cyrilzakka/clinical-trials huggingface dataset:
New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.

New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes

Sepsis is recently defined as life-threatening condition caused by dysregulated body response to infection leading to organ dysfunction and even death. Patients who are vulnerable to catch sepsis are those with immune-compromising diseases, old aged people and chronic medical condition such as diabetes, chronic kidney diseases or cancer. Sepsis is symptomized by fever or hypothermia, tachycardia, tachypnea. In critical care units, septic patient are predisposed to have different cardiovascular manifestation as atrial fibrillation, atrial flutter, hypotension, etc. . Many studies reported the association between atrial fibrillation and septic patients in critical care as a complication of sepsis; but data regarding factors and fates is still insufficient. So in this study we aim to observe critical ill patients with sepsis to assess and evaluate the predisposing factors leading to new onset of cardiac arrhythmia in septic patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient of 18 years old and above of both gender admitted with manifestation of sepsis.

Exclusion Criteria:

* Patients below 18 years old.
* Pregnant females.
* Patients with cardiac arrhythmia before admission in the critical unit.
* Patients with previous cardiac surgery.
Validation of an RLIP76 Assay in Humans

The current proposal extends work done in mouse models evaluating the consistency of measuring RLIP76 in a clinical cohort (Aim 1) by using guidelines provided by the NIH for validating biomarkers. We will also proceed to estimate the effect size of a potential correlation of RLIP76 with standard MsY treatment measures such as hgbA1c, LDL, and triglyceride levels in a longitudinal prospective study ( Aim 2) that will follow a cohort of patients with MsY who seek care at the City of Hope Endocrine clinic over a 12 month period..


Eligibility Criteria:
Inclusion Criteria:

* Registered patient of City of Hope and followed in the Endocrine Clinic. Must have documentation of a diagnosis of diabetes identified by the problem list in the patient's electronic health record.
* Must demonstrate features of MsY by possessing any of the following characteristics and/or receiving treatment for diabetes, hyperlipidemia, and/or hypertriglyceridemia.

  * Central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches (female)
  * Dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl)
  * Dyslipidemia: HDL-C \< 40 mg/dL (male), \< 50 mg/dL (female)
  * Blood pressure ≥ 130/85 mmHg
  * Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)
The Impact of Phosphate Metabolism on Healthy Aging

Determine the association between duration and dose of chronic conventional therapy with Pi and renal (nephrocalcinosis/nephrolithiasis), vascular (endothelial function), and cardiovascular function (echo- cardiography) in patients with hereditary hypophosphatemic rickets with hypercalciuria (HHRH) and patients with X-linked hypophosphatemia (XLH).

The central hypothesis of this proposal is that patients with X-linked hypophosphatemia (XLH), when matched for duration and dose of phosphate (Pi) therapy to patients with hereditary hypophosphatemic rickets with hypercalciuria (HHRH), will evidence greater cardiovascular and vascular debility than patients with HHRH. The overall objectives of this project are to utilize our existing longitudinal databases for individuals with XLH and HHRH through an interdisciplinary collaboration between pediatric and adult endocrinology to: i) quantify the impact of exposure to Pi therapy across the lifespan on cardiovascular and renal complications, which are key aging endpoints, ii) determine the acute response to Pi loading in XLH and HHRH by studying the changes in surrogate markers of cardiovascular and renal function.

Eligibility Criteria:
Inclusion Criteria:

* Children above the age of 13 years
* Younger and older adults with XLH and HHRH with confirmed NPT2c mutations affecting both copies of the NPT2c gene (HHRH) or one copy of the PHEX gene (XLH)
* Be willing to provide access to prior medical records to determine eligibility including imaging, biochemical, medical, and surgical history data
* Be willing and able to complete all aspects of the study
* Be willing to adhere to the study visit schedule and comply with the assessments (in the opinion of the investigator).

Exclusion Criteria:

* Subjects will be excluded, if they are children younger than age 13 years
* Subjects that have other diseases likely to impact bone and mineral metabolism (e.g. renal, hepatic, gastrointestinal disorders, and malignancy),
* Subjects that are currently pregnant,
* Subjects that received medical therapy or developed any condition, which in the opinion of the investigator, could present a concern for either subject safety or difficulty with data interpretation.
* Subjects will be excluded from Aim 2, if they are unable to tolerate supplemental phosphate.
Implementing a Comprehensive Handoff Program to Improve Pediatric Patient Safety

The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for pediatric residents on inpatient units at Children's Hospital Boston - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.

Following collection of baseline data on two inpatient pediatric wards, teamwork training is to be provided to all pediatric residents. On our primary intervention unit, this will be accompanied by the introduction of a new computerized handoff tool that facilitates accurate transmission of data. The effects of this combined intervention on safety and workflow will be assessed on the primary intervention ward as compared with the historical control unit and the concurrent unit that received teamwork training without the computerized tool.

Eligibility Criteria:
Inclusion Criteria:

* all residents working on study units during study period, except as below

Exclusion Criteria:

* residents on the teamwork only unit who have previously been on the primary intervention unit
The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear

This study will examine the improvement in middle ear optical coherence tomography imaging from the topical application of glycerol to the tympanic membrane in normal, opaque and post-operative ears

This study will explore whether the utility of Optical Coherence Tomography (OCT) in otology patients can be enhanced through the application of topical glycerol as an optical clearing agent in patients with normal, opaque and post operative tympanic membranes. In each group of subjects, a comparison will be made between OCT images obtained before and after the topical application of glycerol to the tympanic membrane and following washout with saline. Images will also be assessed for their diagnostic utility as determined by the visibility of key structures and the change in middle ear mobility caused by glycerol absorption in the tympanic membrane.

Eligibility Criteria:
Inclusion Criteria:

* Thickened tympanic membrane (e.g. due to fibrosis) x10
* Tympanosclerosis of the tympanic membrane x10
* History of middle ear surgery with partial or total ossicular replacement prosthesis and cartilage tympanoplasty x10
* History of cartilage tympanoplasty without prosthesis implantation x10
* Normal tympanic membrane without history of middle ear disease x10

Exclusion Criteria:

* Narrow or stenotic external auditory canal that prevents visualization of the tympanic membrane
* Mobility disorder that prevents patient from remaining still during imaging
* Perforation of the tympanic membrane
* Open sores or infections of the external auditory canal
APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor

The success of orthotopic liver transplantation (OLT) in treatment of liver malignancy and endstage liver disease has led to an increase in the gap between patients on waiting-lists and available liver grafts. In order to compensate for this scarcity, use of liver grafts harvested from extended criteria donors (ECD) has become more and more frequent.

However, these ECD grafts are known to be associated with a higher rate of primary non function (PNF) or early allograft dysfunction (EAD) because of a greater vulnerability to ischemia-reperfusion injury (IRI).

During OLT, the clamping of the portal vein induces blood congestion in the splanchnic territory leading to increased gut permeability, bacterial translocation and release of endotoxin and pro-inflammatory cytokines at revascularisation, which exacerbate IRI.

Realisation of a temporary porto-caval shunt (TPCS) (i.e. end to side anastomosis between the portal vein and infrahepatic vena cava) during the anhepatic phase, avoids splanchnic congestion and could therefore decrease IRI and improve liver graft function. However, TPCS remains poorly used as no randomised trial succeeds to show its benefit on liver function due to lack of power.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Candidate of liver transplantation
* With cirrhosis from any etiology
* Model For End-Stage Liver Disease (MELD) score \< 25
* Transplanted with a liver graft harvested from an extended criteria donor defined as presence of at least one of the following criteria:

  * Donor age \> 65 years old
  * Intensive care unit stay \> 7 days
  * BMI \> 30
  * Natremia \> 155 mmol/L
  * Aspartate aminotransferase (ASAT) \> 150 IU/mL
  * Alanine aminotransferase (ALAT) \> 170 IU/mL
  * Occurrence of a cardiac arrest before graft harvesting
  * Proven biopsy macrosteathosis \> 30%
* Non-opposition from the patient

Non Inclusion Criteria:

* Fulminant hepatitis
* Retransplantation
* Combined organ transplantation (kidney, pancreas, heart, lung)
* Non heart beating donor
* Complete portal vein thrombosis on preoperative imaging finding

Exclusion Criteria:

* Complete portal vein thrombosis found during procedure
* Split liver graft
* Realisation of a bilio-enteric anastomosis
Bleomycin Jet Injections in Keloids

This is a single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design, in which selected keloids will receive three consecutive treatments of a) bleomycin and b) placebo (saline (NaCl 0,9%)), administered with an electronic pneumatic jet injector.

This is a single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design.All study procedures will be performed at the Department of Dermatology, Erasmus MC Medical Center in patients referred for scar treatment to our outpatient clinic.

Clinical photos will be obtained after signing the informed consent form by patient and investigator. Study visits and clinical assessments will be scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. Measurements include clinical photography, scar volume measured by 3D-camera, POSAS questionnaire, laser speckle contrast imaging to visualize keloid scar vascularization, measurement of residue formation on the skin, and a treatment related questionnaire. The keloid will be divided into two treatment areas, and randomly assigned to three consecutive treatments of: a) bleomycin and b) placebo (saline (NaCl 0,9%)), administered with an electronic pneumatic jet injector.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided written informed consent;
2. Subject is ≥ 18 years of age at time of screening;
3. Subject has at least one keloid scar of ≥ 4 cm in length, or two separate keloids with a length of ≥2cm, with a minimum \> 1.0 cm apart in the same anatomical region.
4. Subject is willing to fill in questionnaires and take photos using an e-diary application on their phone.

Exclusion Criteria:

1. Known hypersensitivity to any component of the test materials;
2. Pregnant or breast-feeding women (pregnancy test prior to treatment);
3. Previous bleomycin treatment of the keloid within the last 12 weeks prior to screening.
4. Non-response to previous bleomycin treatments of the keloid.
5. Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients

Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria
* Meet DSM-IV criteria for Dementia of the Alzheimer type
* MMSE score : 16 to 26 etc.

Exclusion Criteria:

* Meet the exclusion criteria of MRI at screening.
* A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.

etc.
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC

A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received.

We want to:

* determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee
* and if so, does it matter

100 patients operated on with unilateral TKR are included and randomized to either prostheses.

Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.

Eligibility Criteria:
Inclusion Criteria:

* age below 75 years and active
* preop ROM at least 120 degress flexion
* BMI below 30
* intact ligaments

Exclusion Criteria:

* below 18 years
* unable to understand language or purpose
Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans

Studying glucagon-like peptide-1 (GLP-1) induced vasodilatory effects on extra - and intracerebral arteries and headache in healthy volunteers and migraine patients without aura.

The purpose of this study is to examine the association between vasodilation and intensity of headache triggered by glucagon-like peptide 1 (GLP-1) in healthy volunteers and migraine patients without aura.

Eligibility Criteria:
Criteria for the healthy volunteers group

Inclusion Criteria:

* Healthy men/women.
* Age 18 to 60 years old.
* Weight 50 to 100 kg.

Exclusion Criteria:

* Tension headache more than 5 days a month in the preceding year.
* All other primary headache types.
* Headache on the examination day or within 48 hours before infusion of the study drug.
* Smoking.
* Daily intake of medicine of any kind except for peroral contraceptives.
* Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
* Hypertension or hypotension.
* Coronary heart disease of any kind, as well as cerebrovascular disease.
* Pulmonary disease.
* Allergy to contents in the study drug.
* Psychiatric disease or substance abuse.
* Disease of any kind which the examining doctor deems relevant for participation in the study.
* Renouncing the right to information concerning own health.

Criteria for the migraine patients group

Inclusion Criteria:

* Migraine patients, who fulfill the ICHD-3 criteria for migraine without aura.
* Age 18 to 60 years old.
* Weight 50 to 100 kg.

Exclusion Criteria:

* Tension headache more than 5 days a month in the preceding year.
* All other primary headache types.
* Headache on the examination day or within 48 hours before infusion of the study drug.
* Smoking.
* Daily intake of medicine of any kind except for peroral contraceptives.
* Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
* Hypertension or hypotension.
* Coronary heart disease of any kind, as well as cerebrovascular disease.
* Pulmonary disease.
* Allergy to contents in the study drug.
* Psychiatric disease or substance abuse.
* Disease of any kind which the examining doctor deems relevant for participation in the study.
* Renouncing the right to information concerning own health.
Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

Evaluation of upper airway with Magnetic Resonance and polysomnographic at the pre and post operative of 23 women having undergone bariatric surgery (with the Y-Roux technique) for treatment of obesity.

The the present study aims at describing the modifications occurring in the upper airway (UA) and the impact of such modifications on the severity of obstructive sleep apnea after bariatric surgery in women who have obstructive sleep apnea (OSA). The hypothesis is that the massive weight loss after bariatric surgery on OSA women could modify the UA more intensely than previously reported by other therapies for weight loss and that the menopause status may influence the likely reshaping of UA after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients with a recommendation and considered apt for bariatric surgery by the multi-professional group
* aged between 18 and 70
* with a residual (after the 16-week period) BMI above 35 kg/m2
* polysomnographic obstructive sleep apnea diagnosis: Apnea-Hypopnea Index (AHI) above 5 events per hour associated with a co-morbidity and/or complaints of snoring.

Exclusion Criteria:

* patients with body weight above 180 kg - for the impossibility of having a magnetic resonance (MR)
* carrying metal artifacts which contraindicate the performing of MR
* patients with a history of pharyngeal or neoplasia in the head and neck region
* patients affected by gross craniofacial deformities
* pregnant women
* previous UA surgery for OSA
* patients undergoing any other treatment for OSA.
Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia

Schizophrenia patients with anti-psychotics have decreased psychiatric symptoms, but have increased the generation of overweight or obesity. There is correlation between obesity, diabetes mellitus, metabolic syndrome, hypertension, hyperlipidemia and cardiovascular disorders. Cassia seed is one of traditional Chinese herbs, that can decline blood lipedema effect. Therefore, the purpose of the present study was to design a randomized, double blind, control group study to assess the therapeutic effect of Cassia seed in schizophrenia patients with obesity.

Total of 92 schizophrenia patients with obesity will be enrolled and divided randomly into: 1) case group, received oral administration of Cassia seed (3.0g), once/day, 12 weeks; 2) control group, received oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia), 12 weeks. The primary outcome included the changes of body mass index (BMI), waist circumferences (WC); secondary outcome measured included the changes of hemoglobin A1c (HbA1c), total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, CRP (C-Reactive protein), IL-6, systolic blood pressure, diastolic blood pressure, and meridian energy.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years
* diagnosed as schizophrenia at least more 6 months
* no major systemic illnesses based on physical examinations and laboratory test results
* BMI \>= 24, WC \>= 80 cm in female, WC \>= 90 cm in male

Exclusion Criteria:

* participants were pregnant and lactating women
* allergy to Cassia
* SGOT or SGPT more than 2 times normal level
* BUN or creatinine more than normal level
* Fasting blood glucose (serum) \> 140 mg/dL, systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 110 mmHg, serum triglyceride \> 400 mg/dL
QL Block With Exparel in Colectomy

The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.

Participants in this study will receive exparel via an abdominal muscle nerve block procedure immediately prior to their operation. Participants will be in this study for 96 hours following surgery, which is typically 3 days. During participation, the study staff will review participant's electronic health records for pain scores and pain medication needs.

Participants that receive the quadratus lumborum block, may experience improved pain control and/or reduced side effects compared to the epidural pain relief option, but it is not known yet whether this will be the case.

The most common risk is being sore in the flank where the block was placed. Other risks of the block rarely occur (less than .5-1%), these can include infection, allergy to the local anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective, laparoscopic colonic resection by one of three surgeons: Drs. Thacker, Mantyh or Migaly. These surgeons perform this procedure in the same manner
* Age 18-85 years
* American Society of Anesthesiologists (ASA) Physical Class I-III
* BMI 18-35 kg/m\^2

Exclusion Criteria:

* Inability to consent
* Inability to speak English
* Pregnancy
* Emergency surgery
* Contraindications to regional blockade: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
* Allergies/intolerances/contraindications to any of the multimodal agents (acetaminophen, gabapentin, ketorolac)
* Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
* History of drug or alcohol abuse
* Rheumatoid arthritis
* Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments of compliance