cyrilzakka/clinical-trials huggingface dataset:
Driving Pressure in Neurosurgery

The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early postoperative pulmonary ventilation is to be determined for patients undergoing neurosurgery. Patients are recruited to receive volume controlled ventilation with either a fixed PEEP (5cmH2O) or DP titrated PEEP. Early postoperative regional distribution of lung ventilation, expressed as global inhomogeneity (GI) is evaluated by electrical impedance tomography (EIT), a noninvasive, radiation free modality. Center of ventilation (COV) by EIT, as well as the lung ultrasonography（LUS), perioperative ventilatory parameters, arterial oxygenation index (PaO2/FiO2) , serum indicators and postoperative pulmonary complications are secondary outcome variables.

After screened for preoperative risk factors, 44 patients undergoing elective neurosurgery and planned to be extubated in the operating room are randomly assigned to two groups: (1) PEEP = 5cmH2O; (2) driving pressure (DP)-guided PEEP. The ventilation protocol consists of volume-controlled mechanical ventilation (Datex Ohmeda S/5 Advance; General Electric Company Healthcare, Helsinki, Finland) at a tidal volume (VT) of 8 ml/kg predicted body weight (PBW), fresh gas of 2 litre /min, inspiratory to expiratory ratio of 1:2, and a respiratory rate adjusted to normocapnia (arterial carbon dioxide partial pressure between 35 and 45 mmHg). For group 2, trial for the lowest DP was started 10 min after position adjustment by increasing PEEP from 2 to 10 cm H2O incrementally. DP was calculated as "plateau pressure - PEEP". Each PEEP level was maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP was identified and maintained intraoperatively. A plateau pressure of no more than 30 cmH2O is targeted in each group. Early postoperative distribution of regional ventilation global inhomogeneity (GI) is the primary endpoint evaluated by EIT (electrical impedance tomography), which was performed by a trained technician who is blinded to randomization. Center of ventilation (COV) by EIT, lung ultrasonography（LUS) , and arterial blood gas are evaluated, with inflammatory and oxidative mediators tested from venous sample. Brain relaxation will be scored by the neurosurgeon. Postoperative pulmonary complications within 3 days are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent has been obtained
* Elective neurosurgery
* Expected ventilation duration \> 2 hours
* Scheduled to be extubated in the operation
* American Society of Anesthesiologists (ASA) physical status \>2

Exclusion Criteria:

* Mechanical ventilation of \> 1 hour within the last 2 weeks before surgery
* Dysphagia resulting from preoperative cranial nerve damage
* Body mass index ≥ 35 kg/m2
* Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress syndrome)
* Emergency surgery
* Severe cardiac disease
* Progressive neuromuscular illness
* Pregnancy
* Refusal to participate
* Contradicted to EIT scan or lung ultrasound scan
Comparison Between Occlusal Versus Apical Bent Wires in Patients on Erich Arch Bar

Patients with jaw fractures requires placement of Erich arch bar for immobilization of the fractured jaw. However, the usage of Erich arch bar is associated with an increased in the incidence of mucosal trauma and plaque accumulation. Conventionally, the ends of the wires has always been placed apical to the teeth.

This study aims to determine if a change in the placement of the wire by directing it to the occlusal direction will reduce the incidence of mucosal trauma, plaque accumulation and if the stability of the Erich arch bar will be affected by this intervention.

The patients' teeth will be divided into left and right side and randomized into control side (wires end apically) and interventional side (wires end occlusally)


Eligibility Criteria:
Inclusion Criteria:

* 18 years - 60 years old.
* Full Glasgow coma scale.
* Facial fractures requiring Erich arch bar for 4 weeks duration
* No functional deficit that will prevent tooth brushing.

Exclusion Criteria:

* All pathologic fractures due to cysts, tumors, and cancers
* Medical conditions that contraindicate the usage of arch bars (Epilepsy, Asthmatics)
C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases

With new developments that have taken place in the optimization of C-arm computed tomography (CACT) image acquisition and reconstruction, CACT image quality will be better than current standard-of-care CACT scan techniques used for neurovascular patients referred to endovascular treatment or diagnosis. As such, novel acquisition, filtration, artifact reduction and reconstruction techniques will be evaluated against the standard-of-care CACT approach.

This prospective observational study aims to enroll 50 patients diagnosed with various neurovascular conditions with the goal to compare the image quality of new types of head C-arm computed tomography (CACT) image scans with standard CACT scans, and also to compare these novel scans with standard CT scan image quality. These new scans use novel acquisition, filtration and reconstruction techniques compared to the standard-of-care CACT scans being used in the neuroangiography suite at the present time. Patient selection will be based on a suitability of patients for neuro-endovascular interventions in the neuroangiography suite. All research related activities will be done by study team members. The study patients are expected to follow their routine treatment schedule with the exception of 1 extra CACT scan while patient is receiving their standard treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is suitable for an endovascular treatment in the neuro-angiography suite.
2. Subject or subject's legally authorized representative has signed an institutionally approved research informed consent form.
3. Subject ≥ 18 years old.

Exclusion Criteria:

1. Subject or subject's legally authorized representative is unable or unwilling to consent to the study.
2. Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
3. Subject with documented contrast injection contraindication due to severe kidney disease or allergy.
Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study

230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August, 2019 were enrolled in this study. 230 right eyes and 88 left eyes were included for the measurement. All the measurements were performed under non-mydriatic conditions in a dim examination room using the CASIA2 swept-source AS-OCT system.


Eligibility Criteria:
Inclusion Criteria：

* healthy volunteers and patients with age-related cataract

Exclusion Criteria:

* aphakia or pseudophakia
* any other ocular diseases with the exception of senile cataract
* any history of ocular surgery
* fixation difficulties caused by any reasons
Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Informed consent
* ART naive

Exclusion Criteria:

* No informed consent
* History of ART use
* Pregnancy
Evaluating Immune Response to Seasonal FluMist in Healthy Adults

The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus.

This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV of healthy Veterans and VA employees between the ages of 20 and 49 years old.

Specific Aims

1. The primary aim of the study is to evaluate whether people with high mucosal IgA antibodies against flu have a lower immune response to the seasonal LAIV.
2. The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.

Eligibility Criteria:
Inclusion Criteria:

* Medically eligible healthy men and women between the ages of 20 to 49 years old.

Exclusion Criteria:

* A medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airway disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system.
* A history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine
* Currently pregnant
* Have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components
* Have had flu within the current flu season.
* Have had a flu vaccine within the current flu season.
* Have close contact with someone whose immune system is so weak they require care in a protected environment (such as bone marrow transplant unit).
The Effect of Comedy Film on Preoperative Anxiety and Postoperative Pain Level.

When we look at the literature, studies examining the effect of having patients watch comedy films on anxiety and pain are limited. However, it was observed that the anxiety and pain levels of oncology patients who underwent surgery decreased by watching comedy movies. Therefore, in order to use the healing effects of humor, our study was planned to determine the effect of watching comedy films on the level of anxiety and postoperative pain in patients undergoing abdominal surgery.

Whether it is major surgery or minor surgery, preoperative anxiety is observed in all patients in the preoperative period. A high level of anxiety causes many physiological and psychological problems in the body and causes an increase in sympathetic and endocrine system stimuli. Among the physiological and psychological problems seen, many conditions such as recovery time, quality of life, health care expenditures, vital signs and well-being are negatively affected. Therefore, many applications can be used to reduce the level of anxiety before surgery. With humor, which is one of them, the anxiety levels of the patients can be reduced and they can manage their stress management better. In addition to reducing the level of anxiety before the operation, the experience of post-operative pain is one of the important problems experienced by the patients. Pain complaints are a general problem in the postoperative period in abdominal surgeries. The usefulness of using supportive complementary and alternative therapies in addition to pharmacological treatments in postoperative pain management is emphasized in the literature. Among these non-pharmacological treatments, it is stated that humor and laughter increase tolerance to pain and have positive effects on mood. Humor and laughter not only increase pain tolerance, but also reduce fear, anxiety and anger, and help lower the level of anxiety. Therefore, in order to use the healing effects of humor, our study was planned to determine the effect of watching comedy films on the level of anxiety and postoperative pain in patients undergoing abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* Defining the postoperative pain intensity of 4 and above,
* No cognitive problem
* Willing to participate in the research
* Having had Abdominal Surgery.

Exclusion Criteria:

* with a communication barrier,
* Having an uncontrollable psychiatric disorder,
Cognitive and Neural Assessment Platform and Localized Norm for Macau Older Adults.

The current project is dedicated to creating a comprehensive cognitive and neural assessment platform and corresponding norms tailored specifically to the older adults in Macau.

The investigators will establish this assessment platform using a combination of methods, including interviews, surveys, and expert reviews.

Steps include adapting existing assessment methods to the Macau context, developing new cognitive and neural tasks, defining standardized procedures, seeking external expert input, conducting pilot tests, and validation processes, and refining both the platform and its accompanying manual.

Eligibility Criteria:
Inclusion Criteria:

* Must be a local adult resident of Macau
* Age above 50 years for older adult cohort
* Younger adults individuals above 18 will be included as control comparators

Exclusion Criteria:

* History of neurological injury or disease
* Current use of medications that affect brain function or blood flow
* Contraindications to MRI scanning, such as the presence of an electric/mechanical implant or device (e.g., pacemaker)
* Claustrophobia
* Body weight over 300 lbs due to weight and physical constraints of the scanner (i.e., bore size limited to 55 cm)
* Inability to provide informed consent
* Pregnancy
* Being under the legal age of adulthood (children)
* Incarcerated individuals (prisoners)
Everybody Brush: A Community-wide Toothpaste Distribution Campaign

Dental caries (tooth decay) is a disease with significant public health implications afflicting low-income children, with marked rural disparities in disease prevalence and treatment. More than 70% of 11th grade children in Crook, Deschutes and Jefferson counties have experienced tooth decay. Effective approaches to prevent decay include brushing with fluoridated toothpaste and professional dental care. Medicaid enrolled children are legally entitled to dental care under Early Periodic Screening, Diagnosis and Treatment (EPSDT), yet \<50% had any care in 2010. Free distribution of toothpaste and toothbrushes combined with parental education can increase toothbrushing frequency and reducing tooth decay. However, many parents are confused about when to start, how much and often toothpaste should be used, and how to overcome behavioral difficulties in brushing toddlers' teeth or getting older children to brush their own. The investigators' objective is to implement and evaluate a community-wide toothpaste distribution campaign enhanced by telephone support for OHP children and adolescents and their families in Central Oregon

A community-wide toothpaste distribution campaign enhanced by telephone support. A tooth kit with toothpaste and toothbrushes for the whole family together with oral hygiene instructions in English and Spanish will be mailed every 3 months. Half of the population will be randomly assigned to also receive telephone support (Short message service and one-to-one calls). Families will receive biweekly messages with oral hygiene tips. Bilingual culturally competent staff will be available by telephone to support families in overcoming barriers.

Eligibility Criteria:
Inclusion Criteria:

* Family speaks English or Spanish

Exclusion Criteria:

* None
Pioglityazone and Imatinib for CML Patients

This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®) in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e. a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European Leukemia Net recommendations) after at least 2 years of therapy with imatinib.

Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not eradicated by imatinib alone in almost any of the patients.

Treatment discontinuation in patients treated by imatinib and in complete molecular remission for more than 2 years yield molecular relapses within 6 months in half of the patients,indicating the persistence of CML progenitor cells. STAT5 expression is required for CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the dysregulated activity of BCR-ABL in CML.

Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical studies, we went ahead and administered pioglitazone to one patient who suffered from both diabetes type II and CML with residual disease after continuous treatment with Gleevec. The amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3 months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9 months post-treatment, the latest time point assessed. This striking anecdotal result now forms the rationale for filing this formal Phase II clinical trial application.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18y or more
2. Signed informed consent
3. Patient with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity
4. Treatment with imatinib for more than 2 years
5. No dose modification of imatinib within the last 3 months
6. Complete cytogenetic response on the last cytogenetic analysis within the last 12 months
7. Major molecular remission without complete molecular remission
8. ECOG grade 0 to 2
9. SGOT et SGPT ≤ 2.5 N
10. Bilirubin in serum ≤ 1.5 N
11. Women of childbearing potential (WOCBP) must be using an adequate method of contraception

Exclusion Criteria:

1. Participation in another clinical trial with any investigative drug within 30 days prior to study enrollment
2. Prior history of hematopoietic stem cell transplantation (autologous or allogenic)
3. Patient requiring anti-diabetic medication
4. Cardiovascular disease:

   * Stage I to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure
   * Myocardial infarction within the previous 6 months
   * Symptomatic cardiac arrhythmia requiring treatment
5. Grade III or IV fluid retention
6. Known osteoporosis with therapy
Effects of Holistic Spinal Fascial Mobilization in Neck Pain

This study aims to determine the effects of holistic spinal fascial mobilization on pain, range of motion and function in patients with chronic neck pain so that we can have the best treatment option for patients with chronic neck pain, the duration will be 10 months, purposive sampling will be done, subject following eligibility criteria from bahawal Victoria hospital Bahawalpur, were allocated in two groups, a baseline assessment was done, Group A participants were given conventional treatment along with fascial mobilization, Group B participants were given conventional treatment, Numeric pain rating scale(NPRS), Neck Disability Index(NDI) and Goniometry for a range of motion,3 sessions per week were given, data was analyzed by using SPSS version 25.

Chronic neck pain is one of the most common musculoskeletal disorders among the general population. Like a muscular spasm of the neck that can cause neck pain, fascial adhesions are also a common cause of neck pain. Fascia is a form of connective tissue that is made up of collagen, surrounds the body parts, and also resists tissue tensile load. There is huge literature regarding the management of neck pain and yet after decades of research, there are gaps in treatment options. In the modern age of health care, it is a common goal of every health care to make patients self-sufficient as early as possible. The self-care models have tremendous advantages. The current study aims to determine the effects of holistic spinal fascial mobilization on pain, range of motion, and function in patients with chronic neck pain. All treatment methods were employed to see if they improve the ranges accompanying pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* Both genders.
* Age 25-60 years.
* NPRS \>4
* Subjects diagnosed with chronic neck pain with minimum 3 months of chronicity
* Subjects without any other pathology affecting the neck and upper limb.

Exclusion Criteria:

* Subjects with a history of Vertebro-Basilar artery insufficiency
* Any bony, soft tissue, systemic disease, fever, malnutrition or tumor.
* Surgery
The Use of Microneedles in Photodynamic Therapy

The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses

The specific aims are as follows:

1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are 18 and older
2. Subjects who have at least 3 actinic keratoses on each side of the forehead
3. Subjects who signed an IRB approved informed consent

Exclusion Criteria:

1. Subjects who smoke
2. Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.
3. Subjects who received a diagnosis of skin cancer on the face in past year
4. Subjects who received field treatment for actinic keratoses to the face in the past 60 days