cyrilzakka/clinical-trials huggingface dataset:
Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect

The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.

Objectives: In recent years, there has been a growing amount of evidence tying Essential Tremor (ET) to cerebellar dysfunction. This has been clinically observed, demonstrated through specific gait measures of ataxia (often involving tandem gait), and confirmed through Positron emission tomography (PET) imaging. Deep Brain stimulation for ET has become a widely utilized therapeutic intervention for patients, and the bilateral thalamic ventralis intermedius (VIM) is most commonly implanted. However, it has been noted that in some patients gait ataxia significantly worsens post-op. This initially was thought to be a result of disease progression, but recent studies have in fact shown that this is a DBS related phenomenon.

Methods: Participants will have two visits to either the Portland VA or Oregon Health \& Science University (OHSU). At each visit, several assessments of balance, tremor, gait and balance, and DBS settings will be made. The gait and balance assessments will be performed by a unblinded and a blinded rater.

Eligibility Criteria:
Inclusion Criteria:

* Essential Tremor diagnosis at least 3 years duration
* Absence of other neurological signes (such as dystonia, ataxia, or Parkinsonism)
* Patients must be able to walk 2 minutes unassisted.
* Patients must be able to understand and consent to be in the study.

Exclusion Criteria:

* Patients who have had changes in DBS settings within the last 3 months.
* Patients who have had no initial improvement or response to DBS.
* ET medication changes in the last month.
* Actively abusing alcohol.
* A neurologic diagnosis other than ET that in the investigator's opinion could affect gait and/or balance.
* Atypical tremor disorder including by not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease, or parkinsonian syndrome.
* Dementia
WHITE Study: WHIch Decision After a First Venous ThromboEmbolism?

The WHITE study is a multicenter, multinational, investigators-initiated, observational, prospective study conducted in a consecutive series of ambulatory patients who had completed the recommended or practicable period of anticoagulation after a first-ever episode of venous thromboembolism (VTE)

The general aim of the study is to evaluate the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulant therapy.

The WHITE study is an international, non-profit, multicenter, observational, prospective and no profit study 3,200 subjects having experienced a first-ever episode of DVT of the lower limbs and/or PE, receive anticoagulation therapy for a period as recommended by international and/or local practice guidelines will be enrolled across all the countries participating to the study.

When this recommended period expires, the attending physician has to decide whether to continue with anticoagulation, switch to anti-thrombotic of another class, or stop any prophylactic pharmacological treatment.

The primary objective of the study is the evaluation of the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulation therapy.

The secondary objective is the collection of data during the follow-up: the frequency of thromboembolic complications, of bleeding complications, or death from any cause.

Eligibility Criteria:
Inclusion Criteria:

1. subjects who provided a written informed consent and authorization for disclosure of protected health information;
2. male and female adult or elderly patients of any ethnicity having had a first-ever event of provoked or unprovoked DVT of the lower limbs and/or PE and treated with oral anticoagulant
3. for whom the center is in possession of all the data relevant to the index event;
4. having a permanent reference contact.

Exclusion Criteria:

1. subjects \<18 years old;
2. subjects unable or unwilling to issue the written informed consent;
3. subjects for whom the information relevant to the index event are incomplete or inaccessible to the Investigator;
4. subject in whom the index event was a DVT not of the lower limbs;
5. subjects with life expectancy of less than 2 years;
6. subjects participating in any other clinical study, regardless of its nature;
7. subjects considered, by the attending physician, unable to comply with the study procedures.
Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty

We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions.

Restenosis rates after plain-old balloon angioplasty (POBA) are with 30-50 % very high. Therefore, this interventional concept is of limited use today. However, dual antiplatelet therapy (DAPT) is not necessary after POBA. Contrary, 3rd generation drug-eluting stents (DES) proved to be very effective showing delayed restenosis only in 5-15%, but require DAPT for at least 6 months. Drug-eluting balloons (DEB) might be a promising trade-off between POBA and DES, since they effectively inhibit neointimal proliferation despite minimal duration of DAPT. However, there is still very limited data on this interventional strategy. Thus, we aimed to investigate feasibility of fractional flow reserve (FFR) - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions, evaluating the 6-month outcomes by angiography and optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

* Indication for elective PCI according to the guidelines of European Society of Cardiology, American Heart Association and American College of Cardiology
* Age \> 18 years, written consent
* Native de novo coronary lesion suitable for angioplasty and OCT imaging

Exclusion Criteria:

* Pregnancy and breast feeding mother
* Co-morbidity with an estimated life expectancy of \< 50 % at 1 year
* Scheduled major surgery in the next 6 months
* Not able to give informed written consent or non-compliance
* Participation in other PCI trial
* Acute coronary syndromes and cardiogenic shock
* Known allergy to aspirin, thienopyridines or against taxol derivates
* Culprit lesion within the proximal 10 mm of the right or left coronary artery
* Saphenous vein grafts
* Estimated lesion length \> 30 mm
Pharmacogenetics in Primary Care Psychotropics

Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real time intervention improve patient outcomes?


Eligibility Criteria:
Inclusion Criteria:

* Over 18
* Prescribed a drug of interest for the first time

Exclusion Criteria:

* Previous pharmacogenetic testing available
Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet

This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and females, 18 to 50 years of age, inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
* Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
* Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:

  i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec
* Exposure to any investigational drug or placebo within 12 weeks of study drug administration
* Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody
Study to Describe Treatment Patterns and Outcomes in EGFRm NSCLC Patients in Belgium

This is a retrospective, observational, multicentre study to evaluate treatment patterns and outcomes of patients diagnosed with locally advanced or metastatic EGFRm NSCLC in Belgium


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged at least 18 years
* Pathologically confirmed NSCLC
* Tumour harbours a mutation of EGFR
* Diagnosis (radiologically or pathologically confirmed) of locally advanced or metastatic NSCLC, not amenable to curative surgery or chemoradiotherapy between 01 September 2015 and 31 December 2017

Exclusion Criteria:

* No follow-up data available after diagnosis of locally advanced or metastatic EGFRm NSCLC
* Patients who objected to participation to the study
Muscle in Acromegaly and Cushing's Syndrome

Cushing's syndrome (CS) and acromegaly determine myopathy and muscle weakness which persist long-term after control of hormone excess. Fatty infiltration in skeletal muscle (myosteatosis) is associated with muscle atrophy, frailty, and increased morbidity and mortality in several human models. The study is aimed at evaluating muscle structure in patients with controlled CS and acromegaly, and correlate it with functional tests of muscle strength. In addition, circulating molecules potentially mediating persistent myopathy in these patients will also be assessed.

Prior chronic exposure to glucocorticoids or growth hormone (GH) determines fat infiltration and persistent impairment of muscle structure in "cured" patients with CS or acromegaly, respectively. All this leads to irreversible changes in muscle strength and performance, markedly affecting morbidity and quality of life of these patients. In particular, muscle weakness would contribute significantly to the development of severe arthropathy associated with excess GH, as well as deterioration of bone status and increased risk of fracture, as described in patients with either CS or acromegaly in remission. Our aim is to evaluate whether muscular MRI is a useful tool for the assessment of myopathy and myosteatosis in these patients. If this is the case, we would have identified a non-invasive test that would allow the follow-up of patients at risk of developing functional motor problems, anticipating the onset of muscle weakness or fatigue and consequent deterioration of their quality of life. On the other hand, we will examine the role of microRNAs, which can suppress the process of myogenic differentiation, as potential modulators of myopathy in these conditions. Indeed, microRNAs could be used in clinical practice as markers to identify patients at risk of myopathy, and develop strategies for their prevention. Clarifying the impact of muscle fat infiltration on muscle strength would allow us to better understand the interaction between muscle and adipose tissue, encouraging research on potential mediators of this relationship, such as myostatin (MSTN) (able to direct the mesenchymal cell muscle towards the formation of adipocytes at the expense of myocytes) and adiponectin (ApN) (which keeps the levels of fat in the muscle low while favoring the formation and regeneration of muscle tissue).

Eligibility Criteria:
Inclusion Criteria:

* Patients with Cushing's syndrome or acromegaly who have been in remission for at least 5 years.

Exclusion Criteria:

* Pregnancy, breastfeeding, chronic liver/kidney disease, chronic treatment with glucocorticoids.
p-AKT Expression on Clinical Outcomes in Malignant Lymphoma

PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway. However, clinical information about the significance of p-AKT expression in malignant lymphoma is not fully understood yet. In this study, we investigated the overexpression of p-AKT and its prognostic implication in malignant lymphoma.

Recently, among diverse oncogenic signaling pathways, a number of studies have focused on the significance of oncogenic PI3K/AKT (phophatidylinositol 3-kinase/serine-threonine kinase, also known as protein kinase B \[PKB\]) pathway. PI3K(phosphatidylinositol 3-kinase)/AKT pathway phosphorylates and activates AKT as phosphorylated AKT (p-AKT) and plays a critical role promoting malignant phenotype and has prognostic significance in various solid cancers.

However, a systematic approach on the impact of p-AKT overexpression on clinical outcomes has not been performed in malignant lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. the patients were pathologically confirmed of malignant lymphoma, according to the World Health Organization classification;
2. the patients had adequate paraffin-embedded biopsy specimen or unstained slides for immunostaining of p-AKT.

Exclusion Criteria:

1. Primary central nervous system lymphoma was excluded in this study
Impact of Catecholamine Spill-over on Outcome After RDN and EP Ablation

Despite a rapidly increasing number of renal denervation (RDN) procedures, only little is known regarding the patient or procedural characteristics influencing the outcome. None of the detectable variables like number of ablation points, temperature rise, impedance drop, have been shown to correlate with the blood pressure (BP) reduction. In this study, the investigators assess different patient and procedural characteristics, like exact patient medication, stress hormones, heart rate variability, and focus on the change of the catecholamine spill-over, and the impact on BP and heart rate after RDN and after EP ablation. The investigators hypothesize the correlation between reduction of catecholamine spill-over due to denervation and the BP reduction. In this study, the investigators will assess 40 patients undergoing RDN and 40 patients undergoing EP ablation.


Eligibility Criteria:
Inclusion Criteria:

* medically-indicated renal denervation
* Age over 18 years
* written informed consent

Exclusion Criteria:

* pregnancy
* expected compliance problems
* current participation in other studies
Comparative Effects of Neural Mobilization and Muscle Energy Technique in Sciatic Patients

In this study, investigator will see the effects of neural mobilization in comparison to the muscle energy technique in the patients suffering from sciatica. Impact of the these two interventional techniques , there out come measures i.e pain, range of motion and functional disability.

This study is aimed in comparison among two interventional techniques i.e neural mobilization and muscle energy technique patients with sciatica. This study will be a randomized controlled trial with double blinded protocol, patients will be randomly allocated in to the two groups. one is the neural mobilization technique group and other is the muscle energy technique group. both of the groups have the conventional physical therapy in addition to these two interventions. data will be collect from the patients.30 minutes session twice a week will be given to the patients in each group. assessment will be done by using visual analog scale, Goniometer, Modified Oswestry Disability Index. Data will be entered and analyzed by using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* • Both genders

  * Between the ages group of 35-60 years
  * Patients with diagnosis of Sciatica.
  * Straight Leg Raise\< 45°.
  * Having symptoms from past one month.

Exclusion Criteria:

* Inflammatory or other specific disorders of the spine such as ankylosing spondylitis, vertebral collapse, rheumatoid arthritis, stenosis, spondylolysthesis and osteoporosis.

  * History of any previous spinal surgical intervention
  * Symptomatic bilateral radiculopathy
  * Presence of any of red flags related to spinal column
  * History of involvement in any exercise program for lower extremity in recent time
Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas

Primary objective of this study was to assess the intrasession, intersession and interobserver variability of the Pentacam-derived curvature and zernike coefficients in back surface of normal, keratoconic and crosslinked corneas.

The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study.Three study groups were formed: 1) Normal 2) Keratoconus group (KC) included patients with progressive keratoconus and 3) Collagen-Cross-linking group (CXL) included keratoconus patients that had been treated with uneventful CXL at least on year prior to their enrollment in the study.

Three consecutive scans were obtained by two experienced operators. The same procedure was repeated within two weeks for the assessment of intersession variability. In all cases acceptable maps had at least 10.0mm of corneal coverage. Keratometry (K), asphericity (Q), best-fit toric ellipsoid radius (Rs), eccentricity (ecc) and aberrometry (6.0mm pupil diameter), were analyzed. Furthermore we calculated and studied CRMS and CLRMS in order to better appreciate the visual significance of HOAs. Precision (Pre), repeatability (COR) and intraclass correlation coefficient (ICC), were calculated for evaluating intrasession and intersession repeatability. Bland-Altman analysis was used for assessing interobserver repeatability.

Eligibility Criteria:
Inclusion Criteria:

* Ideal refractive surgery candidate (Normal Group)
* Progressive keratoconus (Keratoconus group)
* Corneal collagen cross linking (CxL) treatment at least one year prior to enrollment (CxL group)

Exclusion Criteria:

(Normal Group)

* No indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography
* Uneventful ophthalmologic history

All groups:

* Glaucoma
* Suspicion of glaucoma
* history of herpetic keratitis
* corneal scarring
* severe eye dryness
* pregnancy or nursing
* current corneal infection
* underlying autoimmune disease
Influenza A H1N1: Retrospective Analysis of PCR Confirmed Cases of H1N1 Infections in Styria - Risk Factors, Clinical Features and Outcome.

This retrospective study will analyse all PCR-proven H1N1 cases from the influenza season 2009/2010 treated within the styrian "LKH hospital network". For this purpose all PCR-positive case files are reviewed in Medocs (electronic patients database) and data regarding clinical presentation, laboratory and radiological findings, treatment, outcome and preexisting underlying chronic illnesses will be systematically collected. In a second step the same data collection will be performed in a group of PCR-negative patients, which were tested during the influenza season 2009/2010 for influenza-like illness. The data from the PCR-positive group will be compared to the data from the PCR-negative group. We expect significant differences between the proven and unproven group regarding the primary presentation at hospital. Based on these results a clinical score will be developed. This score should improve H1N1 case identification in emergency departments, even if specific diagnostic test are negative (rapid antigen testing) or still pending (PCR), reduce the number of missed hospitalized H1N1 infection and optimize the decision making process in emergency departments regarding which patient has to be admitted with infection control measures and which not, and as infection control measures are expensive (face masks, gloves) and limited (isolation room), such a score should also reduce unnecessary expense. To evaluate the sensitivity and specificity of the score a prospective study will follow in the influenza season 2010/2011.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  1. All patients tested for influenza illness by PCR of respiratory tract specimens at the Institute of Hygiene, Karl-Franzens-University Graz, and at the Institute for Hospital Hygiene and Microbiology, KAGES Graz.
  2. Stratification according to the following definition:
* PCR-negative influenza-like illness (ILI) is defined as febrile illness tested by PCR for the presence of influenza infection but finally not proved as influenza infection.
* Influenza illness is defined as febrile illness confirmed by positive PCR as true influenza infection.

Exclusion Criteria:

* NONE