cyrilzakka/clinical-trials huggingface dataset:
The Influence of Adalimumab on Cardiovascular and Metabolic Risk in Psoriasis

Psoriasis vulgaris is no longer considered as a chronic inflammatory disease restricted to the skin. Evidence has accumulated in the past that psoriasis is a chronic inflammatory systemic disease. As in rheumatoid arthritis, the chronic inflammatory process plays a central role in the pathogenesis of associated comorbidities such as diabetes and cardiovascular disease. Since several years the armamentarium of psoriasis treatment has been broadened by the availability of TNF alpha blockers. These neutralize systemic TNF alpha which not only plays a central role in the pathogenesis of psoriasis but has also been linked to inflammatory pathways in diabetes and cardiovascular disease. While a few studies have investigated the positive effects of TNF alpha blockers on associated cardiovascular disease in rheumatoid arthritis patients, no research data exist on the effects of these therapeutic agents in patients with moderate to severe chronic plaque psoriasis.

The present study aims at determining the effects of adalimumab, a potent and frequently prescribed TNF alpha blocker for the treatment of psoriasis, on different diabetic and cardiovascular risk factors in patients receiving this treatment as a remedy for moderate to severe plaque type psoriasis. The study is designed to explore whether adalimumab is capable to prevent or modulate psoriasis-associated comorbidities by blocking systemic inflammation. The effects of adalimumab will be compared with those of fumaric acids, which represent an established traditional systemic treatment option for moderate to severe psoriasis.

Study hypothesis:

Therapy with adalimumab will lead to an improvement of several parameters that reflect the risk for diabetes and cardiovascular disease in patients with chronic plaque psoriasis due to chronic inflammation. Endothelial dysfunction, as assessed by ultrasound flow mediated dilatation, will serve as primary outcome measure. Other risk factors such as blood lipids, hsCRP, IL-6, endothelial adhesion molecules, parameters of glucose metabolism and carotid intima-media thickness will be secondary outcomes.

Aim:

If adalimumab and/or fumaric acids will show a significant impact on the above mentioned parameters, these findings would offer a new perspective for the long term management of psoriatic patients and their comorbidities.

Study design: Randomized, prospective, controlled, parallel group study

Study population: 66 patients


Eligibility Criteria:
Inclusion Criteria:

* Chronic severe plaque type psoriasis (PASI \<10) requiring systemic treatment. Non-response or contraindication to previous systemic and/or light treatment
* PASI ≥ 10, BSA ≥ 10
* Age 18 - 80 years

Exclusion Criteria:

* Women of childbearing potential not taking contraceptive measures
* Pregnant or breastfeeding women
* Patients with a history or ongoing malignancy, chronic infections or autoimmune disease
* Patients with severe impairment of their general health
* Patients who are unable to understand or comply with the study protocol
A Pilot Study to Explore the Role of Gut Flora in Myasthenia Gravis

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Myasthenia Gravis.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages.
3. Diagnosis of Myasthenia Gravis by a physician

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
A Study to Evaluate Chronic Hepatitis C Infection

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.


Eligibility Criteria:
Inclusion Criteria:

* Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control
* Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL at screening
* Subject has never received antiviral treatment for hepatitis C infection
* No evidence of liver cirrhosis

Exclusion Criteria:

* Positive screen for drugs or alcohol
* Significant sensitivity to any drug
* Use of contraindicated medications within 2 weeks of dosing
* Certain predefined abnormal laboratory tests
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
RECO in the Endovascular Treatment of Acute Ischemic Stroke

Investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.

Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The Registry was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, to investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Diagnosis of acute ischemic stroke
3. Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);ASPECT or PC-ASPECT ≥ 6
4. Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting
5. The patient or the patient's legal representative is able and willing to sign the informed consent

Exclusion Criteria:

1. Isolated cervical ICA or VA occlusion;
2. No evidence of LVO on DSA.
Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects

The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham Pharmaceuticals) in a test population of 24 adult individuals under fed conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Sex: Male of Female; similar proportions of each preferred.
* Age: At least 18 years.
* Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30.

Exclusion Criteria:

* Subjects not complying with the above inclusion criteria must be excluded from the study.
* In addition, any one of the conditions listed below will exclude a subject from the study.
* History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months
* History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
* History of treatment for any gastrointestinal disorder within the past five (5) years.
* History of, or presence of, asthma
* History of peripheral vascular disease
* History of heart failure
* History of pre-existing cardiac arrythmias associated with tachycardia
* History of severe sensitivity to allergens, requiring urgent medical treatment.
* Females who are pregnant or lactating
* History of hypersensitivity to carvedilol, or any beta adrenergic blocking drug.
* Conditions upon screening which might contraindicate or require that caution be used in the administration of carvedilol, including:
* sitting systolic blood pressure below 100 mmHg, or diastolic pressure below 60 mmHg.
* Heart rate less than 60 beats per minute after a 5-minute rest in a seated position.
* Inability to read and/or sign the consent form.
* Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
* Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums,etc.) Ninety (90) days abstinence is required.
* subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
A Long Term Prospective Follow Up Study For The CATO Study (SAS30018/SER9702)

The CATO population is a very well documented population during two years. During this study patients were treated according to the CATO algorithm, after that patient were treated according to the Dutch national (GINA derived) guidelines up to 6 years of follow-up. The purpose of this prospective follow-up study is to understand the long-term effects of treatment. Therefore the measurements done at baseline (CATO part 1) are repeated after 6 years in this CATO-population (CATO follow-up).

A long term follow up study for a comparison of stepwise treatment of asthmatic children with Salmeterol/Fluticasone propionate combination product (Seretide®) and/or Fluticasone propionate (Flixotide®) based on PD20 methacholine and symptoms or based on symptoms only ("Children Asthma Therapy Optimal")

Eligibility Criteria:
Inclusion criteria:

* Any subject who has given informed consent to participate in the CATO study, and has met all the criteria required for randomisation into the clinical study may take part in this follow up study
* Under the age of 18 years Subjects and both parent(s)/guardian(s) who have given written informed consent to participate in the study
* Subjects from 18 years and older who have given written informed consent to participate in the study

Exclusion criteria:

* Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 4 weeks of visit 1
* Any use of oral/parenteral or depot corticosteroid within 4 weeks of visit 1
* Subjects who are pregnant (a pregnancy test can be performed at the investigator's discretion)
Platelet REactivity in Sepsis Syndrome (PRESS)

Activation of blood platelets is a typical finding in patients with systemic inflammation and sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the exact effects of bacterial products on platelet function have not been found to be consistent and may vary according to the species, the timing of the study, and the pathogenesis of sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation among patients with sepsis compared to healthy controls. Defining platelet's behaviour during sepsis is particularly important in view of recent findings revealing potential association between antiplatelet therapy and reduction in short term mortality, incidence of acute lung injury and intensive care unit admission in critically ill patients.This study aims to measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay, in platelet reactivity units (PRU)- along different stages of sepsis, including bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow up of patients going along different stages will also be performed. At the end of this study analysis of clinical and laboratory findings in correlation with platelet reactivity will be performed to assess platelet aggregation during sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting 0-8 hours post admission with signs of one of the following i) uncomplicated infection/bacteremia ii) sepsis iii) severe sepsis iv) septic shock
* 30 healthy subjects
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Inability to give informed consent
* PLTs\<70.000/ul or PLTs\>741.000 ul
* Ht\<25% or Ht\>52%
* History of P2Y12 or GPIIb/IIIainhibitors the last 15 days prior assortment
* Patients with inherited (vonWillebrand factor deficiency, Glanzmann thrombasthenia, Bernard-Sulier syndrome) or established acquired platelet disorders (HIT)
* Patients undergoing hemodialysis
* History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months.
* Previous history of immunologic disease (neoplasm, autoimmune disorders, HIV)
* Subjects receiving daily treatment with immune-modulating regimens.
Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers

The investigators want to see if healthy people who are given 2 doses of a medication called anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then exposed to a form of air pollution, called Endotoxin, have less inflammation with the medication. Endotoxin is believed to be one of the causes of asthma attacks.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* age 18-50 years

Exclusion Criteria:

* asthma
* pregnant women
* smokers
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.


Eligibility Criteria:
Inclusion Criteria:-

* A diagnosis of UC for ≥3 months.
* Participants with moderate to severe active UC as defined by a Total Mayo Score of

  ≥6, and an endoscopic subscore of ≥2.
* Active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy).
* Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.

Exclusion Criteria:

* Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
* Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
* Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
* 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
* Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
* Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps

A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps


Eligibility Criteria:
Healthy Volunteers:

Inclusion Criteria:

* Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive

Exclusion Criteria:

* subject with evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.

Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP):

Inclusion Criteria:

* diagnosis of CRSwNP (inflammation of the nose and paranasal sinuses characterized in adults by 2 or more symptoms, 1 of which should be either nasal blockage or nasal discharge and/or facial pain and/or reduced smell for greater than 12 weeks)
* bilateral nasal polyps of grade 3 or 4

Exclusion Criteria:

* Forced Expiratory Volume (FEV1) \</= 70%
* Asthma exacerbation requiring systemic corticosteroid treatment or hospitalization for \> 24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone.
Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)

Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.


Eligibility Criteria:
Inclusion Criteria:

* Gestational less than 28 weeks
* Postnatal age less than 12 hours
Epidural Stimulation in Multiple Sclerosis

A study to quantify changes in motor performance of epidural stimulation in progressive multiple sclerosis (MS) patients over the course of 12 rehabilitation sessions.

The purpose of this trial is to study spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and to measure any changes in motor performance during 12 sessions over the course of one month.

Eligibility Criteria:
Inclusion Criteria:

* Myelopathy secondary to Progressive MS
* No clinical or radiologic MS relapses for \> 5 years
* EDSS score of 6.5 (constant bilateral assistance required to walk about 20 meters without resting) as assessed by a Neurologist with a specialty in MS
* Able to ambulate 10 feet independently with or without gait aid use
* At least 22 years of age
* No changes to spasticity medications or dalfampridine over the last 3 months

Exclusion Criteria:

* Currently a prison inmate, or awaiting trial, related to criminal activity
* Pregnancy at the time of enrollment
* History of chronic and/or treatment resistant urinary tract infection
* Spasticity (grade of 4) measured bilaterally in two muscle groups using Modified Ashworth Scale (MAS). Muscle groups tested will include bilateral knee flexors, extensors; ankle plantarflexors, dorsiflexors
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Receiving diathermy treatment
* Active participation in an interventional clinical trial
* Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
* History of coagulopathy or other significant cardiac or medical risk factors for surgery
* Ventilator-dependent respiration
* Diagnosed with cardiopulmonary dysfunction (e.g., chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia)
* Untreated clinical diagnosis of depression
* History of frequent hypotension characterized by light headedness, or loss of consciousness
* History of frequent hypertension characterized by headache, or bradycardia
* Any active, implanted medical device
* Treatment of chemodenervation and/or neurolysis during the trial, or within 6 months of initiating the trial
Sleep at 30 Degrees in Glaucoma

This study is designed to investigate the effect of body posture (particularly when sleeping) on the pressure in the eye. The effect of body posture on progressive glaucoma (glaucoma where a significant change i.e. a disc hemorrhage has occurred) is not known.

The study will involve being admitted to the Sleep Unit of the University Health Network at Toronto Western Hospital for 1 night (14 hours). IOP will be measured in both eyes every 2 hours with a Tonopen, along with brachial blood pressure (BP), in the sitting position until the patients reach their normal sleep cycle time. Patients will then be asked to sleep in either lying down or reclining at a 30 degrees position and have the IOP measurements and brachial BP every 2 hours in that position.

The same cohort of patients will then be invited for a repeat 14 hour IOP and BP measurement but will change their position, i.e. sitting before will now be supine and vice versa.


Eligibility Criteria:
Inclusion Criteria:

* This pilot study included patients with progressive NTG or POAG as evidenced by disc hemorrhage despite well controlled Intraocular pressures (IOP), who were able to sleep flat

Exclusion Criteria:

* Any patients who were not able to sign a consent or lying flat during sleep
RCT KS-SA Versur KS-BA in Diabetic Patients

The aim of this randomized controlled trial is to evaluate whether is better to place KS Osstem Implants with BA or SA surface placed in patients with type 2 diabetes, and to compare clinical and radiographic data.


Eligibility Criteria:
Inclusion Criteria:

* - Patients of at least 18 years old able to sign an informed consent.
* Patients with at least a single tooth loss in the maxilla or mandible. Patient will provide only one site for the research. Implant sites must allow the placement of implants of at least 3.5 mm (upper laterals and lower incisors); 4 mm (central incisors, canines, and premolars) or 4.5 (molars) mm of diameter and at least 7 mm of length.
* Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day).
* Patients with a plaque index (PI) of less than, or equal to 25% at the time of surgery.
* In case of post-extractive sites, they must have been healing for at least 4 months before being treated in the study.
* Patients with controlled type 2 diabetes mellitus with a duration of at least 1 years of disease evaluation and baseline glycated hemoglobin A1c (HbA1c) values between 7.5% and 12% at the time of implant placement will be included.

Exclusion Criteria:

* General contraindications to implant surgery (except for type two diabetes in test group).
* Patients irradiated in the head and neck area.
* Immunosuppressed or immunocompromised patients (except for type two diabetes in test group).
* Patients treated or under treatment with intravenous amino-bisphosphonates.
* Patients with untreated periodontitis.
* Patients with poor oral hygiene and motivation.
* Previous guided bone reconstruction at the intended implant sites.
* Uncontrolled diabetes (except for type two diabetes in test group).
* Pregnancy or nursing.
* Substance abuser.
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for implant placement.
* Patients with infection and or inflammation in the area intended for implant placement.
* Patients participating in other studies, if the present protocol cannot be properly adhered to.
* Patients referred only for implant placement and cannot be followed ant the treating centre.
* Patients unable to be followed for 5 years.