cyrilzakka/clinical-trials huggingface dataset:
PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy

The two main objectives of this prospective study are:

* to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1),
* to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2).

The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer .

This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.


Eligibility Criteria:
Inclusion Criteria :

* Histologically confirmed breast cancer
* Stage II and III breast cancer
* Neo-adjuvant chemotherapy
* Baseline PET-CT-scan (ASAINT 1 and 2)
* PET-CT-scans after second cycle of neo-adjuvant chemotherapy (ASAINT 2)
* Tumor biopsy for diagnosis and biological analysis with hormone receptors and Human Epidermal Growth Factor Receptor-2 (HER2) available
* Surgical intervention after completion of neo-adjuvant chemotherapy
* Evaluable pathological response

Exclusion Criteria :

* Other tumor localization
* Non controlled diabetes mellitus
* Pregnancy
Breathing & Blood Pressure

The purpose of this study is to determine the effect of obesity on cardiovascular responses during various breathing maneuvers.

Adults with higher body mass can have trouble breathing during exercise, which could be due to high respiratory muscle workloads. These breathing muscles can require a lot of energy, which takes away energy from other (e.g., leg) muscles. Participating in this study will help us understand how the heart and blood vessels respond during brief exercise and during various breathing maneuvers.

Eligibility Criteria:
Inclusion Criteria:

• Body mass index values of ≤40 kg/m\^2

Exclusion Criteria:

* Not weight stable (\<5% change in body mass over the past six months)
* Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)
* Current, or history of uncontrolled, Stage 2 hypertension (blood pressure \>140 / 90 mmHg; anti-hypertensive medications are permitted)
* Diagnosed obstructive sleep apnea
* Previous bariatric surgery
* Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)
* Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)
* Per the POWERbreathe® company:
* Patients who have undergone recent abdominal surgery and those with abdominal hernia.
* Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnoea.
* If a patient is suffering from a ruptured eardrum or any other condition of the ear.
* Patients with marked elevated left ventricular end-diastolic volume and pressure.
* Patients with worsening heart failure signs and symptoms after a respiratory/inspiratory muscle training (IMT) session
* If you are suffering from a cold, sinusitis, or respiratory tract infection, we advise that you do not use your POWERbreathe IMT device.
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant (self-reported and urine pregnancy test conducted), lactating (self-reported), or post-menopausal (self-reported) females
* Prisoners
Family-based Telemedicine Vs. Inpatient Anorexia Nervosa Treatment (FIAT)

The FIAT study is funded by the Innovationsfonds of the German Ministry of Health via the DLR Project Management Agency. The study will be conducted in up to 21 hospitals across Germany and in collaboration with 10 German public health insurance companies. The primary aim of this study is to compare Family-Based Treatment delivered via telehealth (FBT) with inpatient multimodal therapy (IMT) with respect to treatment outcomes and health economic data. The results of the study will serve as a basis for the decision on the inclusion of FBT in the German S3 guidelines and the future reimbursement of FBT by public health insurances in Germany.


Eligibility Criteria:
Inclusion Criteria:

* restrictive and bulimic subtypes of anorexia nervosa (ICD-10: F50.00; F50.01)
* inpatient treatment indication according to S3 guideline
* weight \< 3. BMI-percentile or
* weight \<10. percentile and psychiatric comorbidity/rapid weight loss/lack of weight gain during outpatient treatment over last three month
* planned inpatient treatment
* insured with one of the participating health insurance companies
* stable internet connection

Exclusion Criteria:

* weight \<67%mBMI
* acute self harm or danger to others
* acute psychosis or suicidal tendencies
* current substance abuse
* child abuse or domestic violence in the family
* insured with other health insurance company
* judicial placement order for inpatient treatment
* known, currently existing child protection problems or proceedings by the family court
COPING With COVID-19( CWC-19)

The purpose of this study is 1) to understand effects of COVID-19 crisis on wellness of pulmonary and critical care faculty and trainees who are at frontline fighting this pandemic 2) Assess the effectiveness of series of weekly web based crisis management coaching from world renowned experts in coaching and 3) identify future areas of opportunities in physician wellness


Eligibility Criteria:
Inclusion Criteria:

* Any faculty, staff, or trainee from Duke pulmonary and critical care that consents to being in the study

Exclusion Criteria:

-
Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent

The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).


Eligibility Criteria:
Inclusion Criteria:

Patients enrolled in Protocol 127-014 who

1. Were enrolled in Stratum 1
2. Did not undergo angiography during study evaluation
3. Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014.
IMPACT OF THE BIOLOGICAL RATIO ON MEDICAL DECISION MAKING IN WOMEN SUSPECTED OF PREECLAMPSIA

Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. The ratio sFlt-1/PlGF has a higher positive predictive value than the isolated measurement. A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia.

This is a single-center prospective and observational study conducted from the 1rst of October 2019 to the 27th of January 2021, including pregnant women suspected of preeclampsia, above 24 weeks of gestation. Values were measured using the Elecsys sFlt-1/PlGF immunoassay ratio. The aim of the study is to observe the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value


Eligibility Criteria:
Inclusion Criteria:

* pregnant patients over 24 weeks of amenorrhea
* aged 18 and over
* with suspicion of preeclampsia defined by the appearance of pregnancy-induced hypertension (≥ 140 in systolic and/or 90 mmHg in diastolic pressure over 2 measurements at 4 hours intervals) OR proteinuria (≥ 0.3 g per 24 hours).
* who systematically gave oral consent after submitting the information sheet

Exclusion Criteria:

* pregnant women with both hypertension and proteinuria because they already have a confirmed diagnosis of preeclampsia.
* receiving antihypertensive treatment before pregnancy
* or refusing to participate in the study The sFlt-1/PlGF ratio was measured only when clinically indicated as per the investigator's judgment.
Usefulness of 18F-FDG PET/CT in the Initial Staging and Surveillance of Endometrial Cancer Patients

1. To assess the value of 18F-FDG PET/CT in the initial staging and detection of recurrent cases of endometrial cancer.
2. To determine correlation between PET/CT derived parameters including SUVmax, TLG and MTV and clinic-pathological patient characteristics.
3. To detect local and distant recurrence after therapy.

Endometrial cancer (EC) is one of the most common gynaecological malignancies worldwide.The incidence rate of uterine cancer in Egypt was 4.1 per 100,000.

The standard surgery consists of laparotomy, hysterectomy, and bilateral salpingo-oophorectomy. Maximal surgical cytoreduction is recommended for advanced EC. Prognostic impact of complete lymphadenectomy remains controversial, especially in early- stage disease.

With the aim of predicting extrauterine disease pre-operatively and optimizing surgical planning, several techniques have been evaluated, including 18F-fluoro-2-deoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT). PET /CT can be used to effectively and accurately diagnose EC pelvic lymph node metastasis and distant metastasis. It has great value in clinical staging, judging prognosis, diagnosing recurrence.

Radiomics analysis of the uterine primary tumor on pre-operative 18F-FDG PET images may help predict the presence of metastatic nodes, thus reducing false-negative results and increasing the sensitivity of the technique. The maximum standard uptake value (SUVmax), metabolic tumor volume (MTV) and total glycolysis (TLG) of primary lesions are significantly correlated with pathological tissue grading. Previous studies on metabolic parameters of primary lesions examined by 18F-FDG PET/CT for endometrial cancer mainly focused on SUVmax, However, SUVmax can only reflect the functional metabolic degree of the point. It cannot assess the overall metabolic situation of tumor. MTV and TLG can more comprehensively measure the glucose metabolic activity of tumor cells with more clinical value in reflecting the malignancy degree of tumor.

Eligibility Criteria:
Inclusion Criteria:

* Patients proved to have endometrial cancer by curettage or hysteroscopy.
* Patients accepted surgery treatment, without anti-tumor and hormone therapy before surgery.
* Ability to stay still for the duration of the PET/CT scan (\~15 minutes).
* Ability of the patient (or his/her guardian) to sign informed consent.

Exclusion Criteria:

* Patients who recieved neoadjuvant therapy before PET/CT.
* Patients with tumors other than endometrial cancer.
* Pregnancy.
* Inability to give informed consent.
* Inability to stay still for the duration of the scan.
* Claustrophobia
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters

The purpose of this study is to compare two different marketed PICC (peripherally inserted central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion will be compared. It is hypothesized that the non-tapered design has a lower clotting rate and is easier to place than the tapered design. Bleeding rates are expected to be about the same.


Eligibility Criteria:
Inclusion Criteria:

* All inpatients, age 18 to 90, in need of de novo central venous access with a double lumen catheter indication of \> 2 weeks
* Informed consent and HIPAA consent forms discussed and signed by patient or their authorized representative

Exclusion Criteria:

* Skin related problems around the insertion site (infection, phlebitis, scars)
* History of mastectomy/axillary dissection on insertion side
* Coagulopathy with an INR of \> 2.0
* Thrombocytopenia with platelets \< 25,000 uL
* Renal insufficiency with a creatinine of \> 3.0 mg/dL
* Documented current upper extremity or central venous thrombosis
* Hypercoagulable states (protein C or S deficiency, AT-III deficiency, lupus anticoagulant)
* Catheters needed for therapy within less than an hour (emergent placement not allowing sufficient time for proper research consent and randomization)
* Patient has already been enrolled in this research study
* Life expectancy less than 1 month
A Prospective Study of Natural History of Pancreatitis

To prospectively define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP) of varying etiology. To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP. To quantify the behavioral abnormalities associated with CP. To determine psychological and behavioral correlates of CP disease progression and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with pancreatitis

Exclusion Criteria:

* Lack of consent, age \<18 years
Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery

The purpose of this study is to determine if the altered nutrient exposure to the GI tract after bariatric surgery reveals a negative incretin effect of ghrelin.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35 kg/m2
* Age 21-65 years
* Weight ≤ 200 kg

Exclusion Criteria:

* Type 2 or Type 1 diabetes
* Medications that alter insulin sensitivity or carbohydrate metabolism
* Positive pregnancy test
* Known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. Chronic Ulcerative Colitis, Crohn's disease, celiac sprue)
* Prior gastric or intestinal surgery or pancreas resection
* History of cardiovascular disease, including but not limited to: myocardial infarction, angioplasty, arrhythmia, uncontrolled hypertension
* History of chronic kidney disease or renal insufficiency; creatinine \> 1.8 mg/dl.
* History of chronic liver disease, including but not limited to: cirrhosis, hepatitis, portal hypertension; AST and/or ALT \> 2x the upper limit of normal.
* Abnormal ECG
Microbes and Bariatric Surgery

The investigators will study people who are obese and will be treated by bariatric surgery. The investigators will test the hypothesis that some of the features of obesity are related to the bacteria in the gastro-intestinal tract.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65
* Will undergo bariatric surgery for treatment of obesity in Syracuse NY
* Willingness to participate

Exclusion Criteria:

* Any previous gastrointestinal surgery
* Use of antibiotics in the previous 3 months
Neuronal and Sensory Perception of Fat

This project will examine neuronal and sensory fat perception. Our hypothesis is that subjects being either hypersensitive or hyposensitive for fat will show different brain activities. Therefore the investigators will conduct functional magnetic resonance imaging (fMRI) and fat detection threshold tests examining neuronal and sensory fat perception.


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* lactose intolerance
* fMRI contraindications (metal implants,...)
Social Exergaming for Healthy Weight in Adolescent Girls

The purpose is to evaluate the feasibility of a 12-week exergaming dance program for adolescent girls. This study combines dancing, video games, and a full body work-out to test if video games can increase physical activity and promote healthy weight in adolescent girls. We hypothesize that girls who play the dance exergames, versus those in the control group, will lose weight, decrease body fat and visceral fat, improve cardiovascular health, increase physical activity, and improve psychosocial health including self-confidence and quality of life.

Klub Kinect will last about 14 weeks for each participant. The program begins with a 3.5 hour clinic visit, the intervention lasts for 12 weeks, and the participant comes in for a final 3.5 hour clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 14-18 years old
* Female
* Postmenarchal
* BMI percentile equal to or greater than 85th on the U.S. Centers for Disease Control and Prevention growth chart
* Speak, understand, read, and write English
* Willing to accept randomization

Exclusion Criteria:

* Pregnant
* Hospitalization for mental illness within the past 5 years.
* Since the focus herein is on ambulatory activities, participants who use wheelchairs or other impairments that prevent normal ambulation will be excluded
* Indication of cardiac abnormality on an electrocardiogram that requires referral to a cardiologist
* Previous history of, or clinical symptoms or signs of, cardiovascular disease, stroke or transient ischemic attacks, chest pain, unusual dyspnea during physical activity/exercise, severe ankle edema, or intermittent claudication.
* Previous history of musculoskeletal injuries or problems causing severe pain during physical activity or exercise which interferes with daily activities.
* Participant has a pacemaker or other implanted medical device (including metal joint replacements).
* Participant is unable to complete all baseline testing (one session) within 1 month prior to the beginning of the intervention
* Medical problems, including epileptic seizures, that prevent video game play
* Family history of epileptic seizures
* Unable to make the commitment of coming to Pennington Biomedical Research Center for 3 weekly gaming sessions for 12 weeks
PEWS Implementation in an LMIC Setting

The PEWS implementation study will be undertaken with the following objectives:

1. Assess the effectiveness of implementation of PEWS and resuscitation training to identify patients at risk for clinical deterioration and to impact the frequency of clinical interventions made by treating providers on these patients.
2. Assess the effectiveness of implementation of PEWS and resuscitation training to impact time sensitive clinical interventions made on patients at risk for clinical deterioration.
3. Assess the impact of implementation of PEWS and resuscitation training on length of stay for patients admitted to the pediatric oncology ward.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for the study are defined as pediatric patients (between birth and 12 years of age) admitted and subsequently discharged from the pediatric oncology ward in Beit Jala, Palestine and Gaza City, Palestine between March 2019 to June 2020

Exclusion Criteria:

* Patients will be excluded if they are not admitted to inpatient status. No oncology outpatients such as those in the infusion program will be included.
A Novel Approach to Reducing Adiposity Among Young Men

The purpose of this research study is to find out whether a primarily self-guided program can produce changes in weight, body fat and cardiovascular risk among young men.

This self-guided lifestyle intervention may help men to reduce weight and improve heart health because it has been adapted to meet the possible weight loss needs of young men. Young men may experience reductions in body weight after enrollment in the intervention, but this is unknown.

Study participation lasts approximately 3 months. Participants will be assessed by the study staff and fill out questionnaires about current lifestyle practices (diet, physical activity, sleep habits, risk behaviors). Weight, medical events, and medication use within the last 3 months will be assessed. Eligible participants will be randomly assigned (like the flip of a coin) to the control group or self-guided group.

Eligibility Criteria:
Inclusion Criteria:

1. self-identify as a man
2. 18-35 years old
3. BMI 25-45kg/m2
4. Live in North America

Exclusion Criteria:

1. an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension)
2. a diagnosis of Type 1 or Type 2 diabetes
3. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen
4. currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery
5. change in medication(s) within the last 3 months that could influence weight (e.g., steroids)
6. have lost \> 5% body weight within the last 3 months
7. report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months
8. report hospitalization for a psychiatric condition within the last year
9. report high alcohol intake (AUDIT score \> 16).
10. are not able to speak and read English
11. do not possess a mobile device or are unwilling to use it to receive study text messages
12. Given strict data regulations outside of North America (i.e., Europe), we will only include participants living in North America (i.e., United States, Canada).