cyrilzakka/clinical-trials huggingface dataset:
FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis

The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.

The goals of this study are to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy. The goal is to evaluate the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female greater than or equal to 18 years of age
* Must have a diagnosis of moderate-to-severe psoriasis
* Newly starting methotrexate

Exclusion Criteria:

* Allergy to methotrexate
* History of chronic alcohol abuse
* Diagnosis of liver disease
One Team: Changing the Culture of Youth Sport With Pregame Safety Huddles

Randomized controlled trial of a behavioral intervention (Pre-Game Safety Huddles) designed to study the impact of huddles on concussion safety in youth sport, primarily regarding intention to report concussive symptoms.

More than 1 million youth sustain a sport-related concussion (SRC) each year. The middle school age range is particularly concerning because it is a time when children have both a unique susceptibility to brain injury and high participation rates in organized sports with concussion risk, such as soccer and football. There are two avenues to decrease concussion risk: (1) minimizing the number and force of collisions to decrease concussion incidence (primary prevention) and (2) improving concussion identification to decrease morbidity (secondary prevention). The goal of this study is to utilize Pre-Game Safety Huddles to discuss sportsmanship (primary prevention) and concussion reporting (secondary prevention) with a goal of improving concussion safety.

To assess the efficacy of Pre-Game Safety Huddles as a tool for injury prevention, we will conduct a Randomized controlled trial with youth sport teams. We will recruit leagues in the Seattle area (girls' soccer, boys' soccer and football) and randomize them to either intervention or control. Coaches in the intervention group will then be trained to lead Pre-Game Safety Huddles before each game over the course of the season (9-12 weeks). Youth and coaches will be surveyed at three time points and data will be analyzed to determine impact of the intervention on two outcomes: 1) expectations regarding reporting concussive symptoms (CR-E) and 2) expectations regarding engaging in potentially injurious play (IP-E).

Eligibility Criteria:
Inclusion Criteria:

* Participating on a team in one of the recruited leagues and willing to complete surveys

Exclusion Criteria:

* Not willing to complete surveys
Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

The purpose of this study is to study the effect of eltrombopag on chemotherapy induced thrombocytopenia. Thrombocytopenia is when there is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.

The combination chemotherapy regimen of gemcitabine and docetaxel has become an increasingly used treatment choice for subjects with advanced sarcomas. The regimen has shown activity in first and second line for subjects with metastatic uterine leiomyosarcoma, relapsed/refractory pediatric sarcomas, and improved progression-free survival and overall survival in persons with metastatic sarcoma when compared to gemcitabine alone. The regimen has additionally been recognized as a treatment option for subjects with advanced sarcoma.

Chemotherapy-induced toxicity in the blood such as low platelet level is a common and often therapy-limiting side effect of treatment.

There are two phases in this study. The purpose of the Phase I study is to determine the recommended dose of eltrombopag. The purpose of the Phase II study is to determine the safety, tolerability, and efficacy (how well the drug works) of eltrombopag in subjects who are receiving gemcitabine and docetaxel chemotherapy.

Eltrombopag (Promacta) is an FDA approved drug for the treatment of chronic idiopathic thrombocytopenic purpura (ITP)- a condition of having an abnormally low platelet count. Eltrombopag is now being further investigated for other thrombocytopenic (low platelet)disorders.

Participants will take the assigned dose of eltrombopag once a day starting five days before each cycle of chemotherapy and for 5 days after chemotherapy. Eltrombopag is not taken on the day of chemotherapy. Eltrombopag is taken orally.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic soft tissue or bone sarcoma
* 18 years of age or older
* Adequate blood counts
* Adequate kidney and liver function
* At least 1 but no more than 3 prior systemic therapy regimens for this cancer
* Good performance status - able to carry out work of a light or sedentary nature

Exclusion Criteria:

* Pre-existing hear disease such as congestive heart failure, or arrhythmia known to increase the risk of thromboembolic events (blood clots)
* Blood clot in the last 6 months, known clotting problem or platelet disorder
* History of brain cancer
Modified Cervical Inversion During CS in Placenta Previa

There is an increasing rates of placenta previa nowadays

several techniques were described to control bleeding .

Eligibility Criteria:
Inclusion Criteria:

* pregnant women 38 weeks or more with placenta previa

Exclusion Criteria:

* pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta
The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection

Colorectal cancer is the second most common cancer in the world and the second leading cause of cancer-related mortality. Colorectal cancers arise from precursor adenomatous polyps in a well characterized adenoma to carcinoma progression. The removal of such precursor lesions reduces colorectal cancer mortality between 30 to 50%. Colonoscopy is used for detection of neoplastic polyps but significant miss rates of such lesions are reported. Methods to reduce spasm of the colon have been investigated to increase adenoma detection rates including the use of warm water irrigation and hyoscine butyl bromide. Carbon dioxide warmed to body temperature is postulated to have spasmolytic effects. Administration of warmed carbon dioxide during colonoscopy may improve polyp detection.

Objective: In this study, colonoscopy using warmed carbon dioxide insufflation will be compared to standard room temperature air insufflation to see if there is a greater detection of polyps per patient.

Methods: Patients undergoing colonoscopy for screening and surveillance indications will be included and randomized to receive either room temperature room air or warmed carbon dioxide (37 degrees Celsius). Endoscopists and patients will be blinded to the intervention. Data on indication, preparation, sedation, withdrawal time will be recorded. Polyp detection rate will be the primary outcome. Secondary outcomes will include adenoma detection rate and advanced lesion detection rates.

study terminated

Eligibility Criteria:
Inclusion Criteria:

-outpatients undergoing routine screening or surveillance colonoscopy for colorectal cancer and / or polyp surveillance at Hotel Dieu Hospital

Exclusion Criteria:

* patients who have undergone colonic resections
* active inflammatory bowel disease
* hereditary polyposis syndromes
* moderate to severe chronic obstructive pulmonary disease
* obstructive sleep apnea requiring continuous positive airway pressure or biphasic positive airway pressure
* neurologic diagnoses affecting ventilation
Effective Training in Overweight and Obese People

The aim is to come to a consensus about how to prescribe exercise training that actually helps overweight and obese people. Thus, the present study determines the effects of several types of exercise training to define the one with the largest effect with the least effort.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) over 30

Exclusion Criteria:

* Not able to walk on a treadmill
* Participating in an other study
* Serious cardiovascular diseases
Kidney Transplant Volumetry

This study assesses the reproducibility of 3 different formulas in calculating the volume of a transplanted kidney by ultrasound in-vivo measurements.

3 series of measurements will be performed by 2 different operators during the usual ultrasound follow-up of the renal transplant.

The 3 series of measurements

1. Longitudinal section: maximum longitudinal length, width at the hilum, maximum width, width at the upper third, longitudinal cross-sectional area
2. Transverse section at the hilum : thickness, width, hilar cross-sectional area
3. Largest transverse section : thickness, width, maximum transverse cross-sectional area

Clinical and biological patient data collection:

age, gender, date of transplantation, serum creatinine and glomerular filtration rate (GFR), kidney transplant placement (right or left iliac fossa), acute illness or usual follow-up

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recepients with ultrasound follow-up at the University Hospital of Tours
* Age more than 18 years old

Exclusion Criteria:

* Renal deformity of extrinsic origin
* Early post-transplant period (first 3 days post-transplant)
* Transplanted organ out of the field of view
* Dual kidney transplant
* Opposition to the data collection
A Multicenter Phenotype-Genotype Analysis of LGMD Patients in China

Limb-girdle muscular dystrophies (LGMD) are a series of rare progressive genetic disorders that are characterized by wasting and weakness of the voluntary proximal muscles. The onset of the disease is usually at young age, and most patients will be wheelchair-bound due to the progressive deterioration. Since currently genetic therapies for this disease are still immature, better natural history and genotype-phenotype studies are needed for preparing future therapies.

This is multicentered-based, prospective, and observational study, which mainly focuses on the diagnosis and progression of limb-girdle muscular dystrophies (LGMD) in China. the investigators collect patient data including basic information, strength evaluations, genetic data, electromyography results, pathology imaging from muscle biopsies, and MRIs. Previously collected patient data may also be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Identified with variants regarding LGMD related genes revealed by genetic sequencing
* Progressive weakness involving shoulder girdle and/or pelvic girdle
* Myopathic changes in electromyography or in pathological studies

Exclusion Criteria:

* Identified with variants in other genes (non-LGMD related) that may cause muscular dystrophies
Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial

This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle intervention for preschool children. It will consist of both an preschool component and a family component and is aimed at increasing healthy nutrition and physical activity. Half of the participating preschools will implement SuperFIT, while the other half of the preschools will continue as usual.


Eligibility Criteria:
Inclusion Criteria:

* children attending the participating preschools
* at least one parent has to be able to understand the Dutch language
* Both caregivers (if applicable) of the child give informed consent

Exclusion Criteria:

* There are no exclusion criteria for this study
Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery

Major purpose of this research is to evaluate the effect and usefulness of Buprenorphine transdermal system (MTDS) among the patients with lumbar spinal disease who was performed the single-level posterior lumbar fusion.

After surgery, all the patients apply the patient-controlled analgesia. After three days of surgery, patients are divided into two groups.Group A is an experimental group that administer the BTDS after surgery, and Group B is a control group that take tramadol analgesics. If the patient's pain score exceeds the NRS 4, they can take the additional rescue medicine, acetaminophen.

After the surgery, patient's pain score and quality of life would be recorded sequentially. The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months, respectively.


Eligibility Criteria:
Inclusion Criteria:

* adults over 20 years
* taking the lumbar spinal surgery : single-level, posterior fusion
* stay in hospital more than 2 days after operation

Exclusion Criteria:

* pregnancy or breast-feeding
* allergy or contraindication to buprenorphine
* patient with decreased lung function
* patient with taking MAO inhibitor or anticonvulsant
* patient with brain lesion, or severe liver disease
* dependence in opioid drugs
* taking muscle relaxant or tranquilizer
* patient had taken buprenorphine preoperatively
* taking strong opioids before enrolling the study
* another severe source of pain except lumbar spine
* severe cardiovascular, pulmonary, or renal compromised patients
Assessment of Brain Activities in Cervical Dystonia

To address joint position sense in cervical dystonia patients and how it affects the brain activity.


Eligibility Criteria:
Inclusion Criteria:

* patients having cervical dystonia and aged matched healthy control group

Exclusion Criteria:

* cervical dystonia patients with severe head tremor will be excluded
Management of Digestive Haemorrhaging In CHRU of Brest During 2009 and 2014

Gastro intestinal (GI) bleeding is relatively frequent and may lead to intensive care unit admission. Although a restrictive strategy for red blood cell transfusion is supported by a large randomized controlled trial literature, less is known about the impact of transfusion strategy of other blood components and administration of anti fibrinolytic on clinical outcomes.

This study aims to identify parameters that may be associated with the risk of further bleeding in patients admitted to ICU for GI bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Gastro Intestinal Bleeding admitted to either medical or surgical intensive care unit

Exclusion Criteria:

* patients retrieved from another hospital
* age \< 18 years consent withdrawal
Retrospective Evaluation to Compare AKE-1 (Navicam SB) Capsule Endoscope System and PillCam SB3 Capsule System

This is a retrospective study on prospectively collected patient video data from a multicenter, single-blinded pivotal trial (Ethics Approval No. \[2021\] (0635-01)), involving a consecutive series of patients recruited by 3 Chinese centers based on the suspected small bowel disease, gastrointestinal bleeding, etc. All video images will be anonymized (de-identified). Video images from both the investigational device and comparator device are reviewed by two independent reviewers. Once the conventional reading has been completed, each reviewer will then review randomized videos with the ProScan feature enabled in ESView or SBI enabled on the Pillcam Rapid software. Each reviewer should review for normal versus abnormal findings, type of visual findings and categorization (lesions, polyps, bleeding, etc.), diagnosis, reading time, and subjective assessment of visual quality.

This is a retrospective study on prospectively collected patient video data from a multicenter, single-blinded pivotal trial, involving a consecutive series of patients recruited by 3 Chinese centers based on the suspected small bowel disease, gastrointestinal bleeding, etc.

Video images from both the investigational device and comparator device are reviewed by two independent reviewers. Video that will be retrospectively collected, have been anonymized. Each reviewer will review the images collected according to the "conventional reading" as recommended by ACG guidelines.

Once the conventional reading has been completed, each reviewer will then review randomized videos with the ProScan feature enabled in ESView or SBI enabled on the Pillcam software . Each reviewer will then review the videos and document all lesions/findings found by the ProScan and Pillcam software with SBI. Annotations should be done after the reading, each finding shall be labelled and categorized (active bleeding, Angioectasia, polyps/ nodules, tumors or varisces, ulcers, isolated erosions, lesions, other).

For all lesions/findings, if there was significant disagreement between two reviewers for the same image, for both capsule videos, another independent reviewer will then review the video of that examination and provide his review results.

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in the study titled Performance Evaluation of the NaviCam SB Capsule Endoscope System in Comparison to the PillCam SB3 Capsule System for the Diagnosis of Small Bowel Diseases (Ethics Approval No. \[2021\] (0635-01)) and were included in the FAS.

Exclusion Criteria:

* N/A
Follow-up of Inflammatory Responses and Multiorgan Outcomes FoLlowing Neonatal Brain injurY

Babies who have brain injury also frequently have involvement of their kidneys, lung and heart. Although clinical care in the neonatal period is well defined there are few guidelines and evidence for developmental, heart and kidney followup in childhood. The investigators aim to develop and implement guidelines for health care workers and families on Followup after Neonatal Brain Injury.

Inflammation is an important factor in brain injury of newborns and also affects their heart lungs and other parts of their body. The investigators will use tests from the newborn period to predict outcome and help parents with planning health needs for their baby rather than waiting until any issues arise later on. By understanding inflammation the investigators can find methods to decrease the negative effects and improve outcomes in the future for babies and families.

Neonatal brain injury is an important cause of neonatal death and disability such as cerebral palsy. Perinatal global hypoxic ischemic associated with Neonatal Encephalopathy (NE) results in multi-organ dysfunction which may persist in later childhood. In addition perinatal inflammation has been associated with neonatal brain injury and implicated in adult neuropsychiatric conditions.

The investigators aim to examine multi-organ dysfunction in early childhood in children who had NE by examining detailed cardiac, renal, neurological, haematological and neurodevelopmental outcomes. The investigators have previously defined detailed multi organ dysfunction (MOD) in this cohort in the neonatal period in infants with NE including organ outcomes as well as serum, urine and cerebrospinal fluid (CSF) biomarkers. They are now age-appropriate for detailed neurocognitive assessment and correlation with these biomarkers and the investigators plan to compare with age- matched controls. Immunological markers such as the inflammasome and microRNAs are altered in the neonatal period and may persist in early childhood. The investigators will modify negative inflammatory responses in vitro with specific antagonists as well as correlating these immune biomarkers with outcomes.

Quantifying multiorgan dysfunction in the neonatal period to ensure appropriate follow-up of all organs is merited. This would help in advanced clinical planning and long term follow up. In addition, understanding, the immune response in these children with NE and exploring systemic inflammation holds promise for future development of immunomodulatory adjunctive therapies and biomarkers to predict outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Children at 2-3 years
* With diagnosis of Neonatal Encephalopathy
* Required Therapeutic Hypothermia

Exclusion Criteria:

-
Risk Factors for Delirium in Critically Ill Surgical Patients

Delirium is characterized by changes in mental status, inattension, disorganized thinking, and altered consciousness. Prevalence of delirium in critically ill patients has varied from 20\~80% depending on the severity of illness. Despite its high prevalence, delirium is often under-recognized by clinicians due to the difficulties in diagnosis and no interest. Delirium is associated with increased mechanical ventilation days, hospital length of stay, and mortality. The purpose of this study is to analyze the prevalence of delirium and risk factors for delirium in critically ill surgical patients.

The investigators performed a prospective cohort study involving the patients admitted to surgical ICU between april 2013 and august 2013.

The included patients were assessed independently by trained ICU nurses using the confusion Assessment Method for the ICU (CAM-ICU). The patients were recorded general characteristics, disease-related factors, and treatment and environment-related factors. Data were analyzed by SPSS 12.0 software, using t-test, Fisher's exact test and logistic regression.

Eligibility Criteria:
Inclusion Criteria:

1. Above RASS -3 paitent
2. Verbally or nonverbally communication possible patients

Exclusion Criteria:

1. Under age 18
2. Neurological disorder e.g.) Brain injury, dementia and traumatic brain injury
3. Readmitted to ICU
4. History of delirium
5. Transplanted; isolation is required
PPI Versus Placebo in Severe Functional Heartburn

Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.


Eligibility Criteria:
Inclusion Criteria:

* Heartburn twice a week for at least 2 years. Normal EGD and 24hr pH study.

Exclusion Criteria:

* \<18yrs of age,pregnant, unable or unwilling to give consent, allergic to PPI, previous gastric or esophageal surgery, past hx of erosive GERD, unwilling or unable to stop acid suppression meds
Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation

The aim of this study is to collect data on the early visual development of extreme premature infants. The method is the measurement of flash visual evoked potentials and the study population includes premature infants under the 28th weeks of gestation, who have normal cranial ultrasound examinations, normal aEEG, no clinical neurological symptoms and who have a normal ophthalmological status.

fVEP measurements were recorded from the first week of life every second week until term.

The fVEP recordings were performed in active sleep, in stable premature infants, who were continuously monitored. The Nihon Kohden Neuropack 8 was used, the stimulus frequency was 0,5 Hz, artefact free averages were analyzed.

The measurements were analyzed according to the presence and absence of known waveforms, their latencies and amplitudes. Longitudinal analysis was performed to analyse the effect of extrauterine visual development on fVEP with growing gestational ages.


Eligibility Criteria:
Inclusion Criteria:

* All premature infants under the 29th week of gestation entering our ward.

Exclusion Criteria:

* Infants with intracranial abnormalities, cerebral malformations, neurological symptoms or known eye pathology.