cyrilzakka/clinical-trials huggingface dataset:
An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism

To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.

Autism is a developmental disorder affecting approximately 60/10,000 individuals. It is characterized by social and language deficits and repetitive behaviors/restricted interests. Functional imaging is becoming a very useful tool in trying to understand the neurobiology of autism. Oxytocin is a hormone produced by the brain to assist with labor and lactation. Recent evidence suggests that it may be involved in social attachment and in repetitive behaviors. In this project, we will study how oxytocin changes the way the brain of autistic adults processes faces, and deals with response inhibition (the ability to interrupt ongoing responses should they prove ineffective or interfering with attaining a goal). There is currently no functional imaging data assessing the effect of oxytocin on the brain. We will explore the activation patterns in response to oxytocin across circuits involved in social cognition (face fusiform area) and response inhibition (caudate, orbitofrontal and dorsolateral cortex) by administering a specific fMRI task activating those circuits before and during an oxytocin infusion. We will also explore the effect of oxytocin in these areas by administering specific cognitive testing not associated with fMRI before and during oxytocin infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder.
2. Age 18-50.
3. Be seen as outpatients
4. IQ\>80
5. 5. Demonstrate capacity to provide authorized informed consent or provide consent for participation by an approved surrogate on the autistic individual's behalf

Exclusion Criteria:

1. Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures.
2. Subjects with epilepsy.
3. Subjects with a history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder.
4. Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella
5. Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks.
6. Subjects with renal or liver disease or abnormalities in blood chemistry.
7. Any metallic prosthesis such as plates, pins and screws, shrapnel, metallic foreign body, vascular or neurosurgical clips that may be incompatible with the MRI and any electrical devices such as a pacemaker or a defibrillator
8. Claustrophobia
Cystic Breast Masses by Contrast Enhanced Ultrasound (CEUS)

The overarching goal of the proposed research is to evaluate whether qualitative and quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in assessing suspicious indeterminate cystic appearing breast masses and ultimately determine whether or not an ultrasound guided biopsy is necessary. The underlying hypothesis is that breast masses (given BIRADS 4) that lack enhancement on CEUS will have a benign histology obtained by ultrasound guided core biopsy and/or surgery. Then, in the future, these non-enhancing cystic lesions can be followed and do not need biopsy intervention.

Breast cancer is the most frequently diagnosed cancer in women. To diagnose these cancers, more than 1.6 million breast biopsies are performed each year in the United States, of which more than 60% have benign pathology. A large percentage of the benign biopsies show fibrocystic changes of the breast on histology. These biopsies can be avoided with better diagnostic tools identifying fibrocystic change. The Investigators propose that contrast enhanced ultrasound (CEUS) can aid in classifying and predicting if a cystic appearing breast mass is benign or malignant, and can be a supplemental imaging tool to mammography and conventional gray-scale ultrasound (US).

In standard clinical practice, if a breast mass appears to be cystic on gray-scale US but has some suspicious features which make it difficult to tell if the mass is truly cystic or solid, the decision making for follow-up versus biopsy is difficult. This leads to unnecessary biopsies (false positives) since many of these masses are a sequel of benign fibrosis and fibrocystic changes of the breast. CEUS may help classify these masses as cystic or solid. The central premise is based on the microbubble contrast agent used in CEUS, since it stays within the blood pool and will only show enhancement if a mass has solid components and has vascular flow.

The Investigators hypothesize that indeterminate cystic breast masses will not enhance on CEUS and will correlate with benign pathology. Quantitative CEUS parameters will also help classify these lesions. If this is the case, then in the future, the non-enhancing cystic breast masses will not need to be biopsied. This will decrease patient anxiety, unnecessary interventions, and save resources.

The investigators will investigate qualitative and quantitative parameters on CEUS in evaluating indeterminate cystic breast masses given BIRADS 4 and correlate these with histopathology obtained by biopsy and/or surgery. This data will help them to develop protocols to better distinguish between benign and malignant cystic appearing breast masses.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* recommended for an ultrasound guided biopsy due to breast mass detection

Exclusion Criteria:

* \< 18 years of age
* prior history of breast cancer
* prior history of biopsy for that specific lesion
* any condition that would be a contraindication to the microbubble contrast agent used in CEUS such as pulmonary hypertension, 3cardiac shunts, and allergy to perflutren.
A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines.

A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.

The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.

The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).

Participants will have 3 specific study visits and will hereafter be followed for 2 years after the vaccination with regular visits after 3, 6, 12 and 24 month. In this way the participants will be offered an extra close follow up on vaccine effectiveness.

Safety data will be collected at study visits until 3 months after the first vaccination,, with additional safety data collected under this protocol during the first month after vaccination.

Research samples will be collected at each study visit during the two-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained before any trial related procedures are performed
2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the 'Tilvalgsordningen')
3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)

Exclusion Criteria:

1. Male and female under the age of 18
2. Any subgroup of individuals for which the vaccine is contra-indicated
3. Previous SARS-CoV-2 vaccination

   Specific for the Johnson \& Johnson vaccine:
4. Experience of a serious allergic reaction after injection of any other vaccine
5. Serious infection with high fever (\> 38 0C) A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem
6. Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
7. Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)
Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial

The investigators propose a non-randomized clinical trial of 60 HIV-infected infants identified within 48 hours of birth and their mothers to investigate the consequences of very early ART on the establishment and maintenance of the viral reservoir.

The first phase (early ART initiation within 48 hours of birth) will examine the trajectory i.e. changes over time of the viral reservoir and detection of HIV-specific antibody responses in infants testing HIV-positive within 48 hours of birth and initiating early ART.

Secondary pathogenesis aims will test whether markers of neonatal immune quiescence are associated with the extent of seeding and rate of decline of the viral reservoir when ART is started at a young age and investigate whether markers in infant stool samples can be used as a non-invasive method of defining relevant immune and HIV-specific parameters associated with viral reservoir size.

The investigators hypothesize that developmental characteristics of newborn immunity may make this period the optimal time to begin ART and influence the seeding of the viral reservoir.

Prevention of mother-to-child transmission (PMTCT) programs using antiretrovirals (ARVs) have had tremendous success in sub-Saharan Africa. However, HIV transmission continues to occur because (1) implementation of PMTCT is incomplete and (2) ARV interventions are not 100% effective in blocking infection. Thus the challenge of providing treatment to HIV-infected children is far from over. The capacity of early ART treatment to favorably influence the viral reservoir and potentially lead to post-treatment cessation viral control needs to be described in the population of infants, and to identify useful public health strategies.

Eligibility Criteria:
Inclusion Criteria:

* Point of care (POC) or laboratory-based test positive on a sample collected within 48 hours of birth.
* Mother willing and able to provide informed consent.

Exclusion Criteria:

* Expressed intention to leave the Johannesburg area permanently.
* Co-morbidities, birth defects or other conditions which in the opinion of the clinical team have a greater than 50% risk of mortality in the first days of life.
* Co-morbidities or conditions which in the opinion of the clinical team advise against initiation of ART within the first 48 hours of life.
* Active (uncontrolled) maternal psychiatric illness.
Monitoring of Incidence of Mental Discomfort in Pregnant Women During the Serious COVID-19 Pandemic Conditions

This study is aimed to detect severe fear of delivery and its association with the incidence of obsessive-compulsive disorder and symptoms of depression and anxiety in the population of pregnant women in the third trimester during the serious COVID-19 pandemic situation in Slovakia. Data will be acquired from three departments of gynaecology and obstetrics of University Hospital Bratislava. The majority of pregnancies from the region are managed in this hospital; the total number of deliveries in 2020 achieved 7,835

The pregnancy is a risk factor for the first manifestation of several mental disorders. Current serious pandemic situation and a constant risk of COVID-19 infection negatively affects the mental state of the population, risk groups of pregnant women in particular. The aim of this project is to discover the incidence of symptoms of depression, anxiety and obsessive-compulsive disorder in association with the fear of delivery in current COVID-19 pandemic conditions in Slovakia. We also decided to add a short tool for detection of domestic violence among other scales to detect the incidence among Slovak pregnant population. All pregnant women in their third trimester who visit the prenatal clinic for their routine weekly check-up will be asked to participate in the study. The questionnaire which comprises of validated mental scales will be handed out to the patients waiting for their examination. After collection of filled questionnaires, those will be later paired with patients' medical documentation and statistically evaluated. The questionnaires will be collected during the period of 1.4.2021-31.3.2022 and statistical analysis will be conducted in the period of 1.4.2022-1.8.2022. It is expected that approximately 1,500 women will be included into the study. All three departments of gynaecology and obstetrics of the University Hospital Bratislava will participate at the study. In total, approximately 7,800 deliveries a year are managed in the University Hospital Bratislava.

Following questionnaires are planned to be used in the study:

* Wijma Delivery Expectancy/Experience Questionnaire - aimed at fear of delivery
* PASS (Perinatal Anxiety Screening Scale) - aimed at anxiety in women before and after delivery
* PHQ-9-SK (Patient Health Questionnaire) - aimed at depressive disorder
* HITS Domestic Violence Screening Tool - aimed at domestic violence
* DOK (The Obsessive-Compulsive Inventory) - aimed at obsessive and compulsive symptoms
* GAD-7 (General Anxiety Disorder-7) - aimed at general anxiety disorder
* EPDS (Edinburgh Postnatal Depression Scale) - aimed at symptoms of postpartal depression

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy after 34th week
* Vital fetus

Exclusion Criteria:

* Unwilling to participate
* Age less than 18 years
* Foetus mortus or perinatal death of the newborn
* Low knowledge of Slovak language
* Serious pathology in the pregnancy (e.g. placenta praevia, known congenital disorders)
Impact of Bone Mineral Density on Fracture Risk Assessment in RA

This study investigates whether incorporating bone mineral density (BMD) into FRAX calculations changes fracture risk assessment and influences treatment decisions in rheumatoid arthritis (RA) patients. Analyzing 60 RA patients, FRAX scores for 10-year major osteoporotic and hip fractures were calculated with and without BMD. While no significant differences were found between the two methods, discrepancies in treatment recommendations were identified, particularly for hip fractures. The findings emphasize the importance of combining BMD and FRAX for a more comprehensive fracture risk assessment and informed treatment decision-making in RA patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) based on ACR/EULAR criteria.
* Age between 40-90 years.
* Dual-energy X-ray absorptiometry (DXA) results obtained within the past six months.
* Availability of complete clinical and demographic data for fracture risk assessment.
* Patients who provide informed consent for the study.

Exclusion Criteria:

* Patients with secondary causes of osteoporosis (e.g., hyperparathyroidism, Cushing's syndrome).
* Use of medications affecting bone metabolism (e.g., glucocorticoids \>7.5 mg/day, bisphosphonates, denosumab) within the past year.
* History of metabolic bone diseases other than osteoporosis (e.g., osteomalacia, Paget's disease).
* Patients with a history of malignancy, except for non-melanoma skin cancer.
* Incomplete or missing data required for FRAX or DXA analysis.
* Any condition or comorbidity likely to affect fracture risk assessment, as determined by the clinician.
Effectiveness and Safety of Probiotic in Regulating Chronic Constipation

To evaluate the effectiveness and safety of the use of probiotics as food supplements in regulating the intestinal habit of subjects with chronic constipation, in comparison with placebo.


Eligibility Criteria:
Inclusion Criteria:

Patients with chronic constipation (duration more than 3 months with less than three bowel movements per week and/or Bristol Scale 1 and 2).

Exclusion Criteria:

1. Diabetic patients.
2. Pregnant patients.
3. Breastfeeding patients.
4. Patients requiring antibiotic treatment.
5. Patients requiring treatment with tricyclic antidepressants, antiepileptics, antihistamines, antiparkinsonians, antipsychotics, antispasmodics, verapamil, monoamine oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and calcium), antidiarrheals and nonsteroidal anti-inflammatory drugs.
6. Patients who change the type of diet during the study.
7. Patients with allergy or intolerance to any of the ingredients in the formulation of the product under study.
8. Subjects with a history of pharmacological, alcoholic, or other substance abuse, or other factors that limit their ability to cooperate during the study.
9. Excessive alcohol consumption (\>3 glasses of wine or beer/day).
10. Subjects whose condition does not make them eligible for the study, according to the researcher.
Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance

Experimental results are strongly suggesting that PCSK9 and FXR could occur in the physiopathology of human joined dyslipidemia. But no data in the literature can validate the potential role of these two genes in the lipidic and glucidic metabolism control in physiopathological situations. This protocol is based on the hypothesis that the expression levels of PCSK 9 and FXR are modified for some patients suffering from insulin resistance and dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* corporal mass index \> 40 kg/m² or \> 35 kg/m² associated to a co-morbidity resistant to a diet
* bariatric surgery planned
* no lipid-lowering drugs during 4 weeks before surgery
* no treatment by metformin during 4 weeks before surgery
* no treatment by glitazones during 8 weeks before surgery
* age of the patient between 18 and 65 years
* consent form signed
* patient with social insurance

Exclusion Criteria:

* age inferior to 18 years
* women pregnant
* coagulation troubles
* surgery contraindicated
* Chronic hepatitis B or C active
* VIH infected
* other chronic hepatic disease
* patient with dyslipidemia under lipid-lowering drugs in secondary prevention of a cardiovascular pathology
* Type 2 diabetes under insulinosensitivator treatments
Cognitive Behavioral Therapy for Insomnia with RTMS

Depression and insomnia occur together in a substantial number of patients. Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. A form of cognitive behavioral therapy (CBT) has been developed that specifically helps with insomnia (CBT-I). The study team will give CBT-I to patients who are being treated with TMS for depression, who also have insomnia, to determine if it helps insomnia symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-85 years old
* Patients starting rTMS treatment for MDD
* Co-morbid insomnia as determined by meeting the following criteria: (a) Requiring more than 30 minutes to fall asleep at the beginning of the night or more than 30 minutes of time awake after initially falling asleep for at least 3 nights per week for at least 3 months - - An insomnia severity index score of 15 or more
* Manifested sleep disturbances or associated daytime symptoms causing significant distress or impairment in social, occupational or other areas of functioning
* Reliable access to a computer with internet access.

Exclusion Criteria:

* Obligation to an irregular sleep schedule that prevents the adoption of intervention strategies such as shift workers
* Participants who have received or are receiving CBT-I targeting insomnia in the past, or those who have initiated a new sedative medication, or sedating antidepressant within 2-weeks preceding enrollment
* Comorbid psychiatric disorders, including bipolar disorder, psychotic disorders or depression with psychotic features
* Presence of another untreated sleep disorder such as obstructive sleep apne
* Pregnancy
* Active substance use disorder within the past 3 months
* Use of medications that reduce the seizure threshold including Buproprion, stimulants or augmenting thyroid medications (for those without history of hypothyroid)
Prognostic Features for Mortality in Young Adults With Pneumonia

Pneumonia is a major cause of mortality and morbidity. A large body of evidence concerning the mortality risk factors in elderly patients with pneumonia has been reported; however, less is known about causes of mortality in patients of sixty and less. We noted a relatively substantial rate of short term mortality in this group of patients that were admitted to our institution. Therefore, we aimed to estimate the mortality rate and to identify risk factors for mortality among patients of sixty years old and less that were admitted with community acquired pneumonia.

Community acquired pneumonia (CAP) is a major cause of morbidity and mortality. While there is much data about risk factors for severe outcome in the general population, there is less focus on younger group of patients. Therefore, we aimed to detect simple prognostic factors for severe morbidity and mortality in young patients with CAP.

Patients 60 years old or younger, who were diagnosed with CAP (defined as Pneumonia identified 48 hours or less from hospitalization) between March 1, 2005 and December 31, 2008 were retrospectively analyzed for risk factors for severe morbidity or mortality.

Complicated hospitalization was defined as at least one of the following parameters: hospitalization longer than ten days, admission to intensive care unit and in- hospital mortality. Otherwise, the hospitalization was defined uncomplicated

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of community acquired pneumonia Age between 18-60

Exclusion Criteria:

Age less than 18 and more than 60 Transfer from another hospital Hospitalization for any cause other than CAP during the 30 days prior to admission Hospital acquired pneumonia Partial antibiotic treatment before admission.
Static Magnetic Therapy for Carpal Tunnel Syndrome

The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
* ≥ 18 years

Exclusion Criteria:

* Current use of magnets as therapy for Carpal Tunnel Syndrome
* Known allergy to silicone
* Unwillingness to wear wristband for 6 weeks
* Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants

We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.


Eligibility Criteria:
Inclusion Criteria:

* inborn at Mount Sinai Medical Center
* gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
* plan by family for their infant to receive human milk feeds

Exclusion Criteria:

* outborn infants
* gestational age \< 26 0/7 weeks or \> 33 0/7 weeks
* major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
* sepsis and/or other serious clinical complication precluding initiation of enteral feeds
* plan by family for their infant to receive primarily preterm infant formula.