cyrilzakka/clinical-trials huggingface dataset:
Using Doxepin for Urticaria

Isolated urticaria in the emergency department is widely treated by physicians with histamine blocking agents such as diphenhydramine, cetirizine, and cimetidine. Doxepin is a tricyclic antidepressant that has been shown to have much higher concentrations of histamine blocking activity and therefore may be useful in treating urticaria. The purpose of this study is to compare the effectiveness of using doxepin verses a traditional medication, diphenhydramine (Benadryl), in the treatment of isolated urticaria in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-65 years of age
* Presenting to Upstate Adult Emergency Department at either the Downtown or Community campuses.
* Diagnosed with isolated/acute urticaria
* Requires treatment with antihistamines to alleviate symptoms

Exclusion Criteria:

* Pregnant women
* Prisoners
* Patients with altered mental status/have impaired decision-making capacity.
* Presenting with symptoms suggesting life threatening illness or anaphylaxis.
* Patients who have received any antihistamine (H1 antagonist) within the past 2 hours via any route of administration.
* Patients who have received an H2 antagonist within the past 2 hours.
* Patient received steroids by any route within the past 4 hours.
* Patient received epinephrine within the past 20 minutes.
* Patients currently taking concomitant p-glycoprotein inhibitors.
* Patients on any of the following CYP2D6 inhibitors: Bupropion, Fluoxetine, Paroxetine, Quinidine, Tipranavir.
* Patients with a history of serotonin syndrome.
* Patients currently taking another tricyclic antidepressant, selective serotonin reuptake inhibitor, and/or serotonin-norepinephrine reuptake inhibitor.
* Patients who have a condition where an antihistamine may be contraindicated.
* Patients with a contraindication to anticholinergic medications.
* History of adverse effects to tricyclic antidepressants or antihistamines.
* Patient who, based on their medical history or in the opinion of the clinician, have chronic urticaria, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response.
* Patients taking antileukotriene compounds (montelukast), calcineurin inhibitors (tacrolimus) or anti-serotonin agents (cyproheptadine)
Artificial Intelligence Empowered Anesthesia Ultrasound Guided Regional Anesthesia Training

Evaluate the effectiveness of AI powered anesthesia ultrasound in ultrasound-guided regional anesthesia (UGRA) training.

The AI powered anesthesia ultrasound system integrates ScanNav and NeedleTrainer modules, providing real-time training for medical staff to simulate punctures. Combined with ScanNav's real-time anatomical structure recognition function, it is expected to significantly enhance the training effectiveness of ultrasound-guided regional anesthesia technology.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participants;
* Sign the informed consent form.

Exclusion Criteria:

* allergic to ultrasound coupling agents
Targeting Reconsolidation to Prevent Return of Fear

The overall aim of this project is to determine if using a cue to trigger (and reactivate) the fear memory 10 minutes prior to exposure treatment sessions leads to less anxiety in patients with a fear of flying. The long term goals are to establish if targeting the reconsolidation of fear with a reminder of the fear is effective for human clinical populations in reducing relapse (return of fear). In this investigation, the investigators propose to treat 64 patients diagnosed with a fear of flying (FOF) using virtual reality exposure therapy (VRE). All patients in the study will receive exactly the same exposure treatment using a virtual airplane.

Prior to each VRE session, the investigators will test a brief, easy-to-implement manipulation that triggers the fear memory and presumably allows it to be changed in a way that prevents the fear from returning later (i.e., prevents relapse). The investigators propose to randomly assign eligible participants to 1 of 2 conditions: 1) VRE therapy preceded by a reminder of the feared stimulus (a VR clip of a virtual airplane taxiing and taking off) presented 10 minutes prior to all VRE therapy sessions, or 2) VRE therapy preceded by a neutral cue (a VR clip of a virtual living room) presented 10 minutes prior to all VRE therapy sessions. Participants will be evaluated pre- and post-treatment and at a 3 month and 6 month follow-up visit to assess long-term effects.

Eligibility Criteria:
Inclusion Criteria:

1. Adult participants, male and female, ages 18-70;
2. Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for specific phobia, situational type or panic disorder with agoraphobia, in which flying is the primary feared stimulus, or agoraphobia without a history of panic disorder, in which flying is a feared stimulus; Participants may have comorbid depression or anxiety disorders to increase generalizability of sample, but fear of flying must be the primary complaint;
3. Participants must have flown at least once before;
4. Participants on psychoactive medications must be stabilized on that dose and medication for at least three months, and must agree to remain on that dose throughout the project. All assessments will include a form inquiring about any medication changes, and participants on medications will be monitored by their prescribing physician; and
5. Participants must be literate in English.

Exclusion Criteria:

1. Patients with current or history of mania, schizophrenia, or other psychoses;
2. Patients with current (past 3 months) prominent suicidal ideation;
3. Patients with current alcohol or drug abuse/dependence; and
4. Patients unable to wear the virtual reality head mounted display for any reason (i.e. due to panic disorder, head discomfort, etc.)
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial

The purpose of this study is to examine whether the extract of the green tea is effective on obese women.

We conducted the pilot study in 2005. The initial findings showed the extract of green tea is benefit on obese women. The potential benefit include appetite lowing, lipid markers decreasing and regulating balance of obese related hormone peptides. So we designed this trial.

Eligibility Criteria:
Inclusion Criteria:

1. Age 16-60 years old female
2. BMI\>27㎞/m2
3. Signed informed consent

Exclusion Criteria:

1. Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
2. Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
3. Allergy and Immunology disease.
4. High aminotransferases ( Alanine, Aspartate \>80 IU/L) or high serum Creatinine (\>2.5 mg/dL)
5. Pregnant or lactating women.
6. Childbirth within 6 months.
7. Stroke or otherwise unable to exercise
8. Management for weight control within 3 months.
9. Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.
Digital Treatments for Opioids and Other Substance Use Disorders in Primary Care

The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. The DIGITS Trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, and Kaiser Permanente Washington, a healthcare delivery system in Washington State.

In this study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in Kaiser Permanente Washington primary care clinics. The study will evaluate the extent to which two implementation strategy interventions, health coaching and practice coaching, improve the implementation. Primary care clinics are randomized to receive these implementation strategy interventions. Each clinic will have a 12-month active implementation period beginning on its date of randomization. To study the continued use of reSET and reSET-O after the active implementation period is completed, a sustainment period of up 12 months will follow the active implementation period.

Specific Aims of the DIGITS Trial are to:

1. Estimate the effect of practice facilitation and health coaching implementation strategies in increasing the reach and fidelity of a digital therapeutic for substance use disorders in primary care clinics.
2. Compare the population-level cost-effectiveness of each implementation strategy in increasing reach, fidelity, and abstinence.

Eligibility Criteria:
Patient Inclusion Criteria:

* Had a primary care visit in a participating clinic during the active implementation period or sustainment period
* Screened positive for substance use on the day of the visit or in the prior year
* Adult aged 18 years or older at time of visit

Clinic Inclusion Criteria:

- At least 1 clinician trained in the use of reSET/reSET-O

Patient Exclusion Criteria:

- Patients who have requested through their health system to opt out of research

Clinic Exclusion Criteria:

- Previously participated in a pilot implementation of reSET/reSET-O
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability

The purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.


Eligibility Criteria:
Inclusion Criteria:

* A recipient must meet the following requirement to enroll into the study:
* Requires a single or bilateral lung transplant and is listed for transplant at UNC or Duke
* Male or Female, 15 years of age or older.
* Subject or Subject's Representative provides a legally effective informed consent.
* Recipient does not have HIV, active Hepatitis or is colonized with Burkholderia cepacia.
* Potential subjects who have undergone previous lung transplants and meet all other inclusion criteria, are eligible for study participation.

Exclusion Criteria:

•Recipient fails to meet standard of care requirements for lung transplant, or decides not to participate.
Identifying and Measuring Depression in Older Cancer Patients

The purpose of this study is to develop an accurate and useful way of measuring older patients' moods and reactions to the combined issue of cancer treatment and aging. Also, the purpose of this study is to test a new self-report measure of depressive symptoms tailored to the needs of older adults with cancer. Findings from this research will help us develop improved methods of diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

For Patients in Phases 1- 3:

* Current or previous cancer diagnosis and treatment (any site and any stage)
* All Phases 1,2,3- 70 years of age or older
* For Phase 1b only; 50 participants ages 50-69 will also be recruited
* For Phase 2 only: As per medical record or self report, history of Depression, Dysthymia, or Adjustment Disorder with Depressed Mood
* For Phase 3 depressive subset: As per medical record or self report, a history of depressive symptoms such as

  * Adjustment Disorder with depressed mood
  * Adjustment Disorder with mixed depressed mood and anxiety
  * Mood disorder (i.e., due to general medical condition, Not Otherwise Specified)
  * Depressive Disorder (i.e., Major Depressive Disorder (MDD) single episode, MDD recurrent, Depressive disorder not otherwise specified, Dysthymia)
* In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English

Exclusion Criteria:

For Patients in Parts 1- 3:

* In the judgment of the consenting professional and/or as per medical record, severe psychopathology or cognitive impairment likely to interfere with the participation or completion of the protocol or ability to provide meaningful information.
* For Phase 1\&2 only: Score of \> 11 on the Blessed Orientation-Memory-Concentration Scale (BOMC)
* For Part 2 only: As per medical record or self report, a diagnosis of a Schizophrenia Spectrum Disorder, current substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, Attenuated Psychotic Disorder, and Adjustment Disorder (except for Adjustment Disorder with Depressed Mood).
A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms) as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15 mg orally once daily (QD) was used as an active control. The primary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in the PANSS total score at Day 42. The first key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42.

The trial consists of a screening/tapering period, treatment period, and follow-up period. The 6-week active treatment period includes an inpatient phase and outpatient phase. Participants who complete the trial may continue treatment under a long-term extension protocol (P05689). Participants who do not continue in the treatment continuation trial (whether they complete the 6-week trial or discontinue prematurely) will have a follow-up visit 7 days after their last dose of trial medication.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated subtype
* Minimum PANSS total score of 70 at Screening and Baseline
* Score of at least 4 (moderate) in two or more of the five items in the positive subscale of the PANSS
* Confirmed to be experiencing an acute exacerbation of schizophrenia
* CGI-S scale score of at least 4 (moderately ill) at Baseline
* Has responded positively to an antipsychotic medication other than clozapine (Clozaril®) in a prior episode

Exclusion Criteria:

* Body mass index (BMI) \<18.5 or \>40.0 kg/m\^2
* Laboratory and/or clinical evidence of clinically significant hepatic conditions
* Known history of, or undergoing treatment for, narrow angle glaucoma
* Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile seizures
* Known serological evidence of human immunodeficiency virus (HIV) antibody
* History of neuroleptic malignant syndrome or tardive dyskinesias
* Past or current diagnosis of schizoaffective disorder, schizophrenia of residual subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission, or borderline personality disorder
A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj.

The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety, tolerability and pharmacokinetic profiles and to assess the efficacy of CKD-516 Tablet in Combination with Irinotecan inj. in Patients with Previously Treated Advanced Colorectal Cancer

CKD-516 tab. in combination with Irinotecan inj.(1cycle=14days)

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 19 years or older
2. Patients who failed existing anti-cancer therapies
3. ECOG performance status ≤ 1
4. Life expectancy of ≥ 12 weeks
5. Adequate hematological, hepatic and renal functions:
6. Patients who give written informed consent voluntarily

Exclusion Criteria:

1. Prior systemic chemo-, radiochemo-, radio-, immuno-, hormonal and/or biological therapy within 2 weeks before study participation (in case of nitrosoureas and/or mitomycin, within 6 weeks before study participation)
2. Patients who received major surgery within 4 weeks before study participation (in case of VATS and/or ONC surgery, within 2 weeks before study participation)
3. Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.)
4. NYHA class III or IV heart failure, uncontrolled hypertension (SBP/DBP \> 140/90 mm Hg), other clinically significant cardiovascular abnormalities at investigator's discretion (e.g., LVEF \< 50%, clinically significant cardiac wall abnormalities or cardiac muscle damages)
5. Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months
6. Uncontrolled arrhythmia
7. Significant cerebrovascular diseases including stroke within 6 months
8. Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases
9. Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease
10. Patients who cannot receive IP by mouth and have a history of clinically significant gastrointestinal disorders which can impede administration, transit or absorption of the IP
11. A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP
12. Pregnancy or breast-feeding
13. Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 3 months after the end of treatment
14. Patients who received other investigational products or used other investigational devices within 3 weeks before participation
15. Patients who cannot participate in this trial by investigator's discretion
Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)


Eligibility Criteria:
Inclusion Criteria:

* Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1.
* Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1.
* Patients must have serum GH level \> 2.5 ng/mL AND serum IGF-1 level \> 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg.

Exclusion Criteria:

* The patient has received pituitary radiation therapy of any kind at any time prior to visit 1.
* The patient has received pituitary surgery within 3 months prior to visit 1.
* The patient's serum creatinine is higher than 150 µmol/l.
Testing Protocol for Cold-sensing Fibers

This project aims to evaluate whether electrical stimulation can modulate the cold detection threshold and the cold pain threshold. The hypothesis is that different electrical stimulation will either decrease or increase the cold threshold depending on the shape of the electrical stimulus. If a combination of electrical stimuli and cold stimuli could be used, this could lead to a novel method for estimating the excitability properties of cold-sensing fibers. The sub-project takes place in 1 session (1.5 hours).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-80 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or breast feeding
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
* Skin diseases
* Past history of conditions possibly leading to neuropathy
* Inability to cooperate
* Current use of medications that may affect the study, e.g., analgesics
* Previous traumatic experience of an electrical accident
* Consumption of alcohol or painkillers within the last 24 hours
* Participation in other pain studies throughout the study period
* Patients with cardiac diseases (e.g., pacemaker).
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.

Nonprobability sampling was done by invitation to volunteer.

Eligibility Criteria:
Inclusion Criteria:

* All patients on substitution therapy, that are willing to switch to Suboxone, can be included.
* Therapeutic indications and contraindications for Suboxone® must be taken into consideration when selecting patients.

Exclusion Criteria:

* According to product information
* In accordance with the product information pregnant women will be excluded.
Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber.

Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete.

Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification
* Is able to follow the protocol specified contraception methods
* Is willing and able to comply with any restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results