cyrilzakka/clinical-trials huggingface dataset:
Mobile Health Application to Improve HIV Medication Adherence

Inadequate adherence to antiretroviral therapy (ART) can impede successful viral suppression and consequently lead to negative health consequences. This study aims to refine and test the efficacy of a mobile health ART adherence application (ARTAA), delivered over a smartphone, with helping individuals improve their ART adherence.

The CDC estimates that 1.1 million people living in the U.S. are infected with HIV \[1\]. Only a quarter of person living with HIV (PLWH) successfully keep the virus under control \[2\]. Medication non-adherence is a significant contributor to unsuccessful viral suppression; a recent meta-analysis found that only an estimated 59% of participants in North American studies were adherent at a commonly accepted minimal threshold for successful viral suppression \[3\]. While newer antiretroviral therapy (ART) medications can produce viral suppression at lower levels of adherence, relatively high adherence is still necessary to avoid disease progression and shortened lifespan \[4-6\]. In addition, low levels of adherence increase the risk of infecting others and contribute to the development of treatment resistant strains of HIV \[7;8\].

Interventions have been developed to address the significant public health problem presented by poor adherence, with most studies demonstrating some degree of success in the short-term \[9\]. However, the impact of the interventions is generally not sustained over time \[9\], and most HIV treatment settings do not have the resources to deliver more intensive interventions. As a result, there has been interest in developing efficacious electronically-delivered interventions. Very little research has focused on establishing the efficacy of mobile health applications for ART adherence. Further, no published studies have examined a single session face-to-face intervention combined with a mobile application and coaching support to reinforce sustained adherence.

Delivered over a smartphone, portable applications would allow for real-time adherence tracking and feedback and ready access to content or services to enhance adherence. The long-term goal of this line of research is to disseminate an efficacious, mobile health ART adherence application that can be integrated readily into clinical care. The objective of this application is to develop a mobile health ART adherence application, to pilot the application, and to conduct a preliminary randomized controlled trial of the application.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed ART, infected with HIV, have a detectable viral load (\>20 copies/mL) with the past 6 months, report less than 100% medication adherence, and have a smart phone capable of downloading the mARTAA application.

Exclusion Criteria:

* Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension, active psychosis, and not fluent in English.
Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma

The hypothesis of the study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC.

Characters of the patients:

* list item one: 168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC were diagnosed
* list item two: Treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or IMRT).
* list item three: Median time to recurrence was 30 months (range 1-180months). The median follow-up time was 28 months (range, 4-135 months).

Objectives:

Recurrent T1-2 Nasopharyngeal Carcinoma (rT1-2) may be salvaged by 3D - CRT（3D-Conformal Radiotherapy）, IMRT（ Intensity Modulated Radiotherapy）, Brachytherapy (BT), BT combined 3D - CRT or IMRT . The aim of this study is to address the efficacy and toxicity profile of aforementioned four modalities for rT1-2 NPC.

Methods and Materials:

168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC were diagnosed and treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or IMRT) . Median time to recurrence was 30 months (range 1-180months). The median follow-up time was 28 months (range, 4-135 months).

Eligibility Criteria:
Inclusion Criteria:

* recurrent T1-2 nasopharyngeal carcinoma patients

Exclusion Criteria:

* non recurrent T1-2 nasopharyngeal carcinoma patients
A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)

This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).


Eligibility Criteria:
Inclusion Criteria:

* Verified diagnosis of primary sclerosing cholangitis (PSC) for at least 12 months, with or without inflammatory bowel disease (IBD).
* Serum alkaline phosphatase (ALP) ≥ 1.5 times ULN and with no \>15% fluctuation in the past 3 months.
* In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.
* Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.

Exclusion Criteria:

* Presence of documented secondary sclerosing cholangitis or small duct PSC
* Bacterial cholangitis within 30 days prior to Screening
* Presence of percutaneous drain or endoscopic bile duct stent
* History of, or suspicion of cholangiocarcinoma.
* Prior liver transplantation, or currently listed for liver transplantation
* Presence of other concomitant liver diseases
* Moderate to Severe active IBD or flare in colitis activity within the last 3 months
* Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder
* Any active malignant disease (within 3 years), other than non-melanomatous skin cancer
* Human immunodeficiency virus (HIV) infection
* Existing or intended pregnancy, or breast feeding
* Has received medication from another clinical trial within the past 30 days
Exelon Patch and Combination With Memantine Comparative Trial

The primary objective is to compare the tolerability between rivastigmine patch monotherapy and combination therapy with memantine in patients with Alzheimer's disease (AD). The secondary objective is to compare the efficacy and safety between rivastigmine patch monotherapy and combination therapy with memantine in patients with AD. The study hypothesis is that the tolerability of the combination therapy with memantine is not inferior to that of rivastigmine patch monotherapy in AD patients.

Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. We hypothesized that combination of memantine and rivastigmine patch will be safe and well tolerated and result in more clinical benefit in patients with AD in comparison with rivastigmine patch monotherapy, for the mechanisms of the drugs are different.

Eligibility Criteria:
Inclusion Criteria:

* Dementia by DSM-IV and probable AD by NINCDS-ADRDA
* Age of 50 to 90 years
* Mini-Mental State Examination (MMSE) score of 10 to 20
* Brain MRI or CT scan consistent with a diagnosis of probable AD
* The caregiver must meet the patient at least once a week and be sufficiently familiar with the patient to provide accurate data.
* Ambulatory or ambulatory-aided (is, walker or cane) ability
* Written informed consent will be obtained from the patient (if possible) and from the patient's legally acceptable representative. Even if unable to provide written informed consent, the patient must assent verbally to participating in the study.

Exclusion Criteria:

* Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disease, active peptic ulcer disease, severe hepatic or renal disease, or any medical condition which would prohibit them from completing the study
* Any psychiatric or primary neurodegenerative disorder other than AD
* Any patients with hearing or visual problem that can disturb the efficient evaluation of the patients.
* Any patients with a history of drug addiction or alcohol addiction for the past 10 years
* Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second ot third degree A-V blocks
* Clinically significant laboratory abnormalities to affect cognitive function (i.e.abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or syphilis, etc)
* History of allergy to topical products containing any of the constitution of the patches
* Current diagnosis of an active skin lesion
* Involved in other clinical trials or treated by experimental drug within 4 weeks
* Patients with hypersensitivity to cholinesterase inhibitors
Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension

Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.


Eligibility Criteria:
Inclusion Criteria

* Males or females with essential hypertension, blood pressure values between 140 mmHg and 179 mmHg systolic and between 90 mmHg and 109 mmHg diastolic
* Given written informed consent prior to starting the study

Exclusion Criteria

* Women with childbearing potential, breast feeding or pregnant;
* Inability to discontinue all prior antihypertensive medication;
* Secondary hypertension
* Severe hypertension
* Severe diabetes mellitus (HbA1c greater 8.5%)
Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors

Our objective in this study will be to determine if implementing the glucose/insulin clamp (GICT) on cadaveric organ donors can:

* Prevent hyperglycaemia
* Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
* Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant
* Assess graft function by evaluating:

  * Liver: post-transplant liver function score (PTLF)
  * Kidney: graft function as defined by UNOS (immediate graft function IGF, slow graft function SGF and delayed graft function DGF and
  * Pancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at day one and seven post-transplantation


Eligibility Criteria:
Inclusion Criteria:

* Donors must be over 18 years of age
* Brain death donors only
* Getting consent prior to any specific protocol procedure under Transplant Quebec regulations.

Exclusion Criteria:

* Inability to obtain a research consent
* Time interval between the start of the study and cross-clamping less than 6 hours.
* No solid organs retrieved for transplantation
* Diagnosed with Type 1 Diabetes
* Donor has uncontrolled serum blood glucose levels (above 10 mmol/L) at time of inclusion
Effect of Aerobic Interval Training With Vitamin D Supplement on Functional Capacity and Perceived Myalgia

This study aimed to investigate whether there will be an effect of adding a program of aerobic interval training in managing patients suffering from myalgia associated with vitamin D deficiency.

Forty five women complaining from myalgia with vitamin D deficiency participating in this study. Their ages are ranged from 30 to 40 years.

They are assigned randomly into three groups:

* Group (A): included 15 patients who are participating in an aerobic interval training exercise program with vitamin D supplementation (cholecalciferol 400 IU/day).
* Group (B): included 15 patients who are receiving vitamin D supplementation only (cholecalciferol 400 IU/day).
* Group (C): included 15 patients who are participating in an interval training exercise program only.

The intervention will last for 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Forty five sedentry women with non specific myalgia pain.
* The patients' ages ranged from 30 -40 years.
* All patients have non specific muscle pain for more than 2 months.
* They have vitamin D deficiency.
* All patients have BMI from 25 to 34.9 kg/m2.
* All patients were clinically and medically stable when attending the study.

Exclusion Criteria:

* Unstable cardiovascular and chest problems.
* Patients with diseases which affect vitamin D level as a history of rheumatic or metabolic bone diseases and diabetes.
* Patients taking drugs which affect vitamin D level as steroids and anticonvulsants drugs .
* Musculoskeletal disorders which may affect their physical ability to do the exercises.
A Comparison of the Estimates of Fuwai and Reynolds Risk Model

There are many risk prediction models. And their estimates are different. This study aimed to investigate the differences between the estimates of Fuwai and Reynolds risk model in Chinese, and investigate the reason for the differences.

The participants will examined for cardiovascular risk factors, and their cardiovascular risks will be calculated based on the values of the risk factors using cardiovascular risk models. The estimates of different risk models will be compared, and the levels of traditional risk factors will be adjusted in order to evaluate the impacts of uncommon risk factors such as social and genetic risk factors.

Eligibility Criteria:
Inclusion Criteria: adults -

Exclusion Criteria: with coronary heart disease

-
SURPASS Retrospective Study

This study aimed to determine whether sentinel lymph node biopsy (SLNB) could be a reliable option for evaluating nodal status in patients who had responded well to neoadjuvant systemic therapy (NAST), even if they had initially presented with a high nodal burden. The study investigated the outcomes of SLNB followed by axillary lymph node dissection (ALND) in this patient population, taking into account the response to NAST and the breast cancer subtype.

To determine the feasibility of sentinel lymph node biopsy (SLNB) in this study, the investigators evaluated the false-negative rate (FNR) of SLNB. The FNR was calculated as the number of patients with negative SLNs who had a residual disease in the rest of the axillary lymph nodes (ALNs) divided by the total number of patients with residual disease in either the SLNs, the rest of the ALNs, or both: FN/true-positive + FN. The investigators compared the FNR of the SLNB according to the radiologic response measured using breast MRI in each subtype. The investigators further evaluated the FNR in subgroups stratified by clinical nodal stage. Additionally, the investigators assessed additional metastatic ALNs in cases with 1-2 metastatic SLNs through the completion of ALN dissection.

Eligibility Criteria:
Inclusion Criteria:

* cN1-3 breast cancer at initial presentation
* received neoadjuvant systemic therapy (NAST)
* received sentinel lymph node biopsy (SLNB) followed by additional axillary lymph node dissection (ALND)
* breast MRI performed at baseline and post-NAST.

Exclusion Criteria:

* case with unavailable data for breast MRI and operation
Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO

The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of gas exchanges improvement in patients with acute respiratory failure due to community-acquired pneumonia.

Community-acquired pneumonia (CAP) is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up t 30%.

Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration via a Venturi mask for the treatment of acute respiratory failure in immunocompetent patients with community-acquired pneumonia.

Therefore, the aim of this study is to compare the efficacy of CPAP delivered by a helmet and O2 administration via a Venturi mask in terms of gas exchanges improvement in early acute respiratory failure (PaO2/FiO2 between 210 and 285)due to community-acquired pneumonia.

A Steering Committee composed by the principal investigators will request an interim analysis at 20% enrolment in order to monitor the criteria for equipoise of the two treatments.

Eligibility Criteria:
Inclusion Criteria:

* Community-acquired pneumonia (CAP) defined as: new chest x-ray pulmonary infiltrate, fever, and respiratory symptoms
* Acute Hypoxemic Respiratory failure
* Respiratory Rate \< 35 breaths/min
* PaO2/FiO2 \> 200 and \< 300 while breathing oxygen for at least 15 minutes via a Venturi mask with FiO2 0.5

Exclusion criteria

* Immunosuppression
* acute cardiogenic pulmonary edema
* Patients belonging to Class II-III-IV of the NYHA
* Acute coronary syndrome
* Acute Respiratory Acidosis pH \< 7.35 and PaCO2 \> 45 mmHg
* More than 3 acute organ failures
* Systolic Pressure \< 90 mmHg under fluid resuscitation or vasopressor drug use
* Seizures
* Decreased level of consciousness (GCS \<12)
* Inability to clear secretions
* Pre-defined intubation criteria
A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus

This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.

This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and DNA yield, using a randomized factorial design pilot trial. Participants will first undergo the sponge on a string test followed by clinical endoscopy. Following completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity configuration selected from Phase 1. Study procedures, testing and follow up will be the same as Phase 1.

Eligibility Criteria:
Inclusion Criteria:

Subjects with known Barrett's Esophagus (BE).

* Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
* Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
* Undergoing clinically indicated endoscopy. Subjects without known evidence of BE - Undergoing clinically indicated diagnostic endoscopy

Exclusion Criteria:

* Subjects with known BE.

  * Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
  * Patients with history of esophageal resection for esophageal carcinoma. Subjects with or without known evidence of BE (on history or review of medical records).
  * Pregnant or lactating females.
  * Patients who are unable to consent.
  * Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
  * Patients on oral anticoagulation including Coumadin, Warfarin.
  * Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
  * Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.
  * Patients with history of known varices or cirrhosis.
  * Patients with history of esophageal resection for esophageal carcinoma.
  * Patients with congenital or acquired bleeding diatheses.
  * Patients with a history of esophageal squamous dysplasia.
  * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
A Trial to Improve Quality of Life in People With Cirrhosis

This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic Encephalopathy (HE), but report reduced quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis - must meet one of the following criteria:

  1. liver biopsy, OR
  2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
  3. 2 of the following 4 criteria:

     1. Ultrasound, Computed tomography (CT) or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
     2. Fibroscan liver stiffness score \>13 Kilopascal (kPa)
     3. Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) \>2.0
     4. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices

        Exclusion Criteria:
* Non-English speaking
* Pregnancy (self-reported)
* Unable or unwilling to provide consent
* History of liver transplant
* Disorientation at the time of enrollment, Dementia, or Treated Memory Disorder
* History of prior lactulose use or HE within 6 months
* Metastatic solid malignancy or blood malignancy
* Hemoglobin A1C \> 12 (within past year)
Post Market Clinical Follow-up Study Venezia

The investigational device is the Advanced Gynecological Applicator (AGA) Venezia configuration, an applicator to treat locally advanced stage cervical cancer. The goal of the study is to assess the performance and the unknown risks or complications of the AGA Venezia configuration during clinical use of the applicator.

This is a multi-center, prospective, post-market clinical follow-up study to assess the performance and the unknown risks or complications of the Advanced Gynecological Applicator (AGA) Venezia configuration during clinical use of the applicator. The AGA Venezia configuration is a CE-marked, FDA approved and commercially available product. The AGA Venezia configuration is a gynaecological applicator for intracavitary and interstitial brachytherapy. The radiation oncologist can use it for treatment of cancers in the vagina, cervix and uterus. Forty (40) participants will be included in this study at 5 sites: 3 centers in Europe and 2 centers in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced cervical cancer stage IB to IVA
* Patients eligible for brachytherapy according to the criteria of the treating radiation oncologist and center guidelines
* Patients that are eligible to undergo brachytherapy with the Advanced Gynecological Applicator Venezia Configuration according to the criteria of the treating radiation oncologist
* Patient is able to understand and has voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures.

Exclusion Criteria:

* Patients that have been treated or will be treated for cancer other than cervical cancer.
* Advanced stage cervical cancer patients who have been treated with pelvic radiotherapy, incl. brachytherapy, before.
* Patients younger than 18 years at the time of diagnosis.