cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Onset and Duration of Action of RX-10045 in Allergic Conjunctivitis

To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic solution in alleviating the signs and symptoms of allergic conjunctivitis

Allergies are relatively common among the general population. Ocular signs and symptoms include itching, discomfort, redness, chemosis, tearing, and eyelid swelling. Allergic reactions can vary from a mild, self-limiting disease, to a debilitating condition that significantly impairs the quality of life of allergen-sensitive individuals.

Currently approved treatments for ocular allergy reduce the signs and symptoms of the early phase reaction; however, evidence suggests that many patients suffer from the persistent late phase reaction. Manifestations of the late phase reaction occur 6 to 24 hours after allergen exposure and are characterized by an influx of acute inflammatory cells into the conjunctivae. Administration of anti-inflammatory agents decreases allergy signs and symptoms in both the early and late phase reactions.

RX-10045 has been shown to be efficacious in multiple pre-clinical dry eye disease models and in a pre-clinical model of allergic conjunctivitis. The objective of this clinical study is to assess the safety and efficacy of RX-10045 ophthalmic solution for the treatment of the signs and symptoms of allergic conjunctivitis induced in the Conjunctival Allergen Challenge Model of allergic conjunctivitis at 15 minutes and 8 hours after medication instillation. It is anticipated that RX-10045 has therapeutic potential for the treatment of allergic conjunctivitis and an acceptable risk-benefit profile.

Eligibility Criteria:
Inclusion Criteria:

Subjects MUST:

1. Have a positive history of ocular allergies
2. Have a positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

Subjects MUST NOT:

1. Have known contraindications or sensitivities to study medication or its components
2. Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
3. Use a disallowed medication during the period indicated prior to the enrollment or during the study
4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Effects of ACS in Twin With LPB: Study Protocol for a RCT

This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.

Antenatal corticosteroid (ACS) has been proven to prevent adverse outcomes including respiratory morbidities in preterm neonates before 34 weeks of gestations. Recently, it has been suggested that ACS may be also effective for reduction of respiratory complications in singleton late preterm pregnancies. On the contrary, there is a paucity of information regarding the effectiveness of ACS in twin neonates with late preterm birth, and nowadays guidelines are recommending the use of ACS in twin pregnancies based on the evidences in singleton pregnancies. However, the effect of ACS in twin needs to be determined, because the rate of neonatal morbidities in twin preterm neonates seems to be different from that in singleton neonates. This study aims to determine the effectiveness of ACS in late preterm twin neonates.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age over 18 years
* (2) Twin pregnant women at 34weeks 0days to 36weeks 5days of gestation
* (3) At risk for preterm birth such as preterm labor, preterm prematrue rupture of membrane or maternal-fetal indications that need preterm delivery. Preterm labor is defined as regular uterine contractions with or without the following symptoms; pelvic pressure, backache, increased vaginal discharge, menstrual-like cramps, bleeding/show, cervical changes
* (4) Availability of written informed consent.

Exclusion Criteria:

* (1) Gestational age before 34weeks 0days or after 36weeks 6days
* (2) Lethal major fetal anomaly, fetal distress or fetal death in utero
* (3) Expected to deliver within 12 hours; for example, advanced cervical dilatation (\>8cm) in preterm labor or active phase labor (cervical dilatation\>4cm) in preterm premature rupture of membranes
* (4) History of a previous administration of ACS before 34weeks of gestation for fetal lung maturation
* (5) Administration of systemic steroid for medical indications
* (6)Diagnosis of clinical chorioamnionitis Fever \>37.8 and the presence of two more following conditions: uterine tenderness, foul-odored vaginal discharge, maternal leukocytosis(\>1500), maternal tachycardia(\>100) or fetal tachycardia(\>160)
Xanthohumol and Metabolic Syndrome

The purpose of this study is to determine the pharmacokinetics (PK) of xanthohumol (XN). Small amounts of xanthohumol occur naturally in hops, used to make beer, and XN is also found in beer itself. Studies in animals have shown that XN can lower blood sugar and blood lipids such as triglycerides, which can contribute to heart disease. The purpose of this study is to see how much of the XN is absorbed into the blood and how fast it leaves the body when taken by mouth. Once the PK study has been done, the investigators' long-term goal is to learn if xanthohumol can lower risk factors for heart disease and type-2 diabetes in humans.


Eligibility Criteria:
* BMI 18-32 kg/m2 (to avoid confounders with extreme obesity).
* Smoking or non-smoking.
* Having normal or clinically acceptable physical examination and clinical laboratory tests.
* Willing to abstain from beer consumption for four days prior to and during the study because beer contains XN and related prenylated (PN) flavonoids, such as IX, 8-PN and 6-PN.
* Not currently taking prescription drugs.
* Not having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study.
* If female, not pregnant (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study, and using effective method of contraception (hormonal methods NOT permitted).
* If male with a partner of childbearing potential, willing to inform their partner of their participation in this clinical study and use highly effective methods of birth control during the study.
* Not currently following an extreme diet, such as Atkin's, Zone or Ornish, and willing to maintain their current diet without extreme changes for the duration of the study.
Clinical Validation of AI-Assisted Radiotherapy Contouring Software for Thoracic Organs At Risk

The goal of this clinical trial is to evaluate performance and clinical applicability of AI-assisted radiotherapy contouring software for thoracic organs at risk. The main question it aims to answer is:

• Does AI-assisted contouring (AI contouring with manual modification) offer greater accuracy and time efficiency compared to manual contouring? After screening, the qualified participants' thoracic CT images will be anonymized and segmented using three methods: manual, AI (AI-only), and AI-assisted contouring. The researchers will compare the results generated by the three different contouring methods with the ground truth established by expert consensus, in order to evaluate both accuracy and time-related parameters


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old, no gender limit.
2. Patients diagnosed with breast cancer, lung cancer, or esophageal cancer, who are scheduled for chest CT scanning followed by thoracic radiotherapy.
3. CT slice thickness ≤5mm.
4. Patients understand the goal of the trial, are willing to attend the trial and sign the informed consent.

Exclusion Criteria:

1. Congenital malformations or abnormal anatomical structures resulting from non-tumor factors in the scan area.
2. Artifact, prosthesis or implantation causing images undistinguishable.
3. CT images not conforming to DICOM standards.
4. Investigators consider not suitable.
Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty

This study is designed to evaluate pain control of continuous adductor canal blocks placed proximally versus distally within the canal. The investigators hypothesize that there will be similar pain control between both groups.

This study is a non-inferiority trial designed to determine whether placement of a continuous block within the adductor canal has a substantial impact on pain following total knee arthroplasty. Our primary outcome to determine this difference will be opioid consumption within the first day following surgery. Secondary outcomes will include: pain scores, quadriceps strength, and distance ambulated during physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral Total Knee Arthroplasty
* ASA physical status I-III
* \>18 years old
* Non-pregnant
* Consent to participate in the study

Exclusion Criteria:

* Refusal to participate
* \<18 years old
* Chronic opioid use
* Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic
Evaluation of Woulgan in Diabetic Foot Ulcer

The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Type I or II diabetes mellitus.
* Target ulcer area between 0.5 and 5 sqcm, and more than 4 weeks old.
* Ankle-brachial pressure index above 0.7.

Exclusion Criteria:

* Ulcers due to non-diabetic etiology.
* Uncontrolled diabetes defined as HbA1c above 70 mmol/mol and insufficient nutritional status.
* Ulcers older than 1 year.
* Any of gangrene, osteomyelitis, cellulitis, or Charcot osteoarthropathy.
Multiparametric Imaging for Analysis of MVNT (Multinodular and Vacuolating Neuronal Tumor)

Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.

Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.

However, in order to avoid an invasive surgical procedure to remove the lesion, a certain diagnosis of its benignity is essential. The contribution of advanced techniques in MRI, such as spectroscopy in the characterization of these lesions, has not yet been studied today

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Suspicion of MVNT on an MRI: it is considered that it will be necessary at least the 2 major criteria associated with at least 1 minor criterion to enter the definition of suspicion of MVNT:

Major criteria:

* Multinodular aspect in cluster
* High FLAIR hypersignal / T2

Minor criteria:

* Absence of mass effect
* Hyposignal T1
* Center of the lesion in hypsignal FLAIR or T1 hypersignal

  * Affiliate or beneficiary of a Social Security scheme
  * Having received informed information about the study and consenting to participate in the study

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or lactating woman
* Contraindication to MRI
Drug Use Investigation for PAXIL Tablet

This post-marketing surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine.


Eligibility Criteria:
Inclusion Criteria:

* Patients with depression/depressed state or panic disorder

Exclusion Criteria:

* Patients who had been taking PAXIL since before the start of the survey
* Patients with hypersensitivity to paroxetine
* Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome


Eligibility Criteria:
Inclusion Criteria:

* Agree to avoid systemic \& topical ophthalmic meds \& disallowed meds
* Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
* Diagnosis of moderate dry eye syndrome

Exclusion Criteria:

* Uncontrolled ocular or systemic disease that could interfere with study
* Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
* Contraindications or hypersensitivity to use of study meds or components
* Wear contact lenses
* Secondary dry eye to surgery
* Eye surgery (including laser) within 6 months
* Use of systemic or topical ophthalmic meds within 14 days
* Punctal plugs in one or both eyes in place for \<45 days
* Permanent occlusion of the lacrimal puncta
Sugammadex Administration in Pregnancy

In this study, the investigators aimed to evaluate the maternal and fetal effect of sugammadex in pregnant patients undergoing a non-obstetric surgery. The investigators mainly focused on the short- and long-term adverse effects such as an abortion or a teratogenic effect and that may occur in fetus and the adverse effects that may be seen in mother.

Since the approval in Europe in 2008, sugammadex has been widely studied among pregnant patients in the context of cesarean deliveries. However, the use of sugammadex in pregnant patients undergoing a non-obstetric surgery is not clearly defined. The package insert indicates that there are no data on its use in pregnant women regarding the drug-associated risks. There are some questions raised, and answers needed from the scientific community about the maternal and fetal effect of sugammadex administered in pregnant patients.

This is a retrospective case-control cohort study which was conducted in a single-center territory university hospital. The investigators used the hospital information management system for determining the patients that are eligible for inclusion. Patients operated between January 2017 and june 2022 were included in the study. Patient data was obtained by manual review of anesthesia charts of eligible patients. Pregnant patients who underwent a non-pregnancy surgical intervention within the study period were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who were operated under general anesthesia during pregnancy and who used sugammadex during the awakening phase.

Exclusion Criteria:

* Patients with severe hepatic and renal impairment
* Patients with missing data
* Patients with fetal anomaly detected before the procedure
Poststroke Depression in Hemorrhagic Stroke

A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.

Patients who suffered aneurysmal subarachnoid hemorrhage will be randomly assigned either an oral antidepressant or placebo and evaluated for the preventative treatment of depression and health-related quality-of-life.

Eligibility Criteria:
Inclusion Criteria:

Patients 18-85 years of age aged 18 years and older will be included.

Patients admitted for subarachnoid hemorrhage from a ruptured cerebral aneurysm will be included.

Only patients who provide informed consent will be included.

Exclusion Criteria:

Non-English speaking patients will be excluded.

Patients currently receiving therapy for depression or related mental health diagnoses before admission will be excluded.

Patients with medical contraindications to fluoxetine therapy will be excluded.

Pregnant patients or patients considering pregnancy during the trial period at the time of consent will be excluded.

Patients with active psychosis will be excluded.

Patients who are incarcerated or in police custody will be excluded.

Patients with a comorbidity or cognitive impairment (as determined by a recruiter-administered Montreal Cognitive Assessment; Patients scoring \>26 are considered of appropriate cognitive function for consent) that precludes informed consent and participation in the research interviews will be excluded.
A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral

A multicenter phase I/II Clinical trial,randomized, controlled with placebo, triple blind to evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal stem cells cells from adipose tissue in patients with Amyotrophic Lateral Sclerosis (ALS).

A multicenter phase I/II Clinical trial,randomized, controlled with placebo, triple blind to evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal stem cells cells from adipose tissue in patients with Amyotrophic Lateral Sclerosis (ALS).

40 patients will be enrolled and will be randomized into one of the following 4 arms:

* 10 patients in the control group (placebo)
* 10 patients received a dose of 1 million MSC / kg
* 10 patients received a dose of 2 million MSC / kg.
* 10 patients received a dose of 4 million MSC / kg

The follow-up phase of each patient from the cell infusion/placebo will be 6 months.

At the time that each patient completed the follow-up period (i.e., 6 months after the infusion of the cellular product or placebo), the blind will be open, and patients who have been assigned to the control group, will receive the cell product as secondary treatment. These patients will be randomized to receive each of the doses used in the first phase. From this point, they begin a second period of follow up of 6 months.

In addition, after 6 months of MSC infusion, every patient will continue in an open extension study for 36 months to assess the safety of MSC.

Eligibility Criteria:
Inclusion Criteria:

1. Women and males over 18-year-old.
2. Good understanding of the protocol and aptitude to grant the informed assent.
3. Diagnosis of sporadic ALS, with diagnosis of certainty, that is to say, definite or probable, in agreement with the criteria of "El Escorial", of the World Federation of Neurology.
4. Forced vital capacity of at least 50 % of the one that would correspond to them for sex, height and age.
5. More than 6 and less than 36 months of evolution of the disease (from the beginning of the symptoms).
6. Possibility of obtaining, at least, 50gr of adipose tissue.
7. Treatment with riluzole, for at least, a month before the inclusion.

Exclusion Criteria:

1. Any concomitant disease that under investigator's criteria could concern the measures of the clinical variables of the trial (hepatic, renal or cardiac insufficiency, diabetes mellitus, etc).
2. Previous therapy with stem cells.
3. Participation in another clinical trial during 3 months previous to the entry in this trial.
4. Any disease lymphoproliferative
5. Tracheostomy and /or gastrostomy.
6. Haemophilia, diathesis hemorrhagic or anticoagulative current therapy.
7. Hypersensitivity known to the bovine foetal whey or the gentamicin.
8. Medical precedents of infection of the HIV or any serious condition of immunocompromised.
9. Positive HBV or HCV serology
10. Levels of creatinine in whey \> 3.0 in subjects not submitted to haemodialysis.
Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT

The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.


Eligibility Criteria:
Inclusion Criteria:

* newborns born in the same hospital
* either gender
* diagnosis of any pathological/clinical medical condition

Exclusion Criteria:

* lack of guardian consent
* newborn transferred to/from other hospital
* lack of any of the inclusion criteria
Effects of Atorvastatin on Endothelial Progenitor Cells After Coronary Surgery

Experimental data have demonstrated favourable effects of statins on endothelial progenitor cell (EPC) mobilization from the bone marrow, and cardiac homing. The purpose of the present prospective randomized controlled trial is to determine the effects of aggressive atorvastatin treatment (40 mg daily 2-weeks prior to surgery) on the number of endothelial progenitor cells (EPCs) after cardiopulmonary bypass by comparing with placebo.

Endothelial progenitor cells, a subgroup of hematopoietic stem cells have a significant role in vascular homeostasis. In animal models of ischemia, endothelial progenitor cells are rapidly incorporated into sites of neovascularization, have the potential to induce and augment vasculogenesis/ angiogenesis, prevent cardiomyocyte apoptosis in peri-infarct regions, and reduce adverse remodeling. Treatment with atorvastatin has been shown to increase endothelial progenitor cell count in patients with coronary artery disease. Therefore, we will investigate whether atorvastatin augments the number of endothelial progenitor cells after cardiopulmonary bypass in patients undergoing coronary artery bypass surgery (CABG). Thus, we conducted a randomized double-blind, placebo-controlled, 2-way parallel trial in 60 patients undergoing coronary artery bypass surgery. Patients will receive either 2-week treatment with atorvastatin or placebo prior to surgery. Endothelial progenitor cells will be quantitated by flow cytometric phenotyping obtained from peripheral blood samples. In addition, cardiac markers (CK-MB mass, cardiac troponin-I), biochemical profile, liver function tests, high sensitive C-reactive protein (hsCRP) and coagulation profile will be determined at 4 time points: 1) preoperatively (baseline); 2) 6 hours after the end of cardiopulmonary bypass; 3) 24 hours after surgery; 4) 5th days postoperatively. Clinical, operative characteristics, cardiac markers, high sensitive C-reactive protein and endothelial progenitor cell count will be compared between the groups. Adverse outcomes will also be noted and reported.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective isolated coronary artery bypass surgery with on-pump technique
* Written informed consent

Exclusion Criteria:

* Concomitant valve or aortic surgery
* Left ventricular aneurysm repair
* Re-operation
* Emergency surgery
* History of myocardial infarction within less than 4 weeks
* Hepatic impairment
* Chronic renal impairment
* Drug related side effects (allergy or hypersensitivity)
* Familial Hyperlipidemia
* Autoimmune conditions which require steroids
The Role of Noncontrast Computed Tomography Markers in Predicting the Clinical Outcome of Cerebral Hemorrhage

The goal of this observational study is to To investigate the ability of Noncontrast Computed Tomography to predict clinical prognosis in Intracerebral Hemorrhage.

The main question it aims to answer is:How to judge the prognosis of patients with cerebral hemorrhage by CT image reading at admission.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years
2. had completed a CT examination within 24 h of disease onset;
3. had a hemorrhage that was located in the brain parenchyma, including the basal ganglia, thalamus,brain lobes, brainstem, and cerebellum.

Exclusion Criteria:

1. had secondary ICH caused by brain trauma,cerebrovascular malformations, aneurysms, and tumors;
2. had ischemic cerebral infarction hemorrhagic transformation;
3. had undergone surgical treatment (e.g.hematoma removal or puncture drainage) before the CT examination;
4. had images of poor quality that could notbe accurately evaluated;
5. had a hematoma withborders that could not be delineated, thus precluding delineation of the region of interest (ROI).