cyrilzakka/clinical-trials huggingface dataset:
Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome

There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer. Because these children now live longer, researchers are recognizing developmental disabilities (the children are behind in their thinking or physical activity) in children with hypoplastic left heart syndrome. The purpose of this research study is to help the investigators learn more about developmental disabilities in children with hypoplastic left heart syndrome.

During the time of your child's first surgery for hypoplastic left heart syndrome, a monitor was placed on your child's forehead to measure the oxygen levels in the brain. This monitor is called Near Infrared Spectrometry (NIRS). The researchers involved in this study want to know if oxygen levels in the blood vessels of the brain have any effect on developmental disabilities later in life in children with hypoplastic left heart syndrome. The researchers plan to enroll 60 research subjects.

Our study is a cross-sectional, descriptive study to evaluate the developmental outcome for school-age children with HLHS. The general approach of the proposed research is confirmatory study/hypothesis testing. The hypothesis (neurodevelopmental outcome of children with HLHS is inversely correlated with cerebral oximetry values as measured by NIRS in the 48 hours following the Norwood operation) was formulated based on a meticulous review of the literature, which clearly demonstrates a substantial prevalence of neurodevelopmental deficits in children with HLHS who have undergone surgical palliation. The methodologies for measuring developmental outcome are highly reproducible and have been validated in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Hypoplastic left heart syndrome is defined as normal segmental anatomy with mitral and/or aortic atresia or stenosis and a left ventricle too small to sustain the systemic circulation
2. Ages 2.5 to 6 years old
3. Surgical palliation with the Norwood procedure (Stage I palliation) at Children's Healthcare of Atlanta after January 1, 2001

Exclusion Criteria:

1. Primary language in the home is not English
2. Named genetic syndrome associated with profound developmental delay, such as DiGeorge Syndrome
Laser Treatment Of Leg Telangiectasias

Is 1064 nm YAG Laser better than sclerotherapy to treat leg veins?

Comparison between laser and sclerotherapy in the treatment of telangiectasias of legs.

Eligibility Criteria:
Inclusion Criteria:

* patients with leg telangiectasias

Exclusion Criteria:

* varicose veins
* DVT
* pregnancy
Probiotics in Occupational Shift Workers

Purpose: To evaluate the influence of probiotic supplementation on body composition and other markers of health in occupational shift-workers.

Participants: Healthy, overweight females (ages 22-55 yrs) who are employed on a shift-working schedule.

Procedures (methods): In a randomized, placebo-controlled intervention, subjects will complete 3 different testing sessions (pre-screening, 1 baseline, 1 post-testing session) as well as a 6-week intervention period. Prescreening will include written informed consent, a health history questionnaire, baseline anthropometric measures, assessment of resting heart rate, and exercise protocol familiarization. Baseline testing will involve body composition, a fasted blood draw, mood surveys, and an exercise treadmill test. Subjects will be randomized to a treatment group (multi-strain probiotic or placebo) for 6 weeks of supplementation that includes 2 electronic contacts, followed by post-testing that will occur in the same fashion as baseline testing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, pre-menopausal women
* Currently employed on a shift-working (rotating, evening, or night) schedule and has maintained this schedule ≥ 6 months prior to enrollment
* Participant agrees to maintain usual activity lifestyle
* Participant has a body mass index of ≥25 kg/m2
* Participant has provided written and dated informed consent to participate in the study
* Participant is willing and able to comply with the protocol
* Participant is apparently healthy and free from disease, as determined by a health history questionnaire
* Participant agrees to abstain from smoking, caffeine, tobacco, and alcohol before testing days
* Participant is not currently pregnant and does not desire to become pregnant in the next 8 weeks.

Exclusion Criteria:

* Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders
* Participant is using, or has used a probiotic supplements within 8 weeks prior to enrollment
* Participant has lost or gained greater than 8 pounds within the previous 2 months
* Participant is in, or has participated in another clinical trial within 4 weeks prior to enrollment
* Participant had or currently has a self-identified eating disorder
* Participant is pregnant or plans on becoming pregnant
* Participant has a known allergy or sensitivity to any ingredient in the test product or placebo (determined from health history questionnaire)
Comparison of Three Approaches of Electrode Placement to Detect Changes in Motor Evoked Potentials During Spine Surgery

Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. This study investigates the utility of three separate quadriceps MEP recording approaches over a total of 40 limbs (20 participants).

The long-term objective of this research is to understand how differing recording techniques may enhance the ability to accurately identify clinically relevant changes in Motor Evoked Potentials (MEPs) during a variety of surgeries where the central motor tracts or lumbar spinal roots are at risk.The specific aims of the proposed research are:

1. Using transcranial magnetic stimulation, evaluate the effects on compound muscle action potentials utilizing intramuscular bipolar recording vs subdermal referential recordings vs subdermal bipolar recordings.
2. Evaluated the variability of amplitude and area between the intramuscular and subdermal recording techniques.

The initial focus will be on recording techniques to obtain stable MEPs in a proximal lower limb muscle, specifically the quadriceps. Continuation research may focus on stimulation techniques to facilitate proximal MEPs and ultimately to improved specificity of MEP changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥18 years of age
* Patients must be undergoing thoracic or lumbar spine surgery where quadriceps MEP recording would be the standard of care
* Patients should have normal preoperative quadriceps strength
* Patients are capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed

Exclusion Criteria:

* Patients with ongoing psychiatric concerns would be excluded.
* Patients who are non-English speakers.
Fucoidan Assisted Eradication of Helicobacter Pylori

The purpose of this study is to investigate whether the eradication rate of H.pylori will be improved when adding fucoidan to the duplex scheme combination of amoxicillin and vonoprazan, and to explore the effect of fucoidan on gastrointestinal flora of patients.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 60 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg TID, fucoidan 1000mg bid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg TID for 14 days. On the 10th and 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 44th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old;
2. Patients diagnosed as HP positive;
3. Patients who have not received HP eradication treatment in the past, or who have failed in the early eradication but have not received eradication treatment within half a year;
4. Voluntarily participate in this trial and sign the informed consent form.

Exclusion Criteria:

1. Allergic to the study drug (penicillin allergy, etc.);
2. Patients with chronic gastritis and peptic ulcer;
3. Patients who have received HP eradication treatment within half a year;
4. Antibiotics and bismuth agents were used 4 weeks before the start of the study treatment, and histamine H2 receptor antagonists or PPIs were used 2 weeks before the start of the study treatment;
5. Use adrenocortical hormones, non steroidal anti-inflammatory drugs or anticoagulants;
6. History of esophageal or gastric surgery;
7. Pregnant and lactating women;
8. Suffering from serious accompanying diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
Etiology of Community Acquired Pneumonia

The proposed study aims to provide current information, etiology and outcome of community-acquired pneumonia (CAP), risk factors for for CAP in isolates of Streptococcus pneumoniae and Haemophilus influencae, Mycoplasma pneumoniae, chlamydia pneumoniae and Legionella. Risk factors, including patient demographics, comorbid illnesses, setting of presentation, causative organisms, antibiotic history, and resistance profiles will be assessed and outcome will be recorded.

The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), date of positive culture, prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, co-morbid illnesses, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* All patients with Streptococcus pneumoniae, Haemophilus influencae, Mycoplasma pneumoniae, chlamydia pneumoniae and Legionella species infections during the time period the study will be reviewed. A community-associated pneumonia isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC who had no established risk factors for infection with an antibiotic resistant organism. Established risk factors are defined as: Isolation of the organism two or more days after admission for hospitalization OR history of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date OR The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture OR Previous isolation of an antibiotic resistant organism.

Exclusion Criteria:

* Does not meet entry criteria
The Impact of Non-Alcoholic Fatty Pancreas Disease on Outcome of Acute Pancreatitis

Obesity is a well-established risk factor for acute pancreatitis (AP). As for non-alcoholic fatty pancreas disease (NAFPD), it is evident that it is correlated with obesity. This is apparently the first study evaluating the association between NAFPD and severity of AP after taking into account several covariates.

Acute pancreatitis (AP) is a common disease with a highly variable clinical course, which can range from a mild, self-limited disease to severe disease with a mortality rate of 10-20%. It is vital to distinguish severe cases early because they require more aggressive fluid resuscitation and early nutritional support.

Obesity is a well-established risk factor for acute pancreatitis (AP). It leads to ectopic fat accumulation in visceral organs, such as the liver, skeletal muscles, heart and pancreas.

Assuming that attenuation in the pancreas seen on unenhanced computed tomography (CT) scanning is inversely associated with severe outcomes in AP, we investigated the relationship between NAFPD and severity of AP and the significance of pancreas attenuation for the prognosis and mortality in AP patients. The result of this study suggest that decreased pancreas attenuation and P/S ratio are strong predictors of severe pancreatitis, mortality, systemic complication.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with AP
2. age\>18y

Exclusion Criteria:

1. age\<18y
2. missing data in the electronic medical record
3. prior attacks of AP
4. without spleen
5. with ambiguous pancreatic margin
Early Versus Late Upper Extremity Mobilization After Autograft

Rationale: There is currently no observational study or randomized clinical trial published evaluating the impact of early versus late mobilization in the upper extremity after split thickness skin autograft. As the current post-operative care protocols vary based on physician preference, evidence is needed to optimize post-operative rehabilitation protocols guided by evidence which optimize wound healing, extremity range of motion, graft site pain, as well as minimize risks of complications and length of stay in hospital.

Objective: To determine if early mobilization is non-inferior to late mobilization of the upper extremity after split thickness skin autograft with regards to wound healing measured as percent graft take on post-operative day 5 in adult burn patients.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older at the time of surgery.
2. Injury: Acute (within 72h of injury) thermal flame or scald burn.
3. Surgery: Skin split-thickness meshed autograft (STSG) applied directly on the wound bed.
4. Location: Upper extremity burn - distal to the axilla and proximal to the wrist.

Exclusion Criteria:

1. Injury: Electrical and chemical burn.
2. Location: Autograft exclusively to the wrist, hand, axilla or non-upper extremity.
3. Patients on vasopressors the day of the operation.
4. Pre-existing comorbidities causing upper extremity mobility restrictions.
5. Patient unable to comply with mobilization protocol.
EpiCheck and Short-term Intensive Chemoresection in NMIBC

The aim of this explorative study is to evaluate whether EpiCheck can be used as a predictor of tumour response to short-term, intensive chemoresection with Mitomycin.

The study will be conducted as an exploratory, prospective observational study. Participants consists of patients referred to short-term, intensive chemoresection due to recurrent NMIBC. The treatment adhere to the regimen described in the NICSA trial with the ClinicalTrials.gov identifier NCT03348969. Treatment consists of short-term, intensive chemoresection with Mitomycin; 40 mg is administered intravesically three times a week for two weeks. To evaluate tumour response, an early cystoscopy is performed in the outpatient clinic one to two months after treatment completion. No visible tumour and residual tumour with benign histology is considered complete response. Residual tumour tissue with neoplastic histology is considered incomplete response and will be treated with TURBT or tumour fulguration. Subsequently patients continue a standardized follow-up program as Danish guidelines prescribe which is initiated after four months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a known history of Ta HG with recurrent disease
* Patients referred to short-term, intensive chemoresection
* Patients older than 18 years

Exclusion Criteria:

* Known allergy or intolerance to Mitomycin
* Incontinence or small bladder capacity (\< 100 mL)
* Previous pelvic radiation therapy
ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves

To evaluate the safety and performance of the ConfidenHT System

To evaluate the safety and performance of the ConfidenHT System for diagnostic mapping of renal nerves; functional distribution of renal nerves and the effect of renal nerve stimulation on the blood pressure

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Age \>18 years and \<75.
3. Either:

   1. Hypertensive patients planned to undergo elective cardiac catheterization
   2. Potential candidates for renal sympathetic denervation
4. Main renal artery with diameter ≥ 4.0mm.
5. Glomerular Filtration Rate (GFR) \>45 mL/min
6. A patient who is mentally competent with the ability to understand and comply with the requirements of the study.
7. The patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests.
8. Female patients with childbearing potential must agree:

   * to use a valid method of contraception (oral contraceptives, intrauterine device, subcutaneous contraceptive implant, vaginal ring)
   * to perform a pregnancy test

Exclusion criteria:

1. Previous participation in another study with any investigational drug or device within the past 30 days.
2. Relevant renal artery disease (% diameter stenosis\>30%, aneurysm or fibromuscular dysplasia).
3. Known secondary causes of hypertension.
4. The patient has a life expectancy ≤ 12 months.
5. The patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts.
6. The patient has chronic oxygen use other than nocturnal support for sleep apnea.
7. The patient has type I diabetes mellitus.
8. The patient has had a previous organ transplant or is awaiting a renal transplant.
9. Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator).
10. The patient has triple ipsilateral artery ostia.
11. Moderate to severe valvular heart disease.
12. The patient has other concomitant conditions that may adversely affect the patient or the study outcome.
13. Female who is pregnant, nursing or planning to become pregnant.
14. Documented contraindication or allergy to contrast medium not amenable to treatment.
Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced NSCLC After Chemo-radiotherapy

The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Non small cell lung cancer patients confirmed by pathology;
2. They were 18-80 years old;
3. The tumor could not be resected or could not tolerate surgery;
4. Planed to receive chemoradiotherapy and subsequent immunoconsolidation therapy;
5. Clinical stage III (AJCC, 8th Edition, 2017);
6. After systematic detection of non-small cell lung cancer core indicators including EGFR, ALK, ros1, KRAS, ntrk, TMB, etc;
7. Patient informed consent.

Exclusion Criteria:

1. After radiotherapy and chemotherapy, the disease progressed and immune maintenance therapy could not be carried out
2. It can not cooperate with the completion of baseline mutation screening and subsequent sample detection
3. Factors judged by other researchers not suitable for further study
Limited-English Proficiency (LEP) Virtual Reality (VR) Study

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations with limited English proficiency (LEP).


Eligibility Criteria:
Inclusion Criteria:

* Ages 0-99 (Child participants will be ages 0 to 17. Parents of children of any age may also be enrolled)
* Able to consent
* Self-identified as having a limited English proficiency or English-proficiency

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Current Nausea
* Seizures
* Visual Problems
* Patients whose children are clinically unstable or require urgent/emergent intervention
First in Human Study of AZD9592 in Solid Tumors

This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.


Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* Life expectancy ≥ 12 weeks
* Measurable disease per RECIST v1.1
* Adequate organ and marrow function as defined in the protocol

Additional Inclusion Criteria for Module 1:

• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.

Additional Inclusion Criteria for Module 2:

• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.

Additional Inclusion Criteria for Module 3:

• Histologically or cytologically confirmed metastatic CRC.

Key Exclusion Criteria:

* History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Spinal cord compression or a history of leptomeningeal carcinomatosis.
* Active infection including tuberculosis and HBV, HCV or HIV
* Brain metastases unless treated (prior treatment required only for Module 1), asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment.
* Participants with cardiac comorbidities as defined in the study protocol
Baby Formula and Health

The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.


Eligibility Criteria:
Inclusion Criteria:

* Mothers ≥ 19 years of age
* Singleton birth
* Healthy Infants
* Infant between 3-6 months at the time of visit and exclusively fed one of the formulas for a minimum of 3 months

Exclusion Criteria:

* Delivery before 35 weeks
* Infant birth weight \<2500g
* Infants exhibiting growth faltering (loss of more than 25 percentile points) between 1 month to the time of study visit for either weight or length.
* Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns.
* Infant consumption of more than two servings of complementary foods per day before the study visit.