cyrilzakka/clinical-trials huggingface dataset:
Optimal Cardiac Resynchronization Therapy Pacing Rate

The optimal pacing rate during cardiac resynchronization therapy (CRT) is not known. Investigators investigate the impact of changing basal pacing frequencies on autonomic nerve function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).

This is a double-blinded randomized crossover pilot study testing two basal pacing rates: DDD-60 versus DDD-80. Each patient is paced for 2 periods of 90 days with DDD-60 and DDD-80 in a randomly sequence.

Blood samples NT-proBNP plasma levels are analysed at baseline and at the end of each phase using electrochemiluminescence-immunoassay. Patients rest for 15 minutes before the samples are taken.

These result are monitored by supervisory group to ensure that increase of more than 15% than baseline values result in termination of study.

Investigators conduct two distinct questionnaires (Minnesota Living with Heart Failure (LIfHE) questionnaire and Medical Outcome Survey Short Form (SF-36)) A symptom limiting bicycle (Ergoline, Baden-Württemberg, Germany) exercise test is performed to measure maximum work capacity and oxygen consumption at each phase.

Recordings of resting muscle sympathetic nerve activity (MSNA) are sought in all patients at both rates of pacing. All patients are studied on the same set-up in the semi-recumbent position after 30 minutes of rest. Tungsten microelectrodes (Iowa Bioengineering) are inserted into the common peroneal nerve just below the knee.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with idiopathic dilated cardiomyopathy
* CRT device implanted (with initial indication in accordance with European guidelines) at least 6 months prior to inclusion.
* New York Heart Association functional (NYHA) class II-IV
* Sinus rhythm,
* Hemodynamically stable
* Biventricular pacing \> 90% of the time
* On optimal medical treatment for heart failure with no changes in medications during the past 3 months.

Exclusion Criteria:

* NYHA I
* unable to perform exercise test (e.g. chronic obstructive pulmonary disease, severe arthritis)
* cancer
* plasma creatinine \> 200 micromole per litre
* an admission for decompensated HF or acute coronary syndrome in the preceding 3 months.
Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a

Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver.

Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.

The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.

- Studying intra lymphocyte and blood cccDNA: before inclusions, D0 then each month during the first three months each three months during treatment and follow-up.

- Viral kinetics:Before inclusions, at D0, then monthly till the end of treatment and follow-up: Evolution of quantitative viraemia in serum Evolution of quantitative viraemia in circulating lymphocytes Evolution of quantitative viraemia in total blood

- Studying viral genotypes

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \>18 years of age and \<70 years of age
* Patients AgHbs+ and AgHbe+ or AgHbe-, and B viral DNA \>104 copies/ml PCR COBAS MONITOR
* Patients treated with adefovir dipivoxil and peg interferon alpha 2a
* Chronic liver disease consistent with chronic hepatitis B infection on a biopsy obtained within the past 24 months
* Naïve patients or patients having a relapse or a therapeutic failure after monotherapy lamivudine or interferon, or bitherapy interferon alpha-lamivudine

Exclusion Criteria:

* Co-infection HIV, HCV
Social Media and Cancer Screening Information

NORC/AmeriSpeak will recruit participants who meet the study criteria and invite them to complete a 15-minute survey. Participants will be randomly assigned to one of five conditions, with approximately 400 people in each condition, and will respond to various questions after viewing the study messaging. Once 2,000 participants complete the survey, the data will be de-identified and provided to the study team for analysis.

NORC/AmeriSpeak will put all of the study content into their system. They will send out the opportunity to participate in the study, which should take about 15 minutes, to people in their panel who meet our participation criteria. Participants will be directed to the study information sheet that includes all elements of consent. Participants who agree to participate will start the survey experiment. The survey experiment will randomize participants into one of five conditions: (1) control (no exposure), (2) overall median ranked messages (from the prior study), (3) messages preferred by all participants, (4) messages preferred by Black American participants, and (5) messages preferred by White American participants. Approximately 400 people will complete each condition. After viewing the study stimuli (or no stimuli in the control condition), participants will respond to various outcomes and other variables of interest (see questionnaire draft included). After all 2,000 people have completed the study, the study team will receive a de-identified data file from NORC/AmeriSpeak with all study data and engage in analysis. This study is planned to close the study around that time as the study team completes data analysis and write-up the findings.

Eligibility Criteria:
Inclusion Criteria:

* Identify as white/Caucasian or Black/African American.

Exclusion Criteria:

* Do not identify as white/Caucasian or Black/African American.
* Previously diagnosed with colorectal cancer
* Non-English speakers
Evaluation of a Navigator-Nurse Care Team on the Management of High Blood Pressure and Cardiovascular Disease Risk

The purpose of this trial is to study the effect of a patient navigator-nurse team in improving the management of hypertension and other cardiovascular disease risk factors in a health care system taking care of a vulnerable, mostly Latino population.

This study represents one phase of a large partnership grant with The Colorado Health Outcomes Program of the University of Colorado at Denver Health Sciences Center (UCDHSC) and Denver Health and Hospital Authority (DH). The overarching goal of Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR) is to improve the primary and secondary prevention of cardiovascular disease (CVD) in Hispanics through a comprehensive research program aimed at (1) increasing awareness of CVD risk in the Hispanic community and increasing participation of high risk Hispanics in the health care system, (2) developing more effective models of care delivery for high risk patients in a health system, and (3) identifying markers that will more effectively identify Hispanic patients at high risk of CVD than current approaches based on traditional risk factors.

This trial has been designed to assess the effectiveness of a quality improvement project which focuses on the hypertensive multiracial underserved population within the Denver Health system. In addition, we are hoping at study end to have developed and validate this project as an efficient and sustainable approach to improving blood pressure control and controlling cardiovascular risk factors, especially in the vulnerable patient population served at Denver Health.

The objective of this quality improvement program is to conduct a randomized, primary care-based, efficacy trial evaluating the effectiveness of a patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors using information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study is designed to test the hypothesis that a patient navigator-nurse assisted intervention will improve blood pressure (BP) in vulnerable hypertensive patients, compared with usual clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Active patients from the Target Adult Health Clinic
* Identified with a diagnosis of hypertension
* Uncontrolled hypertension (2 of 3 last BP measurements above target BP range; target BP is defined at 140/90 or 130/80 mm Hg for people with diabetes or kidney disease)

Exclusion Criteria:

* Pregnant or breastfeeding
* End-stage kidney disease requiring dialysis
* Co-morbid illness with life expectancy less than 12 months
* Institutionalized individuals because of the potentially confounding factors due to severe co-morbidity or other medical conditions
A Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay

The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.

The secondary objectives will consist of:

* The evaluation of the confidence in the therapeutic indications of the practitioners before and after the test (assay) results, and by subgroups of cancers
* The evaluation of the rate of secondary effects of chemotherapy,
* The evaluation of the emotional state of patients faced with the therapeutic decision, of their degree of anxiety and of their functional status before and after the Prosigna test (assay) results

Eligibility Criteria:
Inclusion Criteria:

* Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)

  * Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive.
  * HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
* Postmenopausal women defined as:

  * Natural Amenorrhea \> 12 months, regardless of age
  * Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
  * Radiological castration with amenorrhea \> 3 months, regardless of age
  * Hysterectomy and postmenopausal blood levels
* Able to give consent
* Eligible for treatment of breast cancer with adjuvant chemotherapy
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Tumor size T3-T4
* Non-invasive breast cancer (e.g., Paget's disease, DCIS)
* Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+)
* Tumors that are estrogen-receptor negative or HER2 positive
* Have metastatic disease
* Unable to give informed consent
* Unable to complete patient reported outcome surveys
* Have contraindications for adjuvant chemotherapy

  * Age, performance status, significant comorbidities
* ECOG performance status \> 1
Randomized-controlled Trial of Aftercare-Coordination by Phone for Depression and Anxiety

The primary objective of this study is to test in a randomized controlled trial if aftercare-coordination by phone subsequent to inpatient treatment is an effective aftercare approach in the treatment of depression and anxiety.

Depression and anxiety are among the most prevalent mental health problems and are associated with a high risk of chronification. Despite the large capacities in the German health care system only a small percentage of these patients receive treatment. Relevant barriers on the pathways of patients are communication und coordination difficulties between different services and providers.The aftercare subsequent to an inpatient treatment represents one of these interfaces. Here the aim is to consolidate the treatment outcomes and to minimize the so called rebound-effect, the reduction of the positive treatment effects after the inpatient treatment. Although evidence-based treatments for depression and anxiety disorders exist, treatment effects often decrease after treatment due to the lack of an integration of different steps in care. The method of a case management-based aftercare coordination by phone could be a promising approach to overcome the interface between inpatient treatment and aftercare: case management is a patient-centered and situation-based approach which comprises systematic tracking and support of patients by a case-manager. Primary goal is to coordinate and integrate services across treatment settings. This approach can help to maintain and even improve longterm treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Depressive disorder (F32.x; F33.x; F34.1) and/or Anxiety disorder (F40.0; F40.1, F41.0; F41.1) according to ICD-10

Exclusion Criteria:

* Concurrent outpatient psychotherapeutic treatment which will be continued after the inpatient rehabilitation treatment.
* No knowledge of the German language
* Risk of suicide
* Acute psychosis or psychotic symptoms
The Immune Assessment of PD-1 Antibody Therapy in Tumor

This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.

The primary aim of this study is to evaluate the efficacy and safety of PD(L)-1 antibody therapy for malignant tumors in real-world settings. Treatment outcomes will be assessed according to RECIST V1.1 and iRECIST criteria, with safety graded according to CTCAE V5.0 standards. The study aims to enroll 3000 adult cancer patients treated at this center and analyze their prognosis outcomes based on previous treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Pathologically confirmed malignant tumors.
3. Complete medical records.
4. Assessable immune function test data.

Exclusion Criteria:

1. Age \<18 years.
2. No confirmed tumor pathology.
3. Untraceable medical records.
4. Non-assessable immune function tests.
Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 60 years old (inclusive
* having chronic idiopathic urticaria
* at least 6-weeks history of CIU, had at least 3 days of wheals presence/week
* moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms CIU score ≥ 2 at randomization

Exclusion Criteria:

* Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
* atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids
* urticaria caused by physical factors or other known factors
* cholinergic urticaria
* had urticaria due to other systemic disorders
* were on antihistamine drug currently
Study to Evaluate Home Vision Testing in Participants Who Receive Ranibizumab (Lucentis®)

This pilot study will evaluate home vision testing using a mobile medical application in participants with diabetic macular edema (DME) or neovascular age-related macula degeneration (nAMD) who receive intravitreal ranibizumab therapy. In the main, decentralized study, participants will be recruited via digital media, advocacy groups, or through their own ophthalmologist. The traditional substudy will evaluate the association between visual acuity and anatomical markers of disease status determined using clinical "gold standard" assessments (certified Early Treatment Diabetic Retinopathy Study \[ETDRS\] protocol visual acuity and macula optical coherence tomography \[OCT\]) and the results of home vision testing using the myVisionTrack\^TM (mVT) application.


Eligibility Criteria:
Inclusion Criteria:

* DME or active nAMD in at least one eye
* Current treatment with intravitreal ranibizumab therapy, with evaluations planned every 4 to 8 weeks
* Access to an approved mobile device with a data plan or WiFi internet access

Exclusion Criteria:

* Any other eye condition causing eye disease that limits vision and cannot be corrected, other than DME or nAMD
* Dementia or other neurologic or psychological limitation that would prevent the participant from performing regular self-testing of visual function
Assessing Frailty in Older Adults With Functional Mental Illness

The purpose of this study is the development of, and two stages of pilot testing of, a tool designed to assess frailty in older adults with a diagnosis of a functional mental illness. During the tool's development stage, participants' input, ideas and feedback will be sought to inform the tool's design. In the first pilot test the comprehensibility, acceptability and feasibility of the tool will be established. The tool will be amended based on information gained in the first pilot test. In the second pilot test the comprehensibility, acceptability and feasibility of the revised tool will be established. Reliability of the tool will be explored and preliminary examinations of both the interpretability and construct validity of the tool will be completed.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥65 years
* Diagnosis of one of the following functional mental illnesses; depression, anxiety, bipolar affective disorder, schizophrenia.
* Currently in receipt of mental health services under The Care Programme Approach (CPA).
* Presence of ≥2 of the following frailty indicators: Aged ≥75 years old, prescribed ≥5 medications, a history of ≥1 fall/s in the 6-month period prior to assessment, admission to hospital in the 6-month period prior to assessment. In receipt of weekly support for Activities of Daily Living (ADL) tasks, In receipt of daily support for Instrumental Activities of Daily Living (IADL) tasks, ≥2 chronic physical health conditions.
* Fluent in English language.
* Able to provide informed consent to engage in the study.
* Able to tolerate the mental and physical demands of the study

Exclusion Criteria:

* A diagnosis of a neurodegenerative condition (e.g. mild cognitive impairment or dementia), neurological condition (e.g. stroke, Parkinson's disease) or head injury (where a loss of consciousness greater than 10 minutes is reported/recorded).
* The presence of a severe sensory impairment (e.g. registered blind or deaf).
* Presence of a developmental intellectual disability.
* Current alcohol/substance abuse or dependence.
A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer

The main purpose of this study is to see what levels of Bone Mineral Density post-menopausal women with breast cancer have, and to see if the level of Bone Mineral Density changes during a women's treatment after her surgery.

This trial studies changes in Bone Mineral Density and markers of of bone activity in post-menopausal women receiving treatment for early stage breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of breast cancer
* Last menstrual period occurring more than 5 years ago
* Non-metastatic breast cancer tumor with the diagnosis of Tis, Tl-T4, N0-3, M0
* DCIS is allowed, but LCIS (only) is not

Exclusion Criteria:

* Any metabolic bone disease other than postmenopausal osteoporosis or osteopenia
* Use of systemic gonadal hormonal medications or supplements within the past 24 months
* Prior use of tamoxifen or raloxifene is permitted if the medication was discontinued more than 24 months prior to the diagnosis of breast cancer.
* No adjuvant antiestrogen, antineoplastic, therapies are permitted on study.
* Chronic use of systemic steroids for disease process other than breast cancer chemotherapy premedication or antiemetics
* History of rheumatoid arthritis, ankylosing spondylitis, hyperparathyroidism, renal osteodystrophy, moderate to severe inflammatory or autoimmune disease or newly diagnosed thyroid condition requiring titration of medications.
* Lobular carcinoma in situ or Stage IV breast cancer and patients with a concurrently active second malignancy other then adequately treated non-melanoma skin cancers or in situ cervical cancer.
* participation in other clinical trials that are measuring BMD as a study parameter
* Patients with conditions that are expected to distort BMD reading and make DEXA results unreliable
* Patients with concurrent medical or psychiatric conditions that would keep them from understanding and complying with this clinical trial.
Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes

Primary Objective:

To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics.

Secondary Objectives:

* To document the profile of Type 1 diabetes patients.
* To document the glycemic parameters (Fasting blood glucose \[FBG\] and glycosylated hemoglobin \[HbA1c\]) of Type 1 diabetes.
* To capture the current therapeutic management.

The overall duration of this study is expected to be 12 months. The recruitment period for a given center will be four months following site initiation of that center. telephonic follow-up for all the patients shall be conducted after 15 days ± 5 days.

\*Each patient (cases as well as controls) will be required to undergo laboratory tests for insulin autoantibodies and hemoglobin A1c tests. Both the tests will be conducted through centralized laboratories for all recruited patients.

Since the result of insulin auto-antibodies test is one of the inclusion criteria, it is mandatory for all patients to undergo this test, and detailed information for the same has been included in the informed consent form.

Eligibility Criteria:
Inclusion criteria :

Inclusion Criteria for Cases

* Age ≥ 2 years and ≤ 20 years.
* Type 1 diabetes mellitus (T1DM) at any stage of life assessed as:
* Insulin initiated within one year of diagnosis.
* One or more islet autoantibodies (insulin auto-antibodies \[IAA\], glutamic acid decarboxylase (GAD), or IA2) positive at the time of enrolment. The laboratory value for IAA ≥ 2.4 units/mL, ≥ 10 IU/mL for IA2 and ≥ 5 IU/mL for anti-GAD to be labelled as positive.
* Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than legal limit which is 18 years of age.

Inclusion Criteria for Controls

* Age ≥ 2 years and ≤ 20 years. Every control will be matched for a specific patient within ± two years of age.
* Non diabetic.
* All islet autoantibodies negative at the time of enrolment (IAA, GAD, or IA2). The laboratory value for IAA ≤ 2.4 units/mL, ≤ 10 IU/mL for IA2, and ≤ 5 IU/mL for anti-GAD to be labelled as negative.
* Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than 18 years of age.

Exclusion criteria:

Exclusion Criteria for Cases:

* Age ≤ 2 years and \>20 years.
* Patients with any other pre-existing auto-immune disease.
* Gestational Diabetes.
* Pregnant Woman.

Exclusion Criteria for Controls:

* Age ≤ 2 years and \> 20 years.
* Patient with history of Type 1 (T1) and Type 2 Diabetes Mellitus (T2DM).
* History of T1 and T2DM in siblings.
* Gestational Diabetes.
* Pregnant Woman.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.