cyrilzakka/clinical-trials huggingface dataset:
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment

The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.

Additional information regarding sponsors: Abbott GmbH \& Co. KG is sponsor for EU member states. Abbott US is sponsor for non-EU member states.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \>= 18 years of age
* Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
* Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
* Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

* Subject has previous exposure to adalimumab
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
* Subject is taking or requires oral or injectible corticosteroids
* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
* Subject considered by the investigator, for any reason, to be an unsuitable candidate
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
* Subject has a calcium metabolism disorder
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.

Prophylactic tranexamic acid will be instilled via endobronchial route in all patients undergoing transbronchial cryobiopsy. The medication will be administered through the bronchoscope one minute prior to the cryobiopsy. 500 mg of TXA diluted in 10 ml of saline and the procedure would be carried out as usual.

The study will be a prospective, single-arm, non-randomized trial Location: Ascension Via Christi Saint Francis. Medication: Tranexamic acid 500 milligrams per 5 mL ampule (Baxter, NDC 43066-008-01) mixed with 10 mL normal saline.

Patients: A total of 100 patients will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Signed informed consent
* Receiving a transbronchial cryobiopsy

Exclusion Criteria:

* Age below 18
* Pregnancy
* Bleeding diathesis (INR \>1.5 or known hematological problems)
* Subarachnoid hemorrhage
* Any active bleeding (any site)
* Decompensated liver disease
* Active intravascular clotting
* Prior VTE
* On oral contraceptive therapy
* Platelet count less than 50,000
* Use of antiplatelet medication other than low-dose aspirin within 5 days of procedure
* Use of therapeutic anticoagulation within the last 24 hrs
* Known severe pulmonary hypertension (pulmonary artery systolic pressure \> 60 mmHg)
* Chronic renal failure (estimated GFR below 30 mL/min)
* Allergy or hypersensitivity to tranexamic acid or any of its ingredients
* Prisoners
* Comfort care planned or initiated within 72 hours of admission
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study

This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

The objective of this clinical registry study is to evaluate safety and performance of the Weck® Auto Endo5® 5 mm automatic endoscopic 35 cm applier device (Teleflex Incorporated, Morrisville, NC, USA - further referred to as AE05ML) for delivery of Hem-o-lok® Medium Large (ML) polymer clips for the purpose of vessel / tissue structure ligation in laparoscopic surgery. This is a prospective, observational, multi-center, clinical registry study. All subjects will undergo vessel / tissue structure ligation using AE05ML during their indicated laparoscopic procedure as per standard of care and institutional policy and procedure.

The primary objective is to evaluate the safety and performance of AE05ML for delivery of ML Hem-o-lok polymer clips for the purpose of vessel / tissue structure ligation in adult subjects during laparoscopic procedures.

Primary Endpoints

* Safety: Incidence of device related adverse events (AE)
* Performance: Success / Failure of polymer clip delivery attempts The secondary objectives are to evaluate device performance characteristics and operator reported feedback regarding their experience using the device for each case.

Secondary Endpoint

• Results of Device Performance and Operator Feedback Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Scheduled for a laparoscopic procedure in which AE05ML will be used for vessel / tissue structure ligation
* Capable of providing informed consent for participation

Exclusion Criteria:

* Imprisoned
* Cognitively impaired and unable to provide informed consent
Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

The POWER-study is a two-arm exercise intervention study for pediatric patients following acute cancer treatment. This clinical trial will investigate the effects of a 12-week moderate to high-intensity exercise program on cardiorespiratory fitness in children and adolescents beginning 6 weeks after completion of acute cancer treatment.

The main objective of the POWER study is to investigate the effects of a 12-week moderate to high-intensity, partially supervised exercise program on cardiorespiratory fitness (VO2peak) in children and adolescents who have completed acute cancer treatment. This randomized controlled trial will include n=56 patients. Patients will be randomly assigned to the intervention or the control group. Patients in the intervention group will perform two supervised exercise sessions per week, one personal training session and one group-based training session. During an initial consultation, both groups receive recommendations for individual physical activity goals and a brochure with exercise recommendations as well as a fitness tracker to monitor their daily physical activity. Only the intervention group will receive daily activity targets, which will be adjusted on a regular basis. The study starts 6 weeks after completion of the patient's acute cancer treatment.

Secondary aims of this interventional study are to evaluate additional performance markers, including muscle strength, functional mobility, balance, body composition and patient-reported outcomes including QoL, fatigue, and cognitive function as well as blood markers to evaluate changes in metabolic, immune, and heart health.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents between 7 and 23 years of age
* Completion of acute cancer treatment and receiving follow-up care in Krefeld (Helios Hospital Krefeld)
* 6 weeks post cancer-treatment
* Signed informed consent (Parents and Patient)

Exclusion Criteria:

* \<7 years of age, \>23 years of age
* Medical condition that limits participation in one of the study arms
* Inability to follow the training-protocol
* Inability to carry out the spiroergometry on a cycle ergometer
Atacand (Candesartan) Real Life Study

This study is a Swedish historical cohort study in patients prescribed Atacand or Cozaar for hypertension by selected primary care centres. Data will be extracted anonymously from electronic medical records. In addition, data regarding morbidity and mortality will be collected by merging the cohort with the following national registries: the Hospital Discharge Register (Slutenvårdsregistret), the Cause of Death Register and the Heart Intensive Care Admission (RIKS-HIA)


Eligibility Criteria:
Inclusion Criteria:

* Recorded blood pressure prior to therapy of \> 140 and/or 90 mmHg
* Diagnosed as hypertensive within 15 months
* First prescription of Cozaar or Atacand between 1 January 1999 and 31 December 2007, inclusive

Exclusion Criteria:

* Previous prescription within 15 months any drug from the ATC groups C02, C03, C07 - C09 inclusive
Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms

This is a multicenter, randomized, open Label, add-on study.

This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with severe Influenza-Like Symptoms.

The purpose to determine the efficacy and safety of Oseltamivir Phosphate combined with or without Xiyanping injection in the treatment of severe Influenza-Like Symptoms. The study will enroll 72 Pediatric severe Influenza-Like Symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Oseltamivir Phosphate and Xiyanping injection for severe Influenza; volunteers from the second group will receive Oseltamivir Phosphate for severe Influenza. Xiyanping injection will be administration as intravenous injection of 0.4mL/kg/day once daily for 7-10 days concomitantly with Oseltamivir Phosphate for severe Influenza-Like Symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age between 3 and 6 years old;
* Clinical diagnosis of Severe Influenza with hospital treatment needed;
* Patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment;

  （1)Fever ≥ 39°C (tympanic temperature) for at least 3 days with Severe cough,sputum, blood stasis, or chest pain; （2）Combined pneumonia;
* The rapid viral antigen test of throat swab and nose swab results were positive;
* Guardians understood and assigned the informed consent;

Exclusion Criteria:

* Participants allergenic to XiYanPing injection, Andrographolide or Oseltamivir Phosphate;
* Creatinine clearance \<80ml/min or received continuous renal replacement therapy (CRRT) test;
* Need extracorporeal membrane oxygenation (ECMO) at baseline;
* Glasgow Coma Rating Scale (GCS) score ≤ 9 points when dyspnea, altered consciousness, severe vomiting, or coma appeared at baseline;
* Crisis influenza Symptoms, such as respiratory failure, acute necrotizing encephalopathy, septic shock, multiple organ dysfunction and other serious clinical conditions requiring monitoring;
* Use of systemic steroids or other immunosuppressants;
* Participants with the following underlying diseases, including: heart disease (such as New York Heart Function Classification II-IV) or clinically significant arrhythmia (such as QTc ≥ 480ms), malignant tumor or other malignant diseases, autoimmune diseases; liver and kidney diseases ( ALT and AST ≥ 1.5 × ULN; Cr and BUN \> 1.2 × ULN), blood diseases, nervous system diseases, immune system diseases and endocrine diseases, consciousness, speech, behavioral abnormalities caused by encephalitis / encephalopathy or limb paralysis, severe malnutrition, etc.
* Participants used Influenza virus vaccine within 3 months;
* Participants with drug dependence or with mental disorders within 1 year;
* Participants participated in other clinical research in the last 30 days;
* Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason.
Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity

The purpose of this study is to find out whether plantarflexion has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO).

Patients with urodynamic DO will be included in this study. During urodynamics, the mean peak detrusor pressures of each contraction will be documented and compared. At the beginning of the 2nd or 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor. Following each wave, patients will be asked to grade the severity of the urgency by a visual analogue scale

Eligibility Criteria:
Inclusion Criteria:

All patients with urodynamic detrusor overactivity

Exclusion Criteria:

Inability to perform plantarflexion due to mental or physical disability
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy

The overall goal of this project is to better understand the micro-physiology of human epilepsy and cognition using the intracranial electroencephalogram (iEEG), electrical brain stimulation, functional magnetic resonance imaging (fMRI), and histology.

The overall goal of this project is to better understand the micro-physiology of human epilepsy and cognition using iEEG, electrical brain stimulation, fMRI, and histology.

Specific AIM 1: Mapping cognitive networks using intracranial electrodes, functional magnetic resonance imaging, and cognitive tasks. To identify brain areas and mechanisms involved in cognitive function we will ask participants to perform tasks while their brain activity is measured with intracranial electrodes or functional magnetic resonance imaging (fMRI).

Specific AIM 2: Using microelectrodes to better understand the mechanisms of seizure genesis/spread and human cognitive function. We will use microelectrodes to measure activity within single neurons, data that will allow us to tease apart incoming and outgoing activity to a brain area.

Specific AIM 3: Using macroscale measures of brain connectivity to map functional and epileptogenic brain areas. We will measure connectivity between macroscale brain regions via variety of techniques: diffusion tensor imaging (DTI), fMRI, cortico-cortical evoked potentials (CCEP), and intracranial electrophysiology. We believe that epileptogenic and functional regions will be mutually segregated by their connectivity patterns.

Specific AIM 4: Using EEG/iEEG source localization to better identify the sources of epileptiform activity. We will construct models of participants' heads via MRI and CT, which will potentially allow us to localize the neural generators of EEG and iEEG recordings.

Specific AIM 5: Investigating the effects of transcranial and direct electrical stimulation on cortical excitability and cognitive function. We will apply direct electrical brain stimulation to epileptogenic and functional brain regions and evaluate the effects of this stimulation on electrode recordings, CCEPs, and cognitive tasks. Electrical stimulation may be applied with consideration of endogenous cognitive biomarkers to probe and elucidate the function of these biomarkers as they relate to cognitive function.

Specific AIM 6: Studying local connectivity of epileptic brain tissue with histology. We will reserve a small portion of resected brain tissue from patients who have undergone surgical resection for histological analysis to better understand altered patterns of neural connectivity in epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are selected on the basis of intractability of their seizures to medical intervention by antiepileptic drugs and following a noninvasive workup that indicates the patient would be an excellent candidate for resective surgery.

Exclusion Criteria:

* Patient is under the age of 5
Postprandial Blood Glucose Control and Gastric Emptying in Type 1 Diabetes: Pathogenetic Factors and Therapeutic Options

This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients (DM1) free of chronic complications in comparison with a group of healthy control subjects. The investigators will also assess the relationship between GE and glucose control (HbA1c, postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and gastrointestinal symptoms.

In addition, in patients with delayed GE the investigators will investigate the effect of "tailored" pre-prandial insulin bolus administered by means of insulin pump in reducing postprandial glucose variability, evaluated through continuous glucose monitoring system.

Diabetic patients with a delayed GE will be studied in 2 separate occasions in euglycemic condition and under CGM. On both occasions, they will have to take a standard meal poor of lipids (rice 60 g; yellow squash 200 g; extra virgin olive oil 7 g; adult veal lean cuts 90 g; bananas 180 g; ordinary bread 75 g).

On the first occasion pre-prandial insulin will be administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load.

On the second occasion the amount of pre-prandial insulin will be the same as the first one test but fractioned into a double-wave bolus. The "tailored" insulin bolus will be defined according to the individual pattern of GE, as follows:

* GE T1/2 121-180 min= 60% as bolus + 40% during following 2 h
* GE T1/2 \>180 min= 40% as bolus + 60% during following 4 h Glycemic variability will be assessed by the means of Continuous Glucose Monitoring System and the following indexes of glucose variability will be calculated: number of hypoglycemic events, number of hyperglycemic events, standard deviation of glycemia, glycemia variation coefficient, mean range of daily glycemia, interquartile range, M value, mean amplitude of glycemic excursions (MAGE), low blood glucose index (LBGI), high blood glucose index (HBGI).

Eligibility Criteria:
Inclusion Criteria:

* DM1;
* Use of insulin pump;
* Disease duration ≥ 3 years.

Exclusion Criteria:

* Presence of chronic complications of DM (including cardiovascular autonomic neuropathy);
* BMI ≥ 30 kg/m2;
* Presence of chronic diseases other than DM1;
* Diseases that interfere with GE;
* Medications that interfere with blood glucose homeostasis (except insulin) and GE.
Analysis of Stem and Non-Stem Tibial Component

The purpose of this study is to compare rates of varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA) and will review the degree of influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion.

The purpose of this study is to identify varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA). In addition, this study will review the degree of influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion.

Female patients with BMI of 35 kg/m2 and above will be randomized into two groups: the non-stem tibial component (control group) and the stem tibial component (treatment group). Previous studies done in the past in normal weight patients showed that there is little or no advantage in using the stem tibial implants over the non-stem ones. Theoretically, biomechanical studies have suggested that there may be improved fixation and load distribution with the use of stem tibial implants. Thus, it is necessary to see if there is any difference between both implant options among female patients who have the highest incidence of varus collapse. In terms of design, the stem tibial implants are slightly longer than the non-stem ones. They are designed to extends deeper into the tibia to enhance fixation and improve load distribution. The use of either stem tibial implants is usually based on patients' characteristics and surgeons' preference.

Following informed consent, standard perioperative patient-reported metrics will be collected (Knee Injury and Osteoarthritis Outcome Score for Joint Replacement \[KOOS-JR\], American Knee Society score, and Patient-Reported Outcome Measurement Information System 10 \[PROMIS-10\]) before surgery and after surgery (6 weeks, 12 weeks, 1 year, 2 years, 3 years, and 5 years). After surgery, study participants will receive routine surgical care which includes two knee radiographs at 12 weeks and one year. In addition to this, the study participants will be evaluated at 2 years, 3 years, and 5 years postoperative periods where they will complete routine PROMs as listed above and have knee radiographs during each visit.

Eligibility Criteria:
Inclusion criteria:

* Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty
* 35 kg/m2 and above
* Only patients from the PI's clinic will be included.
* Women who are still menstruating and are currently on contraceptives and women who are in menopause.

Exclusion Criteria:

* Patients who have some active local or widespread infection (including secondary or inflammatory osteoarthritis)
* medical conditions that put them at risk of complications or death during and after the study would not be eligible for surgery
* Patients with previous knee surgery on arthroplasty site will be excluded
* Pregnant patients and women who are capable of getting pregnant
Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429

The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 50 years inclusive (unless local regulations dictate a minimum age of 21 years). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption.
* 12-lead ECG demonstrating QTcF \>450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.
Treatment of Early Nasal Polyposis With Topical Triamcinolone

The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.

nasopore, a bio-absorbable nasal dressing, may offer an alternative route of sustained steroid drug delivery. The use of topical targeted intranasal steroids may prevent the routine adverse effects of oral steroids while maintaining the same therapeutic / clinical efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients with early nasal polyposis

Exclusion Criteria:

* Age \< 18 years
* Patients with active sinus infections
* Patients on long term steroids
* Allergy or sensitivity to steroids
* Patients with Antrochoanal polyps
* Patients who received topical steroids by bio-resorbable sponge or oral steroids