cyrilzakka/clinical-trials huggingface dataset:
Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.

This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.

Eligibility Criteria:
Inclusion Criteria:

* Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis

Exclusion Criteria:

-
Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling

1. Preliminarily explore the correlation factors of differences in the efficacy of levamlodipine besylate in the treatment of hypertension.
2. Quantitatively analyze the influence of covariates such as patient demographic factors, personal history, combined medications, and biochemical indicators on the efficacy of levamlodipine besylate, and establish a population pharmacokinetic model of levamlodipine besylate, to achieve clinical Individualized treatment and rational drug use.

This study is a retrospective study, which intends to collect and extract relevant information from outpatient medical records from the information center of our hospital, and evaluate the difference in the efficacy of antihypertensive treatment with levamlodipine besylate in newly diagnosed hypertensive patients in our hospital; After antihypertensive treatment with levamlodipine besylate, the correlation analysis was carried out on the influencing factors of blood pressure control in the follow-up, and the covariates such as demographic factors, personal history, combined medications, and biochemical indicators were initially explored. The curative effect of dipine.

Through the population pharmacokinetic modeling method of quantitative pharmacology, the influence of covariates such as demographic factors, personal history, combined medication, and biochemical indicators on the curative effect of levamlodipine besylate was quantitatively explored. The population pharmacokinetic model of levamlodipine besylate was established in order to provide reference for clinical individualized treatment and rational drug use.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients with hypertension in our hospital (sex, age is not limited).
2. Patients whose initial treatment is levamlodipine besylate.

Exclusion Criteria:

1. Patients who cannot be followed up regularly or are lost to follow-up after initial diagnosis and treatment.
2. Patients who were initially treated with other antihypertensive drugs.
3. Blood pressure was not measured when the patient came to the hospital for follow-up.
Statins at the Primary Care Level

Hypercholesterolemia, a major cause of disease burden in both the developed and developing world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%, whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was 37.3 % and the proportion of those who are under pharmacological treatment was dismally low: only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and low-dose aspirin were available free-of-charge at the primary care clinics of the public sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg) were incorporated into the package of drugs provided free-of-charge for patients with high cholesterol, according to CVD risk stratification. The goal of this study is to test whether a multifaceted educational intervention targeting physicians and pharmacist assistants, improves detection, treatment and control of hypercholesterolemia among uninsured patients with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will test whether a multifaceted educational intervention program lowers LDL-cholesterol levels and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance with clinical practice guidelines, and improves patient care management and adherence to medication. A cost-effectiveness study will be conducted to compare the intervention to the usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public primary care clinics who will be assigned to receive either the intervention or the usual care. This study is timely and will generate urgently needed data on effective and, practical and sustainable intervention programs aimed at the prevention and control of CVD risk that can be directly used in other primary care settings and health care systems in LMICs.


Eligibility Criteria:
Inclusion Criteria:

* Arteriosclerotic cardiovascular disease: defined as acute coronary syndrome; history of myocardial infarction, stable or unstable angina, coronary revascularization, stroke, or transient ischemic attack presumed to be of atherosclerotic origin and revascularization.
* Moderate-High CVD risk according to the WHO charts adapted by the National MoH (estimated 10-year CVD risk ≥ 20%)
* LDL-C level ≥ 190 mg/dL
* Type 2 diabetes in patients between 40 and 75 years of age

Exclusion Criteria:

* Patients that are already receiving statins, pregnant women, bed-bound, and patients who cannot give informed consent.
* End stage chronics kidney disease receiving dialysis ,HIV/AIDS, tuberculosis, alcohol or drugs abuse.
Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)

This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
* HbA1c ≥7.0% and ≤10.0% before study start

Exclusion Criteria:

* History of Type 1 diabetes mellitus or a history of ketoacidosis
* History of any of the following medications: thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation and sodium glucose cotransporter 2 (SGLT2) inhibitors anytime
* Currently has a urinary tract infection or genital infection with subjective symptom
Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding

Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. To examine how anthocyanin absorption and metabolism may be affected this study will examine urinary excretion of anthocyanins over one month, followed by a one week washout, and then one more dose of blueberry juice.


Eligibility Criteria:
Inclusion Criteria:

* Provided written consent (see: Information and Consent Form)
* Fluent in English
* Complete a confidential medical questionnaire (Appendix 6)
* Able and willing to abide by the dietary restrictions as described
* Able and willing to abide by the urine collection protocols as described

Exclusion Criteria:

* No written consent
* No confidential medical questionnaire
* Unable to comply with diet restrictions and other study requirements
Pain Intensity After RObotic Assisted Urological Surgery

Postoperative pain remains a widespread but still underestimated problem. Studies have shown that despite improvements in pain management, many patients still suffer from moderate to severe postoperative pain. Severe pain is associated with decreased patient satisfaction, delayed postoperative ambulation, prolonged length of stay, risk of developing chronic postoperative pain, and increased morbidity and mortality. Therefore, it is of great importance that surgical procedures that result in severe pain and the optimal analgesic strategies for these procedures can be identified. Most recommendations on postoperative pain management (prevention and treatment) are not procedure-specific. However, risk factors for postoperative pain depend on the patient and the procedure.

In order to develop procedure-specific postoperative pain management guidelines, pain must be assessed in a procedure-specific manner. Additionally, data is sparse on relatively new procedures like robotic surgery. A study, Harel et al. compared pain intensities after ureteral reimplantation with robotic or open surgery in children and reported lower pain scores after robotic surgery. This single study reinforces the clinical findings that robotic surgery is associated with less pain. However, pain assessment after robotic urologic surgery has not been evaluated before.

In order to add to the evaluation of postoperative pain in different surgical groups, we wish to evaluate pain intensities after robot-assisted urological surgery. In this cohort study, we seek to provide an estimate of the pain intensities that can be expected after most types of robot-assisted urological surgery in relation to analgesic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Programmed robot-assisted urological surgery
* Patient who did not declare any opposition to participating in the study

Exclusion Criteria:

* Urgent surgery
* Impossibility of communicating in French
* Cognitive deficit
* Adults legally protected or deprived of liberty
Heuristics, Algorithms and Machine Learning: Evaluation & Testing in Radiation Therapy

The Hamlet.rt study is a prospective data collection and patient questionnaire study for patients undergoing image-guided radiotherapy with curative intent.

The aim of the study is to use novel machine learning and mathematical techniques to build a model that can predict the risk of significant side effects from radiotherapy treatment for an individual patient: using calculations of normal tissue dose from radiotherapy treatment planning and patient baseline characteristics derived from image and non-image data, continuously updated as the patient is reviewed both during and after treatment.

A secondary goal of the project is to facilitate research in machine learning and medical image processing for radiation therapy through the creation of a discoverable and shared data resource for research use.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male or Female
* Aged 18 years or older
* Diagnosed with primary prostate cancer, head and neck cancer, lung cancer, or brain tumour
* Treated with curative intent
* Suitable for radical image guided radiotherapy
* WHO ECOG performance status 0 or 1
* Expected survival of 18 months or more

Exclusion Criteria:

* Participant is not willing or able to complete the protocol-stated requirements of the study, e.g. accessing \& completing web-based long-term follow-up questionnaires.
Efficacy of Electromagnetic Stimulation Therapy for Chronic Prostatitis and Chronic Pelvic Pain Syndrome

In 1995 the National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) workshop reached a consensus on the definition and classification of prostatitis syndromes.The commonest and yet most poorly understood of these prostatitis syndromes is category III or chronic pelvic pain syndrome (CPPS). It has been shown that, while men with CPPS have significantly higher leukocyte counts in urine and expressed prostatic secretions compared with age matched controls, inflammation and infection do not necessarily correlate with symptom severity.

The lack of a direct relationship between inflammation and symptoms is supported through studies of prostate histopathology, in which moderate or severe inflammation was identified in only 5% of men with CPPS.Conventional treatment has focused on long, empirical courses of expensive broad-spectrum antibiotics, mostly of the quinolone class, with or without the concomitant use of an α-blocker and anti-inflammatory agents. At the turn of the 19th century stimulation with electrical current and changing magnetic fields was used to treat surface conditions associated with intractable pain, such as painful malignant ulcers. The analgesic benefits of pulsed electromagnetic fields for relieving pelvic pain has been investigated in women with tissue trauma and chronic refractory pelvic pain.Despite its uncertain etiology there is some evidence that the symptom complex found in CPPS may be founded at least in part in pelvic floor muscular dysfunction and/or neurogenic hypersensitivity/inflammation.

We hypothesized that the application of a electromagnetic stimulation to the perineum of the subject may result in neural excitation and pelvic floor muscle stimulation to a degree that breaks the cycle of tonic muscular spasm and neural hypersensitivity/inflammation, thereby, restoring more normal pelvic floor muscular activity.


Eligibility Criteria:
Inclusion Criteria: male patients with

* Age ≥ 18
* NIDDK category III chronic prostatitis/chronic pelvic pain syndrome
* Symptom duration ≥ 3 months
* The sum of 1 or 2 domain of NIH-CPSI ≥ 1 point
* The sum NIH-CPSI ≥ 15 points

Exclusion Criteria: patients with

* History of prostate cancer
* History of pelvic irradiation
* History of transurethral surgery
* Urinary tract infection within 6 months to screening
* Postvoid urine volume ≥ 150ml
* Interstitial cystitis
A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease

The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild to moderate Alzheimer Disease (AD) dementia. This is done by looking at participants: thinking and memory (cognition), everyday activities and sleep, AD symptoms, physical activity, irritability or anxiety. The study is expected to last approximately 26 weeks and may include up to 14 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have gradual and progressive decline in memory function for greater than or equal to 6 months that is severe enough to interfere with activities of daily living.
* Have MMSE score of 13 to 24.
* Have eligibile plasma P-tau or historical evidence of AD pathology.
* Have a reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant and will be available at designated times.
* Males with partners of childbearing potential must agree to abide with provided contraception guidance.

Exclusion Criteria:

* Are individuals of childbearing potential.
* Have significant central nervous system or psychiatric disease, other than AD, that in the investigator's opinion may affect cognition or the ability to complete the study (e.g: head trauma, stroke, seizure disorder etc.,).
* Have cardiovascular-related risk factors or history that include uncontrolled hypertension, heart failure, stroke; or liver-related abnormalities.
* Use of moderate or strong CYP3A4 inhibitors or inducers.
* Have participated within the last 30 days in a clinical trial involving an investigational product.
* Participant is, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
Factors Influencing Flu Vaccination in Primary Health Care

This study aims to study the barriers to flu vaccination among at-risk people at the Primary Health Care level in order to increase the vaccination rates as recommended by the World Health Organization.

People from vulnerable groups (e.g., those diagnosed with Diabetes, Chronic Obstructive Pulmonary Disease, Asthma) are at increased risk of developing complications from infection with influenza virus, that could ultimately result in death.

Flu vaccination is recommended by many authorities, including the World Health Organization, as a means to decrease the risk of developing such life-threatening conditions. However, vaccination rates are well below the recommended threshold.

Eligibility Criteria:
Inclusion Criteria:

* People 65+ otherwise healthy;
* Patients of any age diagnosed with at least one of the following conditions: Diabetes, Asthma, COPD, Coronary Disease or Hearth failure;
* No history of flu vaccination in the previous year.

Exclusion Criteria:

* Patients who have been vaccinated against the flu but who have no record of it in the clinical records;
* Patients with contraindications to flu vaccination;
* Patients that cannot be reached either by phone or letter.
Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study

A case-control study will evaluate the clinical utility of the Congo Red test GV-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period

A case-control study (n=150) will evaluate the clinical utility of the Congo Red test GV-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period. Women with preeclampsia (n=100) (cases) and clinically healthy women (n=50)(controls) who are hospitalized postpartum will be recruited for the trial. All women will be asked to provide a urine sample. Samples will be collected daily during a woman's hospitalization. The Congo Red test GV-005 and a standard urine dipstick proteinuria test will be performed by a lab technician within 72 hours of sample collection. The purpose of this research is to evaluate progression of urine congophilia postpartum by following patients diagnosed with preeclampsia and clinically healthy women.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum
* Clinical diagnosis of preeclampsia (severe, mild or superimposed) including eclampsia (n=100) OR Clinically healthy (n=50)
* Eligible to consent for research
* Agree to comply with study procedures
* Able to give informed consent

Exclusion Criteria:

* None
Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes

In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.

Intensive medical management will include

1. VLCD
2. Physical activity
3. Exenatide
4. Metformin
5. Insulin detemir

Eligibility Criteria:
Inclusion Criteria:

Type 2 Diabetics with

1. BMI ≥ 27.5 kg/m2
2. HbA1c 7-10%
3. Age 20-70 years

Exclusion Criteria:

1. Prior gastric surgery
2. Pregnancy and lactation
3. renal disease (GFR \< 60 ml/min)
4. Pancreatitis
5. Symptomatic gallstone disease
6. Active malignancy
7. Secondary causes of obesity ( Cushing's syndrome, uncontrolled Hypothyroidism)
8. Severe psychiatric illness
9. Allergic reaction to exenatide
Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis

Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenosis or occlusions in the superficial femoral artery (SFA) may result in intermittent claudication or even critical ischemia, which may be treated by balloon angioplasty with or without stenting .

Atherosclerotic disease in the femoropopliteal (FP) artery consists of perfusion to the legs and feet. Percutaneous transluminal angioplasty (PTA) has been routinely used to manage FP artery disease and is recommended as an alternative to surgical bypass. Recently, newer endovascular approaches such as covered stent, drug-eluting balloon (DEB), drug-eluting stent (DES), or catheter based atherectomy have been introduced as treatment options for FP artery disease. Nevertheless, FP artery-in stent restenosis (ISR) is still a major challenge with endovascular therapy .

Although the use of peripheral arterial stents brought about a dramatic improvement in patients' clinical and procedural outcomes, the long-term outcome of stent implantation remains significantly constrained by the risk of developing in-stent restenosis (ISR) over time.

Advancements in endovascular stent technology have addressed limitations associated with conventional percutaneous transluminal balloon angioplasty in patients with chronic peripheral arterial disease (PAD) of the lower limbs, such as elastic recoil,residual stenosis and flow-limiting dissection . However, a considerable proportion of patients with PAD treated with stenting will require secondary interventions due to in-stent restenosis (ISR), which is particularly common in long and complex lesions ISR refers to loss of luminal volume from an ingrowth of cells, extracellular matrix, and thrombus within the cylinder of the stented artery and 5-mm margins proximal and distal to the stent. ISR has been reported to occur in 18-40% of patients undergoing stenting in the femoropopliteal segment within the first year of treatment .

The treatment of ISR is one of the major challenges in endovascular therapy for PAD. The treatment options for ISR include standard balloon angioplasty with or without repeat stenting (using bare-metal stents, stent grafts or drug-eluting stents), drug-coated or cutting balloon angioplasty, cryoplasty and directional or laser atherectomy .


Eligibility Criteria:
Inclusion Criteria:

- Patients with PAD undergoing peripheral vascular intervention with SFA in stent stenosis for two years from the start of study and has critical limb ischemia.

Exclusion Criteria:

* Refusal of the patients