cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye

The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.

Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range from 20 million people in the United States being affected with mild to moderate dry eye, to as many as one out of every five Americans.

EyeGate completed a single-center, randomized, double-masked, placebo-controlled Phase 2 efficacy study in 105 subjects with mild to moderate dry eye disease, utilizing the Controlled Adverse Environment (CAE), a clinical model which allows for standardized measurement of dry eye signs and symptoms in the investigation of therapeutic agents. In this Phase 2 study, the improvements documented in dry eye signs and symptoms relative to the placebo group indicated that the ocular iontophoresis treatments with EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) had both a rapid onset of action and a long-term effectiveness.

The Phase 3 study is intended to confirm and extend the results from the Phase 2 study, utilizing the CAE model. The study is designed to assess the safety and efficacy of EGP-437 at two different dose levels: Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA compared to Ocular Iontophoresis with placebo (sodium citrate buffer solution) for the treatment of the signs and symptoms of dry eye.

Eligibility Criteria:
Inclusion Criteria:

* Have a reported history of dry eye in each eye
* Be at least 12 years of age
* Demonstrate a response when exposed to the Controlled Adverse Environment model at Visits 1 and 2

Exclusion Criteria:

* Have contraindications to the use of the test articles
* Have known allergy or sensitivity to the study medications or their components
* Have any ocular infections, active ocular inflammation, or preauricular lymphadenopathy
* Be current contact lens wearers or wear contacts during the study
Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis

This study evaluates the efficacy of Pediatric Integrative Manual Therapy in the treatment of positional plagiocephaly in infants. 25 participants will receive a protocol of Pediatric Integrative Manual Therapy and educational physiotherapy in combination, while the other 25 will receive a stretching protocol and educational physiotherapy

The Manual Therapy has shown efficacy in different pathologies in the adult but it is not know its utility in infants and children population, nor in specific pathologies as non synostotic plagiocephaly.

In the conservative treatment of plagiocephaly the educational physiotherapy and the helmet therapy have the better level of evidence among other treatments. When babies present preferential position of the head or Congenital Muscular Torticollis, stretching has shown efficacy.

A protocol of ten sessions of Pediatric Manual Therapy will be applied to infants with positional plagiocephaly in combination with educational physiotherapy. The protocol consists in soft cervical mobilisation, myofascial induction and the application of some pressures to the cranial bones to improve the asymmetry of the head. Educational therapy which consists in more "tummy time" stimulation, stimulation to the non preference position of the head and counter positioning. The control group will receive a protocol of stretching at home done by their parents and Educational therapy.

Eligibility Criteria:
Inclusion Criteria:

* Sign of positional plagiocephaly
* Infants below 12 moths age

Exclusion Criteria:

* No neurological disorders
* No infectious diseases
* No respiratory diseases
* No other treatments
Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

The overall objective of the study is to test whether the use of small electrical currents to stimulate proprioceptors of the upper limb has potential for improving robot-assisted upper-limb rehabilitation in stroke survivors.

Study participants will be instructed to perform upper-limb movements using a system designed for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides subjects with unloading of the stroke-affected arm thus facilitating the performance of upper-limb movements. The system will be used to track the movements of the stroke-affected arm. Simultaneously, a custom-designed system (a prototype developed by the investigators) will be used to deliver small electrical currents to the arm. We hypothesize that the currents delivered to the arm will improve the accuracy of the movements performed by study participants.

To assess if delivering small currents to the arm has an effect on the accuracy of the movements performed by the study participants, they will receive actual stimulation for some trials and sham stimulation for other trials. Because the investigators will deliver very small currents, study participants will be unable to perceive such currents and hence tell if they are performing the movements while receiving actual or sham stimulation. By comparing trials performed while subjects receive actual stimulation with trials performed while subjects received sham stimulation, the investigators will determine if the stimulation has an effect on the accuracy of the movements performed by the subjects.

It is worth noticing that the investigators collected primary outcome data to assess changes associated with the use of actual stimulation vs sham stimulation. Data during a follow-up session was also collected, but not for the purpose of collecting outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* unilateral and cortical, subcortical, or cerebellar stroke
* 6 months post-stroke
* Upper extremity impairments but able to move upper extremity against gravity 25% of the range
* Ability to understand directions and follow simple instructions
* Medically stable
* Upper Extremity Fugl-Meyer between 28 and 55
* At least four (4) months since last botox treatment
* Mini-Mental State Examination (MMSE) ≥ 23

Exclusion Criteria:

* Participation in other forms of therapy/ intervention for upper extremity motor recovery
* Upper extremity or trunk fractures
* Severe fixed contractures affecting the upper limbs
* Severe perceptual deficits or visual field impairments
* Severe cognitive deficits
* Pregnant women
* Presence of an implanted electrically operated medical device
* Evidence of more than one clinical stroke
* Serious medical or neurological illness
* History of head trauma or cerebral infectious disease
Role of FDG PET, Immune and Hypoxic Marker in NSCLC

This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with surgery with radical intent at our center.

This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 130 patients with NSCLC treated with surgery with radical intent at our center.

We will review FDG-PET acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to hypoxic and immune-related markers at immunohistochemistry (IHC). These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NSCLC (Stage I-III)
* FDG PET before surgery

Exclusion Criteria:

* Absence of tumor specimen
* No clinical data
* FDG-PET can not be evaluated
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals

ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta.

Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality.

Confirmation of reference intervals of the ROTEM® systems.

The main innovation of ROTEM® sigma is the development of a sample handler and a cartridge allowing for a of full automated test operation. As in ROTEM® delta four different tests can be run simultaneously on the four channels of the analyser.

Whereas the tests in ROTEM® delta are performed manually by pipetting a blood sample and liquid system reagents, in ROTEM® sigma the reagents are contained in freeze dried pellet form in a cartridge. Test operation is performed by inserting a cartridge and attaching a blood sample to the analyser.

The five available ROTEM® tests INTEM, EXTEM, FIBTEM, APTEM, and HEPTEM are contained in different combinations in two cartridge configurations:

* Cartridge type 1 including INTEM, EXTEM, FIBTEM, APTEM
* Cartridge type 2 including INTEM, EXTEM, FIBTEM, HEPTEM

Aim of the study is the performance evaluation of the new ROTEM® sigma coagulation analyzer in comparison to the current ROTEM® delta thromboelastometry system.

As a valid method comparison requires test results that cover the whole measurement range of the test system it is also necessary to include acute bleeding and emergency patients in the study. Only the inclusion of acute bleeding and emergency patients will produce strong pathologic test results allowing for a valid evaluation of the test system.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Age ≥ 18 years
* Informed written consent
* Patients with an acute bleeding during surgery
* Or: trauma patients with acute bleeding
* Or: hypercoagulable (above normal fibrinogen) patients at the ICU

Healthy Volunteers:

* Adult healthy individuals (≥ 18 years)
* Written informed consent

Exclusion Criteria:

Patients:

• none

Healthy Volunteers:

* Any indications of alcohol or illegal drug abuse
* Any chronic disease with possible effect on the coagulation (liver disease, coronary heart disease)
* Any acute illness within the last 14 days
* Any hemostasis associated disease (myocardial infarction, thrombosis , stroke etc.) within the last year
* Intake of any coagulation affecting medication (aspirin, pain-killers, anti-rheumatic drugs, marcumar, platelet inhibitors) within the last 14 days
* Females only: known pregnancy
* Females only: breast feeding
* Any indication for any hemostasis disorder as interrogated by a specific history of bleeding tendencies
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector

This is a Phase I/II clinical trial of gene transfer for treating Beta-thalassemia using a self-inactivating lentiviral vector to functionally correct the defective gene(s). The objectives are to evaluate the safety and efficacy of the gene transfer clinical protocol.

Thalassemia is considered the most common genetic disorder worldwide. Beta-thalassemia is caused by mutations in the beta-globin gene which encodes the beta-globin protein, leading to the ineffective erythropoiesis, hemolysis and anemia. Currently, the only cure for thalassemia is bone marrow transplantation from a related, compatible donor, which has, however, the significant risk of transplant related mortality, graft versus host disease and limited source. Therefore, gene transfer, achieved by transplantation of the patient's own stem cells that have been genetically-modified with the corrected gene, could potentially cure thalassemia.

This study will use an experimental gene transfer procedure performed in a laboratory to insert the related gene into the participant's autologous stem cells using a self-inactivating lentiviral vector. The purpose of this study is to evaluate the safety and effectiveness of the gene transfer procedure and to determine the ability of the gene-corrected cells at generating new, healthy blood cells in individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Beta Thalathemia.
2. Age: ≥ 4 years.
3. Karnofsky: ≥ 80%.
4. Left ventricular ejection fraction (LVEF): \> 50%; no obvious heart disease and pulmonary hypertension.
5. Pulmonary function is normal; forced expiratory volumein one second (FEV1) and vital capacity greater than 60% and DLCO \> 50%.
6. Serum creatinine ≤ 2 × upper limit of normal range.
7. MRI showed no super-iron load in the heart and liver, and no severe cirrhosis.
8. Normal Coagulation.
9. Written, informed consent obtained prior to any study-specific procedures.

Exclusion Criteria:

1. Diagnosis of active malignant disease (other than Bowen disease or cervical cancer); or has family history of cancer.
2. Myelopathy, tumor-related cytogenetic changes or other more severe blood diseases.
3. Has alcoholism experience within 6 months prior to enrollment.
4. History of epilepsy.
5. History of bone marrow transplantation.
6. Existence of an available HLA-identical related donor.
7. Pregnant or lactating females.
8. Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
9. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Selegiline Transdermal System for the Treatment of Cocaine Dependence - 1

The purpose of this study is to evaluate the Selegiline Transdermal System for the treatment of cocaine dependence.

The study objectives are to assess the efficacy and safety of the Selegiline Transdermal System (STS) in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that selegiline treatment compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).

Eligibility Criteria:
Inclusion Criteria:

* Male/Female
* At least 18 years of age
* DSM-4 diagnosis of cocaine dependence
* Ability to understand and provide written consent
* Female subjects must use acceptable birth control

Exclusion Criteria:

- Additional Criteria available during the screening process at the site.
Brief Advice, Nicotine Replacement Therapy Sampling and Active Referral (BANSAR) for Smoking Fathers

This study aims to evaluate the effects of a combined "cocktail", cessation intervention of brief advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers on smoking cessation outcomes

Secondhand smoke (SHS) exposure cause substantial harms to pregnant women, foeti and infants. Smoking cessation (SC) interventions for smoking expectant fathers are needed particularly in China where male smoking predominates and many pregnant women (about 30% in Hong Kong) were exposed to SHS. Prenatal period presents a valuable teachable moment to engage smoking expectant father in tobacco dependence treatment. However, most smoking cessation trials were conducted in the Western countries on smoking pregnant women or smoking couples. Very few trials were designed to target fathers quitting.

Given the busy clinical settings in Hong Kong Public Hospitals, evidence-based, low-cost and sustainable brief cessation intervention applicable in real-world practice is imperative. Informed by previous research, a combined cessation intervention of brief advice, nicotine replacement therapy sampling and active referral (BANSAR) has been developed for smoking expectant father. This multicentre, pragmatic, assessor-blinded, individually-randomized controlled trial aims to evaluate BANSAR for smoking cessation outcomes in smoking expectant father visiting prenatal clinics in Hong Kong

Eligibility Criteria:
Inclusion criteria for both expectant father and mother:

1. Hong Kong resident aged 18 or above
2. Able to read and communicate in Chinese
3. Living together in the past 7 days

Inclusion criteria for expectant father:

1. Having smoked 1 or more cigarettes daily in the past 3 months
2. Having a telephone or mobile phone contact

Inclusion criteria for expectant mother:

1. Not having smoked any cigarette in the past 30 days

Exclusion Criteria for expectant father

1. Having any history of severe angina, arrhythmia, or acute myocardial infarction
2. Having psychiatric/psychological diseases or regular psychotropic medications
3. Having used smoking cessation aids or participated in other smoking cessation services or projects in the past 3 months
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis.

This study is not enrolling patients in the United States.


Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region)
* minimum severity score (PODSI) ≥ 4
* age 18 and older

Exclusion Criteria:

* Ongoing use of the following treatments is NOT allowed after the start of study drug:

Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme).

* Systemic immunosuppression
* History of malignancy of any organ system, treated or untreated, within the past 5 years
T Cells Response to SARS COV 2 Peptides

The analysis method described in this protocol is a novel simple plausible immunological approach which is non-invasive, high throughput, real-time quantitative monitoring of metabolic activity (MA) profiles of fresh Peripheral Blood Mononuclear Cells (PBMC) in response to various reagents at different concentrations. The purpose of this study is to evaluate the T cells reactivity to SARS COV 2 immunogenic selected peptides by Metabolic Activity Method in convalesce and healthy individuals and to compare it with Antibody response (ELISA) and clinical information

This is a prospective, four groups, open, comparative, controlled study. A total of 400 completed, evaluated subjects will be enrolled in this study. Main Study Measures: Reactivity of T cells to selected SARS COV-2 peptides by MA test and IgG Antibody response to SARS COV-2 by commercial ELISA test.

Study Procedures:

* Screening
* Informed consent signing
* Medical history review
* Blood collection.
* MA test and ELISA test will be performed at Savicell's Laboratory site.

Eligibility Criteria:
Inclusion Criteria:

* All recruited subjects are between 18 to 90 years old.
* All recruited subjects read the informed consent and then signed the informed consent.
* All recruited subjects filled out the questionnaire form

Exclusion Criteria:

* Subject has active infection or inflammation determined clinically at screening.
* Subject is currently treated with concomitant medication related directly or can affect the immune system as steroids.
* Subject has impaired judgment.
* Known positive HIV, hepatitis B, or hepatitis C, autoimmune disease.
* Known history of a significant medical disorder, which in the investigators' judgment contraindicates the patient's participation.
* Drug or alcohol abuse
* Subject is participating in any other clinical trial for drug investigation within 10 days prior sample collection
Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer

This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.

This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect.

The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria.
* Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy
* ECOG score 0-2
* Adequate organ and bone marrow function
* The expected survival time is ≥ 12 weeks
* Had normal swallowing function, without dysfunction of gastrointestinal absorption
* Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures

Exclusion Criteria:

* The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel;
* The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy
* Known to be allergic to the active ingredients or excipients in this study.
* Had other active malignant tumors within 5 years before entering the study.
* Subject with cerebral metastasis
* Have a clear history of serious and uncontrolled other disease or mental disorders;
* Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy
* Other situations that the researcher considers inappropriate to participate in the research.
Study on the Influence of Fluoroscopy in the Diagnosis of Peripheral Lung Lesions With Endobronchial Ultrasound Guidance

The purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).

See above

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients referred for the bronchoscopic diagnosis of peripheral pulmonary lesions at the Institut Universitaire de Cardiologie et de Pneumologie de Québec(not visible endobronchially)
* Adults over the age of 18

Exclusion Criteria:

* Therapeutic anticoagulation
* Antiplatelet therapy other than aspirin
* Known hemorrhagic diathesis
* Acute respiratory failure
* Pregnancy
* Inability to provide informed consent