cyrilzakka/clinical-trials huggingface dataset:
Improving Situational Awareness Before Acute Care

This study aims to assess the impact on the trauma team's situational awareness of using a dashboard to synthesize and disseminate available information on a critical patient incoming to the trauma center.

This trial will be carried out at the Grenoble Alpes University Hospital's simulation center. Volunteer professionals will run scenarios simulating the information transmission chain "pre-hospital team - trauma leader - trauma team" just prior to the admission of a critical patient to the trauma center. In each scenario, the trauma leader will be alerted by phone that a patient is being managed by a pre-hospital medical team and is about to be transferred to the trauma center. The trauma leader will have to synthesize and disseminate the available information to the trauma team (composed of a junior physician, a resident and a nurse). Depending on the allocation group, the transmission chain will be supported or not by a specific trauma dashboard. The scenario will be discontinued at the end of this handover and before the patient's arrival.

Eligibility Criteria:
Inclusion Criteria:

* Physicians, residents and nurses from the Grenoble Alpes University Hospital volunteering to participate.

Exclusion Criteria:

* Prior knowledge of the study scenarios
* Study investigator
The Impact of Heartfulness Program on Loneliness in High School Students in the US

This quantitative study assesses the baseline loneliness scores in all the high school students in the US. Assessments at baseline will include the UCLA loneliness scale. The Google form questionnaire will ask the high schoolers for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.

The specific aims of the study are:

1. To assess the current level of loneliness in high school students through the UCLA loneliness scale.
2. To assess the beneficial impact of the Heartfulness program on loneliness in high school students in the US.

Eligibility Criteria:
Inclusion Criteria:

* Participants are High School students in the US and willing to participate in the study

Exclusion Criteria:

* Non-English speaking high school students in the US and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.
A Study of the Effect of Food on Pirtobrutinib (LOXO-305) in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) after meals and on an empty stomach. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). Participants will stay in this study for up to 53 days (screening through follow-up call).


Eligibility Criteria:
Inclusion Criteria:

* Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive at Screening
* Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
* Must have comply with all study procedures, including the 15-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
* Positive polymerase chain reaction (PCR) test for COVID-19 at Screening
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
* Have previously received pirtobrutinib (LOXO-305) in any other study investigating pirtobrutinib (LOXO-305), within 30 days prior to Day 1
Rehabilitation of Adolescents Living With Chronic Fatigue

Previous studies have shown that health-related quality of life (HRQoL) in adolescents living with chronic fatigue syndrome (CFS/ME) is low if compared with healthy adolescents and adolescents living with other chronic diseases. Effective strategies to improve HRQoL in this group are still lacking. Recently we have observed HRQoL in a group of Norwegian adolescents with CFS/ME (not yet published), which is the background for a new study where we have planned an intervention with health promoting dialogues between patient and nurse, as a strategy to improve HRQoL. In this study we have also opened to include adolescents with other chronic fatigue diagnosis with similar challenges in follow-up as in CFS/ME.


Eligibility Criteria:
Inclusion Criteria:

* chronic fatigue as main symptom (including but not limited to diagnostic codes ICD-10 G93.3 CFS/ME, F48.0 Neurasthenia, R53 Fatigue)
* having undergone an interdisciplinary diagnostic evaluation at The Children's Clinic or at The Fatigue and CFS/ME Outpatient Clinic, St. Olavs hospital during the period 1.8.2019 - 1.4.2020.
* being a pupil or wishing to be a pupil.

Exclusion Criteria:

* not Norwegian speaking
* for any reason unable to read and answer a questionnaire
* for any reason unable to take part in the health promoting dialogues
Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients

To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.

The involvement of microcirculation in diabetes microangiopathy may be the cause of ulceration and severe incapacitation. Torpid ulcers of the lower limbs affect up to 15% of diabetic patients at some moment of their lifetime; about one-third of patients developing ulcers will never achieve their definitive cure, and half of them will die within three years .

Heparins, besides their well known antithrombotic effects, have been shown to stimulate both the synthesis of heparan sulphate -a potent endogenous anticoagulant- in endothelial cell cultures and the proliferation of fibroblasts taken from diabetic ulcers .

After noticing the highly positive evolution of chronic ulcers in six diabetic patients who had received LMWHs in their homes for the prophylaxis of deep vein thrombosis , and considering the excellent safety record of these drugs, we decided to explore the effects of LMWHs on the evolution of diabetic foot ulcers and the quality of life of diabetic patients seen in our primary care practices.

Comparison: bemiparin vs placebo

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years;
* type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years;
* presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner's classification ) and existing for at least three months;
* giving their written informed consent.

Exclusion Criteria:

* hypersensibility to heparin or pig derivatives
* body weight lower than 35 kg
* presence of clinical signs of infection that did not resolve in spite of oral antibiotics;
* anticoagulant therapy;
* severe impairment of renal or hepatic function;
* bleeding disorder;
* active peptic ulcer;
* arterial hypertension with poor control;
* pregnancy or lactation;
* terminal illness or a prognosis of survival under three months.
Fear of Childbirth (Tokophobia) - Etiology, Essence and Clinical Implications

The purpose of this study is twofold:

* to understand the etiology and the essence of fear of childbirth
* to examine the implications and efficiency of several forms of psychological therapy.

Fear of childbirth (Tokophobia) is inconsistently defined in the research literature: some define it as an anxiety disorder while it is often defined as a form of phobia; some regard only the pre-pregnancy period, some regard the anxiety during pregnancy and some focus on the labor process. Despite the high prevalence (between 13%-20% of fertile women), research in this area is scarce and the current findings are incohesive due to various conceptualizations of the phenomenon and to various measurement methods.

Eligibility Criteria:
Inclusion Criteria:

* subjective diagnosis of tokophobia

Exclusion Criteria:

* currently undergoing psychological therapy
* Major Depression
* Acute Anxiety
* Psychosis
* Bipolar Disorder
* Suicidal
* Substance abuse
* Non-compliant personality disorder
* Health problems during pregnancy that affect perception
Prevalence of Spontaneous Pneumothorax in BHD

To assess the prevalence of BHD (Birt-Hogg-Dubé syndrome) among patients with spontaneous pneumothorax. Patients who were treated for primary spontaneous pneumothorax in Rijnstate hospital are to be included. Patients will receive a questionnaire. When given consent, the investigators will invite them for a one-time visit to the out-patient clinic. Patients will be asked for a blood sample to determine pathogenic FLCN (folliculin) mutations and a pulmonary CT scan for evaluation of presence of lung cysts.

Based on the results of the pilot study in VUmc \*Free University Medical Center), in which 3 out of 40 tested patients had a pathological FLCN mutation, the investigators decided to extend the study to a second center; Rijnstate Hospital Arnhem. In this hospital a retrospective search was performed; patients who were treated for primary spontaneous pneumothorax were included. In the dossiers the investigators searched for medical history, pneumothorax side and recurrence, diagnostic imaging, treatment, co-morbidity, complications of treatment, skin abnormalities, kidney disease, smoking behavior, medication, and familial incidence of pneumothorax and other diseases. Patients will receive a letter with explanation of the research and a questionnaire in which the investigators ask them their about the medical status, co-morbidity, pneumothorax (number and side), smoking behavior, use of drugs, familial incidence of pneumothorax and other diseases.

The population will be formed out of patients who have returned the fully filled in questionnaire and who have given permission to receive information for further research. This further information will consist of an information letter on BHD syndrome and a consent form for a one-time visit to the out-patient clinic of Rijnstate hospital. Investigators expect that about 200 patients will return the fully filled in questionnaire and give their consent for further research. In a one-time visit in out-patient clinic, there will be given personal information on BHD syndrome and there will be performed physical examination for finding fibrofolliculomas. A pulmonary CT scan for evaluation of presence of lung cysts will be performed. Two samples of venous blood will be collected to access information on DNA diagnostics for pathogenic FLCN mutations. These are associated with the BHD syndrome. This last diagnostic testing will be performed in VUmc (Vrije Universiteit medisch centrum or Free University Medical Centre).

Eligibility Criteria:
Inclusion Criteria:

* treated in Rijnstate hospital for primary spontaneous pneumothorax
* informed consent

Exclusion Criteria:

* secondary or iatrogenic pneumothorax
Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).


Eligibility Criteria:
Inclusion criteria:

* at least, 50 patients with "recent" type 1 diabetes,
* 30 patients with long-term type 1 diabetes,
* 10 patients with Latent Autoimmune Diabetes,
* 10 subjects with a risk for diabetes,
* 20 type 1 diabetic patients with pancreatic graft or Langerhans islet graft.
* 50 healthy subjects paired to HLA class I and to the age

Those subjects have to respect the following criteria :

* Age from 7 to 70 -Caucasian
* Affiliated to a national insurance scheme
* Written informed consent obtained For children, written informed consent is required from the two parents.

Non-inclusion criteria :

* Age strictly inferior to 7 or strictly superior to 70 years old
* Pregnancy
* Secondary diabetes
* No written informed consent
Adiana Post-Approval Clinical Study (APACS)

The Adiana Post-Approval Clinical Study (APACS) has been designed to compile information on the efficacy and safety of the Adiana Permanent Contraception System in the post market setting. Specifically, data will be collected that is relevant to the evaluation of the safety and efficacy of the Adiana System for women who desire permanent birth control by occlusion of the fallopian tubes. This study is an observational study that is not intended to test specific hypotheses.

Adiana Post-Approval Clinical Study is a prospective, single armed, multi-center, observational study that is designed to provide additional efficacy and safety data regarding the FDA-approved Adiana Permanent Contraception System. This study will be conducted at 8-10 clinical sites and enroll 1000 subjects. Enrolled subjects will have baseline data collected at the time of their Adiana procedure and will then be followed for a period of 2 years with visits occurring at 3 months following the Adiana procedure, 6 months following Adiana procedure (as applicable), 12 and 24 months post relying date.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are seeking permanent sterilization
* Women 18-45 years old
* Subjects who are at risk of becoming pregnant
* Subjects willing to use alternative contraception for at least three (3) months following device placement and bilateral tubal occlusion is confirmed by HSG
* Subjects who are able to provide informed consent

Exclusion Criteria:

* Subjects who are uncertain about their desire to end fertility
* Clinical evidence of an active pelvic infection or history of a recent pelvic infection
* Has intra-uterine pathology which would prevent access to either tubal ostium or the intramural portion of either fallopian tube (i.e., large submucous fibroids, uterine adhesions, apparent uni or bilateral proximal tubal occlusion, suspected unicornuate uterus, etc.)
* Is pregnant (as evidenced by pregnancy test result) or suspects pregnancy
* Is currently less than three (3) months since her last pregnancy
* Has previously undergone a tubal ligation
* Is currently taking immunosuppressive medication (e.g., steroids)
* Has a known allergy to contrast media
* Has external pacemaker or internal cardioverter defibrillator
* Subject is unable to follow the protocol and return for follow up visits
* In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study
Effect of Laughter Therapy on hemodıalysıs patıents

Internet-based behavioral therapy applications made during the quarantine and isolation period during the pandemic process, and the application of laughter therapy, which is a group-oriented technique that increases the feeling of togetherness and happiness, can be used as an online method to reach large masses. However, since there are a limited number of studies in the literature on online laughter therapy in patients and not all sessions are online in the study, it was thought that more and methodological studies are needed to confirm the effectiveness of the therapy on the applicability of the online platform. Therefore, this study was conducted to evaluate the blood cortisol levels, depression, anxiety, stress levels and quality of life of laughter therapy in hemodialysis patients.

In this research, laughter therapy applied to hemodialysis patients; This is an experimental design with pretest and posttest control groups in order to examine the effects on serum cortisol levels, depression, anxiety, stress levels and quality of life. The study will be conducted between March 2023 and June 2023 on 80 patients who are receiving hemodialysis treatment in two Dialysis Centers in Zonguldak city center and meet the inclusion criteria. Introductory information form, Depression Anxiety and Stress Scale, Kidney Disease Quality of Life Form will be used in the study and blood samples will be taken from the patients for cortisol. Laughter therapy will be applied three days a week, for a total of 12 sessions for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Do not prevent you from doing laughter yoga (having undergone abdominal surgery in the last three months, uncontrollable hypertension, chronic cough, incontinence, acute low back pain, acute mental disorders, consumption of antipsychotic drugs, glaucoma, hernia, epilepsy)
* History of psychiatric illness (major depression, alcohol abuse, substance abuse, schizophrenia or paranoid disorders, personality disorder, somatoform disorder)
* Standardized Mini Mental Test (SMMT) score 24\>
* Not doing laughter yoga before
* Being able to use smart phone/computer/tablet and using internet applications actively

Exclusion Criteria:

* Initiation of medication that may affect serum cortisol levels
* Diagnosis of psychiatric illness during sessions
* Surgery on the abdominal region during laughter sessions
Neural Changes Following Cognitive Behavior Therapy for Procrastination

The aim of this study is to compare the efficacy of and the neural changes following two cognitive behavior therapy (CBT) protocols for procrastination with a wait-list control group. The interventions will be delivered online in group settings. Both protocols include identical psychoeducation and cognitive modules aiming at identification and modification of dysfunctional automatic thoughts related to procrastination but will differ in the behavioral modules. The behavioral module in the first protocol is focused on timely beginning and realistic planning. The second protocol implements working time restriction. The wait-list control group will receive one of the CBT protocols after a waiting period that will last as long as the CBT intervention and the assessments performed directly after treatment. It is assumed that the interventions will be superior to the wait-list control. Primary (procrastination) and secondary (depression and anxiety) measures will be collected prior to and after the interventions (or waiting period in the wait-list group) and after 6 months in the two active condition groups. Additionally, neuroimaging measurements will be conducted before and after the interventions (or waiting period in the wait-list group). Approximately half of the participants will undergo functional Magnetic Resonance Imaging (fMRI), and another half will undergo electroencephalography (EEG). Both methods are aimed at exploring neural correlates of the expected improvements in participants' self-regulation abilities.


Eligibility Criteria:
Inclusion Criteria:

* Bachelor's and Master's university students
* Self-reported primary difficulties related to chronic and severe procrastination
* Serious procrastination problem lasting for at least one year as confirmed during clinical interview
* Having a postponed/procrastinated project to complete in the course of therapy
* Willing to participate in the study
* Fluent in Polish language
* Computer access and stable Internet connection

Exclusion Criteria:

* Current participation in other psychotherapy
* Use of psychiatric medication during the last 12 weeks
* Severe anxiety or affective disorders or any other severe psychiatric disorders that require other types of specialized care and are primary to procrastination problem (e.g. major depressive episode, social phobia, PTSD, etc.)
* Active suicidality
* Psychosis, bipolar disorder
* Alcohol or substance dependence
* Severe personality disorders (with the exclusion of avoidant, dependent and obsessive-compulsive personality disorders)
* For Warsaw participants: contradictions for fMRI measurement (metal elements in the body, claustrophobia, neurological conditions, pregnancy etc), non right-handedness.
* For Poznań participants: neurological conditions (e.g. epilepsy)
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors

Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced solid tumor for which no curative or standard therapies exist.
* Karnofsky Performance Status ≥60.
* Adequate hematological function.
* Adequate organ function.
* Women of non-child-bearing potential (defined as being \>1 year post-menopausal) or using effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the investigational product may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of MEDI-573. Male subjects with partners of child-bearing potential must be surgically sterile or use contraceptive method as described above from the time of the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.

Exclusion Criteria:

* No prior treatment within 4 weeks of study drug administration.
* No concurrent therapy for treatment of cancer.
* No uncontrolled diabetes.
* New York Heart Association Grade ≥ 2 congestive heart failure.
* History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry.
* Documented brain metastasis.
* Pregnancy or lactation or plans to become pregnant while on study.
* Clinically significant abnormality on ECG.