cyrilzakka/clinical-trials huggingface dataset:
FREDO-ODX Study: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy

The aim of this study is to assess the clinical outcomes in real-life setting of early breast cancer RH+ HER2- patients with systemic therapy guided by Oncotype DX (ODX) Breast Recurrence Score®.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old With invasive breast carcinoma diagnosed on biopsy or surgical sample (histological evidence) Operable breast cancer HR+ (at least ER+) /HER2- tumors With ODX assay performed

Exclusion Criteria:

* Inoperable tumor(s) or inoperable patient (e.g., patient too frail to undergo surgery) Synchronous breast cancers with different clinico-pathological features (e.g. : HR+/HER2 negative and triple-negative or HER2-positive breast cancer Patient undergoing neoadjuvant chemotherapy or neoadjuvant hormone therapy Nodal involvement in more than 4 lymph nodes (pN2 or higher) Metastatic breast cancer at diagnosis Other malignancy diagnosed in the past 10 years (except for cutaneous malignancies other than melanoma) The patient participated in the RxPONDER study in France The patient communicated a refusal to participate in the study (via a refusal letter to the investigator) Legal incapacity or limited legal capacity
Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers

Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion.

Phase I Study

* to determine and compare the safety of single ascending doses of POL6326 by intravenous infusion
* to determine the relationship between 2-hour single intravenous infusion doses of POL6326 and the concentration of HSC and mature WBC in peripheral blood using immunophenotypic assays.

Eligibility Criteria:
Inclusion Criteria:

1. Mobilization and collection of hematopoietic stem cells (HSCs) using G-CSF at least 6 weeks but less than 6 months prior to protocol enrollment.
2. Ages greater than or equal to 18 years and less than or equal to 55 years.
3. Normal liver and renal function, normal CBC, normal ECG, normal blood pressure including adequately medically controlled idiopathic arterial hypertension, no other contraindications to mobilized peripheral blood stem cell donation according to WMDA criteria and relevant SOPs at the study site defining additional exclusion criteria for stem cell donation.
4. Subject must be eligible for normal blood donation according to requirements for IDMs as laid out by national law for blood donors.
5. Ability to comprehend the investigational nature of the study and provide informed consent.

Exclusion Criteria:

1. Active infection or history of recurrent infection- hepatitis B and C (HBsAg, Anti-HBc, Anti-HCV), HIV and HTLV-1.
2. History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous.
3. History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin.
4. History of any hematologic disorders including thromboembolic disease.
5. History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias OR related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention OR treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk.
Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma

The prognosis of small liver cancer (≤5 cm) with stereotactic body radiotherapy (SBRT) is encouraging, the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, and 3-year overall survival rate around 70%. So far, there is no randomized controlled study comparing SBRT and surgical treatment for early-stage liver cancer. It is hoped that this study will further compare the efficacy of SBRT and surgery for early stage liver cancer.

Early stage liver cancer, according to Milan criteria, are chose for this study. The patients are divided into two groups randomly. Patients in group A receive laparoscopic hepatectomy, group B patients receive SBRT.The 3-year progression free survival, 3-year local recurrence free survival, 3- year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to surgery.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old and above.
2. Clinical or pathological diagnosis of hepatocellular carcinoma, initial treatment (without surgery, radiotherapy, chemotherapy or targeted therapy).
3. Early-stage hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis.
4. No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency.
5. The neutrophil count is at least 1.0\*10\^9/ml, and the platelet count is at least 50\*10\^9/ml. Hemoglobin is at least 80g/L.
6. Men or women with fertility are willing to take contraceptive measures during the trial.
7. Eastern Cooperative Oncology Group score 0-1 points.
8. Expected survival period \> 3 months.
9. Voluntary participation and signing of informed consent.

Exclusion Criteria:

1. Patients who have undergone chemoradiation or targeted therapy for liver cancer.
2. Recent hematemesis due to portal hypertension.
3. Child-Pugh score ≥10 points.
4. Total bilirubin\>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
5. who was considered unsuitable for surgery after hepatobiliary and pancreas multidisciplinary treatment（MDT） meeting.
6. Patients undergoing major surgery within 1 month of study initiation
7. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years)
8. Researchers consider it inappropriate to participate in the test
Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.

Chronic subdural hematoma (CSDH) is one of the most common neurosurgical conditions, which is considered to be an inflammatory disease. Dietary factors can have an impact on the inflammatory mechanism in human body, which can increase a variety of inflammatory biomarkers in the blood. The risk of malnutrition in the elderly is generally high, and nutritional status can affect the risk of CSDH in the elderly. Little is known about the association of dietary factors with CSDH. The investigators speculate that dietary factors participate in and promote the occurrence and development of CSDH. This study will clarify whether there is a correlation between dietary factors and CSDH, which will reveal the pathogenesis and prevention of CSDH.

Eligibility Criteria:
Case group (CSDH group)

Inclusion Criteria:

* Patients (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
* CSDH verified on cranial computed tomography or magnetic resonance imaging.
* Written informed consent from patients or their next of kin according to the patient's cognitive status.

Control group (Healthy group)

Inclusion Criteria:

* non-CSDH patients (18 years to 90 years) with matched age and gender.
* Written informed consent from patients or their next of kin according to the patient's cognitive status.

Exclusion Criteria for both case and control group:

* Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before.
* CSDH turned from acute subdural hematoma.
* Existing malignant tumors, poor medication condition or severe comorbidity.
* Difficulty in feeding requiring long-term enteral or parenteral nutrition support.
* Dietary and nutritional survey is estimated to be completed difficultly.
* Reproductive-age women without verified negative pregnancy testing.
* Participating in other research.
Does Long-Term Natalizumab (NTZ) Therapy Normalize Brain Atrophy Rates and Quality of Life (QOL) in Relapsing Remitting Multiple Sclerosis (RRMS)?

Primary Aims: To determine how effective long term Natalizumab (NTZ) therapy is in slowing the progression of whole brain atrophy. Whole brain atrophy rates will be measured through magnetic resonance imaging (MRI) scans and compared between patients with Multiple Sclerosis (MS) who have been using NTZ for at least 2 years versus age and gender-matched healthy controls. The primary outcome will be whole brain atrophy rate measured as the percent change in brain volume (PBVC) over a two-year period.

Primary hypothesis:

The investigators hypothesize that long term (\>2 years) NTZ therapy will slow the rate of whole brain atrophy in patients with Multiple Sclerosis (MS) (as measured by percent change in brain volume), reaching a whole brain atrophy rate similar to that of non-MS controls (a true "disease activity free" state).


Eligibility Criteria:
Inclusion Criteria:

* 18-55 inclusive years of age at the time of informed consent
* Diagnosis of relapsing multiple sclerosis as defined by the 2010 revised McDonald criteria
* Currently taking Tysabri

Exclusion Criteria:

* Systemic steroid users
* comorbidities that could confound MRI outcomes
A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)

Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 18 and 60 with mild to moderate asthma
Imagery Vividness and Arousal Responses to Prospective Imagery

Research has shown that mental imagery appears to carry emotion better than verbal communication. One way this can be noted is that emotional mental imagery trigger physiological arousal responses. These may be important for treatment techniques using mental imagery, such as imaginal exposure and imagery re-scripting. However, as the development of clinical applications increasingly considers the use of flashpoint imagery, i.e. mental imagery of short duration, it is of interest to examine whether also flashpoint imagery trigger arousal responses. This study examines the arousal response to flashpoint imagery of different valence (positive, negative, and neutral).

Moreover, emerging evidence suggest that depressed individuals find it more difficult to produce mental imagery of positive future events (less accessible and vivid) than healthy controls. In addition, individuals with clinical anxiety appear to be able to produce imagery of negative future events more easily than healthy controls. This study explores whether these results can be noted also in sub-clinical symptoms of depression and anxiety, and if so, if they are accompanied with corresponding changes in arousal responses.

This study takes part in a single session. Participants will produce flashpoint imagery of future events while skin conductance responses, imagery vividness ratings, valence and arousal ratings are collected. Participants will also fill in questionnaires on depression and anxiety symptoms, as well as a questionnaire measuring general propensity for mental imagery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Fluent in Swedish
* Willing and able to provide informed consent and complete study procedures

Exclusion Criteria:

* Current psychiatric disorder
* Current use of psychotropic medication
Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery

Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.

In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.

With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective coronary artery bypass graft (CABG) surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used
The Effect of Motivational Interviewing-Based Education on Treatment Adherence and Self-Care Agency in COPD Patients

This randomized controlled trial will be conducted to evaluate the effect of education and motivational interviewing on treatment adherence and self-care power in COPD patients.

Hypotheses of the Study; H1: Education and motivational interviewing in COPD patients increase treatment adherence in patients.

H2: Education and motivational interviewing in COPD patients increase self-care power in patients.

There will be two groups in the study: control and intervention groups. Before the intervention, pre-test data will be collected in the control and intervention groups. After the intervention, post-test data will be collected in both groups in line with the data collection forms.

In line with the randomization list, patients will be assigned to the intervention and control groups in line with the inclusion criteria. Pre-test data will be collected face-to-face in the intervention group in accordance with the data collection forms. After collecting the pre-test data, the patient will be allowed to rest for about 10 minutes, and then COPD training will be given to the patient in a single session lasting about 45-50 minutes in line with the training booklet and by evaluating the pre-test data. The education booklet will be given to the patient. On the 3rd day, the first session of motivational interview will be held. On the 5th day and 7th day and 15th day, motivational interview sessions will continue with the patients. During the motivational interview, patients will be supported in line with the training booklet. On the 30th day, the patient will be interviewed face-to-face and post-test data will be collected.

Patients in the control group will be interviewed and no intervention will be made after the pre-tests are applied. Patients in the control group will continue their routine controls. In the final test (1st month), an appointment date will be set with the patient and the final test data will be collected face-to-face.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COPD for at least 6 months
* Admitted to the chest clinic
* No communication problems
* Patients who volunteered to participate in the study.

Exclusion Criteria:

* In the period of exacerbation
* Uncooperative due to dyspnea
* With a malignant disease
* Patients with a confirmed diagnosis of psychiatric illness
Easypod United States User Trial

This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules. Adherence will be compared between a group of subjects who are aware of the injection log on the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™ injection log. It is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. Subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypod™ compared to two other rhGH pen injection devices.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female from 10 to 18 years of age, inclusive, with open epiphyses
* Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6 months
* Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer Genotropin® pen injection device for at least 6 months
* Be willing and able to comply with the protocol for the duration of the trial
* Have access to the Internet
* Be able to read, speak and understand English
* If female of childbearing potential, have a negative urine pregnancy test at Screening and use an acceptable form of birth control during the trial, including abstinence, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide

Exclusion Criteria:

* Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for click.easy® cartridge)
* Severe illness during the previous 6 months
* Active malignancy (except non-melanomatous skin malignancies)
* Diabetes mellitus (type I or II)
* Pregnancy or lactation
* Any medical condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the investigational device
* Participation in any other investigational study during the duration of participation in this trial
Effects of Brain-stimulation on Metamemory Monitoring and Control

When people learn and remember information, it is often accompanied by a feeling of subjective confidence about whether or not information has been learned and accurately remembered. These subjective feelings of confidence are often related to actual memory performance, but are sometimes incorrect. The investigators have previously shown that applying high definition transcranial direct current stimulation (HD-tDCS) over the dorsolateral prefrontal cortex leads to more accurate feelings of subjective confidence, at least when subjects are asked for their confidence about future memory performance. Accurate confidence judgments are useful in that they may later subsequent behavior, and inaccurate ones may be costly. For example, a student who erroneously believes that studied material was learned may stop studying and not do well on a test. Individuals who have a feeling-of-knowing about the answer to a general knowledge question will continue to search their memory, whereas individuals who do not have a feeling-of-knowing will stop searching their memory. Individuals who are confident they know the answer to a question are more likely to answer it. In this study, the experimenters are testing the effects of brain stimulation on subjective awareness of memory (termed metamemory monitoring) and how people use those subjective judgments (termed metamemory control). The approach taken is to have participants visit the laboratory on 3 visits and receive brain stimulation while completing memory and metamemory tasks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, right-handed adults ages 18-35. English spoken since age 5. Normal or corrected-to-normal vision.

Exclusion Criteria:

* Participants will be excluded if they have chronic skin disease or a medical skin condition, or an unhealed open wound on the scalp, face, neck, or forehead near the electrode location.
* Participants will be excluded if they self-report significant medical, neurological, or psychiatric illness and/or a history of substance abuse
mFOCUS (Multilevel FOllow-up of Cancer Screening)

To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal cancer screening test.

Standard care consists of well-characterized existing decision support and systems for follow-up in these three participating primary care networks and their affiliated integrated delivery systems (Brigham and Women's Hospital, Massachusetts General Hospital, and Dartmouth Hitchcock Health, the largest health care provider in New Hampshire). The primary outcome will be whether an individual receives follow-up, defined based on the type of screening abnormality and organ type (breast, cervical, lung or colorectal cancer), within 120 days of becoming eligible for mFOCUS. Secondary comparisons will assess multi- and cross-level (individual, team, system) outcomes. The study design will allow us to examine the marginal effectiveness of system, team and individual-level enhancements, and exploratory analyses will address subgroups defined by race/ ethnicity, socioeconomic status and cancer type.

Eligibility Criteria:
Inclusion Criteria:

individuals who have an abnormal screen that is due for follow-up including:

* Breast: women 40-80 years with an incident (i.e., newly detected) abnormal screening mammogram or digital breast tomosynthesis (DBT) exam.
* Cervical: women 21-65 years with an incident abnormal screening Pap.
* Colorectal: adults 40-80 years with an abnormal screen, including incident FOBT (Fecal Occult Blood Test) / FIT (Fecal Immunochemical Test), or prevalent colonoscopy. Because of the long periods of time required for follow-up of colonoscopies, we will look back over a 5-year period and will therefore find prevalent abnormalities that become due for follow-up.
* Lung: adults 55-80 years, current and former smokers, with an incident abnormal LDCT (Low Dose Computed Topography) result.

Exclusion Criteria:

We will exclude patients who:

* are not English or Spanish-speaking
* have had prior cancer of the organ for each screening test (i.e., women with prior breast cancer will not be tracked for breast cancer screening abnormalities) as these individuals may have non-standard follow-up care recommendations.
Gut Microbiome and Colorectal Cancer

Colorectal cancer (CRC) is reported to be the third leading cause of cancer deaths worldwide, and its prevalence is steadily rising in developing countries. It can be considered a marker of socioeconomic development and a marker of significant changes in food habits and lifestyle. In Egypt, CRC represents the seventh most common cancer. It is the third most reported cancer in males and the fifth most common cancer in females. microbiome dysbiosis may be involved in the pathogensis and thus pose a therapeutic target

Many reports suggested the role of westernized dietary lifestyles, including high consumption of red meats, animal fats, and cholesterol-rich foods, as well as smoking, decreased physical activity, obesity, diabetes, alcohol consumption, or smoking, in CRC development. These changes in lifestyle are called the external factors, which are now linked to changes in the inner gut microenvironments, mainly the microbiomes. Our aim is to investigate the the changes in microbiome profile in relation to clinical, pathological and lifestyle factors

Eligibility Criteria:
Inclusion Criteria:

* Age of 40 years to 80 years
* Patients with a newly diagnosed CRC

Exclusion Criteria:

* Patients with previously known CRC
* Pregnancy or Lactation
* Abdominal surgery within/up to 6 months prior to sample collection
* Antibiotics, corticosteroids, or probiotics up to three months prior to sample collection
* History of other types of cancer
* Subjects on a special diet
* Diabetes, liver, or kidney diseases
* CRC patients who used enema or underwent colonoscopy up to one week before sample collection.