cyrilzakka/clinical-trials huggingface dataset:
Improving Medication Adherence: A Study With Talking Pill Bottles

The aim of this research project is to compare the use of "Talking Pill Bottles" to usual care in patients who have low functional health literacy and who purchase medications for primary hypertension at a retail pharmacy with regard to:

1. feasibility of the procedures,
2. utility of the equipment,
3. medication adherence,
4. self efficacy in medication self management, and
5. blood pressure control.

Introduction: Across the healthcare continuum, patients with low functional health literacy may have worse outcomes due to difficulties in following prescribed medication regimens. While reasons for non-adherence can be drawn from the intra-personal, interpersonal, and systemic perspectives; one starting point is the difficulty that patients have reading and understanding medication instructions on a prescription bottle labels. Labels can provide a vital reminder and decision support aid for patients and healthcare proxies. Yet, skills must be available for reading and understanding the labels. The investigators will utilize "Talking Pill Bottles" to record prescription medication instructions so that patients can re-play the instructions as needed in their homes. Purpose: The aim of this research project is to compare the use of "Talking Pill Bottles" to usual care in patients who have low functional health literacy and who purchase medications for primary hypertension at a retail pharmacy with regard to: a. feasibility of the procedures, b. utility of the equipment, c. medication adherence, d. self efficacy in medication self management, and e. blood pressure control. Design: This novel intervention will be tested within the context of a retail pharmacy in the Pacific Northwest. The pilot test will use a randomized trial design with two research arms. Analysis: Within-group change scores on a self efficacy measure and blood pressures will be examined with the paired t-test; between group measures will also be examined between the two treatment arms. The investigators will also track medication complexity as a potential confounder and conduct semi-structured exit interviews. Conclusion: Results will help establish the feasibility and utility of providing this technology to patients who have low functional health literacy in a retail pharmacy. The investigators will gather preliminary descriptive data along with variance and effect size measures for power estimations in a future multi-site, randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* 21 years or older
* Filling a prescription for hypertension treatment
* Able to understand spoken English.

Exclusion Criteria:

* Cannot understand English;
* Hearing impaired when not using hearing assistive devices
* Cognitively impaired.
* Unable to read labels with corrected vision
Eating Disorder Prevention Program for Women With T1D

This study aims to test the effectiveness of an evidence-based eating- disorder prevention program specifically targeted for individuals with Type 1 Diabetes (T1D) compared to an educational control group. The Diabetes Body Project (DBP), is an adaptation of the Body Project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. DBP has been adapted slightly for individuals with T1D who are at ultra-high risk for eating disorders. The study aims to test the effectiveness of the DBP of reducing body image concerns and reducing eating pathology and improving glycemic control.


Eligibility Criteria:
Inclusion Criteria:

I)female-identifying II) aged 15-30 years old III) diagnosis of T1D for at least a 6-month duration per American Diabetes Association(ADA) criteria who are taking insulin IV) have visited their diabetes care provider in the past year V) body image concerns

Exclusion Criteria:

I) not female identifying II) not in age range III) does not have a diagnosis of T1D for at least 6 months per ADA criteria who are taking insulin IV) have not visited their diabetes care provider in the past year V) do not report some level of body dissatisfaction
Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension

Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.


Eligibility Criteria:
Inclusion Criteria

1. Patients with essential hypertension.
2. Patients who are eligible and able to participate in the study.

Exclusion Criteria

1. Severe hypertension.
2. History or evidence of a secondary form of hypertension.
3. History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.
DNX-2440 for Resectable Colorectal Liver Metastasis

The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have curative-intent liver resection surgery. Up to 18 patients will receive two sequential intra-tumoral injections of DNX-2440 into a metastatic liver tumor prior to surgery for liver resection, to evaluate safety and biological endpoints across 3 dose levels (dose escalation). Upon conclusion of the dose-escalation phase, the selected safe and biologically appropriate dose will be administered using the same schema for an additional 12 patients with colorectal cancer liver metastasis (expansion cohort) using established biologic endpoints.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female aged ≥ 18 years at time of consent
* Diagnosis of liver metastases from colorectal, breast, gastric, periampullary, melanoma, renal cell cancer, sarcoma, squamous cell carcinoma or gastrointestinal stromal tumor
* Multiple (≥ 2) liver tumors
* Candidate for curative-intent surgery
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Candidates eligible for targeted therapy, as per standard of care guidelines (and based on mutational status as indicated), must have completed therapy
* Preoperative chemotherapy is allowed

Key Exclusion Criteria:

* Recurrence of liver metastasis
* Diagnosis of neuroendocrine tumor liver metastasis
* Liver metastasis treated with \> 12 cycles of systemic chemotherapy
* Condition that requires ongoing systemic immunosuppressive therapy
* Evidence of inadequate organ function based on lab parameters
* Liver transaminases (aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\]) or total bilirubin \> 5x the upper limits of normal
* Males or females who refuse to use a double-barrier form of birth control during the study and for up to 6 months after injection with DNX-2440
Postoperative subQ Pain Control for Spinal Fusion Surgery

Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.

For patients randomized to the experimental or to the placebo groups, two subcutaneous catheters will be tunneled under the skin with large hollow-bore needles along the entire length of the incision on either side prior to closure. These catheters will deliver study drug (0.25% Marcaine) directly into the incision. They will be affixed to the skin with steri-strips. The catheters will then be attached to a drug delivery pump at 2mL/hour and will be removed prior to discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or greater
* Surgery to be done at Banner University Medical Center-Tucson
* Elective Surgeries only
* Lower Thoracic or Lumbar fusions only - Posterior Approach
* Postero or Posterolateral Instrumented Fusions with or without Interbody graft
* Transforaminal Interbody Fusions
* Must be able to cooperate in the daily VAS assessment

Exclusion Criteria:

* Patients under 18 years of age
* Prisoners
* Pregnant women
* Hypersensitivity to infusion medication
* Deformity Correction cases requiring osteotomies
* Surgical fusion in acute phase for traumatic injury
* Anterior Lumbar Interbody Fusion, Direct Lateral Interbody Fusion procedures
A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight

Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable.

Exclusion Criteria:

Women of childbearing potential, people with unstable medical conditions, people with gallstones
Registry of Patients With Hypophosphatasia

In this prospective, observational, long term registry patients of all ages with a diagnosis of hypophosphatasia (HPP) are followed at participating sites in multiple countries.

The HPP Registry is an observational, prospective, long-term registry designed to collect data on HPP epidemiology, disease history, clinical course, symptoms and burden of disease from patients of all ages who have a diagnosis of HPP.

Evaluation of safety and effectiveness data in patients with HPP who have/are receiving treatment with Asfotase alfa

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants, of any age, with a confirmed diagnosis of HPP.
* Participant must have documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, or a documented ALPL gene mutation.
* Participant or legal representative is able to read and/or understand the informed consent and study questionnaires in the local language.
* Signed informed consent and medical records release by the patient or legal representative. Patient or patient's parent/legal representative must be willing and able to give written informed consent, and the patient must be willing to give written informed assent, if appropriate and required by local regulations.

Exclusion Criteria:

* Currently participating in an Alexion-sponsored clinical trial. Enrollment in the Registry will not exclude a patient from enrolling in a future clinical trial.
Investigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)

A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.


Eligibility Criteria:
Inclusion Criteria:

* Operable cataracts;
* Good ocular health;
* Qualifies for AcrySof Toric IOL via AcrySof Toric Calculator (1.03-2.06 D cylinder at corneal plane)

Exclusion Criteria:

* \>2.06 D astigmatism at corneal plane;
* irregular astigmatism;
* prior or ongoing corneal disease or scarring;
* history of ocular disease
Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia

Retrospective, analytical, longitudinal, multicenter study to evaluate the safety of the fixed-dose combination of rosuvastatin / ezetimibe as treatment for patients with dyslipidemia in routine medical practice.

To assess the safety of the fixed-dose combination of rosuvastatin / ezetimibe in subjects older than 18 years of age (gender indistinct) with dyslipidemia who at the discretion have been candidates for treatment with the combination. For the safety analysis, all the research subjects who have taken rosuvastatin / ezetimibe will be considered. The information recorded by the treating physicians in the file will be reviewed and within the case report format (CRF) of all adverse events that occur in the study. The terms originally used in the case report format by the investigators to identify adverse events (AE) will be coded in the analysis stage of Results using the current MEdDRA dictionary. The incidence of AE will be synthesized such as the frequency count and percentage of research subjects with events adverse by organ / system.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years of age.
* Diagnosis of dyslipidemia.
* That treatment with the fixed-dose combination of rosuvastatin / ezetimibe is documented.
* Have security questioning on at least two occasions.

Exclusion Criteria:

* Subjects who has taken any other statins, fibrates, bile acid sequestrants, niacin (\> 500 mg) or inhibitors of PCSK9 concomitantly during treatment with rosuvastatin / ezetimibe.
TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.


Eligibility Criteria:
Inclusion Criteria:

* All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included.

Exclusion Criteria:

* None
Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea

The purpose of this study is:

1. To determine the frequency of cardiovascular diseases in patients with OSA, obese, overweight, and lean (BMI\<25)
2. To analyze the CPAP treatment over the clinical evolution of OSA patients
3. To determine if OSA is a independent predictor of cardiovascular risk

Obstructive Sleep Apnea (OSA) is a condition with important cardiovascular repercussions. However, the association between OSA, cardiovascular diseases, and obesity has not been totally clarified. We hypothesized that the cardiovascular consequences of OSA are due to obesity.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with OSA (apnea-hypopnea index higher than 5 events/hour)

Exclusion Criteria:

* Body mass index higher than 40
Comparison Between Fentanyl and Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block for Postoperative Analgesia After Knee Surgeries

This study will be undertaken to compare the analgesic effects of of fentanyl versus dexmedetomidine as adjuvant to bupivacaine in combined IPACK and ACB for pain management after total knee arthroplasty.

* To measure the total amount of rescue analgesic consumption in the first 48 hours post-operatively in each group
* To assess pain score in each group by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points: PACU, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs.
* To measure the time of first request of rescue analgesia in each group
* To record the incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting) and length of hospital stay.
* Over all patients' satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Eligibility Criteria:
Inclusion Criteria:

1 - Patient acceptance 2. Cooperative patients 3. Age: ≥21 and 85\< years' old 4. Sex: both sexes (males or females). 5. Physical status: ASA Ι \& II\& Ш. 6. Body Mass Index (BMI): ≤ 35 kg/m2. 7. Type of operation: elective unilateral knee surgeries (TKA, ACL, knee arthroscopy)

Exclusion Criteria:

. Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site) 2. Patients with known history of allergy to the study drugs (bupivacaine, dexmedetomidine and fentanyl).

3. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.

4.Chronic opioid use (more than 3 months or daily oral morphine \> 5 mg /day for 1 month)

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Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)

This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with Friedreich's Ataxia.


Eligibility Criteria:
Inclusion Criteria:

* Completion of 52 weeks in study SNT-III-001
* Body weight ≥ 25 kg
* Negative urine pregnancy test
* Eligibility to participate in the present extension study as confirmed by investigator

Exclusion Criteria:

* Safety or tolerability issues arising during the course of SNT-III-001 which in the opinion of the investigator preclude further treatment with idebenone
* Clinically significant abnormalities of haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of SGOT, SGPT or creatinine
* Parallel participation in another clinical drug trial
* Pregnancy or breast-feeding
* Abuse of drugs or alcohol
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of HCC based on histological confirmation
* Participants must have an advanced HCC
* Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
* Child-Pugh score 5 or 6
* Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Prior liver transplant
* Episodes of hepatic encephalopathy (greater than or equal to \[\>=\] Grade 2) within 12 months prior to randomization
* Active brain metastases or leptomeningeal metastases

Other protocol-defined inclusion/exclusion criteria apply.
Bolt CSP-M Holter Study

The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.

Among LBB area pacing (LBBAP), it has been reported that left ventricular (LV) septal pacing (LVSP), which refers to a pacing approach that only captures the LV septal myocardium, produces homogeneous electrical propagation in the septum and leads to delayed LV lateral wall activation. Although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the LBB capture over LVSP.

During the implantation of a device, the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs. A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold (PCT) of the local myocardium is different from that of the LBB (i.e., LBB-PCT), indicating a transition between capturing the LBB and LVSP without any LBB capture. So far, there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status. Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>=18 years
* Patients who are willing to provide Informed Consent
* Patients who have received LBBAP therapy \>= 1 month for 1 to 4 months (including 1 and 4 month)
* Patients implanted with a single/dual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port
* Implanted device can provide at least 3-channel real-time intracardiac electrogram

Exclusion Criteria:

* Patients who are pregnant or have a plan for pregnancy during the study
* Patients who have medical conditions that would limit study participation
* Patients who were already enrolled in clinical trial(s) which would impact study participation
A Feasibility Study Using the CoronaCheck Device to Identify Incident Cases of SARS CoV-2 Covid-19

Point of care testing is urgently required to enable the immediate detection of SARS-CoV-2 infection to allow effective transmission prevention precautions to succeed.

The Coronacheck device is a hand-held, portable, point-of-care device which will allow the safe collection of EBC. It provides an automated platform for the detection of SARS-CoV-2 using an existing sensor repurposed with immobilised recombinant ACE-2 to bind the virus. This produces a measurable signal indicating whether SARS-CoV-2 is present or not.

EBC is collected by the CoronaCheck device during tidal breathing, making this investigation non-invasive, repeatable and easy to perform. Previous studies using Inflammacheck™ in people with respiratory conditions have shown it is well tolerated, even in people with severe lung disease. The full test cycle including sample collection and test assay typically occurs in less than 5 minutes.

Given the risk of infection, this CoronaCheck™ device has an integrated sensor and breath collection system combined in a fully enclosed, disposable unit to mitigate the risk of cross-infections between users and also reduces any exposure risk to healthcare staff. It is appreciated that disposable plastic has a negative environmental impact, however due to the highly contagious nature of SARS-CoV-2 it is felt unavoidable at present.

Using the CoronaCheck does not require laboratory equipment or expertise, and is a quick, easy-to-use point-of-care investigation which provides an immediate result. This could potentially be applied to screening for SARS-CoV-2 in a wide variety of environments for example: GP practices, drive-thru centres, colleges, universities, airports and sports arenas.

Any person undergoing a swab for a possible SARS CoV-2 infection is eligible for inclusion, participants will not be assigned an intervention.

The participants will breathe into the CoronaCheck device. This involves breathing for up to 6 minutes into a single use, fully sealed unit attached to the hand-held device. This disposable unit has a bacterial-viral filter attached to both the breathing inlet and the exhale outlet to eliminate any risk of contamination. The CoronaCheck device then provides a reading reflecting EBC ACE2 binding which will be documented on the eCRF. This result will not be recorded in the clinical notes as it is not intended to inform patient management decisions in this study.

Eligibility Criteria:
Inclusion Criteria:

o Any adult (≥ 16 years of age) who is:

* undergoing a swab for possible SARS-CoV-2 infection
* willing and able to give informed consent for participation in the study
* unlikely to suffer harm as a result of testing in the opinion of the investigator

Exclusion Criteria:

o Participants receiving:

* invasive ventilation, non-invasive ventilation or nasal high flow oxygen
* supplementary oxygen with symptomatic hypoxia or oxygen saturations ≤92% (≤88% in COPD) despite 4L oxygen via nasal cannulae
* unable to comprehend the study or provide informed consent