cyrilzakka/clinical-trials huggingface dataset:
EASYTRAK 3 Downsize Lead

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.

This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.

Eligibility Criteria:
Inclusion Criteria:

* Must be indicated for a Guidant CRT-P or CRT-D device
* Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enrollment
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
* Geographically stable residents who are available for follow-up

Exclusion Criteria:

* Have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
* Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement
* Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
* Currently requiring dialysis
* Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
* Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
* Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
* Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study
* Have a pre-existing unipolar pacemaker that will not be explanted/abandoned
* Have a mechanical tricuspid heart valve
* Women who are pregnant or plan to become pregnant. Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.


Eligibility Criteria:
Inclusion Criteria:

* Active plaque psoriasis involving \>10% body surface area and/or minimal screening PASI score 8.
* Methotrexate \>7.5 mg/week for the last 3 months

Exclusion Criteria:

* Predominantly guttate, erythrodermic or pustular psoriasis
* Other skin conditions than psoriasis
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab

This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.

The study for each participant consists of a Screening period, a Treatment period that includes an Induction treatment period and a Maintenance treatment period, and a Follow-up period.

The study will consist of a Phase Ib dose escalation with concurrent backfill part and a randomised controlled Phase II part.

During the screening period of up to 28 days before starting SCLC treatment, each participant will be assessed for somatostatin receptor (SSTR) expression by \[68Ga\]Ga-DOTA-TATE imaging PET/scan.

The dose escalation part in this study will be guided by the dose limiting toxicity (DLT) rate observed during the DLT period. To achieve a more robust dataset and to aid dose decisions, additional participants may be backfilled in each dose level.

Upon dedclaring RD, a 1:1 randomised Phase II with approximately 140 participants with newly diagnosed ES-SCLC will be enrolled and receive either \[177Lu\]Lu-DOTA-TATE at the RD in combination with carboplatin, etoposide and atezolizumab (experimental arm) or carboplatin, etoposide and atezolizumab alone (control arm).

Eligibility Criteria:
Key Inclusion Criteria:

* Participant is \>= 18 years on the day of signing informed consent form
* Histologically or cytologically confirmed ES-SCLC
* Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan
* No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
* ECOG status =\< 1
* Provision of tumor tissue to support exploratory biomarker analysis
* Life expectancy of \>= 6 months

Key Exclusion Criteria:

* Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1
* Any major surgical procedure requiring general anesthesia =\< 28 days before Cycle 1 Day 1
* History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
* Known hypersensitivity to the active substances or any of the excipients of the study drugs
* Concurrent participation in another therapeutic clinical study
LPHP-Philos-PHN Conservative Treatment

The aim of the study is to compare the results regarding fracture healing

and functional outcome after the treatment of proximal humeral fractures

with the four different treatment methods after 12w./6months and 12 months

based on radiological evaluation as well as the "constant score" and the

"neer score".

Evaluation of proximal humeral fractures using a new stable-angled implant.

Eligibility Criteria:
Inclusion Criteria:

* fractures of proximal humerus
* age over 18 years
* completed skeletal development
* fracture less than 5 days old

Exclusion Criteria:

* open fractures
* pseudoarthrosis, pathological or refractures
* ipsilateral fractures of distal humerus or elbow
* polytraumatic conditions
* pregnancy
* subject with known history of diseases that influence the healing process
* alcohol, drug abuse
Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).


Eligibility Criteria:
Inclusion Criteria:

* Subject completed Study C2N-8E12-WW-104 (NCT02494024)
* Subject was not eligible to enroll in Study M15-562 (NCT02985879)

Exclusion Criteria:

* Subject weighs less than 35 kg at screening
* Subject has any contraindication or inability to tolerate brain MRI
* Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization

Several aspects on the use of portal vein embolization (PVE) are poorly studied and todays recommendations are based on low-grade evidence. In this Scandinavian multicenter cohort study we will study some of the controversial aspects on the use of PVE to try to provide clearer answers on its optimal use. Six tertiary university hospital hepatobiliary units in Sweden, Norway and Denmark participate and contribute with all PVE procedures performed at their units during the study period. We will then study several aspects PVE technique in relation to induced hypertrophy and surgical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Right-sided PVE

Exclusion Criteria:

* Left-sided PVE
A Single Group Study to Evaluate the Effects of a Multivitamin on a Range of Health and Wellbeing Outcomes.

This is a hybrid single-group clinical trial that will last 12 weeks. Participants will take 2 capsules daily with the first meal of the day in the morning. Participants will undertake blood tests at Baseline and Week 12. Study-specific questionnaires will be completed at Baseline, Week 4, Week 8, and Week 12. Cognitive Battery Testing will take place at Baseline, Week 4, Week 8, and Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Female at birth.
* Aged 18+.
* Interested in supporting their health and wellbeing.
* Not planning to introduce or change prescription medications, vitamins, minerals, or supplements one month prior to and during the study.
* Generally healthy with no uncontrolled chronic conditions.

Exclusion Criteria:

* Recent surgeries or invasive treatments.
* Introduction of new health-related products in the last 12 weeks.
* Allergies to product ingredients or use of Epi-Pen.
* Chronic health conditions affecting participation.
* Endocrine or glucose-related disorders, including diabetes.
* Hematological disorders, including anemia.
* Pregnant, breastfeeding, or planning to conceive.
* History of substance abuse or recent smoking.
* Unwillingness to follow the study protocol.
* Participation in other clinical trials.
Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease

For non-alcoholic fatty liver disease, there is currently no effective treatment options. Traditional Chinese medicine (TCM) has a long history of treating liver diseases. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients.

For non-alcoholic fatty liver disease, there is currently no effective treatment method. Some studies suggest that a low-calorie diet, exercise, weight loss, etc., may help alleviate clinical symptoms, but the evidence is inconsistent. Traditional Chinese medicine (TCM) has a long history of treating liver diseases, and the formation of non-alcoholic fatty liver disease may be due to liver depression and blood stasis caused by spleen-stomach disharmony. In treatment, traditional Chinese medicine usually focuses on soothing the liver, promoting qi circulation, activating blood circulation, and resolving blood stasis. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged between 20 and 75 years old.
* Capable of understanding and signing the Informed Consent Form (ICF) document.
* Diagnosed by a physician with non-alcoholic moderate fatty liver.
* Liver function index, AST or ALT, elevated to 2 to 5 times the normal value for more than 1 month.

Exclusion Criteria:

* Diagnosed with alcoholic fatty liver, viral hepatitis, autoimmune hepatitis, Wilson's Disease, drug-induced hepatitis, or hemochromatosis.
* Currently suffering from major illnesses such as cancer, stroke, end-stage kidney disease, cirrhosis.
* Men who consume more than 140g of alcohol per week, or women who consume more than 70g of alcohol per week.
* Consuming other chinese herbal medicine.
* Pregnant or lactating women.
* Patients using lipid-lowering and diabetes medications.
* Patients with Covid-19.
Population Screening Using Smartphone in Milpa Alta

The objective of this study is to make a suicide screening in the entire population of Milpa Alta (approximately 150,000 inhabitants), taking into account other outcomes such as depression, anxiety, alcohol and drugs. For this, an app for Smartphone (MeMind) or a web platform (www.MeMind.net) will be used in which the participants will take a self-administered questionnaire, composed of several psychometric instruments .

It is expected that 70% of the population between 15 and 70 years old can do so directly with their own Smartphone, although web access posts will be enabled in educational and municipal units to avoid discrimination based on age or access to technology.

Our main hypothesis argues that the early identification of people at risk in almost the entire community can be done with an App for Smartphone, serving to depict a map of mental health and related needs of the population, serving for the planning of healthcare services of the local environment, and ultimately for the best assistance of groups and individuals with greater needs through their identification and early reference to medical assistance.


Eligibility Criteria:
Inclusion Criteria:

1. Use a smartphone as personal or computer terminals enabled by the municipality of Milpa Alta or educational services.
2. Be able to understand the nature, purpose and methodology of the study.
3. Accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given.

Exclusion Criteria:

1. Subject deprived of liberty (by judicial or administrative decision)
2. Subject protected by law (guardianship or conservatorship)
Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus

The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.

72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are acquired. Images are analyzed at a later stage.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be a healthy volunteer
* OR subject must have a suspicion of EoE
* OR subject must have a prior clinical suspicion of EoE
* Subject must be older than 14 years of age
* Subject must be able to give informed consent

Exclusion Criteria:

* Subjects with the inability to swallow pills and capsules.
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management, dose regimen, and to the effectiveness and safety in special patient groups (children 1-12 years of age), in relation to treatment conformity to the Summary of Product Characteristics (SmPC).

Eligibility Criteria:
Due to the design as an Observational Study no inclusion or exclusion criteria for therapy are named. The included patient group is described under "Cohort / Group".

Observational Criteria (=inclusion criteria for documentation):

* Males and females
* Children 1-12 years old
* Adults \>12 years old
* suffering from nervous diseases, e.g. sleep disorders due to nervousness.

Exclusion criteria for documentation:

* children younger than 1 year
* no nervous diseases, e.g. sleep disorders due to nervousness.
* no treatment with PASCONAL NERVENTROPFEN
Online Intervention to Promote Resilience to Traumatic Stress During Pregnancy

The investigators will design, construct, and pilot a prototype of a trauma-informed online intervention, which will be called "SunnysideFlex," that functionally integrates a web-based intervention targeting skills to decrease symptoms of PTSD and better manage mood during and after pregnancy. SunnysideFlex will build upon the previously IRB-approved "Sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. Women in weeks 16-28 of their pregnancy who self-report symptoms of PTSD will be randomized to one of three study groups: (1) SunnysideFlex, (2) the original Sunnyside intervention (active control), or (3) treatment as usual (TAU). The SunnysideFlex intervention will consist of 6 weeks of trauma-informed online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Outcomes will be measured at baseline, post-intervention, 6 weeks postpartum, and 12 weeks postpartum. SunnysideFlex has the potential to provide a novel paradigm for improving maternal and child health outcomes in high-risk, trauma-exposed women.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years and older
* Pregnant and between 16-28 weeks gestation
* Are currently engaged in prenatal care with a healthcare provider (OB/GYN, nurse, midwife, etc.)
* Endorse a history of one or more potentially traumatic events meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Criterion A for PTSD (i.e., "exposure to actual or threatened death, serious injury, or sexual violence," American Psychological Association \[APA\], p. 271) that is interpersonal in nature (e.g., sexual or physical assault, child abuse/maltreatment, witnessing family violence)
* Endorse a score of 33 or greater on the PTSD Checklist for DSM-5 (PCL-5)
* Have access to a broadband internet connection
* Able to read and speak English

Exclusion Criteria:

* Pregnant with multiples
* Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
* Have been diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous based on self-report
* Report currently being in an abusive or unsafe relationship
* Currently receiving treatment (medication or psychotherapy), or have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy)
A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma

To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.

Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month.
* Maintenance therapy for tuberculosis, fungal, and herpes infections.
* Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
* Foscarnet or ganciclovir for CMV infection.
* Colony stimulating factors and erythropoietin.

Patients must have:

* Moderate to severe AIDS-related Kaposi's sarcoma.
* Documented anti-HIV antibody.
* No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).

NOTE:

* Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant cardiac disease.
* Confusion or disorientation.

Concurrent Medication:

Excluded:

* Other cytotoxic cancer chemotherapy.

Patients with the following prior conditions are excluded:

* Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
* History of idiosyncratic or allergic reaction to anthracyclines.
* History of major psychiatric illness.

Prior Medication:

Excluded within the past 4 weeks:

* Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol).
* Interferon treatment.

Prior Treatment:

Excluded within the past 3 weeks:

* Radiation or electron beam therapy.
A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors

Picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of cancers. Phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients whose cancer returns or does not improve after treatment with chemotherapy. In these studies, picoplatin was administered intravenously. A capsule containing picoplatin has been formulated. This study will investigate the activity of the oral capsule in humans. Participants with advanced solid tumors will be enrolled.

The primary study design is a randomized, two-period crossover, open label study in which a single dose (Cycle 1) of picoplatin will be given either IV or by oral capsule, followed 4 weeks later by a single dose (Cycle 2) of picoplatin given either IV or by oral capsule (whichever route was not used in Cycle 1). Participants may continue to receive cycles of IV picoplatin every 3 weeks, beginning with Cycle 3, as part of a Continuation Study.

This study will determine the relative safety, bioavailability, pharmacokinetics, pharmacodynamics, and urinary excretion of picoplatin administered orally with reference to picoplatin administered intravenously.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of non-hematological malignancy.
* Patients for whom no standard therapy exists and for whom, in the opinion of the investigator, treatments with single agent picoplatin is appropriate.
* 18 years of age or older.
* ECOG performance status 0-2.
* Life expectancy of at least 12 weeks.

(Additional inclusion criteria apply.)

Exclusion Criteria:

* Symptomatic or uncontrolled brain metastases.
* Prior radiation involving ≥ 30% of the total bone marrow space.
* Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study.
* Gastrointestinal surgery that might interfere with absorption of orally administered drug.
* Active inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding.
* Clinical evidence of pancreatic injury or active pancreatitis.
* Female subjects who are pregnant or breastfeeding.

(Additional exclusion criteria apply.)