cyrilzakka/clinical-trials huggingface dataset:
Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV

Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen (HBeAg) have an increased risk of becoming infected with HBV. This study will determine whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.

Infants of HBV-infected mothers with positive HBeAg have an increased risk of becoming infected with HBV. Standard immunoprophylaxis against mother-to-infant transmission of HBV includes administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine; however, approximately 5-15% of the infants are not protected despite having received these preventive measures. It is reported that antiviral prophylaxis among HBV-infected pregnant women can reduce mother-to-infant transmission of HBV. However, more research is needed to obtain the definite conclusion. This study will determine whether telbivudine among HBsAg- and HBeAg-positive pregnant women during the third trimester, in addition to standard immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at preventing HBV infections in these infants.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women at 28-32 weeks of gestation
* both HBsAg and HBeAg positive
* good compliance

Exclusion Criteria:

* Coinfection of HAV, HCV, HEV, HIV, and STD
* With history of antiviral treatment against HBV
* With chronic disease, such as heart and kidney disease, asthma, diabetes, hyperthyroidism, severe anemia, bleeding disease, autoimmune diseases
* With threatened miscarriage or relevant treatment during the pregnancy
* With pregnant complications such as pregnancy hypertension, preeclampsia, etc
* With history of fetal deformity, or fetal deformity detected by ultrasound examination
* With ALT \>10 times upper limit, or total bilirubin \>3 times upper limit, of normal value
Systems Analysis and Improvement to Optimize pMTCT

Despite significant increases in global health investment and the availability of low-cost, efficacious interventions designed to reduce mother to child HIV transmission in low and middle income countries with high HIV burden, the translation of these scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. Enhancing the implementation of pMTCT interventions through contextually appropriate systems analysis and improvement approaches can potentially reduce drop-offs along the pMTCT cascade, leading to dramatic improvements in infant and maternal outcomes. The goal of this proposal is to develop a model for systematic assessment and improvement of pMTCT services in sub-Saharan Africa. In specific aim 1, we will identify health system factors and service delivery approaches associated with high and low performing pMTCT services in Côte d'Ivoire, Kenya and Mozambique. In specific aim 2 we will adapt evaluate the feasibility and impact of a systems analysis tool and associated performance enhancement approach for pMTCT services in Côte d'Ivoire, Kenya and Mozambique. This systems analysis tool and associated performance enhancement approach is currently being developed and piloted for pMTCT services in Mozambique. The results of this implementation research are expected to generate knowledge of global health significance, and by disseminating the study results and intervention tools through the broad PEPFAR network, can rapidly impact pMTCT service delivery enhancements across the highest need countries.


Eligibility Criteria:
Inclusion Criteria:

* health facility with pMTCT services in central Mozambique, northern Cote d'Ivoire or western Kenya
* health facility with at least 20 HIV-infected women identified in antenatal care per year

Exclusion Criteria:

* health facility over 20 kilometers from a main transport corridor
* health facility with an ongoing prospective study or systems analysis and improvement approach in place
Data Collection and Evaluation of OptiBP Under Investigational Use

The purpose of this study is to collect data to develop and evaluate the use of state-of-the-art machine learning approaches within a mobile phone application for the estimation of blood pressure.

Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor on the upper arm, while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
2. Live in the United States of America
3. Have an Android smartphone
4. Have access to an arm-worn blood pressure monitor (cuff)
5. Have access to the Google Play store to download the OptiBP study app on their phone
6. Be comfortable communicating in written and spoken English
7. Be willing and able to provide informed consent to participate in the study

Exclusion Criteria:

1. Known contact dermatitis to nickel/chromium
2. Lesion or deficiency on hand, preventing placing a finger on the smartphone camera
3. Known dysrhythmia like bigeminy, trigeminy, isolated VPB, atrial fibrillation
Understanding Concussion/Mild Traumatic Brain Injury

Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.

In a blinded trial, any patient who during a game or practice situation had head contact, thus possible Traumatic Brain Injury (TBI) aka Concussion, in addition to the current approved protocols, patients are scanned with the Blink Reflexometer. Results are not available until the end of the season, thus eliminating the potential of someone relying on the results. The Blink Reflexometer uses 5 puffs of air on the side of the eye over 20 seconds. The air causes a blink reflex which is being correlated to a concussion. The results of the blink post concussion are compared to a baseline scan taken at the beginning of the season.

Eligibility Criteria:
Inclusion Criteria:

* Read, understand and sign patient consent (parent approval needed when pt is under 18yo)

Exclusion Criteria:

* Diagnosed concussion in past 4 weeks
* Ingesting any drugs banned by the US Anti-doping Association (USADA)
* Never prior diagnosed with a neurological abnormality, including Alzheimer's, MS, Huntington's, Epilepsy, etc.
Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia

Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.

Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.

Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery

Exclusion Criteria:

* Patients refusal
* History of amide local anesthetics allergy
* Alcohol or drug abuse
* Chronic opioid intake
* Language barriers
* Patient with psychiatric disorders
* Contraindications for regional anesthesia
* BMI \> 40 Kg/m2
* Obstructive sleep apnea that preclude PCA opioids
Hydrocortisone Use After Etomidate in Intensive Care

the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate

Etomidate is a hypnotic widely used for patients in intensive care who require rapid induction, because of its short duration of action, its excellent cardiovascular tolerance and maintenance of cerebral perfusion pressure.

For this reason etomidate remains the hypnotic of choice for induction of unstable patients. Other hypnotics currently in existence do not provide adequate safety with a sufficiently predictable and stable effect in this situation. However, it may induce acute adrenal insufficiency by inhibition of 11-b-hydroxylase necessary for the synthesis of cortisol from compound S. An observational study conducted at the Grenoble University hospital in 2006 showed that the duration of this blockage can reach up to 48 hours. Acute adrenal insufficiency in intensive care patients is associated with a poor prognosis. The main objective of this study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate.

This is an interventional, prospective, randomized, placebo-controlled, double-blind, analytical study with a cohort of 100 patients between 18 and 80 years, of both sexes, who have had tracheal intubation in a pre-hospital or shock treatment setting with the administration of a single injection of etomidate.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received an unique injection of etomidate in pre-hospital situation or at "déchocage" in the previous 6 hours.
* informed consent signed by the patient or the reliable person
* affiliation to a regime of social security

Exclusion Criteria:

* persons aimed at the articles L. 1121-5 à L. 1121-8 of the french code of public health
* toxic shock requiring a treatment by HSHC inn accordance with the criteria of Annane et Al. \[13\]
* purpura fulminans
* chronicle suprarenal insufficiency
* patients likely to present an acute suprarenal insufficiency : current treatment with antifungal : ketoconazole or fluconazole, known HIV infection, Sheehan syndrome
* corticotherapy in the 6 last months
* initiation of hydrocortisone therapy out of the study
* survival estimated at less than 48 hours
* no benefits of social security
* refusal to participate by patient or reliable person
Timing of Tracheotomy in Covid-19 Patients

Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality through the ICU stay will be evaluated and compared.


Eligibility Criteria:
Inclusion Criteria:

* Verified Covid-19 infection
* Intubated due to respiratory insufficiency and need for mechanical ventilation
* Informed consent from patient or relative

Exclusion Criteria:

* Age below 18 years
* Need for mechanical ventilation less than 14 days
* Tracheotomy not possible within 7 days
* Tracheotomy not possible due to anatomical or other medical reasons
Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis

The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.

Eighty individuals with MAP will be randomly assigned into two treatment groups, i.e. treatment with quetiapine and haloperidol. The quetiapine group will receive quetiapine at least 100 mg per day and the haloperidol group will receive haloperidol at least 2 mg per day orally once a day for four weeks. The doses will be increased every 5 days until no psychotic symptom is observed from the Positive and Negative Syndrome Scale. Common antipsychotic adverse events will be checked and documented daily.

Eligibility Criteria:
Inclusion Criteria:

* Having a psychotic episode with current use of methamphetamine
* Positive urine toxicology test for methamphetamine on the first day of hospitalization

Exclusion Criteria:

* Using other illegal substances
* Having a history of primary psychotic disorders or using antipsychotic agents
* Having a chronic medical disease, e.g. essential hypertension, diabetes, epilepsy, stroke
Improving Health Insurance Literacy Among Utah's Hispanic Population

This is a test of an existing health insurance education program (HIEP) in the Utah Hispanic community (aged 18-64). The study will evaluate whether the HIEP delivered by Utah Health Policy Project (UHPP) staff improves participants' health insurance and cost-related literacy. Participants will complete a brief baseline survey, be guided through the HIEP by UHPP staff, and complete a brief survey after completing the sessions.

The goal of this research is to refine and pilot test an existing health insurance education program (HIEP) to improve health insurance and cost-related literacy among the Hispanic community in Utah. This study will be conducted in conjunction with the Utah Health Policy Project, which has long been active in the Hispanic community and has been instrumental in reducing the number of uninsured adults and children in Utah. Initially, community and key-informant feedback on how to best adapt this intervention to the Hispanic community, including what topics are most important, and how the intervention should be delivered, will be obtained. After the HIEP is adapted accordingly, it will be investigated to see if it improves participants' health insurance and cost-related literacy.

Upon enrollment, participants will fill out a survey containing questions about their current health insurance, employment, demographics, acculturation, preferred language and health insurance knowledge. Participants will then receive an educational session surrounding health insurance use and laws. This educational sessions will be conducted, in person, over video conference calls, or over the telephone, and will cover:

* Overview of health insurance options and understanding of insurance and costs
* Learning about types of insurance coverage and how to select/access coverage
* Navigating one's coverage plan
* Managing care costs

This sessions will be 60 minutes.

After completing the HIEP participants will be given a second survey including similar questions to those in the first survey. This survey will include questions to obtain feedback on the acceptability of the content and potential implementation issue areas, as well as any discordance in cultural values, beliefs, or feelings about health insurance.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Hispanic
* Resident of Utah
* Primary Policy Holder
* Recently enrolled in health insurance within the past year

Exclusion Criteria:

* Younger than 18 years of age
* Not Hispanic or Latino/Latina in origin
* Non-Utah resident
* Non Policy holder
* Not recently enrolled in health insurance
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 1 year
* HbA1c below 12.0%
* Treatment with regular human insulin and insulin NPH for at least 1 month
* Receive more than 2 injections daily

Exclusion Criteria:

* Receipt of investigational product within 6 months prior to trial participation
* Known or suspected allergy to investigational product
* Receipt of of insulin aspart within 3 months prior to trial participation
Non Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers

Evaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET, topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class III tubulin. These targets have been chosen because they are targets for chemotherapeutic agents that are currently used in clinical management of these diseases. In total 50 specimen will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt to establish a correlation between the pre-selected tumor markers and response to chemotherapy, and thus to be able to create a clinically useful classification that would provide clinical guidance for selection of the most effective chemotherapy for a individual patient, and thus be able to logically design more effective clinical trials for the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed lung cancer who received standard platinum-containing doublet chemotherapy followed by EGFR tyrosine kinase inhibitors.

Exclusion Criteria:

* non
Method of Fish Oil Administration on Patient Compliance

Many patients complain of fishy breath, upset stomach, or heartburn when taking the recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken daily. The hypothesis of this study is that taking fish oil with milk will help lead to better patient compliance with no difference in adverse effects versus other administration methods.

Fish oil has many proposed health benefits such as lowering triglycerides, decreasing inflammation, and reducing risk factors for cardiovascular disease. In order to take the recommended daily dose for hypertriglyceridemia using an OTC fish oil supplement, the daily recommended dose is at least 2 grams (2 capsules) three times a day. The American Heart Association recommends 2-4 grams of omega-3 fatty acid a day to aid in triglyceride reduction. Fish oil is known to cause GI-related adverse effects. Although reported to help, freezing fish oil capsules is inconvenient requiring access to a freezer three times a day. Currently there is a lack of literature to specify the best administration technique or patient compliance data for OTC fish oil supplements. The purpose of this study is to determine an ideal method of taking fish oil. This study will include up to 60 patients that are between the ages of 18-65 years who would be considered generally healthy. Patients will be recruited via e-mails sent to faculty and students of the School of Pharmacy, via flyers in Walgreen's stores, and through word of mouth. The patients will be randomly assigned to one of four treatment groups. Each treatment group will be given 180 capsules and instructed to take two capsules three times a day for thirty days with either food, no food, milk, or frozen. At the end of thirty days, the patient will return the bottle with any remaining pills to the investigator and take a survey. The investigators will assess compliance via pill count.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-65 years of age
* Minimal medication usage and controlled chronic health conditions

Exclusion Criteria:

* Patients with significant renal, hepatic, autoimmune or gastrointestinal tract disease
* Patients with uncontrolled chronic health conditions (e.g., diabetes, high blood pressure, high cholesterol or hypothyroidism)
* Receiving prescription anti-coagulation, prescription anti-platelet, prescription anti-inflammatory drugs, biologics, chronic steroids, chemotherapy, or otherwise excessive medication regimens
* Pregnant/nursing women, \<18 years of age, prisoners, or the mentally ill
Sildenafil Citrate and Recurrent Abortion

Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation.

The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard pulsatility index (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications.

Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation.

The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (\|IUGR).

Eligibility Criteria:
Inclusion Criteria:

* Unexplained recurrent spontaneous abortion.

Exclusion Criteria:

* Abnormal uterine cavity.
* Luteal phase insufficiency.
* Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus.
* Antiphospholipid syndrome.
* Inherited or acquired thrombophilia.
* Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.