cyrilzakka/clinical-trials huggingface dataset:
Food Additives Effects on EEG Profiles in College Students With ADHD

The purpose of this study is to examine the effects of food additives on college students with ADHD. This study could potentially answer an important question which still remains unanswered as to whether certain food additives may be able to cause cognitive and electrical activity changes in college students with and without ADHD. In this context, food additives will be artificial food coloring.

Consent will be obtained at the first visit. Baseline data will be collected on the participants, including height, weight, computerized cognitive functioning, and an EEG recording. Participants will also be taught how to keep a detailed food and symptom diary over the following week. One week later, the participant will return to the lab and turn in the food/symptom diary. All ADHD participants and a subgroup of controls (called extended controls or EC) will be trained on how to follow the dietary intervention. Detailed information on the diet will be given, including food additives to avoid, healthy foods which should be eaten, and shopping tips. For the next two weeks, the participant will follow the dietary intervention at home with access to Dr. Holton to answer any questions. The participant will return to the lab after following the diet for two weeks and assessments (cognitive testing, and EEG) will be completed again along information on dietary compliance will be collected. The third meeting will also mark the beginning of the first challenge period. For the challenges, the participant will consume chocolate cookies every Monday, Tuesday, and Wednesday for two weeks. The cookies may or may not contain artificial food coloring depending on the week. Every Wednesday repeat testing will be completed after the cookies are consumed. The participant will be asked not to take ADHD medication on testing days. After two weeks of challenges the study will be completed. The participant will receive information on their performance and on the study results overall.

Eligibility Criteria:
Inclusion Criteria:

* Generally good health
* 18-24 years old
* Currently attending college
* Physician's diagnosis of ADHD (unless control participant)
* Stable medication dose and frequency for 3 months before the study
* Willing to suspend ADHD medication administration on testing day and the day after testing

Exclusion Criteria:

* Presence of comorbid psychiatric condition other than comorbid depression or anxiety
* Autism
* Severe asthma requiring past hospitalization
* Seizure disorder
Scapular Stabilization During Manual Horizontal Adduction Stretches and Its Effect on Increasing Posterior Shoulder Flexibility

The purpose of this study is to determine if stabilizing the scapula (shoulder blade) during a common shoulder stretch is more effective at improving shoulder range of motion than not stabilizing the scapula. Investigators hypothesize that scapular stabilization during horizontal adduction stretching will demonstrate greater gains in shoulder range of motion than stretching without scapular stabilization.


Eligibility Criteria:
Inclusion Criteria:

* athletes with at least two years of volleyball experience
* athletes with no current shoulder pain
* athletes between the ages of 15 and 21
* athletes with a 10 degree or greater difference in internal rotation between shoulders

Exclusion Criteria:

* athletes currently experiencing shoulder pain
* athletes having less than two years of volleyball experience
* athletes not meting inclusion criteria
The Corona and COVID-19 Study in Telemark and Agder

Through SARS-CoV-2 IgG testing of PCR positive and negative cases the study will follow the COVID-19 immune response by monitoring the SARS-CoV-2 IgG antibody levels over a period of two years. Further, risk factors will be identified by the use of the test-negative design including population controls, allowing comparison of participants with positive and negative tests, and with population controls (triangulation). Special emphasis will be on high risk groups in general and on different occupational, environmental and socio-economic groups in particular. Finally, severity of illness, deaths and the use of health care during will be assessed using national register data from Telemark and Agder.

Objectives

The main objectives are:

1. Monitor the incidence of COVID-19 and the development of the SARS-CoV-2-IgG levels of cases in Agder and Telemark over a period of two years (WP1).
2. Identify risk factors for COVID-19 by comparison of SARS-CoV-2 antibody positive and negative cases in Telemark and Agder, and comparison of these groups separately with population controls (WP2).
3. The incidence of neurocognitive symptoms and fatigue in COVID-19 patients (WP3).
4. Investigation of severity, death and the use of health care for the COVID-19 patients based on data from national registers (WP4).

The main exposures are (WP1-3):

* Infection (mild, severe) with COVID-19.
* Occupational risk factors assessed by occupational codes (ISCO88) and job exposure matrix categorisation.
* Environmental risk factors (road traffic outside bedroom window, travel by foot or bicycle alongside busy roads, and the use of a fireplaces in residential homes. Further, estimated measurements of air pollution may be linked to participants' home address.
* Socioeconomic status; age, sex, comorbidity, medication use, lifestyle factors (smoking, BMI, physical activity, others), geographic region/municipality, education and income.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 85 years
* Performed SARS-CoV-2 PCR test

Exclusion Criteria:

* Non-Norwegian speakers.
* Deceased
* inability to answer questionnaire due to dementia or similar conditions
CAR-T Cells in the Treatment of Malignant Hematological Tumors

To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Eligibility Criteria:
1. With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor
2. Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis;
3. Age 14-70 (including boundary value), both male and female;
4. Subjects with a physical status of 0\~2 in the American Eastern Oncology Collaboration Group (ECOG);
5. The results of treatment related antigens were positive;
6. The expected life span is more than 3 months from the date of signing the informed consent;
The Role of Nutrition in Muscle Function of Bariatric Surgery Patients

Current recommendations for protein intake after bariatric surgery are not based on strong scientific evidence. It remains unclear how much protein should be eaten to minimize muscle loss and preserve the metabolism and function of individuals post-bariatric surgery.

The objective of this study is to analyze the relationships between changes in body composition, nutrition and protein intake, and muscle function after bariatric surgery to further our understanding of the nutritional needs of patients after bariatric surgery.

We intend to recruit around 75 participants, men and women, aged between 18 and 65 years. Participants will be recruited from the Bariatric Surgery Clinic, McGill University Health Center.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Aged 18 to 65 years old
* Undergoing first bariatric surgery (any type)
* Diabetics and non-diabetics
* Non-smokers and non-cannabis consumers

Exclusion Criteria:

* Pregnant and breastfeeding women
* Individuals undergoing second bariatric surgery
* Regular smokers and cannabis consumers
* Current use of Ozempic (or Ozempic-like medication) and anti-psychotic meds
* Limited physical mobility (using walking aids such as canes, walkers, or wheelchairs) and issues with hand resistance
* Kidney disease, non-controlled / unstable hypertension and hypothyroidism, and any metabolic disease other than diabetes
The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis

The goal of this clinical trial is to understand the patient and clinic visit characteristics that affect health outcomes for individuals with knee osteoarthritis (OA) pain using topical diclofenac gel. The main questions it aims to answer are:

* What baseline patient characteristics predict response to topical diclofenac?
* Does patient physiology during the study visit predict response to topical diclofenac?
* Do study visit characteristics predict response to topical diclofenac?

Participants will:

* attend 2 study visits to complete study questionnaires and have blood drawn
* apply topical diclofenac to their knee for 8 weeks
* complete biweekly questions about knee pain and diclofenac use between study visits

220 older adults with symptomatic knee OA will attend a single research clinic visit (one of four different types of study visits) with a study clinician. The investigators will video record the visits and measure participant heart rate and skin conductance during the visit. Participants will complete baseline questionnaires immediately prior to the study visit. All participants will receive diclofenac gel (a topical over-the-counter non-steroidal anti-inflammatory drug \[NSAID\]), a guideline recommended treatment for knee OA-related pain at the end of the first study visit. Participants will identify an "index" knee (worst pain, right or left) that they will treat and follow during the study. Between study visit 1 and the 8-week follow-up visit, participants will receive an every other week text message asking them to report on pain and diclofenac use to better understand changes in pain over time. Final questionnaires will be completed at the second study visit at week 8.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* 50 years of age or older
* Radiographically confirmed knee OA of K/L grade 2 or higher within the past 2 years
* Knee pain at least 15 days/month.
* Average worst daily pain 3/10 or higher over a two-week period.

Exclusion Criteria:

* Medical contraindication to taking NSAIDs such as: history of coronary artery bypass graft, myocardial infarction, coronary artery stent placement, or stroke within the past 6 months; systolic heart failure with ejection fraction \<45%; chronic kidney disease stage ≥4; severe gastrointestinal bleed or stomach ulcer within the past 6 months; current pregnancy; cirrhosis; currently taking blood thinners (aspirin 81 mg daily is okay); allergy to NSAIDs or aspirin; or any other medical contraindication to using topical NSAIDs.
* Inflammatory arthritis
* Partial or total knee replacement of the index knee
* Recent therapeutic injection of the index knee (less than 12 weeks)
* Planned knee/lower limb surgery during the two-month study period
* Active cancer treatment not in remission or life expectancy less than 6 months
* Inability to provide informed consent (e.g. dementia)
* Current use of topical or oral NSAIDs more than 3 days per week.
* Inability to receive text messages or emails to complete questionnaires between study visits.
* Unable to follow the study protocol.
Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden

The aim of this study is to evaluate a new cancer diagnosis center (Diagnostiskt Centrum, DC) in Kristianstad, Sweden. Patients aged ≥ 18 years who are suspected of having serious illness but who have no organ-specific symptoms will be referred to the DC for further investigation after preliminary assessment in primary care. The overall purpose of the study is to evaluate whether the DC meets its target time for diagnosing cancer. In addition, we will evaluate secondary issues, such as survival, to determine whether this pilot project merits extension to other parts of southern Sweden.

Diagnostiskt Centrum (DC), Sweden's first specialized cancer diagnosis center, was established at Kristianstad General Hospital in 2012 as a model for reducing the time taken to diagnose cancer in primary care patients with diffuse, non-organ specific symptoms. If it is successful, the DC model could be rolled out to other areas of Sweden. This study by the Center for Primary Health Care Research in Malmö, Sweden and Regionalt cancercentrum syd will investigate whether the DC process reduces the time from (1) the point when the patient first contacts his/her primary care center with symptoms to (2) the point when he/she is informed about his/her diagnosis (of cancer or another disease). This will be achieved by comparison with matched control patients with suspected cancer who will be referred to Helsingborg General Hospital for further investigation according to existing diagnostic procedures. Various outcome measures will be investigated, and patients' experiences of the DC process will be assessed using a tailored questionnaire. In addition, the DC model will be subjected to health economics analysis.

Eligibility Criteria:
Individuals in two cities in southern Sweden (Helsingborg and Kristianstad) who contact their primary care center because of diffuse, non-organ-specific symptoms

Inclusion criteria: suspicion of cancer following preliminary investigation in primary care

Exclusion criteria: (1) age \< 18 years; and (2) inability to fill in the patient questionnaire
Validation of the French Version of Ask Suicide-Screening Questions (ASQ) in Adolescents Managed in Pediatric Emergency Unit

The ASQ-Fr study aims at validating the French version of Ask Suicide-Screening Questions composed of 5 items in adolescents managed in pediatric emergency department. Therefore, use of this brief valid screening instrument could assess the risk for suicide in pediatric patients and then improve the prevention of suicidal tendencies in this population.

ASQ-Fr is a prospective, cross-sectional instrument-validation study evaluated 5 candidate screening questions assessing suicide risk in adolescents between 10 and 18 years of age managed in two urban, pediatric emergency departments associated with tertiary care hospitals.

ASQ-Fr questionnaire is conducted by a psychologist before or after the French version of the SIQ/SIQ Junior (Suicidal Ideation Questionnaire), depending on the randomisation in the unit. SIQ is composed of 30 items and valid for adolescents aged 15 years or more. SIQ Junior is composed of 15 items and valid for children up to 14 years old.

Questionnaires are followed by an interview in adolescents and parents separately by the psychologist to evaluate perceptions, feasibility and acceptability of questionnaires.

It is planned a convenience sample of 200 patients aged 10 to 18 years who presented with either medical or surgical chief concerns to the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* patient with informed consent of adolescents and at least one of parents or a guardian
* patient with social protection cover
* in adequation with emergency management

Exclusion Criteria:

* patients with mental disorder
* minor without parent/gardian at the emergency unit
Cognitive Function After Treatment of Primary CNS Malignancy

In this study, the investigators propose to evaluate cognitive function and determine the feasibility of neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent. The investigators will use the CogState software to quantify changes in verbal learning, memory, and executive function over the initial months and years following radiation treatment. Cognitive changes and temporal patterns of function will be compared to baseline performance for each patient. Data regarding cognitive function, fatigue, quality of life, and standard patient reported outcomes will be collected to characterize the daily impact of treatment. In addition, observed outcomes will be correlated with dosimetry values, radiation dose volumes, and anatomic dose distribution.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 4 years with primary CNS malignancy
* Able to use computer for assessment battery
* Receiving photon- or proton-based radiation for primary intracranial malignancy
* Demonstrates the capacity to sign informed consent

Exclusion Criteria:

* Patients with WHO Grade IV tumors
ASA- and Clopidogrel-Responsiveness in Patients With Peripheral Arterial Occlusive Disease and Interventional Procedures

The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in patients with peripheral arterial occlusive disease (PAOD) requiring interventional procedures and to investigate if patients with "resistance" to ASA or Clopidogrel have an unfavourable outcome during long-term follow-up


Eligibility Criteria:
Inclusion Criteria:

* PAOD patients
* Age 18-85 years
* Need for a catheter interventional procedure
* Antithrombotic therapy with aspirin or clopidogrel

Exclusion Criteria:

* Comedication additionally compromising platelet function
* Known bleeding disorder
* Life expectancy \< 6 months
The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion

The process of bony fusion is a dynamic bone remodeling process and a variety of risk factors have been identified to contribute to pseudoarthrosis.Vitamin D deficiency has been reported to be associated with more pseudoarthrosis, prolonged time to fusion, and poorer spine function and quality of life after spinal fusion.However, as the review article presented, it lacks high-quality evidence to investigate the role of vitamin D supplements in spinal fusion. Therefore, this randomized controlled trial aimed to evaluate the effectiveness of oral vitamin D supplements on fusion outcomes in patients receiving elective lumbar spinal fusion.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 80 years
* Indicated of elective spine fusion surgery for spinal stenosis or degenerative spondylolisthesis at the study hospital from January 2016 to December 2017.

Exclusion Criteria:

* Spinal instability due to trauma, infection, or malignancy
* History of previous spine surgery
* Hemodialysis
* Long-term steroid use
* History of medical treatments for osteoporosis
* Postoperative follow-up for less than 12 months
* Newly-onset compression fracture after study procedure
A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma

Radiotherapy (R/T) for locally advanced hepatocellular carcinoma (HCC) is often used in patient who is not suitable for transarterial chemoembolization (TACE) and other local therapy, especially in those with portal vein tumor thrombosis (PVTT) caused by tumor cells. Several previous studies have showed that local R/T is tolerable and can induce a substantial tumor response in HCC management. In addition, the safety, toxicity and preliminary efficacy of Lipotecan® (TLC388) has also been proved in patients with terminal malignancy. This study aims to evaluate the safety, tolerability and efficacy of concomitant Lipotecan® and radiotherapy in patients with locally advanced HCC and PVTT.

Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with cytotoxic activities against a variety of human tumor cell lines and anti-tumor activities in several xenograft models with human tumor cell lines. Structurally, TLC388 HCl is related to other camptothecins, but it has been chemically modified to improve stability and potency, and to minimize toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Females or males 20-70 years of age (inclusive)
* Patients with histological confirmed HCC or other conditions
* Patients with locally advanced HCC and PVTT that is not suitable for other local therapies
* Other inclusion criteria also apply

Exclusion Criteria:

* Females who are pregnant/lactating or planning to be pregnant, or patients of childbearing potential who are not using medically recognized method of contraception.
* Patients with documented extrahepatic metastasis
* Patients with stage III-IV encephalopathy or tense ascites
* Patients who have received any local or systemic therapy for HCC within 4 weeks prior to the initiation of study treatment
* Patients who have received Lipotecan® treatment prior to the initiation of study treatment
* Other exclusion criteria also apply
Cortical Excitability in Cyclic Vomiting Syndrome

This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).

This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).

Using the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).

Some clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CVS

Exclusion Criteria:

* history of CVS (for healthy control population only)
* psychosis or altered cognitive status
* history of head injury, metal in the skull, stroke, or a history of seizures
* implantable devices, such as a pacemaker or nerve stimulator
* current use of the following medications or use of substances which are known to lower the seizure threshold: clozapine (Clozaril), chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 or more alcoholic drinks per day
* pregnancy