cyrilzakka/clinical-trials huggingface dataset:
Tailored Teen Alcohol and Violence Prevention in the Emergency Room (ER)

This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.

This study will screen \~3000 adolescents in the ED (ages 14-18) over 30 months. Eligible adolescents will be asked to participate in the longitudinal study, stratified by age and gender and randomized to conditions (n=225/group): Computer Prevention Program, Counselor Prevention Program, or an informational handout control condition. Primary outcomes will be evaluated at 3, 6 and 12-months and include alcohol use/misuse, violent behaviors, illicit drug use, unintentional injury, delinquency, and weapon carriage. The proposed study integrates brief intervention strategies for alcohol misuse and violent behaviors using state-of-the-art technology to tailor the interventions to the specific risk factors of the adolescent. Tailored computerized programs use available technology to replace the need for clinical staff in the ED setting, where there is limited staff time to effect behavior change. This project will provide the critical first step toward the implementation of an integrated prevention program addressing overlapping risk factors that has the potential to be delivered to the millions of adolescents visiting urban Emergency Departments each year.

Eligibility Criteria:
Inclusion Criteria:

* adolescents (ages 14-18) presenting to the ED for a medical injury or illness (except exclusions as noted below)
* adolescents ability to provide informed assent/consent depending on age
* access to a parent or guardian to provide informed consent

Exclusion Criteria:

* adolescents who do not understand English
* prisoners
* adolescents classified by medical staff as "Level 1" trauma
* adolescents deemed unable to provide informed consent
* adolescents treated in the ED for suicide attempts
* adolescents triaged to the psychiatric ED
S100B in Intensive Care Patients With and Without Traumatic Brain Injury

The neurotrophic protein S100B has been promoted as a neuromarker for decades, and to reflect the severity of brain injury. On the other hand, S100B is a tumor marker. The interpretation of its serum levels may be altered by a contribution from extracerebral sources and its renal elimination.

In the present study we investigate the relevance of S100B as a prognostic factor, as well as the correlation with different CT classifications in a large cohort of patients with and without brain injury. Furthermore, we examine whether S100B is elevated in brain tumors.

Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg, undergoing surgery for sellar lesions were prospectively included. The study protocol was approved by the local Ethical Committee. Informed written consent was given by the participants or the next-of-kin in each case. Exclusion criteria comprised of those below 18 years of age, pregnancy and a drug intolerance.

Patients baseline information included age, gender, clinical presentation, and preexisting medical conditions. In four different cohorts of patients, S100B was measured:

1. ICU TBI, patients treated on the ICU with brain injury
2. ICU tumor, patients treated on the ICU because of an intracranial tumor
3. ICU surgery, patients treated on the ICU following surgery without brain injury
4. ICU control, patients treated on the ICU without TBI, tumor or surgery

The performed diagnostic tests included blood, cerebrospinal fluid and urine samples. In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.

Samples were immediately centrifuged for 10min at 1.300xG and 4°C and stored at a temperature of -80°C until the assays were performed. Analysis was performed with commercially available kits on automated immunoanalyzers (LIAISON® Sangtec®100 by chemiluminescence immunoassay, Diasorin). The sensitivity of the assay was 0.02ng/ml.

In all cohorts the clinical status was documented with Glasgow Coma Score (GCS), and the outcome was assessed applying the Glasgow Outcome Score (GOS) or the Karnofsky Status Scale. The radiological work-up included a computed tomography (CT) or a magnetic resonance imaging (MRI). In brain injured patients, the CT was classifiied by the Marshall and Rotterdam Score. Extracranial injuries or surgical procedures were documented

Statistical analysis was performed with SPSS, and p\<0.05 was accepted as significant.

Eligibility Criteria:
Inclusion Criteria:

* patients of the Department of Neurosurgery, University of Erlangen Nürnberg, patients with traumatic brain injury,
* patients with intracranial tumor,
* intensive care patients,
* informed written consent was given by the Patient or the next of kin in each case.

Exclusion Criteria:

* age under 18
* pregnancy
Methylene Blue in Early Septic Shock

Septic shock is a subset of sepsis characterized by a decrease in vascular tone, which contributes to impaired regional blood flow distribution, and leads to organic failure. Besides intravenous fluids and adequate antimicrobial therapy, patients with septic shock require vasopressor support, which can lead to many adverse effects, therefore, non-vasopressor agents that can improve hemodynamic status are needed. In this randomized controlled-study, the investigators will address the efficacy and safety of infusion with methylene blue in patients with septic shock.

Unlike sepsis, septic shock mortality is not declining for the last decade, and is still around 40%. After restoring intravascular volume, many patients need vasopressor agents to maintain arterial blood pressure, which leads to improvement of perfusion at some vascular beds, however some organs may suffer from maldistribution of blood flow. These changes of regional blood flow may compromise oxygen delivery and perpetuate the inflammation and tissue damage associated with the state of shock.

One of the main mechanisms of vasodilation after inflammatory insults, is the activation of the inducible isoform of Nitric Oxide Synthase (iNOS), and the subsequent increase in the levels of nitric oxide, which even reduces the response to vasoconstrictor agents. Methylene blue (MB) is a selective inhibitor of iNOS, which has been used successfully in patients with post-cardiopulmonary bypass associated vasoplegia, however, the evidence of the use of MB in septic shock patients is limited to case reports, observational and small studies. In this randomized controlled trial, the investigators will compare the efficacy and safety outcomes of repeated doses of MB in patients with septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock diagnosis, according to the Sepsis-3 consensus.
* Prior adequate fluid resuscitation according to dynamic predictors of volume responsiveness.
* More than 6 h and less than 24 h of norepinephrine requirement to maintain a mean arterial pressure ≥65 mmHg.

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy.
* Not expected to survive 48 hours.
* Presence or high suspicion of concurrent hemorrhagic, obstructive or hypovolemic shock.
* Personal or familiar history of glucose-6-phosphate dehydrogenase deficiency.
* Allergic to methylene blue, phenothiazines, or food dyes.
* Recent intake (4-weeks) of selective serotonin re-uptake inhibitors.
* Refusal of the patient or decision maker to enroll in the study.
Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin

Treatment of pericarditis largely remains empirical due to the relative lack of randomized controlled trials. Nevertheless, some recommendations have been formulated to guide management and follow-up of acute pericarditis. Aspirin or an NSAID at medium to high dosages is the mainstay of treatment. Optimal length of treatment is not established.

PERICARDITE is a French multicentric placebo controlled double blind randomized trial assessing efficacy of a brief treatment based on Aspirin (4 days) versus a longer treatment (21days) in treating a first episode of probably idiopathic acute pericarditis. It is a non inferiority trial.

Exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction, autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis, neoplastic disease).

Primary endpoint is: 30 days recovery defined as the normalization of all clinical and paraclinical initial abnormalities.

Secondary endpoint is: 6-month recurrence.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* first episode of acute pericarditis
* chest pain lasting less than 24 hours

Exclusion Criteria:

* contraindication to aspirin
* previous history of atypical chest pain
* previous history of connective tissue disease, tuberculosis, recent MI, auto immune disease, neoplastic disease, thoracic trauma, previous thoracic surgery, antiplatelet routine treatment, anticoagulation
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea

The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll up to 300 patients, that meet the Health Insurance Review and Assessment (HIRA) guidelines for LVAD implantation, from up to 25 sites in South Korea. Subjects who will be implanted but not included in the PMS can be enrolled retrospectively after obtaining their informed consent. The surveillance period for this PMS is expected to be 4 years from the time of HM3 approval in Korea, concluding on June 2, 2024.


Eligibility Criteria:
Inclusion Criteria

General Inclusion Criteria: All patients approved for HM3 implantation in Korea as per HIRA guidelines will be eligible to be enrolled in the PMS. Only the patients who provide written informed consent will be included in the study. If a subject has had an outcome after the HM3 implantation but prior to providing informed consent, no consent will be obtained, and a limited anonymized data will be collected.

Exclusion Criteria

General Exclusion Criteria: This post market surveillance does not have specific exclusion criteria
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman

Up till now, there is insufficient evidence that daily fetal movement counting for pregnant women who are already have a history of high risk pregnancy is beneficial or not in term of early detection and preventing adverse pregnancy outcomes.

Aim The aim of the current study is to evaluate the effect of fetal movement counting on maternal and fetal outcome

The researchers met the pregnant women in antenatal clinics during their routine follow up. Woman who was eligible to be recruited in the study signed the consent after description of the study's purpose. Pregnant women in the study group received verbal information regarding normal fetal movements (i.e. description of the changing pattern of movement as the fetus develops, normal sleep/wake cycles, and factors which may modify the mother's perception of movements such as maternal weight and placental position), and its importance to be followed during the third trimester. Further, each pregnant woman in the study group was trained how to count the fetal movement (i.e.lying down on her left side after taking her meal, and concentrating on fetal movements, calculate it three times per day, half an hour/ one time and record it in the chart). As a rule, if there are less than 10 movements felt in 2 hours, women should contact her health care provider immediately (Royal college of obstetrician \& gynecologists, 2011). Fetal movements counting chart was provided and women telephoned once a week in order to ensure proper recording. They also asked to present the fetal movements' chart to the researcher and thier health care providers in each antenatal follow up visit. Pregnant women in both groups; the study and the control groups followed according to thier antenatal visits schedule till delivery. Women in the control group received the antenatal hospital standard care. The maternal and neonatal outcomes had been assessed at delivery unit.

Eligibility Criteria:
Inclusion Criteria:

* Second gravida
* Singleton
* 28 weeks gestation
* History of pregnancy induced hypertension (PIH)
* History of premature rupture of membrane (PROM)
* History of preterm labor
* History of gestational diabetes
* History of antepartum hemorrhage
* History of stillbirth
* History of fetal growth restriction

Exclusion Criteria:

* History of psychological problems
* Drugs abuse
* Experience any terrible life events during the past 6 months
* Oligohydramnios
* Multi-fetal pregnancy
* Fetal abnormalities
* Smoking
Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1

This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.

The study will be conducted at the UW Primary Infection Clinic and the UW AIDS Clinical Trials Unit. Secondary objectives will characterize safety, tolerability, plasma HIV-1 RNA and CD4+ T-cell values. The 3-drug HAART will be chosen and provided by the subject.

Eligibility Criteria:
Inclusion Criteria:

* Acute or Early HIV-1 infection
* HIV-1 RNA \> or equal to 500 copies/mL
* Acceptable safety lab results (specified in protocol)
* Negative pregnancy test for females
* Willingness to use contraception (for females of reproductive potential

Exclusion Criteria:

* Prior receipt of investigational HIV-1 vaccine
* Use of immunomodulators other than systemic steroids within 30 days before entry
* Serious medical or psychiatric illness that would interfere with study participation
* Active drug or alcohol use that would interfere with study participation
* Allergy/hypersensitivity to raltegravir
* Pre- or Post-exposure prophylaxis for the exposure that led to HIV-1 acquisition
* Pregnancy or breastfeeding
* History of malignancy (other than localized squamous cell or basal cell cancer of the skin)
Pulmonary Rehabilitation and Quality of Life

In this study, the effect of a pulmonary rehabilitation (PR) program on the respiratory function and quality of life of patients undergoing CABG surgery with an open-heart technique is examined. A randomized controlled experimental design was used. The study was conducted with two groups: the intervention group (n=25) and control group (n=25). The control group received standard care after CABG. In contrast, the experimental group, in addition to standard care, participated in a PR program created by the researchers. After CABG, the respiratory functions of both groups (clinical care day 4) and quality of life (6th week) evaluated


Eligibility Criteria:
Inclusion Criteria:

* Patients who were extubated in twenty-four hours,
* aged 18 or above,
* had undergone CABG surgery using the open-heart method and using a saphenous vein graft for CABG,
* who were conscious,
* without visual and hearing problems,
* who spoke Turkish,
* had not orthopedic, psychiatric and neurological problems,
* no co-morbid lung disease,
* who had not been re-operated on,
* had not postoperative cardiac dysfunction,
* had not developed postoperative atrial fibrillation,
* who were willing to participate in the study.

Exclusion Criteria:

* Patients who were not extubated in twenty-four hours,
* who were under 18 years of age,
* had not undergone CABG surgery using the open-heart method and using a saphenous vein graft for CABG,
* who were not conscious,
* were visual and hearing problems,
* who don't spoke Turkish,
* had orthopedic, psychiatric and neurological problems,
* co-morbid lung disease,
* who had been re-operated on,
* had postoperative cardiac dysfunction,
* had developed postoperative atrial fibrillation,
* who were not willing to participate in the study.
Pharmacokinetics of Piperacillin and Meropenem in ICU Patients

The purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment.


Eligibility Criteria:
Inclusion Criteria:

- Patient being treated in one of the participating ICUs and planned to recieve treatment with meropenem or piperacillin.

Exclusion Criteria (fullfilling any exlusion criteria means that patient cannot be included in the study):

* Not possible to retrospectively ask the patient or next of kin for consent to take part in the study or patient or next-of-kin not providing consent.
* Not posisble to obtain and process blood samples as specified by protocol.
* Ongoing renal replacement therapy.
* Patient having received the same antibiotic within the previous 96 h.
Patient-Centred Perioperative Mobile Application

With increasingly more complex surgical patients and the trend toward decreased hospital stay after operations, continuity of care and prompt management of symptoms and side effects perioperatively are ever more crucial. The investigators' goal is to improve perioperative care with a patient-centred mobile application, starting with a pilot in patients undergoing elective Cesarean delivery. The investigators have completed a research study where they created a prototype based on feedback from patients and anesthesiologists. In this study, the investigators would like to learn about how patients use our mobile application after delivery and how the mobile application can be integrated into daily practice.

The objective of this cohort study is to build the mobile application and evaluate its feasibility in providing patient education and reminders for self-monitoring for cesarean delivery patients. The investigators will measure the extent of patient engagement with our application through in-app usage data, as well as receive quantitative and qualitative feedback regarding feasibility. By understanding user behavior and needs through questionnaires and application usage data, the investigators could design more effective and tailored interventions for patients. Results of this study will help further development and implementation of an interdisciplinary mobile monitoring and communication platform for perioperative care.

This study is funded by the Dalhousie University Department of Anesthesia, Pain Management \& Perioperative Medicine.

Eligibility Criteria:
Inclusion Criteria:

Part 1 (screened by asking nurse)

* Patient scheduled for elective Cesarean delivery
* Age equal or greater than 18
* American Society of Anesthesiologists (ASA) Physical Status I-III (i.e. not in life-threatening situation)

Part 2 (screened in person)

* Possesses an iOS Smartphone with active data plan and access to WiFi, and self-reported use of it on a regular basis (at this stage in development, the mobile application prototype is only available on iOS)
* Self-reported proficiency with Smartphone and mobile applications
* Reported fluency in English

Exclusion Criteria:

Self-reported physical or psychiatric condition that may impair the ability to use the mobile application, answer questionnaires and surveys, and/or provide insights representative of the general population, such as blindness, under current influence of recreational drugs or alcohol.
Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia

The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict recurrence of high-grade CIN.

Cervical samples for human papillomavirus (HPV) DNA analysis and cytological analysis were obtained from women with abnormal smears referred to Umeå university hospital, Sweden, for treatment with conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24 and 36 months after treatment. The HPV DNA testing was performed with a PCR-based genotyping method.

Eligibility Criteria:
Inclusion Criteria:

* Referral to Umeå university hospital for treatment due to abnormal Pap smear.

Exclusion Criteria:

* Lack of informed consent.
Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer

1st-line treatment of HER2/neu overexpressing breast cancer

The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78%. This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy. The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, metastatic breats cancer.
* HER2-neu overexpression (IHC3+ or IHC2+/FISH+)
* Written informed consent
* no previous therapy with vinorelbine or trastuzumab
* Age \* 18 and \* 75 years
* Karnofsky-Performance status \> 70%
* Life expectance 16 weeks and more
* Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions
* Exclusion of pregnancy and adequte contraception during childbearing age.

  * Adequate hematological, renal, and hepatic function
* Normal cardiac function. LVEF should not be \>10% below normal.
* Adequate compliance to perform treatment and subsequent follow-up visits

Exclusion Criteria:

* Locoregional recurrence of breast cancer only or development of contralateral breast cancer
* Pregnancy or lactation
* Symptomatic brain- or meningeal metastasis
* Concurrent endocrine antitumor therapy
* Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix
* Peripheral neuropathy \>= NCI CTC Grade 2.
* other severel disease which preclude adequate treatment
* Participation in a clinical trial within the last 30 days.
* Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up