cyrilzakka/clinical-trials huggingface dataset:
The Impact of Premorbid Illnesses on the Risk of ICU Admission and Short-term Outcome

The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring intensive care unit (ICU) -care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish adult respiratory distress syndrome (ARDS) -cohort.

The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring ICU-care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish ARDS-cohort.

Eligibility Criteria:
Inclusion Criteria:

° Individual registered in the Swedish intensive care registry (SIR) with COVID-19 Before 27 May 2020.

or

* Individual registered in the SIR with Severe sepsis or septic chock 2011-2016. or
* Individual registered in the SIR with ARDS 2011-2016.

Exclusion Criteria:

* Age below 18 years
* Individual registered in the Swedish intensive care registry without a personal identification number
Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency

Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Prescriptional pattern of these drugs will be analyzed in a clinical cohort.

Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Little attention has been given to the indications and dosage schedules of such drugs, many of which are employed as off-label prescriptions because of lack of official guidelines.

Prescriptional patterns of these drugs will be analyzed in a clinical cohort of home parenteral/enteral nutrition patients, registered at the outpatient service of Hospital das Clinicas, Sao Paulo, Brazil.

Eligibility Criteria:
Inclusion Criteria: Home nutritional support longer than 12 months,full records and return visits available at the hospital system.

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Exclusion Criteria: Critical illness, death, discontinuation of nutritional therapy, registered for intestinal transplantation, additional gastrointestinal operations for short bowel syndrome (valves, lengthening) or for other conditions (gallbladder disease, intestinal obstruction, necrosis, infection).

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Behavioral Indicators of Pain Representation

The goal of this observational study is to compare the postural response to the mental simulation of everyday situations identified as painful in participants with non-specific low back pain and healthy volunteers.

The main questions it aims to answer are :

Do participants with low-back pain show reduced variability in center of pressure displacements compared with non-painful participants when faced with mental simulation of everyday situations identified as painful? Is the postural response correlated with the level of kinesiophobia? Participants will be faced to pictures of everyday situations identified as painful while several physiological measurements (posturography, electromyography, heart rate) are being recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55
* Non-specific chronic low back pain for the concerned group

Exclusion Criteria:

* Low back pain for 0 to 3 months
* Unable to stand 1 minute without technical aid
* Neurological, motor or cognitive know impairment
* BMI \> 30
Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020)

Objective :

Anorectal malformations (ARMs) are part of a spectrum of malformations due to an abnormal separation between the urogenital and digestive tracts during embryonic life. The prevalence of ARM is 1/2000 - 1/5000 live births, making it a relatively common malformation.

The impact of an ARM depends mainly on the type of malformation, which can be difficult to evaluate in the antenatal period, and whether it is isolated or associated (50-80%) with other malformations or genetic syndromes. Only 1 to 16% of ARMs are diagnosed in the antenatal period.

The objective of this study is to compare cases of prenatal diagnosis of ARM, cases of postnatal diagnosis of ARM with other antenatal ultrasound abnormalities, and those with normal antenatal ultrasound, in terms of management and functional prognosis, to identify ways to improve prenatal counseling.

Materials and methods :

In this retrospective monocentric study, the investigators have included all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier. The Krickenbeck classification was used to classify the ARMs and to assess the functional prognosis.


Eligibility Criteria:
Inclusion criteria:

* fetuses and newborns born between January 2010 and September 2020 with anorectal malformations
* diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier.

Exclusion criteria:

* foreign-born patient
* anorectal malformation associated with an abdominal wall defect
Correlation of Non Invasive Hemoglobin Measurement With Laboratory Hemoglobin Measurement in Living Liver Donors

Pulse CO-Oximetry (Masimo Corp, Irvine, CA, USA) is a method that allows non-invasive continuous hemoglobin (Hb) measurement. This technology measures continuous Hb with a multi-wavelength spectrophotometric fingertip sensor.

Aim of investigators in this study is to make continuous Hb measurement with Pulse CO-Oximetry method in living liver donors, to compare these measurements with the laboratory results routinely taken during the operation, to determine the level of correlation for this patient group.

Continuous Hb measurement with Pulse CO-Oximetry (SpHb) can be usefull for living liver donor and improve the quality of intraoperative care. This technology measures continuous Hb with a multi-wavelength spectrophotometric fingertip sensor.

The perfusion index (PI) is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. Perfusion Index thus represents a noninvasive measure of peripheral perfusion that can be continuously and noninvasively obtained from a pulse oximeter. Changes in PI can also occur as a result of local vasoconstriction (decrease in PI) or vasodilatation (increase in PI) in the skin at the monitoring site. These changes occur with changes in the volumeof oxygenated bloodflow in the skin microvasculature. PI values can change due to surgical process and may affect SpHb measurement.

Aim of investigators in this study is to make continuous Hb measurement with Pulse CO-Oximetry method in living liver donors before and after surgery incision, to compare these measurements with the laboratory results routinely taken during the operation, to determine the level of correlation for this patient group.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing hepatectomy with general anesthesia

Exclusion Criteria:

* Patient's lack of consent, essential data missing, patient participating in other research projects, drug allergy, anesthetic complication story, excessive surgical bleeding, presence of disease that impairs peripheral circulation, use of vasoactive agents.
Mobile Integrated Care for Childhood Obesity

The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.

Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months.

The other group will be in our Healthy Lifestyle program for 6 months. This will include:

* Check-ins with lifestyle specialists and community health workers,
* A mobile app to help support a healthy lifestyle, and
* Access to community programs and activities.

The main questions the study aims to answer are:

* Do children in the Healthy Lifestyle program have better weight outcomes?
* Do more families in the Healthy Lifestyle program stay in the study?
* Does the Healthy Lifestyle program work better for families from certain communities?


Eligibility Criteria:
Caregiver and child dyads will be enrolled

Inclusion Criteria:

* Child 4-12 years of age
* Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro
* Child has a BMI ≥ 95% for age and sex
* Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)

Exclusion Criteria:

* Caregiver not child's legal guardian
* Caregiver not proficient in English or Spanish
* Caregiver does not have a device and reliable internet
* Child has a genetic syndrome or endocrine disorder that predisposes to obesity
* Child is on a medication that impacts weight
* Child is already enrolled in a weight management program
A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers

This study will estimate how fast two antiepileptic drugs (Levetiracetam and Brivaracetam) enter the human brain. Brain imaging will be used to measure how quickly the radioactive probe \[11C\]UCB-J exits the brain when Levetiracetam or Brivaracetam are given. This will be used to estimate how fast the antiepileptic drugs enter the brain.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Subject is male or female and between 18 to 55 years of age (inclusive)
* Subject is in good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history, physical and neurological examinations, vital signs, 12-lead Electrocardiography (ECG), and clinical laboratory tests
* Female subjects of childbearing potential must have a negative pregnancy test; female subjects of childbearing potential have to confirm that, for 1 month prior to the first administration of the study medication and during the entire study until the Safety Follow-Up (SFU) Visit she will either use a highly effective contraceptive method (eg, oral contraception, intrauterine device, diaphragm with spermicide) or abstain from sexual activity that can cause pregnancy

Exclusion Criteria:

Exclusion Criteria:

* History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, pancreatic, hematological, cardiovascular, musculoskeletal, genitourinary, immunological, or dermatological disorders, or any type of cancer
* Subject has a history of a neurological diagnosis, including but not limited to stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, or any other neurological disorder that may influence the outcome or analysis of the scan results
* History of donation of more than 450 mL of blood within 60 days prior to dosing in the Yale PET center or planned donation before 30 days has elapsed since intake of study drug
* The subject has Magnetic Resonance Imaging -incompatible (MRI - incompatible) implants and other contraindications for MRI, such as a pacemaker, artificial joints, non-removable body piercings, etc.
* Subjects who have received a diagnostic or therapeutic radiopharmaceutical less than 7 days prior to participation in this study
* Participation in other recent research studies \< 1 month or \< 1 year for studies involving ionizing radiation that would cause the subject to exceed the yearly dose limits for healthy volunteers
REM Sleep and Dreaming- a Case Study

a case study of a man with a unique condition that negatively affects his sleep architecture. we want to study this man's sleep and see (through interviews) how his condition affects his ability to dream


Eligibility Criteria:
Inclusion Criteria:

- one patient- not relevant

Exclusion Criteria:

-

one patient- not relevant
Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor

This research will determine 1) whether the very weak pelvic floor can be improved with surface electromyography (s-EMG)-triggered electrostimulation added to pelvic floor muscle training and 2) whether sEMG-triggered electrostimulation added to pelvic floor muscle training can reduce leakage in Stress Urinary Incontinence (SUI)

Among women with pelvic floor dysfunction, it has long been known that PFM training is the first-line therapy for stress incontinence. One of the difficulties that clinicians often find upon examination is that many women present a very weak pelvic floor and are unable to contract their PFM. There is overwhelming evidence to show that conservative treatment in the form of pelvic muscle exercises (and to a lesser degree, electrotherapy, and vaginal weight therapy) is effective in the treatment of stress urinary incontinence. To date, there is some evidence to support the use of electrical stimulation for stress urinary incontinence in women, but we are still very uncertain about the full potential of this treatment because of the low quality of the existing evidence.

Eligibility Criteria:
Inclusion Criteria:

* • Adult women (18 years old - 50 years old), with a Modified Oxford Score, determined by digital palpation, of 0 - 1, complaining leakage episode occurring more than once a week.

  * Between six and eighteen months after childbirth
  * Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
  * Willing and able to undergo an extensive physical function evaluation

Exclusion Criteria:

* • pregnancy

  * severe neurological disease (Multiple Sclerosis, Parkinson's disease, spinal cord injury, major stroke or neuromuscular junction diseases)
  * previous operation for cancer or radiotherapy in the lower abdomen
  * Prior surgical intervention for urinary incontinence within the past 12 months
  * Hysterectomy within 12 months
  * voiding dysfunction
  * pelvic pain
  * severe prolapse (≥ grade 3)
  * recurrent urinary tract infection
  * pelvic or disseminated malignancies
  * women who were virgo intacta
  * women who declined vaginal examinations for any reasons
  * before four months of pregnancy
  * Having significant cognitive impairment or dementia
  * Unsafe to exercise (severe cardiopulmonary disease)
  * Unable/unwilling to provide informed consent
  * Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
Limiting IV Chloride to Reduce AKI After Cardiac Surgery

This primary aim of this study is to test the impact of a strategy of perioperative chloride-restriction through intravenous (IV) fluid therapy on the incidence of acute kidney injury after cardiac surgery.

A prospective, open-label, single-centre 4-period sequential study of varying strategies of perioperative IV fluid composition will test the hypothesis that a perioperative protocol for the administration of chloride-poor intravenous fluids compared to chloride-rich intravenous fluids will reduce the incidence of AKI after adult cardiothoracic surgery.

After an initial run-in period of approximately 1 month (using a chloride-rich fluid strategy), the first study period of 5 months will commence, also comprising a chloride-rich perioperative IV fluid therapy strategy (0.9% saline or 4% albumin). This will include intraoperative fluid and postoperative fluid for the duration of stay in the intensive care unit. This will then be followed by a 1-month transition period before a second period of 5 months will commence where perioperative intravenous fluid therapy will consist of chloride-poor fluids (Lactated Ringer's solution or concentrated 20% albumin). A subsequent 1-month transition period will then be followed by a third period of 5 months characterized by perioperative IV fluid therapy with an alternative combination of chloride-poor solutions (PlasmaLyte® 148 or concentrated 20% albumin). A final 1-month transition period will be followed by a fourth and final period of 5 months characterized by a return to perioperative IV fluid therapy with chloride-rich fluids (0.9% saline or 4% albumin). A final 1-month run-off period using a chloride-rich perioperative fluid strategy will follow prior to study completion.

Eligibility Criteria:
Inclusion Criteria:

All adult patients undergoing surgery by Division of cardiothoracic surgery

Exclusion Criteria:

Nil
Relevance of Gastric Aspirate in HCMV Detection

Human cytomegalovirus (CMV) is the leading cause of neonatal viral infection and can have a significant impact on the neurosensory development of newborns and especially premature infants. CMV infection can result from materno-fetal transmission during pregnancy (congenital infection) or postnatal transmission. The prevalence of congenital CMV infection in the newborn is estimated to be between 0.1 and 0.5%. Among the newborns in utero infected by CMV, it is estimated that 10-15% will present symptoms at birth (hypoacousia / unilateral or bilateral deafness, microcephaly, chorioretinitis, psychomotor retardation, etc.) and 0.5% of them will die. 20% of infected infants, mainly symptomatic newborns, suffer permanent sequelae, mainly loss of hearing. Many asymptomatic children at birth will present hearing loss and other delayed neurological complications. A progressive neurosensory hearing loss may develop for 13-15% of asymptomatic newborns at birth. Deafness is bilateral in 50% of cases, severe in more than 50% of cases, and its occurrence is often delayed. The hearing loss has a significant impact on the future life of the child, mainly on language acquisition and school performance.

A systematic CMV screening is not currently recommended at birth due to the frequency of asymptomatic forms, difficulty in fetal diagnosis and prognosis, lack of consensus for preventive and curative treatment of the infection. New treatments are being evaluated and encouraging results could revive the debate.

PCR from urine is the gold standard for the diagnosis of CMV infection. Urine collection is not systematic in newborns and its realization can sometimes be difficult. On the other hand, in children at risk (hypotrophy, prematurity, infectious risks, fetal distress or respiratory distress at birth), gastric aspiration is systematically performed at birth to overcome obstruction of the upper aero-digestive tract, to prevent oesophageal atresia, to avoid inhalation by reflux and sometimes to make a bacteriological diagnosis.

Our hypothesis is that this liquid could be used for the detection of CMV infection without adding any invasive action in newborns. Ultimately, gastric aspirate could allow for routine CMV screening in children at risk and thus allow for appropriate care by nursing staff.The occurrence of immediate or delayed sensory sequelae in these children would be then limited.


Eligibility Criteria:
Inclusion Criteria of the newborn:

- Child born in maternity and / or child hospitalized in the Neonatal Médicine Department of the University Hospital of Besançon for which a urine sample (minimum volume = 0.5 mL) and a gastric aspiration fluid sample (minimum volume = 0.7mL) were collected (regardless of gender, birth weight or pathology presented at admission).

Exclusion Criteria of the newborn:

* Child died before the sampling
* A volume of gastric aspiration fluid dedicated to the study less than 0.7 mL.
* An impossible collection of urine (malformation, skin irritation of the perineum, contamination with meconium).