cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk

Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA) and Department of Defense (DoD). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 55
2. History of deployment in the Global War on Terror
3. Eligible to receive care through VA ECHCS
4. Reliable access to the Internet
5. English speaking
6. Able to provide informed consent
7. Current insomnia diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) criteria

Exclusion Criteria:

1. Currently enrolled in/participating in other intervention research studies
2. Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)
3. Currently receiving formal psychological treatment for insomnia (not including sleep medications)
4. Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep
5. History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder
6. Untreated seizures or seizure disorder
7. Physical illness that is active, unstable, degenerative, and/or progressive
8. Currently pregnant or plan to become pregnant in the next 6 months
9. Irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns
10. Significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in SHUTi
11. Current non-alcohol Substance Use Disorder, excluding Cannabis Use Disorder, as determined by chart review and/or self-report screen of drug use (\> 1 time) in past 3 months
12. Current Alcohol Use Diagnosis, as determined by SCID 5 module, in the past 3 months
Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the "RITUXIMAB 3" Trial

Pemphigus is an autoimmune disease specific to the skin and mucous membranes characterized by the production of IgG4 isotype autoantibodies (AC) directed mainly against two proteins involved in interkeratinocyte adhesion: desmoglein 1 (Dsg1 ) and desmoglein 3 (Dsg3) (1-3). The binding of auto-AC on these proteins disrupts their adhesion function, resulting in inter-keratinocyte dysjunction called "acantholysis" responsible for the formation of intraepidermal bubbles.

Treatment of pemphigus is typically based on systemic corticosteroids. High doses are usually necessary because of the frequent cortico-resistance of the disease. In recent years, several studies have focused on the treatment of pemphigus with anti-CD20: rituximab. The "Ritux 3" study (NCT00784589), a randomized, multicentre, randomized, non-blind clinical trial involving 90 patients, found that the use of rituximab as first-line therapy in combination with short corticosteroid therapy was extremely effective and that cortisone sparing was thus obtained limited the occurrence of side effects of treatment. On the other hand, this study showed that the 2 rituximab maintenance infusions of 500 mg to M12 and M18 allowed the maintenance of a high rate of complete remission up to the 3rd year of follow-up.

Questions remain to explain the long-term action of rituximab, in particular that of the evolution of these auto-reactive B cells (specific DSG) away from lymphocyte reconstitution B, as well as the evolution of auto-AC. anti-DSG and total IgG CAs, so as to ensure that the disappearance of the auto-reactive compartment is not accompanied by a long-term overall immunosuppression (and therefore a possible risk of infection).

The immunological changes induced in the long term as well as the precise mechanism of action of these treatments and particularly rituximab which allows a complete remission 5 years after treatment in many patients remain little known.


Eligibility Criteria:
Inclusion Criteria:

* Patient included in the RITUXIMAB 3 study
* Major patient who has read and understood the newsletter and signed the consent form

Exclusion Criteria:

* Person deprived of liberty by an administrative or judicial decision
* Person placed under the safeguard of justice
* Person under tutorship or curators
* Pregnant or lactating woman
Identification of Pre-Malignant Lesions in Pediatric Patients with Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired with Artificial Intelligence

This is a single arm pilot trial of a novel whole-body Magnetic Resonance Imaging paired with artificial intelligence intervention, to evaluate feasibility defined as scan-rescan reliability, and to estimate the positive predictive value of changes in Magnetic Resonance Imaging scans from baseline to 12-month visit using an Artificial Intelligence algorithm, among 15 pediatric patients with neurofibromatosis type 1 at Cedars-Sinai Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 5 and \<18 years at the start of study. If subject will turn 18 during the study, they will be allowed to enroll.
* Clinically or molecularly confirmed diagnosis of NF-1. Subjects with mosaic/segmental NF-1 also qualify for the study.

Exclusion Criteria:

* Requiring sedation for imaging.
* Implants and/or Devices: Mechanical, magnetic or electrical activated implants; Ferromagnetic implants and foreign bodies
* Claustrophobia, problems being in enclosed spaces, or inability to lie facing upwards.
* Allergy to animal dander or animal-instigated asthma.
Artificial Intelligence-assisted Common Bile Duct Stent Selection in Endoscopic Retrograde Cholangiopancreatography

Common bile duct stenosis is an important indication for endoscopic retrograde cholangiopancreatography(ERCP). Appropriate selection of bile duct stent size is not only conducive to successful stent implantation but also to improve the prognosis of patients. Currently, the selection of stent specifications is based on the operator's empirical estimation, which is not only not accurate but also increases the radiation exposure time, causing unnecessary harm to both the operator and the patient. Our objective is to develop an artificial intelligence algorithm to automatically select appropriate stent.

Endoscopic Retrograde Cholangiopancreatography (ERCP) is an operation with high risk. Common bile duct stone and stenosis are important indications. The quality control of ERCP is the key to improve its success rate and reduce complications, which has received great attention. In 2015, the American Society of Gastrointestinal Endoscopy/American College of Gastroenterology (ASGE/ACG) issued ERCP quality control indicators, among which biliary stent placement and radiographic fluoroscopy time are important intraoperative quality control indicators.

The selection of appropriate biliary stent size is not only conducive to successful stent implantation but also to improve the prognosis of patients. Choose a stent of appropriate length. The proximal side of the stent should be 1cm above the obstruction segment, and the distal tail should be located just outside the nipple. The length of the stent can be determined by measuring the distance between the proximal end of the obstruction and the nipple under X-ray.

Current stent size selection is based on the operator's empirical estimation :(1) estimate the distance by endoscope diameter or cone length or catheter marking; (2) By retracting the guidewire, calculate the distance of the guidewire retracting between two points to estimate the length of the stent.The long radiation exposure time results in unnecessary injuries to both the operator and the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old who underwent ERCP

Exclusion Criteria:

* failed cholangiopancreatography caused by failed intubation, gastric retention, duodenal disease and so on
* patients proved no stenosis in common bile duct
* poor cholangiograms due to the lack of contrast agent or insufficient filling of contrast agent (cholangiograms without the completed CBD or thumbnails)
The Epidemiology of TST Change in Korea

TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.

Enroll criteria

* A term of whole military conscripts per year in one Reserve Force Battalion
* Military conscripts gather from all around area in Korea randomly
* Each participant undertake a chest X-ray (CXR) and blood tests including human immunodeficiency virus (HIV) at the start of initiatory training.

Exclusion Criteria

* Chest X-ray suggesting active TB
* HIV positive in serology

Design

* After giving informed consent, all participants receive one-step TST following standard procedures.
* The largest transverse diameter of induration is measured 48-72hr after injection.
* The investigator and these trained nurses were blinded to the status of their demographic characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Military Conscripts age 18-29 years old

Exclusion Criteria:

* Chest X-ray suggests active TB
* Positive HIV in serology
Stress Reduction: A Pilot Study With Adolescents

This study will evaluate the feasibility of providing an onsite mindfulness intervention, delivered as part of the school health curriculum, to help high school-attending adolescents cope with stress.

For this study, sophomores who are enrolled in health at Jesuit High School, (n = 320 students) will be invited to participate in a research study, conducted during health class, comparing mindfulness to a wellness or waitlist control. The students will be randomized by classroom, to either wellness or mindfulness or waitlist, with approximately 3-4 classes per intervention or control. Initially, six classes or sections of health will be randomized to one of the two active interventions, with the remaining classes/sections of health on the waitlist. Both of the intervention groups will meet weekly, during one of the regularly scheduled health classes, and have daily assignments. The students in the waitlisted classrooms will receive an intervention at the start of the next term. At the end of the study, students will have access to the materials from the other group, if desired.

Eligibility Criteria:
Gender:

•Both: both female and male participants are being studied

Age for students:

•Minimum age 13 year, 0 months; •Maximum:16 years, 0 months

Age for parents:

N/A°

Inclusion Criteria:

Adolescents who are enrolled in health class at Jesuit High School,

* Who have access to an iPad, cell phone or computer,
* Are considered reliable and compliant with the study protocol including willing to abide by randomization process, willingness to commit to daily practice activities for the duration of the study.
* Students taking psychiatric medication including stimulants, anti-depressants or anxiolytics are eligible to participate provided they are stable on their current dose of medication, have been taking it for at least two weeks, and will remain on the same dose for the remainder of the study. Any changes in medication will be noted.

Exclusion:

* Intellectual disability, as reported by parent or teacher;
* Current manic episode
* Psychotic episode
* Untreated Post Traumatic Stress Disorder, identified through parent or student report.

Exclusion Criteria:

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Effect of Nicotine on Brain Reward Pathways

The investigators will determine whether an acute dose of nicotine, in the form of the nicotine lozenge, impacts brain and behavioral measures of mood and reward responsiveness in individuals with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria for subjects with Major Depressive Disorder:

1. Provide written informed consent;
2. Both genders and all ethnic origins, age between 18 and 45;
3. Meet DSM-IV diagnostic criteria for MDD (diagnosed with the use of the SCID);
4. A baseline HAM-D score of 16 or greater;
5. Absence of pregnancy;
6. Absence of any psychotropic medication for at least 2 weeks:

   1. 6 weeks for fluoxetine
   2. 6 months for neuroleptics
   3. 2 weeks for benzodiazepines
   4. 2 weeks for any other antidepressants

Inclusion Criteria for Healthy Controls

1. Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse); as assessed by subject history and a structured clinical interview (SCID);
2. Provide written informed consent;
3. Both genders and all ethnic origins, age between 18 and 45;
4. Absence of any medications for at least 3 weeks;
5. Absence of pregnancy.

Exclusion Criteria:

1. Subjects with suicidal ideation where outpatient treatment is determined unsafe. These patients will be immediately referred to a licensed psychologist or psychiatrist to determine the appropriate clinical treatment;
2. Serious or unstable medical illness
3. Lifetime history of seizure disorder;
4. Lifetime history or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, ADHD, patients with mood congruent or mood incongruent psychotic features; simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to MDD;
5. Patients with a lifetime history of electroconvulsive therapy (ECT);
6. Failure to meet standard MRI safety requirements;
7. May not have used any nicotine product in the past year; must report fewer than 20 lifetime uses of nicotine
8. Must have an expired carbon monoxide level of less than or equal to 10 ppm.
9. Use of anticholinergic drugs in the past week
10. Any past or present history of cardiac problems including known arrhythmias, acute coronary syndrome, or ischemic heart disease
11. Uncontrolled hypertension
12. History of substance abuse in the past 6 months (other than caffeine), self-reported use of marijuana in past month, or history of treatment with methadone
13. Heavy caffeine users (consume greater than 500 mg on a regular or daily basis)
14. Subjects that cannot speak English
Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation

The researchers want to investigate the effects of muscle relaxation with rocuronium bromide during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic consumption in patients with total hip prosthesis replacement (general vs. spinal anaesthesia).


Eligibility Criteria:
Inclusion Criteria:

1. patient agreement
2. indication for total hip replacement
3. age 55 - 80 years
4. weight 65 - 95 kg
5. first intervention
6. ASA classification I - III
7. general and spinal anaesthesia possible in this patient

Exclusion Criteria:

a) neuromuscular diseases b) surgery with muscle trauma (within the last 3 months) c) permanent immobility d) intramuscular injections (within the last 4 weeks) e) medication with opioids f) medication with co-analgetics g) contraindications for general or spinal anaesthesia h) dementia, cognitive dysfunction or sleep apnea

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SOMNOmedics Clinical Validation Trial

Observational study in which pulse transit time (PTT) as a method and the device to register this data is compared with arterial blood pressure.

The population is composed of pediatric and adult patients in anesthesia or intensive care in need of arterial blood pressure monitoring.

Plan to enroll patients who accept the terms of the study consecutively. The population is composed by pediatric and adult patients in anesthesia and intensive care in need of close blood pressure monitoring.

After informed consent from the patients themselves, patient and parents and sometimes only parents.

The device measuring PTT is the prepared and calibrated with existing arterial blood pressure. Data is then recorded via the storage capacity of the device and via videocamera. The videocamera is used to identify large disturbances in data registration. This is to identify confounding data and in the end calibrate the device to be more accurate.

Data from the PTT device and the camera is then downloaded to the study computer and to an external hard drive in order to create redundancy in data storage.

Data is then analysed to compare the difference between data recorded from the PTT device and arterial pressure respectively. Aim is to be able to collect sufficient data to be able to decide wether to recommend or advice against clinical use.

Patient data is registered and then handled by our departmental clerk. Data is stored for ten years.

Eligibility Criteria:
Inclusion Criteria:

* Arterial line planned or existing

Exclusion Criteria:

* suspected major perioperative hemodynamic variation.
* non existing consent.
Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer

Esophageal cancer (EC) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018. The incidence of EC is strikingly varying among the regions and sexes. Approximately 70% of EC cases occur in men, and there is a 2-fold to 3-fold difference in incidence and mortality rates between regions worldwide. According to the latest reported in 2017, esophageal cancer ranks the sixth most common cancer and the fourth leading cause of cancer-mortality in China. Currently, esophagectomy is considered as the standard treatment for resectable EC patients. However, the prognosis of stage IIA-III esophageal cancer after esophagectomy remains poor, and local regional lymph node recurrence is the major patterns of recurrence, and mediastinal lymph node recurrence is one of the most common sites. Previous retrospective study has found that salvage chemoradiotherapy is a effective treatment option for these patients. However, the optimal dose remains unknown. In addition, no prospective trials have been conducted to investigate the efficacy and toxicities of salvage chemo-radiotherapy by using simultaneous integrated boost for the treatment of mediastinal lymph node recurrence after radical surgery of esophageal Cancer


Eligibility Criteria:
Inclusion Criteria:

Histo-pathologically proven diagnosis of esophageal squamous cell carcinoma. Age ≥18 and ≤80 ECOG performance status 0-1. Clinical diagnosis of ≤5 mediastinal lymph nodes recurrence after esophagectomy.

Patients without distant metastasis and life expectancy ≥ 3 months. adequate liver and renal function and adequate bone marrow reservation. Written, signed informed consent.

Exclusion Criteria:

Prior radiotherapy to recurrence site of esophageal cancer. Other co-existing malignancies or malignancies diagnosed within the last 5 years.

Pregnant women. Women who are breastfeeding a baby. Patients with uncontrolled serious medical or mental illnesses.
Pre-operative Surgical Difficulty Stratification Using Predicted Tumor Perfusion and Consistency

Pituitary adenomas (PAs) are among the most prevalent lesions of the sella turcica, accounting for 10%-25% of all intracranial neoplasms. Pituitary macroadenomas (PMAs) are defined with a maximum diameter of over 1 cm. Tumor characteristics are key factors influencing surgical effectiveness and complications of PMAs, with tumor perfusion and consistency identified as major predictive factors in literature. Conventional sequences provide limited information for predicting the perfusion and consistency of pituitary adenomas. Advanced sequences offer additional insights. However, the efficacy of combining radiomic features from multiparametric sequences, incorporating both conventional and advanced sequences, has not yet been proved.

We aim to develop machine learning models that combines radiomic features developed from both conventional and advanced sequences to predict the perfusion and consistency of PMAs. Furthermore, we aim to demonstrate the clinically applicability of these models by constructing a MR-PIT stratification (Multiparametric Radiomic derived and tumor Perfusion and consIsTency based surgical difficulty stratification), which correlated with the surgical strategy and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients with tumor more than 2.5 cm of maximal diameter in the coronal plane
* Functional and non-functional pituitary tumors

Exclusion Criteria:

* incomplete image data
Misoprostol With Intrauterine Device Insertion

The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.

The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.

Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation)
* Ages 18-45
* Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette

Exclusion Criteria:

* Pregnancy occurring less than 6 weeks from time of presentation
* History of prior intrauterine device placement
* History of Mullerian tract anomalies
* History of uterine surgery
* Allergy or intolerance to misoprostol or other prostaglandin
* Pelvic inflammatory disease (current or within the past 3 months)
* Sexually transmitted diseases (current)
* Puerperal or postabortion sepsis (current or within the past 3 months)
* Purulent cervicitis (current)
* Undiagnosed abnormal vaginal bleeding
* Malignancy of the genital tract
* Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion
* Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)