cyrilzakka/clinical-trials huggingface dataset:
A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer

The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* \>/= 65 years old
* documented diagnosis of lung, breast, or ovarian cancer, or NHL
* scheduled to receive one of 15 standard chemotherapy regimens
* chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease
* life expectancy of at least 3 months
* ECOG performance status \</=2
* adequate renal and hematologic function
* informed consent for participation in the study prior to any study specific procedures

Exclusion Criteria:

* known hypersensitivity to any of the products to be administered during dosing
* primary prophylactic antibiotics in all cycles
* prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases
* prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation
* clinically symptomatic brain metastases
* Folstein mini-mental state exam score \<18
* Any premalignant myeloid condition or any malignancy with myeloid characteristics
* History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies
* unstable/uncontrolled cardiac conditions or hypertension
* active infection
* subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents
Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020

The accuracy and safety of the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects should voluntarily participate in the clinical trial and sign the informed consent form;
2. Subjects must be willing and able to follow the study procedures;
3. Subjects are over 18 years old whose wrist circumference should be within 13.0-21.0cm.

Exclusion Criteria:

1. Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period;
2. Subjects with sickle cell disease;
3. Subjects with prior mastectomy or arm lymph node dissection;
4. Subjects who are allergic to nylon, fluororubber or thermo-plastic polyurethane elastomer (TPU);
5. Subjects with wounds on the limb at the measurement site or inflammation of the wrist
6. Subjects who are undergoing intravenous fluid therapy, blood transfusion or other catheterization at the measurement site limb;
7. Subjects who have eaten, consumed alcohol, smoked cigarettes, or exercised vigorously 30 minutes prior to the trial;
8. Subjects who have participated in other clinical trials within 30 days that may affect this trial;
9. Subjects who, in the opinion of the investigator, should not participate in this clinical trial.
Study to Assess Platelet Dysfunction With Verify Now Assay

The purpose of this study is to conduct a Verify now assay to detect platelet aggregation defects in patients with Myelodysplastic syndrome(MDS), immune thrombocytopenia purpura (ITP) and myeloproliferative disorders (MPD).

Verify Now is a rapid, simple, point-of service assay to measure platelet aggregation. The verify now assay is designed to assess platelet function based on the ability of activated platelets to bind fibrinogen. It is hoped that this study will detect the subtle platelet functional abnormalities in patients with hematological disorders.

Eligibility Criteria:
Inclusion Criteria

- Patients with common blood disorders such as immune thrombocytopenia purpura(ITP) myelodysplastic syndrome MDS)and myeloproliferative disorders (MPV)

Exclusion Criteria

- Patients with normal platelet counts
hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors

PROGLIO is a French mono-centric study with longitudinal follow-up, in which patients with high grade brain tumors will be included. Blood samples will be taken during their therapeutic follow-up to evaluate plasma concentrations of hPG80 (circulating progastrin).


Eligibility Criteria:
Inclusion Criteria:

* Female or male 18 years of age or older.
* Patients with a high grade primary glial tumor (Astrocytoma grade 3; Glioblastoma; Anaplastic Oligodendroglioma)
* Patients scheduled to begin radiation and/or chemotherapy.
* Able to give informed consent to participate in the research.
* Enrolled in a social security plan or beneficiary of such a plan.

Exclusion Criteria:

* Patient under guardianship or curatorship
* Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial.
* Refusal to participate.
* Pregnant or breastfeeding woman.
Safety And Efficacy Of Solifenacin In Men With Overactive Bladder (OAB) And Detrusor Underactivity

Detrusor underactivity (DUA) in men is responsible for LUTS in a significant minority, the symptoms being indistinguishable from those seen in BOO. The International Continence Society (ICS) defines DUA as 'a detrusor contraction of inadequate magnitude and/or duration to effect complete bladder emptying in the absence of urethral obstruction. Whilst a reduced maximum urinary flow rate (Qmax) is indicative of voiding dysfunction, flow studies cannot distinguish between DUA and BOO, which are the two principal causes of low flow rates. DUA is diagnosed from a pressure-flow study (PFS)and is characterized by a low-pressure, poorly sustained, or wave-like detrusor contraction with an associated poor flow rate.

Overactive bladder (OAB) is the most common term currently used in clinical medicine to describe a complex of lower urinary tract symptoms (LUTS) with or without incontinence but most commonly consisting of urgency, frequency, nocturia, troublesome or incomplete emptying,and, occasionally, pain. With the exception of pain and incontinence, these symptoms are often found together; thus, the term LUTS has come to replace previous terms, such as urgency-frequency syndrome,urethral syndrome, and prostatism.

Drug treatment is frequently used as the initial management approach for LUTS in older men.Among men who desire treatment, general practice prescribing data have shown that antimuscarinics are not often given to elderly men. There is theoretical concern that the inhibitory effect of antimuscarinics on detrusor contraction could aggravate voiding difficulties or cause urinary retention in patients with BOO. There are virtually no data evaluating the safety and efficacy of solifenacin treatment in men with DUA and OAB.


Eligibility Criteria:
Inclusion Criteria:

* Men aged \> 40 years were eligible if by 7-day bladder diary they had urinary frequency (8 or more micturitions per 24 hours) and urgency, with or without urgency incontinence (1 or more episodes per 24 hours) together with coexistence low detrusor contractility.

Exclusion Criteria:

* Urinary tract infection,
* Bladder stone, urogenital tumors,
* Prostate surgery,
* Use of indwelling catheter or self-catheterization program,
* Medications that could affect the lower urinary tract function,
* History of neurological disease,
* Acute urinary retention or any condition for which antimuscarinic was contraindicated.
* Antimuscarinic, antispasmodic, or electrostimulation within 1 month;
* Any investigational drug within 2 months; or
* A 5a-reductase inhibitor within 3 months of screening.
A Computerized Intervention for Depression

The primary purpose of this study is to examine how much change in depressive symptoms will be observed in persons who use an electronic Problem Solving Treatment (imbPST) compared to a control group at pre-, mid-point, and post-test assessments.

An interactive multimedia computer-based treatment program was developed to provide an electronic version of problem solving therapy for depression (imbPST). The program was entirely automated and did not require the involvement of a live clinician, even though it was designed to provide a "virtual therapy" experience that feels more like interacting with a person than with a computer. The imbPST program was built to help individuals who did not have access to traditional therapy due the living conditions or individual preferences (e.g. rural, poor and persons desiring privacy or with significant time constraints). This computer-based treatment of depression offered several advantages. It can be used anywhere without a therapist present, and offered a standardized and consistent therapeutic approach.

The aim of this study is to reduce symptoms of depression in subjects through the use of a new, electronic Problem Solving Treatment (imbPST). Adult participants with moderate to severe depression symptoms are randomly assigned to either treatment or a wait-list condition. The Beck Depression Inventory-II was used as the primary outcome measure

Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years of age or older.
2. Present symptoms from the following criteria based on the Diagnostic \& Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR): Major Depressive Episode, Mood Disorder Due to a General Medical Condition and/or Adjustment Disorder with Depressed Mood.
3. Depression must be the primary diagnosis and not occur secondary to any another diagnosis such as Post-Traumatic Stress Disorder (PTSD), social phobia, or complicated bereavement, though comorbid diagnoses (e.g., anxiety disorders and PTSD) will not be exclusionary unless they are primary, except as specified below.
4. Not receiving psychological treatment (e.g., face to face) at the time of the study.
5. Not currently be receiving Problem Solving Treatment in any other context.
6. Not reporting/reported suicidal attempts in the year prior to their participation in the study.
7. Be able to write and speak English according to Rapid Estimate of Adult Literacy in Medicine (REALM test scores)

Exclusion Criteria:

1. Current suicidal ideation, history of suicidal attempts or self-injurious behavior at any point during the protocol.
2. Have been diagnosed with schizophrenia, bipolar I disorder, with psychosis, other disorder with psychotic symptoms, and/or brain injuries that includes loss of consciousness \> 15 minutes and / post-traumatic amnesia of any duration.
3. Any history of treatment with anti-psychotic medication.
4. A felony conviction.
5. Any current or recent (i.e. within the previous 6 months) substance abuse/dependence diagnosis (other than nicotine or caffeine).
6. Current psychological treatment (e.g., face to face).
Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy

Optical Coherent Tomography Angiography (OCTA)-Directed PDT Triple Therapy for Treatment-Naïve Patients with Exudative Age-related Macular Degeneration (ARMD) versus Standard of Care Anti-VEGF Monotherapy

This study is a 48 week, single center, randomized controlled clinical trial. Approximately 150 subjects will be randomized into three separate arms. This study compares the efficacy of standard of care Lucentis (ranibizumab) monotherapy versus OCTA-Directed PDT Triple Therapy with Lucentis (ranibizumab), PDT with Visudyne (verteporfin), and Triescence (triamcinolone acetonide) in treatment-naïve patients with Exudative Age-Related Macular Degeneration. OCTA-Directed PDT Double Therapy with Lucentis (ranibizumab) and PDT with Visudyne (verteporfin) will also be tested to confirm the hypothesis that steroids are necessary.

Eligibility Criteria:
Inclusion Criteria:

* Willing to give written informed consent
* Willing and able to comply with all study procedures for the duration of the study.
* Presence of Exudative ARMD with evidence of choroidal neovascularization: type 1, 2, and/or 3 on spectral domain OCT, fluorescein angiography, indocyanine green angiogram and optical coherent tomography angiography
* Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study
* Intraocular pressure less than or equal to 25mmHG
* Females of childbearing potential that are willing to use medically acceptable methods of birth control.

Exclusion Criteria:

* Exudation maculopathies without drusen
* Previous treatment with macular photocoagulation, anti-VEGF medication or PDT with Visudyne
* Myocardial infarction or cerebrovascular accident within the last 6 weeks
* Previous vitrectomy
* Optic neuropathy
* Diabetic retinopathy
* Traction maculopathies
* Allergies to fluorescein and indocyanine, dilating agents or anti-VEGF medications
* Have received previous treatment for ARMD
* Any uncontrolled condition or illness that in the opinion of the investigator makes the subject unsuitable for the study
Prospective Cohort With Incident Stroke

The primary aim of the study is to derive and validate risk scores for vascular endpoints (recurrent stroke, myocardial infarction, and other complications of stroke) and for death following an incident stroke. For this purpose patients with an incident stroke will be followed for 36 months with additional assessments at 3, 12, 24 and 36 months.

Risk of vascular disease including stroke, myocardial infarction, and vascular death is high after stroke but there are only few prognostic models for long term risk up to 3 years. About 850 patients with an incident stroke will be followed for 3 years with assessments at baseline and at 3, 12, 24, and 36 months. Factors that have already been reported to be significant predictors of vascular diseases in previous studies as well as new biomarkers (e.g. neuroimaging, blood based biomarkers) identified in this cohort will be considered. The improvement of discrimination including these new variables in the models will be investigated. Several measures of improving predictive properties (e.g. calibration, discrimination, net reclassification) will be used to compare predictive models with different complexity. The model will be validated using the bootstrap method (internal validation) and an independent external sample in cooperation with the prospective CSB-stroke cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Language: German
* First ever acute ischemic stroke that occurred with stroke onset in the last 7 days
* Written informed consent by patient prior to study participation
* Willingness to participate in follow-up

Exclusion Criteria:

* Prior stroke (definition according to WHO criteria)
* Patients presenting brain tumour or brain metastasis
* Participation in an intervention- / AMG-study
Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer

The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

patients with primary non-small cell lung cancer who received first chemotherapy in Beijing Chaoyang Hospital affiliated to Capital Medical University were collected, and the percentage of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by flow cytometry method.We will investigate the changes of patients' lymphocyte subsets in chemotherapy courses. The correlation of the percentage of lymphocyte subsets and age, gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will be further analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Each Period Non-small Cell Lung Cancer, Which Was Confirmed by Histopathology. patients has only lung cancer .
* Functional Status Score (PS) ≧ 70.
* The first time for chemotherapy .
* A Written Informed Consent.

Exclusion Criteria:

* Merging other tumors.
* HAve autoimmune diseases.
* AIDS
Electrocautery vs Q-switch for Seborrheic Keratosis

The primary objective of this study is to compare the efficacy and risk of adverse events of electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of flat seborrheic keratoses.

This study is a pilot study designed to determine feasibility of these procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are Caucasian or Asian.
2. Subjects who are between 18-65 year olds.
3. Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy.
4. Subjects have Fitzpatrick skin type I-III.
5. Subjects are in good health.
6. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion Criteria:

1. History of keloids or hypertrophic scars.
2. Pregnant or lactating or intends to become pregnant in the next 3 months.
3. Active skin disease or skin infection in the treatment area.
4. Previous history of lidocaine allergy.
5. History of methemoglobinemia
6. Unable to understand the protocol or to give informed consent.
7. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.
A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 18-80 years of age with active RA for at least 6 months;
* Received treatment for RA on an outpatient basis and experienced an inadequate response or intolerance to treatment with at least 1 anti-TNF alpha therapy (etanercept, infliximab or adalimumab);
* Must have received MTX for a minimum of 12 weeks, with the last 4 weeks, prior to screening at a stable dose;
* Participants with swollen joint count (SJC) and tender joint count (TJC) of at least 8 joints at screening and at randomization;
* Radiographic evidence of at least 1 joint with a definite erosion due to RA;
* Participants of reproductive potential must be using reliable contraceptive methods.

Exclusion Criteria:

* Bone or joint surgery within 8 weeks prior to screening or joint surgery planned within 24 weeks of randomization;
* Class IV functional status of RA;
* Previous treatment within 6 months with intravenous gamma globulin, or the Prosorba column;
* Intraarticular or parenteral corticosteroids within 4 weeks prior to screening visit;
* With a live vaccine within 4 weeks prior to randomization;
* Previous treatment with rituximab or other cell-depleting therapies;
* Concurrent treatment with any disease-modifying anti-rheumatic drug (except for MTX) or any anti-TNF alfa factor or other biologic therapy;
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
* Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders;
* Known contraindications to receiving rituximab;
* Known active bacterial, viral, fungal, mycobacterial or other infection;
* History of recurrent significant infection or history of recurrent bacterial infections;
* Primary or secondary immunodeficiency (history of, or currently active);
* History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured);
* Women who are pregnant or breast-feeding;
* History of alcohol, drug or chemical abuse within 6 months prior to screening;
* Neuropathies and neurovasculopathies which might interfere with pain evaluation;
* Participants with poor peripheral venous access;
* Intolerance or contraindications to oral or intravenous corticosteroids.
Comparative Effect of Accelerated Rehabilitation and Eccentric Strengthening Exercises on Patients With AT

A common overuse injury to the Achilles tendon, Achilles tendinopathy frequently causes pain, restricted range of motion, and functional impairment.

The purpose of this randomized clinical research is to evaluate the benefits of eccentric strengthening exercises and rapid rehabilitation on Achilles tendinopathy patients. Using techniques including TENS, isometric exercises, balance training, and endurance exercises, the 12-week accelerated rehabilitation program emphasizes pain management, mobility restoration, and functional recovery through incremental phases. However, in order to improve tendon strength and resilience, eccentric strengthening entails progressively raising resistance and functional loading. Both approaches are backed by earlier research but lack direct comparison in terms of effectiveness. This study will open the door for more research and improve rehabilitation techniques worldwide by adding to the expanding corpus of material on Achilles tendinopathy care.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age greater than 18 years, clinically diagnosed with Achilles tendinopathy.
* Participants that are clinically diagnosed with Achilles tendinopathy.
* Duration of symptoms or pain for more than 1 month.
* Positive clinical tests, such as Thompson test, confirming Achilles tendinopathy.
* Tenderness to palpation along the Achilles tendon or localized pain during activity.
* Patients with a history of overuse injuries related to repetitive activities, such as running or jumping.

Exclusion Criteria:

* Following participants will be excluded from this study:
* Presence of systemic conditions such as rheumatoid arthritis, diabetes, or other inflammatory or neuromuscular disorders.
* History of complete Achilles tendon rupture or previous surgical intervention on the affected tendon.
* Patients with other lower limb injuries or conditions (e.g., fractures, ligament tears) that could interfere with Achilles tendinopathy treatment.
* Severe tendon degeneration or calcification confirmed by imaging, unsuitable for rehabilitation.
Internet and Social Media Use in Dermatology Patients

This study is to assess Internet and social media use in dermatology patients

The Internet and social media bear potential in terms of heath care consumer education, prevention of diseases and dissemination of evidence-based information. The use of the internet and social media platforms both by dermatologists and patients is rapidly evolving. In order to improve the presence and visibility of dermatology-related evidence-based informations on the Internet and in social media, the use and behavior of dermatology patients in this context is studied in more detail.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated at the Department of Dermatology of University Hospital Basel

Exclusion Criteria:

* Insufficient knowledge of German language