cyrilzakka/clinical-trials huggingface dataset:
Reducing Brief Thermal and Electrical Pain (Four Study Days)

Ultimately, the purpose of the present study is to help improve pain control in burn patients during wound care and physical therapy, where pain levels with opioids alone are often excessively high.

This study measures how much virtual reality pain distraction reduces pain compared to traditional opioid pain meds, and whether there is additional pain reduction when Virtual Reality distraction + Opioids are combined. In addition to studying the amount of pain reduction, this study will also measure side effects (if any) of the two treatments (Virtual Reality pain distraction and Opioids) alone and when combined.

Healthy volunteers will be recruited from advertisements will undergo a trial of the pain testing. They will receive a series of brief stimuli (at a painful but tolerable safe intensities they select and approve during baseline testing), separated by intervals of no pain.

Participants will rate how much pain they felt after each brief stimulus, and will fill out side effects questionnaires after finishing the pain session.

Subjects will participate in each of the four conditions in which the order is randomized.

* No opioids (0ng/ml hydromorphone) + no virtual reality Snow World distraction
* No opioids + yes virtual reality Snow World distraction
* Moderate dose of pain medicine (4ng/ml hydromorphone) + no virtual reality
* Moderate dose of pain medicine + yes virtual reality Snow World distraction

It is our hypothesis that VR distraction + opioids will show a reduced perception of pain in subjects more than opioids alone or no intervention (control).

In this study, healthy volunteers aged 18-45 who sign up after seeing a flyer or web posting are screened for exclusion via telephone interview, and if eligible, a health background interview. Initial contact will come from the subject's response to recruitment materials. Subjects may withdraw at any time.

These safe laboratory studies with healthy volunteers are designed to help us figure out how to maximize the effectiveness of virtual reality when used with severe burn patients at Harborview Burn Center

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women 18-45 years old
* Normal height and weight ratio

Exclusion Criteria:

* women who are pregnant and nursing
* history of substance abuse
* access to opioids in the workplace
* smokes cigarettes
* history of medical problems with the following: heart, lungs, liver, kidneys, endocrine, neurologic, migraines, or psychiatric requiring medical intervention
* anemia
* chronic pain
* allergy or hypersensitivity to opioids, velcro, or latex
* severe motion sickness
* unusual sensitivity or lack of sensitivity to pain
* sensitive skin or feet
Evaluation of Intrafractional Motion of Liver Tumors Using Markers

Radioopaque fiducial markers or electro-magnetic transponders will be implanted into or in close proximity of the tumor. During a radiotherapy treatment session image and/or signal acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging or by specialized signal detectors The data will help to characterize tumor and organ motion during one treatment session which may in fact have impact on dose distribution

With the development of more conformal and precise radiation techniques such as Intensity-Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT) and Image-Guided Radiotherapy (IGRT), patients with hepatic tumors could be treated with high local doses by sparing normal liver tissue. However, frequently occurring large HCC tumors are still representing a dosimetric challenge in spite of modern high sophisticated RT modalities. This interventional clinical study has been set up to evaluate the value of different fiducial markers, and to use the modern imaging methods for further treatment optimization using physical and informatics approaches.Radioopaque fiducial markers or electro-magnetic transponders will be implanted into or in close proximity of the tumor. During a radiotherapy treatment session image and/or signal acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging or by specialized signal detectors The data will help to characterize tumor and organ motion during one treatment session which may in fact have impact on dose distribution

Eligibility Criteria:
Inclusion Criteria:

* indication for high precision radiotherapy of primary and secondary liver tumors using IGRT (image-guided radiotherapy)
* age ≥ 18 years of age
* ability of subject to understand character and individual consequences of the clinical trial
* written informed consent (must be available before enrolment in the trial)

Exclusion Criteria:

* refusal of the patients to take part in the study
* medical reasons impeding marker implantation or IGRT for treatment of liver tumors.
* non-compliance of patients
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure (Visit 1).
* Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104).
* For woman of childbearing potential, the following is required:

  * Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
  * Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.

Exclusion Criteria:

* Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
* For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
* Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).
Tecovirimat for Treatment of Monkeypox Virus

The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox (mpox) in combination with standard of care (SOC). Participants will be randomly assigned to receive oral tecovirimat plus SOC or placebo plus SOC for 14 days.

This is a randomized, placebo-controlled, double-blind study to test the antiviral drug tecovirimat for the treatment of adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo. Eligible and consented participants will be randomized 1:1 to receive either oral tecovirimat or placebo, each administered in the hospital with standard-of-care (SOC) treatment for 14 days. Participants will be followed for 28 days with an optional visit at Day 59 for long-term assessment.

If a participant reaches full body lesion resolution but subsequently develops at least one new lesion consistent with mpox after discharge but while still enrolled in the study, they will be eligible to make a sick visit and will be offered standard of care for mpox.

Eligibility Criteria:
This study has no age restriction.

Inclusion Criteria:

* Laboratory-confirmed monkeypox virus infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
* Monkeypox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
* Weight ≥3 kg
* Men and non-pregnant women of reproductive potential must agree to use effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Acceptable methods of contraception include the following:

  * Hormonal contraception
  * Male or female condom
  * Diaphragm or cervical cap with a spermicide
  * Intrauterine device
* Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
* Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so

Exclusion Criteria:

* Current or planned use of a meglitinide (repaglinide, nateglinide)
* Planned use of midazolam while on study drug
* Severe anemia, defined as hemoglobin \<7 g/dL
* Current or planned use of another investigational drug at any point during study participation
* Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
* Participants who are unable to safely swallow oral medications, such as those who are at risk of aspiration
Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF

The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.

The study is a prospective, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).

Eligibility Criteria:
Inclusion Criteria:

* Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)
* Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal support with vaginal micronized progesterone.
* Single fresh D5 embryo transfer

Exclusion Criteria:

* Frozen-thawed embryo transfer
* Donor egg in the current transfer
* More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
* Serum P4 greater than 1.5 ng/mL prior to hCG administration
Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)

The purpose of the study is to see if "Behavioral Activation and Social Engagement for PTSD" (BASE for PTSD), an individual therapy for PTSD, will help Veterans with PTSD 1) through improved understanding of how PTSD affects them, 2) by reducing ways in which they avoid meaningful activity due to PTSD, 3) by enabling them to do more of the things they really care about, and 4) by improving, strengthening, and building up their social supports.

Posttraumatic stress disorder (PTSD) is a mental health condition that some people develop following exposure to a traumatic event. PTSD often results in a reduction in feelings of connection to other people and changes in views about others, as well as reduced participation in valued activities. Many veterans with PTSD do not seek treatment offered in specialty mental health settings and may forgo treatment of any kind.

This study is an open-trial format (no comparison condition) of U.S. military veterans who will participate in a brief psychotherapy treatment for PTSD offered in a Primary Care setting. This is a pilot trial to see if the treatment is effective at reducing symptoms of PTSD and increasing feelings of social support, and an exploratory aim is to see if veterans engage in additional treatment after completing this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Veterans who:

  1. are currently enrolled in either of the Primary Care Clinics (including Women's Clinic) or Primary Care Mental Health Integration clinic at VA Puget Sound Health Care System - Seattle Division
  2. meet criteria for clinical or subclinical PTSD
  3. are willing to have therapy sessions audiotaped for the purposes of supervision
  4. plan to live in the Seattle area for 6 months following entry into the study

Exclusion Criteria:

* Veterans who:

  1. exhibit the presence of severe mental illness diagnosis (e.g., active psychosis and/or uncontrolled bipolar disorder)
  2. have been a psychiatric in-patient admission in the past 30 days
  3. have had a suicide attempt in the last 60 days
  4. have had a plan or intent to harm self or others in the last 30 days
  5. have a behavioral flag in their medical record
  6. have had a psychiatric medication dosing or receipt that has changed in the last 30 days
  7. are unwilling to provide at least 1 collateral contact
  8. have impaired decision making capacity (as measured by evidence in the Computerized Patient Record System record of moderate-severe Traumatic Brain Injury, uncontrolled psychosis, dementia, communication flag, or by clinical judgment in speaking with the participant
  9. are prisoners
  10. are illiterate or have limited or no English proficiency
  11. are terminally ill
  12. are currently participating in Cognitive Processing Therapy (CPT) or Prolonged Exposure Therapy (PE)
Studying RNA in Samples From Younger Patients With T-Cell Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

PURPOSE: This laboratory study is looking into RNA in samples from younger patients with T-cell (T) acute lymphoblastic leukemia (ALL).

OBJECTIVES:

* Characterization of the transcriptomic landscape in diagnosis and relapse of T-cell acute lymphoblastic leukemia (ALL) and the direct comparison with corresponding physiological samples (human thymus).
* Perform high-throughput transcriptome ribonucleic acid (RNA) sequencing using matched diagnostic T-precursor pediatric ALL samples (peripheral blood or bone marrow).

OUTLINE: Archived peripheral blood and bone marrow samples are analyzed for long non-coding RNA (IncRNA) expression and sequencing.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Peripheral blood and bone marrow samples from pediatric patients with diagnosed and relapsed T-ALL

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Clinical Trial for the Assessment of Delayed Antibiotic Treatment in Pediatric (DAP-Pediatrics)

The general hypothesis is that delayed antibiotic treatment strategy present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.

The current project (DAP Pediatrics) is a study that explores the optimization of antibiotic prescribing in our country by evaluating the delayed prescription of antibiotics. The proposed trial will take place in the context of a prior similar study we conducted in adults. The study currently underway is the DAP-Adults study (a randomised controlled trial that evaluates several antibiotic prescribing strategies, including de delayed prescription in uncomplicated acute respiratory infections in adults in primary care).

The aim of this study DAP-Pediatrics (randomized, multicenter parallel) to determine the efficacy and safety of delayed prescription of antibiotics compared to direct prescription and non-prescription of antibiotic in uncomplicated acute respiratory infections in pediatric patients. This 3 arms clinical trial will include 450 children and will evaluate the duration and severity of symptoms, antibiotic consumption, parents' satisfaction, the perceived efficacy of antibiotics and the number of visits generated. The project also includes a qualitative study, by means of structured interviews, to assess the perception and attitudes of parents towards the different treatment strategies and carry out a full analysis of economic evaluation.

Eligibility Criteria:
General Inclusion Criteria:

In this study can be enrolled children (2 to 14 ages) with non-complicated acute respiratory tract infections, including pharyngotonsillitis, rhinosinusitis, acute bronchitis and acute media otitis. The doctors include children with these infections if they have reasonable doubts if they should treat with antibiotics.

General Exclusion Criteria:

* Patients not aged between 2 and 14.
* Patients have participated in the DAP-pediatrics previously.
* Patients are severely affected or patients has been felt severely affected for one week (all time).
* Patients with symptoms and signs suggestive of serious illness or severely affected and/or complications (particularly pneumonia, mastoiditis, peritonsillar abscess, peritonsillar cellulitis, intraorbital or intracranial complications).
* Patients at high risk of serious complications due to prior comorbidity. This includes significant heart disease, lung, kidney, liver or neuromuscular, immunosuppression, cystic fibrosis.
Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay

The worldwide health system has been marked by the SARS-CoV-2 pandemic. French educational system has been upset, especially medical schools, which, because of their hospital location, are particularly exposed to the spread of the virus. The medical school of Paris-Saclay University, located within bicetre University Hospital, AP-HP, must therefore adapt on a daily basis to ensure educational continuity. Taking advantage of an exceptional scientific ecosystem, innovative viral epidemic propagation modeling approaches based on both simulation and contact tracing data will be tested in real-life conditions. These propagation models will serve to scientifically optimize future educational organization procedures in this medical school.

All the participants will be equipped with individual wireless contact tracing technology. Anonymised contact events will be automatically monitored for a period of two months to measure the daily contact flow density between the students at medical school. Epidemic simulation models will be enriched with these real contact tracing data to generate optimized viral propagation probability networks. During the same period, CO2 measurement will be performed in several relevant sectors (classrooms, amphitheaters, corridors etc) to allow a more holistic understanding of the propagation conditions. Finally, the probabilistic models will be confronted to the results of a two step COVID-19 screening campaign.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers of adult men and women over 18 from the Paris-Saclay Medicine UFR

  * Belonging to the teaching staff
  * Belonging to the promotions of DFGSM 2 and 3, and DFASM 1 and 2 (2nd to 5th year of medical study)
  * administrative staff
* Affiliated to a social security scheme or beneficiary (excluding AME)
* Informed and written consent

Exclusion Criteria:

* Absence of intercurrent disease before inclusion
* Positive antigenic or PCR test at the time of inclusion
Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors

The purpose of this study was to assess the safety of the combination of relacorilant (CORT125134), a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in participants with solid tumors and to determine the preliminary efficacy of the combination of relacorilant and nab-paclitaxel. The structure for the study was a single arm, non-randomized, open- label, multicenter trial with no control group.

The study consisted of two segments to evaluate alternative dosing schedules of relacorilant administered at escalating dose levels. Segment I was to evaluate a continuous-dosing regimen and Segment II was to evaluate an intermittent-dosing regimen. Enrollment in Segment I and Segment II were mutually exclusive, and the two segments enrolled participants concurrently.

In Segment I continuous-dosing cohorts, participants received a single nab-paclitaxel lead-in infusion on Day 1 of Week -2 before Cycle 1, and oral relacorilant lead-in once-daily of Week -1 before Cycle 1. After the Data Review Committee review of data for 2 dose levels, the nab-paclitaxel lead-in was discontinued. The lead-in period was followed by oral relacorilant administered continuously once daily, in combination with nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment 1 enrolled a total of 64 participants.

In Segment II intermittent-dosing cohorts, participants received a single relacorilant lead-in dose on Day -1 before Cycle 1, followed by oral relacorilant, administered intermittently the day before, the day of, and the day after nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment II enrolled a total of 21 participants.

Eligibility Criteria:
Inclusion Criteria:

* Participants with advanced or metastatic solid tumors who have disease progression after treatment with available therapies and for whom nab-paclitaxel treatment is appropriate.
* Measurable or evaluable disease.
* Up to 3 prior cytotoxic chemotherapeutics regimens or myelosuppressive therapies in the advanced setting.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* For Part 2 Only: Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, or Triple Negative Breast Cancer with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in at least 1 lesion, that in the opinion of the Investigator is appropriate to treat with nab-paclitaxel.

Exclusion Criteria:

* Any major surgery within 4 weeks prior to the first dose of study drug.
* Some protocol specified treatments prior to the first dose of study drug.