cyrilzakka/clinical-trials huggingface dataset:
The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome

This research study was designed to look at the effect of human albumin transfusion on circulating levels of Vascular Endothelial Derived Growth Factor (VEGF), a protein that is believed to be responsible for the syndrome of ovarian hyperstimulation. Patients have been asked to participate because they are identified as at risk for the Ovarian Hyperstimulation Syndrome (OHSS), a potentially serious complication of in vitro fertilization. It has been established that the onset of OHSS may be preventable by the infusion of albumin at the time of egg retrieval; however, we do not know by what mechanism albumin works. As we know the pathogenesis of OHSS is related to VEGF released from the ovaries, we believe human albumin may serve to "bind up" this VEGF and prevent it from causing its harmful effects. The purpose of this study is to evaluate the effect of albumin infusion on blood and urine VEGF levels in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Infertile patients undergoing in vitro fertilization with or without ICSI
* Estradiol \> 3000 pg/mL at the time of hCG administration
* \>/= 20 follicles seen during ultrasound monitoring
* Patients with polycystic ovarian syndrome

Exclusion Criteria:

* Patients with only one ovary
* Patients with medical contraindication to human albumin (hypersensitivity, hypervolemia, cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, severe anemia, renal failure)
Implementation and Evaluation of Bright Futures Curriculum Within CORNET Continuity Practice

The purpose of "Bright Futures" is to promote and improve infant, child, and adolescent health within the context of family and community. CORNET (COntinuity Research NETwork of the Ambulatory Pediatric Association) is a national practice-based research network of resident continuity practices, whose mission is to establish a self-sustaining collaborative research network among pediatric continuing clinic clinicians who will produce quality research in primary care, health care delivery, and education.

"Bright Futures" offers a child and family-centered approach to health promotion in incorporating partnership and communication skills of providers. Two areas of importance are promotion of oral health and prevention of iron deficiency. Residents will be randomized to one of these two groups and will receive web-based education about that particular topic. Residents randomized to group 1 will receive training consisting of 7 modules: 3 on the Bright Futures concepts and 4 on oral health promotion. They will be trained in performing an oral health assessment, identifying caries, and encouraged to establish a dental home for patients. They must communicate with at least one dental practice in the community to determine barriers to care, issues regarding insurance, potential solutions to improve referral, and access to dental care. Residents in group 2 will complete a single educational module on the identification and prevention of iron deficiency. They will be trained to identify iron deficiency and iron deficiency anemia, understand risk prevention strategies, improved methods of identification, and treatment.

Each resident will recruit 3 patients, children between the ages of 12-35 months, for whom he/she is the primary care provider. Each parent-child dyad will participate in one well-child care visit. Each visit will be observed by a faculty preceptor.

This study design was chosen to compare a more sophisticated and time-intensive curriculum to a more modest one. By having a curriculum with minimal overlap between the two groups, the investigators hope to examine the knowledge obtained by the residents, which health promotion aspects they address during their encounters, and to compare the establishment of a dental home in the two groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 12-35 months

Exclusion Criteria:

* None
Decision Aid for the Improvement of Decision-Making in Patients With Non-small Cell Lung Cancer

This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. Refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process.

II. Conduct a trial at two comprehensive cancer treatment centers representing academic and Veterans Affairs medical centers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive the conversation tool.

ARM II: Patients receive usual care.

Patients in both arms are followed up within 4-8 weeks after baseline to complete a second questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* PART I: Completed treatment for suspected or confirmed stage I-IV non-small cell lung cancer (NSCLC)
* PART I: English fluency
* PART II: Undergoing diagnostic work-up for suspected stage I-IV NSCLC
* PART II: English fluency
* PART II: \> 6-month life expectancy
* PART II: Score of \> 3 on the 6-Item Screener for Cognitive Impairment
Correlation Between Quantitative Analysis of Coronary MRA and FFR

This study aims to evaluate whether quantitative analysis of coronary MR angiogram would improve the detection of functionally-significant coronary artery stenosis.

Coronary MR angiography is performed with a 3.0-T imager with 32-channel coils. Qunatitative analysis of coronary MR angiogram is evaluated on the basis of the signal intensity (SI) profile along the vessel. Quantitative analysis of coronary MR angiogram (QCMRA) is calculated as \[1 - (SImin/SIref)\] x 100, where SImin is minimal SI and SIref is corresponding reference SI. Diagnostic performance of quantitative analysis of coronary MR angiogram for predicting functional significant coronary stenosis was evaluated by using fractional flow reserve (FFR) as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* 1 or more coronary stenoses in the major coronary artery with a vessel diameter ≥ 2mm on coronary MR angiogram
* Patient who were planned to undergo invasive coronary angiography and fractional flow reserve

Exclusion Criteria:

* clinically unstable patient
* a history of coronary revascularization
* infiltrative cardiomyopathy, hypertropic cardiomyopathy, myocarditis
* contraindication to use of adenosine
* complete occlusion of target lesion
A Comparative Analysis on Physical Activity Performance and Motor Function of Affected Upper Extremity Before and After a CIMT Program in Young Children With Hemiparetic Cerebral Palsy

This study evaluates CIMT(Constraint Induced Movement Therapy) in the treatment of physical activity performance and motor function of the weaker extremity in young children with cerebral palsy. Half of participants will receive CIMT while the other half will receive no treatment.

Constraint-induced movement therapy (CIMT) is a short-term, intensive treatment to promote functional arm and hand skills in people with hemiparesis. It usually involves constraint of the non-involved extremity and intensive movement practice of the weaker extremity.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with spastic hemiplegic cerebral palsy
* age between 18 months and 36 months
* Mini-MACS level 1-4

Exclusion Criteria:

* botox injection in upper extremity within 6 months
* poor cooperation with cognitive impairment
* any musculoskeletal disease
* visual or hearing impairment
* uncontrollable epilepsy
* skin damage that makes impossible for participant to wear a splint
* Mini-MACS level 5
Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study

Sometimes, cancer comes back after it has been successfully treated-a situation called recurrent cancer. When recurrent cancer is suspected, the standard approach to diagnosis is to perform a combination of imaging tests, such as x-rays, ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine scans. Sometimes, however, after performing these tests it still may not be clear whether or not the cancer has come back.

Some studies have shown that a diagnostic imaging test called Positron Emission Tomography/Computed Tomography (PET/CT) may be helpful in the diagnosis of recurrent lung, breast, head and neck, ovarian or esophageal cancer or lymphoma. However, it is not clear if PET/CT can offer better results than standard approaches to diagnosis.

This feasibility study is needed to determine how common it is for a diagnosis of recurrent cancer to be unclear even after standard diagnostic imaging tests have been completed. If the enrollment goal is reached (\~60 patients enrolled in 18 months), a larger clinical trial is being planned to determine if PET/CT is helpful in making the diagnosis of recurrent cancer in situations where standard imaging tests have not been helpful. It is also expected that the results of this feasibility study will help to define exactly which patients should be enrolled in this larger clinical trial of PET/CT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a previous history of non-small cell lung cancer, breast cancer, head and neck cancer (not thyroid cancer), ovarian cancer, esophageal cancer, or lymphoma (Hodgkin's or non-Hodgkin's) who have suspected recurrence on history and/or physical exam.
* Conventional imaging (e.g., X-ray, ultrasound, CT, MRI, bone scan) is non-diagnostic.

Exclusion Criteria:

* Age less than 18 years.
* Patient with established recurrence requiring staging of recurrent disease.
* Patients who, at the time of the initial evaluation, have already undergone PET/CT within 6 months prior to registration.
* Unable to lie supine for imaging with PET/CT.
* Pregnant or lactating female.
* Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac disease, significant chronic obstructive pulmonary disease) making the patient unfit for further cancer therapy.
* Unable to give informed consent.
Nucleus Hybrid L24 Extended Duration Post Approval Study

This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.

The Hybrid L24 Implant System (P130016) was the subject of a pivotal clinical trial (IDE G070191) from 2007 through 2012. Data on the 50 subjects enrolled in the study, in support of safety and efficacy of the device, was submitted in June 2013 as part of Premarket Approval (PMA) #130016. As a condition of approval, March 20, 2014, a Post-Approval Study was designed to monitor the long-term (5 years postactivation for each subject) safety and effectiveness of the device in this existing cohort of implanted subjects was designed.

Eligibility Criteria:
Inclusion Criteria:

- Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study

Exclusion Criteria:

* Recipients who withdrew or were terminated from the L24 pivotal IDE study
* Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant
Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women defined as women who have stopped having menstrual periods
* Written informed consent to participate in the trial
* Biopsy confirmation of invasive breast cancer
* Evidence of hormone sensitivity
* Willingness to undergo biopsies

Exclusion Criteria:

* Any previous treatment for breast cancer
* Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
* Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
* The presence of more than one primary tumor
* History of hypersensitivity to castor oil
* History of known bleeding disorders
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.

Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* negative pregnancy test
* no prior pregnancies beyond 14 6/7 weeks
* no PID in last 3 months
* no current cervicitis
* be willing to follow-up in 1-2 months for an IUD string check.

Exclusion Criteria:

* active cervical infection
* current pregnancy
* prior pregnancy beyond 14 weeks gestation
* known uterine anomaly
* fibroid uterus distorting uterine cavity
* copper allergy/Wilson's disease (for Paragard)
* undiagnosed abnormal uterine bleeding
* cervical or uterine cancer.
Recovery Levels of Depression Patients and Caregiver Psychoeducation

To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels.

The samples of the research are 'The experiment that was followed up in the inpatient service at Adnan Menderes University Research and Practice Hospital Psychiatry Service with diagnoses of F32 (Depressive Disorder according to ICD 10 code) and F33 (Recurrent Depressive Disorder according to ICD 10 code) and met the inclusion criteria for the study (n = 46). ) and a control group (n=46) with a total of 92 depression patients and their caregivers. The experimental group patients and their caregivers and their relatives were included in the psychoeducation program application within the framework of the training recommended in the "Guide for the Treatment of Patients with Major Depressive Disorder" published by APA in 2010. This application is a psychosocial treatment program consisting of structured sessions and including an experiential interactional process. Data were collected from patients using the Beck Depression Scale, Recovery Assessment Scale; It was collected by caregivers using the Emotional Expression Scale and Zarit Family Burden Scale.

Eligibility Criteria:
Inclusion Criteria:

* Patient selection criteria included in the sample for the research;
* Being 18 years or older
* Receiving inpatient treatment with a diagnosis of F32 (Depressive Disorder) or F33 (Recurrent Depressive Disorder)
* Does not have a developmental disorder
* Without psychotic features
* Not having communication problems
* Being at least a primary school graduate Caregiver selection criteria included in the sample for the research;
* Being 18 years or older
* Being the primary caregiver of the patient
* Being at least a primary school graduate

Exclusion Criteria:

* • Patient selection criteria for exclusion from the sample for the research;

  * DSM-V Axis I comorbidity Caregiver selection criteria for exclusion from the sample for the research;
  * With mental retardation or psychotic disorder
  * Having speech and hearing disorders
  * It was created as having one of the diagnoses of a cognitive disorder such as delirium, dementia, or amnestic syndrome.
Paclitaxel Liposome and Cisplatin as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer

There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with cisplatin is evaluated by median survival time, progression free survival,and response rate.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic esophageal tumors with no previous treatment for advanced disease or recurrent disease after previous treatment for at least one year.
* At least one measurable lesion according to the RECIST1.1 (Response Evaluation Criteria in Solid Tumors RECIST Version 1.1) criteria. Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques.
* Patients aged between 18 and 70 years, inclusive, at the time of acquisition of informed consent
* Patients with performance status(ECOG) 0 to 1.
* Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 10.0g/dl, platelet count ≥ 100 x 109/L)
* Creatinine clearance ≥ 60 ml/min, Serum creatinine ≤ 1.5mg/dl
* Serum bilirubin ≤ 1.5mg/dl. ALT(Alanine transaminase ), AST(Aspartate Transaminase) ≤ 2.5 x upper normal limit (or ≤ 2.5 x upper normal limit in the case of liver metastases)
* Life expectancy ≥ 3 months
* Patients who have given written informed consent to participate in this study

Exclusion Criteria:

* Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer)
* Serious, uncontrolled, concurrent infection(s) or illness(es)
* Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia)
* Patients with brain metastasis
* Patients receiving continuous administration of steroids
* Patients who have experienced serious drug allergy in the past
* Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment
* Patients who are pregnant and lactating or hope to become pregnant during the study period
* Patients with prior Taxane treatment (Paclitaxel)
* Others, patients judged by the investigator or coinvestigator to be inappropriate as subject
Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma

The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine.

Exclusion Criteria:

* unwillingness to participate in the study
* severe media opacity
A Phase 1b Study of QX1206 in T2DM Patients With NAFLD

This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent must be obtained and documented
* 18 years of age and \< 65 years old
* BMI ≥ 18 kg/m\^2 and \< 45 kg/m\^2
* T2DM diagnosed per 2021 American Diabetes Association criteria
* Diagnosis of NAFLD
* For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study
* Women of child-bearing potential (WOCBP) must have a negative pregnancy test
* Serum creatinine \< 1.5×ULN or creatinine clearance ≥ 60 ml/min
* Participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient

Exclusion Criteria:

* Uncontrolled diabetes
* Patients with an active, serious medical disease that limit activities of daily living
* Patients with current, significant alcohol consumption or a history of significant alcohol consumption
* Patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary:
* Fasting triglycerides \> 500 mg/dL
* Fasting direct LDL-C \> 190 mg/dL
* AST \> 5.0 × upper limit of normal (ULN)
* ALT \> 5.0 × ULN
* Alkaline phosphatase (ALP) ≥ 2 × ULN
* HbA1c \> 10.5%
* Fasting plasma glucose (FPG) \> 240 mg/dL (13.3 mmol/L)
* Platelets count \< 140,000/mm\^3
* Patient takes drugs historically associated with NAFLD and other known hepatotoxins
* Treatment with drugs (e.g., vitamin E \> 400 IU/day) or herbal supplements with potential anti-NAFLD effect