cyrilzakka/clinical-trials huggingface dataset:
Is Bio-adrenomedullin (Bio-ADM) a Prognostic Factor in Patients With COVID-19 Treated in the ICU?

This is prospective, observational study using point of care test to determine bio-ADM whole blood concentrations and its predictive value in patients with COVID-19 treated in the ICU.

About 5% of all patients infected with the SARS-CoV-2 virus require treatment in the ICU. The main reason for admission to the ICU is acute hypoxemic respiratory failure, which in most cases is associated with the need for mechanical ventilation. The progression of lung damage affects not only alveoli but also endothelium of the pulmonary vessels. Occurring endotheliopathy is caused by direct infection with SARS-CoV-2 virus and activation of the immune system leading to an increased inflammatory reaction. Damage to the endothelium barrier with concomitant cytokine storm lead to activation of the coagulation system and formation of microthrombotic events in the vascular bed, resulting in thromboembolic complications and development of multiorgan failure. The reflection of the above pathophysiological phenomena in laboratory tests is a significant increase in the concentration of D-dimers. At present, no specific markers of endotheliopathy in patients with SARS-CoV-2 are known.

Adrenomedullin (ADM) is a peptide hormone that plays a key role in regulating the function of the endothelium, by modulating its integrity and permeability, it also has an effect on the vascular muscle, leading to vasodilation. Recently, the role of ADM has been intensively studied, including in sepsis. Several studies have confirmed an association between elevated ADM levels and poor prognosis in sepsis and septic shock. In these studies, measurements of various adrenomedullin precursors and free, biologically active adrenomedullin (bio-adrenomedullin, bio-ADM) were performed. The role of bio-ADM in the course of COVID -19 remains unclear.

The aim of the study is to determine the baseline concentration of bio-ADM and to determine the dynamic of the concentration changes in three measurements in patients with COVID-19 during ICU treatment. Additional measurement of bio-ADM will be performed as standard monitoring in patients suspected of septic complications of the course of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* polymerase chain reaction (PCR) confirmed COVID-19
* severe stage of pneumonia caused by SARS-CoV-2 requiring oxygen therapy
* informed consent to participate in the study

Exclusion Criteria:

* qualification to palliative care
* life expectancy \< 48 h
* mechanical ventilation at the beginning of the hospitalization
* transfer from other ICU
* pregnancy
Maternal Vitamin D for Infant Growth (MDIG) Trial

The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3 supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at 1 year of age among infants born to women who received vitamin D 28,000 U/week during pregnancy. Infants enrolled in the study will be followed for 2 years to document the persistence of any observed effects measured at 1 year of age. This study aims to enroll 1300 pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will be randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months postpartum. In addition to linear length, the trial will include analyses of inflammatory and hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D metabolism, and diarrheal and respiratory morbidity in the infants.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years and above.
* Gestational age of 17 to 24 completed weeks estimated based on recalled last menstrual period (LMP) and/or ultrasound.
* Intends to permanently reside in the trial catchment area for at least 18 months.

Exclusion Criteria:

* History of medical conditions that may predispose the participant to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, or history of renal calculi.
* High-risk pregnancy based on one or more of the following findings by point-of-care testing:

  * Severe anemia: hemoglobin \<70 g/L assessed by Hemocue
  * Moderate-severe proteinuria: ≥ 300 mg/dl (3+ or 4+) based on urine dipstick
  * Hypertension: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg
* Multiple gestation, major congenital anomaly, or severe oligohydramnios based on maternal history and/or ultrasound.
* Unwillingness to stop taking non-study vitamin D or calcium supplements or a multivitamin with calcium and/or vitamin D.
* Currently prescribed vitamin D supplements as part of a physician's treatment plan for vitamin D deficiency.
* Previous participation in the same study.
Treatment of Copper Intra Uterine Device Associated Heavy Menstrual Blood Loss

Intrauterine contraceptive device is the most commonly reversible method used among women of reproductive age worldwide. Almost one in five married contraceptive users is currently using Intrauterine contraceptive device. The Egyptian demographic and health survey results indicate that 30% of currently married women interviewed in the Egyptian demographic and health survey were using Intrauterine contraceptive device. Main reasons for discontinuation of Intrauterine contraceptive device as cited by women were excessive bleeding per vagina 39.68%, abdominal pain 38.62%, low backache35.97%.


Eligibility Criteria:
Inclusion Criteria:

1. Women usingsopperT380A and reporting heavy menstrual blood loss during use.
2. Menorrhagia , will be defined as a Pictorial blood loss assessment chart-Score greater than 100.
3. No contraindication to drugs used in treatment.
4. No other cause for heavy menstrual blood loss

Exclusion Criteria:

1. Refusing to participate.
2. Irregular menstrual cycle.
3. Misplaced Intrauterine device.
COVID-19 Vaccine Induced Immunity

This study aims to address the following three objectives:

1. Longitudinal evaluation of the development of CMI responses in response to SARS-CoV-2 Vaccine: T cells isolated from the blood of COVID-19 vaccine recipients will be evaluated for their functionality in response to vaccine antigens. The temporal and functional properties of CMI responses will be correlated with the humoral or antibody responsiveness. CMI responses will be measured in vaccine recipients prior to vaccination to determine whether the presence or functionality of pre-existing responses to common cold coronaviruses (CCCs) or previous SARS-CoV-2 infections affect the development of CMI responses to the COVID-19 vaccine.
2. Identification of cellular and soluble factors that influence vaccine responsiveness:

   While it is known that poor clinical outcomes in COVID-19 patients are strongly associated with markers of systemic inflammation, the influence these systemic markers will have on COVID-19 vaccine responsiveness is not clear. Using systems biology approaches, the investigators will perform comprehensive profiling of cellular immune subsets, inflammatory signatures to identify determinants influencing the development of CMI responses to vaccine.
3. Examine variability of immune and viral genes and their relationship to vaccine induced immune responses: Human leukocyte antigen (HLA), T cell receptor (TCR) and B cell receptor (BCR) proteins are highly genetically diverse and critical to development of protective immunity. The investigators will perform HLA sequencing on whole blood-derived DNA samples and TCR and BCR sequencing on sorted, SARS-CoV2 vaccine antigen-specific T cells and B cells, respectively, to assess how different sequence combinations impact the CMI responses to vaccine.


Eligibility Criteria:
Inclusion Criteria:

* all individuals eligible to receive one of the approved SARS-CoV-2/COVID-19 vaccines.

Exclusion Criteria:

* individuals under 18 years of age
Sitting Postural Control in Infants With Cerebral Palsy

The overall goal of this research is to understand the mechanisms underlying the development of postural control in sitting using new methodology, in order to provide a scientific basis for evaluation and treatment of posture and movement disorders in infants with cerebral palsy. The development of early posture control remains poorly understood despite considerable therapeutic effort. Infants with cerebral palsy show their first delays in the acquisition of sitting, with subsequent problems developing adequate posture and movement control. Identifying the delay, determining the nature of the problem, and evaluating the effectiveness of treatment quickly, are vital in the early part of an infant's life, since this is the time of greatest plasticity. Tools from nonlinear dynamics, which are increasingly being used to examine other biological rhythms, are used in this study to analyze postural sway from center of pressure data during the development of sitting postural control.

Background: The ability to sit independently is fundamental for function but delayed in infants with cerebral palsy (CP). Studies of intervention directed specifically toward sitting in infants with CP have not been reported. Objective: Our purpose was to compare two interventions for improving sitting postural control in infants with CP. Design: For this randomized longitudinal study, infants under 2 years old and at risk for CP were recruited for intervention directed toward sitting independence. Setting: The intervention was conducted at home or at an outpatient facility. Patients: Fifteen typically developing infants (5 months old, SD .5 months at entry) were followed longitudinally as a comparison for postural variables. Thirty-five infants with delays in achieving sitting were recruited. Infants with delays were randomly assigned to a home program (1x/week for 8 weeks; mean age=15.5 months, SD=7 months), or a perceptual-motor intervention (2x/week for 8 weeks; mean age=14.3 months, SD=3 months). Measurements: The primary outcome measure was Center of Pressure (COP) data, from which linear and nonlinear variables were extracted. The Gross Motor Function Measure (GMFM) sitting subsection was our clinical outcome measure. Results: There was a main effect of time in the GMFM sitting subscale and in two of the COP variables. Interaction of group by time factors indicated significant differences between intervention groups on two COP measures, in favor of the group with perceptual-motor intervention. Limitations: The small number of infants limits the ability to generalize the findings. Conclusions: Although both groups made progress in the GMFM, the COP measures indicated an advantage for the group with perceptual-motor intervention. The COP measures appear sensitive for assessment of infant posture control and quantifying intervention response.

Eligibility Criteria:
Inclusion Criteria:

* able to prop sit for 10 seconds
* 1.5 SD below mean on Peabody motor assessment
* between 5 months and 24 months old
* diagnosis of CP or at risk for CP

Exclusion Criteria:

* blindness
* dislocated hip
Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.

A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic colorectal cancer.
* EGF-receptor testing.
* No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).
* No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.
* No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.
* Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).
* Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists.
* Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).
* Written informed consent.

Exclusion Criteria:

* Concurrent treatment of colorectal cancer (except study medication).
* EGF-receptor testing not possible.
* Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary).
* Known or expected contraindication against study medication.
* Participation in other studies during 30 days before study entry.
* Prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min).
* Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years).
* Known or suspected cerebral metastasis.
* History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.
* Drug or alcohol abuse. Lack of adequate legal capacity.
* Breast-feeding or pregnant women.
* Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or derivatives.
Exercise Hemodynamics in Patients With Pulmonary Fibrosis

The study evaluates the rest and exercise hemodynamics of patients presenting either idiopathic fibrotic pulmonary disease or pulmonary fibrosis secondary to connective tissue disease.

Patients with fibrotic pulmonary disease of the above origin will undergo detailed assessment of functional status with the following examinations: pulmonary function tests, echocardiogram, 6 minute exercise test, cardiopulmonary exercise test (in the absence of contra-indications) and finally right heart catheterization. Hemodynamic assessment will take place at rest and at exercise following the exercise protocol that was recommended by Herve et al (ERJ 2015) using a cycle ergometer at bedside.

The purposes of the study are:

1. to evaluate the response of the hemodynamic parameters at exercise compared to the resting parameters in this patient group.
2. to discriminate between precapillary from postcapillary etiology of pulmonary hypertension.
3. to correlate non-invasive parameters of functional limitation with invasive hemodynamic parameters.
4. to assess the prognostic role of exercise induced pulmonary hypertension in the specific patient group.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of pulmonary fibrosis secondary to connective tissue disease, according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) revised classification criteria , or diagnosis of idiopathic fibrotic diffuse pulmonary disease according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
2. Forced vital capacity (FVC) ≥ 40 %

Exclusion Criteria:

1. Presence of contra-indications to exercise tests, such as acute myocardial infarction, unstable angina, uncontrollable arrythmia or skeletal disease that limits the ability to exercise.
2. History of pulmonary embolism during the year before enrollment
3. Presence of severe valvular disease.
4. Current treatment with vasoactive drugs of the pulmonary circulation
5. Pulmonary wedge pressure (PAWP) at rest \> 15 mmHg
Using Artificial Intelligence (AI)-Assisted Pulse Diagnosis Analysis on Precision Critical Medicine.

Precision/personalized medicine becomes an important part of modern medical system in the recent years. In the past, the treatments for patients have been decided by doctors according patients' symptoms and/or regular biochemical profiles. However, it is not uncommon that patients' condition varies tremendously even they have same diagnosis, and under such condition, treatment efficacy may be limited due to the heterogeneity among patients. Therefore, lack of therapeutic efficacy may be not really ineffective, and the main reason may be inadequate patient classification. For this reason, the "omics"-based personal/precision medicine emerges recently and becomes more and more important. However, in contrast to feasible and common "personalized" medicine, the approach of precision medicine to the molecular medicine level is still difficult, especially among patients in intensive critical units (ICUs). In contrast to cancer, which has remarkable advances in the past decades, the precision/personal medicine is more difficult in critical and emergent medicine. One reason is the amount of omics data is quite huge and thus dealing with omics data is time consuming. Therefore, it is not effective in daily clinical practice in ICUs care. For this condition, the investigators propose that the combination of clinical data, including pulse diagnosis by traditional Chinese medicine (TCM) doctor or ANSwatch wrist sphygmomanometer, fluid responsiveness by "Masimo" Radical-7 Pulse CO-Oximeter, and the specific database from monitors in ICUs may be a feasible way to predict outcome among ICU patients. There are two main goals for this study: (1) After establishing clinical traditional Chinese medicine (TCM) pulse diagnosis and ICU clinical parameters databases, acquiring and features of pulse diagnosis by applying AI and (2) analyzing the correlations between the features of pulse diagnosis and important clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* 1.The patient in ICU is willing to participate in the research project or patient's family member is willing patient to participate in the research project.
* 2.Acute circulatory failure

Exclusion Criteria:

* 1. The patient do not want to participate in the research project or patient's family member do not want the patient to participate in the research project.
* 2. Pregnant woman.
* 3. Goals of treatment is palliative care.
* 4. Patient is heritable immunodeficiency or acquired immunodeficiency.
* 5. Known existing cardiac arrhythmia, valvular heart disease, right ventricular dysfunction, intra-cardiac shunt, air leaking from chest drains, abdominal compartment syndrome.
The LETS Study: A Longitudinal Evaluation of Transition Services

This project will describe and evaluate the impact of a unique partnership model designed to coordinate transfer of care by formally linking pediatric and adult heath care services. The experiences of young people receiving this model of care will be compared and contrasted against the experiences of young people receiving the current standard of care. Young people with a diagnosis of Cerebral Palsy (CP), Acquired Brain Injury in childhood (ABIc), and Spina Bifida (SB) will be followed during the transition period. Preparation for transition, health care, and transfer of care service delivery will be detailed in a process evaluation. An outcome evaluation will measure the ability of the two models of service to enable youth to maintain continuity within the health care system after transitioning from pediatric to adult care. Secondary outcomes, including how health, well-being, social participation, transition readiness, and health care utilization are affected will also be explored.

Due to advances in medical treatment, most children with disabilities such as cerebral palsy or acquired brain injury can expect to live normal lifespans. As children, these individuals are cared for by expert healthcare providers working in coordinated teams in specialized pediatric settings. As these children reach adulthood, the availability of services and expertise drops dramatically because the adult health care system has not evolved to meet their specialized needs. In addition, transitioning from pediatric to adult services is often very difficult and stressful. Young people and their families must leave familiar healthcare settings and providers, and secure care in unfamiliar adult health care environments.

This proposed project will describe and evaluate the impact of a unique partnership model designed to coordinate transfer of care by formally linking pediatric and adult health care services. The LIFEspan model aims to (a) prepare youth and their families to adapt to adult healthcare provision, (b) provide a coordinated transfer process from pediatric to adult providers, and (c) establish sustainable access and appropriate adult care. The project will detail the specific service delivery that occurs with respect to preparation for transition and transfer of care in a process evaluation. An outcome evaluation will measure the effectiveness of the model in terms of its abilities to enable youth to maintain continuity within the health care system after transitioning from pediatric to adult care. Secondary outcomes, including how health, well-being, social participation, transition readiness, and health care utilization are affected by the LIFEspan model, will also be explored.

Eligibility Criteria:
Inclusion Criteria:

* Prospective groups: 16th Birthday between September 2008 - August 2009, diagnosis of cerebral palsy or acquired brain injury, spina bifida
* Retrospective group: 16th Birthday between September 2002 - August 2003, diagnosis of cerebral palsy or acquired brain injury

Exclusion Criteria:

* N/A
ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial

The purpose of this study is to examine the impact of the RADPAD in proximal operators in a contemporary cardiac catheterization laboratory (CCL), during diagnostic, coronary and structural cardiac catheterization procedures, in a large prospective, randomized controlled trial. Up to 1,000 patient-cases and up to 100 proximal operator-subjects expected to be enrolled across 1 site. The proximal operator cohort is expected to include a few interventional cardiologist attending physicians, interventional cardiology fellows, cardiovascular disease fellows and physician assistants performing multiple cases each, which in total would amount to 1,000 cases performed by 100 proximal operators. The primary outcome of interest was relative exposure of the proximal operator between the guideline directed radiation protocols and RADPAD use vs. guideline directed radiation protocols alone.


Eligibility Criteria:
Inclusion Criteria (Employees):

* Proximal operator of a cardiac catheterization procedure as defined by the individual performing the procedure closest to the source of radiation. This may be either physician assistants of the CCL, fellows of cardiovascular disease, interventional cardiology fellows or attending interventional cardiologists at NYU Langone Hospital - Long Island.
* Age ≥18 years
* Willing and able to consent.

Inclusion Criteria (Patient Cases):

* Cardiac catheterization procedure at NYU Langone Hospital - Long Island.
* Age ≥18 years of the patient undergoing cardiac catheterization.

Exclusion Criteria (Employees):

* Anyone unable or unwilling to give informed consent.
* Anyone pregnant or breastfeeding.
* A proximal operator performing a cardiac catheterization procedure where there are not located on the right-side of the patient and/or behind the radiation shield.
* Any proximal operator who wishes to use the RADPAD regardless of being in the study/is unwilling to be randomized

Exclusion Criteria (Patient Cases):

There are no specific exclusion criteria that pertain exclusively to the cardiac catheterization procedure.