cyrilzakka/clinical-trials huggingface dataset:
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy

Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of meconium staining, low Apgar scores, preterm delivery, and stillbirth.Other predictors such as level of transaminases, history of cholelithiasis, and hepatitis virus infection have been studied but the results are inconclusive.A more comprehensive investigation involving multiple neonatal outcomes and a wide variety of outcome predictors is needed in order to establish guidelines for optimal timing of delivery in pregnancies complicated by ICP. The aim of our study was to evaluate wide variety of predictors of adverse neonatal outcomes in a large cohort of women with ICP .

We performed a retrospective cohort study of all women diagnosed with ICP. Pregnancy outcomes including delivery gestational age, spontaneous preterm delivery, iatrogenic preterm delivery, birth weight, mode of delivery, oligohydramnios, intrauterine growth restriction (IUGR), placental abruption, preterm premature rupture of membrane (PPROM), concerning fetal heart tracing, chorioamnionitis, endometritis, postpartum hemorrhage, transfusion, stillbirth, neonatal intensive care unit (NICU) admission, hyperbilirubinemia, meconium stained amniotic fluid, respiratory distress syndrome(RDS) or transient tachypnea of newborn(TTN) (transient tachypnea of the newborn), and composite neonatal outcome were ascertained. A composite adverse neonatal outcome was created and defined as any of the following: NICU admission, hypoglycemia, hyperbilirubinemia, RDS, TTN, mechanical ventilation use, oxygen by nasal cannula, pneumonia, and stillbirth. PPROM was defined by rupture of membrane before 37 weeks gestation. Concerning fetal heart tracing was defined as recurrent variable or late decelerations with moderate variability, prolonged decelerations, or category 3 tracing. Providers who were caring for the women reviewed and independently characterized fetal heart tracings. Since fetal heart tracings were not accessible to authors, authors accepted the providers' interpretation. For analysis of concerning fetal heart tracing, women with non-labor cesarean section were excluded. Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy. Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion. Diagnosis of RDS and TTN were made by the managing neonatologist and based on standard clinical guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Newborns were born in maternal and child health hospital of Yong Chuan District from January 2012 to December 2020;②all Newborns' mothers diagnosed intrahepatic cholestasis of pregnancy.

Exclusion Criteria:

The newborns were born with severe congenital heart disease and deformities
Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

The purpose of this study is to make nationwide registry for antimicrobial resistance of Helicobacter pylori using single method with agar dilution in Korea.

Backgrounds:

The success rate of Helicobacter pylori eradication in Korea is not sufficient in recent days. The main cause of eradication failure is known as antimicrobial resistance and previous studies showed that resistant rates were different according to the regions in Korea. However, until now, there are not enough studies about the nationwide results for antimicrobial resistance and previous reports used various methods for the resistant test.

Theories and Plans:

The nationwide resistant registry of Helicobacter pylori using standardized single method, agar dilution test, can be useful for the development of new eradication methods to make eradication rate higher. Moreover, the higher rate of Helicobacter pylori eradication can reduce the chance of gastric cancer and also can reduce the medical expenses.

Eligibility Criteria:
Inclusion Criteria:

* Aged 19 to 79 year person who need the examination of Helicobacter pylori infection during upper gastrointestinal endoscopy.
* No history of Helicobacter pylori eradication.
* No history of antibiotics within one month.
* Person who agree on the consent.

Exclusion Criteria:

* History of antibiotics more than 3 days sequentially within one month.
* History of subtotal gastrectomy.
* Person who does not agree on the consent.
Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

the investigators performed a retrospective multicenter propensity score matching study. From July 2016 to July 2021, 382 consecutive patients from different Chinese surgical departments were available for inclusion out of an initial cohort of 412, who underwent robotic or laparoscopic right hemicolectomy with CME.

All consecutive patients who underwent robotic or laparoscopic right hemicolectomy with CME from July 2016 to July 2021 at three Chinese surgical departments (Department of General Surgery, Army Medical Center, Chongqing;Department of Colorectum, Chongqing University Three Gorges Hospital, Chongqing;Department of Colorectum, the 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, Lanzhou) were included in the study. A retrospective review of multicenter institutional database was conducted. The Da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) has been employed since 2016 in three centers. From July 2016 to July 2021, an initial cohort of 412 consecutive patients underwent robotic or laparoscopic right hemicolectomy with CME in three departments. With 30 cases meeting the exclusion criteria, 382 cases, including 204 males and 178 females, were available for inclusion. Of these, 149 cases by robotic right hemicolectomy with CME were classified as the robotic group, while the other 233 cases by laparoscopic right hemicolectomy with CME as the laparoscopic group.

Eligibility Criteria:
Inclusion Criteria:

1. Adenocarcinoma was confirmed by preoperative colonoscopy and it was located in the right colon.
2. Preoperative enhanced abdominal CT examination showed no invasion of abdominal wall or adjacent organs.
3. The patient underwent robotic or laparoscopic right hemicolectomy with CME.

Exclusion Criteria:

1. Multiple primary colorectal tumors
2. Metastasis to abdominal
3. Pelvic or distant organs
4. Accompanied with bowel obstruction or perforation
5. Neuroendocrine tumors
6. Lymphomas
7. Other malignant tumors.
HDL Lipidomic, Proteomic and Functional Changes in Women After Eating Eggs

The objective of this randomized, single blinded cross-over study is to investigate effects of daily egg versus yolk-free egg substitute consumption on High Density Lipoprotein (HDL) composition and function in a population of overweight and obese postmenopausal women.

The investigators hypothesize that after 4 weeks of daily consumption of whole egg versus yolk-free egg will result in differences in the HDL composition and profile of lipids and proteins (lipidome and proteome), which will be associated with changes in HDL functionality. It is further hypothesized that it will be possible to discriminate between responders and non-responders to eggs in terms of increasing both apolipoprotein A-1 (ApoA-I) content in the plasma, corresponding with more protective HDL particles; and increasing HDL functionality (cholesterol efflux and anti-oxidant capacity).

Subjects will consume an egg free diet during study protocols, except for the egg meal provided by the study. The study is comprised of two 4-week feeding periods with a 4-week washout between testing periods. While on the study, subjects will consume the equivalent of two eggs for breakfast, either whole egg or yolk-free egg. Following a 2-week low-egg lead-in period, subjects will be randomly selected to start on either arm and cross over to the other arm after the 4-week washout period.

Measured results will be compared between the baseline and the 4-week end point for each arm. Additional comparisons may be made between 4-week endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 45-70 years old
* Overweight or obese (BMI 25-35 kg/m2)
* Post-menopausal (confirmed by clinical hormone levels assessed at screening if within one year of last menses)
* Plasma HDL cholesterol greater than or equal to 50 mg/dL.

Exclusion Criteria:

* Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, cancer (active), or previous cardiovascular events
* Having 3 or more traits of Metabolic Syndrome
* Egg allergy or multiple food allergies or food intolerances that would significantly limit food intake
* Smoker
* Current consumption more than 1 alcoholic drink/ day
* Extreme dietary or exercise patterns
* Recent weight fluctuations (greater than 10% in the last six months)
* Anemia
* Taking prescription lipid medications or other supplements known to alter lipoprotein metabolism such as isoflavones, red yeast rice, or \> 1 g of fish oil/day.
* Taking exogenous hormones (i.e. hormone replacement therapy)
National Longitudinal Mortality Study (NLMS)

To estimate probabilities of death by cause for a representative United States population, according to age, sex, race, occupation, industry, income, education, residence, country of birth, calendar year, and a number of other demographic and epidemiologic factors. The representative population is derived from selected Bureau of the Census files and is matched to the National Death Index maintained by the National Center for Health Statistics. The Bureau of the Census provides the data processing, coding and management necessary to complete this objective.

BACKGROUND:

The current National Longitudinal Mortality Study began in 1983 with agreements with the Census Bureau which prepared baseline files from surveys representative of the United States and with the National Center for Health Statistics which prepared the National Death Index identifying deaths in the baseline populations. The baseline population of over one million persons has been matched to the NDI on several occasions, resulting in approximately 100,000 deaths occurring in 1979 to 1989. Using available data, an analysis was conducted relating socio-economic characteristics to subsequent mortality.

DESIGN NARRATIVE:

The NLMS is a national study of mortality over time among selected Census Bureau population samples numbering about 2.4 million. The census samples are matched to the National Death Index (NDI) maintained by the National Center for Health Statistics. The NDI is a file of all U.S. deaths since 1979 and is used to determine which individuals in the Current Population Surveys (CPS) have died. The samples are matched every other year to obtain deaths among these cohorts. Death certificates are then purchased from the states and coded for causes of death and other data. Mortality rates by age, sex, race, national origin, occupation, industry, income, education, state of residence and other factors are then obtained. The follow-up period begins with 1979, the first year covered by the NDI and ends with 1998. The total number of deaths for these cohorts is estimated to be about 250,000.

Census samples in the NLMS are being matched to the Centers for Medicare \& Medicaid Services (CMS) medicare database. Hospitalization, physician, outpatient, and other CMS data will be incorporated into the NLMS database for all participants meeting the Medicare age eligibility criteria. The study continues through December, 2009.

Eligibility Criteria:
No eligibility criteria
Should I Continue Taking My Acid Reflux Medication? Development and Pilot Testing of a Patient Decision Aid

BACKGROUND: Proton pump inhibitors (PPIs) treat problems such as gastroesophageal reflux disease (GERD). In many patients with mild or moderate GERD, PPIs should be used for 1-2 months but are often continued longer unnecessarily. This is a problem because PPIs may cause harm when used long-term. PPI use is associated with severe C. difficile infections, fractures and pneumonia. Canada's public drug programs spent $247 million on PPIs in 2012 (not including Quebec or PEI). Due to concerns with long-term PPI use, patients may face the decision to continue their PPI, use a lower dose or stop and use on-demand (only when symptoms return). This decision should be made collaboratively between patients and clinicians, though patients tend to have a poor understanding of when reducing a drug is appropriate. Using a lower dose or using on-demand may be viewed as difficult because of the chance of symptoms returning. Patient decision aids (PDAs) inform patients on benefits and risks of treatment options and improve ability to make informed decisions and clarify values. OBJECTIVES: Develop a PDA to help patients with the decision to continue PPI or stop and use on-demand/use a lower dose. Evaluate whether: 1) the PDA changes patient preference to continue or stop and use on-demand/use a lower dose of PPI 2) the PDA improves patient knowledge and realistic expectations 3) patients and pharmacists feel they made a shared decision 4) there is a change in PPI prescribing 8 weeks post-PDA and 5) patients' choices match up with their values. METHODOLOGY: The PDA will be developed by a team of doctors, pharmacists and patients. It will be delivered during a visit with a pharmacist. Patients (n=54) will indicate which choice they prefer (continue PPI/stop or use lower dose) before and after going through the PDA. We will use Mcnemar's test to compare the number of patients preferring to continue their PPI before and after. We will evaluate whether there is a difference in knowledge test scores and expectations test scores before and after the PDA. After the PDA, we will ask patients and pharmacists to rate the extent to which shared decision making occurred and measure the agreement. Values/choice congruence will be evaluated using logistic regression. Eight weeks after patients have received the PDA, we will look at whether there is any reduction in PPI use.


Eligibility Criteria:
Inclusion Criteria:

* Taking PPI for greater than or equal to 4 weeks, no current symptoms, taking PPI for mild to moderate upper GI symptoms (mild to moderate gastroesophageal reflux disease, grade A/B esophagitis)

Exclusion Criteria:

* Severe esophagitis (grade C/D), severe GERD or upper GI symptoms, currently experiencing upper GI symptoms, taking PPI for gastroprotection due to NSAID therapy (at moderate or high risk of GI bleed), history of Barrett's esophagus, history of bleeding peptic ulcer, taking PPI for treatment of current ulcer not healed
Common and Differentiated Representations Between Social Exclusion and Social Separation

Explore the shared or separated neural mechanisms of social exclusion and social segregation and compare differential effects of AVP and OXT on these social interaction function.

A large body of research has shown that there are differences in the neural representation between social exclusion and social segregation, but the results are inconsistent, and the exploration of the neural basis is still insufficient. In addition, there are two mainstream theoretical explanations for these differences, namely the construction-level theory and the emotion-based theory, but there is no consistent theoretical model yet. Therefore, further exploration is necessary to confirm the cognitive and neural mechanisms underlying the differences between social exclusion and social segregation, and to attempt to reveal the theoretical explanations for these differences. In this project, the investigators propose to perform behavioral and functional magnetic resonance imaging (fMRI) techniques to examine the shared or separate neural mechanisms of social exclusion and social segregation (exp 1: social exclusion; exp 2: social separation) and investigate the modulatory effects of OXT/AVP on them (PLC/24IU OXT/20IU AVP).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects;
2. Without any past or present psychiatric or neurological disorders;
3. Without any current psychotherapeutic medication.

EXclusion Criteria:

1. With any past or present psychiatric or neurological disorders;
2. With any current psychotherapeutic medication.
Impact of Confinement and Preventive Measures in Period of SARS-COV2 Infection on Clinical Features, Diagnostic and Therapeutic Management and Prognosis of Patients With Lung Cancer

The unexpected onset of SARS-COV2 infection modified our practices, especially in routine medicine. In order to reverse the epidemic curve of severe cases and slow the spread of the infection, confinement was generalized in France from March 13, 2020.These restrictive measures were imposed on anyone with symptoms compatible with the infection, with the exception of dyspnea and other criteria of severity. March 12, 2020 is the pivotal date when the management of COVID came to interfere with medical and healthcare organizations. From this date, it is likely that some imaging or endoscopic exams have been de-scheduled for symptoms that are sometimes wrongly judged to be non-urgent and have seen their numbers drop dramatically.Otherwise, concerning lung cancer, preventive measures have been extremely strengthened. For instance, it is recommended to delay surgeries for localized tumors, to relieve or remove some chemotherapy or to delete radiotherapy sessions deemed non-essential. However, symptoms that may initially be attributed to viral infection, such as cough, fever, fatigue, or chest pain may be clinical indicators of early-stage Lung cancer. In addition, lung cancer is likely to make the patient more susceptible to pneumopathy, due to a weakened of immune response to viruses and bacteria. Consequently, as necessary as the restriction measures are, a risk of slowing down in the management of the Lung cancer pathology exists.

The CBP-COVID Study intends to assess consequences of restrictive measures linked to the SARS-COV2 epidemic, by comparing clinical characteristics at diagnosis, treatment times and treatments, regarding to 2 distinct time periods identical to the calendar, but one in 2019, the other in 2020.


Eligibility Criteria:
Inclusion Criteria:

* Patient newly diagnosed with a lung cancer based on histological or cytological criteria.
* Patient followed by investigating site participating in the study.
* Patient informed verbally and by an information document specifying the interest of the study and having given his oral agreement for the participation for the prospective part of the study.

Exclusion Criteria:

* Patient investigated and / or monitored in a site not involved in the study.
* Patient with lung cancer of incidental finding during hospitalization for another reason.
* Patient with recurrence of a previoulsy known lung cancer.
* Patient included in a clinical research trial.
OneShot Renal Denervation Registry

This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.


Eligibility Criteria:
Inclusion Criteria:

* Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.
* Patient is ≥ 18 years old.
* Patient provided written informed consent.

Exclusion Criteria:

* Patients who are pregnant, nursing, or planning to become pregnant.
* Patients who have only one functioning kidney.
* Allergy to contrast or known hypersensitivity to device materials
* Patients with renal arteries \< 4 mm in diameter.
* Patients whose life expectancy is less than the planned period of study involvement.
A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088

This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is \> = 18.0 to \< = 32.0 kg/m\^2 after rounded to the tenths decimal, at Screening and upon confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
* Part 3 Only: Han Chinese Participant must be first-or second-generation Han Chinese of full Chinese parentage. First-generation participants will have been born in China to two participants and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. OR
* Japanese Participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

Exclusion Criteria:

* Part 1 (Groups 1-4), Part 2 and Part 3: History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.
Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study

There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mCRPC and bone metastases
* ≥ 40 years of age at diagnosis of mCRPC
* Initiated first line treatment for mCRPC with abi/enza (use of sipuleucel-T prior to initiation of abi or enza is allowed)
* Receipt of at least one cycle of radium-223 after 15 May 2013
* First cycle of Ra-223 occurs while receiving first line treatment with abi/enza
* Treated with abi/enza for at least 28 days (1 cycle) following initiation of Ra-223
* Initiation of Ra-223 at least 6 months after the start of treatment with abi/enza
* Completion of Ra-223 treatment prior to the receipt of any chemotherapy for mCRPC
* At least 12 months of follow-up (or until death) from date of initiation of Ra-223
* Known date of death (if patient deceased)

Exclusion Criteria:

* Receipt of any prior chemotherapy during hormone sensitive disease or any time before mCPRC
* Active participant in an interventional clinical trial for CRPC in first line
* Presence of visceral metastases at initiation of Ra-223 treatment
* Treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease