cyrilzakka/clinical-trials huggingface dataset:
A Non-interventional Study to Describe the Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine

Prurigo nodularis (PN) is a skin disease characterized by the presence of single to multiple symmetrically distributed, intensively itching nodules. The main symptom is uncontrollable itching leading to prolonged, repetitive, and uncontrollable rubbing, scratching which in turn causes injuries to the skin. In recent years, number of studies evaluating PN, the affected population and the disease burden has increased but PN remains still understudied. This non-interventional study is intended to describe the long-term effectiveness of dupilumab (Dupixent®) in participants aged 18 years or older and suffering from moderate-to-severe PN who receive dupilumab for PN treatment in a real-world setting in Germany according to the prescribing information (Summary of Product Characteristics \[SmPC\]). The decision to initiate dupilumab treatment is made by the treating physician and participant according to the participant's medical need and to the standard of best medical practice. This decision is made independently and before data inclusion in this non-interventional study.

The individual observational period is planned to be up to 2 years, with assessments at baseline, one month after baseline and afterwards, every 3 months in the 1st and every 6 months in the 2nd year after dupilumab initiation, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Participants at least 18 years of age at baseline visit
* Signed written informed consent
* New initiation with dupilumab or in whom treatment with dupilumab was started within the last 7 days for moderate to severe prurigo nodularis according to the prescribing information/Summary of Product Characteristics (SmPC)
* Patients who received the initial diagnosis of PN

Exclusion Criteria:

* Patients who have a contraindication to dupilumab according to the current prescribing information label/SmPC
* Patients who have been treated for more than 7 days with dupilumab
* Any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results
* Participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Oral Valganciclovir Versus Valacyclovir

To determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab (Campath) is reduced by the use of valganciclovir prophylaxis.

Researchers will study the effectiveness of valganciclovir to help prevent cytomegalovirus infections in patients receiving alemtuzumab. Since alemtuzumab eliminates T-cells, which are the body's usual defense against viruses, patients taking alemtuzumab have an increased risk of developing CMV.

Before treatment, you will have a physical exam. You will also have around 3-4 tablespoons of blood drawn for routine tests and for tests to see if you have ever been exposed to CMV.

You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will be given treatment with valganciclovir. Participants in the other group will be given treatment with valacyclovir. This drug protects against herpes infections but not CMV.

If you are assigned to the group that will receive valganciclovir, you will take valganciclovir by mouth once a day starting of your first day of alemtuzumab therapy. You will continue to take valganciclovir for 2 months after the end of alemtuzumab therapy.

If you are assigned to the group that will receive valacyclovir, you will take valacyclovir by mouth once a day starting of your first day of alemtuzumab therapy. You will continue to take valacyclovir for 2 months after the end of alemtuzumab therapy.

Every 2 weeks while you are receiving alemtuzumab (usually 4-12 weeks)you will have a repeat blood test to look for CMV.

Your participation in this study will last for a maximum of 5 months.

This is an investigational study. Both valganciclovir and valacyclovir are FDA approved and commercially available. However, the use of valganciclovir for this study is experimental. valganciclovir will be provided free of charge during the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving alemtuzumab
* Age \> 15
* Signed informed consent form

Exclusion Criteria:

* Active cytomegalovirus disease or infection. Asymptomatic patients with positive CMV pp65 antigenemia will not be excluded.
* Patients with a creatinine clearance of \< 10 ml/min as calculated via the Cockcroft-Gault equation.
Lipoic Acid and Prevention of Heart Disease

The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants.

The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants.

Recruitment will be in the Portland, Oregon area.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* Overweight (BMI, 25.0-29.9 kg/m2) or obese (BMI, \>30 kg/m2);
* Elevated plasma triglycerides (100-400 mg/dl);
* Weight stable for the last three months and at lifetime maximum;
* Exercise limited to 30 minutes 3 times a week or less;
* Hs-CRP level at baseline of ≤ 10 mg/L;
* Consuming ≤ 2 alcoholic drinks per day;

Exclusion criteria:

* Pregnant, breastfeeding, or planning to become pregnant before the end of the study.
* Having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study
* Diagnosed as having diabetes (fasting glucose \<125 mg/dl for entry), cardiovascular disease, congestive heart failure, angina, thyroid disorders, cancer, inflammatory disorders or renal, hepatic, or hematological abnormalities;
* Currently taking lipid-lowering drugs, anti-hypertensive drugs, insulin , or oral hypoglycemic agents, anti-inflammatory drugs, weight loss medications, or hormone replacement therapy;
* On an extreme diet and not maintaining a prudent diet;
* Currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
* Smoking within the last three months;
Voluntary Activation During Isokinetic Contractions in Subjects with Neuromotor Disorders

Activation is the amount of voluntary recruitment of a muscle during voluntary contraction. Full activation implies the recruitment of all muscle fibres at their tetanic frequency. In healthy subjects, and even in sports performances, full activation may be rarely achieved despite a subjectively maximal effort.

Highly decreased activation has been observed in patients affected by various orthopaedic and neurological disorders. In these subjects, paresis may be caused or aggravated by primitive impairments of the central nervous system and/or, by stimuli arising from peripheral damaged tissues that inhibit the corticospinal or the intraspinal recruitment of motoneurones ("arthrogenous muscle weakness"). There are numerous investigations in the literature on activation measured during isometric contractions, while they are substantially missing as far as isokinetic concentric contractions are concerned. There are reasons to suppose that, contrary to what has been demonstrated for healthy subjects, in patients with various motor impairments the activation is diminished the more, the higher is the joint rotation speed.

The present study aims to investigate the amount of activation of the quadriceps femoris during subjectively maximal isometric contractions at 40° knee flexion (0°=complete extension) and isokinetic concentric contractions at an angular velocity of 100°/s in patients with various orthopaedic and neurologic conditions.

Activation will be measured on an isokinetic dynamometer, through the "interpolated twitch technique". This consists of stimulating a representative sample of the muscle belly through an electric shock. If the shock does not generate an extra force during contraction, all muscle fibres belonging to the sample reached by the electric shock can be claimed to be recruited at their tetanic frequency. Otherwise, following the stimulus, a twitch can be observed revealing submaximal voluntary recruitment of the muscle.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70 years old;
* ability to sign the informed consent form;
* ability to understand the instructions and to complete the motor task;
* voluntary knee flexion-extension range of at least 70°;
* maximal extension of angle \< 30° (0°=full extension, 180° sagittal tibio-femural angle).

Exclusion Criteria:

* pregnancy;
* a history of epilepsy (to avoid the risk for seizures triggered by the stimuli);
* Mini Mental State Examination ≤27/30;
* implanted electro-sensitive devices;
* any orthopedic condition limiting the articular mobility or muscular strength of the lower limbs;
* current treatment with oral anticoagulant therapy (to avoid the risk for muscle hemorrhage);
* medium/serius osteoporosis (femoral Bone Mineral Density on the affected side, t-score \< (-3.5));
* familiarity with the testing method.
Innovation in Endobronchial Sampling

Evaluating an integrated diagnostic work-up of virtual navigation bronchoscopy (VNB), confocal laser endomicroscopy and micro computerized tomography (micro-CT) in the diagnostic path of pulmonary lesions in the non-oncological patient.

The region(s) of interest that has/have to be sampled, will be selected upfront. Guided by the endobronchial pathway that is created by virtual bronchoscopy, the flexible bronchoscope will be navigated to the regions of interest and an optical biopsy of the region will be obtained using pCLE. One biopsy sample will be processed in the endoscopy suite to be able to prepare it for micro-CT analysis.

Eligibility Criteria:
Inclusion Criteria:

* Presence of diffuse pulmonary disease necessitating bronchoscopic evaluation.
* Informed consent available
* Age \> 18
* FVC \> 50%pred
* DLCO \> 35%pred
* PaO2 \> 55 mmHg, pCO2 \< 45 mmHg (ambient air)
* No exclusion criteria

Exclusion Criteria:

* Age \> 75
* Systolic arterial pressure in the pulmonary artery : PAPS \>40mmHg
* Platelet count \<100000/µl
* INR \> 1.4
* BMI \>30
* Diffuse bullous lung disease
* Active anti-platelet or anticoagulant treatment
* Active heart failure or unstable coronary heart disease
Electronic Medical Records and Genomics (eMERGE) Phase III

The Electronic Medical Records and Genomics (eMERGE) Network is in its third phase and during this time is enrolling and sequencing 25,000 individuals on a custom sequencing panel of clinically relevant, actionable genes. The genetic results will be returned to participants and outcomes tracked through the electronic health records.

The Electronic Medical Records and Genomics (eMERGE) Network is a National Human Genome Research Institute (NHGRI)-funded consortium tasked with developing methods and best practices for utilization of the electronic medical record (EMR) as a tool for genomic research. Phase III is focused on returning actionable gene variants to patients and measuring clinical outcomes. Ultimately, eMERGE hopes its efforts will result in improvements in health care, through safer and more effective prescription methodology, augmentation of primary and secondary prevention strategies, and enhanced understanding of the biology of disease.

eMERGE is composed of 10 clinical sites \[ Childrens Hospital of Pennsylvania (CHOP); Cincinnati Children's Medical Center (CCHMC); Columbia University; Geisinger; Kaiser Permanente Washington with Washington University and the Fred Hutchinson Cancer Research Center; Harvard University; Mayo Clinic; Meharry Medical College; Northwestern University; Vanderbilt University Medical center (VUMC)\], one non clinical site: Marshfield Clinic, two sequencing centers \[Baylor college of Medicine; Partners Healthcare with Broad Institute\], a Coordinating Center (VUMC), and the NHGRI. More information on the eMERGE Network can be found at www.gwas.org.

Each sites' research study is tailored to their specific interests. An eMERGE specific sequencing panel was designed and ran on participants covering 109 genes and 1551 Single Nucleotide Variants (SNVs), of which 68 genes and 14 SNVs are clinically actionable and are being returned to patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 1 day old
* Vital status: Alive

Exclusion Criteria:

-None
Insulin Cardioplegia for Poor Left Ventricular Function

The purpose of this investigation is to develop a means to improve the recovery of cardiac metabolism and ventricular function following coronary artery bypass surgery (CABG) in patients with poor preoperative ventricular function (e.g. ejection fraction \<40%).

Hypothesis

Insulin added to blood cardioplegia will improve the results of Coronary Artery Bypass Graft by reducing the incidence of low output syndrome (i.e., the requirement for inotropic or balloon pump assistance) in patients with a preoperative ejection fraction \<40%.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been referred for isolated coronary bypass surgery.
* LV grade 3 or 4, LVEF \<40% by angio, echo, RNA.

Exclusion Criteria:

* Patient is undergoing reoperative surgery (i.e., has had any previous cardiac surgery)
* Surgeon has planned another procedure in addition to coronary bypass surgery (e.g., valve repair, replacement, ascending aorta repair or replacement, left ventricular aneurysm resection, repair of congenital defect, carotid surgery, repair of abdominal aortic aneurysm).
* Patient is scheduled for minimally invasive surgery.
* More recent assessment of LV function with LV grade 1 0r 2, LVEF\>40%.
* 5 or 6 days post MI.
Balloon Pump Assisted Coronary Intervention Study

This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP) in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of IABP.


Eligibility Criteria:
Inclusion Criteria:

* impaired left ventricular function (Ejection Fraction \< 30%)
* large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)

Exclusion Criteria:

* cardiogenic shock
* acute STEMI within previous 48 hours
* complications of recent AMI (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias)
* contraindications to IABP use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)
Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

The objective of this parallel group study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adults 30-85 years of age.
* Diagnosis of either POAG or OHT in both eyes.
* Not receiving medication for IOP, or able to stop such medication for a washout period and the duration of the study without significant risk of adverse consequences related to glaucomatous disease.
* Elevated IOP (≥ 24 and ≤ 33 mm Hg at 8 AM and ≥ 21 and ≤ 33 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment \[after a washout phase in those subjects who were receiving ocular hypotensive therapy\]).

Exclusion Criteria:

Ophthalmic exclusion criteria:

* Uncontrolled intraocular hypertension defined as \> 33 mm Hg in either eye at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy).
* Receiving more than one medication for IOP in either eye at time of screening.
* Abnormal central corneal thickness.
* BCVA worse than 20/200 (logMAR 1.0) in either eye
* Significant visual field loss.
* Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

Postmenopausal at least 5 years; Screening bone mineral density more than or equal to 2.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.

Exclusion Criteria:

Metabolic bone disease other than osteoporosis; Taking approved medications for osteoporosis; Have had a recent osteoporotic fracture (within 1 year) and/or have a bone mineral density more than 4.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.
OC000459 Dose Finding Study in Hay Fever Sufferers.

The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis

This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
* Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening.
* Acceptable contraception includes the use of TWO of the following:

  * oral contraception (i.e. the Pill);
  * intrauterine device (an IUD or 'Coil');
  * barrier contraception (i.e. condoms or diaphragm/cap);
  * transdermal patch

Exclusion Criteria:

* Medical conditions likely to affect the outcome of the study.
* Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee.
* Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
* Immunotherapy treatment course in the past 28 days
* Use of inhaled or local corticosteroids in the past 28 days.
Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP

Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells.

3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS as it increases strength and improves autonomic symptoms in LEMS patients. It is not currently approved by the FDA for use in the United States. The investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University MDA/ALS Research Center.


Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with LEMS or a type of CMS likely to respond to 3, 4-DAP.
* If female of childbearing age, have negative pregnancy test, and be willing to practice and effective form of birth control during the study.
* Tested and found by ECG not to have a prolonged QTc syndrome.
* Agrees to have a second ECG at the time of peak drug effect. Has understood and signed the Informed Consent.

Exclusion Criteria:

* Is known to have a sensitivity to 3, 4-DAP.
* Has a history of past or current seizures or of severe asthma, or has an epileptiform EEG.
* Is believed by the investigator to be unable to comply with the protocol.
* Is unable to give informed consent.
* No patient will be excluded based on race, ethnicity, gender, or HIV status
Pharmacokinetics and Pharmacodynamics of Extended-Infusion Cefepime in Continuous Renal Replacement Therapy

This prospective, multi-center study aims to determine the pharmacokinetics and pharmacodynamics of extended-infusion cefepime in continuous renal replacement therapy (CRRT).

This prospective, multi-center study aims to determine the pharmacokinetics and pharmacodynamics of extended-infusion cefepime in CRRT. Patients on CRRT who are being initiated on cefepime 2000 mg IV every eight hours with a four-hour infusion will be considered for enrollment. Pre- and post-membrane serum levels will be drawn at scheduled intervals for both the first dose and again during another dose at steady state. Concomitant effluent and urine levels will also be obtained. A pharmacokinetic analysis will be performed and Monte Carlo simulations will be used to determine the probability of target attainment for various pharmacodynamic endpoints. Documented organism MICs will be used to determine the cumulative fraction of response.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admission to medical intensive care unit (MICU), surgical intensive care unit (SICU), neuroscience intensive care unit (NSICU), or cardiovascular intensive care unit (CVICU), at the University of Cincinnati Medical Center, or the mixed ICU at West Chester Hospital
* Patients receiving continuous venovenous hemofiltration or continuous venovenous hemodialysis
* Receiving empiric or definitive cefepime 2 g IV every 8 hours with a four-hour infusion

Exclusion Criteria:

* Prisoners
* Pregnant women
* Patients with cystic fibrosis
* Burns patients
* 24-hour urine output \> 400 mL or unknown