cyrilzakka/clinical-trials huggingface dataset:
Cytokines Polymorphisms and Acetaminophen Toxicity

Genotyping assays for polymorphisms in the interleukin 10(IL10)gene and the inducible nitric oxide synthase (iNOS) gene will be performed. Genotypes will be compared to the severity of toxicity following overdose.

It was recently reported that IL-10 is protective in Acetaminophen (APAP) toxicity and it down-regulates iNOS production. In an ongoing Pediatric Pharmacology Research Unit (PPRU) Network study, plasma IL-10 levels were higher in patients that developed significant toxicity, as compared to those with minimal hepatic transaminase elevations. In these patients IL-10 elevation is likely a compensatory response to hepatic injury. To further examine the relationship of IL-10 and iNOS in the APAP overdose patients, we will examine genetic variability in the promotor regions of iNOS and IL-10 in patients with APAP overdose. Data from the literature indicate the polymorphisms in the promotor regions of iNOS and IL-10 influence the severity and expression of various diseases. In addition to genotyping for iNOS and IL10 promotor region polymorphisms, plasma levels of nitrotyrosine and IL-10 will be measured in overdose patients.

Blood samples will be obtained from study patients for the analysis of inflammatory cytokines and nitrotyrosine. Blood samples will be obtained at the time of blood sampling for the routine clinical management of the APAP overdose patient. Patients who are hospitalized will have study blood samples drawn at the time daily blood samples are obtained. The sampling will continue daily until the patient is discharged. In addition to blood sampling the following data will be collected: age, gender, race, circumstances of the ingestion, dose of the ingestion, treatment for the ingestion, concomitant therapy, medical history and cigarette use.

Eligibility Criteria:
Inclusion Criteria:

* Males and females of any age admitted to a participating site for acetaminophen overdose (acute or chronic).

Exclusion Criteria:

* Patients who are unable to tolerate study procedures.
I-gel vs Ambu AuraGain in Laparoscopic Gynecological Surgery

To compare the effects of i-gel and Ambu AuraGain on ventilation parameters and surgical view during Trendelenburg position laparoscopic gynecological surgery in cases administered positive pressure ventilation without the use of neuromuscular agents.

Prospective, multicenter, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.

The patients are randomly assigned to 2 groups:

Group i-gel Group Ambu AuraGain

Procedure:

The investigation protocol contains the following sections:

1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway device.
2. Bispectral index values will be held between 40-60.Bispectral index values will be within this interval by increasing or decreasing propofol infusion by 1 mg/kg after additional bolus dose of propofol (1 mg/kg).
3. Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations.
4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 4-10 mg/kg/hr propofol IV infusion
5. Functionality of the gastric drainage channel of the airway device
6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2), before desufflation (T3), before removal of airway device (T4). The maximum pressure allowed is 40 cm H2O.
7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and at T1, T2, T3 and T4.
8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway intervention requirements, hypoxia (SpO2 \< 92%)
9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point scale), dysphonia (yes/no), dysphagia (yes/no).

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I-II
* Between 18-65 years
* Undergoing elective laparoscopic gynecological surgery

Exclusion Criteria:

1. Those with any neck or upper respiratory tract pathology
2. Those at risk of gastric content regurgitation/aspiration (previous upper GIS surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy)
3. Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases)
4. Obese patients (BMI \>35)
5. Those with throat pain, dysphagia and dysphonia
6. Those with possible or previous difficult airway
7. Those with operations planned for longer than 4 hours
8. Conversion to laparotomy
9. Neuromuscular blocking agent used
Digitally Delivered Exercise in Helping People to Move More

The main objective of this study is to examine the influence of the digital exercise prescription platform in increasing habitual physical activity in people on a weight management programme.

Participants will be provided with individualised exercise training from exercise specialists. Participants will be recruited from the BCUHB NHS KindEating programme for people who have obesity (BMI of \>30 kg/m2). Participants will be recruited remotely, via their KindEating dietitian. The assessments and exercise programme will be conducted remotely in the participants' own home.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled into the KindEating programme with BCUHB
* ≥ 18 years of age
* Able to provide written informed consent

Exclusion Criteria:

* Any uncontrolled medical condition that is exacerbated by exercise
* Unstable angina, unstable or acute heart failure, new or uncontrolled arrhythmias, resting or uncontrolled tachycardia, uncontrolled hypertension \>180/100 (in either), symptomatic hypotension, febrile illness, acute uncontrolled psychiatric illness, other rapidly progressing terminal illness, uncontrolled diabetes \>16.7mmol, patient's currently undergoing anti-biotic treatment for cellulitis, acute infections active foot ulceration
* Inability to provide informed consent
Viokase 16, Viokase16 Plus Nexium and Nexium Alone

Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females age 18 to 75 years inclusive. Female subjects of child bearing potential or less than two years post-menopausal must use a medically acceptable form of birth control or barrier method and have a negative pregnancy test prior to entry into study.
2. History of abdominal pain associated with chronic pancreatitis
3. Evidence of chronic pancreatitis as manifested by an abnormal secretin test, calcification of the pancreas on plain film, an abnormal CT showing a dilated pancreatic duct and/or atrophy, an abnormal Endoscopicretrogradecholangeopancreatography (ERCP), or diffuse changes on Endoscopic Ultrasound (EUS), fecal elastase \> 100ug/g stool, or serum trypsinogen \> 20ng/ml

   -

Exclusion Criteria:

1. Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours.
2. Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.
3. Female subjects who are pregnant or lactating
4. Subject use of enzyme therapy other than that called for in this study
5. Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.
6. Past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -
Nature-based Intervention to Enhance Well-being

The aim of the present study is to investigate the effectiveness of a nature-based intervention on adaptive psychological functioning. We compared a structured protocol with a high level of nature engagement and involvement of multiple sensory processes with a waitlist control group. We expected that participants in the structured protocol of nature contact will report higher levels of mental health and more positive work-related functioning immediately and three months after the interventions.

This study aims to test the associations of nature contact with multiple dimensions of psychological functioning. A total of 90 university employees were randomly assigned to spend their lunch breaks on a (1) 30-minute structured protocol of nature contact and a (2) control group for 10 consecutive weekdays. Psychological distress, psychological well-being, and work-related psychological outcomes were assessed at baseline (T1), the day after the 10-day intervention (T2), and three months after the intervention (T3).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Cantonese speaking
* Full-time employment of The Education University of Hong Kong

Exclusion Criteria:

* NA
Scleroderma ARFI Imaging of the Skin

Scleroderma and other rheumatologic conditions can affect the skin. Scleroderma in particular involves skin thickening and hardening.

Currently, looking at the degree that the skin is affected by scleroderma is measured based on a combination of a physical exam and a skin biopsy.

The researchers propose to measure skin hardness using ultrasound imaging of elasticity. They will use a technique using acoustic radiation force impulse/shear wave velocity imaging , known as ARFI/SVI).

The investigators hypothesize that ARFI/SVI may be able to distinguish between normal skin and skin affected by scleroderma.. This tool may also help to quantify the amount of fibrosis in the skin.

This type of radiologic biomarker could be used to help confirm the diagnosis of scleroderma.

Scleroderma as well as numerous other rheumatologic conditions can affect the skin. Scleroderma in particular causes skin thickening and hardening.

Currently, evaluation of degree to which skin is affected by scleroderma is measured by a combination of a physical exam and skin biopsy results.

The investigators propose to measure skin hardness using ultrasound elasticity imaging, in the form of acoustic radiation force impulse/shear wave velocity imaging (ARFI/SVI).

The investigators hypothesize that ARFI/SVI may be able to distinguish normal skin from skin affected by scleroderma (and other rheumatologic conditions). And, this ultrasound technique might measure the amount of fibrosis in the dermis (skin).

Such a radiologic biomarker could be used to help confirm the diagnosis of scleroderma. In addition, it may be usable for following patients over time and measuring their response to therapy and progression of disease.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Rheumatologic disease of the skin including: Limited Scleroderma, Diffuse Scleroderma, or Eosinophilic Fascitis (Schulman's Syndrome)

Exclusion Criteria:

1. None
Parabiotics Use with Nutritional Management in Pediatric Celiac Patients

This is a sequential study to evaluate the effect of parabiotics as an adjuvant therapy with gluten restriction on quality of life in children with Celiac disease.


Eligibility Criteria:
Inclusion Criteria:

• Celiac cases diagnosed either by non-biopsy approach {serology based: high IgA antibodies against transglutaminase ≥10 times the upper limit of normal with positive endomysial antibodies or diagnosed by biopsy using March classification

Exclusion Criteria:

* Immunocompromised patients
* Patients taking immunosuppressant drugs or antibiotics within the last 4 weeks or during the study
A Study to Evaluate the Quality of Life in Male and Female Adult Participants With Severe Asthma Treated With Dupilumab in a Real-world Setting

Primary Objective:

- To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks compared to baseline.

Secondary Objectives:

* To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline.
* To assess the safety during the year of treatment in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
* Participant for whom decision of initiation and prescription of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was made by the investigator within four weeks before the inclusion in the study. Oral CorticoSteroid (OCS) or non-OCS-dependent patient could be included.
* Participant for whom St. George's Respiratory Questionnaire (SGRQ) score is available within the last 4 weeks prior to dupilumab initiation. SGRQ score could be collected at baseline visit for participants who have not yet started dupilumab.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Participant below 18 years of age. - Participant participating in a clinical trial at the time of enrolment.
* Participant under guardianship, trusteeship or under judicial protection.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Upper Extremity Muscle Strength, Balance and Functional Skills in DMD

This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with DMD by a child neurologist and confirmed by genetic test results,
* were at Level 1-4 according to Brooke Lower Extremity Functional Classification (able to ambulate independently and get up from a chair)
* had cooperation with the researchers

Exclusion Criteria:

* had undergone a surgical operation in the last 6 months
* had contractures that would affect functional activities
Progesterone and Atomoxetine for Cocaine Cessation

The purpose of this study is to examine the role of progesterone (a hormone found in both men and women) on stopping cocaine use. The study will examine whether the medication, in combination with behavior therapy will decrease cocaine use, cigarette smoking, withdrawal symptoms, impulsivity and stress.


Eligibility Criteria:
Inclusion Criteria:

* Females between 18 and 45 and males between 18 and 60 years-of-age;
* Understand the study procedures and provide written informed consent;
* Meet DSM-IV criteria for cocaine or methamphetamine and nicotine dependence;
* Minimum of cocaine use 4 days/months over last 3 months;
* Minimum of 5 cigarettes/day for last twelve months;
* Stable psychiatric status;
* Stable medical status; Willing to use double-barrier contraception method if sexually active and not surgically sterilized;
* Regular menstrual cycles (for females);
* No contraindications to progesterone treatment;
* Ability to participate fully in research elements for the duration of the trial.

Exclusion Criteria:

* DSM-IV diagnoses for current or lifetime psychotic disorders (unless substance induced), bipolar disorder, current ADHD and other current substance dependence (except nicotine dependence, or alcohol or cannabis dependence not exhibiting withdrawal or other features requiring medical attention);
* Currently using nicotine pharmacotherapy preparations;
* history of thromboembolic events, diabetes, stroke, heart disease;
* Psychotropic medications other than stable doses of anti-depressants;
* Currently pregnant or nursing;
* Liver enzyme levels three times normal limits;
* Previous treatment with or adverse response to progesterone.
* Serious suicide attempt within preceding 2 years;
* Current use of exogenous hormones.
* Conditions contraindicated to progesterone treatment (including, but not limited to, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke, allergy to peanuts, hypersensitive to progesterone and liver dysfunction).
* History of pheochromotytoma or narrow angle glaucoma,
* Current hypertension, tachycardia or clinically relevant ECG abnormalites;
* Allergy to peanuts,
* Current suicidality or need for emergency psychiatric treatment.
Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory.
* Body mass index of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia

This prospective observational study aims to determine, if an tracheal intubation-related decrease in heart rate is associated with intraoperative reflex bradycardia in patients undergoing microlaryngoscopy (MLS) in general anesthesia.

Small studies and case series reported precipitous bradycardia or even asystole due to reflex vagal activity during tracheal intubation and/or laryngoscopy attributable to a so called laryngocardiac reflex (reflex bradycardia); however, larger systematic trials are still lacking. For the purpose of MLS, ENT surgeons frequently apply suspension laryngoscopy (Kleinsasser laryngoscope) in order to visualize the glottis and to enable surgery. Severe bradycardia has been reported during MLS that has been suspected to be induced by reflex vagal activity possibly promoted by the superior laryngeal nerve.

It is still unknown, which patients are at risk for relevant intraoperative bradycardia and moreover, which patients might benefit from preemptive measures such as prophylactic application of positive chronotropic drugs like atropine sulfate, epinephrine or glycopyrrolate. Predictive factors for MLS-induced intraoperative bradycardia have not systematically been investigated yet.

In particularly, it is unknown, if patients that present with a preoperative tracheal intubation-related decrease in heart rate have a predisposition for intraoperative reflex bradycardia during MLS.

This prospective observational study aims to determine, if an tracheal intubation-related decrease in heart rate is associated with intraoperative reflex bradycardia in patients undergoing microlaryngoscopy (MLS) in general anesthesia. Moreover, if we find a positive association, we further aim to determine the predictive value of intubation-relatd bradycardia.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring general anesthesia with tracheal intubation for elective MLS
* Age ≥ 18

Exclusion Criteria:

* Pregnant or breastfeeding women
* Confirmed indications for awake fiberoptic intubation
* Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
* Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
* Cardiac pacemaker
* Atrial fibrillation
* Denial of consent
Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes

Patients with diabetes treated with insulin often gain weight, which may deter patients from adhering to insulin treatment. Detemir is one type of long acting insulin approved by the Food and Drug Administration for use in people with diabetes. It is similar to other long acting insulins (Neutral Protein Hagedorn \[NPH\], glargine) except that it has been associated with less weight gain compared to other types of insulin. The reasons for this are still unclear. One possibility is that detemir insulin acts differently than do other insulins in affecting how diabetic patients eat meals. The purpose of this study is to determine whether appetite and calories eaten during a meal are affected by the type of insulin used to treat diabetes. This is a pilot study which means we are gathering preliminary information to determine if a larger study can be done.

Insulin detemir is a neutral, soluble long acting insulin analog with weight neutral properties. In limited studies, it has been shown to result in less weight gain in type 1 and type 2 diabetics compared with other long acting insulin formations. A possible mechanism for its weight neutrality is the fatty acid chain that may allow for improved central nervous system activity and effects on satiety. The primary objective of this study is to determine if patients with type 1 diabetes consume fewer calories when allowed to eat to satiety while treated with insulin detemir compared to insulin glargine. Secondary objectives are 1) subject responses on validated satiety scales and food diaries, 2) bioelectrical impedance analysis, 3) resting energy expenditure on indirect calorimetry/metabolic cart measurement, and 4) centrally acting mediators of satiety measured in the serum (Peptide YY \[PYY\], ghrelin, leptin).

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Treated with long-acting and meal time insulin therapy for at least 2 years
* Ages 18 to 60 years of age
* Glycosylated hemoglobin value between 7 - 9 mg/dL
* C-peptide value less than 1.0 pmol/ml 90 minutes after oral Boost Plus administration.

Exclusion Criteria:

* Advanced complications of diabetes (nephropathy, retinopathy, significant neuropathy, coronary artery disease)
* Severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure
* Pregnancy
* Alcohol or drug abuse or dependence within three months of study entry
* Less than 50 % agreement on 50-item Food Questionnaire with the Food Array "buffet style" study meal.
* Women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.

Participants will:

* Complete two phases involving 6 visits
* Undergo additional research PET/CT, and possibly SPECT/CT scans

The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.

In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor

Exclusion Criteria:

* Unable to lie flat during or tolerate PET/CT or SPECT/CT
* Known incompatibility to CT. SPECT, or PET scans
* Unlikely to comply with study procedures, restrictions and requirements and judged by the investigator that the participant is not suitable for participation in the study