cyrilzakka/clinical-trials huggingface dataset:
Rapid Diagnostic Test for Detection of Group B Streptococcus in Pregnancy

This study evaluates the use of a new method of growing and detecting Group B streptococcus in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the advantage of detecting GBS in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.

Intrapartum infection with group B streptococci (GBS) may lead to untoward neonatal sequelae such as pneumonia, septicemia, and meningitis. Several clinical trials have demonstrated that the use of intrapartum intravenous antibiotic prophylaxis (with penicillin being the agent of choice due to a narrower spectrum of antimicrobial activity) is highly effective to prevent early-onset neonatal GBS infections. It has been estimated that 10% to 30% of all pregnant women are GBS carriers, and it is likely that GBS colonizes virtually every female at some point. Consensus guidelines from the Centers for Disease Control and Prevention (CDC), American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics, recommend prenatal screening at 35 to 37 weeks of gestation and chemoprophylaxis at delivery based upon this culture result. The CDC-recommended method for detecting GBS colonization involves collecting a combined vaginal and rectal specimen and culturing the organism in a selective broth medium, followed be subculturing onto blood agar plates.

However, this traditional method of culture takes up to 72 hours for results to be available. With 12.8% of patients experiencing a preterm delivery prior to when a GBS screening occurs, and up to 15% of term pregnancies not having routine GBS screening performed, a significant portion of women present with unknown GBS status at the time of potential delivery. These clinical situations require obstetricians to utilize a risk-based strategy that has been shown to be only half as effective as culture-based screening. Thus, a need exists for a rapid detection method for GBS.

Recent research has focused on polymerase chain reaction (PCR) based methods for detection of GBS. Sensitivity for detection of GBS by the PCR assay has ranged from 87% to 91%. These methods are limited by high cost, and inability to perform antibiotic sensitivities for GBS (in women with a penicillin allergy). New technologies, called bionanopore (BNP) and bionanofilter (BNF) are rapid, microbial detection systems that utilizes sandwiched-membrane petri technology. These have the advantage of detecting GBS in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* 35-37 weeks pregnancy
* Patient receiving prenatal care at UT Houston Hermann Memorial OB/Gyn resident or attending clinic.

Exclusion Criteria:

* Pt elects not to participate
Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker

The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active RA in participants who have failed treatment with MTX and at least one TNF-alpha blocking agent.

This is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of HuMax-CD4 in the treatment of participants with active RA who have failed treatment with MTX and at least one TNF-alpha blocking agent. Participants are randomized to receive one of two doses of HuMax-CD4 or placebo. The drug will be administered as a subcutaneous infusion (given just under the skin), more often in the beginning and then followed by a maintenance dose. There is a 4 week follow up period, and the final evaluation of the clinical endpoints takes place 26 weeks after treatment start. The trial lasts about 28 weeks in all.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 revised criteria (ACR) of at least 6 months duration.
* Active disease at the time of screening.
* Failure to tolerate MTX, or lack of efficacy after a minimum of 6 months treatment with MTX.

Exclusion Criteria:

* Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary Sjögren's disease).
* Syndromes such as Fibromyalgia which require chronic pain treatment.
* Most past or current cancers.
* Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest, nasal or throat infections, tuberculosis, hepatitis B and C.
* History of infected joint prosthesis within 5 years.
* Most active medical conditions such as heart disease, kidney disease, liver disease, blood diseases, hormonal disturbances, lung disease, psychiatric disease.
* Drug or alcohol abuse.
* Pregnant or breast-feeding women may not participate. Women of childbearing potential must use either contraceptive pills or an intra-uterine device for the entire study period.

Note: Other protocol defined Inclusion and Exclusion criteria may apply.
Effect of Levonorgestrel Intrauterine System on Hemoglobin Level

To study the effect of LNG-IUS on improving iron status in reproductive-aged women presenting for contraception.

Women come to family planning clinic to insert levonorgestrel intrautrine system and take a blood sample from her to analyse hemoglobin level

Eligibility Criteria:
Inclusion Criteria:

1. The study will include married women attending the outpatient clinics of the forementioned health facilities for contraception counseling
2. Age between 18 and 45 years
3. Women who choose LNG_IUS for contraception
4. Any parity including nulliparous

Exclusion Criteria:

* 1.Women with any inherited hemoglobinopathy (thalassemia, sickle cell anemia) or acquired hemolytic anemia 2.Women with sever iron deficiency anemia requiring immediate treatment 3.Women with any contraindication to Mirena insertion (pelvic inflammatory disease, cervical or vaginal infection, cervical cancer) 4. Any uterine abnormality making LNG_IUS insertion difficult (septate uterus or fibroid distorting the cavity) 5. Women within 6 months of delivery
The Effect of Whole Grain on Gut Microbiome and Metabolic Health

Objective: To identify how specific changes of the whole grain content in the diet affect the host-gut microbiome interactions with implications for metabolic health .

Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60 participants will be included.

Intervention: low vs. high whole grain intake.

The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a diet rich in whole grain in the active treatment period and a refined grain diet during the control period.

Measurements: Insulin sensitivity will be assessed by means of a meal challenge test and by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) which is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, appetite hormones, transit time, and GM composition. Furthermore, selected control measures are included; 4-day food records and a study intervention diary.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): 25 - 35 kg/m2
* No medical prescribed diet
* Weight stable
* No blood donation during the study
* Intense sporting activities less than 10h/ week
* Alcohol consumption less than 14 units/ week (female) and 21 units/ week (male)
* Signed written consent

Exclusion Criteria:

* Pharmacological treatment; hypertension, diabetes and blood lipid regulation
* Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study
* Participation in another biomedical trial 1 month prior to study start
* Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis
* Reported chronic gastrointestinal disorders
* Antibiotic treatment for 3 month prior to study start
* Intake of vitamin, mineral, or pre- or probiotic supplements for 1 month prior to study start
* Blood hemoglobin \< 7.0 mmol/l
* Blood donation within 1 month prior to study start
Pleth Variability and Asthma Severity in Children

Research has shown that pleth variability can be used to assess asthma severity in children with status asthmaticus. The investigators would like to use an FDA-cleared monitor (Masimo Radical 7) which measures Pleth Variability Index (PVI) to see if the degree of PVI can be used to help triage patients who present to the pediatric ED in status asthmaticus.

Patients with asthma have obstruction to exhalation resulting in hyperinflation of their lungs. This hyperinflation results in a phenomenon known as pulsus paradoxus in which the physiologic drop in blood pressure normally seen with inhalation is exaggerated. Studies have shown that patients with more severe asthma exacerbations (i.e. more hyperinflation) have a greater degree of pulsus paradoxus. Typically, pulsus paradoxus is measured using a sphygmomanometer, however, researchers have demonstrated that it can also accurately be measured using plethysmography, a term known as pleth variability index (PVI). Using this concept, Arnold et al (2008, 2010) showed that a greater degree of pulsus paradoxus correlates with asthma severity.

The investigators' study aims to simplify the association between PVI and asthma severity. The investigators hypothesize the following:

1. Patients with a higher admission PVI will have a higher likelihood of being admitted to the hospital.
2. Patients admitted to the Intensive Care Unit (PICU) will have a higher PVI than patients admitted to a floor.
3. PVI can be accurately used to gauge response to bronchodilator/anti-inflammatory therapy.
4. PVI is as effective as respiratory severity score in predicting asthma severity and in gauging response to bronchodilator therapy.

To do this the investigators will recruit children who present to the pediatric ED in status asthmaticus. They will be connected to a Masimo Radical 7 monitor upon admission to the ED and then again 4 hours later. In addition the investigators will calculate respiratory severity scores at those same time intervals. The investigators will then look at the disposition of the patient upon leaving the ED: discharge to home, admission to an inpatient floor or admission to the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma or reactive airway disease upon leaving the ED
* Greater than 10 kg

Exclusion Criteria:

* Patients in whom effective pulse oximetry tracings cannot be obtained
* Patients who are diagnosed with conditions other than asthma/reactive airway disease that are known to cause pulsus paradoxus
Deciphering the Role of Circular RNAs in ALKpositive Anaplastic Large-cell Lymphoma

The objective of thE project is to determine, whether circRNAs could be used as circulating prognostic and/or predictive biomarkers of ALK+ ALCL resistance to treatment and whether they can be exploited as therapeutic targets.

Anaplastic large-cell lymphoma (ALCL) is an aggressive T-cell pediatric lymphoma. 85% of ALK+ ALCL cases harbor a fusion between the nucleophosmin (NPM) and anaplastic lymphoma kinase (ALK) genes, leading to a constitutively activated and oncogenic fusion protein. Most ALK+ ALCL cases initially respond well to the frontline chemotherapy, but 30% of patients relapse and are of poor prognosis. Understanding the origins of therapy resistance is of major importance to improve treatment and patient prognosis. Current research highlights deregulated expression of regulatory non-coding RNAs (ncRNAs) as an important factor in therapy resistance. To date, microRNAs and long noncoding RNAs have been linked to therapy resistance in ALK+ ALCL. Circular RNAs (circRNAs) are a class of highly stable noncoding RNAs that have recently come into the focus of researchers. circRNAs can control target gene expression by e.g. interacting with microRNAs or proteins. This project aims to elucidate their role in ALK+ ALCL biology including their impact on noncoding RNA networks and therapy resistance. This project will (1) identify a signature of circRNAs associated with therapy resistance in ALK+ ALCL, (2) analyze their effect on treatment response, (3) elucidate their mechanism of action, and (4) evaluate circRNA candidates as predictive and prognostic plasma biomarkers using liquid biopsies. The goal of the study is to characterize the role of candidate circRNAs in this well-defined cancer type, which can serve as a model for other ALK+ cancers. Project results will add to the current mechanistic understanding of ALK+ ALCL pathogenesis and the origins of therapy resistance, and could define new druggable targets and associated predictive biomarkers for high-risk disease. Establishing the blood-based alternative confirmation for the ALK+ ALCL diagnosis could also produce a less invasive predictive tool capable of longitudinal patient monitoring for early relapse detection.

Eligibility Criteria:
Inclusion Criteria:

* patient at diagnosis of ALK+ ALCL
* patient at the time of relapse for ALK+ ALCL
* patient without ALK+ ALCL

Exclusion Criteria:

-
U87 CART in Treatment of Advanced Solid Tumor

This is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .

Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary informed consent is given;
2. Age 18 to 75;
3. Patients with pathologically confirmed advanced solid tumor who have failed first-line therapy; or patients who are intolerant to first-line standard therapy and voluntarily give up standard therapy;
4. Immunohistochemical (IHC) staining of tumor tissue samples from patients was positive for U87 specific antigen (≥ 2 +, and the expression rate was ≥ 20%);
5. Expected survival ≥12 weeks;
6. Measurable tumor lesions according to RECIST 1.1;
7. ECOG performance score 0-1;
8. Sufficient venous access for mononuclear cell collection;
9. HBc Ab positive, HBsAg negative can be included in the group when the PCR detection of HBV DNA is negative;
10. Patients should maintain adequate organ function;
11. Dyspnea (CTCAE v5.0) ≤ Grade 1; Blood oxygen saturation\>91% without oxygen inhalation;
12. Pregnancy test was negative in women of childbearing age; Both male and female subjects should agree to use effective contraceptives during the treatment period and within the following year;

Exclusion Criteria:

1. Pregnant or lactating women;
2. Uncontrolled active infections;
3. Active Syphilis, HIV, hepatitis B or hepatitis C infection;
4. Congenital immunodeficiency;
5. Have serious allergic reaction to any drug to be used in this study;
6. Other incurable malignant tumors in the past three years;
7. History or presence of clinically relevant CNS pathology such as epilepsy, Cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease;
8. Have undergone cardiac angioplasty or stent implantation within 12 months, or have a history of myocardial infarction, unstable angina or other clinically significant heart diseases;
9. Subjects requiring anticoagulation or long-term antiplatelet therapy;
10. Subjects who have undergone major surgery or significant trauma within four weeks before enrolled in the study.
11. Other situations that the investigator thinks are not suitable for participating in this study.
Cardiac Output Assessment by Using Saline Contrast Injection

Cardiac output (CO) assessment is one of the cornerstone of hemodynamic evaluation in ICU patients. CO is usually measured using invasive methods or non-invasive methods. Thermodilution is considered as the gold standard for CO assessment. Cardiac Doppler as well demonstrated to be accurate but needs manipulations and good knowledge and skills. The investigators developed a new technique using injection of agitated saline solution to evaluate CO without any manual measurement and then observer independent.

The investigators decided to conduct a prospective observational study to compare contrast assessment of CO and cardiac Doppler technique. Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.

Eligibility Criteria:
Inclusion Criteria:

* all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.

Exclusion Criteria:

* patients under 18 years old
* pregnant patients
* moribund patients
The Effect of Video Streaming With Virtual Reality Before Coronary Angiography

This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography. Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form.

This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography. Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form. In addition to the standard practices of the clinic, individuals in the intervention group will be shown a video with virtual reality glasses before entering the angiography procedure. Only standard practices of the clinic will be applied to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Can speak and understand Turkish,
* Over 18 years of age,
* No previous angiography procedure,
* Oriented to place and time,
* No psychiatric illness,
* Not taking any sedative medication,
* No vision and hearing problems,
* Patients who volunteered to participate in the study will be included.

Exclusion Criteria:

* Patients with any pain or chronic pain prior to coronary angiography,
* Patients diagnosed with anxiety,
* Patients with pacemakers,
* Patients requiring emergency angiography,
* Patients taking antihistamines and psychiatric drugs,
* Patients who did not volunteer to participate in the study,
* Patients taking tranquilizers or pain medication up to 5 hours before the angiography procedure were excluded.
Reducing HIV & Domestic Violence Risk in Women Offenders

The long-term goal of this work is to reduce the prevalence of HIV and domestic violence among women at risk by encouraging self-protective behaviors. To obtain this goal, Multnomah County Health Department and Oregon Department of Human Services have conducted a randomized trial of an intervention to prevent HIV and domestic violence among women who have recent criminal justice involvement and who are at risk for HIV infection.

Women enrolled in the study were randomly assigned to one of three study conditions:

* Group 1: these women received information on local resources addressing HIV prevention, domestic violence, and life stability issues; they did not receive any counseling sessions as part of the study itself.
* Group 2: these women received up to ten supportive counseling sessions based on the techniques of motivational interviewing. These sessions aimed to reduce HIV risk and to improve life stability.
* Group 3: these women received up to ten supportive counseling sessions based on motivational interviewing. These sessions aimed to reduce risk for HIV and domestic violence and to improve life stability.

The primary hypotheses of this study were:

* 1. Supportive counseling (motivational interviewing) addressing HIV prevention and increased life stability will lead to reductions of HIV risk behavior among women enrolled in the study.
* 2. Supportive counseling (motivational interviewing) addressing domestic violence prevention, HIV prevention, and increased life stability, will bring about reductions in experiences of domestic violence and a reduction of HIV risk among these women.
* 3. The supportive counseling received in this study will enhance these women's self-efficacy, self-esteem, and psychological well-being.

Women in all three experimental groups were interviewed at the beginning of the study and again after 4, 7, and 10 months. These assessment interviews asked questions about: HIV risk; experiences of domestic violence; and life stability issues such as education, employment, and housing; and included biological testing for HIV and sexually transmitted diseases. Women in Group 2 and Group 3 participated in up to 10 sessions of supportive counseling (motivational interviewing) between the time of enrollment and the 4-month interviews.


Eligibility Criteria:
Inclusion Criteria:

* women
* who were 18 years or older
* who had been in jail or prison in the past year or who were currently on parole or probation
* who had engaged in HIV-related risk behaviors (injection drug use, crack use, intercourse with a male injection drug user, exchanging sex, or having had ten or more sexual partners) in the past year

Exclusion Criteria: Women were excluded from the study if:

* they were unable to give informed consent
* they were HIV positive at the time of screening for enrollment
* they reported highly unstable living conditions at screening