cyrilzakka/clinical-trials huggingface dataset:
Cortisol Control of Human Inflammatory Responses to Endotoxin

The purpose of the research is to study a common and dangerous medical condition called 'septic shock' that often occurs in critically ill patients. In order to learn about septic shock in humans, we will administer a substance called 'endotoxin' to participants in this study. Endotoxin causes a temporary period of inflammation in the human body, a brief 'virtual' infection. This is an established method for the investigation of inflammation properties. We are interested in how the natural hormone, cortisol, can affect the human response to endotoxin. We know that when cortisol is given at the same time as endotoxin it can decrease the inflammation that occurs due to endotoxin. In this study we will test whether or not cortisol, when given the day before the endotoxin, will work to change the inflammation that occurs due to endotoxin. In order to test this, two-thirds of the study participants will receive cortisol on the day before they receive the endotoxin and one-third of the study participants will receive a placebo (no medication) before the endotoxin.


Eligibility Criteria:
Inclusion Criteria:

* 18 \< age \< 55
* Weight \> 50 kg
* The participant is healthy, without known or suspected medical illness following routine history and physical examination and is expected to easily tolerate the clinical effects of endotoxin.
* The participant does not take any regularly scheduled medication other than thyroid replacement therapy, birth control pills, or estrogenic hormone replacement therapy.

Exclusion Criteria:

* History of chronic disease of any kind such as diabetes, heart disease, cancer, HIV infection, hypertension, asthma, etc.
* History of chronic medication use other than hormone therapy as above
* History of recent acute illness within 30 days prior to study
* Inability to provide informed consent
* History of recent exposure to drugs known to alter immune function including steroids or recent infection (\< 3 months)
* Pregnancy
* History of known risk factors for HIV infection (recent multiple partners, sexually transmitted disease and unprotected sex; intravenous drug use; blood transfusion before 1985)
"Maze Out": A Serious Game to Improve Self-efficacy and Mutual Understanding in Eating Disorders.

Eating Disorders (EDs) are mental disorders with long recovery time and high mortality. Despite the importance and extensive research in the field, an effective treatment for EDs has yet to be found.

In co-production with ED patients, clinicians, and technology experts a Serious Game called "Maze out" was developed and initially evaluated through a feasibility study. Maze out is an innovative first player tool focusing on improving self-efficacy, mutual understanding, and family functioning in adults with EDs.

The game has been evaluated through a usability study. Study findings demonstrate that patients found Maze out easy to use, meaningful and fun.

The usability study was thus a first step in developing and testing an evidence-based intervention to be implemented in the treatment repertoire of adolescents and adults with EDs.

The present study is a Randomized Controlled Trial, whereby the investigators will explore the effectiveness of Maze out as an additional treatment to Treatment as Usual (TAU)


Eligibility Criteria:
Inclusion Criteria:

* All sexes aged 18+
* Diagnosis of anorexia nervosa, bulimia nervosa, other eating disorders and eating disorders unspecified (ICD-10 codes: F.50.0-F.50.9)
* Receiving treatment from one of psychiatry centers in the Mental Health Services of Region South Denmark, or in Endocrinology Services specialized in ED of Region South Denmark; or living in a mental health care institution in Region of Southern Denmark.

Exclusion Criteria:

• No Danish speaker
Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients

For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections
* Expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy
* Have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5 mg/dL).

Exclusion Criteria:

* Pregnancy
* End-stage renal disease
* Receipt of more than 4 grams of vancomycin prior to enrollment on current admission
* Absolute neutrophil count \< 1000/mm3
Retrospective Analysis of capsaïcin Patch in Complex Regional Pain Syndrome

Complex regional pain syndrome is a painful syndrome often secondary to a traumatic lesion. Treatment is difficult, of long duration with variable outcomes. Patch of capsaïcin has been proposed as adjuvant to a multimodal treatment. Capsaïcin may act by its effect on transient receptor potential vanilloid 1. Efficacity and outcome studies with this treatment are lacking.

The aim of this retrospective study is to evaluate pain intensity over time assessed by visual analog scale in patient with complex regional pain syndrome treated with capsaïcin patch in addition to their usual treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with complex regional pain syndrome on maximum medical treatment
* Age ≥18 years
* Patients treated between 2012 and August 31, 2022 in the pain clinic of the CHU Brugmann

Exclusion Criteria:

- incomplete medical chart
An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity

Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale

This study is assessing the association between neurotrophic keratopathy and diabetic retinopathy severity by examining subjects with diabetic retinopathy to associate DRSS and disease characteristics with corneal desensitization. In addition, to better understand the relationship of disease duration, HbA1c, and status of concurrent systemic therapies and diabetic retinopathy treatments, predictive modelling will be performed to determine predictive factors of patients at highest risk of developing reduced corneal sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Have Type 1 or Type 2 diabetes with DRSS of 3 or higher
* Be willing and able to sign the informed consent form (ICF)
* Be at least 18 years of age
* Be literate and able to complete questionnaires independently
* Have provided verbal and written informed consent

Exclusion Criteria:

* Have a history of vitrectomy
* Have a history of cornea, eyelid, glaucoma, or retina surgery
* Have a history of previously diagnosed neurotrophic keratopathy or other cranial nerve V pathology, such as trigeminal neuralgia
* Have a history of ocular herpes simplex virus infection
* Have a history of herpes zoster ophthalmicus
* Have a history of ocular chemical trauma
* Have a history of underlying corneal dystrophies
* Have had cataract surgery less than 3 months prior
* Have a history of pan-retinal photocoagulation (PRP)
* Have current Stage 2 or 3 neurotrophic keratopathy
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1
Collection of Gastrointestinal Tissue Samples for the Characterization and ex Vivo Functional Assessment of Chemoreceptors

The purpose of this study is to help scientists understand how the gut senses ingested nutrients and what kind of processes take place for their absorption in order to establish the association with diabetes and other metabolic diseases Scientists need human specimens to study.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women age 18 years and older who are having elective gastrointestinal surgery
2. Able to provide written, informed consent

Exclusion Criteria:

1. Unable to provide written, informed consent
2. Use of antibiotics for more than 5 consecutive days in the three months prior to the study
The Effect of Flexitarian, Time-restricted Eating on Cardiometabolic Traits in Normal Weight, Young Men

The goal of this factorial randomized controlled trial is to find out whether time-restricted eating and flexitarian diet (on its own and combined) can improve cardiometabolic health markers in normal weight, young men with metabolic abnormalities?

Participants will be assigned to four groups: control, flexitarian, time-restricted eating and time-restricted eating + flexitarian. Investigators will look for men with elevated fasting blood glucose or blood lipids level or blood pressure and with normal body weight and waistline. Participants from the flexitarian group will be asked to follow a diet that has been carefully designed for them by the PI and dietitian for the period of 8 weeks. Participants from the control group will receive general healthy eating recommendations.

We aim to investigate if the experiment had any effect on changes in metabolic, inflammation and nutritional markers, blood pressure and body weight and composition. Also, the effect of diets on men's sleep, general wellbeing and satisfaction with treatment will be investigated.

The proposed study can test a potentially effective nutritional intervention which is feasible to adopt and sustainable (in line with recent planetary diet recommendations). Confirming its effectiveness can fill the research gap, providing new knowledge and approach to the prevention and treatment of metabolic abnormalities in young, lean men.


Eligibility Criteria:
Inclusion Criteria:

* Males
* Age 18-40 years
* Normal body weight
* At least one of metabolic abnormalities (elevated fasting glucose level - but not diabetes, elevated blood lipids, elevated blood pressure)

Exclusion Criteria:

* Females
* Age \<18 and \>40 years
* Overweight or obesity (BMI\>25 kg/m2)
* WC \> 94cm
* Alcohol \>14 units/week
* Smoking
* On medication
* Diabetes or other chronic diseases
* Vegetarians or vegans
* Don't own or unable to use a Smartphone with Apple iOS or Android OS
Efficacy of Lidocaine Versus Placebo in Palliative Care Patients With Opioid-refractory Cancer Pain With Neuropathic Component: a Multicenter, Prospective, Double-blind Randomized Placebo-controlled Study.

This is a multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel groups study comparing lidocaine (experimental group) to placebo (control group). The study protocol was elaborated using the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) Statement.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Patient suffering from cancer pain refractory to standard opiates (numeric pain intensity scale NPIS \>=4/10 after 24 hours of continuous intravenous morphine or oxycodone administration \[SOR 2002, analgesics drugs for adults cancer nociceptive pain\]), regardless of the nature of the primary cancer\]
* Patient suffering from cancer neuropathic or mixed pain (DNA survey score\> = 4 \[Bouhassira 2004\])
* Patient receiving palliative care as defined by French Society of Palliative and Support Care \[Charte des Soins Palliatifs, 1996, Act No. 99-477 of 9 June 1999 to guarantee the right of access to palliative care\] according to the definition of the World Health Organization (WHO) \[World Health Organization. WHO's pain ladder. http://www.who.int/cancer/palliative/painladder/en/. Accessed December 9.2011\]
* Patient with histological diagnosis of cancer, locally advanced or metastatic disease
* Patient without curative cancer treatment, and with or without palliative anticancer treatment
* Patient hospitalized in a specific palliative care unit
* Patient with an estimated survival higher than 48 hours (physician estimation) Patient providing written informed consent for participation prior to any study procedures.

Exclusion Criteria:

* Patient with a known hypersensitivity to lidocaine
* Patient with a history of porphyria, arrhythmias, disorders of atrioventricular conduction requiring permanent pacing not yet realized, uncontrolled epilepsy, uncontrolled hypertension
* Patient with hematologic malignancy, abnormal renal, hepatic and cardiac functions
* Patient with a altered sleepiness (Epworth scale score ≤ 16)
* Patient with altered cognitive function (TELECOM scale score\> 11) \[Arsène 2000\]
* Patient not native French speaker Patient defined as vulnerable subject (minor subject, pregnant or nursing woman, subject freedom deprived)
Reach Through Equitable Implementation of Turtle Island Tales

Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts.

Turtle Island Tales is an obesity prevention program for AI families with young children (3-8 years) that was developed to address the gap in home-based, family wellness programs for this population. Substantial research as been conducted on the effectiveness of this program for participating families. The primary aim of the current project is to investigate community-engaged dissemination to improve the reach of Turtle Island Tales. Dissemination strategies will be undertaken in partnership with community leaders and/or local Supplemental Nutrition Assistance Program Education (SNAP-Ed) agents who will disseminate the program through existing Extension/SNAP-Ed delivery mechanisms (SNAP-Ed is commonly administered through Extension programs of land-grant universities). Turtle Island Tales was accepted as a SNAP-Ed eligible program in 2022. As such, the program will be administered as part of usual/typical SNAP-Ed delivery in participating communities and largely constitutes program evaluation.

The primary research question is: What is the reach of the evidence-based Turtle Island Tales wellness program intervention within AI communities? A secondary aim for this project is determining the effectiveness of Turtle Island Tales among participating families using program evaluation survey data obtained via SNAP-Ed program evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Residence in one of identified persistent poverty census tracts
* Person \>18 years of age caring for a child 3-8 years old

Exclusion Criteria:

* Residence outside of identified persistent poverty census tracts
* Caregiver \<18 years of age
* No child 3-8 years old living in household
A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.

This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.


Eligibility Criteria:
Inclusion Criteria:

* Must have ended treatment from one of the following sunitinib studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.

Exclusion Criteria:

* See inclusion criteria
AAV Gene Therapy Study for Subjects with PKU

This is a Phase 1/2, open-label, dose escalation study to evaluate the safety, efficacy and tolerability of BMN 307 in adult PKU subjects with PAH deficiency. Participants will receive a single administration of BMN 307 and will be followed for safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency
* Ability and willingness to maintain dietary protein intake consistent with baseline intake
* Willingness to abstain from hepatotoxic substances post-BMN 307 administration
* Willingness and capable per investigator opinion to comply with study procedures and requirements
* Willingness to use effective methods of contraception
* Plasma Phe levels \> 600 µmol/L

Exclusion Criteria:

* Subjects with primary BH4 deficiency or other forms of BH4 metabolism deficiency
* Clinically significant liver dysfunction or disease
* Prior treatment with gene therapy
* Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study
* History of malignancy
A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus
* Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin
* Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes
* Has been treated with:

  1. A thiazolidinedione (TZD) within 4 months of study participation, or
  2. A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or
  3. Insulin within 12 weeks prior to study participation, or
  4. Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD)
  5. Omarigliptin (MK-3102) at any time prior to study participation
* On a weight loss program and is not in the maintenance phase; has started a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation
* Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
* Human immunodeficiency virus (HIV)
* New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months
* History of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
* Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.


Eligibility Criteria:
Inclusion Criteria:

* Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683)

OR:

* Patient is in good, stable health
* Patient has been fed solid foods for at least 1 month
* Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
* Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

* Patient was hospitalized at the start of the study or had any major surgery 4 weeks prior
* Patient had an allergy to apples or applesauce
Incidence of Opioid-Induced Respiratory Depression in Medical and Trauma Patients

The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous (IV) opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.


Eligibility Criteria:
Inclusion Criteria:

1. Spontaneously breathing adults 18 to 89 years of age
2. English speaking
3. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
4. Admitted to the general care floor from the emergency department

Exclusion Criteria:

1. Less than 18 or greater than 89 years of age
2. Transfer to the general care floor from the Intensive Care Unit
3. Receiving intrathecal or epidural opioids
4. Inability or unwillingness to wear the etCO2 sampling line nasal cannula or pulse oximetry sensor
5. History or diagnosis of a sleep disordered breathing syndrome
6. Use of Continuous Positive Airway Pressure or (CPAP) or Bilevel Positive Airway Pressure (BIPAP) non-invasive ventilation as home regime
7. Receiving non-invasive ventilation
8. Presence of a co-morbidity that impacts respiration or ventilation (e.g Chronic Obstructive Pulmonary Disease or Pulmonary Fibrosis)
9. Unwilling or unable to participate
10. Member of a vulnerable population such as pregnant women or prisoners.