cyrilzakka/clinical-trials huggingface dataset:
App-based Cognitive Training at Home

This randomized controlled trial is for investigating the effects of multidisciplinary intervention program on cognition and activity of daily living ability in community dwelling healthy elderly. The intervention consists of cognitive group training every month, daily home cognitive training using cognitive training smartphone application, record of weekly physical activity and body weight and feedback program, and alcohol and smoking cessation monitoring and feedback program. Among these interventions, app-based cognitive training at home is the major intervention in this study. The total duration of intervention is 1 year, and the tablet-based cognitive screening test and the patient-reported questionnaires to evaluate subjective memory decline, quality of life, depression, and activity of daily living are used for outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* literate
* education years \>= 6 years
* not demented
* mini-mental status examination \>= 24
* android cellular phone users
* no significant decline in activities of daily living (Korea- Instrumental Activities of Daily Living =\<5)

Exclusion Criteria:

* Who has a history of major cardiovascular diseases within 3 months of study enrollment (ex. myocardial infarction, stroke)
* Who has current illnesses that could possibly affect cognition or with anticipated life expectancy of less than 2 years (ex. end stage cancer, on chemotherapy)
* Who has a severe hearing difficulty or visual disturbance
* Who has a limitation in communication
* Who was diagnosed with dementia
* Who has a plan for immigration or move in 1.5 years after study enrollment
* Who underwent a cognitive training within 6 months of study enrollment
Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.

The goal of is this study is to investigate the reliability and validity of a classification system for neck pain patients. In a previous study clinical experts were asked about the clinical criteria they considered to be determinative for 5 predefined dysfunction patterns in patients with neck problems: 1) articular, 2) myofascial, 3) neural, 4) central, and 5) sensorimotor control dysfunction pattern. This Delphi survey revealed a list of pertinent anamnestic and clinical criteria per dysfunction pattern.

In the present study we will collect anamnestic and clinical data of 200 neck pain patients. This will be obtained by approximately 20 clinicians that fill out a standardized registration form at the intake of their patients with neck pain.

The therapists and patients will receive an informed consent that clarifies the purpose of the study and what happens next with the collected data.

Per patient the therapist indicates the dominant clinical pattern based on his/her experience. Prior to the data analysis, the researchers will be blinded to the patient identification data. Subsequent, the registration forms will be screened for the presence of clinical criteria (obtained from previous Delphi study), independent of the therapist's diagnosis/conclusions. A second independent researcher will gather this information, which will be used for statistical analysis, in order to investigate which clinical criteria can be considered as determinative for a particular pattern. Outcome measures for these analysis are:

* sensitivity and classification specificity
* (positive and negative) likelihood ratios
* odds ratios
* diagnostic accuracy


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from neck pain

Exclusion Criteria:

Known serious underlying pathology (RED FLAGS):

cancer, metastatsis, untreated fractures, history of diabetes or pathology of the central nervous system, non-musculoskeletal neck pain
HLA Antibodies in Systemic Lupus Erythematosus

Patients suffering from autoimmune diseases show false-positive results when anti-HLA antibodies are identified. This false positivity makes it difficult to obtain an organ transplant based on immunological compatibility (absence of anti-HLA antibodies directed against graft antigens). The objectives of this project are to study the prevalence of these false positivities in a population of lupus patients, and to evaluate biological tests that can negate these false positivities.


Eligibility Criteria:
Inclusion Criteria:

* Patients Adults
* Followed in the internal medicine department of Amiens University Hospital - With systemic lupus erythematosus
* Without HLA immunization risk factors (no history of pregnancy, transfusions or transplants)
* With sera stored in the biobank

Exclusion Criteria:

* minor Patients
* Opposing the re-use of their personal data for research purposes
Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient

This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years.

Participants will undergo an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. This will include specific imaging for tissue characterization and assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow. The investigators will then draw blood (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest. The participants will undergo exercise testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6 month study period the participants will return back for a follow up and repeat all the testing completed at enrollement.

This is a single center prospective longitudinal study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years. The investigators will enroll from pediatric cardiology and heart failure clinics and inpatient care units at Children's Health Dallas, adult congenital heart disease clinics and inpatient care units at Clements University Hospital and the Clinical Heart Center. This study will evaluate the multimodality biomarkers for assessment of Fontan circulation including heart, liver and lung and change in these markers with exercise training.

Participants will receive an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. A blood draw (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest will be completed. The participants will also complete exercise testing and will then start a 3-6 month long cardiac rehabilitation program. Frequent phone follow up (conducted by the research staff) and regular download of data from heart rate monitors will ensure adherence.

After the 3-6 month study period the participants will return for a follow up and repeat all testing completed at enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a congenital heart defect that leads to single ventricle physiology
* Previously performed TCPA surgery
* Current age 10 years to 40 years
* Informed consent

Exclusion Criteria:

* History of exercise intolerance (peak VO2\<12ml/kg/min)
* Unstable arrhythmia at the time of screening
* Listed or being evaluated for heart transplantation
* Pregnancy or breast feeding
* Patient with pacemaker, AV block other than 1st degree block, sick sinus syndrome or other arrhythmia that may influence ability to perform exercise test or magnetic resonance imaging
Expanding PrEP By Embedding Unannounced SNAPS Navigators in High STI Testing Clinical Sites

The goal of this study is to assess the impact of an intervention, known as SNAPS, to expand Preexposure Prophylaxis (PrEP) prescriptions at Health + Hospitals (H+H)/Bellevue. In addition, evaluating whether this intervention, ie SNAPS, helps patients get on PrEP and stay on PrEP to prevent STIs like HIV. PrEP is a medication that needs to be taken on a regular basis in order to be effective to prevent HIV transmission.

The objective of the investigator's proposal is to evaluate the effectiveness of an intervention to (1) increase PrEP initiation overall, (2) increase uptake among groups disproportionately impacted by the HIV pandemic, and (3) to preserve high PrEP retention while expanding use. In addition, the proposal includes innovative secondary outcomes of (4) identifying barriers and facilitators of PrEP use that may be unique to urban safety-net populations, and (5) estimating the HIV infections averted due to greater PrEP uptake from the intervention.

The intervention is multi-level yet, targets the "weakest chains in the link" of PrEP initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. It consists of Surveillance by STI testing, Navigation by unannounced patient navigators to the Sexual Health Clinic (SHC), Accelerated follow-up with providers with PrEP expertise, Point-of-care PrEP counseling and laboratory testing, and Seamless, consistent, longitudinal, comprehensive care (SNAPS).

Eligibility Criteria:
Inclusion Criteria:

Historical comparison group:

* all adults ≥18 years of age prescribed PrEP at H+H/Bellevue one year prior to SNAPS intervention initiation.

Prospective group:

* all patients will be considered for study participation who are accessing care at H+H/Bellevue ≥ 18 years of age,
* have unknown HIV status,
* requesting STI testing/treatment or inquiring about PrEP or PEP in the ED or urgent care, OB/GYN, and Dermatology clinics.

Exclusion Criteria:

* patients who are HIV positive
* refuse consent
COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY

In patients with pituitary adenoma scheduled for endoscopic transsphenoidal pituitary surgery, it was aimed to compare the efficacy of postoperative pain relief of a selective α-2 agonist "Dexmedetomidine" and the rapid and short-acting opioid "Remifentanil" using the "Numerical Rating Scale" (NRS) administered alongside propofol in perioperative maintenance anesthesia. .


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* ASA-1 and ASA-2 patients

Exclusion Criteria:

* Patients in need of postoperative intensive care
Gene Therapy to Improve Wound Healing in Patients With Diabetes

Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene therapy with the platelet-derived growth factor-B gene has been shown to help with the healing of chronic wounds. This study will evaluate a new way to deliver the gene to the wound tissue.

Chronic wounds, such as diabetic ulcers, pressure ulcers, and venous stasis ulcers, cause significant morbidity in millions of patients each year in the United States. Individuals with long-standing diabetes develop both peripheral vascular disease and peripheral neuropathy. These patients may not feel pressure from shoes or objects which can damage their skin. Once a wound is formed, it may heal very slowly or not at all due to diabetic complications.

Platelet-derived growth factor-B (PDGF-B) has been approved for use in diabetic ulcers. However, delivery and maintenance of the drug at the wound site in sufficient quantities for a sufficient period of time is a major hurdle to widespread use.

Gene activated matrix (GAM) technology offers the opportunity to place a therapeutic gene contained within a structural matrix into a wound site. This study will evaluate the safety and potential clinical utility of topical applications of GAM501, a gene for PDGF-B contained within an E1-deleted adenoviral vector and formulated in a bovine type I collagen gel. This formulation allows for the migration of wound repair cells into the structural matrix, where they encounter the viral vector and subsequently produce the therapeutic protein within the local wound environment.

Participants in this study will receive up to four treatments with GAM501. Participants will be followed by multiple observations over a 6 to 7 month period.

Eligibility Criteria:
Inclusion Criteria

* Adequately controlled diabetes mellitus (type I or II) as defined by HbA1c \< 10.0%
* Cutaneous, lower extremity, plantar medial or lateral surface ulcer between 1 and 10 cm2 post-debridement
* Ulcer present for \> 6 weeks prior to study entry
* Ulcer free of all necrotic and infected soft tissue
* Affected limb transcutaneous oxygen pressure (TcpO2) \> 30 mmHg at screening or a palpable dorsal pedal or posterior tibial pulse
* Inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 monofilament in the peri-ulcer area
Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori

The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.

Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide.

Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people.

Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori.

Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.

Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.

Eligibility Criteria:
Inclusion Criteria:

* patient proved with infection of H. pylori in gastric mucosa
* adult with signed inform consent

Exclusion Criteria:

* woman in breast feeding or pregnancy.
* allergy to drugs used in study.
* three months without use of any antibiotic agents.
* patients under 20 years old.
Soluble ST2 and Cardiovascular Outcome

Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant cardiovascular morbidity and mortality. Soluble suppression of tumorigenicity 2 (sST2) is biomarker of myocardial remodeling and fibrosis; however, little is known regarding their potential association with cardiovascular events. This study aimed to investigate the release of sST2 and its association with cardiovascular events undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Congenital heart disease requiring surgery
* Valvular heart disease requiring surgery
* Arrhythmia requiring surgery
* Aortic dissection requiring surgery
* Coronary heart disease requiring surgery

Exclusion Criteria:

* age \<18 years
* pregnancy
* severe renal dysfunction (creatinine \>200µmol/L)
* not capable of understanding or signing informed consent.
Non Invasive Optical Imaging of WBC Count

This research study is looking at a small device that measures white blood cell (WBC) counts by being placed against the finger nail for participants who are undergoing stem cell transplantation at Massachusetts General Hospital or have a hematologic malignancy and are being seen as an outpatient.

The objective of this study is to obtain data that would support the use of a method to obtain WBC counts from images of small blood vessels called capillaries. These would be obtained by pressing a small device on the surface of participants' finger nails to look through the nail. These images will be obtained using a portable microscope called the Dino-Lite Digital Microscope.

Having a non-invasive way to quickly measure WBC counts could be useful for a variety of healthcare applications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lymphoid malignancies or plasma cell dyscrasias who are admitted to the Massachusetts General Hospital to undergo autologous stem cell transplantation or are seen in the outpatient clinic
* Age ≥ 18 years
* Ability to understand and the willingness to sign a written informed consent document.
* Patients must have WBC ≥ 3000 / µl and ANC ≥ 1500 / µl at admission or their last clinical visit to be enrolled.

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition of baby oil.
* Myelodysplasia
* Skin phototype \< 4 in the Fitzpatrick scale.
Risk for Short-term Adverse Events in Older Users in the Emergency Department

The study evaluates the performance criteria of abnormal PRISMA-7 score, length of stay in Emergency department and in hospital, and hospital admission in older Emergency department users.

In Quebec, Canada, the "Program of Research on Integration of services for the Maintenance of Autonomy" (PRISMA-7) is the Ministry of Health and Social Services' reference tool for the frailty assessment of older Emergency department users. This tool has been initially developed and validated to assess disabilities in older community dwellers with the aim to quickly identify older individuals at risk for disabilities and who should undergo a comprehensive assessment. PRISMA-7 has a high sensitivity for identifying frailty in older community dwellers but its performance criteria for this goal has never been examined in older Emergency Department users. Recently, a systematic review underscored that PRISMA-7 has all characteristics for being a usable clinical tool in Emergency department because it is a brief (i.e., \<5 min), simple and multidimensionality assessment. PRISMA-7 is composed of 7 questions assessing health and functionality of older adults and stratifies risk for disability in two levels: low versus high. PRISMA-7 is a prognostic tool for disabilities.

Eligibility Criteria:
Inclusion Criteria:

* Being enrolled in the ER2 study( Emergency Room Evaluation and Recommendation)
* Having a score test of Prisma 7( Program of Research on Integration of Services for the Maintenances of Autonomy) at Emergency.

Exclusion Criteria:

* Never being enrolled in the ER2 study( Emergency Room Evaluation and Recommendation)
* Never having a score test of Prisma 7( Program of Research on Integration of Services for the Maintenance of Autonomy) at Emergency
ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery

This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.

Obtaining erectile function after phalloplasty in female-to-male transsexuals remains a challenging issue and requires the implantation of a device. For biological males, several erectile implants exist and widespread research has demonstrated the successful outcome of these devices. However, substantial differences exist between a native penis and a neophallus and explain the poorer outcome of these devices in female-to-male transsexuals.

In 2018, Falcone et al. published the largest retrospective series on this subject so far and reported that after a mean follow-up of 20 months, only 58% of their patients still had their original implant in place. The main obstacle in these female-to-male transsexuals is represented by the lack of corpora cavernosa in the neophallus which leads to difficult anchorage of the prosthesis, little stability of the prosthesis and a higher risk of cylinder erosion.

Until recently, all penile implants were manufactured for erectile dysfunction in biological males and thus presumed the presence of two corpora cavernosa. In 2016 however, the Swiss company, Zephyr Surgical Implants (ZSI), created a 3-piece inflatable erectile device specifically for female-to-male transsexuals: the Zephyr ZSI 475 FTM. This prosthesis has a realistic gland shape, only one cylinder, and a specific anchorage device made of titanium and silicone to anchor the system to the pubic bone of the patient. These specific features could potentially address the aforementioned issues with implanting erectile devices in the neophallus and hopefully lead to better surgical outcomes in these particular patients.

So far, no literature regarding surgical or functional outcome of the Zephyr ZSI 475 FTM exists. The aim of this study is to prospectively collect data of all female-to-male transsexuals that are treated with the implantation of this device at Ghent University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
* Age ≥ 18 years.
* Female-to-male transsexual patient.
* Implantation of Zephyr ZSI 475 FTM erectile device.

Exclusion Criteria:

* Absence of signed written informed consent.
* Age \< 18 years.
* Biological males.
* Patients opting for penile implants other than the Zephyr ZSI 475 FTM.
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

This project focuses on anti-seizure medication (ASM) clearance and physiological factors determining blood concentrations in pregnant adult women with epilepsy and amounts of exposure to their unborn children and nursing infants.

The goal of this study is to develop modeling of pharmacokinetic changes for Antiseizure medications (ASMs), lamotrigine (LTG), and levetiracetam (LEV) during pregnancy and postpartum that can be used to:

1. Adjust doses in practice without obtaining frequent visits to the lab for therapeutic drug monitoring.
2. Predict exposure of ASMs in mothers and their infants in order to maintain the individualized target concentrations, thus protecting mothers from seizure worsening and minimizing fetal toxicity.

Hypotheses:

1. Drug concentrations obtained in preconception and early pregnancy predict clearance changes throughout the remainder of pregnancy for individual pregnant women with epilepsy.
2. Validated model allows the prediction of drug concentration changes at all stages throughout and after pregnancy, which will more accurately predict increased seizures and medication side effects.

Additionally, pilot data will be obtained for oxcarbazepine (OXC) in a small number of participants and contribute to data for ASMs that undergo glucuronidation (LTG).

Eligibility Criteria:
Inclusion Criteria:

* Woman with epilepsy between the ages of 18-45 planning pregnancy or in the early first trimester of pregnancy.
* Women with epilepsy ability to maintain a daily medical diary
* Women with epilepsy ability to answer side effect questionnaires
* Women with epilepsy currently being treated with lamotrigine (LTG) or levetiracetam (LEV) or oxcarbazepine (OXC)

Exclusion Criteria:

* Women with epilepsy having history of functional seizures.
* Women with epilepsy history of other major medical illnesses including renal or hepatic disease, progressive cerebral disease,
* Women with epilepsy who have inability to maintain a seizure and medication daily diary
* Women with epilepsy with present or recent history of drug or alcohol abuse, or the use of any concomitant medications that interact with the ASM they are taking (lamotrigine, levetiracetam, oxcarbazepine).