cyrilzakka/clinical-trials huggingface dataset:
Deep Brain Stimulation in HUCH Region Between 2006 and 2014

This study reviews the outcome of deep brain stimulation treated patients in Helsinki and Uusimaa University Hospital between 2006 and 2014. The aim of the study is to investigate the outcome and possible side effects of deep brain stimulation treatment.

Deep brain stimulation is a FDA approved method in treating patients with advanced Parkinson's disease when the best medical treatment is insufficient. In this study the aim is to investigate the outcome of deep brain stimulation treated patients in Helsinki and Uusimaa University hospital between 2006 and 2014. This study is a retrospective study based on existing patients' medical records and does not include an intervention in the treatment of an individual patient.

Deep brain stimulation carries the risks of major surgery. A complication risk for a hemorrhage is 1-2 % and for an infection is 3-10%. The aim of this study is to evaluate the complications that have occurred and the possible benefit of deep brain stimulation in deep brain stimulation treated patients with advanced Parkinson's disease.

The gathered data will be processed anonymously and an individual patient cannot be identified. The data will be processed with an appropriate statistical program (SPSS). No data will be given to external parties.

Eligibility Criteria:
Inclusion Criteria:

* Patient with advanced Parkinson's disease and given deep brain stimulation according to the best clinical protocol. This study only observes the outcome of given deep brain stimulation and does not affect on the given treatment.

Exclusion Criteria:

* The normal exclusion criteria for deep brain stimulation which are dementia, a significant vascular atrophy seen in brain CAT scan or MRI, Parkinson's disease with non-levodopa response with less than 30 % improvement in levodopa challenge test, disease duration less than 5 years
Predictors of Para-aortic Lymph Node Metastasis of Cervical Cancer

The goal of this observational study is to identify predictive factors and to develop a risk model predicting para-aortic lymph node metastasis in patients with locally advanced cervical cancer based on the analysis of surgical staging results. The main questions it aims to answer are:

* What are the risk factors to predict para-aortic lymph node metastasis in patients with locally advanced cervical cancer?
* What is the indication for prophylactic extended-field radiation therapy in patients with locally advanced cervical cancer Individual data of patients with locally advanced cervical cancer treated with surgical staging at our institution from 2020 to 2022 were pooled analysed.Multivariate Logistic regression analysis was used to identify the predictive factors and to develop the prediction model.

Individual data of 336 patients with locally advanced cervical cancer treated with surgical staging at our institution from January 2020 to August 2022 were pooled analysed. The following factors were collected from each patient to identify variables predicting para-aortic lymph node metastasis: age, T-staging，histopathological type，tumor size, differentiation, pretreatment tumor markers (squamous carcinoma antigen, carcinoembryonic antigen, Carbohydrate antigen 125 and cytokeratin fragment 21-1 , human papilloma virus type, the status of pelvic lymph node on images, common iliac lymph node and the short-axis diameter of the largest positive and the status of para-aortic lymph node on surgical staging results. Multivariate Logistic regression analysis was used to develop the prediction model. A simplified scoring system for each independent predictive factors was developed according to its coefficient. Internal validation was performed to assess the model. An independent validation cohort contained 116 patients with the same criteria from March 2018 to December 2019.

Eligibility Criteria:
Inclusion Criteria:

* In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA;
* It was treated initially without surgical and chemotherapy.
* Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology.
* Abdominal pelvic CT, MRI or PET/CT were performed before treatment.
* Patients with successful surgical staging and the pathological data of para-aortic lymph node were obtained.

Exclusion Criteria:

* Patients were excluded if the histopathological type was not squamous cell carcinoma or Adenocarcinoma, and the data of LN status was not available.
Ascertainment of EMR-based Clinical Covariates Among Patients Receiving Oral and Non-insulin Injected Hypoglycemic Therapy

The objective of this study is to identify EMR-based clinical covariates and quantify their association with the prescribing of each specific type 2 diabetes (T2DM) medication under investigation. This will include an assessment of how well these covariates are captured through claims data proxies, and their potential to confound comparative research of T2DM medications.

Purpose:

Eligibility Criteria:
Inclusion criteria:

* Dispensing of an oral or non-insulin injected hypoglycemic medication between May 2011 and June 2012
* Diagnosis of type 2 diabetes mellitus
* Presence of electronic medical records (for the EMR-based subset)

Exclusion criteria:

* Age \<18 at T2DM medication initiation
* Missing or ambiguous age or sex information
* At least one diagnosis of type 1 diabetes mellitus
* Less than 6 months enrolment in the database preceding the date of the first dispensing
* Prior use of the index drug
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following:

1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity.
2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes.
3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.

Delirium is a common complication of hospitalization and major surgery for older adults, and it can lead to loss of independence and substantial healthcare costs. One approach to preventing delirium is through the Hospital Elder Life Program (HELP). HELP personnel work to prevent delirium by providing orienting communication, assisting patients with walking and exercise, providing help with nutrition and fluids, implementing sleep protocols, and helping patients with vision and hearing aids.

However, it is unknown whether involving family members in these activities along with HELP staff (i.e., "FAM-HELP") might be more effective with preventing delirium. The objective of this clinical trial is thus to compare the traditional HELP program with a family-augmented version of HELP (FAM-HELP) to determine which program is more effective with preventing delirium and related complications in older, hospitalized patients.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* At least 70 years of age
* Anticipated length of hospital stay at least 72 hours
* Family member or care partner available to be on-site in the hospital
* At least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment)
* Evaluable cognitive function at baseline (i.e., ability to complete baseline cognitive function assessment)

Exclusion Criteria:

* Delirium on admission
* Unable to communicate verbally (e.g., coma, mechanical ventilation)
* Unable to participate fully in interventions (e.g., terminal condition, advanced dementia)
* Staff safety concerns (e.g., violent behavior)
* Cardiac or intracranial surgery (due to competing causes of delirium)
ALTO-300 in Depression (ALTO-300-004)

The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of moderate to severe major depressive disorder
* Currently taking a SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
* Must have failed to adequately respond to the current antidepressant medication
* Willing to comply with all study assessments and procedures
* Must not be pregnant or breastfeeding at time of enrollment or throughout study

Exclusion Criteria:

* Evidence of liver impairment or disease
* Active suicidal ideation
* Moderate to severe Alcohol Use Disorder
* Diagnosed bipolar disorder or psychotic disorder
* Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia

The investigator's goal in this study is to evaluate the efficacy and safety of nebulized amikacin versus intravenous amikacin in patients with hospital and ventilator acquired pneumonia in surgical patients admitted to the intensive care units infected with gram negative bacilli

prospective, randomized, controlled study on post-cardiac surgery patients , included two groups, over one year period. The first group was administered intravenous (IV) amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered intravenous (IV) piperacillin/tazobactam empirically.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU
* Clinical suspicion of VAP or HAP defined by a new persistent radiological infiltrate and one of the following signs:
* purulent tracheal aspirations, or
* temperature of 38° or higher, or leucocyte count \> 10000/ml or
* Positive culture sensitive to amikacin
* In case of empirical treatment, risk of multi resistant bacteria defined as follows:
* Antimicrobial therapy in preceding 90 days and
* Current hospitalization of 5 d or more

Exclusion Criteria:

* History of Asthma
* Multi organ failure or any psychiatric illness
* allergy to amikacin or intolerance to nebulized amikacin
* Myasthenia gravis.
* Severely impaired renal function (creatinine clearance lower than 10 mL/min or renal replacement therapy)
* Vestibulo-cochlear disease.
* Pregnancy.
* Brain death
A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)

The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.

The trial was initially conducted and submitted by Algeta ASA. After acquiring Algeta, Bayer is now the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry
* Known castration-resistant disease
* Karnofsky Performance Status (KPS): ≥70% within 14 days before start of study treatment (ECOG 1)
* Life expectancy at least 6 months.
* Acceptable hematology and serum biochemistry screening values
* Eligible for use of docetaxel according to the product information (package insert or similar).

Exclusion Criteria:

* Has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period.
* Has received external radiotherapy within the last 4 weeks prior to start of study treatment.
* Has an immediate need for radiotherapy.
* Has received prior hemibody external radiotherapy .
* Has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases.
* Has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier.
* Has received more than ten previous infusions of docetaxel.
* Previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation.
* Previous use of G-CSF for persistent neutropenia after docetaxel treatment.
* Has received blood transfusion or erythropoietin (EPO) within the last 4 weeks prior to start of study treatment.
* Has received prior treatment with Alpharadin.
* Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
* Symptomatic nodal disease, i.e. scrotal, penile or leg edema.
* Visceral metastases from CRPC (\>2 lung and/or liver metastases \[size ≥2cm\]), as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment.
* Uncontrolled loco-regional disease.
* Other primary tumor (other than CRPC) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
* Has imminent or established spinal cord compression based on clinical findings and/or MRI.
* Unmanageable fecal incontinence
Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)

The VILT-502 study is Non-interventional Study(United States)/Low-intervention Clinical Trial (Canada) of Viltolarsen administered intravenously once weekly for 10 years to boys with DMD who complete the NS-065/NCNP-01-202 study.

The VILT-502 study is an open-label, single-arm study to assess the long-term safety and effectiveness of viltolarsen, an exon skipping therapy for the treatment of DMD. Patients who complete the Phase II long-term extension study and meet the additional inclusion and exclusion criteria of the present protocol will be invited to enroll. Viltolarsen will be administered through weekly IV infusions, at the study site or at home.

The VILT-502 study will be conducted as a non-interventional study in the US, and as a low-intervention clinical trial in Canada where viltolarsen is not yet commercially available, owing to differences in the stage of regulatory approval in the two countries.

Eligibility Criteria:
Inclusion Criteria:

1. Patient, patient's parent or legal guardian have provided written informed consent/medical record release authorization prior to any extension study-specific procedures, and the patient has provided assent appropriate for his age and developmental status.
2. Patient completed the NS-065/NCNP-01-202 study and was judged by the investigator as appropriate to participate in the VILT-502 study.
3. Patient and parent or legal guardian are willing and able to comply with scheduled visits, study treatment administration plan, and study procedures.

Exclusion Criteria:

1. Patient has an allergy or hypersensitivity to the study drug or to any of its constituents.
2. Patient has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator.
3. Patient has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and observation will be correctly completed or impair the assessment of study results, in the opinion of the investigator.
4. Patient had a treatment which was made for the purpose of dystrophin or its related protein induction after completing the NS-065/NCNP-01-202 study.
5. Patient took any other investigational drugs after completing the NS-065/NCNP-01-202 study.
6. Patient plans to participate in another clinical trial.
7. Patient was judged by the investigator and/or the Sponsor as not appropriate to participate in the study for reasons other than #1 - #6 above.
Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and patient reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma
* Pan-invasive for the purposes of the protocol will be defined as meeting each of the following 2 major criteria: (1). tumor volume greater than 20 cc at enrollment, and (2). suprasellar extension. In addition, a pan-invasive tumor must meet any one of the following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b) bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension in any direction unlikely to be completely removed by specifically a transphenoidal surgical approach.
* Patients who meet the two major criteria above (1 and 2) and are medically inoperable for tumor resection (due to confounding co-existing medical problems) are eligible without meeting any of the three minor criteria (a, b, or c).
* Patients should be immediately threatened for vision loss or other significant neurological impairment directly related to tumor mass effect. As such, all patients enrolled would likely benefit from tumor response (shrinkage).
* Patients must have visible tumor on imaging studies (MRI or CT)
* The patient's Zubrod performance status must be 0-3.
* Patients must be at least 18 years of age.
* Mandatory Imaging Studies: Must be done 45 or fewer days prior to :

MRI or CT scan of the brain including the entire skull base and all areas of tumor extension

Exclusion Criteria:

* Patients who are unable to undergo general anesthesia
* Patients who are unable to undergo placement of a stereotactic head frame
* Patients who are unable to provide informed consent
* Patients who are pregnant or nursing
* Patients with severe kidney dysfunction
* Patients who have contraindications to MRI, such as implanted pacemaker device
* Patients with diagnosis of pituitary carcinoma
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.


Eligibility Criteria:
Inclusion Criteria:

* Japanese (both biological parents are ethnically Japanese)
* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory evaluations
* Body Mass Index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive. BMI = weight (kg)/(height \[m\])\^2

Exclusion Criteria:

* Significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor's medical monitor
* History of heart disease, retinopathy, uveitis, other clinically significant ocular disease, gastrointestinal disease, stroke or transient ischemic attacks (TIA)
* Inability to tolerate oral medication
* Women who are of childbearing potential, breastfeeding, or lactating

Other protocol-defined inclusion/exclusion criteria apply
Evaluation of Efficacy and Safety of the triLift™ System

Single center, single-arm, prospective, open Label with Before \& After Study Design.

Single center, single-arm, prospective, open Label with Before \& After Study Design. The control group will be the subjects before the triLift™ treatment protocol and the experimental group will consist of the same subjects after completion of the triLift™ treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to read, understand, and sign the informed consent.
* Healthy male or female aged 35 - 55 years.
* Fitzpatrick skin type 1-6.
* Subject is capable of reading, understanding, and following instructions of the procedure to be applied.
* Subject is able and willing to comply with the treatment. Women in childbearing age who is willing to conduct a pregnancy test prior to each treatment.

Exclusion Criteria:

* Pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
* Concurrent participation in any other study.
* Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
* Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
* Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
* Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
* Subject has used oral isotretinoin (Accutane® or Roaccutan®) within 6 months prior to study.
* Subject has used topical retinoids in the past 1 month.
* History of systemic cancer; premalignant skin lesion or skin concern treatment area.
* Concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
* Poorly controlled endocrine disorders such as diabetes.
* Impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
* History of collagen disorders, keloid formation or abnormal wound healing.
* Takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing.
* Subject has used oral steroids in the past 6 months.
* Subject has used topical steroids in the past 3 months.
* History of bleeding coagulopathies or use of anticoagulants.
* Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment.
* Subjects who cannot feel heat to give proper treatment feedback. (nerve damage, etc.)
* Mental disorders that in the opinion of the Investigator would interfere with the ability to comply with the study requirements.
* Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study.
Entia Liberty: Capillary Validation

This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old at the time of study entry
* Currently receiving standard of care systemic anti- cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle.
* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
* Can provide written informed consent
* Blood samples collected and stored in K2-EDTA vacutainers only

Exclusion Criteria:

* Known inherited or acquired bleeding disorder
* History of haematological malignancy
* Known poorly controlled anti-coagulation
* Inadequate use and understanding of the English language, requiring a translator