cyrilzakka/clinical-trials huggingface dataset:
Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis

Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction. However, irreversible myocardial damage, such as replacement fibrosis, leads to increased morbidity and mortality despite treatment. Improved patient selection and timely treatment is thus warranted. T1 mapping, a non-invasive method to quantify myocardial fibrosis by cardiac magnetic resonance (CMR), could be a marker to guide treatment.

Aims: To investigate the change of myocardial fibrosis\* in AS patients following AVR and if these changes are associated with disease and/or procedural characteristics.

Methods: This is an observational clinical trial. Approximately 60 patients with severe AS planned to undergo AVR (either surgical or transcatheter) at Rigshospitalet, Denmark will be included. Participants will undergo CMR before surgery and at a 1-year follow-up. Other assessments include clinical evaluation and blood sampling. The primary end-point is change in T1 values after AVR.

Hypotheses and perspectives: The investigators hypothesize that (1) myocardial fibrosis\* will regress in patients undergoing AVR as a group, (2) the degree of myocardial fibrosis is positively correlated with the degree of symptoms, (3) the regression of myocardial fibrosis is greater in patients undergoing TAVR compared to SAVR, and (4) the regression of myocardial fibrosis is greater in patients with tricuspid aortic stenosis compared to bicuspid aortic stenosis. Ultimately, T1 mapping is a potential marker for improved patient selection for the timing of AVR.

\* Estimated by T1 mapping


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Severe aortic valve stenosis (Vmax \> 4 m/s and/or mean gradient \>40 mmHg)

Exclusion Criteria:

* Reduced left ventricular ejection fraction (\<50%)
* More than mild left-sided valvular insufficiency
* Previous or planned primary coronary intervention (PCI) or coronary artery by-pass grafting (CABG)
* Persistent atrial fibrillation
* Contraindications for CMR (pregnancy, severe claustrophobia, magnetic metallic implants)
* Pacemaker/ICD
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study

The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs


Eligibility Criteria:
Inclusion Criteria:

* Candidates will come from the investigator's general ICD population who meet any of the accepted indications for an ICD implant according to the "ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death" (Zipes et al., JACC Vol. 48, No. 5, Sept. 2006:1064-1108).

Exclusion Criteria:

* Ventricular tachyarrhythmia that may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes
* Incessant tachyarrhythmia
* Implanted pacemaker
* Primary disorder of bradyarrhythmia or atrial tachyarrhythmia
* Of minor age
* Pregnant
* Participating in another clinical study
A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment

This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.

This study will be conducted in patients with type 2 diabetes mellitus and mild to moderate renal impairment who have inadequate glycemic control on an exercise program and stable diet, or one oral hypoglycemic agent.

The severity of the reduction in renal function in each subject will be classified according to the glomerular filtration rate (GFR) estimated using the Japanese GFR estimation equation. Subjects will start with a screening period, followed by a single-blind placebo run-in period, and will be randomized to the ASP1941 groups or the placebo group at a ratio of 2:1. For randomization, subjects will be stratified according to the severity of the reduction in renal function. In a treatment period, subject will receive study drug or placebo for 24 weeks under double-blind conditions.

At 24 week, subjects who are willing to continue participation in the study will receive study drug for another 28 weeks in an open label condition. ASP1941 can be increased. After completion of the study drug administration, a follow-up period will be provided.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus patient
* subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)
* estimated GFR value based on the Japanese GFR estimation equation of ≥ 30 mL/min/1.73 m2 and \< 90 mL/min/1.73 m2
* HbA1C value between 6.5 and 8.5%
* body mass index (BMI) 29.0 - 45.0 kg/m2

Exclusion Criteria:

* type 1 diabetes mellitus patients
* proliferative diabetic retinopathy
* subject has received insulin within 12 weeks before the study
* subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic
* serum creatinine \> upper limit of normal
* proteinuria (albumin/creatinine ratio \> 300mg/g)
* dysuria and/or urinary tract infection, genital infection
* significant renal, hepatic or cardiovascular diseases
* severe gastrointestinal diseases
Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery

The purpose of this clinical trial is to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery.

The investigators are proposing a developmental interdisciplinary pilot study to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery. This study (a follow up to smaller pilot studies) will serve as a means to further develop a treatment protocol and to generate an accurate effect size for a full scale trial. The present study will constitute a development clinical trial with a primary aim of developing an effect size for smoking cessation at the time of surgery (7-day point prevalence abstinence), and a secondary aim of creating an effect size for long-term abstinence at 3 months post-surgery.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 or older
2. smoking ≥ 1 cigarettes per day
3. CO \> 6 ppm
4. diagnosed with or suspicion of any type of operable thoracic, head and neck, breast, or gynecologic cancer
5. agreement on a 2-5-week pre-surgical tobacco intervention by both patient and surgeon, and 6) residence within reasonable driving distance to New Haven.

Exclusion Criteria:

1. unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
2. unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days
3. pregnant or breastfeeding women
4. those with limited decision making capacity.
Ketogenic Diet vs.Antiepileptic Drug Treatment in Drug Resistant Epilepsy

This is an open randomized controlled study in children with mental retardation and refractory epilepsy in which treatment with ketogenic diet (KD) is compared with treatment with the antiepileptic drug (AED), not tried by the patient before, which we consider to be the most appropriate AED for the patient.

There are two trials in the study:

* To compare the effect of the ketogenic diet with the effect of the most appropriate AED after 4 months
* To evaluate the effect of the ketogenic diet after 4 and 13 months on the children who have been randomized to this treatment, the seizure frequency is compared with the frequency before start of treatment

Eligibility Criteria:
Inclusion Criteria:

* The patient is mentally retarded
* The patient has tried at least 3 different AED:s including one combination with two or more different AED:s.
* The parents are willing to include their child in the study after written and verbal information.
* Patients with all types of epilepsy can be included.
* The patient has at least 6 seizures/month.
* The patient is submitted to our epilepsy center.
* The seizures are possible to count
* The patient has either generalized epilepsy, multifocal epilepsy or an epilepsy where it is undetermined whether it is localized or generalized such as Dravet syndrome classified as G40.3-G40.9 in ICD X.

Exclusion Criteria:

* The family is expected to have compliance problems with treatment and/or seizure registration.
* The hospital which have submitted the patient is not willing to accept the inpatient stays and the procedures that are necessary for the project.
* The patient's seizures are under acceptable control.
* The patient has got a vagus nerve stimulator implanted within the last 18 months, has started a new antiepileptic drug within the last 2 months or has changed his antiepileptic drugs the last month.
* The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
* The patient has a localized epilepsy classified as G40.0-G40.2 in ICD X.
* The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet.
* The patient has within the last 2 months been using medications or herbal medications that has a considerable effect on glucose metabolism, such as oral glucocorticoids.
* The patient has within the last 2 months been using medications or herbal medications that has a considerable effect on metabolism of AED:s.
* The patient uses herbal medicine which can interact with AED or Ketogenic diet.
Whole-body MR in Staging Bone and Soft Tissue Metastases in Breast Cancer Patients(MetaMaRBo)

Prospective MR-imaging study : role of magnetic resonance (MR) and Diffusion weighted imaging (DWI) MR in staging and therapy assessment in breast cancer patients with bone metastases.

About 50 patients with a proven breast cancer and bone metastases will be included.

First step : staging

* nuclear bone scan
* Positron Emission Tomography (PET/CT)
* MR (whole body short tau inversion recovery (STIR)-sequence and T1-sequence and Diffusion weighted imaging (DWI),no contrast administration

Aim :

* Validation of whole body diffusion weighted imaging in detection of bone metastases and visceral metastases, comparing to Bone scan en PET/CT results.
* To calculate cut-off values for DWI for bone and visceral metastases.

Second step : therapy follow-up/therapy assessment.

* Two groups of patients (oncologist takes the decision about therapy)

  1. Patients treated by chemotherapy
  2. Patients treated by hormonal therapy
* on week 3, 12-16 and 52 in the chemotherapy or hormonal therapy-setting, a whole body MR (same protocol, no contrast) will be performed.

End-point:

Whole body MR with DWI is useful and reliable to assess the treatment response.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a proven breast cancer (by biopsy or imaging)
2. Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.
3. Patient with an informed consent.

Exclusion Criteria:

1. Patients with a single bone metastasis treated by Radiotherapy will be excluded.
2. Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).
3. Claustrophobia
4. Patient in a bad general condition.
Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.

China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease

To estimate the overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment This will be a multicenter prospective observational study carried out in China. Investigator will collect data in a pre-specified Case Report Form from the outpatient. Informed consents will be needed. Investigator will provide patient diary card to each patient for them to note down the symptom frequency every day. Main data from each outpatient will include demographics, Gerd Q, symptom frequency and Proton Pump Inhibitor empirical treatment. Data from each outpatient will be collected on the screening day, 2 weeks and 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female or male, and any race, Age ≥ 18 years and≤ 65 outpatients.
* Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.
* GerdQ≥8
* The subject will not have endoscopy within 4 weeks after enrolment.
* Ability to provide informed consent, adhere to the study visit schedule, and complete all study assessments and complete the patient diary by his/herself.

Exclusion Criteria:

* If participating in any interventional clinical trial.
* Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia, hematemesis, melena).
* Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive drug within 2 weeks before screening.
* The need for H2-receptor antagonists (H2RA) including cimetidine, ranitidine and famotidine or sucralfate, antacids, traditional Chinese medicine and prokinetics during the upcoming 4 weeks (study duration).
* Previous gastroesophageal surgery.
* Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.
* Peptic ulcer
* Diabetes
* Cerebral vascular disease
* Zollinger-Ellison syndrome
* Scleroderma
* Hiatus hernia women
* Pregnant or lactating women
* Any other subjects were not suitable to this study in the opinion of the investigator.
Linkage of Medicaid Enrollment Information to Surveillance, Epidemiology and End Results Data

Background:

The SEER database collects data about people with cancer. SEER stands for Surveillance, Epidemiology, and End Results. Medicaid is a kind of health insurance. It is for people who have low income or serious medical needs. Many studies have shown that Medicaid recipients with cancer are more likely to be diagnosed later in the disease than people with other insurance. They are also less likely to get treatment. Researchers want to compare Medicaid data and SEER data. They want to make this available to other scientists.

Objectives:

To link people in the SEER database to Medicaid data for the years around their cancer diagnosis. To create a file that contains SEER case numbers linked to Medicaid numbers.

Eligibility:

No people are enrolled in this study.

Design:

The SEER finder file will be securely uploaded to the CMS Data Center.

The finder file will be matched against the Medicaid Personal Summary file at the CMS Data Center.

If participants appear in both the SEER file and Medicaid file, their data will be extracted.

The dates of Medicaid data will be compared with the SEER date of diagnosis. Researchers will see if the Medicaid dates fall in certain periods. These are 12 months before, the month of, and 11 months after diagnosis.

If participants are eligible for Medicaid for these periods, a flag will be created in the file. It will note the participants is eligible and why.

The SEER finder file will be destroyed.

The only data saved will be:

Each participant's unique random SEER case number linked to their Medicaid number

Monthly flags about Medicaid eligibility

Numerous studies have demonstrated that Medicaid recipients with cancer are more likely to be diagnosed at an advance stage and less likely to receive recommended treatment than are patients with other types of health insurance. The objective of this project is to link persons included in the Surveillance, Epidemiology and End Results (SEER) data to Medicaid enrollment information during the year before and after their cancer diagnosis. NCI is also seeking permission to create and maintain a file that crosswalks each patient's SEER case number to their Medicaid enrollment number. Information about Medicaid enrollment would be available by special request to all researchers who want to use SEER data to assess the impact of Medicaid enrollment on stage and treatment.

Eligibility Criteria:
* INCLUSION:
* Cancer Diagnosis
* Medicaid Member
* Registered within the SEER Program

EXCLUSION:

-None
Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly

ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

* age 65+
* at risk of malnutrition/ malnourished

Exclusion Criteria:

* • Mental status that is incompatible with the proper conduct of the study

  * Illness of such severity that life expectancy is considered to be less than 12 months
  * Use of diabetes medication (e.g. insulin, methformin)
  * Use of an oral nutritional supplement in the previous three months
  * Participating in any regular exercise training program (≥2h/w)
  * Renal insufficiency (eGFR \<30 mL/min/1.73 m2)
  * Unstable organ failure or organ failure necessitating a special diet
  * Chronic corticosteroids use
  * Recent (previous 2 months) use of antibiotics
  * Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin)
  * Recent blood donation (\<1 month prior to Day 01 of the study)
  * Not willing or afraid to give blood during the study
  * Allergic or sensitive for milk proteins
  * Reported vegan or macrobiotic life-style
  * Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week)
  * Individual unable to give informed consent
  * Current participation in other research from the Division of Human Nutrition
  * Not having a general practitioner
  * Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
Evaluate the Efficacy and Safety of MUSK Pill on Coronary Microvascular Dysfunction

Objective to evaluate the effect of Shexiang Baoxin Pill on myocardial ischemia in patients with coronary microvascular dysfunction (non obstructive coronary heart disease) through a randomized, double-blind, placebo-controlled clinical multicenter study.At the same time, the effects of exercise tolerance and quality of life were also observed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-80, male or female;
2. Selective coronary angiography or coronary CTA showed that the diameter of coronary artery ≥ 2.5mm, the degree of stenosis \< 50%, without myocardial bridge;
3. They were able to perform treadmill exercise, and the treadmill test (EET) was positive;
4. Angina pectoris was found;
5. Patients are willing to follow up and sign informed consent; All the above criteria should be met.

Exclusion Criteria:

1. Coronary heart disease complicated with hypertrophic cardiomyopathy;
2. There was a history of AMI, PCI and CABG, and myocardial bridge was found by angiography or CTA;
3. Patients with severe medical diseases (liver, kidney, hematopoietic system and other serious primary diseases, etc.);
4. Mental disorders and mental diseases;
5. Patients with pulmonary failure and NYHA heart function grade III-IV, unable to carry out exercise test;
6. Contraindications of Shexiang Baoxin Pill: forbidden for pregnant women;
7. Those who have known history of allergy to Shexiang Baoxin Pills;
8. Recently, the patient has taken Shexiang Baoxin Pill and other anti ischemic traditional Chinese medicine regularly, or it contains borneol, toad venom and other ingredients in Shexiang Baoxin Pill;
9. Combined with frequent ventricular premature beats, ventricular tachycardia, atrial fibrillation, sinoatrial block, atrioventricular pathway block, left bundle branch block and right bundle branch block, which may affect the judgment of exercise ECG results;
10. Researchers think that there are other factors that are not suitable to participate in the trial; If one of the exclusion criteria is met, it can be excluded.
The Effect of Non-Surgical Periodontal Treatment on Bone Metabolism in Type 2 Diabetes and Systemically Healthy Individuals

In this study, it was concluded that sclerostin and irisin may be alternative markers for evaluating the effectiveness of periodontal treatment and healing of periodontal tissues by affecting bone metabolism.

Background: Diabetes and periodontitis are chronic inflammatory diseases with similar pathogenesis and clinical and immunological interrelationships. The aim of this study is to determine periodontal clinical parameters and sclerostin, irisin, Receptor Activator of Nuclear Factor κB Ligand (RANKL)/Osteoprotegerin (OPG), interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels in gingival crevicular fluid (GCF) in individuals with type 2 diabetes and systemically healthy periodontitis and to evaluate the effect of non-surgical periodontal therapy on these clinical parameters and biomarkers.

Method: Within the scope of this study, applying to Necmettin Erbakan University Faculty of Dentistry Periodontology Clinic; A total of 50 individuals, including 25 patients with type 2 diabetes and periodontitis (DMP group) and 25 patients with systemically healthy and periodontitis (SSP group), were included in the study. After recording the clinical periodontal parameters (gingival index (GI), plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL)) of each individual included in the study, GCF samples were obtained and non-surgical periodontal therapy were completed. The individuals were invited to the controls 3 months later and the procedures for clinical periodontal measurements and DOS samples collection were repeated. Levels of biomarkers in DOS samples were determined by ELISA (Enzyme Linked Immunosorbent Assay) method.

Eligibility Criteria:
Inclusion Criteria:

* Having at least 20 teeth in the mouth, excluding the third molars,
* Individuals between the ages of 18-65
* Diagnosed as stage 2 or stage 3 periodontitis as a result of periodontal examination
* Those who do not have predisposing factors (restoration, caries, etc.)

Exclusion Criteria:

* Smoking or using alcohol,
* Any periodontal treatment performed in the last 6 months,
* Being in pregnancy and/or lactation period,
* Individuals who had received any anti-inflammatory, antibiotic, antioxidant or corticosteroid treatment in the last 6 months and refused to participate in the study were excluded from the study.