cyrilzakka/clinical-trials huggingface dataset:
Staph Household Intervention for Eradication (SHINE)

The investigators propose a pragmatic comparative effectiveness trial evaluating several decolonization strategies in patients with Staphylococcus aureus infection, their household contacts, and household environmental surfaces. The central hypothesis of this proposal is that an integrated approach of periodic personal and household environmental hygiene will reduce S. aureus transmission in households and subsequently decrease the incidence of skin and soft tissue infections (SSTI).

Patients with active or recent S. aureus SSTI will be recruited from St. Louis Children's Hospital and community pediatric practices affiliated with the investigators practice-based research network. All participants (index patients and their household contacts) will perform a baseline S. aureus decolonization protocol for 5 days consisting of enhanced hygiene measures, application of mupirocin antibiotic ointment to the anterior nares twice daily, and daily body washes with chlorhexidine antiseptic. Following the 5-day baseline decolonization regimen, households will be randomized to one of three intervention groups: 1) Periodic personal decolonization performed by all household members, to include chlorhexidine body washes twice weekly for 3 months and application of intranasal mupirocin for 5 consecutive days each month for 3 months; 2) Household environmental hygiene, including targeted cleaning of household surfaces and laundering of bed linens, weekly for 3 months; and 3) Integrated periodic personal decolonization and household environmental hygiene for 3 months. Households will be followed prospectively (1, 3, 6, and 9 months following randomization) to measure the prevalence of S. aureus colonization in the participants, household environmental surfaces, and pet dogs and cats and to document the incidence of recurrent SSTI. Molecular strain typing will be performed on all recovered S. aureus isolates to illuminate transmission dynamics and the effects of the decolonization measures on genetic epidemiology. Lastly, the investigators will assess resistance to the prescribed topical antimicrobials at baseline and longitudinal samplings.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and younger
* Confirmed (i.e., culture-positive) active or recent (within the past 2 months) S. aureus cutaneous infections
* Reside within 75 miles of St. Louis Children's Hospital
* Provide written, informed consent, or consent is provided by a parent or legal guardian

Exclusion Criteria:

* Patients with nosocomial infections (i.e., \>48 hours after hospitalization)
* Patients with traditional risk factors for HA-MRSA (e.g., immunodeficiency, indwelling catheter or percutaneous medical device, undergoing dialysis, presenting with a surgical site infection, or residing in a long-term care facility within the past year).
* Patients who are unable to give consent or for whom consent is not obtained
* Patients refusing home environmental cultures by the study team
* Patients without a permanent home (e.g., living in a shelter or group home)
Severe and Cerebral Malaria Investigated Through Host Metabolomics

* The aim is to describe disease mechanisms of severe and cerebral malaria and identify new targets for adjunctive therapies.
* Despite treatment between 10-30% of patients with severe malaria die.
* Metabolic acidosis and cerebral malaria are major complications associated with mortality across all age groups. Still, their underlying pathogenesis remains incompletely understood.
* Using a metabolomics approach, this study aims to characterise the spectrum of acids accumulating during acidosis, and investigate patterns of metabolic dysregulation associated with coma and seizures.


Eligibility Criteria:
Severe/Cerebral Malaria:

* Any P. falciparum parasitaemia detected by asexual stages on a peripheral blood-slide or a positive rapid diagnostic test in combination with one or more Modified WHO Criteria for Severe Malaria (Hien et al, 1996)
* \< 24 hours after treatment commencement with either parenteral artemisinin or quinine
* Age \> 12 years
* Full informed written consent obtained

Uncomplicated malaria:

* Any level of Plasmodium parasitaemia, detected by asexual stages on a peripheral blood-slide or a positive rapid diagnostic test without any of the complications of severe malaria stated above.
* Age \> 12 years
* Full informed written consent obtained

Sepsis:

* Clinical signs of infection in combination with any two of the following signs:

  1. Heart rate \> 90 beats per minute;
  2. Respiratory rate \> 20 breaths per minute, a PaCO2 of \< 32 mmHg, or the use of mechanical ventilation for an acute respiratory process;
  3. Tympanic temperature \> 38°C or \< 36 °C;
  4. White-cell count of \> 12x109/L or \< 4x109/L, or a differential count showing 10% immature neutrophils ;
* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria
* \[As bacterial culture is not routinely available at the study site, positivity of cultures is not required\]
* Age \> 12 years
* Full informed written consent obtained

Acidosis:

* Clinical suspicion of metabolic acidosis in combination with any of the following:

  1. Peripheral venous bicarbonate \< 15 mmol/L
  2. Peripheral venous base excess \< -3 mmol/L
* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria; and not meeting any of the inclusion criteria for sepsis as stated above.
* Age \> 12 years
* Full informed written consent obtained

Encephalitis:

* GCS \< 11/15
* Documented fever \> 38°C
* Onset of symptoms \< 2 weeks, with an indication a lumbar puncture as part of the diagnostic work up
* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria
* Age \> 12 years
* Full informed written consent obtained

Healthy volunteers:

* No chronic or acute disease
* No fever in the past 2 weeks
* Age \> 16 years
* Full informed written consent obtained

Exclusion Criteria:

* Known pre-existing chronic medical conditions including advanced hepatic disease.
Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

The study will recruit and follow up patients for five years patients newly diagnosed with congenital heart disease associated pulmonary arterial hypertension(CHD-PAH) from the investigator's hospital. The main aim of the study is to describe the aetiology, natural history and management practices of CHD-PAH in central China.

baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart.

Lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases.

Right heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests

main outcome measure include:

death heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of \>15% from baseline in 6MWD (or \>30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）

Eligibility Criteria:
Inclusion Criteria:

-Clinical diagnosis of CHD-PAH (by RHC)

Exclusion Criteria:

* PAH due to other criteria;
* unable to participate
UGT1A1 Genotyping in Taiwanese Cancer Patients

Irinotecan is commonly used to treat lung, colorectal, pancreatic, stomach, esophageal, and other types of cancer. The main metabolic pathway of SN-38, the active product of Irinotecan, is grape glycoalkaloid acidification by UDP - glucuronosyltransferase (UGT1A1) and then excreted through bile and urine. Clinically, Irinotecan treatment can cause many adverse reactions, and differences in UGT1A1 genotypes can lead to structural changes or functional defects in enzymes, causing reduced acidification of grape glycolaldehyde, and increasing Irinotecan side effects. Therefore, if the patient's ability to metabolize the drug can be assessed before taking the drug, it will be of great help in treatment.

Until 2021, cancer will remain the top ten causes of death in Taiwan, of which colorectal and pancreatic cancer rank third and seventh among the top ten cancers in Taiwan, respectively, and these two cancers often use complex chemotherapy including irinotecan. Routine detection of UGT1A1 genotype in patients with colorectal and pancreatic cancer before irinotecan treatment predicts the drug metabolism capacity of irinotecan and adjusts the dose, allowing patients receiving irinotecan to reduce the harm of side effects. At present, the UGT1A1 genotype evaluated is usually only UGT1A1\*28, but the common UGT1A1 genotype in Taiwan also has UGT1A1\*6 and UG1A1\*63, etc. There is no literature on Taiwanese cancer patients with actual irinotecan chemotherapy, so this study aims to explore the influence of the UGT1A1 genotype and develop other UGT1A1 genotype test methods. It is expected that molecular testing tools can improve cancer precision medicine and provide personalized medicine.


Eligibility Criteria:
Inclusion Criteria:

Colorectal or pancreatic cancer patients.

Exclusion Criteria:

Age less than 20 or greater than 90.
Research on the Relationship Between Cognitive Function Changes and Cerebrovascular Health in Patients With Coronary Heart Disease

The purpose of this study is to elucidate the imaging mechanisms of cognitive function changes in patients with coronary heart disease before and after surgery or conservative treatment, and to evaluate and predict the postoperative neurological function recovery and cerebrovascular health level of patients by combining serum markers and patient cardiovascular health evaluation indicators.

The focus of this study is to elucidate the impact of coronary heart disease on the morphology and cognitive changes of cerebral blood vessels in patients. Record imaging data, neuropsychological cognitive scales, serum markers, adverse cardiac events, and patient evaluation indicators before and after clinical treatment and follow-up period, and explore relevant factors affecting changes in cerebrovascular morphology and cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed coronary heart disease or risk of coronary heart disease through clinical testing
* Conscious and capable of completing neuropsychological scales

Exclusion Criteria:

* Patients with other serious heart diseases (such as aortic aneurysm)
* People with uncontrolled hypertension or diabetes
* There are contraindications to MRI examination (there are metal implants in the body, such as cardiac pacemakers, metal dentures, artificial joints, non paramagnetism stents, etc.; there is claustrophobia)
* Have a history of severe stroke, epilepsy, traumatic brain injury, and transient ischemic events
* Existence of neurological and mental disorders (schizophrenia, depression, etc.), post-traumatic stress disorder, obsessive-compulsive disorder, multiple sclerosis, amyotrophic lateral sclerosis, etc
* Have a history of alcohol or drug abuse
* Those with significant organ dysfunction such as lung, liver, and kidney;
* Patients with tumor, infectious diseases, blood system disease and immune system disease;
* Currently participating in other clinical studies at the same time.
Early Prophylaxis Immunologic Challenge (EPIC) Study

The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype (ie, joint bleeding), together with the minimization of immunological danger signals, can reduce the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Participants with severe and moderately severe hemophilia A (FVIII ≤ 2%)
* Participants \< 1 year of age
* Participants must have ≤ 3 exposure days (EDs) to any FVIII concentrate or FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more than 2 infusions per event), or for preventative or precautionary infusions following possible injury
* Participants with prior circumcision are allowed to enroll only if bleeding issues related to circumcision were the cause for the original diagnosis of hemophilia A and no more than 2 EDs of FVIII treatment were required
* Adequate venous access (without need for central venous access device (CVAD)-placement) as determined by the physician
* Written informed consent from legally authorized representative(s)

Exclusion Criteria:

* Life-threatening conditions (intracranial hemorrhage, severe trauma) or requirement for surgery at the time of enrollment
* Evidence of inhibitor ≥ 0.6 Bethesda Unit (BU) in Nijmegen-modified Bethesda Assay at study start (samples may be retested using lupus-insensitive inhibitor tests to reduce the number of false positive inhibitor test results)
* Inherited or acquired hemostatic defect other than hemophilia A
* Any clinically significant, chronic disease other than hemophilia A
* Known hypersensitivity to ADVATE or any of its constituents
* Any planned elective surgery that cannot be postponed until after the first 20 EDs
* Participation in the Hemophilia Inhibitor Previously Untreated Patient Study
* Application of red blood cell, platelet, or leukocyte concentrates, or plasma
* Administration of any medication affecting coagulation or platelet function
* Systemic administration of any immunomodulatory drug (eg, chemotherapy, intravenous glucocorticoids)
* Participation in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or during the course of this study
Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial

Spina Bifida is a developmental congenital disorder caused by the incomplete closing of the embryonic neural tube, leading to serious malformations of the nervous system. Caudal neuropore malformations almost always lead to sensory-motor deficits (including complete paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere).

The purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.

Sphincter dysfunctions impair the quality of life and patients' self-esteem. However, defecation disorders are important issues the Spina Bifida National Reference Center has to deal with. Indeed, more than half of patients are concerned. These disorders are mainly due to fecal stasis. Treatments include laxatives and hygiene recommendations. Colonic irrigation can also be useful, especially to achieve colonic vacuity and improve continence. The use of intra-rectal balloon inflation probes and the control of instillation flow improved retrograde colonic irrigation efficacy. Nevertheless, this technique is currently not evaluated in young adults suffering from Spina Bifida functional digestive sequelae, who are mainly concerned by Malone enema.

The purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.

Eligibility Criteria:
Inclusion Criteria:

* Patients aging at least 15 years old with Spina Bifida neurological pelvi-perineal sequelae, objected by neurologic exam , functional urinary and/or anorectal and/or neurophysiological data,
* Patients with NBD score above 9,
* Written and informed consent (Minor children may be included with the consent of the two parents).

Exclusion Criteria:

* Patients with psychiatric disorders, cognitive or intellectual disabilities compromising the assessment of primary outcome measure,
* Patients using currently irrigation colonic technique,
* Patients with functional colostomy, known anal or colorectal stenosis, colorectal cancer, acute or chronic inflammatory disease, recent anal or colorectal surgery for less than 3 months, polyp removal for less than 4 weeks, ischemic colitis.
* Patients with urinary trophic or orthopedic disease with planned surgery during inclusion or follow-up periods,
* Patients with progressive anal disease (suppuration, hemorrhoid or rectal prolapse)
* Patient with a hard follow-up ( judged by the investigator)
* Person involved in another clinical trial
* Pregnant women
* Person with a measure of legal protection (guardianship)
Changes in Cerebral Blood Flow With Spinal Manipulative Therapy vs. Voluntary Motion

The investigators are performing a study to determine whether changes in blood flow occur in the neck and back of the brain following a series of head positions and a manipulation of the upper neck. Each participant will be asked to undergo a series of MRI's to evaluate whether there are any changes in blood flow resulting from any of the head positions or manipulation. The study will be conducted over a period of 1 day and each participant can anticipate the testing to take approximately 120 minutes.

The goal is to further investigate the cerebrovascular hemodynamic consequences of cervical spine positions, including rotation and manipulation in-vivo under clinically relevant circumstances using two advanced forms of MRI technology on the VA and posterior cerebral vessels. According to the knowledge of the investigators, a study utilizing MRI and functional blood oxygen level dependent (fBOLD) imaging to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these vessels has yet to be conducted.

Eligibility Criteria:
Inclusion/Exclusion Criteria

1. Enrolled and matriculated as a student in the Canadian Memorial Chiropractic College.
2. Healthy asymptomatic male patients who would otherwise receive cervical manipulation on a regular basis as a part of their normal learning experience and will have had a cervical manipulation in the last 3 months.
3. Sufficient English language ability to complete study questionnaires (see appendix).
4. No history of disabling neck, arm or headache pain within the last 6 months.
5. No current or prior history of neurological symptoms including, facial or extremity weakness, abnormal sensation to the face, body or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing.
6. Subjects will have had no prior history of head trauma or prior history of surgery to the neck region.
7. No history of claustrophobia, metallic implants or tattoos to ensure compatibility with MRI requirements.
Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients

Our aim is to examine the influence of blood pressure and glycemic control together with N-acetylcystein utilization on the endothelia function of hypertensive diabetic patient.The study population will include 50 diabetic patient with uncontrolled hypertention that will be recruited from the Hypertension Clinic of Soroka University Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with uncontrolled hypertension that will be recruited from the Hypertension Clinic of Soroka University Medical Center

Exclusion Criteria:

* Pregnancy,secondary hypertention,malignancy or other serious illness
Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance

Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction. Therefore human performance of brief maximal exercise is limited, in part, by the availability of ATP to the contracting muscle. Because muscle ATP storage is small (enough to sustain maximal exercise for less than 1 second), factors that enhance either storage or resynthesis of ATP may have a positive impact on repeated muscle contractions. The current study will test the hypothesis that increasing ATP availability to muscle via oral supplementation will improve performance of repeated high intensity exercise as measured by a) work performed in each of the three 50 contraction fatigue tests, b) sum of total work performed, and c) percentage decrement in total work from the first to third third 50 contraction test.

To date we have studied 10 subjects who have followed through with all 3 of the original interventions (Placebo, 250 mg PeakATP/d and 400 mg PeakATP/d). Currently we have received approval and are expanding the study with 5 additional subjects who will receive the Placebo, 400 mg PeakATP/d and the 400 mg PealATP/d plus proprietary blend interventions.

Eligibility Criteria:
Inclusion Criteria:

* No major medical conditions;
* Able to perform fatigue testing procedures;
* Not currently taking prescription medications;
* Not currently taking dietary supplements (a daily multi-vitamin not exceeding RDA is permitted)

Exclusion Criteria:

* Major medical condition affecting metabolism or general function;
* Not able to perform fatigue testing;
* Taking prescription medications;
* Taking a dietary supplement other than a multi-vitamin not exceeding RDA
Navigating the Grey Zone for Antenatal Corticosteroids

The purpose of this study is to find out if including a decision support tool in clinical practice guidelines will improve how doctors discuss the option of antenatal corticosteroid treatment with patients who might deliver at 34 to 36 weeks of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 year or older.
* Delivered a live neonate at 34+0 to 36+6 weeks of gestation.
* Speaks English.
* Agrees to participate in the questionnaire during their first week post-partum.
* Delivered at one of the six participating obstetrical hospitals.

Exclusion Criteria:

* None.