cyrilzakka/clinical-trials huggingface dataset:
Submucosal Saline Injection Followed by Endoscopic Ultrasound

Endoscopic ultrasound (EUS) is unsatisfactory in distinguishing between T1a and T1b stage esophageal squamous cell carcinoma (ESCC). Consequently, the National Comprehensive Cancer Network guidelines recommend endoscopic resection (ER) as a diagnostic tool for substaging T1 stage ESCC. However, as an invasive approach, diagnostic ER is not an optimal approach especially for T1b cases as most of them might not be fully cured by ER. It is necessary to develop reliable and less invasive methods to distinguish between T1a and T1b stage ESCC. In our previous unicentral trial, we found that submucosal saline injection (SSI) significantly improved the diagnostic accuracy of EUS in differentiating between T1a and T1b stage ESCC. It can be used as an alternative to diagnostic ER for preoperative substaging T1 stage ESCC cases in remote regions where few endoscopists are able to perform diagnostic ER. The use of EUS and SSI would help T1b stage patients avoid invasive diagnostic ER.

Therefore, we aim to conduct a multi-center clinical trail to examine whether SSI can improve traditional EUS accuracy in distinguishing between T1a and T1b stage ESCC.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old, no gender limited;
* Patients with esophageal squamous cell carcinoma who be confirmed by ordinary endoscopy and pathologic biopsy;
* Patients who agree to accept endoscopic resection or surgical excision of the lesion in esophagus;
* patients with normal cardio-pulmonary function and normal coagulative function,are predicted to be tolerated anesthesia and surgery;
* patients who understand test purpose, volunteer to join these study and sign the consent inform.

Exclusion Criteria:

* Patients with stages of T2, T3, or T4 displayed by EUS;
* Patients who can't tolerate endoscopy and surgical treatment for various reasons;
* Patients who have distant metastasis, or multiple source of malignant tumors;
* Patients with blood coagulative disorder;
* Patients don't accept the endoscopic examination or surgical treatment;
* Patients with poor compliancy.
E-PRIME For Children With Medical Complexity

Children with medical complexity (CMC) have very high needs for health and support services. CMC have very rare diseases that involve multiple organ systems. As a result, all CMC have multiple chronic conditions and need care from many specialists and services. While there are important benefits to the child and family in living at home, the continuing need for complex medical care places a profound burden on caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.

The specific aims of this study are to: compare the effectiveness of Enhanced Primary Care via Telehealth (E-PRIME) verses usual care in improving child-level appointment and outcome measures; compare the effectiveness of (E-PRIME) verses usual care in reducing caregiver stress and improving caregiver satisfaction in primary care and care coordination services; evaluate how acceptable, appropriate, and feasible E-PRIME is from the perspective of practice providers and staff, and caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.

Eligibility Criteria:
Inclusion Criteria:

* Less than 18 years of age on the date of enrollment (date consented)
* Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months
* Complexity of the condition, defined as needing ongoing care with 4 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)

Exclusion Criteria:

* CMC whose permanent address is outside of the state of North Carolina
* CMC at a long-term care facility
* CMC who are wards of the state, except when the caregiver is a legal guardian and can consent
* CMC whose caregivers do not speak English or Spanish
Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.

The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined at baseline and after 6 weeks, 6 months and 2 years.

Levels of glutamate and gamma-aminobutyric acid (GABA) are measured by proton magnetic resonance spectroscopy (1H-MRS) in the anterior cingulate cortex ACC and thalamus. Presynaptic Dopamine level is measured with Positron Emission Tomography Computed Tomography (PET/CT)-scanning using 3,4-dihydroxy-6-\[18F\]fluoro-L-phenylalanine (18F-DOPA). Disturbances of the reward system is measured with functional magnetic resonance imaging (fMRI) . Regional cerebral blood flow and activity in the same regions are measured with Pseudo-continuous arterial spin labelling (pCASL). The default mode network, functional and structural connectivity in the associated macro circuits are measured with resting state fMRI, EEG, and diffusion tensor imaging. Structural brain changes (in grey and white matter) are measured with MRI. Cognitive functions are measured with a neuropsychological test battery, and early information processing with event related EEG and electromyography (EMG) (psychophysiological examinations). Further patients psychopathology will be rated.

Eligibility Criteria:
Inclusion Criteria Patients:

* Fulfilling the diagnostic criteria of schizophrenia or schizoaffective disorder according to ICD-10 (International Classification of Diseases version 10) or DSM-IV/V (Diagnostic and Statistical Manual version 4 /5)
* Age 18-45 years
* Never treated with antipsychotic compounds or central nervous system (CNS) stimulants
* Legally competent

Inclusion criteria controls:

* Matching patients on age (+/- 2 years), sex and parental socioeconomic status
* Age 18-45 years
* No psychiatric or physical disease

Exclusion Criteria patients:

* Substance abuse on a daily basis during the last 3 month or patients fulfilling the criteria of ongoing substance abuse due to ICD-10/DSM-IV/V
* Treatment with antidepressant during the last 30 days
* Head injury with more than 5 minutes of unconsciousness
* Patients involuntarily admitted or treated
* Components of metal implanted by operation
* Pacemaker
* Pregnancy
* Severe physical illness

Exclusion criteria controls

* First degree relatives with psychiatric disease
* Substance abuse during the last 3 month or positive screening of drugs in urine-sample
* Head injury with more than 5 minutes of unconsciousness
* Components of metal implanted by operation
* Pacemaker
* Pregnancy
* Severe physical illness
Male Infertility and Assisted Reproductive Technologies Research Biobank

The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART).

The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART). These specimens include testicular tissue, sperm, semen samples, donor sperm or discarded sperm preps. These samples were possibly utilized for diagnostic testing such as semen analyses or DNA fragmentation testing or for ART procedures such as intrauterine insemination (IUI) in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) and are no longer needed clinically. Rather than discarding those samples the men who provided them or the sperm recipient in the case of donor sperm may elect to donate them for future research purposes. These samples will be used for future research regarding male infertility and assisted reproductive technologies.

Eligibility Criteria:
Inclusion Criteria:

* Males providing testicular tissue, sperm, semen samples, discarded sperm preps for IUI/IVF/ICSI or the sperm recipient for those utilizing donor sperm, for cryopreservation at the respective site(s) for either clinical use or preservation

Exclusion Criteria:

* Samples that are quarantined or in isolation dewars for infectious diseases
Colistin-rifampin Combination and Colistin Monotherapy in Extensively Drug-resistant Acinetobacter Baumannii

The investigators aimed to confirm the utility of the synergy test results (E-tesT) in vitro to predict the efficacy and safety of colistin-rifampin combination and colistin monotherapy in extensively drug-resistant acinetobacter baumannii.

We will searched pneumonia patients with CoRAB in Gangnam Severance Hospital. Subjects will be enrolled and randomized in a blinded fashion using a computerized random number generator (permuted-block randomization) for treatment with colistin and rifampin combination and colistin only at a ratio of 1:1. We will perform the E-test MIC:MIC ratio method to predict in vitro synergy of colistin and rifampin combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* Pneumonia, blood septicemia, urinary tract infection, or other infection or even colonization with evidence of extensively drug-resistant Acinetobacter baumannii infection

Exclusion Criteria:

* Hypersensitivity reaction to colistin or rifampin
* use of colistin or rifampin in 15 days prior to screening
* evidence of extensively drug-resistant Acinetobacter baumannii infection in 15 days prior to screening
* CLcr \< 15 mL/min, ALT or AST \> 3xULN, total bilirubin \> 2xULN, Hb \< 7 gm/dL, ANC \< 500/mm3, Platelet \< 50,000/mm3
Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum

This study evaluates the gallbladder functions and serum cholecystokinin levels in pregnant women diagnosed with hyperemesis gravidarum. Half of the participants are healthy pregnant women and half of the participants are pregnant women diagnosed with hyperemesis gravidarum. Two groups will be compared by means of gallbladder functions and serum cholecystokinin levels.

Previously gallbladder functions have been observed in human with gallbladder disease. However it has never been evaluated whether there is any difference in gallbladder functions between healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum. Moreover correlation between hyperemesis gravidarum symptom scores and gallbladder functions has never been assessed. There is also few data comparing serum cholecystokinin levels between healthy pregnant women and those diagnosed with hyperemesis gravidarum. The investigators will measure serum cholecystokinin levels after a fatty meal (100 g chocolate) and compare two groups. In this study the investigators would like to evaluate gallbladder functions and serum cholecystokinin levels in women with hyperemesis gravidarum and compare these with healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* gestation week between 6 and 14 weeks,
* singleton pregnancy with a live embryo,
* healthy women without any medical disorders,

Exclusion Criteria

* any systemic disease,
* gallbladder disease
* any psychological disorder that can cause vomiting,
* multiple gestation
Study of CEP-701 in Treatment of Prostate Cancer

The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.

A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 yrs of age
* diagnosis of adenocarcinoma of the prostate
* no detectable metastatic disease as assessed by bone and CT scans
* has increasing serum PSA concentrations
* life expectancy of at least 3 months
* ECOG of 0 or 1
* has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period

Exclusion Criteria:

* has asymptomatic disease
* has active GI ulceration or bleeding
* has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
* bilirubin \>2x ULN or ALT or AST \>2xULN or serum creatinine \>1.5mg/dL
* hemoglobin \<9g/dL or platelets below 100,000/uL or ANC below 1500/uL
* receiving treatment for HIV with protease inhibitors
* has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
* has used investigational drug with previous one month
Role and Molecular Mechanism of Farnesoid X Receptor(FXR) and RIPK3 in the Formation of Acute Respiratory Distress Syndrome in Neonates

In the clinical data, the changes of RIPK3 and FXR were monitored in the lung lavage fluid and blood from the patients.

In vivo experiments to find high risk factors to induce AEC necrosis and further lead to ARDS evidence, can provide a more direct theoretical research foundation for the pathogenesis of ARDS.

Divided into 3 Arms ALI :Diagnostic criteria: 1.Acute onset；2.FiO2/ PaO2\< 40.0 kPa (300mmHg, ALI); 3.Chest X-ray showed that the double lung texture increased, the increase of crude, fuzzy, visible diffuse patchy infiltration shadow with compensatory emphysema, for the most early performance; B. double lung field large sheet, asymmetric, edge fuzzy infiltration shadow, the most dense in the lung；4. Echocardiography, left atrial hypertension; 5.The gestational age \>35 week, have maternal age cholestasis (severe), sepsis or meconium aspiration syndrome (MAS) understanding of history, and with the exception of the primary pulmonary surfactant (PS) lack of.

ARDS :Pediatric acute respiratory distress syndrome (ARDS) is a severe lung injury caused by pneumonia, sepsis, and trauma.Diagnostic criteria: 1.Acute onset；2.FiO2/ PaO2\< 26.7 kPa (200mmHg, ARDS); 3.Chest X-ray showed that the double lung transparent brightness is generally lower, the glass sample, with bronchial inflatable sign, and even double lung field common density increased, the heart shadow is not clear, a white lung, as the most important performance；4. Echocardiography, left atrial hypertension; 5.The gestational age \>35 week, have maternal age cholestasis (severe), sepsis or meconium aspiration syndrome (MAS) understanding of history, and with the exception of the primary pulmonary surfactant (PS) lack of；6.Need to use a ventilator.

Control group: Patients with mechanical ventilation due to external causes of the lung, no ALI-ARDS performance,FiO2/ PaO2\< 40.0 kPa (300 mmHg), such as premature apnea or HIE.

Eligibility Criteria:
Inclusion Criteria:According to the diagnostic criteria, the diagnosis was ALI or ARDS； Exclusion Criteria:Severe congenital or hereditary disease of the newborn, is clearly diagnosed as NRDS, which is caused by the lack of the primary PS。
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.

This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time.

Hip dysplasia is a developmental abnormality of the acetabulum (hip socket) that causes abnormal stresses inside the hip joint and leads to painful arthritis at a young age. Many patients develop painful symptoms in their hip before advanced arthritis occurs.

The periacetabular osteotomy (PAO) is a surgical procedure that reorients the acetabulum to reduce the stresses inside the hip joint. The PAO is very effective at improving symptoms and quality of life. However, some patients may have residual symptoms.

Frequently, people with hip dysplasia will have an MRI done before their surgery, which helps to identify other the abnormalities inside their hip joint (e.g., labral tears). These abnormalities inside the joint cannot easily be addressed through PAO alone, however they can be addressed with hip arthroscopy. Hip arthroscopy is a separate minimally invasive surgical procedure that allows the surgeon to access the inside of the hip joint with a small camera and address any abnormalities.

At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.

This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time. Patients will be followed for 2 years after surgery. Symptomatic differences between the two patient groups will be assessed to determine added benefit of the hip arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia/hip instability
* Pre-Operative MRI at 3T and/or gadolinium MR arthrogram
* Age, 16-50 years old
* Patient capable of giving informed consent

Exclusion Criteria:

* Prior hip/pelvis surgery of any kind on the surgical side
* Prior hip arthroplasty surgery on either side
* Radiographic evidence of arthritis (i.e. Tönnis grade =2)
* Known connective tissue disorder (e.g. Ehlers-Danlos Syndrome, etc.)
* Known neuromuscular disorder (e.g. Cerebral Palsy, Spina bifida, etc.)
* Known skeletal dysplasia (e.g. Achondroplasia, Multiple Epiphyseal Dysplasia, etc.)
* Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires.
* Patient unable/unwilling to complete all required follow-up visits
* Concurrent proximal femoral osteotomy and/or surgical hip dislocation
The Relationship Between Plantar Fascia and Achilles Tendon Thickness Asymmetry and Spatio-temporal Parameters of Gait

There are studies on loading the foot with an increase in the thickness of the Plantar Fascia and Achilles Tendon.

However, no study was found that evaluated the relationship between morphological features such as plantar fascia and Achilles tendon thickness and spatio-temporal parameters of gait in healthy individuals.

In this study, it is aimed to investigate the relationship between the asymmetry in the thickness of the plantar fascia and Achilles tendon and the asymmetry in the spati-temporal parameters of gait.

Healthy adult volunteers aged 20-40 will participate in the research. Demographic data of the participants will be recorded in the study. Following this, a clinical evaluation of the foot and ankle will be made. The Optogait Photoelectric Cell System (Microgate, Bolzano, Italy) device will be used to record the spatio-temporal parameters of gait, and the Sonostar Double Head Wireless Mini Ultrasound device (Sonostar Inc., China) will be used to assess the thickness of the plantar fascia and Achilles tendons.


Eligibility Criteria:
Inclusion Criteria:

* Being physically healthy (No symptoms or complaints at the moment, and no disease or trauma affecting the musculoskeletal system in the last 6 months)
* Being 20-40 years old
* Body Mass Index (BMI) being within the limits accepted as normal (18.5-24.9kg/m2) according to the World Health Organization (WHO)
* Classification of foot type as normal (API score= 0 to +5) as a result of the evaluation made with the Foot Posture Index (API) (38)
* Not having done any compelling (jogging, walking, weight or resistance training, yoga, pilates, aerobics, collective exercise sessions such as stepping...) exercises and activities in the last 2 days before the evaluation.

Exclusion Criteria:

* Disease or problems that may affect walking (plantar fasciitis, having to use walking aids, visual or hearing impairment, other problems related to the lower extremities or spine)
* Having undergone orthopedic trauma or surgery involving the lower extremity
* Having symptoms of severe shortness of breath or intolerance of walking while walking
* Person; have a medical history that may indicate an increased risk of falling, such as fainting of unknown cause, blood sugar imbalance, unstable low or high blood pressure
* Congenital (pes planus, pes cavus, pes equinovarus, vertical talus, etc.) or acquired (pes planus and planovalgus, pes cavus, other deformities associated with foot arches...) foot deformity defined by clinical evaluation
* Presence of cardiovascular, neurological or musculoskeletal orthopedic or rheumatological disease or systemic disease associated with diabetes, connective tissue disorder
* In addition, hypoechoic areas, perifascial fluid, and plantar fascia thickness measuring more than 4 mm during ultrasound imaging (39).
Angeliq Regulatory Post Marketing Surveillance

Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500.


Eligibility Criteria:
Inclusion Criteria:

* Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause
* Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis

Exclusion Criteria:

* Undiagnosed genital bleeding
* Known, past or suspected cancer of the breast
* Known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer)
* Untreated endometrial hyperplasia
* Previous idiopathic or current venous thromboembolism (e.g. deep venous thrombosis, pulmonary embolism)
* Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)
* Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
* Porphyria
* Severe renal insufficiency or acute renal failure
* Known hypersensitivity to the active substances or to any of the excipients