cyrilzakka/clinical-trials huggingface dataset:
Targeted Fortification of Pasteurized Donor Human Milk

This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs). Pools of PDHM will be analyzed for macronutrient content using the Miris Human Milk Analyzer. The control arm will receive standard of care, which is PDHM without additional protein fortification. The intervention arm will receive PDHM with a fat content of 3.8g/dL or more, with additional protein fortification of 0.67g/dL. Primary outcome will be rate of malnutrition at hospital discharge or 37 weeks, whichever earlier. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.

Our hospital milk bank provides pasteurized donor human milk (PDHM) to very low birth weight (VLBW) infants without sufficient mother's milk, with the overall aim of lowering the risk of necrotizing enterocolitis in this population. However, with the introduction of PDHM in our setting, rates of suboptimal weight gain have increased (60.2% to 65.7%). This is likely due to the fact that PDHM is often lower in energy and protein than preterm mother's own milk. One solution to delivery adequate nutrition in this VLBWs receiving PDHM, is targeted fortification, which involves measurement of the macronutrient content of human milk, and adding extra macronutrients to reach nutrient goals. In this proposed study, we will conduct a pilot randomized controlled trial of a modified targeted fortification versus standard care. This study will include preterm VLBW infants (\<1500g), without congenital conditions resulting in growth restriction, and receiving \>25% of PDHM use in the first week of life. 40 patients in each arm will be recruited over a period of 2 years. The intervention group will receive a modified targeted fortification, consisting of selection of high fat PDHM (3.8g/dL or more) with the addition of protein fortification of 0.67g/dL from week 2 of life until a gestational age of 37 weeks or hospital discharge, whichever earlier. The control group will receive usual regular PDHM with standard fortification using human milk fortifier as per current practice. The primary outcome is the rate of suboptimal growth (drop in weight z-score from birth ≥0.8) at discharge or 37 weeks. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight less than or equal to 1500g
* Born at our study hospital or transferred to study hospital within first week of life
* Achieving at least 40ml/kg/day of enteral feeds by day 7 of life
* Receiving at least 25% of pasteurized donor human milk within first 7 days of life

Exclusion Criteria:

* Diagnosed or suspected inborn errors of metabolism
* Acute or chronic renal impairment
* Congenital disease associated with significant growth impairment (including, but not limited to, Trisomy 21, neonatal encephalopathy and seizures, neonatal tumours, achondroplasia, complex congenital heart disease, anorectal malformations, gastrointestinal disorders)
Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients

The purpose of this study is to determine whether F-18 FPCIT is effective and safe radiopharmaceutical for the objective diagnosis of Parkinson's disease.

Parkinson's disease is a common neurodegenerative disorder with loss of dopaminergic terminals in the striatum. Essential tremor is one of the conditions most commonly misdiagnosed as parkinsonism, and early clinical differentiation between these conditions can be difficult. F-18 FPCIT is a promising radiopharmaceutical for PET imaging to assess the dopamine transporter in the striatum.

Eligibility Criteria:
Inclusion Criteria:

Parkinson's disease

* Male or female with age over 40 years
* Clinical diagnosis of Parkinson's disease
* Ability to give informed consent

Essential tremor

* Male or female with age over 40 years
* Clinical diagnosis of Essential tremor
* Ability to give informed consent

Healthy volunteers

* Male or female with age over 40 years
* No any symptoms or sign suggesting Parkinson's disease or essential tremor
* Ability to give informed consent

Exclusion Criteria:

Parkinson's disease and essential tremor

* Current pregnancy and breast feeding
* Current or past medical history of cardiac and neuropsychiatric disease
* Clinical evidence of dementia
* Inability to hold antiparkinsonian medication
* History of surgical therapy for tremor
* Severe or unstable medical or psychiatric condition
* Medication affecting CNS in last 6 months(e.g. CNS stimulants, sympathomimetics)
* Prior participation in other research protocol within 30 days

Healthy volunteers

* Current pregnancy and breast feeding
* Current or past medical history of cardiac and neuropsychiatric disease
* Severe or unstable medical or psychiatric condition
* Drug abuse or medication affecting CNS (e.g. CNS stimulants, sympathomimetics) within 6 months
* Prior participation in other research protocol within 30 days
Effects of Acute L-NMMA Treatment on Renal Hemodynamics and Vasoactive Hormones in Patients With Congestive Heart Failure

The study tests the hypothesis that nitric oxide availability is changed in congestive heart failure with regard to the regulation of renal hemodynamics, renal sodium excretion and release of vasoactive hormones. The study tests these hypotheses by comparing the effects of systemic nitric oxide inhibition with L-NMMA in congestive heart failure patients with healthy subjects on renal hemodynamics, blood pressure and plasma levels of vasoactive hormones.

The purpose of the study is to investigate the effects of systemic treatment with Ng-monomethyl-l-arginine in congestive heart failure and healthy controls on:

* glomerular filtration rate and renal plasma flow
* blood pressure and heart rate
* plasma levels of vasoactive hormones
* lithium clearance

The study is randomized and placebo controlled

Eligibility Criteria:
Inclusion Criteria:

Healthy controls

* Age 20 to 60 years
* Both men and women
* Weight below 100 kg
* Normal clinical examination and laboratory screening
* Fertile women only if using contraception
* Informed consent according to the regulations of the local ethics committee

Heart failure

* Both men and women
* Age 20 to 75 years
* Patients with heart failure in NYHA group II-III. Heart failure must be derived from ischaemic heart disease or dilated cardiomyopathy. Diagnosis must be verified by history and echocardiography or isotope cardiography.
* ejection fraction \< 0.40
* P-creatinin \< 250 µmol/L
* Fertile women only if using contraception
* Informed consent according to the regulations of the local ethics committee

Exclusion Criteria:

Healthy controls

* History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
* Current medication
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
* Donation of blood less than 1 month before the experiments

Heart failure

* Cardiac valvular disease with stenosis
* Significant cardiac arrythmia
* Myocardial infarction, PTCA or by-pass surgery less than 3 months before the study
* Diseases of the lever, kidneys, lungs or endocrine organs which are not secondary to congestive heart failure
* Arterial hypertension
* Neoplastic disease
* Cerebrovascular insult
* Treatment with ACE-inhibitors or nitrates which cannot be stopped 1 week before study
Same Day Discharge Following Pelvic Reconstructive Surgery

This is a prospective cross-sectional study in which patients undergoing major pelvic reconstructive surgery with total vaginal hysterectomy will be recruited and enrolled. At approximately 2 weeks and 12 weeks postoperatively, enrolled patients will be asked to complete a survey detailing their experience with SDD, surgical recovery, and advice for prospective patients.


Eligibility Criteria:
Inclusion Criteria:

* Total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy
* Apical repair with uterosacral ligament suspension or sacrospinous ligament fixation
* They may also have any of the following concurrent procedures: Anterior repair, Posterior repair, Enterocele repair, Suburethral sling for incontinence
* Surgery by one of the fellowship trained urogynecologists at TriHealth
* English speaking

Exclusion Criteria:

* Enrollment in the "Diazepam Research Study" (Protocol ID:19-130)
* Concomitant procedure with another surgeon
* Chronic pain conditions that require daily use of narcotic pain medications (including but not limited to: chronic back or pelvic pain, interstitial cystitis, fibromyalgia)
* Concomitant anal sphincteroplasty, mesh removal or use of mesh for prolapse (excluding sling procedures)
Prediction Model for Minimizing the Risk of Median Nerve Puncture

The main aim of this study was to correlate anthropometric measures of the forearm in healthy subjects with the ultrasound pronator teres depth to determine the needle length in order to avoid injury of the median nerve during pronator teres dry needle approach. A cross-sectional study, was carried out in order to perform a predictive model for the median nerve depth into the pronator teres muscle using a decision tree analysis algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Asinthomatic subjets

Exclusion Criteria:

* Pain in the 3 moths before in the forearm
Bipolar Research And Innovation Network - BRAIN

To describe the broad spectrum of Bipolar Disorder patients admitted to out-patient and in-patient psychiatric departments in Norway. Include all admitted Bipolar patients both with and without co-morbid disorders.

Norway is both social, genetically and culturally a homogeneous society. The health service is public and has a nearly total responsibility for psychiatric care in given catchment areas. This provides excellent opportunities to describe the frequencies and patterns of the broad spectrum of bipolar illness, including co-morbid substance use disorders, to follow the patients for several years and to do molecular genetic mapping.

Methods: Participating centers consist of outpatient clinics and hospital departments from different parts of Norway and one third-line clinic with referrals from all over Norway. Specifically trained clinicians in each center include bipolar patients systematically and perform the patient evaluation as part of their clinical duties. In addition, CT or MRI scans and EEG are performed and blood samples are collected for clinical chemistry screening and for DNA sampling.

Eligibility Criteria:
Inclusion Criteria:

* All admitted patients giving written consent to participate in the study

Exclusion Criteria:

* Patients without competence for consent.
Acute Effect of Massage and Exercise on Muscle Tenderness

Many people experience pain, tenderness and soreness of joint and muscles, both in sport and working life. Pain killers can provide acute relief of pain, but may not be a feasible solution for all people. Here the investigators examine the acute effect of massage and exercise on induced muscle tenderness (delayed onset muscular soreness).


Eligibility Criteria:
Inclusion Criteria:

* working age adults

Exclusion Criteria:

* blood pressure above 160/100
* disease of the cervical spine
Ti PC Software for Analyzing Longitudinal Data

To develop TI (pronounced 'T-sub-I'), a personal computer program to analyze time-varying data generated by periodic patient reports, repeatedly-observed disease signs, or serial biomarkers to study chronic disease.

BACKGROUND:

With the advent of quasi-likelihood, generalized estimating equations, and new ways to handle missing data, has come a striking increase in applicable models, perhaps more than after the 1972 introduction of the Cox model for survival data. TI provided a way to analyze the data.

DESIGN NARRATIVE:

TIl provided graphics for data exploration and model validation. TI ran under most current version of Windows, used Civilized Software's MLAB as its programming language, offered context-sensitive help, a dictionary of relevant terms, identification of file entries from their screen position, and simple animation. TI permitted the user to analyze time-varying data from the two perspectives of repeated measured using a variety of models and time series where both time and frequency domain tools were provided.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.

Commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and texture) and can modify their bioavailabilities. Thus, the traditional thermal processing is being replaced by less intense thermal technologies (e.g. low-temperature pasteurization / refrigerated storage) and non-thermal treatments such as the high-pressure processing (HPP) and the pulsed electric fields (PEF) as an alternative to enhace food safety and shelf-life without compromising organoleptic qualities (retain the flavour, color healthiness of fresh foods) and keeping their health-promoting capacity. The beneficial health effect derived from the orange juice intake is partly related to the bioavailability of their bioactive compounds.

The aim of this study was to assess the effect of the intake of freshly squeezed orange juice (Citrus sinensis L.) and processed orange juice elaborated with different treatments (low pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects using multiple dosis.

Methods Twelve healthy subjects (6 men), age 20-32 y, were enrolled in a cross-over study, to consume 500 mL of orange juice/day during 14 days periods. All volunteers consumed the LP and HPP, six consumed PEF or FS-orange juice. Fasted blood was collected at baseline and on days 7 and 14. Carotenoid concentrations in serum and orange juice were analyzed by high performance liquid chromatogry (HPLC).

Eligibility Criteria:
Inclusion Criteria:

* age (20- 32 y)
* body mass index (BMI)
* serum cholesterol and triglycerides concentrations within the normal range
* serum retinol within the range 31 - 70 µg/dL.

Exclusion Criteria:

* vitamin / mineral supplements intake
* regular medication
* pregnancy or lactating
* chronic disease
* smoking habit.
Sorafenib In Relapse of FMS-like Tyrosine Kinase 3 (FLT3)-Internal Tandem Duplication (ITD) AML Trial

In this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention. The investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with FLT3-ITD AML relapse after allo-HSCT.

The preliminary data of the investigators demonstrate potent activity of Sorafenib combined with Donor lymphocyte infusions (DLI) in relapse of FLT3-ITD+ Acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HSCT). The investigators therefore launched an observational multicenter trial. The outcomes are assessed in 4 pre-defined groups of individuals according to the therapeutic intervention (chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group). The specific interventions to the subjects of the study are assigned by the individual transplant center. The investigators will determine the outcome of each group by monitoring the survival and the response rates (complete remission, disease burden reduction, no response) of patients with FLT3-ITD AML relapse after allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Histology/PCR proven relapse of FLT3-ITD+ AML after allo-HSCT
* Age ≥18 years
* Treatment with either chemotherapy-alone, chemotherapy/DLI, sorafenib alone or sorafenib/DLI
* Written informed consent
* Ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion Criteria:

* Age \< 18 years
* Lack of informed consent
* Patients that cannot be classified in one of the 4 groups: chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group
Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children

Reliability of isokinetic strength measurement of the knee in typically developing children has yet been studied and seems to be good. Because in daily life activities strength of the hip- and ankle-joint muscles are also important, the investigators aim to study the reliability and validity of isokinetic strength measurements of the hip and ankle.

Intra-tester reliability of isokinetic strength measurements of the knee, hip and ankle in a Biodex System 4 device will be studied. Children will be assessed at different movement velocities using the test-positions as proposed by the manufacturer. Maximum peak torque will be established.

Children will also perform functional strength assessments and the relation with the results of isokinetic strength measurements will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* healthy children with good intellectual capacities

Exclusion Criteria:

* children with chronic disease or intellectual deficiency
Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study

This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 80 years old
2. life-expectancy at least 10 years
3. fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria:

1. Already diagnosis with prostate cancer;
2. cannot tolerate prostate biopsy or has contraindication to biopsy;
3. cannot tolerate prostate biopsy or has contraindication to MRI examination;
4. undergo biopsy within 1 year
5. patients judged by the investigator to be unsuitable to participate in the clinical trial;
Vaginal Ecosystem and Network in the United States Study

The central premise of this study is that the intricate balance and diversity of the vaginal microbiome plays a pivotal role in the onset, progression, and severity of various gynecological conditions. Specifically, the research aims to investigate how imbalances in microbial communities, such as the overgrowth of pathogenic bacteria or the depletion of beneficial ones, are linked to conditions like Bacterial Vaginosis, Candidiasis, Urinary Tract Infections, Vaginal Atrophy, and others. By employing PCR testing and the outcomes of next-generation sequencing (NGS) of the microbiome, the study seeks to identify distinct microbial profiles and patterns that are characteristic of each condition. This nuanced understanding is expected to lead to more accurate and early diagnosis, facilitating personalized and effective treatment strategies that go beyond the conventional, often indiscriminate use of antibiotics.

This study protocol is developed to analyze the vaginal microbiome of women using a 56-panel PCR test and NGS test. The aim is to collect vaginal swab samples from a wide range of participants, including both healthy individuals and those with diagnosed gynecological conditions, to identify different microbiome profiles.

A key aspect of this study is the creation of a registry that will compile the data obtained from the PCR/NGS test results and participant information. This registry will serve as a valuable resource for ongoing research and will support the development of personalized approaches in women's health care. By systematically collecting and analyzing data, the registry will facilitate a better understanding of the vaginal microbiome's role in health and disease, aiding in the advancement of diagnostic and therapeutic strategies.

Additionally, the registry will provide a foundation for future studies, allowing for the exploration of long-term trends and relationships within the vaginal microbiome. This could lead to new insights into how the microbiome influences gynecological health and the development of targeted treatments. The combination of validating a precise diagnostic tool and establishing a comprehensive registry is aimed at enhancing patient care and supporting the broader research community in women's health.

Eligibility Criteria:
Inclusion Criteria:

* Healthy cis-gender women between ages 18 and 89

Exclusion Criteria:

* Immunosuppressed or otherwise immunocompromised
* Pregnant or trying to conceive (i.e. IVF, IUI)
Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography

Contrast induced nephropathy (CIN) is a well-known possible complication of percutaneous coronary intervention (PCI) with an incidence varies from 3.3% to 14.5% in patients undergoing PCI.

Many previous randomized and non-randomized studies have shown very conflicting results regarding the use of ACE-Is prior to coronary angiography, and whether it decreases or increases the risk of CIN. The importance of this study is to help find an acceptable and reliable answer for the use of ACE-I/ARBs prior to cardiac catheterization.

This research aims to study the effect of withholding ACE-Is or ARBs on the incidence of contrast induced nephropathy in patients undergoing coronary angiography who have chronic kidney disease (GFR\<60 ml/min/1.73 m2) and to help build evidence-based data and guidelines on the safety of continuing or withholding ACE-I/ARBs pre contrast administration.

The study design is a Randomized Control Trial; it will be done on two groups of patients. The two groups are group A (continue ACE-I/ARBs) and group B (withhold ACE-I/ARBs).

The study will be conducted at the cardiology units at An-Najah National University's hospital (NNUH) in Nablus, Palestine.

Study population includes chronic kidney disease patients taking ACE-I or ARBs therapy and are undergoing elective coronary angiography.

Patients who will meet the inclusion criteria and have none of the exclusion criteria will be enrolled in the trial when the appointment of their procedure is set.

They will be randomly divided into two groups; group A (continue ACE-I or ARBs therapy) and group B (withhold ACE-I or ARBs therapy)using block randomization, each block consists of four participants.

Patients in the continuation group will take their regular ACE-I/ARBs on the day of the angiogram. Patients in the discontinuation group will be withheld from their ACEI or ARBs 24 h before cardiac catheterization.

Eligibility Criteria:
Inclusion Criteria:

1. At least one month of continuous therapy with an ACEI or an ARBs and
2. Undergoing elective coronary angiography and
3. Have CKD stage3-4 (15≤GFR\<60 ml/min/1.73 m2).

Exclusion Criteria:

1. Acute STEMI within 2 weeks
2. NYHA class IV heart failure by history
3. Administration of contrast load within the previous 6 days
4. acute renal failure (ARF) preceding coronary angiography
5. potassium level more than 5.0 meq/l
6. GFR \<15 ml/min/1.73 m2
7. previous percutaneous cardiac catheterization within one month
8. Acute pulmonary edema
9. hemodynamically instability
10. uncontrolled hypertension
11. combination ACEI and ARB therapy
12. Cardiogenic shock
13. Sepsis
14. pregnancy
15. Age below 18 year