cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

The primary objective is to determine the efficacy of AKR963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 1500 mg/dL.

Increases in triglyceride concentrations have been correlated with increased risk for pancreatitis as well as for coronary heart disease (Ginsberg 2001, 2002). The incidence rates for major coronary events in the Munster Heart Study increased from 4.4% among Subjects with baseline TG concentrations under 200 mg/dL to 9.3% among Subjects with TG concentrations in the 200-399 mg/dL range, and up to 13.2% in Subjects with TG levels ranging from 400-799 mg/dL (Assmann 1996).

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18-79
* Fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant
* Use of non-statin lipid-altering drugs which cannot be stopped or other supplements with potential lipid-altering effects
* History of pancreatitis
* History of bariatric surgery or currently on weight loss drugs or in weight loss programs
* Treatment with any agent that may affect lipid levels or hepatic function
* Consumption of more than 3 alcoholic beverages per day
* History of cancer within last 2 years
* Participation in another clinical trial involving an investigational agent in the last 30 days
* Other parameters will be assessed at the study center to ensure eligibility for this study
'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians

Older patients with co-morbidity are increasingly represented in interventional cardiology practice. They have been historically excluded from studies regarding the optimal management of NSTEACS. Though there are associated risks with invasive treatment, such patients likely derive the greatest absolute benefit from PCI. Small, though highly selective, studies suggest a routine invasive strategy may reduce the risk of recurrent myocardial infarction.

The study aims to include, as far as possible, an 'all-comers' population of patients aged 80 and above to define the optimum amount of revascularization required to achieve good outcomes and satisfactory symptom relief for this challenging cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥80 years
* Non-ST-elevation acute coronary syndromes, defined as per guidelines:

  * Ischaemic chest pain or equivalent AND either
  * Electrocardiography with persistent or transient ST-depression and/or T-wave inversion OR
  * Biomarker positive for myocardial necrosis
* Multi-vessel coronary artery disease, defined as the presence of an angiographic \>90% diameter or FFR-(\<0.81) or iFR-(\<0.90) positive stenoses(29) in a non-culprit vessel of reference diameter ≥2.5mm.

Exclusion Criteria:

* Inability to give written informed consent
* Resuscitation from cardiac arrest
* Life expectancy \<12 months
* Cardiogenic shock
* Ventricular arrhythmias refractory to treatment at the time of randomization
* Coronary artery disease not amenable to PCI
* Heart Team decision for coronary bypass surgery
* Type 2 myocardial infarction(30) or alternative diagnoses such as tako-tsubo cardiomyopathy, as defined by the operator in light of the clinical picture at presentation
* Estimated glomerular filtration rate (eGFR) \<20mL/min/m2 (by Cockcroft-Gault formula)
* Documented anaphylaxis induced by iodinated contrast media
* Documented allergies to either aspirin, clopidogrel, ticagrelor or oral anticoagulants
* Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following:

  * Active internal bleeding
  * Bleeding diastheses precluding treatment with dual antiplatelet therapy and/or oral anticoagulation
  * Platelet count \<90,000/μL at screening
  * Previous intracranial haemorrhage
  * Clinically significant gastrointestinal bleeding within 12 months before randomization
  * Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening (confirmed with repeat testing): alanine transaminase (ALT) \>5 times the upper limit of normal or ALT \>3 times the upper limit of normal plus total bilirubin \>2 times the upper limit of normal
  * Major surgery, biopsy of a parenchymal organ, or serious trauma (including head trauma) within the past 30 days
* Any active non-cutaneous malignancy
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis

This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.

This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo pills and placebo patches. Sixty subjects will be randomized to one of 6 treatment sequences. It is expected that this trial will take approximately 2 years to complete.

Eligibility Criteria:
Inclusion Criteria:

* "Definite MS" as defined by revised McDonald criteria.
* Bilateral distal symmetric burning pain involving both feet for at least three months.
* Baseline weekly average pain rating equal to four or greater on 0-10 numerical scale.
* Stable MS medication and pain-related medications for 8 weeks prior to screening.
* Must come to Research Center for appointments

Exclusion Criteria:

* Topical treatment with lidocaine, capsaicin, or other topical analgesics within 3 months prior to screening.
* Any treatment with opioid analgesics or tramadol within 3 months prior to screening.
* Hypersensitivity to Lidoderm, lidocaine, or other local anesthetics.
* Hypersensitivity or inability to tolerate opioid analgesics.
* Current treatment with a total of 3 or more antidepressant or anticonvulsant drugs for pain.
* Current treatment with Class I anti-arrhythmic agents at baseline.
* Beck Depression Inventory score \> 16 or clinically significant depression or dementia.
* History of suicide attempt or current intent or plan.
* History of excessive alcohol use or any illicit drug use within the past 2 years.
* Lack of adequate birth control in pre-menopausal women of childbearing age.
* Other pain more severe than lower extremity burning pain.
* Open skin lesions in the area where the lidocaine patch is to be applied.
* Cancer within the previous 5 years other than skin cancer.
* MS exacerbation or any treatment with corticosteroids within 3 months prior to screening.
* History of peripheral neuropathy, lower limb amputation, or another neuromuscular syndrome or systemic disorder known to be associated with sensory neuropathy.
* Does not meet criteria of baseline lab values at screening visit.
* Nerve conduction studies consistent with peripheral neuropathy.
Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.

This study aims to 1) Characterize the effect of elevated glucocorticoids during encoding on long-term memory for alcohol-related information; 2) Identify the neural mechanisms by which glucocorticoids influence encoding of alcohol-related experiences; and 3) Determine how glucocorticoid modulation of alcohol-related encoding relates to drinking after retrieving alcohol-related memories.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and write English
* BMI 18-35
* Beer drinking

Exclusion Criteria:

* Meet current criteria for any substance use disorder, excluding caffeine
* Current significant medical conditions or psychiatric symptoms requiring medication
* Current use of medications/drugs that interfere with the HPA axis response
* Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies
* Metal in body (for MRI safety)
* Systemic fungal infections (contraindication for hydrocortisone)
* Known hypersensitivity to components of hydrocortisone tablets (hydrocortisone, calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose)
A Study Comparing Amounts of Tafamidis In The Blood Without Food

3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations

Auditory verbal hallucinations (AVH) are prevalent among patients with psychiatric disorders. Not only being highly stressful and functionally impairing, AVH often persist despite treatment. Recent attempts to treat AVH with add-on repetitive transcranial magnetic stimulation (rTMS) when targeting the temporoparietal junction (TPJ), a language node in the brain, has gained limited success. The aim of this investigation is to reduce AVH with rTMS using continous theta-burst stimulation over a novel target, the supplementary motor area (SMA), in participants with frequent AVH, while also assessing potential neurophysiological mechanisms underlying the symptom.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the AVH group:

* Reported AVH with a minimum frequency of at least daily occurrence, with onset more than one month ago
* Stable psychopharmacological treatment past month

Inclusion criteria for the non-AVH control group

* Reporting no occurrences of AVH for the past year
* Stable psychopharmacological treatment past month

Inclusion criteria for the healthy control group

* No life-time occurrence of AVH
* No history of psychiatric disorders as assessed with a Mini-International Neuropsychiatric Interview (M.I.N.I.)

Exclusion Criteria:

* Ferromagnetic or electromagnetic implants that may pose a risk during magnetic resonance imaging (MRI) and/or cTBS
* A history of epilepsy
* Pregnancy
* Current substance use disorder or a history of alcohol use disorder as assessed with Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), urine samples with test for illicit drugs and Phosphatidylethanol (PEth)
* Daily benzodiazepine use
* Factors that make the participant unlikely to be able to complete the study
Millet Products Study - Investigation of Glycemic Index and Satiety

The purpose of this study is to investigate how millet incorporation into different baked product types influences glycemic response and satiety.

The purpose of this study is to investigate how millet incorporation into different baked product types (i.e. an extruded snack versus a biscuit) influences glycemic response and satiety.

This project will examine the effect of millet, on glycemic response and satiety. To determine the effect of product matrix and processing methods, testing will be done using an extruded snack, porridge, a couscous-like product and a biscuit.

All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Men, age 19-40, non-smoking
* Normal fasting plasma glucose (\<5.6 mmol/L but not below 3.6 mmol/L)
* Normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. \<7.8 mmol/L but not below 3.6 mmol/L)
* BMI ranging from 18.5 to 29.9 kg/m2

Exclusion Criteria:

* Insulin resistance (IR) will be calculated from fasting glucose and insulin values using the Homeostasis Assessment Model 2 (HOMA2). A HOMA2-IR value of greater than 1.0 will be considered indicative of insulin resistance (Levy J.C. et al. 1998).
* Regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week
* Smoking or use of recreational drugs
* Heavy alcohol use (defined as typically \>14 drinks per week or \>4 drinks on one occasion)
* Very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings.
* Restrained eater as defined by the questionnaire at screening (Three Factor Eating Questionnaire, Stunkard et al.,1985)
* Food neophobic defined by Food Neophobia Scale questionnaire
* Unusual sleep patterns or irregular breakfast consumption
* Recent (i.e. \>4 kg in previous 3 months) or intended weight loss or gain
* Food allergies or any life-threatening allergy (food or otherwise)
* Inflammatory bowel disease or other gastrointestinal disorders
* Use of drugs which influence carbohydrate metabolism
* Training or elite athletes
* Inability to adhere to Study Protocols
A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis

The incidence of choledocholithiasis is gradually rising with the increase of gallstone incidence. The popular minimally invasive treatment options include endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic common bile duct exploration (LCBDE). Currently, three-dimensional (3D) video system for laparoscopy is developed to ofer surgeon a superior depth perception and a much better user experience, thus potential increasing operation accuracy and stability. It have suggested that compared with 2D laparoscopy, 3D laparoscopy can effectively reduce operation time and numbers of errors. However, rare experimental studies are performed to evaluate the safety and effectiveness of 3D laparoscopy in choledocholithiasis patients. The aim of this study is to compare the perioperative outcomes between 3D laparoscopy and ERCP in choledocholithiasis patients through a multicenter randomized controlled design.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of choledocholithiasis based on preoperative image studies including abdominal ultrasonography, computed tomography (CT), and/or magnetic resonance cholangiopancreatography (MRCP) with relevant supporting laboratory examinations
2. Age \<80y and \>18y
3. Non-emergency surgery

Exclusion Criteria:

1. Diagnosis of Mirizzi's syndrome,
2. Acute suppurative cholangitis
3. Detection of bilioenteric anastomosis
4. Pathological diagnosis of cholangiocarcinoma
5. Extended surgery due to multiple biliary strictures,
6. Intrahepatic stones
You.Mind! | Boosting First-line Mental Health Care for Youngsters Suffering From Chronic Conditions With Mindfulness

Adolescents with chronic conditions often experience high levels of stress, anxiety and depression and reduced quality of life. Mindfulness-Based Interventions (MBI) have been found to improve emotional distress in clinical and non-clinical populations. Recent reviews suggest that MBIs are a promising technique to support adolescents with a chronic condition in managing their symptoms and ultimately enhance their quality of life.

To test the effects of an MBI on emotional distress and quality of life and delineate the underlying mechanisms, the You.Mind! study uses a randomised staggered within-subjects design. 30 adolescents with a chronic condition (taking drop-out into account) will be randomised to a baseline phase of 14 to 28 days followed by an MBI, consisting of 4 online group sessions and online support spread over 8 weeks. Outcomes will be assessed by short, repeated measurements throughout the baseline, training, and follow-up phases and by standardized questionnaires and experience sampling measures before randomisation, at post-intervention and 3-months follow-up. Analysis will be based on general linear modelling and multilevel mixed-effects modelling. The investigators hypothesize that a MBI can help adolescents with a chronic condition to reduce their symptoms of stress, anxiety and depression, and increase their quality of life.

Once a pool of 15 participants has been enrolled, they will be randomised to one of three MBI groups, which start their training with half a week time lag. Within each group, participants will be randomised to a baseline phase of 2, 2.5, 3, 3.5 or 4 weeks, with 3-4 days between starting points of individual participants. Thus, the baseline phase will start at different time points for participants within the same group to enable them to start the intervention simultaneously while having baseline phases of varying length. Participants from different groups may begin their baseline phase at the same time while their intervention starts at a different time point. The same procedure will be repeated for the second pool of 15 participants.

Eligibility Criteria:
Inclusion Criteria:

* The adolescents suffer from a chronic condition lasting one year or more that impairs functional mobility and/or requires ongoing medical care.
* They should understand and speak Dutch.
* Written informed consent (including informed consent from a parent for those \<18yrs) after having been informed on all aspects of the study.

Exclusion Criteria:

* Evidence of a current or lifetime severe mental illness.
* Current treatment for a psychiatric disorder.
Value on Survival of Liver Volume After an Acute Decompensation of an Alcoholic Cirrhosis

Investigator seek to determine whether the volume of the liver can predict the survival after a decompensation of a patient suffering from chronic liver disease caused by excessive alcohol consumption (or alcoholic cirrhosis). Our hypothesis is that patients with a "small" liver have a lower survival compared to patients having a "normal" sized liver.

In this observational, prospective and multicentre clinical trial, investigator seek to determine the prognostic value of liver volume during an acute decompensation. Investigator plan to enroll admitted adult patients with acute decompensation of an alcoholic cirrhosis (abstinent or not), followed for one year or until death or liver transplantation. Liver volume will be evaluated using CT-scan or MRI reconstructions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patient suffering from alcoholic cirrhosis (withdrawn or not)
* Patient admitted in emergency for an alcoholic cirrhosis decompensation only
* Prescription for a cutting imaging (CT scan or MRI) during hospitalisation
* Alcohol consumption of more than 3 units per day for men and 2 units for women in average, over at least the last 5 years before the cirrhosis diagnosis
* Patient suffering from decompensated cirrhosis defined by at least one of the following criteria : Model For End-Stage Liver Disease (MELD) score above or equal to 15, ascites needing iterative punctures, symptomatic bacterial ou fungal infections, acute digestive bleeding due to portal hypertension, hepatic encephalopathy defined by a West Haven score above or equal to 2

Exclusion Criteria:

* Nodule with typical criteria of hepatocellular carcinoma
* B or C viral infections actives
* Presence of transjugular intrahepatic portosystemic shunt (TIPS)
* Presence of an occlusive thrombosis of the porta or one of the principal branches
* Presence of a thrombosis of the sus-hepatic vein
* Active extra-hepatic malignant tumor
* Decompensated cardio-vascular disease
* Patient unwilling to participate to the study
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo

Subjects were randomized in a ratio of 3:1 to receive a single subcutaneous dose of dasiglucagon (0.6 mg) or matching placebo. Randomization also determined whether the subject was to be injected in the buttock or deltoid. During the dosing visit (Visit 2), hypoglycemia was induced by a fast-acting insulin glulisine (Apidra®) infusion, and trial drug was administered when the subject's plasma glucose level was 45-60 mg/dL (2.5-3.3 mmol/L). During the insulin-induced hypoglycemia, pharmacokinetic and pharmacodynamic samples were drawn, and plasma glucose levels were monitored closely at site for safety reasons. A rescue glucose infusion could be administered to ameliorate persistent hypoglycemia. Subjects were followed for at least 28 days after dosing to perform an adequate immunogenicity evaluation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3).
* Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
* Hemoglobin A1c \<10%.
* Aged between 18 and 75 years, both inclusive.

Exclusion Criteria:

* Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program.
* Known or suspected allergy to trial drug(s) or related products.
* History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).
* Previous participation in this trial. Participation being defined by signing the informed consent document.