cyrilzakka/clinical-trials huggingface dataset:
Prognosis and Risk Factors for Acute Kidney Injury

The aim of our study is to analyze the accurate diagnosis and prognosis of acute kidney injury (AKI) based on its severity and to define long-term clinical and socioeconomic outcomes.

Investigators defined the AKI group among adults aged 20 years or older who visited enrolled center and underwent at least two blood tests, including serum creatinine, within an interval of 7 days or less and a control group was matched 1:1 to the AKI group based on age, sex, year of visit, and baseline kidney function, forming the study population. Investigators then collected and analyzed various clinical, laboratory, and hospitalization records including demographic data, anthropometric data, laboratory data, and medical history.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years old who visited Parcitipating Medical Center (Seoul National University Hospital, Bundang Seoul National University Hospital, SMG-SNU Boramae Medical Center, Keimyung University Dongsan Medical Center) between 2006 and 2021
* The AKI group is defined as individuals meeting the AKI diagnostic criteria of the KDIGO Guideline (an increase in serum creatinine of ≥0.3 mg/dL or ≥1.5 times the baseline level) is enrolled.
* The Control Group is defined as individuals from the study population who do not meet the AKI criteria and are matched 1:1 based on age, sex, year of visit, and baseline renal function.

Exclusion Criteria:

* Individuals under 20 years old
* Individuals who did not undergo serum creatinine tests meeting the criteria
* Individuals with pre-existing end-stage kidney disease (ESKD) who have undergone dialysis or kidney transplantation
Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants

This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation compared to infants of parents who receive the control intervention.

Peripartum mothers will be randomly assigned to receive the modified ABC intervention or the control intervention (modified DEF). Hypotheses relate to parent and child outcomes associated with the intervention.

Hypothesis 1: Compared to mothers who receive the control intervention, mothers who receive the ABC intervention will show more nurturing and sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production.

Hypothesis 2: Compared to infants of mothers who receive the control intervention, infants of mothers who receive the ABC intervention will show more organized and secure attachment patterns, better behavioral regulation during stressors, more advanced social-emotional development, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production.

Hypothesis 3: Enhanced maternal sensitivity will mediate effects of the ABC intervention on improved infant outcomes.

Eligibility Criteria:
Inclusion Criteria:

* In third trimester of pregnancy or up to one month postpartum
* Receiving medication-assisted treatment for opioid use disorder

Exclusion Criteria:

* None
Compare the Outcomes of XT and XEC Adjuvant Chemotherapy in HER2-negative Luminal B Breast Cancer Patients

Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete response(pCR) are randomly divided into the group treated with XT protocol and the group with Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the disease free survival(DFS) and overall survival(OS) of two subgroup.

Individualized treatment of breast cancer has become one of the main directions in the clinical and research areas of breast cancer,and the individualized treatment of the estrogen receptor(ER) positive patients which covered 65% of total cases is of vital importance. Historical research showed that among the ER-positive and HER2-negative breast cancer,Luminal B breast cancer with Ki67\>14% is more likely to be benefited from chemotherapy,compared with the Luminal A breast cancer with Ki67\<14%. And the results of our previous research showed that, the neoadjuvant XT protocol has more than 17% pCR rate in Luminal B subtype breast cancer.However,to those who didn't reach pCR,we've got no evidence whether switching to Anthracycline-based post operative protocol can benefit them.So that,we sketch out a randomized controlled multicentric phase III clinical trail.HER2 negative Luminal B subtype breast cancer patients are included. After 4 cycles of XT protocol neoadjuvant chemotherapy ,those who reach PR but not pCR are randomly divided into the group treated with XT protocol and the group with XEC protocol ,then compare the DFS and OS of two subgroup.

Eligibility Criteria:
Inclusion Criteria:

* Chinese population surgery patients with invasive breast cancer；
* Stage II-III；
* ER positive；
* HER2 negative；
* Ki67≥14%；
* Aged between 18 and 70 years old；
* The maximum diameter of the primary tumor greater than 1cm；
* ECOG score 0-1 points； -Have adequate baseline bone marrow and organ function reserve : absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 8g/dl; the ≥ 100000/mm3 hemoglobin concentration and serum creatinine ≤ 1.5 times the upper limit of normal ; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal , bilirubin ≤ 1.5 times the upper limit of normal ; left ventricular ejection fraction ( LVEF ) ≥ 50%

Exclusion Criteria: - Non - Chinese population of patients；

* Non- invasive cancer patients;
* Inflammatory Breast Cancer patients;
* Metastatic breast cancer patients;
* HER2 positive patients;
* Ki67\<14% patients;
* No adequateBaseline bone marrow or organ function reserve;
* ECOG PS score ≥ 2 points;
* Younger than 18 years of age or greater than 70 years old;
* Already accepted therapy including chemotherapy , endocrine therapy or targeted therapy before neoadjuvant treatment;
* HER2-positive patients with left ventricular ejection fraction less than 55 % can not receiving Herceptin;
* Known allergy of docetaxel , capecitabine , epirubicin , ring phosphonamide .
Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases

Patients are invited to participate in a research study of liver perfusion (how blood flows to the liver over time). Researchers hope to learn whether perfusion characteristics of liver metastases may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment. Patients were selected as a possible participant in this study because they are identified as having liver metastases

PRIMARY OBJECTIVES:

I. The purpose of this study is to perform a pilot feasibility study on 3-dimensional (3D) ultrasound imaging of liver metastases and to evaluate whether perfusion characteristics (measurements of blood-flow) of hepatic metastases can predict tumor response to treatment in patients with liver metastases. The investigators long term goal is to assess whether early perfusion changes at 2 weeks after chemotherapy initiation can be used as a non-invasive early biomarker for treatment response assessment.

OUTLINE:

Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy, at 2 weeks, and at 2 months.

Eligibility Criteria:
Inclusion Criteria

* Provides written Informed Consent and is willing to comply with protocol requirements.
* Has at least 1 focal lesion in liver or kidney
* Patient may be (i) in the process of receiving treatment (1 scan session), (ii) never treated (3 scan sessions) or (iii) changing treatment regimen/ type and/or receiving a new form of treatment and/or has been on a treatment break ('holiday')(3 scan session)
* Is at least18 years of age.

Exclusion Criteria

* Is determined by the Investigator that the subject is clinically unsuitable for the study.
* Known right to left cardiac shunt, bidirectional or transient.
* Hypersensitivity to perflutren.
* Hypersenstivity to the contrast agent Definity.
* Pregnant and lactating women
Patient and Physician Preference Study in Resectable, Non-small Cell Lung Cancer Treatments

The purpose of this study is to investigate the perspectives and preferences of patients and healthcare professionals (medical oncologists, pneumologists, thoracic surgeons) regarding treatment options in the resectable non-small cell lung cancer (NSCLC) setting


Eligibility Criteria:
Inclusion Criteria:

Patients

* Aged ≥18 years at the time of enrollment in the study
* Resident of the US, Germany, or Japan
* Able to read, speak, and understand English, German or Japanese
* Diagnosed with resectable phase II to IIIB non-small cell lung cancer (NSCLC)

Physicians

* Resident of the US, Germany, or Japan
* Lung cancer-treating physician specialized in one of the following medical areas: oncology, pneumonology, thoracic surgery, or radiology
* Treated at least three new patients with resectable NSCLC in the past year

Exclusion Criteria:

Patients

* Appears to have sensory and/or cognitive impairment(s) that could interfere with their ability to provide online and/or verbal consent, or complete any other interview activities (based on screener judgment)
* Being diagnosed with another malignancy alongside NSCLC
* Not willing to be audio-recorded during the interview

Physicians

* Appears to have sensory and/or cognitive impairment(s) that could interfere with their ability to provide online and/or verbal consent, or complete any other interview activities (based on screener judgment)
* Not willing to be audio-recorded during the interview
Machine Learning Approach Based on Echocardiographic Data to Improve Prediction of Cardiovascular Events in Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy is a pathology with a highly variable course, ranging from patients who are asymptomatic throughout their lives to those who experience sudden death and/or terminal heart failure.

The main objective is to develop and validate an algorithm (constructed through supervised learning) using cardiac imaging data to predict the risk of cardiovascular events in sarcomeric hypertrophic cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Patients with confirmed sarcomeric hypertrophic cardiomyopathy

Exclusion Criteria:

* Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient)
* Other causes of left ventricular hypertrophy that may hamper the diagnosis (p.e. aortic or sub-aortic stenosis, severe renal insufficiency, hypertension).
* History of ischemic heart disease or associated myocarditis
* Opposition of the patient to the use of his/her data
Correlation Between Umbilical Resistance Index and Fetal Growth

The aim of our study was to investigate the correlation between the umbilical resistance index and weight gain during the third trimester of low-risk pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.

Exclusion Criteria:

* -The lack of an ultrasound carried out during the first trimester to confirm the term of the pregnancy.
* A medical condition in the mother: diabetes, high blood pressure or a known chronic illness.
* A medical condition in the fetus: suspicion of fetal hypotrophy (fetal biometrics lower than the 10th percentile), a birth defect (a chromosomal abnormality) during the pregnancy.
* Patients with tobacco addiction.
* A body mass index (BMI) ≥ 30 before the pregnancy.
* Multiple pregnancies
* A gap of less than 4 weeks between the date of the ultrasound and the date of delivery.
Influence of Manual Relaxation of the Diaphragm on the Tension of the Posterior Superficial Fascia

The diaphragm performs many functions that are vital to the body as a whole. Some of them are not related only to ventilation. The diaphragm is part of the myofascial system in the human body. Therefore, the proper functioning of the diaphragm should be a significant element of physiotherapy, e.g. in patients reporting pain in the lumbosacral spine.

Considering the complex role of the diaphragm, it seems reasonable to investigate the influence of the mobilization of the diaphragm (aimed at reducing diaphragm tension) on the tension of the extensor muscles of the lumbar spine.

The assumption of this reserach is to investigate the correlation between the tension of the fascia in the area of the diaphragm to the tension of the muscles in the area of the lumbar spine. The fascial connections between the diaphragm and the muscles in the lumbar spine presented above suggest that the manual therapy performed within the diaphragm can effectively prevent the occurrence of pain, and might be a supportive measure in the treatment of pain in the spine.

The aim of the study is to investigate the corellation between the tension of the fascia within the diaphragm and the tension of the posterior superficial tape.

Research questions:

1. How does manual therapy in the area of the tendon attachments of the diaphragm affect the relaxation of the extensor muscles of the lumbar spine?
2. How can the therapy conducted only within the diaphragm, without interfering with the structures surrounding the spine, reduce the tension of the extensor muscles of the lumbar spine and, consequently, increase the range of its mobility in all planes?
3. How will the introduced therapy change the tidal volume of the lungs?


Eligibility Criteria:
Inclusion Criteria:

* age within 20-40 yrs,
* BMI within normal range (18.5-24.9)
* lack of abdominal obesity
* lack of chronic musculoskeletal conditions
* written, conscious consent

Exclusion Criteria:

* former abdominal surgery
* abdominal diseases (i.e. (np. kidney stones, ulcers, irritative bowel sindrome, etc.),
* pregnancy
* fever,
* tumors,
* blood hypertension,
* former surgery of respiratory system ,
* condition after surgical procedures in the area of the spine,
* the occurrence of pain in the spine in the 3 months preceding the research experiment,
* lack of conscious consent
Load Experienced While Using a Stander in Children With Cerebral Palsy

The goal of this project is to design and validate a force-measuring platform that will measure the magnitude and duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their Bone Mineral Density.

Non-ambulatory children with a neuromuscular disability are at significant risk for poor bone health as reflected by low bone mineral density (BMD) and increased propensity to fracture. In large part, this is due to abnormally low levels of load experienced by the skeleton. A common approach for increasing BMD is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this typically takes the form of using an assisted standing device to enable the child to spend time in a standing position so that their lower limbs can experience some degree of body weight. Some of these physical interventions result in varying degrees of improvement in BMD, and some do not. This lack of clarity in outcomes may result from a failure to objectively measure the magnitude and duration of the load experienced by the lower extremities. A lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight due to load-sharing with the assistive device, or to an inadequate duration of standing time. The goal of this project will be to design and validate a force-measuring platform that will measure the magnitude and duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their BMD.

Eligibility Criteria:
Inclusion Criteria:

1. \< 18 years old
2. Diagnosed with Cerebral Palsy (CP)
3. Treated at Gillette Children's Specialty Healthcare
4. Gross Motor Function Classification System level of IV or V (non-ambulatory without assistance)
5. Participating in a standing program using a stationary assisted standing device
6. Parent/Guardian willing and able to give consent

Exclusion Criteria:

None
Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health.

Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.

South Africa has one of the worst and fastest growing HIV epidemics in the world. Highly active antiretroviral therapy (HAART) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal HIV transmission. However, expenses, feasibility, long-term adherence, and effective delivery of HAART remain formidable barriers, particularly in developing nations. Recently, international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa. Simplified, once-daily HAART regimens with directly observed therapy (DOT) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa.

Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months. Study measures will include CD4 cell count and HIV viral load, adherence questionnaires, genotypic HAART resistance testing, and incidence of new or recurrent opportunistic infections.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Viral load greater than 1000 copies/ml
* CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease
* Living in the area of the study site
* Had a known address for more than 3 months
* Willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets
* Willing to disclose HIV status to a treatment supervisor and ready to commit to long-term antiretroviral therapy
* Acceptable methods of contraception

Exclusion Criteria:

* Pregnant
Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease

The purpose of this study is to determine the efficacy of SonoVue® in participants with Crohn's disease and ulcerative colitis to various aspects including type of Inflammatory Bowel Disease, disease activity, the need for surgical treatment.

Each patient is subjected to clinical, laboratory and endoscopic evaluation, each eligible patient is assigned to one of the arms:

Arm 1: patients with ulcerative colitis (50 patients) Arm 2: patients with Crohn's disease (50 patients) In each arm, patients are classified according to clinical an endoscopic activity of the disease.

Each patient is subjected to ultrasound examination of the bowel using a Philips iU 22 machine according to a standardized protocol:

* 12h fasting period
* exploratory scanning with the use of convex C5-1 probe
* detailed scanning with the use of linear L 12-5 probe with Power Doppler
* choosing a bowel segment with the most prominent changes
* Contrast-enhanced Ultrasound (CEUS)

CEUS is performed according to the following protocol:

* administration of drotaverine hydrochloride (No-Spa ®) to reduse excessive peristaltic movement
* visualization of the previously chosen affected bowel segment with the use of DCE-US (Dynamic Contrast-Enhanced Ultrasound) technology
* administration of 2.4 ml SonoVue® intravenously with a bolus injection through a peripheric venous line (left antecubital vein), followed by a 10ml 0.9% Natrium Chloride bolus
* the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min)
* the original DICOM loop is sent to a work station Philips QLab platform is used to acquire a fitted Local Density Random Walk Wash-in Wash-out algorithm (LDRWIWO algorhithm) time-intensity curve of contrast agent wash-in and wash-out. Qualitative and quantitative (Time to peak, Rise time, Mean transit time, Wash-in Slope, Peak intensity, Area under curve, Time from peak to one half) parameters are calculated for each region of interest (ROI).

Eligibility Criteria:
Inclusion Criteria:

* patient with verified UC/CD aged from 18 to 60y
* signed informed consent form for the study

Exclusion Criteria:

* pregnancy
* known allergy or history of adverse reaction to sulfur hexafluoride preparations
* marked pulmonary hypertension
* uncontrolled hypertension
Early Detection of Postoperative Anastomotic Leak by CT

Postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery.

Postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery. Oral contrast agent is used for CT. Investigators carefully collected all the data prospectively and standard definition of anastomotic leak was applied.

Eligibility Criteria:
Inclusion Criteria:

Patients with gastric cancer surgery

Exclusion Criteria:

Patients with non gastric cancer surgery