cyrilzakka/clinical-trials huggingface dataset:
The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics

Summary:

A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the induced sputum of atopic asthmatics following inhalation of allergen.

Hypothesis:

Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the airway lumen in atopic asthmatics during the timeframe of the late asthmatic response.

Objective:

The objective of this study is to examine the kinetics of dendritic cells in induced sputum following allergen challenge in atopic asthmatic subjects.

Subjects will be put through two study periods. Each study period will consist of four visits and will be separated by 2-4 weeks. On the first visit, subjects will undergo screening procedures, including complete history and physical examination. In addition, methacholine inhalation challenge and skin-prick testing will be preformed to assess airway hyper-responsiveness and determine atopic status respectively. Lastly, sputum will be induced before challenge (0 hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7 hours following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.

Before the next study period begins, there will be a washout period of 2-4 weeks. On the first visit of the second study period, a methacholine challenge will be performed to ensure the return of PC20 to within one doubling dose of baseline values. Also, sputum will be induced before challenge (0hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7hrs following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.

Eligibility Criteria:
Inclusion Criteria:

* Mild atopic asthmatics, presently well controlled on ß2-agonists.
* Non-smokers.
* Baseline FEV1 more than 70% of predicted normal.

Exclusion Criteria:

* Airway infection during the last 4 weeks.
* Exacerbation during the last 4 weeks.
* Inhaled or oral steroids during the last 4 weeks.
* Antihistamines during the last 48 hours.
* Asthma medication other than inhaled and/or oral ß2-agonists during the last 4 weeks.
* Pregnant women.
The ARIES HeartMate 3 Pump IDE Study

Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
2. Subject will receive the HeartMate 3 as their first durable VAD.
3. Subject must provide written informed consent prior to any clinical investigation related procedure.
4. In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.

Exclusion Criteria:

1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).
2. Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
3. Patients who are nil per os (NPO) post-implant through day 7.
4. Subjects with a known allergy to acetylsalicylic acid (aspirin).
5. Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
6. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Telemedicine Education for Caregivers and Asthma Control in Children

Asthma control in pediatric patients remains a critical issue for healthcare providers. Telemedicine has emerged as an effective solution for overcoming distance barriers in healthcare delivery. This study aims to utilize telemedicine-based education for caregivers to improve asthma control in children with uncontrolled asthma. By providing remote guidance and support, the study seeks to enhance caregivers' knowledge and management practices, ultimately leading to better asthma outcomes for pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric asthma patients diagnosed according to the GINA guidelines, classified as having uncontrolled asthma, are managed and followed up for at least 1 month at the pediatric asthma unit of the outpatient department.

Exclusion Criteria:

* Pediatric patients who do not cooperate or are unable to complete the Childhood Asthma Control Test questionnaire.
* Caregivers who cannot complete the questionnaires related to the assessment of asthma control and associated factors.
* Pediatric patients who have siblings participating in the study.
* Patients currently participating in another clinical study (excluding non-interventional studies or registries).
An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization

This is an open-labelled clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization

This study is an open-labelled phase Ⅲ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.A total of 1195 subjects who received vaccine in the phase Ⅲ lot-consistency clinical trial were be enrolled .All subjects except C0243 and C0556 were divided into 3 groups according to the order of study number.Subjects in 3 groups received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3 years after primary immunization,respectively.About 3.0ml of venous blood was collected from each enrolled subject at pre-booster immunization,30 days after booster immunization and the serum was separated for neutralizing antibody detection.The antibody levels were used to evaluate the immunity persistence and immunogenicity after booster immunization of live attenuated varicella vaccines .

Eligibility Criteria:
Inclusion Criteria:

* Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial;
* Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

Exclusion Criteria:

* Received one dose live attenuated varicella vaccine at the end of the phase Ⅲ lot-consistency clinical trial;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity

This is a prospective, open-label, single-arm study evaluating the safety and efficacy of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be ≥ 18 years of age at signing of informed consent.
2. Subject must be diagnosed with relapsed or refractory DLBCL (including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma) and scheduled to receive treatment with Yescarta.
3. Female subjects of childbearing potential who are sexually active and male subjects who are sexually active and have female partners of childbearing potential must agree to use a highly effective method of contraception with their partners during exposure to defibrotide and for 30 days after the last dose of defibrotide.
4. Subject must be able to understand and sign written informed consent.

Exclusion Criteria:

1. Subject is currently receiving dialysis or expected to receive dialysis.
2. Subject has used any investigational anticancer agent within 3 weeks prior to the first dose of defibrotide, or is using or plans to use any investigational agent during the study.
3. Subject has previously been treated with CAR-T therapy.
4. Hemodynamic instability requiring vasopressors or uncontrolled hypertension with persistent systolic blood pressure \> 180.
5. Subject has clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding as determined by the Investigator.
6. Subject plans to use any medication that increases the risk of bleeding.
7. Subject is pregnant or lactating and does not agree to stop breastfeeding.
8. Subject has a known history of hypersensitivity to defibrotide or any of the excipients.
9. Subject has primary CNS lymphoma.
International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU

An anonymous international multicenter - clinical survey, one-day observational study.

Delirium is a serious complication in postoperative and critically ill patients and is independently associated with cognitive impairment at hospital discharge and with significantly higher 6-month mortality. Furthermore, ICU delirium is associated with more days requiring mechanically ventilation, longer ICU length of stay, and longer hospital length of stay. More recently a study by Pisani and co-workers' could show an association between days of delirium and mortality; - each additional day spent in delirium is associated with a 20% increased risk of prolonged hospitalization - translating to over 10 additional days - and a 10% increased risk of death.The reported prevalence of delirium in critically ill patients ranges widely from 11% to 87%. The aim of our study is to investigate the implementation rate of routine delirium assessment in European ICUs.

Eligibility Criteria:
Inclusion Criteria:

* Patients staying in the ICU on the 25th of January (one-day prevalence study)

No exclusion Criteria:
A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)

The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Between the ages of 18 and 70

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or ketoacidosis.
* Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
* Patient has had surgery within 30 days of starting the study or has planned major surgery during the study
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for bunion surgery

Exclusion Criteria:

* daily opioid use
* drug or alcohol abuse
* pregnant or breastfeeding women
Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile

The purpose of this study is to establish which of the following tests perform best in diagnosing clostridium difficile. PCR, Enzyme Immunoassays (EIA) and C. difficile cytotoxin assay (CTA).

This comparative study will be carried out in the hospital microbiology laboratory of a tertiary academic health center, St. Joseph's Healthcare (SJH) affiliated with McMaster University, Hamilton, ON on 500 individual stool samples from patients greater than 12 months of age to determine an efficacy of distinction between current gold standard and other methods of testing for Clostridium difficile. This study is required to find a faster test for diagnosis of CDI in order to facilitate prompt treatment and reduce the complications of CDI. Identification of infected cases will lead to the enforcement of infection control measures and thereby prevent spread to other susceptible children. This is turn will reduce costs, length of stay, morbidity, and mortality from CDI if instituted correctly.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 12 months of age
* Having diarrhea

Exclusion Criteria:

* Inadequate volume of sample to perform all three diagnostic tests (less than 3mL
* Formed stools
The "Suicide Guard Rail": A Structural Intervention for Hospitals Avoid Suicides by Jumping From Heights Buildings

Background: Suicides by jumping from the high buildings of acute hospitals are dramatic events which are highly traumatizing to families, staff and fellow pts. In the 10 years from1995 to 2010 the investigators have counted 10 suicide cases despite extensive measures taken to predict and avoid them.

The investigators hypothesized that constructive measures at the windows that would render access more difficult could discourage spontaneous suicidal behaviour and would reduce the suicide rates.

Intervention: Starting in 6/2004, a 20 mm diameter metal guard-rail (which resists 250kg) was installed at each window of a 360 bed acute hospital at a height of 113cm, 18cm above the window parapet with the aim to visually, psychologically and physically discourage potential suicidal impulses.


Eligibility Criteria:
Inclusion Criteria:

* person at risk for suicide

Exclusion Criteria:

* no
Changes of Keratometric Value and Ocular Aberration After Treatment of Meibomian Gland Dysfunction

Ocular aberration may play a role in determining optical quality. Recently performed study reported that ocular aberration of preocular tear film would be important factor in not only diagnosing the dry eye but also determining the efficacy of treatment. Therefore, in this study, the investigators will aim to prove the improvement of quality of vision via ocular aberration changes indirectly after the proper treatment for moderate and severe meibomian gland dysfunction. Also, the investigators will evaluate the changes of keratometric values after treatment for moderate and severe meibomian gland dysfunction, which could be demonstrated by autokeratometry, IOLMaster, Pentacam, and iTrace.


Eligibility Criteria:
Inclusion Criteria:

(1) stage 3 or 4 meibomian gland dysfunction

Exclusion Criteria:

1. history of previous ocular or intraocular surgery
2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,
3. history of intolerance or hypersensitivity to any component of the study medications,
4. wearing contact lenses during the study period, presence of current punctal occlusion,
5. pregnancy, lactating women, and children.
6. Additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment MGD or dry eye, including topical or oral antibiotics, topical cyclosporine A, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears
Physical Activity Training Program for Patients With Alzheimer's Dementia

The purpose of this study is to determine if a home based physical activity training program for patients with Alzheimer's dementia has effects on clinical and neurobiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* age \>55 years
* German is the dominant language (necessary for neuropsychological testing)
* minimum of 8 years formal school education
* caregiver (e.g. spouse) living at home with participant
* physical examination does not reveal contraindications to physical activity
* stable dose of pharmacological dementia treatment according to German guidelines (DGPPN) with acetylcholinesterase inhibitor or memantin or combination for at least 6 months
* no other medication that could influence cognitive functioning (e.g. benzodiazepines, sleep aids, neuroleptics)

Exclusion Criteria:

* history of neurological or psychiatric disease other than AD
* history of substance abuse disorder
* history of electroconvulsive therapy (ECT) during the last 6 months
* structural brain deficits diagnosed in the MRI scan, also without clinical relevance (incidental finding)
* pacemaker, artificial heart valve, insulin pump or other medical implants
* average steps/day are above 10.000 steps/day
The Effect of Hyperextension Exercises In Lumbal Disc Hernia

The aim of this study was to examine the short-term effect on pain severity, disability level, flexibility and performance level of McKenzie hyperextension exercises applied in addition to conventional physiotherapy approaches in patients diagnosed with LDH.

A total of 48 consecutive female patients diagnosed with LDH at L4-S1 were randomly separated into 2 groups of 24 as the study group and control group. The control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and TENS. The study group subjects received 15 sessions of McKenzie hyperextension exercises in addition to the conventional physiotherapy program.

Aim: The aim of this study was to examine the short-term effect on pain severity, disability level, flexibility and performance level of McKenzie hyperextension exercises applied in addition to conventional physiotherapy approaches in patients diagnosed with LDH.

Method: A total of 48 consecutive female patients diagnosed with LDH at L4-S1 were randomly separated into 2 groups of 24 as the study group and control group. The control group subjects were applied with 15 sessions of conventional physiotherapy consisting of hotpack, ultrasound, and TENS. The study group subjects received 15 sessions of McKenzie hyperextension exercises in addition to the conventional physiotherapy program. Before treatment, immediately after treatment, and at 3 months after the end of treatment, the two groups were compared in respect of pain severity (Visual Analog Scale- VAS), performance level (Half-Squat Test and The 5 Times Sit-Stand Test), flexibility level (Modified Sit And Reach Test), and disability level (Oswestry Disability Index - ODI).

Eligibility Criteria:
Inclusion Criteria:

* The patients included were diagnosed on MRI with L4-S1 LDH (bulging level),
* were taking no drugs other than simple painkillers,
* had LDH symptoms ongoing for at least 3 months.

Exclusion Criteria:

* Patients were excluded from the study if they had a history of lumbar spinal surgery,
* had any disease involving the lumbar spine other than LDH (piriformis syndrome, infection, spondylosis, spondylolysis, spondylolisthesis, ankylosing spondylitis, spinal stenosis, facet syndrome, spinal malignancy, osteoporosis),
* severe neurological loss,
* diabetes mellitus, or were pregnant.
Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.

The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give informed consent
* Vaginal delivery
* Postpartum hemorrhage due to suspected uterine atony
* Oxytocin given during 3rd stage of labor

Exclusion Criteria:

* Known allergy to prostaglandins or misoprostol
* Underwent cesarean section
* Postpartum hemorrhage NOT due to suspected uterine atony
* Oxytocin NOT given during 3rd stage of labor
* Severe ill health
* Unable to give informed consent