cyrilzakka/clinical-trials huggingface dataset:
Comparison of Biodegradable and Titanium Fixation Systems in Mandibular Symphysis or Parasymphysis Solitary Fractures

The mandible bears a wide range of mechanical load from the contraction of masticatory muscles, and has a significant function in normal chewing movements. Mandibular fractures are the most common maxillofacial fractures, accounting for 40%-71% of all maxillofacial fracture cases with an average of 62%. The etiology of mandibular fractures mainly includes assaults, road traffic accidents (RTAs), falls, and sports injuries. Although a wide variance exists in the reported percentage of anterior mandible fractures, aggregate analysis approximates these fractures at 17% of all mandibular fractures. The rigid internal fixation (RIF) technique has become a common treatment for mandibular fractures, in which titanium plates are used in the operation. Some patients have to remove the titanium plates in a second operation following bone healing because of sequelae, such as stress shielding. Biodegradable plates and screws have been developed to eliminate the problems associated with titanium fixtures. In this study, we aim to compare the clinical performance between biodegradable and titanium fixation systems after 12 months of follow-up in fixation of mandibular symphysis and parasymphysis solitary fractures. We also investigate the stress distributions of biodegradable and titanium fixation systems at mandibular symphysis solitary fracture on the conditions of intercuspal position, labial teeth occlusion, and premolar and molar occlusion using finite element analysis.


Eligibility Criteria:
Inclusion Criteria:

* Undisplaced and displaced mandibular symphysis and parasymphysis solitary fractures conducted at the department of Oral and Maxillofacial (OMF) Surgery, Tianjin Medical University General Hospital

Exclusion Criteria:

* The exclusion criteria were comminuted fractures
* Diabetes
* Connective tissue diseases
* Patients under the age of 18 and over the age of 60
Early Indicators of Chronic Rejection in Lung Transplant

The purpose of this research is to discover the different patterns of cytokine production in patients who may develop Bronchiolitis Obliterans Syndrome-0p (BOS-0p) which means ongoing rejection. This is an early indicator of chronic rejection in lung transplant recipients. These cytokines can be detected in the bronchoalveolar (lung) and tissue samples of lung transplant recipients.

Lung transplant recipients are routinely followed in clinic every three months after the first year post-transplant. Spirometry with measurement of FEV1, FVC and FEF25-75 are obtained at each visit. In addition, lung transplant recipients undergo surveillance bronchoscopy at one, three, six, nine and twelve months. All bronchoscopy specimens that are obtained for this study will be obtained during bronchoscopies that were scheduled per the physician caring for the patient. An extra 90 cc of sterile solution will be instilled into bronchus and two extra transbronchial biopsies will be performed in addition to the routine bronchoscopic procedure. Routinely, 4-8 transbronchial biopsy samples are obtained from the transplanted lung. Two specimens will be randomly selected for study and the rest will undergo routine histopathologic study. The study biopsies will be set aside and processed. The study visits for this research will occur at the same time as standard of care post transplant visits. We will collect subject's history,demographic of subject's transplant data,donor procurement information, physical exam information, pregnancy tests,blood test and spirometry results from the visits mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Lung transplant recipients between the ages of 18 and 65 years old
* All patients must be able to give written informed consent

Exclusion Criteria:

* Lung transplant recipients who are unable to undergo bronchoscopy
* Lung transplant recipients who are unable to give informed consent
The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.

One of the biggest challenges of today is the high stress levels among employees in companies and organizations. Physical exercise may be an effective preventive measure for stress-related problems. This relatively simple and inexpensive action is believed to be important for increasing and maintaining work ability and reduce the cost of stress-related ill health in the workplace.

The aim is to investigate how regular physical exercise affects the individual's ability to mentally and physiologically cope with stress. Acute stress physiological responses are measured before and after a 6 -month intervention, where 100 untrained individuals are randomized to either regular physical exercise or a control group.

The hypothesis is that exercise leads to lesser activation of the individual's stress physiological systems and to an efficient physiological protection system. Mental ability to handle stress is also studied as well as possible effects on the brain's cognitive functions. From a work perspective, cognitive impairment due to high exposure to stress is a major problem leading to substantial costs in businesses and organizations as a result of reduced performance and production.

We believe that physical activity can alter and mitigate individual stress reactions. This study brings new knowledge that can contribute to increased motivation to prioritize physical activity in everyday life. The study could also provide evidence for businesses and organizations of the benefits of engaging in interventions and fitness initiatives to facilitate/enable increased physical activity in daily life for its employees. With an aging population, we are expected to work longer, which poses a challenge as the ability to manage stress and maintain cognitive abilities decline with age. For older employees, regular physical activity could be an important factor directly affecting the prospects for a sustainable working life.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported good health
* Sedentary
* Work or study at least 50%

Exclusion Criteria:

* Diabetes
* Cardiovascular disease
* Blood pressure \> 140/90
* Psychiatric disease
* Anemia
* Medication with substances that could affect any of the outcome measures
Survival and cArdiovascular eVents in Patients With Acute Myocardial Infarction

This prospective and prospective cohort study aims to establish a long-term follow-up cohort of patients with acute myocardial infarction, and combine multi-omics studies, wearable devices, artificial intelligence technology, etc., to describe the clinical characteristics of patients with acute myocardial infarction and the changing trend of treatment strategies, and analyze the related influencing factors. Explore new biomarkers and indicators affecting recurrent cardiovascular events for accurate risk stratification and risk prediction; To evaluate the factors affecting lifestyle intervention, drug efficacy and safety, and their impact on outcome, and improve chronic disease management mode, in order to improve the quality of life and prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction is diagnosed meets the universal definition of acute myocardial infarction

Exclusion Criteria:

* Did not agree to participate in the study
To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients

This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia.

The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Non-penetrating traumatic brain injury
* Glasgow Coma Scale (GCS) motor score ≤5 (not following commands)
* Estimated or known age 22-65 years
* Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury
* Estimated time of injury to time to reach temp of 35°C\<6 hrs

Exclusion Criteria:

* Total GCS = 3 and bilateral fixed and dilated pupils
* Following commands after an initial period of coma (GSC motor score of 6)
* Known pre-existing neurological deficit (e.g., previous traumatic brain injury (TBI), stroke)
* Concomitant spinal cord injury
* Arrival temperature is \<35°C
* Hemodynamic instability (i.e., mean arterial pressure (MAP)\<60 millimetres of mercury (mmHg) for 30 minutes)
* Active cardiac dysrhythmia resulting in hemodynamic instability
* Pregnancy
* Duret hemorrhage
* Prisoner or Ward of the State
* Known history of clotting disorder (e.g., heparin induced thrombocytopenia, pulmonary embolism/deep venous thrombosis)
* Injury to other body organ where hypothermia would be precluded because of bleeding risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or international normalized ratio (INR) \>1.4)
* Inability to obtain informed consent or utilize exception to informed consent for emergency research.
Identification of Metabolic Phenotypes Associated With Melanoma Metastasis

The goal of this study is to observe metabolic features associated with human melanoma tumors.

This is a single center, correlative study designed to assess metabolic features of melanoma tumors in patients. The study will involve the collection of melanoma tissue at the time of surgical biopsy or excision. All samples will be assessed by mass spectrometry for metabolomic analysis. A subset of patients will have received \[U-13C\]glucose infusions which will be utilized for isotope tracing metabolic analysis. Relevant clinical data (eg survival, metastasis) will be correlated with metabolic findings.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known or probable malignant melanoma lesions requiring surgical biopsy or excision.
* Subjects of all races and ethnic origins over age 18.

Exclusion Criteria:

* Not a surgical candidate
* Poorly controlled diabetes
Predicting Developmental Disability Type and Mental Retardation Level in Children With General Developmental Delay

The purpose of this study is to find the relationship between the stage and quality of developmental delay during infancy and toddler age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).

The purpose of this study is to find the relationship between the stage and quality of developmental delay at a young age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders). We assume that analysis of developmental subtests can show the developmental direction of the child and predict his later diagnosis. The developmental test which is chosen for this purpose is the BSID which is a comprehensive and worldwide developmental test. In addition, we want to find the correlation between the developmental delays in early age and the intellectual functioning in the future. We assume that through analyzing the subtests of developmental tests we will succeed in predicting the expected cognitive level (IQ).

Medical files of participating children will be analyzed. The files will be sorted and only those of GDD diagnosis containing BSID test data will be selected. The performances of the BSID test and the current diagnosis of the children will be recorded. A trained researcher will process the BSID data and build a database which will include the findings of the test, the current diagnosis of the child and the level of MR, in case the child suffers from MR (only or comorbidly). In order to test the research assumptions appropriate statistic tests will be done using the statistical program SPSS version 17.

This study has important implications. Findings which show that the developmental tests are effective tools, not only to evaluate general developmental delay, but as auxiliary tools for diagnosing and predicting the type of disability and level of retardation. These findings are a breakthrough in the diagnostic field. In addition, the ability to predict the type of disability and level of mental retardation by a developmental test that is used so widely allows early intervention, and as has been widely proven, the earlier the intervention, the better the outcome.

In addition, a vast range of people will benefit from the findings. Professionals such as doctors, psychologists and paramedical therapists, government bodies and community resources that can design and build a support system and services for the child and his family. Most importantly, the family of the diagnosed child and the child himself will be able to prepare themselves to the new reality and design their life accordingly.

Eligibility Criteria:
Inclusion Criteria:

* GDD diagnosis in two axis' at least
* BSID test in its second or third version

Exclusion Criteria:

* If not all of the data is available for all of the assessments
A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy

The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Participate in the study voluntarily, sign the informed consent form.
2. Recurrent or metastatic gynecological malignancies that had failed standard treatments.
3. At least one measurable lesion (RECIST version 1.1).
4. ECOG 0\~ 1.
5. With adequate organ functions.
6. Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of SHR-A2102，Female participants' HCG must be negative within 72 hours prior to enrollment and must be non-lactating.

Exclusion Criteria

1. With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.
2. Previous or contemporaneous malignancies, unless these malignancies reached complete remission at least 5 years prior before screening and did not require or are not expected to require other treatment during the study period. Such as Cutaneous squamous cell carcinoma, cervical carcinoma in situ etc.
3. Had previously received antibody drug conjugates containing topoisomerase I inhibitors.
4. Had undergone major surgery other than a diagnosis or biopsy within 28 days prior to the first administration; undergone minor traumatic surgery within 7 days prior to first administration.
5. Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
6. Had active pulmonary tuberculosis within 1 year prior to enrolment.
7. Known to be allergic to any of the components of SHR-A2102.
8. Were not fit to participate in this study by investigator's judgment.
Online Survey in Studying Smoking Attitudes and Behaviors Among Current Smokers

This trial uses an online survey to study smoking attitudes and behaviors among current smokers. An online survey consisting of questions about general demographics, smoking history, smoking attitudes, smoking behaviors, smoking intentions, health and qualities of daily life may help researchers understand the differences in smoking attitudes and behaviors among current smokers.

PRIMARY OBJECTIVES:

I. To examine if self-affirmation attenuates the effects of cigarette smoking stigmatization on smoking risk perceptions, pro-smoking beliefs, and intentions to change smoking behavior.

OUTLINE:

Participants are recruited and pre-screened via an online crowdsourcing program called Amazon Mechanical Turk (MTurk). Participants then respond to a one-time research survey over 20 minutes on SurveyGizmo, an on-line survey software platform.

Eligibility Criteria:
Inclusion Criteria:

* United States (US) adult smokers.
Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy

This study will investigate implementation of a process to enhance Clinical Practice Guideline (CPG) adherence to limit unwarranted variability in initial treatment decisions with high potential for providing more effective and efficient physical therapy management for patients with neck and low back pain.

Effective implementation of CPGs to augment initial clinical decision making during physical therapy management of patients with spine related musculoskeletal pain will have several important goals: 1) improve patient pain and disability outcomes, 2) limit over utilization of physical therapy services, and 3) increase adherence to limit unwarranted variation in clinical practice. This proposed pilot study proposal will test if a multifaceted intervention strategy for implementation of neck and low back CPG meets these goals and provide necessary data for larger system wide implementation efforts.

Specific Aim 1: Determine if physical therapy clinics that receive neck and low back pain (LBP) clinical practice guideline (CPG) training are associated with improved patient outcomes compared to those that have not received training. Neck and LBP specific disability and pain intensity will be assessed at intake, on a weekly basis and at discharge (Specific Aim 1a). Secondary patient outcomes will consist of patient satisfaction scores (Specific Aim 1b). Statistical analyses will evaluate for temporal effects of training considering the stepped wedge study design.

Specific Aim 2: Determine if multifaceted interventions for CPG implementation positively impacts physical therapist beliefs, attitudes, knowledge and behaviors over time. CPG adherence (by clinicians) will be indirectly assessed using quantitative and qualitative methods consisting of: 1) clinician checklists, 2) clinician questionnaires, 3) quality indicators, and 4) total proportion outcome measure assessments (Specific Aim 2).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Receiving outpatient physical therapy for a diagnosis covered in previously published CPGs for neck or LBP
* Able to read and comprehend English language (necessary for completion of self-report e-forms)

Exclusion Criteria:

* Any diagnosis indicating systemic involvement
* Widespread chronic pain syndrome
* Neuropathic pain syndromes
* Neurological disorders.
The Montefiore Metoclopramide Study

Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.

The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. In contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. This emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale.

In addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. Akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. However, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.

Eligibility Criteria:
Inclusion Criteria:

* primary or secondary complaints of nausea/vomiting
* age 21-65

Exclusion Criteria:

* pregnancy
* use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours of presentation
* previous adverse reaction to study medications
* use of opioid medications prior to study start time within that ED visit
Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study

The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment

This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* No significant medical illness
* Subjects with the willingness and ability to understand and provide informed consent

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who have had previous surgical treatment of the lower eyelid area or previous use of filling agents in the under eye area
* Subjects with a known allergy to the components in Restylane® or Perlane®
* Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
* Subjects with liver/kidney disease or compromise or who are immunocompromised
* Subjects with a known susceptibility to keloid formation or hypertrophic scarring
* Subjects with an open, non-healing sore or infection near the site of injections
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness