cyrilzakka/clinical-trials huggingface dataset:
Insulin Regulation and Severity of Severe Acute Respiratory Syndrome COVID-19 Infection

The Coronavirus Disease of 2019 (COVID-19) pandemic has caused an international healthcare crisis and produced a large healthcare burden. Diabetes mellitus is a common disease that can be controlled via pharmacologic agents; however, many patients have poor glycemic control, leading to disease-related complications. Diabetes mellitus has been reported in the literature to be associated with increasing morbidity and mortality in COVID-19 patients, and some hypothesize that this is due to insulin dysregulation propagating a pro-inflammatory state. The investigators aim to contribute to the growing body of literature that assesses the associations between glucose homeostasis and COVID-19 disease severity and mortality.

The Coronavirus Disease of 2019 (COVID-19) is caused by an infection from the severe acute respiratory syndrome coronavirus 2, and the first case in the United States was documented on January 31, 2020. Severe acute respiratory syndrome coronavirus 2 is a RNA virus that has 82% homology with severe acute respiratory syndrome coronavirus 2, which caused a pandemic in 2003. Severe acute respiratory syndrome coronavirus 2 enters cells via the angiotensin converting enzyme 2 (ACE2) receptor, which is primarily expressed in the lung. COVID-19 has led to a worldwide pandemic, with over six million deaths attributed to the virus, according to the World Health Organization. This emerging infection has caused an international healthcare crisis with a significant burden on healthcare workers.

Advanced age, male sex, cardiovascular disease, and diabetes mellitus are known to be associated with increasing risk for COVID-19 severity and mortality. Diabetes mellitus is a common disease that affects the general population by disrupting glucose homeostasis. Impaired glycemic control produces a state of hyperglycemia, which leads to multi-organ injury via a chronic, pathophysiologic inflammatory state. Early retrospective studies demonstrated the association of insulin dysregulation with COVID-19 disease severity and mortality. With more data availability and time, many studies have been conducted to better characterize the relationships between hyperglycemia and elevated hemoglobin A1c (HbA1c) with COVID-19 disease susceptibility, severity, and mortality.

Through this retrospective analysis, the investigators investigate the associations of HbA1c levels and hyperglycemia with COVID-19 mortality and disease severity.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* COVID-19 confirmed by laboratory testing (ICD10 U07.1)
* Pneumonia due to COVID-19 (ICD10 J12.82)
* Diagnosis of Diabetes Mellitus

Exclusion Criteria:

* All patients under the age of 18
* COVID in pregnancy
Foley Catheter Versus Double-balloon Catheter for Cervical Ripening

The objective of this study is to compare pregnancy results which were used foley catheter or double-balloon catheter for cervical ripening among high-risk pregnant women.

This is a prospective observational study. The planned sample size was calculated as 109 patients per group with 80% power and 0.05 alpha error.

The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score \<6, using a foley catheter or cook balloon for cervical ripening and high-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders).

The exclusion criteria are being younger than 18 or over 40, communication problems, bishop score \>6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred uterus (cesarean or myomectomy), fetal structural or chromosomal anomaly, non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage.

The primary outcomes are the rate of bishop score \>6 after ripening, vaginal delivery rate and vaginal delivery within 24 hours of the initiation of ripening.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40
* Singleton pregnancy
* Vertex presentation
* Bishop score \<6
* Using a Foley catheter or cook balloon for cervical ripening
* High-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders)

Exclusion Criteria:

* Being younger than 18 or over 40
* Communication problems (foreign national)
* Bishop score \>6
* Being at active labor
* Multifetal pregnancy
* Non-vertex presentation
* Scarred uterus (cesarean or myomectomy)
* Fetal structural or chromosomal anomaly
* Non-reassuring fetal cardiotocography before cervical ripening
* Regional anesthesia during the first stage
You and Me Healthy

The You and Me Healthy Registry provides a resource for collecting information on people currently living in the United States. The overall goal of the Registry is to create and engage a community of people who may be eligible for participation in future research studies aiming to answer research questions about COVID-19 and other conditions.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus responsible for the COVID-19 pandemic. In the United States (US) up until January 2022, \> 60 million people have been infected with the SARS-CoV-2 virus and \>800,000 died, with infections and deaths disproportionally affecting populations that have been historically marginalized1. Wide disparities also persist by race/ethnicity and age with COVID-19 testing and vaccine uptake related to social and structural factors, resulting in adverse health consequences.

As public health measures have scaled up, mitigation strategies are increasingly being considered to reduce community spread of infection. These measures include rapid-result at-home tests, protective measures (masking, social distancing, increased hygiene), treatments, and contact-tracing and isolation. As the pandemic evolves, new discoveries, technologies, and strategies to combat COVID-19 are being implemented with limited backing of research data. To address this continued unmet public health need, the You and Me Healthy registry is being created to engage community members and serve as a way to provide and collect information from all people who are interested in engaging in upcoming research studies, including those related to COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Currently residing in the United States
* Age ≥ 2 (for minors, parents/legal guardian will be the primary point of contact)
* Able to speak and read in the language used in the surveys/assessments available

Exclusion Criteria:

There are no specific exclusion criteria for this registry
The Changes of Treg Cells Frequency and Function During Antiviral Therapy

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, Treg cells Regulatory T cells played a negative role in immune. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.

Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, Treg cells play an important role in immune regulation.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of Treg cells in the case of hepatitis and the function enhancement of Treg cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer

This is a prospective, single-center, open, historically controlled real-world study.

The aims of this study is to evaluate the safety and effectiveness of Nab-paclitaxel combined with oxaliplatin and S-1 in the treatment of patients with advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Gastric adenocarcinoma diagnosed by histology.
* Ambulatory cases, 18-75 years old
* ECOG performance status ≤ 1
* Have not received anti-tumor therapy previously (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
* Patients able to tolerate abdominal surgery above grade 3
* Has adequate organ function as defined by the following criteria:

  * WBC\> 4.0×10\^9/L
  * ANC\> 1.5×10\^9/L
  * ANC ≥ 1.5×10\^9/L
  * HB ≥ 80 g/L
  * PLT ≥ 100×10\^9/L
  * TBIL ≤ 1.5×ULN
  * ALT and AST \<2.5 × ULN, for patients with liver metastases, ALT and AST \<5 × ULN
  * BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min
* No history of other tumors
* Be willing and able to comply with the plan during the research period
* Has given written informed consent
* Life expectancy ≥ 6 months

Exclusion Criteria:

* Those with a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ
* HER-2+ and willing to receive Trastuzumab
* Pregnancy or breast-feeding women; Men and women who are sexually active (possible to have children) and unwilling to use contraception during the study period
* Severe, uncontrolled medical diseases and infections; chronic bowel disease or short bowel syndrome
* Major organ failure, such as compensatory cardiopulmonary liver and kidney failure; severe liver and kidney metabolism abnormalities, affecting the normal metabolism of drugs
* Patients with other surgical contraindications, such as serious diseases that are difficult to control
* The researcher believes that patients with a clear gastrointestinal bleeding tendency and/or patients with abnormal blood coagulation function (INR \> 1.5)
* Active HBV or HCV
* Peripheral neuropathy ≥ Grade 2 according to NCT-CTC AE5.0
* Patients who are allergic to the drugs in this study, or determined by the investigator as unsuitable to participate in this clinical study
A Cohort Analysis Study of Intestinal Flora in Infants

The purpose of this study is to investigate the influence factors of gastrointestinal microbiome in infants.

The gastrointestinal microbiome is believed to be critically important for infant growth and development. As we all know, the gut microbiota can influence gut maturation, metabolic, immune and brain development in early life. Host genotype, gestational age, antibiotic use, mode of delivery, diet and the context in which the infant is born (rural vs urban, presence of siblings, pets and other factors) can influence the development of infant gut microbiota. In the early life stage, intestinal flora disorders may alter the host immune function and increase the susceptibility to immune or metabolic diseases.

This research intends to establish a birth cohort of healthy newborns. The influence factors of gastrointestinal microbiome will be investigated by means of questionnaire survey, specimen collection and high throughput sequencing analysis. What's more, the correlation of gut microbiome, infant growth as well as related diseases will be explored either. The results will provide constructive suggestions for the establishment of infant normal intestinal flora and play an indispensable role in exploring the occurrence, development and prevention of related diseases.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborns

Exclusion Criteria:

* Newborns with diseases such as congenital heart disease or congenital malformation and so on
Target Muscle Re-innervation and Regenerative Peripheral Nerve Interfaces Alone and in Combination for the Treatment of Residual and Phantom Limb Pain in Cancer Patients Who Have Received an Amputation

This clinical trial evaluates two surgical techniques (targeted muscle re-innervation \[TMR\] and regenerative peripheral nerve interfaces \[RPNI\]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. Emerging microsurgical treatments for post-amputation pain are very promising. TMR and RPNI are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. This trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation.

PRIMARY OBJECTIVE:

Determine the relative effectiveness of three surgical techniques, TMR, RPNI, and TMR with RPNI, on chronic and phantom limb pain in the oncologic amputee using the validated Numerical Rating Scale (NRS) and Patient-Reported Outcomes Measurement Information System (PROMIS) Behavior, Intensity, Interference, and Global Health Forms.

SECONDARY OBJECTIVES:

I. To estimate the rate and total quantity of any pain medication use among oncology amputees who received one of the three surgical techniques.

II. To estimate the rate of prosthetic use among oncologic amputees. III. To compare NRS and PROMIS among three surgical techniques to calculate the effect size and project the sample size which will be used to plan a multi-institutional study.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM 1: Patients undergo TMR procedure.

ARM 2: Patients undergo RPNI procedure.

ARM 3: Patients undergo TMR in combination with RPNI.

After completion of study procedure, patients are followed up at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons
* Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue
* Patients able to complete informed consent

Exclusion Criteria:

* Patients under 18 years of age
* Patients unable to give consent
* Patients receiving an amputation for non-oncologic purposes
* Patients with amputations performed for immediate palliation (life expectancy less than 3 months), as this technique takes a minimum of 3-6 months for effect
* Patients with multiple limb amputations
* Patients receiving nerve management in a delayed fashion (patients who have previously received an amputation and present with neuroma)
Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.

Eligibility Criteria:
Inclusion Criteria:

* Body weight \> 30 kg
* Histologically or cytologically confirmed recurrent or metastatic HNSCC
* Not considered a candidate for other curative therapy (i.e. surgery/RT)
* Documented progression of disease after receiving platinum based regimen
* ECOG performance status 0-2

Exclusion Criteria:

* Nasopharyngeal and salivary gland tumors
* Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.
Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation

The purpose of this study is to collect data on laser ballon (2nd gen) systems for catheter ablation for AF, in order to determine the safety and the efficacy of this technique.

Moreover, the investigators aim to determine the short and long term outcomes of pulmonary vein isolation evaluating arrhythmia recurrence, especially using continuous rhythm monitoring with implantable loop recorders (ILR).

LIGHT-AF is an observational, multicentric study designed to collect pre-procedural, procedural and follow-up data of consecutive patients that underwent catheter ablation for AF with laser ballon (2nd gen system). A number of 3 enrolling centers is estimated with an overall number of about 100 patients. A minimal follow-up of 3 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term recurrence of AF, evaluated with intracardiac rhythm monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Patients with paroxysmal, persistent or long-standing persistent AF
* Patients able to provide written informed consent or have informed consent as provided by a legal representative

Exclusion Criteria:

* Age \< 18 years
* Patients unable or unwilling to receive oral anticoagulation
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)

The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).

This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent and comply with study procedures and follow-up through 1 year.
* Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours.
* Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome.
* Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following:

  * 60 years of age or more
  * Electrocardiogram changes (ECG)
  * Elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or CK-MB levels
* Or have all 3 of the following:

  * Prior history of cardiovascular disease
  * Elevated troponin or CK-MB levels
  * 50-59 years of age

Exclusion Criteria:

* pregnancy (known or suspected)
* renal dialysis within 30 days prior to randomizing in study
* other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated
* Stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma.
* History of certain hematologic problems following treatment with heparin or eptifibatide.
* Therapy with certain related drugs within a short time before randomization into the trial.
Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

An open-label, prospective phase III study to compare the efficacy and safety of administering evolocumab versus treatment with LDLapheresis in patients with familial hypercholesterolemia and high cardiovascular risk.

STUDY DESIGN An open-label, prospective phase III study to compare the efficacy and safety of administering evolocumab versus treatment with LDLapheresis in patients with familial hypercholesterolemia and high cardiovascular risk.

STUDY POPULATION The chosen population is constituted by patients belonging to the LDL-apheresis program of the General University Hospital Gregorio Marañón with the diagnosis of familial hypercholesterolemia and a history of cardiovascular disease.

Number of patients expected to participate in the study according to the base of patients treated with LDL-apheresis: 10.

STUDY DESIGN:

Non-controlled intervention study to evaluate the different therapies in the treatment of hypercholesterolemia, in which each patient will be self-controlled. The variables will be analyzed during different phases

1. LDL-apheresis phase: Retrospectively during the previous year, pre- and postapheresis variables will be collected from the following lipid parameters: total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, atherogenicity index, Lipoprotein A, apo-A, apo- B; inflammatory parameters: PCR, ferritin, fibrinogen, leukocytes and polymorphonuclear and immunological parameters: immunoglobulins and complement.
2. Evolocumab phase: LDL-apheresis will be suspended for three months and Evolocumab administered: 140 mg / 15 days subcutaneously. The same parameters indicated in the previous section will be measured every two weeks.
3. Combined phase: During the following three months evolocumab will continue to be administered biweekly and the LDL-apheresis procedure will be spaced from biweekly to monthly, the same analytical parameters being measured again every two weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients with age\> 18 years
* hypercholesterolemia with LDL-cholesterol\> 100 mg / dl in treatment with the maximum dose tolerated by statins and a history of severe cardiovascular disease
* patients who are included in the LDL-apheresis / biweekly program

Exclusion Criteria:

* contraindications to receive evolocumab according to technical data.
* hospital admission of any cause in the last three months prior to the inclusion of the study
* cardiovascular event in the three months prior to the inclusion of the study
* Inability to sign informed consent
* pregnant women and non-menopausal women who do not use at least one adequate contraceptive method