cyrilzakka/clinical-trials huggingface dataset:
Validation of an AI-Assisted Pancreatic EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial

The goal of this clinical trial is to verify the auxiliary role of the artificial intelligence (AI) system in pancreatic endoscopic ultrasound (EUS) scans. The main questions it aims to answer are as follows:

1. A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
2. Whether the AI system can improve the quality of scans for EUS endoscopists. Participants will conduct EUS scanning with or without the assistance of the AI system.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, \<80 years old 2.Patients who need endoscopic ultrasonography of pancreas; 3. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

Subjects who meet any of the following criteria cannot be selected for this trial:

First. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography:

Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc. Anesthesia assessment failed Pregnancy or breastfeeding In the acute stage of chemical and corrosive injury, it is very easy to cause perforation Recent acute coronary syndrome or clinically unstable ischemic heart attack Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure\> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.

Second. Disagree to participate in this study.

Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:

Pancreatic disease has undergone surgery or radiotherapy and chemotherapy beforehand; Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients

Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.

Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, ages 21-75.
2. Able and willing to provide written informed consent.
3. Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea.

   1. For participants diagnosed with Hunter Cheyne Stokes Breathing, at least 3 cycles of crescendo-decrescendo breathing amplitude AND either a Central Apnea Index (CAI) ≥ 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic Polysomnogram (PSG).
   2. For participants diagnosed with Central Sleep Apnea with current daily Opioid use or any other predominant central sleep apnea, an Apnea/Hypopnea Index (AHI) ≥ 15 and CAI \> 5 from an attended Diagnostic PSG.
   3. For participants diagnosed with Complex Sleep Apnea, an AHI ≥ 15 and CAI \> 5 from a CPAP titration.
4. Systolic blood pressure \> 80 mm Hg at Visit 1.
5. Agreement to undergo a full-night, attended Diagnostic PSG.
6. Agreement to undergo a full-night, attended CPAP titration PSG.
7. Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG

Exclusion Criteria:

1. Active participation in another interventional research study.
2. Diagnosis of acute decompensated heart failure.
3. Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.
4. Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure.
5. Qualifying for or awaiting heart transplantation.
6. Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous).
7. At home treatment with adapted Servo Ventilation (ASV) or Bilevel Positive Airway Pressure (PAP) therapies.
8. Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues.
9. Participants in whom PAP therapy is medically contraindicated.
10. Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg).
11. Narcolepsy.
12. Untreated Restless Legs Syndrome.
13. Periodic Limb Movement arousal index \> 20/hr.
Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing

The goal of this clinical trial is to investigate the role of switching from cigarette smoking (CS) to tobacco heat system (THS) on the clinical outcome of closed lower limb (tibia and femur) fractures from smokers' orthopedic patients. Validated and standardized assays, medical state and self-reported outcomes will be evaluated in orthopedic patients' smokers or switch from CS to using THS throughout six months compare to ex-smokers (control).


Eligibility Criteria:
Inclusion Criteria:

* Closed tibia or femur fracture (according to AO/OTA: 41A2-41C3, 42A-C, 43A-C, 32A-C, 33A2-3, 33B-C) which is surgically treated within 14 days after the trauma at the BG trauma clinic Tübingen.

Additional inclusion criteria for the smoking and THS groups:

* Smokers with 10-20 packyears smoking history.
* Smoking history \>10 years.
* Decision not to participate in the free smoking cessation seminars.

Exclusion Criteria:

* Legal guardian or loss of capacity to consent.
* Refusal to participate in the study.
* Open fractures or concomitant injuries or complications requiring surgery existing at the time of surgical indication.
* Initial surgical treatment of the fracture has occurred ex domo.
* No initial surgical treatment within 14 days of sustained trauma.
* Using nicotine delivery electronic devices.
* Pre-existing autoimmune, immunological, bone or malignant diseases.
* Pregnant, breastfeeding and women of childbearing age with existing desire to have children.
* History of alcohol abuse or drug abuse.
* Taking antioxidants approval by the German Federal Institute for Drugs and Medical Devices (BfArM).
* Taking drugs with known effect on bone metabolism (according to Institute for medical and pharmaceutical examination issues (IMPP): allosteric CaSR modulators, bisphosphonates, calcium release inhibitors, alkaline earth ions, RANKL inhibitors, calcitriol, colecalciferol).
Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer

This Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old with histologically confirmed HER2 positive breast cancer.
2. Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive.
3. Physician has determined that treatment with pyrotinib is indicated.
4. Traceable medical record available.

Exclusion Criteria:

1. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent .
2. Pregnant or breast feeding patients
3. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment.
4. Patients not suitable for this study under investigators' consideration.
Endoscopic Resection for Small Rectal Neuroendocrine Tumors

According to clinical practice and relevant retrospective research data, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic mucosal resection with a ligation device(ESMR-L) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) . However, there is a lack of multicenter prospective studies to evaluate the advantages and disadvantages of mEMR-C and mEMR-L. mEMR-C is the modified ESMR-L without submucosal injection.

We aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with mEMR-L for the treatment of small rectal neuroendocrine tumors (NETs) in ten tertiary hospitals in China.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 80 years;
2. With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;
3. With tumor size ≤10 mm assessed by colonoscopy;
4. Plan to receive mEMR-C or mEMR-L treatment and provide written informed consent;

Exclusion Criteria:

1. Unable to tolerate mEMR-L or mEMR-C as assessed by the research team of each center;
2. Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;
3. Rectal NET with lymph node metastasis or distant metastasis;
4. Received resection of rectal neuroendocrine tumor by other surgical procedures;
5. Multiple rectal neuroendocrine tumors;
6. Vulnerable groups such as pregnant women or patients with mental disorders;
7. Poor compliance, unable to cooperate with treatment.
No Drop Post-Op Cataract Surgery

This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post operatively.

Topical NSAIDs have been known to reduce post-operative macular edema, inflammation and pain in patients undergoing cataract surgery. Routine cataract surgery without the protection of topical NSAIDs results in an increase of the number of patients with macular edema and macular thickening.

Omidria (phenylephrine and ketorolac injection 1%/0.3%) infusion is used in patients during cataract surgery to decrease post-operative pain and inflammation. It is also indicated to maintain pupil dilation during cataract surgery.

This study will evaluate whether treating patients with Omidria during cataract surgery will control post-operative pain and inflammation as well as reduce or eliminate macular edema without the use of adjunctive topical NSAIDs.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 55-90 years with visual significant cataracts in one or both eyes.
* Healthy individuals able to tolerate outpatient cataract surgery under local anesthesia via either phacoemulsification and/or femtosecond assisted cataract surgery. Well-controlled diabetes, hypertension will be included.
* Females of childbearing potential must agree to use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation or vasectomy of the partner (with confirmed negative sperm counts) in monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge. A pregnancy test is required at least 10 days from the last normal menstrual period, if the patient is a sexually active female of childbearing potential.

Exclusion Criteria:

* Allergy to Phenylephrine or NSAIDs.
* Inability to sit steady and upright for the Optical Coherence Tomography (OCT).
* Complications during surgery, including posterior capsular rupture, vitreous loss, zonular dialysis, or iris trauma.
* Macular thickness above 300 microns at baseline
* Currently taking a prostaglandin analogue
* Presence of an epiretinal membrane on the preoperative OCT.
* Retained lens fragment post-operatively.
* Inability to return for follow appointments
* Female patients who are pregnant, lactating or planning to become pregnant during the course of treatment.
Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gastroparesis
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

* Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
* A positive test for drugs of abuse at the screening or evaluation visits
* Pregnancy or nursing
* Evidence of uncontrolled blood glucose (including HbA1C \>11% at screening or metabolic crisis in past 60 days)
Novel Index (PIMR) in PAH

The chief regulator of resistance in pulmonary arterial hypertension (PAH) is the small arteries. In the heart, the invasive measurement of the resistance of the small arteries has been shownto be safe, easy, reliable, and prognostic. This study is intended to translate prior work in heart arteries to the PAH space and invasively measure the resistance of the small arteries of the lung (pulmonary index of microcirculatory resistance \[PIMR\]) and the coronary artery supplying the right ventricle (acute marginal of the RCA; RV-IMR). Importantly, these measurements will be made during standard of care cardiac catheterizations (right heart catheterization \[RHC\] +/- left heart catheterization). The correlation between these new indices and the standard ones measured during RHC typically used to determine the severity of pulmonary hypertension will be analyzed. In addition, among newly diagnosed patients, the study will evaluate how these indices change 6 months after starting treatment. Finally, the association of these indices with clinical outcomes at 1 year will be assessed. The findings from this study may deliver an immediate impact to patient care by identifying a new metric to help better identify those who may benefit from a more intensive, personalized treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Group 1 PAH with invasive pulmonary hypertension defined as: Mean pulmonary arterial pressure ≥ 20 mmHg, pulmonary capillary wedge pressure \< 15 mmHg, and pulmonary vascular resistance ≥ 3 Wood units.
* Serum creatinine \< 2.0 mg/dL
* Able to provide informed written consent

Exclusion Criteria:

* Other groups/forms of pulmonary hypertension (i.e. groups 2-5)
* Contraindicated to undergo fluoroscopy and/or coronary angiography
* Pregnancy
Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Hypothesis:

Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence.

Objectives:

To test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence

Specific Aims:

1. To test a novel interview instrument to classify patients into "adherence profiles"
2. To validate this instrument with quantitative scores of mesalamine adherence and objective testing.

Study Design Rationale:

Qualitative research design and prospective validation

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age \>18)
* Diagnosis of IBD (confirmed by endoscopy and histology) \> 3 months
* In clinical remission (based on Simple Colitis Activity Index score \<2.5)
* On mesalamine compound for maintenance of remission
* Stable mesalamine dose for 1 month

Exclusion Criteria:

* Not receiving primary GI care at BIDMC
Evaluation of a Patient 'nudge' on Engagement in Lung Cancer Screening

The purpose of this quality improvement project is to conduct and evaluate the effect of sending an electronic reminder message to patients who qualify for lung cancer screening, haven't had a screening previously, and who have an upcoming scheduled appointment with their doctor.

United States Preventive Services Task Force (USPSTF) lung cancer screening (LCS) guidelines recommend LCS for those aged 50-80 with at least 20 pack-years smoking history, who currently smoke or quit within the last 15 years. In 2023, our study team found that there are approximately 6,000 - 8,000 Kaiser Permanente Colorado (KPCO) members who are unscreened and eligible for lung cancer screening (LCS). In support of KP's Population Health priority initiative to expand lung cancer screening participation for those who are eligible, our study team was selected to move this work forward in 2024 with feasible implementation opportunities for the KPCO LCS Operational/Institute for Health Research partnership at its core. The primary objective of this project is to conduct and evaluate a randomized quality improvement pragmatic intervention of a 2-arm electronic message outreach to unscreened LCS members who are eligible for LCS and who have an upcoming scheduled Primary Care Provider (PCP) visit.

Eligibility Criteria:
Inclusion Criteria: Qualifies for Lung Cancer Screening based on USPSTF criteria (aged 50-80, at least 20 pack years smoking history, currently smoke or quit in the last 15 years); have an upcoming, scheduled Primary Care visit in a KP clinic in the coming 7-14 days, have not completed a low-dose CT scan.

Exclusion Criteria:

* None
A Follow-up Physician Survey to Evaluate Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe

With this follow up physician survey researcher want to collect the same data from all participants of the study using a highly structured questionnaire. The questionnaire will gather information related to physician characteristics and experience with Aflibercept, as well as assess physicians' knowledge and understanding of storage and preparation, proper injection technique, and the risks associated with Aflibercept injection into the eye (intravitreal injection). Analysis will be done using descriptive statistics.


Eligibility Criteria:
Inclusion Criteria:

* Has signed informed consent
* Is a licensed and practicing ophthalmologist
* Has prescribed and/or administered aflibercept to at least one patient in the past 6 months

Exclusion Criteria:

* None
Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)

The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.

The duration of treatment is 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Insomnia
Behavioral Pharmacology of THC and Beta-Myrcene

This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.

The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 9 acute drug administration periods in which they will administer THC alone, myrcene alone, THC and myrcene together, or placebo. Subjective drug effects and vital signs will be assessed following drug administration. Each participant will receive all 9 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help us understand the individual and interactive effects of THC and b-myrcene, two common constituents found in cannabis.

Eligibility Criteria:
Inclusion Criteria:

1. Have provided written informed consent
2. Be between the ages of 18 and 55
3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
4. Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
5. Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
6. Have a body mass index (BMI) in the range of 18 to 36 kg/m2
7. Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
8. Have no allergies to any of the ingredients used to prepare vapor (delta 9-THC, myrcene).
9. Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score over 75).

Exclusion Criteria:

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
2. History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
3. Use of an OTC, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
4. Use of a prescription medication (with the exception of birth control prescriptions) within 5 half-lives for that specific drug; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
5. Cannabis use that is inconsistent with protocol requirements.
6. Clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
7. Individuals with anemia or who have donated blood in the prior 30 days
Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO)

The purpose of this study is to show that a permissive hypercapnia during mechanical ventilation in children under general anaesthesia will improve cerebral perfusion.

Mechanical ventilation interferes with cerebral perfusion via the changes in intrathoracic pressure and/or as a consequence of hypocapnia. This latter occurs frequently following traditional ventilation strategies with relatively high tidal volume and respiratory rate. New trends in anesthesia intend to promote protective lung ventilation by keeping a normocapnic or even mildly hypercapnic state. However, cerebral vascular vasotonicity is carbon dioxide (CO2)-dependent with hypocapnia potentially leading to vasoconstriction and subsequent decrease in cerebral blood flow. Changes in cerebral vasoreactivity can be assessed by the near infrared spectroscopy (NIRS) device. This monitoring evaluates the changes in various parameters (deoxygenated hemoglobin, oxygenated hemoglobin, the tissue oxygenation index (TOI) and the tissue hemoglobin index (THI)) that act as surrogate for cerebral vasoconstriction.

We, therefore designed this prospective observational comparative effectiveness study in order to characterize the potential beneficial effect of permissive hypercapnia on cerebral perfusion in infants.

Eligibility Criteria:
Inclusion Criteria:

* term neonates during their infancy
* for elective surgery requiring general anesthesia and endotracheal intubation

Exclusion Criteria:

* all infants with cardiac anomalies, chronic pulmonary disease (bronchopulmonary dysplasia, cystic fibrosis, asthma), pulmonary hypertension or cranial hypertension will be excluded
* all infants where no access to the forehead is possible as a consequence of the operating field