cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Fasting Mimicking Diet

Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Both arms will have a final study visit at month 7.

Determine the effects of the FMD on cardiovascular (CV) biomarkers, coronary heart disease (CHD) risk factors (body weight, body mass index (BMI), body composition, blood pressure, serum lipid levels and dysglycemia blood measurements), noninvasive cardiovascular testing for endothelial function, arterial stiffness of large and small arteries and autonomic function testing in adult subjects over a seven-month study period.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index equal to or greater than 28
* EndoPAT® Score for endothelial function of less than or equal to 2.0 or AC 2 small resistance artery compliance by computerized arterial pulse wave analysis (CAPWA) of less than or equal to 5.0.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
* Pregnant females
* Any cancer within the past 5 years
* Documented myocardial infarction within past 5 years
* Documented cerebrovascular accident within past 5 years
* Chronic steroid use (longer than 45 consecutive days
* Type I insulin-dependent diabetes mellitus
Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

1. Group 1: sIPV + DTaP + HepA,
2. Group 2: sIPV only,
3. Group 3: DTaP only,
4. Group 4: HepA only.

The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.

Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.

To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ HepA(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives HepA (0.5ml).

Blood samples will be collected before vaccination and 30-40 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04053010) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
* Subjects aged 18-19 months old at the date of recruitment;
* With informed consent form (ICF) signed by parent(s) or guardian(s);
* Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
* Subjects have not been vaccinated with sIPV/DTaP/HepA at the age of 18-month-old yet;
* No less than 14 days since the last dose of vaccination;
* Axillary temperature ≤37.0℃.

Exclusion Criteria:

* With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
* Allergic to any ingredient of vaccine or with allergy history to any vaccine;
* Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
* Administration of immunoglobulins within 30 days prior to this study;
* Acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
* With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
* With any serious chronic illness, acute infectious diseases, or respiratory diseases;
* With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
* With any kind of infectious, purulent, or allergic skin diseases;
* With any other factor that makes the investigator determines the subject is unsuitable for this study.
Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer

To compare the kinetics and efficacy of two functionally different diagnostic agents, Lymphoseek (CD206 receptor targeted) and 99mTc-Sulfur Colloid (SC) (Sulfur Colloid non-specific mapping agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).

Single center, blinded, randomized, parallel-group, comparative study of Lymphoseek and 99mTc-SC in the preoperative and intraoperative detection of lymph nodes in subjects with known breast cancer. All subjects will receive a single dose of 50 μg Lymphoseek radiolabeled with 0.5 millicurie (mCi) Tc 99m or 0.5 mCi of 99mTc-SC. Subjects may also receive up to 1 mL of vital blue dye (VBD) as a companion ILM agent. All radio-labeled agents will be administered in a single intradermal injection.

Eligibility Criteria:
Inclusion Criteria:

* The subject must be female and 18 years of age or older.
* The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer
* The subject must have a diagnosis of primary breast cancer.
* The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.
* The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2
* The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study

Exclusion Criteria:

* The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.
* The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.
* The subject has a positive pregnancy test or is lactating.
* The subject has had prior surgery to the indicated breast or axilla.
Whole Body 111In-exendin-4 Imaging Study in Insulinoma Patients

The purpose of this study is to determine whether the investigators' new imaging modality (111In-exendin-4) has advantages in detecting insulinomas in comparison to conventional imaging.

Insulinomas arise from pancreatic cells and are the most frequent hormone-active tumours of the pancreas. Insulinomas produce insulin and can become life threatening if they cannot be localised and removed surgically. Complete tumour resection cures most patients, hence surgery is the treatment of choice for begin and malignant insulinomas. The potential for surgical cure necessitates accurate tumour localisation before surgery because preoperative imaging facilitates the detection of small localised, multiple and metastatic insulinomas. However, the successful localisation of insulinomas is an challenging problem since approximately 30% of insulinomas cannot be visualised radiographically.

A novel nuclear medicine scanning method using radioactive exendin-4 (111In-exendin-4) has recently been developed for imaging of insulinomas. 111In-exendin-4 accumulates specifically in insulinoma cells via the glucagon-like peptide-1 (GLP-1) receptor. The accumulation of 111In-exendin-4 can be visualised by the use of a special camera (Single Photon Emission Computed Tomography (SPECT) camera) that detects radioactivity and lights up tumours as hot spots.

The decision to perform surgery is independent of this study. If surgery is performed a small sample of the tumor will be used for identifying the sites where 111In-exendin-4 binds to the tumor.

Eligibility Criteria:
Inclusion Criteria:

* Biochemically proven endogenous hyperinsulinism confirmed by hypoglycaemia with neuroglycopenic symptoms, inadequately high serum insulin and C-peptide concentrations and negative sulfonylurea screening as well as low serum beta-hydroxybutyrate concentrations
* Able and willing to provide written informed consent

Exclusion Criteria:

* Renal insufficiency (creatinine \> 140 micromol/l)
* Pregnancy or positive pregnancy test which will be performed in all patients without contraception and aged \< 50 years
* Allergy to exendin-4 (Byetta®)
Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.

The goal of this comparative, interventional randomized controlled trial is to use albumin during resuscitation in pediatric burn patients on day 2, as it can reduce extravasation of fluids and decrease the overall fluid requirements, along with mortality and maintain circulation.

Participants will be divided into 2 groups. Albumin will be administered additionally in group A, while only crystalloids will be used for resuscitation in group B.

The randomized controlled trial will be done at Department of Pediatric Surgery, Mayo Hospital Lahore from January 2022 to December 2022. Ninety patients (forty-five patients in each group) will be enrolled using a non probability convenient sampling technique. Patients will be randomly divided into 2 groups. Albumin solution will be administered in group A and in group B only routine crystalloids will be given. Basic demographic information will be noted. Effect modifiers (hemoglobin, Albumin level, weight and height) will be noted.

Group A: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight(100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour. 12, 75 5% Albumin solution will be administered @0.5ml/kg/%burn over initial 8 hours of day 2 and It's amount will be subtracted from the 24 hours fluid calculated earlier.

Group B: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight (100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour.

Eligibility Criteria:
Inclusion Criteria:

* 25-40%, less than 12 hours old, scald or flame burn patients
* Full thickness

Exclusion Criteria:

* Burns with inhalational injury.
* Patients hypersensitive to Albumin.
* Deranged renal or hepatic profile.
* Patients with known Cardiac or debilitating Congenital anomalies.
* Patients with known metabolic disease.
* Burns associated with trauma including fractures, head injuries, intra-abdominal bleed etc.
* Albumin level lower than 1.8g/dl at time of admission.
The Natural History of Parkinson's Disease-associated Spinal Disorders

This is a prospective single-institution longitudinal study to access quality of life and serial imaging and biodynamic testing to assess spinal disorders associated with Parkinson's disease patients.

This is a prospective single-institution longitudinal study to access quality of life with PROMIS testing, ODI, NDI, VAS and short form 36 health physical component score. The study will also include serial radiographic assessments and biodynamic force plate and hand dynamometer testing. This study will follow for five years post-consent.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr scale 1-3) Age 18-75

Exclusion Criteria:

* Prior spinal fusion Diagnosis of ankylosing spondylitis, diffuse idiopathic spinal hyperostosis (DISH), or other systemic condition that affects spinal function Inability to consent Current incarceration Presence of other medical condition or neurologic condition that would hinder ability to perform biodynamic testing
A Study to Learn More About the Menopausal Hormone Therapies in Korea

The purpose of this study is to learn about how the commonly used menopausal hormone therapies were prescribed and taken in practice. This is done by using healthcare database, to study the overall dangers and benefits of menopausal hormone therapies in real-world practice.

This study will include subjects who were newly diagnosed menopausal symptoms between 2012 and 2019. They were all followed up for 12 months at least.

The study included the below subjects who:

* were aged 40-59 years
* were diagnosed to have menopausal symptoms through some medical check-ups

The data collected will be used to understand:

* how the commonly used menopausal hormone therapies were prescribed and taken in practice
* how patients took medication as prescribed by their doctors This might help to understand treatment trends of these therapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-59 years at cohort entry date
* Patients who had at least one inpatient or outpatient diagnosis of menopausal symptoms between 01 Jan 2012 and 31 Dec 2019 with any of following diagnosis codes: N95.1, N95.2, N95.3, N95.8, N95.9, M80.0, M81.0, M81.99, M85.99

Exclusion Criteria:

* Patients diagnosed with breast cancer (C50, D05), endometrial cancer (C54.1), and granulosa cell tumor (C56) within 1 year prior to the index date.
* Patients diagnosed with coronary heart disease (I20-I25, I51.6), stroke (I60-64), and VTE (I80.2, I80.3 I26) within 1 year prior to the index date.
* Patients diagnosed with viral hepatitis (B16-B19), cirrhosis (K70.2-K70.4, K71.7, K72.0-K72.1, K72.9, K74.0-K74.6, K76.1, K76.6-K76.7, R18, I85.0, I85.9, I86.4, I86.8, I98.2-I98.3), and hepatic cancer (C22) within 1 year prior to the index date.
* Patients diagnosed with gallbladder disease (K80, K81, K82, K83, K85.1), gallbladder cancer (C23), extrahepatic bile duct cancer (C24) within 1 year prior to the index date.
Study of Left Side of Laparoscopic Cholecystectomy

Prospectively selected 100 cases of patients who suffered from gallstones ro cholecystic polypus and treated with laparoscopic cholecystectomy in our hospital. Randomly divided into the experimental group and the control group. The experimental group preserve the main cystic artery, and the control group treated with conventional laparoscopic cholecystectomy. Collection of statistics: including general data(gender, age, BMI, etc.), time of surgery, intraoperative blood loss, incidence of surgical complications (delayed hemorrhage, biliary injury, etc.) and postoperative pain score, etc.

1. research object (1)patients who suffered from gallstones ro cholecystic polypus. (2)Informed and consented to participate in this clinical trial (3)Number of enrolled cases：100.（About 700 cases were treated in our hospital）
2. Inclusion criteria

(1) consistent with the indications of cholecystectomy (2) no cholangitis or pancreatitis (3) no diabetes (4) the operation time is less than or equal to 1 hour 3.Exclusion criteria

1. patients with acute cholecystitis
2. cystic arterial variation causes related complications
3. patients receiving analgesic drugs after surgery 4.research methods 4.1 Grouping method: random number table method was applied to randomly divide into 2 groups.

4.2 surgical method：Laparoscopic cholecystectomy with the preservation of the main cystic artery

1. General anesthesia, use laryngeal mask
2. making CO2 pneumoperitoneum through the superior border of umbilical pneumoperitoneum pressure 12 -- 14 mmHg(1 mmHg=0.(133 kPa), the puncture sleeve was placed under laparoscopy according to the three-hole method.
3. To expose the gallbladder triangle, cut the serous membrane of the triangular region along the gallbladder tube, expose the neck and the left half of the gallbladder tube, push the rest tissue of the triangular region (including the main cystic artery, etc.) to the right, and separate the right half of the gallbladder tube, exposing the whole gallbladder tube.
4. Cutting off after clipping the gallbladder tube;
5. Turn up the gallbladder neck, cut off the superficial and deep branches of the gallbladder artery by electric hook along the gallbladder wall.
6. Remove the gallbladder. through the umbilical hole and close the puncture hole. 4.3 main outcome measures

(1) General data of patients (gender, age, BMI, etc.); (2) Operation time, intraoperative blood loss, surgical complications (delayed hemorrhage, biliary tract injury, etc.) incidence.

Eligibility Criteria:
Inclusion Criteria:

1. consistent with the indications of cholecystectomy
2. no cholangitis or pancreatitis
3. no diabetes
4. the operation time is less than or equal to 1 hour

Exclusion Criteria:

1. patients with acute cholecystitis
2. cystic arterial variation causes related complications
3. patients receiving analgesic drugs after surgery
French Observatory of Rare Malignant Tumors of the Ovary

To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.

* to establish prognosis factors for the disease
* to proceed in a centralised examination of histologic laminas
* to reach in the long-term and homogenous follow-up of the patients
* to follow-up the long-term toxicities of the treatments given
* to analyse and follow-up the later fertility of the patients
* to evaluate the interest of setting a multi-disciplinary discussion forum on the Web

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* germinal or sexual cords ovary tumors histologically proven
* first line or relapse treatment
* written informed consent

Exclusion Criteria:

* mental ineptitude to understand and follow the study
Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery

Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis.

This results in a normal functioning aortic valve, with a low forward gradient across the left ventricular outflow tract.

Little is known about how the repaired aortic valve behaves in conditions of controlled exercise, and how the gradients across the valve change during exercise.

In a cohort of patients operated on since 2000 with a valve sparing operation for aortic root aneurysm in the Department of Cardiac surgery of the University Hospital Ghent, Belgium, and with gradients at rest across the aortic valve of \<20mmHg, a graded exercise test on a bicycle (stepwise increase of afterload) will be performed, and the gradient across the aortic valve will be monitored by transthoracic echocardiography at each exercise level. Patients with tricuspid and bicuspid valves will be compared. An age matched, unoperated, and asymptomatic control group with normal functioning tricuspid and bicuspid valves will be examined with the same exercise protocol.

The purpose of the study is the description of the gradients across the aortic valve during exercise, and the discrimination of risk factors that may induce increased gradients.

The hypothesis is that patients with bicuspid valves will demonstrate higher gradients than patients with tricuspid valves, in operated and unoperated individuals.

Eligibility Criteria:
Inclusion Criteria:

* been operated with a valve sparing root procedure in the University Hospital Ghent, Belgium, since 2000
* being able to perform an exercise test on a reclining bicycle
* normal left ventricular function

Exclusion Criteria:

* \<18 years or \>60 years of age
* peak gradient across the aortic valve at rest of \>20mmHg
* decreased left ventricular function
L-NMMA Dose-response Study in Healthy Subjects

The purpose of this study is to investigate the effect of different levels of nitric oxide inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor of the nitric oxide synthase, is administered as bolus injection followed by continuous infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age 18-35 years
* BMI 18.5-30.0

Exclusion Criteria:

* Tobacco or illicit drug use
* Current use of any prescription or non-prescription drugs
* Alcohol abuse
* History of heart failure, lever failure, chronic kidney disease or cerebral insult
* Diabetes
* Clinical or paraclinical signs of infection
* Pathologic ECG
* Ambulatory blood pressure \>140/90 mmHg
* Abnormal blood or urin screening tests
A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant Female Patients greater than or equal to 18 years of age
2. Induction of labor for a single live intrauterine pregnancy
3. Greater than or equal to 37 weeks gestational age
4. Cephalic presentation
5. 20 minute reassuring fetal heart rate (reactive nonstress test (NST))
6. Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.
7. Equal to 3 or less uterine contractions over 10 minutes

Exclusion Criteria:

1. Previous uterine scar
2. Contraindication to vaginal delivery
3. Patients with preeclampsia
4. Grand multiparty - greater than or equal to 5 live births or stillbirths
5. Premature rupture of membranes
6. Suspected intrauterine growth restriction
7. Fetal anomalies
8. Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)
Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes

Discharging patients home with air leak and chest tube to portable drainage device after thoracic resection is cost effective and safe without compromising patients outcome or satisfaction. Despite good outcomes this practice is not done universally by thoracic surgeons.

Medical chart database to identify patients ,of one thoracic surgeon over the last seven years, who underwent thoracic resection and were discharged home with an air leak and chest tube to portable drainage device was completed. Once all patients were identified, all possible vulnerable patients were discarded. Written consent for participation was obtained by eligible patients and subjects willing to participate were given further explanation of the study. All willing participants completed an Outpatient Chest Tube Quality of Life Questionnaire. Upon completion of the questionnaire participants involvement in the study was complete. Data was collected and correlations between variables statistically analysed to determine significant factors affecting care.

Eligibility Criteria:
Inclusion Criteria:

* all patients 18-89,
* all genders,
* all patients undergoing thoracic resection,
* all patients discharged with chest tube

Exclusion Criteria:

* minors,
* all patients \> 90 years old,
* all mentally challenged,
* all non-English speaking patients