cyrilzakka/clinical-trials huggingface dataset:
Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies

This study will collect blood plasma and white blood cells for laboratory research using a procedure called apheresis. Apheresis is a method of collecting larger quantities of certain blood components than can safely be collected through a simple blood draw.

Patients 7 years of age and older with a parasitic infection or condition associated with a parasitic infection (i.e., elevated levels of IgE antibodies or of a type of white cell called eosinophils) who are currently enrolled in a NIH clinical research protocol may be eligible for this study. Relatives of patients and normal healthy volunteers will also be enrolled. Candidates will have a medical history, physical examination and blood tests. Individuals weighing less than 25 kilograms (55 pounds) may not participate.

Participants will undergo one of the following two apheresis procedures:

* Automated pheresis Whole blood is drawn through a needle placed in an arm vein and circulated through a cell separator machine. The plasma (liquid part of the blood) and white cells are extracted, and the red cells are re-infused into the donor through a needle in the other arm. The procedure takes 1 to 2 hours.
* Manual pheresis Whole blood is drawn through a needle placed in an arm vein and circulated through the cell separator machine. The red blood cells are separated from the rest of the blood and returned to the donor through the same needle. Usually only one needle stick is required and the procedure takes from 30 to 45 minutes. This method is used only in individuals who weigh less than 35 kg (77 pounds).

In order to carry out in vitro research procedures on the plasma or leukocyte components of blood, it is often necessary to obtain larger quantities of plasma and/or leukocytes, than can be safely obtained by simple phlebotomy. These components can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit. This protocol is specifically designed to conform to the requirements of the Apheresis Unit for donors to have apheresis procedures (\>7 years of age and greater than or equal to 25kg). Donors must first be admitted to another approved clinical research protocol of the LPD, NIAID before they may have the apheresis procedures described in this protocol. The investigational nature of the studies in which the samples will be used, as well as the risks and benefits of the donation process will be explained to all donors, and a signed informed consent document will be obtained.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Enrolled on another LPD protocol.
* Weight greater than or equal to 25 kg
* Willingness to participate

EXCLUSION CRITERIA:

* Age less than 7 years
* Weight less than 25 kg
* Cardiovascular instability
* Hct less than 30
* Inadequate venous access
* PTT or PT greater than 1.5 normal
* Pregnancy
* Women who are actively breastfeeding
* Other condition which the attending physician or Apheresis Unit staff considers a contraindication to the procedure
* For Hetastarch procedure

  * Hypertension
  * Evidence of fluid retention
A Trial of Telemonitoring in Adults With Heart Failure

This is a randomized controlled trial of telemonitoring vs usual care provided by home care agencies for patients with heart failure.

The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent care visits, unscheduled physician appointments, Emergency Room visits in patients with heart failure over the 60 day post hospitalization period.

A 60 day stratified, randomized clinical trial of a home-based telemonitoring system (TEP) vs. usual home-care with educational package (EP). Both Groups will receive intensive patient education and primary care physicians will be prompted to adhere to heart failure management guidelines. The study will be conducted on 100 patients receiving home care nursing services post-hospital discharge.

Each participant will be randomized in equal amounts to treatment (TEP) or no treatment (EP).

Eligibility Criteria:
Inclusion Criteria:

* Heart Failure (primary or secondary) diagnosis regardless of ejection fraction (EF) and New York Heart Association (NYHA) class II- IV at the time of Home Health Care (HHC) admission and HHC services initiated following a hospital stay

Exclusion Criteria:

* Inability to stand on a scale, weight over 500 pounds, unable to hear and/or see, or no working land line phone in the residence.
* Additional exclusion criteria were: patients with severe ischemic heart disease, Myocardial Infarction (MI) and/or Coronary artery bypass graft surgery(CABG) in the last 6 weeks, severe uncorrected valvular disease, home inotropic therapy, severe lung disease (oxygen dependent), active cancer, uncorrected thyroid disease, AIDS, or end stage renal disease on dialysis.
Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers

To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV


Eligibility Criteria:
Inclusion Criteria:

1. Untreated oropharynx epidermoid carcinoma
2. Patient ≥ 18 years old
3. Patient affiliated to a social security scheme or beneficiary of such a scheme
4. Information to the patient or his legal representative and signature of informed consent

Exclusion Criteria:

1. Non-oropharyngeal epidermoid carcinoma
2. Oropharyngeal epidermoid carcinoma previously treated
Air Stacking Technique For Pulmonary Reexpansion

A cross-over randomized clinical trial carried out at the Intensive Care Unit. Patients who are on mechanical ventilation for more than 24 hours will be included in the study. The following techniques will be applied: aspiration in a closed system with an expiratory pause of 10 seconds associated to hyperinflation maneuver with a mechanical ventilator with the Air Stacking technique and aspiration technique in a closed system of aspiration with an expiratory pause of 10 seconds.

After randomization, all patients will be positioned in dorsal decubitus with the head elevated at 30 degrees and will be aspirated once with a closed suction system and with a vacuum limited to 150 cmH2O.

Two hours later, hemodynamic and ventilatory parameters will be collected and recorded.

If randomized to Protocol 1 (Air Stacking technique), the aspiration technique with closed system and expiratory pause will be performed three times during a 30-second interval, with a probe of the same caliber and the same vacuum value. One ml of saline solution will be instilled in the aspiration system to washing the closed suction circuit.

Immediately after, the Air Stacking maneuvers will be performed. If Protocol 2 (No Air Stacking technique), only tracheal suction with closed system.

Hemodynamic and ventilatory parameters will be collected after 1, 10 and 30 minutes of application. The secretions aspirated into the collection flasks will then be weighed, on a precision balance, by a collaborator blinded that is not part of the study, and the weight will be transcribed to the data collect.

Eligibility Criteria:
Inclusion Criteria:

* patients 18 years or older
* patients on mechanical ventilation for more than 48 hours
* patients on volume or pressure controlled ventilatory mode
* patients hemodynamically stable (equal mean blood pressure or more than 60 mmHg, and dose of Norepinephrine less than 1μg / Kg / minute)
* patients whose legal representatives authorize participation in the study.

Exclusion Criteria:

* undrained pneumothorax and hemothorax, and emphysema subcutaneous
* fracture of ribs
* ventilatory parameters with peak pressure greater than 40 cm/H2O
Therapeutic Lactose to Support Vaginal Microbiota

The aim of the study was to investigate whether the administration of a vaginal tablet containing lactose can modulate the bacterial flora of women with bacterial vaginosis (BV).

Design: Double-blind, placebo-controlled randomised trial.

Setting: Women with BV who responded to advertisements in local newspapers and on posters at the Institutions for Education in Health Science in Eastern Jutland, Denmark. These individuals were supplemented with patients enrolled at a gynaecological clinic.

Participants: Forty women with BV diagnosed through the Amsel test. By randomisation, 20 were assigned to receive lactose tablets, and 20 were assigned to receive placebo tablets.

Interventions: Twice daily application of one lactose tablet or placebo tablet for 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Amsel criteria positive defined as 3/4 of the following: Vaginal discharge, Fishy odor, pH\>4.5 and Clue cells in a wet smear.

Exclusion Criteria:

* Not able to provide written informed consent.
Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.


Eligibility Criteria:
Inclusion Criteria

* Males and females of at least 18 years of age with metastatic RCC of predominantly clear cell histology who have received 0 to 2 prior treatment regimens for metastatic disease.
* Measurable disease according to Response Criteria for Solid Tumors.
* Negative pregnancy test (women of childbearing potential only).
* Pretreatment laboratory levels that meet specific criteria.
* Signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations
* Patients must have failed at least one approved or investigational tyrosine kinase inhibitor (TKI).

Exclusion Criteria

* Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or unclassified.
* Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
* Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
* Systemic chemotherapy, immunotherapy, radiation therapy, or monoclonal antibody therapy within 4 weeks of M200 administration.
* Documented central nervous system (CNS) tumor or CNS metastasis.
* History of thromboembolic events and bleeding disorders within the past year.
* Medical conditions that may be exacerbated by bleeding.
Super Chinese Nephrotic Syndrome Registration System (SUCCESS)

The investigators are registering all nephrotic syndrome (NS) patients regardless of the primary causes and developing a NS database in China. Patients will be followed-up and both baseline and follow-up information will be recorded in the registration system. The treatment response, longitudinal changes of renal function, renal survival, patient survival, infection events and acute kidney injury etc, will be analyzed using the NS database.

The investigators are registering all NS patients regardless of the primary causes in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of NS, and lab measurements of serum, urine), pathological characteristics, treatment and treatment response, complications and outcomes. Patients will be followed up, the demographic, clinical characteristics, treatment, lab tests of blood and urine and complications of patients will be collected and recorded at each visit. The investigators also record the outcome at each visit, such as treatment response, longitudinal changes of renal function, hospitalization, occurrence of infection or cardiovascular events etc. The outcomes will be analyzed using the NS database.

Eligibility Criteria:
Inclusion Criteria:

* Nephrotic syndrome patients regardless of the primary causes

Exclusion Criteria:

* No
Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis

The purpose of this research study is to more accurately measure the amount of true red blood cell breakdown (hemolysis) in newborn babies with potentially problematic blood type mismatch with their mothers (ABO incompatibility), and to examine how the true level of red blood cell destruction relates to other laboratory tests obtained in newborns with jaundice.

A better understanding of the true amount of red blood cell destruction that is caused by blood type mismatch, as well as how it relates with other laboratory tests ordered for ABO incompatibility and red blood cell destruction, would help avoid unnecessary testing, treatment and prolonged hospital stays in such babies.

Clinically severe jaundice due to ABO incompatibility can occur when infants with blood type A or B are born to mothers with type O blood. An estimated 20 percent of pregnancies are ABO incompatible, but only a very small proportion of blood type A or B babies born to O type mothers develop overt ABO hemolytic disease. Despite the relative rarity of ABO hemolytic disease, it is common practice among pediatricians and family practice physicians to perform routine blood typing and antibody screening on all newborns born to type O mothers.

A very accurate and reliable laboratory measure of red blood cell destruction is the plasma carboxyhemoglobin level (COHb). COHb levels can be determined using a minute amount of blood, obtained at the same time the newborn's heel is pierced to obtain blood for the mandatory newborn screen (performed on all newborns prior to discharge) in order to avoid an additional invasive procedure.

Our hope is to determine whether routine blood typing and anti-globulin testing of infants born to type O mothers is necessary, or if these tests should instead be obtained only in the context of significant visible jaundice. This would help clarify the proper management of a very common problem in the newborn, and minimize the potential for subjecting infants of type O mothers to unnecessary blood tests, unwarranted treatment, and prolonged hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* mother blood type O
* mother Rh +
* healthy infants
* ≥37 wks gestation
* ≥ 2500 gm birth weight
* Apgar ≥5 at 1 and 5 minutes

Exclusion Criteria:

* major anomalies
* infants evaluated for sepsis or infants with transitional respiratory problems requiring \>6 hrs observation in the NICU
* significant birth trauma with continued bruising and/or sequestration of blood still evident at the time of discharge
* known perinatal blood loss with hemodynamic consequences such as persistent tachycardia, need for fluid boluses or supplemental oxygen
* neonatal anemia with Hb\<13.5g/dL
* known family history of hereditary hemolytic disease such as G6PD deficiency, hereditary spherocytosis or hereditary elliptocytosis
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events, changes in vital signs and laboratory test results.


Eligibility Criteria:
Inclusion Criteria:

* 19-45 years of age, male or female
* presumed diagnosis of urogenital C. trachomatis infection
* use condoms during sexual activity during study (enrollment thru day 28)

Exclusion Criteria:

* Clinical diagnosis pelvic inflammatory disease or epididymitis at baseline
* Diagnosis of N. gonorrhoea
* HIV infection
* Active Hepatitis B or C infection
* Prior hysterectomy (partial or total)
* Treatment with antimicrobial therapy with known activity against urogenital C. trachomatis within 28 days of enrollment
Hospital In-Patient Insulin Study

Hyperglycaemia has been shown to increase morbidity and mortality in patients with critical illness, myocardial infarction and stroke. This study aims to look at patients with hyperglycaemia and reduce their blood sugar levels using differing combinations of subcutaneous and intravenous insulin.

This is a randomised trial involving patients with type II diabetes who are brought into the hospital with a problem other than a diabetic emergency. Patients will be included, who have a blood sugar \> than 17mmols. They will be randomised to one of two groups and either given intravenous or subcutaneous insulin. Outcome measures are length of stay, glucose control and comparison of the two regimens. Cost implications will also be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes
* Blood glucose \> 17mmols

Exclusion Criteria:

* Type I diabetes
* Hyperosmolar non-ketotic coma (HONK)
* Diabetic ketoacidosis (DKA)
* Myocardial infarction (MI)
* Vomiting
Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery

The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Ages 18 to 65 years old

Exclusion Criteria:

* Patients who is taking steroid or who had been treated for the gastrointestinal disease
* Patients who have troubles with the kidney or liver
* Patients transferring to the ICU after the surgery
* overfat patients
* Patients who had taken antiemetics within 24 hours before the surgery
Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease

The distinctive symptoms of Meniere's disease (MD) include recurrent vertigo spells, fluctuating hearing loss, aural fullness and tinnitus. Conservative treatment in MD comprises lifestyle modifications, such as low-sodium diet, avoidance of caffeine, alcohol and stress, in addition to medication such as diuretics and betahistine. When conservative treatment fails, surgical management is attempted. Surgical interventions comprise transtympanic steroids or gentamicin, endolymphatic sac surgery (ES), ventilation tube placement, vestibular neurectomy, and labyrinthectomy. Recently, Loader et al. have presented encouraging results of the effectiveness of tenotomy of the stapedius and tensor tympani muscles (TSTM) in the management of patients with definite MD. Also, satisfactory results were obtained with endoscopic assisted minimally invasive vestibular neurectomy (MIVN). The aim of this study is to compare the clinical outcomes of MD patients who were submitted to either MIVN or TSTM in our department.


Eligibility Criteria:
Inclusion Criteria:

* unilateral definite Meniere's disease.

Exclusion Criteria:

* other peripheral or central vestibular disorders, bilateral MD and neurologic disorders.
* Previous history of chronic otitis media or middle ear surgery.
Relationship Between Maternal Awareness About Vitamin D for Under- Five Years Children and Their Health Status Outcomes

The observational study aims to identify the relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes. The research Question is :

Is there a relationship between maternal awareness about vitamin D for under-five years children and their health status outcomes? Mothers of children under five will be interviewed about their knowledge and practices regarding vitamin D and their children's health status. Each child will be observed for the manifestation of vitamin D deficiency and to measure their weight and height.

The observational study aims to identify the relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes. The research Question is :

Is there a relationship between maternal awareness about vitamin D for under-five-year-old children and their health status outcomes? This study will be conducted in the Outpatient and Inpatient Departments of Smouha Children's University Hospital (SCUH) at Alexandria and Matrouh General Hospital and Specialized Children's Hospital at Matrouh City.

Mothers of children under five will be interviewed about their knowledge and practices regarding vitamin D and their children's health status. Each child will be observed for the manifestation of vitamin D deficiency and to measure their weight and height. Written informed consent for participation will be obtained from a under five years mothers after an explanation of the aim of the study, their voluntary participation, and the right to withdraw from the study at any time.

Eligibility Criteria:
Inclusion Criteria:

* under-five years

Exclusion Criteria:

* any associated neurological and chronic disorders
Assessing Neurodevelopment in Congenital Heart Disease.

Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns per year. Children with CHD are a known risk population for brain injury, with neurodevelopmental alterations shown over time in up to 50% of cases. No adequate description exists of the type of neurocognitive anomalies or risk factors associated with CHD, and consequently no prognostic markers that may allow identification of high-risk cases are available.

The main objectives of this study are: 1. to describe the neurodevelopmental outcome of patients with CHD at 24 months of age; 2. identify the subgroup with poorer outcome; and 3. evaluate the utility of fetal and postnatal diagnostic techniques for early detection of patients at risk for altered neurological outcomes.

Seven Spanish referral centers for CHD included in the research network on maternal and child health currently participating in this prospective multicentric case-control coordinated study. Fetuses with CHD (transposition of great arteries, tetralogy of Fallot, hypoplastic left heart syndrome and septal defects) will be studied from 24 weeks of gestation to 2 years of age. Diagnostic tests will be repeated throughout the study in all patients, from the fetal period to 24 months of age, and will include: fetal cerebral hemodynamic Doppler assessment, functional echocardiography, brain MRI, regional cerebral oxymetry, electroencephalography and serum neurological and cardiac biomarkers analysis. Neurodevelopmental assessment will be made at 12 months of age using the ages and stages questionnaire (ASQ) and at 24 months of age with the Bayley-III test. From this data, statistical analysis will select the most useful as predictors of damage; to be then combined and create algorithms for predicting brain damage and poor neurodevelopment. Once description has been made, we will proceed to identify amongst our results, children with the poorest neurological outcome and remark possible common prenatal and early life markers in them as well as the CHD severity they present.

While advances in early diagnosis and postnatal management have increased survival in CHD children, worrying long-term outcomes, particularly neurodevelopmental disability, have emerged as a key prognostic factor in the counseling of these pregnancies. Evidence available does not allow clinicians to assess on neurological prognosis although has opened up the possibility of finding prenatal markers of brain damage. Even though, no prospective studies have been performed until now. We present a multicentric prospective study able to recruit enough fetal CHD affected pregnancies to obtain neurological prognostic tools.

Eligibility Criteria:
Inclusion Criteria:

* Single pregnancies
* Major Congenital Heart Disease
* Informed Consent Signed

Exclusion Criteria:

* Major extra-cardiac malformations
* Parental Refusal to participate
* Maternal Chronic Disease
* Multiple Pregnancies