cyrilzakka/clinical-trials huggingface dataset:
Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial

Inflammatory bowel diseases (IBD) is an invalidating disease mainly diagnosed in young people. The disease is characterized by a heterogenic phenotype and the disease course by flares and remissions. As in most chronic diseases the economic burden of IBD is important due to direct health care costs and disability. Health care reorganization for IBD patients in the Netherlands is necessary for several reasons. First chronic (sub)clinical mucosal inflammation results in irreversible bowel damage and complications and none of the presently available drugs is effective for all patients and many drugs have possible severe side effects. To prevent complications of the disease and side effects IBD should be monitored carefully. In the Netherlands however there is a shortage of gastroenterologists where the incidence of IBD is rising. Secondly evidence exists that direct involvement of health care workers, patient empowerment and integrated care can improve the outcome of chronic diseases. Thirdly many clinically relevant aspects (e.g. malnutrition) of this complex disease are not systematically followed in routine care. Finally the government demands registration of efficacy endpoints for expensive drugs in the near future. Therefore the investigators developed a web-based Telemedicine tool for IBD patients in collaboration with the Dutch IBD patient's organization (CCUVN). "myIBcoach" contains E-learning modules, monitors disease activity, disability, quality of life, adherence, infections, smoking status, side effects, stress and malnutrition on fixed time points with validated questionnaires, allows the patient to communicate with health care workers and gives feedback to the back office and the patient. A feasibility study in 30 IBD patients in 3 centres showed a high satisfaction and compliance of IBD-patients and health care workers with this telemedicine tool.

The aim of this study is to compare standard care for IBD patients in 3 hospitals with a care via the telemedicine tool myIBDcoach.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed IBD
* Age 18-75 years
* Patients who have access to internet by computer, tabloid or smartphone

Exclusion Criteria:

* Not able to give informed consent
* Not able to understand and use the Dutch language
* In the two weeks after a hospital admission patients can not be included
Interleukin-2 in Treating Patients With Metastatic Melanoma

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma.

OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2. II. Assess the toxicity of this regimen.

OUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. Patients with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited. Patients are followed for survival.

PROJECTED ACCRUAL: 20 patients will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven melanoma that is metastatic No tumor replacement of 25% or more of liver on CT or MRI No involvement of the CNS or a major nerve Measurable disease required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelets less than 80,000) Hepatic: Bilirubin normal Renal: Creatinine normal Cardiovascular: No abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or EKG Pulmonary: FEV1 or VC greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma
Autonomic Regulation Trial (ART)

The purpose of this study was to develope and evaluate a new method for risk stratification which predicts high mortality risk in patients with cardiac disease based on simultateous examination of high resolution ECG, continuous arterial pressure and a breathing signal.


Eligibility Criteria:
Inclusion Criteria:

acute myocardial infarction, presence of sinus rhythm

Exclusion Criteria:

diseases (other than acute myocardial infarction) with impact on prognosis
Single Cell Landscape of HBV-related Acute-on-chronic Liver Failure Patients

This study aimed to profile the peripheral blood immune cells of patients with HBV related acute-on-chronic liver failure using single-cell RNA sequencing to reveal the immunopathological mechanisms of HBV related acute-on-chronic liver failure.

Acute-on-chronic liver failure (ACLF) is a complex clinical syndrome characterized by acute deterioration of liver function in patients with chronic liver disease, exhibiting liver and extrahepatic organ failure and a high short-term mortality. Immune imbalance plays an important role in the progression of HBV-related ACLF. Further investigation of the immune cell characteristics of HBV-related ACLF is helpful to understand its pathogenesis, and may provide reference for the effective therapeutic agent. Single-cell RNA sequencing (scRNA-seq) is the quantitative analysis of transcription at the single-cell level, which could provide systematic analyses of transcriptomic profiles, infer cell-cell interactions. This study will combine single cell transcriptomics and molecular biological experiment to elucidate the immunopathological cell states associated with HBV-related chronic liver disease vs. ACLF.

Eligibility Criteria:
Inclusion Criteria:

Acute liver failure is a well-defned medical emergency which is defned as a severe liver injury, leading to coagulation abnormality usually with an INR ≥ 1.5, and any degree of mental alteration (encephalopathy) in a patient without pre-existing liver disease and with an illness of up to 4 weeks duration

Exclusion Criteria:

* Associated with other types of hepatitis virus infection or HIV infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② Suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ Patients with incomplete data and patients unable to participate in the experiment.
Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study

The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P \< 0.05 was conducted to measure difference between the arms.


Eligibility Criteria:
Inclusion Criteria:

Subjects were required to:

1. have a mature tooth with closed apices;
2. have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
3. be prepared to appear for follow-up and
4. sign informed consent form.

Exclusion Criteria:

Subjects with:

1. moderate or severe marginal periodontitis;
2. internal or external root resorption in periapical radiograph;
3. active systemic disease;
4. physical or mental disability,
5. pregnant or lactating
The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations

The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB).

Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels.


Eligibility Criteria:
Inclusion Criteria:

* The study group consisted of volunteer individuals aged between 18 and 35 years.
* The first blood glucose measurement was taken after at least 8 hours of fasting and any of the bread types were given to the participants for consumption.
* All measurements were taken between 09.00-13.00.
* During the measurements, the volunteers were observed to avoid water, coffee, and any food intake and to avoid excessive exercise.

Exclusion Criteria:

* Pregnant,
* lactating women
* patients with physician-diagnosed chronic diseases
* Medication use
Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders

This study will evaluate and follow patients with various allergic, hypersensitivity and inflammatory disorders. The protocol is not designed to test new treatments; patients will be managed with standard of care therapies. Participants may be referred to other current NIAID protocols as appropriate or to new studies as they are developed, but will not be required to join another study.

Patients with allergic, hypersensitivity or inflammatory disorders between the ages of 3 years and 80 years may be eligible for this study. Conditions of interest include, but are not limited to, asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy.

Participants will have a medical history and physical examination, plus standard tests for diagnosing and treating their specific disorder. Tests may include routine blood and urine studies, X-rays or other imaging studies, allergy skin tests and lung function tests. Blood samples may be collected for research on immune system cells and other substances involved in immune function. Generally, about 2 to 6 tablespoons will be drawn at a time, but no more than 16 ounces will be collected over a 6-week period.

NIH does not provide emergency medical treatment or treatment for other, unrelated conditions the patient may have. Therefore, patients must maintain a personal physician for these purposes.

Allergic, hypersensitivity and inflammatory disorders, including but not limited to asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy are exceedingly common disorders. The pathogenesis of these various disorders are being investigated under a number of Laboratory of Allergic Diseases clinical research protocols. This protocol is an evaluation and long term follow-up protocol of such disorders, for the purposes of maintaining a group of patients on which LAD investigators draw for our other various protocols. The patients admitted under this protocol also provide training and experience for members of the NIAID Allergy and Immunology fellowship training programs.

Eligibility Criteria:
* INCLUSION CRITERIA:

Males and females ages 3 years to 80 years.

Allergic, hypersensitivity or inflammatory diseases.

Willingness to participate in clinical protocols when appropriate.

Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders.

EXCLUSION CRITERIA:

Unacceptably poor compliance which, in the opinion of the investigator, would interfere with one's ability to study or provide quality medical care for the patient.
GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient with Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-02)

CLIC-YYC-GPNMB-02 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-02 has progressive metastatic alveolar soft part sarcoma (ASPS). We propose to treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).


Eligibility Criteria:
Inclusion Criteria:

* Completion of Informed Consent Form
* Adequate organ function, defined as creatinine clearance \>30 ml/min and LVEF \>45%.

Exclusion Criteria:

* Any active uncontrolled infection, pregnancy or nursing.
Patient-Centered Communication of Life Expectancy Estimates in Genitourinary Malignancies

Investigators will conduct a randomized trial to determine if providing patient-specific life expectancy estimates during treatment counseling via a targeted, patient-centered communication approach improves shared decision making and reduces rates of overtreatment of genitourinary malignancies.

Subjects in the intervention arm will be provided with life expectancy estimates specific to their age and health status. Life expectancy estimates for prostate and kidney cancer patients will be estimated by age and Charlson comorbidity score cutoffs, and life expectancy for bladder cancer patients will be determined using definitions as noted by Cho et al. Talking points will be provided to counseling physicians on how to meaningfully communicate life expectancy data. Subjects will also complete a computer-based conjoint analysis exercise prior to the counseling visit; results will be used to help physicians understand how the subject values life expectancy compared with other decision attributes. The control arm will consist of the current standard of care for treatment counseling.

The intervention will be randomized at the level of the patient after stratification by type of cancer.

All participants will be asked to fill out a validated questionnaire to measure decisional conflict at the conclusion of their counseling visit. Investigators will audiotape treatment counseling visits to allow for qualitative analysis of the quality of communication of life expectancy information. Treatment choice will be documented to assess rates of aggressive versus non-aggressive treatment among patients with limited life expectancy.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed clinical T1-2 prostate adenocarcinoma with Gleason scores of 7 or less
* Newly diagnosed clinical T1a kidney cancer or renal masses \< 4cm
* Newly diagnosed clinical T2 nonmetastatic urothelial carcinoma of the bladder

Exclusion Criteria:

* Under 18 years of age
* Subjects with difficulty communicating or dementia
* Non-English speakers
Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate

To explore the feasibility of Jefcare Sterile Medical Sheets in preventing incontinence-associated dermatitis and maintaining a stable local skin microclimate in adult patients in the intensive care unit.

Jefcare Sterile Medical Sheet is an incontinence care product designed by researchers following the Expert consensus on the clinical application of disposable absorbent care products for adults with incontinence. The product has good laboratory test indicators and has the potential to prevent incontinence-associated dermatitis and maintain the stability of the local skin microclimate. Still, there is a lack of high-quality clinical studies.

Eligibility Criteria:
Inclusion Criteria:

1. Intensive care unit incontinent patients (incontinence time ≥2 days)
2. Age ≥18 years
3. patients at high risk of IAD (Perineal Assessment Tool ≥ 7)
4. Voluntarily participate in the study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to incapacitation or other reasons, their guardian is required to represent the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness will be required to witness the informed process and sign the informed consent form.

Exclusion Criteria:

1. Patients who have developed IAD
2. Expected subsequent stay in the intensive care unit \<5 days
3. Use of nappies, pull-ups, incontinence pads, etc.
4. Simple urinary incontinence with indwelling catheterization, external urinary bag without leakage; simple fecal incontinence with built-in drainage device, external ostomy bag, OB tampon without leakage; double incontinence with indwelling catheterization, external urinary bag, built-in drainage device, external ostomy bag, OB tampon without leakage.
5. The IAD may affect the skin area within the scope of the disease that affects the IAD judgment.
6. The IAD may affect the skin area within the scope of the skin breaks, infection
7. Patients who are not suitable for turning and cannot tolerate the side-lying position.
8. Patients with known allergies or keloid scarring
9. Women who are known to be pregnant or breastfeeding or who are planning to have a baby during the study period.
10. Patients who have participated in a clinical trial of another drug or medical device within 3 months.
11. Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial.
The Impact of Playing Tetris on Migrants' Mental Health

This study examines if playing Tetris prevents the development of Post-traumatic stress disorder or related anxiety and depressive symptoms. The investigators recruit 300 participants in total in Greece and in the Netherlands. The participants are immigrants who have applied for asylum at any point in the past. The participants are asked to answer three questionnaires (on Post-traumatic stress disorder, related anxiety and depressive symptoms, and post-migration living difficulties) on a recurring basis - once every 4 weeks, 12 times in total. Half of the participants (treatment group) are randomly selected to play Tetris after completing the questionnaires. Participants in the treatment group are instructed to play Tetris for at least 15 minutes while trying to remember bad things that recently happened to them. Tetris is administered at three instances and participants in the treatment group are encouraged to play Tetris in case of experiencing any traumatic events or having any intrusive memories during the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* Arabic-speaking immigrants of any gender who have applied for asylum in Greece or in the Netherlands, regardless of the outcome of their asylum application and their current residency status (rejected asylum seekers, recognized refugees, undocumented migrants).

Exclusion Criteria:

* Minors (under the age of 18).
Clinical Observation of Titration Induction and Convention Induction of Propofol

As we know propofol is popular use in the anesthesia induction with kilogram and it always cause hypotension. So we compare haemodynamic changes and drug consumption between propofol titrated administration and traditional administration for anesthesia induction.

GroupⅠreceived propofol 2 mg/kg intravenously by Fresenius pump at the speed of 250 mg/min, GroupⅡreceived propofol intravenously by Fresenius pump at the speed of 1 mg/kg/min, and observe's assessment of alertness and sedation(OAA/S) scale of the patients was titrated to 1, then changed to a maintenance dose

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists(ASA)Ⅰor Ⅱ and aged 18-60 yr, who were scheduled for general anesthesia.

Exclusion Criteria:

* Hypertension, Severe heart,pulmonary,brain，liver and renal dysfunction; excess obesity , predicted difficult intubation,hearing obstacles;. Allergic to propofol or its fat emulsion;addictive to sedative and other drugs.
Otoacoustic Emissions in Different Blood Types

The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds.

Many factors have a significant impact on otoacoustic emission (OAE) measurement and quality of analysis. Race, age and gender are among the non-pathological factors. To date there is clear data to demonstrate the association of blood types with OAEs. The aim of our research is to investigate the relation of different blood groups (ABO) and Rh factors on transient evoked OAE and distortion product OAE amplitudes and inner ear potentials, differences between ears and to contribute to the limited literature on cochlear hearing loss susceptibility and blood groups with the hypothesis that blood groups may be associated with hearing thresholds.

Eligibility Criteria:
Inclusion Criteria:

* not having hearing loss
* having a blood group card obtained from health institutions

Exclusion Criteria:

* not meeting inclusion criteria