cyrilzakka/clinical-trials huggingface dataset:
Effects of BPA on Insulin and Glucose Responses

The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides). Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.

The prevalence of diabetes is well established affecting \>29 million Americans with 90-95% of these individuals diagnosed with type 2 diabetes. The etiology of type 2 diabetes is not fully understood, but clearly diet, physical activity, and genetics play roles. Emerging data suggests a novel hypothesis that synthetic non-persistent endocrine disruptors used in a variety of common consumer goods, including the industry-produced chemical bisphenol A (BPA) play a pivotal role in type 2 diabetes and obesity rates. In support of this hypothesis, National Health and Nutrition Examination Survey (NHANES), Nurses' Health Study II (NHSII), and other cross-sectional data have shown associations between urinary BPA concentrations and type-2 diabetes, pre-diabetes, insulin resistance, and hemoglobin A1c. The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides) in the pathogenesis of Type 2 diabetes and cardiovascular disease. Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.

Eligibility Criteria:
Inclusion Criteria:

* BMI = 18.5-35
* Age 18-50 years
* Non-smoking
* English speaking

Exclusion Criteria:

* History of infertility
* Type 2 or Type 1 diabetes
* Cardiovascular disease, or any other metabolic disease/complication
* Hypertension (systolic blood pressure ≥140, diastolic blood pressure ≥90) assessed by sphygmomanometer
* History of major psychiatric illness, drug abuse, or unsafe dieting practices
* History of bariatric surgery
* Pregnant women or women expecting or trying to become pregnant
* Participating in other studies
Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol

Abstract Background Neuropathic pain is a common complication in neuromyelitis optica spectrum disorder (NMOSD), which seriously affects the quality of life of NMOSD patients, with no satisfactory treatment. Through the previous literature study and clinical observation, we found that acupuncture has good curative effect in the treatment of pain, especially electric acupuncture, but thestudies on acupuncture intervention in pain of NMOSD are still scare.

Objective To evaluate the clinical efficacy of electroacupuncture on NMOSD patients with pain.

Materials and Methods In this exploratory randomized controlled study, NMOSD patients with pain were recruited from March 21, 2022 to February 21, 2023. Patients meeting the inclusion and exclusion criteria were randomly assigned to the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group) by simple random method (envelope method) according to the inclusion order. Totally, there are 20 patients enrolled.

The experimental group received electroacupuncture therapy and the control group received sham electroacupuncture therapy. A total of 8 sessions were given twice a week for 30 minutes each. On the baseline, demographic information, medication history, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected, the brain, cervical and thoracic MRI were perfected and collected, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SDS, EDSS. After the treatment, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected again, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SD, EDSS. The main outcome indicators were SF-MPQ, and the secondary outcome indicators were EDSS, NRS, SAS, SDS, SF-36, IL-6, and TNF-α.

Conclusion This is the first exploratory randomized controlled study to evaluate the efficacy of electroacupuncture on pain in patients with NMOSD. The study will provide clincial evidence of the practice of electroacupuncture on NMOSD with pain.

Key Words neuromyelitis optica spectrum disorders; pain; electroacupuncture


Eligibility Criteria:
Inclusion Criteria:

1. people diagnosed as NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria.\[21\]
2. NRS≥4.
3. people were treated with stable doses of biological therapy and/or prednisone, with no regimen adjustment within 30 days prior to enrollment.
4. people did not adjust any standard pain medication combinations, including antiepileptic drugs, antidepressants, and opioids, within 30 days before enrollment.
5. people or their families provided written informed consent.

Exclusion Criteria:

1. people enrolled in other clinical studies.
2. people with low cognitive or mental ability.
3. people who became pregnant during the study period, breastfed, or planned to become pregnant.
4. people with serious diseases related to the heart, liver, kidney or hematopoietic system.
5. people with diabetic peripheral neuropathy.
Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions

With a prospective case series study of 15 patients The aim of this study is to estimate the clinical outcomes in patients with unstable anterior pelvic ring fractures ( B\&C ) after treatment with (INFIX)

Unstable pelvic ring fractures are usually associated with high energy trauma. They account for about 1.5-3.9% of all fractures, but they have a high rate of morbidity and mortality. Although the posterior pelvic ring provides the main stability (60%), the anterior ring still account for 40% of stability fracture pelvis B \&C according to tiles classification require fixation of the anterior ring or anterior-posterior ring simultaneously.

The external fixator is the most widely used treatment for initial and temporary stabilization of anterior pelvic ring injury, especially in emergency situations. It can be quickly placed and can easily stabilize the disrupted pelvic ring and decrease pelvic cavity haemorrhage. However, many clinical complications associated with the external fixator have been reported, including wound infection, loosening of the fixator, and impingement on the skin.

Moreover, the anterior pelvic external fixator limits patients' daily activities, such as sitting, lying in the lateral position, rolling over, and sexual intercourse

Recently, anterior subcutaneous internal fixator (INFIX) was proposed by several scholars to treat anterior pelvic ring injury.

INFIX was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. It proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care .

INFIX was initially designed as an alternative to the external fixator, but recently its indications have been expanded and multiple complications have been reported.

Eligibility Criteria:
Inclusion Criteria:

* skeletally mature patient.
* type B2 / B3 \& C1 pelvic fracture.
* open book B1 fracture with urogenital disruption.
* Patient with fatty tissue that cover pubic bones enable insertion of the rod.
* if there is a contraindication to Anterior symphyseal plating.

Exclusion Criteria:

* associated comorbidities preventing surgery.
* pelvic fracture associated with iliac bones fracture
* combined pelvis and acetabulum fracture.
Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay

The present study was to evaluate the usefulness of a whole-blood interferon-r release assays (IGRAs) as diagnostic tool of the latent tuberculosis infection for healthcare workers.


Eligibility Criteria:
Inclusion Criteria:

* doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.

Exclusion Criteria:

* Non-applicable
Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled

All consecutive patients with altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery and indication for ERCP with biliary and/or pancreatic indication, who underwent routine Enteroscopy-assisted ERCP using MSE, at the study center during the study period, will be enrolled in the analysis.

Primary endpoint of the study will be efficacy and safety of MSE-assisted ERCP.

Retrospective epidemiologic Study (not interventional) was approved by local IRB and ethical committee of the North-Rhine Chamber of Physicians (Düsseldorf, Germany), Reference Number: 177/2021.

Eligibility Criteria:
Inclusion Criteria:

* altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery
* indication for ERCP with biliary and/or pancreatic indication
* Enteroscopy-assisted ERCP using MSE, at the study center during the study period

Exclusion Criteria:

- due to the retrospective design of the study, no exclusion criteria are defined
Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room

The management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (VOS). The place of virtual reality remains to be defined in a busy environment, in which the permanence of care generates a significant turn over of medical and paramedical personnel.

With Its immersive nature, allowing the patient to detach from his immediate environment, wich is often stressful for patients, we can hope that in multimodal management, Virtual Reality (VR) can contribute to a faster reduction in pain with lower doses of morphine, but so far we have no data.

Our pilot study aims to assess the effectiveness, feasibility and tolerance of adding virtual reality to the management of VOS in sickle cell patients in the ER.

It will be a Before-after study: this study will be conducted in 2 phases in the emergency department

* a period of usual management of sickle cell patients with VOS
* then a phase during which the device will be used. Each phase will last 3 months; the duration of the periods may be shorter if recruitment targets are met. Patients will be included consecutively.

The main objective of the study is to measure the impact of virtual reality on the total dose of morphine administered to the emergency room in the treatment of vaso-occlusive seizures after initial morphine titration.

The primary endpoint is the total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by PCA (patient-controlled analgesia) and secondary titrations in the event of a recurrence of painful spikes with analog verbal scale (AVS) \>7.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* sickle cell patient consulting in the emergency room for VOS
* Signature free and informed consent

Exclusion Criteria:

* Consultation in the ER for the same reason in the 14 days prior to inclusion (same episode)
* Emergency room consultation more than 12 times in the previous year
* Nausea and vomiting at the time of inclusion
* History of epilepsy
* A visually impaired or hard of hearing patient
* Pregnant patient
* Previous inclusion in the study
LungVITamin D and OmegA-3 Trial (lungVITAL)

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.

Chronic obstructive lung disease (COPD) and pneumonia are leading causes of death in United States and worldwide. COPD, which is also a significant source of disability, is increasing in prevalence. Approximately 14 million adults have asthma, which leads to approximately 12 million missed work days per year in the United States. In adults, COPD and asthma often coexist. Treatment options for COPD are limited, and prevalence of vitamin D deficiency is high. COPD lung disease (COPD, asthma, airflow obstruction), and most COPD additional co-morbidities responsible for COPD progression (e.g., respiratory infections/pneumonia, muscle weakness, cardiac failure) may benefit from vitamin D supplementation therapy, but this requires rigorous testing. Marine omega-3 fatty acids work through different pathways from vitamin D to affect inflammation. Observational studies and clinical trials suggest that consumption of fish and/or fish oil may protect against COPD, asthma or pneumonia, but the data are not consistent. Thus, there is a compelling need for a clinical trial to evaluate the potential benefits or risks of vitamin D and fish oil supplementation on COPD and asthma exacerbations, airflow obstruction and decline of lung function, and risk of pneumonia.

The primary outcomes of interest in Lung VITAL are COPD exacerbations; airflow obstruction and decline of pulmonary function; and pneumonia. Asthma exacerbations and asthma control are secondary outcomes. A tertiary goal is to assess whether the effects of the interventions differ by baseline dietary intake or baseline blood levels of the nutrients.

Depending on the primary outcome, Lung VITAL will be conducted among all participants in VITAL (NCT 01169259), or in subsets of the VITAL population who were followed by detailed respiratory questionnaire and/or lung function testing.

Eligibility Criteria:
* This study is open to all VITAL participants (NCT 01169259). Population includes men 50 years of age or older and women 55 years of age or older in the United States
* Participants who live in selected metropolitan areas of the U.S. (where we set up the infrastructure for clinic or home visits), are eligible for pulmonary function measurements.
Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study

Wireless video capsule endoscopy (VCE) is a non-invasive technology that looks into small intestine and gives images of its lumen as the wireless capsule passes through it. It is used widely to access this anatomically difficult part of the body that cannot be seen via either colonoscopy or endoscopy. Currently various studies have been done that give multiple comparisons between various bowel preparation in terms of quality of the small bowel visualization. No studies have been done where simethicone (Gas-X) is ingested after capsule swallowing. We intend to give patients simethicone 1 hour after capsule ingestion for two consecutive hours and compare results of capsule endoscopy outcomes like small bowel transit time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ) and completion rate (CR).

Currently various studies have been done that give multiple comparisons between various bowel preparation in terms of small bowel transit time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ), completion rate (CR). Studies suggest that using Polyethylene glycol (PEG) prep is significantly better compared to clear liquid and overnight fast in terms if SBVQ and DY (Rokkas et al 2009). Other studies have shown using simethicone 30 minutes before capsule ingestion increases visibility compared to clear liquid and PEG preparation but no significant difference in gastrointestinal transit time or examination completion rate (Wei et al 2008). No studies have been done where simethicone is ingested after capsule swallowing.

Simethicone helps absorb the air bubble in the lumen which can improve the image quality. It decreases the surface tension of gas bubbles thereby dissolving them and preventing gas pockets from forming in GI system. It's often used over the counter for gas relief. Gastric emptying time is usually less than 5 hours, small bowel transit time is usually less than 6 hours, and colonic transit time is usually less than 59 hours (Rao et al 2009). Giving simethicone till 2 hours after swallowing capsule can help clear gas bubble before the capsule migrates into the small bowel.

Albert et al 2004 gave patients 80mg simethicone before swallowing the wireless capsule for their study. Wei et al 2008 gave 300mg of simethicone 20 minutes before swallowing the capsule. Chen et al 2011 gave 20ml (40mg/ml) simethicone 30 minutes before capsule ingestion which amounts to 800 mg total. Current FDA recommendation for adults is 500mg maximum daily dose. The liquid form comes in concentration of 20mg/0.3ml which constitutes to 7.5 ml for 500mg dose.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 and older
* patients undergoing capsule endoscopy for standard of care
* patients able to give consent for themselves

Exclusion Criteria:

• prisoners
Influence of CPB and Mini CPB to the Absorption of the Metoprolol

Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.

Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.

Blood samples for concentration of metoprolol are taken preoperaively, 1. and 3. day after operation, before and 10 times after intake of 50 mg metoprolol.

Sudy is randomized into 3 groups: 1. Miniperfusion n.15 2. Perfusion n.15 3. offpump n.15

Eligibility Criteria:
Inclusion Criteria: elective CABG patient -

Exclusion Criteria: contraindication to metoprolol

-
Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

the risk of aspiration pneumonitis during cesarean sections has significantly decreased. Nevertheless, precaution against gastric aspiration is still vital in patients in whom regional anesthesia contraindicated or in whom general anesthesia has to be administered (for example; during emergency cesarean delivery). The administration of intravenous anesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. Moreover, a high level of sedation also reduces the tone of the LES (lower oesophageal sphincter). Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anesthesia

Since regional anesthesia has largely replaced general anesthesia, the risk of aspiration pneumonitis during cesarean sections has significantly decreased. Nevertheless, precaution against gastric aspiration is still vital in patients in whom regional anesthesia contraindicated or in whom general anesthesia has to be administered (for example; during emergency cesarean delivery). The administration of intravenous anesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. Moreover, a high level of sedation also reduces the tone of the LES (lower oesophageal sphincter). Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anesthesia .

The risk of aspiration increases in outpatients if the volume of the gastric contents increases beyond 25 ml, and its pH falls below 2.5. However, the risk of aspiration significantly decreases in "fasted" outpatients. Since most patients awaiting elective surgery remains fasted, routine prophylaxis for preventing aspiration pneumonitis not recommended anymore. Studies suggest that metoclopramide, in combination with H2-receptor antagonists (such as cimetidine), significantly reduces the risk of postoperative emesis and aspiration pneumonitis. However, the time available for administering oral prophylaxis with such anti-emetic and anti-histaminic is too short for these medications to be effective

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* age range between 20 to 38 years
* provided informed consent to participate.

Exclusion Criteria:

* patient refusal
* associated co-morbidity as diabetes mllitus, hypertension, preeclampsia, renal or hepatic diseases
* neurological and psychological disorders, ,
* chronic gastroesophageal reflux diseases