cyrilzakka/clinical-trials huggingface dataset:
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities

This study provides substance use and mental health treatment for young sexual and gender minority adults in Durham and Charlotte, NC and seeks to provide intensive wraparound services that address factors that influence substance use and mental health among this population such as minority stressors and lack of social support, housing instability, lack of access to affirmative health care, and limited job opportunities.

Project Uplift provides evidenced-based substance use and mental health treatment, intensive case management, and peer support services for sexual and gender minorities, ages 18-35. The program is based in two metropolitan areas in North Carolina, Durham and Charlotte, and will offer services for approximately 80 sexual and gender minority young adults. Survey data collected from participants at baseline and at the end of the 6-month program will be used to evaluate the effectiveness the comprehensive care program.

Eligibility Criteria:
Inclusion Criteria: 1) age 18-35; 2) substance use in the last 90 days; 3) self-identify as a sexual and/or gender minority; 4) reside in the Durham or Charlotte geographic areas including neighboring counties

Exclusion Criteria: 1) inability to speak and read English
Cystic Fibrosis Blood Neutrophils

The purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18 who is not under legal protection
* Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including:

  * 15 patients with severe mutation but not chronically infected with PA and not treated with lumacaftor / ivacaftor
  * 15 patients homozygous phe508del, chronically infected with PA and not treated with lumacaftor / ivacaftor
  * 15 patients homozygous phe508del, chronically infected with PA and treated with lumacaftor / ivacaftor
  * 15 hospitalized patients for respiratory exacerbation
  * 40 patients initiating Ivacaftor-Tezacaftor-Elexacaftor treatment.
* No change in baseline treatment for 15 days (including antibiotic treatment).
* Patient affiliated to a social security system
* Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study.

Exclusion Criteria:

* Informed consent impossible to obtain
* Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.
Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease

The study evaluates the safety and the efficacy of the addition of intravenous transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease, which have actively progressing disease with rapid loss of pulmonary function on the background of routine treatment.

Despite significant progress in the treatment of interstitial lung disease, achieved thanks to new drugs, such as pirfenidone and nintedanib, there are many patients for whom these drugs are not available or poorly tolerated. In addition significant evidence of their effectiveness and safety is valid only for idiopathic pulmonary fibrosis. The transplantation of allogeneic stem cells is a promising direction in the modern medicine with the proven safety for different diseases. But the effectiveness of this therapy is still under research. We believe that in most severe cases of a rapidly progressive interstitial lung disease the transplantation of mesenchymal stem cells may be an effective technology due to their immunomodulatory properties.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 20-80 years old
* Diagnosis of idiopathic interstitial pneumonia or secondary to connective tissue diseases interstitial lung disease, based on:

  * Clinical symptoms \> 12 months duration,
  * Histologically diagnosed or diagnostic chest HRCT features of interstitial pneumonia
* Forced Vital Capacity (FVC) ≥ 40% predicted and Diffusing Lung Capacity (DLCO) ≥20%
* Loss more than 10% of FVC (L) and DLCO during the last 12 months
* Signed informed consent.

Exclusion Criteria:

* Diagnosis of an interstitial lung disease other than idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease (sarcoidosis, pulmonary alveolar proteinosis, lymphangioleiomyomatosis, pulmonary amyloidosis, exposure-related lung disease etc)
* Obstructive lung disease: FEV1/FVC \< 0.70
* Clinically significant medical condition, in the opinion of the investigator, may compromise the results of the study
* Evidence of active infection within 4 week prior to enrollment
* History of malignancy \< 5 years prior to enrollment
* Unable to cooperate with any study procedures
* Pregnant or breast-feeding
* Treatment with antiinflammatory or antifibrotic drugs including oral steroids, cytostatic drugs, pirfenidone, D penicillamine, colchicine, tumor necrosis factor α blockers, imatinib, interferon γ, monoclonal antibodies \< 6 months prior to randomization.
* Active listing for transplant of any organ.
* Known history of alcohol abuse within 1 year prior to enrollment
* Participation in another clinical trial
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections

This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections.

The study is an open label controlled efficacy trial of Aionx patented antimicrobial surface for the prevention of healthcare-associated infections (HAIs). It will take place at Penn State Hershey. Half of the single occupancy rooms of the 5th and 7th floor will be assigned to contain the antimicrobial surface at five locations: bed rails, overbed table, door handles, counter, and arm rests of bedside chair. The remaining rooms will serve as controls. Data on HAIs will be gathered for all the patients admitted to the rooms during the duration of the study. After 45 days the rooms will be flipped so that test rooms become controls and control rooms become test rooms. The duration of the study will be for a minimum of 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Admission to a single occupancy room in a participating floor at Hershey Medical Center

Exclusion Criteria:

* Refusal to participate in the study.
Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes

Eyes with abnormal tear film function have been found to show larger optical aberrations than normal eyes which may be attributed to the unstable and irregular tear film, uneven ocular surface, and increased scatter due to the exposure of the rough surface of corneal epithelium after tear break-up.

These hypotheses have been supported by the findings that instillation of artificial tears (sodium hyaluronate preparation) in dry eye patients reduces both corneal and ocular aberrations, improving the optical quality of the retinal image.

However, the previous studies only evaluated the short-term effects of a single administration of an artificial tear but did not determine the duration of action or inflection point at which the ocular aberrations increase back to baseline. Also, there has clearly been no such clinical trial that has been a well randomized controlled study to date.

This report is the first randomized controlled trial that investigated the long-term effects of a single dose of sodium hyaluronate-based artificial tears on wavefront aberrations in patients with dry eye.

Parameters used to determine treatment outcomes included ocular aberrations and severity of dry eye symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18 years or over.
2. Documented history of bilateral dry eye for at least 3 months.
3. Schirmer's I test (without anesthesia) less than 10 mm wetting/5 minutes for each eye.
4. Tear film break-up time (TBUT) less than 10 seconds for each eye.
5. Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Contact lens wear.
3. Non-mydriatic pupil size less than 5.0 mm.
4. Other ocular surface pathologies or coexisting ocular diseases.
5. Ocular surgery or trauma within the past 4 months.
6. Use of concomitant eye drops or eye ointments within the past 2 weeks.
7. Abnormality of the nasolacrimal drainage apparatus.
8. Permanent or temporary occlusion of lacrimal puncta in any eye.
9. Known hypersensitivity to hyaluronic acid or any component used in the study.
10. Taking the following systemic medications within the previous 2 months: tricyclic antidepressive agents, anti-histaminic agents, phenothiazines, cholinergic agents, antimuscarinic agents, NSAIDs, beta-blockers, immunomodulators, anti-acneic agents, diuretics, corticosteroids and tetracyclines.
11. Very severe dry eye causing inaccurate aberrometry measurements.
WeCareAdvisor Study for Caregivers of People Living With Dementia

The WeCareAdvisor is an online tool to help caregivers manage behavioral and psychological symptoms of people living with dementia. The trial will evaluate its efficacy to reduce caregiver distress, improve confidence managing behaviors, as well as reduce occurrences and severity of behavioral and psychological symptoms.

Visit https://wecareadvisorstudy.com/ for more information.

Caregivers enrolled in the study will use the web-based WeCareAdvisor tool for either three or six months, depending upon group allocation (immediate treatment vs. 3-month waitlist). Caregivers will be interviewed at baseline, 1, 3 and 6 months by telephone to evaluate their health and wellbeing. Also, utilization data of the tool will be captured.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as the primary caregiver to the person living with memory loss or dementia;
* has been a primary caregiver for at least 6 months;
* report managing \>1 behavioral symptom(s) in the past month;
* has an email account or smartphone (to receive daily tips and reminder messages);
* English speaking;
* has own smartphone, tablet, laptop, or desktop computer and access to Internet;
* If person living with dementia is on an anti-dementia or psychotropic medication, they must be on a stable dose for at least 60 days prior to enrollment.
* If caregiver is on an anti-depression or other psychotropic medication, they must be on a stable does for at least 60 days prior to enrollment
* Lives in the United States or US territory

Exclusion Criteria:

* Caregiver currently involved in another clinical trial of psychosocial or educational interventions for dementia;
* Caregiver has a visual impairment that prohibits interaction with the tool, and/or have a hearing impairment sufficient to prohibit telephone communication;
* Caregiver reports person living with dementia is not responsive to his/her environment (e.g., unable to understand short commands or recognize a person coming in/out of the room);
* Caregiver reports person living with dementia is an active suicide risk
* Caregiver reports person living with dementia is likely to have an imminent placement in a long-term care facility (within 6 months).
* Either caregiver/person living with dementia has a terminal disease with life expectancy \< 6 months, is in active treatment for cancer, or has had more than 3 acute medical hospitalizations over the past year.
Lupus Atherosclerosis Prevention Study

Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke contribute to long-term morbidity in surviving patients. Atherosclerosis in SLE is multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk factors, and prothrombotic factors all playing important roles. Multiple groups have shown that hyperlipidemia is predictive of later atherosclerosis in SLE. In the general population, statins have become the drug of choice in preventing atherosclerotic events, through two mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to prevent rupture. In the Lupus Atherosclerosis Prevention Trial we will determine if atorvastatin reduces the progression of atherosclerosis on helical computed tomography (CT) and carotid duplex. Recent work has confirmed that statins have an immunomodulatory role. This study will also determine whether statins improve clinical lupus activity or lupus serologies (anti-dsDNA and complement).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of SLE, confirmed by a faculty rheumatologist at Johns Hopkins.
* Patients must be 18 years of age or older
* Give informed consent.

Exclusion Criteria:

* SLE patients with a known atherosclerotic event, such as angina, myocardial infarction, or stroke, with an abnormal lipid profile for which a statin would be standard of care, are excluded.
* Pregnant patients (or patients planning to become pregnant in the next two years) are excluded.
* Patients who have known chronic liver disease, have unexplained elevation of their liver enzymes greater than 2 times the upper limit of normal , or an elevated CPK greater than 1.5 times the upper limit of the normal value for the patient's racial group, are excluded.
* Patients with triglycerides greater than 500 mg/dl or LDL greater than 190 in the absence of 2 risk factors (and who are unwilling to participate in a formal nutritional/lifestyle modification program that we recommend for them) are excluded.
Clinical Evaluation of a Wearable Sleep Diagnosis Technology

The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.

The clinical investigation will be performed at the Royal Free London Hospital. Physiological signals will be pseudo-anonymized and only viewed by the research team.

The Study will involve patients who will have been referred for diagnosis of sleep apnoea, will aim to determine AcuPebble's positive and negative predictive ratios, sensitivities as specificities. Likelihood ratios for diagnosis of sleep apnoea. Clinical experts will determine patients' diagnostic information using the current diagnostic standards. AcuPebble will also generate diagnostic results independently and automatically. Both set of results will be subsequently compared and the relevant performance metrics listed above will be determined.

Consecutive patients referred for sleep study will be recruited to the study. Patients that are willing to participate will be consented on the day of their sleep study and sent home with both - the Trusts usual multichannel polygraphy and the Acupebble.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.

Exclusion Criteria:

* Age under 18 or over 70 years.
* Subjects who are not fluent in English, or who have special communication needs.
* Known allergy to the adhesive dressing.
* Subjects with physical or mental impairments who would not be able to use the new technology on their own.
* Subjects with very loose/saggy skin in the neck area which would unavoidably result on - AcuPebble swinging if moving the neck.
* Subjects with pacemakers.
* exclude patients who have any type of implanted electronic devices (these include patients in ICDs and left ventricular assist devices and loop recorders).
Comparison of Two Methods of Bronchial Methacholine Provocation

This study is meant to compare two routine diagnostic approaches in patients with bronchial asthma. Patients are challenged with methacholine in order to measure their bronchial response. We compare the evaluation of the effects of incremental concentrations versus incremental dosages.

Bronchial methacholine challenge is well established in asthma diagnostic and research purposes. ATS guidelines provide a short five-breath dosimeter protocol using a five-step dilution schedule. The Viasys APS system enables a feasible and less time consuming provocation with incremental dosages. In 48 young adults with bronchial hyperreactivity (BHR) the ATS-protocol with a five-step protocol using a single dilution of 16 mg/ml methacholine should be compared.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 12-45 years
* Known bronchial hyperreactivity

Exclusion Criteria:

* Age \< 12 \> 45 years
* Clinical asthma requiring regular inhalation
* Vital capacity \< 80%
* FEV1 \< 75%
* Chronic disease conditions or infections
* Pregnancy
* Inhalative or systemic steroid use
* Substance abuse
* Incapability of understanding the study's purpose and performance
Diagnosis of Hallux Valgus by Using a Foot Pressure Platform as an Alternative to Radiological Images

Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The current diagnostic tool is using X-ray which is expensive and includes radiation exposure. The current study is aimed at using the foot pressure platform as an alternative method for diagnosis and evaluation of the deformity. The main subjects will be recruited from orthopaedic outpatient clinics.

The recruited subjects will undergo the non-invasive and radiation free study by walking on a pressure platform. Then their pressure data will be correlated with their radiological study which has already been done in the clinic. The aimed outcome of the study is use the foot pressure platform as first line of diagnosis and evaluation of the Hallux Valgus deformity.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with hallux valgus.
* Patients who are diagnosed with hallux valgus and scheduled for surgery ( to be seen pre and post-surgery)
* Patient who are diagnosed with hallux valgus and had surgery

Exclusion Criteria:

* Any other foot deformity
* Previous foot surgery (which is not related to HV
The Effect of Health Literacy Education

The study was conducted with a parallel group randomized controlled experimental design to evaluate the effect of health literacy education given in early adolescence on the health literacy of adolescents. The population of the study consisted of 6th and 7th grade (12-13 years old) students studying in a secondary school in Ankara. Power analysis was used to determine the sample size. A total of 80 adolescents who met the inclusion criteria were included in the sample.


Eligibility Criteria:
Inclusion Criteria:

* Consent by the student's family
* Volunteering to participate in the research
* Having a low level of health literacy

Exclusion Criteria:

* Read and write Turkish
* Have a moderate or high level of health literacy
* Physical/mental disability or illness
Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression

The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
2. Has a clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:

   1. rest tremor
   2. rigidity
   3. bradykinesia and/or akinesia
   4. postural and gait abnormalities
3. Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines
4. If currently taking an anti-depressant, is being treated with only one SSRI or SNRI antidepressant at a dose within the US FDA-approved dose range. Subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a sub-therapeutic dose or for an inadequate duration at Screening, and can be discontinued from this agent before the Baseline visit (in the opinion of the Investigator), may be eligible for the study.
5. Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening
6. If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception

Exclusion Criteria:

1. Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer)
2. Had a myocardial infarction within the 6 months prior to Screening
3. Has a known personal or family history or symptoms of long QT syndrome
4. Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor
5. Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder.
6. Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
7. Is pregnant or breastfeeding
8. Has previously been treated with pimavanserin or is currently taking pimavanserin
9. Has a sensitivity to pimavanserin or its excipients
10. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Heart Failure with EF ≥ 40% (by TTE within last 3 months)
* Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
* Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
* Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
* Cardiac index (CI) ≥ 1.7 L/min/m2
* NYHA Class II or III
* Glomerular Filtration Rate (GFR) ≥ 25 ml/min
* Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment

Exclusion Criteria:

* Ambulatory with a Life expectancy of \< 1 years
* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
* Unable to tolerate right heart catheterization
* Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
* Severe aortic, mitral or pulmonary valve regurgitation
* Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy
* Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)