cyrilzakka/clinical-trials huggingface dataset:
Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

The researchers are testing if counseling alone or counseling plus over-the-counter nicotine replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily smokers quit smoking.

Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4 African Americans are non-daily smokers. African Americans seem to have a harder time quitting and have greater medical problems related to smoking even at lighter usage rates compared to Whites.

Current tobacco treatment guidelines target daily smokers. There are no guidelines for non-daily smokers. This study will allow the researchers to explore treatment options for African American non-daily smokers and find out if some treatments work better than others.

Participation in this study will last about 6 months. Over this course of time, participants will be asked to visit the study location 3 times and will talk with a member of the study team on the phone 4 times.

Eligibility Criteria:
Inclusion Criteria:

* African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening

Exclusion Criteria:

* Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening
Real-world Diagnostic Effectiveness of Artificial Intelligence Algorithm in Diabetic Retinopathy Screening

Recently, artificial intelligence algorithm has made great progress in the prediction of diabetic retinopathy based on fundus images，showing very high sensitivity and specificity. However，the real-world diagnosis effectiveness of deep learning model is still unclear.

This study is designed to evaluate the clinical efficacy of such an algorithm in detecting referable diabetic retinopathy.

This prospective clinical study is designed to evaluate the real-world diagnostic performance of an AI model in detecting referable diabetic retinopathy (RDR, defined as more than mild NPDR), by evaluating its sensitivity and specificity compared to the clinical reference standard- seven-field stereoscopic photography.

The subjects enrolled in this study are patients with T1DM or T2DM. Qualified color fundus images and seven-field stereoscopic photography images of each eyes of the subject are taken. The fundus images are graded for RDR by the algorithm under test, and seven-field stereoscopic photography images of the same eye are graded by ophthalmologist, which serving as the gold standard to compare the algorithm performance against.

The trial plans to enroll 1000 subjects. With a 95% confidence interval, the sensitivity is expected to be at least 87% whereas the specificity at 89% or above.

The quality of fundus images are assessed according to the National DR Screening Imaging and Grading Guideline published by Chinese Ophthalmological Society and Chinese Medical Doctor Association in 2017.

The grading of RDR is based on the National DR Clinical Diagnosis and Treatment Guideline published by Chinese Ophthalmological Society in 2014.

A brief overview of the clinical protocol is as follows:

Candidate recruiting phase: recruiting qualified participants; Clinical phase: imaging and diagnosing by AI and ophthalmologist ; Statistical analysis phase: comparing two outputs; Closing phase: final report and archiving

Eligibility Criteria:
Inclusion Criteria:

1. Subject must understand the study, participate voluntarily, and has signed informed consent
2. Age 18 or older, no limitations on gender identity
3. Patients with type 1 or type 2 diabetes.

Exclusion Criteria:

1. Subjects diagnosed with eye diseases other than diabetic retinopathy
2. Subjects diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radioactive retinopathy or retinal vein obstruction.
3. Pregnant woman, subjects with mydriatic allergy, unclear refractive medium, family history of glaucoma, or diagnosed as narrow angle
4. Subjects with a history of laser therapy, retinal surgery or anti-vascular endothelial growth factor injection
5. Subjects currently participating in another ophthalmic research, receiving ophthalmic research products.
6. Subject who is photo-sensitivity or taking medication that causes photosensitivity
7. Subjects received photodynamic therapy recently
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults

The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 to 50 years old
2. Participants willing to give written informed consent to participate in the trial

Exclusion Criteria:

1. History of invasive pneumococcal infection within 5 years at screening
2. Known hypersensitivity to any component of the study vaccine
3. Immune deficiency or immunosuppressive disorder
4. Immunized with any licensed vaccine within 4 weeks prior to screening
5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
6. Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure
Analysis of Brain Tumors Using Matrix Assisted Laser Desorption/Ionization Mass Spectrometry

We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis, looking for unique protein signatures.

We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis. Data from different brain tissues including tumors of different histological sub-types will be analyzed for unique protein signatures. These protein signatures will then be statistically correlated with clinical data including time to tumor progression and response to therapy.

The goal of this study is to determine molecular patterns that will be more predictive of tumor behavior, thus leading to an improved understanding of the basic biology of these poorly understood cancers. This in turn, may lead to more refined therapies and improved outcomes.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of brain tumor or other non-cancerous tissue and are considered candidates fro a surgical procedure to biopsy or remove the brain tumor or other tissue type at Vanderbilt University Medical Center.
* Age 2 to 85

Exclusion Criteria:

* Patient or guardian that is unable to understand the informed consent process.
Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain treatment.

* double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial.
* Experiment duration: 04 days.
* 03 visits (days 0, 2 and 4).
* Efficacy will be evaluated for back pain relief based on visual analogic scale.
* Adverse events evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Consent of the patient or legal guardian.
* Men or women aged between 18 and 65.
* Diagnosis of acute low back pain with moderate to severe pain (Visual Analogic score greater than 4 cm)

Exclusion Criteria:

* fracture confirmed by X-ray
* Diagnosis of infection, fever,
* Pregnancy, lactation;
* Diagnosis of fibromyalgia;
* Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory
A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)


Eligibility Criteria:
Inclusion Criteria:

* Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
* Discontinuations in another clinical trials caused by side effects
Comparison Between Vaginal Misoprostol Gel and Oral Misoprostol Solution in Induction of Labor

The goal of this clinical trial is to study the efficacy of vaginal versus oral misoprostol solution in cervical ripening for induction of labor.

The main questions it aims to answer is : is Vaginal misoprostol solution as effective as oral misoprostol solution for induction of labor? Researchers will compare oral Misoprostol Solution and vaginal misoprostol solution prepared by KY gel Participants will then be randomized into two groups using a computer-generated randomization list , the first group will receive oral solution equal to 25 microgram misoprostol every 2 hours while the second group will receive 25 microgram vaginal misoprostol solution every 4 hours The cervix will be assessed and scored at each examination. They will be reviewed before the stipulated time if they were contracting. The administration of the drugs will be discontinued when a favorable cervix is diagnosed (modified Bishop score ≥6 ) or 24 hours of study drug had been given.


Eligibility Criteria:
Inclusion Criteria:

1. Women with a singleton pregnancy.
2. Cephalic presentation.
3. Age range: 18-40 years.
4. Gestational age between 36 and 42 weeks.
5. Intact fetal membranes.
6. Absence of spontaneous uterine contractions.
7. Non favorable cervix (Bishop score ≤ 5).
8. A reactive non stress test in case of positive fetal life.

Exclusion Criteria:

1. History of cesarean section or uterine scars
2. Grand Multipara P ≥5
3. Known fetal non-cephalic presentation
4. Any known allergy to misoprostol.
5. Multiple pregnancy
6. Contraindication to vaginal delivery.
Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study

The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS putty bone substitute in posterior maxillary sites and the survival of implants placed in these sites following healing.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with non-contributory medical history that will present for bilateral sinus lift surgery prior to implant placement

Exclusion Criteria:

* Patients that will not agree to participate in this study or sign the consent form
* More than 8mm of residual bone height at the implant site
* Subjects smoking more than 10 cigarettes per day
* History of acute sinus infection
* History of prior maxillary sinus surgery (Caldwell-Luc, direct or indirect sinus lift, etc)
* Medications that affect bone healing (chronic steroid regimen, oral or IV bisphosphonates, etc.)
* Patients allergic to bovine derivatives
* Patients who are a carrier of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks
* Females during pregnancy or lactation or females that plan to become pregnant in the following year (pregnancy test prior to enrollment)
Value of MicroRNA30a in Philadelphia Positive Leukemic Patients

The Philadelphia chromosome in leukemogenesis:The truncated chromosome 22 that results from the reciprocal translocation t(9;22)(q34;q11) is known as (Ph) and is a hallmark of (CML). This aberrant fusion gene encodes the breakpoint cluster region-proto-(BCR-ABL1) oncogenic protein with persistently enhanced tyrosine kinase activity. Besides CML, the Ph is found in acute lymphoblastic leukemia, and mixed-phenotype acute leukemia.

Chronic myeloid leukemia is a myeloproliferative neoplasm, characterized by the unrestrained expansion of pluripotent bone marrow stem cells.The hallmark of the disease is the presence of a reciprocal t(9;22)(q34;q11.2), resulting in a derivative 9q+ and a small 22q-. The latter, known as the Philadelphia chromosome, results in a BCR-ABL fusion gene . The diagnosis requires fluorescent in situ hybridization (to demonstrate the BCR-ABL fusion gene or(PCR) to demonstrate the BCR-ABL mRNA transcript.

our study will discuss the possible value of microRNA30a as early predictor for TKIs resistance in newly diagnosed CML patients.

the study will dectect the possible value of microRNA30a as prognostic marker in Philadelphia positive acute leukemic patients(ALL, mixed-phenotype acute leukemia) on TKI therapy by assessment level of microRNA30a inpatients who achieved complete hematological remission(CHR) and who failed to achieve CHR.

The study goal has been taken through the role of microRNA30a in reducing ABL1 and BCR-ABL1 protein expression and microRNAs are capable of changing the levels of several key proteins at various steps of the autophagic pathway.

Eligibility Criteria:
3 a-Inclusion criteria

1_clinical diagnosis of Philadelphia positive leukemic patients (males and females).

2- Aged from 18- 60 years. 3-All eligible patients presenting at Clinical Haematology Unit Internal Medicine Department.

4- Without contraindication to receive TKIs therapy. 5-Must able to swallow tablet(TKI therapy).

-exclusion criteria

1. NO bone marrow aspirate and flow cytometry confirm their diagnosis.
2. patients who refuse to participate in the study.
Adjunctive Laser for Periodontal Intrabony Defects

Participants with periodontitis and presence of bilateral intrabony defect will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be periodontal clinical parameters at 3 months, 6 months, 9 months and 12 months after treatment, radiographic parameters at 12 months, patient-reported parameters and laboratory analyses.

The study is a Double-masked randomised controlled trial with split-mouth design.

Participants with periodontitis will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be periodontal clinical parameters at 3 months, 6 months, 9 months and 12 months after treatment, radiographic parameters at 12 months, patient-reported parameters and laboratory analyses.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 20 teeth. Diagnosis of Severe Periodontitis (Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)

Presence of at least 2 teeth with ≥ 6 mm pockets and minimum of 3 mm intrabony defect, in opposing quadrants of the upper or lower arch.

Exclusion Criteria:

* Inclusion:

Minimum of 20 teeth. Diagnosis of Severe Periodontitis (Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)

Presence of at least 2 teeth with ≥ 6 mm pockets and minimum of 3 mm intrabony defect, in opposing quadrants of the upper or lower arch.

Exclusion:

* Wearing of a removable appliance/denture
* Wearing of orthodontic appliances.
* Current smoking - any history of smoking or vaping within last 5 years
* Relevant medical history likely to affect periodontal disease or taking relevant medication, including diabetes, as judged by the examining clinician
* Periodontal treatment (surgical/non-surgical root surface debridement under local anaesthesia) within last 12 months, as judged by the examining clinician
* History of any antibiotic use within last 3 months.
* Pregnant patients
* Teeth with hopeless prognosis indicated for extraction (Cortellini et al 2011)
* Patients with a non-adequate level of English
Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex

Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. The objective of this randomised controlled trial is to confirm in the clinical practice these preliminary results.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo microlaryngoscopy and ear-nose-throat endoscopic procedures

Exclusion Criteria:

* contraindication to dexamethasone administration
* contraindication to sugammadex administration
* contraindication to rocuronium administration
Taste Physiology in Obese Volunteers Before and After Bariatric Surgery

The objective is to investigate neuro-anatomical correlates of gastrointestinal taste stimulation by means of functional MRI before and after bariatric surgery. Intragastric administration of glucose, monosodium glutamate, chloroquine and placebo is followed by functional brain MRI in obese humans before and 3 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* morbidly obese patients (BMI min 35kg/m2) scheduled for bariatric surgery
* right handed

Exclusion Criteria:

* cardiovascular disease
* neurologic/psychiatric disorders
Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement

Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities.


Eligibility Criteria:
Inclusion Criteria:

* Total hip or knee replacement in fast-track setup
* Age 60 years or above
* ASA class 1-3

Exclusion Criteria:

* Anesthesia within the pas 30 days
* Daily use of alcohol \> 21 units / week
* Use of anxiolytics or hypnotics within the past 30 days
* Inability to read and understand Danish
* Marked reduction of sight or hearing
* Parkinson's disease or other neurological disaese causing function deficits
* Inability to cooperate to sleep monitoring
* allergy to the drug tested
Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women

The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself! compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments. Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV)
* Body Mass Index (BMI) greater than or equal to 30
* Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study)

Exclusion Criteria:

* current substance dependence
* history of psychotic symptoms
* high risk of suicide/self-harm
* current enrollment in a weight-loss program
* weight loss surgery in the past year
* current psychotherapy
* inability to postpone weight loss or depression treatment interventions for the duration of the study
* taking antipsychotic, tricyclic, or oral corticosteroid medication
* unwilling to be randomized to the study treatments
Canadian Continuation of Roll-over Study in Patients With Endogenous Cushing's Syndrome

The purpose of this study is to continue the evaluation of long-term safety of osilodrostat in 7 Canadian patients who have already received osilodrostat treatment in a previous Global Recordati-sponsored roll-over study and who, based on investigators' judgement, will continue benefiting with its administration.

There will be no screening period for this study. Eligible subjects can start their treatment with osilodrostat as soon as they are enrolled in the study. The first study visit will be scheduled at the time of the last study visit for the parent study. Subjects must return to the study center at least on a quarterly basis (every 12 weeks ± 2 weeks) for safety and clinical benefit assessments, and resupply of study medication. Drug dispensing and administration information and adverse events will be collected. The subject may return to the clinic at any given time as per standard of care or treating physician recommendation; however, only the quarterly study visits will be recorded in the Case Report Form (CRF). Study medication dispensed will be recorded in the CRF dose administration page.

All adverse events and serious adverse events, including pregnancy, will be collected throughout the study. Subjects will continue to be treated in this roll-over study until they are no longer benefiting from their osilodrostat treatment as judged by the Investigator or until osilodrostat is commercially available or until one of other discontinuation criteria is met.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is currently participating in a Global Recordati-sponsored roll-over study receiving osilodrostat for any type of endogenous CS and has fulfilled all their requirements in the parent study.
2. The patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.
3. Patient has demonstrated compliance, as assessed by the Investigator, with the parent roll-over study protocol requirements.
4. Willingness and ability to comply with scheduled visits and treatment plans.
5. Written informed consent obtained prior to enrolling into the study

Exclusion Criteria:

1. Patient has been permanently discontinued from osilodrostat study treatment in the parent roll-over Recordati-sponsored study.
2. New patients not previously enrolled in parent roll-over Recordatisponsored study.
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory evaluation.
CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?

Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media.

The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Male and female patients 18 y. o. and older
* Verified stable coronary artery disease (CAD)
* Receiving optimal medical treatment and requiring percutaneous coronary intervention (PCI) with iodinated contrast media

Exclusion Criteria:

* Pregnancy, lactation
* Conditions affecting the prognosis (kidney failure, liver failure, oncology)
* Acute coronary syndrome (ACS)
* Stroke
* Contraindications to PCI
* Therapy with nephrotoxic drugs during the enrolment which cannot be stopped
* Refusal to sign the informed consent