cyrilzakka/clinical-trials huggingface dataset:
Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)

The United Kingdom and wider world is in the midst of the 2019 novel coronavirus (SARS-CoV-2) pandemic. Accurate diagnosis of infection, identification of immunity and monitoring the clinical progression of infection are of paramount importance to our response. Widespread population testing has proven difficult in western countries and has been limited by test availability, human resources and long turnaround times (up to 72 hours). This has limited our ability to control the spread of infection and to develop effective clinical pathways to enable early social isolation of infected patients and early treatment for those most at risk. The life sciences industry has responded to the pandemic by developing multiple new in vitro diagnostic tests (IVDs). To leverage the potential clinical benefit of those tests we require efficient but robust clinical evaluation. Therefore, to optimise resource utilisation in this global pandemic, we will conduct a platform adaptive diagnostic study on a national level, utilising a national network of expertise in the evaluation of diagnostic technology. This study will enable the evaluation of multiple assays in three priority areas:

1. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2
2. Evaluation of assays monitoring the immune response to SARS-CoV-2 infection
3. Evaluation of the prognostic value of commercially available tests for predicting prognosis in patients with suspected or confirmed SARS-CoV-2 infection. (This arm will not be active immediately but may be activated after initiation).


Eligibility Criteria:
Work Stream A (in-hospital; Group 1 and Group 2):

Group 1 Inclusion Criteria:

We will include participants (patients or staff):

1. That are 18 years or older
2. That will require testing for COVID-19 in the opinion of the treating clinician
3. That may have presented with acute symptoms of COVID-19 (e.g. fever, cough, dyspnoea, anosmia) or chest x-ray changes or they may be asymptomatic but require testing for other reasons

Group 2 Inclusion Criteria:

We will include participants:

1. That are 18 years or older
2. That have been admitted for another reason other than suspected SARS-CoV-2 infection, but when routinely swabbed they have been identified as positive for SARS-CoV-2 PCR

Work Stream B (Group 3):

We will include participants:

1. That are 18 years or older

   EITHER:
2. They have been identified as positive for SARS-CoV-2 PCR through testing at national laboratory infrastructure OR
3. They have been identified as negative for SARS-CoV-2 PCR through testing at national laboratory infrastructure

Work Stream C (Group 4):

We will include participants:

1. That are 18 years or older
2. Who are undergoing testing for COVID-19, whether they are symptomatic or symptomatic for COVID-19

Exclusion Criteria for all Work Streams:

1. Patients where it is impossible/unsafe to obtain the required research samples
2. Prisoners
3. Patients where sampling is not feasible
The Muti-centered Investigation，Pathogenesis and Intervention Study of Non-suicidal Self-injury Behavior in China

Non-suicidal self-injury (NSSINSSINSSI) refers to a series of direct and consequently repeated injuries to one's body without suicidal intent. At present, it has become an important issue of mental disorders. This study is expected to complete a multi-center epidemiological survey of non-suicidal self-injury in China, and to study its pathogenesis and intervention methods.

(1) NSSI NSSI epidemiological survey. For example, epidemiological investigation. For example, in the period of 2020.1.1-2020.6.30 half a year, the psychiatric departments of fourteen hospitals of different regions, regions and nature (psychiatric specialist hospitals/general hospitals), hospitals of different types in Jiangsu Province, and hospitals of different types in Jiangsu Province were selected by stratification. In outpatient and inpatient departments, a certain proportion of young people were selected from outpatients and inpatients. Guided by the recommended diagnostic criteria of DSM-5 and guided by semi-structured interviews, the patients with NSSI behavior were screened out by semi-structured interviews. The incidence, comorbidity, incidence, comorbidity and basic psychosocial factors were investigated.(2) Exploring the pathogenesis of NSSI. Exploration of pathogenesis. A case-control study was designed on the basis of flow survey. The NSSI NSSI group and the normal control group were set up. The data of symptomatology, genetic factors of social factors of psychological cognitive function and brain imaging were collected. The data of brain imaging, brain imaging and other data were collected, and the data of social-psychological-biological data collection and mechanism exploration were carried out.(3) Clinical intervention study of NSSI. NSSI patients were randomly divided into structured DBT group intervention group (DBT-ST) and support group discussion group (SGT). The experimental group was given structured DBT group therapy intervention, while the control group was given the same frequency of support group discussion. To explore the therapeutic effect and mechanism of structured DBT group therapy intervention on NSSI behavior. In order to provide a scientific and effective treatment for NSSI behavior.

Eligibility Criteria:
Inclusion Criteria:

1. 10-40 years old;
2. Voluntary participation, signing informed consent and obtaining the consent of family members of patients under 18 years old;

Exclusion Criteria:

1. history and family of neurological or psychiatric disorders;
2. history of psychiatric disorders and family history;
3. severe somatic diseases;
4. taking psychotropic drugs within three months;
5. pregnancy and lactation
Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)

The purpose of this study is to understand variation in the symptoms of Parkinson disease. This study uses an iPhone app to record these symptoms through questionnaires and sensors.

Living with Parkinson disease means coping with symptoms that change every day. Yet these changes are not tracked frequently enough. Most people with Parkinson disease see a clinician only once or twice a year. This study measures changes in Parkinson disease symptoms in real time using an app. The app remotely monitors Parkinson disease symptoms using surveys and the sensors on mobile devices. This study may contribute to increasing our understanding of the variability in Parkinson disease symptoms. This knowledge could be used to improve quality of life for people living with Parkinson disease.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years
2. Have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
3. Be able to read and understand an official language of the country of participation
4. Be able to provide informed consent (i.e., pass assessment quiz)
5. Be willing to follow study procedures

Exclusion Criteria:

1. Age 17 years or younger
2. Not a resident of the of a country where the app is approved for use
3. Not have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
4. Not be able to read and understand an official language of the country of participation
5. Not be able to give informed consent
6. Not be willing to follow study procedures
Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics

The hypothesis of this study is that respiratory physiotherapy can promote improvement in respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is more effective in improving respiratory mechanics in childrens and does not alter the hemodynamic proved safe


Eligibility Criteria:
Inclusion Criteria:

* children aged between one and 60 months
* diagnosed with respiratory failure
* undergoing mechanical ventilation

Exclusion Criteria:

* had traumatic brain injury
* severe thrombocytopenia (\<20,000 pl/mm³)
* hypovolemia and cyanogenic congenital heart defects
* pneumothorax, hemothorax and/or pleural effusion without previous drainage
Evaluate the Safety and Efficacy of a Steerable Catheter in the Treatment of Vascular Interventional Access

This is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy of a steerable catheter in the establishment of vascular intervention access. five centers participate in this study. The total enrollment number is 68. In the procedure of vascular interventional surgery or angiography diagnosis, the steerable catheter are used to building vascular interventional access. Evaluate the safety and efficacy of the product, by the observation and record the relative index of subjects intraoperative and postoperative (discharge) before and after 30 days .

This is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy of a steerable catheter in the establishment of vascular intervention access. five centers participate in this study. The total enrollment number is 68. In the procedure of vascular interventional surgery or angiography diagnosis, the steerable catheter are used to building vascular interventional access. Evaluate the safety and efficacy of the product, by the observation and record the relative index(like catheter compliance, catheter directivity, and catheter visibility under X ray) of subjects in the procedure, telephone follow up at 30 days investigate the subjects healthy condition.

Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 80, male or female.
* Complying with the standard of peripheral vascular interventional operation treatment , complying with the standard treatment of vascular angiogram, need to establish vascular interventional treatment access.
* The subject who is able to understand the test purpose, voluntarily join this clinical trial with informed consent forms.

Exclusion Criteria:

* Patients with cerebrovascular accident or major gastrointestinal bleeding in six months unable to carry out antithrombotic therapy because of having contraindications to antiplatelet agents and anticoagulants and have haemorrhage tendency
* Hypohepatia, hematuria, deep vein thrombosis, and/or receiving the immunosuppressant therapy
* The distal target vessel blood flow low may produce thrombosis
* The women who pregnancy, lactation and can't contraception during the trial period
* Patients has been involved in other drugs or medical devices clinical trials related to treatment of the target lesion or has been involved in other drugs or medical device clinical trials but have not reached the primary endpoint of the study
* Patients unable or unwilling to participate in this trial
* the researcher determine the patient is not suitable to participate in clinical research
Metabolic and Nutritional Characteristics of Long-stayer ICU Patients

The intensive care (ICU) patient population has increasing number of very long ICU stays. Long-stayers are usually defined as requiring more than 1 week of mechanical ventilation and of ICU therapy: little is know about their metabolic characteristics and their relation to outcome. The study aims at describing the demographic, nutritional and metabolic aspects of their stay.

Analysis of 200-250 consecutive patients admitted to the ICU long-stayer program.

Data extracted from the computerized ICU system (PDMS): age, Simplified acute physiology score (SAPSII), weight, BMI, Nutrition Risk Score (NRS-2002), daily energy, protein, and glucose intakes, Energy balance, blood glucose (dysglycemia and Glu variability) and lactate, 24hr-insulin (Goal Glu 6-8 mmol/l).

Outcome variables: length of stay (LICU), muscle strength (MRC), vital status at 90 days.

Patients will be followed in detail until ICU discharge and for vital status until day 90 after admission Data will be presented as mean or median, univariate and multivariate analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* ICU length of stay \> 7 days and enrollment to the long-stayer ICU program

Exclusion Criteria:

* Major burns
* Brain injury
* Severe neurological condition as primary disease
eGFR Evolution in HCV Patients Receiving SOF-based or SOF-free DAAs

Data regarding the nephrotoxicity of sofosbuvir (SOF) remain controversial. The investigators compared the changes of estimated glomerular filtration rate (eGFR) in patients with chronic hepatitis C virus (HCV) infection receiving SOF-based or SOF-free direct acting antivirals (DAAs).

Chronic hepatitis C virus (HCV) infection is a major health problem that affects 71 million people worldwide. Patients with chronic HCV infection may present with various hepatic and extrahepatic manifestations which lead to substantial morbidity and mortality. In contrast, the long-term health outcome improves following successful HCV eradication by antiviral therapies.

Owing to the excellent efficacy and safety as well as the short treatment duration, the use of interferon (IFN)-free direct acting antivirals (DAAs) has become the standard-of-care for managing HCV. Sofosbuvir (SOF) is a pyrimidine nucleotide analogue which acts as the HCV ribonucleic acid (RNA) chain terminator by inhibiting HCV non-structural protein 5B (NS5B) RNA-dependent RNA polymerase following intrahepatic activation to uridine triphosphate form. Dephosphorylation results in the formation of inactive metabolite (GS-331007) that undergoes extensive renal excretion. Clinically, SOF is administered once-daily with pangenotypic potency, well tolerability and a high genetic barrier to drug resistance. Furthermore, SOF can be used in combination with NS3/4A protease inhibitors (PIs), NS5A inhibitors, and/or ribavirin (RBV) to achieve high rates of sustained virologic response (SVR). Therefore, applying SOF-based DAAs for HCV is welcome to most treating physicians.

Following the widespread use of SOF-based DAAs for treating HCV in different populations, a large-scale real-world HCV-TARGET study enrolling 1,789 patients indicated that patients with a baseline eGFR ≤ 45 mL/min/1.73m2 were associated with a higher risk of worsening renal function than those with a baseline eGFR \> 45 mL/min/1.73m2 following SOF-based DAAs. Moreover, three retrospective studies showed that SOF-based DAAs negatively affected the on-treatment and off-therapy eGFR. On the contrary, other studies showed that the use of SOF-based DAAs did not worsen the eGFR. Because most studies were retrospective in nature without protocol-defined time point for eGFR assessment or patient election, and did not enroll patients receiving SOF-free DAAs as the controls, the investigators thus conducted a prospective study to evaluate the evolution of eGFR in patients with chronic HCV infection receiving SOF-based or SOF-free DAAs.

Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV patients receiving SOF-based or SOF-free DAAs for 12 weeks

Exclusion Criteria:

* Decompensated cirrhosis (Child-Pugh B or C)
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
* Active hepatocellular carcinoma (HCC)
* Organ transplantation
* Hepatitis B virus (HBV) co-infection
* Human immunodeficiency virus (HIV) co-infection
* Not received off-therapy follow-up till week 24
Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease

The purpose of this study is to evaluate the feasibility and preliminary efficacy of the Promoting Resilience in Stress Management (PRISM) intervention in patients with adult congenital heart disease.

After consent is obtained, eligible patients (moderate or complex ACHD, stages B, C, or D) will complete the baseline study measures assessment and be randomized to receive PRISM or usual care (anticipated n=86, 43 per group). Patients in the intervention group will participate in the six PRISM sessions over 3 months. At 3 months following enrollment, patients in both groups will again complete study measures. We will define feasibility as a) the proportion of eligible patients who enroll and b) the proportion of patients who complete the intervention among those randomized to intervention. We will define preliminary efficacy as the change in mean resilience from baseline to 3 months after randomization between those randomized to intervention and usual care. Exploratory analyses will examine PRISM's impact on patient-centered outcomes of quality of life, symptoms of anxiety and depression, and perceived competence for health care.

Eligibility Criteria:
Inclusion Criteria:

* adults with moderate or complex ACHD, stages B, C, or D as defined by the 2018 ACHD guidelines
* receive care in our health system

Exclusion Criteria:

* diagnosis of another life-limiting illness
* inability to participate in study activities independently and in English
A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for LASCCHN

This study is a retrospective real-world study. In this study, we plan to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab .

This study is a retrospective real-world study. The diagnosis and treatment of patients, disease management, and information collection are completely dependent on the daily medical practice. In this study, we plan to select 5 to 8 hospitals nationwide to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018. Patients included in the study will be followed up for survival. The main endpoint is 3-year overall survival (OS) rate; the secondary endpoint are 3-year progression-free survival (PFS) rate, 3-year Local-regional control (LRC) rate, objective response rate (ORR), disease control rate (DCR) and safety.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, no gender limitation;
* Histopathologically or cytologically proved to be phase III-IVb of head and neck squamous cell carcinomas (including oral cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, but except for nasopharyngeal carcinoma).
* Patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018;
* Patients in the study group received nimotuzumab, while patients in the control group did not receive nimotuzumab. And patients in the control group were collected 3 times as many cases as the study group in each center. If the number of patients in the control group were less than 3 times of the study group, all cases were collected.

Exclusion Criteria:

* Complicated with primary malignancies other than head and neck tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* Patients received other targeted therapy, immunotherapy, or Traditional Chinese medicine with anti-tumor effect, along with the application of nimotuzumab;
* Lack of critical evaluation information.
Acute Kidney Injury in Cancer Patients Receiving Anti-Vascular Endothelial Growth Factor Monoclonal Antibody vs Immune Checkpoint Inhibitors

The goal of this a retrospective real-world study is to compare the AKI events in cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody (AntiVEGF) vs immune checkpoint inhibitors (ICIs). The main question it aims to answer is whether the choice between AntiVEGF and ICIs affects the risks of acute kidney injury in cancer patients.

Cancer patients receiving AntiVEGF will be compared to those treated with ICIs to see if the AKI incidence is higher in patients receiving ICIs.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=20yr;
* Patients must have at least one "Evaluation and Management"visit with a diagnosis of cancer within 12 months before index date (In situ biopsy will not be required, since patients may receive a diagnosis from a biopsy of metastatic site);
* Indication to initiate AntiVEGF or ICIs

Exclusion Criteria:

* Patients without valid data and less than 3 months followup;
* Patients without baseline Scr value within 12 mon before index date;
* Patients with combination therapy of Anti-VEGF and ICIs ;
* Patients with chronic renal failure
Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life

Minimal hepatic encephalopathy (MHE) has a negative effect on patients' daily functioning. No study has so far investigated the effect of treatment related improvement in cognitive functions on health related quality-of-life (HRQOL). This study was carried out to determine the influence of treatment on psychomotor performance and on HRQOL in patients with MHE.

The mean number of abnormal NP tests decreased significantly in patients in treated group compared with patients in untreated group MANOVA for time and treatment, P =.001). Mean total SIP score improved among patients in the treated group after 3 months compared with patients in untreated group after 3 months (MANOVA for time and treatment, P=.002). Improvement in HRQOL was related to the improvement in psychometry. In conclusion, treatment with lactulose improves both cognitive functions and HRQOL in cirrhotic patients with MHE.

The study has been published in March 2007 in Hepatology

Lactulose Improves Cognitive Functions and Health-Related Quality of Life in Patients with Cirrhosis WhoHave Minimal Hepatic Encephalopathy.Srinivasa Prasad, Radha K. Dhiman, Ajay Duseja, Yogesh K. Chawla, Arpita Sharma, and Ritesh Agarwal. (HEPATOLOGY 2007;45:549-559.)

Eligibility Criteria:
Inclusion Criteria:

* All the patients diagnosed as having cirrhosis of liver

Exclusion Criteria:

* Overt HE or a history of overt HE;
* History of recent (\< 6 weeks) alcohol intake;
* Infection, recent (\< 6 weeks) antibiotic use or gastrointestinal bleeding;
* History of recent (\< 6 weeks) use of drugs affecting psychometric
* Performances like benzodiazepens, antiepileptics, psychotropic drugs;
* History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension;
* Electrolyte imbalance;
* Renal impairment;
* Presence of hepatocellular carcinoma;
* Severe medical problems such as congestive heart failure, pulmonary disease, neurological or psychiatric disorder, etc., that could influence quality-of-life measurement;
* Inability to perform NP tests and to complete the SIP questionnaire due to bad vision.
The Effect of Mechanical Bowel Preparation Prior to Gynaecological Laparoscopic Surgeries on the Surgical Conditions

This RCT aims to investigate the real surgical effects of MBP prior to the gynecological laparoscopic surgeries. Those effects include lowest pneumoperitoneum pressure, lowest Trendelenburg inclination angle, the ease of the surgical view and the preferences of the patients with objective measures.

Mechanical bowel preparation (MBP) has been routinely used prior to minimally invasive gynaecologic procedures (MIGP) hypothetically to improve intraoperative bowel handling and visualization of the surgical field, and also to reduce faecal contamination in the setting of bowel injury and/or resection.

The studies investigating the effect of MBP on MIGP are limited and most of existing data are extrapolated from the reports of colorectal and urological surgery studies.

Besides, evaluation of the surgical workspace visualization and intraoperative bowel handling are far from being objective since they were mostly measured by a 4/5/10-point Likert scales or rated verbally on scales of excellent to poor by the operating surgeons.

In contrary, it is planned to use objective visualize index, and objective surgical conditions to measure whether MBP has any effect or not.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Able to provide informed consent
* Undergo laparoscopic gynecological surgery for a benign condition

Exclusion Criteria:

* History of previous abdominal surgery
* Clinically significant present or past systemic diseases
* Inability to perform mechanical bowel preparation
* Suspicion of malignancy
* Association with non-gynaecological surgical pathologies
* Severe endometriosis (stage ≥ III according to the classification of the American Society for Reproductive Medicine)
* Psychiatric disorders precluding consent