cyrilzakka/clinical-trials huggingface dataset:
Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.

To address our specific aims we will use a single-center, prospective, three-arm, parallel group, randomized controlled trial design. At the time of identification of eligibility for participation, patients will be randomized to one of three arms (1:1:1 ratio): Arm 1 consists of patients randomized to conventional cardiac rehab only, Arm 2 consists of patients randomized to conventional cardiac rehab with the addition of the mHealth platform, and Arm 3 consists of patients randomized to remote case management using the mHealth platform only. Clinical metrics will include traditional cardiovascular risk factors with additional tracking of service utilization and adherence, and quality of life. Measures will be made at baseline (pre-intervention) and \~3-months (coinciding with completion of conventional CR). Additional follow-up will occur at 12 months post CR entry. Randomization to study arms will be done with a multidimensional dynamic allocation algorithm, minimizing imbalances in age, sex, body mass index, and race across study arms.

Eligibility Criteria:
Inclusion Criteria:

* Own or have reliable access to a smartphone or desktop computer with internet access
* Have an email address
* Patients who have a history of one of the following; acute myocardial infarction/acute coronary syndrome, stable angina pectoris, percutaneous coronary intervention, or heart failure.
* Patients who have undergone a surgical procedure which includes an indication for cardiac rehabilitation (coronary artery bypass surgery, heart valve repair/replacement, or heart transplant)

Exclusion Criteria:

* Patients referred to cardiac rehab with ventricular assist devices.
A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease

The purpose of this study is to find out if a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients. Two dose levels will be studied: a single dose and a double dose. We expect both dose levels to safely immunize patients against HBV. The study will determine which dose does this best.

Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. While acute HBV infection is associated with significant illness, the risk of chronic infection is of great importance since 5-10% of infected adults will not clear the infection after the initial phase of the illness. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis.

This study will evaluate the safety and immunogenicity of HEPLISAV™ when administered to adults who have end-stage renal disease (glomerular filtration rate \[GFR\] ≤ 45 mL/min). Once subjects have been consented, screened, and randomized to treatment, subjects will receive a total of three injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Subjects will receive 1 of the following 2 regimens:

* HEPLISAV™ single dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months)
* HEPLISAV™ double dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months)

Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local and systemic reactogenicity.

Immunogenicity will be evaluated by the proportion of subjects exhibiting a seroprotective immune response (anti-hepatitis B surface antigen antibodies \[anti-HBsAg\] ≥ 10 milli-international unit (mIU)/mL) at Weeks 4, 12, 24, 28 and 50.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent
* Have a glomerular filtration rate (GFR) ≤ 45 mL/min
* Have an expectation of going on hemodialysis or are already on hemodialysis
* Is serum negative for hepatitis B virus (HBV) antibodies, hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
* Have repeated resting blood pressure measurements ≤ 165/105 mmHg
* Women of childbearing potential must be consistently using a highly effective method of birth control

Exclusion Criteria:

* Women who are pregnant, breastfeeding or planning a pregnancy
* Any previous HBV infection
* Previous vaccination (1 or more doses) with any HBV vaccine
* Any previous autoimmune diseases
* Have a diagnosis of chronic renal failure due to autoimmune disease
* Are at high risk for recent exposure to HBV, HCV or HIV
* Received any antibodies within 3 months prior to study entry
* Ever received an injection with DNA plasmids or oligonucleotides
* Received any vaccines within 4 weeks prior to study entry
* Received any other investigational medicinal agent within 4 weeks prior to study entry
Quality of Life in Patients with Standard External Compared to Custom-made Breast Prosthesis.

Despite improvements in surgical techniques, approximately 30% of mastectomies are still performed. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the external breast prosthesis. The main objective is to evaluate whether the "custom-made" MEAVANTI prosthesis improves the quality of life of patients who have had a mastectomy compared to the external standard prosthesis.

In France, breast cancer is a public health issue with around 59,000 new cases per year. Despite improved surgical techniques, there is still around 30% mastectomy performed every year. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the use of external breast prosthesis. Currently, there are 3 silicone brands that are marketed and refunded. These standard prostheses take into account only the curve of the patients and not the weight of the remaining breast making adaptation difficult to all body types. The difference in breast weights can cause several disorders: postural, pain, discomfort, psychological impact on quality of life as well as medico-economic impact. MEAVANTI is an external breast prosthesis for custom calibration and personalization, which can prevent postural compensation and provide greater comfort.

The main objective of this study is therefore to evaluate whether the MEAVANTI prosthesis improves the quality of life of patients who have undergone a mastectomy compared to the standard prosthesis (through the EORTC questionnaires - European Organization for Research and Treatment of Cancer). This study will be monocentric, cross-over (2 periods), prospective, open with a wash-out period of 15 days. The period of the study will be conducted over 13 months.

The expected benefits can be major. The main benefit expected is the improvement of quality of life of the patients carrying the MEAVANTI breast prosthesis compared to those carrying the so-called standard prosthesis. A reduction in back and neck pain could also reduce the costs of patient management. In addition, this will demand referencing by the HAS of the custom-made prosthesis so that it is reimbursed in the same way as existing ones.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral mastectomy performed.
* Satisfactory healing
* Informed consent form signed.
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Elastomer type plastics or silicone allergy
* Contraindication to the use of the MEAVANTI or Standard external prosthesis: damaged or irritated skin in the area of application of the prosthesis
* Patient under the age of 18 years
* History of back problems (scoliosis)
* History of spine surgery
* Other cancer being treated,
* Dorsal hyperalgia
* Acute infectious episode (cellulitis, erysipelas, lymphangitis)
* Presence of subcutaneous osteosynthesis material with an external part at the level of the upper limb to be treated,
* Impossibility to comply with the constraints of the protocol,
* Pregnancy,
* Breast feeding
* Adult protected by law (tutelage, curators and safeguard of justice).
Double Voiding and Post-transplant UTI

Urinary tract infections (UTI) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Such UTIs increase the risk for blood stream infection and acute rejection of the kidney, Improvements in urinary voiding techniques may reduce the frequency of UTI. The purpose of this study is to evaluate the benefits of "double voiding" in kidney transplant recipients.

Urinary tract infections are common in kidney transplant recipients and are an important cause of morbidity and hospital readmissions. Several risk factors for UTI, both modifiable and unmodifiable, have been described in the literature. In normal (non-transplant) individuals, because of the anatomy of the ureter insertion into the bladder that creates a valve-like effect during voiding, reflux of urine into the kidney is prevented . However, after kidney transplantation, urine refluxing into the transplanted kidney is common. Depending on the surgical technique used for connecting the transplant ureter to the urinary bladder, reflux may occur in up to 79% of kidney transplant recipients. In addition, the routine usage of ureteral stents (double J stents) for the first 4-6 weeks after transplantation results in reflux. Vesicoureteral reflux increases the risk of UTI Double voiding, a process of passing urine more than once each time, is a technique that may assist the bladder to empty more effectively when urine is left in the bladder. By reducing the amount of left-over urine in the bladder after each void, double voiding may help reduce the incidence of UTI in kidney transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* All adult kidney transplant recipients who undergo routine follow-up at the New York Presbyterian - Weill Cornell Medicine (NYP-WCM) Transplant Clinic.

Exclusion Criteria:

* Kidney transplant recipients who are discharged after a transplant with an indwelling catheter (Foley)
Definitive Chemoradiotherapy and Cetuximab in the Treatment of Locally Advanced Esophageal Cancer

In patients with esophageal cancer, treatment with curative intent can be given to medically fit patients without distant metastases. It may consist of chemoradiotherapy or surgery alone or in combination. Surgery in combination with chemotherapy is another option. For patients who are not medically fit for surgery or with unresectable invasion in adjacent structures the only alternative with curative intent is, with current knowledge, definitive chemoradiotherapy. In the current study the investigators aim to improve prognosis for patients not suitable for surgery. Patients receive treatment with conventional chemoradiotherapy (oxaliplatin, fluorouracil and radiotherapy) with the addition of a more recently developed drug, an antibody called cetuximab.

Patients are treated with three cycles of oxaliplatin and fluorouracil 750 mg/m2/24 hours, day 1-5. Each cycle lasts for 21 days. Oxaliplatin is given with 130 mg/m2 in the first cycle and in cycle 2 and 3 which are administered concomitant with radiotherapy the dose is reduced to 85 mg/m2.

A loading dose of cetuximab 400 mg/m2 is given one week before the start of radiotherapy, and thereafter 250 mg/m2 is given weekly during the course of radiotherapy.

Concomitant with chemotherapy radiotherapy to a total dose of 50 Gy is given (2 Gy once daily in 25 fractions, 5 days a week) with a photon beam linear accelerator.

After treatment patients are followed every 6 months for three years with clinical examination and a CT-scan.

Eligibility Criteria:
Inclusion Criteria:

* Histological verified squamos cell carcinoma or adenocarcinoma of the oesophagus or cardia
* Performance status WHO 0-2, age 18-75 years
* Locally advanced disease, non-resectable (T4 N0-N3 M0) or disease which is not operable for any other reason (T2/T3 N0-N3 M0)
* Adequate hematological, liver and renal function
* Written informed consent

Exclusion Criteria:

* Distant metastases
* Prior chemotherapy or radiotherapy for oesophageal cancer or cancer of the cardia
* Symptomatic peripheral neuropathy equal to or greater than NCI grade 2
* Other concomitant serious illness or medical condition that would not permit the patient to complete the study treatment or sign the informed consent
* Myocardial infarction within 6 months prior to study entry
* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 2 years
* Pregnancy
Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.

The purpose of this study is to investigate how a high-fructose diet, either by high fructose intake from complex, natural foods or by fortifying the diet with corn syrup, affects the metabolism. Furthermore, it will be investigate if there are differences between obese and normal weight participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, aged between 20 and 30 years
* normal weighted (BMI ≤ 25 kg/m2) and obese (BMI 35-50 kg/m2)
* written informed consent

At initial medical examination an anamnesis, physical examination, blood sample collection (10 ml) was performed to check for eligibility. Furthermore, a hydrogen breath test was performed to detect potential fructose intolerance

Exclusion Criteria:

* smoking,
* fructose intolerance/ -malabsorption,
* pregnancy
* chronic gastrointestinal diseases (e.g. chronic inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.),
* operation on the gastrointestinal tract (exclusively appendectomy)
* anemia,
* hepatic or renal disease
* diabetes mellitus
* consuming illnesses (e.g. cancer, acquired immunodeficiency syndrome (AIDS)) - drug intake affecting lipid or glucose metabolism (cholesterol- or glucose reducing or antihypertensive drugs, steroids, L-Thyroxin, antidepressants, weight reducing drugs).
Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT

A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8.
* informed consent

Exclusion Criteria:

* chronic rhinosinusitis with or without nose polyps
* Previous immunotherapy (SLIT or SCIT)
* BMI \> 35
* house dust mite allergy with symptoms
* allergy towards furry animals if exposition cannot be avoided
* 25(OH)Vitamin D levels \< 25 or \> 75 nmol/L
* use of Vitamin D supplementation or excessive use of sun tanning booths
* mental incapacity to follow study protocol
* other significant disease
* allergy towards study medication
* uncontrolled asthma
* severe atopic dermatitis
* pregnancy or nursing
* autoimmune disease
* hyper IgE-syndrome
* cardiovascular disease
* lung disease
* liver or kidney disease
* hematologic disorder
* metabolic disease
* chronic infectious disese
* medications interacting with the immune system
* cancer
* previous cytostatic therapy
* medication with beta-blockers or ACE-inhibiters, if medication cannot be paused at the day for treatment
* drug or alcohol abuse
* intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1
* withdrawn consent

Exclusion Criteria only for ILIT group (due to vitamin D treatment)

* medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics)
* tendency for formation of kidney stones
* hyperparathyroidism or other disease conferring risk of hypercalcemia
* hereditary pseudohypoparathyroidism with decreased phosphorous secretion
* malabsorption or bowel disease with diarrhea
* Mb Paget, osteoporosis or sarcoidosis
* skin disease at the groin (where the treatment will be injected)
Atrial Fibrillation With Sinus Node Dysfunction: Intensive Device Follow-up

The study will try to access the efficacy of atrial pacing, medication and radiofrequency ablation in treating patients with paroxysmal atrial fibrillation and sinus node dysfunction; to identify the response to these treatments in patients with "functional" and organic sinus node dysfunction respectively; to explore the necessity of pacemaker implantation in patients with "functional" sinus node dysfunction. Patients who meet the inclusion criteria will receive pacemaker implantation followed by trial pacing, medication and radiofrequency ablation of AF. Device data will be analyzed to answer the question. And after follow-up of 1 year, lower rate of pacemaker will be set as 40 bpm for patients without AF. The proportion of pacing and patients' tolerance will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 - 80 years
* Longest RR interval ≥ 3 seconds in sinus rhythm or when atrial arrhythmia (atrial fibrillation/atrial arrhythmia/atrial flutter) is converted to sinus rhythm (documented by either holter monitor or electrogram).
* Meet the indications of permanent pacemaker implantation in patients with SND according to the 2012 ACCF/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities.
* Evidence of paroxysmal atrial fibrillation ( two or more symptomatic episodes within 6 months)
* Willing to sigh informed consent

Exclusion Criteria:

* Type II second-degree or three-degree atrioventricular block (in sinus rhythm)
* Intrinsic PR interval ≥ 300 ms in sinus rhythm
* Persistent AF（including long-standing persistent AF）
* Severe structural heart disease(e.g. ischemic heart disease that requires revascularization, rheumatic heart disease that requires valve replacement, cardiomyopathy except hypertensive myocardial hypertrophy)
* Work high above the ground or heavy physical labour
* Malignant ventricular arrhythmias
* New York Heart Association (NYHA) class III or IV
* AF secondary to electrolyte imbalance, thyroid dysfunction, vasovagal reaction or other reversible or non-cardiac causes
* Previous procedures dealing with AF (including radiofrequency ablation and surgical operation)
* Cardiac implantable electronic device implantation history
* Severe hepatic and renal dysfunction(serum creatinine above the upper normal limit of the center, or chronic renal dysfunction ; ALT or AST more than 2 times the upper normal limit of the center, or bilirubin more than 2 times the upper normal limit of the center, or hepatic cirrhosis)
* Contraindication to propafenone/amiodarone/dronedarone(except bradycardia)
* Contraindication to oral anticoagulants
* Women who are pregnant
* Presence of malignant tumor
* Severe coagulation disorder (without any anticoagulation treatment)
* The investigators do not think the patient is eligible for this study
* Patient is unwilling to cooperate with the study procedures
Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder

A double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with posttraumatic stress disorder (PTSD) symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV).

N=92 patients with posttraumatic stress disorder (PTSD) will be enrolled into a double-blind randomized placebo-controlled trial to further investigate glecaprevir/pibrentasvir (GLE/PIB), a direct acting antiviral (DAA) that has been associated with PTSD symptom improvement when prescribed for the treatment of chronic hepatitis C viral infection (HCV). The research is intended to test the efficacy of GLE/PIB for PTSD symptom improvement in the absence of HCV.

Primary Aims:

Aim 1: Determine the efficacy of GLE/PIB for PTSD symptom improvement. Aim 2: Determine the efficacy of GLE/PIB for functioning improvement among patients with PTSD.

Aim 3: Assess the safety and tolerability of GLE/PIB treatment for patients with PTSD in the absence of HCV.

Eligibility Criteria:
Inclusion Criteria:

1. Age 19-70 years
2. Weight ≥ 45 kg
3. Diagnosed with PTSD as determined by the CAPS-5 within seven days of enrollment
4. Eligible for Veterans Affairs healthcare
5. If person with childbearing potential, use of acceptable method of birth control (i.e., effective contraceptives, abstinence) is required.
6. Able to read, understand, and sign the informed consent document.

Exclusion (unable to participate) Criteria:

1. Pregnant or lactating person
2. Moderate or severe hepatic impairment (Child-Pugh B or C)
3. History of prior hepatic decompensation
4. Current use of drugs listed as having significant drug interactions on prescribing label
5. Advanced liver disease
6. Current or prior hepatitis B infection
7. Prior clinical use of GLE/PIB or HCV NS5A inhibitor AND NS3/4A protease inhibitor
8. Current HCV infection
9. Current psychosis or mania
10. Significant suicidal ideation
11. Unstable medical conditions
12. Current severe alcohol or substance use disorder (excluding nicotine)
13. Evidence-based PTSD psychotherapy changes in the past two months
14. Evidence-based PTSD medication changes in the past two months
Real-time Artificial Intelligent (AI)-Assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in ICU Patients

This study aims to investigate the feasibility of using a real-time artificial intelligent (AI)-assisted tool for Rectus Femoris cross sectional area measurement from muscle ultrasound to improve reliability, reduce inter- and intra-observer variability and reduce operator time spent on ultrasound examination

This project proposes to develop computational methods to automatically analyze conventional 2D muscle ultrasound images in real time to assist operators circumvent achieve high quality reproducible views and measurements specifically for Rectus Femoris muscle.

Study design: This is a prospective observational study to test the reliability of AI-assisted muscle ultrasound at the patient's bedside compared to standard RFCSA ultrasound. All measurements will be performed in adult patients with severe tetanus (Ablett Grade 3 or 4) admitted to the Adult ICU at HTD expected to stay at least 5 days. All patients are on mechanical ventilation, muscle relaxation and neuromuscular blockers following the Ministry of Health guidelines.

Study procedures: Three ultrasound examinations will be carried out according to a standard operating procedure where patients are in the supine position with the leg in neutral rotation. Measurements will be taken using 12L-RS linear probe, Venue Go ultrasound machine (General Electric Healthcare, London, UK).

Statistical analysis: Study will compare the intra- and interobserver variability of measurements and examination duration. All statistical analysis was performed with R version 4.0.4.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥16 years
* Written informed consent
* Staff and equipment available for ultrasound
* Admitted to Viet Anh Ward ICU with a diagnosis of meningitis or encephalitis or Ablett Grade 3 or 4 tetanus
* Within 72 hours of ICU admission
* Duration of ICU stay expected at least 5 days

Exclusion Criteria:

* Informed consent not given
* Contraindication to ultrasound scan