cyrilzakka/clinical-trials huggingface dataset:
Exploration of the Relationship Between Inflammation and Integrity of the Blood-Brain Barrier in Suicidal Behaviour

Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. However the relationship between peripheral and central inflammation in suicide is probably mediated by complex biological processes that are yet elucidated. An increase of blood S100B levels (biomarker of neurovascular damage; PMID 14530574) has been reported in adolescents with suicidal ideation vs. controls and independently of psychiatric disorder. The investigators hypothesize that peripheral inflammation may alter BBB which normally acts as a filter to ensure proper neuronal functioning in suicidal vs. non suicidal patients.

105 participants will be recruited :

* 35 depressed patients having attempted suicide (maximum 3 attempts in life)
* 35 depressed patients without history of suicide attempt (affective controls)
* 35 healhy controls with no lifetime psychiatric history.

Only one visit is planned. A clinical assessment (2 hours) will be performed to characterise pschopathology and suicidal characteristics. Blood and salivary samples will be obtained in order to measure inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old
* Able to understand nature, aims, and methodology of the study

Depending on the population :

* Current depressive episode (according to DSM-5 criteria) with a recent suicide attempt (within the 8 days before inclusion) and no more than 3 attempts in life
* Current depressive episode (according to DSM-5 criteria) without suicide attempt
* No psychiatric history (according to DSM-5 criteria)

Exclusion Criteria:

* Inflammatory diseases or intercurrent infections, or chronic diseases such as hepatitis C or B, HIV, Alzheimer's, cancer or autoimmune disease
* Current antibiotic or anti-inflammatory treatments
* Refusal to participate
* Lifetime Schizoaffective disorder or schizophrenia
* On protective measures (guardianship or trusteeship)
* Deprived of liberty subject (administrative decision)
* In exclusion period for another protocol
* Not affiliated to a social security agency
* Unable to understand and/or answer a questionnaire
* Pregnant or lactating women
Magnetic Resonance (MR) Imaging in the Post Operative Follow-up of Cholesteatoma in Children

Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a large serie of surgically verified cases.

Classical imaging techniques are inaccurate to detect residual cholesteatoma. Thin-section CT detects that the postoperative cavity is filled with a soft tissue mass. Classical MR imaging (T2 and T1 weighted spin-echo sequences) can not provide additionnal information about the nature of this filling : cholesteatoma, granulation or fibrous tissue.

Eligibility Criteria:
Inclusion Criteria:

* Female or male child enters 5 and 18 years
* Child having benefited from a surgical operation for cholesteatoma of the average ear acquired or congenital, one-sided or bilateral
* Child for whom an additional operating time is indicated
* Child without contraindication in the MRI
* Child having signed a enlightened assent
* Child among whom the parents or the legal representatives signed a enlightened assent

Exclusion Criteria:

* Child of less than 5 years old and more than 18 years
* Child presenting a chronic renal insufficiency
* Child for whom an additional operating time is not indicated
* Child having a contraindication in the MRI
* Child not having signed the assent or the parents of which did not sign the assent
Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life

Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin which is given every other month.. Inhalation of Tobramycin was proven as an effective treatment that improves the respiratory function and reduces the concentration of bacteria in the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and therefore adherence is a major problem. The effect of switching from inhalation treatment to inhaler treatment on patient's adherence and quality of life has not been studied.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 years and above, Chronic Pseudomonas infection

Exclusion Criteria:

* Younger than 6 years; No chronic PSeudomonas infection
Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia

This is an open-label, single arm, phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with DNA methyltransferase inhibitor decitabine in elderly patients with relapse and refractory acute myeloid leukemia.

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, 29 relapsed or refractory acute myeloid leukemia patients will be enrolled. Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Age: 60-75
* Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
* ECOG：0-2
* Life expectancy ≥ 3 months
* Adequate laboratory parameters during the screening period as evidenced by the following:

  1. Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L
  2. ALT and AST ≤ 3 × upper limit of normal (ULN)
  3. FEV1,FVC,DLCO ≥ 50% predicted value
  4. Left ventricular ejection fraction (LVEF) ≥ 40%, no symptomatic arrhythmia
  5. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

* Treatment-related AML
* Allergic to Camrelizumab, Decitabine, other monoclonal antibody or pharmaceutical excipients
* Use of immunosuppressive drug within 2 weeks before entering the group
* Abnormal liver and kidney function(does not meet the inclusion criteria)
* Suffering from heart failure
* Active tuberculosis or HIV positive
* Active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,Hepatitis B and hepatitis C infection in common.
* Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
* Concurrent medical condition requiring the long-term use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids \> 10 mg/day topical prednisone or equivalent
* Suffer from other hematological neoplasm
* Known history of use other immune checkpoint inhibitor
* Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.
Text Message Treatment for Social Anxiety

This is an intervention study designed to evaluate a text message based safety behavior fading treatment for people with social anxiety disorder.

This study hopes to assess whether a month long text message based safety behavior fading protocol is effective in reducing safety behaviors and social anxiety symptoms. Over the course of four consecutive weeks, text messages will be sent to participants the first day of the study and every other day for four weeks (14 texts in total). These text messages will remind participants to either avoid using their three most engaged in safety behaviors (assessed at pre-treatment) or to stay present-focused. The past week frequency of the participants' safety behaviors will be assessed at the beginning of pre-treatment, post-treatment, and four week follow up assessments Participants will be asked to complete an additional online questionnaire for both a post-treatment and a 4-week post-treatment follow up assessment. We hypothesize that: 1) the safety behavior group will show a greater overall reduction in social anxiety symptoms, 2) that the safety behavior group will show a reduction in the frequency of safety behavior use, and 3) that the present-focused group will show an increase in mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* Social Phobia Inventory score \> 29

Exclusion Criteria:

* receiving therapy
* changes in the past 4 weeks with medication for emotional difficulties
* psychotic symptoms
Local Adaptation of Cost Effectiveness Model for Apixaban Atrial Fibrillation Indication - Venezuela

To characterize treatment patterns and healthcare resource utilization among adults diagnosed with non-valvular atrial fibrillation (NVAF) from the private setting in Venezuela.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of AF (incident and prevalent cases)
* Patient with at least 18 years
* Patients enrolment before and during the study period
* Patients treated in Venezuela

Exclusion Criteria:

* Women who were pregnant at any moment during the study period
The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine

This study compares the efficacy of low dose Ketamine versus Compazine for the control of headache in patients presenting to the Emergency Department.

After enrollment, each patient will randomized either to the standard treatment arm to receive prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV, OR to the study arm to receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. The diphenhydramine or ondansetron will be administered first, and immediately afterward the prochlorperazine or Ketamine will be administered. The prochlorperazine or Ketamine will be diluted in saline so that the total volume is 5 mL, and will be administered over 2 minutes. The diphenhydramine will be diluted in saline so that it is 2 mL (the same volume as the ondansetron). Both groups will also receive a 500 mL normal saline bolus after the study medications are administered. The ED pharmacist will be responsible for preparing the medications, using a double-blind protocol. He or she will record which arm the patient was randomized to. Only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. Emergency providers will be instructed not to administer any rescue medications for at least 30 minutes. The electronic medical record order will read "randomized study medication" (for the Ketamine or prochlorperazine) and "randomized add-on medication" (for the ondansetron or diphenhydramine).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* Temperature \< 100.4° F
* Diastolic Blood Pressure \<104 mm Hg
* Normal neurological exam and mormal mental status

Exclusion Criteria:

* Pregnant or breastfeeding.
* Meningeal signs are present
* Acute angle closure glaucoma is suspected.
* Head trauma within the previous two weeks
* Lumbar puncture within the previous two weeks
* Thunderclap onset of the headache
* Weight more than 150 kg or less than 40 kg.
* Known allergy to one of the study drugs.
* History of schizophrenia or bipolar disorder.
* History of intracranial hypertension.
* Is a prisoner
* Patient declined informed consent
* Non-English speaking patient.
* Attending provider excludes patient
The Effect of Patient-Family Communication Via Audio Recording

The study was conducted as a randomized controlled blinded study. The sample consisted of 55 patient relatives (27 in the experimental group and 28 in the control group). The patient's relatives in the experimental group said what they wanted to say to their patient in line with the content determined by the researchers and recorded it using a voice recorder. The researcher played the recorded message to the patient, and the patient's feedback was conveyed to the patient's relative.

Visitor restrictions in coronary intensive care units (CICUs), which make it difficult for relatives to communicate with and support their patients, can lead to negative emotional reactions such as anxiety, depression and anger in family members. This study was conducted to determine the effect of playing the voice recording of the relatives to the patients hospitalized in CICU on the anxiety, depression and satisfaction levels of the relativesThe study was conducted as a randomized controlled single blinded study. The sample consisted of 55 patient relatives (27 in the experimental group and 28 in the control group). The patient's relative in the experimental group said what they wanted to say to their patient in line with the content determined by the researchers and recorded it using a voice recorder. The recorded message was played to the patient by the researcher and the feedback of the patient was conveyed to the patient's relative by the researcher. The relatives of the patients in the control group were routinely informed. The "Patient Relative Introduction Form", "Hospital Anxiety Depression Scale (HADS)", "Visual Analog Scale-Anxiety (VAS-A)" and "Satisfaction Scale of Families of Patients Hospitalized in Intensive Care Unit (FS-ICU)" were used to collect the data.

Eligibility Criteria:
Inclusion Criteria:

* Being able to speak and understand Turkish,
* Being a first-degree relative of a patient hospitalized in the CICU with AMI.

Exclusion Criteria:

* Hearing and speech problems.
Microplasmin Administered Via the Trellis-8 Infusion System for Treatment of Acute Iliofemoral DVT

A single centre, single-arm study to evaluate safety and efficacy of microplasmin administration via the Trellis-8 Infusion System in patients with acute iliofemoral DVT


Eligibility Criteria:
Inclusion Criteria include:

* Patients with radiographically-confirmed acute proximal DVT

Exclusion Criteria include:

* Isolated calf or popliteal vein DVT, based on duplex ultrasound
* Thrombus involving the inferior vena cava (IVC)
* Proximal (e.g. cranial) aspect of thrombus cannot be adequately assessed to level of the iliac veins or inferior vena cava, based on duplex ultrasound.
* Cannot traverse the target vessel segment with guidewire
* Symptomatic pulmonary embolism is present at time of presentation
* Documented history of prior DVT in target extremity
* History of anticoagulants administered for \> 30 days for undocumented/ unclear reason (e.g. for reasons other than presence of mechanical cardiac valve, atrial fibrillation, etc.)
* Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
* Cannot receive standard secondary prevention pharmacotherapy \[i.e. heparin or LMWH and vitamin K antagonists (VKA)\] due to contraindications to anticoagulation \[e.g. known bleeding diathesis, thrombocytopenia (platelets \< 100,000 mm3), heparin induced thrombocytopenia (HIT), known allergy to heparin or warfarin\]
* Absolute contraindication to thrombolytic therapy
* Previous central nervous system haemorrhage
* Life expectancy less than 1 year, due to other comorbid condition.
* Previous intervention in target limb to address venous thrombus.
* Target limb has chronic venous insufficiency of C4 or greater severity
* Acute or chronic symptomatic musculoskeletal condition in target limb (e.g. trauma, fracture, severe arthritis).
* Documented patent foramen ovale or other right-to-left cardiac shunt.
* Absolute contraindication to contrast media or renal insufficiency (baseline creatinine \>2.0 mg/dL).
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism

The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit.


Eligibility Criteria:
Inclusion Criteria: - CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment - An iPTH determination within 14 days before randomisation must be greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) - A serum calcium determination (corrected for calcium) within 14 days before randomisation must be greater than or equal to 8.4 mg/dL \[2.1 mmol/L\] Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Are currently breast-feeding - Are performing peritoneal dialysis - Have had a parathyroidectomy in the 3 months before day 1 - Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United States

To assess the impact of reactogenicity among health care workers and first responders receiving an updated 2024-25 Novavax COVID-19 vaccine as compared with those receiving an updated 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine

This is a prospective interventional study of health care workers (HCW) and first responders (FR) receiving an updated 2024-25 COVID-19 vaccination at the University of Utah (UT). Participants can choose which COVID-19 vaccine type they would like to receive from the study team. For this study, health care workers and first responders are defined as anyone having direct face-to-face contact, defined as being within 3 feet, or about an arm's length, with patients as part of their full-time or part-time (greater than or equal to 20 hours per week) job responsibilities.

Approximately 660 health care workers and first responders from Salt Lake City, Utah and surrounding areas will be enrolled into the study. This study will only enroll participants who intend to get an updated 2024-25 COVID-19 vaccine during Fall/Winter 2024-25 SARS-CoV-2 virus circulation. Eligible participants will choose their desired vaccine type (protein subunit: Novavax, or mRNA: Pfizer). Study vaccinators will then administer the chosen vaccine. Following vaccination, study participants will receive a post vaccination questionnaire 48-hours after vaccine administration. Self-reported information on systemic and local reactogenicity symptoms, socio-demographics, occupational history, medical history, COVID-19 and flu vaccine history, and impact on daily activities and work will be collected through the post vaccination questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older who have received at least one COVID-19 vaccination in the past 4 years
* Health care workers or first responders who have direct face-to-face contact, defined as being within 3 feet, or about an arm's length, with patients as part of their full-time or part-time (greater than or equal to 20 hours per week) job responsibilities
* Intends to receive a dose of the updated 2024-25 COVID-19 vaccine
* Able to understand and provide informed consent
* Comfortable reading and responding to text messages and emails sent in English or having an interpreter assist them
* Able and willing to comply with all study requirements
* Access to a smartphone, tablet, or computer to complete the consent, screener and study questionnaires

Exclusion Criteria:

* Ongoing participation in other vaccine or investigational product trials within 90 days of study enrollment
* History of self-reported severe allergic reaction to prior COVID-19 vaccine
* Receipt of COVID-19 vaccine within 60 days of enrollment
* Plans to receive additional vaccines within 7 days after the vaccination visit for study enrollment. (Co-administered vaccinations at time or day of COVID-19 vaccination are permissible)
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

The primary purpose of this study is to assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption, in patients previously exposed to exenatide.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes.
* Have been exposed to exenatide for at least 3 months in previous Amylin/Lilly Studies H8O-MC-GWAO, H8O-MC-GWAP, H8O-MC-GWAT, or H8O-MC-GWBA.
* Have interrupted exenatide treatment for a period of at least 2 months.
* HbA1c of ≤10.5%.

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Have previously completed or withdrawn from this study.
* Have taken marketed exenatide (Byetta) during the interim period between studies GWAO, GWAP, GWAT, or GWBA and the current study.
* Used drugs for weight loss (for example, Xenical® \[orlistat\], Meridia® \[sibutramine\], Acutrim® \[phenylpropanolamine\], Accomplia® \[rimonabant\], or similar over-the-counter medications) within 3 months of screening.
* Are currently treated with any of the following excluded medications: Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
* Use insulin with daily dosage exceeding 1 U/kg.