cyrilzakka/clinical-trials huggingface dataset:
GAMBIT Task with PTSD and Healthy Control Participants

This is a pilot study of a digital training task called GAMBIT. This study will be the first to examine potential relationships between GAMBIT task completion and brain circuit flexibility, behavior, and symptoms in participants with PTSD.

This is a single-site pilot study for the GAMBIT intervention, which is a computerized task that addresses behavioral inhibition. The primary objective of this study is to determine whether the GAMBIT task improves mental health symptoms associated with PTSD over time. The secondary objective of this study is to determine whether the GAMBIT task promotes flexibility in inhibitory control network as determined by functional neuroimaging. Additional laboratory measures associated with cognitive flexibility, and clinician and patient-rated symptom data, will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-55 years
* Participants must be able to provide informed consent
* Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process
* Must meet criteria for one of the following study groups:

  * PTSD Group:

    i. Meets diagnostic criteria for current PTSD according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5)
    1. Has been exposed to a Criterion A trauma of the civilian type (e.g., non-combat, threatened or actual interpersonal violence) or non-civilian
    2. Must have a total score ≥ 25 on the CAPS-5 (past-month version) at the time of screening, indicating moderate PTSD symptom severity.
  * Healthy Control Group:

    i. Has no lifetime history of any psychiatric disorder

Exclusion Criteria:

* Current or lifetime history of schizophrenia or other psychotic disorder, bipolar disorder, obsessive-compulsive disorder (OCD), eating or feeding disorder, neurodevelopmental disorder, or neurocognitive disorder;
* Any neuropsychiatric disorder that is judged to be the primary presenting problem, other than that which is specified as study group eligibility criteria;
* Substance use disorder within the past 1 year;
* Urine toxicology positive for illicit drugs or dis-allowed concomitant medications as per study protocol; intermittent cannabis use that does not meet criteria for a substance use disorder may be permitted under the protocol.
* Suicidal ideation or risk of self-harm that is judged by the PI to be clinically significant and to warrant intervention
* Concurrent treatment with opioid medication, or with long-acting or daytime short-acting benzodiazepines within two weeks of study start
* Current cognitive impairment, as defined by a score \<23 on the Montreal Cognitive Assessment (MoCA)
* Estimated IQ \<80
* Currently receiving evidence-based psychotherapy for PTSD (e.g., prolonged exposure, cognitive processing therapy).
Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR

The purpose of this study is to assess the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT. We hypothesize that imaging with F18 Fluciclovine will be superior to anatomic MR imaging in lesion volume assessment before treatment and that residual F18 Fluciclovine defined tumor will predict local post-LITT disease recurrence.

Primary Objectives

-To estimate the accuracy of F18 Fluciclovine PET MR for laser interstitial thermal therapy (LITT) treatment response assessment as determined by T1 post-contrast MR brain imaging.

Secondary Objectives

* To assess changes in F18 Fluciclovine defined disease with LITT.
* To assess the volume change of the idealized quantitative T1 values of lesions compared -To assess the volume change of idealized quantitative T2 values of lesions compared to -Chemical Exchange Saturation Transfer (CEST) MRI - To assess the ability of CEST imaging to differentiate treatment change from residual disease in brain malignancy following LITT.
* Multiple B Value Diffusion Imaging (Adv Diff) - To assess whether Adv Diff can differentiate treatment changes from residual disease in brain malignancy following LITT.
* Gradient- and Spin-Echo DSC perfusion imaging - To assess whether GESE DSC improves differentiation of treatment change from residual disease in brain malignancy -Adv ASL perfusion imaging - To assess the ability of Adv ASL to differentiate treatment change from residual disease in brain malignancy following radiation therapy.
* Exploratory Objectives
* To assess the relationship between post-LITT enhancing brain tissue and F18 -To assess changes in regional homogeneity (ReHo) values after LITT.

Eligibility Criteria:
Inclusion Criteria

* An adult patient with suspected or pathology-proven central nervous system neoplasm.
* MRI of the brain, positive for at least one intra-axial lesion greater than 5 mm.

Exclusion Criteria

* Contraindication to MR imaging.
* Known allergy to gadolinium-based contrast agents.
* Renal failure as defined by a GFR less than 30 or the use of hemodialysis.
* Pregnant.
* Patients less than 18 years of age will be excluded.
Impact of Extracorporeal Membrane Oxygenation Care Strategy Application Development

The objective of this study was to develop an educational training App for ECMO care, and to apply a blended learning approach to improve the knowledge and skills of nurses.

In recent years, for patients with acute cardiac infarction, severe cardiac shock, and refractory acute respiratory distress syndrome, the intervention of Extracorporeal Membrane Oxygenation (ECMO) has become an adjunctive treatment for severe cardiopulmonary diseases, which can temporarily replace cardiopulmonary function, slow the deterioration of cardiopulmonary function, and buy time to assist in clinical treatment. However, the education and training of ECMO is mainly based on traditional classroom teaching, which has also been affected by COVID-2019, resulting in training process difficulties as nurses are easily restricted by time and environment.

Eligibility Criteria:
Inclusion Criteria:

* licensed nurse practitioners working in the intensive care center of the teaching hospital and willing to participate in the study.

Exclusion Criteria:

* those who did not use smart phones.
Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
* Diagnosis of opioid-induced bowel dysfunction (OBD) as confirmed during the screening period.
* If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
* Use of prescribed or Over-the-Counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
* If treated for clinical depression with Selective serotonin reuptake inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
* Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.

Exclusion Criteria:

* Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
* Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
* Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
* Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
* Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
* Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
* Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug
* Have a Psoriasis Area and Severity Index (PASI) greater than (\>)10 or Body Surface Area (BSA) \>10 at screening and at baseline
* Have a Dermatology Life Quality Index (DLQI) \>10 at screening and at baseline
* Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug; for information on Bacille Calmette-Guérin (BCG) vaccination, agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug
* No dipstick detection of proteins or glucose in urine. If there are signs of proteins and/or glucose on urine test strip, the urine sample must be analyzed centrally. Here, protein and glucose levels must not exceed trace levels, example, \<=(+); one re-test (central urine analysis) is allowed

Exclusion Criteria:

* Has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients
* Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

Osteoarthritis (OA) is a highly prevalent degenerative joint disease that contributes to chronic pain and disability in approximately 10% of people over the age of 55. With 25% of Canadians expected to be aged 55 or older by 2036, an increasing number of Canadians will be impacted by knee OA. In affected individuals the risk of medical co-morbidities is increased which can lead to adverse cardiovascular outcomes, depression, and poorer quality of life. Current conservative therapy includes oral analgesia, lifestyle modification, corticosteroid injection, and viscosupplementation. These current conservative measures have variable responses. In patients who would prefer to avoid surgery or are not surgical candidates safe and consistently effective treatment options are lacking.

Geniculate artery embolization (GAE) is a minimally invasive alternative with low risk of complications that has shown promise in exploratory studies. GAE provides benefit by disrupting angiogenesis in the knee which can contribute to chronic inflammation of the affected joint, and helps prevent the growth of new sensory nerve fibers which can reduce the pain associated with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

1. VAS score of at least 50 mm for knee pain
2. Pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection).
3. Age \> 40 years
4. Radiographs demonstrating knee osteoarthritis on same side as pain
5. Patient not a surgical candidate or declines surgical management

Exclusion Criteria:

1. Radiographically severe knee osteoarthritis (Kellgren-Lawrence grade \>2)
2. Severe non-knee related lower limb pain with VAS \> 50 mm.
3. Local infection and inflammatory arthritis.
4. Malignancy
5. Previous knee surgery
6. Bleeding risk - known hematologic disease increasing risk of bleeding, pre-procedure INR \> 1.4, pre-procedure PTT \> 40 seconds or pre-procedure platelets \< 50,000/uL
7. Known chronic renal failure or eGFR \< 45
8. ECOG grade \> 2
9. Patient weight \> 300 lbs
10. Patient unreliable for follow up
Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.

This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES


Eligibility Criteria:
Inclusion Criteria:

* Allergic asthma patients
* Inadequately controlled patients

Exclusion Criteria:

* - History of severe anaphylactoid or anaphylactic reactions
* Previous treatment with omalizumab
* History of cancer or cancer

Other protocol-defined exclusion criteria may apply.
MR Fingerprinting for Vestibular Schwannomas

MR Fingerprinting (MRF) will be performed in patients who will be treated with Gamma Knife radio surgery for a vestibular schwannoma before the intervention. Fifty patients will be included with a vestibular schwannoma of minimum 1cm in size. During follow-up, response of the tumor to radiosurgery will be evaluated for each patient with MRI. The aim of the study is to find patterns of vestibular schwannomas in MRF data which correlate with the type of response to radio surgery, i.e. tumor control after radiosurgery, further tumor growth despite radiosurgery, cystic transformation after radiosurgery.


Eligibility Criteria:
Inclusion Criteria: Planned Gamma Knife radiosurgery for vestibular schwannoma of minimum 1cm in size -

Exclusion Criteria: Vestibular Schwannoma of less than 1cm in size. Other a priori treatment than Gamma Knife radiosurgery

-
Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients

The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Adult males/females aged 20\~75 years
* Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents
* Subjects who voluntarily agree to participate in this clinical test with written consent

Exclusion Criteria:

* Patients impossible gastroscopy
* In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis
* Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded)
* Patients with malignant tumor on digestive organ
* Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)
A Phase IIa Study of TAS-205 for Duchenne Muscular Dystrophy

The objective of this study is to evaluate the efficacy after 24-week repeated oral doses of TAS-205 in patients with Duchenne Muscular Dystrophy (DMD) in an exploratory manner.

Duchenne Muscular Dystrophy (DMD) is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in 3,500 lives male births. DMD patients suffer from a relentless decline in muscle strength that impairs the ability of walking and breathing, resulting in their lives with wheelchairs and then loss of upper body function. The main objective of this study is to evaluate the efficacy after 24-week repeated oral doses of TAS-205 in patients with DMD in an exploratory manner. The objective of this study is also to evaluate the safety, the dose-response and the urinary excretion of pharmacodynamic (PD) marker after 24-week repeated oral doses of TAS-205 in DMD patients.

Eligibility Criteria:
Inclusion Criteria:

* Able to give an informed consent. If applicable, able to give an informed assent.
* Phenotypic evidence of DMD.
* Male and ≧5 years of age.
* Bodyweight ≧7.5 kg and \<60 kg.
* Able to complete the 6MWD test with a distance of at least 75 m.
* Able to take tablets.
* If taking oral glucocorticoids no significant change in the total daily or dosing 6 months before enrollment.

Exclusion Criteria:

* Any serious drug allergy.
* A forced vital capacity (FVC) of \<50% of predicted value.
* Wearing a respirator continuously (except for the use during sleep).
* A left ventricular ejection fraction (EF) of \<40% or fractional shortening (FS) of \<25% on echocardiogram.
* Clinically significant cardiac failure and respiratory failure.
* Ongoing immunosuppressive therapy (other than corticosteroids) .
* Surgical history or plan for surgery that may affect muscular strength or motor function.
* Any injury that may affect muscular strength or motor function.
* With any systemic allergic disease or any chronic inflammatory disease.
* Previous gene therapy (exon skipping, or stop codon read through therapy), cell-based therapy, or any other investigational agents.
A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. The secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 18 and ≤ 23 kg/m2
* Able to provide written informed consent
* Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits
* AST, ALT, Tbili within normal limits at screening
* Medical and psychiatric history and physical examination devoid of any significant findings that would interfere with participation or interpretation of results in this study
* Agree to use a barrier method of birth control for 28 days following the last dose of study medication
* Have maintained a stable weight for at least 6 months prior to Screening

Exclusion Criteria:

* Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
* Positive urine drug screen for any drug of abuse (including amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) unless prescribed by a physician
* Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
* Have a history of an allergic reaction to either mifepristone or risperidone
* Any other clinically significant abnormality on screening laboratory tests
* QTc Bazzett's ≥ 450 msec
* History of or current major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
* Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
* Any history of a movement disorder such as Tardive Dyskinesia, Parkinsonism
* Any personal or family history of Neuroleptic Malignant Syndrome
Electroacupuncture for Chemotherapy-Related Cognitive Impairment

The objective of this trial is to evaluate the effect of electroacupuncture compared to sham acupuncture in preventing CRCI among breast cancer patients scheduled to undergo chemotherapy.

Participants will be randomized to receive either acupuncture or sham acupuncture treatment. Both treatments will be administered twice a week, starting one week before chemotherapy and continuing throughout the chemotherapy period. The study outcomes will be evaluated at three time points: baseline (before acupuncture and chemotherapy), during chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle). Each cycle typically lasts for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed with stage I-III breast cancer
2. Scheduled to undergo chemotherapy
3. Aged between 18 and 75 years
4. MoCA score ≥ 26
5. Voluntary agreement to participate in the study and sign an informed consent

Exclusion Criteria:

1. Demonstrated tumor metastasis or recurrence
2. Had a prior history of chemotherapy
3. Reported a history of brain tumors, head trauma or stroke
4. Were diagnosed with cognitive function-impaired disorders, such as Alzheimer's disease
5. Were unable to cooperate with testing for any reasons
6. Had severe hepatic or renal insufficiency
7. Had hemorrhagic disorders, including von Willebrand disease, or were taking anticoagulant or antiplatelet medication
8. Had an implanted cardiac pacemaker
9. Had a history of alcohol abuse or drug addiction
10. Were participating in another interventional trial
Effect of Deep Breathing Exercises on Post Operative Sleep Duration

This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality. This study will provide the evidence that during the postoperative period deep breathing exercise combined with physical training can positively influence the sleep duration and quality.

Subjects will be randomly placed into Control group and Interventional group. The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises. Two daily sessions with an average duration of 25 min will be performed. In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days). Deep breathing exercises will start 48 hours after extubation and full education along with the routine care (i.e.: from the fourth to sixth postoperative day).

Eligibility Criteria:
Inclusion Criteria:

* Ability to read and write
* Stabilization of vital signs \[blood pressure, pulse, respiration)
* Patient undergoing OFF Pump Coronary Artery Bypass Graft (CABG) Procedure

Exclusion Criteria:

* History of severe mental diseases resulting in hospitalization and drug treatment within the previous 6 months
* Use any kind of other complementary methods such as massage therapy, aromatherapy, etc. to treat sleep disorders for the previous two weeks
* History of sleep or respiration disorders and used CNS medications in the night.