cyrilzakka/clinical-trials huggingface dataset:
The Use of Dual-handset Interpreter Phones in an Inpatient Setting to Improve Communication With Limited English Proficiency Patients at MSKCC

The purpose of this study is to introduce new technology and interpreter practices in the inpatient setting at MSKCC. We plan to install dual handset phones at the bedsides of limited English proficiency (LEP) patients and to assess the impact on both patient and physician communication effectiveness with this technology.

During the first 5-6 weeks of the study standard of care will be conducted as usual practice by the medicine teams at MSKCC. It is expected that during that time they will care for at least 20 LEP patients who meet our inclusion criteria. There are no specific target numbers for any of the included languages. During the following 5-6 weeks, the phones will be installed by the 10 house-staff teams and approximately an additional 20 LEP patients who meet the protocol inclusion criteria will be enrolled. Therefore, in the first half of this study about 20 LEP patients and 40 practitioners (two practitioners per LEP patient) will provide data and the same numbers will account for the second half of the study after the intervention is instituted. There will be no randomization of patients or physicians. The only data that will be analyzed are those questions from the surveys to assess communication effectiveness with LEP patients. The number of patients who are interviewed will depend on MSKCC inpatient census at the time of study.

Eligibility Criteria:
Inclusion Criteria:

* LEP patients identified by the Department of Interpreter Services at MSKCC admitted to the Hepatobiliary surgery service, the Colorectal Surgery service the GMT surgery service, GI, GU, Breast, General Medicine, Leukemia, or Lymphoma services with a primary language of Spanish, Russian, or Chinese.
* LEP patients who are expected to have at least a two days hospital course.
* Patients who are alert and oriented to person, place, and time as determined by the medical doctor taking care of the patient
* Patients who are willing to participate and complete the survey
* Patients whose physicians and nurses are willing to participate
* Only persons ≥ 18 will be included and there will be no children.
* Providers must be willing to participate and complete the survey
* TY interns cannot complete provider surveys

Exclusion Criteria:

* Patients on contact isolation
* Patients who previously completed the survey
A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications

This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for vascular access.

This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route.

In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath.
2. Male or female ≥ 18 years old.

Exclusion Criteria:

1. Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded.
2. Subjects treated before January 1, 2011, are excluded from this analysis.
Assessing Patient Engagement in Keratoconus Clinical Research

This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.

In essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.


Eligibility Criteria:
Inclusion Criteria:

* Signed Written Informed Consent
* Aged ≥ 18 years old
* No prior treatment for keratoconus

Exclusion Criteria:

* Participant is actively receiving study therapy in another
* Inability to provide written informed consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
Survey in Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy

The purpose of this survey is to describe long-term tolerance as seen under current conditions of use for anastrozole.


Eligibility Criteria:
Inclusion Criteria:

* woman treated with anastrozole as adjuvant therapy for hormone-dependant breast cancer in post-menopausal women with positive hormone-receptors
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants

The purpose of this study is to see if a medication called Curosurf can reduce the length of time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS, stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a medication that is already used in other countries around the world but not yet in Canada.

Babies born under 32 weeks of gestation frequently need respiratory support after birth, including being placed on a breathing machine or respirator. The most common reason is Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a soapy like substance that helps the air sacs open and close. Our current standard treatment is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be able to be removed from the ventilator sooner.

Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the investigators will monitor their progress during their Neonatal Intensive Care Unit admission.

The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this study.


Eligibility Criteria:
Inclusion Criteria:

1. Infants born between 24+0 and 31+6 weeks gestational age, admitted to the study centers
2. Infants with RDS requiring intubation and surfactant therapy within 48 hours after birth

Exclusion Criteria:

1. Any infant more than 48 hours of age
2. Any infant with a pulmonary hemorrhage
3. Any infant with life-threatening congenital anomaly or one that is considered non-viable
4. Any infant on rescue high frequency ventilation
5. Any infant known to require early intubation and ventilation for surgical treatment of a congenital anomaly
6. Any infant with anomalies of the upper or lower airway or mandible precluding use of nCPAP
7. Any infant born after prolonged premature rupture of membranes (\<22 weeks GA or \>28 days prior to delivery)
8. A parent/LAR who is incapable of, or unwilling, to give consent
9. Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol
10. Any other reason as deemed significant by the Investigator
Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION

Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival \< 3% at 5 years). Less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. It is not standard first-line chemotherapy validated for unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4 months). In case of tumor progression ater this first line therapy, no treatment is currently being validated.

RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium microspheres.

In the patients with unresectable CCK , the first pilot studies showed interesting results with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety.

Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic CCK in tumor progression after first-line therapy.

Extended description of the protocol, including information not already contained in other fields, such as comparison studied.

It is a pilot study including 20 patients with unresectable intra-hepatic CCK in tumor progression after first-line therapy.

Description of the protocol :

1. Information and signed CONSENTMENT
2. Preparatory phase : pre-treatment mesenteric angiography and technetium-99m macroaggregated albumin scans are performed to assess gastrointestinal flow and lung shunting.
3. Therapeutic phase : intra-arterial administration of resin-based microspheres ( SIRSPHERES, SIRTEX). The RE can be performed in 2 sessions, especially if liver disease is bi-lobar.
4. Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans and /or MRI)

Eligibility Criteria:
Inclusion Criteria:

* Unresectable intra-hepatic CCK histologically proven
* Tumor progression documented on imaging evaluation ( CT or MRI) according to RECIST criteria version 1.1 after first-line therapy
* Performance status \< 2 ; 4) Bilirubin \< 36 micromol/l
* age \> 18 years

Exclusion Criteria:

* Extra-hepatic metastases
* Uncontrolled biliary obstruction
* Contra-indications to RE.
At-Home Telehealth Yoga for Treating Chronic Pain in People With Alzheimer's Disease and Their Caregiver's

This feasibility study will evaluate yoga as a treatment for chronic pain in people living with Alzheimer's disease, and their Caregivers. The experimental treatment is yoga delivered via a tablet computer to participants at home ("teleyoga").

The investigators will demonstrate the feasibility of conducting a trial involving teleyoga for people with Alzheimer's disease and their Caregivers. Participants with Alzheimer's disease and chronic pain (n=15) and their Caregivers (n=15) will all participate in teleyoga classes. Yoga classes will be given weekly for 12 weeks. At the end of treatment, participants will provide feedback by completing a satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

AD PATIENTS

Inclusion Criteria for AD patients (As determined by):

* Diagnosis of probable Alzheimer's disease- Baseline
* Mini-Mental State Examination (MMSE) score 18-25 (Mild AD)(screening interview)
* ≥ 18 years old
* Has a primary care provider who can provide medical clearance for participation in the study
* Diagnosis of chronic musculoskeletal pain \> 6 months
* Minimum pain intensity at screening visit: pain rated ≥4 on a 0-10 Numeric Rating Scale (NRS)
* Not begun new pain treatments or medications in the past month
* If on a psychotropic medication regimen: stable regimen for at least 4 weeks prior to entry to the study; willingness to remain on a stable regimen during the 12-week acute treatment phase
* English literacy
* Wireless internet connection at home (Screening interview)
* Has a caregiver who is willing to accompany AD patient for treatment, and who can receive yoga treatment at the same time as AD patient.

Exclusion Criteria for AD patients (As determined by):

* Participation in another concurrent clinical trial
* Back surgery within the last 12 months
* Back pain potentially attributed to a specific underlying cause, disease, or condition (VA EMR; screening interview)
* Baseline pain \<4 or ≥9 on a 0-10 Numeric Rating Scale (NRS)

Inclusion Criteria for CAREGIVERS of AD patients (As determined by):

* Are caring for a patient diagnosed with AD who will practice yoga together with them
* Has a primary care provider who can provide medical clearance for participation in the study (Yoga Medical Clearance Form)
* Exclusion Criteria for Caregiver
* Participation in another concurrent clinical trial
* Attended or practiced yoga ≥ 1 x in the past 12 months
* Attended or practiced yoga ≥ 1 x in the past 12 months
Comparison of UFR With QFR in Stable Coronary Artery Disease

Quantitative flow reserve (QFR), derived from coronary angiography, has shown high accuracy in detecting significant lesions. Ultrasonic flow ratio (UFR), a new development from IVUS, integrates physiological estimation with intravascular imaging. Although both QFR and UFR are effective, there's no conclusive evidence favoring one over the other. The study aims to compare UFR and QFR's diagnostic performance against the conventional FFR standard in detecting significant coronary lesions.

Coronary artery disease (CAD) remains a prevalent global health concern, necessitating precise diagnostic strategies for optimal patient management. Fractional Flow Reserve (FFR), defined as the distal-to-proximal pressure ratio across a coronary stenosis during maximal hyperemia and typically measured by a pressure guidewire during coronary angiography (CAG), is considered a gold standard tool for detecting ischemia-causing stenosis and guiding revascularization decisions. However, wire-based FFR has been significantly underutilized due to practical reasons, including its invasive nature and the requirement for hyperemia. Consequently, there is growing interest in developing and validating computational FFR from anatomical information derived from CAG and intravascular imaging modalities, such as intravascular ultrasound (IVUS).

Quantitative flow reserve (QFR), derived from CAG, has been extensively investigated and has demonstrated high diagnostic performance for detecting hemodynamically significant lesions. Beyond CAG, research has indicated that IVUS imaging can also be utilized for computing FFR. IVUS, a widely accepted and powerful modality for evaluating vessel luminal size and characterizing plaque morphology in the context of coronary intervention, has given rise to IVUS-based FFR, known as ultrasonic flow ratio (UFR). UFR has been recently developed, integrating an estimation of physiology with intravascular imaging in the same IVUS pullback. Despite the proven effectiveness of both UFR and QFR, there is currently no evidence supporting the superiority of one technique over the other. In the present study, investigators aim to compare the diagnostic performance of UFR and QFR for the detection of functionally significant coronary lesions, using conventional FFR as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent both IVUS imaging and FFR measurement on the same artery

Exclusion Criteria:

* Inadequate quality of CAG or IVUS images for QFR or UFR calculation
* Left main or ostial right coronary artery lesion
* The use of balloon predilatation or stent placement prior to FFR measurement or IVUS imaging
* Incomplete IVUS pullback across the entire lesion segment
* The presence of a severe myocardial bridge (defined as ≥30% systolic diameter stenosis) in the examined vessel
* History of previous coronary artery bypass grafting,
* Left ventricular ejection fraction \<35%
Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle

The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cataract extraction

Exclusion Criteria:

* Under 18 years
Comb Effect of 4-7-8 Breathing Technique and Stationary Cycle on PP, QOL and Dyspnea in Post CABG Patients.

To determine the combined effects of 4-7-8 breathing technique and stationary cycle on physical performance, quality of life and dyspnea in post CABG patients.

Patients who meet the inclusion criteria and will be excluded from the exclusion criteria will be recruited by convenient sampling technique and will be allocated to simple randomization process. By taking a sample of 58 patients through non-probability convenience sampling and randomly assigning them into two groups, Group A and Group B for 18 exercise sessions per month (four to five times in a week), out of which group A will receive 4-7-8 breathing technique and stationary cycle (n=29). Group B will alone receive Stationary cycle (n=29). The study will be Single-blind where patients will be only blind. Pre and post treatment training outcomes of physical performance will be measured through 6-minute walk test, quality of life will be measured through Short-item 36 (SF-36) questionnaire 2.0 version and dyspnea will be measured through modified Borg scale. The data will be analyzed through SPSS version 26. Generalized active range of motion will be given to both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a successful CABG (no complications during surgery
* and/or in the following weeks)
* Female and male whose age between 40 to 70 years of age
* Phase II cardiac rehab patients
* Patients who were extubated and hemodynamically stable
* Patients with stable chronic heart failure.
* Patients had no arrhythmias
* Patients who had ability to read and write
* Patients who voluntarily participated in the study.

Exclusion Criteria:

* Ventricular Septal defect repair.
* Patients have limitation of motion that prevents them from performing physical activities such as walking for 6 minute.
* Patients who had undergone previous cardiac surgery.
* Severe renal dysfunction requiring dialysis.
* Altered level of consciousness.
* A history of musculoskeletal problems
* Having an orthopedic problem that prevents the use of lower and upper extremity bikes.
* Cancer patients receiving radiotherapy and chemotherapy.
* Clinical diagnosis of uncontrolled Diabetes Mellitus and Hypertension.
* Physical Discomfort at any stage of the study and/or any reaction to the tests (nausea, dizziness, discomfort, feeling faint, tachycardia, excessive sweating), and if they failed to attend the scheduled sessions.
High Protein Oral Nutritional Support With Special Nutrients in Patients With Type 2 Diabetes and Foot Ulcer

To assess the supplement of a high protein oral nutritional supplement enriched with arginin, zink, vitamin c and antioxidants on the healing of foot ulcers in patients with type 2 diabetes mellitus

The intervention group receive 2 x ONS drink daily (total 2 x 200 kcal, 3 g arginin, 250 ml vitamin C, 38 mg vitamin e, 64 micr.g selenium, 9 mg zink)

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes with newly diagnosed foot ulcer
* accept study participation

Exclusion Criteria:

* HbA1c \>90 mmol/L
* cognitive challenges, fx dementia
* history with known alcohol or drug abuse
* allergy to milk or soya
* home less
* critical ischemia, distal blood pressure \<0.30
* EGFR \< 30
* dialysis or planned dialysis or patients with terminal kidney insufficiency
Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori

Comparison Efficacy of 14-day Triple Therapy between Clarithromycin and levofloxacin on the Eradication of Helicobacter Pylori in Syrian population


Eligibility Criteria:
Inclusion Criteria:

1-Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria:

1. Children and teenagers aged less than 18 years.
2. Previous eradication treatment for H. pylori.
3. Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
4. History of gastrectomy.
5. Gastric malignancy, including adenocarcinoma and lymphoma,
6. Previous allergic reaction to antibiotics (Amoxicillin, Clarithromycin, Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
7. Contraindication to treatment drugs.
8. Pregnant or lactating women.
9. Severe concurrent disease.
10. Liver cirrhosis.
11. Chronic kidney disease.
12. Patients who cannot give informed consent by himself or herself.
Empowering Immigrants in the Greater Boston Area to Connect to HBV Care

This Study will attempt to provide information / linkage to HBV care for persons at risk in the Greater Boston area.

Specific Aims

1. Provide HBV education at community sites where immigrants at risk for HBV could be informed of the risks related to HBV, in a culturally and linguistically sensitive manner.

   1. Chelsea, Charlestown, and Revere MGH Community Health Centers: posters, pamphlets, and telephone line to provide HBV education
   2. Senegalese Community Center: community meeting, posters, and pamphlets
   3. African Students' Association, Suffolk University: community meeting, posters, and pamphlets
   4. Revere Cambodian Community Centers: community meeting, posters, and pamphlets
2. Provide at-risk persons with the tools to develop an HBV diagnosis plan with his / her provider.

   1. Provide counseling on the significance of different testing results prior to testing
   2. Connect to testing, and appropriate post-test follow-up appointments
3. Provide an education hub for patients and providers to return to with questions regarding: test interpretation, available treatments for those who test positive, and screening for hepatocellular carcinoma in those who are infected.

   1. Provide copy of an easy to understand US HBV treatment algorithm in native languages
   2. Provide information related to genotype-specific risks for HCC (increased with GT C).

Eligibility Criteria:
Inclusion Criteria: all persons interested in hearing more information about HBV -

Exclusion Criteria: children

-
CLinical Prediction Rule Score in Veterans

We will study whether the health care costs and health utilities differ in patients with gout and those without gout and whether they differ between those with more severe versus less severe gout

The purpose of this project is to study the out-patient and inpatient utilization and costs associated with tophaceous gout (a classic form of treatment-failure gout), compare these costs to patients with non-tophaceous gout and evaluate health utilities associated with these gout states. The analyses will be conducted in a manner to support a burden of illness type of presentation / manuscript.

Study Questions

1. What are the VA health care costs (inpatient and outpatient) for patients with gout compared to those without gout?
2. Does health utility, as calculated by SF-6D, differ in patients with gout compared to patients without gout and between tophaceous and non-tophaceous gout?
3. What are the relationships between costs and health utility?
4. How does the burden of illness differ by subgroups of gout patients (costs and utilities)?
5. What are the VA health care costs for patients with tophaceous gout and are they higher than patients with non-tophaceous gout?

Inclusion criteria Patients with and without gout from the Veterans database described above will be included in the analyses for Study aims 1 and 5. This is approximately 3000 gout patients and 67,000 non-gout patients

Patients with SF-36 data from the above cohort will be included in the analyses for Study aims 2-4. This is approximately 1500 gout patients and 38,000 non-gout patients

Eligibility Criteria:
Inclusion Criteria:

* participated in the survey
* Have SF-36 adn utilization data

Exclusion Criteria:

* Absence of utilization and/or cost data