cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

The aim of this study is to evaluate if the multi modality treatment pemetrexed combined with cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* cytological or histological proven NSCLC
* unresectable stage III NSCLC
* presence of at least one measurable lesion (RECIST criteria)
* adequate haematological, renal and hepatic function
* adequate lung function reserve
* good condition, weight loss \<10 % over previous 6 months, life expectancy \> 3 months

Exclusion Criteria:

* previous chemo- or radiotherapy for NSCLC
* distant metastasis or a malignant pleural or pericardial effusion
* second active primary malignancy or serious concomitant medical disease
* interstitial lung disease
* auto-immune systemic disease with potential involvement of the lungs
* inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period
* concomitant use of amiodarone
Bed Rest, Alternate Daily Fasting and Incretin Effect

Bed rest produces insulin resistance in healthy volunteers. In this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest.

The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need).

The investigators hypothesize:

1. Bed rest reduces the incretin effect
2. Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet
3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet

All subjects will undergo 8 days of bedrest. Outcome measures will be performed before, under and immediately after the bed rest period.

The individual study period will be 10 days in total.

Eligibility Criteria:
Inclusion Criteria:

* BMI\<25kg/m2
* VO2 max normal for age

Exclusion Criteria:

* Tobacco smoking
* Alcohol ingestion \> 14 units per week
* Diabetes in nearby relatives
* Resection of the small intestine
* History of gastric bypass surgery
* Risk of deep venous thrombosis
* Female
COVID-19 and Venous Thromboembolism Risk

Coronavirus disease 2019 (Covid-19) is now a leading cause of death among U.S. adults. In addition to profound respiratory and multi-organ failure, hypercoagulable states and venous thromboembolism (VTE) have been increasingly reported in patients with severe Covid-19. The aim of this study is evaluate the risk of VTE related to Covid-19 infection in a real-world community-based population.

This is an observational study of adult (age ≥18 years) members enrolled in the Kaiser Permanente Northern California (KPNC) or Kaiser Permanente Southern California (KPSC) integrated healthcare delivery systems during the time period January 1, 2020 through January 31, 2021, (representing the first year of the Covid-19 pandemic) and diagnosed with incident Covid-19. The outcomes will be incident VTE and all-cause death, assessed through February 28, 2021. The primary analysis will describe the rate of post-Covid-19 VTE after index diagnosis. A second analysis will compare the risk of VTE in hospitalized patients with Covid-19 compared with matched hospitalized controls without Covid-19.

Eligibility Criteria:
Inclusion

* Covid-19 diagnosis (defined as date of a positive laboratory test for SARS-CoV-2 virus) during the time period January 1, 2020 to January 31, 2021
* Age \>=18 years
* Continuous pharmacy benefits and health plan membership for at least 12 months before the index date

Exclusion

• incomplete information on age and sex
Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus

The purpose of the study is to investigate different stimulation parameters for a new noninvasive approach for modulating the brain that could potentially be beneficial for decreasing tinnitus perception. The new approach is called Multimodal Synchronization Therapy (mSync). mSync uses a combination of acoustic stimulation played through headphones and low levels of electrical current delivered via electrodes placed on the surface of different body regions. The timing interval between the acoustic and body stimulation is varied in order to cause different types of changes in the brain. In addition to acoustic and body stimulation, noninvasive cortical stimulation will also be presented as part of mSync to attempt to further modulate or decrease the tinnitus percept. Cortical stimulation will be performed by placing a magnetic coil over a spot on the head and sending a brief magnetic pulse that can travel through the skin and bone to create electrical current inside the head. For this study, different body locations as well as specific timing intervals among acoustic, body, and cortical stimulation will be investigated to identify appropriate parameters that can modulate and potentially decrease tinnitus perception. Different mSync parameters will be investigated across multiple testing sessions (up to 16 weekly sessions) and the tinnitus percept will be closely monitored throughout the study.

This study is not specifically seeking to treat tinnitus but is designed to investigate various mSync parameters that can alter the tinnitus percept. Findings from this study will help identify specific mSync parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.

Eligibility Criteria:
Inclusion Criteria:

* Have subjective, non-pulsatile, and bothersome tinnitus
* Will not start any new tinnitus treatment during the study
* Ability to give informed consent and understand study objectives in English
* Willing and able to understand and comply with all study-related procedures

Exclusion Criteria:

* Substantial hearing loss or hyperacusis that may interfere with the study
* Medical history of other ear or brain disorders, history of seizures, or currently using any medication or treatments that can cause or increase the chances of seizures
* Any implanted medical or metal device, such as a pacemaker, aneurysm clip, or cochlear implant
* Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children need extra protection for their safety)
* Any handicap that prevents the subject from reliably performing the tests
Jing Si Herbal Tea in the Treatment of Dyspeptic Symptoms

Dyspepsia refers to chronic or recurrent upper gastrointestinal symptoms. According to the Rome IV criteria, functional dyspepsia (FD) symptoms included meal-related fullness, early satiation, epigastric pain or burning which are unexplained after routine investigation. FD causes substantial psychophysical burden because of its unknown etiology and high prevalence. Although FD is currently associated with local inflammation of the gastrointestinal tract and microbiota alteration, current available treatments for FD are of limited effectiveness. In view of this, many studies have applied Chinese herbal medicine in FD and achieved some therapeutic benefit. The Jing Si Herbal Tea composed of eight native Taiwanese herbs (wormwood, hickory grass, Ophiopogon japonicus, houttuynia cordata, platycodon, licorice, perilla leaves, chrysanthemum) has obtained a special export license from the Ministry of Health and Welfare. The Jing Si Herbal Tea also has been registered in clinical trials as a complementary treatment for COVID-19. The preliminary data demonstrated that the Jing Si Herbal Tea may improve gastrointestinal symptoms and anxiety in patients with COVID-19. Therefore, this study aims to investigate the impact of the Jing Si Herbal Tea on psychophysical burden and metabolites of microbiota in patients with FD through a double-blind randomized manner.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-79 years old.
2. Those who meet the definition of functional dyspepsia (FD). (Functional dyspepsia (FD) is chronic (once a week, lasting at least three months, at least six months before the first symptom) upper gastrointestinal symptoms (any of the following): postprandial abdominal distension, easy to feel full, Epigastric pain or burning sensation in the upper abdomen, and no symptoms of gastrointestinal bleeding or significant weight loss, no abnormality after upper gastrointestinal endoscopy).
3. Be conscious and willing to sign the subject's consent form.

Exclusion Criteria:

1. Abnormal liver and kidney function;
2. Abnormal blood tests and thyroid abnormalities;
3. Have received surgery on the digestive tract;
4. Abnormal upper gastrointestinal endoscopy;
5. Have gastric pylori infection;
6. Antibiotics are being used for infectious diseases;
7. Pregnant or breastfeeding women;
8. Suffering from heart, liver, or kidney failure;
9. Physical weakness, allergies, coldness, chronic diseases, poor kidney function, infants under three years old, children, Pregnancy, lactation, menstrual period.
Special Survey of Production of Insulin Aspart Specific Antibody

This study is conducted in Japan. The aim of this study is to collect data of production of insulin aspart specific antibody under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes requiring insulin therapy

Exclusion Criteria:

* Patients who had a treatment history of NovoRapid® (insulin aspart)
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.


Eligibility Criteria:
Key Inclusion Criteria:

* Genotype 1 or 2 HCV infection
* Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
* Previously treated with a DAA-containing regimen of at least 4 week duration

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Is Monocyte/HDL Ratio a Predictor of Mortality in Aortic Valve Surgery

In this study, the investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and morbidity in patients who underwent aortic valve replacement due to aortic stenosis.

Inflammation is causally associated with both coronary artery disease and aortic stenosis. Although aortic stenosis is considered a static degenerative and calcific process, recent evidence has shown the opposite. The role of inflammation in the pathogenesis of AS It will be investigated that mortality may be associated with increased inflammation in patients treated with AVR.

Adult patients (aged ≥18 years) with ASA II-IV who underwent elective aortic valve replacement under cardiopulmonary bypass (CPB) due to aortic stenosis in our clinic between January 1, 2010 and March 31, 2022, will be included in the study by retrospectively scanned from the computer system and patient cards. The exclusion criteria from the study are as follows; those with signs of acute infection, those with autoimmune disease, those with severe renal (serum creatinine \>2.0 mg/dl) disease, those with severe hepatic disease, those with suspected malignancy.

Demographic characteristics of patients (age, gender, body mass index, diabetes mellitus, hypertension, chronic kidney disease-failure, peripheral vascular disease, smoking history, hyperlipidemia, atrial fibrillation history, left ventricular ejection fraction, coronary artery disease history, Cabg history) Europe Cardiac Operative Risk Assessment System II (EuroSCORE), Systemic Immune-Inflammatory Index (SII), APACHE II, SOFA Score, NYHA III/IV values, drugs used (ASA, oral anticoagulants, beta blocker, statin, ACE inh., ARB) , preoperative glucose, HbA1c, urea, creatinine, total cholesterol, LDL, HDL, triglyceride, hemoglobin, hematocrit, platelet, WBC, neutrophil, lymphocyte, monocytes, monocyte/HDL ratio, CRP, preoperative and postoperative EF and PAB values, ICU admission duration, duration of invasive mechanical ventilation, type of discharge, amount of ES replaced will be recorded. Operation time, cardiopulmonary bypass (extracorporeal circulation) time, cross clamp time, inotropic and vasopressor requirements will be recorded)

Eligibility Criteria:
Inclusion Criteria:

be over the age of 18, ASA II-IV Patients scheduled for cardiac surgery due to on-pomp aortic valve replacement

Exclusion Criteria:

emergency operations, off pump)pumpless surgery, revision (repetitive) operations, those with signs of acute infection, those with autoimmune disease, those with severe renal (serum creatinine \>2.0 mg/dl) disease, those with severe hepatic disease, those with suspected malignancy, patients where data variables cannot be saved due to technical problems.
The Effect of Different Education Methods Before Invasive Urodynamics

Aim: This study was carried out to compare the effects of different education methods utilized before a urodynamic testing procedure on patients' pain, anxiety, readiness for the procedure, and satisfaction.

Background: Urodynamic testing is an invasive procedure that causes pain and anxiety. Patient education is an evidence-based nursing intervention that relieves pain and anxiety and increases patient satisfaction.

Design: The study is a single-center, randomized controlled clinical trial. Method: Participants (n=80) were randomly assigned to four groups. While patients in the control group were provided with routine clinical information, patients in the intervention group were given education with brochures, videos, and brochure-supported videos. The research data were collected by using a Data Collection Form with items about participants' descriptive characteristics, the State Anxiety Inventory, and the Visual Analog Scale.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age,
* Had urodynamics for the first time,
* Had no communication problems,
* Volunteered to participate in the study

Exclusion Criteria:

* Had major hearing, vision, and speech impairments,
* Used antidepressants, or anxiolytic drugs,
* Had an indwelling urinary catheter,
* Used any analgesic in the 24 hours before coming to the urodynamic laboratory
Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) Utilizing Ultrasound and Percutaneous Liver Biopsy

Prospective determination of the prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)in a primary care setting using ultrasound and percutaneous liver biopsy.

Patients between the ages of 18 and 70 years who are eligible for care at Brooke Army Medical Center are considered for enrollment. After obtaining informed consent, a baseline questionnaire is given to patients who present to the Primary Care Clinic for routine clinic visits or during colon cancer screening classes within the Gastroenterology Clinic. The questionnaire includes information about the patient's past medical history to include: known history of chronic liver disease, current medications, current and past alcohol ingestion, dietary habits that included consumption of fructose containing beverages and frequency of fast food visits. Patients are excluded if they are found to have a history of chronic liver disease, HIV, on medications that are associated with a fatty liver, or consumption of more than 20 grams of alcohol per day. Right upper quadrant ultrasound will then be performed to determine if there is evidence of fatty liver disease. All patients with a positive ultrasound for hepatic steatosis are then offered a liver biopsy after obtaining fasting blood work that included a complete blood count, coagulation studies, liver function tests, fasting lipid panel, glucose and insulin. Patients with a negative ultrasound for fatty liver are not referred for liver biopsy and are considered as completed study patients. Serum is also stored for adipokine and cytokine analysis. A study investigator using a 14g Bard Monopty biopsy gun will perform the liver biopsy. A single expert hepatopathologist will review all liver biopsies and utilize the Brunt system (9) for grading and staging of steatohepatitis if present.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 to 70 years of age were recruited from the Primary Care Clinics or the Gastroenterology Clinic at Brooke Army Medical Center. After completing a baseline questionnaire, all patients had a right upper quadrant ultrasound. If fatty liver was identified, then laboratory data and a liver biopsy were obtained.

Exclusion Criteria:

* ETOH consumption over 20 grams/day
* known fatty liver disease, chronic liver disease, HIV, or medication ingestion associated with fatty liver disease
Comparison of Frequency of Use of Optive and Systane

The purpose of this study is subjectively compare duration of action between Optive and Systane.


Eligibility Criteria:
Inclusion Criteria:

* Males or females \> 18 years old
* Mild to moderate dry eye symptoms
* Score of at least 2 and no more than 4 on the SESOD at the initial screening visit
* Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

* Current use of topical cyclosporine
* Known contraindications to any study medication or ingredients
* Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
* Ocular surgery within the past 3 months,
* Active ocular allergies
Yoga in the Treatment of Osteoporosis

The study measures change in bone mineral density by the DEXA scan before and two or more years after beginning ten minutes of daily yoga designed to put pressure on the spine, hips and femur.

After collecting blood and urine samples, and pre-study DEXA scans, qualifying patients are given an entry DEXA scan and a DVD with instructions to advance from beginner versions of 12 Iyengar-style yoga poses to more advanced levels in daily practice for 2 years. fter two years or more, subsequent DEXA scans are recorded. Interested participants are also encouraged to have hip and spine X-rays, and bone quality studies on study entry and two years later. Actual subject participation, intercurrent illnesses, fractures and changes in medication are self-monitored with an on line scorecard, supplemented by emails and/or telephone calls when judged necessary by the PI. Results are calculated by change in bone mineral density in the lumbar spine, hips and femurs by the DEXA scan, changes in osteoarthritis according to the X-rays, and changes in bone quality before and two or more years after beginning the ten minutes of daily yoga. Dose-response relationships between the amount and intensity of yoga practice and bone mineral density and quality are sought. Yoga-related fractures and other adverse effects are also noted.

Eligibility Criteria:
Inclusion Criteria:

* Past DEXA scan and, all within 6 months of study entry, DEXA scan and normal values for: Metabolic panel, TSH, PTH, ESR (or CRP), Vitamin D 25 hydroxy, Vitamin D 1,25 dihydroxy, Urine NTX.

Exclusion Criteria:

* Known metabolic bone disease such as osteogenesis imperfecta, current treatment with steroids, chemotherapy, or currently healing fractures of lumbar spine, hips or femurs.
Improving Insulin Resistance in Gynecological Cancer Patients

This is a research study to see if the addition of cinnamon to a provided food plan would improve insulin resistance in gynecological cancer patients. One study suggests that patients with gynecological cancers are more likely to be insulin resistant and/or have higher levels of fasting insulin. The study will be 24 weeks in length.


Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed with gynecological cancer and has completed all surgical intervention, chemotherapy, and/or radiation at least 3 months prior to enrollment but not greater than 24 months
* post-menopausal
* BMI \> 25 but \< 40

Exclusion Criteria:

* no previous diagnosis of diabetes
* no other cancer diagnosis (excluding skin)
* no chronic use of medication(s) interfering with glucose metabolism
Identification of Preoperative Parameters to Predict Acute Kidney Injury Risk Following Vascular or Digestive Surgery

The study aims to identify the preoperative parameters associated with the risk of postoperative acute kidney injury (in particular the parameters of the SPARK score) in patients of the Besançon University Hospital who have undergone digestive or vascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Digestive surgery or vascular surgery at Besancon University Hospital between 01/01/2019 and 31/12/2019 (retrospective) or between 01/01/2023 and 31/12/2023 (prospective)

Exclusion Criteria:

* No preoperative creatinine value
* Outpatient surgery
* Surgery other than digestive or vascular (organ procurement surgery/nephrectomy surgery/renal transplantation)
* Kidney/urinary tract surgery
* Arteriovenous fistula surgery
* End-stage renal disease or renal replacement therapy, except for renal transplant patients
* Acute kidney injury KDIGO≥1 within 2 weeks before surgery
* Patients in need of emergency surgery for ongoing haemorrhage
* Legal incapacity or limited legal capacity
* Subjects with no social security coverage.