cyrilzakka/clinical-trials huggingface dataset:
Exploring the Long-term Effects of Cognitive Exercise on Cognition After Stroke

This project will investigate the effectiveness of an intensive and focused working memory training program for chronic stroke patients. The investigators hypothesize that working memory training will be an effective method of improving working memory and related cognitive and behavioural functions in this population.

Vascular cognitive impairment due to vascular disease and stroke frequently includes problems with attention, working memory and executive functions (e.g., monitoring, planning, and organization).

These deficits are common - 32-73%, and chronic, and interfere with a patients response to rehabilitation, independence in activities of daily living, community re-integration, and overall quality of life after stroke. Attention, memory and executive function impairments can adversely affect the ability to relearn various skills.

Cognitive impairments and their impacts on other components of functioning not only impact on the individual, but can also adversely affect the family via increases in caregiver distress and burden. Thus, the presence of cognitive impairment has wide-reaching impact and deserves effective and consistent intervention similar to the attention devoted to improving function in physical domains.

Cognitive training can improve cognitive function, particularly in those areas known to involved in vascular cognitive impairment, i.e., attentional and executive function. Accumulating evidence indicates that computer-based training can improve cognitive skills in healthy older adults as well as in clinical populations. Attention and working memory training has also been shown to be effective in patients in the chronic phase post stroke.

The investigators propose that specific cognitive training to improve working memory could provide direct benefit to chronic stroke patients. Promising interventions focused on intensive and direct working memory training are emerging and have been shown to generalize to other cognitive domains, such as fluid intelligence.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must: (i) be ≥18 years of age, (ii) have been received the diagnosis of ischemic or hemorrhagic stroke \>6 months ago, (iii) be experiencing stroke-related cognitive problems that interfere with daily functioning, (iv) be able to perform a two-step command, (v) live within a 75 km radius of the Queen Elizabeth II

Exclusion Criteria:

* Subjects must not: (i) have moderate or severe receptive aphasia, (ii) have a terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness.
Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea (PD) patients.

It is well established that excess prostaglandin production in primary dysmenorrhea (PD) leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients with non-steroid anti-inflammatory drugs (NSAIDs) being the most effective with the overall success rate of more than 75%. Oral contraceptive pills (OCP) are also an established treatment for PD with the success rate of 70%. Lately, OCP's have been used continuously in patients with endometriosis and had better pain control than traditional administration of OCP.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women ages 18-35 with a history of PD (onset \< 3 years after menarche).
* Subjects must have had regular (25-31 day) menstrual cycles for the three month period preceding enrollment, with symptoms of moderate to severe PD during those cycles.

Exclusion Criteria:

* Patients who have contraindications to OCP therapy.
* Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome).
* Concomitant treatment with oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs.
* The use of contraceptive implants, injectable contraceptives or intrauterine devices. The washout period on all these medications will be 3 months.
* Migraines, depression requiring hospitalization or associated with suicidal ideation during previous estrogen or ocp use.
* Known or suspected hypersensitivity to trial drug.
* Patients enrolled simultaneously into other investigative studies that require meds.
Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Males or females aged 18 to 55 years (inclusive)
* Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
* Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
* Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
* Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
* Any previous treatment with fostamatinib
The Mediating Effects of Decentering on Self-Management of Stress and End of Life Planning

Caregivers of persons with cancer may face many challenges as they support and care for a person receiving treatment. Sometimes having to help make treatment decisions for a patient can cause distress for caregivers. The purpose of this study is to evaluate 2 different electronic approaches to providing support for a caregiver. One group will have access to an on-line program with videos, providing education on decision making strategies for caregivers of patients with cancer, to watch and a daily meditation application and the other group will have access to the daily meditation application. Investigators will randomly assign participants to each group.

Investigators will conduct a randomized trial pilot study to examine two arms of the intervention among 20 caregivers of patients with advanced cancer. Investigators will collect mixed methods data to describe changes in proximal and distal outcomes. Investigators have chosen the time points to capture neural and behavioral changes associated with the intervention and to capture end of life quality of life (QOL) for a majority of caregivers after death of their loved one. Investigators aim to:

1. Evaluate the short and longer-term effects of the end of life care with medication (EOL_M) and meditation only (M_Only) interventions on stress reduction and end of life (EOL) planning behaviors and determine if there are different effects between EOL_M and M_ Only interventions.
2. Evaluate the short-term and long-term effects of the intervention on caregiver distress, decisional regret, and EOL values and goals of care for treatment.
3. Evaluate the impact of decentering on the association between the interventions, self-management behaviors (stress reduction and EOL planning behaviors) and distress, anxiety, concordance between EOL values and goals of care for treatment, decisional regret and satisfaction with EOL care.
4. Describe the neural activity processes that are associated with increased self-management activities.

Eligibility Criteria:
Inclusion Criteria:

* caregivers of patients who have been diagnosed with Stage IV gastrointestinal (GI) cancer
* coming with the patient at the Seidman Comprehensive Cancer Center at University Hospitals Case Medical Center (UHCMC)
* have access to the internet and a computer, tablet, or smart phone, and
* speak and comprehend English.

Exclusion Criteria:

* currently practicing mindfulness-based interventions (yoga, meditation, deep breathing)
* require psychotherapy within the last three months
* have a history of dementia, major neurological illness
* pregnant
* history of a medical condition or procedure that is contraindicated for functional magnetic resonance imaging (fMRI) scanning (i.e. cardiac pacemaker, sternal wires, or metal implants); and
* claustrophobia requiring anxiolytics or sedation; or
* expect to relocate from Northeast, Ohio within 2 months
Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation

The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.

It is not clear that dual antiplatelet therapy is better than aspirin beyond 12-months period patients receiving sirolimus drug-eluting stent implantation. If aspirin plus clopidogrel reduced MACE rates without increasing blood events, the investigators will evaluate risk-benefit ratio. The investigators will observe all cause mortality, nonfatal myocardial infarction, or clinical-driven target vessel revascularization TVR in a 1-year trial duration. In addition, strokes, stent thrombosis, cardiac re-hospitalizations, dialysis/hemofiltration, duration of hospitalization and bleeding events will be observed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of older.
* The latest PCI with DES implantation before 12 months (stents must be one or more sirolimus-eluting stents).
* Angiographically confirmed major epicardial vessels (\>=2.5mm in diameter) without significant stenosis or restenosis (\>=50%).
* Geographically accessible and willing to come in for required study visits.
* Signed informed consent.

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to aspirin and clopidogrel.
* Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment and within 12 months.
* EF\<35% within 12 months.
* Severe cardiac valves disease, or idiopathic cardiomyopathy such as dilated cardiomyopathy, hypotrophic cardiomyopathy. Other severe system diseases.
* Previous ACS within 12 months.
* Previous stroke or transient ischemia attack within 12 months.
* Previous myocardial infarction and clinical-driven target vessel revascularization within 12 months.
* Current enrollment in another clinical trial.
* Suspected pregnancy.
* Big bleeding events within 12 months.
* Planned surgical procedure.
* Previous other type DES implantation or BMS implantation history.
* Extra-cardiac stent implantation history.
* Current or planned dialysis.
* The patient has a known hypersensitivity or contraindication to statins.
* Current or planned high dose and long-term glucocorticoid treatment.
* that is expected to limit survival to less than 1 years.
Study Assessing Safety and Performance of OrtoWell Distractor in Patients Undergoing Spinal Surgery

Study to Assess the Safety and Performance of the OrtoWell® Distractor in Patients Undergoing Spinal Surgery

This is a Prospective, single-arm, multi-center, observational, post-market clinical follow-up study The OrtoWell® Distractor System (CE marked) is a device intended for separating and holding apart vertebral bodies in the spinal column, to facilitate removal of damaged discs, and implantation of disc prostheses or spinal cage prostheses, as well as for repositioning the vertebral bodies following implantation of disc or cage prostheses The OrtoWell® Distractor System will be used in patients undergoing anterior or lateral spinal surgery, where separation of vertebrae is required, including corpectomy, insertion of disc prosthesis, insertion of an anterior lumbar interbody fusion (ALIF) cage, and tumor surgery The study will enroll up to 32 patients in Germany that require one of the above listed intervention except the patients with a known osteoporosis Study subjects are expected to participate for approximately 30 days following the surgery. Participation will involve a screening period, surgery and scheduled follow-up assessment at 30 days post implant

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing spinal surgery, where use of the OrtoWell® Distractor System is indicated
* Signed written informed consent

Exclusion Criteria:

* Pregnant patients at the time of spinal surgery
* Known osteoporosis
* BMI ≥ 30
* Obstacles to performing radioscopy (primarily lateral), such as obesity
[18F]AlF-NOTA-FAPI-04 PET/CT in Inflammation and Fibrosis in Renal Diseases

The goal of this observational study is to explore the feasibility of using 18F-labeled FAP molecular probe for PET/CT imaging (18F-FAPI PET/CT) to accurately evaluate inflammation and fibrosis in renal diseases. The main questions it aims to answer are:

* Can 18F-FAPI PET/CT accurately evaluate the inflammation and fibrosis of kidney disease?
* What is the value of 18F-FAPI PET/CT as a non-invasive assessment of inflammation and fibrosis in kidney disease? Participants will receive \[18F\]AlF-NOTA-FAPI-04 PET/CT and renal aspiration biopsy.


Eligibility Criteria:
Inclusion Criteria:

* The pitients of nephritis or fibrosis disease

Exclusion Criteria:

* Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
* Renal biopsy cannot be performed for severe exclotting disease
* Complicated with chronic liver disease, myocardial infarction, stroke, and malignant tumor
* Unable to cooperate with renal puncture biopsy due to language communication or other problems
* Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
* Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes
* Alcohol allergy
* Patients with significant decrease in urine volume due to disease
* Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved protocol
* Other circumstances deemed inappropriate by the investigator for participation in the study.
LUEbeck Registry of Intensive Care Patients - Characterization of the Patients Intestinal MICROBIOME

The purpose of the current study is to analyze the effects of ICU-care on changes in microbiome and the influence of intestinal microbiome changes on short-term and long-term morbidity and mortality of ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* All patients receiving intensive medical care
* A written informed consent from the patient or two independent doctors or legal guardians.

Exclusion Criteria:

* Age \<18 years
Valsartan in Elderly Isolated Systolic Hypertension Study

The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan.

Although antihypertensive therapy has been proven to reduce cardiovascular morbidity and mortality, it is unclear how much blood pressure should be decreased in elderly patients with hypertension. The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study is a multicenter parallel-group study comparing the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg, under treatment with valsartan, an angiotensin II receptor blocker, as an initial antihypertensive drug in elderly patients with isolated systolic hypertension. The number of patients to be recruited is 3,000 and the duration of follow-up is at least 2 years. This 3,000-patient trial was designed with a two-sided α level of 0.05 and 80% power to detect the difference in incidence of cardiovascular events between the target blood pressure levels based on estimation of the cardiovascular events ratio as 21.5/1,000 patient-years and 29.1/1,000 patient-years for the two blood pressure levels. The VALISH study, a large-scale investigator-initiated trial in Japan, will determine whether age should be considered in setting target blood pressure in treatment of isolated systolic hypertension in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged over 70 years and less than 85 years, regardless of sex.
* Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks.
* Previously untreated patients or patients who are on other therapy that can be converted to valsartan.

Exclusion Criteria:

* Patients with secondary hypertension or malignant hypertension.
* Patients with seated systolic blood pressure of over 200 mmHg.
* Patients with seated diastolic blood pressure of over 90 mmHg.
* Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study.
* Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry.
* Patients with severe heart failure (NYHA functional classification III and IV).
* Patients with severe aortic stenosis or valvular disease.
* Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.
* Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.
* Patients with serious liver dysfunction.
* Patients with a history of hypersensitivity to valsartan.
* Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.
Effect of Testosterone Treatment on Drug Metabolism and Transport

This project will evaluate the effect of gender-affirming testosterone treatment on how other medications are processed by the body.

Gender-affirming hormone therapy may include testosterone, a hormone that the body creates and uses naturally. Testosterone is prepared as a medication that patients may take to increase hormone levels. Changes in testosterone concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how testosterone therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm testosterone treatment does not affect natural bacterial in the gut.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified trans\* adult at least 18 years of age.
* Not taking testosterone treatment currently.
* Planning to start testosterone treatment through care provider for gender-affirming medical care.

Exclusion Criteria:

* Unwilling/unable to return for project follow-up visits.
* Unwilling/unable to provide written informed consent.
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage

This study aims to determine whether in-bed cycle ergometry, early in the hospital course after a brain hemorrhage could balance damaging and reparative inflammation in the brain. Inflammatory factors of two groups of patients with brain hemorrhage will be compared, one group will receive in-bed cycling beginning 3 days after hemorrhage plus usual care and the other group will receive usual care only.


Eligibility Criteria:
Inclusion Criteria:

* Supratentorial intracerebral hemorrhage with or without intraventricular hemorrhage
* Pre-morbid modified Rankin Score of 0-2
* Patient must be able to provide informed consent or have a legally authorized representative to provide consent on patient's behalf

Exclusion Criteria:

* Patients with known inflammatory conditions, infection requiring antibiotics or pregnancy
* Patients receiving daily anti-inflammatory medications including but not limited to prednisone, methotrexate, non-steroidal anti-inflammatory medications (ibuprofen, naproxen, indomethacin, celecoxib) and aspirin \>325mg
* Glasgow Coma Score (GCS) 3 48 hours after admission
* Patients in whom withdrawal of life support is being considered by surrogate decision makers
* Injury to the lower extremities, hips or pelvis, weight \>250 kg (weight limit of cycle), or body habitus precluding normal function of cycle
LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy

A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer.
* Prior chemotherapy regimen(s) for lung cancer

Exclusion Criteria:

* History of other malignancy in the last 5 years
* Major surgery within the past 21 days
Vulvar Paget Disease

In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.

In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.

All the information of the patients will be gathered retrospectively from their medical file , after they gave their consent.

Eligibility Criteria:
Inclusion Criteria:

* Vulvar Paget disease

Exclusion Criteria:

* No exclusion criteria
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with twins and a short cervical length at 18-22 weeks scan.

This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

* Twins
* Minimal age of 18 years

Exclusion Criteria:

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* Spontaneous rupture of membranes at the time of randomization
* Cervical cerclage in situ
* Active vaginal bleeding
* Placenta previa