cyrilzakka/clinical-trials huggingface dataset:
Zanamivir Aqueous Solution Compassionate Use Program Retrospective Chart Review Study

GSK is conducting a global retrospective chart review of patients treated with zanamivir as part of the Compassionate Use Program (CUP), in an effort to collect as much information as possible on the use of this investigational drug. The retrospective chart review is intended to gain a better understanding of the safety profile of investigational zanamivir and of clinical outcomes in the large number of patients treated outside of a clinical trial setting.

This is an observational, retrospective, multi-centre, cohort data collection study.

The CUP retrospective review study has been designed to collect safety and clinical outcome data from pediatric and pregnant patients (collectively referred to as the "Tier 1" cohort) treated globally within the CUP during the 2009/2010 pandemic (from May 2009) through 31 January 2011. The study will also attempt to collect data from other adult patients (referred to as the "Tier 2" cohort) who were treated at sites identified as having Tier 1 patients.

The treating physician at each site will receive a letter from the GSK medical director inviting him/her to participate in the retrospective chart review study. Physicians (or their delegates) who agree to participate will receive study-related documentation \[including the protocol and case report form (CRF)\] to orient the site to the study details and CRF. For the purposes of this study, the term "site" generally refers to a hospital where in-patient treatment was provided.

The retrospective chart review will be monitored via remote visits by telephone. The interviewer will be a Kendle associate assigned to the study who will not have direct access to the patient's source documents or medical records during conduct of the study. The physician/delegate will review the patient's chart and record data on a paper CRF. The CRF will be in the English language. Site personnel will mail completed CRFs to Kendle. Kendle will review the CRF for data quality, and conduct a remote monitoring visit via telephone to address any data queries, if required. No visits to participating sites are planned.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011 (Tier 1 cohort).
2. Adult patients (Tier 2 cohort) that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011, treated at the same site as a Tier 1 patient.

Exclusion Criteria:

1. Adult patients that received zanamivir aqueous solution at non-Tier 1 sites.
2. Pediatric or pregnant patients that received zanamivir aqueous solution as part of the Compassionate Use Program after 31 January 2011.
Hemodilution and Coagulopathy With 3 Colloids

Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination of FBG and FXIII.

In blood of 12 volunteers the following measurements are performed at baseline and 60% dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and determination of factor concentrations are again performed.

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

* signed informed consent from before blood withdrawal

Exclusion criteria:

* known coagulation disorders,
* any form of anticoagulation therapy,
* use of acetyl-salicylic acid within the past five days,
* use of non-steroidal anti-inflammatory agents within the past 24 hours,
* known renal disease or plasma concentrations of aspartate aminotransferase (\>50 U l -1) or alanine aminotransferase (\>50 U l-1)
* patients incapable of understanding the German language
Home Within the Heart: a Playful Journey to Strengthen Family Resilience

The primary aim of this clinical trial is to enhance open and secure communication within the family, strengthen the parent-child bond, and reinforce feelings of safety and stability, and strengthen family resilience.

In addition,the investigators want to assess the effectiveness of a short-term therapeutic workshop in enhancing reflective functioning, beliefs about the malleability of emotions, the reported use of effective emotional regulation strategies, and the perceived parental self-efficacy and child behavior.

The participants will:

Complete questionnaires and participate in clinical interviews regarding their relationship with their children and their mental functioning prior to the workshop.

The intervention group will engage in a 4-session workshop (held once a week) facilitated practitioners from various therapeutic disciplines, including clinical, educational, and developmental psychologists, as well as group facilitators.

During each session, observers document the quality of the interaction between the parent and child, focusing on aspects such as emotion, responsiveness, encouragement, and instruction.

After the workshop, participants will again complete questionnaires.

Eligibility Criteria:
Inclusion Criteria:

A parent who have been evacuated from war zones in the northern and southern regions of the country, and has a child of ages 3-6.

Exclusion Criteria:

* A parent under the age of 18.
* A parent who have not been evacuated from war zones.
* A parent who has a child under 3 years of age, or above 6 years of age.
Effect of Estrogen & Stress for Postmenopausal Women

The study tests the hypothesis that estradiol administration exacerbates the effects of the stress hormone cortisol on cognition and mood for postmenopausal women. This randomized, placebo-controlled, double-blind study was designed to examine the effects of an eight-week trial of transdermal estradiol replacement therapy (0.10 mg/day) in combination with 4 days of oral hydrocortisone (90 mg/day in 3 daily doses of 30 mg per dose) in the last week of hormone therapy on cognition and mood in healthy postmenopausal women. Forty cognitively healthy postmenopausal women were randomized to receive either placebo or estradiol skin patches for 8 weeks. In the middle of the 7th week (day 57), subjects in each group were again randomized to receive either a placebo tablet or an oral hydrocortisone tablet 3x/day for 4 days. Memory testing and blood collection occurred at baseline, at week 4, and again at week 8.

Estrogen replacement has been associated with improved learning and memory in both animal and human studies. However, there is some evidence to suggest that "stress" has a detrimental effect on learning for female animals who still have naturally circulating estrogen. Interestingly, when the effects of this hormone are blocked in the body, stress no longer impairs learning. Several investigators have raised the possibility that the physiological response to stress may be exaggerated for women compared to men. Gender differences in biological systems that control the release of gonadal and stress hormones may explain why estrogen is beneficial for women under nonstressed conditions, but detrimental for them under stressed conditions. To date, no study has carefully controlled or manipulated both estrogen use and cortisol levels to further explore this issue. In this placebo-controlled, double blind, parallel-group design clinical study we will evaluate whether estrogen use exacerbates stress-related impairments in cognition for healthy postmenopausal women. Forty subjects will receive either 0.10 mg/day of transdermal beta-estradiol or a placebo skin patch for 8 weeks. In the last week of treatment, subjects will receive 90 mg/day of oral hydrocortisone or a placebo for 4 consecutive days. Scores on tests of memory, attention, and mood, as well as blood levels of estrogen and cortisol will be assessed at baseline, and at weeks 4 and 8. We predict that the estrogen+cortisol combination will have a deleterious effect on cognition and mood relative to the effects of either hormone administered alone. The results of this study are likely to provide important information regarding not only the nature of the interaction between these hormonal systems that occurs in response to stress, but also the conditions under which the beneficial effects of estrogen may be overshadowed.

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women

Exclusion Criteria:

Current HRT use Hx of DVT current steroid user Cushing's or other similar disease Breast or uterine cancer
Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption of CHF 5074 after single oral administration in young healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.
* Subject has a body mass index between 18 and 30 kg/m\^2, inclusive.

Exclusion Criteria:

* Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
* Abnormal result of liver function tests, renal function tests or thyroid tests performed at screening.
* Significant allergic conditions that require medical treatment
* Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
* Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
Expression of Toll-Like Receptors 2 and 4 in Asthmatic Patients.

Introduction: Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of Pathogen-Associated Molecular Patters (PAMPs). The possible role that TLRs play in IgE-dependent asthma (not eosinophilic) and its recognition as a new endotype asthma, could open new therapeutic expectations.

Objective: To analyze the expression of TLR 2 and 4 in monocytes/ macrophages and neutrophils in peripheral blood and induced sputum from asthmatic patients

The investigators studied patients with asthma. All patients underwent the same day an induced sputum, pulmonary function studies, fractional exhaled nitric oxide, blood total IgE and skin test by prick technique. Asthmatic patients were classified according to the criteria of the GINA 2012. The cellular composition was analyzed by flow cytometry. Expression of TLR2 and TLR4 were analyzed using monoclonal antibodies conjugated with fluorochromes appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Adults with persistent asthma (defined as per the Global INitiative for Asthma Management (GINA) criteria)

Exclusion Criteria:

* If they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion
* If they were receiving oral steroids or immunosuppressive treatments.
Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.

The purpose of this study is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in the operation room, the time to full mobilisation postoperatively and the time to complete recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* ASA classification I-II
* Speaks and writes danish
* Signed informed consent

Exclusion Criteria:

* ASA classification III-VI
* Emotional disorder - medically treated within a week before surgery
* Patients in risk of perioperative aspiration - who must be intubated
* BMI \> 35
* Patients who have been using pain medicine within a week before surgery (except PCM and NSAID)
* Patients who have been using sleeping medicine or sedatives within a week before surgery
Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation

The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation.

Extraction of the teeth is still one of the most commonly undertaken procedures in dental practices due to various reasons that render the teeth non-restorable. Following extraction, replacing the lost teeth with a prosthetic alternative that provides for both optimal esthetics and function can be challenging due to the inevitable events of socket healing that results in the reduction in alveolar bone height and width. To overcome these limitations and provide for adequate ridge volume, different bone preservation or augmentation techniques can be utilized with different clinical applications.

Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. To overcome this problem, various approaches using various grafting materials and/or covering membranes have been proposed with varied success. The extracted tooth is no longer considered as clinical waste, it has been explored as an appropriate source for autogenous graft substitute. This idea emerged due to the shared embryonic origin of bone and teeth as well as the similarities in chemical structure as dentin is composed of 30-35% organic part and 65-70% inorganic part in comparison to alveolar bone, with inorganic and organic parts of 35% and 65% respectively. Both whole-tooth and particulate forms has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.

Eligibility Criteria:
Inclusion Criteria:

* Non-restorable tooth indicated for extraction
* single-rooted teeth
* Patients at least 18 years or older
* Motivated patients, agree to sign informed consent and complete the follow-up period

Exclusion Criteria:

* Pregnant females
* active infection at extraction site
* Smokers
* systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
Study to Determine Quicker Methods of Diagnosing Pneumonia Caused by a Breathing Machine in Critically Ill Patients

Critically ill patients on a breathing machine are at risk of developing a type of pneumonia called Ventilator Acquired Pneumonia (VAP). The purpose of this study is to determine if regular lung rinses sent for microbiological testing can reduce the time to diagnose VAP. The study also plans to test the accuracy and speed of a new technology, using multiplexed automated digital microscopy, to identify the germs causing the VAP.

Ventilator-associated pneumonia (VAP) is a common, life-threatening hospital-acquired infectious complication of prolonged mechanical ventilation (MV). Despite aggressive efforts to prevent VAP, rates remain high because clinical diagnosis is imprecise and microbiological diagnosis is frequently delayed. Diagnosis of VAP depends on clinical signs as well as microbiologic evidence from Bronchioalveolar Lavage (BAL) cultures. Ordinarily, these cultures are only ordered after the patient presents with clinical signs and symptoms of VAP, which can significantly delay diagnosis and effective therapy. This research proposes to implement additional surveillance BAL cultures in order to reduce the time to diagnosis of VAP in mechanically ventilated critically ill adults. To further reduce the time to diagnosis of VAP, this research aims to test part of the BAL cultures using a novel flowcell/surface-capture device that allows direct from specimen visualization of bacteria using multiplexed automated digital microscopy (BACcel™) for rapid bacterial identification and antibiotic resistance testing. Additionally, molecular assays of the BAL sample will characterize lower respiratory tract antimicrobial peptide host-innate immune molecule and local anti-oxidant defenses in mechanically ventilated adults at risk for VAP.

Eligibility Criteria:
Inclusion Criteria:

1. Written, informed consent (by surrogate if unconscious or if altered mental status)
2. ≥ 18 years old
3. Admission to a Medical Intensive care unit
4. Orally/nasally intubated, evaluable within 72 h of initial intubation
5. Expected to remain mechanically ventilated for at least 48 h after the first study procedure

Exclusion Criteria:

1. Previously documented cystic fibrosis
2. Diffuse bronchiectasis
3. Severe or massive hemoptysis
4. Presence of an advanced directive to withhold life-sustaining treatment
5. Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition
6. Participation in a clinical trial of any unlicensed drug or device within 30 days
7. Pregnant or Nursing
Amobarbital and Cardiopulmonary Bypass

Explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.

AMO is a short acting complex I blocker that blocks mitochondrial complex I between flavoprotein and ubiquitin, and its blocking effect can be rapidly reversed. Our study is to explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-65 years old, undergo elective cardiac surgery with extracorporeal circulation.
* ASA II-III;
* surgical duration is 3-6 hours;
* Sign the informed consent form

Exclusion Criteria:

* BMI less than 18 kg/m2 or greater than 30 kg/m2;
* Individuals with a history or potential history of drug abuse or alcohol dependence;
* Preoperative use of sedatives or analgesics;
* Individuals with severe liver and kidney dysfunction;
* Individuals who are allergic or potentially allergic to barbiturates;
* Patients with coagulation dysfunction, endocrine disorders, or other conditions that affect hemodynamic status;
* Participated in other clinical studies in the past 3 months;
* The researchers believe that participants who are not suitable to participate in this study.
Avatar-based Social Physical Activity

This study is testing program where teens with type 1 diabetes play Meta Quest 2 virtual reality exercise games and talk, act, and paint about physical activity in virtual meetings with their peers and young adult role models. The outcomes are feasibility and user satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Age of 14-17 years
* Diagnosis of type 1 diabetes or other absolute insulin deficiency diabetes for ≥6 months
* Moderate-to-vigorous physical activity less than half of recommended levels (defined as ≤3 days per week achieving ≥60min daily MVPA)
* English literacy
* Home Broadband wireless Internet (≥25 mbps downloads, ≥3 mbps uploads on google Internet speed test). This is used in \~98% of US households.
* Willing to use continuous glucose monitor for the duration of participation in the trial.
* Willing to use a computer or smartphone with web camera.
* Under regular care by a healthcare provider (defined as attending at least one appointment in the past year, plus access to verified 24hr phone number to reach the provider's team for insulin dose adjustments if assistance is needed)

Exclusion Criteria:

* A condition or disability besides type 1 diabetes that would preclude participation in group moderate-to-vigorous physical activity (e.g., cerebral palsy, current pregnancy)
Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma

The purpose of this study is to evaluate mechanical bowel preparation (MBP) with polyethylene glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal resection for malignancy.

Surgical site infections (SSI) in colorectal surgery (anastomotic leakage, wound infection, intraabdominal abscess) are associated with increased mortality, postoperative hospital stay and costs. From a recent metanalysis and randomized clinical trial there is the emerging evidence that mechanical bowel preparation (MBP) before elective colorectal surgery is not associated with reduction of SIS, although it causes high discomfort for patients. On the same way other more recent studies show that MBP may cause an higher incidence of SIS, and that MBP may alter the bowel mucosa morphology. Other Authors report an increased incidence of anastomotic leakage requiring surgery for patients undergoing a single preoperative phosphate enema whereas but an higher cardiovascular mortality for patients undergoing MBP. Two recent studies do not clarify the usefulness of MBP for reducing SIS after colorectal surgery and one stage anastomosis. For these reasons a more precise understanding of the relationship between MBP and SIS could increase patients satisfaction and decrease unnecessary procedures and costs. At this point MBP represent the clinical standard for patients undergoing elective colorectal surgery at the European Institute of Oncology.

Eligibility Criteria:
Inclusion Criteria:

* Patients candidates to colorectal surgery for histologically confirmed colorectal cancer
* Age 18-80 years
* Obtained written consent

Exclusion Criteria:

* Patients at high risk for receiving a stoma (e. g. patients affected by distal rectal cancer \<5cm from the anal verge; patients whose tumour is located \>5 cm from the anal verge who underwent neoadjuvant CT-RT without downstaging or tumour shrinkage
* Intestinal obstruction
* Emergency procedures
* Patients who underwent colonoscopy within 7 day from surgery
* ASA 4-5 patients
* Patients unable to give informed consent
* Renal failure (serum creatinine \>3 mg/dl)
* Pregnant women
* Breast feeding women
Study on New Strategies for Hepatitis B Virus Immunization

To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.

By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.

Eligibility Criteria:
Inclusion Criteria:

* aged 25-55 years
* negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination

Exclusion Criteria:

* a history of vaccine component allergies
* autoimmune diseases
* immunodeficiency
* vaccinations received within the past month
* acute illnesses within the past week
* fever (axillary temperature exceeding 38°C) within the past three days