cyrilzakka/clinical-trials huggingface dataset:
A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares

The overall objective of this proposal is to implement a smart phone application (app) + population management system to monitor rheumatoid arthritis (RA) disease activity between scheduled physician office visits. The population management system includes: 1) a web-based dashboard that consolidates incoming patient-reported data using pre-programmed algorithms to identify increases in disease activity, and 2) the population manager, a trained individual who monitors the web-based dashboard and connects patients with their healthcare providers (HCPs). The investigators central hypothesis is that the combined smart phone app + population management system will improve patient satisfaction and management of RA disease activity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA by a board-certified rheumatologist
* Taking a DMARD (sulfasalazine, methotrexate, leflunomide, azathioprine, certolizumab, cyclosporine, adalimumab, etanercept, infliximab, golimumab, abatacept, tocilizumab, anakinra, tofacitinib, rituximab, hydroxychloroquine)
* Own a smart phone with either an Android or iPhone operating system
* Be English-speaking

Exclusion Criteria:

* Patients who do not plan on receiving follow-up care at the Brigham and Women's Hospital Arthritis Center
Studies of Disorders and Mechanisms Related to Atrial Fibrillation Before and After DC-Conversion.

The purpose of this study is to investigate if breathing disorders are related to atrial fibrillation and if it is possible to predict recurrence of atrial fibrillation after DC-conversion by changes in heart rate variability and 24 hour ECG.


Eligibility Criteria:
Inclusion Criteria:

* persistent atrial fibrillation
* scheduled for electrical cardioversion

Exclusion Criteria:

* known obstructive sleep apnea
Comparison of a SegNet-based Algorithm Estimating Epifascial Fibrosis

To approval for detecting lymphedema fibrosis before its progression, verification of CT-based quantification of suprafascial microscopic fibrosis has been tried.

In lymphedema, proinflammatory cytokine-mediated progressive cascades always occur, leading to macroscopic fibrosis. However, no methods are practically available for measuring lymphedema-induced fibrosis before its deterioration. Technically, CT can visualize fibrosis in superficial and deep locations. For standardized measurement, verification of deep learning (DL)-based recognition was performed. A cross-sectional, observational cohort trial was conducted at a teaching university hospital. The protocol of this study was approved by the University Hospital Institutional Review Board and was registered at the Protocol Registration and Results System (PRS), www. clini caltr ials. gov (NCT04811677: https:// clini caltr ials. gov/ ct2/ show/ NCT04 811677? term= NCT04 81167 7\& draw= 2\& rank=1). All methods were performed in accordance with the relevant guidelines and regulations. The trial conformed to the tenets of the Declaration of Helsinki. Patients were included if they were clinically diagnosed with unilateral limb lymphedema and had undergone BEI analysis and CT scanning. The subjects provided written informed consent for publication of the case details. Data were collected as close to the CT scanning date as possible. Patients who were diagnosed with deep vein thrombosis, bilateral limb involvement, vascular disease, or local infection were excluded.

After narrowing window width of the absorptive values in CT images, SegNet-based semantic segmentation model of every pixel into 5 classes (air, skin, muscle/water, fat, and fibrosis) was trained (65%), validated (15%), and tested (20%). Then, 4 indices were formulated and compared with the standardized circumference difference ratio (SCDR) and bioelectrical impedance (BEI) results. In total, 2138 CT images of 27 chronic unilateral lymphedema patients were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* The patients who were clinically diagnosed with unilateral limb lymphedema and who underwent multi-frequency bio-electric impedance (BEI) analysis and CT scanning.

Exclusion Criteria:

* The patients who were diagnosed with deep vein thrombosis, bilateral limbs involvement, vascular diseases or local infection were excluded.
Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction

The main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* child between 1 month and 15 years of age
* affiliation to the French social security system or equivalent
* child receiving mechanical ventilation for at least 4 hours and less than 48 hours
* ventilation to be provided for at least 8 hours
* less than 30 days in pediatric intensive care
* child under intravenous sedation
* consent of both parents
* consent of child when possible

Exclusion Criteria:

* curarized child
* ketamine treatment
* children suffering from facial and/or severe brain traumatism
* known hypersensitivity reaction to morphine or intolerance insufficiency to sufentanyl
* respiratory
* chronic obstructive pulmonary disease
* myasthenia
* treatment with morphine agonists-antagonists, or combination with MAOIs
* renal or liver disorders
* preterm birth of more than one month of life (but not at full term by corrected age)
* associated treatment or pathology contra-indicating administration of Sufentanyl epidural
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.

A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers

It's a single-center,randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of Hepenofovir Fumarate Tablets in healthy adult subjects.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the nature of the study, comply with the protocol, and provide informed consent.
* Subjects willing to adhere to protocol requirements and to finish the study.
* Subjects were willing to use methods of contraception from the time of screen to 6 months post the last dose administration.
* Subjects aged between 18 and 55 years (both inclusive).
* Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)) ,with minimum of 50 kg weight for male, 45 kg weight for famale.
* Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.

Exclusion Criteria:

* History or presence of significant smoking (more than 5 cigarettes/day prior to 3 months the first dose of the study drug).
* Hypersensitivity to different kinds of drugs and food.
* Presence of significant alcoholism or drug abuse.
* Volunteer who have donated blood or lose blood(\>450mL)within past 90 days prior to the first dose of the study drug.
* Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 28 days prior to dosing of the study.
* Use of any prescribed medication or OTC medicinal products during the last 14 days prior to dosing of the study.
* Consumption of spcial food(including gragon fruit, mango, grapefruits) or strenuous excercise,or other factors which may effect the absorption,distribution,metabolism,excretion of drugs for within 2 weeks prior to dosing of the study.
* Any treatment which could bring about induction or inhibition of CYP3A4.
* Volunteer who have participation in a drug research study within past 90 days prior to the first dose of the study drug.
* Difficulty in swallowing or other gastrointestinal disease or disorder.
* Presence of an abnormal electrocardiogram (ECG), which was clinically significant.
* Female subjects who were breast-feeding or had a positive pregnancy test at screening or at any time during the study.
* Subjects with abnormal health as determined by personal medical history, clinical examination and laboratory examinations,which was clinically significant.
* Subjects who, in the opinion of the Investigator, should not participate in the study.
Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury

There exist a variety of outcome measures to asses gait function in individuals with a spinal cord injury (SCI). The most established measures are the 10-meter walk test (10MWT) and the 6-minute walk test (6mWT). They are used to assess treatment efficacy and recovery of gait function in individuals with SCI. However, the 10MWT is appropriate for poor walkers but not sensitive in good walkers and the 6mWT can be time-consuming and is very demanding for severely impaired patients. Therefore the 2-minute walk test (2mWT) has gained more attention in the SCI field. The 2mWT has been established in numerous neurological diseases and has shown to correlate with the 6mWT in patients with neuromuscular disease, multiple sclerosis and stroke. Though the 2mWT has not yet been validated in individuals with SCI.

A limitation that affects all timed walking tests is that they suffer from limited information about gait quality (i.e. how walking function is achieved). Being able to receive information on the gait quality of a patient can help to understand the underlying mechanisms of walking improvements after an intervention (e.g. compensation vs recovery). The research in the field of inertia measuring units (IMU) develops and advances very rapidly at the moment resulting in the possibility to perform a gait analysis with a simple IMU setup. However, the reliability of such measurement setups has not yet been shown in individuals with SCI.

The primary aim of this study is to test the validity and reliability of the 2mWT in the SCI population.

Additionally, it will be investigated if a simple sensor setup can give additional reliable information about the gait pattern of individuals with SCI.


Eligibility Criteria:
Inclusion Criteria:

* Participants fulfilling all of the following inclusion criteria are eligible for the study:
* Informed Consent as documented by signature (Appendix Informed Consent Form)
* At least 18 years old
* Spinal cord injury
* Able to walk with a speed of at least 0.17m/s with or without walking devices and or bracing

Exclusion Criteria:

* Current orthopaedic problems of lower limbs
* History of severe cardiac condition
* Premorbid major depression or psychosis
* Unlikely to complete the intervention or return for second visit
* Enrolment of the investigator, his/her family members, employees and other dependent persons
mHealth Titration and Management

The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. iSage Rx (isageapp.com) allows providers to prescribe basal insulin treatment plans to patients and manages basal insulin doses utilizing clinically proven algorithms. In this pilot study, we hypothesize that this user-friendly application and seamless data capture will improve glycemic control (achieve HgbA1c \<7%) and reduce the frequency and severity of hypoglycemia. Exploratory measures will include healthcare resource utilization and patient and provider satisfaction. The basal insulin titration algorithms used in iSage have had thousands of user-years' experience in FDA-mandated, closely supervised clinical trials, both for long-acting insulins (e.g., Lantus, Levemir) that have been available for a long time and for the newer ultra-long-acting ones (e.g., Tresiba, Toujeo). However, the effectiveness of iSage with a connected glucose meter has not been studied in a "real world" clinical environment. Broad use of such an application and connected devices will, we believe, prove to be cost-effective, favor early and appropriate prescription of insulin, reduce provider effort, shorten time to achieve glycemic goals, and simplify the transition to basal insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* T2DM (WHO criteria) treated with basal insulin (glargine, detemir, degludec)
* HgbA1c 8 or above
* GFR \>60 ml/min within the last 12 months
* English speaking, informed consent
* Has an Android or iOS based compatible smartphone (iOS 9.0 or above; Android 4.4 or above)
* Currently performs at least 3 fasting fingerstick glucose measurements/week
* Have a PCP within the KU Health System

Exclusion Criteria:

* Diagnosis of hypoglycemic unawareness within 6 months of enrollment
* Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
* Recent (within the last 6 months)/current use of non-topical steroids
* Insulin requirements in excess of 1U/kg per day
* Use of pioglitazone or another thiazolidinedione (TZD)
* In the opinion of the provider, HgbA1c goals should adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
Olive Oil Polyphenols, Vitamin D, Docosahexaenoic Acid (DHA) and Locomotor Function (PolivD3)

The present project hypothesizes that the potential protective effect of olive oil relies on its polyphenols profile (quality and quantity) and that it may be synergistic to other food components. Among the nutrients that may be of interest for bone and muscle tissues, unsaturated fatty acids and vitamins are the most described.

Consequently, based on the promising available preliminary data, the present project aims to investigate the possible preventive effect of olive oil polyphenols and eventually the synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order to prevent any locomotor dysfunction.

Volunteers will be supplemented during 9 months. The primary and secondary outcome measures will be performed at baseline, 3 and 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian female
* Within at least 7 years post-menopause
* Generally healthy as determined by standard medical assessment on physical and mental health
* Normal weight as determined by BMI (20≤ BMI ≤30)
* Affiliated to National Health Insurance
* Willing to comply with the study procedures
* Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
* Having received both oral and written explanations about the study
* Having provided her written informed consent

Exclusion Criteria:

* Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignancy, chronic malnutrition
* Osteoporosis (defined by T-score of -2.5 standard deviation (SD) at hip and/or spine)
* On therapy with drugs known to interfere with bone and muscle metabolism
* Taking regular calcium and vitamin D supplements
* Currently participating or having participated in another clinical trial during past 1 year prior to the beginning of this study, this depending on the type of previous study•
* Intense Physical activity
Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.

The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.

This study is multi-center, open-label, randomized controlled phase 4 study to evaluate the efficacy and safety of certirobell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.

On the first visit the patients scheduled to be operated liver transplant in 35 days will be conducted screening. Patients who meet the criteria of this clinical trial will be randomized to CertiroBell or mycophenolate mofetil on the second visit. Each group will take CertiroBell or mycophenolate mofetil and will conduct scheduled tests with 5 additional visits.

Eligibility Criteria:
\* Inclusion Criteria:

\[Time of screening\]

* Patients who have transplanted in primary living donor liver in 35 days or who plan to be transplanted in primary living donor liver.
* Over 20 years old(male or female)
* Agreement with written informed consent

\[Time of randomization\] - Patients who have transplanted liver within 4 weeks(25 days to 35 days)

\* Exclusion Criteria

\[Time of screening\]

* Patients who have transplanted non-liver organs or have plan to be transplanted non-liver organs.
* Patients with bioartificial liver (cell system)
* Patients who diagnosed with malignant tumor within 5 years \[however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled\]
* Patients with severe systemic infection
* Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
* Participated in other trial within 4 weeks
* In investigator's judgement

\[Time of randomization\]

* Patients with acute rejection who have been clinically treated after liver transplantation.
* Patients with complication related to the hepatic artery such as hepatic artery thrombosis at the time of randomization.
* At screening

  * WBC \<1,500/mm\^3 or PLT \<30,000/mm\^3 or over 3 times upper than normal range of liver function tests(T-bilirubin, AST, ALT) levels
  * Protein/Creatinine ratio(urine test) \> 1 or eGFR by MDRD\< 30mL/min/1.73m\^2 or Total cholesterol \> 350mg/dL or triglycerides \> 500mg/dL
* Patients taking HCV(hepatitis C virus) Therapeutic Drugs
* Patients who had plasmapheresis within 1 week.
* Patents who had a record of taking mTOR inhibitor before.
* In investigator's judgement
Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis

The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients not previously treated with the current standard of care, or can be given to patients who have either failed or were unable to tolerate the current standard of care. Administration will be on top of a glucocorticosteroid, which is usually part of the current recommended treatment.

The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients not previously treated with the current standard of care, or can be given to patients who have either failed or were unable to tolerate the current standard of care. Administration will be on top of a glucocorticosteroid, which is usually part of the current recommended treatment.

All participants in the NI-0501-04 study (NCT01818492) were invited to participate in the long-term follow-up study NI-0501-05 (NCT02069899). For the primary completion date, mentioned here, we refer to the NI-0501-04 study, even though in accordance with the NI-0501-04 study objectives, namely the assessment of long-term efficacy and safety endpoints, the study analyses also included data collected in the long-term follow-up study NI-0501-05. Hence these data are reported together. Study NI-0501-05 accepts patients from NI-0501-04 and NI-0501-06. Data collection for the patients from NI-0501-04 is completed.

The primary efficacy and safety analyses are based on the regulatory cut-off date of 20 July 2017. Refer to the publication in N Engl J Med 2020 May 7; 382 (19):1811-1822. Follow-on analyses have been conducted on all patients enrolled in the study, i.e. including the patients enrolled after the cut-off date of 20 July 2017. The results reported here refer to the totality of the 45 patients enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Gender: male and female
* Age: up to and including 18 years at diagnosis of Haemophagocytic Lymphohistiocytosis
* Primary HLH patients
* Patient (if ≥ 18 years old), or patient's legal representative(s) must have signed informed consent

Exclusion Criteria:

* Diagnosis of secondary Haemophagocytic Lymphohistiocytosis consequent to a proven rheumatic or neoplastic disease.
* Body weight \< 3 kg.
* Patients treated with biologics within a specific timeframe
* Active Mycobacteria, Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter and Leishmania infections.
* Presence of malignancy.
* Concomitant disease or malformation severely affecting the cardiovascular, pulmonary, liver or renal function
Evaluating the Risk of Postoperative Venous Thromboembolism in Cervical Cancer Patients

The aim of this study is to develop a machine learning model to accurately predict the risk of venous thromboembolism in patients with cervical cancer after surgery.

Venous thromboembolism (VTE) is a common and life-threatening complication in patients with cervical cancer following surgery. The objective of this study is to develop a machine learning model with the potential to predict the risk of VTE in these patients postoperatively. We plan to employ partial dependence (PD) curves, breakdown (BD) curves, Ceteris-paribus (CP), and SHapley additive exPlanations (SHAP) values for a comprehensive analysis. The goal is to explore how different machine learning algorithms can be utilized as tools for personalized postoperative VTE risk assessment in cervical cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of cervical cancer through pathological examination.
* Receipt of surgical treatment for cervical cancer at Chongqing University Cancer Hospital in China.
* Provision of comprehensive case information.

Exclusion Criteria:

* Patients under the age of 18.
* History of VTE caused by other reasons before surgery.
* Secondary cervical cancer or accompanying primary malignant tumor.
Imaging Location of Hamstring Muscle Lesions in Sport and Relationships With Injury Mechanism.

Hamstring muscle injuries are a common pathology in sports mainly present in sprint and acceleration sports, accounting for about 12% of all football injuries. Because of their frequency, risk of reinjury and financial cost, they can be considered as a public health problem. Improving knowledge of the pathophysiology of hamstring muscle injury appears to be a relevant research focus for prevention purposes.

This study is a cohort of athletes in the context of suspicion of hamstring muscle injuries.

Eligibility Criteria:
Inclusion Criteria:

* To be recreational sportsmen, competitions, amateurs, high-level or professional
* Aged 18 to 50 years
* Perform an Magnetic Resonance Imaging (MRI) or an ultrasound of the thigh in the context of the suspicion of an acute hamstring muscle injury
* Injury during sport since less 21 days old.

Exclusion Criteria:

* a history of surgery of the anterior cruciate ligament with removal of the transplant in the posterior compartment of the thigh
* an antecedent of surgery of the thigh.
* inability to understand the French language for completing the self-questionnaire
Examining Macrophage Influx and Vascularization in Chronic Pancreatitis

Our aim in this study is to find out if we can locate the similar reduction in the recruitment of macrophages, remodeling of vasculature and do they correlate in the number and area of the islets in pancreas as in the mouse model.


Eligibility Criteria:
Inclusion Criteria:

* Pancreas tissue sections from preparates from pancreatic surgery.
* Patients having chronic pancreatitis with or without diabetes