cyrilzakka/clinical-trials huggingface dataset:
A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C.

Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.

Eligibility Criteria:
Summary of inclusion criteria:

Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group.

Summary of exclusion criteria:

Conflict of interest. Technical expertise.
Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure

The purpose of this study is to determine whether extra education of patients with chronic heart failure can reduce 6 months readmission rate to hospital.

The prevalence of heart failure (HF) has increased in the western world and is a major concern due to increasing prevalence and rising health care costs. The prognosis remains poor despite improvement in survival due to treatment with ACE-inhibitors and beta-receptor antagonists. HF has a high rate of readmission and hospitalisation. Some readmissions are ascribed to patients' lack of compliance, insufficient knowledge about diet, medication and symptoms of heart failure. Education of patients has become an important component in order to increase the patients' self-care and compliance. Intense education and counselling of patients is recommended in both European and American guidelines for HF.

Several systematic reviews of studies on strategies for improvement of outcomes of heart failure patients after discharge have been published, but very little emphasis has been put on methodological issues, e.g. methods of education. In most programs the methods and equipment used for education and information have only consisted of verbal and written material; computer-based tools seem to be relatively new.

Interactive CD-ROM programs for HF patients can increase patients' knowledge about heart failure and its treatment. However, no studies have examined the clinical outcome, e.g. rate of readmission.

Comparison: Extra educated patients (interactive CD-ROM education) compared to standard educated patients on readmission rate or death during 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients treated for heart failure with left ventricular ejection fraction (LVEF) \< 40 % at echocardiography or at least two of the criteria pulmonary rates, peripheral oedema, a third heart sound and signs of heart failure at chest X-ray.

Exclusion Criteria:

* Somatic disease or physical handicap with difficulties to communicate or handle the technical equipment, patients with only little knowledge in Swedish, patients with expected problems with compliance due to alcohol/drug abuse or major psychiatric illness, and participation in a trial.
LOL: It's All Improv After Cancer! The Impact of Improvisational Comedy on Well-Being Among Patients With Cancer

Managing distress and improving well-being is critically important for optimal survivorship care. Treatment of distress leads to better adherence to treatment, better communication, fewer calls and visits to the oncologist's office, and avoidance of development of severe anxiety or depression. Based on national guidelines, distress is typically managed with pharmacologic options (i.e. benzodiazepines), support groups, individual counseling, or chaplaincy services. To our knowledge, the role of a structured improvisational comedy (improv) program in reducing distress and improving well-being has never been evaluated in the oncology setting.

With over 14 million cancer survivors today in the United States comes a unique constellation of challenges and opportunities for health care providers trying to optimize health at a time when many patients are struggling and open to learning new skills for strengthening their own resiliency and ability to cope. Not only does a significant subset of patients with cancer experience an increase in negative emotions, such as distress, anxiety and depression, but they often also experience a lack of positive emotions (Hart 2010). Managing distress and improving well-being is critically important for optimal survivorship care. Treatment of distress leads to better adherence to treatment, better communication, fewer calls and visits to the oncologist's office, and avoidance of development of severe anxiety or depression (Partridge, Wang et al. 2003; Carlson and Bultz 2004; 2014). Based on national guidelines, distress is typically managed with pharmacologic options (i.e. benzodiazepines), support groups, individual counseling, or chaplaincy services. To our knowledge, the role of a structured improvisational comedy (improv) program in reducing distress and improving well-being has never been evaluated in the oncology setting.

Eligibility Criteria:
Inclusion Criteria:

* Female, diagnosed with breast cancer stage 1-3 (no distant metastases)
* Completed cancer treatment (including chemotherapy, radiation therapy, biologic treatment, and/or any combination) at least 1 month (30 days) from their last treatment and no more than 12 months (365 days) post-treatment. Long term hormonal/biologic treatments are ok.
* Female age ≥ 18
* Scores a at least 4/10 (≥4) on the National Comprehensive Cancer Network Distress Thermometer
* Agrees to complete study surveys
* Agrees to attend 6 improv classes
* English speaking
* Emotionally stable (per physician clearance) to participate in this series
Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus

The purpose of this study is to determine whether the Tacrolimus added to histidine-tryptophan-ketoglutarate (HTK) solution given through intraportal and intraarterial infusion during back-table procedure is capable of reducing the degree of early allograft liver dysfunction, as assessed by postoperative levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), during first 7 postoperative days and by serum and histochemical markers of liver injury and inflammation.

Early allograft liver dysfunction remains a significant complication of cadaveric liver transplantation with resource consuming and costly treatment, increased risk of multiorgan failure and 6-months mortality.

Ischemic reperfusion injury (IRI) is a main reason for early allograft liver dysfunction. Inflammatory response to brain death in donor can precipitate the extent of dysfunction after reperfusion in recipient (1). Clear inflammatory pathways in response to IRI have been reported to be associated with early allograft liver dysfunction (2,3). It was shown that ex vivo intraportal tacrolimus perfusion suppressed inflammation and immune response in the transplanted liver on a genome-wide basis (4).

We hypothesize that Tacrolimus added to HTK solution given through intraportal and intraarterial back-table infusion is capable of reducing the degree of early allograft liver dysfunction, as assessed by incidence of postreperfusion hyperfibrinolysis, postoperative levels of AST,ALT, during 1-7 postoperative days as well as serum and histochemical markers of liver injury and inflammation compared to no intraportal and intraarterial back-table infusion.

Eligibility Criteria:
Inclusion Criteria:

* Donor:

age 15-65 years macrovesicular steatosis \< 40% (macroscopy or biopsy) sodium \<165 mmol/l ICU stay and ventilation \< 11 days cold ischemia time \< 13 hours AST \< 200 U/l ALT \< 200 U/l bilirubin \< 50 μmol/l application of norepinephrine is allowed

* Recipient age: 18-69

Exclusion Criteria:

Recipient:

* live donor liver transplant
* reduced and split grafts
* multi organ failure
Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

Empirical antibiotic therapy has been known to reduce the mortality and morbidity rate in neutropenic fever. Until now, ceftazidime was the first line choice of neutropenic fever. However, resistance against ceftazidime has been reported. Several countries have reported cefepime in reducing fever and shorten the length of hospitalization better than ceftazidime. This study is aimed to compare the effectivity of ceftazidime and cefepime to reduce fever and to increase the absolute neutrophils count (ANC) in the first 72 hours.

This study is a randomized controlled trial with single blinding, conducted in the children's hematology-oncology wards of Cipto Mangunkusumo Hospital and Harapan Kita Children's Hospital in Jakarta, December 2018 through May 2019. Study population includes all children with leukemia with febrile neutropenia episodes that are being hospitalized in our hospitals in the appropriate time. Subjects were chosen by consecutive sampling. Inclusion criteria includes children with leukemia aged 1 month to 18 years old undergoing chemotherapy, having fever of ≥ 38,3 degree celsius in axillar temperature with ANC \< 1000/mm3. Patients' parents or guardians must be willing to participate and willing to sign a written informed consent form. Exclusion criteria includes patients with a history of penicillin or cephalosporin allergy and/or patients with kidney dysfunction. Block randomization was done to place each patient into cefepime or ceftazidime group. Data analysis was done using SPSS ver. 21 software. Numerical data was shown as mean with standard deviation if the data is normally distributed or median with minimum-maximum value if the data is not normally distributed. Chi-square as the correlation test was done in order to determine the association between free and dependent variables, based on nominal data. Mann Whitney test was done as the correlation test in order to test the difference between medians of uncoupled groups and one categorical variable, and one interval variable and the not normally distributed data.

Eligibility Criteria:
Inclusion Criteria:

* children with leukemia aged 1 month to 18 years old undergoing chemotherapy
* having fever of ≥ 38,3 0C in axillar temperature
* ANC \< 1000/mm3
* patients' parents or guardians must be willing to participate and willing to sign a written informed consent form

Exclusion Criteria:

* patients with a history of penicillin or cephalosporin allergy
* patients with kidney dysfunction
Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)

Collect blood samples and associated clinical data prior to, during, and post radiation treatment.

In order to further refine and independently validate the performance of DxTerity's test developed during the previous pilot study, the study will collect pre-, during, and post-irradiation blood samples and associated clinical and self-reported information from up to five hundred (500) subjects for analysis. Patients with a diagnosis of primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer requiring radiation treatment to the primary disease site will be included in the study. Combining chemotherapy is allowed.

Blood samples for this study will be collected from cancer patients scheduled to undergo radiation therapy prior to and either during or after treatment. Approximately 150μL of blood per time point will be obtained via fingerstick remotely, from the participant's home or doctor's office; participation in this study will not affect any aspect of patient treatment. Samples will be collected using DxTerity's proprietary DxCollect® MCD Fingerstick Kit (MCD).

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients age 18 or older
2. Have a permanent address in the United States for the duration of the study
3. Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer
4. Planned radiation therapy to the abdominal/pelvic area as part of clinical care
5. Able to provide informed consent

Exclusion Criteria:

1. Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment
Biomarkers for Intestinal Permeability

This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods.

This study aims to find easy-to-measure biomarkers of intestinal permeability as surrogate markers for effortful "gold standard" methods. In healthy volunteers potential biomarkers for intestinal permeability as well as an established "gold standard" method for intestinal permeability (urinary lactulose/mannitol excretion) will be measured at one time point. Using correlation analyses, potential associations will be assessed and potential biomarkers will be addressed and discussed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Written informed consent

Exclusion Criteria:

* Underweight (BMI \<18 kg / m2) and obesity from grade II (BMI ≥ 30 kg / m2)
* Acute or chronic gastrointestinal diseases
* Chronically consuming diseases (e.g. chronic tumor disease, florid infections, etc.)
* Smokers (12 hours before the test and during the test it is not allowed to smoke)
* Ingestion of intestinal therapeutics, antibiotics, immunosuppressants or similar within the last 3 months
* Simultaneous participation in another clinical study
* Pregnancy / breastfeeding
* Intolerance to the sugar solution
* Occurrence of relevant diseases
* Revocation of consent
Feasibility and Pilot Study of a Rule-based Chatbot Application for Adolescents With Anxiety Symptoms

The goal of this feasibility and pilot study is to investigate the feasibility and preliminary clinical effects of a new rule-based chatbot intervention for adolescents with anxiety symptoms. The main questions are:

* Is the intervention feasible for adolescents who are experiencing anxiety symptoms?
* How do the adolescents experience the use of the intervention?
* Does the intervention lead to a reduction in anxiety symptoms?
* Does the intervention lead to a clinically significant reliable improvement at functional level?

Anxiety is one of the most common psychiatric disorders and the anxiety symptoms typically onsets in adolescence. The anxiety symptoms may be persistent into adulthood, leading to a poorer life quality and function impairments. The goal is to prevent the development of anxiety and comorbid disorders, as well as function impairment due to anxiety symptoms. This study wishes to investigate the feasibility and preliminary clinical effects of a digital intervention in an open pre-post and 3 months follow up study. The intervention consists of a rule-based click-chatbot, combined with therapist-guidance. This study will recruit N = 30 adolescents from Norway from age 13 up to 16 years old to investigate the feasibility and preliminary clinical effects of a rule-based click chatbot-intervention, and whether it causes a reduction in anxiety symptoms and increases of life functioning. If the intervention is feasible with promising results, the study will serve as a first step to a future randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* reporting anxiety symptoms that hinders them in participating in daily activities
* spending time trying to avoid these anxiety symptoms
* aged 13 and up to 16 years
* can read Norwegian

Exclusion Criteria:

* clinical cut-off on OCD subscale on RCADS-47\> 10,
* clinical cut-off on Depression subscale on RCADS-47 \> 16,
* ongoing treatment
* extensive reading/writing difficulties
* extensive concentration problems
Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol

Primary Objective:

To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).

Secondary Objectives:

To assess the effects of SC doses of alirocumab on:

* Various parameters of the metabolism and turnover in plasma of different lipoproteins
* Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a))
* Lipoprotein particle size profile
* PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.

Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.

Eligibility Criteria:
Inclusion criteria:

Generally healthy; LDL-C level in serum or plasma ≥ 100 mg/dL and \< 190 mg/dL at Screening.

Exclusion criteria:

* LDL-C ≥ 160 mg/dL at Screening if more than 2 major Coronary Heart Disease risk factors, as defined in National Cholesterol Education Program guidelines.
* Receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with history of moderate-to- severe rheumatoid arthritis for more than 6 months according to the American College of Rheumatology (ACR) 1987 revised criteria for the classification of RA.
* Patients who failed to achieve clinical response to treatment of at least 2 DMARDs(disease modifying anti-rheumatic drug) (including MTX) for at least 12 weeks within 12 months prior to screening, of which MTX must have been at a stable dose of 10-20 mg/wk for at least 12 weeks prior to screening. All other DMARDs should be given at standard therapeutic dose.
* Patients who satisfy swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
* C-reactive protein (CRP) level ≥ 1 mg/dl or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening and at baseline.

Exclusion Criteria:

* Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
* Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
* Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
* Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
* Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand \& foot fungal infections can participate.
Oxytocin Effects on the Tolerance of Infidelity

To investigate whether intranasal oxytocin (40 IU) treatment can influence the tolerance of infidelity in males and females.

In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effect of oxytocin treatment on the tolerance of infidelity. Male and female subjects would firstly see a neutral face of the opposite sex presented with a sentence descried their fidelity or infidelity behavior (sexual or emotional) in a relationship. Next the participant will rate the attractiveness, likability and trustworthiness of each individual, and whether they would like to have a short/long relationship with him/her. After that there will be some implicit attitude tasks to test their implicit attitude towards potential partners exhibiting previous fidelity or and infidelity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* pregnant,menstruating,taking oral contraceptives
* medical or psychiatric illness.
Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the ADR

In this study, the investigators used the optical flow method to measure the colonoscopy withdrawal speed, and doctors were selected from multiple hospitals to collect prospective colonoscopy screening videos, and the percentage of colonoscopy withdrawal overspeed was calculated to explore the relationship between it based on optical flow method and the adenoma detection rate.

Study showed that adequate withdrawal time is an important prerequisite for full mucosal inspection. In a large population-based analysis, a 1-min increase in withdrawal time led to a 3.6% increase in the ADR. Protocols or expert consensus recommend a standard withdrawal time of 6 min or longer. However, Findings of studies showed that a number of colonoscopies had a withdrawal time less than 6 min, which greatly reduces the ADR.

Investigator's preliminary experiments have shown that deep learning can monitor the colonoscopy withdrawal time in real-time and improve the adenoma detection rate. Based on the above rich foundation of preliminary work and the massive demand for improving the colonoscopy withdrawal assessment system.

The investigators improved EndoAngel to use optical flow method to monitor the colonoscopy withdrawal speed. The performance of the EndoAngel system was verified in colonoscopy videos. The investigators then aimed to evaluate whether the EndoAngel system could improve polyp detection rate after restricting the colonoscopy withdrawal speed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years old;
2. Able to read, understand and sign an informed consent;
3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
4. Patients requiring screening colonoscopy.

Exclusion Criteria:

1. Have drug or alcohol abuse or mental disorder in the last 5 years;
2. Pregnant or lactating women;
3. Patients with known multiple polyp syndrome;
4. patients with known inflammatory bowel disease;
5. known intestinal stenosis or space-occupying tumor;
6. known colon obstruction or perforation;
7. patients with a history of colorectal surgery;
8. Patients with a previous history of allergy to pre-used spasmolysis;
9. Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
10. High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.