cyrilzakka/clinical-trials huggingface dataset:
A Study of Lasmiditan in Participants With Migraine

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between acute migraine attacks.

Information about any side effects that may occur will also be collected.

This study includes two study periods. Each study period requires an overnight stay in the Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up to two outpatient appointments. This study will last approximately 5-6 weeks (not including screening).

Follow-up is required four to seven days after last dose of investigational drug. Screening is required within 28 days prior to the start of the study.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Males or females with history of migraine with or without aura, as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for at least 1 year, based on medical history
* Have a body mass index (BMI) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion Criteria:

* Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan
* Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
* Have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (≤) 90 or greater than (\>) 155 millimeters of mercury (mmHg) or diastolic blood pressure ≤ to 50 or \>95 mmHg
* Have clinically significant electrocardiogram (ECG) findings, including a QT interval corrected for heart rate using QT interval corrected for heart rate using Fridericia's formula (QTcF) value \>450 milliseconds (ms) (males) or \>470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias
* Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder)
* Have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
* Have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit
Effects of Exercises in MS on Postural Control With Dual Task

Multiple sclerosis is a progressive neurological disease that associated with demyelinization and axonal damage. Decreased postural control is one of the initial symptom of disease. Improving postural control in people with neurological impairment is a common goal of physiotherapy. Doing exercises in water or land are examples for effective solutions. Pilates and aquaplyometric exercises are some of these approaches.

Performing daily activities at the same time requires dual tasking or multi tasking. Dual tasking is frequently impaired in MS. The aim of the study was to determine effect of combined Pilates and Aquaplyometric exercises on postural control with or without dual task in patients with multiple sclerosis.

MS patients with decreased postural control will be enrolled eight-week, 45 minutes combined Pilates and aquaplyometric exercise programme. Postural control, hand dexterity and other functional parameteres will assess besaline and at the eighth week of exercise programme by the physiotherapist. Postural control will evaluate with and without dual task.

Eligibility Criteria:
Inclusion Criteria:

* being over 18 years old
* ability to walk independently or with single walking aid
* having stable symptoms

Exclusion Criteria:

* being acute or unstable phase of disease
* having EDSS score\>6
* insuitable for the pool (incontinance, dermatological disease etc.)
fMRI Investigation of Depression in Patients With Epilepsy

Depression is very common in epilepsy. Depression is the strongest predictor of poor quality of life in patients with epilepsy. The biological basis for depression in epilepsy remains poorly understood. This study uses functional MRI (fMRI) to examine brain response to emotional and non-emotional stimuli in healthy control subjects and in patients with epilepsy who are either depressed or not depressed. Results from this study will contribute to a better understanding of depression in epilepsy, which may eventually inform development of better treatment modalities..


Eligibility Criteria:
Enhancing Epilepsy Management With Precision Deep Brain Stimulation

The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study.

Aim 1: To objectively monitor epilepsy burden with the provided sensing capabilities of the DBS leads by quantifying the association between neuronal activity and seizure frequency

Aim 2: To use the neuronal activity to inform programming of DBS for patients with epilepsy, and assess the impact on patient and caregiver quality of life and hospital costs.

Epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures that affects millions of individuals worldwide and poses a significant burden on their quality of life. Despite considerable advancements in treatment strategies, approximately one-third of patients are considered to have drug-resistant epilepsy. Patients with drug-resistant epilepsy frequently visit the emergency room, are hospitalized regularly, and have many seizure-related injuries. Deep brain stimulation (DBS) offers a unique treatment option by delivering precise electrical pulses with surgically implanted electrodes to the specific brain regions responsible for seizures, disrupting the seizure pathways. Long-term favorable findings showing significant seizure reduction at five-year post-implantation for patients who otherwise have no treatment options have convinced many centers to incorporate DBS into their healthcare practise.

For assessing the treatment response in epilepsy, healthcare providers are dependent on patient-reported seizure diaries. Recent research in DBS has focused on the biological implications of neuronal recordings through the implanted electrodes. These signals offer objective insight into brain activity, specifically epileptic burden, and offers potentially predictive capabilities. Current research focuses on whether the sensing capabilities of DBS can provide reliable seizure burden detection, and whether this can be achieved with less demand on the patient.

In this prospective observational cohort study, the researchers aim to improve the impact of DBS treatment on the seizure burden and quality of life of patients diagnosed with drug-resistant epilepsy in Atlantic Canada. This will be done by investigating the neural activity underlying epileptic events as a representation of epileptic burden, affording the opportunity to tailor DBS interventions with more precision and efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Patients qualifying for deep brain stimulation on the basis of drug-resistant epilepsy
* Informed consent

Exclusion Criteria:

* Lack of consent
* Electrical or other devices that preclude the performance of an MRI for pre-operative imaging
Vitreous Fragments Length After Pars Plana Vitrectomy

To measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates

Pars plana vitrectomy consists in the removal of vitreous obtained with a vitreous cutter. The instruments attracts vitreous in its port through active suction and cuts with a blade at different cut rates. There is no consensus as to which cut rate would be ideal in order to minimize traction, neither there is agreement on whether increasing cut rates generate shorter collagen fragments or the fluid turbulence creates unpredictable flows at the port generating fragments of different length.

The investigators plan to gather vitreous cut at 1,000, 2,000, 4,000, 8,000 and 16,000 cuts per minute and measure vitreous collagen average length

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing pars plana vitrectomy for:
* macular pucker
* macular hole-
* retinal detachment
* age \>18

Exclusion Criteria:

* unwilling to participate
* previous trauma
* vitreous haemorrhage
Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent Places

A protocol for recording cardiopulmonary arrest (CRP) data in the in-hospital surgical block has been designed with the Utstein template model. The database is hosted in accordance with European legislation on patient data protection.

Invitation to participate will be sent to Spanish hospitals in the first phase. Once this is over, participation in the registry will be opened to European hospitals. Survival and neurological outcome will be evaluated upon discharge from the surgical block. The study design is a prospective observational registry of a cohort of subjects who have suffered a CRP in the surgical block.

Patients will be enrolled by participating researchers from Spanish hospitals that have a pediatric surgery service, in addition to surgery on adult patients, who will collect and upload the data into a protected web-based electronic database. The recorded variables are grouped as follows: patient variables, hospital data, data prior to cardiopulmonary arrest (CRP), data from cardiopulmonary arrest (CRP), data after cardiopulmonary resuscitation (CPR), results of cardiopulmonary resuscitation (CPR). For the study, cardiorespiratory arrest (CRP) is defined as cardiac arrest for which resuscitation is attempted with chest compressions, defibrillation, or both. In the pediatric population it may include patients receiving chest compressions for poor perfusion in the setting of severe bradycardia.

The inclusion criteria are: all patients older than 1 month who undergo sedation, anesthesia or monitored anesthetic surveillance performed by an anesthesiologist and suffer cardiorespiratory arrest in the surgical block. Subsequent episodes of cardiorespiratory arrest (CRP) in the same subject may be included. Exclusion criteria: hospitals that do not have a pediatric surgery service in their service portfolio, patients being treated with extracorporeal circulatory support (ECMO, extracorporeal circulation pump or ventricular assistance) at the time of cardiorespiratory arrest. Patients who suffer cardiac arrest and require any type of extracorporeal circulatory support for the recovery of spontaneous circulation after performing the corresponding cardiopulmonary resuscitation (CPR) will not be eliminated.

The data collection period will be valid for 48 months, starting on June 1, 2025 and the last day being June 1, 2029.

Eligibility Criteria:
Inclusion Criteria:Patients over 1 month of age who suffer cardiac arrest in the surgical unit and/or in those places where some type of monitored surveillance technique, sedation and/or anesthesia is performed by an anesthesiologist or internal resident specialist (EIR) of the specialty of Anesthesiology.

Exclusion Criteria:

* Patients with procedures defined as major outpatient surgery in the hospital where the cardiac arrest occurs.
* Patients in supportive treatment extracorporeal circulatory system (ECMO) or ventricular assist at the time of cardiac arrest.
Treatment of Malignant Glaucoma by Anterior Vitrectomy From Two Different Approaches

To compare the surgical outcomes of treating phacoemulsification with intraocular lens implantation combined with goniosynechialysis (Phaco-IOL-GSL) associated malignant glaucoma (MG), using different incision sites in anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).


Eligibility Criteria:
Inclusion Criteria:

* MG was diagnosed based on the presence of a central and peripheral shallow anterior chamber with normal or elevated intraocular pressure (IOP).

Exclusion Criteria:

* The diagnosis was made only after confirming the absence of choroidal detachment or hemorrhage and posterior segment mass lesion, using B-scan ultrasonography or ophthalmoscopy
Selenoprotein and Renalase Blood Levels in Patients With Hypertensive Heart Disease and Obstructive Sleep Apnea

The aim of the study is to determine whether selenoprotein activity and blood renalase level correlate with subclinical hypertensive heart disease and obstructive sleep apnea. The correlation will be assessed using selected electrocardiographic, ultrasound and laboratory indicators.

The study will be conducted in the Department and Clinic of Internal Medicine, Occupational Diseases, Hypertension and Clinical Oncology at Borowska 213 street in Wroclaw. This decision follows the high percentage of people with obstructive sleep apnea and hypertension among those hospitalized in the Clinic and also the wide availability of research tools in the hospital.

150 more patients with hypertension and obstructive sleep apnea will be included in the planned observational study.

The study is observational, research procedures are non-invasive and no additional medical experiment is planned. The study was approved by the Bioethics Committee of the Wroclaw Medical University.

Patients enrolled in the study will be asked to share the results of their previously performed examinations or, in case they do not have any, new examinations will be performed to complement the diagnostic process of hypertension and obstructive sleep apnea.

The planned procedures include: medical interview, physical examination with basic anthropometric measurements (age, height, body weight); biochemical tests including blood selenium, selenoproteins, renalase and creatinine levels; total antioxidant status (TAS), 24-hour Holter electrocardiography, polysomnography, ultrasound assessment of peripheral vascular endothelial function and echocardiography.

Laboratory tests will be performed using commercially available standardized tests. The levels of selenoproteins, renalase and creatinine in the blood, as well as TAS will be determined by ELISA (Enzyme-linked immunosorbent assay) in accordance with the instructions. Blood selenium level will be measured by means of atomic absorption spectrometry (AAS). 24-hour Holter ECG monitoring will be performed using a Lifecard CF recorder, followed by an analysis of the record by the Impresario Solo system (Delmar Reynolds, Hertford, UK). Ultrasound examination will be performed using the ProSound Alpha 6 (Aloka Inc, Tokyo, Japan).

Eligibility Criteria:
Inclusion Criteria:

* arterial hypertension

Exclusion Criteria:

* age \<18
* pregnancy
* refusal to participate in the study
A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer

The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder,urethra,ureter or renal pelvis
* Measurable disease by CT or MRI
* Progression or recurrence after treatment
* i) With at least 1 platinum-containing chemotherapy regimen for metastatic or surgically unresectable locally advanced urothelial cancer, or
* ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer
* Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases
* Tumor tissues (archived or new biopsy) must be provided for biomarker analysis
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

* Subjects with active cancer that has spread to the central nervous system
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
* Subject with active, known or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
* Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

Exclusion laboratory criteria:

* Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
* Known history of testing positive for human Immunodeficiency virus (HIV) or known acquired Immunodeficiency syndrome (AIDS)

Other protocol-defined inclusion/exclusion criteria apply
Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).


Eligibility Criteria:
Inclusion Criteria:

* Must sign an Informed Consent document;
* Current wearer of commercial DAILIES TOTAL1® contact lenses;
* Have spectacles in current prescription available to be worn in conjunction with the investigational product;
* Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
* Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Eye injury in either eye within 12 weeks prior to study enrollment;
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* History of herpetic keratitis, refractive surgery or irregular cornea;
* A pathologically dry eye that precludes contact lens wear;
* Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
* Monocular (only 1 eye with functional vision);
* Other protocol-specified exclusion criteria may apply.
A Study of Vedolizumab in Adults With Crohn's Disease (CD)

The main aim of this study is to see if adults with CD treated with vedolizumab have less symptoms and inflammation of the bowel assessed by ultrasonography.

Participants will be treated with vedolizumab according to their clinic's standard practice.

This is a non-interventional, prospective study of participants with moderately to severely active CD who are initiating treatment with vedolizumab according to the current summary of product characteristics (SmPC) in the real world setting.

The study will enroll approximately 100 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

Participants with CD

This multi-center study will be conducted in Canada, Italy, and Israel at specialized gastroenterology centers. The overall duration of the study will be 18 months.

Eligibility Criteria:
Inclusion Criteria:

1. Has moderately to severely active CD with a BWT of \>3 mm, based on IUS performed within the previous 4 weeks from baseline.
2. Newly initiating IV vedolizumab induction treatment in accordance with the current SmPC either at enrolment or within 2 weeks after enrolment (switch to SC is acceptable at maintenance treatment stage).

Exclusion Criteria:

1. Prior history of intolerability, hypersensitivity to the active substance or to any of the excipients of vedolizumab.
2. Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML).
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Current or previous participation in an interventional clinical trial for CD within the past 30 days, or planned to be enrolled in an interventional clinical trial for CD.
5. Ongoing or planned pregnancy or breastfeeding participants.
6. Active perforating complications or significant current strictures (assessed by IUS, with or without pre-stenotic dilatation) as per clinical judgement.
7. Characteristics precluding IUS visualization of affected bowel segments or normal BWT of \<=3 mm for all segments.
Standardized Clinical Application of Antibacterial/Anitifungal Drugs

The purpose of this real world study is to observe the clinical status for standardized using of antibacterial/anitifungal drugs in patients with infection,and to evaluate the efficacy and safety of anti-infection therapy.

This study is a prospective,multicenter,non-interventional real-world study.The purpose of this study is to observe the clinical status of infection patients under standardized application of antibacterial/anitifungal drugs,and to evaluate the efficacy and safety of anti-infection treatment.

This study plans to enroll 5000 hospitalized patients (≥ 18 years old with infectious disease),who take antibacterial/anitifungal drugs for more than 3 days. Patients mainly come from ICU,Respiratory Department and Hematology Department.

The clinical data collection is divided into five parts,including Baseline,3rd and 7th day after the first dosing of antibacterial/anitifungal drugs,End of antibacterial/anitifungal drugs treatment (EOT),14th day after EOT. The collected clinical data cover general characteristics,condition assessment and severity evaluation,pathogenic diagnosis,the use of antibacterial/antifungal drugs,antibacterial/antifungal drugs-related adverse events,et al.

After completing the collection of case data, the proportion analysis, efficacy evaluation and safety evaluation for the standardized application of antibacterial/antifungal drugs will be carried out.

Eligibility Criteria:
Inclusion Criteria:

- Hospitalized patients (≥ 18 years old)

-≥ 3 days receiving antibacterial/antifungal drugs therapy

Exclusion Criteria:

-
A Trial on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip

Developmental dislocation of the hip is a common disease in children, and its incidence in China is about 9 ‰.The pathological changes of it is complex. The reluxation , subluxation and residual deformity and other complications are relatively common after treatment. The X-ray appears great acetabular index and wide medial gap , small central-edge angle. As there is no effective methods for treating such complications , investigators conducted this trial to find and prove optimal intervention time and treatment programs.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria consists of patients with large acetabular index ,small central-edge angle after reduction in developmental dislocation of the hip

Exclusion Criteria:

* Age \>14 years
* Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth.
* Patients are complicated with cerebral palsy, multiple joint contractures disease.
* Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
* Parents refused further treatment.