cyrilzakka/clinical-trials huggingface dataset:
Mepolizumab for the Treatment of Chronic Spontaneous Urticaria

This is an exploratory study designed to generate preliminary data in evaluating the efficacy of Nucala in the treatment of chronic spontaneous urticaria.

This is an open-label, single arm exploratory study of mepolizumab in the treatment of CSU. The primary endpoint will be the mean reduction in the seven day urticaria activity score (UAS7) before and after 10 weeks of treatment with mepolizumab. Secondary endpoints will be the mean reduction of the urticaria control test (UCT) score and the weekly itch severity score (ISS) before and after treatment. Enrollment examination will include a standardized history and examination, baseline UCT score, CBC with differential, serum IgE level, chronic urticaria index, IgE Fc receptor antibody functional assay, and a 4 mm punch biopsy of lesional skin to confirm the urticarial tissue reaction includes eosinophils and is not neutrophilic predominant. Patients will discontinue all anti-histamines and start cetirizine 10 mg PO BID which may be continued throughout the study duration. Patients will be provided with a log book to track daily urticaria signs and symptoms in a standardized manner for UAS scoring. At week 0 (enrollment visit +7 days), baseline UAS7 and ISS score will be assessed and skin biopsy results reviewed. Patients with a confirmatory skin biopsy will receive 200 mg SC of mepolizumab at week 0,2,4,6,and 8. UAS-7 and weekly ISS score will be calculated at week 0, 4, 8, and 10. UCT scoring will be calculated at week 0 and at week 10. Repeat CBC with differential, serum IgE level, and measures of basophil serum activation (chronic urticaria index, IgE FC Receptor antibody functional assay) will be assessed at week 10. Attached to this document is a protocol summary.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years or older.
* Clinical and/or histopathological diagnosis of conventional CSU
* Unresponsive to oral antihistamine therapy
* Good general health as confirmed by medical history
* Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
* Patients who read and sign an approved informed consent for this study

Exclusion Criteria:

* Vulnerable study population
* Pregnant or nursing women
* Women planning a pregnancy within the study period
* Current or previous Xolair use
* Biopsy proven neutrophilic rich urticaria
* Known history of adverse reaction to Nucala
* Severe asthma requiring high-dose inhaled or systemic corticosteroids
Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain

The purpose of the trial is to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.

Subcutaneous carbon dioxide insufflations popular in Central und Eastern Europe are a safe and inexpensive treatment modality in complementary medicine and are used mainly in musculoskeletal pain and vascular conditions. However, no rigorous trial exists on their efficacy.

The study is designed as a double blind sham controlled randomized trial to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.Since acute non specific neck pain is often self limiting, speed of recovery rather than outcome at fixed points in time is evaluated.

Participants receive either a maximum number of 9 subcutaneous carbon dioxide insufflations or a maximum number of 9 sham ultrasound administered by 4 therapists in a randomized order, thrice weekly. Carbon dioxide gas is insufflated subcutaneously at the locations of neck muscle tenderness. Per tender location 25 ml carbon dioxide gas is administered.

Primary outcome measure is recorded daily by means of a diary. Analysis is done by intention to treat. Differences in time curves are tested using the logrank test. Time curves are graphically displayed by a 1 minus survival Kaplan-Meier plot.

Eligibility Criteria:
Inclusion Criteria:

* participants must report neck pain lasting for less than 7 days
* participants must report a current pain intensity of ≥ 40 mm on a 100 mm visual analogue scale.
* participants must state local neck muscles tenderness during clinical examination at one or more locations

Exclusion Criteria:

* neck pain of specific etiology (e.g., radiculopathy, infection, inflammation, primary tumor, or metastases)
* whiplash injury
* former neck surgery
* pregnancy
* breast feeding.
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency

The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.


Eligibility Criteria:
Inclusion criteria

* Male or female 18 - 70 years old
* Patient who has undergone a primary liver transplantation 12 to 60 months ago from a cadaveric or a living donor
* Patient with a calculated GFR ≤ 60 and ≥ 20mL/min
* Patient receiving tacrolimus with C0-h level ≥ 3 and ≤ 8 ng/mL or Neoral® with C0-h level ≥ 50 and ≤ 150 ng/mL or with C2-h level ≥ 250 ng/mL and ≤ 650 ng/mL with or without any of the following (MPA or AZA or steroids)
* Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 6 months
* Patient in whom an allograft biopsy will not be contraindicated
* Female capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study

Exclusion criteria

* Recipient of multiple solid organ transplants
* Patient on dialysis
* Patient with an identifiable cause of renal dysfunction other than CNI toxicity
* Patient with proteinuria ≥ 1.0 g/24h
* Patient with any acute rejection within 6 months prior to randomization
* Patient with platelet count of ≤ 50,000/mm³ or white blood cell count of ≤ 2,000/mm³ or hemoglobin value ≤ 8 g/dL
* Undergone a liver transplantation for a hepatocellular carcinoma with sign of recurrence;
* Severe graft dysfunction;
* HCV positive patient who needs an active anti-viral treatment
* HIV positive patient
* Patient who is breast feeding
* Patient with a current severe systemic infection
* Patient who has received an unlicensed drug or therapy within one month prior to study entry
* Presence of any hypersensitivity to drugs similar to everolimus (e.g. macrolides)
* Use of any other immunosuppressive drugs than tacrolimus/cyclosporine microemulsion, steroids, azathioprine and mycophenolic acid

Additional protocol-defined inclusion/exclusion criteria may apply.
Tai Chi Exercise in Patients With COPD

This is a pilot randomized controlled trial of feasibililty and prelimnary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease


Eligibility Criteria:
Inclusion Criteria:

* physician diagnosis of COPD
* FEV1\<65% of predicted and FEV1/FVC\<70% of predicted
* ≥45 years old

Exclusion Criteria:

* COPD exacerbation requiring ER visit or hospitalization within past month
* planned major pulmonary intervention in coming 3 months
* severe peripheral vascular disease/claudication or other physical condition precluding walk test
* inability to perform bicycle ergometry
* severe cognitive dysfunction (MMSE ≤ 24)
* inability to speak English
* current participation in a pulmonary rehabilitation or regular practice of tai chi
Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC

The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.

Pancreatic ductal adenocarcinoma (PDAC) incidence has increased with a high rate during the past few years (+4.7% per year between 2005 and 2012, source InfoCancer 2013). No cure is currently available for this deadly disease, with an overall survival \<5%. Survival can reach 20% when surgery is possible, giving the best chance to the patients. If patients present locally advance disease, it is crucial to quickly establish resectability to avoid unneeded and even deleterious surgery in patients with metastatic stages. It is also important to increase the rate of true R0 resection with effective preoperative therapy. However, when the cancer is suspected, neoadjuvant chemotherapies are often delayed because the mandatory histologic proof is difficult to make with non-informative biopsies. It is necessary to find new markers to help for rapid diagnosis that could allow neoadjuvant therapies and surgery when anatomo-pathologic proof is not available. New developments in the field of liquid biopsy hold great promise in providing valuable information for diagnosis assistance. The project will be run in two steps. First, several methods will be compared for tumor cell recovery after cell spiking in blood of non-cancer patients and pancreatic cell line onco-exosomes will characterized by flow cytometry. Second the best method will be used to detect and enumerate CTCs in 20 PDAC patients and 20 non-cancer patients. In parallel GPC1+ exosomes from patients' plasmas will be quantified. Diagnosis accuracy will be established and compared. Correlations between circulating tumor elements presence and clinical and biological parameters will be evaluated at the time of the diagnosis. Patient clinical outcome will be assessed according to initial circulating element quantification.

Eligibility Criteria:
Inclusion Criteria:

* Patient with informed consent
* Patient with health care coverage
* Group of PDAC patients: Patient with resectable lesion with suspicion or recent diagnosis of PDAC recruited in the surgery department
* Group of non-cancer patients: Patients in the surgery department without cancer lesion, Patients with intestine inflammatory disease, Patients with gastric bypass or sleeve gastrectomy procedure

Exclusion Criteria:

* Patients \<18 or under tutelage
* Patient with recent chemotherapy or radiotherapy
* Pregnant or lactating woman
* Patient with negative or non-informative biopsy
* Patient with technically unserectable disease
Impact of an Atrial Fibrillation Decision Support Tool (AFDST) on Thromboprophylaxis for Atrial Fibrillation

Study objective was to improve decision-making and thromboprophylaxis for patients with Atrial Fibrillation (AF) by developing and implementing a computerized decision support tool for individual patient-level decision-making about oral anticoagulant therapy. To accomplish these goals, the investigators studied the incremental impact of adding a quality-improvement (QI) intervention to an educational package (for practice staff and clinicians) using a computerized aid, the Atrial Fibrillation Decision Support Tool (AFDST) for individual patient-level decision-making about oral anticoagulant therapy in patients with non-valvular AF. The decision support tool incorporates individual patients' risk factor profiles for ischemic stroke and bleeding and provides a recommendation for treatment based upon the projected quality-adjusted life expectancy gained or lost with the addition of either oral anticoagulant therapy or aspirin compared with no thromboprophylaxis.

Setting - Cluster randomized trial. Setting - Primary care practices of an integrated healthcare system. Participants - 1,493 adults with non-valvular AF seen between April 2014 and March 2015.

Intervention - Treatment recommendations were made by an Atrial Fibrillation Decision Support Tool (AFDST) based on projections for quality-adjusted life expectancy calculated by a decision analytic model that integrates patient-specific risk factors for stroke and hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* Study subjects were physicians in our primary care network.
* Patients included in the study were identified through our health system's clinical data store with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), diagnosis of atrial fibrillation (427.31) or atrial flutter (427.32)

Exclusion Criteria:

Diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve transplant (V42.2) or heart valve replacement (V42.3).
Impact of Ranolazine on Coronary Microcirculatory Resistance

This study is being done to determine if Ranolazine treatment improves coronary microcirculation function among patients with coronary microcirculation dysfunction. We are also looking to learn if symptomatic improvement of chest pain during treatment with Ranalozine is related to improved coronary microcirculation function.


Eligibility Criteria:
Inclusion Criteria:

* - Patients with subjective symptoms of ischemia without flow limiting angiographic CAD (\<50% epicardial coronary stenosis) and abnormal IMR (\>20 U).
* Definition of ischemia (any one):

  * chest pain with dynamic ischemic ECG changes (t wave inversions or \> 1 mm ST depressions
  * Exercise treadmill testing induced chest pain with ≥1 mm of downsloping or flat ST segment depression during exercise or recovery; ≥2 mm of ischemic ST depression at a low workload (stage 2 or less or ≤130 beats/min); early onset (stage 1) or prolonged duration (\>5 min) of ST depression; multiple leads (\>5) with ST depression
  * Nuclear stress perfusion defect \> 10%
  * Stress echocardiogram with stress induced wall motion abnormality

Exclusion Criteria:

* - Age \< 18 yrs
* Flow Limiting epicardial CAD \>50%
* Life expectancy \< 6 months
* Recent (\<1 week) myocardial infarction or positive biomarkers
* Severe aortic stenosis
* Contraindications to IMR testing including inability to utilize antithrombotic therapy and/or intravenous adenosine
* Contraindications to Ranolazine therapy:
* Patients with known hepatic insufficiency, prolonged QT or renal failure (GFR \< 60)
* use of drugs that inhibit CYP3A such as diltiazem, verapamil, ketoconazole, macrolides and HIV protease inhibitors
* Pregnancy, breastfeeding
* Patients taking drugs which prolong QT interval
The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)

To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)

Open-label, ascending-exposure-time, single center trial in which a total of 36 subjects will be enrolled. The time to remove the vitreous will be recorded and a vitreous sample will be obtained at the beginning of vitrectomy for determination of ocriplasmin activity; 32 subjects will receive 125 μg ocriplasmin intravitreal injection prior to vitrectomy and 4 subjects will not receive ocriplasmin intravitreal injection prior to vitrectomy (control arm).

Study drug will be administered in the mid-vitreous by injection. The study eye will be examined after study drug injection to exclude retinal non-perfusion or other complications.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥ 18
* Eye disease for which a primary vitrectomy is indicated
* Best Corrected Visual Acuity (BCVA) of 20/800 or better in the non-study eye
* Written informed consent obtained from the subject prior to inclusion in the trial

Exclusion Criteria:

* Proliferative diabetic retinopathy.
* Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either Optical Coherence Tomography (OCT) and/or fluorescein angiogram in the study eye
* Aphakia in the study eye
* High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length \>28 mm is an exclusion).
* Subjects with history of rhegmatogenous retinal detachment in the either eye
* Subjects who have had ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior three months
* Subjects who have had laser photocoagulation to the macula in the study eye at any time
* Subjects with uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 26 mm Hg in spite of treatment with anti-glaucoma medication)
* Subjects with a history of uveitis in either eye.
* Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods of birth control include intrauterine device, oral, implanted, or injected contraceptives, and barrier methods with spermicide.
* Subjects who, in the Investigators view, will not complete all visits and investigations
* Subjects who have participated in an investigational drug trial within the past 30 days
* Subjects who have previously participated in this trial
Treatment of Suicidal Women With Borderline Personality Disorder

This study is a component analysis of dialectical behavior therapy (DBT) to determine the importance of DBT skills training and DBT individual therapy in treating suicidal women with borderline personality disorder.

People with borderline personality disorder have limited behavioral skills and react abnormally to emotional stimulation. Standard dialectical behavior therapy (SDBT) has been shown to be an effective treatment for borderline personality disorder. This treatment combines weekly group sessions, at which patients learn new ways of dealing with their emotions, with weekly individual sessions with a therapist to discuss their emotions. The study compares SDBT to both individual DBT with no skills training and DBT skills training with no individual therapy. The study will determine whether efficacy of standard DBT is reduced when either DBT skills training or individual DBT therapy is removed.

Participants are randomly assigned to receive 1 year of SDBT, DBT with group sessions but no individual sessions, and DBT with individual sessions with no group sessions. Participants are monitored for 1 year after completing their assigned therapy. Throughout the 1-year study and during the 1-year follow-up period, self-report scales and questionnaires are used to assess participants every 4 months. These scales and questionnaires measure participants' suicidal thoughts and attempts, treatment compliance, emotional coping skills, social functioning, and overall well-being.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BPD
* At least one suicide attempt in the year prior to study entry AND at least one intentional self-injury within the 8 weeks prior to study entry
* Willing and able to comply with all study requirements

Exclusion Criteria:

* IQ less than 70
* Life-threatening anorexia
* Street homelessness with no contact information
* Admittance to a hospital with no expectation of discharge within 3 weeks prior to study entry OR sentenced to a jail or prison term that will last for more than 3 weeks
* Ordered by the court to receive psychological treatment
* Meet DSM-IV criteria for schizophrenia, bipolar disorder, or seizure disorder
* Medical conditions other than BPD that may interfere with the study
Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA)

Single arm clinical investigation, post-market confirmatory interventional to assess performance, safety and tolerability of "CR500 SINGLE-DOSE GEL" medical device in patients with knee osteoarthritis (KOA).

Subjects 26-83 years old will receive CR500 SINGLE-DOSE GEL given for the treatment of osteoarthritis of the knee over a 4-week time period. The primary objective of the study is to evaluate the effect of CR500 SINGLE-DOSE GEL in the treatment of KOA.

Eligibility Criteria:
Inclusion criteria

1. Male or Female, aged ≥18 years at the time of the signature of ICF (Informed Consent Form).
2. Patients with a diagnosis of primary or secondary KOA affecting only one knee (monolateral KOA) of "mild" (score 1 - 4) or "moderate" (score 5 - 7) severity according to the LKI score.
3. Willing to follow all study procedures, including attending all site visits, tests and examinations.
4. Willing to participate in the study and sign the ICF.

Exclusion criteria

1. Osteoarthritis (OA) in both knees (bilateral KOA).
2. Other - different - clinical conditions of the knee.
3. Infective or inflammatory processes near the area of treatment.
4. Damaged skin in the area of treatment.
5. Ongoing cutaneous allergies.
6. Serious and chronical pathological skin conditions (i.e. rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy.
7. Allergy to device components (Sodium hyaluronate; Synthetic Human (SH)-Polypeptide-85; SH-Polypeptide-93; Glycerin; Propylene glycol; Ethylhexylglycerin; Panthenol; Polyethylene Glycol (PEG)-40 hydrogenated castor oil; Sodium hydroxide; Xanthan gum; Phenoxyethanol; Benzoic Acid; Carbomer; Dehydroacetic Acid; Disodium EDTA).
8. Any other systemic or local therapy for the treatment of KOA.
9. Any other systemic or local therapy (e.g. NSAIDs, corticosteroids) for the treatment of other inflammatory diseases (e.g. dermatitis, acute or chronic bronchitis, gastroenteritis, etc.) or painful states (e.g. headache, dental abscess, etc.) that may interfere with the clinical course of KOA under treatment with the medical device CR500.
10. Immune system illnesses.
11. Uncontrolled systemic diseases.
12. Known drug and/or alcohol abuse.
13. Mental incapacity that precludes adequate understanding or cooperation.
14. Participation in another investigational study.
15. Pregnancy\* or breastfeeding.
An Investigation of Attentional and Inhibitory Processes During Active Visual Search in Humans

The goal of this study is to investigate the finding that there are large individual differences in how participants move their eyes during active visual search. For example, some individuals tend to fixate, that is point their eyes steadily at a single location, for longer than other individuals before moving to another location. This experiment will use behavioral tasks to measure an individual's attentional and inhibitory functioning, and then see how each of these contributes to between-participant variability in eye movement behavior during visual search.

To accomplish the goal of understanding the source of individual variability in eye movement patterns, each participant will complete three separate tasks. The first task will require participants to find a target and eye movements will be measured to assess individual differences in fixation duration and other types of eye movement behavior. A second task will evaluate attentional functioning over the visual field by requiring participants to detect briefly-presented targets using their peripheral vision. Finally, a third task will assess inhibitory functioning by having participants attempt to stop eye movements after they have been programmed.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old

Exclusion Criteria:

* Self-reported history of neurological illness
* Uncorrected vision problems