cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Home Programs After Lumbar Spinal Decompression Surgery

The study will be conducted with volunteer patients who are followed up by Bursa Çekirge State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone lumbar decompression surgery and who meet the study criteria. The cases will be divided into 2 groups by randomization software. The control group will receive post-operative exercise training and will be encouraged to move. The study group will receive a core stabilization program in addition to education via telerehabilitation. The first evaluation will be performed 2 months post-operatively and the second evaluation will be performed 2 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Having undergone lumbar decompression surgery without fusion and 2 months of history
* Participate in all necessary follow-up assessments
* Being between 18-65 years old
* Understand simple commands
* Signing the consent form

Exclusion Criteria:

* Presence of a previous spinal fusion surgery
* Presence of malignancy
* Having undergone spine surgery before
* Have any other orthopedic or neurological problem that may affect treatment and assessments
* Situations that prevent communication
* Lack of cooperation during the study
ACS Registry - A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow

Cardiovascular diseases (CVD) are currently the leading cause of death in industrialized countries and are expected to become the leading cause of death in emerging countries by 20201. According to the official Russian statistics, in 2015, CVD was the cause in 34% of deaths in Russia2.

Acute Coronary Syndrome (ACS) is the most prevalent manifestation of CVD and is associated with high mortality and morbidity. No other life-threatening disease is as prevalent or expensive to society3. In 2014 in Russian Federation 46 250 people died from acute myocardial infarction (MI) and 17 605 people died from recurrent MI4.

ACS is a clinical syndrome characterized by unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). The most common cause of ACS is reduced myocardial perfusion that results from coronary artery narrowing caused by the formation of partially or totally occlusive thrombi in response to rupture of atherosclerotic plaques on the vessel wall5-7.

In Russian Federation ACS management after ACS is provided in out-patient settings by doctors of different specialties (cardiologists and general practitioners (GPs)). However, the management of ACS in out-patient settings in some regions in Russian Federation is frequently suboptimal. Moscow city significantly differs from other parts of Russia from ACS management at hospital stage (up to 90% of PCI managed ST elevation myocardial infarction (MI) patients, no thrombolysis, short first medical contact to balloon time etc.) but it is unclear if management of post MI patients in Moscow out-patient settings is also optimal. In-hospital mortality in MI patients decreased last years but there is no data on clinical outcomes during 12 months after MI in Moscow.

This study will provide the epidemiological data about rates of major adverse cardiovascular and cerebrovascular events (MACCE) (MI, stroke, cardiovascular death) within 12 months after MI in real clinical practice in Moscow and describe DAPT at out-patient setting. The information received in this study will help to optimize management of Russian patients with ACS. The data will be used in discussion with payers


Eligibility Criteria:
Inclusion Criteria:

The subject population that will be observed in this prospective study must meet the following criteria:

1. Patients survivors who visited outpatient setting after discharge from hospital due to MI (STEMI or NSTEMI) within 1 month after discharge from hospital;
2. Obtained written informed consent for participation in this study.
3. Age of 18 year or older.

Exclusion Criteria:

1. Current participation in a clinical study.
2. Unknown type of MI
A Study of Mycophenolate Mofetil Combined With Glucocorticoid Therapy in Relapse Vogt-Koyanagi-Harada Disease

This project is designed to test the hypothesis that Mycophenolate Mofetil is clinically useful for patients with relapse Vogt-Koyanagi-Harada disease

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of Mycophenolate Mofetil, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with relapse VKH divided into two groups: Mycophenolate Mofetil therapy group and traditional therapy group.

For Mycophenolate Mofetil therapy group, an initial dose of 0.5-1.0g bid MMF was orally administered every day, glucocorticoid was started at a dose of 0.5-0.8 mg/kg/day and no more than 60 mg/day. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with Cyclosporine. Study participants will be followed for up to one year to determine efficacy and side effects.

According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and immunosuppressive effects of MMF in treatment of relapse VKH.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 to 70 years of age.
2. Subjects who do not have previous, active or latent tuberculosis (TB).
3. Subject must start Vogt-Koyanagi-Harada disease more than two months, and develop at least one recurrence.

Exclusion Criteria:

1. Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
2. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
3. Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy (except intravitreal anti-vascular endothelial growth factor \[VEGF\] therapy) with a potential therapeutic impact on non-infectious uveitis.
4. Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
5. Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
6. Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit
Acupuncture for Breast Cancer Related Lymphedema

The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months.
* Stage II lymphedema according to the 2016 consensus by the international society of lymphology.
* Women aged 18 to 80 years
* Out-patients
* Estimated life expectancy \> 6 months
* Upper extremity lymphedema is defined a more than 10% volume difference between the affected and unaffected arms

Exclusion Criteria:

* Bilateral breast cancer related lymphedema
* Tumor metastasis or recurrent patient
* Patients who is undergoing chemotherapy, radiation therapy or targeted therapy
* Taking diuretic
* Upper extremity lymphedema reached more than 80% volume difference between the affected and unaffected arms
* History of primary lymphedema
* A diagnosis of severe heart, liver, kidney or hematologic disease
* Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition
* Have hypoproteinemia
* Inflammation, scar, or trauma at the site of operation, or other active skin infections
* Unable to self-care, had a history of psychological disorders, or unable to communicate
* Received lymphedema treatment within the past 1 month
* Pregnancy or breastfeeding
* The presence of electronic medical device implants
* Deny to sign the informed written consent, or unwilling to conform to randomization
* Participation in other clinical trials during the study period
A Prospective Evaluation of the Filler for Jaw Contouring

The goal of this prospective study is to analyze volumetric changes in the lower face after hyaluronic acid filler injections over 90 days. The main question it aims to answer is:

To quantify volume change of the lower face area over time after injection of filler

* Participants will receive hyaluronic acid filler injections (Juvéderm Volux XC) for contouring of the jawline. Each patient will receive FDA approved dosages of filler to the lower face region to treat facial contour or asymmetry, as per FDA approved indications.
* Prior to injection patients will be imaged with 3-dimensional photogrammetry. Subjects will return post-injection in 2 weeks, 1 month, and 3 months for re-imaging.


Eligibility Criteria:
Inclusion Criteria:

1. Age 22-55
2. Patients interested in jaw contouring
3. Participants must sign the informed consent form.

Exclusion Criteria:

1Prior filler for facial contouring 2) Filler injection within the past 12 months or during duration of study 3) Prior facial cosmetic surgery (ie. facelift) 4) Prior facial trauma (ie. orbital fracture) 5) Pregnant or breastfeeding 6) Planned dental work within next 2 weeks 7) The following contraindications: patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies, gram-positive bacterial protein allergies and lidocaine allergies
Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)

PEDIS Study is an observational, cross-sectional, multicenter Italian study conducted in a consecutive series of patients who refer to the Emergency Departments (either spontaneously or sent by their attending physicians) for the recent (less than one months) development of exertional dyspnea.

The general aim of the study is to assess the prevalence of PE in the overall population referring to the Emergency Departments without potential explanations for dyspnea

PEDIS Study is an observational, cross-sectional, multicenter and no Profit Study.

600 consecutive patients referring to the Emergency Departments of the participating centers because they have developed one or more episodes of exertional dyspnea since less than one month will be enrolled. All eligible patients will be interviewed and examined by trained study physicians. The presence of already known potential explanations for the dyspnea will be assessed. In addition, symptoms of the lower extremities will be elicited, as well as the presence of risk factors for venous thromboembolism (VTE).

The presence or absence of pulmonary embolism will be assessed with the use of a validated algorithm based on pre-test clinical probability and D-dimer result. In patients in whom the pre-test clinical probability is low and the D-dimer result is negative, no further testing will be done, and PE will be considered excluded. In patients with high clinical probability, positive D-dimer result, or both, computed tomography (CT) pulmonary angiography will be performed

The primary study objective is to evaluate Prevalence of PE in the overall population

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 and younger than 75
* Recent (less than one month) development of exertional dyspnea
* Able to provide informed consent

Exclusion Criteria:

* Anticoagulation required for other indications
* Contraindication to CT angiography (allergy to the contrast dye, severe renal failure \[creatinine clearance \< 30 ml/min\])
* Involvement in simultaneous clinical trials
* Unable to provide their written informed consent
MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis

The purpose of the proposed study is to evaluate the effect of lateral extra-articular tenodesis (LET) on anterior cruciate ligament reconstruction through evaluation of postoperative magnetic resonance imaging (MRI). This will be a single-center non-randomized controlled study. The study is comparing postoperative graft MRI findings in two cohorts: patients undergoing isolated ACLR and patients undergoing ACLR with lateral extra-articular tenodesis (LET). Postoperative MRIs will be obtained at 6, 9 and 12 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* ACL deficient knee
* skeletally mature (as defined by closed growth plates on plain radiograph)
* at least 13 years of age
* less than 26 years of age
* not pregnant
* two or more of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
* no concomitant lateral meniscus tear

Exclusion Criteria:

* knee with intact ACL
* skeletally immature (as defined by open physis on plain radiograph)
* less than two of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
* pregnant
* less than 13 years of age
* older than age 25
* previous ACL repair
* concomitant lateral meniscus tear
* unable to speak english or perform informed consent
* multiligamentous knee injury (two or more ligaments requiring surgical attention)
* varus or valgus malalignment greater than 3 degrees
Regional Anesthesia for Lower Extremity Surgery

In this study, patients who underwent osteosynthesis with plate via standard anterolateral incision due to proximal tibia fracture in the orthopedic clinic within the last year; those who underwent perioperative anesthesia with spinal block, those who underwent postoperative analgesia with Ultrasound-guided popliteal sciatic nerve block, lumbar-sacral Erector Spine plane block combinations in the recovery unit will be identified and their files will be scanned retrospectively. Gender, surgical duration, postoperative block, pre-post block pain levels will be reviewed via Visual Analog Scale scoring, postoperative analgesics consumed and their amounts, Bromage scale, mobilization times, block-related complications, satisfaction levels will be determined and these two groups of patients who underwent block will be compared in terms of analgesia, complications, and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65
* Patients undergoing spinal anesthesia
* Patients undergoing postoperative erector spinae plane block
* Patients undergoing postoperative sciatic nerve block

Exclusion Criteria:

* Pregnant patients
* Patients who cannot be contacted
* Patients who have undergone perioperative general anesthesia
* Patients with a history of cerebrovascular disease
* Patients with data loss
* Patients who did not receive consent
Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY

The primary purpose of this single center, randomized, open label study in relapsing Multiple Sclerosis (MS) patients on PLEGRIDY (peginterferon beta-1a) is to assess the effect of Preparation H (phenylephrine) Maximum Strength Cream compared to no topical treatment of injection site erythema after PLEGRIDY injection.


Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of relapsing multiple sclerosis, as defined by McDonald criteria.
* Age 18 to 70 years old, inclusive, at the time of informed consent.
* Naïve to PLEGRIDY or less than or equal to 12 months on PLEGRIDY therapy.

Exclusion Criteria:

* Primary progressive, secondary progressive or progressive relapsing MS.
* Concurrent enrollment in any clinical trial of an investigational product.
* Known allergy to any interferon or any component of PLEGRIDY (peginterferon beta-1a).
* Known allergy to phenylephrine, pramoxane or any component of Preparation H.
* History of hypersensitivity or intolerance to naproxen or acetaminophen (Tylenol) that would preclude the use of at least 1 of these during the study.
* History of inadequate response to subcutaneous interferon beta therapy.
* History of human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection.
* History of premalignant and malignant disease including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
* History of seizure disorder or unexplained blackouts.
* History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1.
* Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia), at the discretion of the Investigator, within 3 months prior to Day 1.
* History of drug or alcohol abuse (as defined by the Investigator) within 6 months prior to Day.
* Active bacterial or viral infection.
* Inability to comply with study requirements.
Positive PsychoTherapy in Acquired Brain Injury (ABI) Rehabilitation

Stroke, head injury and other forms of brain injury are a major cause of physical, psychological and social disability in the adult population. Psychological distress is common following brain injury, but the evidence base for specific psychotherapeutic methods in this population is limited, and standard treatment approaches may not be suitable. Recently there has been a growing interest in positive psychology - the study of wellbeing, positive emotions and characteristics, and personal growth. The investigators believe that positive psychotherapy interventions may be beneficial after acquired brain injury, to reduce psychological morbidity. Because such interventions have not previously been applied in this population, the investigators propose to conduct a pilot randomised controlled trial to examine the feasibility of a brief positive psychotherapy intervention in an out-patient setting. This project will produce essential information to allow us to plan future full-scale clinical trials in this area.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over;
* Diagnosis of stroke or acquired brain injury (confirmed clinically and/or radiologically);
* Between 3 and 12 months post-injury at time of recruitment;
* Presence of emotional distress (score in moderate or above range on at least one sub-scale of the Depression Anxiety Stress Scales; DASS-21);
* Medically stable;
* Able to consent to research.

Exclusion Criteria:

* Significant communication impairments that would preclude participation;
* Diagnosis of mild traumatic brain injury (due to the known additional complexities contributing to outcome in this population);
* Comorbid developmental learning disability or degenerative neurological condition.

Pre-injury history of mood disorder will not lead to exclusion.
Cyclophosphamide and Celecoxib in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with celecoxib may help kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with cyclophosphamide in treating patients with advanced cancer.

OBJECTIVES:

* To describe the toxicities of oral cyclophosphamide when administered with escalating doses of celecoxib in patients with advanced malignancies.
* To evaluate the effects of this regimen on plasma levels of vascular endothelial growth factor.

OUTLINE: This is a dose-escalation study of celecoxib.

In the first course, patients receive oral cyclophosphamide once daily on days 1-35 and oral celecoxib twice daily on days 8-35. In all subsequent courses, patients receive oral cyclophosphamide once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline, periodically during treatment, and at time of tumor progression. Samples are analyzed for vascular endothelial growth factor levels and stored for future analysis of circulating DNA of angiogenic biomarkers.

After completion of study therapy, patients are followed periodically.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically proven diagnosis of a malignant disease for which no satisfactory treatment exists at the time of enrollment
* Patients with brain metastases that, at the time of study enrollment, are controlled and do not require treatment with corticosteroids are eligible

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy ≥ 3 months
* ANC \> 1.5 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Creatinine clearance \> 50 mL/min
* Serum bilirubin \< 1.5 mg/dL
* AST or ALT \< 2.0 times upper limit of normal (unless clearly due to the presence of tumor)
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Patient must be capable of understanding the nature of the trial and must give written informed consent
* No unstable or severe intercurrent medical conditions or active, uncontrolled infection
* No history of allergic reactions to nonsteroidal anti-inflammatory drugs
* No bleeding peptic ulcer within the past 3 months
* No allergy to sulfa drugs

PRIOR CONCURRENT THERAPY:

* Recovered from all prior therapy
* No radiotherapy or chemotherapy within the 3 weeks (nitrosoureas or mitomycin C within 6 weeks) prior to anticipated first day of dosing
* No concurrent therapy with other investigational agents or antineoplastic therapy