cyrilzakka/clinical-trials huggingface dataset:
Toric Orthokeratology - Slowing Eye Elongation

The aims of this study are to investigate the effects of ortho-k for astigmatic and myopic reduction and myopic control in children, and the long term effects on corneal curvatures and biomechanics.

Ortho-k has been shown to be effective in correcting low myopia but relatively ineffective for astigmatism, using spherical reverse geometry lens designs. Toric ortho-k lenses have been introduced in recent years but the efficacy for astigmatic reduction and for myopic control in children have not been confirmed. The mechanism of myopic reduction in ortho-k cannot be fully explained by changes to the anterior corneal curvatures. It is therefore possible that other corneal parameters such as posterior corneal curvature and corneal biomechanics may contribute to the mechanism.

The current study aims at investigating the efficacy of toric ortho-k lenses for correcting myopic astigmatism and for retarding myopic progression in children compared to children wearing single-vision spectacles. Long term changes to other corneal parameters such as posterior cornea curvatures, topographical corneal thickness, corneal hysteresis, corneal resistance factor, with and without ortho-k lens wear will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Myopia (refractive sphere): more than -0.50DS to -5.00DS
* Astigmatism: with-the-rule astigmatism more than -1.25DC
* Anisometropia: ≤ 1.50D in both refractive sphere
* Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
* Availability for follow-up for at least 2 years

Exclusion Criteria:

* Strabismus at distance or near
* Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
* Prior experience with the use of rigid lenses (including orthokeratology)
* Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)
* Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
* Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
Cost-effectiveness Analysis Between Biosynthetic and Biological Parietal Prostheses

Eventration corresponds to the dehiscence of the abdominal wall, with passage of peritoneum and / or intra-abdominal viscera, through an acquired orifice of the abdominal wall. It is secondary to an old incision and occurs in 10 to 20% of cases after a laparotomy. At present, if there is no debate on the type of prosthesis to implant in case of clean surgery: it is a synthetic prosthesis. But in the case of contaminated surgery (modified Ventral Hernia Working Group grade 3), there is no consensus.

Since the 1990s, biological prostheses have been recommended, but they represent significant expenses for health facilities. They are very numerous, and their prices vary between 3 000 € and 12 000 €. The choice is therefore difficult for the surgeon.

In 2016 the Strasbourg University Hospital general surgery team made the choice to use biosynthetic prostheses. This attitude does not seem consensual and is not based on any recommendations at present, either in France or internationally. The homogenization of practices requires the availability of clinical and medico-economic data, particularly in view of the price differences that exist between different types of prostheses.

The main objective of this study will be to compare the use of biosynthetic prostheses with biological prostheses in the treatment of curative surgical treatment of mVHWG grade 3 incisional hernias in terms of cost and serious complications at 6 months.

The secondary objective of the study will be to estimate the number of early recurrences at 6 months avoided, thanks to the use of biosynthetic prostheses compared to biological prostheses.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* Patient who has consented to the use of her medical data for research purposes.
* emergency or planned surgery for an abdominal wall reconstruction, in the context of a contaminated surgery (mVHWG grade 3) at the CHU Strasbourg Hautepierre
* use of biological type (Cellis®, Xenmatrix®, Strattice®) or biosynthetic (Phasix®) parietal prostheses

Exclusion Criteria:

* Refusal of the patient to participate in the study
* prosthesis placed prophylactically, subcutaneously, endoscopically, for bridge
Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

In this study we want to evaluate the effect of mannitol on postoperative renal biomarkers in patient receiving cadaveric renal transplantation. Furthermore we want to evaluate the effect of mannitol on perioperative redox status in patients receiving renal transplantation using the oxidation-reduction potentials assessed with the RedoxSYS®system.

We are planning to perform a double-blind randomized controlled trial. In the study, mannitol 20% with a dose of 1g / kg / BW (5 ml / kg / BW) will be compared to placebo with NaCl 0.9% in the dose of 5 ml / kg / BW. Patients will be randomized to receive either the mannitol or NaCl. The follow-up of the study is 24 hours. The following biomarkers will be determined befor induction of anesthesia and 24 hours after administration of study medication: CCL2, CHI3LI, GH, HGF, MMP1, MMP8, Tie2, TNF-R1, VCAM-1, KIM-1, Cystatin C, FGF23, IGFB7, NGAL and IL 18.

Furthermore we want to perform sORP and cORP before induction of anesthesia, just before bolus of mannitol, 5 min after bolus of mannitol and after operation in anesthetic recovery room.

Data will be collected, compared and published at the end of the study. It is planned to include a total of 34 patients in the study.


Eligibility Criteria:
Inclusion Criteria: all patients with end stage renal diseases -

Exclusion Criteria: Patients younger than 18 years of age or older than 80, alergy to mannitol, Pregnancy, Breast-feed

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Efficacy Study of Combined Treatment With Uric Acid and rtPA in Acute Ischemic Stroke

The purpose of this study is to determine whether the combined treatment with Uric Acid and rtPA is superior to rtPA alone in terms of clinical efficacy in acute ischemic stroke patients treated within the first 4.5 hours of symptoms onset.

Oxidative stress is a major contributor to brain damage in patients with ischemic stroke. Uric acid (UA) is an endogenous product derived from the metabolism of purins which in man is responsable of the 60% of the total antioxidant capacity of the organism. Recent experimental evidences gathered by our and other research groups have shown that the exogenous administration of UA is neuroprotective both in cortical and subcortical brain areas as the result of its antioxidant properties. In these studies, animals treated with UA disclosed smaller brain infarction after transient focal ischemia, both using the intraluminal model or after the injection of autologous clots. Moreover, our group first described greater neuroprotection in animals pretreated with rtPA (alteplase). Likewise, we have recently shown that the administration of UA was free of serious adverse effects in stroke patients receiving rtPA within 3 hours of stroke onset. Yet, preliminary data suggested that this intervention might translate into clinical benefits at 3 months follow-up. Based on these data, we aim to conduct a phase 3, randomized, double-blind, controlled trial assessing the clinical efficacy of UA administration in acute ischemic stroke patients. Currently, rtPA is the only approved therapy for stroke patients within the first hours of clinical onset, and oxidative stress is thought particularly relevant following ischemia/reperfusion. Based on this ground, we aim to conduct this phase 3 clinical trial in ischemic stroke patients which are currently treated with rtPA within the 4'5 hour window.

Eligibility Criteria:
Inclusion criteria:

* Age older than 18 years old.
* Acute ischemic stroke treated with rtPA within the first 4.5 hours of clinical onset. Baseline National Institute of Health Stroke Scale (NIHSS) \>6 and \<25, and modified Rankin Scale (mRS) of 2 prior to the stroke.
* Cranial CT disclosing the absence of blood in the CNS.
* Informed consent.

Exclusion criteria:

* Presence of any of the valid exclusion criteria for the administration of rtPA in the current clinical practise.
* History of gout with or without history of gouty nephropathy, or uric lithiasis. Asymptomatic hiperuricemia under chronic treatment with allopurinol, or chronic treatment with lithium.
* Chronic renal insufficiency (baseline creatinine \> 1,5mg/dl).
SPI and Remifentanil in Skull Pin Fixation

Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations.

Data collection: heart rate, mean blood pressure, Surgical Pleth Index, bispectral Index, pulse pressure variance, systolic pressure variance, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 20 years old and less than 80 years old
2. With anesthesia risk grade below grade three (including grade three) (ASA I\~III).
3. Patients who are expected to undergo intracranial surgery for skull pin fixation

Exclusion Criteria:

1. Those with anesthesia risk classification ASA class IV or higher
2. Those who are allergic to opioid analgesics or propofol drugs
3. Emergency patients
The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia

This project will investigate whether reduction in ambient light and elimination of noise on induction of anesthesia alters anxiety (modified Yale Preoperative Anxiety Scale or mYPAS) or compliance (induction compliance checklist or ICC scoring), alters recovery following emergence using pain scores, analgesic requirements, and emergence delirium (post anesthesia emergence delirium or PAED), or post-discharge behavior at 1, 7 and 14 days (modified post hospitalization behaviour questionnaire or PHBQ) in patients who receive anxiolytic premedication. In addition, the investigators will assess the cumulative level of nose exposure that patients experience during the perioperative period.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing general anesthesia for tonsillectomy/adenoidectomy, tympanomastoidectomy, or general abdominal laparoscopic surgical procedures lasting at least 30 minutes.
* Receiving midazolam prior to the procedure as part of standard of care.

Exclusion Criteria:

* Patients that are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs.
* Allergy to midazolam.
* History of emergence delirium.
* Cardiac disease, other than functional heart murmurs.
* Developmental delays.
* Parent refusal of midazolam for standard clinical care.
Cumulative Live Birth After Double Stimulation Protocol Versus Antagonist Protocol for Poor Ovarian Responders

To compare the difference in cumulative live birth rates within one year between double stimulations protocol and two-cycle antagonist protocol in poor ovarian responders.

The theory of multicyclic development of follicles during the menstrual cycle prompted new approaches to ovarian stimulation such as double stimulation within the same menstrual cycle, in both follicular and luteal phases. The double ovarian stimulation protocol has been proposed to optimize the number of oocytes retrieved within the shortest possible timeframe.In general, the aim of DUOSTIM is to obtain the highest number of oocytes in the shortest time, thus avoiding waste of time, which is crucial for these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Women diagnosed with Poseidon criteria or expected poor ovarian responder （the number of oocyte retrieval ≤9）
2. Women aged ≥20 years old
3. Women who are undergoing their first or second ART cycles
4. Women who are undergoing IVF,ICSI or PGT-A cycles
5. Women with the number of oocyte retrieval ≤9 after their first ovarian stimulation cycle since radomization, and the number of follicle measuring 8mm or larger ≥3

Exclusion Criteria:

1. Women with RIF or RSA
2. Women diagnosed with uterine abnormalities including uterine malformations, adenomyosis, submucosal fibroids, uterine adhesions or endometrial polyps
3. Women with untreated hydrosalpinx that is visible under pelvic ultrasound
4. Women with chromosomal abnormalities, or women who are undergoning PGT-SR or PGT-M cycles
5. Women with a history of canceled FET cycle(s) due to a thin endometrium (\<7mm)
6. Man with operation to get sperm
Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.

The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Must have a performance status of at least 70% (able to carry on most normal activities)
* Must have life expectancy of at least 3 months
* Must have adequate organ and marrow function as determined by lab tests
* Women of child-bearing potential and men must agree to use two forms of contraception
* Ability and willingness to sign a written informed consent document
* Histologically confirmed solid tumor malignancy that is metastatic or unresectable

Exclusion Criteria:

* Pregnant or breastfeeding and/or lactating women
* Patients who have received any other investigational agents within 28 days of the first day of study drug
* Patients with known CNS metastases
* History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)
* Inadequately controlled hypertension
* Significant vascular disease
* Invasion or encasement of a major artery
* Evidence of bleeding diathesis or coagulopathy
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug
* Serious illness or medical condition
* History of myocardial infarction, unstable angina, cardiac or other vascular stenting
* History of stroke
* HIV, Hepatitis C, Hepatitis B or other serious chronic infection
* Impairment of Gastrointestinal function or disease
* History of interstitial lung disease
* Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.
Zinc Supplementation in Alcoholic Cirrhosis

The purpose of this study is to determine if zinc therapy: (1) strengthens your intestine's defensive barrier preventing damaging substances from reaching your liver, (2) decreases liver injury (inflammation, oxidative stress, cell death) and scarring, and (3) improves your liver-related health. Based on our preliminary animal data and other published reports, we expect zinc therapy to achieve all of these goals. Zinc is affordable, available over the counter or by prescription, and has an excellent safety profile. Positive results from this study will show that zinc is a significant therapy for millions of Americans with alcoholic liver disease.

Two-thirds of Americans consume alcohol, and an estimated 14 million Americans are alcoholics. It has been estimated that 15%-30% of heavy drinkers develop advanced Alcoholic liver disease (ALD). The prevalence of ALD in the United States is conservatively estimated at 2 million persons. Nearly 50% of liver-related deaths and 30% of hepatocellular carcinomas in the US are due to alcoholic cirrhosis. Despite recent advances in our understanding of ALD, there is currently no FDA approved medication for any stage of ALD. Zinc sulfate is inexpensive, available over the counter, and has an excellent safety profile. If zinc positively influences the mechanisms postulated to play a role in human ALD, this affordable treatment would become relevant to millions of people worldwide.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent.
2. Clinical diagnosis of alcoholic cirrhosis.
3. Between the ages of 18 years and 70 years.
4. Ability to attend all clinic visits and participate in monthly telephone calls.
5. Child-Pugh score of A or B.

Exclusion Criteria:

1. Allergy or intolerance to zinc sulfate.
2. Hospitalization within the previous 28 days.
3. Pregnancy.
4. Illicit drug use within the past 12 months.
5. Infection with hepatitis B, hepatitis C, or HIV.
6. Known or suspected cancer within the past 5 years.
7. Serum creatinine greater than 1.5 mg/dl within the past month.
8. Any severe chronic disease other than liver disease.
9. Impairment (slowness) of behavior, intelligence, and neuromuscular function which may indicate hepatic encephalopathy (slow or confused thinking due to your liver disease).
10. Participation in another clinical trial.
11. Any type of infection within the past month.
Flash Glucose Monitoring Targets in Gestational Diabetes

The use of glucose monitoring sensors is already well-established in pregnant women with type 1 diabetes (T1D), where it has been proven to improve glycemic control and perinatal outcomes. However, it has not yet been sufficiently researched in the area of gestational diabetes (GDM). Some smaller studies have shown a favorable effect on glycemic control, but no statistically significant differences were observed in reducing perinatal complications. A randomized, prospective study will include 200 pregnant women with GDM, treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases at the University Medical Centre Ljubljana. Participants will be divided into two groups. The first group will measure subcutaneous glucose using FSL in addition to self-monitoring of blood glucose (SMBG) while fasting and 60 minutes after main meals at the same time intervals. In both groups, glycemic targets, maternal outcomes, and neonatal outcomes will be monitored. In the FSL + SMBG group, sensor parameters for glycemic control will also be tracked.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases for gestational diabetes (GDM),
2. Agreement with the study protocol and ability to follow the study protocol,
3. Diagnosis of GDM established using the standard recommended OGTT method between the 24th and 28th weeks of pregnancy,
4. Age between 18 and 40 years.

Exclusion Criteria:

1. History of bariatric surgery,
2. Treatment with systemic corticosteroids for more than 14 days prior to inclusion in the study,
3. Multiple pregnancy,
4. Hospitalization for psychiatric illness within the last year,
5. First visit to the Diabetes Outpatient Clinic after the 34th week of gestation.
Evaluation of the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV)

The variety of breech presentation at term is about 3-4% of all births. Our study aims to assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some patients algic or relaxed, the success rate seems more important.

It's a single blind prospective randomized controlled study, comparing success rate of ECV after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).

We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we will give the patient a satisfaction questionnaire. We compare the success rate of ECV as primary outcome.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* pregnancy at term (≥36 weeks)
* singleton foetus in breech or transverse presentation
* acceptance of ECV
* signature of informed consent

Exclusion Criteria:

* contraindications of ECV: placenta praevia, obstacle praevia, multiple pregnancy, foetal death, foetal heart rhythm disorder, lack of amniotic fluid, HIV-positive patient
* contraindications of equimolar mixture of oxygen and nitrous oxide : patient who require pure oxygen ventilation, disorders of consciousness that impede the cooperation of the patient, pneumothorax, pulmonary embolism, ocular surgery
Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients

This study is to find the fewer side effects formula of anesthesia for TVOR patients, to compare the BIS level during emergence and to find the correlation between BIS and transcutaneous carbon dioxide concentration.

Transvaginal oocyte retrieval (TVOR) is a procedure often used in infertility women . During the procedure, sedation, analgesia or anesthesia are often required. Propofol and alfentanyl are used for these patients for years, but these drugs are used in intravenous form and can be found in follicular fluid. Although further investigation needs to be undertaken to investigate any potential influence on fertilization and implantation rates, we anesthesiologist want to lower the use of drugs in these women. Target-controlled infusion (TCI) pumps can estimate and calculate the target and plasma concentration of propofol. By using these pumps , we can estimate the stable concentration of drugs. Besides, Bispectral index (BIS) monitor can help us to evaluate awareness or unarousable amnesia when we turn lower the drug use and keep patients amnesia during the procedure. Transcutaneous carbon dioxide monitor (tcCO2) can mimic the level of CO2 in patients by using noninvasive method. During anesthesia, CO2 will retain and may induce CO2 nacrosis, so we use these noninvasive method to help us to detect CO2 level preventing CO2 nacrosis and to see if there are any relationship with BIS.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II women age between 25 and 45 y/o participating to receive TVOR

Exclusion Criteria:

* Allergy history to alfentanyl, propofol or lidocaine