cyrilzakka/clinical-trials huggingface dataset:
Personalized Medicine Decision-Making in a Virtual Clinical Setting

Background:

-How people respond to drugs depends in part on their genes. For some drugs, doctors can use an individuals genetic background to help in dosing the drug. Researchers want to know how doctors incorporate personalized or genomic medicine into clinical practice.

Objective:

-To study how physicians make personalized treatment decisions

Eligibility:

-Healthy adult primary care physicians who are internal (or family) medicine residents.

Design:

* Participants will complete a screening form.
* Participants will put on a headset, called a head-mounted display, showing a virtual reality environment.
* The environment will contain an exam room and the virtual patient.
* After interacting with the virtual patient, participants will complete a series of survey measures.
* Participation will last for about 60 minutes. The virtual patient interaction and follow-up questions will be audio taped.

This study will examine factors related to primary care physicians clinical decision-making. Using a virtual clinical interaction experiment, we aim to better understand physicians decision-making processes and to explore their communication behaviors toward patients in the clinical encounter. Physician participants will enter a virtual exam room where they will be asked to respond to a virtual patient, acting as her primary care physician in a follow-up visit to evaluate her for depression. Various aspects of physician communication in the virtual clinic and self-report measures related to decision-making will be analyzed.

Eligibility Criteria:
* INCLUSION CRITERIA:
* All physicians will be healthy adult volunteers who are medical residents in the internal medicine specialty.

EXCLUSION CRITERIA:

1. persons with seizure or vestibular disorders;
2. persons who are highly prone to motion sickness;
3. those without normal or normal to corrected vision or hearing;
4. all current and past employees and contractors of NHGRI; and
5. persons who have received information about the study purpose or procedure from a past participant.

NHGRI employees are excluded for this protocol because they are likely to have specialized genomic knowledge and may think differently about genomics in the clinical interaction.
A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has had a self-reported oculo-visual examination in the last two years.
3. Has read and signed an information consent letter;
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
6. Is willing to wear contact lens in both eyes for the duration of the study;
7. Has a minimum astigmatism of - 0.75, determined by refraction;
8. Can be fit with the two study contact lens types in the powers available;
9. Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
10. Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
11. Has clear corneas and no active\* ocular disease;

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical trial;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study measure;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
5. Has known sensitivity to fluorescein dye or products to be used in the study;
6. Appears to have any active\* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
8. Is aphakic;
9. Has undergone refractive error surgery;
10. Has participated in the previous QUENA study.
A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants

The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are 18 to 55 years of age.
* Participants who are overtly healthy.
* One SARs-CoV-2 negative test is required prior to dosing
* Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive).
* Capable of giving signed informed consent.
* Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.

Exclusion Criteria:

* History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
* Current or chronic liver disease, hepatic or biliary abnormalities, or relevant hepatitis.
* Abnormal blood pressure.
* Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years. Participants with exclusionary electrocardiogram findings.Positive HIV test or ongoing behaviors that put the participant at high risk for HIV acquisition.
* Participants who are breastfeeding or plan to become pregnant during the study.
* Past or intended use of exclusionary medications or vaccines.
* Exposure to \>4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
* ALT \>1.5x upper limit of normal (ULN), total bilirubin \>1.5x ULN, and/or estimated serum creatinine clearance \<60 mL/min.
* History of or current infection with hepatitis B or hepatitis C.
* Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
* Positive HIV antibody test.
* Participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.
A Retrospective, Natural History Study in Children With CLN2

This is a multi center, retrospective, chart review study to document the evolution of ocular disease progression in pediatric patients with CLN2.

CLN2 is a rare disease with limited available ocular natural history data. While current standard of care slows motor degeneration, it is not known to treat the ocular manifestations of disease. This study is planned to document, through retrospective data collection, ocular disease progression in children with a clinical presentation consistent with CLN2. No investigational product is administered in this retrospective, chart review study.

Eligibility Criteria:
Inclusion Criteria:

A participant is eligible to be included in the study only if all of the following criteria apply:

1. The participant's legal guardian(s) is(are) willing and able to provide them written, signed informed consent.
2. The participant has a documented diagnosis of CLN2 disease due to TPP1 deficiency, or has a relative clinically diagnosed with CLN2 disease who has the same CLN2 mutations as the participant
3. The participant has had one or more eye examinations by an eye care specialist at any time since birth.

Exclusion Criteria:

No exclusion criteria apply to this study.
Community Development Teams to Scale-Up Multidimensional Treatment Foster Care (MTFC) in California

The effects of using Community Development Teams to increase the number of counties that successfully implement and sustain Multidimensional Treatment Foster Care programs is studied in a randomized trial in 40 California counties. MTFC is an alternative to group or residential placement for youth with severe conduct and emotional problems referred from the juvenile justice and child welfare systems.


Eligibility Criteria:
Inclusion Criteria:

* Non-early adopters of evidence-based practice (MTFC)

Exclusion Criteria:

* Placed fewer than 6 youth per year in group care
The Leicester City and County Chronic Kidney Disease Cohort

Chronic kidney disease (CKD) is estimated to affect 6-8% of the adult population and is independently associated with increased cardiovascular (CV) disease risk. This risk increases as CKD advances both in relation to worsening glomerular filtration rate and development of proteinuria. The overall cost of CKD to the NHS (National Health Service) in England has been estimated as £1.45 billion per annum, or 1.3% of the NHS's total budget. This includes £175 million, or 13% of the CKD budget, annually spent in relation to 19,000 excess myocardial infarctions and strokes related to CKD.

The epidemiology of CKD in primary care is poorly studied. This is particularly the case in non-white populations who have an independent higher risk of progression to end stage renal failure (requiring dialysis or transplantation), CV events and death.

Further, CV disease risk in CKD remains poorly described beyond simple risk stratification by CKD stage. A recent systematic review identified some CKD-specific CV disease risk scores. However, all the risk scores had significant methodological limitations, such as a lack of external validation or the perception that they were not 'clinically useful'. The Leicester City and County Chronic Kidney Disease (LCC-CKD) cohort will be created from anonymised GP (general practice) records of individuals with CKD. We will aim to retrospectively create a cohort with 5 years follow-up to the present day. In addition, a present day cohort will be created to both aid research and provide data for practices and clinical commissioning groups for quality improvement (QI) purposes. We will aim to include 30,000 individuals with CKD in the cohort.

The principal objectives of the study are:

1. To study the natural history of CKD in a multi-ethnic primary care setting
2. To contribute to the creation of a risk prediction tool for heart attacks and strokes in CKD

The risk prediction tool would more accurately stratify risk of CV events for individuals with CKD. This would aid patients and clinicians in deciding on treatments aimed at reducing the risk of future myocardial infarctions and strokes. Currently, individuals with CKD, despite higher risk of CV disease, may not be receiving optimum treatment such as statins and anti-hypertensive medications. Improved management of cardiovascular risk factors in CKD is likely to see a reduction in CKD associated excess CV events and their associated costs, including longer average duration of inpatient admissions.


Eligibility Criteria:
Inclusion Criteria:

* Practice Level - all primary care practices within the 3 Clinical Commissioning Groups participating in the study.
* Patient Level - any individual 18 years or over with an MDRD (Modification of Diet in Renal Disease) or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) eGFR (estimated glomerular filtration rate) less than 60ml/minute/1.73m2, proteinuria or a Read code CKD diagnosis.

Exclusion Criteria:

* Aged less than 18 years of age
* Endstage renal failure i.e. already receiving dialysis or with a kidney transplant.
Phenotypic Characteristics of Responders to Obstructive Sleep Apnea Treatment Using Mandibular Advancement Devices

Currently, mandibular advancement devices (MAD) are recommended by the American Academy of Sleep Medicine (AASM) as the first treatment a line in cases of mild and moderate OSAS in patients without severe cardiovascular comorbidity and in severe OSAS when treatment with CPAP fails or is rejected. Although oral appliances (OD) have less impact on AHI reduction, both treatments have been shown to have a similar impact on clinical outcomes, including symptomatology and cardiovascular outcomes. In addition, MAD is a treatment that is better tolerated by patients, which results in greater compliance on their part, and therefore a similar efficacy in clinical practice.

Its mechanism of action consists of maintaining the patency of the upper airway, preventing collapse. They act by correcting the anatomical imbalance of patients with OSAS, specifically stabilizing and increasing the space of the velopharyngeal airways, reducing their collapsibility.

However, the effectiveness of the treatment of this pathology using MAD is limited by the inter-individual preference of the results of the treatment and the lack of information in the correct selection of the appropriate patients. In fact, oral appliances are an effective treatment for 60-70% of patients. Therefore, the precise selection of patients is essential to optimize the results of MAD treatment and thus avoid the necessary costs. This justifies the need to identify phenotypes likely to predict response to MAD treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Adult patients with obstructive sleep apnea diagnosed according to the third edition of the International Classification of Sleep Disorders.
* Apnea-hypopnea index (AHI) of at least 5/hour of sleep.

Exclusion Criteria:

* Patients with heart disease.
* Central sleep apnea.
* Patients who had degenerative pathologies of the temporomandibular joint.
* Patients who had moderate or advanced periodontal disease.
* Pregnant patients.
Assessment of the Ocular Microbiome in Health and Disease

The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults.

The microbiome is defined as a community of microbial organisms that reside in a specific host niche. There is a growing body of literature on the association between gut microbiome and disease entities such as inflammatory bowel disease, colon cancer and presumably an association that might influence response to treatment in some patients.

Recent data suggest the existence of a resident ocular microbiota that may play a protective role in corneal infections \[1-4\]. However, not much is known about the ocular microbiome and its association with disease or response to treatment. The National Eye Institute (NEI) recently hosted a symposium to discuss challenges to characterize the ocular microbiome and its role in promoting or preventing ocular diseases. One of the major challenges discussed is the lack of a normative population- based database describing the ocular microbiome.

In response the NEI as part of the Anterior segment initiative put out an RFA requesting proposals on methods of collection of biological samples and associated clinical data (e.g. demographic, residence, medications, allergies); processing of samples to extract analytes (e.g., DNA, RNA, protein, metabolites) and characterizing microorganisms in a low biomass niche, specifically the ocular surface using16S rRNA marker gene, whole metagenome sequencing (WMS), and metatranscriptomics approaches.

Eligibility Criteria:
Inclusion Criteria:

We will include subjects who meet all of the following criteria:

* 18 years of age or older
* Provide informed consent
* Cohort A - normal eyes with no ocular disease
* Cohort B - primary open angle glaucoma/Ocular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months
* Cohort C - non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)
* Cohort D - Dry AMD (age related macular degeneration)
* Cohort E - Wet AMD
* Cohort F - diabetic retinopathy

Exclusion Criteria:

We will exclude subjects who meet all of the following criteria:

* Prior ocular disease either of the anterior or posterior segment
* Any medical comorbidities except well controlled DH and HTN
* Unable to follow up with study procedures as described
Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

Voluntarily participate and sign an informed consent form; Age\>18 years old, female； received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection； Invasive cancer, postoperative axillary lymph node negative, with pathological staging of T1-3N0M0 stage (Stage IA, IIA, IIB)； including two or more high-risk factors based on four clinical high-risk recurrence factors \[tumor size (\>2cm), tumor site (medial and central quadrants), Ki-67 level (\>14%), and vascular status (positive)\]; KPS ≥ 80, estimated survival time \>5 years; Complete healing of Surgical incision, no incision infection, etc; Reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study

Exclusion Criteria:

Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; History of malignant tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ); Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by pathology or imaging;
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care

The overall objective of this study is to conduct a randomized effectiveness-implementation trial to test the non-inferiority of tele-Brief Behavioral Treatment for Insomnia vs. tele-Cognitive-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults with insomnia in the primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Meet clinical diagnostic criteria for insomnia
* Insomnia severity score \> 10
* Eligible to receive care through publicly supported medical assistance, OR
* Identify as race or ethnic minority
* Has capacity for informed consent

Exclusion Criteria:

* Untreated, current major depressive disorder
* History of bipolar or psychosis
* Active substance abuse or drug abuse
* Excessive daytime sleepiness
* Seizure within the past 1 year
* Main sleep period outside of 8pm - 11am
* Regular nightshift work
* Untreated, previously diagnosed moderate to severe sleep apnea
* Severe medical condition, which may require hospitalizations over the next 6 months
* Active suicidal ideation, if elicited passively during screening
* Pregnant or planning to become pregnant
Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome

We aimed this study to determine and compare frequency of induction of ovulation in women with polycystic ovarian syndrome treated with Letrozole versus clomiphene citrate as published literature shows variations.

Discrepancy between ovulation induction rate and pregnancy rate is related to anti-estrogenic effects on cervical mucus and endometrium and long acting gonadotrophins are more effective than clomiphene citrate. This study was aimed at comparing frequency of induction of ovulation in women with polycystic ovarian syndrome treated with Letrozole versus clomiphene citrate.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of polycystic ovarian syndrome.

Exclusion Criteria:

* All women having endocrine disorders like thyroid disorders.
* Women having hyperprolactinemia.
FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).

Subjects will undergo a single CT or MRI-guided intracerebral administration of human interneurons that secrete the inhibitory neurotransmitter, gamma-aminobutyric acid (GABA), into the temporal lobe region of the brain where the seizures are thought to arise. NRTX-1001 is intended to suppress the onset and spread of seizures. Safety, tolerability, and effects on reducing seizure frequency and epilepsy disease symptoms will be assessed at quarterly intervals for 2 years after the administration of NRTX-1001. After the two-year period, subjects will be followed with quarterly phone calls and annual visits in years 3 through 5, and then annual visits in years 6 through 15. Subjects will be placed on an immunosuppressant medication regimen for a duration of one year to partially suppress the subjects' immune system to promote the intended long-term persistence of NRTX-1001. This immunosuppressant medication is intended to be discontinued after the first year; however, the NRTX-1001 cells are intended to persist long-term.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or Female, age ≥18 to 75
2. Focal seizures, clinically defined as unilateral MTLE
3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses
4. Currently on stable doses (at least 1 month) of approved ASDs
5. Single seizure focus confirmed within one hippocampus
6. Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focal seizures per 28-day period with objective manifestations or more severe types, over the 6 months prior to the Screening Visit.
7. Considered (by Investigator) to be a candidate for temporal lobectomy (TL) or Laser Interstitial Thermal Therapy (LITT) following evaluation at a qualified epilepsy surgery program (National Association of Epilepsy Centers \[NAEC\] Level 4).

Key Exclusion Criteria:

1. Epilepsy due to other and/or progressive neurologic disease
2. Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin.
3. Significant other medical conditions which would impair safe participation
4. History of status epilepticus in the year prior to screening. A history of cluster seizures is permitted.
5. Primary or secondary immunodeficiency
6. Suicide attempts in the past year
7. Severe psychiatric disorders
8. Prior lobectomy or LITT procedure
9. MRI indicating potential malignant lesion
10. Pregnancy, or currently breastfeeding.