cyrilzakka/clinical-trials huggingface dataset:
Oxytocin's Effect on Socioemotional Aging

This study will investigate the extent to which intranasal oxytocin affects changes in social decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the body and the brain and has been shown to be relevant for many behaviors, particularly in social situations. Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging.

In order to demonstrate oxytocin as a causal mechanism in socioemotional aging, the investigators propose to temporarily elevate oxytocin levels and then measure activity in the brain while participants engage in socially relevant tasks. Participants in this study will be randomly assigned (much like flipping a coin) to receive either a single administration of oxytocin or a placebo (a substance that looks like the oxytocin but does not have any active drug). Neither participants nor the investigator will know to which condition each participant is assigned. Prior to being enrolled into the study a screening to determine eligibility will be conducted. Once the screening visit is completed and it has been determined that subjects can be randomized into the study, an appointment will be scheduled for the full study visit.

The purpose of the screening is to determine whether the individual is eligible for participation in the study and will consist of a series of questions about demographics and health history, two saliva samples, two short tasks, blood test, and brief meeting with a licensed clinician to ensure that it is safe for the individual to take part in the magnetic resonance imaging (MRI) and drug administration.

The study visit will comprise two collections of saliva for laboratory tests prior to and following the oxytocin administration in order to measure levels of the hormone in the body at baseline and after the spray. Saliva samples will also allow for an examination of how oxytocin-related genes may impact cognition and behavior during study tasks. Participants will work on various social tasks while in the MRI scanner, and response accuracy, response time, and brain activity will be recorded. After the scan, participants will complete a series of brief questionnaires on paper and on the computer.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-30 years or 63-85 years
* English fluency
* Caucasian
* Right-handed

Exclusion Criteria:

* Pregnant or possibly pregnant
* Breastfeeding
* Claustrophobia
* Currently on vasoconstrictors, pseudoephedrine or antidiuretic medication
* Large pieces of metal in the body, particularly in the face or neck
* Piercings or metal implants that cannot be removed from the body
* Surgery on the brain or any prior serious brain damage or disease
* Dementia or severe cognitive disorders
* History of hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone, psychogenic polydipsia, or motion disorder
Swedish Age Assessment Study

It is important that asylum seekers should have as accurate age assessment as possible and that children's fundamental rights are met by choosing methods based on best available knowledge. The aim is to provide, on the basis of best available knowledge, suggestions for methods of medical age assessment of whether a person is over or under 18 years of age.

The primary issue is to investigate whether five selected growth zones in knee joint, ankle and wrist individually or in combination can better determine the 18-year limit compared with previous research.

Swedish Age Assessment study is conducted with the aim of

* Deepening the knowledge of age-assessment methodology with magnetic camera examinations among born and registered in Sweden aged 14.0 through 21.5 years
* With a magnetic camera, investigate whether five selected growth zones in the knee joint and ankle joint (distal femur, proximal tibia, distal tibia and calcaneus) and distal radius (wrist) individually or in combination can better determine the 18-year limit compared with previous research
* To investigate how gender and growing environment can affect the end of growth zones

Eligibility Criteria:
Inclusion Criteria:

* Healthy children / young adults without prior illness (such as asthma, growth hormone treatment, prolonged peroral cortisone treatment, cancer treatment, diabetes, rheumatic disease) that may have affected growth can be included in the study.

Exclusion Criteria:

* Children or adolescents with ongoing drug treatment for chronic disease.
* Contraindication against MRI examination
* Pregnancy
Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients

The purpose of this study is to decrease deconditioning of elderly inpatients in acute care institutions and to assess the safety and feasibility of a newly developed resistance training device. Investigators believe this device will help hospitalized seniors maintain their independence by preventing the loss of functionality from deconditioning and improve value of care through decreased length of stay and utilization of care. Current therapy will be complemented with a new in--bed resistance training device to target weak elderly patients and standardize progressive resistance training in facilities.


Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 70 years old
* Admitted to acute inpatient medicine unit at NYU Langone Health (17E and 17W) from - - - - - Emergency Department
* Receiving Physical Therapy
* Initial AMPAC 6 clicks score 11-18
* English Speaking

Exclusion Criteria:

* ICU level care
* Acute cardiac risk (including recent acute MI and stroke, unstable arrhythmias, or uncontrolled hypertension)
* Exercise-limiting physical disability (ie rotator cuff injury, neurologic impairment)
* Severe cognitive impairment (1) No significant dementia or delirium (2) Patient able to accept readiness for PT and comprehend education
* Contact Precautions
A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor

This study is researching an experimental drug called ALN-PNP. This study is focused on participants who are known to have nonalcoholic fatty liver disease (NAFLD), and a specific variant of the patatin-like phospholipase domain containing 3 (PNPLA3) gene.

The aim of this study is to see how safe, tolerable, and effective the study drug is.

This study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How the study drug works to change liver fat content in NAFLD
* How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in your blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
* Better understanding of the study drug and NAFLD


Eligibility Criteria:
Key Inclusion Criteria:

1. Participants from 18 (or country's legal age of adulthood) to 65 years of age, inclusive, at screening visit 1
2. Body mass index (BMI) from 23.0 kg/m\^2 to 40.0 kg/m\^2, inclusive, for East Asians (including but not limited to South Koreans, Chinese, Taiwanese, and Japanese) and BMI from 27.0 kg/m\^2 to 40.0 kg/m\^2, inclusive, for any other ethnicity at screening visit 1
3. Meets genotype criteria for the rs738409:G PNPLA3 risk allele: homozygotes (for Part A and Part B) or heterozygotes (optional Part C); p.I148M variant (PNPLA3 rs738409:G \[p.I148M\]) at screening visit 1
4. Liver fat content ≥8.5% as measured by MRI-PDFF at screening visit 3
5. Generally stable diet (based on participant's recall) for at least 3 months prior to the screening visit

Key Exclusion Criteria:

1. Evidence of other forms of known chronic liver disease, as defined in the protocol
2. Has a contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made out of metal (for example, cochlear implant, nerve stimulators, magnetic vascular clips, and metallic heart valve), severe claustrophobia, or other contraindications for MRI
3. Is taking a medication to treat a co-morbid condition that is not permitted during the study
4. Has any laboratory parameter assessments at screening, as defined in the protocol
5. History of Type 1 diabetes
6. Bariatric surgery within approximately 5 years prior or planned during the study period
7. Has lost or gained more than 4.0% body weight over the 3 months prior to or during the screening period
8. Has known human immunodeficiency virus (HIV) infection, evidence of current or chronic hepatitis B virus (HBV) infection, or current or chronic hepatitis C virus (HCV) infection, as defined in the protocol
9. Was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit

Note: Other protocol defined Inclusion/Exclusion Criteria apply
Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden

The researchers study time trends of childhood-onset type 1 diabetes and its most serious complication, end-stage renal disease. They further analyse physical, psychological and socio-economic long-term effects on patients and families to identify potentially preventive factors in a population perspective. The researchers investigate the economic burden of disease and study and improve statistical methods for case-control data. The projects use a longitudinal nationwide database involving about 23 000 childhood-onset diabetes cases with maximum follow-up of 48 years and for each case 4 matched controls. The Swedish Childhood Diabetes Register is linked to a number of official, Swedish registers: the Renal register, the Cause of Death register, the National Patient register, the Prescribed Drugs register, the Cancer register and the Integrated Database for Labour Market Research. The researchers use GAM modelling for time trend analyses, standard case-control/cohort analyses, Cox regression for life table analyses, linear fixed effect probability for career development and propensity score models for confounding. The project group is multidisciplinary and involves experts in paediatrics, nephrology, epidemiology, health economics and statistics. This unique database and team continues to yield population-based new knowledge on the consequences of this increasingly common chronic childhood-onset disease.


Eligibility Criteria:
Inclusion Criteria:

* Two prescriptions of insulin in the Prescribed Drug register.
* Age below 15 years of age. Controls are of the same age and born in the same municipality as the cases.

Exclusion Criteria:

* No
Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory malignant glioma.

OBJECTIVES:

* Determine tumor response rate, duration of response, time to disease progression, and overall survival of patients with recurrent or refractory malignant glioma treated with topotecan and thalidomide.
* Determine safety and tolerance of this regimen in these patients.

OUTLINE: Patients receive topotecan IV continuously on days 1-21 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed recurrent or progressive supratentorial glioblastoma or anaplastic astrocytoma
* Measurable disease by MRI or CT scan
* No gliomatosis cerebri, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma
* Concurrent registration for the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) program

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 2.0 mg/dL

Renal:

* Creatinine less than 1.6 mg/dL

Other:

* No other concurrent malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 methods of effective contraception 1 month prior to, during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No more than 2 prior chemotherapy regimens in adjuvant or metastatic setting
* At least 4 weeks since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* Concurrent anticonvulsants allowed
Studying Dexamethasone and Prednisone Sensitivity in Samples From Younger Patients With High-Risk B-Cell Precursor Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.

OBJECTIVES:

* Identify differences in the effect of dexamethasone (Dex) and prednisone (Pred) on glucocorticoid receptor (GR) occupancy and gene expression in high-risk (HR) B-cell precursor (BCP)-acute lymphoblastic leukemia (ALL) samples from patients aged 1-9.
* Identify differences in gene expression and GR occupancy of response elements in HR BCP-ALL patients \> 10 years old in response to both Dex and Pred.

OUTLINE: Archived samples are analyzed for gene expression analysis and genomic location of glucocorticoid receptor by ChIP sequencing (ChiPseq) and RNA sequencing. Data of gene expression and ChiPseq data sets are compared by luciferase reporter assay.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia
* Samples from patients treated and not treated with Dex and Pred

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Prediction of Clinical Course in COVID19 Patients

In the context of the COVID19 pandemic and containment, chest CT is currently frequently performed on admission, looking for suggestive signs and basic abnormalities of COVID19 compatible viral pneumonitis pending confirmation of identification of viral RNA by reverse-transcription polymerase chain reaction(PCR), with a reported sensitivity of 56-88% in the first few days, slightly higher than PCR (60%) (1). Nevertheless, currently established radiological abnormalities are not specific for COVID19 and the specificity of the chest CT is \~25% when PCR is used as a reference (1). Deconfinement and its consequences will complicate the triage of COVID patients and the role of the scanner, with the expected impact of a decrease in the prevalence of infection in the emergency department and an increase in the number of "all-round" patients, including patients with non-COVID viral infiltrates or pneumopathies.

In addition, there are currently no imaging criteria to complement the clinical and biological data that can predict the progression of lung disease from the initial data.

In image processing, computational medical imaging has demonstrated its ability to predict a therapeutic response or a particular evolution after extracting relevant anatomical, functional or even non-visually perceptible information from the volume of images, making it possible to construct a powerful radiomic signature or to use robust anatomical/functional measurements to provide estimates of ventilation or vascular state. By combining these data extracted from the scanner with the standard clinical-biological data produced at admission during triage, our ambition is to build a predictive model using unsupervised classification approaches capable of helping predict clinical evolution with the aim of optimizing the management of the resource.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* clinical suspicion of COVID-19 confirmed by RT-PCR
* CT scan at ER admission
* RT-PCR sampling

Exclusion Criteria:

* CT scan failure or loss of CT data
* RT-PCR initial results unavailable
Automated Imaging Differentiation of Parkinsonism

The purpose of this study is to test the performance of the AID-P across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease diagnosis within 5-9 years of baseline date
* MSAp diagnosis
* PSP diagnosis

Exclusion Criteria:

* metal implants in the body that preclude an MRI (pacemaker, metallic clip, neurostimulator, etc)
* claustrophobia
* pregnancy
Methotrexate Polyglutamates as a Marker of Clinical Response and Toxicity in the Treatment of Psoriasis

Methotrexate (MTX) is widely prescribed to treat inflammatory conditions including psoriasis, where it is the recommended first-line systemic therapy in moderate-to-severe disease. Approximately 40% of patients with psoriasis have a sub-optimal response to MTX and a significant number experience side effects that may include deranged liver enzymes. There is currently no validated test to predict how patients with psoriasis will respond to MTX, in terms of disease outcome and/or toxicity, or to guide dose escalation in this group.

Data for this study is drawn from the BSTOP (Biomarkers of Systemic Treatment Outcomes in Psoriasis) cohort. This is a multi-centre, prospective, cohort study to establish clinically relevant biomarkers and pharmacogenetic markers of systemic treatment outcomes in patients with severe psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis
* Taking oral or subcutaneous methotrexate
* Measurement of methotrexate polyglutamates on at least one occasion during therapy.
* Patients who have given written informed consent

Exclusion Criteria:

* Unable to consent
* Not taking methotrexate
Mixed Antagonist of Serotonin for Claudication Optimal Therapy

To investigate in patients suffering from intermittent claudication due to Fontaine stage II PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of SL650472 to placebo, and to calibrate such effect versus cilostazol


Eligibility Criteria:
Inclusion Criteria:

* 1. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis origin (symptoms present for 6 months or longer and not significantly changed within the past 3 months);
* 2. ICD of 30 to 200 m at screening constant workload treadmill test
* 3. Doppler-measured pre-treadmill ABI of 0.90 or lower after 10 minutes of rest or, for patients with an ABI of greater than 1.3 (non-compressible arteries), a Toe-Brachial Index (TBI) of less than 0.7.

Exclusion Criteria:

* 1. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years;
* 2. Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome);
* 3. Limb-threatening (grades III and IV) chronic limb ischemia, manifested by ischemic rest pain, ulceration, or gangrene.
* 4. Patients with a history of malignant or proliferate breast disease.
Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on echocardiographic indices of diastolic function in elderly patients with heart failure with preserved ejection fraction (HFPEF). In previous studies the only echocardiographic parameters studied were ejection fraction (EF) and chamber size. The objective of the proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic function assessed by echocardiography in patients over the age of 50 with a clinical diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be utilized for this study as it has been shown to have superior bioavailability when compared to oxidized CoQ.


Eligibility Criteria:
Inclusion Criteria:

* Typical signs and symptoms of congestive heart failure (CHF) (New York Association Class 2-4).
* Normal ejection fraction on echocardiography (EF ≥50%).
* Evidence of diastolic dysfunction on non-invasive imaging (E:e' \> 15 or e:e' \> 8 with other measures of diastolic dysfunction such as e/a \< 0.5 with elevated deceleration time or left atrial volume index \> 40 cc/m2 or presence of elevated left ventricular mass index or elevated pulmonary pressures).
* Stable medical therapy for 4 weeks prior to randomization

Exclusion Criteria:

* Chronic atrial fibrillation.
* Acute coronary syndrome or coronary revascularization within 60 days.
* Clinically significant valvular disease.
* Known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease.
* Inability/refusal to provide informed consent
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers

The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.

The objectives of this study are to evaluate the humoral immunogenicity and safety of the parenteral formulation of the 2010/2011-season influenza vaccine, Inflexal V, using HA antigen obtained from 2 different production facilities, and to compare the immunogenicity of both formulations to pre-defined EMA criteria for the annual relicensing of seasonal influenza vaccines. The evaluation will be done in young adults and elderly.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adults
* Aged ≥18 years on Day 1
* Written informed consent

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine (including the H1N1 pandemic swine flu vaccine) in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or spouse and children of the investigator, or relative living in the same household as the investigator and/or are dependent on the investigator
* Suspected non-compliance