cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm

To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA


Eligibility Criteria:
Inclusion Criteria:

* Adult between ages 18 and 75 years
* All patients, diagnosed of essential blepharospasm, with Grade 2\~4 of Severity of Spmasm (by Scott's Method)

Exclusion Criteria:

* Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy
* Patients with hypersensitivity history to botulinum toxin products previously
* Patients with secondary blepharomspasm
* Patients with hemifacialspasm
* Patients with treatment following drugs ; Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa
* Patients with previous injection of other botulinum toxin products in 3 months
* Patients with any other significant neuromuscular disease like Myasthenia gravis
* Pregnant or breastfeeding women
Efficacy of Intralesional PRP +/- Topical Silymarin in the Treatment of Melasma

Melasma is an acquired disorder of melanogenesis leading to hyperpigmentation and manifested by symmetrical brown to gray-black macules and patches with serrated irregular edges . It occurs especially in sun-exposed areas and affects young to middle-aged women. It is most commonly seen on the face and less commonly on the neck, arms, and chest . Platelet rich plasma (PRP) is defined as a small volume of autologous plasma that contains a high concentration of platelets obtained by centrifugation of autologous blood and subsequent suspension of platelets


Eligibility Criteria:
Inclusion Criteria:

* Females in the reproductive age (18 years old and above) presented with melasma confirmed by wood's light.

Exclusion Criteria:

* Pregnant and lactating.
* Systemic diseases that may cause facial hyperpigmentation (e.g: thyroid diseases, renal, hepatic or endocrinal disorders).
* Patients receiving depigmenting drugs oral or topical in previous 3 months, drugs that prolong bleeding as aspirin, hormone replacement therapy or contraceptive pills.
* Patients with anemia, thrombocytopenia, coagulopathies or patient on anticoagulant therapy and patients with iron deficiency.
* Patient with infections in the face e.g. herpes.
* Patients with history of scarring or keloid formation.
Measurement of vanilloïd Compounds in Urin of Autistic vs Control Patients, as Potential Biomarkers

In a former study, four vanilloid compounds were observed increased in the urin of autistic patients. The present study is aimed at performing a ambispective study to confirm or not these preliminary results. 70 urins from autistic children (already collected) will be compared to 70 urins of non autistic children (collected without intervention, remaining sample from the standard care), in terms of measurements of four vanilloid compounds using a GCMS apparatus.


Eligibility Criteria:
Inclusion criteria :

For cases :

* Male children aged 2 years to less than 15 years inclusive years at time of sample collection
* Children with a diagnosis of autism (ICD-10 F84.0) after assessment by a child psychiatrist.

For healthy chlidren:

* Children aged 2 years to less than 15 years old performing an ECBU at the CHRU of Nancy as part of their care.
* Patient whose ECBU is negative with respect to cytobacteriology (absence of urinary infection).
* Child can be matched to a CAS

Exclusion criteria

For cases:

* Children in whom one of the following pathologies is found during the anamnesis or in the clinical record : (i) renal insufficiency; (ii) urinary tract infection at the time of sampling and/or metabolic disease
* Children on antibiotic treatment at the time of collection

For healthy chlidren :

* children whose urine culture come from one of the following departments: Pediatric Nephrology (potential risk of renal failure) or Pediatric Neurology (potential risk of neurological disorder).
* with a diagnosis of autism
* with a metabolic disease
* children undergoing antibiotic treatment at the time of collectio
Prognostic Study of Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease Based on Metabolomics, and Lipidomics

To investigate whether there were differences in metabolomics and lipidomics in patients with coronary artery disease who had major adverse cardiovascular events during follow-up compared with those who did not.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients with the diagnosis of any type of coronary artery disease;
2. Age ≥18 years of age;
3. Patient or guardian provided informed written consent.

Exclusion Criteria:

1. Prior surgery, trauma or clinically evident coagulopathic bleeding within the previous 2 weeks;
2. Bipass population with missing follow-up records in Qilu Hospital emergency follow-up cohort.
Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications

The primary research question to be answered in this project is "Are patients with locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are immobilised in a radiotherapy treatment shell?" This will be assessed by measuring the proportion of patients that complete the full scanning protocol and by obtaining participant feedback on their experience of completing the scan.

The secondary question is "Can a PET-MRI scan fused with a planning CT scan improve the accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be assessed by:

1. Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan.
2. Comparing inter- and intra-observer variability in treatment contours with and without the use of a PET-MRI scan within and between oncologists and implications of that.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or over
2. Able to give informed written consent.
3. New diagnosis of biopsy-proven head and neck cancer.
4. WHO performance status ≤ 2.
5. MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy.
6. MRI and PET-CT staging scans for diagnosis.

Exclusion Criteria:

1. Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents.
2. Claustrophobia or other contraindications to MRI.
3. Unable to pass through a 55 cm hula hoop.
4. Female patients that are pregnant or breastfeeding.
5. Unable to understand written or spoken English.
6. Patients not undergoing radical intent radiotherapy.
7. Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or contrast administration.
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo for approximately 18 months (72 weeks) in approximately 540 participants diagnosed with early Alzheimer's disease

Participants will be randomized 1:1:1 to receive either 100mg or 200mg of CT1812 or placebo. CT1812 or placebo will be administered as 2 capsules to be taken orally once daily.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 50-85 years.
2. Diagnosis of either MCI due to AD or mild AD dementia.
3. MMSE 20-30 (inclusive).
4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.

Exclusion Criteria:

1. Screening MRI of the brain indicative of significant abnormality.
2. Clinically significant abnormalities in screening laboratory tests.
3. Clinical or laboratory findings consistent with:

   1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
   2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
   3. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
4. A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen \[HbsAg\] or anti-hepatitis C \[HCV\] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
5. A current DSM-V diagnosis of active major depression or GDS \> 6, schizophrenia, or bipolar disorder.
Multi-Colored Placido Disk Viability

The purpose of this study is to show that the multi-colored Placido Disk set-up can get reliable data over long time periods.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clinically diagnosed Dry Eye or Sjörgren's syndrome.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
* Ability to give informed consent
* Willing to spend time for the study; approximately 30 minutes for a visit
* Either gender
* Any racial or ethnic origin

Exclusion Criteria:

* Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
* Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy.
* Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago.
The Effect of Intercostal Nerve Block With Dexamethasone and Ropivacaine on Rebound Pain After Thoracoscopic Surgery

Regional nerve block is one of the commonly used methods for postoperative analgesia after thoracoscopic surgery. Recent studies have found that rebound pain may occur after regional block, which is defined as acute postoperative pain that occurs after the resolution of sensory block related to regional anesthesia, and seriously affects the quality of postoperative recovery of patients. There is evidence that rebound tenderness is associated with local anesthetic toxicity and proinflammatory effects. The aim of this study was to investigate the effect of dexamethasone on rebound pain after a single intercostal nerve block in patients undergoing thoracoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective thoracoscopic surgery Age \> 18 years old ASA ⅰ-ⅲ Informed consent was signed

Exclusion Criteria:

* Patients with aoagulation disorders Patients with allergy to local anesthetics Patients with severe cardiopulmonary diseases Patients had systemic steroid use Patients with chronic pain Patients with uncontrolled diabetes and mental disorders History of drug abuse; Body Mass Index more than 35 kg.m-2 Pregnant or breastfeeding woman.
Study of Glaucoma Treatment With Food Additives

The purpose of this study is to determine if certain food additives are effective in the treatment of glaucoma, improving and reversing the progress of the disease.

Glaucomatous neuropathy is a condition that worsens with time causing atrophy of the optic nerve and narrowing of the visual field which may culminate in blindness. The treatment tested in the trial employs certain food additives intended to reverse this pathology.

Eligibility Criteria:
Inclusion Criteria:

* Stable open angle glaucoma - with equilibrated eye internal pressure
* Above the age of 50 years and have severe damage that does not progress to the vision field in the upper and lower half. Scoring of the vision field will be made according to the Agis study instructions.

Exclusion Criteria:

* Eye diseases excluding past cataract operation
* Allergy to one of the components in the preparation
* Deterioration in the vision field in the last year
* Kidney diseases, gastrointestinal (G.I.) tract, liver diseases, coagulation problems and thyroid diseases
* Persons who take steroids
* Diabetics or unbalanced hyperglycemia
* Autoimmune diseases
* Hypertension (not responding to treatment)
* Psychiatric treatment with drugs, psychiatric pathologies
* Pregnancy
* Ability to take more than 3 pills per day regularly
* Smoking
A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction).

The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.


Eligibility Criteria:
Inclusion Criteria:

* Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
* Planned for primary PCI (percutaneous coronary intervention)
* Men and women without child-bearing potential aged 30-80 years of age
* Capable and willing to provide informed consent.
* Capable of completing study visits

Exclusion Criteria:

* Fibrinolytic administration for index event
* Known prior MI or prior coronary artery bypass graft (CABG) surgery
* Known pre-existing cardiomyopathy
* History of anaphylaxis
* Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)
A Pharmacogenomic Exploration of Lacosamide Response

This is an observational study exploring the genetics of lacosamide response. The study will last 3 years and has been divided in to three stages; 1) recruitment, 2) observational phase, 3) genotyping and analysis. Patients initiating lacosamide are recruited and their baseline seizure frequency is assessed retrospectively. Patients are then monitored for 18 months with an assessment (via interview and where possible seizure diaries) of seizure frequency and other treatment related phenotypes every 3 months. The recruitment period will span months 1-12, the observational period will span months 1-30 and analysis of data will be conducted between months 30-36 (see Figure 2 below). Target sample size is 610.

Primary objective: To determine the clinical relevance of genetic variation in predicting lacosamide responsive and non-responsive patients.

Secondary objectives: To determine the clinical relevance of genetic variation in predicting:

* Optimal dose of lacosamide
* Adverse drug reactions to lacosamide


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with partial onset seizures (simple and/or complex) with or without secondary generalization (based on 1981 ILAE seizure classification scheme)
* Over 18 and under 65 years of age at date of recruitment in to the study
* Currently undergoing pharmacological treatment for refractory partial epilepsy ('refractory' here refers to patients who continue to have seizures despite treatment (current) with two or more appropriate anti-epileptic drugs at appropriate doses)
* Deemed suitable for treatment with lacosamide (following drug guidelines)

Exclusion Criteria:

* Patients experiencing seizure type other than partial onset seizures (with/without secondary generalisation)
* Patients with a history of chronic alcohol or drug abuse within previous 3 years.
* Non refractory epilepsy patients
* Patients suffering any other clinically significant disease e.g. cancers, progressive neurological disorder, heart failure, respiratory failure etc
* Patients who are pregnant or who are intending on getting pregnant within the period of the trial.
Cerebral Bases of Arithmetics Processing

The aim of this study was to identify neural correlates involved in arthmetics processing in adults and children aged 8 to 14 with normal cognitive function. Brain area will be identified by functional magnetic resonance imaging (IRMf).


Eligibility Criteria:
Inclusion Criteria:

* children aged 8 to 14 with parents' consent
* adults aged 18 to 24
* right-handed
* affiliated to the French social security

Exclusion Criteria:

* known neurological disorders including epilepsia
* known psychiatric disorders including Attention Deficit Disorder
* birth complications needing intensive care
* central nervous system treatment
* important hearing disabilities
* not corrected impaired vision
HORMONES IN VERNAL KERATOCONJUNCTIVITIS

VKC is more common in males and tends to resolve with pubertal development. Clinical observation was not followed by an investigation that clarified whether there is a correlation between the hormonal pattern and the evolution of the disease, in particular it is not defined whether there is a correlation between the hormonal pattern and the resolution of the disease.

This study aims to evaluate the hormonal pattern in patients with VKC and, in particular, the possible role of these hormones in the resolution of this condition in puberty.

The study presents a retrospective and prospective transversal observational design, non-pharmacological, monocentric, non-profit.

It is based on the collection of clinical, laboratory and therapy data on databases of patients affected by Vernal keratoconjunctivitis.

Participation in the study will be proposed to parents of patients with VKC over 10 years of age at puberty (B2 according to Tanner for females and G2 according to Tanner for males), based on endocrinological evaluation. Patients, differentiated by gender, will be divided into two groups: patients with active VKC and patients with resolved VKC. Both study groups will be offered a blood sample to determine the serum levels of LH, FSH, estradiol, DHEAS, androstenedione, total testosterone, SHBG, DHT, 17OH-progesterone, TSH-R, albumin, ACTH and cortisol. In postpuberal females, the sample must be taken in the first 5 days of the menstrual cycle.

This study provides for the enrollment of patients diagnosed with VKC followed at the Allergy Outpatient Clinic of the UOSD Pediatrics High Intensity of Care - IRCCS Ca 'Granda Foundation Ospedale Maggiore Policlinico di Milano. The source documentation of the data will be the medical record and the reports of the examinations, provided for by the study, performed at the Institute. On the same day, a blood sample and a pubertal stage assessment will be performed. An allergy / ophthalmological examination for VKC will be carried out only if it had not been performed in the 12 months prior to the execution of the blood sample. There is no follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of VKC assessed by an allergologist or ophthalmologist over 10 years of age

Exclusion Criteria:

* Presence of pre-existing pathologies of the endocrine system.
Expanding Comparative Effectiveness Research (CER) Capability Through Complex Patient Relationship Management

The investigators are testing whether patients with diabetes can communicate with our health care system through text messaging. The investigators will look at how often they respond to prompts for blood pressures, blood sugars, and step counts. The investigators will also see if they come in for lab tests when prompted by text message. Also, for patients overdue for medication refills, the investigators will ask them why they have not yet called for the refill.

Patients will be sent text messages through a software interface, the Patient Relationship Manager (PRM). A registered nurse will also use PRM to receive incoming responses. Tasks will be created for her to outreach to patients who have out of range text responses or poor response rates. This intervention if a feasibility study to see if patients can communicate with the investigator's health care system and potentially utilize PRM to better manage their diabetes.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years
* diabetes
* own a cell phone
* 2 primary care visits in last year
* English or Spanish speaking

Exclusion Criteria:

* End-stage disease with estimate of less than 6 months to live
E-learning to Prevent Wrong Site Surgery in Anesthesia

The purpose of this observational study is to assess the efficiency of an e-learning in order to put into practice some preventive measures to avoid wrong site surgery during anesthesia.

Before the study, the investigators selected 7 preventive measures to avoid wrong site surgery during regional anesthesia combined or not with general anesthesia . These measures were learned to the entire anesthesia team (nurse, resident and anesthesiologist) during conventional meetings. An initial evaluation of the application of these measures will be carried out before the introduction of e-learning. This assessment will be conducted by nurses without the knowledge of the anesthetic team evaluated. After this initial evaluation, e-learning will be broadcast on the hospital intranet. Then a second evaluation of the application of the preventive measures will be carried out 6 month and 1 year after the introduction of e-learning.

Eligibility Criteria:
Inclusion criteria:

* patient undergoing regional anesthesia with or without general anesthesia

Exclusion criteria:

* general anesthesia without regional anesthesia
* perimedullar anesthesia
* bilateral surgery
Support Via Online Social Networks to Promote Safe Infant Care Practices

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in WIC, or it not, then have either Medicaid or no health insurance
* Must be English speaking
* Must be pregnant and less than 30 weeks gestation
* Must live in the United States
* Must have regular access to Facebook and short message service (SMS) texting (mobile phone)

Exclusion Criteria:

* Not planning to live in same home as infant after birth.
* Prenatal diagnosis expected to impact on infant care practices in a manner not compatible with study goals, including contraindications to feeding any breastmilk or supine infant sleep positioning.
* Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process.
* Meets the definition of a minor according to applicable state law.
* Participants who consent to participation in the study, must complete the Agile Onboarding process before they reach 30+0 weeks gestation.
* Currently or previously received a TodaysBaby educational program (randomized to a TodaysBaby program through either the SMARTER, or SUPERSONIC study), either in their current or a previous pregnancy.