cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas

Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic lesion produces an immune response in patients with metastatic carcinoma of the pancreas.

Secondary Objectives: To characterize the kinetics of an immune response induced by radiotherapy. To characterize the dependency of the immune response on prior exposure to chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of pancreatic carcinoma
* Patients ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0,1,or 2
* Patients must have distant metastatic disease (stage 4)
* Satisfactory organ and bone marrow function as defined by: Absolute neutrophil count\> 1,000/uL, Platelets \> 75,000uL Hemoglobin \> 9 Bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor,
* Creatinine ≤ 1.5x the institutional normal upper limit
* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit.
* A clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made.
* Must be able to provide informed consent.

Exclusion Criteria:

* No prior radiation to the area planned for radiotherapy
* Active invasive cancer other than pancreatic adenocarcinoma. Non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with PSA level \< 1.0 are not excluded.
* Known HIV, HCV and/or HBV positive (by patient report/medical record)
* Patients with ongoing or active infection
* Planned concurrent treatment with systemic high dose corticosteroids.
* Received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment.
* Immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment.
* Immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.
HealthSmart: Promoting Healthy Lifestyles for Young Adult Cancer Survivors Using Educational Videos

To assess the efficacy of the two SunSmart intervention videos to change sun protection attitudes and behaviors

SunSmart is a novel video intervention designed to prevent secondary skin cancer in young adult cancer survivors by increasing their adherence to recommended sun protection.

This study will assess two versions of the SunSmart video intervention. These are: 1) The INFORMATION VIDEO providing basic information about UV risks, including secondary skin cancer and the benefits of sun protection (SP), as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor; and 2) THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure. Primary aim of the study is to assess the impact of the video intervention on sun protection intentions and behavior in young adult cancer survivors compared to a control intervention. Secondary aims are to describe the impact of the appearance information when included in the SunSmart intervention, to investigate the extent to which the intervention changes sun protection through hypothesized mediating variables, and to describe the consistency of sleep behaviors over time in cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* History of cancer diagnosis at least one year prior
* Current age 18-35
* No cancer therapy in the prior 3 months (excluding chemoprevention agents)
* No future cancer therapy planned
* Able to read and write in English
* Not compliant with recommended sun protection, as determined by at least one of the following criteria:

  1. Any intentional sunbathing, artificial tanning or a sunburn in the past 5 years; OR
  2. Having a moderate to light complexion (Fitzpatrick skin types I-IV), and not using sunscreen ≥ 90% of the time during incidental sun exposure.

Exclusion Criteria:

* History of skin cancer diagnosis
* Enrolled on DFCI protocol 17-385 or any other sun protection intervention in the past 5 years.
* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all measures independently
The Effect of Psychosocial Skills Focused Group Psychoeducation in Schizophrenia Patients

The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. The study was planned as a randomized controlled pretest-posttest design. In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data. The sample size was calculated as 34 people (experimental group= 17, control group= 17). Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.

The aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. This research will be conducted in Giresun Community Mental Health Center. The study was planned as a randomized controlled pretest-posttest design. In addition to the Sociodemographic Information Form prepared by the researchers, the Functional Recovery Scale in Schizophrenia, the Modified Morisky Treatment Adherence Scale and the Warwick-Edinburgh Mental Well-Being Scale will be used to collect the data. The sample size was calculated as 34 people (experimental group= 17, control group= 17). Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation. Forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation. Thus, the effect of the psychoeducation program on the determined parameters will be evaluated. After the completion of the research, short-term counseling services will be provided to the control group in line with ethical principles. SPSS 25 package program will be used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Having a diagnosis of schizophrenia according to DSM-5 diagnostic criteria
2. To have continuity in the Community Mental Health Center
3. Being in remission (period without psychotic exacerbation) as a result of the evaluation of the outpatient clinic doctor,
4. To be mentally capable of understanding the questions posed
5. To have the cognitive competence to understand the training provided
6. Not having any visual or auditory disability
7. Graduating from at least primary school

Exclusion Criteria:

1. Refusing to participate in the study
2. Being under 18 years of age
3. Being illiterate in Turkish
4. Having Mental Retardation
Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea

This research study is designed to learn, first, whether two anesthetics have different effects on collapse seen within the upper airway during sleep endoscopy. A second purpose is to learn whether collapse at several levels of the upper airway is associated with obstructive sleep apnea that persists after adenotonsillectomy, the surgery that removes the tonsils and adenoids.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Obstructive sleep apnea (OSA) by the following criteria: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 1.5, confirmed on nocturnal, laboratory-based polysomnography within the previous 12 months scored using American Academy of Sleep Medicine pediatric criteria in an accredited sleep lab.
2. Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist.
3. Clinical determination by the child's otolaryngologist surgeon that the child would benefit from sleep endoscopy prior to adenotonsillectomy due to one or more reported risk factors for residual sleep apnea after surgery, which may include:

   1. Obese (\>95th percentile of body mass index for age)
   2. Severe preoperative OSA (AHI ≥10 events/hour)
   3. Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity;
   4. African American race
   5. Age ≥7 years old
4. Male or Female ages 3.00 - 11.99 years
5. Parent/guardian ability to understand and willingness to sign a written informed consent..
6. Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.

Exclusion Criteria:

1. Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred \>18 months prior to recruitment.
2. Major medical diagnosis that may be exacerbated by the study treatment, pose undue risk to the patient, or that may impact interpretation of study results
3. History of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane
4. Allergy to eggs, egg products, soybeans or soybean products.
5. Contraindication to receiving general anesthesia
Efficacy and Safety Study of EVERA to Augment Small Breast

Expected Total Number of Subjects

* Level of significance, alfa 0.05
* Power 0.80
* Mean difference between two treatments is assumed 35
* Standard Deviation is assumed 35.
* Follow-up loss is assumed 20%
* N=34(each group:17)

Study design

* single center, randomized, unblind clinical study Medical device
* Investigational Medical Device: EVERA
* Comparator: ESTES Process
* For eligible subjects, investigator apply Standard Deviation or Comparator on the breast
* The Investigational Medical Device is determined by randomization.
* Subjects will be applied for 12 weeks.
* Subjects will receive Patient Compliance Diary
* Subjects will visit the hospital to measure breast volume with VIVID 9i every 2 weeks for 16weeks

Eligibility Criteria:
Inclusion Criteria:

* Female aged between 24 and 40
* BMI of over 20
* Subjects who want to augment breasts
* Subjects who understand the study contents and signed the informed consent
* Subjects who can follow study procedure

Exclusion Criteria:

* Pregnant or Lactating subjects
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis

The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.

This was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. Two groups (Pilot 15 mm and Efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated Splint (received in one ethmoid sinus) compared to the control Splint (received in the contralateral ethmoid). The other group of patients (Safety/PK 25 mm) received bilateral drug-coated Splints, and served as a pharmacokinetics (PK) study group.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older.
* Patient has a diagnosis of bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration.
* Patient has a clinical indication for and has consented to bilateral FESS.
* CRS diagnosis documented by CT scan within 60 days of the procedure.
* Patient has minimal total CT stage (Lund-Mackay method) of 6.
* Patient has bilateral disease defined as minimal CT stage per side of ≥3.

Exclusion Criteria:

* Oral-Steroid dependent COPD, asthma or other condition.
* Immune deficiency (IGG subclass deficiency or IGA deficiency).
* Symptomatic coronary artery disease.
* Patient undergoing chemotherapy treatment.
* Morbid obesity (BMI \> 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study.
* Evidence of active infection.
Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.

The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information. Therefore, a big data of genome-clinical information is important.

To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS, duration of response and overall survival )of patients with advanced cancer, the investigators are going to take a tumor tissue of patients and process molecular profiling and receive molecular profile directed treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 19 years of age.
2. Subject has a histologically or cytologically confirmed diagnosis of hepatocellular carcinoma/rare cancer, melanoma, neuroendocrine tumor, sarcoma etc.
3. Prior treatment with anti-PDL1 antibody or immune check point inhibitor or ramucirumab therapy in the First-line or maintenance setting is allowed
4. They must have refractory or progressive disease for which there is no further curative therapy available.
5. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status.
6. Must have a life expectancy of 3 months or more
7. Written and voluntary informed consent understood, signed and dated.

Exclusion Criteria:

1. Patients who do not have enough tissue for acquisition
A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence

Asthma is common in children and impacts their health. There are effective medications for improving asthma, but some families have difficulty using medicines on a regular basis. This study in the emergency department will improve medicine use for children 2-12 years-old with asthma by developing content for a customized, tablet-based electronic intervention. A clinical trial will then be used to compare asthma outcomes for this intervention with routine asthma care.

The investigators have used focus groups to get ideas from parents of children with asthma to best design the intervention. This has helped us create the questions that are being used in the intervention, and make the computer program appealing and acceptable to parents of children with asthma.

The investigators will study the success of the intervention for children who receive it compared to children who obtain routine emergency department care. Participants who receive the intervention will complete a series of questions on a tablet computer. Questions will guide creation of individualized education and advice to improve medication use for each participant. The intervention will also allow for customized communication with each child's primary care provider. The investigators will include educational boosters at 2 and 4 weeks after the intervention delivered as chosen by the participant (email / text / RSS / mail). Children in the routine asthma care arm will not receive the intervention, and instead will receive routine discharge instructions by the emergency room doctors.

The investigators will compare the success of the intervention group to routine emergency department care by using a device (DOSER CT) that measures daily administered doses of medicine. Data from the DOSER CT will be collected monthly at home visits for three months. The investigators will also measure health care use and quality-of-life for each child using a survey at these home visits. The investigators believe that the intervention will improve doses of medicine given, reduce unnecessary health care use, and improve children's quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosis by physician or parent report
* Ages 2-12
* Prescribed an inhaled corticosteroid asthma controller medicine

Exclusion Criteria:

* Parent does not speak English
* Child is prescribed inhaled corticosteroid seasonally
* Patient is on a combination inhaled corticosteroid controller asthma med
Wild Mushroom Poisoning: a Case Series from Himalaya District

Introduction: Mushroom poisoning is a significant yet underreported issue in Nepal, particularly in rural areas where wild mushrooms are a vital food source. Poisonous mushrooms, often indistinguishable from edible species, pose severe health risks.

Case reports: This case series documents ten patients (6 males, 4 females) aged 19 to 39 from Mustang, Nepal, who developed symptoms of cholinergic toxicity approximately one hour after consuming wild mushrooms collected from a high-altitude region. Common symptoms included blurry vision (80%), vomiting (60%), sweating (50%), and abdominal pain (20%). A notable case involved a 19-year-old female who exhibited severe symptoms, including hypotension, tachycardia, and respiratory distress, requiring atropine therapy. All patients were managed with supportive care, including intravenous fluids and symptomatic treatments, and recovered fully within 12 hours.

Keywords: Cholinergic; Muscarinic; Toxidrome; Toxin

Introduction Mushroom poisoning can present with a wide range of clinical features, including gastrointestinal distress, neurotoxicity, myotoxicity, metabolic disturbances, and severe outcomes such as liver and kidney failure.These poisonings are most frequent during the spring and autumn seasons, as the cool, damp evenings in these periods promote mushroom growth. Non-toxic and toxic mushrooms often grow in close proximity, and many poisonous species are difficult to distinguish from edible ones, increasing the risk of accidental ingestion.

The growing popularity of mushroom consumption has contributed to a rise in poisoning cases. This is often attributed to difficulties in distinguishing toxic species, accidental ingestion of nearby poisonous mushrooms, improper cooking methods, or contamination with bacteria or viruses.

Nepal is home to a diverse range of mushrooms, with 159 edible species, 74 medicinal species, and 100 known poisonous species. Mushroom poisoning is a recurring issue in the country, leading to dozens of deaths and hundreds of hospitalizations annually, with many others relying on local treatments.

During the rainy season, the dependency on wild mushrooms increases among poorer communities, who often use them as a vital food source. Although locals possess significant knowledge of wild mushrooms, tragic accidents still occur, sometimes resulting in the loss of entire families. Many individuals remain confident in their ability to identify toxic mushrooms despite having witnessed fatalities. The lack of documentation for numerous poisoning incidents in remote areas highlights the need to preserve and record traditional knowledge before it is lost.

This case series provides essential data to address gaps in literature regarding toxicological effects of specific mushroom, supporting clinicians and researchers. It also encourages further studies in clinical medicine, toxicology, mycology, and public health to improve management and awareness of mushroom-related risks.

Eligibility Criteria:
Inclusion Criteria:

* Consumed wild mushroom

Exclusion Criteria:

* Didn not consume wild mushroom
Epidemiology and Long-term Outcome of Patients With VHD

Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.

Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy.

Patients with moderate and severe valvular heart diseases are included into the study. The set of variables subject to interpretation consisted of demographic data, medical history, result of coronary angiography, and type of applied percutaneous and surgical treatment

Eligibility Criteria:
Inclusion Criteria:

* Valvular heart disease in moderate and severe stages

Exclusion Criteria:

* Age \< 18 years old
Cellular and Molecular Analysis of Synovial Tissue of Patients With Arthritis

This study aims to study the inflammatory response in various forms of arthritis.

Arthritis, a significant heald burden is characterized by joint inflammation that severely impacts patients' quality of live. Despite advancements in treatment, many individuals with conditions like rheumatoid arthritis (RA), osteoarthritis (OA), and spondyloarthritis (SpA) do not achieve satisfactory outcomes, underscoring the need for more precise therapeutic strategies.

The project aims to characterize the inflammatory response in various form of arthritis by collecting and analyzing synovial tissue-the connective tissue lining joints. Biopsies will be collected through ultrasound-guided biopsies (UGSB), a minimally invasive and well-tolerated procedure. Presence of immune and stromal cells in the tissue, their interactions, and their relationship to clinical symptoms are characterized by histological and molecular methods. By comparing these features across different forms of arthritis, the study aims to identify molecular pathways and biomarkers that distinguish these diseases and their subtypes. The study hopes to contribute to a broader understanding of arthritis pathophysiology, ultimately translating into novel therapeutic targets and tailored clinical strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Clinically relevant arthritis in one or more joints as assessed by the treating rheumatologist, including RA, SpA, connective tissue disease and OA.

Exclusion Criteria:

* Known allergies to local anesthetics
* Family history of bleeding, history of increased bleeding tendency or prolonged bleeding, current treatment with oral anticoagulants or platelet aggregation inhibitors; Quick \< 65%, international normalised ratio (INR) ≥ 1.3, thrombocyte count \< 100'000/μl, activated partial thromboplastin time (aPTT) \> 37 sec
* Inability or insufficient knowledge of project language to understand the information given in the informed consent form
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients

The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition
* FEV1\> 70% of predicted normal value pre-bronchodilator

Exclusion Criteria:

* Having a known or suspected allergy to study therapy (active drugs or additive)
* Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure
* Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months
* Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks