cyrilzakka/clinical-trials huggingface dataset:
FET-PET Directed Simultaneous In-field Boost for Primary GBM

The combination of anatomical MRI examination with functional examination of tissue metabolic activity such as FET-PET (PET using the radiotracer - 18F-fluoro-ethyl-tyrosine) is a valuable tool to determine the actual tumor infiltration. The FET-PET examination can be performed using the dual-time point aqusition of FET for exact treatment planning. It has also been proven that using the dual FET-PET method, it is possible to obtain a precise image of the glioblastoma infiltration corresponding to the location and shape of the recurrence, and the tumor volumes in dual FET-PET are significantly larger than in MRI. Moreover, tumor defined in dual FET-PET is different than that of the tumor defined in single FET-PET acquisition.

In the DualFETboosT trial we plan to assess the safety and preliminary efficacy of hypofractionated irraditon using simultaneous in-field boost directed on dual FET-PET based tumor volumes for treatment of primary glioblastoma multiforme with concomitant temozolomide.

In the case of the treatment of glioblastoma multiforme, as a standard, radiotherapy lasts 6 weeks, and the extension of treatment may adversely affect the tumor cells death, the patient's well-being and treatment costs (prolonged hospitalization). In turn, escalating the dose may increase the toxicity of radiation therapy by increasing DNA damage in healthy brain tissue. Using of dual FET-PET images for treatment planning allow to reduce volumes of healthy tissue irradiated. Dose-intensification proposed in the study using simultaneous in-field boost allows the dose escalation without increasing the overall treatment time. All patient will be treated with moderately hypofractionated radiotherapy (2.6 Gy per fraction) directed on PET positive volumes and conventional fractionation (60Gy in 30 fractions) on tumor margin.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological confirmation of glioblastoma (WHO grade IV)
* Age between 18-75 years of age
* General condition according to the Zubrod scale 0 or 2
* The results of the blood counts are normal
* Liver enzyme parameters normal
* The results of the parameters of the patient's functions are normal
* Informed consent to participate in the category

Exclusion Criteria:

* Coexistence of another cancer
* The location of the tumor in the area of the brain stem or cerebellum
* Prior brain radiation therapy
* No uptake visible in the FET-PET imaging
* Contraindications for MRI
* Contraindications to radiotherapy or chemotherapy
* Pregnancy, lack of consent to the use of protection against pregnancy, puerperium
* Alcohol addiction
* Mental illness
* Claustrophobia
Combined Use of a Novel Cardioplegic Formula With Myocardial Protection System (MPS)® Versus Cardioplexol ® in Isolated Coronary Artery Bypass Grafting (CABG) Using MiECC;

Combined use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).


Eligibility Criteria:
Inclusion Criteria:

* CABG using MPS® or Cardioplexol ®

Exclusion Criteria:

* use of other colloid solution than Cardioplexol ® or MPS®
* other inventions than CABG
* myocardial infarction \<7 days before CABG
* patients denial of data use
The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels

To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction,test is made by random double-blind controlled.patients with acute cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin group,and health people. The main indexes are the serum level of VEGF, MMP-9 and EPC.The review is made by the reference to NIHSS and so on. So, Erigeron Injection have the function of promoting angiogenesis in multiple targets through this test.

OBJECTIVE:

To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction.

METHOD:

40 patients with acute cerebral infarction(in accordance with the inclusion criteria) were divided randomly into erigeron injection+aspirin group,aspirin group,and 20 health people. Erigeron injection+aspirin group and aspirin group drew peripheral blood on the prior treatment,the posttreatment 1th, 3th and 7th day,and tested the level of VEGF, MMP-9 and EPC.Tested the health people one time.

Eligibility Criteria:
Inclusion Criteria:

* patients aged no younger than 18yrs
* attack within 72 hours
* NIHSS score in the 2-25 points
* Ischemic Stroke occurred for the first time, or with a history of stroke disease but without sequelae
* Signed the informed consents

Exclusion Criteria:

* patients aged younger than 18yrs
* Patients with tumor, coronary heart disease, valvular heart disease, psoriasis, rheumatism, hematologic diseases, infertility, varieties of acute inflammation
* Patients with severe cognitive impairment
* Refused to cooperate or been unable to cooperation for neurological disorders
* Cerebral hemorrhage or hemorrhagic cerebral infarction
* Unstable vital signs dued to massive cerebral infarction
* Patients with serious heart, liver and renal insufficiency
Intestinal Inflammation in CF Patients

Cystic Fibrosis (CF) is a disease that affects salt and water transport in multiple organs. Many CF patients suffer from abdominal pain and this could be due to intestinal inflammation. However, so far we do not know how many of the CF patients actually do have intestinal inflammation when looking at intestinal specimens. There is a proven connection between chronic inflammation and developing colorectal cancer and over the years more CF patients are developing colorectal cancer. Thus, it becomes increasingly important to look for the presence of intestinal inflammation in CF patients since early treatment may improve their symptoms and reduce the risk for colorectal cancer.

The aim is to determine the prevalence of intestinal inflammation by measurement of fecal calprotectin and/or histological evaluation of intestinal tissue biopsies in both pediatric and adult CF populations.

Pediatric CF population (Age 10-18 years):

1. Determine the prevalence of intestinal inflammation in a cohort of pediatric CF patients based on fecal calprotectin levels in stool samples.
2. Assess the correlation between fecal calprotectin and abdominal symptoms/QOL.

Adult CF population (Age ≥ 18 years):

1. Determine the prevalence of intestinal inflammation in a cohort of adult CF patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples

   1. in adult CF patients who have not undergone lung or liver transplantation.
   2. in adult CF patients who have undergone lung or liver transplantation.
2. Assess the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult CF patients.
3. Assess the correlation between histological-proven intestinal inflammation and abdominal symptoms/QOL as well as the correlation between fecal calprotectin and abdominal symptoms/QOL.

Eligibility Criteria:
INCLUSION CRITERIA ;

Pediatric cohort:

1. Diagnosis of CF
2. Informed consent obtained
3. Age 10-18 years

Adult cohort:

1. Diagnosis of CF
2. Informed consent obtained
3. Age ≥ 18 years
4. Patient undergoing a colonoscopy for a clinical indication

EXCLUSION CRITERIA ;

Pediatric Cohort:

1. Patients with the diagnosis of IBD.
2. Patients during an episode of acute gastroenteritis or a pulmonary exacerbation.

Adult cohort:

1. Patients with the diagnosis of IBD.
2. Any health condition, e.g. coagulopathy, sepsis, severe bacterial colitis that would increase the risk for perforation or bleeding when taking intestinal tissue biopsies.
Digital Single Session Intervention for Youth Mental Health

The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.

There is a massive unmet need for youth mental health care in America; only ¼ of youth in need receive services. The problem has been underscored and exacerbated by the pandemic. The need for child and adolescent mental health care, particularly for depression and anxiety, has surged while clinician availability and clinic funding have shrunk. One result is that clinic waitlists, always lengthy, have stretched, with youths and families who seek care waiting for up to 12 months for a first appointment, and many giving up and dropping out before the much-delayed appointment. There is a clear need-in both pandemic and normal times-for efficient mental health support that can be provided when need is acute, to sustain young people through periods of delayed access, and to reduce burden for professionals. Fortunately, recent evidence shows the surprising potential of brief, low-cost, digital interventions that could go a long way toward bridging the need-to-access gap. Single-session interventions have substantial effects, in some cases rivaling effects of full-length in-person psychotherapy. Remote therapies for youth mental health problems are beneficial on average and approximately as beneficial as in-person psychotherapy.

The current trial will test a brief (one 30-45-minute session), online, interactive mental health and behavior change intervention for adolescents (9-17 years old), who have been placed the waitlist for outpatient treatment at participating mental health clinics in the United States. Previous RCTs show beneficial effects of the principle of Practicing the Opposite (PTO) on youth mental health when using the therapeutic elements present in PTO (e.g., exposure, to overcome anxiety; behavioral activation, to overcome depression). The single-session PTO intervention uses stories, interactive activities, and engaging graphics to teach youths a key principle: by practicing the positive opposite of unhelpful behaviors, one can, over time, change their emotions thoughts, and actions.

Eligibility Criteria:
Inclusion Criteria:

* Youth/family has contacted a participating outpatient clinic to seek mental health care, and is placed on the waitlist.
* Youth is between the ages of 9-17 years (inclusive) at the time of study enrollment.
* Youth and at least one guardian consent to the youth's participation in study.
* Youth reads English well enough to effectively complete the digital programs (defined as taking classes in English, as opposed to ESL classes).
* Youth has access to a digital device.

Exclusion Criteria:

* Youth is non-English speaking, as the program is only available in English.
* Youth does not have access to a digital device.
Effects of Pregabalin on Pain After Total Knee Arthroplasty

Total knee arthroplasty can cause severe postoperative pain, and patients typically receive oral opioid analgesics for over 2 weeks. Side effects of pain management may impair participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems that pregabalin is very helpful to patients after total knee arthroplasty. However, pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses may not be effective, but use of high doses may increase the incidence and severity of side effects.The purpose of this study is to determine which dosage of pregabalin is the most effective at reducing pain after knee surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
* Age 18 to 80 years old
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
* Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

* Patients younger than 18 years old and older than 80
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Patients with hepatic (liver) failure
* Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance \< 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr \< 30 mL/min, CLcr=\[(140-age (years)\] x weight (kg)x0.85 (for female patients)/\[72xserum creatinine (mg/dL)\])
* Patients with difficult to manage diabetes mellitus, including insulin-dependence
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with major prior ipsilateral open knee surgery.
* Chronic neurontin/lyrica use
Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit

In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute lung injury, and acute respiratory distress syndrome. There are some questions on the oxidative stress of the critical illness. First, the investigators want to search out the effects of the past history, smoking, alcohol drinking, use of antioxidants, different diseases, and different duration of SIRS on the degree of oxidative stress. Second, besides total count of ROS, the investigators used new techniques to determine superoxide(O2●-), hydrogen peroxide (H2O2), and hypochlorous acid(HOCl). Furthermore, we want to investigate the correlation of the degree of different reactive oxygen species and the severity of SIRS or shock. Third, we try to investigate the correlation between the change of oxidative stress and the prognosis of the patients.

The investigators wish this study will help them to investigate the effect of oxidative stress on critical ill patients, to modulate the oxidative stress, to decrease the occurrence of SIRS, shock, and multiorgan failure, and to improve the long term outcome of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y/o
* Admitted to surgical ICU

Exclusion Criteria:

* Patients with brain death
The Utility of Nexium in Chronic Cough and Reflux Disease

The purpose of this research study is to investigate different doses of proton pump inhibitors in reducing cough symptoms felt to be associated with Gastroesophageal reflux disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by lowering the amount of acid in the stomach.

The proton pump inhibitor used in this study is called, Esomeprazole (brand name Nexium), and is already marketed for treating GERD. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation), belching and coughing. Even very small, unnoticeable amounts of rising stomach acid may cause patients to cough.

Because there may be a link between chronic cough and GERD, study doctors are interested in learning if giving high-dose Nexium (40 milligrams, twice daily) will help in treating chronic cough.

This study will be a randomized, double-blind, placebo controlled, comparative parallel-group trial of subjects with chronic cough of unknown origin presenting to the Otolaryngology/ Head and Neck Surgery, Pulmonary Medicine, and Gastroenterology outpatient clinics at the University of North Carolina Hospital system.

Potential subjects with chronic cough of unknown origin will be identified through the above outpatient clinics. Those who meet the inclusion and exclusion criteria will be asked to join the study testing the efficacy of twice daily esomeprazole 40 mg taken for 3 months in the setting of chronic cough. Potential subjects will be consented for the study prior to leaving the enrolling clinic. A total of 40 subjects will be recruited into our study.

Eligibility Criteria:
Inclusion Criteria:

1. males and females (of non-childbearing potential. ie-surgically sterile, or willing to use an approved form of birth control) between the ages of 18 and 70 who speak and write in English,
2. chronic cough (\> 8 wks/another article used \> 6 wks) with symptom severity criteria of 2 or greater on the Fisman Cough Severity Score and 3 or greater or the Fisman Cough Frequency Score, and,
3. failure to respond to post nasal drip therapy.

Exclusion Criteria:

1. abnormal chest x-ray,
2. patients taking H2 blockers within the previous 3 days or PPI's within the previous 7 days,
3. failure to respond to past PPI therapy given for cough that lasted at least 12 weeks,
4. use of an investigational drug within the past 30 days,
5. previous surgical antireflux or non-surgical endoscopic anti-reflux procedure (ex., Stretta or endoscopic sewing device),
6. previous aerodigestive malignancy,
7. current smokers, or ex-smokers (defined as those who quit smoking less than 3 months prior to study enrollment or those who have quit, but have a 20 pack year smoking history),
8. upper respiratory infection within 8 weeks prior to study enrollment,
9. current use of a B- blocker, ACE-I, or anticholinesterases at time of enrollment.
Early Mobilisation of Post Cardiac Surgery in Geriatrics.

Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease.

Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications.

After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations.

A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B).

Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises.

A total of 100 geriatric patients-69 men and 31 women-who had undergone heart surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B). The patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group

Eligibility Criteria:
Inclusion Criteria:

Individuals who had previously had valve replacement procedures or coronary artery bypass grafting (CABG) and if all of these procedures were done by sternotomy were included in the study. The study's patients were all classified as geriatric, with ages ranging from 65 to 75. There were people of both genders in the sample. Throughout their recovery, patients who were awake, conscious, and able to communicate vocally as well as those who were able to understand and complete scales and questionnaires. Patients who signed consent forms voluntarily agreed to participate, as well as those who successfully passed the two-minute walk test (2MWT), which assesses how long it takes to walk for two minutes.

Exclusion Criteria:

* Patients unable to complete the two-minute walk test (2MWT), scales, or questionnaires. Individuals who suffered from stroke, extensive bleeding, renal failure or insufficiency, atrial fibrillation, the necessity for a second operation, or a serious infection of the sternal wound following surgery. Those who struggle with vocal and auditory communication. individuals who underwent surgery and had a pacemaker inserted. those who have experienced a prior cerebrovascular accident. Those who have suffered from neurological disorders like hemiplegia after heart surgery and mental health problems like intellectual incapacity.
Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.


Eligibility Criteria:
Inclusion Criteria:

* 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
* Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
* Histologically confirmed HR+ (ER or PR positive, and \>50% cell in IHC) HER2 negative breast cancer by pathological evaluation
* No other previous treatment for primary breast cancer
* Without other tumor or unstable complication or uncontrolled infection
* No contradiction for the third generation AIs, LHRHa, chemotherapy
* Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

* Metastasis disease by pathological or radiological diagnosis
* the history of other tumor
* contradiction for the third generation AIs, LHRHa, chemotherapy
* Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
* Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
* other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
* have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study
Anesthesia-Related Peroperative Critical Events

Peroperative anesthesia-related critical events (CE) lead to adverse health outcomes in patients. To minimize recurrence of these outcomes, identifying problems causing CEs and obtaining information about their frequency and severity are important. This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system.


Eligibility Criteria:
Inclusion Criteria:

* All patients

Exclusion Criteria:

* intubated outside the operating room
* taken into operation from the intensive care unit (ICU).
Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation

The purpose of this study is to evaluate new computer software on breast magnetic resonance imaging (MRI). The information from this study may help doctors and scientists develop better ways to find breast cancer, and may help future patents with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients over the age of 21 undergoing a diagnostic Breast MRI.

Exclusion Criteria:

* Patients who would be normally excluded from undergoing an MRI examination
* Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* Patients under the age of 21.
* Female patients who are pregnant.