cyrilzakka/clinical-trials huggingface dataset:
Biomarkers of Cytomegalovirus Fetal Infection and Disease

The purposes of this study are to determine 1) if the diagnosis of CMV fetal infection could be done directly in the maternal blood instead of requesting an amniocentesis and 2) if innovative technologies such as proteomic, transcriptomic, methylomic and lipidomic applied in fetal samples could allow the discovery of new biomarkers of fetal infection.

Human cytomegalovirus (HCMV) is the most common cause of congenital infection worldwide. The diagnosis of CMV fetal infection relies on the detection of viral DNA in amniotic fluid by polymerase chain reaction after amniocentesis. Non-invasive diagnosis of fetal infection directly in maternal blood is not available. Symptoms develop in about 10% of HCMV-infected fetuses. Despite important advance in medical imaging, establishing the prognosis of an infected fetus remains challenging. Thrombocytopenia, blood HCMV DNA, anti-HCMV immunoglobulin M and β2-microglobulin are recognized biomarkers of symptomatic fetal infections. However, the predictive value of these individual markers is not. Omics technologies could help to establish multimarker signatures of symptomatic infections.

The objective of the study is to:

* validate fetal blood HCMV DNA, anti-HCMV immunoglobulin M , β2-microglobulin and platelet count as biomarkers of fetal disease;
* identify new biomarkers of severe fetal disease using transcriptomic, methylomic and lipidomic analyses of fetal blood and of amniotic fluid.
* validate a non-invasive CMV fetal infection diagnosis tool based on deep-sequencing of targeted CMV genes in maternal blood

Eligibility Criteria:
Inclusion Criteria:

CMV cases:

* Informed consent obtained from the mother;
* Pregnant women either with a history of primary CMV infection in pregnancy or carrying a fetus with ultrasound features compatible with CMV infection and willing to have amniocentesis for fetal diagnosis of CMV infection

Control cases :

- Pregnant women carrying a fetus with aneuploidy-dysgonosomy

Exclusion Criteria:

CMV cases:

* Fetuses older than the 26 weeks of gestation at the time of diagnosis of HCMV infection or impossibility to collect foetal samples by the end of the 26th week of gestation
* Mother unable to understand the protocol
* Absence of informed consent
* Any clinical rationale not to perform cordocentesis
* Mother \<18 years age
* Administration of immunoglobulins or anti-viral therapy to the mother before the collection of fetal samples or before the diagnosis of symptomatic fetal infection
* Administration of anti-HCMV drugs to the foetus before the collection of fetal samples or before the diagnosis of symptomatic fetal infection
* Administration of immunosuppressive drugs to the mother during pregnancy
* Maternal auto immune disorders
* Multiple pregnancies.

Control cases :

* Mother unable to understand the protocol
* Absence of informed consent
Data Collection With the P200TE and P200TxE

The primary objective is to collect OCT scans on a modified P200TxE and P200TE.


Eligibility Criteria:
Inclusion Criteria :

* Male or female volunteers 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
* Volunteers who can follow the instructions by the clinical staff at the clinical site;
* Volunteers who agree to participate;
* Volunteers who have been diagnosed with retina pathology with intra-retinal and/or subretinal fluid present in the posterior pole region.

Exclusion Criteria:

* Volunteers unable to tolerate ophthalmic imaging;
* Volunteers with ocular media not sufficiently clear to obtain acceptable OCT images.
Perfusion Index and Pain in Ankle Surgery

Perfusion index (PI) measured via a pulse oximeter has been shown to correlate with activation of the sympathetic nervous system, such as by pain stimulation, as a result of involuntary contraction of the arterioles. Thus PI holds potential for use as a tool for "objective pain measurement", although its practical usefulness and dependability as such have not previously been investigated.

The investigators aim to explore associations between changes in PI and onset of pain following cessation of regional anaesthesia in alert patients following ankle fracture surgery.

Methods:

The investigators report an exploratory, observational analysis of prospectively gathered PI data from patients undergoing regional anaesthesia with spinal or peripheral nerve block for ankle fracture surgery as participants of the randomised AnAnkle Trial (EudraCT: 2015-001108-76). PI is measured on an unaffected extremity in approximately 20 consecutive patients already included in the AnAnkle Trial at Herlev University Hospital, evenly distributed between spinal anaesthesia (SA) and peripheral nerve block (PNB).

Both anaesthesia forms and pain medication regimes are standardised as part of AnAnkle Trial and participants register pain scores on a 0-10 numeric rating scale every three hours and register the time of cessation of anaesthesia identified by return of sensation to the ankle. Morphine consumption is also registered.

The investigators will explore correlations of changes in PI to increases in pain upon cessation of the regional anaesthesia and, secondly, differences in cessation related PI changes with SA versus PNB.

Ethics:

All participants have already given informed, written consent for use of this data for the AnAnkle Trial. All necessary ethical and legislative approvals have been obtained for initiation of AnAnkle Trial in July 2015.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for internal fixation of an ankle fracture
* Age \> 18 years
* Ability to read and understand Danish and give informed written consent

Exclusion Criteria:

* Allergy towards NSAID, paracetamol, morphine or local anaesthetics
* Bodyweight \< 52 kg; to avoid toxic doses of local anaesthetics
* Contraindications for SA
* Current gastro-intestinal bleeding
* Proximal fibular fracture or multitrauma / other simultaneous fractures
* Cognitive or psychiatric dysfunction or alcohol/narcotic substance abuse causing expected inability to comply with study protocol
* No available anaesthesiologist with PNB capability at scheduled time of operation
* Neuropathy / neurological dysfunction in the lower extremities
* Habitual daily use of opioids
* Pregnancy or breastfeeding
* Infection at anaesthesia injection site
* Nephropathy requiring dialysis
* Acute porphyria
USS Training to Improve Social Function in People With Psychosis

Psychotic spectrum disorders (PSD) are associated with poor social function. By doing this study, the investigators hope to learn which of two different types of 2-month long training courses is more effective in improving day-to-day interactions and quality of life.

Participants will be randomly assigned to one of the two training courses. All participants will be asked to fill out questionnaires, engage in interviews, and complete paper and pencil tasks at the beginning of the study, at the halfway point of the training course (1 month), and end of the training course (2 months), and another 2 months later. One training focuses on how to make good judgments about what other people may be thinking or feeling in social situations, and why people might act in certain ways in different situations. The other training focuses on different strategies for handling everyday problems and stressors. Both trainings are done in one-on-one sessions with a research staff member. There will be 16-20 training sessions, each about 45-60 minutes long. The investigators will ask participants to attend 2 training sessions per week, so the total training time should be about 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Veteran with diagnosis of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder, psychosis NOS, etc);
* psychiatrically stable (30 or more days since last hospitalization/change in psychiatric medication)
* fluent in English
* able to provide legal written informed consent

Exclusion Criteria:

* current substance use disorder
* developmental disability
* severe, uncorrected auditory/visual impairment
* diagnosis of medical or neurological illness known to impair brain function including dementia, presence of seizures, history of head trauma with loss of consciousness \> 1hr, or clear cognitive sequelae from other illness or injury
* currently enrolled in another treatment study targeting, or expected to impact, functioning.
A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial

Current literature has only limited information on the natural history of acute ischemic stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from this trial will advance our knowledge on this important topic and may serve as a bench mark for future trials


Eligibility Criteria:
Inclusion Criteria:

* From 18 to 85 years of age.
* Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1)(TICI 0-1) from CT Angiography. Target vessel occlusion may include the anterior circulation.
* Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
* At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score greater than 10
* Known core infarct volume assessed by CTP, CTA or DWI scans

Exclusion Criteria:

* History of stroke in the past 3 months.
* Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 1
* Known severe allergy to contrast media
* Uncontrolled hypertension (defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure less than 110 mmHg)
* CT evidence of the following conditions before enrollment:

  * Significant mass effect with midline shift
  * Evidence of intracranial hemorrhage
* Treated with endovascular therapy for acute stroke
* Life expectancy less than 90 days
* Participation in another clinical investigation that could confound the evaluation of the study
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 18 years of age
* Subject has specified disease in his/her descending thoracic aorta.
* Subject have anatomical compliance for the device specified for both access vessels and treatment area.
* Subject must be willing to comply with the follow-up evaluation schedule.
* Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.

Exclusion Criteria:

* Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm.
* Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.
* Subjects with specified compromised circulation.
* Subjects with specified prior procedures.
* Subjects with allergy to contrast media or device components.
* Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.
* Subjects that are pregnant or planning to become pregnant during the course of the study.
The Effect of Message Framing on Blood Donation-Study 1

Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4 percent of the Han population. Therefore, low inventory is often found in blood collection and supply agencies in many regions in China. On July 18, 2018 blood stockpile of O-negative and B-negative in Guangzhou Blood Center reached the warning line, and we took measures for emergency recruitment. O-negative and B-negative blood donors whose last donation dates were between January 1, 2015 and December 31, 2017 were identified and randomly assigned to three groups. Three different recruitment text messages were send to these groups respectively. At the same time, A-negative and AB-negative blood donors were marked as control group. We observed the re-donation rates among four groups within three months.


Eligibility Criteria:
Inclusion Criteria:

* Rh- negative blood donors whose last donations were between January 1, 2015 and December 31, 2017.

Exclusion Criteria:

* Donors with an obviously invalid phone number. Donors whose serological results of the last donation were positive.
Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures

Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter.

Prospective, single-center, non-randomized, open label, single arm study. Ten consented subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure) and post procedure follow up. All subjects will have a follow up visit within 24 hours post procedure.

All procedures will be performed under standard fluoroscopic guidance for the treatment of atrial flutter ablation procedure, and the D700 system will be used additionally to demonstrate system safety, feasibility and usability.

The entire procedure will be conducted as customary, using standard and approved off- the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the D700 system that will merely be a 'silent witness'. The operator will neither use nor rely on any of the D700 system output for clinical decision making.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures.
3. Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
4. Subject is generally in good health.
5. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
6. Subject is deemed amenable to therapeutic ablation for atrial flutter.

Exclusion Criteria:

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
3. Patient had experienced previous stroke (TIA or CVA).
4. Patient has a pacemaker.
5. Thrombi detected in the heart.
6. Known marked valvar insufficiency.
7. Life expectancy less than 12 months.
8. Known severe renal insufficiency.
The Timing of Prophylactic Antibiotics in Cesarean Section and the Risk of Post-operative Febrile Morbidity

The purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. The specific aim of the project is to test the hypothesis that preoperative antibiotic administration will decrease the rate of composite postoperative febrile morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 36 weeks
* Ability to understand requirements of the study
* Elective/non-emergent cesarean section selected as route of delivery by treating physicians

Exclusion Criteria:

* Known fetal anomaly
* Exposure to antibiotics within 7 days of admission, including intrapartum group B streptococcal (GBS) prophylaxis
* Emergent cesarean delivery (i.e. for fetal distress, maternal distress, obstetric hemorrhage)
* Overt maternal intrapartum infection requiring antibiotics
* Prolonged rupture of membranes (\>18 hours)
Evaluation of Efficacy of Intraligamentary Anesthesia for Mandibular Molar Extractions

Dental extraction is the most common procedure undertaken in the department of Oral Surgery, inferior alveolar nerve block (IANB), till today, is the most commonly used local anaesthesia technique for extraction of lower posterior teeth. The anatomical complexity of this technique carries the risk of anaesthetic failures necessitating repeated needle penetrations and hence a painful experience for the patient. In addition, IANB technique, many times, becomes impossible to perform in fearful adult and paediatric patients, those with restricted mouth opening or intellectual disability. Certain coagulation defects are a contraindication to administration of IANB due to its depth of penetration into the tissues that may lead to fatal consequences in case of uncontrolled bleeding. Because of these shortcomings of IANB, there is always a need for alternative anaesthesia techniques that are less painful and carry lesser risks.

Anaesthetic injection into the Periodontal ligament space (space between tooth root surface and the bone forming the socket wall) as an alternative to IANB have been tested by many researchers with varying results. The expected advantages of this technique are reduced pain on injection, shorter duration of anaesthesia that prevents inadvertent lips and cheek biting after completion of the procedure. It is expected to be easier to perform in cases of restricted mouth opening and uncooperative patients due to any reason and carry lesser risk of bleeding within tissues.

The objective of our study is to evaluate the efficacy of Intra-ligamentary injection for posterior mandibular molar extraction as an alternative to inferior alveolar nerve block (IANB) so that it can be used in cases where IANB is either difficult to perform or not indicated.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* Both genders.
* Teeth selection: Mandibular first and second molars needing extraction under local anaesthesia.
* Healthy patients or those with well controlled systemic disease.
* Patients consenting to participate in the study.

Exclusion criteria:

* Patients younger than 18 years.
* Mandibular third molars, acutely inflamed or infected first and second molars.
* Pregnant patients and those with poorly controlled systemic disease.
* Mentally handicapped patients.
* Patients not consenting to participate in the study.
Post-Stroke Osteopathy

The sudden biomechanical inactivation, direct neuro-humoral effects and sustained systemic stress reaction, which commonly occur after stroke or TIA, all may be of relevance in triggering alterations in bone metabolism and remodelling of bone microstructure.

The objectives of this observational pilot study are to characterize falls and fractures and their circumstances (sex and age specific incidence, time course, risk conditions, localization) in ischemic stroke patients, study changes in the bone microstructure after ischemic stroke supported by high-resolution peripheral quantitative Computer Tomography, unravel a molecular mechanisms underlying the increased fracture risk (focus on Wnt-signaling and ß-adrenergic projection), establish risk factors to estimate the risk of falls based on information from gait analysis as well as construct deep learning algorithms to identify bone microstructure parameters for predicting fractures.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion in the STROKE-CARD Registry Study
* Modified Rankin Scale (mRS) \< 5
* Provision of signed and dated informed consent form
* Willingness to comply with all study procedures and ability to participate in the study over the complete study duration

Exclusion Criteria:

* Persistent motor deficit before the onset event
* Not able to walk without walking aid or not able to put the full bodyweight on either leg before the onset event
* Medical history of stroke
* Premedication with Corticosteroids for more than 6 Weeks or Pioglitazone or Bisphosphonate within the last 12 months
* Limb amputation
* BMI \< 18,5 kg/m2 or \> 35 kg/m2
* Present or previous fracture in the distal Radius or Tibia interfering with HR-pQCT
* Movement disorder interfering with HR-pQCT imaging
* Women of childbearing potential
Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship

The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit.

Background: The growing antimicrobial resistance in bacterial pathogens represents a severe public health problem. Isolation of Escherichia coli ESBL has been identified more frequently over the years due to the worldwide dissemination of strains with this phenotypic profile. The ICU has a fully functioning Antimicrobial Stewardship team, with data managed daily. Thus, the investigators identified increasing E. coli ESBL isolates resistant to standard empiric antimicrobial therapy in community-based severe infections.

Purpose: The choice of empirical antimicrobial therapy is an increasingly present challenge in clinical practice, often determining the outcome of critically ill patients. As this is a highly relevant topic in managing this patient profile, antimicrobial stewardship protocols are essential in health services, enabling continuous community monitoring of emerging resistance profiles. The justification for this study is based on the possibility of adding knowledge on the topic, aiming to add to the global theoretical collection and alert about the locoregional occurrence of changes in the bacterial resistance profile.

Objectives: The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the ICU.

Eligibility Criteria:
Inclusion Criteria:

* All 18 years and old patients admitted to the ICU
* Positive cultures for E. coli
* Any sample collected within 48 hours of hospital admission

Exclusion Criteria:

* Lack of necessary data