cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)

This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV.

This is a Phase 1/2a, open-label, multiple-cohort, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of IVT ABI-110 (AAV2.N54-VEGF-Trap) injection in subjects with wAMD), including symptomatic macular PCV.

This trial will include a screening period, confirmation of response to EYLEA (aflibercept), single administration of ABI-110, and follow-up period of 104 weeks after IVT ABI-110 injection.

Eligibility Criteria:
Key Inclusion Criteria:

* General:

  1. Must be willing and able to provide written, signed informed consent.
  2. Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent

     Study eye:
  3. Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center
  4. The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening.
  5. BCVA ≤ 20/32 and ≥ 20/250 (≤ 78L and ≥ 30L ETDRS letters)
  6. History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment
  7. Response to anti-VEGF at trial entry
  8. Must be pseudophakic

Key Exclusion Criteria:

* Study or Fellow Eye:

  1. Prior gene therapy, either eye
  2. Any active ocular/intraocular infection or inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis) or history of idiopathic or autoimmune-associated uveitis, either eye
  3. History of retinal disease other than wAMD or PCV, study eye
  4. Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye.
  5. History of (or active) retinal detachment, study eye
  6. Uncontrolled glaucoma (defined as IOP \> 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye
  7. History of intravitreal therapy, (other than anti-VEGF therapy) such as intravitreal steroid injection or investigational product, in the 6 months prior to screening, study eye
  8. Any prior treatment with photodynamic therapy or laser photocoagulation, study eye
  9. History of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.
Kinect Sensor in Cerebral Palsy Children Phase 2.2

There are 3 phase of the study. This registration is phase 2.2. This registration will conduct a randomized controlled trial study in the cerebral palsy children. Due to the limitation of period of time of grant, we changed the study type into pilot-randomization. Our new method of study will collect all of our study which previously separated into pilot and randomized controlled trial in just only one study "pilot-randomization".


Eligibility Criteria:
Inclusion Criteria:

* Spastic cerebral palsy aged 10-15 years
* Sufficient cognitive/attention capacity to understand basic instructions
* Can cooperate with the therapist for short period of time during training
* Manual Ability Classification System (MACS) 2-3
* Zancolli classification of the affected upper extremity was grade I-II.
* Give the informed consent

Exclusion Criteria:

* Inability to understand the instruction and follow the task
* Severe comorbidities, visual or auditory impairment
* Had history of Botulinum toxin injection on the affected upper extremity for last 6 months or receive the injection during the study time
* Other treatment options planned on the affected upper extremity during the study time
* Wear daytime orthosis on the affected limb
* Zancolli classification of the affected hand was grade III.
* Got an epilepsy or convulsive condition
* Denied to give the informed consent or continue the study
Cognitive Training in Children With Attention Deficit/ Hyperactivity Disorder (ADHD)

The purpose of this study is to determine the effect of computer program C8 on specific cognitive functions, symptoms and functional outcome compared to treatment as usual in children with ADHD. Furthermore, if the effect is sustained 12 and 24 weeks after training. In addition, it will be investigated, whether younger children benefit more from training than older children.


Eligibility Criteria:
Inclusion Criteria:

1. ADHD- diagnosis
2. age 6-13 years
3. Patient has access to computer og internet from home
4. Informed consent

Exclusion Criteria:

1. Comorbidity: conduct disorder, autism spectrum disorders, depression, or schizophrenia
2. Head trauma or neurological disease
3. Intelligence quotient (IQ) \< 80
4. Motoric or perceptual handicap
5. Medical disease requiring treatment
6. No informed consent
Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation

The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF.


Eligibility Criteria:
Inclusion Criteria:

1. Patients agreement of consent
2. Patients who age more than 19
3. patients who undergoing catheter ablation of atrial fibrillation
4. Patients who are not vascular disease

Exclusion Criteria:

1. patients who do not agree with study inclusion
2. persistent AF
3. Patients with vascular disease or venous anomaly
4. Patients with structural abnormality of the heart
SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea

This is a prospective, non-interventional, open-label, multi-centre study. It will provide additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical settings.

Study Design:

regulatory Post Marketed Surveillance study

Eligibility Criteria:
Inclusion criteria:

* Age \>= 18 years at enrollment
* Patients who have been started on Pradaxa in accordance with the approved label in Korea
* Patients who have signed on the data release consent form

Exclusion criteria:

* Patients with previous exposure to Pradaxa
* Clinically significant bleeding
* Increased risk of bleeding due to following diseases;

  * Recent gastrointestinal ulceration
  * Recent intracranial or intracerebral bleeding history
  * Intraspinal or intracerebral vascular abnormalities
  * Recent brain, spinal or ophthalmic surgery
  * Recent brain or spinal injury
  * Known or suspected oesophageal varices
  * Arteriovenous malformations
  * Vascular aneurysms
  * Presence of malignant neoplasms at high risk of bleeding
* Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from Pradaxa or when UFH is given at doses necessary to maintain an open central venous or arterial catheter
* Severe renal impairment (CrCl \< 30mL/min)
* Concomitant treatment with oral ketoconazole or dronedarone
* Patients hypersensitive to dabigatran or dabigatran etexilate or to any ingredient in the formulation
* Prosthetic heart valve replacement
* No creatinine clearance collected within at least one year prior to enrollment
* Current participation in other clinical trials
Rapamycin-Eluting Stents With Different Polymer Coating to Reduce Restenosis (ISAR-TEST-3)

The purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent platforms to reduce coronary artery reblockage after stent implantation

Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neointimal proliferation, the main cause of lumen re-narrowing after stent implantation. At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with DESs. Based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of polymers in DESs, which have a proinflammatory and prothrombinogenic potential, and sometimes may induce a hypersensitivity reaction. This trial will compare the anti-restenotic efficacy of the permanent polymer (PP), biodegradable polymer (BP) and polymer-free (PF) rapamycin-eluting stents in patients with coronary artery disease. Cypher stent (PP) is a stainless steel stent coated with sirolimus with use of permanent polymers while the ISAR stent is a rough surface stainless steel stent which allows not only polymeric coating (for example biodegradable polymer, BP ISAR stent) but also coating without the need of polymer (PF ISAR stent) in the cath lab.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels.
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

* Target lesion located in the left main trunk or bypass graft.
* In-stent restenosis.
* Cardiogenic shock.
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Known allergy to the study medications: aspirin, clopidogrel, rapamycin, stainless steel.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.
Evaluation of the Efficacy of a New Specific Infant Formula in Case of Functional Constipation

This study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a superiority, double-blind, randomized, placebo-controlled trial.

The study comprises a selection period of 1 week where the eligibility of the infant to participate in the study will be evaluated. Once his/her participation is confirmed, the tested formula will be compared to a standard formula during a 2-month study period followed by an optional follow-up period of 2 months where only the tested formula will be used.

Eligibility Criteria:
Selection Criteria:

Infants presenting with constipation according to modified Rome IV criteria, i.e. they must present with 1 month the following:

* Infants without spontaneous stools or with at least one painful or hard spontaneous bowel movement per week AND
* At least one of the following:

  * Two and fewer spontaneous defecations per week
  * History of excessive stool retention
  * History of large-diameter stools

Non-selection Criteria (non-exhaustive list):

* Preterm birth (\<34 weeks of gestational age)
* Exclusively or partially breastfed infants within 3 days prior to visit V-1
* Infants with organic causes of constipation (e.g. coeliac disease, paediatric intestinal pseudo-obstruction, hypothyroidism, spina bifida, anorectal malformation or Hirschsprung's disease) or constipation secondary to endocrine, metabolic, neurologic or autoimmune disorders, surgery or drugs.
* Infants on laxative treatment
* Infants taking drugs that are known to affect gastrointestinal motility as well as any probiotic supplements
* Infants treated with antibiotics
* Infants with a known allergy to one of the formula ingredients (e.g. cow's milk proteins...)
* Infants with anaemia who have been prescribed an oral iron supplement as treatment
* Infants participating in another trial
* Infants presenting with any other situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the infant

Inclusion Criteria:

* Infants having completed the selection period and still compliant with non-selection criteria
* Infants being constipated according to modified Rome IV criteria based on information recorded in parents' diary during the week preceding visit V0 (inclusion visit)
Efficacy of Oral Ibandronate in Osteoporosis

There has been no comparative data between oral ibandronate and oral ibandronate plus active vitamin D


Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic patients who want to take oral ibandronate

Exclusion Criteria:

* Patients who are allergic to oral ibandronate or vitamin D Patients who have not taken oral ibandronate for the last 2 years
The Use of cineMRI to Evaluate Botox in Patients With Medication Refractory Overactive Bladder

With the goal of providing improved treatment to patients with overactive bladder symptoms (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum toxin on bladder physiology. The investigators will specifically aim to assess the physiological mechanism by which intravesical botulinum alleviates urgency and urge incontinence symptoms in women with OAB refractory to medical therapy.

Overactive bladder (OAB) is defined by the International Continence Society as urinary frequency and urgency, with or without urge urinary incontinence. The burden of OAB on the American public is immense in both human and financial terms. Despite this burden, there is a lack of effective diagnostic and treatment modalities for OAB. Other than two-dimensional video urodynamics, which has remained relatively unchanged for decades, there is a lack of diagnostic modalities that will allow investigators to characterize subtypes of OAB and measure the effects of treatment on bladder physiology. Newer imaging techniques are desperately needed to help guide treatment and predict and improve outcomes of different treatment modalities. Intravesical botulinum toxin is a minimally invasive treatment for OAB refractory to medical therapy. Despite the widespread use of intravesical botulinum toxin injection for OAB refractory to medical therapy, to date the optimal placement of the drug has not been determined. Typically ten injections are given, either dispersed evenly across the bladder or in two rows of five injections. However, it remains unknown which injection method will optimize outcomes and reduce the risk of urinary retention after Botox®. This lack of knowledge is a direct result of the fact that there has been no mechanism to study the effect of Botox® on bladder filling and emptying in a three-dimensional fashion. CineMRI-UDS will provide this mechanism, and has the potential to significantly improve care and urologic education by enhancing the understanding of bladder physiology.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 21 years or older
* Overactive bladder symptoms

Exclusion Criteria:

* Age less than 21 years
* Inability to give informed consent
* Claustrophobic
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction

The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction

Exclusion Criteria:

* Types of pulmonary hypertension other than group 2.2 of Dana Point Classification
High-sensitivity C-reactive Protein and United Kingdom Prospective Diabetes Study (UKPDS) Risk Score in Type 2 Diabetes

The UKPDS risk score is recommended to assess global risk for future coronary heart disease (CHD) events in primary prevention. Recently, high-sensitivity C-reactive protein (hsCRP) has emerged as a strong independent risk factor for CHD. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising imaging technique for the evaluation of vascular inflammation that reflects vulnerable atherosclerotic plaque.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes

Exclusion Criteria:

* Myocardial infarction, unstable angina, stroke, peripheral artery disease, or cardiovascular revascularization
* Resting blood pressure ≥160/100 mmHg
* Malignancy, or severe renal or hepatic disease
* Participants were free of any lipid-lowering therapies and postmenopausal hormone replacement therapy at least the 6 month period prior to enrollment
* History of inflammatory condition or those taking medications that might affect inflammatory status within 6 months
Extracorporeal Shock Wave Therapy Treatment for Nocturnal Leg Cramps

Nocturnal leg cramps (NLCs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. The investigator performed extracorporeal shock wave therapy (ESWT). This experiment used a randomized experiment to assess the immediate, short-term and long-term effects of extracorporeal shock wave therapy on patients with nocturnal leg cramps.

Nocturnal leg cramps (NLCs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. The pathophysiology of nocturnal leg cramps is unclear, but it is generally considered to be associated with excitability lower motor neurons, sleep posture at night, leg muscle fatigue, nerve disability or damage (eg, Parkinson's disease), metabolic diseases (eg : hyperphosphatemia). Generally, quinine or magnesium oxide is the most commonly used pharmacological treatment. The common non-drug treatments are stretching exercise, massage or hot therapy, but there is not enough evidence to indicate which treatment is specific effective.

In a previous study, they proposed that nocturnal leg cramps may be associated with myofascial trigger points (MTrPs) of the gastrocnemius. Other studies have also proposed that extracorporeal shock wave therapy (ESWT) applying to the MTrPs of the upper trapezius muscle could improve cervicogenic headache. We will conduct a randomized parallel study to investigate the efficacy of ESWT on nocturnal leg cramps. Participants will be randomized into two groups: one is only general physical therapy (gPT) and the other one is ESWT + gPT.

The outcome measurement tools including the frequency of nocturnal leg cramps, visual analog scale (VAS), pain pressure threshold (PPT) and muscle tone in the gastrocnemius, range of motion of knee and ankle, and quality of sleep questionnaire were used to compare two groups with regard to the pain intensity, quality of sleep, and overall satisfaction in subjects with nocturnal leg cramps.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 20 y/o patients with NLCs: (1) 4 times/week, last 2 weeks; (2) Occurred in nighttime or resting time of daytime
2. Patients with MTrPs on gastrocnemius (According to the diagnostic criteria proposed by Simons \& Travell)

Exclusion Criteria:

1. (1) Taking medication for leg cramps (eg. Quinine, Magnesium oxide); (2) Other drugs that affect research and evaluation (eg. diuretics, statins, calcium channel blockers, anticonvulsants)
2. Congenital lower limb musculoskeletal diseases, Lower limb or spine surgery
3. Uncommunicated or cognitive impaired
4. Patients refused to be recruited
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)

This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.

The duration of treatment is 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation