cyrilzakka/clinical-trials huggingface dataset:
Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance. NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* Male or female (of non-childbearing potential) aged 18-64 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) 25.0 to 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) greater than or equal to (\>=) 10 percent and liver stiffness greater than 8 kilopascal (kPa) as measured by FibroScan® (vibration-controlled transient elastography \[VCTE™\]).

Additional inclusion criteria for participants in the open-label liver biopsy cohort apply:

* Alanine aminotransferase (ALT) in men greater than (\>) 30 units per liter (U/L), women \> 19 U/L
* Liverstiffness, measured by FibroScan® (VCTE) \> 8 kPa and less than (\<) 12 kPa
* Informed consent obtained at screening for a liver biopsy to be performed at baseline and post-treatment.

Note: Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH), based on a prior liver biopsy, can be included in the open-label cohort.

Exclusion Criteria:

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Any laboratory safety parameter, at screening, outside the extended laboratory ranges, and considered clinically significant per the principal investigator (see laboratory provided reference ranges for specific values). Of note, re-screening or re-sampling is NOT allowed if the individual has failed one of the exclusion criteria related to the following laboratory parameters:
* ALT \>= 3 × upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \>= 3 × ULN
* Bilirubin \> 1.5 × ULN
* Estimated glomerular filtration rate (eGFR) \< 60 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening.
Position Changes in Cirrhosis Hemorrhagic Spot Detection

The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.

The patients who conducted position change due to massive EGVB resulting in poor visualization in the stomach were included. Those with incomplete information were excluded. The patients were characterized in terms of age, sex, causes of liver cirrhosis, adverse events (AEs) during position change, additional findings after body position change, treatment regimens and follow-up information.

The gastroscopes procedure was started in the left lateral position in all patients. Bleeding varices detected before the position change were stopped by the endoscopic hemostatic measures described above. The following conditions would consider a change of position during gastroscopy: (1) A large amount of blood or blood clot was found after reaching the stomach, making it difficult to suction adequately which led to poor mucosal visuality; (2) Persistent massive bleeding from a blood vessel that filled the stomach cavity rapidly after suction, making it impossible to clarify the bleeding vessel.During position changing procedure, endoscopist withdrew the gastroscope from the stomach and patients changed from the left lateral position to the right lateral position with the help of the nurses. Then endoscopist reinserted the gastroscope into the stomach and tried to detect the addition varices after position change.

Bleeding varices were treated by injection of N-butyl-Cyanoacrylate glue (glub B or Beltran, Compex) or/and Lauromacrogol (Shanxi, Tianyu).

Eligibility Criteria:
Inclusion Criteria:

* conducted position change due to massive EGVB resulting in poor visualization in the stomach

Exclusion Criteria:

* incomplete information
Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy

Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, and corpus callosum).

Epilepsy is a condition associated with seizures as a result of an over excitable cerebral cortex. Despite the introduction of several new antiepileptic medications, less than half of the patients diagnosed with partial epilepsy are well controlled. However, studies have shown that non-invasive stimulation of the brain can decrease the excitability of the cerebral cortex.

Researchers are interested in the potential therapeutic effects of TMS on patients with epilepsy that have responded poorly to standard medication. This study will use TMS to decrease the excitability of the areas of the brain responsible for seizures.

The purpose of this protocol is to study the effects of transcranial magnetic stimulation (TMS) at 1 Hz on the excitability of the seizure focus in patients with poorly controlled epilepsy refractory to pharmacological treatments. 1 Hz TMS is a rate proven to induce long term depression in animal models and reported to decrease the excitability of both human and animal cerebral cortex.

Eligibility Criteria:
Age 5 to 60 at entry to protocol.

History of partial or Complex Partial Epilepsy for two or more years.

Patients should be on a stable anti-convulsant regimen defined as unchanged medicines and dose modifications lower than 20% in the last month. Blood levels of anti-convulsants will be measured at the beginning of the study, prior to stimulation and after the study to assure that the type and dose of medication will remain constant.

Seizures not completely responsive to medical treatment (1 or more seizures per week for at least 6 months) and patients have failed at least two anti-convulsant regimens in the past.

The patients have a localized seizure focus.

Epilepsy refractory to medical treatments.

No pregnant women (will be tested with urine pregnancy test).

No severe coronary disease.

No metal anywhere in the cranium except the mouth.

No intracardiac lines.

No increased intracranial pressure as expressed by the presence of papilledema.

No cardiac pacemakers.

Must not be taking neuroleptic or antidepressant medications.

No progressive neurologic disease.
Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies

The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of Dravet syndrome (according to Recommendation from a North American Consensus Panel, 2017) or other refractory epilepsy (per the judgment of the treating physician)
2. Male or female, age at least 2 years at the time of informed consent
3. Currently treated with lorcaserin, that the treatment is for Dravet syndrome or other refractory epilepsies, and the treatment was initiated before 13 Feb 2020; or has completed Study E2023-A001-304
4. Has a clinical benefit from lorcaserin in the opinion of the treating physician

Exclusion Criteria:

None
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.

The purpose of this study is to compare the difference in medication dosage and total daily dose necessary of Astagraf XL® in order to reach therapy goal, when taken with other medications that are routinely used for kidney transplantation, which may stop the development of a substance that can cause long-term damage to the transplanted kidney. African American kidney transplant patients aged 18 and above who are underwent a kidney transplant are eligible to participate. The duration of the study is 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Signed informed consent
3. African American race
4. History of a solitary renal transplant
5. Stable tacrolimus dose for at least 2 weeks prior to randomization

Exclusion Criteria:

1. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
2. Currently enrolled in an investigational drug trial
3. History of a non-renal organ transplant
4. History of acute cellular rejection within 1 month prior to randomization
5. An increase in serum creatinine by \> 20% in the 2 weeks prior to randomization
6. Maintenance immunosuppression that does not consist of tacrolimus IR given twice daily, mycophenolate mofetil \> 1000mg TDD or mycophenolate sodium \> 720mg TDD, and prednisone ≥ 5mg daily
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema

The purpose of this study is to determine how well different treatments for acquired lymphedema work.

The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.

This study will compare 5 non-invasive lymphedema treatments.

Patients will be assigned to either:

- A combination of arm exercises, arm elevation, and wearing of a compression garment every day

OR

- One of four possible pneumatic compression devices for just two hours every day.

Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken.

None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home.

The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acquired lymphedema of the arm.

Exclusion Criteria:

* Refusal of consent
* Unlikely compliance with the research protocol
* Acute upper extremity DVT
Validation of the Back Beliefs Questionnaire to the Turkish

The Back Beliefs Questionnaire (BBQ) developed by Symonds et al. in 1996 is used to measure patient's attitudes and beliefs towards recovery and return-to-work; and expectations regarding the negative circumstances that could be created as a result of low back pain (LBP).The aim of this study was the translation to Turkish language, cross-cultural adaptation and assessment of reliability\&validity of BBQ for the patients suffering from chronic LBP.

Back Beliefs Questionnaire was translated and culturally adapted into Turkish regarding to the published guidelines. This observational cross-sectional study was performed with 110 chronic low back pain patients. All participants were asked to complete Back Beliefs Questionnaire and also fill the socio-demographic data form and evaluation tools (Numeric rating scale-pain, Oswestry Disability Index, Fear Avoidance Beliefs Questionnaire, Hospital Anxiety and Depression Scale). Internal consistency was evaluated with Cronbach's alfa coefficient. Intraclass correlation coefficient was used to assess test-retest reliability. Structural validity was assessed by correlations with other tools.

Back Beliefs Questionnaire had a good internal consistency (Cronbach alfa= 0.79) and an excellent test-retest reliability (Intraclass correlation coefficient = 0.84). A moderate correlation was determined between Back Beliefs Questionnaire and Fear Avoidance Beliefs Questionnaire. Correlations with Numeric rating scale-pain, Oswestry Disability Index, Hospital Anxiety and Depression Scale were fair.

Turkish version of Back Beliefs Questionnaire is a valid and reliable questionnaire that can be used to evaluate beliefs about pain in patients with chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Turkish speaking
* Suffering from low back pain during activity for over 3 months

Exclusion Criteria:

* pregnancy
* malignancy
* infections
* fractures
* inflammatory diseases
* cognitive impairments that might create a problem in comprehending and filling the survey
Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy

Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. All patients included in the study had an average of 3 months disease course and were considered refractory to conservative treatment. Patients were evaluated with stringent inclusion criteria with the Levine severity and functional status scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are reported.

Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and in an ambulatory setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy.

Exclusion Criteria:

* Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.
Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine

Caudal epidural analgesia (caudal block) is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).

This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements.


Eligibility Criteria:
Inclusion Criteria:

* Age 2 years or younger.
* Weight 33 kg or less.
* Scheduled for elective inguinal herniorrhaphy or orchiopexy.
* American Society of Anesthesiologists Class 1, 2 or 3.

Exclusion Criteria:

* Age over 2 years.
* Weight over 33 kg.
* Allergy to ropivacaine.
* Usual contraindications to caudal anesthesia (patient refusal, skeletal or spinal cord anomaly, coagulopathy, infection at insertion site, ongoing bacteremia)
INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.

This is a single-center, non-randomized, prospective interventional pilot study. Feasibility of intraoperatively visualizing tumour (margins) in penile and tongue tumours using EMI-137 will be investigated. Patients, ≥ 18 years of age, with ≥T1 penile or tongue cancer undergoing primary tumour surgery will be included. All patients will receive an intravenous bolus injection of EMI-137 prior to surgery. Main study parameters/endpoints are: Intraoperative visualization of primary penile or tongue tumours using a dedicated clinical fluorescence camera. The in vivo detected fluorescence signal will be correlated to ex vivo measurements and pathological assessment of the ex-cised tissue.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, prior to performing any protocol related procedures.
* Age ≥ 18 years at time of study entry.
* ≥ T1 penile or tongue squamous cell cancer
* Scheduled for surgical primary tumour resection

Exclusion Criteria:

* Involvement in the planning and/or conduct of the study.
* Pregnant woman
* Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days.
* Severe kidney insufficiency
Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with high morbidity.

The aim of the study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.

Background:

Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with hight morbidity.

In 2001, in France more than 50% of intubations in neonates were performed without any premedication or anesthesia.

The most frequently used anesthesias are based on benzodiazepine or opioids. Unfortunately, these treatments are responsible for respiratory and hemodynamic adverse effects. Recently, 2 new possibilities for anesthesia before intubation has been tested: propofol was better than association of morphine, succinylcholine and atropine and we shaw that inhaled sevoflurane was better than no treatment.

The aim of the present study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.

Objectives:

The objective of this study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation of neonates.

Methods:

Prospective, controlled, randomized, monocentric study.

Subjects:

Neonates in neonatal intensive care requiring intubation.

Evaluation criteria:

Recovery time after intubation, facilitation of procedure, tolerance of treatment (mean arterial pressure, apnea).

Eligibility Criteria:
Inclusion Criteria:

* Neonates
* Hospitalized in neonatal intensive care unit
* Needing of an endotracheal intubation

Exclusion Criteria:

* Emergency state
* Predictable difficult endotracheal intubation
* Decrease of blood pressure
* Neurological disorders
* Morphinic treatment
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage

The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA


Eligibility Criteria:
Inclusion Criteria:

* Subject is greater than or equal to 18 years of age and less than or equal to 80 years of age
* Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (\>=60 years of age), CABG (\< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure
* The subject is willing and able to provide written informed consent and comply with study requirements
* The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE)

Exclusion Criteria:

* Thrombus in the LAA and/or left atrium
* Prior LAA isolation attempts
* Subject is unable to take an anticoagulant during the study follow-up period
* Subject is undergoing an emergency cardiac procedure
* Life expectancy of less than 12 months
* Pregnancy or desire to be pregnant within the 12 months of the study procedure
Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery

Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old patients admitted for elective colorectal surgery

Exclusion Criteria:

* Pre-existing chronic pain
* Chronic medication that may interfere with pain: antiepileptics, NSAIDs, corticosteroids
* Contraindications to any of the medications in the study
* Significant psychiatric disorders (Axis I disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.)
* Hepatic (ALT and / or AST\> 2 normal wave) or renal (serum creatinine\> 2 mg / dl)
* Convulsive conditions that require medication in the last 2 years
* Planned regional analgesia and / or anesthesia (spinal or epidural)
* Corticosteroid-dependent asthma
* Autoimmune disorders
* Antiarrhythmic drugs (verapamil, propafenone, amiodarone) that may interfere with the antiarrhythmic action of lidocaine
A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve

Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement.

Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2) explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. The investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* the first time to receive elective mitral and/or aortic mechanical prosthetic valve replacement
* willing to join in the clinical trial and comply with the protocol.

Exclusion Criteria:

* other ethnic groups than Han
* previously receive any other cardiac surgery
* emergent surgery
* simultaneously carry out other cardiac surgeries,such as CABG
* age younger than 18y or older than 65 year
* drug abuser and wine abuser
* any malignancy
* moderate or severe hepatic or kidney insufficiency
* any thyroid disease
* the history of warfarin or VitK consumption 2 week before the surgery
* any hematological disease or history of bleeding
* combination with any drugs that significantly influence warfarin other than Cordarone
* pregnancy
* any contraindication of warfarin
* infectious endocarditis
* advanced valvular disease
* pathological obesity
* psychological disease
* any patient having joined in other clinical trial in the previous 30d
* basic INR \> 1.4