cyrilzakka/clinical-trials huggingface dataset:
Strain Echo in Acute Heart Failure

The purpose of this project is to evaluate the utility of left ventricular strain as part of the assessment of patients in the emergency department with acute heart failure (HF). The central hypothesis of the investigation is that left ventricular strain will prove to be a treatment response variable in patients with acute HF. Patients who are being treated for acute HF with intravenous (IV) vasoactive medications (diuretics, vasodilators, inotropes) will be eligible for enrollment. Patients who give written consent will receive a focused bedside echocardiogram within 30 minutes of the initiation of therapy for acute HF. Images that are captured during this echocardiogram will be interpreted by a blinded cardiologist offline. 23 hours after this initial focused echocardiogram a member of the study team will perform a follow-up focused echocardiogram, capturing the same images that will then be interpreted by a blinded cardiologist offline.

Offline analysis will be performed using a proprietary software package from General Electric called Automated Function Imaging (AFI). The AFI software will be used to calculate longitudinal strain of the left ventricle (LV). Regional and global strain values will be calculated for each focused echocardiogram for each subject. It is our hypothesis that LV strain will demonstrate improvements from the initial echocardiogram to the follow-up echocardiogram, unlike other echocardiographic indices in HF such as LV ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* Ability for the patient to provide written informed consent
* Planned treatment with intravenous (IV) medications (diuretics, vasodilators, inotropes) for acute HF

Exclusion Criteria:

* Need for emergent, resuscitative intervention (e.g., cardiopulmonary resuscitation, endotracheal intubation)
* Rapid atrial fibrillation or other arrhythmia that requires IV rate or rhythm control
* Plans for emergent percutaneous coronary intervention (PCI) from the ED
* Pregnancy
* Incarceration
* history of cardiac transplant
* planned transfer to another institution
Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic

The purpose of this study is to determine the incidence of Fabry Disease in young stroke patients in an Israeli stroke clinic.


Eligibility Criteria:
Inclusion Criteria:

diagnosis of stoke or TIA Time period within last 5 years -

Exclusion Criteria:

Known diagnosis of stroke or index event due to trauma

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Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization

Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours.

Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours. The aim of this study is to compare through a randomized clinical trial to reduce the rest time in bed for five hours after elective diagnostic cardiac catheterization, with a 6F sheath with a transfemoral approach, for a period of three hours of the occurrence of bleeding, hematoma, pseudoaneurysm and a vasovagal reaction.

Eligibility Criteria:
Inclusion Criteria:

* age equal too or above 18 years
* patients undergoing elective diagnostic cardiac catheterization on an outpatient basis and
* who agree to participate by reading and signing the informed consent form.

Exclusion Criteria:

* patients with restriction ambulation;
* users of coumarin anticoagulants;
* IMC greater than 35 kg/m2;
* patients with hypertension (systolic PA \> 180 mmHg and diastolic PA \> 110 mmHg) at the end of the procedure
Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity

The purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and Expanding variety (CHANGE) obesity program.

The purpose of the study is to develop and test the feasibility of a structured, innovative approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder (ASD). This 16-week program integrates behavioral psychology and nutrition science to meet the challenges of obesity in children with autism spectrum disorder (ASD). The PI will apply an evidence-based behavioral intervention to increase food variety,15 use applied behavior analytic strategies to teach physical activities in a developmentally-appropriate manner, employ biometrics to assess progress, utilize dietetic interventions to improve nutritional balance, and train caregivers to use behavior management strategies.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of ASD confirmed by a clinical psychologist using a "gold standard" diagnostic tools
* Overweight status, as evidenced by a BMI percentile \> 85% to 94%, and 4) mild to no food selectivity, as evidenced by either history of consuming some fruits and vegetable, tolerating new foods near their plate, and/or trying new foods

Exclusion Criteria:

* Children being treated with atypical antipsychotics (e.g., olanzapine, aripiprazole, risperidone) or other medications known to cause weight gain will be excluded from the study due to the weight gain associated with these medications
* Children with unstable medical conditions will be excluded for safety concerns
* Children presenting with severe aggression, self injury, or other disruptive behaviors that require intensive behavioral intervention will be excluded and referred to other services as needed
Pre-Prostatectomy Celecoxib or Placebo

This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2) inhibition suggested by preclinical systems occur in human prostate cancer. To answer this question, men who have chosen prostatectomy will be randomly assigned to preoperative treatment with celecoxib or placebo for four weeks. Carefully collected tumor, premalignant, and benign prostate tissue will then be examined for apoptosis, androgen receptor and prostaglandin E2 levels. Tumor COX-2 expression will be correlated with observed treatment effects. The data generated by this study will serve as a foundation for the development of COX-2 targeted therapies for prostate cancer, will provide preliminary evidence for larger scale clinical trials aimed at treatment and prevention of prostate cancer, and will validate current preclinical models used to study COX-2 in prostate cancer.

PRIMARY OBJECTIVE

I. To determine if COX-2 inhibition with celecoxib significantly increases apoptosis in human adenocarcinoma of the prostate.

SECONDARY OBJECTIVES

I. To determine if COX-2 inhibition with celecoxib reduces levels of Prostaglandin E2 and androgen receptor in fresh tumor tissue collected at prostatectomy

II. To collect pre- and postoperative serum Prostate Specific Antigen (PSA) for exploratory analyses

III. To determine the effect of celecoxib on adverse effects, perioperative surgical complications and post surgery analgesic use

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically or cytologically proven adenocarcinoma of the prostate and planned prostatectomy
* Age \>= 18
* Performance status (ECOG \<= 2)
* Hemoglobin \> 10 g/dL (within 4 weeks)
* Creatinine \<= 1.5 mg/dL
* Signed informed patient consent

Exclusion Criteria:

* Other preoperative or prior treatment directed at prostate cancer
* Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* Use of non-steroidal anti-inflammatory agents within seven days of celecoxib treatment
* Hypersensitivity to celecoxib
* A history of asthma, urticaria, or anaphylaxis precipitated by an NSAID
* History of significant upper gastrointestinal bleeding or active peptic ulcer disease
* Current treatment with anticoagulants
* Allergy to sulfonamide
Renal Prognosis in Chronic Kidney Disease Patients With Hyporesponsive Anemia to Erythropoiesis Stimulating Agents

This is an observational clinical research on patients with chronic kidney disease who are not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major objective is to explore novel erythropoiesis stimulating agent (ESA) response index in association with deterioration of renal function as well as occurrence of cardiovascular disease events.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are planning to start treatment with darbepoetin alfa within 8 weeks after enrollment,
2. Patients with eGFR \<60 mL/min/1.73m2 at the latest examination performed within 8 weeks before enrollment,
3. Patients with a hemoglobin level \<11.0 g/dL at the latest examination performed within 8 weeks before enrollment,
4. Patients aged at least 20 years or older at the time of providing informed consent,
5. Patients who voluntarily provided written informed consent to participate in the study.

Exclusion Criteria:

1. Patients who are planning to start hemodialysis or to have a renal transplant within 24 weeks after enrollment,
2. Patients with a history of treatment with ESA except the ones who were treated temporarily more than 12 weeks before the enrollment,
3. Patients with malignant tumor, hematological disease, or hemorrhagic lesions,
4. Patients with hypersensitivity to ESA or any ingredient thereof,
5. Pregnant, lactating or possibly pregnant women or those who wish to become pregnant during the study period,
6. Patients who are participating in other clinical study,
7. Patients who are assessed as not eligible for the study by the investigator.
Treatment of Human Cord Blood Mononuclear Cell for Delayed Encephalopathy After Carbon Monoxide Poisoning

The effects and safety of Human cord blood mononuclear cell for delayed encephalopathy after carbon monoxide poisoning

To evaluate the effect and mechanism of human cord blood mononuclear cell transplantation for delayed encephalopathy after carbon monoxide poisoning

Eligibility Criteria:
Inclusion Criteria:

* 35-60 years old.
* No serious infection, chronic diseases, diabetes and tuberculosis.
* Written informed consents were obtained from all subjects.
* Symptomatic Delayed Encephalopathy After Carbon Monoxide Poisoning.

Exclusion Criteria:

* The heart, liver, kidney and other viscera serious organic disease.
* Allergic constitution, clotting disorders, autoimmune diseases and tumors.
* Pregnancy.
* Moribund patient.
* History of prior brain injury.
* History of central nervous system disease.
Study Intestinal Complaints During Chemotherapy.

Study intestinal complaints during chemotherapy. A prospective study into intestinal complaints in patients undergoing chemotherapy treatment. A pre and post implementation design is used to establish if eating two kiwi fruits per day can prevent constipation.

The Medical Research Involving Human Subjects Act (WMO) does not apply to this research. Nonetheless it will be conducted according to the principals of Good Clinical Practice (GCP), privacy legislation (AVG) and Medical Treatment Agreement Act (WGBO). The consumption of eating two kiwi's a day can be seen as a slight variation on standard advice with regards to a healthy diet. Maintaining a diary may take some time from the participant but at the same time is of use during follow up visits where side effects, including the occurrence of constipation are discussed. The The study is approved by the Advisory Committee on Local Feasibility (ACLU) of the Spaarne Gasthuis.

Eligibility Criteria:
Inclusion Criteria:

1. First chemotherapy/cytostatics treatment
2. Neo-adjuvant or adjuvant treatment
3. Performance status World Health Organization (WHO) 0-1
4. Age 18+
5. Written informed consent
6. Command of the Dutch language

Exclusion Criteria:

1. Kiwi allergy
2. Patients using standard laxatives prior to the first chemotherapy/cytostatic treatment.
3. Patients with a history of bowel resection
4. Patients with stoma
OFA in Thoracic Surgery

to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value

Opioids used to have its irreplaceable role in standard opioid-based anesthesia, yet with the help of hypnotics, local anesthetics, anti-inflammatory drugs, α-2 agonists and epidural techniques, opioid-free anesthesia (OFA) has been proved to be safe and feasible for non-cardiac major surgeries. Opioid-sparing anesthesia (OSA) is encouraged by the needs of enhanced recovery and recommended by the latest guidelines for anesthesia of lung surgery. According to previous studies, both opioid-sparing and opioid-free anesthesia would reduce the incidence of opioid-related adverse events and speed up the postoperative recovery to some extent, yet no studies ever are dedicated to compare these two different techniques.

Eligibility Criteria:
Inclusion Criteria:

* going through thoracoscopic lung surgery including lobectomy, segmentectomy, single or multiple wedge resection, and two of the above procedures combined;
* able to complete the pain scoring face-to-face;
* no cognitive dysfunction or history of anesthetic drug allergy;
* ASA grade I-II

Exclusion Criteria:

-psychological disorders
Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

The purpose of this study is to assess the antitumor effects and safety of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle cell lymphoma.

Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride has a unique structure compared with the marketed agents, and has an innovative mechanism of action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives for patients with refractory/recurrent indolent B-cell Non-hodgkin's lymphoma.

Eligibility Criteria:
Inclusion Criteria:

Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.

* Patients with histologically or cytologically confirmed indolent B cell Non-Hodgkin's lymphoma or mantle cell lymphoma.
* Patients who had not received treatment for at least 4 weeks (for at least 12 weeks in the case of antibody therapy) after completion of prior therapy and who are judged to carry no effect from the prior therapy.
* Patients aged from 20 to less than 75 years.
* Performance Status (P.S.): 0 or 1.
* Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions).
* Patients from whom written consent to participate in this study has been obtained.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded.

* Patients with apparent infections.
* Patients with serious complications (hepatic failure or renal failure).
* Patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
* Patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
* Patients who are known to be positive for HBV, HCV or HIC.
* Patients receiving other investigational drugs within 3 months before registration in the study.
* Patients with allogenic bone-marrow transplant.
* Women who are pregnant, of childbearing potential, or lactating.
* Patients who do not agree to contraception.
* Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
Zanubrutinib, Lenalidomide and Rituximab (ZR2) in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)

This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) regimen in elderly treatment-naive patient with diffuse large B-cell lymphomas.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive pathologically confirmed patients with diffuse large B-cell lymphoma (DLBCL)
* Refuse to undergo systemic chemotherapy or not suitable for chemotherapy
* Radiography detects measurable lesions defined as at least 1 clearly defined lesion/nodule with both long and short diameters longer than or equal to 1.5cm
* Life expectancy of at least 3 months determined by researchers
* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research
* Research drugs have not been used before

Exclusion Criteria:

* The patient has received systemic or local anti-tumor treatment, including chemotherapy, within three weeks before enrollment
* The patient has complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

  1. Neutrophils\<1.5 x 10\^9/L
  2. Platelets\<80 x 10\^9/L
  3. ALT or AST is 2 times higher than the normal upper limit, AKP and bilirubin are 1.5 times higher than normal upper limit
  4. Creatinine is 1.5 times higher than the normal upper limit
* Other concurrent and uncontrolled medical conditions that the researchers believe that they will affect the patient's participation in the study, including patients with psychosis or other known or suspected patients who cannot fully comply with the research protocol
* HIV-infected patients
* Patients with HbsAg positive are required to have negative HBV DNA before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and if the result is positive, anti-viral treatment is also required, and negative HBV DNA is required before entering the group
* Other medical conditions determined by the researchers that may affect the study
Study of Zonal and Balance Acupuncture Pain Relief Effect

The aim of the study is to investigate how effective is zonal acupuncture method compared to balance method to obtain a short coming pain relief effect, which takes place several minutes after needle insertion.

Main purpose of the study is to estimate the efficiency of the zonal acupuncture method compared to control group and the balance acupuncture method.

This study includes random completion of 3 groups of participants : zonal acupuncture, control group, balance acupuncture approximately 20 participants each.

The zonal acupuncture group will receive a treatment according to a zonal method and a pain level will be estimated by the investigator according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.

The control group will provide only the estimation of the the pain level according to a visual analog pain scale (VAS) but receive no acupuncture treatment. Then if possible the pain level will be measured again approximately 24 hours after the first measurement and the change of the pain level will be recorded for a control group too.

The balance acupuncture group will receive a treatment according to a balance method, and a pain level will be estimated according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.

These measurements are primary outcome of the experiment. Provided statistically consistent they will be treated to extract method efficiency estimation.

The participants from all tree groups may receive drug analgesia at some recorded moment of time before the procedure, however the investigators want to investigate the effect of acupuncture analgesia at the time when no other analgesia effect is present, so the investigators can exclude possible interference.

Eligibility Criteria:
Inclusion Criteria:

* post traumatic pain syndrome
* vertebrogenic pain syndrome

Exclusion Criteria:

* oncological diseases
* narcotic dependency
* psychiatric disorders
R-ESHAP Followed by Autologous Transplantation for Refractory or Relapsed Diffused Large B-cell Lymphoma

The aim of study is to prove R-ESHAP regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is effective.

The standard treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of R-ESHAP regimen in a multi-center basis.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-65 years old
* Histological confirmed diffuse large B-cell lymphoma
* Refractory or first relapsed disease
* Prior anthracycline exposure
* Measurable disease
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧90g/L
* Liver function: total bilirubin, ALT and AST \<1.5×UNL
* Renal function: Cr\<1.5×UNL, CCR≧50ml/min
* No contraindication for transplantation

Exclusion Criteria:

* Evidence of CNS and bone marrow involvement
* More than 1 type of chemotherapy regimens exposure
* High level of HBV DNA
* Contraindication of high-dose methylprednisolone
* Pregnant or lactating women
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* History of allergic reaction/hypersensitivity to rituximab
* Significant active infection