cyrilzakka/clinical-trials huggingface dataset:
Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer

The potential of the administration of indocyanine green (ICG) allows the execution of SLN biopsy, avoiding the multiple administrations of radiocolloid in the pre-operative phase, painful for the patient, elimination, and exposure to radioactivity. Therefore, while requiring standardization of the methodology and a large-scale application, this procedure could open a new surgical management perspective in patients with early-stage vulvar cancer.

According to The European Society of Gynaecological Oncology (ESGO) guidelines, the investigators decided to treat patients with vulvar squamous cell carcinoma (vSCC), FIGO stage IB with radical vulvectomy, sentinel lymph node search, and removal with indocyanine green (ICG) subsequent bilateral inguinofemoral lymphadenectomy.

Intraoperative imaging system The SPY Portable Handheld Imager (SPY-PHI) © Stryker was used as the intraoperative imaging device. This device uses SPY fluorescence imaging technology to visually assess blood circulation in blood vessels and associated tissue perfusion during surgery. The design of SPY-PHI makes the device versatile, enabling the operator to frame the operating field and use the acquired images in real-time, integrating fluorescence signal data with white light images in real-time. The SPY Portable Handheld Imaging System Camera, with integrated optics and cables for real-time fluorescence imaging in visible light and near-infrared, is ideal for open surgery.

Intraoperative detection of the sentinel lymph node The fluorescent agent was administered to patients placed in the lithotomy position under general anesthesia. Indocyanine green (ICG) prepared with a 25 mg vial of green indocyanine green (ICG) (Pulsion Medical Systems AG, Munich, Germany) diluted in 50 mL of water for injections (B. Braun Medical) was used, resulting in a concentration of 0.5 mg/mL. Injection of 1 ml per quadrant was administered in the three quadrants around the vulvar lesion. After the injection, the infrared camera, equipped with a movable arm, was placed in front of the patient to detect transcutaneous fluorescence during surgery. Subsequently, the SLN was localized based on the fluorescence intensity. The intraoperative fluorescence detection camera system was used to open, identify, and remove the SLN and the vulvectomy of the groin. After the excision, the capture of the residual lymphatic pathway could be seen bilaterally through the infrared camera. Additionally, all SLNs were subject to ex vivo imaging due to the presence of fluorescence. The excised SLNs were sent to pathological anatomy and processed according to the standard SLN protocol.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with vulvar squamous cell carcinoma FIGO IB stage

Exclusion Criteria:

-
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study

This pilot study seeks to compare the change in energy expenditure and fitness levels of patients seen in the Children's Hospital Preventive Cardiology program receiving standard of care provider exercise counseling to similar patients receiving Frequency, Intensity, Time, Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an online interactive tool.

The investigators primary hypothesis is that this interactive technology coupled with support from a exercise specialist will increase the energy expenditure of the investigators patients over standard of care provider counseling.

The investigators Secondary hypotheses include greater improvement in measured physical fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group compared to control.


Eligibility Criteria:
Inclusion Criteria:

1. Patients at increased risk of atherosclerosis based on lipid profiles (Total Cholesterol \> 199 mg/dL, High Density Lipoprotein \< 40 mg/dL, LDL \> 129 mg/dL, blood pressure (Systolic Blood Pressure or Diastolic Blood Pressure \> 90th percentile), obesity (\>85%Body Mass Index)
2. Ages 13-21 years
3. Reporting an average of less than 60 minutes per day of moderate to vigorous exercise most (5) days of the week.
4. Regular access to the internet with the capacity to download the device
5. Commitment on the part of a parent to supervise internet access as part of this protocol

Exclusion Criteria:

1. Unable to exercise based on physician recommendations or medical conditions
2. Unable/unwilling to complete requirements of the research study including consent and assent.
3. Not proficient in English
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.


Eligibility Criteria:
Inclusion Criteria:

* Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease
* No hormone related symptoms
* Well or moderately differentiated tumour confirmed by histology
* Tumour lesions which are measurable by a CT or MRI scan

Exclusion Criteria:

* Previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days
* Treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide
* Had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for 5 years
* Pregnant or lactating
* Females must use adequate contraception during the study
Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction

This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI.

Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.

At Inclusion Visit (Visit 2 \[within 72 hours after acute MI\]), subjects will be randomly assigned to 1 of the following 3 treatment groups in a 1:1:1 ratio:

* Group 1: Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks
* Group 2: Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks
* Group 3: Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks

Then subjects will undergo study procedures at Titration Visit (Visit 3 \[Day 14\]), Treatment Visit (Visit 4 Day 42\]) and End-of-Treatment Visit (Visit 5 \[Day 84\]).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as chest pain \>30 minutes and ST elevation ≥0.2 mV in at least 2 consecutive electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1 V6).
* Primary PCI of the index-MI-related artery within 24 hours after the MI.

Exclusion Criteria:

* Body mass index \>45 kg/m².
* Subject is hemodynamically unstable or has cardiogenic shock.
* Subjects with clinical signs of HF (Kilipp III and IV).
* Systolic blood pressure \<100 mmHg at inclusion visit
* Early primary PCI of the index-MI-related artery performed within 3 hours after MI.
* Subjects treated with angiotensin-converting-enzyme inhibitor (ACE I), angiotensin receptor blocker (ARB) or sacubitril/valsartan prior to the index magnetic resonance imaging. Note: if treatment was for HTN, ACE I/ARB should be stopped, and, if necessary, another therapeutic class can be prescribed for HTN. If the ACE I/ARB was prescribed for congestive HF, the subject is not considered eligible; if the ACE I/ARB prescribed for another reason cannot be stopped, the subject is not eligible for study inclusion.
* Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy, or pacemaker within the next 3 months. If an ICD is indicated for ventricular arrhythmia during the course of the study, a life vest, when possible, should be prescribed and the ICD scheduled after study completion.
Rutgers University Study of the Genetics of Breast Cancer.

The goal of this observational study is to learn more about how genes impact the risk of breast cancer. Anyone 18 or older living in the US is eligible, and a diagnosis of cancer is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost.

This is an online research study to learn more about how genes affect the risk of breast cancer. No office visit is required and in return, participants may receive information about their genetic ancestry for free. BRCA1 and BRCA2 explain only about 25% of the genetic cause of breast cancer. This study will increase our understanding of the genetic basis of breast cancer, which is a crucial step in drug development to improve current treatment options. The study investigators seek a diverse population because men can also get breast cancer and diversity among participants maximizes the usefulness of the data. Participants will use our online study portal to answer questions about their health and provide their DNA via a saliva sample using a pre-paid mailer. Participation takes approximately 20 minutes. Participants will be invited to share data from their electronic health records, but this is not required for study participation. The study investigators keep participants engaged with short monthly newsletters.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* currently living in the United States
* able to understand and follow written instructions in English
* have access to the internet and a computer, laptop, tablet or smart phone
* willing to provide written informed consent for participation
* willing to provide DNA via a saliva sample using a collection kit mailed to the study participant's home
* willing to complete a survey with questions about health related to the study of breast cancer.

Exclusion Criteria:

* Not able to meet or fulfill any of the inclusion criteria
Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy.

This study will define the postoperative analgesic effect of ultrasound-guided bilateral External Oblique İntercostal (EOI) Plane Block and compare the control group in patients undergoing laparoscopic cholecystectomy.

The aim of this study is to compare postoperative opioid consumption of EOI plane block versus control group. It is hypothesized that postoperative opioid use will be less in patients with EOI plane block than in patients who only receive routine multimodal analgesia.

Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (LC). Regional blocks used in addition to multimodal analgesia for postoperative pain after LC usually block the anterior branches of the intercostal nerves. After it was suggested by Hamilton et al. in 2018 that it could block the lateral cutaneous branches between T7-T11 intercostal nerve by administering local anesthetic to the thoracic facial plane and could be used in lateral abdominal surgeries, the EOI plane block has become a block that can be used for analgesic purposes in upper and lateral abdominal surgeries. Blocking the anterior and lateral branches together may produce analgesia in a wider area, resulting in less postoperative opioid consumption.

This study will be conducted as a single-center, prospective, randomized trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, EOI Plane Block will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. An anesthesiologist who performed blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative opioid consumption,pain scores, nausea and vomiting, antiemetic use, and Quality of Recovery score will be blinded to group assignment.

Eligibility Criteria:
Inclusion Criteria:

Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study.

Exclusion Criteria:

* presence of coagulation disorder
* infection at the injection site of the block
* known allergy to local anesthetics
* advanced hepatic or renal failure
* can not communicate in Turkish
* history of abdominal surgery or trauma
* conversion of laparoscopic to open surgery
* consumption of any pain killers within the 24 h before the operation
* chronic opioid consumption
* pregnancy
* alcohol or drug abuse
* body mass index (BMI) ≥ 35 kg m-2.
The Effectiveness of Two Different Methods in Heel Blood Collection

This study aims to evaluate the effectiveness of 2 non-pharmacological methods that will reduce the traumatizing effect of routine heel pricking in infant babies within the scope of the metabolic endocrine screening program. One of the interventions to be used in the study is kinesio taping, a type of taping that does not contain any medication. Another intervention is Shotblocker, which does not belong to any drug or device group.

Studies on pain indicate that severe pain experienced in the early period of life causes a weakening of the cognitive functions of the infant, especially by shrinking the thalamic volume. Pain management in the neonatal period aims to help the infant cope with pain by relieving it. For effective pain management, it is very important to diagnose and evaluate the baby's response to pain early and accurately within a multidisciplinary team approach, and to select appropriate interventions to alleviate the pain experience. It is stated that nonpharmacological methods in relieving procedural pain strengthen the baby's natural regulation and coping mechanisms when faced with painful intervention and reduce pain and stress. For this reason, this study aimed to determine the effect of kinesiology taping and ShotBlocker applied to the heel during heel blood collection in infant babies on pain, comfort and crying time.

Eligibility Criteria:
Inclusion Criteria:

* Term birth infants,
* Infants with a birth weight of 2500 g and above
* Infants with stable clinical condition
* Infants who can perform vital functions without support,
* Infants who were fed, calm and not crying within one hour before the procedure will be included.

Exclusion Criteria:

* With a genetic or congenital anomaly,
* Neurological, cardiological and metabolic diseases,
* In need of respiratory support,
* Infants receiving analgesics, antiepileptics before the procedure will be excluded.
99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis

Postmenopausal women with differentiated thyroid cancer (DTC) taking suppressive doses of levothyroxine (L-T4) are thought to have accelerated bone loss and increased risk of osteoporosis. Therefore, the investigators try to investigate the effects of 99Tc-MDP,alendronate sodium in postmenopausal women with DTC under TSH suppression and osteoporosis.

Differentiated thyroid cancer (DTC) has become one of the most common endocrine malignancies. According to American Thyroid Association (ATA) and Chinese Thyroid Association (CTA), most of DTC patients undergo total or near total thyroidectomy, radioiodine ablation and TSH (thyroid stimulating hormone) suppression. Osteoporosis (OS) and fractures are important comorbidities in patients with DTC, with potential negative impact on quality of life (QOL) and survival. The main determinant of skeletal fragility in DTC is the TSH suppression. Postmenopausal women with DTC under TSH suppression therapy are more vulnerable to OS. Technetium-99 methylene diphosphonate (99Tc-MDP) is a decay product of 99mTc-MDP (used for bone scintigraphy) and a novel bisphosphonates, which has been used in China for diseases like rheumatoid arthritis (RA), ankylosing spondylitis (AS) and osteochondral lesions of the talus, etc. However, as a member of bisphosphates, little attention has been paid to its anti-OS effect for DTC under TSH suppression.

Eligibility Criteria:
Inclusion Criteria:

(1) They were pathologically diagnosed with DTC including papillary or follicular carcinoma. (2) They received a near total thyroidectomy and radioiodine treatment. (3) TSH suppression should be at least one year before the study. (4) Bone mineral density (BMD) in lumbar spine and/or hip was tested by Dual-energy X-ray absorptiometry (DXA) at baseline, 6 month (m) and/or 12m follow up. 5) The diagnosis of osteoporosis was T-score ≤-2.5 SD at the lumbar spine, or hip.

Exclusion Criteria:

1. patients having medications for osteoporosis before TSH suppression treatment;
2. secondary osteoporosis ;
3. severe liver or kidney disease;
4. myelosuppression;
5. digestive disease;
6. long term use of immunosuppressive agent, estrogen or estrogen receptor modulators. This study was approved by the Institutional Review Board of Hospital Research Ethics. All the patients were fully acquainted with their treatment and consented to participate in the clinical trial.
Preventive Potential of Bilirubin

The prevalence of mild hyperbilirubinemia, also known as Gilbert´s Syndrome, is usually defined using an unconjugated bilirubin (UCB) blood concentration above 17.1 µmol/l. The prevalence of GS is remarkably common, affecting 5-10% (depending on ethnicity and gender) of the adult population.

The aim of this project is to investigate whether there is a difference in health related marker between 60 subjects with Gilbert´s Syndrome (mild hyperbilirubinaemia) and 60 age and gender matched control subjects.


Eligibility Criteria:
Inclusion Criteria:

In general

* Signed declaration of consent
* Age: 20-80 years
* Liver enzymes (AST, ALT, GGT) \< 1.5x over norm values
* Non smoking
* Moderate physical activity
* Ability to communicate with the study team in the local language to understand the study procedure

Cases (GS):

* Total blood bilirubin \> 1.2 mg/dl
* Unconjugated bilirubin \> 1 mg/dl

Controls (non-GS):

* Total blood bilirubin ≤ 1.2 mg/dl
* Unconjugated bilirubin ≤ 1 mg/dl

Exclusion Criteria:

In general

* Age \< 20 or \> 80 years
* Cardiovascular diseases
* Liver diseases (including Hep B and C)
* Cholelithiasis
* Hemolysis
* Renal diseases
* Active tumors
* Diabetes mellitus
* Smoking
* Professional athletes
* Subjects with organ transplants
* Intake of antioxidants within the last 4 weeks
* Intake of liver influencing medication within the last 5 weeks

Cases (GS):

* Total blood bilirubin ≤ 1.2 mg/dl
* Unconjugated bilirubin ≤ 1 mg/dl

Controls (non-GS):

* Total blood bilirubin \> 1.2 mg/dl
* Unconjugated bilirubin \> 1 mg/dl
The Effects of Nutrition Supplementation and Education on the Healing of Diabetic Foot Ulcer (DFU)

The overall aim of this study was to assess the effects of nutritional supplementation and education on the healing of foot ulcers in diabetic patients. The hypothesis was that improving dietary intake can promote wound healing by improving nutritional status, blood flow, and decreasing inflammatory biomarkers while increasing anti-inflammatory factors.


Eligibility Criteria:
Inclusion Criteria:

male or non-pregnant, non-lactating female ages 50 ± 20 years, diagnosis of diabetes mellitus, undergoing pharmacological treatment for glycemic control, with at least one foot with one ulcer of grade 1A based on University of Texas classification -

Exclusion Criteria:

Subjects were excluded from the study if they had HbA1c concentrations \> 12%, bioengineered tissue use within four weeks prior to initial screening, a history of radiation treatment to the ulcer site, known immunosuppression, active malignancy, chronic kidney disease, liver failure/cirrhosis, heart failure and/or myocardial infarction in the past three months, use of warfarin, alcohol abuse, or any mental or physiological condition that may interfere with nutrition education and nutritional supplement intake.-
Treatment With Aspirin After Preeclampsia: TAP Trial

The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

This is a pilot randomized, single-center, double-blind placebo-control study of low dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or identical appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum individuals ≥18 years old
* Preeclampsia diagnosis

Exclusion Criteria:

* Fetal anomaly
* Multiple gestation
* Pre-pregnancy hypertension
* Allergy or contraindication to low-dose aspirin
* Pre-pregnancy diabetes