cyrilzakka/clinical-trials huggingface dataset:
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactivity Disorder (ADHD).

The primary objective of this study is to evaluate whether OROS MPH (Concerta), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with ADHD. The study will involve an estimated 252 participants, recruited from approximately 6 sites.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ADHD2
* Smoked cigarettes for at least 3 months
* Currently smoking \> 10 cigarettes/day
* Have an interest in quitting
* Negative urine screen for cocaine, methamphetamine, opiates, benzodiazepines, and marijuana

Exclusion Criteria:

* Have a clinical diagnosis for current abuse or dependence for any psychoactive substance other than nicotine, depression, or anxiety; or a life-time clinical diagnosis of psychosis or bipolar disorder
* Allergic to OROS-MPH
* Pregnant or breastfeeding
* Abnormal electrocardiogram (ECG)
* Taking a Monoamine Oxidase (MAO) Inhibitor
* Taking any medication used for treating either ADHD or smoking
* Use of tobacco products other than cigarettes in the past week
* Blood pressure readings greater than 135/85 and/or a heart rate more than 90 beats per minute on three consecutive clinic visits
Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.

There is a mounting evidence of the modulation properties of the major catechin in green tea, epigallocatechin-3-gallate (EGCG), on dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) gene overexpression in the brains of DS mouse models.The aims are to investigate the clinical benefits and safety of EGCG administration in young adults with DS, to establish short-term EGCG effects (three months) on neurocognitive performance, and to determine the persistency or reversibility of EGCG related effects after three months of discontinued use.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed of DS neurological disease, aged between 14-29 years, have given the consent to participate (official custody).

Exclusion Criteria:

* Subjects with neurological disease other than DS, relevant medical disease, co-morbid mental disorder or currently taking any treatment that could interfere with cognitive function or alter any key biomarkers and biochemical parameters analyzed.
* Having suffered from any major illness or undergoing major surgery in the last three months before the study;
* Regular ingestion of medication in the month preceding the study. Exceptions were made for single doses of symptomatic medication administered up to the week preceding the trial.
* Current ingestion of vitamin supplements or catechins or AINE in the two weeks preceding the study.
* History of gastrointestinal, hepatic or renal problems or any other cause that may alter processes of absorption, distribution, metabolism, or excretion of the drug, or that might suggest gastrointestinal irritation to drug.
* Subjects following a vegetarian diet.
* Practice of physical exercise for more than 2 hours per day or energy consume/consumption of more than 3000 kcal per week.
An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes
* Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
* Selection will be at the discretion of the individual physician

Exclusion Criteria:

* Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
* Previous enrolled in this study
* Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites

Study Design

This is a Phase 1, multi-center, extension study to collect safety data up to 75 ± 10 days postdose from the Phase 1 studies RPC01-1912, RPC01-1913 and RPC01-1914 (ie, the "parent studies") and PK/PD data up to 75 ± 10 days postdose from studies RPC01-1913 and RPC01-1914. This study consists of two parts:

* Mandatory data collection for safety: Subjects enrolled in the parent studies were consented to have data on adverse events (AEs), serious adverse events (SAEs), pregnancy test results, and concomitant medications up to the 75 ± 10 days postdose follow-up collected and reported in this study.
* Optional sparse sampling for PK/PD: Eligible subjects from studies RPC01-1913 and RPC01-1914 will be offered the opportunity to return to the clinical research unit (CRU) at four separate occasions for PK/PD sample collections up to the 75 ± 10 days postdose follow-up. After signing the informed consent form, eligible subjects will be randomized to one of three sequences with stratification by site/protocol. Subjects will return to the CRU in the morning (between approximately 8 am and 11 am) once at each of the four time windows.

Study Population The approximate number of subjects will be 230 for safety data and 129 for PK/PD data.

Length of Study The study duration is up to 84 days.


Eligibility Criteria:
Inclusion Criteria:

1. For the mandatory data collection for safety, subjects who enrolled in the Phase 1 studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or investigational product (IP) as applicable per the parent studies are eligible, except for subjects who discontinued during Period 1 of study RPC01-1913.
2. For the optional sparse sampling for PK/PD, subjects must satisfy the following criteria:

   1. Subjects in study RPC01-1913 have completed the study at least through Period 2 and completed the 7 ± 2 days postdose follow-up assessments; or subjects in study RPC01-1914 have completed the study through the 7 ± 2 days postdose follow-up.
   2. Subjects had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments.
   3. Subjects must be able to comprehend and provide written informed consent, and must be able to comply with the requirements of the study, including the study visit schedule and other protocol requirements or restrictions.

Exclusion Criteria:

No Exclusion Criteria
Combined Effects of Vestibular Rehabilitation With Dual Task Training in Vestibular Disorders

Patients with vestibular disorders often experience cognitive-motor interference which can adversely affect their motor performance, significantly impair daily functioning, increase instability, reducing quality of life and increasing the risk of falls. Vestibular rehabilitation is a well-established therapeutic approach for managing vestibular disorders in reducing symptoms and improving balance and mobility. Similarly, Dual Task Training improves cognitive-motor integration by enhancing both cognitive and motor functions and has shown promising results in other populations. This study is aimed to determine the combined effects of both interventions as it might provide a more comprehensive and effective treatment, ultimately improving patient outcomes and quality of life.

In previous studies, vestibular rehabilitation is well-documented in enhancing balance, gait, reducing dizziness and improving quality of life through specific exercises aimed at improving vestibular function. Similarly, dual task training has shown promise in improving functional mobility and cognitive processing. However, no randomized control trial to date has systematically investigated the potential synergistic effects of these two interventions when applied together which leaves a critical gap in understanding whether the integration of dual task training into vestibular rehabilitation could yield superior outcomes for patients suffering from vestibular disorders. This research could provide valuable insights and potentially enhance therapeutic strategies for this population.

Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of dizziness for longer than 3 months
* Patients with history of at least 1 bout of dizziness per month
* Patients with history of at least 1 fall in previous 6 months
* Diagnosed Patients as having vestibular disorder by an otolaryngologist
* Mini Mental State Examination (MMSE) score greater than 24

Exclusion Criteria:

* Patients with Meniere disease and bilateral vestibular disorders
* Patients with central nervous system disorders, and psychiatric disorders
* Patients having visual impairment that could not be treated with lenses or glasses
* Dizziness not resulting from vestibular disorder or use of Medication for Dizziness
* Movement limitation due to orthopedic problems
* Those who were unable to sign informed consent form
Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner

The primary purpose of this study is to measure the clinical utility (accuracy) of the hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results will be compared to the results of a current mammogram and/or ultrasound. The duration of study participation is approximately 30 minutes one day.

The FDA approved class II device in this clinical trial is a low-cost hand-held breast scanner (intelligent Breast Exam, iBE). This device is to be used a pre-screening tool for mammograms or ultrasounds. Determination of the accuracy of iBE for the detection of clinically relevant breast lesions will be performed by means of a prospective study.

The iBE evaluation will be performed by a trained licensed practical nurse or ultrasound technologist who is blinded to the outcome of the radiology studies at the time the iBE is performed. The iBE training will be done by the leading iBE user in the United States. The iBE evaluation will be done prior to the patient's original scheduled imaging visit. After the completion of the imaging visit the radiologist will evaluate the mammogram and/or ultrasound images along with the iBE report.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Women and men with symptomatic breast lump (either by palpation or imaging) OR
* Asymptomatic women presenting to the imaging center for a screening mammogram
* Signed Informed Consent

Exclusion Criteria:

* Patients under 18 years of age
* Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests
Using Vegetable and Berry Products Can Improve Skin Conditions

Hypothesis: vegetable and berry products for 8 weeks can improve skin condition

Hypothesis: Using vegetable and berry products for 8 weeks can improve skin condition

Eligibility Criteria:
Inclusion Criteria:

1. Dry skin
2. Rough skin
3. Large pores
4. Dark yellow complexion
5. Sagging skin

Exclusion Criteria:

1. Skin disorders
2. Liver diseases
3. Kidney diseases
4. Allergy to cosmetics, drugs, or foods
5. Pregnant and lactating women
6. People who had any cosmetic procedures before 4 weeks of the study
7. Area of facial spot over 3 cm2
8. Vegan
9. People who took collagen supplements in the past 3 months.
CAPTION AI to Minimize Risk of COVID Exposure

Participants scheduled for for an echocardiogram (echo) and being evaluated for, or is positive for COVID-19 will be asked if they would be willing to have their echo done using a new software program on one of the hand-held ultrasound scanners.

The new software program guides the investigator, or any other non-sonographer, to take the best possible pictures of the participants heart. The prior version of this software is already being used clinically and is FDA approved. The main reason for using the updated version is that it's faster and better in terms of guiding the user.

To enable healthcare professionals that are not proficient in transthoracic echo (TTE) to acquire images in patients being evaluated for or positive for COVID-19. By leveraging the capabilities of the Caption AI which is designed to train novice users on how to acquire TTE, this would minimize the risk of sonographers to be exposed to COVID-19. Additionally, minimizing sonographer interaction with patients being evaluated for or positive for COVID 19 minimizes the risk of sonographers as vectors for transmission to other patients. Lastly, since the Caption AI device will be dedicated to the COVID wards and COVID ICU and not transported to other locations, use of the CAPTION AI device will help to limit viral transmission via the surfaces of the ultrasound machine. These images will be assessed by qualified medical professionals for diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Duke patients within the MICU and COVID overflow areas
* transthoracic echocardiogram ordered by their provider
* suspected or positive for COVID-19.
* Patients who consent to participating in the study or Physician discretion that information to be gained is important to the patient
* Patients ≥18 years old

Exclusion Criteria:

* Unable to lie flat for study
* Patients unwilling to give consent
Periodontitis and Coronary Heart Disease

"Atherosclerosis is an inflammatory disease". The hypothesis of an infectious burden as trigger or initiator of the inflammatory process in atherosclerosis has been extensively discussed in the past years. One part of this discussion is focused on the infectious agents responsible for periodontitis. Several studies have found an association of periodontitis and/or bacteria related to this disease and atherosclerosis. However, a study focussing on the prognostic relevance of these factors is missing.

The hypothesis of this study is that periodontitis is a prognostic relevant risk factor for patients with angiographically proven coronary heart disease. Furthermore, the infectious pathogen burden by PCR-detection of periodontal pathogens will be evaluated as a prognostic factor.

960 consecutive patients with angiographically proven coronary heart disease will be included in this study. After inclusion of patients an extensive periodontal examination including PCR-sampling for 11 bacteria (Porphyromonas gingivitis, Actinobacillus actinomycetemcomitans, and others) will be performed. After 12 months patient will be follow up for any major adverse events (cardiovascular death, myocardial infarction, stroke).

If this study will find a relation of periodontitis or its microbiological agents to cardiovascular outcome of patients with coronary heart disease, further studies are necessary to investigate potential therapeutic consequences for patients with CHD and periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Coronary heart disease as defined by previous or current detection of 50% stenosis of a main coronary artery by coronary angiography or previous or current percutaneous coronary intervention (PCI) or previous or current coronary artery bypass surgery (CABG)

Exclusion Criteria:

* Inability to give written informed consent
* Periodontal treatment and/or antibiotic therapy during the last 6 months
* Pregnancy
* Current alcohol or drug abuse, or psychological reasons that make study participation impractical
* Drugs which are potential causal for gingival hyperplasia (Hydantoin, Nifedipine, Cyclosporin A, and other)
Study of VIR-2482 in Healthy Volunteers

This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male or Female age 18 to \< 65 years
* Body mass index (BMI) of 18.0 kg/m\^2 to 32.0kg/m\^2

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* History of influenza-like illness or confirmed influenza infection within 3 months prior to randomization.
* Fever-like illness within 5 days of randomization.
* History or clinical evidence of conditions considered high risk for developing influenza-related complications.
Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis

Etanercept, a fully human soluble tumor necrosis factor (TNF) receptor fusion protein, has been demonstrated to be safe and efficacious for the treatment of patients with polyarticular JIA. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial. It has been shown that the clinical response to two anti-TNFalpha biological agents (infliximab, adalimumab) closely follows the trough drug levels and the presence of antibodies directed against the drugs. This study was undertaken to investigate whether serologic monitoring of etanercept bioavailability and immunogenicity in individual patients with JIA would be useful in optimizing treatment regimens to improve efficacy and tolerability

Eligibility Criteria:
Inclusion Criteria:

* Patient with Juvenile Idiopathic Arthritis
* Age \<18 years and\> 4 years (which corresponds to the pediatric AMM)
* Patient on Etanercept treatment in the context of his usual care, whatever the dose (but the dose should remain stable in the weight during the study period). The patient must have received at least one injection of etanercept before participating in the study.
* Signature of consent by the guardians of the child
* Patient affiliate or entitled to a social security scheme

Exclusion Criteria:

* Infection progressive
* Pregnancy and lactation. For adolescents of reproductive age and sexually active, contraception should be used during the duration of treatment with etanercept
* Contraindication to treatment with Etanercept
* Refusal of the study
A Phase I Study of GFH312 in Healthy Chinese Subjects

The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects.

This study was planned to enroll about 26 healthy subjects, subjects were planned to receive single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple administrations of 120 mg GFH312, as well as their matching placebo. Subjects were randomized in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in the study and sign the informed consent;
* Male or female healthy subjects aged 18-55 years (inclusive) (single sex ratio not less than 25% of the sample size of each cohort);
* Body mass index (BMI) between 18-28 kg/m2 (inclusive), and weight ≥ 50kg; BMI = Weight (kg) /\[Height (m)\]2.
* During the screening period and day 1, patients with normal or abnormal results but no clinical significance based on detailed medical history, comprehensive physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram and vital signs.
* Able to communicate well with researchers, understand and comply with research requirements.

Exclusion Criteria:

* Any procedure or disease that may significantly alter drug absorption, distribution, metabolism, or excretion, or participation in this study may compromise the safety of the subject.
* Tuberculin test positive
* Abnormal electrocardiogram with clinical significance
* Use any prescription drugs, Chinese herbs and/or OTC or health products within 2 weeks before starting the administration.
* Women who are pregnant or breastfeeding, or subjects with positive pregnancy test results at the time of screening or at baseline, or who plan to become pregnant during the study period or within 30 days after the end of the study.
* Subjects who have any factors deemed unsuitable for participation in this study by the investigator.
Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.

The purpose of this study is to compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare.

A total of 20 patients will be included. 10 patients with uveitis and 10 control patients scheduled for phacoemulsification. Each patient will undego complete ophthalmic examination and clinical biomicroscopic grading of the anterior chamber flare applying the SUN working group grading system. Aqueous specimens will be obtained by anterior chamber paracentesis for protein analysis. Each Patient will undego paracentesis and 0.2 ml of aqueous will be obtained. The aqueous sample will be stored at -70°C until the time of analysis for protein content. Objective assessment of flare will be done.

Eligibility Criteria:
Inclusion Criteria:

* 10 patients with uveitis with cataract
* 10 patients without uveitis with cataract
* Inactive inflammation for at least 3 months

Exclusion Criteria:

* Infectious uveitis
* endophthalmitis
* cases with corneal scar
CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation

In this clinical trial, the investigators aim to apply CD62L depleted donor lymphocyte infusion (DLI) together with in vitro T cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) to treat patients with malignant or non-malignant disease in need of HSCT. The investigators shall evaluate the graft failure-free, graft-versus-host disease (GVHD)-free survival at one year, frequency of adverse events and post-transplant complications, and immunoreconstitution.

The peripheral stem cell harvest product from the patient's related haploidential donor will be divided into two portions. One portion will undergo T cell receptor (TCR) αβ depletion and the other portion will undergo CD62L depletion. Both depleted products will be infused intravenously to the patient on the same day.

Eligibility Criteria:
Inclusion Criteria:

* Patient who requires allogeneic hematopoietic stem cell transplant, has no human leukocyte antigen (HLA)-matched sibling donor but has an HLA-haploidentical donor.
* Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy
* Karnofsky or Lansky performance status score ≥50

Exclusion Criteria:

* Pregnant or lactating woman
* HIV infection
* Patients for whom alternative treatment is deemed more appropriate by treating physician
* Patients who are unlikely to benefit from haploidentical hematopoietic stem cell transplantation, e.g., terminal malignancy with multiorgan failure