cyrilzakka/clinical-trials huggingface dataset:
Variation of Spatiotemporal Parameters in School Children Carrying Different Backpack Loads

Backpacks (BP) represent the method most used by students to transport external cargo. Previous studies cite that between 4.7% and 38% of children carry daily BP loads greater than 20% of their body mass. The purpose of this study was to analyze spatiotemporal parameters of gait in children using varyingly loaded BPs.

This study examined 231 schoolchildren (118 boys, 113 girls) aged six to 12 years, carrying a traditional BP to manipulate loading (Crossing Backpack Children Arpenaz 7 Litres, Junior Red Quechua). The inclusion criteria were: age between six and 12 years, no pain in the lower limb and back at the time of examination. The exclusion criteria were: recent injury to the lower limb and back, alterations in the foot bones, congenital structural changes to the ankle, flatfoot associated with cerebral palsy, surgical treatment of foot or lower leg, or any genetic, neurologic or muscular conditions.

The parents were provided with information about the study, and those consenting for their children to participate, also completed a questionnaire. The children were fully informed of the procedures involved and gave assent. All procedures were in accordance with the ethical standards of the institution of University of Malaga (CEUMA 91/2016H) and with the 1964 Helsinki declaration.

Load was added to the BPs in increments of 5%, 10%, 15% and 20% of the child's body weight. Spatio-temporal parameters were measured with the OptoGait® system.

Two examiners were responsible for the system software and collecting data. General information, including height and weight, were recorded. To measure gait parameters, the protocol used for the Optogait reliability testing was used. This involved the children walking on a walkway at a comfortable speed, repeating this walk three times and calculating the mean speed. Prior to data collection, the children performed one familiarization trial for five minutes. Children were asked to walk naturally, facing forward, with their hands out of pockets; wearing light, comfortable clothes, with the BP placed correctly. As the children started walking, the researchers selected the foot of the first step inside the bars, in the Optogait software. After being instructed to 'walk slowly at a comfortable speed', the children walked from a point two metres in front of the bar and stopped at a point two metres behind the last bar, to minimize effects of acceleration and deceleration

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were: age between six and 12 years, no pain in the lower limb and back at the time of examination.

Exclusion Criteria:

* The exclusion criteria were: recent injury to the lower limb and back, alterations in the foot bones, congenital structural changes to the ankle, flatfoot associated with cerebral palsy, surgical treatment of foot or lower leg, or any genetic, neurologic or muscular conditions.
The Potential Impact of Clindamycin on Neurosurgery Patients.

A prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy to assess its effect on neurological complication in relation to Neuron-specific enolase (NSE) and Neurotensin biomarkers levels.

1. This is a prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy is prescribed (900 - 1200 mg twice daily) will be recruited from Alexandria University Main Hospital.
2. Whole blood samples will be collected for Analyses of Neuron-specific enolase (NSE) and Neurotensin will be detected by ELISA.
3. All patients will be assessed for complete blood count (CBC), kidney function, liver function, Methodology

   * Patients will be enrolled if they underwent surgery or presented with clinical signs of meningitis.
   * All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen.
   * Complete physical, laboratory, and radiological assessment will be done for all patients
   * All patients will be followed up during 2 weeks period.
   * Serum samples will be collected for measuring the biomarkers.

Eligibility Criteria:
Inclusion criteria

1) Adult patients will be enrolled if they underwent neurosurgery or presented with clinical signs of meningitis.

Exclusion criteria

1. Age lower than 18.
2. Females with a positive pregnancy test.
3. Known congestive heart failure or ischemic heart disease.
4. Any injury that disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias).
5. Severe brain disease (For example CVA history or brain tumor).
6. Renal failure with GFR lower than 60 ml/min.
7. Patients with unknown identity.
Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.

Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems.

To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics.

The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.

The study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and SenSura). Each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. The participants will visit the study investigator at study start and at cross-over. Evaluation of the test products will occur via questionnaires the subjects fill in at home.

50 healthy subjects with a colostomy will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Be able to handle the bags themselves (application, removal)
* Have a colostomy with a diameter less than 45 mm
* Have had a colostomy for at least 3 months
* Currently use a 1-piece flat ostomy appliance with closed bag
* is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)
* Use minimum 1 product per day
* Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days
* Have the mental capacity to understand the study and questionnaires

Exclusion Criteria:

* Use irrigation during the study (flush the stoma with water).
* Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
* Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
* Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
* Are pregnant or breastfeeding
The Iguratimod Effect on Lupus Nephritis (IGeLU)

This study is a 52-week, randomized, open, active-controlled trial of patients with active diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed with azathioprine, both combined with steroids.


Eligibility Criteria:
Inclusion Criteria:

* Active lupus nephritis:

  * Fulfill ACR classification criteria (2009) for SLE
  * Proteinuria ≥1g/24h at screening
  * Nephritis of class III, IV, V, III+IV or IV+V, confirmed by renal pathology within 90 days prior to screening
* Body weight ≥40kg
* SLE-2K score ≥8
* Agreement of contraception
* Informed consent obtained

Exclusion Criteria:

* Active severe SLE-driven renal disease or unstable renal disease at screening
* Active severe or unstable neuropsychiatric SLE
* Clinically significant active infection including ongoing and chronic infections
* History of receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil or rituximab treatment with 90 days prior to screening
* History of human immunodeficiency virus (HIV)
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C
* Active tuberculosis
* Live or attenuated vaccine within 4 weeks prior to screening
* Subjects with significant hematologic abnormalities
* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
* History of peptic ulcer or GI bleeding; treatment with warfarin or other anticoagulants within last 14 days
Early Detection of Anastomotic Leakage by Microdialysis Catheters

Anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death. Microdialysis catheters can detect focal inflammation and ischemia, and has a potential for early detection of anastomotic leakage. This observational study will examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.

Pancreaticoduodenectomy (Whipple´s procedure) offers the only potential cure for patients with tumor in the head of the pancreas, bile duct or periampullary region. This procedure is associated with high perioperative and postoperative mortality and morbidity. Postoperative pancreatic fistulae (POPF) is the most feared complication, and is often discovered with significant delay resulting in development of organ dysfunction and sepsis. Current standard for clinical detection of POPF is limited and nonspecific.

Microdialysis catheters allow bedside measurements of metabolism such as lactate, pyruvate, glucose and glycerol. The method has a high sensitivity and specificity in detecting complications in several types of abdominal surgery. However, microdialysis used after pancreaticoduodenectomy is not well documented. This observational study examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Tumor in the head of the pancreas, the bile duct or the duodenum detected on a computed tomography (CT) scan or magnetic resonance imaging (MRI), and evaluated by a multidisciplinary team to be resectable with a pancreaticoduodenectomy.
* Written informed consent was obtained before study enrollment.

Exclusion Criteria:

* \<18 years
* patient with tumor which was not resectable
Efficacy and Safety of Midostaurin in Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia

The purpose of this study was to determine the efficacy and safety of twice daily (bid) oral midostaurin in patients with Aggressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) with or without an Associated Hematological clonal Non-Mast cell lineage Disease (AHNMD).


Eligibility Criteria:
Key inclusion criteria:

* Patients ≥ 18 years of age who provided written informed consent, Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 and a life expectancy of \>12 weeks, electrocardiogram with a QTcF of ≤ 450 ms, with a diagnosis of SM and sub-variants based on WHO criteria.
* Patients with ASM or MCL were to have one or more measurable clinical findings (termed "C-findings") and defined as those attributable to the mast cell disease component and not to AHNMD or any other cause.
* Patients with MCL were to have BM aspirate smears with ≥ 20% immature MCs. Patients with AHNMD were eligible if it was not life-threatening or in an acute stage.

Key exclusion criteria:

* Patients with cardiovascular disease including congestive heart failure class III or IV according to the New York Heart Association classification, left ventricular ejection fraction (LVEF) of \<50%, myocardial infarction within the previous 6 months, or poorly controlled hypertension.
* Patients with a heart block of any degree at screening (for Canada only).
* Patients with an AHNMD who required immediate cytoreductive therapy or targeted therapy (other than midostaurin).
* Patients who had demonstrated relapse after 3 or more prior regimens of SM treatment regardless of treatment regimen for supportive care (e.g., symptom-limiting therapies).
* Patients who had received any investigational agent, targeted therapy, chemotherapy, interferon-α, or 2 chlorodeoxyadenosine within 30 days prior to start of midostaurin treatment.
* Patients who had ASM with eosinophilia and known positivity for the FIP1L1- PDGFRα fusion unless they had demonstrated relapse or disease progression on prior imatinib therapy.
* Patients who had received any treatment with midostaurin prior to study entry.
* Patients who had received hematopoietic growth factor support within 14 days of Day 1 of midostaurin treatment.
* Patients who had any surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) within 14 days of Day 1 of midostaurin treatment.
* Patients with any pulmonary infiltrate, including those suspected to be of infectious origin. In particular, patients with resolution of clinical symptoms of pulmonary infection but with residual pulmonary infiltrates on chest x-ray were not eligible until the pulmonary infiltrates had completely resolved. Exception: patients with ASM/MCL ± AHNMD-related pleural effusion as judged by the Investigator and approved by the SSC Chairperson or designee were permitted to enter the study.
Improving Sexual Health in Gynecologic Cancer Patients

This study seeks to find out if an early intervention of providing directed sexual health education and treatment for gynecologic cancer patients will improve patient outcomes as compared to routine clinic visits.

Participants will be randomly placed to one of two groups. This random placement allows our research study to be more significant when the study team checks the results. In one group, the "control" group, participants will attend their usual clinic visits with their provider every 3 months for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time.

In the other group, the "intervention" group, participants will attend one focused Sexual Health Clinic visit, where a provider specialized in sexual health for cancer patients will review a focused history and physical, and will provide education, as well as recommend any helpful treatments.

This provider may or may not recommend follow up with her again after this initial visit. Participants will otherwise continue the usual every 3 month clinic visits with their Gynecologic Oncologist for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time. Participants will not need any additional blood draws or procedures. During their gynecologic exam, a swab will be collected to test participants vaginal pH - a test to see the health of their vaginal flora.

In brief, participants will have their usual 4 clinic visits: one at 3 months, 6 months, 9 months, and 12 months. At each visit, participants will fill out 3 surveys and have a gynecologic exam performed as they usually would, but with a vaginal swab for vaginal pH. This swab will be assessed in the clinic by their provider as the swab will change colors to show pH at the time of exam. This result will be noted in the participants' chart and the swab will be discarded.

Eligibility Criteria:
Inclusion Criteria:

* Able to consent
* Screening positive for sexual health dysfunction as per baseline FSFI
* Diagnosed with any gynecologic malignancy

It is acceptable to have received treatment prior to or during enrollment, including prior surgery, chemotherapy, radiation, hormonal therapy, or clinical trial.

Exclusion Criteria:

* Unable to speak English
* Patients unable to consent
White Blood Cell Counts and Onset of Cardiovascular Diseases: a CALIBER Study

The complete blood count is a commonly performed blood test, and previous small studies have suggested that the counts of some types of white blood cell in the complete blood count may be related to the onset of cardiovascular diseases such as stroke and heart attack. This is of interest because this information may help to predict strokes or heart attacks and may guide new therapies which act on white blood cells to reduce the risk of cardiovascular disease.

The hypothesis is that counts of particular types of white blood cell are associated with a range of cardiovascular diseases.

There is evidence from epidemiological studies that counts of some types of white blood cell, such as neutrophils, are associated with increased incidence of coronary disease. Associations with other initial presentations of cardiovascular diseases have not been studied in large cohorts, but may be of interest for use in risk prediction or to guide therapeutic strategies.

The aim of this study is to estimate associations between counts of lymphocytes, neutrophils, eosinophils, monocytes and basophils, and initial presentation of a range of cardiovascular diseases.

The study will use data from the CALIBER dataset of clinically collected electronic health record data from England. Patients enter the study when they have a full blood count (complete blood count) recorded in the dataset, and they are followed up until they experience one of the cardiovascular endpoints, death or transfer out of the participating primary care practice.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the National Institute for Health Research (NIHR) and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (Clinical Practice Research Datalink) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 30 and over, registered with a participating general practice during the study period.

Exclusion Criteria:

* Patients without a measurement of full blood count during the study period.
* Patients with prior atherosclerotic disease, as recorded in primary care or hospitalisation data.
Implementing Artificial-intelligence Wristbands to Help in Recording Seizures

The investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband Embrace

Currently, seizure tracking relies on subjective patient and family recall. In several studies patients report only approximately half of their seizures, and even less during sleep.

Sudden unexplained death in epilepsy (SUDEP) is the cause of premature death of up to 17% of all patients with epilepsy and as many as 50% with chronic refractory epilepsy (with rates as high as 1% per year). Its etiology is probably due to peri-ictal respiratory, cardiac, or autonomic nervous system dysfunction.

Wristband sensors help caregivers assist patients during seizures and may reduce risks for complications such as injuries and SUDEP.

Accurate seizure detection may improve the quality of life (QoL) of subjects and caregivers by decreasing burden of seizure monitoring and may facilitate diagnostic monitoring in the home setting. Possible risks are occurrence of alarm fatigue and invasion of privacy.

The wristband Embrace has an overall sensitivity of 89.1% and an overall specificity of 93.1%. The investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband Embrace.

Methods:

When the smart wristband detects the seizure, the mobile phone sends a text message to the companion and the nurse, the latter will see or get in touch with the companion and keep a record.

In-patients receiving video-electroencephalography (VEEG) exam use Embrace during the VEEG recording which usually takes 3-5 days.

Out-patients use Embrace for 8 weeks. The investigators will enroll 30-50 patients, half in-patients and half out-patients.

The benefits are evaluated in terms of satisfaction. .

Eligibility Criteria:
Inclusion Criteria:

* At least one seizure per month in the 3-month period before entering the study

Exclusion Criteria:

* Uncountable seizures, psychogenic seizures, alcohol or drug abuse, severe heart or lung disorder, rapid progressive brain disorder, life-terminal disease, severe infection/ bleeding/ liver/ kidney disorder, platelet \<80,000/μL, neutrophil \<1,000/μL, clinically significant ECG abnormality, unstable psychiatric disease (except anxiety).
GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors

Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouch surgery.

Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouchsurgery.

The samples will be collected into sealed plastic containers, clearly labeled with "Biohazard" stickers and patient's code and be kept on ice for up to 30min and then freezed in -20deg to -80deg.

Characterization and quanification of small molecules- and protein biomarkers of GI diseases such as IBD will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ages 18-75 years
* Subjects referred to endoscopic procedures gastroscopy, esophagogastroduodenoscopy (EGD), colonoscopy, single balloon or double balloon enteroscopy Or Subjects having ileostomy or colostomy bags Or Subjects having an ileal pouch
* Subjects agree to sign consent form

Exclusion Criteria:

* Patients has any medical condition that requires special handling of body fluids beyond routine infection control measures (i.e. standard surgical gloves)