cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects

Primary Objective:

To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553 (REGN727) administered at 3 different injection sites in healthy subjects.

Secondary Objectives:

* To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and apolipoproteins.
* To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727).
* To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553 (REGN727).

Total duration of the study per subject is about 15 weeks.

Eligibility Criteria:
Inclusion criteria:

Healthy subjects.

Exclusion criteria:

Healthy subjects with history or presence of clinically relevant illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female at least 18 years of age
* Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)
* Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal and hepatic function

Exclusion Criteria:

* Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
* Known history of bleeding disorders, eg, von Willebrand disease or hemophilia
* Cavitary tumors or tumors invading or abutting large blood vessels
* Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening
* Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening
* Grade 2 or higher peripheral neuropathy
Technical Development of Multi-Parametric Renocerebral MRI

The purpose of the study is to investigate the associations of the age-related changes in the brain, kidneys and cognitive performance in healthy adults by utilizing multiple anatomic and functional MRI methods along with a battery of cognitive tests.


Eligibility Criteria:
Inclusion Criteria:

1. English-speaking as primary language
2. No hearing loss or uncorrected vision

Exclusion Criteria:

1. Lacking capacity to consent
2. Having known history of cardiovascular diseases (e.g., clinical stroke)
3. Having acute and chronic obstructive pulmonary disease
4. Having known history of renal diseases (e.g., acute kidney injury)
5. Having known history of cognitive disorder or psychiatric illness
6. Having known history of chemical dependence (e.g., alcohol and narcotics)
7. Being treated with stimulant medications, anticonvulsants, antihypertensives or ß-adrenergic blockers
Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, and how safe it is in participants with metastatic cancer (cancer that has spread).

This is a rollover study. Only participants who continue to receive clinical benefit from continuation of sacituzumab govitecan-hziy therapy and are tolerating therapy at the time of enrollment are eligible for this study. Participants enrolled may continue to receive sacituzumab govitecan-hziy at the dose that they were receiving in the Gilead parent study at the time of consenting to participate in this rollover study.

Eligibility Criteria:
Key Inclusion Criteria:

* Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study
* Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy

Key Exclusion Criteria:

* Females who are pregnant or lactating
* Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the parent study in which they participated
* Experienced a toxicity from sacituzumab govitecan-hziy that resulted in permanent discontinuation of therapy
* Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Correlation of Clinical Types and Complexity of Coronary Artery Disease With Patients' Metabolic Profile

The purpose of the research project is to investigate the potential association of the complexity and the severity of coronary artery disease (as assessed via SYNTAX score) with patients' metabolic profile. The aim of the study is to combine biochemical, clinical and laboratory data in order to create an algorithm that will enable an individualized therapeutic patient approach.

The objective of this observational study is to expand our knowledge on the biochemical process and pathogenesis of atherogenesis and to recognize clinically important metabolic biomarkers correlated with the severity and clinical presentation of Coronary Artery Disease (CAD). 1050 patients who will undergo coronary angiography will be enrolled in the study. SYNTAX score will be calculated for all participants and their blood samples will be collected before coronary angiography. Metabolomics-based analysis will be performed in order to confirm CAD prognostic biomarkers previously reported in the literature and to investigate their correlations with CAD clinical data. The ultimate aim of this study is to predict the risk of cardiovascular events by incorporating metabolomic information into the SYNTAX score and provide personalized therapeutic guidance to patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients giving voluntary written consent to participate in the study
2. Adults
3. Patients without previous history of coronary artery disease
4. Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes

Exclusion Criteria:

1. Cardiac Arrest at admission
2. Patients with serious concurrent disease and life expectancy of \< 1 year
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis

Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.


Eligibility Criteria:
Inclusion Criteria:

* weight at diagnosis \> 700 grams
* confirmed NEC (Bell's stage II or III)
* radiological evidence of pneumatosis coli
* systemic compromise as defined by increase in ventilation requirement and/or requiring inotopic support
Brain Biomarkers of Response to Treatment for Apraxia of Speech

The study will use MRI brain imaging to identify brain changes associated in stroke patients after they receive speech-language treatment for their speech difficulties.

The goals of the current study are to identify grey and white matter regions that are predictive of speech treatment response and measure neural plasticity in response to speech treatment, using state-of-the-art neuroimaging and statistical processing techniques in a group of well-characterized left hemisphere patients meeting strict inclusionary criteria. Specifically, the investigators will use voxel-based lesion symptom mapping to identify lesion sites most predictive of a positive response to speech treatment and advanced diffusion imaging techniques to map changes in the integrity of white matter tracts from pre- to post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are age 40-90
* primary English speaker since \< age 5
* a history of a single left hemisphere stroke
* at least 1 year post-stroke
* at least 12 years of education
* pre-morbidly right-handed (Edinburgh Handedness Questionnaire)
* within normal limits on the Test of Non-Verbal Intelligence

Exclusion Criteria:

* Exclusion criteria will include a pre-morbid neurologic or psychiatric history
* history/current substance abuse disorder
* MRI contraindications
* other motor speech disorders (e.g., dysarthria)
* current or recent (\<2 months) speech/language therapy
* prior SPT
* pre-morbid history of speech/language disorders
* significant hearing disabilities (based on a pure-tone audiological screen at 35 dB HL at 500, 1K, and 2K Hz for at least one ear)
* aphasia severity resulting in \<30th percentile performance on the Porch Index of Communicative Ability-R
A Long-term Study of AK102 in Patients With Hypercholesterolemia

This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Body weight ≥ 40 kg for both men and women.
3. Participated in the AK102-202 study, and completed the AK102-202 study last visit.

Exclusion Criteria:

1. Poor compliance in AK102-202 study per investigator's judgement.
2. AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period.
3. Prior use of PCSK9 inhibitors other than AK102.
Pilot Study on The Flanks of Asian Patients

This study will evaluate CoolSculpting and the CoolCurve applicator for non-invasive fat reduction in the flanks with sharp body curvature.

The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for non-invasive fat layer reduction in flanks for Asian patient population.

Eligibility Criteria:
Inclusion Criteria

1. Male or female subjects \> 18 years of age.
2. Subjects must be of Asian descent.
3. Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
4. Subject has not had weight change exceeding 10 pounds in the preceding month.
5. Subject with body mass index (BMI) up to 25. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
6. Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
7. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
8. Subject has read and signed a written informed consent form.

Exclusion Criteria

1. Subject has had a surgical procedure(s) in the area of intended treatment.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
4. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
7. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
8. Subject is taking or has taken diet pills or supplements for weight loss within the past month.
9. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
11. Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject is unable or unwilling to comply with the study requirements.
14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women

This study is a Multicentre cohort study with inclusion throughout the full duration of the study.

The primary objective is the study of human papillomavirus related genital pathology in HIV positive women.

The secondary objective are:

1. To study the characteristics of HPV infection and related disease in the context of long term HAART and HIV infection ;
2. To study the characteristics of atypical cells of uncertain significance detected in Pap smears, whose prevalence has dramatically increased in the last years;
3. To describe cervical cancers observed in the cohort
4. To study the evolution of recurrent high-grade lesions after surgery
5. To describe the evolution of vaginal lesions developed after hysterectomy for high-grade lesions ;
6. To describe the specific aspects of surgery for the treatment of cervical lesions according to the specific localization in the endocervix in HIV-positive women ;
7. To study the in situ T cell HPV specific response in cervical lesions and the relationship between virological and clinical parameters, host immune status and natural history of lesions ;
8. To initiate a prospective study on anal HPV infection and related disease among women infected with HIV.
9. To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of immunosuppression and a high rate of HPV infection ;

Data were be collected into evaluate:

* Analysis of prognostic factors (CD4, antiviral therapy) of cervical lesions, using Cox models.
* Estimation of rates of Incidence of high grade lesions, of recurrence after surgical treatments using Kaplan Meier tests.
* Logistic regression analysis for the study of factors associated with complete excision after surgical treatment.
* SIR (standardised incidence rate) evaluation for cervical cancer

Study procedures are Annual follow-up in case of normal Pap smear, biannual follow-up in case of cervical lesions. Surgical management of High grade lesions.

Eligibility Criteria:
Inclusion Criteria:

* women \> 18 years old
* attending outpatient gynecology consultation
* HIV positive
* with written informed consent
* on social security

Exclusion Criteria:

* unaffiliated to the social healthy security french system
The Role of Music in Palliative Care: A Proposal for a Rural Based Initiative in Music Based Interventions

Current practice in larger palliative care centers offer many supportive service modalities, which are often unavailable in the rural setting. Music Therapy by experienced registered Music Therapists is an example of such a modality. The current evidence continues to grow, identifying Music Therapy's benefits to help with symptom relief as well as to improve Quality of Life in many aspects of medicine, but especially in the context of palliative care. This proposal outlines an initiative to provide music-based interventions in a rural community palliative care unit where there is limited availability to a registered Music Therapist.

Study participants in the pilot phase will include patients admitted to the Aberdeen Hospital Palliative Care Unit. Patients excluded from participating would include those unwilling to participate for any reason. All patients will be invited to complete the McGill Quality of Life Questionnaire - Revised (McGill QOL-R) upon admission to the unit. The Questionnaire will not be part of the permanent medical record and the participants will remain anonymous. Afterwards participants will be asked if they would like to listen to music during their stay in the hospital. Music will be selected according to their choices from an i-Tunes playlist. Participants will be invited to listen to music at their own discretion. Prior to discharge from the hospital or after 3 days all willing patients will be again invited to complete the McGill QOL-R questionnaire. The participants will remain anonymous, but will be identified as to whether they listened or did not listen to music during their hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the Aberdeen Hospital Palliative Care Unit.

Exclusion Criteria:

* those patients unwilling to participate for any reason
Arnogene: A Phosphocalcic Study in Dialysis

Searching for high morbi-mortality risk Klotho variants in dialysis patients


Eligibility Criteria:
Inclusion Criteria:

* Every adult \> 18 years old and treated by dialysis in centers located in the Rhone Alpes area in France.
Artegraft Versus Propaten Dialysis Grafts

Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs better than the other. How long each one lasts until a complication arises or until the graft is no longer used will be compared.

The study hypothesis is that the Artegraft, being an actual blood vessel, will work better than the manufactured Propaten graft.

Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care. Patients will be assessed at 2-3 weeks post-operatively and again at 6 and 12 months for flow characteristics, dialysis adequacy and graft associated complications such as stenosis, infection and thrombosis. Data on urea reduction ratio (URR), kinetic modeling (Kt/V), and access flow (QB) will be collected at 3, 6, 9 and 12 months via phone call to the hemodialysis center in order to evaluate patency and function.

Access complications (stenosis, thrombosis, infection) will be treated per our standard protocol. These data will be recorded and then primary, assisted primary and secondary patency rates will be calculated and the graft arms compared using life table analysis.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Candidate for hemodialysis
* Not a candidate for native AV fistula
* In need of a new AV graft in the upper arm location
* Artery and vein \> 3mm.
* Medically stable and have a life expectancy of ≥ 12 months
* The patient or legal guardian understands the study and is willing to comply with the requirements.

Exclusion Criteria:

* \< 18 years of age
* Current history or within 6 months of IV drug abuse
* Chronic hypotension (\<100 mm systolic pressure) not responsive to treatment
* Pregnant or lactating
* Known hypercoagulable state
* Requires only a revision of an existing graft
* Receiving artery or vein is less than 3 mm in diameter at the time of implantation
* Known axillary/subclavian occlusion or stenosis that has not been treated
* Known or suspected systemic infection
* Heparin sensitivity (known HIT)
* Enrolled in another investigational study.
* Subject has more than 1 graft in target limb.
High Flow Nasal Cannula for Stabilization of Extremely Premature Infants

A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 6-8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low Saturation of oxygen (SpO2).


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between 25+0 and 27+6 gestational weeks
* Weight above 500 grams

Exclusion Criteria:

* Previable rupture of membranes,
* Congenital malformations previable
* Acute intrauterine hypoxia.
Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

Scientific background: Bronchoscopy is a procedure commonly performed in the management of persistent respiratory illness. In the last decades this exam has become a routine and safe procedure even in children and there are few side-effects. However, one known side effect is transient fever and even high fever a few hours after the bronchoscopy. This side effect is not dangerous but very uncomfortable for the patients and it would be interesting to try to reduce this phenomena. This fever is due to a release of cytokines during the broncho-alveolar lavage procedure and not to sepsis. In a previous study a single dose of dexamethasone was shown to prevent the fever post bronchoscopy with no apparent detriment to the child. It is well known that steroids are immunosuppressive. Even though the post-bronchoscopy fever is not caused by an infection, it seems preferable to use other anti-inflammatory drugs to fight this very inconvenient side effect.

Ibuprofen (Nurofen\*) is known as an effective medication to reduce fever in infectious illnesses and is even considered as superior to paracetamol. It has no immunosuppressive effect and is usually well tolerated by children with very few side effects when taken in the normal therapeutic dose of 10mg/Kg. The investigators postulate that a dose of Nurofen prior to bronchoscopy could significantly reduce fever post bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* under twelve years of age
* all patients undergoing bronchoscopy and bronchoalveolar lavage

Exclusion Criteria:

* children with immune deficiency
* allergy to NSAIDS
* previous exacerbation of asthma due to NSAIDS
* fever on the day of the examination
* current antibiotic treatment
Rosuvastatin ORBITAL Germany

The primary objective of the study is to compare the effect of rosuvastatin therapy plus compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term cumulative direct and indirect disease-related costs during the 36 month.


Eligibility Criteria:
Inclusion Criteria:

* high cholesterol with an indication for cholesterol-lowering medication (statins)

Exclusion Criteria:

* contra-indications for statin therapy