cyrilzakka/clinical-trials huggingface dataset:
Evaluation Of Lymph Nodes After Neoadjuvant Chemotherapy

This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).

* This research study is a Pilot Study, which is the first time investigators are examining this study intervention locally; although this intervention has been studied nationally in published clinical trials.
* In this research study, the investigators are studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).
* A sentinel lymph node biopsy is a surgical evaluation of the lymph nodes in the underarm area in patients who have early breast cancer. Approximately, two-five nodes are removed from the underarm area for evaluation. The sentinel lymph node biopsy is performed in patients with breast cancer to determine if there are cancer cells in the lymph nodes in the armpit.
* The sentinel lymph node biopsy procedure is performed by injecting one or two dyes into the breast, which then travel to the armpit region via small vessels in the immune system. These nodes are called the sentinel lymph nodes. They represent the first nodes that drain the breast tissue. They are closely evaluated by a Pathologist to determine if cancer cells are present.
* This information allows physicians to know how far the cancer may have spread and recommend therapies accordingly.
* If sentinel lymph node biopsy is determined to be accurate in patients who are known to already have cancer cells in the axillary lymph nodes who receive neoadjuvant therapy, then in the future, many of the patients in this population may be spared the procedure of a full axillary lymph node dissection, which removes a larger number of lymph nodes and thus has increased risks and side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will include any patients with biopsy-proven breast cancer and biopsy-proven axillary lymph node metastases at Beth Israel Deaconess Medical Center who are candidates for Neoadjuvant Chemotherapy or Neoadjuvant Endocrine therapy.
* A core needle biopsy or fine needle aspiration is acceptable for diagnosis of metastatic disease in lymph nodes.
* Patients will be identified as possible participants in the Radiology Imaging suites and Breast Surgery Clinics.

Exclusion Criteria:

-Patients with inflammatory breast cancer or distant metastases will be excluded from participating in this study
Probiotics and Infections in Children Attending Day Care Centres

The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses.


Eligibility Criteria:
Inclusion Criteria:

* Age 2 to 6 years in the beginning of the intervention
* Attendance at a day care centre participating in the study (5 days a week)

Exclusion Criteria:

* Milk allergy or lactose intolerance
* Congenital heart diseases that requires regular medication
* Malign diseases
* Cytostatic treatment
* Use of biological rheumatic medication
* Continuous microbial medication
* Regular use of oral corticosteroids (inhalable accepted)
* Diabetes
* Simultaneous participation in other clinical trials
Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment

The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.

Immunotherapy with anti-PD1 antibody, such as Pembrolizumab, is widely used in the treatment of stage III/IV non small cell lung cancer. In order to refine treatments and patients' prognosis, early assessment of tumour response is needed.

The aim of this study is to describe the early tumour metabolic changes in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response.

Eligible patients with stage III/IV, PDL1\>50% NSCLC will receive pembrolizumab treatment as per standard of care.

Tumour metabolism will be assessed by 18-FDG PETscan before each of the 3 first pembrolizumab infusions. Treatment response will be determined by RECIST, irRC and mCHOI criteria at 3 months.

Prognostic and predictive value of baseline and dynamic metabolic parameters will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Non operable non small cell lung cancer
* Indication of treatment by Pembrolizumab
* PD-L1 status superior to 50 %
* Age more than 18 years
* At least one measurable target
* Written inform consent

Exclusion Criteria:

* no treatment by pembrolizumab
* immunosuppressive treatment
* uncontrolled diabete
* Pregnancy or breast-feeding
* curatorship or guardianship
* not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons
Long Term Neurocognitive Effects of Low-dose Radiation in the Brain: Study of 150 Patients in the French Hemangioma Cohort

Context: Studies that address specifically the neurocognitive consequences that can be caused by low-dose radiation receiving during the childhood have still to be performed. In this issue, we focus on an investigation with patients who have received radiotherapy for a benign tumor (skin hemangioma), in France.

Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy. These patients have been treated and followed by Gustave Roussy, so their clinical records can be tracked with great accuracy and the ionizing radiation dose to the brain have been estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A total of 150 patients is expected. They will be contacted by letter to explain the purpose and methods of carrying out tests. Two groups will be analysed according to the received ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory, arithmetic, orientation, etc.) will be used.

Expected results: We expect to describe the potential neurocognitive dysfunction or disorder and to identify risk factors and brain structures whose lesions are responsible for the neurocognitive dysfunction or disorder.

A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive dysfunction or disorder.

CogRad is an interventional study designed within the European project called Cognitive and Cerebrovascular Effects Induced by Low Dose Ionizing Radiation (CerebRad).

CerebRad is a collaborative European project funded in 2011 within the 7th European Union (EU) framework programme, Nuclear Fission and Radiation Protection. CerebRad aims to identify the potential cognitive and cerebrovascular risks of radiation doses below 100 milliGray (mGy) when delivered to a young child (pre- or postnatally).

Eligibility Criteria:
Inclusion Criteria:

* Subject treated by radiotherapy for a skin hemangioma in childhood at Gustave Roussy between 1941 and 1973 and who have received less than 1 Gy of radiation doses in the brain
* Inhabitants of Île-de-France
* French medical insurance
* Good knowledge and understanding of the French language

Non-inclusion Criteria

* Cerebral hemangioma
* Syndrome genetic predisposition
* Pregnant woman
* Private person of liberty or under guardianship
* Radiation dose to the brain greater than 1 Gy during radiotherapy treatment of skin hemangioma
* Chemotherapy during skin hemangioma treatment
* Inability to undergo counseling for geographical reasons

Exclusion Criteria:

* Pregnancy
* Inability to perform neurocognitive tests battery for medical reasons
Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers

To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects.

Study hypothesis: The degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.

The experimental are comprise of 50g fat, 14g protein and 84g carbohydrate. Each of the test fat \[palm mid fraction (PMF), shea butter (SB) and high oleic sunflower oil (HOSF)\] will be compared which will be in a form of experimental meals (muffin).

33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a 6-week period. They will be randomized, blinded and will undergo a 3x3 arms crossover. The first 15-ml ("0" min) fasting venous blood samples is obtained. Immediately thereafter, the subject consumes the test meal plus a glass of water within 15 minutes. The time sequence is started mid-way of consuming the test meal.

At 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4 hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the subjects hand/arm).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or female staff, aged between 25-50 years
2. BMI 18.5 - 25.0 kg/m2
3. Blood pressure: Systolic: \<140 mmHg, diastolic: \<90 mmHg

c. Normolipidemic (Total cholesterol \<6.2 mM/L (\<240 mg/dL), Fasting TG \<1.70 mM/L (\<150 mg/dL) d. Fasting glucose 4.0- 7.0 mM/L

Exclusion Criteria:

1. Smokers
2. On cholesterol or blood glucose medication
3. Substance abuse (eg. alcohol, cigarette smoking)
4. For women, pregnant or lactating
5. Going overseas during period of study
6. Blood clotting problem
7. Public transportation to work
A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with PAD\* (\*Criteria for diagnosis of PAD: diagnosed with Burger's disease, obstructive arteriosclerosis, diabetic peripheral vascular disease, or with ischemic symptoms such as ulcers, pain, cold sensation, etc.)
2. tODI \< 3 at randomization
3. Aged ≥ 19 years
4. Written informed consent

Exclusion Criteria:

1. Patients requiring acute or two or more antiplatelet agents
2. Patients requiring anticoagulant therapy
3. Patients requiring surgical procedure due to vascular occlusion
4. Patients whose results are confirmed at the screening as follows:

   * hemoglobin (Hb) test value: male \< 13 g/dL, female \< 12 g/dL
   * platelet count \< 60,000/µL
   * severe renal disease (eGFR \< 30 mL/min/1.73 m2)
5. Patients with a history of cerebrovascular and cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, percutaneous coronary intervention) within the last 6 months
6. Contraindications stated in the SPC of sarpogrelate
7. Patients who are pregnant or planning to become pregnant
8. Those participating in other clinical trials with administration of investigational products at the screening
9. Those who are deemed to be ineligible to participate in the trial by investigator
Multiple Sclerosis, Menstrual Cycle and Physical Acivity

This study aims to identify moderating variables that modify satisfaction with physical activity practice throughout the menstrual cycle (MC) in women with and without multiple sclerosis (MS) during High-Intensity Interval Training (HIIT) and strength training sessions, and to compare the acute effects of different types of physical activity sessions in women with and without MS. This study used a randomized crossover trial study and single-blind performed by women with MS, matched 1:1 based on age, lifestyle factors and country of residence, with women without MS to analyse the effect of physical activity practise on satisfaction, functionality, fatigue, and inflammatory profile throughout MC. Participants will visit the facilities approximately 10 times (4 preliminary familiarization visits and 6 visits to carry out a physical activity session in each phase of the MC) over a period of 3-4 months. Evaluation will comprise clinical, nutritional and psychological interviews including different variables such as satisfaction on physical activity; visual analogue scale of fatigue; abdominal obesity and anthropometric variables; dietary and nutritional monitoring; bioimpedance analysis; blood profile of hormone, inflammatory and cognitive function blood profile; neuromuscular strength, voluntary activation, and contractile properties; functional assessment (spasticity, knee angles, gait speed, walking endurance, balance, sit-to-stand test, timed up and go test); rating of perceived exertion; pain; muscle oxygen saturation; lactate; heart rate variability; quality of sleep and life; and body temperature. During the luteal phase, women with MS are expected to exhibit different acute responses to HIIT and strength training sessions compared to women without the disease.


Eligibility Criteria:
Inclusion Criteria:

* women aged between 18-40 years;
* women with a menstrual cycle length of ≥ 21 days and ≤ 35 days of natural menstruation;
* absence of iron deficiency anaemia (serum ferritin \> 20 μg/L, hemoglobin \> 115 μg/L, transferrin saturation \> 16%)
* being in a stable phase of the disease,
* to ambulate autonomously for more than 100 meters

Exclusion Criteria:

* a score \< 2 or \> 6 on the Expanded Disability Status Scale (EDSS);
* experienced a relapse in the 12 months prior to enrolment;
* received corticosteroid treatment in the previous 2 months;
* participated in a structured exercise programme in the past 6 months;
* secondary amenorrhoea (absence of ≥ 3 consecutive periods despite not being pregnant and having previous menstruation);
* used or currently use hormonal contraceptives for 3 months before recruitment
* reported musculoskeletal or neurological injuries not associated with MS, recent surgical interventions, or pregnancies in the previous year,
* have unrelated diseases to MS
the Effect of Educational Program on Teachers' Knowledge Self-reported Practice Towards TDIs

The study aims at evaluating the effect of an oral health educational program on the knowledge and self-reported protocol of primary school teachers in Beni-Suef towards traumatic dental injuries.

Traumatic dental injuries (TDIs) are considered a public health concern representing 5% of all injuries. According to the world health organization (WHO) about 16-40% of children across the world are subjected to TDIs with the most susceptible age group between 6-12 years old. Dental trauma may be caused by falls, blows to the face and sports which could be mild as concussion or subluxation, or complicated as avulsion ). The majority of the injuries took place at home followed by school, so teachers are one of the first to be present at the site of action, making their knowledge of emergency management essential to the provision of proper care to an injured child .

For example, in cases of avulsion of permanent tooth the proper management is to find the missing tooth and immediately replant, or transport the tooth in suitable transportation media, then referral to the dentist for treatment and follow up. The prognosis of such case mainly depends on the time between the injury and the replantation and the media of transportation . The unnecessary negative consequences of not providing proper first aid management in such case could lead to more time consuming and costly treatment and in a worst-case scenario permanent loss of one or more tooth . This could cause pain and have significant functional, esthetic, speech, and psychological effects on children thus affecting their quality of life .

A number of studies have evaluated the knowledge level of schoolteachers with respect to dental trauma and its emergency management concluded that teachers lack knowledge towards traumatic dental injuries. They recommended establishing oral health educational programs to raise the teachers' knowledge and improve their attitude towards TDIs . Other educational studies showed remarkable increase knowledge after oral health educational program and that is why educational programs and training are needed to improve proper management of traumatic injuries by schoolteachers and avoid unnecessary negative consequences.

Eligibility Criteria:
Inclusion Criteria:

* Both males and females teachers.
* All ages and different periods of experience.
* From both private and public schools.
* Teachers in Beni-Suef district

Exclusion Criteria:

* Primary school teachers who refuse to participate.
* Teachers who attended any previous first aid course.
Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome

The purpose of this study is to examine in detail the acute and chronic effects of pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk for the premature development of atherosclerosis (CAPITAIN).


Eligibility Criteria:
Inclusion Criteria:

* Patients with metabolic syndrome
* Patients with LDL-C \> 130mg/dL
* Eligible, able to participate and have given informed consent

Exclusion Criteria:

* Body Mass Index \>35 kg/m2
* LDL-C \> 190mg/dL
* Fasting triglycerides \> 400 mg/dL
* Diabetes mellitus (fasting glucose \>7 mmol/L) or taking diabetic therapy
* Uncontrolled hypertension (Systolic Blood Pressure \>= 140 mmHg or Diastolic Blood Pressure \>= 90mmHg)
* Any conditions that cause secondary dyslipidaemia or increase the risk of statin therapy
* ALAT and ASAT \>3 x ULRR
* Impaired renal function (Serum Creatinine \>1.5 x ULRR or eGFR \<60 mL/min)
* History of any muscle disease or unexplained elevation (\>3 x ULRR) of serum creatine kinase
* Evidence of symptomatic heart failure (NYHA class III or IV)
* Current or recent user of supplements or medications known to alter lipid metabolism
Persea Americana for Total Health (PATH)-2

The goal of this clinical trial is to learn about the effects of avocado consumption on gastrointestinal health in adults with overweight and obesity. The main questions is aims to answer are:

How does avocado consumption affect the gut microbiome? How does avocado consumption affect thinking? Are there connections between the microbiome and cognition? Participants will be asked to eat provided meals with and without avocados for three 4-week periods. At the end of each 4-week period, participants will be asked to provide stool samples and complete computer games that assess thinking and memory.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 25 and 74 years old
* BMI ≥ 25 kg/m2
* Ability to drop off fecal sample within 15 minutes of defecation
* 20/20 or corrected vision

Exclusion Criteria:

* Avocado allergy or intolerance
* Food allergies or intolerances
* Prior diagnosis of liver or gastrointestinal disease (primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), diabetes, hepatitis, HIV, or cancer
* Women that are pregnant, have given birth in the previous 12 months or are lactating
* Individuals that smoke, use tobacco, abuse drugs, or consume \> 2 alcoholic beverages per day.
* \> 5% weight change in the past month or \> 10% change in the past six months
* Oral antibiotics during the previous 6 weeks.
* Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin.
* History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery.
* Are unable to consume the experimental meals/snacks.
* Allergic to latex
* Concurrent enrollment in another dietary, exercise, or medication study
ARCH II Study (Alcohol Research Center on HIV Study II)

This study is being done to learn about the interaction of alcohol consumption and HIV on brain function. The proposed study will have two broad objectives. The first is to incorporate functional neuroimaging (FMRI) approaches, along with additional Magnetic Resonance Spectroscopy (MRS) methods that will enable a delineation in both functional and cerebral metabolic disturbances affecting specific functional brain systems that are associated with the interaction of ethanol (ETOH) consumption on Human Immunodeficiency Virus (HIV)-associated brain dysfunction. Recent data indicate that HIV infected patients with heavy ETOH consumption have FMRI abnormalities and exhibit alterations on other neuroimaging measures compared to moderate drinkers and people who do not drink at all. The second objective is to examine the extent to which reductions in ETOH consumption among heavy drinkers with HIV infection result from a motivational intervention. The findings from this study will provide important information on how heavy ETOH and HIV interact to affect the brain functional responsiveness, and the extent of improvement that might be gained by reducing heavy ETOH use.

In this research study, participants will be randomized (much like flipping a coin) by a computer program to either no counseling or FMRI during the baseline visit in the second session for this visit.

Each time point (baseline, 3 months and 9 months) consists of 2 participant sessions. Session 1) at baseline is for the purposes of recruiting and determining if participants meet study criteria; during all visits, study criteria are reviewed to ensure that enrolled participants are still eligible. After determining eligibility, study information is explained by the research assistant and consent is then obtained. Additional psychiatric and substance use assessment and neurological and will be performed. Blood and urine specimens will be obtained and sent to lab for measurement of immunological, virologic, and hepatic status and other biomarkers. The remainder of the blood specimens will be frozen and banked for future analyses. All blood specimens banks for future analyses will be deidentified. A neurocognitive assessment performed by a research assistant. The duration will be approximately 120 minutes. Session 2) will occur within one week of visit one. It will consist of an MRI scan lasting approximately 50 minutes. Functional imaging will be conducted during this MRI time. All participants will undergo all procedures at baseline, and three and nine months.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected;
* English speaking;
* Physically mobile;
* Willingness to participate in the Motivational Interviewing (MI) to reduce ETOH consumption.

Exclusion Criteria:

* Neurological disorders;
* Evidence of dementia;
* Past opportunistic brain infection;
* Major psychiatric illness;
* Current major psychiatric disturbance;
* Unstable medical conditions (cancer);
* MRI contraindications (e.g., pregnancy, claustrophobia, metal implants);
* Physical impairment precluding motor response or lying still.