cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes

What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.

Background: Ketones are molecules that are naturally produced by our body during fasting or diets low in carbohydrates. Ketones can affect how our liver produces and maintains our body's blood sugar levels, which could be important in the management of type 2 diabetes (T2D), where high blood sugar levels are partly because of excess sugar production by the liver.

Objectives: To determine if, and how, a ketone drink can lower blood glucose in people with T2D following a meal.

Methods: Twelve people with T2D will visit our laboratory in the morning on two occasions and ingest a drink containing ketones or placebo on each visit in a random order before ingesting a milkshake style drink containing sugar. Blood samples will then be taken at regular intervals over 4 hours to determine if the ketone drink has lowered blood sugar levels in response to the meal, and if this was due to reduced sugar production by the liver.

Value: This research will provide new knowledge about the regulation of liver blood sugar production in response to ketone ingestion. This may also inform future clinical trials to establish if ketone drinks could be used as a treatment for T2D.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes by a physician, a current HbA1c of 6.5-8.5%, and receiving treatment with lifestyle advice or oral glucose-lowering medications.
* Non-smoking
* Blood pressure \<160/100 mm/Hg

Exclusion Criteria:

* Exogenous insulin or SGLT2 inhibitors for type 2 diabetes treatment.
* Following a low-carbohydrate ketogenic diet, periodic fasting diet, or consuming ketogenic supplements.
* Other diagnosed chronic metabolic, cardiovascular, respiratory, neurological, or gastrointestinal disease.
* Smoker
* Blood pressure \>160/100 mm/Hg
* Lactose intolerant
Exercise Changes to Peripheral Blood Mononuclear Cells in Children

The goal of this research is to determine how the peripheral immune system is altered by exercise and differences related to gender, pubertal status and health.

SPECIFIC AIMS:

1. To systematically measure for the first time in healthy children and adolescents the effects of brief bouts of exercise on:

   1. Numbers of circulating PMBCs, their subsets and key intercellular adhesion molecules (ICAMs).
   2. PBMC gene regulation of stress, inflammatory, and growth/repair mediators \[including: interleukin-4 (IL-4), IL-6, IL-10, tumor necrosis factor-alpha (TNF-alpha), interferon-gamma), growth hormone (GH), insulin-like growth factor-I (IGF-I), heat shock proteins (Hsp)\].
   3. Circulating (serum) and intracellular PBMC levels of key mediators by flow cytometry and cell culture techniques.
   4. Circulating endogenous triggers of PBMC mediator responses-soluble Hsp, IL-6, and F2-isoprostanes.
2. To determine how the acute PBMC responses are altered by gender, pubertal status, body composition (measured by whole-body and regional DEXA), and fitness (measured by progressive cycle ergometry and gas exchange).
3. To determine the relationship in healthy children and adolescents among acute PBMC responses to exercise, biochemical precursors of the metabolic syndrome (insulin, glucose, lipids), and the balance of the TH1/TH2 immune response.

Eligibility Criteria:
Inclusion Criteria:

* appropriate Tanner Stage
* No evidence of disease or disability

Exclusion Criteria:

* no use of antiinflammatory medications, alcohol, illegal drugs or bronchodilators
* elite children participating in extensive exercise or dance programs
* pregnant
Temozolomide Chronotherapy for High Grade Glioma

Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of this drug and known oscillations in DNA damage repair make it an ideal candidate for chronotherapy.

Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas.

Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the invesitgators hypothesize that the timing of TMZ treatment will alter its efficacy and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed and recurrent high grade gliomas (WHO grades III \& IV) and high risk WHO grade II gliomas who are to begin treatment with monthly high dose temozolomide therapy.
* Scheduled to receive adjuvant temozolomide therapy after having completed concurrent temozolomide and radiation therapy.
* At least 18 years of age.
* Karnofsky performance status ≥ 60%
* Ability to understand and willingness to sign an IRB approved written informed consent document

Exclusion Criteria:.

-Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).

This is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.

Eligibility Criteria:
Inclusion Criteria:

Age 18 years and older

PH-HFpEF confirmed diagnosis by RHC:

* Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg AND
* Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg AND
* Transpulmonary Gradient (TPG) ≥ 12 mmHg

Exclusion Criteria:

* Age less than 18 years;
* SBP \> 170 or \< 110 mmHg
* DBP \>95 or \< 60 mmHg
* Hemoglobin A1C \> 10
* Positive urine pregnancy test or breastfeeding;
* Ejection Fraction (EF) \< 40%;
* Dementia
* End-stage malignancy
* Major cardiovascular event or procedure within 6 weeks prior to enrollment
* Severe valvular disease
* Known chronic psychiatric or medical conditions that may increase the risk associated with study participation in the judgment of the investigator, would make the subject inappropriate for entry into this study;
* Smoker
* Hemoglobin \<9 g/dL
* Serum creatinine \> 3.0 mg/dL
* Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days; RHC \< 2 weeks from study screening RHC unless clinically indicated
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.

Eligibility Criteria:
Primary Inclusion Criteria

1. Have completed the LBSL02 trial and achieved a satisfactory response.

Primary Exclusion Criteria

1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
3. Used any of the following prohibited medications during their participation in LBSL02:

   * Other investigational agents.
   * Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
   * Intravenous cyclophosphamide.
   * Corticosteroids \>100 mg/day prednisone equivalent for reasons other than severe SLE flare.
A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension which will enroll up to 48 adult subjects with tenosynovial giant cell tumor for intra-articular doses over a 24-week dosing period (Part 1) with a Part 2 open-label extension of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥ 18 years
2. TGCT with only 1 joint involvement
3. Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1
4. Stable prescription of analgesic regimen
5. Agrees to follow contraception guidelines
6. Women of childbearing potential must have a negative pregnancy test
7. Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
2. Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors within 3 months prior to Baseline
3. History of extensive or reconstructive surgery on the affected joint
4. Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
5. Metastatic or malignant transformation of TGCT
6. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
7. Known active tuberculosis
8. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
9. Women who are breastfeeding
10. A screening Fridericia-corrected QT interval (QTcF) ≥ 470 ms
11. MRI contraindications (e.g., pacemaker, loose metallic implants)
12. History of hypersensitivity to any ingredient of the study drug
13. History of drug or alcohol abuse within 3 months before baseline
14. Any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment or interfere with interpretation of study results and, in the Investigator's opinion, make the subject inappropriate for this study
15. Subjects who, in the Investigator's opinion, should not participate in the study for any reason, including if there is a question about their ability to comply with study requirements
Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry

The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:

* Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region).
* And by the evaluation of the reproducibility of the BC measurement results in terms of fat mass and lean mass.

The secondary objective of this study is to cross calibrate the measures of bone mineral content (BMC) and bone mineral density (BMD) from the Stratos DR against those of the Discovery A on the whole body and its subregions.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is referred by a doctor for the performance of an osteodensitometry examination.

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection or any kind of guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The subject is suffering from a visually significant scoliosis
* The patient is pregnant or breastfeeding
* Patient weighing over 160 kg
* Patient having undergone X-ray examination using a contrast medium such as barium in the 7 days preceding the visit
* Patient who underwent an examination using γ rays in the 15 days preceding the visit
A Comparison of Electrical Pudendal Nerve Stimulation and Pelvic Floor Muscle Training for Female Stress Incontinence

The purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than pelvic floor muscle training with Transvaginal electrical stimulation in treating female stress incontinence.

Conservative therapy could be considered a choice of treatment for stress urinary incontinence (SUI) as it seems to have no side effects and causes significant and long-term improvement in symptoms. Pelvic floor muscle training (PFMT) and electrical stimulation are two commonly used forms of conservative treatment for SUI.

PFMT improves the structural support of the pelvis. However, many patients-especially women-have difficulty identifying and isolating their pelvic floor muscles (PFM) and are unable to perform the exercise effectively. Furthermore, patients who can identify the PFM often find that the required daily exercise routine is burdensome. Hence, the primary disadvantage of PFMT is lack of long-term patient compliance.

Electrical stimulation (ES) is a non-invasive, passive treatment that produces a muscle contraction. Transvaginal electrical stimulation (TES) has almost no side-effects and patient compliance in published reports is 70-85%. TES will result in PFM contraction by indirect nerve stimulation, mainly by polysynaptic reflex responses. The indirect stimulation and reflexive contraction may be the reason why the effect of electrical stimulation is not as good as that of PFMT when performed correctly.

By combining the advantages of PFMT and TES and incorporating the technique of deep insertion of long acupuncture needles, we developed electrical pudendal nerve stimulation (EPNS). In EPNS, long acupuncture needles of 0.40 Х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves (PN) and contract the PFM. CT transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to PN at Alcock's canal) the Bion device is implanted for chronic PN stimulation. Besides the radiographic evidence, simultaneous records of perineal ultrasonographic PFM contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN,contract the PFM and simulate PFMT. Our previous study has also proved that EPNS has a good therapeutic effect on female SUI. The purpose of this study is to compare the efficacy of EPNS to PFMT with TES in treating female SUI.

Eligibility Criteria:
Inclusion Criteria:

* SUI history
* Positive stress test result
* Urodynamically confirmed SUI
* Postvoid residual urine volume \<50ml

Exclusion Criteria:

* Urge incontinence (overactive bladder or detrusor overactivity incontinence)
* Neurogenic bladder
Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea

The primary purpose of this study is to evaluate comparative effectiveness and safety outcomes of therapies to prevent thromboembolic events in patients with nonvalvular atrial fibrillation by using Korean nationwide health claims database.


Eligibility Criteria:
Inclusion criteria:

1. Patients aged 18 years or older on the index date
2. Patients had ≥1 medical claim for AF (refer to Table 1) before or on the index date with at least one hospitalization or at least two outpatient visits:
3. Patients prescribed aspirin, warfarin, or NOACs during intake period (from July 1, 2015 to November 30, 2016)

Exclusion criteria:

Patients meeting any of the following criteria will not be included in the study.

1. Medical claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
2. Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis during the 12-month baseline period (Valvular AF / Prosthetic heart valves)
3. Medical claims indicating a diagnosis code of VTE (Venous thromboembolism) during the 12-month baseline period
4. Medical claims indicating a diagnosis or procedure code of transient AF, or cardiac surgery during the 12-month baseline period (Thyrotoxicosis, Hypertrophic cardiomyopathy, Elective defibrillation, radiofrequency ablation, or left atrial appendage occlusion)
5. Medical claims indicating a diagnosis code of other conditions during the 12-month baseline period (End-stage chronic kidney disease / Kidney transplant / Dialysis / Pericarditis)
6. For the comparison of "NOAC versus NOAC", and "NOAC versus warfarin", patients with any OACs (apixaban, dabigatran, rivaroxaban, or warfarin) in the pre-index period (from 1 year prior to the day before index date)
7. For the comparison of "NOAC versus aspirin", patients with following medications in the pre-index period (from 1 year prior to the day before index date)

   * NOAC user: OACs (apixaban, dabigatran, rivaroxaban, warfarin)
   * Aspirin user: none
The Neurofibromatosis-associated Tumor Biobank

Neurofibromatosis-associated Tumor is very rare bone tumor. The investigator set up the biobank to ensure every patient has the chance to participate in future research

Samples of blood and other stored material such as slides,frozen tissues or leftover diagnostic material.

Questionnaire information, including health history, growth and development, physical activity and family medical history information.

If patients have been diagnosed with a neurofibromatosis-associated tumor or another condition the investigator is interested in， the investigator will ask the patient to release medical record information relating to diagnosis and treatment of neurofibromatosis-associated tumor, other cancers, blood disorders, and similar conditions.

Eligibility Criteria:
Inclusion Criteria:

Proband Inclusion criteria: A diagnosis or suspected diagnosis of neurofibromatosis-associated tumor Family member inclusion criteria: Biological parents and full biological siblings of a case diagnosed with neurofibromatosis-associated tumor

Exclusion Criteria:

non-asian
A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects

A number of common eye diseases such as age-related macular degeneration and glaucoma are associated with ocular perfusion abnormalities. Although this is well recognized there is not much possibility to improve blood flow to the posterior pole of the eye in these diseases.

For many years, moxaverine has been used in the therapy of perfusion abnormalities in the brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the drug, but also on the rheological properties of red blood cells. In two recent studies the investigators have shown that intravenous moxaverine increases choroidal and retrobulbar blood flow in healthy young subjects, in elderly people with healthy eyes and in patients with eye diseases associated with hypoperfusion. The present study aims to investigate, whether ocular blood flow is also improved after oral administration of moxaverine.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmoker
* Body mass index between 16 and 30 kg/m²
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 dpt, anisometropia \< 2 dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages or drugs
* Participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug
* Blood donation during the previous 3 weeks
* Presence of any ocular pathology that interferes with the aims of the present study
* Hypersensitivity to moxaverine
* Acute gastric bleeding, massive cerebral hemorrhage related to stroke
* Women: pregnancy or lactation
Efficacy of Two Onabotulinum Toxin Doses

The changes in bladder function after the injection of Onabotulinum toxin into the detrusor in individuals with neurogenic bladder overactivity will be investigated retrospectively. The records of all patients treated with Onabotulinum toxin injections into the detrusor since 2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units of Onabotulinum toxin will be compared with the changes after the injection of 200 units. Furthermore, the differences in urinary continence, duration between injections, side effects and complications between the two groups will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* neurogenic detrusor overactivity
* spinal cord injury
* Onabotulinum toxin injections into the detrusor from 2000-2017

Exclusion Criteria:

* missing urodynamic values before or after Onabotulinum toxin injections
Massive Burns: Retrospective Analysis of Changes in Outcomes Across 18 Years

Burns treatment and management has evolved since the 90s, particularly for massive burns (≥ 50% of total body surface area (TBSA)). This study aims at analyzing the impact of the management changes on the length of intensive care unit (ICU) stay, the take of skin grafts and the mortality.

Review of all massively burned patients treated at Lausanne University Hospital burn intensive care unit (ca. 40-60 patients). Analysis of changes in length of intensive care unit stay (LICU), skin graft take rate or mortality between 2000 and 2018.

Hypothesis : the optimization of resuscitation procedures and of nutrition therapy combined with the use of novel surgical techniques has brought a significant improvement in outcomes.

Association between outcomes and year of admission will be assessed through correlation analysis and logistic regression analysis. Potential cofounders will be assessed through stepwise linear regression analysis

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (\>18 years old) with burns ≥50% TBSA admitted in the burn intensive care unit (ICU) of the Lausanne University Hospital

Exclusion Criteria:

* Patients admitted in the burn center ICU with another primary diagnosis than burn (e.g. necrotizing fasciitis, gangrene, toxic epidermal necrolysis)
* Patients referred from and/or to another ICU
* Patients in which active withdrawal of care was decided within 48h of admission
* Patients with first degree burns only