cyrilzakka/clinical-trials huggingface dataset:
Guided Narrative Technique After Coronavirus Outbreak Influencing Positive and Negative Emotions and Cognition for Children--A Randomized Controlled Trial

At the beginning of 2020, the COVID-19 broke out in Wuhan, raging across the country quickly afterwards. As a sudden public health emergency, this epidemic caused some stress reactions (including emotional, cognitive, and behavioral reactions) in children. These stress responses, in moderation, may be beneficial as a response to the challenge. However, excessive, and inappropriate stress responses may damage children's mental health, immune function, and daily function.

School-based CBT intervention is effective in alleviating children and adolescent anxiety. However, the effect last only shortly. Therefore, adding a new intervention component is necessary. Guided Narrative Technique (GNT) is an intervention focusing on narrative coherence and emotional expression. It has writing and drawing versions. The writing version was developed from Expressive Writing and has a significant effect on the improvement of various negative emotions and negative cognitions of traumatized individuals.

In this study, a randomized controlled experiment will be implemented. All participants will take a CBT course first. Then, they will be asked to write or draw about the epidemic or other life events using GNT. The study will explore the impact of CBT course combined with GNT on negative emotions and cognition of children after such a public crisis.


Eligibility Criteria:
Inclusion Criteria:

* have the ability to read and write in Chinese

Exclusion Criteria:

* no parental consent
The Diagnosis and Mechanism of Pleural Effusion

The diagnosis, treatment and mechanism of pleural diseases

The diagnosis and treatment of benign and malignant pleural effusions, the mechanisms of pleural diseases

Eligibility Criteria:
Inclusion Criteria:

Patients with pleural effusion, who has not been treated

Exclusion Criteria:

Patients with pleural effusion, who has already been treated
Skintel Integration Study

The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI).


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Able to read, understand, and sign the Informed Consent Form
* Willing and able to comply with all study requirements

Exclusion Criteria:

* Hypersensitivity to light in the near infrared wavelength region
* Sun-damaged skin (treatment contraindicated with Alex laser only)
* Unprotected sun exposure (for Alex laser within four weeks of treatment; for
* Nd:YAG laser within one week of treatment), including the use of tanning beds or
* tanning products, such as creams, lotions and sprays
* Take medication which is known to increase sensitivity to sunlight
* Seizure disorders triggered by light
* Take anticoagulants
* Take or have taken oral isotretinoin, such as Accutane®, within the last six months
* Take medication that alters the wound-healing response
* History of healing problems or history of keloid formation
* Active localized or systemic infection, or an open wound in area being treated
* Significant systemic illness or an illness localized in area being treated
* History of skin cancer or suspicious lesions
* Lupus
* Have received or are receiving or gold therapy
* Pregnancy, planning on becoming pregnant or have been pregnant recently
Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities

The goal of this research project is to conduct a pilot RCT of Text4Strength, an interactive automated text messaging extension of Sources of Strength (SoS), a universal school-based suicide prevention program that prepares diverse 'key opinion leaders' to conduct public health messaging and activities with peers to increase school-wide positive coping norms, communication with trusted adults, and seeking help for suicidal peers (Wyman et al., 2010). The investigators previously developed and field tested Text4Strength messages (RSRB#00047481 and 53924 closed) to demonstrate feasibility, safety, student engagement, and student-perceived relevance for a universal texting extension. The investigators will now conduct a pilot randomized controlled trial in one large school in Western New York that has implemented Sources of Strength for the past two years. The school will continue with Sources of Strength in the 2016-17 school, and add this school-wide texting component as part of this research study. Consistent with Leon's guidelines on pilot studies, the primary focus will be to identify areas of promise, success in reaching proximate targets, and the need for additional modifications (Leon, Davis, \& Kraemer, 2011). Findings from this study will inform further refinement of the text messaging program and provide preliminary data for a larger efficacy trial.


Eligibility Criteria:
Inclusion Criteria:

* 9th-12th grade students in study school
* must have own cell phone

Exclusion Criteria:

* no cell phone
* not sufficiently English-speaking to complete surveys
Treatment of the Symptomatic Sacral Perineurial Cysts

There are very few data and analysis in the literature regarding the symptomatic sacral perineurial cysts. Most studies are case reports or small retrospective sample, which rarely more than 20 cases. There is no an consensus on the choice of treatment (medicine conservative treatment and surgical treatment) for symptomatic sacral perineurial cysts.Our aim, therefore, is to compare the efficacy of medicine conservative treatment and surgical treatment for symptomatic sacral perineurial cysts by a randomized controlled trial. Meanwhile, resting-state functional magnetic resonance imaging is used to detect the changes at pain related brain areas, which will be develop an objective method to evaluate the clinical curative effect of the two treatment options.


Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosed with symptomatic sacral perineurial cysts(e.g., lumbosacral or perineal pain, fecal or urinary functions change, sexual function change, lower limb radiation pain, muscle abate, paresthesia, etc)
* 2. Visual analog scale more than or equal to 4
* 3. Signed the informed consent
* 4. Years, range 18-60
* 5. Self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores \< 50
* 6. No Congenital,Mental and other Nervous system diseases
* 7. No Serious Cardiac,Pulmonary,Hepatic and Nephritic disease
* 8. No history of drug allergy
* 9. No pain(including dysmenorrhea) or drug use (e.g., antipyretics,sleeping pills) within the last month
* 10. MRI finding of sacral perineurial cysts, but without any clinical symptoms, included in the negative control group
* 11. MRI finding healthy volunteers don't have sacral perineurial cysts, included in the negative control groupblank control group

Exclusion Criteria:

* 1. Patients with lumbar common diseases(e.g., Lumbar disc, Lumbar spinal stenosis, Lumbar slippage, etc)
* 2. Researchers think that Patients with disease may be interference results(e.g., Spinal deformity, spine fracture, ankylosing spondylitis, spinal tuberculosis and spinal infection, spinal tumor, pelvic inflammatory disease and other disease of department of gynaecology, etc)
* 3. Patients with other nervous system diseases(e.g., cerebral tumor, neurinoma, trigeminal neuralgia,etc)
* 4. Patients with Magnetic resonance imaging contraindication ,including claustrophobic syndrome patients
* 5. Patients with recent (less than 3 years) use chemical drugs or have obvious psychological problems
* 6. In the past 2 months involved in other drugs or devices clinical trials
Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer

Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and quality of life versus patient directed home exercises.

The purpose of this prospective, interventional, pilot investigation is to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes and quality of life in the immediate and short-term basis compared to patients receiving standard of care patient directed independent home swallowing therapy. Patient compliance with home exercises programs is reportedly inconsistent. Patients may experience changes in their physical functioning and overall well-being that may impact their ability to follow-through with independent home therapy. Clinician directed swallowing therapy allows for ongoing assessment of changes that may warrant modifying the therapy program in terms of intensity of exercises and/or expectations. This facilitates individualizing the patient's therapy plan to maximize their function and ability to achieve goals. It is anticipated that individualizing swallowing therapy through weekly session will result in improved swallowing function.

This is a single-site, two-arm, 1:1 randomized, prospective, interventional, pilot study to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes when compared to patient-directed home-based swallowing therapy.

The investigators anticipate at least 40 subjects will need to be enrolled/consented in order to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30 participants.

All subjects in each group will receive a face-to-face education session with a speech pathologist to review a recommended program of swallowing exercises prior to initiation of chemoradiation at their baseline (pre-treatment evaluation session).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV) related and non HPV related tonsil and base of tongue)
2. Scheduled to undergo definitive chemoradiation therapy
3. At least 18 years of age or older
4. Subject must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Surgical management in addition to chemoradiation therapy;
2. Cancer of the sinus, brain, or parotid;
3. Prior treatment for head and neck cancer;
4. Receiving chemoradiation treatment at an outside institution (i.e., non-University of Miami (UM) clinic);
5. Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer;
6. Prior neurologic disorder (i.e., Cerebrovascular accident (CVA), Traumatic brain injury (TBI), dementia) or current degenerative neuromuscular disease;
7. History of prior c-spine surgery;
8. History of prior vocal fold immobility
Effect of Magnesium Sulphate on Neostigmine

The purpose of this study is to evaluate the effect of magnesium sulphate on neostigmine-induced reversal of neuromuscular block by rocuronium

Comparison of reversa time by neostigmine in magnesium group and control group

Eligibility Criteria:
Inclusion Criteria:

* ASA status 1 or 2
* patients undergoing surgery for more than 60 min under general anesthesia

Exclusion Criteria:

* electrolyte abnormalities
* medication on aminoglycoside, antiepileptic drug, magnesium
* underweight or obesity (BMI \<18.5 or \>30)
* renal insufficiency (Cr\>1.4 mg/dl)
* AV block
* neuromuscular disease (ex: Myathenia gravis)
Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

The primary objective of this study is to compare the clinical outcomes of arthroscopic rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs). Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines and by supplying growth factors to their implanted environment. They have been shown to be effective in improving both overall healing and tendon integrity in rotator cuff repair. This study will follow 100 patients in the United States and track their clinical outcomes for at least one year post-operatively.

Rotator cuff repair is one of the most commonly performed arthroscopic procedures in the United States, but re-tear remains a common long-term complication. This can lead to pain, decreased shoulder function, and the need for corrective surgery. Mesenchymal stem cells have been shown to improve healing rates in arthroscopic rotator cuff repair, primarily due to their retained ability to differentiate into several different adult cell lines, such as tenocytes, chondrocytes, and osteoblasts. MSCs further enhance the healing process by releasing growth factors into the local environment to promote tissue regeneration.

While MSC augmentation of arthroscopic rotator cuff repair has led to higher rates of healing and improved tendon integrity, there remains a paucity of data surrounding clinical improvement after the procedure. Outcomes such as post-operative strength, range of motion, and shoulder function have yet to be compared with standard rotator cuff repair. The incidence of post-operative persistent structural defects in the tendon after MSC augmentation must also be further elucidated.

Eligibility Criteria:
Inclusion Criteria:

* Patient is determined to have a full thickness rotator cuff tear (1-3 cm) or partial tear converted to a full-thickness tear-on the pre-operative MRI scan or found arthroscopically-and is scheduled to undergo surgical repair
* Written informed consent is obtained

Exclusion Criteria:

* Revision surgery
* Irreparable tear or partial repair
* Any patient lacking decisional capability
* Subscapularis involvement
Remote Fu's Subcutaneous Needling for Patients With Chronic Neck Pain

This is a randomized controlled trial to compare the efficacy of Fu's subcutaneous needle (FSN) and Transcutaneous electrical nerve stimulation (TENS) on chronic neck pain by using more objective assessment tools such as Neck Disability Index, Visual Analog Scales, Pressure Pain Threshold and Myotone of MTrPs of Upper Trapezius Muscles, Range of Motion of Stretch of Upper Trapezius Muscle, and Pittsburgh sleep quality index.

Neck pain combining limited range of motion is very common. Lasting for only a few days, it will taper off without any treatment. If the neck pain symptoms persist for more than two months without any improvement, it will be categorized as chronic neck pain causing not only pain but also functional impact, even in daily life, working, and sleep quality.

Fu's subcutaneous needling is utilized in treating disease related with myofascial trigger point, including soft tissue pain, joint pain, even some internal problems. Indeed it reduce pain immediately with no obvious side effects. There were some clinical articles of subjective symptoms description published lacking scientific accessment of efficacy.

Research team leading by Professor Chang-Zern Hong has already prove that excitability can be reduced by distal acupuncture. Needling TE5 and LI11 can reduce pain intensity and average amplitude of MTrPs end plate in upper trapezium m., and increase pain pressure threshold.

Comparing to traditional acupuncture, whether safer and pain-less Fu's subcutaneous needle also has the distal treatment effect or not still needs more scientific experiment to prove. This is a randomized controlled trial to compare the efficacy of Transcutaneous electrical nerve stimulation and Fu's subcutaneous needle on chronic neck pain by using more objective assessment tools such as Neck Disability Index, Visual Analog Scales, Pressure Pain Threshold and Myotone of MTrPs of Upper Trapezius Muscles, Range of Motion of Stretch of Upper Trapezius Muscle, and Pittsburgh sleep quality index.

Eligibility Criteria:
Inclusion Criteria:

* Having chronic neck pain for more than 2 months and subjective subjective pain intensity (VAS) greater than 5 points.
* Patients with myofascial pain diagnosed with unilateral upper trapezius muscle.
* This pain is not effective for previous medication or physical therapy.

Exclusion Criteria:

* Contraindications for general treatment, such as serious medical problems, recent trauma, or pregnancy.
* There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
* Have received neck, upper back, or upper and lower limb surgery.
* People with central or peripheral nerve disease.
* Cognitive dysfunction cannot be matched with the experimenter.
* People with cardiac pacemakers, epilepsy, etc. cannot place electrode patches on the skin.
Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection

This study aimed to evaluate the effect of vapocoolant spray and EMLA in reducing pain from spinal injection

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Vapocoolant spray group and eutectic mixture local anesthetics (EMLA) group). Intravenous (IV) cannulae with Ringer Acetate fluid, non-invasive blood pressure monitor, and pulse-oxymetry were set on the subjects in the operation room. Vital signs were recorded. Patients were positioned in sitting position and were instructed to flex their head and bend their back. Identification of intervertebral space L4-5 were performed. Asepsis and antisepsis procedure were performed. The Vapocoolant spray group received vapocoolant spray at a distance of 10 cm for 2 seconds and we waited for 10 seconds. The EMLA group received EMLA cream which consisted of 2.5% lidocaine and 2.5 % prilocaine in 2 ml of water/oil emulsion and then they received tegaderm as the dressing for 45-60 minutes before the cream was wiped off. Spinal injection using 27G needle were performed after the intervention to each groups. Needle bevels were aligned parallel to dura fibres. Patients' visual analog score (VAS) and movements were recorded. Evaluation was only done in the first injection attempt, and was followed until the depth of the needle was around 5 mm. After the injection was successfully performed, patients' position were changed into supine position. Evaluation and recording were performed by person who was blinded from the intervention. Vital signs were recorded for every 3 minutes in the first 15 minutes, and then every 5 minutes until the end of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* woman aged \>18 years old
* American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo one-day care elective surgery at operating room in spinal anesthesia
* patients who were planned to undergo brachytherapy

Exclusion Criteria:

* Subjects with history of allergy to anesthetic agents
* unstable hemodynamic
* history of active psychotropic drug consumption
* spinal anesthesia contraindications such as local infection, severe coagulopathy, severe hypovolemia, or increased intracranial pressure
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones

The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. ALLN-177 is an orally administered form of oxalate decarboxylase. The goal of therapy with ALLN-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract.

Eligible subjects will be randomized to 7 days of treatment with a dose ALLN-177 or placebo and following a washout period, crossed over to an alternate treatment. Urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study.

The study allows for up to 60 subjects.

Eligibility Criteria:
Inclusion Criteria:

* History of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years
* Hyperoxaluria at screening
* May be taking drugs for the prevention of stone disease

Exclusion Criteria:

* Hyperuricosuria
* Glomerular filtration rate \< 55 mL/min/1.73m2
* Hypercalcemia or hypothyroidism
* Obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney
* Treatment with cholestyramine
* Average daily dietary intake of oxalate \<75 mg per day
Inpatient Capture: a Mixed Methods Study to Develop an Inpatient Lung Cancer Screening Program in a Safety Net Hospital.

Lung cancer continues to be the leading cause of cancer death in the United States. There are several important disparities in lung cancer mortality: racial and ethnic minorities, those with serious mental illness and those with lower socioeconomic status experience higher lung cancer mortality compared to the general population. Lung cancer screening (LCS) with annual low dose chest CT can reduce lung cancer mortality by 20% for high-risk patients, but has been generally underutilized with uptake of 5-15% by eligible patients across the United States. Half of all patients eligible for LCS remain current smokers, and the additional benefits of tobacco cessation services can increase the benefits of LCS clinical encounters in these patients. Despite the proven benefit of LCS and tobacco cessation, it remains out of reach for many with barriers across the patient, provider, and health-care system levels with resultant disparities in uptake of LCS and effective tobacco cessation that may exaggerate disparities in clinical lung cancer early detection and mortality. The majority of LCS care occurs across several visits in an outpatient clinical setting, which may make it inaccessible to the most vulnerable patients.

Our central objective is to extend the reach of lung cancer and tobacco screening through the implementation and evaluation of a program extending these services inpatient in a public hospital that serves a known high-risk and diverse population in East Harlem. Preliminary data obtained from a retrospective quality improvement project examined data from patients admitted over a 3 month period in early 2022. Of 1374 unique patients were admitted to our hospital, 112 patients met LCS eligibility criteria and over 80% had no evidence of having been screened. Forty-seven percent identified as Black and 33.9% as Hispanic, groups known to have worse lung cancer outcomes. While smoking data was incomplete on a majority of patients, 75% of all inpatient admissions were noted to be currently smoking. This, our preliminary data suggest that an inpatient program to provide smoking cessation and LCS in a safety-net hospital may be an effective tool to increase the reach of LCS in a known high-risk demographic and address disparities in LCS and tobacco cessation services.

This proposal represents a prospective pilot study to develop, implement and evaluate an inpatient LCS and tobacco cessation program.


Eligibility Criteria:
Inclusion Criteria:

* 50-80 years of age
* greater than or equal to 20 pack year history
* currently smoking or have quit within the last 15 years

Exclusion Criteria:

* \< 50 years of age, \> 80 years of age
* \< 20 pack year history
* quit smoking greater than 15 years