cyrilzakka/clinical-trials huggingface dataset:
Student Behavior in School Accident Precautions

Accidents are an important public health problem due to temporary or permanent disability and deaths. Injuries are among the most important causes of death and lifelong disability between the ages of 5-14. Children at these ages spend long hours at school and are physically very active in school. It is reported that 15% of child accidents occur at school. For this reason, it is important to increase the standard of knowledge of children to improve their behavior towards safety precautions.

Purpose of this study is to research the impact of the education that has given towards the health belief model, for the behavior of children about precautions against school accidents. This study is Quasi-experimental study. There will a experiment and a control group in the study. Within the scope of the study, the researcher will train students about school accidents and how to prevent them for 30 minutes a week at the total of 4 weeks. No intervention will be applied to the control group. The scale will be applied to the students, before the training and afterwards to determine the behaviors of students towards safety precautions in school accidents.

The behavior score averages and standard deviations of the two groups in a previous study (Dilek, 2018) and the effect size were calculated to determine the sample size of the study. Power analysis (significance level 0.05 for type 1 error, effect size 0.50, and power 0.95). (Gpower 3.1 version) was carried out. In the power analysis, the minimum number of participants was 87 in the experimental group and 87 in the control group.

In this context, the research will be conducted with 100 participants in each group, taking into account the possibility that non-parametric statistics may need to be used due to the non-normal distribution of the dependent variable, incomplete and erroneous data, and absenteeism.

Experimental and control groups will be selected from the branches 3rd and 4th grade. 3 branches will be selected for the experimental group and 3 branches for the control group. Branches will be determined by drawing. In order not to interfere with the education of students during the training, the groups will be designated as class branches.

Ethical permission was obtained from the Ethics Committee of Afyonkarahisar Sağlık Bilimleri Üniversitesi (Afyonkarahisar Health Sciences University) (date: 03.June 2022; Number: 2022/340)

Eligibility Criteria:
Inclusion Criteria:

* Being educated in 3rd and 4th grade
* Volunteer to participate in the research
* Consent of the student's parent
* Speak and understand Turkish

Exclusion Criteria:

* Being visually and hearing impaired
* Using a language other than Turkish
* Not willing to participate in the study
Neural Correlates of Lidocaine Analgesia

The purpose of this study is to characterize the effects of intravenous lidocaine on pain processing and cognitive function. Functional magnetic resonance imaging will be used to identify the neural correlates of these phenomena. The study will consist of 1 visit and involves no long-term follow up.

This is an observational cohort study of volunteer subjects, which will employ neuroimaging and behavioral measures to characterize the effects of intravenous lidocaine on pain processing and cognitive function. A steady-state effect-site concentration of lidocaine will be achieved, and a short battery of cognitive behavioral tasks will be employed. At the dose target, pain task functional MRI and resting-state connectivity will be determined. This work will use a systems neuroscience approach to fill an important knowledge gap about the central effects of intravenous lidocaine, a commonly-used opioid alternative analgesic agent.

Aim1: Determine cognitive behavioral effects of a steady-state dose of IV lidocaine using a short battery of tasks. The investigators hypothesize that the administration of lidocaine will correlate to decreased pain ratings, slowed psychomotor response, and decreased memory encoding.

Aim2: Determine the neural effects of a steady-state dose of IV lidocaine in response to acute pain, and on resting connectivity. The investigators hypothesize that pain task-related activation will decrease in the insula and anterior cingulate, corresponding to decreased ratings of pain intensity and unpleasantness. Additionally, the investigators expect widespread decreases in long-range functional connectivity between brain areas know to be involved in these two areas and other known to be involved in pain processing.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 70
* Be of normal body-weight
* Be generally healthy
* Have none of the specific exclusion criteria
* Have a valid email address and phone number throughout the study

Exclusion Criteria:

* Pregnancy
* Body mass index \> 40
* Having moderate to severe sleep apnea
* Having chronic pain requiring the regular use of pain medicine 3 or more times per week
* Having neurologic or psychiatric disease, including benign tremor, anxiety, and depression
* Having a history of seizures
* Having history of cardiac rhythm disturbance (such as heart block, or atrial fibrillation)
* Being severely claustrophobic
* Having metal implants or non-removable metal piercings
* Having metal-containing tattoos, particularly on the face
* Having a history of adverse reaction to lidocaine
* Are regularly taking: antiepileptics, antidepressants, anti-psychotics, anti-anxiety medication, stimulants, sleep-aids, or pain medication
* Are taking prescribed medications for psychiatric or neurological conditions
* Having hypersensitivity to lidocaine or to any other local anesthetics of the amide type
* Having Wolff-Parkinson-White syndrome
* Having known renal or hepatic dysfunction
* having glucose-6-phosphate dehydrogenase deficiency or history of methemoglobinemia
Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia

This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.

Individual participation in this study will last approximately 48 months for participants who received AAV2-hAQP1 in Study MGT-AQP1-201 and at least 60 months for participants who receive AAV2-hAQP1 in Study MGT-AQP1-202.

Eligibility Criteria:
Inclusion Criteria:

* Received study drug in Study MGT-AQP1-201

Exclusion Criteria:

* Withdrew consent to participate in Study MGT-AQP1-201.
A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients

This is a monocentric randomized controlled prospective study. A total of 122 patients will be recruited and randomized 1: 1 in the experimental group - Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure - or in the control group - Laparoscopic Sleeve Gastrectomy.

At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GastroEsophageal Reflux Disease and hiatal hernia appearance.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years
* Patient with BMI between 35 and 50 Kg/m2 for whom laparoscopic sleeve gastrectomy indication was made
* Patients with no preoperative gastroesophageal reflux disease symptoms
* Hill 2-3 or 4 (with HH \<2 cm) hypogastric valve diagnosed preoperatively

Exclusion Criteria:

* Gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-H2 drugs
* Hiatal Hernia \>2cm and/or esophagitis and/or Barrett metaplasia
* Previous bariatric and/or gastric surgery
* Normal gastroesophageal valve (Hill 1)
* Motility disorders of the esophagus (documented on manometry)
* PH-study positive for gastro-oesophageal reflux disease (DeMeester Score \>14.1)
* Contraindications to gastroscopy or manometry or ph-study
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Patient not legally competent
* Pregnancy
The Sun Protective Effect of Melatonin

The aim of this study is to investigate the sun protective effect of melatonin, when used as a cream applied before sun exposure.

Sun exposure induces erythema as indication of an inflammatory reaction in the skin. It is proven that the amount of free radicals in the skin are increased by UV exposure. Furthermore, it is known that melatonin is a potent antioxidant. It is hypothesized that melatonin can be protective against the UV induced release of free radicals by acting as a radical scavenger and thereby protect against UV-induced cellular damage.

This study investigates the sun protective effect of melatonin when used as a creme applied before sun exposure.

The study is a randomized, placebo-controlled, double-blinded study conducted on healthy volunteers. The volunteers will have 5 squares of 8 cm\*8 cm on their backs, which each will be randomized to receive one of following: melatonin cream 0,5%; melatonin cream 2,5%; melatonin cream 12,5%; placebo cream (vehicle) and no treatment.

After randomization and received treatment the volunteers will be exposed to strong midday sun (UV-index of approximately 9) for 40 minutes.

The outcomes parameters (degree of erythema and pain sensation) are measured at baseline and 1,4,8 and 24 hours post exposure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes.
* Skin type 1-3 according to Fitzpatrick skin type scale.
* No sun exposure on skin area tested in the study 4 weeks prior to the study.

Exclusion Criteria:

* Active skin disease
* Participant that do not react to the given sun exposure with a change in a-value \>5 are excluded from the data.
* Pregnancy
* Previous malignant or pre malignant skin disease.
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH

The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study. Clinical characteristics, treatment options and responses will be collected. Peripheral blood, bone marrow aspirate and urine samples before and after the treatment will banked for future research. Our team will focus on the clinical and pathological features of PCDs, the correlation between the minimal residual disease (MRD) status and prognosis, and the role of Tumor Microenvironment (TME) in the pathogenesis and progress of PCDs.

Primary

1. To establish a prospective cohort of patients with PCDs in PKUFH.
2. To dynamically analyze the relation between MRD status and prognosis, and the possible role of TME in PCD patients.

Secondary To collect peripheral blood, bone marrow aspirate and urine samples from PCD patients for future study, such as the tumor clone selection and evolution.

OUTLINE: PCD patients enrolled in this study will be assessed at baseline, clinical and laboratory data and biological samples be collected. Follow-up will be done at the 1, 3, 6, 12 months and then yearly after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)
2. Patients of plasma cell disorders (PCDs) are recruited. PCDs include monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple myeloma; plasma cell leukemia; amyloidosis; light chain deposition disease; heavy chain deposition disease; Castleman's disease (CD); Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes syndrome; cryoglobulinemia; Monoclonal Gammopathy of Renal Significance (MGRS); Monoclonal gammopathy of neurological significance (MGNS).
3. Patients are included into this cohort after signing the ICFs.

Exclusion Criteria:

Significant comorbidity may be life-threatening.
Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment

Osteoarthritis (OA) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Platelet-rich-plasma (PRP) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. We will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. We will focus on inflammatory (Wnt system, IL1 pathway, PTX3) and antioxidant (primarily, DPP3/Keap1/Nrf2) pathways. We foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee OA thus maximising the effectiveness of the healthcare allocation.


Eligibility Criteria:
Inclusion Criteria:

* men/women, aged \>40 - \<75 years), OA grade 2-3, BMI \<40, baseline WOMAC PAIN \>1.75 -\<4, \>1 conservative therapy failed. Diagnosis of knee OA according to the American College of Rheumatology (ACR) classification criteria (Altman, 1986) .
* Ability to give informed consent.

Exclusion Criteria:

* Presence of active infection or abnormal knee effusion on Day 1 at pre-injection of PRP
* Diagnosis of chronic inflammatory disease (i.e. rheumatoid arthritis, reactive arthritis, psoriatic arthritis, chondromalacia, arthritis secondary to other inflammatory diseases)
* Untreated acute traumatic injury, presence of a symptomatic meniscal tear, valgus/varus deformity judged by the investigator to be clinically significant, in the index knee
* Recent (within 3-6 months) arthroscopy, open surgery, intra-articular steroid injections, intra-articular hyaluronic acid (HA) injections, systemic steroid treatment, malignancy
* Any serious, non-malignant, significant, acute, or chronic medical condition or active psychiatric illness that, in the investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
* Recent (within 30 days) use of any investigational drug or device prior to screening
Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases

A subset of autoimmune diseases (ADs) in children and young adults are life-threatening and unresponsive to conventional treatments. In these patients, the delivery of high dose immunosuppressive therapy followed by autologous stem cell transplant (ASCT) offers a treatment strategy capable of purging the pathogenic, autoreactive immune system and an opportunity for "immune reset." This strategy has been used in adults across a myriad of indications with evidence for efficacy. This study proposes a pilot study to evaluate this therapeutic strategy in children and young adults with systemic sclerosis (SSc) and systemic lupus erythematosis (SLE), two potentially life threatening autoimmune diseases that may response to this therapeutic approach.


Eligibility Criteria:
Inclusion Criteria:

1. Age 8 ≤ 25 years at time of enrollment.
2. Severe systemic sclerosis or systemic lupus erythematosus based on specific criteria
3. Adequate organ function status
4. No active, untreated infections.

Exclusion Criteria:

1. Previous hematopoietic stem cell transplant (HSCT) or solid organ transplant
2. Pregnancy
3. Ongoing participation in a clinical trial testing an investigational drug or ongoing receipt of disallowed disease modifying anti-rheumatic drugs (DMARD)
4. Severe comorbidity that jeopardizes the ability of the subject to tolerate therapy
VIVO Clinical Study

The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic venous outflow obstruction in one iliofemoral venous segment (i.e., one limb) per patient, demonstrated by:

  * CEAP "C" ≥ 3, or
  * VCSS pain score ≥ 2

Key Exclusion Criteria:

* \< 18 years of age;
* pregnant or planning to become pregnant in the next 12 months;
* planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or any time after the study procedure;
* planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) within 30 days prior to or after the study procedure;
* lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter;
* lesion with malignant obstruction;
* previous stenting of the target vessel;
* iliofemoral venous segment unsuitable for treatment with available sizes of study devices.
Effect of an Electronic Cognitive Aid Versus Static Cognitive Aid on the Management of a Simulated Crisis

Clinical decision support tools with in the electronic medical record can improve clinical care processes. To date, there is little evidence evaluating crisis management with such decision support tools. The investigators aim to create an electronic cognitive aid with embedded decision support to aid clinicians during the management of a crisis. In order to test the effectiveness of this tool, investigators seek to compare the simulated medical management of a crisis (malignant hyperthermia) using a traditional cognitive aid (laminated card) versus a dynamic electronic visual aid with decision support.


Eligibility Criteria:
Inclusion Criteria:

* resident physicians training in Anesthesia

Exclusion Criteria:

* Non resident anesthesia providers
Effects of Probiotic VSL#3 on Expression of Small Intestinal Renin-angiotensin System

Probiotics have become very popular and are by WHO defined as "Live microorganisms which when administered in adequate amounts confer a health benefit on the host". For example, probiotics have been shown to contribute to improvements of abdominal discomfort and intestinal inflammation. The main hypothesis behind the present study is that probiotics influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin II locally in the intestinal mucosa.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers of both sexes
* between 18 and 65 years of age.
* BMI between 18-25 kg/m2

Exclusion Criteria:

* Any drug abuse
* Use of prescription medication within the previous 14 days (with the exception of contraceptives)
* Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control (e.g. IUD, barrier method, oral contraceptive, abstinence)
* In the investigator's judgement, clinically significant abnormalities at the screening examination or in the laboratory test results.
Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome

The purpose of this study is to learn whether or not certain risk factors and patient characteristics are linked with and possibly can predict the development of chronic pain after lumbar spine surgery.


Eligibility Criteria:
Inclusion Criteria For All Participants:

* Ability to read and speak English to allow for written informed consent, phenotyping, and patient-reported outcomes measures

Exclusion Criteria For All Participants:

* Individuals receiving or applying for compensation or disability and other aspects associated with potential secondary gain
* Inability to provide written informed consent
* Severe physical impairment
* Co-morbid medical conditions that may significantly impair physical functional status
* Illicit drug or unreported opioid use
* Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study
* Pregnant or nursing
* Liver failure
* Self-reported liver cirrhosis
* Self-reported hepatitis
* Severe Cardiovascular disease

Inclusion Criteria for Candidates for Lumbar Spine Surgery:

* Deemed to be a candidate for primary lumbar spine surgery including but not limited to: lumbar laminectomy, discectomy, and fusion/instrumentation
* Diagnostic clinical and radiographic findings including but not limited to: lumbar degenerative disc disease, lumbar disc protrusion, herniation, or extrusion, lumbar spondylosis, lumbar spinal stenosis, lumbar spondylolisthesis or spondylolysis
* Willingness to participate in longitudinal follow-up or 6-months after their surgery.

Exclusion Criteria for Candidates for Lumbar Spine Surgery:

* History of previous lumbar spine surgery
* Indication for lumbar spine surgery is due to spinal cancer-related diagnosis
* Need for urgent or emergent lumbar spine surgery

Inclusion Criteria for Candidates with Lumbar Failed Back Surgery Syndrome:

* Chronic low back pain (+/- leg pain) for \>= to 6 months duration after lumbar spine surgery (with or without instrumented fusion)
* Low back pain severity is moderate to severe (Numerical Rating Scale \[NRS\] Score \>=4)

Exclusion Criteria for Candidates with Lumbar Failed Back Surgery Syndrome:

* Have a structural spinal lesion that would make them a current candidate for a revision lumbar spine surgery

Inclusion Criteria for Healthy Volunteers:

* No major diseases or diagnoses influencing pain or function

Exclusion Criteria for Healthy Volunteers:

* No chronic pain condition
* Score 3 or greater on the 2011 FM Survey Criteria (i.e. individuals with very mild fatigue or sleep problems will be allowed to participate as this is extremely common in the general population)
Self-help Cognitive Behavioral Therapy (CBT) for Insomnia

The purpose of this study is to investigate whether a self-help book for insomnia, with or without therapist support, can improve sleep and alleviate insomnia symptoms in individuals suffering from insomnia, also for persons presenting with different kinds of co-morbid problems.

CBT has previously been identified as an effective treatment for insomnia. However, there is a lack of trained CBT-therapists, and self-help is beginning to prove useful for many areas of psychological distress. Earlier studies of different kinds of self-help (e.g. computer based and bibliotherapeutic) suggest that many patients do indeed benefit from self-help treatments for insomnia, but there is a need for independent replications. Also, most previous studies have had very strict inclusion criteria, such that for instance only individuals with primary insomnia and no co-morbid problems have been included. A general question in self-help is whether patients need therapist support to benefit from treatment, or if a book is enough to alleviate symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Diagnosis of Insomnia (Research Diagnostic Criteria)
* Access to computer
* Ability to read and write Swedish

Exclusion Criteria:

* Severe psychopathology (e.g. bipolar disorder, suicidality)
* Shift work