90 PET/CT imaging
* Able to tolerate follow-up imaging with dynamic contrast CT liver phase or MRI with liver specific contrast at 3mo, 6mo, 9mo, 1yr, 2.0 yr, and 3.0 years.

Exclusion Criteria:

* Child Pugh \> B
* Bilirubin \>2 mg/dl
* Albumin\<3.0
* Central portal invasion
* Multi-focal bilobar disease
* Disseminated extrahepatic disease
* Lung shunt \>20% or a estimated Lung dose \> 20 Gy
* Focuses of extra-hepatic liver uptake.
* Patients that cannot tolerate addition follow-up imaging.
A Study of WF 10 IV Solution in Patients With Advanced HIV Disease

The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to patients with advanced HIV disease who cannot or will not take zidovudine, didanosine, zalcitabine, or stavudine. This study also examines how TCDO affects the levels of HIV in the body. TCDO is a solution delivered through a vein.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Approved drugs at a stabilized dose except those specifically excluded.
* Aerosolized pentamidine (300 mg) once a month for PCP prophylaxis.

Patients must have:

* HIV positivity.
* Absolute CD4 count \< 200 cells/mm3.
* Intolerance to or refusal to take AZT, ddI, ddC, or d4T.
* No active opportunistic infection requiring ongoing therapy.
* Life expectancy at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Neoplasm other than basal cell carcinoma of the skin.
* Clinically significant cardiac disease.
* Anemia.

Concurrent Medication:

Excluded:

* Cytotoxic chemotherapy.
* Corticosteroids.

Patients with the following prior conditions are excluded:

History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Any antiretroviral agent.
* Interferon.
* Systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic drugs.

Excluded within 30 days prior to study entry:

* Investigational drugs.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

* Radiation therapy. Active drug or alcohol abuse.
A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy

To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy.

The benefits of breastfeeding for both mother and neonate have been well documented and extensively researched. Breastfeeding rates remain suboptimal despite known advantages including reduced lifetime risk of maternal ovarian cancer, more rapid return to pre-gestational weight, improvement in maternal/neonatal bonding, reduction in neonatal allergic/immunologic conditions. Both non-modifiable and modifiable factors affecting a mother's decision regarding breastfeeding have been identified. Modifiable factors include breastfeeding knowledge, self-efficacy, and confidence. Breastfeeding self-efficacy has been positively correlated with breastfeeding duration. There is a lack of local data on breastfeeding rates, duration, and self-efficacy in the Augusta University women's health population as well as a lack of documented improvement of these factors following educational programs. Our study aims to create a program that is easily accessible and available to our patient population in the form of a free application available on Apple devices capable of accessing the internet (e.g., i-phone, i-pad, etc.). This study will be a randomized control trial. The intervention group will have access to the application while the control group will not. Our hypothesis is that the application will improve long-term breastfeeding rates, duration, and self-efficacy if offered to patients at 32 through 36 weeks gestation. This will be assessed by comparing initial self-efficacy survey results with survey results at 12 months postpartum for the intervention versus control groups. We will also measure breastfeeding duration during the first 12 months postpartum and exclusive breastfeeding rates at 6 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous and multiparous females receiving prenatal care at Augusta University Obstetrics and Gynecology clinic at 32 through 36 weeks gestation.
* No documented anatomic differences in mother's chest anatomy.
* Access to the internet via an Apple® device (such as i-phone or i-pad).
* Delivery at Augusta University Medical Center

Exclusion Criteria:

* Significant maternal intrapartum or postpartum complications (i.e., postpartum hemorrhage \> 2000 mL, uterine inversion, retained products, ICU admission, postpartum psychosis).
* Infants admitted to neonatal intensive care unit \>48 hours
* Pre-term deliveries prior to 37 weeks gestation
* Infants with cleft palate, or other palate/facial defects
* Patients without email access or internet access
* Patients without an Apple® device (i-phone, i-pad)
* Non-English speaker
* Mothers unable to breastfeed secondary to contraindicated communicable disease (i.e.

HIV)

* Mothers unable to breastfeed secondary to contraindicated medications
* Mothers of infants up for adoption
EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection

The EPSILON study aims to comparatively evaluate the submucosal injection using ORISETM gel and glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Traditionally, ESD requires the injection of some colloidal solution (glycerol, geloplasma, hydroxyethylstrach, etc.) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion. Alternatives to colloid-solution assisted ESD have also been developped: pocket creation method and saline-immersion ESD.

Recently, other colloidal solutions have arrived on the market, such as gel (ORISETM gel) in order to improve the lifting during ESD.Our preliminary experience using ORISETM gel as a lifting solution for ESD was unexpectedly favourable with few per-procedural bleeding, quick time and facility.

As the spread of ESD is closely associated to its easiness, procedure duration (itself associated to number of procedural bleedings and instruments change through the operating channel) and safety, we sought to study comparatively two submucosal solutions when conducting ESD in a specific population presenting gastric or rectal superficial lesions.

Eligibility Criteria:
Inclusion Criteria:

* o Patients must have given written informed consent
* o Subjects with documented gastric or rectal lesions with indication of endoscopic removal by ESD, namely:

  * Gastric focal lesion with suspicion of early gastric cancer (low or high grade dysplasia with features of early gastric cancer; adenocarcinoma with morphology of superficial lesion and work-up of superficial lesion)
  * Rectal polyps (adenoma or superficial carcinoma) from 0 to 15 cm from the anal margin; with features being recognized indications of ESD: more than 20mm granular LST, more than 20mm non granular LST, more than 20mm villous or bulging polyps, Paris 0-IIa+IIc lesions, lesions with suspicious pattern (Kudo Vi / JNET 2B), lesions with anal canal involvement.

Exclusion Criteria:

* Subjects who meet any of the following exclusion criteria cannot be enrolled in the study:

  * Gastric and rectal neuroendocrine tumour (NET) with indication of ESD will be excluded
  * Gastric and rectal lesions with indication of ESD but strong fibrosis due to previous partial resection will be excluded
  * Subject is currently enrolled in another confounding research
  * Subjects with any other location of ESD (esophagus, duodenum and colon) will not be included.
Prediction of Intra-abdominal Adhesion Before CS

Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for the surgeon and patients.

the repeated cesarean section is associated with recorded maternal morbidity including placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular injuries. The anticipation of the problem is important for decreasing its adverse effect . preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall, bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior staff obstetrician or others and theatre requirements to overcome any problem happened.

Eligibility Criteria:
Inclusion Criteria:

* pregnant in their 9th-month singleton, planned for elective CS and had a history of previous CS

Exclusion Criteria:

* included multiple pregnancies, preterm labour, emergency CS, skin burn at the site of CS