cyrilzakka/clinical-trials huggingface dataset:
Influence of Oxytocin on Resting State Neurophysiological Measures

In this study, the investigators will explore the influence of oxytocin administration on several neurophysiological responses (EEG, skin conductance and heart rate) during rest.

Oxytocin is known to influence several neurophysiological measures, such as heart rate, EEG and skin conductance during specific tasks (e.g., emotion recognition, fear learning and extinction). However, not much is known about the influence of oxytocin on those measures during rest. Therefore, in this randomized, placebo controlled, double blinded study, the investigators will investigate the influence of oxytocin during a resting period of 5 minutes. Heart rate, skin conductance, respiration and EEG will be measured before and after oxytocin or placebo administration. The investigators expect that oxytocin will increase the heart rate variability and decrease the skin conductance levels. Exploratory, the investigators will conduct a cross-frequency analysis of band power and asses the relationship between distinct indexes of sympathetic / parasympathetic balance.

Please note that this study is part of a larger study in which the investigators also asses the influence of oxytocin on neurophysiological responses elicited by direct gaze

Eligibility Criteria:
Inclusion Criteria:

* right-handed
* male
* age between 18 and 35
* Normal or adjusted-to-normal vision (with lenses only)
* Dutch as mother tongue

Exclusion Criteria:

* not right-handed
* female
* age below 18 or above 35
* Need to wear glasses
* Dutch not as mother tongue
Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis

The objective of the study is to assess the effect of two diets with different fat composition on cholesterol metabolism. The study was a randomized cross-over trial where volunteers follow two study periods with different types of meat (lean and fat red meat) separately by a ten days wash-out period. At the beginning of the study and after the study periods the following parameters are determined: anthropometric (weight, waist, circumference and body mass index), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring, ferritin, uric acid, glucose, HbA1c and insulin). Serum concentration of non cholesterol sterols (sitosterol, campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout along the study in order to demonstrate the effect of different red meat on the hepatic metabolism of cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Normolipemic healthy subjects defined by levels of LDL cholesterol and triglycerides below the 90th percentile adjusted for age and sex.
* Diet and stable lifestyle with controllable feeding.

Exclusion Criteria:

* Pregnancy or intention of pregnancy during the study.
* Lipid lowering drugs in the last 3 months.
Digital Psychological Self-care for Sleep Problems

In this non-randomized treatment feasibility pilot we want to explore if a simplified version of CBT-i as a non-therapist-guided digital tool can work; if the digital tool is perceived as user friendly and if participants' insomnia severity is improved following four weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia complaints of at least medium severity (15 or above on the ISI)
* Insomnia disorder according to DSM-5
* Adequate language skills (Swedish)
* No foreseeable practical hinders to participate
* Can wear actigraph 24/7
* Daily access to the internet, via computer, smart phone or tablet

Exclusion Criteria:

* Sleep disorders requiring other treatment (e.g. sleep apnea)
* Somatic or psychiatric disorders that require other treatment (e.g. suicide risk, severe depression) or that decrease level of functioning enough to prevent working independently.
* Use of alcohol or drugs in a way that will affect sleep negatively, use of medications with a negative impact on sleep. (Stable use of anti depressants and stable use or tapering of hypnotics are allowed)
* Night work or shift work involving night work
* Ongoing or previous psychological treatment including sleep restricion and stimulus control
Effect of Peritoneal Fixation on Lymphocele Formation

The PerFix Trial aims to compare the use of peritoneal fixation technique to standard of care (no fixation) during robot-assisted radical prostatectomy with extended pelvic lymph node dissection (RARP + eLND) for the prevention of symptomatic and radiologic lymphocele formation.

Extended pelvic lymph node dissection (ePLND) is the most accurate staging tool to determine lymph node involvement in prostate cancer. As urologist perform this procedure more often now, thanks to the shift to more advanced and aggressive stages, the role of ePLND is expanding. The main complication of PLND is development of a collection of lymphatic fluid called a lymphocele. Lymphoceles can be associated with abdominal pain, lower urinary tract symptoms, bladder outlet obstruction, penile or scrotal edema, infection/sepsis, lower extremity swelling and deep vein thrombosis. They necessitate intervention in up to 10% of patients treated with RARP + ePLND which includes drainage or surgery. Radiologic incidence can be as high as around 50% of operated patients with unknown clinical relevance. Many interventions aimed at reducing the rate of lymphocele formation with limited success so far. Several retrospective studies suggested using peritoneal flap fixation technique which could direct the lymphatic fluid to the peritoneal cavity out of the pelvis and its ensure its reabsorption there. We hypothesize that peritoneal fixation can potentially lower the incidence of symptomatic and radiologic lymphocele formation. By preventing this potentially very dangerous complication, it could be very beneficial for a large group of patients suffering from aggressive localized prostate cancer who are scheduled for RARP + ePLND.

Our goal is to is to test this hypothesis in a randomized trial comparing the fixation technique to standard of care, i.e. no fixation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Able to give informed consent
* Histologically proven high risk prostate cancer or intermediate risk cancer (≥5% risk of nodal involvement on Briganti 2012 nomogram) according to European Association od Urology (EAU) risk groups
* Suitable for minimally-invasive surgery

Exclusion Criteria:

* Previous pelvic surgery or irradiation.
* Any type of clotting disorder.
* Patients unwilling to undergo CT scan
* Kidney failure, Hemodialysis
* American Society of Anesthesiology Classification\> 3
* Existing contraindications for performing a lymph node dissection
Design the Home Care Platform for the Monitoring of A Hemodialysis Arteriovenous Graft by Intelligent Physiological Signal

Most patients with end-stage renal disease require hemodialysis. An arteriovenous fistula (AVF) or a prosthetic arteriovenous graft (AVG) is the preferred accesses for this. After its surgical creation, the fistular vein immediately faces a tremendous blood flow and the venous lumen is gradually dilated and the wall thickened, producing an access that can be routinely needled and deliver sufficient blood flow for dialysis. However, many hemodialysis patients will experience access stenosis, dysfunction, and even thrombosis, which are the most common complications of a hemodialysis access.

Most physicians, in-charge nurses of the hemodialysis unit, patient, and/or the family use traditional stethoscope as a convenient method to evaluate the patency and function of a hemodialysis access before, during, and after each session of dialysis. The acoustic signal of an access is always affected by environmental noises, non-specific in nature, and the sensitivity to detect stenosis is very low.

With the development and use of electronic stethoscope, the proprietary ambient noise acoustically cancels out an average of 75% of distracting room noise, greatly enhancing overall utility. However, the output acoustic signals are still apprehended by the ear, which is the main source of bias and errors of detection.

Our study purpose is to apply the signal processing technology to transfer the acoustic signals into simple visual signals that provide an easy way to read. It can be used by a professional medical staff, a non-professional person responsible for taking care, or even the patient himself, disability or not, as an early screening detector of stenosis or dysfunction of a hemodialysis access.


Eligibility Criteria:
Inclusion Criteria:

* prosthetic grafts with clinical signs of dysfunctions or malfunctions and were referred for angiographic evaluations.

Exclusion Criteria:

* autologous arteriovenous accesses or known thrombosed accesses.
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Socket Shield Technique Versus Early Implant Placement With Contour Augmentation

comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour

comparing immediate implant placement with socket shield technique and final crown after 3 months with extraction and after 4 to 8 weeks implant placement with contour bone augmentation then after 3 to 4 months final crown delivery

Eligibility Criteria:
Inclusion Criteria:

1. Non-restorable maxillary teeth in the esthetic zone
2. Intact adjacent teeth
3. Adequate palatal and apical bone that allows achieving implant primary stability.
4. Type I socket
5. ≥18 years
6. ≤ 60 years
7. Systemically healthy patients

Exclusion Criteria:

1. Extraction sockets with acute or chronic infection or with adjacent infected teeth
2. Heavy Smokers \> than 10 cigarettes daily
3. Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
4. Unmotivated patients to maintain adequate oral hygiene to follow up.
5. Patients with physical disabilities that could affect follow up.
Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy

The primary objective of the study is to investigate whether topical Vitamin K application reduces the grade of erythema in comparison with a vehicle cream (placebo) through physicians' assessment and participant self-assessment.

The secondary objectives of this study are to evaluate in this study population: effects of Vitamin K in reducing the burning sensation and local pain; effects of Vitamin K in reducing the erythema diameter; and the evaluation of participants' satisfaction related to the injection treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Relapsing-Remitting Multiple Sclerosis (RRMS) participants for which Plegridy is deemed necessary by the neurologist. Participants switching from other Disease Modifying Treatments (DMTs) will be eligible provided that Plegridy is administered at an injection site different from the previous one.

Key Exclusion Criteria:

* Participants with other skin disorders
* Pregnancy or current breast-feeding
* Depression and other psychiatric disorders
* Unwillingness or inability to comply with the requirements of the protocol.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Food Is Medicine: Makin' Healthy Groceries

This is a minimal risk study focusing on food purchasing and consumption in 100 subjects in the greater New Orleans area. There is evidence showing that individually-targeted vouchers effectively increase category-level food purchases in both less healthful and more healthful categories. This pilot study will investigate whether a voucher program using Instacart or a local, brick-and-mortar supermarket in New Orleans, LA lead to changes in food purchasing patterns, food consumption, food insecurity, and access to healthy food options for the participants, who are at risk of cardiovascular disease and/or cardiac complications. The study will also measure concordance between food purchasing and actual consumption.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 50 years of age
* Uncontrolled hypertension (defined as at least two clinically documented blood pressure readings of systolic BP \>= 140 AND diastolic BP \>=90 in the prior 6 months)
* Understands English

Exclusion Criteria:

* No internet access (at home, library, relative, or though phone plan)
* No adequate transportation (personal car, reliable ride, bus, and/or Uber/Lyft) in the New Orleans area
Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series

This study will compare the motor outcomes for five infants with asymmetrical hand function (AHF) who will receive two, three week episodes of standard care separated by a three week episode of mCIMT paired with Neuromuscular Electrical Stimulation. The results of this study will inform decisions on the feasibility and efficacy of the treatment for use in a larger study for infants with AHF at risk for unilateral cerebral palsy.

Infants with asymmetrical hand function will participate in three consecutive phases of treatment.

The first and third phase will consist of three weeks of standard care for children with asymmetrical hand function, 1 hour/day, 1 day/week. The therapist will provide weekly coaching with the parents so they can carry over activities at home one hour/day, six days/week during this phase. In addition, a sock or mitten will be used for short term constraint during the hour of training both in the clinic with the therapist and at home with the parent.

The second phase will consist of three weeks of modified constraint induced movement therapy, 2 hours/day, 3 days/week paired with NMES, 15 minutes/day, 3 days/week. The infants will wear a soft splint on their preferred hand and forearm 24 hours/day during this phase. Parents will be trained by the therapist to carry over activities with their child at home, 1 hour/day, 6 days/week.

The children will return at chronological age of 18 months for follow up testing.

Eligibility Criteria:
Inclusion Criteria:

1. Infant is 7-10 months of age (CCA)
2. Clinical presentation of asymmetrical hand function,
3. Grade 2/5 movement in more impaired upper extremity,
4. Demonstrate potential to participate in 6 hours of therapy/week during 3 week episode of mCIMT-NMES, as determined by principal investigator,
5. Parent/guardian willing to be partners in study and participate in follow-up assessments until child is 18 months of age

Exclusion Criteria:

1. Medical or sensory condition that prevents full therapy participation (active seizures, significant visual impairment)
2. Received Botox injection to more impaired upper extremity within last 6 months,
3. NMES contraindicated (impaired skin integrity, presence of pacemaker, clotting disorder),
4. Previous UE surgery or nerve injury (brachial plexus)
Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain

Prehospital treatment of acute traumatic pain is common in military practice. Analgesics are usually administered intravenously (IV). Research from the civil prehospital environment shows that obtaining IV access can be difficult and time consuming, delaying onset of treatment. The challenges for obtaining IV access in the military prehospital setting are even bigger, for example in combat environments. However, this has not been assessed.

Current guidelines also offer alternative routes of administration for analgesics, for example intranasal (IN) administration. IN administration is a fast, easy and effective route of administration. This study determines whether IN administration of analgesia is faster and leads to increased healthcare provider satisfaction compared to IV administration in patients with acute traumatic pain in a simulated military prehospital environment.


Eligibility Criteria:
Inclusion Criteria:

* All navy healthcare personnel attending (simulation) training on prehospital trauma care.

Exclusion Criteria: none
Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

1. To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world setting across two moderate RA cohorts: a Test Group of patients newly exposed to etanercept (Enbrel) therapy and a Control Group of patients with similar disease characteristics newly exposed to other, non-biologic therapies.
2. To assess the change over time (from baseline to the most recent follow-up) in the characteristics described at baseline in 2 British Society for Rheumatology Biologics Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).

Retrospective database analysis

Eligibility Criteria:
Inclusion Criteria:

The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:

* Patients aged 18 years and over at the time of diagnosis;
* Patients from the BSRBR with moderate RA as defined by a DAS28 (\>3.2 and ≤5.1);
* Patients who have given informed consent for long term follow-up and access to all medical records;
* Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel) for RA.

The Control Group:

* Patients aged 18 years and over a the time of diagnosis;
* Patients from the BSRBR with moderate RA as defined by a DAS28 (\>3.2 and ≤5.1);
* Patients who have given informed consent for long term follow-up and access to all medical records; Patients are receiving at least one traditional DMARD and have never been prescribed a biologic agent;

Exclusion Criteria:

Per BSRBR registry since data is retropsectively being analyzed
Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.

To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP and LDL-C not at target according to governing guidelines

Exclusion Criteria:

* High liver enzymes
Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as Immune Prognostic Biomarker in Breast Cancer Treated by Neo Adjuvant Chemotherapy

Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chemotherapy is the most important prognostic factor for these patients. However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not achieve pCR is poorly documented, and no specific prognostic factors have been clearly identified.Preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. Conversely, tumours can promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory T-cells are associated with less favourable prognosis in breast cancer patients. We have previously shown that a high number of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pCR was achieved, the type of chemotherapy used, and the type of breast cancer. Therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.


Eligibility Criteria:
inclusion criteria

1. Signed informed consent
2. Social security coverage
3. Age between 18 and 80 years
4. Histologically proven breast cancer, regardless of histological type or molecular subtype (triple negative, hormone-receptor positive, HER2+++), including inflammatory forms
5. Localised breast cancer with or without axillary or subclavicular lymph node involvement
6. Absence of bone or visceral metastasis on further evaluation (bone scintigraphy, chest X-ray, abdominal echocardiography or CT scan of the thorax, abdomen and pelvic area)
7. Treatment by neoadjuvant chemotherapy (treatment protocol at physician's discretion)
8. Patient amenable to receiving adjuvant therapy (chemotherapy, radiotherapy, hormone therapy, targeted therapy)
9. Breast surgery (breast-sparing or not) planned after neoadjuvant chemotherapy

exclusion criteria

1. Metastatic breast cancer
2. Neoadjuvant radiotherapy
3. Patient not amenable to surgery
4. Ongoing therapy for any other type of cancer
5. Legal incapacity (incarceration or persons under legal guardianship)
6. Patient unable to sign the informed consent or unable to attend medical follow-up for geographical, social or mental reasons.
Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden

The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study.


Eligibility Criteria:
Inclusion Criteria: Capable of giving signed informed consent and informed assent (as appropriate), which includes compliance with the requirements listed in the informed consent form (ICF) and informed assent form (IAF)

Between 15 and 34 years of age (inclusive)

Participants who agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to relocate from the study area for the duration of the study.

Exclusion Criteria:

History of active TB within the last 24 months (i.e., 24 months from end of treatment to day of screening, based on history \[no documentation required\])

History of previous administration of an experimental Mtb vaccine

Unstable / uncontrolled chronic condition according to the judgment of the investigator

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