cyrilzakka/clinical-trials huggingface dataset:
Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells from the toxic effects of chemotherapy. It is not known whether enalapril is more effective than a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of enalapril with a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.

OBJECTIVES: I. Determine whether enalapril treatment results in a reduction in body surface area-adjusted left ventricular mass in anthracycline-treated survivors of childhood cancer. II. Determine whether improvement in ventricular function achieved by enalapril is sustained and alters the course of late cardiotoxicity. III. Determine the impact of enalapril therapy on quality of life.

OUTLINE: This is a double blind, placebo controlled, randomized study. Patients are stratified based on the cumulative anthracycline dose, age at cancer diagnosis, and the duration of time since cessation of anthracycline therapy. Patients are administered enalapril or placebo by mouth bid. Patients undergo a series of cardiac tests after administration of drug. Follow-up occurs at 2, 6, and 12 months and every year thereafter.

PROJECTED ACCRUAL: 75 patients in each treatment arm will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically diagnosed childhood malignancy that had prior anthracycline therapy Echocardiographic evidence of reduced fractional shortening, reduced contractility, or increased afterload, or any combination At least 6 months oncologic disease free

PATIENT CHARACTERISTICS: Age: At least 8 at study entry and less than 22 at diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No history of renal disease No known renal artery stenosis Cardiovascular: No congenital cardiovascular malformations No active congestive heart failure not attributable to sepsis or renal failure No medication for heart condition No history of symptomatic arrhythmia antedating anthracycline therapy No constrictive pericarditis No uncontrolled hypertension Pulmonary: No primary valvular or outflow tract obstruction Other: Not pregnant or lactating Must use adequate contraception No reaction or intolerance to ACE inhibitors

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 year since prior cumulative anthracycline therapy of at least 200 mg/m2 No prior amsacrine therapy Endocrine therapy: Not specified Radiotherapy: No prior mediastinal, spinal, or total body irradiation that included the heart Surgery: Not specified Other: No concurrent angiotensin converting enzyme (ACE)inhibitor treatment No concurrent treatment with other investigational drug No oncologic therapy within past 6 months
Helicobacter Pylori Resistance

The main goal of the study was to characterize the morbidity, immunological, microbiolical and clinical phenotypes of patients with treated- resistance to Helicobacter pylori (HP) infection, and the effect of triple therapy including the levofloxacin. Control groups were newly diagnosed, previously infected and never infected HP patients

See Nestegard O, et al. PLOS ONE \| https://doi.org/10.1371/journal.pone.0238944 September 23, 2020

Eligibility Criteria:
Inclusion Criteria:

Patients referred to a GI- unite with upper GI complains and performing an upper endoscopy -

Exclusion Criteria:

Patients with severe chronic diseases and not willing to participate
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.

AlloMend® Acellular Dermal Matrix is a sterile, ready to use, human-derived acellular dermal matrix (ADM) allograft that can be used in a number of reconstructive and other surgical procedures. It is made from donated human full-thickness skin. After the epidermal and hypodermal layers are removed, the tissue is treated by a proprietary cleansing process.

AlloMend® is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy, unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older. AlloMend® may be used in either one-stage (direct-to-implant) or two-stage (expander-to-implant) procedures.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following inclusion criteria to participate in this study:

* Diagnosed by a physician and required a single or double mastectomy followed by Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft;
* Surgical intervention using AlloMend® Acellular Dermal Matrix allograft was used;
* Has completed or will complete the anticipated clinically indicated follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months post-surgical intervention.

Exclusion Criteria:

Patients must not meet any of the following criteria to be considered for this clinical trial:

* Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
* Did not have post-operative evaluations at the clinical site.
Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin

The purpose of this study is to assess the effects of Metformin administered over two weeks on the peak plasma glucose concentrations following administration of BMS-754807.

Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following administration of two compounds

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects ages 18 to 55 determined with no clinically significant deviation from normal medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory
* Women who are not of childbearing potential

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations consistent with a healthy volunteer target population
* History of clinically relevant hypoglycemic events
* History of clinically relevant hyperglycemic events
Study to Measure the Prevalence of Asynchrony In Mechanically Ventilated Patients

This study will examine the prevalence of patient-ventilator asynchrony and its determinants. Mechanically ventilated trauma patients often experience asynchrony when their pattern of breathing does not match the triggering of a mechanical ventilator.

Asynchrony is thought to be more common in delirious patients, patients with chronic lung disease and those who are heavily sedated. The study will examine the relationship between (1) delirium and sedation and (2) the prevalence of asynchrony in trauma patients.

This is a prospective observational study to determine the prevalence of patient/ventilator asynchrony in a cohort of trauma and surgical patients. There will be two 20-minute periods of observation. The first will be during the first 24 hours of mechanical ventilation and the second will take place when the patient is being weaned from the ventilator and is triggering half or more of all ventilator breaths.

The study team will use computer-captured waveforms to determine the proportion of all breaths that are asynchronous. This proportion is the primary outcome variable of the study.

The study hypothesis is that the proportion of asynchronous breaths is higher in patients with higher levels of sedation, as measured by the Richmond Agitation-Sedation Scale (RASS) and the Confusion Assessment Methods for the Intensive Care Unit (CAM-ICU). This hypothesis will be tested using repeated measures analysis of variance.

Eligibility Criteria:
Inclusion Criteria:

* Trauma or surgical diagnosis
* Patients requiring mechanical ventilation

Exclusion Criteria:

* Patients with no spontaneous breathing efforts due to injury or chemical paralysis
* Patients with leaks in the patient ventilator system precluding evaluation of waveforms
Improving MAternal Newborn carE In the in the WHO European Region During COVID-19 Pandemic

BACKGROUND COVID-19 response is heavily impacting the availability of essential health services, especially services for pregnant women and newborns that cannot be delayed or rapidly reorganized in other settings. In the current pandemic, due to multiple factors access to high quality and timely maternal and newborn (MN) health care is threatened. Major concerns have also been raised with respect to maternal rights and on disruption of essential practices and increased medicalization of care, despite existing WHO guidance.

Based on preliminary reports heterogeneities in practices is expected within the WHO European Region, with major inequities (eg women experiencing disruption of essential MC health services only in selected countries or areas within the countries, while having access to adequate care in others).

With IMAgiNE EURO we aim at conducting a survey to explore the health service preparedness, quality and resilience, with a specific focus on health services around the time of childbirth, in the WHO European Region during COVID-19 pandemic, and to make available data, which, in collaboration with WHO and other partners, can contribute in improving the quality of MN health care.

HYPHOTESIS AND SIGNIFICANCE

* This project has been developed in coordination with WHO Regional Office for Europe (EURO) and other partners, and ultimately aims at making available and disseminate data that can help improving the quality of MN health services in the Region. Collecting data on the quality of essential MN health services across different countries within the WHO European Region will help addressing specific gaps and planning coordinate response to improve quality of MN care and improve MN health outcomes.
* The project will also offer the opportunity to develop tools and methods to monitor the quality of MN health care across different countries and settings.
* The project will establish and consolidate a research network

Primary objective:

1. Record, analyse, and describe data on MN health service preparedness, quality and resilience - with a specific focus around the time of childbirth as measured both from health workers and women perspectives- across different countries within the WHO European Region, during COVID-19 pandemic.

Secondary objectives: 2.Develop tools and methods to measure, through rapid online surveys, the quality of MN health care across different countries and settings 3.Establish and consolidate a research network


Eligibility Criteria:
Inclusion Criteria:

1. Women of any age who gave births in hospitals, from 1 march 2020
2. Health workers directly involved in assistance at childbirth (pregnancy, childbirth and peripartum) at hospital level, from 1 march 2020

Exclusion Criteria:

1. For women: refusal to participate; home births
2. For health workers: personnel not directly involved in the routine care t childbirth (es physiotherapist, philologist), refusal to participate; absence from work for more than 2 months out of the 4 months immediately before the survey; less than 1 year of experience
Neural Correlates of Stress Hormones

To investigate which neuronal correlates underlie cortisol-induced enhancement of memory retrieval in PTSD and BPD.

The investigators have recently shown that hydrocortisone enhances rather than impairs memory retrieval in patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD). In contrast, in healthy participants memory retrieval was impaired after hydrocortisone compared to placebo.

The proposed studies aim to further investigate these findings and to understand the underlying neuronal correlates. Thus, the mechanisms of enhanced memory retrieval after hydrocortisone in patients with BPD and PTSD will be investigated by fMRI.

In a placebo-controlled study, the effects of 10mg hydrocortisone on brain activity, in particular the hippocampus, will be investigated in patients with PTSD and BPD and will be compared with those in healthy control participants. During the fMRI session, a declarative memory task (retrieval of a previous learned word list) and an autobiographical memory test will be performed. Effects of hydrocortisone on resting state brain activity and the neuronal correlates of memory retrieval will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Borderline Personality Disorder
* Clinical diagnosis of PTSD
* females without psychiatric disorders as control group
* right handed

Exclusion Criteria:

* fMRI exclusion criteria e.g. metal implants, pregnancy, left-handedness, and claustrophobia.
Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery

The dietary and eating behavior outcomes for adolescents who undergo bariatric surgery are virtually unknown. The main trial of the Teen-LABS consortium is not studying dietary intake and eating behavior before and after bariatric surgery. The consortium, however, provides a unique opportunity to investigate these issues in a large and diverse sample through the context of the proposed ancillary study.

Eligibility Criteria:
Inclusion Criteria:

* 19 years old or younger
* have a BMI \> 30 kg/m2
* have attained or nearly attained physical maturity and have a history of unsuccessful, organized attempts at weight management.
* must demonstrate reasonable decision making abilities
* must also fit the following criteria: (1) no prior bariatric surgical procedure, (2) no physical illness not due to obesity, and (3) no full-time special education (due to the high reading demand of study participation).
* Participants will be from all racial and ethnic groups and be both male and female.

Exclusion Criteria:

* We will not exclude participants from this trial based on health status or medication usage. Instead, we will track medical conditions and medication usage at every assessment point throughout the investigation to assess the possible influence of these variables on changes in weight, dietary intake, and eating behavior.
Post-marketing Surveillance Study for Evaluation of Dotarem Safety

Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.

Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion Criteria:

-
Tailored Treatment in Metastatic Colorectal Cancer

To compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial.

The TS and MTHFR polymorphism has been investigated in a new study based on analysis of normal tissue. The results indicated that protein with a 3/3 TS polymorphism or a MTHFR T polymorphism had a significantly higher response rate and a longer time to progression than the other groups when treated with bolus 5-FU.

Capecitabine is metabolised to 5-FU through a number of enzymatic steps. It is the first rationally designed drug that is based upon the high concentration of thymidine phosphorylase (TP) in many human tumors compared to normal tissue. TP is the last step in the conversion of capecitabine to 5-FU and seems to be the limiting factor for the activation. Capecitabine may to some extent mimic continues 5-FU infusion as opposed to bolus 5-FU. A number of small investigations have indicated that patients with 2R/2R TS polymorphism have a higher response rate than heterozygous patients.

The TS and MTHFR polymorphism analysis can easily be performed on sputum, which means an easy collection and sending of the samples.

At present single agent chemotherapy is based on three drugs (5-FU, capecitabine, and Irinotecan) with almost the same overall activity. It seems rational to investigate if improvement can be obtained by tailoring the treatment according to gene polymorphism.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer
* Histopathological verification of the primary tumor
* Measurable disease according to RESIST criteria
* Single agent chemotherapy indicated
* Performance status \>=2
* Age \>= 60 years
* Life expectancy \> 3 months
* Adequate liver and kidney function as evaluated by bilirubin \<= 3 times of normal upper limit, ALAT \<= 3 times upper normal limit (\<= 5 times upper normal limit in case of liver metastases), serum creatinine \<= 1.5 times normal upper limit.
* ANC \>=1.5 x 109/l and platelets \>= 100 x 109/l
* Informed consent

Exclusion Criteria:

* Patients with CNS metastases
* Other malignant disease within the last 5 years except for non-melanoma skin cancer and carcinoma in situ of cervix uteri
* Previous chemotherapy for metastatic disease
* Adjuvant chemotherapy \< 6 months before inclusion
* Patients with previous major toxic or allergic reaction to the protocol drugs
Investigation of the Effect of Conventional Treatment on Postural Stability and Balance in Individuals With Shoulder Pain

Shoulder pain is one of the most common musculoskeletal complaints that people need treatment for. Typical signs and symptoms include pain during reaching, muscle weakness, and interrupted sleep. The shoulder is one of the most common areas of pain, ranking third among musculoskeletal pains in the general population. There is a lack of information regarding the impact of shoulder-related problems on the general population, and therefore there is a growing interest in identifying adverse factors associated with shoulder problems. In our study, the postural stability and balance status of individuals with shoulder pain complaints will be evaluated and the effects of conventional treatment of shoulder pain on postural instability and balance parameters will be investigated.

The muscle that is important in lateral flexion of the trunk is the latissimus dorsi. There is a hypothesis that this muscle acts as a force transmitter from the gluteus maximus muscle to the upper extremity via myofascial connections. In the study of Kaur et al., it was reported that the myofascial connection between the hip muscles and the lateral flexors of the trunk increases the serratus anterior muscle activation. Therefore, deterioration in the performance of trunk muscles may affect the activation of the serratus anterior, resulting in decreased scapular upward rotation and posterior tilt, which may contribute to the development of pain and shoulder injury. Decreased core endurance can result in poor transmission of force generated in the lower body to the upper body and may contribute to upper limb incorrect positioning. 40 individuals with shoulder pain symptoms were planned to participate in the study. The individuals included in the study were divided into two groups the treatment group and the control group. A 24-session physiotherapy program will be applied to the patients in the treatment group. Pain, active joint range of motion, balance, and postural stability will be evaluated first week and eighth weeks.

Eligibility Criteria:
Inclusion Criteria:

* Having a complaint of shoulder pain for at least 3 months
* Being between the ages of 19-60

Exclusion Criteria:

* Having had a surgical operation in the last 6 months,
* Having cognitive problems that prevent participation in exercises.
MRI to Measure Liver Fat Content

This study will determine whether a magnetic resonance imaging (MRI) test of the liver can accurately measure the amount of fat in the liver compared to the results of a liver biopsy.

People 18 years of age and older who are scheduled to have or who have already had a liver biopsy as part of their medical care within 1 month of enrollment in this study may be eligible to participate.

Participants undergo an MRI. For this procedure, the subject lies still on a table that slides into a narrow metal cylinder (the MRI scanner) for 30 to 60 minutes. A special pad or tube is placed around the abdomen to improve the image of the liver obtained. Earplugs are placed in the ears to muffle loud thumping and knocking sounds that occur with the electrical switching of the magnetic field. The findings of the MRI are compared with those of the liver biopsy.

Percutaneous liver biopsy remains the gold standard test to evaluate hepatic fat content, fibrosis and cirrhosis, but there is growing interest in the application of magnetic resonance imaging (MRI) techniques such as (1)H-Magnetic Resonance Spectroscopy ((1)H-MRS) as a non-invasive approach to quantify these characteristics. The ability to accurately quantify hepatic metabolites, such as intrahepatic lipid, has important implications for clinical evaluation and management of patients with liver related diseases and may obviate the need for liver biopsies in a number of clinical settings. The current proposal is designed to develop and validate hepatic (1)H-MRS capabilities at the NIH Clinical Center and to use this technique in a subsequent study to estimate the prevalence of hepatic steatosis among persons living with HIV/AIDS. In the present study we propose to complete MRI with (1)H-MRS in 70 adults who will be undergoing percutaneous liver biopsy in order to establish the ability of (1)H-MRS to accurately assess hepatic fat content compared to histopathological scoring.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age 18+, male or female

Planned liver biopsy or liver biopsy within the past month with pathology samples available to be read at NIH CC

EXCLUSION CRITERIA:

Known current pregnancy or pregnancy within 6 months

Contraindications to MRI

Subject is deemed unable to comply with requirements of study participation