cyrilzakka/clinical-trials huggingface dataset:
SGLT2 for Heart Failure in CHD Patients

Heart failure (HF) in adult patients with congenital heart disease is a major cause of morbidity and mortality. Approximately 30% of patients with significant congenital heart disease will develop signs of heart failure. Heart failure leads to hospitalization and disability with a longer hospital stay and higher health care costs as compared to heart failure patients without congenital heart disease. One-third of deaths in patients with congenital heart disease are attributable to heart failure.

In patients with heart failure and reduced ejection fraction (EF), 2021 ESC recommendations suggest the use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) (dapaglifozin and empaglifozin), a new therapeutic class for heart failure (HF), in a class IA recommendation. In addition to reduced EF, these molecules have shown efficacy in preserved EF, leading to their reimbursement in both preserved and reduced ejection fraction in France.

Unfortunately, given the relatively low number of HF-congenital heart disease, patients, they were not included in previous studies. However, the seriousness of their condition and the absence of therapeutic explain the prescription of SGLT2i in those patients and the likelihood of increased use in the future. This especially underlines the need for safety data in this real-world population.

To date, no data on the safety or efficacy of SGLT2i in HF-congenital heart disease have been published. The results of this study would provide reassurance about the safety of SGLT2i in adult congenital patients and potentially expand the indication of SGLT2i in HF related to congenital heart disease

The objective of this study is to assess on real-life data, through a multicenter registry:

* The efficacy of SGLT2i in patients with heart failure related to congenital heart disease - The indications of SGLT2i use (type of congenital heart disease)
* The safety of SGLT2i (collection of adverse events)


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Congenital heart disease (repaired, unrepaired, or palliated) with clinical heart failure NYHA class II, III, or IV at the time of SGLT2i initiation B59
* Patient in whom SGLT2i therapy has been started within the previous 12 months or is started at the time of the visit.
* Registered to the French social security system

Exclusion Criteria:

* Opposition of the patient to the use of his/her data
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants

This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants, 18 to 55 years of age.
2. Able to provide written informed consent.
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2.
4. Must have been vaccinated against N. meningitidis and S. pneumoniae with approved vaccine according to product label. All participants considered eligible for enrollment will be vaccinated or willing to receive vaccination according to the following:

   1. Vaccination with Meningococcal Group A, C, W135, and Y conjugate vaccine (Menveo® or an acceptable alternative) + Pneumococcal Polysaccharide Vaccine (Pneumovax® 23 or an acceptable alternative) at least 28 days prior to receiving the first dose of RLYB116.
   2. Vaccination with Meningococcal Group B (Bexsero®) at least 14 days prior to receiving the first dose of RLYB116.

Exclusion Criteria:

1. Participants that smoke more than 10 cigarettes per week
2. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus.
3. Pregnant or nursing
4. Donation or loss of greater than 400 mL of blood within 56 days of study enrollment
5. History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.
Selective Subarachnoid Anesthesia. Comparison of Hyperbaric Bupivacaine and Hyperbaric Prilocaine

Selective spinal anesthesia is widely used for ambulatory surgery. Unilateral spinal anesthesia is a suitable option for ambulatory anesthesia as it is efficient and effective. Lidocaine has been the well-known choice for this procedure. However, it is associated to transient neurologic symptoms (TNS). Different anesthetic strategies for this procedure have been performed, for example, the use of small doses of long-acting agents and the use of additives such as opioids. The ideal local anesthetic should be lidocaine-like without risk of transient neurologic symptoms. We design and plan a randomised clinical trial to show if hyperbaric prilocaine 2% would be an alternative.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a scheduled knee arthroscopy
* Patients with a scheduled inguinal hernioplasty

Exclusion Criteria:

* Patient refusal to regional anesthesia
* American Society of Anesthesiologists score risk equal or greater than 4
* Body mass index greater than 32
* Coagulopathy
* Cutaneous infection at injection site
Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

The aim of INS.CORT trial is, by studying glycemic variability in a well-defined patient group with both insulin \& hydrocortisone (patients with concomitant insulin-treated diabetes \& Addison's disease) and collecting information about the administration -time point and doses- of insulin, hydrocortisone and food intake with the help of new technology to improve the treatment in all patients treated with both insulin \& glucocorticoids.


Eligibility Criteria:
Inclusion Criteria:

Men and women at age 18 to 70 years, with BMI 18-32 kg/m2 and well-defined both insulin-treated diabetes \& Addison's disease for \>12 months each, on insulin treatment and stable hydrocortisone replacement with once-daily dual-release hydrocortisone (20-30 mg/day) for \>3 months.

Exclusion Criteria:

* Any medication with other glucose lowering agents than insulin
* Any additional underlying or intercurrent disease that may need regular or periodic pharmacological treatment with glucocorticoids during the study period, including infectious diseases
* Any medication with agents which in the investigator's judgement might interfere with the study drugs kinetics, including therapies affecting gastrointestinal emptying or motility
* Any medication with oral estrogen supplementation and/or regular DHEA medication for the past 4 weeks
* Clinically significant renal dysfunction with a serum creatinine above 160 mmol/L
* Active malignancy
* Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary/pancreatic disease which in the investigator's judgement may interfere with the study assessment
* Pregnant or lactating women
* Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator.
Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions

The aim of this monocentric observational pilot study is to measure the lidocaine plasma level in a limited number of patients to generate explorative data on inter- and intrapersonal stability and safety of drug plasma levels and to investigate whether higher plasma levels of ketamine can be correlated with a better analgesic effect.

There are different treatment strategies for chronic pain. One possible treatment strategy, especially for therapy-resistant pain, is intravenous infusions with certain pharmacological agents, such as lidocaine and ketamine. This study is to measure the concentration of lidocaine in the plasma of patients at the University Hospital of Basel (USB) after an intravenous infusion with 4mg/kg lidocaine over 30 minutes in order to generate explorative data on inter- and intrapersonal stability and safety of drug plasma levels. The prospective side effects of lidocaine and ketamine is assessed and the plasma levels are correlated with the analgesic efficacy and change in possible depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a new recipient of lidocaine-ketamine infusions
* Patient is able to provide Informed Consent

Exclusion Criteria:

* Contraindication to blood sampling (on arm not used for infusion)
* Insufficient knowledge of German language
* Inability to give consent
* Patient is under 18 years of age
* Contraindication to treatment with lidocaine and/or ketamine
Neurocognitive Outcomes and Quality of Life in Adults With Maple Syrup Urine Disease (MSUD)

Maple Syrup Urine Disease (MSUD) is a disorder of protein metabolism that leads to neurological differences. It is an exciting time where people diagnosed with MSUD are living longer. The investigators want to learn about how adults with MSUD think, feel, and live. The purpose of this research study is to 1) look at thinking skills, behavior skills, life skills, and quality of life in adults with MSUD and 2) measure how medical and personal factors impact these areas. The results of the study will be used to learn how to best help adults with MSUD and how to prepare for their success. In this study, the participants will answer questions on thinking, life skills, behavior skills, and quality of life. These questions will be completed on the internet. The participants will have a formal testing of their thinking and behavior completed virtually. The participants may also have a 1-2-hour telephone conversation about their life. All tests will occur virtually at home. The investigators will send the participants a letter with the results of thinking and behavior tests.


Eligibility Criteria:
Inclusion Criteria for Index Subjects:

* Males or females 21 years and older
* Diagnosis of MSUD
* Ability to communicate verbally or using augmentative communication effectively to participate in appropriate neurocognitive testing

Inclusion Criteria for Comparison Subjects:

* Males or females 21 years and older
* Sibling or acquaintance of index subject
* Ability to communicate verbally or using augmentative communication effectively to participate in appropriate neurocognitive testing

Exclusion Criteria for all subjects:

* Inability to communicate verbally or using augmentative communication effectively to participate in appropriate neurocognitive testing
* Subjects or guardians or who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
* Subjects or guardians who do not have internet access
* Subjects who do not speak English as a primary language
Mitoxantrone Following Surgery in Treating Patients With Prostate Cancer at High Risk for Recurrence

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy after surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of mitoxantrone given after surgery in treating patients who have prostate cancer that is at high risk for recurrence.

OBJECTIVES: I. Assess the feasibility of enrolling patients with adenocarcinoma of the prostate at high risk for recurrence following radical prostatectomy in an adjuvant mitoxantrone trial. II. Determine if this adjuvant therapy results in a delay in time to failure or a decrease in the number of treatment failures compared to historical controls in this patient population.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Adenocarcinoma of the prostate treated by radical prostatectomy within the past 3 months Considered to be at high risk for recurrence as defined by at least 1 of the following characteristics on the radical prostatectomy specimen: Positive seminal vesicles Gleason 6 and preoperative PSA greater than 18 ng/mL Gleason 7 and preoperative PSA greater than 14 ng/mL Gleason 8, 9, or 10 and any preoperative PSA Undetectable PSA (i.e., less than 0.1 ng/mL) within 3 months following radical prostatectomy and at time of enrollment Negative lymph nodes at time of radical prostatectomy if lymphadenectomy performed Extracapsular penetration and/or positive surgical margins allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Not specified Cardiovascular: No New York Heart Association class III or IV cardiac disease or angina pectoris No myocardial infarction within the past 6 months

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim or sargramostim except for febrile neutropenia Chemotherapy: No other concurrent chemotherapy Endocrine therapy: No prior neoadjuvant or adjuvant hormonal therapy for prostate cancer No concurrent hormonal therapy except for non-disease related conditions (e.g., insulin for diabetes) No concurrent systemic corticosteriods unless for adrenal insufficiency No concurrent prednisone, dexamethasone, or other steroidal antiemetics At least 6 months since prior finasteride No concurrent finasteride No concurrent antiandrogens (e.g., flutamide, bicalutamide, nilutamide) or gonadotropin releasing hormone agonists (e.g., leuprolide, goserelin) Radiotherapy: No prior adjuvant radiotherapy for prostate cancer No prior pelvic radiotherapy for prostate cancer Surgery: See Disease Characteristics Other: At least 6 months since prior saw palmetto No concurrent compounds with 5 alpha-reductase inhibitor activity (e.g., saw palmetto)
A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)

This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a BMI less than or equal to 42 kg/m\^2 at the screening visit
* Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
* Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
* Participant is a nonsmoker and has not used nicotine containing products for \~ 6 months before start of study

Exclusion Criteria:

* Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
* Participant has a history of stroke, chronic seizures, or a major neurological disorder
* Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
* Participant has glaucoma or is blind
* Participant has a condition known to be related to cataract development
* Participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than Lasik) within 3 months of screening
* Participant has a history of type 1 diabetes or ketoacidosis
* Participant cannot stop taking certain current medications during the study
* Participant consumes greater than 3 alcoholic beverages per day
* Participant consumes more than 6 servings of caffeinated beverages per day (1 serving is \~ 120 mg caffeine)
* Participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food
* Participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study
Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition

The purpose of this study is to determine what the long term survival is after in hospital use of total parenteral nutrition due to intestinal failure.

Earlier studies only followed patients for a maximum of 6 months or included only very specific patients. We were interested in all patients in our hospital and followed them for up to 2 years.

Extensive description is not desired

Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients on TPN

Exclusion Criteria:

* patients from the Pediatric and Haematological Departments
A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

All Participants:

* Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured on Day -1
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* If a woman, must not be of childbearing potential: postmenopausal (amenorrhea for at least 12 months and a serum follicle stimulating hormone within postmenopausal range); or surgically sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation procedure)

Healthy Participants with normal hepatic function:

* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic for participants less than or equal to (\<=) 60 years old and between 90 and 150 mmHg for participants greater than (\>) 60 years old, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted per visit
* Pharmacogenomics: Healthy participants must have matching glutathione S-transferase Mu 1 (GSTM1) genotype (null or non-null GSTM1 genotype) to individual hepatic impairment group participants

Participants with hepatic impairment:

* A 12-lead electrocardiogram (ECG) consistent with adequate cardiac conduction and function as per judgement by the investigator, including: a) Sinus rhythm; b) Heart rate between 50 and 100 beats per minute (extremes included); c) QTc interval \<= 480 milliseconds (ms) (corrected cf. Fridericia; QTcF)
* Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study

Exclusion Criteria:

All Participants:

* Participant has known allergies, hypersensitivity, or intolerance to Lazertinib or its excipients
* Any surgical or medical condition that may alter the absorption, metabolism, or excretion of the study drug (example, gastrectomy, Crohn's disease etc.), with the exception of hepatic impairment
* Active gall bladder or biliary tract disease (example, acute cholecystitis, symptomatic cholelithiasis)
* Participant tests positive for human immunodeficiency virus (HIV)-1 or HIV-2 at screening
* Participant has a lack of adequate venous access
Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes

This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
* HbA1c greater than 7%
* Informed Consent

Exclusion Criteria:

* Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
* Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months
Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients

The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost utility of these two strategies.

Optimizing the management of type 2 diabetes (T2D) will remain a major public health concern for decades to come. T2DM has already affected 4% of the French population and generates each year over 12 billion euros of expenditure. By combining therapies, oral and/or injectable (insulin or analogues of GLP-1), the current management of T2DM provides two thirds of patients with a satisfactory metabolic control (HbA1c \< 7%) and reduced incidence of cardiovascular complications. Its effect on mortality, however, remains more limited, presumably because of the persistence of other cardiovascular risk factors. A recent study has confirmed that French patients with T2DM present an overall mortality risk significantly higher than the general population. In France, this group registered a mortality of 32 deaths per 1000 persons.

Bariatric surgery is now a recognized method for the treatment of severe obesity. It allows for the permanent loss of at least 50% of initial excess weight. In obese patients, this surgery is also associated with a significant reduction in cardiovascular risk factors and particularly T2D. A recent meta-analysis of retrospective studies available suggests that surgery results in remission of T2DM in over 75% of cases. The only prospective randomized study showed that gastric restriction by placing a gastric band, provides better glycemic control than just medical treatment in obese patients with recently discovered T2DM. The gastric by-pass (GBP) which also includes an intestinal by-pass, seems to have an even higher metabolic efficiency than gastric bypass alone. In patients with T2DM, the GBP restores postprandial insulin secretion independently of weight loss. Despite the significant morbidity of the intervention, long-term results seem broadly supportive of the GBP. In a large case-control study, GBP was associated with a decrease of 90% of deaths related to diabetes. In a controlled study conducted in surgical candidates obese diabetics, the GBP decreased the overall world mortality by 75% after 6 years. Despite these very encouraging data, the GBP is now proposed to only a small proportion (\< 1%) of patients likely to benefit from the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus with HbA1c \> 7.5 %
* Body mass index \> 35 and \< 50 kg/m2
* Candidate for Gastric By-Pass
* Treatment with GLP1 (glucagon-like peptide) analogue or insulin

Exclusion Criteria:

* Contraindication to bariatric surgery
* Pregnancy
* Affiliation of health care assurance
* Psychiatric disorders