cyrilzakka/clinical-trials huggingface dataset:
A Pilot Laboratory Study Investigating How Physical Tasks and Hunger Affect Taste Perception

This one time pilot laboratory study focuses on examining the relationship between different types of physical tasks and taste perception of high and low-calorie foods among hungry individuals.


Eligibility Criteria:
Inclusion Criteria:

* Willing to travel to laboratory around lunchtime for the study
* Willing to abstain from eating and drinking caloric beverages for at least 4 hours prior to completing the study
* Typically eats lunch

Exclusion Criteria:

* Diabetes, eating disorder, or any other condition that makes it unadvisable for participant to refrain from eating or drinking caloric beverages for 4 hours.
* Food allergies that would prevent participants from eating chocolate chip cookies or vegetables
* Pregnant or lactating
* Typically goes for longer than 5 hours (not counting sleep time) between meals and snacks
* Physical disabilities that would make it difficult for the participant to walk or to use their hands to grasp objects
Optimization of the Diagnosis of Bone Fractures in Patients Treated in the Emergency Department by Using Artificial Intelligence for Reading Radiological Images in Comparison With Traditional Reading by the Emergency Doctor.

As part of the management of a patient with suspected bone fractures, emergency physicians are required to make treatment decisions before obtaining the imaging reading report from the radiologist, who is generally not available only a few hours after the patient's admission, or even the following day. This situation of the emergency doctor, alone interpreting the radiological image, in a context of limited time due to the large flow of patients to be treated, leads to a significant risk of interpretation error. Unrecognized fractures represent one of the main causes of diagnostic errors in emergency departments.

This comparative study consists of two cohorts of patients referred to the emergency department for suspected bone fracture. The first will be of interest to patients whose radiological images will be interpreted by the reading of the emergency doctor systematically doubled by the reading of the artificial intelligence. The other will interest a group of patients cared for by the simple reading of the emergency doctor.

All of the images from both groups of patients will be re-read by the establishment's group of radiologists no later than 24 hours following the patient's treatment.

A centralized review will be provided by two expert radiologists. Also, patients in both groups will be systematically recalled in the event of detection of an unknown fracture for hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Major Subject
* Patient admitted to the emergency department for suspected peripheral fractures in the extremities of the upper limb and/or lower limb (wrist/hand and ankle/foot).
* Patient affiliated to or entitled to a social security system
* Patient having received written and informed information about the study and having signed a free and informed consent to participate in the study.

Exclusion Criteria:

* Patient previously admitted to the emergency room for suspicion of fractures and not included in the study
* Patient admitted to the emergency room with suspicion of multiple fractures
* Refusal to participate in the study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision and under judicial protection
* Pregnant, breastfeeding or parturient patient
Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder

This randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 35 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501).


Eligibility Criteria:
Key Inclusion Criteria:

* Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may be a first or recurrent episode).
* Participant's current major depressive episode must be confirmed by independent assessment.
* The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit.
* Have a MADRS total score of 25 or higher at Screening and Baseline.
* A change in MADRS total score between Screening and Baseline of ≤20%.

Key Exclusion Criteria:

* Have failed 2 or more courses of antidepressant treatment at sufficient doses for at least 6 to 8 weeks for the current MDD episode.
* Currently or in the past year have been diagnosed with a personality disorder per the DSM-5-TR or in the past 3 years have been diagnosed with any of the following DSM-5-TR disorders: anorexia nervosa, bulimia nervosa, or binge eating disorder. Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, or panic disorder for whom MDD is considered the primary diagnosis are not excluded.
* Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, schizoaffective, schizophreniform, obsessive compulsive disorder, or post-traumatic stress disorder (PTSD).
* Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine).
* Are actively suicidal (eg, any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) (score of "YES" on suicidal ideations Item 4 or 5 within 3 months prior to Visit 1 \[Screening\]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator. Participants who are currently hospitalized for MDD symptoms or suicidality are not allowed into the study. If there is a recent history (within 3 months of screening) of hospitalization due to MDD symptoms, the participant should be discussed with the Medical Monitor for eligibility.
Visual Focused Play Intervention for Children With ADHD

This is a single-center, randomized, double-blind, sham-controlled study that will recruit children with attention deficit hyperactivity disorder and randomly assign them to a test group and a control group. The patients in the test group will be given a visual focus game to play and the patients in the control group will be given an animated video of the game that had no therapeutic effect. Treatment will be required at least 5 times per week for 2 weeks, with each game or video session lasting 30 minutes. Clinical scales and functional near-infrared spectroscopic imaging will be performed before and at the end of the 2 weeks of treatment, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for ADHD in the U.S. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5);
* Aged 6-14 years old;
* Right-handedness (habitual or good use of the right hand in daily life, work, study and labor activities);
* Voluntarily agree to sign an informed consent form;

Exclusion Criteria:

* Wechsler Intelligence Scale for Children (WISC) \<80 points;
* The cranial CT or MRI found that there are clear infarction foci, soft foci, occupations and other organic lesions;
* Suffering from serious physical diseases or other severe mental diseases, such as schizophrenia, bipolar disorder, etc;
* Inability to cooperate with fNIRS data collection
A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer

This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer. The safety, tolerability, and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will assess preliminary evidence of the effect of food and famotidine on the pharmacokinetics of oral ixabepilone.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of solid tumor malignancy unresponsive to current treatment options
* Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors
* Lapse of at least 1 week since minor surgery and of at least 3 weeks since major surgery and radiation therapy
* Eastern Cooperative Oncology Group performance status of 0-1
* Lapse of at least 4 weeks since immunotherapy or chemotherapy
* Negative pregnancy test result within 72 hours of study drug administration for any woman of childbearing potential (WOCBP)

Exclusion Criteria:

* WOCBP unable or unwilling to use birth control during study and for up to 4 weeks after study completion
* Women who are pregnant or breastfeeding
* Fertile men not using effective birth control with partners who are WOCBP
* Gastrointestinal(GI) disease or GI tract surgery that could impact drug absorption
* Inability to swallow capsules
* Inability to be venipunctured or to tolerate venous access
* Known symptomatic brain metastases
* Common Terminology Criteria for Adverse Events Grade 2 or greater neuropathy or history of Grade 3 or greater neuropathy
* Psychiatric conditions inhibiting compliance with protocol requirements
* Uncontrolled medical disorder or active infection that would impair participant's ability to receive protocol therapy or whose control may be jeopardized by the study treatment protocol
* Inadequate hematologic, hepatic, or renal function
* History of significant drug allergy
* Previous exposure to ixabepilone
* Exposure to any investigational drug or placebo within 4 weeks of enrollment
* Concurrent chemotherapy regimen
* Use of cytochrome P4503A4 inhibitors or inducers within 2 weeks of treatment initiation (unless approved by medical monitor)
* Use of steroids (except as antiemetic)
* Prisoners or subjects involuntarily detained for treatment
Effects of Forest Bathing in Vancouver, B.C. Parks

This study aims to investigate environmental factors that influence people's responses to the Japanese practice of forest bathing in Vancouver, B.C. parks.

The primary research aim is to investigate the relationship between biotic and abiotic factors in a sample of Vancouver, B.C. forested parks and specific health-related outcomes after forest bathing interventions. Forest bathing programs are a promising therapeutic method for enhancing heart rate and blood pressure functions and an effective psychological relaxation strategy. This study will investigate changes in autonomic nervous system activity and mood states after a 60-90 minute forest bathing program in four Vancouver, B.C. parks. Approximately 100 adult participants will be recruited for the study and participate in four sessions over one year. Physiological responses, pulse rate, systolic and diastolic blood pressure, and psychological indices will be measured before and after each session.

The health effects of forest-based interventions will vary due to environmental factors such as weather, temperature, humidity, light, and participants' psychological and physiological states. We are taking measurements pre- and post-treatment to detect any change in response during each session and seasonally.

Primary endpoint is to determine if the guided walk provides greater enhanced heart rate and blood pressure functions and an effective psychological relaxation strategy over the self-guided walk.

Secondary endpoints: 1) to determine if participants living in neighborhoods with below average street trees receive greater benefits than participants that live in neighborhoods with average or above average street trees, 2) assess changes within the same individuals over time 3) if there are different outcomes seasonally 4) if there are different outcomes between study sites.

Eligibility Criteria:
Inclusion Criteria:

* Adults (19+) that are residents of Vancouver, B.C.
* Spend time on a trail in a Vancouver park for at least 60 minutes per month
* Willing to refrain from tobacco products, alcohol, caffeine, marijuana, and psilocybin for at least two hours prior to arriving at the study site and during the forest bathing sessions

Exclusion Criteria:

* Must be able to move along a barrier-free trail independently
* Non-residents (e.g. tourists)
* Children (under 19 years of age)
* Participants with pets
Seeing the World Through Assorted Glasses

The purpose of the study is to test the use of amber glasses at night as a method to block blue light from the eye, allowing the brain to produce a dim-light melatonin onset. The investigators hypothesize that blue-blocking will produce measurable benefits in subjectively and objectively rated sleep quality and mood as well as salivary melatonin levels during the night.

Participants will complete a self-report battery containing measures of sleep quality, morningness-eveningness chronotype, and mood. Participants will then wear a wrist-worn accelerometer for 14 days to objectively record activity level and sleep quality. Participants will also fill out a daily sleep log and short self-report measures assessing sleep and mood. On days 4-7 and 11-14 of the study the participants will wear either amber or placebo control lenses prior to sleep onset in a randomized crossover design (i.e., participants will be randomized to wear either amber lenses or placebo lenses for the first part of the protocol and then switch to wear the opposite lenses for the second part of the protocol). Participants will spend nights 7 and 14 of the study in a sleep laboratory in order to obtain hourly melatonin samples and wear a wrist sleep monitor to non-invasively and objectively measure sleep state and quality using peripheral arterial tone and oxygen perfusion.

Eligibility Criteria:
Inclusion Criteria:

* Good physical health
* Proficiency in written and spoken English
* Reported average total sleep time \<9 hours (so nights spent in sleep lab will not result in sleep deprivation)

Exclusion Criteria:

* Taking regular medication affecting sleep and/or mood
* Travel across more than two time zones within the past month
* Smoke \> 5 cigarettes per day
* Excessive caffeine use (\>2 cups at one time or \>500 mg daily)
* No current Axis I Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Disorder
* No current use of street drugs
* No history of sleep disorder/bipolar disorder/psychosis/seizure disorder/chronic medical condition
* Night shift work within the past 2 months
MRI Contrast Clearance Analysis for Glioma Grading and Genotyping

Gliomas are the most common primary brain tumor. Gliomas with different grades have different clinical behaviors that determine treatment planning and patient prognosis in clinical practice. In the 2021 World Health Organization (WHO) classification of tumors for the central nervous system, glioma genotyping was considered the most relevant information for neuroradiologists. The isocitrate dehydrogenase (IDH) genotype and 1p/19q codeletion status are two essential molecular markers that divide glioma into three groups: IDH wild-type, IDH mutant with 1p/19q non-codeletion, and IDH mutant with 1p/19q codeletion.

MRI contrast clearance analysis (CCA) is based on T1 delayed-contrast subtraction map, Blue/tumor regions in CCA represent efficient clearance of contrast from the tissue (delayed signal\<early signal), while red/nontumor regions in CCA represent contrast accumulation (delayed signal\>early signal).

However, there are not any reports on the role of MRI CCA in glioma grading and genotyping, Thus, We hypothesized that the proportion of blue/red region and their histogram analyses, which could be acquired for predicting IDH genotypes and 1p/19q codeletion in gliomas, and to assess the application of CCA in glioma grading.

This is a single-center bidirectional cohort study. The subjects of this study were patients diagnosed as glioma by pathological biopsy. Patients with suspicious mass will be performed extra 30 and 60 min after contrast agent application delayed T1-weighted sequences as same as before. Then enter the next experimental stage. (1) Image format conversion; (2) Registration;(3) Subtraction;(4) ROI segmentation;(5) ROI histogram analyses. Histogram parameters of blue and red ROI includes 1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.

Finally, statistical methods were used to determine whether those parameters was statistically significant for IDH mutation status、1p/19q codeletion status and tumor grading.

Eligibility Criteria:
Inclusion Criteria:

* Patients with brain space -occupying lesions, have not yet undergone antitumor therapy;
* MRI with T1-contract delayed sequence was performed less than 2 weeks before surgery;
* Definite histopathologic diagnosis of glioma.

Exclusion Criteria:

* WHO 1 gliomas and other non-glioma brain tumors;
* Poor image quality and heavy artifact affect the subsequent image processing.
Study of FemVue(TM) Sono Tubal Evaluation System Method Comparison to HSG

Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control.

Study cancelled prior to recruitment.

Eligibility Criteria:
Inclusion Criteria:

Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have:

* Been attempting conception for 6 months or
* A history of PID (including the conditions listed below) or

  * Chlamydia
  * Gonorrhea
  * Endometriosis
* A history of pelvic surgery or
* Advanced maternal age (≥ 35) And
* Negative test for Gonorrhea/Chlamydia or prophylactic antibiotic treatment
* Without current bi-lateral tubal sterilization
* Signed Informed Consent

Exclusion Criteria:

Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure)

* obstructing access to uterine cornu
* distorting fundus at the midline region
Adding Urea to the Final Dialysis Fluid

At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis.

Ure-Na 15 gram tablets would be used to add to the dialysis fluid How much urea to add would be a simple calculation based on the 45X dialysis system and the patients serum urea concentration. The dialysate fluid urea concentration would be made to be about 15-40 mg/dL lower than the serum concentration. The patients labs/vitals and symptoms would be closely monitored throughout the dialysis treatment.

Eligibility Criteria:
Inclusion Criteria:

* Serum Urea \> 120
* Serum Potassium \> 5.5 or serum CO2 \< 15 or need for aggressive dialysis due to toxic ingestion
* need for dialysis

Exclusion Criteria:

* Pediatric
* need for CRRT
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain

Brief Summary: Low back pain is very common problem in all the developed countries and affects children to elderly. Based on the etiology the low back pain is divided into two type: nonspecific and specific low back pain. If the pathological reason is known it is defined as specific and if the reason for the pain is unknown it is defined as nonspecific low back pain. The postulated reason for nonspecific low back pain is the segmental instability of the lumbar spine. Diaphragm muscle has a role in maintaining the segmental stability. The aim of this study to reduce the severity of the low back pain with improving the stability of the lumbar spine by using diaphragm training.

The study is a randomized controlled trial. The participants are divided randomly into two groups. One of the groups take part in a complex training which contains stretching, strengthening, mobilizing exercises and proprioceptive training and this training is completed by diaphragm strengthening exercises. This group is defined as diaphragm training group. The members of the diaphragm training group use the POWERbreathe Medic Plus device. Opposed to the diaphragm training group the members of the control group take part only in the complex training without strengthening the diaphragm muscle. The pain intensity is assessed by Visual Analogue Scale and the diameter of the stabilizer muscles' belly is measured by B-mode ultrasound examination, using Zonare Z.One Ultrasound System (Mountain View, CA, USA). The thickness of the transversus abdominis muscle, the lumbar multifidus muscle and the diaphragm muscle is assessed in two different positions: during lying and during sitting position with weightlifting. The muscles are measured in two different states: a relaxed and a contracted state. Functional tests and a balance platform (NeuroCom) are used to measure the stability, and the function of the diaphragm is assessed by using a POWERbreathe KH2 device.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain
* Do not take part in other treatment
* Be able to learn the usage of diaphragm trainer

Exclusion Criteria:

* Balance problems with neurological cause
* Malignant tumor
* Serious organ disease
* Respiratory disease
* A previous surgical intervention which affected the trunk
* The patient is unable to cooperate
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Paediatric Patients With Severe Haemophilia A

A prospective, non-controlled, international, multi-centre phase 3 study to investigate the pharmacokinetics, efficacy, safety, and immunogenicity of Wilate in previously treated children with severe haemophilia A


Eligibility Criteria:
Inclusion Criteria:

1. Severe haemophilia A (\<1% FVIII:C) according to medical history
2. Male patients aged 1 to \<12 years
3. Previous treatment with a FVIII concentrate for at least 50 exposure days (EDs)
4. Immunocompetence (CD4+ count \>200/μL)
5. Voluntarily given, fully informed written and signed consent obtained by the patient's parent(s) or legal guardian and, depending on the children's developmental stage and intellectual capacity, informed assent by the patients before any study-related procedures are performed

The interval between the Screening Visit and the PK Visit should not exceed 30 days. If the 30-day interval is exceeded, determination of the CD4+ count is to be repeated and must be \>200/μL for patients to be enrolled (i.e., inclusion criterion no. 4).

Exclusion Criteria:

1. Any coagulation disorders other than haemophilia A
2. History of FVIII inhibitor activity (≥0.6 BU) or detectable FVIII inhibitory antibodies (≥0.6 BU using the Nijmegen modification of the Bethesda assay) at screening, as determined by the central laboratory
3. Severe liver or kidney diseases (alanine aminotransferase \[ALAT\] and aspartate transaminase \[ASAT\] levels \>5 times of upper limit of normal, creatinine \>120 μmol/L)
4. Patients receiving or scheduled to receive immunomodulating drugs (other than antiretroviral chemotherapy), such as alpha-interferon, prednisone (equivalent to \>10 mg/day), or similar drugs