cyrilzakka/clinical-trials huggingface dataset:
Beta-blockade in Unruptured Intracranial Aneurysm

Subarachnoid haemorrhage is a devastating type of stroke, with high mortality and morbidity rate. In approximately 85% of cases, it is caused by an intracranial aneurysm rupture. Majority of patients with diagnosed intracranial aneurysm are eligible for interventional treatment, however, some patients are managed conservatively. Currently, the only recommendations for patients with conservatively managed intracranial aneurysms, are routine imaging follow-ups and minimization of rupture risk factors. There are no medications proven to decrease risk of aneurysm rupture, that might be prescribed to such patients. In preliminary study the investigators found that patients with intracranial aneurysms who took β-blockers had significantly smaller aneurysm rupture rate and dome size, as well as more favorable hemodynamic parameters. No other antihypertensive drugs showed similar associations. Therefore, in this project the investigators aim to further analyze the impact of β-blocker intake on fate of intracranial aneurysm and find possible explanations for its protective role. The investigators aim to perform a randomised, double-blind, placebo-controlled clinical trial. One hundred patients with unruptured intracranial aneurysm, , qualified to conservative management will be enrolled. Two arms (50 patients each) will be receiving nebivolol or matching placebo. Treatment in each arm will last 12 months. The following examinations will be performed at baseline and at 6 and 12 months: clinical assessment, angio-MRI with vessel wall imaging, Doppler ultrasound to extract blood flow waveforms from Internal Carotid Artery, Vertebral Artery Middle Cerebral Artery, Anterior Cerebral Artery and Posterior Cerebral Artery, as well as blood samples. Based on the results the investigators will assess changes in aneurysm size and wall contrast enhancement. The investigators will also analyze levels of possible aneurysm growth biomarkers in peripheral blood. Additionally, the investigators will prepare three-dimensional models of the artery harbouring aneurysm and perform patient-specific computer modelling of blood flow through such artery to assess hemodynamic parameters of aneurysm dome. All obtained measurements will be compared at baseline and at 6 and 12 months. The investigators hypothesize that, in comparison to the placebo group, β-blocker therapy in patients with unruptured intracranial aneurysm will contribute to favorable changes in hemodynamic parameters of aneurysm dome, decrease wall degradation process and prevent from aneurysm growth.


Eligibility Criteria:
Inclusion Criteria:

* freshly (within 12 months) diagnosed unruptured intracranial aneurysm, non-eligible for surgical or endovascular treatment
* age \> 18 years
* informed consent

Exclusion Criteria:

* contraindications to β-blockers intake
* previous SAH
* intake of β-blocker currently or in the past
* presence of other intracranial pathology
* history of surgical or endovascular aneurysm treatment
* contraindications for contrast-enhancement MRI examination
The Effect Of Anaerobic Exercise On Bone Morphogenetic Protein 9

Bone morphogenetic protein (BMP) 9 from the BMP family has an important role in the remodeling of bone and cartilage. Due to these features, BMP9 can play an important role in especially anaerobic exercise training adaptations. However, the role of anaerobic exercise in these effects is still unclear. The aim of this study is to investigate the role of BMP9 on the effects of acute and chronic anaerobic exercise on bone metabolism markers. Postprandial venous blood samples were taken pre- and post- acute YOYO intermittent recovery test (level 1) in 40 trained male athletes aged 18-35 who did anaerobic sports (such as basketball, volleyball and handball) and 41 sedentary volunteers aged 18-35. Serum BMP9, as markers of bone formation and resorption; alkaline phosphatase (ALP), C-terminal telopeptide of type 1 collagen (CTX1), cartilage oligomeric matrix protein (COMP) and calcium levels were determined. The data to be obtained as a result of our study can give information about the relationship between the skeletal and bone health of the athletes and anaerobic exercise.


Eligibility Criteria:
Inclusion Criteria:

* being male
* having a body mass index of less than 30 being

Exclusion Criteria:

* to have some disease or disability
* to regularly use cigarettes and alcohol
* to use any medication or antioxidant substance
Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male, Age 20 to 45
2. Subject must be willing and able to provide written informed consent to the study.

Exclusion Criteria:

1. History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
2. History of any significant gastrointestinal system and surgery of gastrointestinal.
3. History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
4. Over 10 tobaccos a day.
5. Other condition which in the opinion of the investigator preclude endrollment into the study.
Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David

Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six centers (Nantes - Rennes - Brest - Angers - Tours \[two centers\]). The main objective of this study is to evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI).

Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David.

Inclusion criteria: Patients undergoing aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at one of the six centers: Nantes, Rennes, Brest, Angers, Tours (two centers).

Non-inclusion criteria: Prosthetic replacement of the aortic valve intraoperatively during the first operation.

Objectives and endpoints :

* The survival without re-intervention for aortic valve dysfunction (surgery or TAVI)
* The overall cardiovascular survival
* The survival without aortic insufficiency of grade equal to or greater than two
* The survival without aortic infective endocarditis
* Assessment of long-term stroke risk Assessment of the risk of a major bleeding event in the long term Data analysis : The AORTLANTIC study is included in the EPICARD registry which is the official, national database of the French Society of Cardiac Surgery. Study data will then be collected using EPICARD's electronic Case Report Form (eCRF) and then analyzed using a multivariate Cox model. For the follow-up, the WEPI eCRF is used.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2021, at one of the six centers: Nantes, Rennes, Brest, Angers,Tours UH.

Non inclusion criteria :

* Prosthetic replacement of the aortic valve intraoperatively during the first operation.
Topography Guided LASIK by Different Protocols for Treatment of Astigmatism

Background and Rationale:

LASIK has been among the highest satisfaction rates of surgical procedures, ranging from 82%-98%. Different ablation profiles have been developed over the years. The purpose of this study is to validate this novel measurement by comparing the visual outcomes when the TMR is used in myopic astigmatic LASIK to using the standard manifest refraction or the Topolyzer measurements alone.

Objectives :

To evaluate the safety, efficacy and predictability of topography-guided myopic LASIK with three different refraction treatment strategies.

Candidates for refractive surgery above 18 years with myopic astigmatism and no previous ocular surgery.

Sample size 60 eyes. surgery:

* 60 eyes of myopic topography-guided LASIK procedures with the same refractive platform (FS200 femtosecond to create a flap between90: 110 μm with diameter 8:9 mm and EX500 excimer lasers) will be randomized for treatment as follows:
* Group A: 20 eyes will be treated using Contoura vision with the standard manifest refraction.
* Group B: 20 eyes will be treated with Contoura vision using the topographic astigmatic power and axis and without change in the spherical power (using the same spherical power as the manifest refraction).
* Group C \[TMR\]: 20 eyes will be treated with Contoura vision using the topographic astigmatic power and axis and modifying the spherical power to obtain the same spherical equivalent as the manifest refraction. This is done by subtracting half of the difference between topographic astigmatic power and the manifest astigmatic power from the spherical power (topography-modified treatment refraction).
* The standard postoperative treatment is combined steroids and antibiotics eye drops 5 times daily for one week ,then three times daily for three days and lubricant eye drops 5 times daily for six months.

Postoperatively, the patients will be examined at 1 week, 1 month and 3 months. All postoperative follow-up visits included measurement of UDVA, CDVA (if indicated) and refraction, besides full ophthalmological examination and performing pentacam and topolyzer after 3 months

Eligibility Criteria:
Inclusion Criteria:

* Stable refractive error: Myopic astigmatism ≥ -1.5 D
* Valid Topolyzer maps (at least four out of eight right maps with green analyzed area and the registration box is green).

Exclusion Criteria:

1. Estimated postoperative residual stromal bed thickness of less than 300µm.
2. Glaucomatous patients.
3. Patients with keratoconus.
4. Patients with pervious refractive surgery.
5. History of previous ocular trauma or surgery.
6. History of recent herpetic ulcer or viral keratitis.
7. Basement membrane disease, history of recurrent corneal erosions.
8. Sicca syndrome, dry eye.
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma

A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids

This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before first visit
* Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
* Pre-bronchodilator FEV1 of at least 60% predicted
* FEV1 reversibility of at least 12% and 200mls
* Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist

Exclusion Criteria:

* History of life-threatening asthma exacerbation within the past 10 years
* Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
* Current or recent respiratory infection or current oral candida infection
* Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
* Known or suspected allergy to study drug or materials
* Taking another investigational medication or prohibited medication during the study
* Previous treatment with inhaled fluticasone furoate in a phase II or III study
* Current smokers or former smokers with significant tobacco exposure
* Children in Care
Clinical Benefit of Topoisomerase Downregulation

1.1 To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16)

1.2 To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer.

The rationale to study the downregulation of topoisomerase enzyme in ovarian cancer in relationship to the cell cycle distribution of the cancer cells after a prolonged continuous exposure to topo I and II poisons is to better understand the relationship between cell cycle and topo poisoning, which may lead to better clinical trial designs.

Eligibility Criteria:
Inclusion Criteria:

* All patients, 18 years of age or older, with incurable ovarian advanced cancer are eligible provided that they have measurable disease by CT-scan imaging, or evaluable disease by tumor markers, following the criteria described by Rustin et al. (14). (Response to a specific treatment has occurred if after two CA-125 samples there has been a 50% decrease, confirmed by a fourth sample (50% response), or a serial decrease over three samples of greater than 75% (75% response). The final sample has to be at least 28 days after the previous sample.)
* Patients must have a life expectancy of at least 12 weeks.
* Patients must have a Zubrod performance status of 0-2.
* Patients must sign an informed consent.
* Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \>100,000/mm3 and absence of a regular red blood cell transfusion requirement.
* Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.

Exclusion Criteria:

* Patients with symptomatic brain metastases are excluded from this study.
* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
* Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
* Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
The Effectiveness of a Post-ICU Recovery Program on Relatives

Relatives of intensive care patients are at risk of developing symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired health-related quality of life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. The hypothesis is that relatives to former intensive care patients will improve their HRQOL one year after intensive care. We want to determine whether relatives to former intensive care patient's benefits from a recovery programme with improved HRQOL, Sense Of Coherence (SOC) and symptoms of anxiety, depression and PTSD compared to standard care one year after intensive care.

Relatives of intensive care patients are affected of critical illness with symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired mental health. Recovery programs aimed at patients after a stay at the intensive care unit (ICU) have been tested and implemented, but the effectiveness is inconclusive, and on relatives sparse. The aim is to determine whether relatives to former intensive care patients benefits from a recovery programme with improved health-related quality of life (HRQOL), Sense Of Coherence (SOC), and symptoms of anxiety, depression, and PTSD compared to standard care during the first year after ICU discharge.

This was a sub-study of the "Recovery and Aftercare in Post-Intensive care Therapy patients" (RAPIT) trial; a pragmatic, non-blinded, multicentre, parallel-group, randomized controlled trial. We recruited patients and relatives concurrently during the RAPIT-trial study-period, and now we are doing analysis on relatives. We wants to include adult relatives defined by the patients from 10 Danish ICUs.

The study was powered to detect an effect size of a 5-point increase in the Medical Health Survey Short-Form 36 (SF-36) on the mental component score (MCS) in the intervention group at 12 months post-ICU. Power calculation was based on an expected distribution of MCS from a matched population with a mean of 36.7 (SD 11.7) from a similar study. With a statistical power of 80% and significance level of 0.05, we estimated that 86 relatives were needed in each group to complete follow-up.

The statistical analysis plan was based on intention-to-treat (ITT) as was per protocol (PP) analysis and investigating difference between intervention and controls. Relatives were considered to have received the intervention if the patient attended at least one of the three consultations, which accounted for the PP analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Defined by the patients

Exclusion Criteria:

* If the patients dropped out or died during the study period
Safety and Efficacy of YB-1113 in Treatment of POI

This phase 1 study is to evaluate the safety and tolerability of YB-1113 administered via intravenous (IV) infusion in the treatment of premature ovarian insufficiency (POI).


Eligibility Criteria:
Key Inclusion Criteria:

1. Female, 18 to \<40 years old, who are seeking fertility or preservation of fertility
2. Oligo/Amenorrhea for at least 4 months
3. At least two menopausal FSH levels (≥ 25 IU/L) with 4 to 6 weeks interval.
4. AMH levels ≤ 1.0 ng/mL (measured on day 2-5 of the menstrual period).
5. Subjects who are generally healthy by laboratory tests (normal complete blood count (CBC), comprehensive metabolic panel (CMP), and urinalysis) at screening
6. For subjects who had contraception before, the duration of amenorrhea should be more than 3 months after discontinuation of the oral contraception pill (OCP) or more than 6 months after discontinuation of Depo Provera (or similar) therapies

Key Exclusion Criteria:

1. 1. Primary amenorrhea or FSH ≥ 40 IU/L
2. Presence of contraindications to pregnancy
3. POI due to cytotoxic chemotherapy or radiation therapy
4. Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family history of POI
5. Subjects under hormonal treatments including hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology.
6. Washout period less than 3 months for HRT.
7. Subjects with a history of breast cancer or other estrogen responsive cancer.
8. Subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm.
9. Subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease
10. Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS)
11. Subjects with endocrinopathies including Cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia.
12. Subjects under active management for autoimmune disease.
13. Subjects with intra-uterine devices (IUDs).
14. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
15. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.
16. Subjects with polyglandular autoimmune disease or other conditions require chronic administration of steroids higher than 30 mg/day of hydrocortisone or its equivalent
17. Subjects with hereditary or acquirement coagulopathies, including but not limited to hemophilia, Von Willebrand disease, liver disease, Vitamin K deficiency, and platelet disorders.
The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition

The purpose of this trial is to investigate if pharmacologically safe dose intravenous glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications, and other secondary outcomes

Trauma Patients are characterized by alteration in the immune response, increased exposure to infectious complications, sepsis, and consequently organ failure and death. Glutamine supplementation to parenteral nutrition is one of the nutritional interventions that have been proven to be associated with improved survival rate, decreased infectious morbidity, costs, intensive care unit, and hospital length of stay. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. A number of trials investigated the beneficial effects of intravenous alanyl-glutamine supplementation in critically ill patients receiving enteral nutrition. However, these trials were: pilot trials, investigated surrogate outcomes, or supplementation was for a short period of time. Therefore, a well designed trial is needed to investigate the effect of intravenous alanyl-glutamine supplementation in critically ill patients with multiple trauma receiving enteral nutrition on major clinical outcomes.

Our hypothesis is that trauma patients receiving standard enteral nutrition supplemented with intravenous alanyl-glutamine will demonstrate improved clinical outcomes compared to patients receiving standard enteral nutrition without supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-58 years
* Patients admitted with a diagnosis of multiple trauma requiring enteral feeding for \> 48 hours
* Expected length of stay in ICU \> 48 hours
* Has a functional access for enteral tube feeding and a central access for administration of test solution
* Negative Beta HCG (pregnancy test) in females (18-60 years)

Exclusion Criteria:

* Age \< 18 years
* Significant hepatic failure (Patients with Childs C Cirrhosis)
* Severe renal failure (estimated glomerular filtration rate \[eGFR\] \< 50 ml/min)
* Patients with severe metabolic acidosis (pH \<7.35)
* Not expected to be in the ICU \> 48 hours (due to imminent death)
* Unable to tolerate enteral nutrition within 72 hours
* Enrolment in other ICU intervention study if contraindicated
* Patients in whom parenteral nutrition is required from the outset
* Absolute contraindication to enteral nutrition
Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects

To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects.


Eligibility Criteria:
Criteria:

* Healthy male and female aged 18 to 50 years.
* Women of nonchildbearing potential (WONCBP).