cyrilzakka/clinical-trials huggingface dataset:
Safety of CRIS100 on Treatment Spinal Cord Injury

The goal of this clinical trial is to test CRIS100 treatment in participants with acute thoracic spinal cord injury. The main questions it aims to answer are:

* safety of CRIS100
* efficacy of CRIS100

Participants will receive 75 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.

Participants with complete spinal cord injury between T2 and T10 (ASIA A, according to ISNCSCI, 2019 revision) and:

* occurred less than 72 hours ago
* with surgical indication
* bulbocavernous reflex present
* who can receive treatment with CRIS100 within 72 hours after the trauma (preferably within 24 hours)

Eligibility Criteria:
Inclusion Criteria:

* Signature of the Free and Informed Consent Term by the participant or legal guardian
* Age between 18 and 70 years old;
* Thoracic spinal cord injury between T2 and T10, with surgical indication, occurred less than 72 hours before surgery;
* Presence of bulbo cavernosum reflex;
* Patients with a lesion classified as ASIA A according to the ISNCSCI (2019 revision);

Exclusion Criteria:

* Absence of bulbocavernous reflex up to 72 hours after the trauma.
* Presence of severe brain trauma.
* Patients with lesions above T2 or below T10.
* More than one site of spinal cord injury.
* History of alcohol or illicit drug abuse, as defined by DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition or later).
* Patients who need permanent mechanical respiratory support.
* Polytraumatized patients who, in the investigator's assessment, compromise the neurological evolution.
* Neurological diseases or functional dependence of any etiology prior to the trauma.
* Any other comorbidity that, at the discretion of the investigator, makes it impossible to include the patient in the study.
Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1

The purpose of this study is to gather preliminary data to determine if ranolazine is a safe and effective treatment for the symptoms of myotonia congenital, paramyotonia congenita, and myotonic dystrophy type 1. The duration of the study is 5 weeks.

Recent advances in the understanding of myotonia congenita have identified potential areas that could possibly respond to treatment in a drug study. The drug ranolazine (trade name Ranexa) is a FDA-approved medication to treat chest pain in patients with heart disease. Ranolazine has been studied in mice with myotonia congenita. The data from this animal model suggest that ranolazine may improve the symptoms and signs of myotonia. All individuals that participate will be placed on active drug. The investigators want to see if this drug is safe to take without causing too many side effects for people with myotonia congenita, paramyotonia congenital and myotonic dystrophy type 1. Participants will go to The Ohio State University for study visits. Participants will take ranolazine for four weeks. Participants can expect a total of 4 study visits and 2 phone calls over the 5 week period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myotonia congenital, paramyotonia congenital or Myotonic Dystrophy Type 1 established by genetic testing in the subject or in a first-degree relative.
* Clinically evident myotonia

Exclusion Criteria:

* Contraindications to ranolazine use:

  * for fungus infection: ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
  * for infection: clarithromycin (Biaxin)
  * for depression: nefazodone
  * for HIV: nelfinavir (Viracept), ritonavir (Norvir), lopinavir and ritonavir (Kaletra), indinavir (Crixivan), saquinavir (Invirase).
  * for tuberculosis (TB): rifampin (Rifadin), rifabutin (Mycobutin), rifapentine (Priftin)
  * for seizures: phenobarbital, phenytoin (Phenytek, Dilantin, Dilantin-125), carbamazepine (Tegretol)
  * the herbal supplement St. John's wort

    * you have scarring (cirrhosis) of your liver
* Concurrent use of mexiletine, lacosamide, acetazolamide, phenytoin, quinine, procainamide, Saint John wort or tocainide. Patients who were previously treated with these medications may participate. They need to be off of the medication for at least a week prior to enrollment.
* QTc \>470 ms for men and \>480 ms for women.
* Women who are pregnant or breastfeeding
* Direct family history of sudden cardiac death
Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure

Multivisceral failure syndrome (MVFS) in humans is associated with a very high risk of mortality, ranging between 30 and 50%. This syndrome is associated with significant systemic inflammation and a high risk of bacteremia, the origin of which is not always identified. Among the possible causes of bacteremia, digestive translocation is the most probable but has not been formally proven to date. This translocation is made possible by the numerous cellular and metabolic alterations secondary to MVFS, which can lead to increased intestinal barrier permeability. Intestinal permeability is currently not systematically evaluated in clinical practice in humans.

This increased intestinal permeability, associated with the presence of inflammatory markers and a septic state, has been studied in several animal models ranging from the fruit fly (Drosophila) to the mouse. These studies have shown a high risk of mortality associated with increased intestinal permeability.

We propose to use this methodology in intensive care patients with at least one organ failure to investigate the link between increased intestinal permeability and survival chances.


Eligibility Criteria:
Inclusion Criteria:

Patient with single organ failure, secondary to sepsis, hospitalized in intensive care for a foreseeable duration of \> 48 hours

* SAPS2 between 20 and 40 at the sixth hour after the diagnosis of organ failure.
* Consent from the patient or their trusted person.
* Affiliation to a social security system.
* Functional digestive tract and possible feeding (per os or via a nasogastric tube whose indication was determined independently of the study's needs).

Second group of patients with multi-organ failure:

* Multi-organ failure syndrome with at least 2 organ failures, secondary to sepsis.
* SAPS2 between 60 and 80 at the sixth hour after the diagnosis of organ failure.
* Consent from the patient or their trusted person.
* Affiliation to a social security system.
* Functional digestive tract and possible feeding (conscious patient able to swallow or with a nasogastric tube whose indication was determined independently of the study's needs).

Exclusion Criteria:

* Pregnant and breastfeeding women;
* Minors;
* Persons under administrative and judicial supervision;
* Absence of a functional digestive tract (patient unable to swallow and absence of a nasogastric tube, contraindication to enteral feeding);
* Patients with gastroparesis;
* Refusal of the patient or their trusted person;
* Patient with a SAPS2 at the sixth hour after the diagnosis of organ failure \< 20 or between 40 and 60 or \> 80.
Community Pharmacist Intervention to Enhance Adherence in Cardiovascular Drug Initiators

The goal of this clinical trial is to evaluate a community pharmacist intervention aimed at improving medication adherence in patients starting newly prescribed medication for cardiovascular disease prevention. The main questions it aims to answer are:

* Does this community pharmacist intervention improve medication adherence?
* Which patients benefit the most from the intervention?
* How do patients experience the start-up of newly prescribed medication (which questions do they have and do they experience side effects?)?
* How do patients and pharmacists experience the intervention?


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with a first prescription for one of the following drug classes: antihypertensive drugs (= low-ceiling diuretics, beta blocking agents (excl. non-selective beta-blocking agents), ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers), lipid-lowering drugs (= statins), antidiabetic drugs (= metformin, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose co-transporter 2 (SGLT2) inhibitors), or any combination thereof.
* Age 18 years or older
* Community-dwelling

Exclusion Criteria:

* The drug is prescribed for a non-cardiovascular indication (e.g. beta-blocking agent for migraine prophylaxis)
* Communication with the patient is not possible (e.g. due to cognitive impairment, insufficient knowledge of Dutch or French language)
Prevention of Noise-induced Damage by Use of Antioxidants

The current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100dB for at least 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-25 years old
* Temporary tinnitus after noise exposure: loudness \>5 on a VAS

Exclusion Criteria:

* middle ear problems
* Allergy for magnesium or n-acetylcystein
* Use of hearing protection when going out
RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma

Unsatisfactory immediate outcomes of Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) in surgery of cholangiocarcinoma suggested that patients with biliary cancer should not be treated by ALPPS. Short-term results of ALPPS variants with reduced surgical trauma on the first stage in patients with cholangiocarcinoma were not yet estimated. The objective of the study was estimation of the short-term results of split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage (RALPPS) in patients with hilar (h-CCA) and intrahepatic (i-CCA) cholangiocarcinoma compared with portal vein embolization (PVE).

ALPPS has been recently proposed as the most effective method to induce marked and rapid hypertrophy of FLR with 95-100% completion rate of the second stage. The most common indication for ALPPS is locally advanced multiple colorectal liver metastases. Unsatisfactory immediate outcomes of ALPPS in surgery of cholangiocarcinoma (CCA) including high mortality reached 48% in patients with h-CCA suggested that patients with biliary cancer should not be treated by ALPPS.

Recently reported modifications of in situ splitting (partial ALPPS, RALPPS (radio-frequency-assisted liver partition with portal vein ligation for staged hepatectomy) and ALTPS (associating liver tourniquet and right portal vein ligation for staged hepatectomy) etc) have been aimed to minimize the operating injury on the first stage, hereby reducing postoperative morbidity.

The other important idea was to preserve all initial benefits of ALPPS in terms of liver hypertrophy and completeness of the second stage. To date, there is no evidence of the benefits of any new ALPPS modification over others in reducing the morbidity of procedure, particularly in patients with CCA..

Eligibility Criteria:
Inclusion Criteria:

* h-CCA, type II-IV, T1-3N0-1M0, volume of FLR\<40%
* i-CCA, T1-3N0-1M0, volume of FLR\<40%
* Physical status 1-4 according to American Society of Anesthesiologists Physical Status Classification System
* BMI up to 40 kg/m2
* If cirrhosis is present, class A according to Child-Turcotte-Pugh score

Exclusion Criteria:

* h-CCA, stage 4A, B
* i-CCA, stage 4B
* i-CCA, T4N0-1M0
* i-CCA, h-CCA with volume of FLR \>45%
* acute cholangitis and/or infected fluid collections, liver abscesses, other unresolved surgical complications of biliary draining procedures.
* jaundice with total bilirubin \>50 µmol/L
* prior anamnestic allergic reaction or any other sign of intolerance to iodinated contrast media
* Age under 18 years
* Age above 80 years
* Persons who are incapable of giving consent
* Pregnant or breast-feeding women
* Physical status \>4 according to American Society of Anesthesiologists Physical Status Classification System
* BMI \> 40 kg/m2
* If cirrhosis is present, class B, C according to Child-Turcotte-Pugh score
Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.

Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty.

There has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1\~3 year

Eligibility Criteria:
Inclusion Criteria:

* Cervical stenosis patients with or without cervical myelopathy.

Exclusion Criteria:

* Metastatic cancer patients.
* Any combined fracture.
* Previous surgery to cervical spine.
* inflammatory joint disease
* psychiatric illness
Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept

Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed by patients prior to study entry
2. 18 years of age or older at screening visit
3. Patients with moderate to severe psoriasis
4. Patients who have failed conventional systemic treatment
5. Patients who have a contraindication to conventional systemic therapy
6. Patients who are intolerant to conventional systemic therapy
7. A negative serum pregnancy test at screening in women of childbearing potential
8. Able to self-inject study drug or have a designee who can do so
9. In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol
Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without Insulin

The purposes of this study are to determine: 1. If patients taking insulin lispro LM with metformin will have better overall control of their blood sugar than patients taking a long acting insulin comparator with metformin. 2. If there is a difference in the way the two treatments affect blood sugar control before and after meals and at night. 3. If there is a difference in the insulin dose required with the two treatments. 4. If there is a difference in the numbers of times patients experience low blood sugar with the two treatments. 5. If there is a difference in the effect on patients's body weight.

The aim of the present study is to compare two treatments - LM twice daily plus metformin two or three times daily versus a long acting insulin comparator once daily plus metformin two or three times daily - in patients with type 2 diabetes who are currently using a regimen of one or more oral antihyperglycemic agents.

The primary objective of this study is to demonstrate that, in patients with type 2 diabetes who are new to insulin, hemoglobin A1c at endpoint will be lower after treatment with insulin lispro LM twice daily plus metformin than after treatment with a long acting insulin comparator once daily plus metformin.

This will be a multicenter, randomized, open-label, crossover study comparing twice-daily insulin lispro LM plus two- or three-times-daily metformin to a once-daily long acting insulin comparator plus two- or three-times-daily metformin in patients with type 2 diabetes who were receiving one or more oral antihyperglycemic agents without insulin prior to the study.

Following an 8 (+-2) week lead-in period consisting of treatment with NPH once daily at bedtime plus metformin two or three times daily, approximately 100 eligible patients will be randomized to one of two sequence groups, so that there are approximately 50 patients in each group. One group will receive 4 months of insulin lispro LM administered immediately before the morning and evening meals plus metformin two or three times daily followed by 4 months of a once-daily long acting insulin comparator at bedtime plus metformin two or three times daily. The other group will receive the reverse sequence.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes.
* At least 30 years old and less than 80 years old.
* Using oral agents without insulin for 30 days prior ot study.
* Willing to start insulin injections using a pen device.
* Keep a patient diary.

Exclusion Criteria:

* Undergoing therapy for cancers.
* History of renal transplant or receiving renal dialysis.
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
* Women who are breastfeeding.
* Have been treated with a drug within the last 30 days that has not received regulatory approval.
RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization

The prevalence of heart failure (HF) is constantly increasing in France due to the aging of the population, better management of etiological factors and improved treatments (drug / interventional). On the other hand, re-hospitalizations for heart failure continue to increase, exceeding reception capacities and constitute a real challenge for current public health systems. The PRADO system provides administrative support (through a health insurance advisor) in the management of patient appointments with their doctors as well as home visits by a nurse trained in heart failure. Other interventional medical and educational interventions performed during an out-of-hospital consultation guided by a computer platform would help to optimize the care and continuity of care.

The aim of this study is to demonstrate the value of a multiple intervention program in reducing early readmissions for heat failure in patients hospitalized for cardiac decompensation.

This work will create an interventional assistance program to structure the exit consultation in order to optimize treatment, educate patients, ensure the continuity of hospital-city care and improve compliance (reminders) to reduce re-hospitalizations. This program will be carried out by using a computer platform allowing the systematization of output documents and the sending of messages (e-mail / SMS) for making appointments (medical consultations, biologicals sampling) and perfect therapeutic education.

Eligibility Criteria:
Inclusion Criteria:

* Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy
* Left Ventricular Ejection Fraction ≤ 40%.

Exclusion Criteria:

* Hospitalization for cardiac decompensation leading to an invasive procedure (valve, coronary, etc.).
* Acute reversible cause of heart failure.
* Incurable disease (other than heart failure) or estimated life expectancy of less than one year.
* Patient transferred directly to another department or cardiac rehabilitation center.
* Significant cognitive impairment.
* Patient without cell phone or email.
* Linguistic or psychic refusal or inability to sign the informed consent.
* Current participation in a clinical tria
Correlation Between Core Temperature and Skin Temperature in Pediatrics

During general anesthesia, temperature monitoring is critical especially in pediatrics. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. Conventional skin temperature over carotid artery is also correlated with core temperature in several studies. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.

Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery, besides, pediatric patients are more vulnerable in temperature control. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measured by esophageal prove in several studies. Its mechanism is making zero heat flux on skin applied. But it also cannot apply in head or facial surgery. Other studies showed conventional skin temperature over carotid artery is also correlated with core temperature. The investigators hypothesized using 3M™ Bair Hugger™ on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.

Eligibility Criteria:
Inclusion Criteria:

* scheduled operation under general anesthesia
* Who need esophageal temperature monitoring
* American society of anesthesiology physical status 1 or 2

Exclusion Criteria:

* Body mass index \> 35 kg/m2
* Who cannot be inserted esophageal temperature prove
* Patients with fever \> 38'C
* History of malignant hyperthermia