cyrilzakka/clinical-trials huggingface dataset:
JETi Lower Extremity Arterial Thrombosis

The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi™ Hydrodynamic Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. This post-market study will register approximately 280 subjects at approximately 30 centers Globally. Subjects participating in this Registry will be followed through their 12-month follow up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by the investigator, in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System.
2. Subject or legally authorized representative must provide written informed consent.
3. Subject must be ≥ 18 years of age

Exclusion Criteria:

1. Subject has previously been registered in the JETi Registry in the last 12 months unless treated in the contralateral limb/different anatomy; patients treated in the contralateral limb/different anatomy within the last 12 months may re-enroll in the study.
2. Subject is currently participating in another drug or device clinical investigation.
3. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the past 20 days.
Effect of AI Assisted Documentation in Primary Health Care on Time Saving, Patient Satisfaction and Health Care Provider Satisfaction

Background There is currently no research evidence from randomized trial settings on the effectiveness of AI-assisted documentation. The aim of this study is to provide evidence regarding cost-effectiveness, professional experience, and patient experience.

Design Physician consultations participating in the study are randomized into AI-assisted and traditional documentation groups in a 1:1 repeated crossover design. The goal is to include approximately 1,000 consultations per group.

Methods Professionals will be asked to provide their own assessment of potential time savings, and the time spent on documentation will be measured using technical data from the documentation tools (cost-effectiveness). Additionally, professionals will complete baseline and follow-up surveys (professional experience), and patients will be sent a survey following the consultation (patient experience).

The study will include all acute and non-acute visits for the enrolled clinician. The study excludes sector-specific work and specialized consultations, such as maternity clinics, memory clinics, intellectual disability consultations, as well as non-Finnish-language consultations and interpreter-assisted consultations. The system has been primarily designed to monitor discussions between two individuals, and therefore, consultations where a guardian or companion accompanies the patient are also excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinician practices at a site in Western Uusimaa wellbeing services county where AI-assisted documentation tool is available

Exclusion Criteria:

* none

The study will include all acute and non-acute visits for the enrolled clinician. The study excludes sector-specific work and specialized consultations, such as maternity clinics, memory clinics, intellectual disability consultations, as well as non-Finnish-language consultations and interpreter-assisted consultations. The system has been primarily designed to monitor discussions between two individuals, and therefore, consultations where a guardian or companion accompanies the patient are also excluded from the study.
PATH Partnering to Achieve Tobacco-free Health

The overall aim of this 5-year project is to capitalize on the strong theoretical and promising empirical evidence for Acceptance \& Commitment Therapy (ACT) as an intervention for smoking cessation by comparing the effectiveness of ACT against standard cognitive behavioral therapy (CBT) counseling when both are offered with nicotine replacement therapy (NRT) and delivered within a real world healthcare setting.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18 and older;
2. smoke at least 10 cigarettes per day for every day in the past month;
3. want to quit smoking in the next 30 days;
4. are able to speak and read in English;
5. are a GH member enrolled living in the greater Seattle area;
6. are not currently participating in other smoking cessation interventions;
7. not currently using other nicotine products (e.g., smokeless tobacco)
8. are willing to attend five 90-minute group intervention sessions and to receive NRT over the next 3 months;
9. have no medical contraindications for NRT use (i.e., pregnant, breastfeeding, recent heart attack, or skin allergy preventing use of the patch, as assessed using the standard GH contraindication screening for NRT patch);
10. no household member currently enrolled in the study

Exclusion Criteria:

1. fails to meet the eligibility criteria above;
2. has a significant cognitive or physical impairment (e.g., dementia, deafness) that would preclude full participation in the counseling sessions. This will be assessed both by self-report and by in-person assessment at the baseline enrollment appointment
Safe Drug Use in People With Intellectual and/or Developmental Disabilities - it Applies to Life

The innovation idea is to develop valuable new knowledge about safe drug use in people with intellectual and/or developmental disabilities (IDDs). The main goal is to design a framework (routines and processes) that ensures safe drug use and provides qualitatively better services for people with IDDs. Secondary goals are that employees will experience better security when working with medicines, and interact better with people with IDD and relatives by implementing digital support functions. The innovation idea is specifically to develop/improve the following: 1) Medication management: Coordinating routines, procedures and work processes regarding all aspects of drug use, medication handling, and communication between care units for people with IDDs. 2) Medication therapy: Chart review of prescribed medication and gather knowledge about challenges related to drug use in this group. Based on this, we will develop new methods for drug reconciliation and medication reviews to optimize drug use. 3) New framework for safe drug use in the community-based services for people with IDDs.

Changing, developing, and testing new routines, procedures, and communication methods for safe drug use is challenging. The complexity of systems that are involved in medication management makes it particularly challenging to create well-designed digital solutions that ensure good working procedures. The complex issues faced by people with IDDs, as well as developments within personalized medicine, means that it is crucial to build new knowledge, work in teams, and arrange for medication reconciliation and medication reviews to be carried out regularly. Furthermore, drug information must be provided, and adapted to the specific individual with an intellectual disability. In addition, the focus on personalized medicine means that the municipality must develop new guidelines for the use of pharmacogenetic tests so that the doctor can tailor drug selection and dosage to the individual patient.

Eligibility Criteria:
Inclusion Criteria:

* Users of the municipality's Service for people with disabilities

Exclusion Criteria:

-
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Currently, Enoxaparin is the usual prophylactic anticoagulant treatment at the acute and sub-acute phases of spinal cord injury (SCI). Patients at the sub-acute phase of SCI (rehabilitation) will be given either Enoxaparin 40 mg/day (control) or Apixaban 2.5-5 mg twice a day. Apixaban dose will be determined by the treating physician. Treatment will be continued for either 6 or 12 weeks following injury (for AIS grades C-D and A-B respectively).

Endpoints: Venous thromboembolism will be evaluated by D-Dimer test every 2 weeks and an ultrasound doppler at the end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.


Eligibility Criteria:
Inclusion Criteria:

* spinal cord injury (traumatic of not traumatic), Hebrew speaker.

Exclusion Criteria:

* contra-indication for anticoagulant treatment
* concomitant treatment with any other anticoagulant
* anticoagulant treatment needed for indications other than VTE prevention following spinal cord injury
* active clinically significant bleeding
* any lesion or condition considered a significant risk factor for major bleeding.
* hepatic disease associated with coagulopathy and clinically relevant bleeding risk
* pregnancy or breast-feeding
* heart valve related issues
* galactose intolerance
* active cancer
* patients who require thrombolysis or pulmonary embolectomy
* patients with renal impairment
* sensitivity to excipients of the medication
* anti phospholipid syndrome
* prosthetic heart valve
* acute ischemic stroke
Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients

To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.

A multicenter, randomized, open-label Phase IV study exploring symptom control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks esomeprazole treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* Heartburn and/or regurgitation symptoms last for at least 3 months
* Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8

Exclusion Criteria:

* Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded
* If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment
OX-40 Protein Expression in the Sentinel Lymph Nodes of Patients With Cancer

RATIONALE: Studying protein expression in sentinel lymph node tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is evaluating OX-40 protein expression in the sentinel lymph nodes of patients with cancer.

OBJECTIVES:

* Determine the qualitative and quantitative expression of OX-40 and related markers in sentinel lymph nodes previously removed from patients with cancer.
* Determine the qualitative and quantitative expression of OX-40 and related markers in sentinel lymph nodes freshly removed from patients with cancer.
* Correlate the expression of OX-40 and related markers in sentinel lymph node tissue with expression in nonsentinel tissue from primary tumors and nonsentinel lymph nodes, tumor stage, and patient outcomes.

OUTLINE: Sections of primary tumors, nonsentinel lymph nodes, and sentinel lymph nodes will be analyzed for expression of OX-40 by immunohistochemistry. Sections of negative (no tumor metastases) lymph nodes will be used as internal controls. Fresh tissue and blood will be tested for marker analysis and in vitro assays of immune function.

PROJECTED ACCRUAL: A total of 100 specimens from sentinel lymph nodes previously removed from cancer patients and 100 specimens from sentinel lymph nodes freshly removed from cancer patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed cancer, including, but not limited to, the following:

  * Melanoma
  * Breast cancer
  * Invasive squamous cell cancer
  * Other cancers for which patients underwent or will undergo the following:

    * Adequate archived paraffin-embedded tissue for making slides for immunostaining
    * Adequate freshly removed sentinel lymph node (and primary tumor, if available) tissue for laboratory assays
* Clinical data and date of last follow-up on tumor stage and status must be available
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Validation of a Screening Scale for Misuse of Opioid Analgesics

In oncology, pain is one of the main symptoms of discomfort. It has a significant impact on the quality of life.The use of opioid analgesics is recommended for the treatment of moderate to severe cancer pain.The misuse of opioid analgesics is an international public health problem.Different scales have been developed to help the prescriber screen for the risk of misuse in the general population. Patients with cancer-related pain are also at risk for aberrant opioid-related behaviors, misuse or addiction.

The main objectif of this study is to validate of the screening scale for the misuse of opioid analgesics in patients with chronic pain related to cancer. (Prescription Opioid Misuse Index - POMI).

The study takes place in 2 phases.

Test phase :

Questionnaire no. 1 constitutes the data for the TEST phase: it includes socio-demographic data, medical and family history, lifestyle, treatments, 5 questions from the Concise Pain Questionnaire (QCD), the French version of the POMI scale, the diagnostic criteria of the DSM-V and two questions concerning anxiety associated with pain and therapeutic education.

Retest phase :

questionnaire no. 2 10 to 15 days later.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over,
* Patients with chronic cancer-related pain that has been evolving for at least 3 months,
* Patients with a regular prescription of at least one opioid analgesic medicine taken daily for at least 1 month,
* Patients followed in oncology for an active cancerous pathology.

Exclusion Criteria:

* Stopping opioid prescriptions on the day of the test phase (no Retest possible),
* Patients in the process of weaning (risk of being weaned during the Retest phase),
* Patients unable to complete the questionnaire on their own,
* Patients followed in a pain or addiction centre,
* Patients in terminal palliative situations of their cancer,
* Patients with chronic pain that is more disabling than cancer-related pain,
* Patients refusing to participate,
* Patients under guardianship or curatorship,
* Pregnant or breastfeeding patients,
* Patient with a language barrier limiting understanding of the questionnaire in French.
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes

This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).


Eligibility Criteria:
Key Inclusion Criteria:

* Heterozygous for the F508del mutation (F/MF)
* Forced expiratory volume in 1 second (FEV1) value greater than equal to(≥) 70%

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply
Identification of Hepatic Lesions

Patients with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Present with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment. There should not be more than five liver lesions on type visualized on CT.

   The patient should be in a condition that allows subsequent treatment.
2. Be willing and able to continue study participation following administration of SH U 555 A to ensure completion of all procedures and observations required by the trial protocol.
3. Sign and date fully informed consent prior to entry into the study.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients weighing less than 35 kg.
* Patients who have received any investigational drug within the 30 days prior to entering this study.
* Patients who have previously entered this study or any other study performed with SH U 555 A.
* Women who are pregnant or who are of childbearing potential and have not had a negative urine pregnancy test immediately prior to the administration of SH U 555 A. The urine pregnancy test should be performed in accordance with the manufacturer's recommendations.
* Lactating women.
* Patients who have any contraindication to MRI examination.
* Patients who have received any contrast material in the 24 hours prior to SH U 555 A injection, or who are scheduled to receive any contrast material within 24 hours afterwards. (In the case of any liver specific agent (e.g. MnDPDP, SPIOs, Gd-BOPTA) this will be extended to 14 days prior to the study).
* Patients who have received Lipiodol contrast material at any time in the past or are scheduled to receive this during the study period.
* Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery).
* Patients scheduled for liver biopsy within 24 hours, or who had a biopsy within the 24 hours prior to planned SH U 555 A injection.
* Patients who are scheduled for, or are likely to require, surgery within 24 hours after SH U 555 A injection.
* Patients with a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
* Patients with known hypersensitivity to any of the ingredients of SH U 555 A.
* Patients with already clear op-indication
SCI-210 in the Treatment of Children and Young Adults With AutismEvaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD)

To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)

The innovative compound SCI-210 consists of CBD oil combined with CannAmide (PEA formulation) using the "entourage effect" to enhance efficacy of CBD. It is believed that PEA potentiates anandamide responses in non-vascular tissues. This effect is called "entourage effect". The "entourage effect" can be achieved by enhancing the action of endogenous anandamide through an increase in the affinity for receptors and/or a decrease in enzymatic degradation of anandamide (primarily by fatty acid amide hydrolase, FAAH). Thus, the combination of CBD oil with PEA is believed to be more effective than CBD oil alone, while AEs are not increased by the addition of the natural substance PEA.

SCI-210 has not been tested in clinical trials before, but anecdotal evidence of combined use of CBD and CannAmide in ASD patients has been accumulated in recent months. The evidence suggests the beneficial effects of the combination in alleviating ASD symptoms with no reported adverse events associated with the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged between 5 and 18 years of age (inclusive)
2. Diagnosis of ASD confirmed by the ADOS-2 and DSM-5 criteria
3. Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)
4. Presence of a parent/legal guardian who is able to consent for their participation and completes assessments regarding the child's development and behavior throughout the study
5. Patients eligible for cannabis treatment as regulated by the Israeli Ministry of Health, as out lined in the Medical Cannabis unit circular on Licenses for cannabis use, Procedure number 106, version 5 dated Jan 2021

Exclusion Criteria:

1. Children who are already receiving cannabis, antipsychotic drugs, or stimulants.
2. Children with heart, liver, renal or hematological disorders.
3. History of active seizure disorder or epilepsy; patients who are seizure free for more than 3 years can take part in the study
4. Exposure to any investigational agent in the 30 days prior to trial onset.
5. A current psychiatric diagnosis of bipolar disorder, major depressive disorder (MDD), psychosis, schizophrenia, or post-traumatic stress disorder (PTSD)
6. Subjects who have had changes in non-exclusionary psychotropic medications within 4 weeks of initiation of trial.
7. Allergic to cannabinoids or PEA tablet components.
8. History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel.
9. Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he or she were to participate in the study.
Phase II Study of HAIC Using Cisplatin,Leucovorin and 5-Fluorouracil

The purpose of this phase II study is to determine the recommended dose, as well as the safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular carcinoma (HCC).

The results of our preliminary pilot study suggested that the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to determine the recommended dose as well as the safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.

diagnosed with major or main portal vein invasion (Vp3 or Vp4) KPS≥70； with no previous treatment No Cirrhosis or cirrhotic status of Child-Pugh class A only Not amendable to surgical resection ,local ablative therapy and any other cured treatment.

The following laboratory parameters:

Platelet count ≥ 75,000/µL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy Known history of HIV History of organ allograft Known or suspected allergy to the investigational agents or any agent given in association with this trial.

Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy Evidence of bleeding diathesis. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug Serious non-healing wound, ulcer, or bone fracture Known central nervous system tumors including metastatic brain disease