cyrilzakka/clinical-trials huggingface dataset:
Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy

The cornea forms our "window to the world". Hence, its transparency is of utmost importance for vision. Corneal endothelium plays a central role in the maintenance of a transparent corneal stroma. It limits stromal fluid uptake from the anterior chamber of the eye through the formation of tight junctions. Simultaneously, fluid is actively transported from corneal stroma into the anterior chamber. This maintains the corneal stroma in a state of relative dehydration, thereby ensuring a constant distance of stromal collagen lamellae to each other, which in turn forms the basis for transparency of this tissue. If however corneal endothelial function is impaired, stromal swelling leads to corneal clouding and loss of vision.

Fuchs endothelial corneal dystrophy represents the most common form of corneal dystrophy. It occurs sporadically, however in some cases autosomal dominant inheritance has been described. This condition leads to progressive loss of corneal endothelium (typically around the age of 50-60 years), causing visual impairment due to swelling and opacification of corneal stroma.

Cell culture experiments have been able to show that chemical inhibitors of Rho-Kinase promote corneal endothelial cell proliferation and reduce apoptosis, while topical application in an animal model promoted corneal endothelial wound healing. This has prompted the notion of using topical Rho-kinase-inhibitor treatment to support endothelial cell regeneration in Fuchs endothelial corneal dystrophy.

Since September 2014, Rho-kinase-inhibitor eye drops (ripasudil) are clinically available in Japan for reduction of intraocular pressure in Glaucoma patients. Ripasudil eye drops therefore represent a strong candidate for safe and effective adjunctive treatment in patients with Fuchs corneal endothelial cell dystrophy.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from the subject
2. Understanding of study procedures and willingness to abide by all procedures during the course of the study.
3. Age range: 18-70 years
4. Diagnosis of moderate to advanced FECD with central guttae and clinical relevant corneal endothelial cell loss of \<1,000 cells/mm2 and clinical indication of surgical intervention (descemetorhexis) with or without accompanying cataract operation
5. Reduced visual acuity, defined as BCVA \<20/30
6. Woman of childbearing potential must be using a highly effective method of birth control.
Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest

Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.

Remote ischemic preconditioning (RIPC) protocol after induction of anesthesia and before skin incision consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and at 10 minutes after aortic unclamping during reperfusion of the myocardium.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients \>18 years of age
* Double- or triple-vessel coronary artery disease
* Elective isolated first-time CABG
* Combined valve surgery + CABG
* Written informed consent

Exclusion Criteria:

* Renal failure (creatinine ≥ 200 µmol/L)
* Peripheral vascular disease affecting upper limbs
* Preoperative inotropic support
* Any kind of mechanical assist device
* Acute or recent (\<4 weeks) acute coronary syndromes
* Any PCI (\<6 weeks)
* Any reasons for preoperative cTnI elevation
* Emergency surgery
* Redo surgery
Sentinel Lymph Node Mapping and Analysis in Colon Cancer Using Indocyanine Green Dye

Approximately 20-30 % of colon cancer patients who have no metastasis in lymph nodes after definitive colectomy have recurrence with distant metastasis. These recurrences could be due to missed occult tumor cells or micrometastasis. Detailed examination of all lymph nodes is expensive and time consuming. Sentinel lymph node mapping using Indocyanine green dye helps in identifying the lymph nodes which are most likely to harbour metastasis. These sentinel lymph nodes can be subsequently subjected to detailed pathologic examination and immunohistochemistry which increases the likelihood of identifying micrometastasis and occult tumor cells. Patients found to harbour such metastasis can be treated with additional chemotherapy after surgery. The aim of the study is to examine the feasibility of sentinel lymph node mapping using Indocyanine green dye in colon cancer and evaluate the upstaging rate in post-operative colon cancer patients who don't have metastatic lymph nodes on routine histopathology.

All patients of colon cancer fulfilling the inclusion criteria and excluding the patients according to the exclusion criteria will undergo standard laparoscopic/open colectomy.

Indocyanine green dye is injected around the tumor in subserosal location for open surgeries and submucosally after on-table colonoscopy for laparoscopic surgeries and followed with near-infrared scope. Patients will undergo intra-operative on-table colonoscopy after induction of anesthesia. All sentinel nodes will be marked with clips/sutures for identification by the pathologist post-operatively. Any aberrant lymph nodes identified outside the planned resection margins will be excised, marked with the position of excision and sent separately from the gross specimen. After this the surgeon will proceed with the surgery including vascular ligation and resection of mesocolon.

After surgery, all the lymph nodes identified in the specimen including the tagged sentinel lymph nodes will be examined using standard Hematoxylin and eosin staining. If all the lymph nodes are negative for metastasis, the sentinel lymph nodes will undergo additional stepwise sections and immunohistochemistry for pancytokeratin.

Eligibility Criteria:
Inclusion criteria:

Age 18 years or older Biopsy proven colon cancer Scheduled for laparoscopic/open colectomy

Exclusion criteria:

Prior colorectal surgery Gross lymph node invasion on pre-operative imaging or intraoperative staging Advanced disease (T4 disease or metastasis) on preoperative imaging or intraoperative staging Allergy to iodide containing compounds, human albumin or Indocyanine green dye History of hyperthyroidism or thyroid adenoma Palliative surgery Advanced hepatic failure Advanced renal failure
Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation

The purpose of this study is to find out what effects, good and/or bad, the addition of clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning treatment has. The study will also look at what causes some people to have high drug levels of these medications in their body compared to other people that may have low drug levels even if they all receive the same dose of medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 3 months and ≤30 years of age.
* Stratum A: Non-Malignant Diseases, including:

  * Bone Marrow Failure Syndromes
  * Hemoglobinopathies or transfusion-dependent red blood cell (RBC) defects
  * Congenital Immunodeficiencies
  * Metabolic Diseases known to be treatable with Hematopoietic cell transplantation (HCT) (e.g. Hurler's)
  * Other Bone Marrow Stem Cell Defects (e.g. Osteopetrosis)
  * Severe Immune Dysregulation / Autoimmune Syndromes with at least transient prior response to immunosuppressive therapy
* Stratum B: Myeloid Malignancies, including:

  * acute myeloid leukemia (AML), in greater than first clinical remission, or in CR1 but with detectable disease (≥0.1% Blasts by minimal residual disease (MRD) or Flow, or Positive Cytogenetics), or in CR1 but with a matched sibling Umbilical cord blood (UCB) donor.
  * Myelodysplastic syndromes (MDS)
  * Juvenile myelomonocytic leukemia (JMML)
  * Chronic myeloid leukemia (CML), with detectable disease by polymerase chain reaction (PCR)
* Patients must have a suitable donor based on the University of California, San Francisco (UCSF) Pediatric Bone Marrow Transplant (BMT) standard operating procedures (SOP). 10/10 (HLA-A, -B, -C, -DR, -DQ) matching will be done for related and adult unrelated donors; 8/8 (HLA-A, -B, -C, -DR) for umbilical cord blood donors. Patients with non-malignant diseases will generally be eligible only if they have a mismatched donor, or an accepted clinical reason to be considered high-risk for rejection.
* Liver transaminases (aspartate aminotransferase (AST)/alanine aminotransferase (ALT)) and Direct Bilirubin less than twice the upper limit of normal within 2 weeks of admission.
* Cardiac Shortening Fraction ≥27% within 4 weeks of admission.
* Creatinine clearance by Schwartz formula, glomerular filtration rate (GFR) or 24 hr urine collection ≥50 cc/min/1.73 m2, within 4 weeks of admission.
* Pulmonary diffusion capacity ≥50% of predicted corrected for anemia/lung volume within 4 weeks of admission. If unable to do Pulmonary function testing(PFTs), then no active lung disease by chest x-ray (CXR) and/or oxygen (O2) Saturation ≥90% on room air.

Exclusion Criteria:

* Fanconi Anemia
* Dyskeratosis Congenita
* A known syndrome with increased sensitivity to radiation or alkylating agents
* Severe Combined Immunodeficiency Disease eligible for a non-myeloablative HCT Trial
* A mismatched donor for whom ex vivo T-cell depletion of the donor stem cells is planned
Postoperative Outcomes of Trans-abdominal Open Surgical Repair of Traumatic Diaphragmatic Hernias in Adults.

Objective: Evaluation of our management of acute or chronic traumatic diaphragmatic hernia repair with sutures or mesh.

Between January 2014 and January 2019, a retrospective study on 185 patients with acute and chronic traumatic diaphragmatic hernias was carried out at the general surgery department of Zagazig University. Results both during and after surgery were assessed.

Traumatic diaphragmatic hernias are the outcome of 0.8% to 6% of blunt trauma cases and more than 17% of cases involving thoraco-abdominal-penetrating trauma (TDH) . Chronic traumatic diaphragmatic herniation (CTDH) is a condition that can develop as a result of an enlargement of a defect in the diaphragm brought on by a pressure difference between the thoracic cavity and the abdominal cavity . It is possible that the rupture will not heal on its own due to the inherent pressure difference that exists between the thorax and the abdomen as well as the continuous movement of the diaphragm .

Due to the seriousness of the related organs' injuries, traumatic diaphragmatic rupture presents a complex emergency and typically necessitates a high diagnostic suspicion. The herniated structures may strangulate into the thoracic cavity, and the mortality rate may increase considerably if the traumatic diaphragmatic hernia is not identified and treated in the acute phase of the trauma . These patients may not be diagnosed until weeks, months, or even years after the initial traumatic event, and they may present with acute symptoms related to the cardiovascular system and the digestive tract. A high mortality rate is seen in people with CTDH with viscera that have been strangulated.

Despite advancements in diagnostic technologies, 2.7 - 50% of patients still have a misdiagnosis . Early, accurate diagnosis is now more common thanks to greater experience and the emergence of imaging tools, particularly computed tomography (CT).

A limited number of researches describe acute and chronic traumatic diaphragmatic hernias in terms of intraoperative and postoperative outcomes. To examine the intraoperative and postoperative results of patients with traumatic diaphragmatic hernias repaired using either suture repair or mesh repair in terms of morbidity, mortality rate, and incidence of recurrence, the investigators have established a retrospective cohort analysis for the current investigation.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old, male or female, and had an acute or chronic traumatic diaphragmatic hernia

Exclusion Criteria:

* Hiatus hernias, congenital hernias, diaphragmatic tears without herniation of abdominal organs, eventration of the diaphragm, hernias on both sides of the diaphragm, and recurrent diaphragmatic hernia after prior repair
Somatic Comorbidities in Psychiatric Patients

Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic comorbidities in psychiatric patients population and the general Croatian population.


Eligibility Criteria:
Inclusion Criteria:

* treatment in psychiatric hospital

Exclusion Criteria:

* acute suicidality
* dementia
* mental retardation
* acute psychosis
* intoxication
* inability to answer the questionnaire by themselves
Cortical Activity During Vojta Stimulation in Healthy Adults

The present study is focused on the importance of sensory stimuli at the tactile and proprioceptive level that occur during the activation of the pectoral area, following the treatment protocol of Vojta Therapy (VT), and which are the areas that are activated in the central nervous system (CNS) during stimulation, as well as muscle activity. For the activation record it will be used electroencephalography and electromyography electrods.

The relationship between intrinsic and extrinsic factors condition the development of the human being. The sensory organs are the main recipients of the information, thanks to them we are able to interact with the environment and register the influence of the stimuli inside the organism. The brain receives information from the environment through its senses.

At the tactile level the brain receives afferent information thanks to the activation of mechanoreceptors of the skin during interaction with the environment. The receivers encode the stimulus information and send it to the specific CNS structures. In these structures, the sensations received are combined and the stimulus is transformed into a perfectly elaborated response, both in a conscious and innate way.

Dr. Vojta showed in 1974 the locomotion reflects the result of the study of motor ontogenesis. This discovery was the demonstration of the existence of innate and preprogrammed motor patterns in Humans.

Most of the studies related to VT have showed the improvements obtained by the patients, validating it as a method of treatment and evidencing objective changes after its application. This research aim to go further and verify that cortical areas are activated during the application of an external and proprioceptive stimuli that are performed during the first phase of VT turning and which areas are responsible for producing and organizing the efferent response.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult population with no history of neurological disease or others that may affect the test.
* Age between 18 and 50 years.
* Not having addiction to alcohol or drugs at the time of the study.
* Not knowing the basics of Vojta Therapy, or knowing the responses of stimuli when applying therapy.
* Not having the pharmacological treatment that affects the functioning of the Central Nervous System and may interfere with the test results.

Exclusion Criteria:

* Those who do not meet the inclusion criteria
* Not having suffered ms-skeletal alterations in the last 6 months.
* Known sensory abnormalities.
* Diagnosis of some neurological pathology or condition that could alter the study such as pain, radiculopathy.
* Refuse to sign the informed consent.
* Claustrophobia.
* Those that can spoil the magnetic resonance image.

  * Be a carrier of some metallic material.
  * Pregnancy or nursing mother.
* The contraindications of Vojta Therapy.

  * Acute diseases that present with fever and / or inflammation.
  * Vaccination with live germs, according to medical criteria (usually 10 days after vaccination).
  * In case of crystal bone disease, uncontrolled heart disease.
ED50 of Intratecal Prilocaine in Ultrasound Fusion Prostate Biopsy

The aim of the present study was to determine the ED50 and ED90 of intrathecal hyperbaric 2% prilocaine (HP) for patients undergoing ambulatory prostate biopsy via magnetic resonance imaging (MRI)/ultrasound fusion.

Prostate biopsy to diagnose or exclude cancer is currently performed an estimated one million times annually worldwide. In this method, the operator images the prostate using ultrasound, as performed for the past several decades; while thus viewing the prostate, the MRI of that prostate, which is performed beforehand and stored in the device, is fused with real-time ultrasound using a digital overlay, allowing the target(s), previously delineated by a radiologist, to be brought into the aiming mechanism of the ultrasound machine. The fusion results in creation of a three-dimensional reconstruction of the prostate, and on the reconstructed model, the aiming and tracking of biopsy sites occurs. This method needs for sedation/general/ spinal anesthesia because of patient discomfort with the transperineal approach of the biopsy needle passing through the perineum.

Even though the MRI/ultrasound fusión prostate biopsy is widespread used, the anaesthetic techniques for this procedure are not standardised. Hyperbaric prilocaine is an amide-type local anesthetic widely used in short surgical procedures showing its efficacy for outpatient surgery. The proposed intrathecal doses of prilocaine for various surgical procedures range from 10 to 80 mg. Thus, even though the drug is in clinical use, optimal doses of HP required for specific types of surgery warrant further refinement. The aim of the present study was to determine the ED50 and ED90 of intrathecal HP for patients undergoing undergoing ambulatory MRI/ultrasound fusión prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

ASA II-III patients Aged 18-85 years Prostate fusion biopsy procedure Scheduled to ambulatory surgery Signed informed consent

Exclusion Criteria:

* Standard contraindications to neuraxial blockade, coagulopathy, site infection, neurological impairment, known allergy to local anesthetics. Refusal of the patient to participate in the study.
the Value of Immunohistochemical Expression of Moesin in Endometrial Hyperplasia and Endometrial Carcinoma

Endometrial carcinoma (EC) is the most prevalent invasive carcinoma of the female genital tract in developed countries, while it ranks as the second most frequently occurring neoplasm of women in developing countries, after carcinoma of the cervix uteri. The vast majority of ECs occur in perimenopausal and postmenopausal women .

ECs are classified into two distinct phenotypes; type I which represents more than 80% of all cases of ECs, it has a favorable prognosis. This type is linked to excess, unopposed hyper-estrogenic condition and it is almost always preceded by endometrial hyperplasia. On the contrary, type II endometrial carcinoma is less common than type I, representing less than 10% of all cases of ECs. Type II endometrial carcinomas are high grade, poorly differentiated and estrogen-independent tumors .


Eligibility Criteria:
Inclusion Criteria:

* Hysterectomy specimens diagnosed as endometrial hyperplasia and endometrial adenocarcinoma.
* All cases of endometrial biopsies obtained by curettage (D\&C) diagnosed as endometrial hyperplasia.
* Cases of cyclical endometrium obtained from endometrial curettage or hysterectomy specimens done for pathological conditions other than hyperplastic or neoplastic endometrial lesions.
* Complete clinical data.

Exclusion Criteria:

* Patients with a history of preoperative chemotherapy and /or radiotherapy.
* Biopsies with predominantly blood clots.
* Insufficient or tiny tissue biopsies.
Effects of Milk Derived From Mountain-pasture Grazing Cows on Risk Markers of the Metabolic Syndrome Compared to Conventional Danish Milk

To investigate the effect of milk delivered from mountain-pasture grazing cows on risk markers of the metabolic syndrome and type-2 diabetes with the effect of conventional Danish milk. The study should reveal the importance of phytanic acid content for these effects.


Eligibility Criteria:
Inclusion Criteria:

* sign written consent
* Age: 50-70
* BMI: 20-30
* increased risk of developing MS
* refrain from dietary supplements and blood donations prior to, and during the study

Exclusion Criteria:

* poor compliance
* if they suffering from any chronic or long lasting illness
* abuse of alcohol or medicine
Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma

Curative treatment of peri hilar cholangiocarcinomas is R0 surgery and require major hepatectomy with biliary tract resection. These complexe procedures can lead to high morbidity and mortality. A severe alteration of nutritional status before the surgery might be a poor prognosis for survival.

Peri hilar cholangiocarcinomas are rare tumors, which when diagnosed at the resectable stage, require major hepatic resection associated with biliary reconstruction. These are complex procedures with a high morbidity and mortality, mainly due to postoperative hepatic failure and sepsis.

These patients undergo optimization of liver function with portal embolization according to the volume of the future remaining liver and preoperative biliary drainage. On top of technical challenges of the surgery, the patients usually present a significant alteration of the general condition at the time of diagnosis, with denutrition that can be severe. The importance of evaluating the preoperative nutritional status in the context of oncological surgery is increasingly recognized in the literature. Different nutritional scores exist such as the CONUT score, PNI, or the evaluation of sarcopenia on imaging examinations and have shown an impact on morbi-mortality in liver surgery.

Eligibility Criteria:
Inclusion Criteria:

* Surgical peri hilar cholangiocarcinoma from 01/01/2003 to 04/01/2021 at Nancy University Hospital

Exclusion Criteria:

* Non curative surgery