cyrilzakka/clinical-trials huggingface dataset:
Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.

Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.

Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.

Eligibility Criteria:
Inclusion Criteria:

* The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.
* Participants of both sexes aged 14 years or more.
* Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.
* Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.
* Participants who do not agree to participate and/or do not sign the informed consent form.
* Participants who do not comply with medical indications or do not cooperate with immunotherapy treatment.
Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations

The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. Patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery.

Over all 500 patients admitted for various intraocular surgeries will be included in the study. The study will be prospective, double blind, placebo controlled, and randomized. Patients will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. For patients treated with povidone iodine alone a placebo will also be given. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery. All patients will be followed for 6 weeks for symptoms and signs of infection. Bacterial and fungal culture results will be compared between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years.
* Various intraocular surgeries

Exclusion Criteria:

* Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.
A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy

The purpose of this study is to evaluate both the safety and tolerability of up to 4 dosing cycles of TAR-200 for 21 days per dosing cycle in the induction period.


Eligibility Criteria:
Inclusion Criteria:

* Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder
* Participant must have been as fully resected as possible per the physician's judgment
* Participants must be deemed unfit for RC due to comorbid conditions with a risk of mortality
* Participants must refuse or be deemed ineligible for cisplatin-based chemotherapy
* Participant must refuse or not be eligible for radiotherapy

Exclusion Criteria:

* Other active malignancies
* Presence of any bladder or urethral anatomic feature that in the opinion of the Investigator may prevent the safe placement, indwelling use, or removal of TAR-200
* Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed)
* Evidence of bladder perforation during diagnostic cystoscopy
* Concurrent clinically significant infections as determined by the treating Investigator
rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients/ Chronic Labyrinthitis

Falling is one of the most common consequences of vestibular dizziness. Most of patients with vestibular dysfunction suffer from balance disorders, postural instability and vertigo that may lead to life threating complications as fractures and brain injuries. Non invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been investigated as therapeutic interventions for various neurological disorders like motor deficits and balance disorders after various neurological deficits. To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) added to supervised vestibular rehabilitation program on balance and postural stability in patients with vestibular dizziness

The subjects of both genders with age 40 to 65 will be allocated randomly into two equal groups A and B. Group A Outcomes measure will include : Berg balance scale, computerized dynamic posturography (CDP) . Assessment will be done before and after treatment sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with peripheral vestibular disorders from audiologist or neurologist.
2. The patient's age will be ranged from forty five to seventy years old.
3. Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
4. Symptoms of vertigo and nystagmus lasting from seconds to one minute.
5. Vertigo that arises from changes in head position related to gravity.
6. Patients who experienced symptoms for more than three months (chronic patients)
7. Patients were selected to be ambulant.
8. Patients suffer from balance disturbance with low risk falling (41-56) and moderate risk falling ranges (21-40) according to berg balance scale.
9. All patients were medically stable, controlled with medical drugs for at least three months and failed to medical treatment with no other physical, mental or cognitive disorders.

Exclusion Criteria:

1. Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").
2. Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").
3. Previous surgery of the ear.
4. Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
5. Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension \>190/110...).
6. Pacemaker or other implanted electrically sensitive device.
7. Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests).
8. Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression....).
9. Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).
10. Alcohol abuse.
11. Epilepsy.
Protein Supplementation in Thiazide-induced Hyponatremia

High blood pressure is very common among elderly Canadians. Clinical trials show clear benefit from lowering blood pressure in hypertensive elderly patients. These trials also demonstrate safety for several classes of blood pressure lowering drugs including water pills. However, water pills (thiazide diuretics) used for treatment of hypertension, can cause low sodium (hyponatremia), a significant clinical problem mainly among elderly and very elderly. Causes are age related decrease in kidneys' ability to get rid of water and low salt coupled with high water intake. A standard approach to treatment is lacking since higher salt intake may worsen hypertension, and lower water and higher protein intake is difficult to understand and actually implement. 'Nepro' is a nutritional drink high in protein, and low in potassium and sodium. It is used frequently as a dietary supplement in patients with kidney disease specifically for low sodium and high protein content. The high protein content in Nepro can help the kidney get rid of excess water, and the low sodium and potassium content will make this a safe option to use. Hence investigators propose a proof-of-concept trial on an easy to understand and administer, and relatively affordable solution to this issue. It could be summarized in one sentence: "Will a bottle of Nepro a day keep thiazide-caused hyponatremia and the doctor away?"


Eligibility Criteria:
Inclusion Criteria:

* Elderly (\>65 years old)
* with diagnosed hypertension (HTN) treated with thiazide (hydrochlorothiazide) or thiazide-like (chlorthalidone and indapamide) diuretic and
* mild to moderate hyponatremia (Plasma sodium concentration 125-133 mmol/L).

Exclusion Criteria:

* Pregnancy
* estimated glomerular filtration rate (eGFR) \<45 ml/min/1.75 m2,
* Other causes of hyponatremia (liver cirrhosis, uncontrolled hypothyroidism, adrenal insufficiency)
* unable to provide informed consent;
* patients with generalized volume overload who may require immediate changes in diuretic therapy (at the discretion of treating HTN specialist);
* patients taking drugs which may interfere with urinary sodium excretion (such as carbamazepine, loop diuretics, potassium sparing diuretics, mineralocorticoid and glucocorticosteroids, selective serotonin receptor inhibitors, tricyclic antidepressants, amiodarone, and lithium);
* patients with moderate to severe hyponatremia (Plasma sodium concentration \< 125 mmol/L) who may require immediate discontinuation of the thiazide diuretic .
Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya

This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.

The biologic basis that determines disease progression in multiple sclerosis (MS) patients remains to be defined. We propose that a long term study of patients where inflammatory activity of the disease is expected to be controlled on treatment, will identify patients into cohorts of those whose disease is deemed to be stable with those patients whose disease has been deemed to progress. Once the two groups have been identified, it will then be possible to assess whether there are differences in biologic markers between the two groups. These markers would then have the potential to be used to monitor disease progression or be predictors for patient response to drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* Deemed by the subject's treating physician to be a suitable candidate for Gilenya therapy in accordance with the Canadian Product Monograph for Gilenya
* has an overall EDSS not above 7.0
* is not currently receiving Gilenya
* is able to perform adequately for EDSS assessment and cognitive tests
* is able to undergo a MRI
* is able to provide blood samples

Exclusion Criteria:

* is over 65 years of age and under 18 years of age
* has less than 4 weeks of discontinuation with steroid treatment for a relapse.
Comparison of WaveLight Analyzer and Alcon LadarWave

Comparison of repeated WaveLight Analyzer and Alcon LadarWave measurements in phakic and pseudophakic eyes.


Eligibility Criteria:
Inclusion Criteria:

* healthy eyes or eyes with the study conditions

Exclusion Criteria:

* age \< 18, eye disorders other than mentioned above, participation in any other study,
Study of Clinical Performance of Corneal Topography Measurement Using an Optical Biometer

The purpose of this study is to quantify in-vivo repeatability of a new corneal topography measurement mode of an optical biometer, and the clinical performance of measurement in comparison to reference devices.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* No corneal transplants
* No corneal scar(s)
* No acute infections of the eye
* No weak fixation
* No suspected lack of compliance
* No vulnerable population
A Spanish-Language Intervention to Enhance Routine HIV Patient Care Delivery [CARE+ Spanish]

The purpose of this study is to see if a computer counseling tool helps Spanish-speaking people living with HIV to have safer sex and to do well on their HIV medicines.

Latinos are the fastest-growing group with some of the largest health disparities including HIV. Barriers including language are associated with lower antiretroviral therapy (ART) adherence seen among Latinos. There are no evidence-based interventions (randomized trials that significantly reduced viral load and HIV transmission risk to sexual partners - 'positive prevention') delivered in Spanish in routine clinical practice. Our computerized counseling tool (CARE+) in a phase III trial of English-speaking adults increased ART adherence and reduced viral load and condom use errors. We now propose a longitudinal effectiveness (phase IV) study to evaluate the impact of computerized counseling in audio-narrated Spanish in a busy urban HIV clinic. This 'CARE+ Spanish' proposal is responsive to 06-OD(OBSSR)-101, for new technologies to improve adherence in clinical practice. Aim 1: Adapt CARE+ Spanish for use during routine clinical visits by Spanish-speaking HIV clinic attendees using an expert panel to shorten content and add Spanish audio dialects; do usability testing (n≤8). Aim 2: Establish real-world utility of 'CARE+ Spanish'. Peer staff will recruit Spanish-speaking adults on ART who will be randomly assigned to intervention (Group A n=250) or risk-assessment control (B, n=250) for 0,3-,6-,9-month sessions; at 12-month session groups will switch to opposite arm (delayed intervention design). Linear and generalized linear mixed effects models will analyze impact on 30-day ART adherence, clinic visit adherence, HIV-1 viral load and sexual risks, and to assess whether any Group A changes are sustained at month 12, among an expected n=400 retained study participants (120 female, 280 male). Aim 3: Explore cultural acceptability of tool among clients and clinic providers. Conduct qualitative exit interviews with patients (n=75) to assess technology uptake factors, cultural/linguistic acceptability, and suggestions for ongoing use among older vs. younger, and US-born vs. foreign-born Latino groups. Conduct two focus groups with providers (n≤30) to assess perceived technology barriers/facilitators. Analysis will identify factors affecting acceptability, utilization, and impact. Technology tools like CARE+ present significant opportunities to bridge the health promotion delivery gap, especially if linguistically adapted for often-neglected groups such as Latinos (15% of the US population).

Eligibility Criteria:
Inclusion Criteria:

* Hispanic birth or ancestry
* Speaks Spanish (mono- or multi-lingual)

Exclusion Criteria:

* Lack of fluency in Spanish
* Thought disorder that precludes participation
* Inability to give informed consent due to altered mentation at time of enrollment (e.g., visibly inebriated or high).
Micronutrient Supplementation in Children With ASD

An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report.

Children enrolled in Oak Hill School will enroll in this study and take micronutrient supplement once a day for 8 weeks period. Behavioral measures and metabolites taken from Dried Blood Spots (DBS) will be collected pre and post treatment. Behavioral measures will be taken again at 12 weeks, after 4 weeks of not dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, enrolled at Oak Hill School (OHS), age 6-22 and with a diagnosis of ASD.
2. ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
3. Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
2. Taking multivitamins currently and unwilling to stop during the study period
Recombinant Human Superoxide Dismutase (rhSOD) and Vascular Reactivity

Inflammation is characterised by an increased risk for cardiovascular events. Dysfunction of the vascular endothelium caused by oxidative stress might provide a mechanistic link. In acute and chronic inflammation, oxidative stress occurs when the production of reactive oxygen species \[ROS\] (including superoxide anions \[O2-\]) exceeds the capacity of the endogenous antioxidant defense systems, resulting in ROS-mediated damage. Recombinant human superoxide dismutase (rhSOD) has shown potent antioxidant properties in in-vitro and animal studies and has been tested in phase I clinical trials in humans. rhSOD could offer a therapeutic option for vascular dysfunction in diseases associated with increased oxidative stress. The investigators, therefore, want to test if the hyporesponsiveness to vasoactive drugs (norepinephrine, acetylcholine and glyceroltrinitrate) during acute inflammation by low-dose lipopolysaccharide (LPS) is due to the increased production of superoxide anions, which could be scavanged by the radical scavenger rhSOD.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 45 years
* Nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, or participation in a clinical trial in the 3 weeks preceding the study
* Evidence of hypertension, pathologic hyperglycemia, or hyperlipidemia
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs

Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.

This study will evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of needle-free Intraject sumatriptan to the same anatomic site.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects of child-bearing potential must agree to use acceptable birth control
* Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection
* Fluent in the spoken and written English language
* Provide written informed consent to participate in the study and be willing to comply with the study procedures
* Non-tobacco user for at least 12 months prior to screening (all types of tobacco, including cigars)

Exclusion Criteria:

* A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease
* Other significant underlying cardiovascular diseases including uncontrolled hypertension
* Hemiplegic or basilar migraine
* A history or diagnosis of severe hepatic or renal impairment
* A history of epilepsy or seizure or other serious neurologic condition
* A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs
* A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
* Tattoos, birthmarks or other significant skin discoloration in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation
* Pregnancy or breast-feeding
* Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing
CER-001 Therapy as a Novel Approach to Treat Genetic Orphan Diseases

The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.

Subjects will be required to have acceptable baseline 3TMRI imaging of carotid arteries. Subjects meeting all eligibility criteria will be randomized to receive CER-001 or placebo (2:1 randomization scheme). Randomized subjects will return weekly for a total of 9 infusions and then biweekly for an additional 20 infusions. 3TMRI imaging of the carotid and femoral arteries will be performed at Week 8, Week 24 (primary endpoint) and Week 48. The total study duration from randomization can range from 50 to 54 weeks for patients completing the study as designed.

Eligibility Criteria:
Main Inclusion Criteria:

* Male and female patients, aged 18 and above.
* ApoA-I \< 70 mg/dL
* Symptomatic or asymptomatic cardiovascular disease
* Diagnosis of genetically confirmed HDL-c deficiency due to defects in genes coding for ABCA1 and/or ApoA-1
* Stable doses of lipid lowering therapies for at least 6 weeks prior to baseline procedures

Main Exclusion Criteria:

* Females of childbearing potential
* Patients with LCAT mutations
* Patients who experienced recent cardiovascular or cerebrovascular events
* Hypertriglyceridemia (\>500 mg/dL)
* Severe anemia (Hgb \< 10 g/dL)
* Uncontrolled diabetes (HbA1c \>10%)
* Congestive heart failure (NYHA class II or higher)
* Contraindication for MRI scanning (e.g., implanted metal objects, claustrophobia)