cyrilzakka/clinical-trials huggingface dataset:
LMA Fixation Method

Proseal laryngeal mask airway (LMA) is frequently used for safe airway management in modern anesthesia. Improper fixation of the LMA may result in subsequent displacement despite initial correct placement. In this study, researchers aimed to present the detection method researchers developed for PLMA, which is different from the classical methods.

PLMA will place with a new fixation method in adult patients in the lithotomy position who will undergo uretero-renoscopic lithotripsy. The fixation will prepare by sewing a button on one end of the adjustable elastic. Successful insertion will assess clinically (capnogram, appropriate chest excursion, and the absence of an audible leak at a peak inspiratory pressure of 20 cm H2O) and with a fiberoptic bronchoscope (FOB) (grade and distance visible to vocal cords). At the end of the operation, it will be examined whether there is any displacement.

SPSS 21.0 (Version 22.0, SPSS, Inc, Chicago, IL, USA) program will be used for statistical analysis. After applying the Shapiro-Wilk test for normality, the student's t test will be used if the distribution is normal, and the Mann-Whitey U test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p\<0.05 will be considered significant.

Proseal laryngeal mask airway (LMA) is frequently used for safe airway management in modern anesthesia. Improper fixation of the LMA may result in subsequent displacement despite initial correct placement. In this study, researchers aimed to present the detection method researchers developed for PLMA, which is different from the classical methods.

PLMA will place with a new fixation method in adult patients in the lithotomy position who will undergo uretero-renoscopic lithotripsy. The fixation will prepare by sewing a button on one end of the adjustable elastic. Successful insertion will assess clinically (capnogram, appropriate chest excursion, and the absence of an audible leak at a peak inspiratory pressure of 20 cm H2O) and with a fiberoptic bronchoscope (FOB) (grade and distance visible to vocal cords). At the end of the operation, it will be examined whether there is any displacement.

SPSS 21.0 (Version 22.0, SPSS, Inc, Chicago, IL, USA) program will be used for statistical analysis. After applying the Shapiro-Wilk test for normality, the student's t test will be used if the distribution is normal, and the Mann-Whitey U test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p\<0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing urologic surgery using LMA
* ASA Physical Status I-III
* Mallampati score I-II

  * 18 years

Exclusion Criteria:

* Patients who did not want to participate in the study
* Restricted mouth opening
* BMI ≥ 35 kg/m2
* Risk of airway malformation and aspiration (gastroesophageal reflux, hiatal hernia, history of previous gastric surgery, GIS motility disorder)
Vitamin D Supplementation After Parathyroid Surgery

A randomised double blind clinical trial, accepted by the Medical Products Agency and registered in the European Clinical Trials Database. Aims to evaluate the prevalence of vitamin D deficiency in a pHPT population in relation to gender and age, the correlation between vitamin D status, pre- and postoperative parathyroid hormone level and bone density and the correlation between vitamin D status, metabolic, cardiovascular risk factors and QoL aspects before and after parathyroid adenomectomy.

150 PHPT patients were randomized six weeks after surgery, 75 into each group, to 1 year of oral treatment with either calcium carbonate 1 g (500 mg twice daily) alone or calcium carbonate 1 g combined with cholecalciferol 1600 IU (800 IU twice daily). Exclusion criteria were age under 18, manifest osteoporosis at PHPTdiagnosis, persistent hypercalcemia after surgery, postoperative hypocalcemia requiring vitamin D treatment, glomerular filtration rate (GFR) below 40 ml/min, pregnancy, breast feeding, or logistical difficulties, for example living far from the hospital. Included patients had to withdraw any current supplementation with calcium and vitamin D during the study period. All tablets were identical in appearance, the tins were numbered and randomization followed a list compiled by an independent clinical research support organization. The time for randomization was chosen to make sure that the PHPT patients were cured before starting the study medication. Nearly three-quarters of the patients were randomized within 6 weeks after PTX.The primary end point was the change in PTH after PTX and treatment with the study medication. Secondary end points were vitamin D levels, insulin resistance, blood pressure and other cardiovascular risk factors, biochemical markers of bone turnover, bone mineral density and self estimated health related quality of life (SF- 36).

Eligibility Criteria:
Inclusion Criteria:

* Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion Criteria:

* Renal insufficiency
* Severe osteoporosis
* Pregnancy
Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients

The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks. Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.


Eligibility Criteria:
Inclusion Criteria:

* Females 18 years to 40 years of age
* Diagnosed as PCOS by the 2003 Rotterdam criteria.
* Overweight/obesity (BMI≥25 kg/m2)
* No pregnant plan in recent 6 months
* Written consent for participation in the study

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
* Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
* Serious systemic disease or malignant tumor
* History of pancreatitis (chronic, acute or recurrent)
* Body weight change ≥10% at 3 months before treatment
* Used oral contraceptives or sex hormone drugs in the past 1 month
* Used oral glucocorticoids in the past 1 month
* Substance (alcohol or drug) abuse or dependence within 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d)
* Subjects have a severe systemic disease, such as cardiovascular system
* Renal impairment, eGFR\<60ml/min/1.73m2
* Increase of transaminases up to \< 2.5 times of upper limit of normal value
* Have a history of thromboembolic disease or thrombotic tendency
* Subjects in pregnant or lactating or within 1 year after delivery.
* Subjects have an allergic history to the drugs used in the study
* Subjects have participated in other clinical researches of medicine within 1 month prior to randomization.
* Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening.
The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List

The purpose of this study is to investigate the effect of two different doses of vitamin D3 (2000 IU vs. 4000 IU) on serum 25-hydroxyvitamin D (25OHD) levels in patients with hepatocellular carcinoma on the liver transplant list. The study will help determine the dose of vitamin D3 that is required for patients with liver cancer to reach a normal level of 25OHD in the blood.

Potential participants will be identified from Mount Sinai Hospital's active liver transplant list. The hepatologists at Mount Sinai's Transplant Institute will ask each potential participant if she/he is interested in participating. If the patient expresses an interest in the study, one of the researchers will meet with the patient when the patient is at Mount Sinai for a regular appointment and will describe the study to the potential participant. If a patient continues to be interested in participating, she/he will be given a copy of the IRB-approved consent document to read. The consent document will be used as a guide for explaining the study in detail to the patient. If the patient's preferred language is Spanish, she/he will be given a consent document in Spanish and the study will be explained in Spanish.

Once the subject's 25(OH)D level is known, if the subject's 25(OH)D level is ≤ 15 ng/ml, the participant will be contacted by one of the investigators on the research team and instructed to begin taking 2 tablets per day (4000 IU total) of vitamin D. If the subject's 25(OH)D level is greater than 15 and ≤ 25, the participant will be contacted by one of the investigators on the research team and told to begin taking 1 tablet (2000 IU total) per day of vitamin D. If the participant's vitamin D level is \< 25 ng/ml, they are considered Vitamin D insufficient/deficient. If the Serum Vitamin D is \> 25 ng/ml they will be informed that they are not to take any vitamin D and they will be followed as controls for this study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years and older)
* Diagnosis of hepatocellular carcinoma
* On the list awaiting liver transplantation
* Able to give informed consent
* Expected to receive care following liver transplantation at the Mount Sinai School of Medicine
* Any race/ethnicity/socioeconomic status

Exclusion Criteria:

* Pediatric patient (less than 18 years of age)
* Unable to give informed consent
* Untreated primary hyperparathyroidism (ICD9 codes 252.01XX and 252.00XX)
* Untreated hypercalcemia (serum calcium level \> 11 mg/dl; ICD9 codes 275.42XX, 259.3XX, 252.00F)
* Pregnancy (will be determined by asking the patient and reviewing the medical record)
Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches

This study attempts to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b Colorectal cancer.

Laparoscopic surgery is controversial for patients with T4b colorectal cancer who require multivisceral resection. With the expansion of the indications for laparoscopic surgery in recent years, surgeons try to perform laparoscopic multivisceral resection for the treatment of clinical T4b colorectal cancer. In this study, investigators attempted to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b colorectal cancer.

This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization. According to the operation method, the patients were divided into laparoscopic multivisceral resection group(patients who underwent laparoscopic surgery or conversion to open surgery) and open multivisceral resection group(patients who underwent open surgery directly). The short-term and long-term result was compared between groups.

Eligibility Criteria:
Inclusion Criteria:

1. The patient was pathologically diagnosed as colorectal adenocarcinoma by endoscopic biopsy before operation.
2. All patients were considered to have tumors invading adjacent organs after preoperative radiographic evaluation.
3. All patients were recommended to undergo radical surgery after preoperative multidisciplinary consultation.

Exclusion Criteria:

Patients with distant metastasis or recurrent colorectal cancer were excluded.
Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes

This trial is conducted in Japan. The aim of this trial is to assess the safety after multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Duration of diabetes for more than 12 weeks
* Subjects currently on diet therapy (OHA-naïve) or treated with OHA (oral hypoglycaemic agent)
* monotherapy for more than 12 weeks
* HbA1c (Glycated haemoglobin A1c) between 6.0-9.0 %, both inclusive
* Body Mass Index (BMI): 18.5-30.0 kg/m\^2

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Current treatment with insulin preparations or TZDs (thiazolidinediones)
* Current treatment or expected at the screening to start treatment with systemic corticosteroids
Study of the Spread of COVID-19 in Saint Petersburg, Russia

Seroprevalence study of COVID-19 in Saint Petersburg, Russia is a regional longitudinal cohort study aiming to evaluate the spread dynamics of the COVID-19 disease in the population of Saint Petersburg. Clinically asymptomatic adults are sampled from the population using random digit dialing and tested for the presence of SARS-CoV-2-specific antibodies in the blood serum. Data collection and serial sampling of the same individuals spans four weeks and is conducted every two weeks in order to understand both the spread of the virus in the population.

At least 1 000 individuals, 18 years old and older, are randomly sampled using random digit dialing from the population of Saint Petersburg, Russia. Random sampling is performed by a survey company on the list of mobile phone numbers with designated geography prefixes of St. Petersburg. The baseline questionnaire for computer-assisted telephone interview includes travel history, medical history, and socio-economic status of the respondents. Sampled individuals are then invited to the clinic for blood sampling, their refusal to participate is recorded. Collected blood samples are used for SARS-CoV-2-specific antibodies testing. Data and sample collection spans four weeks and is conducted every two weeks. Participants complete additional questionnaires in the clinic providing information on medical history, history of allergies, chronic disease, smoking, and medication taken regularly. Contact tracing data and environmental conditions of the household are reсorded.

Eligibility Criteria:
Inclusion Criteria:

* Individuals sampled from the population of Saint Petersburg, Russia using random digit dialling.
* Subjects aged 18 and older of both genders.
* Asymptomatic at the time of blood draw.
* Written informed consent for a blood draw, SARS-COV-2 antibody test, and data collection.

Exclusion Criteria:

* Presence of fever or cough or respiratory distress at the time of blood test not attributable to other known chronic disease.
* Age under 18.
* Any health condition that may be a contraindication towards blood sampling in out-patient clinic.
* Residence in Kolpinskiy, Kurortniy, Krasnoselsky, Kronshtadtskiy, Petrodvorcoviy, Pushkinskiy districts of St. Petersburg.
Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD

To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)

Multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate four dose groups of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in up to a maximum of 25 subjects with neovascular age-related macular degeneration

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neovascular age-related macular degeneration in the study eye.
* Active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Two or more prior anti-VEGF intravitreal injections
* EDTRS BCVA score ≤ 75 and ≥ 20 letters

Exclusion Criteria:

* Any active ocular disease, ocular disorders or conditions, prior ocular surgery or infection in the study eye other than nAMD
* Other than IVT anti-VEGF treatments, no topical ocular or intraocular or periocular corticosteroid, or other treatments for CNV
* IOP ≥ 25mmHg or cup-to-disc ratio \>0.8
* Uncontrolled systemic disease (high risk or evidence of arterial and venous thromboembolism, CVA or stroke, unstable cardiovascular disease, uncontrolled hyperthyroidism, poor glycemic control, gastrointestinal bleed and/or high risk of GI perforation or fistula formation) or any other condition or therapy that would make the participant unsuitable for the study
* Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit
The Detection of Early Dementia With the Digital Game Memory

The investigators are going to test if it is possible to detect early dementia with the digital game "memory". The investigators are going to test 15 healthy people and 15 patients with early dementia.

The test consists of playing the game "memory" several times. While playing, several parameters are stored.

The investigators are going to test if any correlation can be found between these parameters and the cognitive state of the person as tested by the Mini-Mental status examination.


Eligibility Criteria:
Inclusion Criteria:

* healthy 75-plusser
* 75-plusser with early dementia

Exclusion Criteria:

* younger than 75
* patient with other cognitive impairments than dementia
Comparison of Treatments in Venous Insufficiency

Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.

In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic superficial vein insufficiency
* patient must be 20-70 years old
* degree of difficulty of vein insufficiency C2-C4
* average diameter of refluxing great saphenous vein 4 -10 mm
* patient is agreeable to the study

Exclusion Criteria:

* peripheral atherosclerotic occlusive disease
* lymphoedema
* severe concomitant disease
* venous ulcers or unclassified skin changes
* BMI more than 40
* pregnancy
* allergy to the foam used in sclerotherapy or to local anaesthetics
* coagulation disorder
* bilateral vein insufficiency (equal symptoms)
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained
2. Male and female patients \<5 months (152 days) of age
3. Patients undergoing cardiopulmonary bypass

Exclusion Criteria:

1. Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
2. Trisomy 13 and 18
3. Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
4. Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
5. Prior participation in the clinical trial
Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood

The purpose of this study is to collect maternal blood samples from pregnant women carrying a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.

The goal of this study is to further develop a non-invasive prenatal blood test that can diagnose genetic disorders in the fetus by looking at fetal DNA (genetic material) found in the mother's bloodstream during pregnancy.

Women carrying a fetus diagnosed with microdeletions/microduplications (small missing or extra pieces of DNA that can cause problems), aneuploidy (trisomy 21, 18, or 13) or other genetic disorders will be asked to participate.

If this study is successful, it will reduce the need for invasive procedures during pregnancy such as amniocentesis and chorionic villus sampling (CVS) but still enable women to find out accurate information regarding their baby's health early in the pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older at enrollment
* Gestation age of at least 9 weeks, 0 days by best obstetrical estimate
* One or more fetuses with a clinically confirmed diagnosis of a genetic variant of interest via karyotype, FISH, chromosomal microarray or other genetic assay AND/OR
* One or more fetuses with any variant of fetal structure that is expected to require medical or surgical intervention in the newborn period, shorten lifespan, affect intellectual development or otherwise indicate a genetic anomaly AND/OR
* Positive high risk noninvasive prenatal screening or serum screening result
* Able to provide informed consent

Exclusion Criteria:

•Maternal history of bone marrow or organ transplantation
Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* acute asthma exacerbation
* requiring oral systemic corticosteroids for management

Exclusion Criteria:

* preference for pills over liquid formulation
* history of Nissen fundoplication surgery
* needed immediate airway intervention
* require oral medications to be given via a G or J tube
* if patient care would be compromised
* enrolled in the study on a previous visit.