cyrilzakka/clinical-trials huggingface dataset:
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of intramuscular INGAP Peptide given for the first time in humans as a potential treatment for diabetes.


Eligibility Criteria:
Inclusion Criteria:

Patients meeting all of the following inclusion criteria at screening can be considered for admission to the study.

Stage 1 and Stage 2:

1. Male and female patients with, type 1 diabetes mellitus that are 18 through 70 years of age, or type 2 diabetes mellitus that are 30 through 70 years of age.
2. Patients who are insulin deficient and are diagnosed with type 1 or type 2 diabetes mellitus, and are currently well managed with insulin, with or without metformin.
3. Patients who have been on stable doses of insulin treatment for 90 days prior to study randomization.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:

1. Patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems.
2. Patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease.
3. Patients who have received any investigational product within 30 days of admission into the study.
4. Patients with a history or clinical evidence of multiple organ autoimmune disorders.
5. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
6. Patients who are lactating and breastfeeding.
Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva

This study aims to identify clinical symptoms and outcomes, as well as response to anti-viral treatment in children living in Geneva, with influenza A/ H1N1 infection during the current pandemic.


Eligibility Criteria:
Inclusion Criteria:

* suspicion of H1N1 infection

Exclusion Criteria:

* Not available for a 30 days follow-up
The Effect of Lavender Essential Oil for Delirium in Elderly Intensive Care Unit Patients: Study Protocol

Elderly critically ill patients in the intensive care unit (ICU) are at risk of delirium, which is primarily characterized by acute consciousness impairment and perceptual, cognitive, and memory impairment, resulting in excess death, care expenditures, and acquired dementia, depression and anxiety, which severely affect the prognosis of critically ill patients. However, there are currently no effective pharmacological strategies for preventing delirium. Inhalation aromatherapy has been proven to benefits the sleep disorder, anxiety or depression and lavender oil is one of the most used essential oils. Therefore, we hypothesized that the use of lavender would reduce the incidence rate of delirium in ICU patients.

This trial was designed to be a randomized, single-center, double-blind, placebo-controlled trial. A total of 68 elderly patients from two ICUs will be randomly allocated at a 1:1 ratio to the intervention group or the control group. Both groups will receive the ABCDEF (A2F) bundle strategy recommended by guidelines, a multicomponent approach including pain and delirium management, breathing trial practice, analgesic and sedation usage control, family engagement and so on, to prevent delirium. The intervention group will additionally receive aromatherapy lasting for five days. The primary outcome is the prevalence of delirium. Secondary outcomes include the severity and duration of delirium, the length of ICU stay, the duration of physical restraint, the duration of analgesic and sedative medication and the 28-day mortality rate. We will use the CAM-ICU and CAM-S to measure the prevalence and severity of delirium, and analyses of variance (ANOVAs) or repeated-measures ANOVAs and Wilcoxon rank-sum tests to analyze the observation results.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients aged between 60 and 90 years old
* Had an expected total ICU length of stay (LOS) of 72 hours or more
* Admitted to the ICU within 48 hours before screening
* Signed the informed consent form.

Exclusion Criteria:

* Incapacitation preventing the assessment of delirium (i.e., coma, sedation, or active seizures)
* History of psychiatric disorders, dementia, Parkinson's disease, use of antipsychotic drugs, or alcohol dependence
* History of traumatic brain injury or brain infection
* Diagnosis of delirium prior to intervention initiation
* Allergies to medications used in the protocol or current participation in other drug studies
* Inability to communicate in Chinese or English
* Expected to be discharged or deceased within 72 hours of admission.
Surgical Stress Markers for Postoperative Complications: a Prospective Study

The aim of this study is to evaluate the predictive value of albumine, C-reactive protein (CRP), procalcitonin, and lactates in terms of surgical stress and postoperative complications. These biomarkers will be measured from the day before surgery until postoperative day four in patients undergoing major surgery. Major surgery was defined as esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal procedures including an organ resection for benign or malignant disease and lasting more than 2 hours.

This prospective study was conducted at the Department for Visceral Surgery at the University Hospital of Lausanne Switzerland (CHUV) between February and December 2015 (NCT02356484). The study was approved by the Institutional Review Board (No. 367/15), and all patients provided written consent prior to surgery. Inclusion criteria were age \>18 years, and elective major abdominal surgery-defined as an operative procedure with anticipated duration ≥2 hours.17 Perioperative care closely adhered to recently published enhanced recovery guidelines (http://erassociety.org.loopiadns.com/guidelines/list-of-guidelines). Standardised fluid administration was followed by advanced haemodynamic monitoring to avoid intraoperative fluid overload. According to the clinical care pathway, intravenous fluid was typically discontinued the morning after surgery.

Biological markers Serum levels of albumin, CRP, PCT and lactate (LCT) were perioperatively measured in a fasting state, Following standardised institutional guidelines. Blood samples were drawn the day before surgery, the day of surgery (4-6 hours after the end of the operation) and on the first, second and third postoperative day. As Baseline values tend to show large variations especially for albumin,4 10 we considered that a dynamic value (difference between two time-points) might be more informative than a snapshot value. Several values based on preoperative and postoperative concentrations were thus calculated for each marker (ie, Δ Max: maximal difference between the preoperative and postoperative values; Δ POD 0: difference of concentration on POD -1 and POD 0; Δ POD 1: difference of concentration on POD-1 and POD 1).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients undergoing esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery
* Operation time more than 2 hours
* Operation including an organ resection for benign or malignant disease

Exclusion Criteria:

* Immunosuppressive therapy
* Cognitive impairment or language comprehension problems
* Absence of the consent form prior to first blood sample
Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea

The main purpose of this study is to assess the concentration of elemental impurities in blood and urine after chronic administration of Smecta® in subjects with chronic functional diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote composition will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, between 18 and 60 years old inclusive, BMI between 19 and 32 kg/m2 inclusive (minimum body weight of 50 kg at screening).
* Functional chronic diarrhoea defined as loose or watery stools occurring in at least 75% of stools for the last 3 months (with symptom onset at least 6 months before diagnosis).

Exclusion Criteria:

* No history of suspected organic or drug induced cause to chronic diarrhoea.
Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy

This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.

Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.

* Quantification and monitoring of KRAS mutations Using droplet digital PCR in ctDNA extracted from collected patient samples.
* Correlation analysis of KRAS mutation results with clinical data.

Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.

* Gene panel composition for pancreatic cancer therapeutic target determination and monitoring.
* A panel was performed using gDNA and ctDNA of tumor tissue collected from pancreatic cancer patients.
* Comparative analysis of panel results and quantitative KRAS mutations and evaluation of clinical applicability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically confirmed pancreatic adenocarcinoma.

Exclusion Criteria:

* Patients disagree with the study.
Navigating the Clinical Research Process for Mild Cognitive Impairment

Participation in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of mild cognitive impairment patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future mild cognitive impairment patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of mild cognitive impairment
* Participant must be 18 years of age or older
* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Participant is actively receiving study therapy in another
* Inability to provide written informed consent
Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon

The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.

Complicated appendicitis with abscess or phlegmon represents a challenging problem to emergency general surgeons, and the preferred treatment remains controversial. A variety of therapies have been recommended including early operative intervention, delayed operative intervention, and non-operative management. Recently, a prospective randomized controlled trial from a single center was conducted in Finland comparing operative and non-operative management of appendiceal abscess. Patients managed in the operative arm were found to have a shorter length of stay, fewer re-admissions, and fewer additional interventions than those managed in the non-operative group, but there is no high-quality randomized control trial conducted in the United States to support this. The investigators, therefore plan to carry out a multi-center, patient choice study comparing operative and non-operative management of complicated appendicitis with abscess or phlegmon in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).

Exclusion Criteria:

1. Antibiotic therapy greater than 24 hours prior to considering for enrollment.
2. Attempted drainage before randomization
3. Pregnancy
4. Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
5. Previous major intra-abdominal surgery by laparotomy
6. Hospitalization within 2 weeks of randomization
7. Presence of septic shock on admission.
8. Mechanical ventilation
9. Acute renal failure requiring dialysis
Ellipsys Fistula for Hemodialysis Access

To report the outcomes of patients having percutaneous proximal radial artery fistula creation.

The study would like to enroll up to 100 patients without age, gender-based, race and ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing potential are not excluded. If a pregnant patient required, an arteriovenous fistula for hemodialysis an Ellipsys® fistula would be an option. The Investigator would like to consent previous Ellipsys® patients with appropriate medical records so that the Investigator may capture participants data for outcomes reporting.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years or older
* Diagnosed with ESRD or chronic kidney disease requiring dialysis or anticipating start of dialysis
* Adjacent vein diameter of \> 2.0 mm at target anastomosis site and confirmed clinically significant outflow
* Arterial lumen diameter of \> 2.0 mm at target anastomosis site
* Adequate collateral arterial perfusion: Barbeau test grade A through C
* Radial artery -adjacent vein proximity \< 1.5 mm measured lumen edge-to-lumen edge via ultrasound

Exclusion Criteria:

* Target vessel that are \< 2mm is diameter
* Distance between the target artery and vein \> 1.5 mm
* Edema of the upper extremity on the ipsilateral side
* Barbeau test grade D
Pediatric Fast Fluid Randomized Controlled Trial

The purpose of this study is to determine the impact of syringe size on the amount of time it takes a health care provider to administer a known volume (900 mL) of resuscitation fluid to a non-clinical, toddler-sized, model. The investigators hypothesize that syringe size will impact fluid resuscitation time.

The Surviving Sepsis Guideline for the resuscitation of pediatric septic shock indicates that up to 60 mL/kg of isotonic saline should be administered within the first 15 minutes of resuscitation. There are practical challenges to achieving these benchmarks. Syringes are often used to perform manual fluid resuscitation as they are generally available and health care providers are typically comfortable using them. Health care providers have been observed to have different preferences regarding the syringe size used to perform manual fluid resuscitation. Larger syringes e.g. 60 mL-size requires more force to depress the syringe plunger, due to a larger crosssectional area, but fewer syringes are needed to administer a given volume. Fewer syringes results in less time spent connecting and disconnecting syringes, which contributes to total fluid resuscitation time using this technique.

Consenting participants will be randomly assigned (by an independent Randomization Coordinator) to one of four syringe size groups (10 mL, 20 mL, 30 mL, 60 mL sizes). The allocation sequence is therefore concealed. After undergoing a standardization procedure, each participant will be instructed to administer 900 mL of 0.9% normal saline using pre-filled provided syringes by manual push as rapidly as possible using the disconnect-reconnect method. Participants will be advised to consider that they are in a situation where they are resuscitating a 15 kg child (represented by the model) in decompensated shock. Syringes for each 300 mL (20 mL/kg) aliquot will be colour-coded for identification purposes.

Eligibility Criteria:
Inclusion Criteria:

* Consenting health care staff and health care students capable of performing manual syringe bolus fluid administration

Exclusion Criteria:

* Non-English speaking individuals
* Any condition that would impact upon the individual's ability to perform manual fluid resuscitation e.g. limited hand strength or dexterity
PRP for the Treatment of Erectile Dysfunction (ED)

Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his informed and signed written consent
* The patient has ED for longer than 1 year but less than 5 years.
* The subject has a stable partner for at least 3 months.
* The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
* IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV \> 25 cm/sec

Exclusion Criteria:

The patient is participating in another study that may interfere with the results or conclusions of this study

* History of radical prostatectomy or pelvic cancer surgery
* Prior history of pelvic malignancies
* Prior pelvic radiation therapy
* Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
* Psychiatric disease which effects erectile function
* The patient is taking blood thinners
* History of Diabetes Mellitus
* History of Coronary Artery Disease
* Evidence Based Criteria: Doppler Clinical Exam ( PSV \< 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies)
* Biochemical evidence of Hypogonadism (total Testosterone \< 300 ng/dL)
Expanded Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

PainQx is conducting a study to collect electroencephalography (EEG) data from 250 people with chronic pain and 50 healthy controls in order to develop algorithms that will objectively assess the level of pain a person is experiencing.


Eligibility Criteria:
Inclusion Criteria:

* Male and female chronic pain patients
* Patients between the ages of 18-85 years
* Patients exhibiting the presence of symptoms in excess of 3 months duration
* Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain
* Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code)

Patients with NRS pain scores across the full range (1-10) at the time of testing Inclusion Criteria, Normal (no-pain) Group

o Subjects will be included with no history of pain with a duration of greater than 3 months, and no report of pain at the time of testing (or within 3 months of testing)

Exclusion Criteria:

* Patients with medically diagnosed psychotic illness
* Patients with medically diagnosed drug or alcohol dependence in the past 12 months
* Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years)
* Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition
* Patients who have a spinal cord stimulator, or other implantable devices
* Patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain

Note: This does not exclude patients who suffer from these disorders if the current source of pain is not due to the disorder. For example, patients with diabetes are NOT excluded, but patients whose pain at the time of the evaluation is a result of diabetic neuropathy are excluded. Similarly, patients with a history of migraines but for whom a migraine is not the current source of pain at the time of the evaluation are NOT excluded.

* Patients with cancer
* Patients on workers compensation or disability
* Patient on anticonvulsant medication
* Patients who have a history of seizures
The Effects of Body Scan on Enteroception in Patients with Heart Failure

The study aims to explore the effects of body scan on enteroception in people with heart failure


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Heart Failure
* Italian speaking
* Willing to sign the Informed Consent Form

Exclusion Criteria:

* Cognitive Impairment documented in the medical records
Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)

To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.

The standard treatment for acute ischemic stroke is intravenous thrombolysis to dissolve fibrin and restore blood flow. However, reocclusion of blood vessels and stroke progression remain challenges after this treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Onset of ischemic stroke symptoms within ≤ 4.5 hours\*, treated with intravenous rt-PA or TNK according to guidelines;
2. NIHSS score of 4-25 before intravenous thrombolysis;
3. Age ≥ 18 years;
4. Able to receive the designated study drug within 60 minutes after intravenous thrombolysis;
5. Informed consent signed by the patient or their legal representative. \*Symptom onset is defined as the last known well time.

Exclusion Criteria:

1. Presence of contraindications to intravenous thrombolysis;
2. Pre-stroke mRS score \> 1;
3. Patients planned to undergo mechanical thrombectomy or other endovascular treatments (e.g., intra-arterial thrombolysis);
4. Patients with a history of atrial fibrillation or emergency ECG indicating atrial fibrillation;
5. Pregnant or lactating women;
6. NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS \< 6;
7. If NIHSS worsens by 2 or more points between start of thrombolysis and start of study drug, repeat brain imaging rules out new intracranial hemorrhage;
8. Severe leukoaraiosis;
9. Currently participating in other clinical trials;
10. Known genetic or acquired bleeding diathesis, or received warfarin and INR \> 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours;
11. Severe renal failure, defined as serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate \[GFR\] \< 30, or patients requiring hemodialysis or peritoneal dialysis;
12. Liver dysfunction (ALT \> 2 times the upper limit of normal or AST \> 2 times the upper limit of normal);
13. Known allergy to tirofiban or other IIb/IIIa inhibitors;
14. Life expectancy \< 1 year;
15. Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patients, etc.).