cyrilzakka/clinical-trials huggingface dataset:
Botulinum Toxin Injections for Thoracic Outlet Syndrome

Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.

To assess the effect of Botulinum Toxin Type A (BTX-A) injections into the scalene muscles on pain, paresthesias and function in subjects with TOS.

Hypothesis:

BTX-A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.

Study design:

Double-blind, randomized, placebo-controlled parallel groups effectiveness trial evaluating changes in pain, paresthesias and function before, at six weeks and four months following injection.

Study population:

Sixty subjects at least eighteen years of age with a clinical diagnosis of TOS of at least three months duration but less than one year, referred to our practice for management of TOS.

Intervention:

Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 100 units of BTX-A (experimental group), or normal saline (control group). Outcome measures:

The primary outcome measure will be pain as measured on a ten point Numeric Rating Scale with a two point reduction considered significant. Secondary outcomes will be paresthesias as measured on a Numeric Rating Scale, function measured on the Disabilities of the arm, shoulder and hand (DASH) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 19 years
* Medically stable
* Able to give informed consent
* Meets criteria for clinical diagnosis of TOS
* Symptoms of TOS present for at least three months and less than two year
* Have had EMG studies and a CT or MRI scan of the cervical spine

Exclusion Criteria:

* Prior treatment with BTX-A
* Allergy to BTX-A
* History of botulinum toxicity
* Prior scalenectomy
* Surgery for TOS planned within four months
* Use of blood thinners, i.e., warfarin; unfractionated or low molecular weight heparin
* History of Myasthenia Gravis, Eaton-Lambert Syndrome or Shy-Drager Syndrome
* Unable to complete follow-up assessments at 6 weeks and 4 months
* Any abnormalities on EMG, CT or MRI studies suggesting an alternate diagnosis
* Pregnancy or planned pregnancy within six months
A Retrospective NIS to Evaluate the Use of Seroquel XR and IR in the Clinical Practice of Outpatients With Schizophrenia

The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary antipsychotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults with a diagnosis of schizophrenia from a district psychiatric clinic in Denmark
* Patients who have received at least one dose of Seroquel XR or Seroquel IR during January - March 2010

Exclusion Criteria:

* Patients already participating in a clinical study during the study-period.
Evaluation of Innovative School-based Interventions on Health Outcomes Among Primary School Students During Post COVID-19 Pandemic

Objectives: To evaluate the effects of innovative school-based (WeJoy + WeHop) on depressive symptoms, physical activities, and sleep quality among primary 3 to 5 school children.

Method: A sample of 408 school children will be recruited from primary schools in Hong Kong. This study will adopt a 2 two-group pre and post-design. Participants are randomly assigned equally into 1 intervention group (WeJoy+WeHop) and 1 control group (Routine Extra curriculum Activity). Participants will be assessed at baseline and post-intervention. The outcomes are depressive symptoms, physical activities, and sleep quality, using the Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC), the Chinese Version of the International Physical Activity Questionnaire (IPAQ-C), and the Chinese version of the Pittsburgh Sleep Quality Index (PSQI-C).

Data analysis: Descriptive and inferential statistics will be performed to examine the research objectives.

The COVID-19 pandemic has altered children's lifestyles, calling for particular attention. Psychological problems, obesity, and sleep disturbance in children have become more prevalent throughout the COVID-19 outbreak. It is vital to develop preventative interventions to enhance psychological well-being, prevent obesity, and improve sleep health. Cognitive behavioural therapy (CBT) is effective in preventing psychological problems, obesity, and sleep problems in children. The provision of CBT faces obstacles such as a shortage of therapists, stigma, protracted wait times, and high costs. Evidence revealed that children prefer interventions with interactive, relatable, and game-like content to improve their engagement.

School-based CBT (WeJoy) allows children to recognize, change, and partake in pleasant activities based on the CBT model. The WeJoy comprises six weekly sessions on psychoeducation, cognitive restructuring, behavioural activation, emotional regulation, and self-monitoring. Exergaming on the interactive floor (WeHop) using a portable interactive projector games system. The WeHop can gain a sense of autonomy, competence, and relatedness to help them regulate their emotions and maintain positive behaviours according to the Self-Determination Theory. Children participate in the interactive floor games by stepping on various targets and moving in response to the game's rules. Combining task division, cooperation, and taking turns constitutes the collaboration mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Primary students ranged from primary 3 to 5 school children.
* Obtained consent forms from their legal guardians.

Exclusion Criteria:

* Primary students in primary 1 due to the adaptation of the new environment.
* Primary 6 due to the preparation of the examinations for secondary schools.
A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis

The purpose of this study is to evaluate pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo.

This is a double-blind (neither the physician nor the patient knows the name of the assigned drug) study evaluating pain relief, safety, and tolerability of a new treatment (JNJ-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo. The study will last for about 42 weeks. Patients will receive treatment for 16 weeks. Patients who qualify for the study based on their level of pain as well as other factors will receive one of the 4 possible treatments as determined by chance. Before entering the study, patients must stop using their present pain medication. During the study, patients will answer questions about their pain, side effects, and have tests performed to monitor their physical condition. The main purpose of the study is to compare pain relief with JNJ-42160443 to that of a standard pain treatment or placebo. After the treatment period, patients can return to taking the pain medication that they used before the start of the study, and their physical condition will continue to be monitored. JNJ 42160443 10 mg/mL will be provided for use in the study. Patients will receive 1 of 4 treatments for 16 weeks (wks): lower dosage of JNJ 42160443 by subcutaneous (under the skin) (SC) injection once every 4 wks + Placebo (P) capsule orally (by mouth) (PO) 2x/day, higher dosage of JNJ 42160443 by SC injection once every 4 wks + P capsule PO 2x/day, standard pain medication capsule PO 2x/day + P by SC injection once every 4 wks, or P capsule PO 2x/day + P by SC injection once every 4 wks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoarthritis of the knee
* Have moderate to severe pain based on a trial questionnaire
* Must be on a stable dose of pain medication for 4 weeks before entering the trial
* Medically stable condition

Exclusion Criteria:

* History of joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial
* Diabetes mellitus
* Uncontrolled cardiovascular disease or hypertension
* Previous treatment with another investigational NGF inhibitor therapy
The Efficacy of Nutrilite All-plant Protein Booster to Improve Sarcopenia and Osteoarthritis in Middle-aged and Elderly People

The goal of this clinical trial is to learn whether Amway Nutrilite All-plant protein booster prototype product (test product) will improve sarcopenia (SA) and osteoarthritis (OA) in middle-aged and elderly people. It will also learn about the improvement of Quality of life (QoL) in them. The main questions it aims to answer are:

* Does the test product will improve the SA in terms of Short Physical Performance Battery (SPPB score) after 12 weeks' intervention?
* Does the test product will improve the OA in terms of Western Ontario and McMaster Universities Arthritis (WOMAC Index) after 12 weeks' intervention?

Researchers will compare Amway All-plant protein booster prototype product to a placebo (a look-alike substance that contains no similar active nutrient ingredients) to see if the test product works to improve SA and OA.

Participants will:

* Take the test product or a placebo 2 spoons (15g) twice per day for 12 weeks
* Visit the site on the baseline day and the 84th day (end day of 12 weeks) for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* Be age 50 to 70 years, female and male
* Participants will be required to have mild to moderately OA \& SA evaluated by Kellgren-Lawrence I-III and SARC-Cal, respectively
* Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part on the study on this
* Participants must be able to read and understand study instructions and any other relevant study documents
* Willing to following the lifestyle restrictions as detailed in the Information Sheet for study
* Will to give written informed consent

Exclusion Criteria:

* Have a fever currently, or for 24 hours before enrollment
* Currently participating in another clinical study
* Have taken other protein powder products and dietary supplements or medicines containing peptides or hyaluronic acid within the past 6 months (subject to product instructions)
* Individuals receiving medical treatment that, in the opinion of the Principal Investigator or Study Physician, may interfere with test results
* The participant is an employee of Amway or SPRIM Medical
* Subject who is in the treatment of gastrointestinal diseases
* Subject with abnormal liver function tests (alanine aminotransferase and aspartate aminotransferase), kidney function tests (blood urea nitrogen and creatinine), blood routine, urine routine, fecal occult blood test, or electrocardiogram.
* Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)

The purpose of this study is to establish the feasibility, accessibility, acceptability, and preliminary efficacy of an individually-tailored intervention to improve EF in adolescents with epilepsy (EFI-E).

Epilepsy is a common childhood condition affecting approximately 326,000 youth in the United States. Adolescents with epilepsy are at significant risk for poor social and academic outcomes, neurobehavioral comorbidities (i.e., internalizing and externalizing symptoms), and poor treatment adherence. Studies have shown that one potential reason for these poor outcomes are deficits in executive functioning (EF), defined as the skills necessary for goal-directed and complex activities, including problem-solving, initiation, monitoring, organization, planning, self-regulation and working memory. EF deficits have been documented in 1/3 of youth with epilepsy, which is 3 times the prevalence in healthy youth. Evidence-based interventions to improve EF could play a critical role in preventing adverse outcomes (e.g., psychological comorbidities, non-adherence to the treatment regimen) and promoting optimal functioning in adolescents with epilepsy; however none exists for this vulnerable population. The aim of the current study is to establish the feasibility, accessibility, acceptability, and preliminary effects of an individually-tailored intervention to improve EF in adolescents with epilepsy (Executive Functioning Intervention-Epilepsy; EFI-E). Thirty participants will be recruited who have at least one clinically-elevated EF subscale or at least two at-risk subscale scores (\> 1 standard deviation above the mean) on the parent Behavior Rating Inventory of Executive Function (BRIEF®)) to qualify for the EFI-E. EFI-E will consist of 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals. Baseline and post-treatment questionnaires will be completed by adolescents and primary caregivers and electronically-monitored adherence will be obtained throughout the open trial. Participants will be in the trial for 9 months.

Eligibility Criteria:
Inclusion criteria

* Age 13-17 years
* Diagnosis of epilepsy
* Have at least two subclinical (\>1 SD; T score between 60-65) or one clinically-elevated BRIEF subscale (T score \> 65)
* Primary caregiver consent and adolescent assent to participate in study

Exclusion criteria

* Diagnosis of non-epilepsy medical disorders requiring daily medications with the exception of asthma and/or allergies
* Diagnosis of significant developmental disorders (e.g. Autism)
* Inability to read and speak English due to the questionnaires and intervention only been developed in English
* Family lives greater than 100 miles away from CCHMC
* If patient is planning to wean from their antiepileptic medication within the next 6 months
Intellivent Versus Conventional Ventilation

Partial automation of mechanical ventilation in resuscitation has been available for several years. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®.

This pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus a conventional ventilation modality.

Rational: Partial automation of mechanical ventilation in resuscitation has been available for several years. It can deliver a continuous ventilation adapted in real time to the patient's clinical condition,and decrease care workload and ventilation weaning duration. New modalities are being developed to completely automate ventilation and oxygenation parameters (IntelliVent®) and preliminary studies show that over short periods (2 to 4 h) such a system can ventilate patients more optimally and more safely, with a better ventilation efficiency (comparable effect on gas exchanges for a less "aggressive" ventilation). This pilot study compares over a longer period (48 hours), the safety and efficacy of IntelliVent®, versus a usual ventilation modality.

Type of study: Monocenter, comparative, prospective, randomized, parallel study.

Objective: To assess IntelliVent® safety, efficacy, and care workload.

Assessment criteria:

* Safety is assessed by measuring the number of times it is necessary to manually intervene on the ventilator settings because for one the following parameters: A range SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR),values considered as non-optimal, as defined a priori and consensually by a panel of experts.
* Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2 and Pplat and VT and RR values considered as optimal, as defined a priori and consensually by a panel of experts.

Efficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values considered as optimal, as defined a priori and consensually by a panel of experts.

- Care workload is assessed by the number of ventilator setting adjustments by nursing staff in each group.

Number of subjects: 80 patients receiving invasive mechanical ventilation for acute respiratory failure.

Methods: The selected patients presenting with inclusion criteria are ventilated either with IntelliVent® or with the unit's usual ventilation following a random selection.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient under invasive ventilation for more than 6 hours and for a planned duration of at least 48 hours
* Body Mass Index (current weight (kg)/height (m)²) \< 40
* Signature of an informed consent by the family

Exclusion Criteria:

* Need for ventricular assistance with intra-aortic balloon counterpulsation.
* Presence of a bronchopleural fistula
* Pregnant women: A pregnancy blood test will be performed in women of reproductive age. The results will be communicated to the patient by a physician of her choice.
* Adults under guardianship
* People deprived of freedom
* Inclusion in another study protocol under consent
Safety and Efficacy of Oseltamivir in Children Younger Than One Year of Age

Currently, there is no standard treatment for influenza with related lower respiratory tract infection (LRTI) in children younger than one year of age, even though influenza related LRTI is a potentially fatal illness in these children. This study will test a medicine for influenza in children younger than one year of age to see if it is safe and effective.

Influenza-related lower respiratory tract infection (LRTI) can cause serious illness or death in children younger than a year old. Only four medications are registered to treat influenza, and these do not have detailed recommendations for treating children younger than one year of age. One of these medications, oseltamivir, has no official recommendation for usage in children younger than one year of age, but it may be the best treatment for certain strains of influenza. A small number of children younger than one year of age have received oseltamivir in several countries with good clinical outcomes and apparently good tolerability. This study will test oseltamivir in children younger than one year of age to see if it is safe and effective.

Children younger than one year of age with influenza will be recruited for this study. Participants will receive the usual care for influenza with the addition of oseltamivir. Oseltamivir will be given orally for 5 days to children with human influenza, 7 days to children with H1N1 influenza in Vietnam, and 10 days to children with avian influenza. Participants will need to remain in the hospital between 5 and 12 days, depending on their illnesses.

Study assessments will be performed daily for 14 days with follow-up examinations occurring 1 to 2 weeks, 6 months, and 12 months after study entry. These assessments will include normal tests for children with influenza, such as blood tests and chest x-rays, but additional blood and nose, throat, and mouth samples will be collected for the study. Participants on a breathing machine will give lung samples.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by a parent or legal guardian
* Younger than 12 months of age when first seen with a lower respiratory tract infection (LRTI)
* LRTI must be moderate or severe and influenza must be virologically proven by a respiratory specimen
* History of fever within 14 days prior to presentation (although fever at presentation is not required) plus any two of the following: cough, difficulty breathing or shortness of breath, increased respiratory rate for current age, intercostal recession, use of accessory muscles, nasal flare or grunting, crepitations with or without wheezing, a consistent abnormal chest x-ray (e.g., new infiltrate, hyperinflation)
* Virological evidence of influenza on any one of the tests specified in the protocol

Exclusion Criteria for Children with Non-Avian Influenza:

* Known allergy to oseltamivir

Additional Exclusion Criteria for Children with Non-Avian Influenza:

* Illness duration greater than 14 days on the day of hospital admission
* Creatinine clearance less than 10 mL/min/1.73m2, including a requirement for dialysis or hemofiltration
Assocaiton Between Uric Acid Trajecteries and Remission of NAFLD in NAFLD Individuals

Uric acid is the end product of dietary or endogenous purines degradation, and hyperuricemia is one of the most common metabolic disorders. A growing body of evidence, comprising a great deal of cross-sectional studies and several prospective ones, also indicates that hyperuricemia is associated with increased prevalence, incidence, and disease severity of non-alcoholic fatty liver disease (NAFLD).

Capitalizing on a cohort study in China, the investigators are aimed to assess the associations of SUA trajecteries with remission of NAFLD in NAFLD individuals and examined whether the association differs across subpopulations.

A cohort study was conducted to evaluate the relationship between the SUA trajecteries and remission of NAFLD. The study enrolled employees who were attending their annual health examination. Furrhermore, the investigators are aimed to explore whether the association differs across subpopulations.

Eligibility Criteria:
Inclusion Criteria:

1. age \>=18 years;
2. agree to be enrolled in this study.

Exclusion Criteria:

1. those taking antihypertensive or antidiabetic agents, lipid-lowing agents, or hypouricemic agents;
2. those with alcohol consumption greater than 140 g/week for men and 70 g/week for women;
3. those with a history of other known causes of chronic liver disease such as viral hepatitis or autoimmune hepatitis, and those using hepatotoxic medications.
Participant Database for Autism Research Studies

The purpose of this study is to create a subject database to recruit for current and future studies in research on autism and other neurodevelopmental disabilities.

Aim 1: to recruit people interested in research on autism and other neurodevelopmental disabilities

Aim 2: to complete a diagnostic assessment, to confirm the diagnosis of autism spectrum disorder or other developmental disability (e.g., developmental language delay) in our patient population and rule out a diagnosis of autism spectrum disorder and other comorbid conditions in our control group

Aim 3: to maintain subject information in a database, from which we can recruit for our studies

Eligibility Criteria:
Inclusion Criteria:

* Typically-developing, healthy adolescents and adults (ages 14-32)
* Adolescents and adults with autism spectrum disorder (ages 14-32)

Exclusion Criteria:

* Extreme premature birth (\<34 weeks)
* Known genetic disorders related to autism (e.g. Fragile X)
* Recent diagnosis of psychosis (within 6 months)
* Some other psychiatric diagnoses may be excluded following screening (e.g. Tourette's syndrome).
* Metal implants / permanent retainers / hair dyes with metallic components