cyrilzakka/clinical-trials huggingface dataset:
The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort

The goal of this study is to enroll 1000 participants with a history of Multiple Sclerosis into the MURDOCK Study (Duke IRB Pro00011196) as well as into the Multiple Sclerosis Cohort study (Duke IRB Pro00023791). All 1000 participants will answer a 4-page questionnaire administered by a trained study coordinator which is designed to collect information on the participant's diagnosis of Multiple Sclerosis. The goal of the study is to seek genetic explanations for response to treatment, progression of the disease, and biomarker validation.

Despite tremendous research efforts, the targets of immune response and the mechanisms for neuronal loss associated with MS have not been fully characterized. Although substantial advances have been made in the development of therapeutic treatments, the drugs currently available to MS patients do not significantly alter the long-term prognosis of the disease. Better markers that represent the biological activity of the disease process and response to therapy are desperately needed. MS is thought to be mediated by autoimmunity which causes demyelination and transection of axons throughout the brain and spinal cord resulting in the formation of multiple scars (or scleroses) on axon myelin sheaths and reducing electrical conductivity and decreased CNS signaling. It is most common in young adults; more than 90% of patients are diagnosed before the age of 55 and less than 5% before the age of 14. Females are 2-3 times more frequently affected than males and children of affected females are at a significantly higher risk of developing MS than children of affected males. A strong genetic component is suggested by the co-occurrence of cases within families and the high disease prevalence in some ethnic populations (particularly those of northern European origin) compared with others (African and Asian groups) irrespective of geographic location.7 The incidence of MS in northern Europe, where the genetically associated haplotype HLA DR2 is most common, is as high as 1 per 750 individuals. MS affects more than 400,000 people in the U.S. and 2.5 million worldwide.

Although numerous putative MS-specific biomarkers, representing different mechanisms of pathogenesis and steps along the inflammatory cascade have been proposed, none have been fully validated. To date, the majority of studies identifying biomarkers associated with MS initiation or progression have been limited to investigation of one to several markers at a time; only one study has attempted open platform proteomic profiling in MS; however, the study size was relatively small and the clinical homogeneity of the dataset of the study is not clear. To understand a complex disease like MS, high throughput technologies capable of profiling multiple etiological changes is needed as well as a well-define population of those with the disease.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Multiple Sclerosis Diagnosis or self report Multiple Sclerosis

Exclusion Criteria:

* Participants who are not willing to participate in this study
Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users

Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked compound action potential (ECAP) of the auditory nerve represents an option to assess changes in auditory nerve responses and the interaction between the electrode and the neural tissue over time.

Aim: To study ECAP in children during the first year of CI use.

Material and methods: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. SERIES STUDY.

Descriptors:

Cochlear Implantation,cochlear nerve,child.


Eligibility Criteria:
This study selected only children implanted younger than three years old and followed them during their first year of CI use.
Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma

This is a single-arm, multicenter, exploratory study to evaluate the efficacy and safety of AK104 in combination with cisplatin and paclitaxel in the treatment of resectable locally advanced esophageal squamous carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years, both men and women
* Pathologically confirmed esophageal squamous cell carcinoma，and the clinic staging is cT2N1-3M0 or cT3N0-3M0 or cT4N0-3M0, TNM staging is II-IVA
* Non-cervical esophageal carcinoma
* Patients who have never received systemic antitumor therapy and who have measurable lesions that meet RECIST 1.1 criteria
* ECOG score 0-1
* Life expectancy ≥12 months
* Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency disease
* For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 7 days before receiving the first study drug administration. Male and female patients need to use high-efficiency contraception during treatment until at least 8 weeks after stop the treatment
* Sign the informed consent form before any trial-related procedures are implemented

Exclusion Criteria:

* -Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
* ulcerative esophageal squamous cell carcinoma
* Esophageal or tracheal fistula
* History of allergy to study drug components
* History of immune disease
* Patients with any serious or uncontrolled systemic disease
* The presence of any adverse event (CTCAE\>grade 1) caused by prior therapy
Effects of a Workplace Prevention Program for Problematic Gambling

The purpose of this study is to determine the effects of a workplace prevention program targeting problematic gambling.

There is a considerable knowledge-gap regarding the efficacy of problem gambling prevention in workplace settings. At the same time, this knowledge is widely requested upon both by researchers and government agencies. The evaluation of prevention programs is important both in a public health perspective and for the organizations investing in preventive interventions for problem gambling at the workspaces and the current study aims to contribute with knowledge regarding the potential effects of such an intervention.

The purpose of this study is to determine the effects of a workplace prevention program regarding problematic gambling, on a variety of outcomes. The authors hypothesize that the program will lead to differences in:

* A change in gambling habits among coworkers and managers
* That fewer workers and managers will report problem gambling
* That the managers who participate in the intervention will report being more confident in handling gambling and problem gambling at the workplace
* That the managers who participate in the intervention will report a higher inclination to engage in a conversation with an employee when suspicion or worry about problem gambling arises
* That the number of actions to help employees with problem gambling or other types of harmful use will raise among organizations who participate in the intervention.
* An increase in the employees' knowledge about what kind of support regarding gambling or addiction is available from the workplace and where to find it.

Eligibility Criteria:
Program Inclusion Criteria:

* To be eligible to participate in the workplace program, the participant must be currently employed as manager in one of the organizations that will participate in the study

Exclusion Criteria:

-
Effect of High Flow Nasal During Exercise in COPD Patients

Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. High flow ventilation in reducing work of breathing and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of COPD

Exclusion Criteria:

* exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
* pH \< 7,35
* Body temperature \> 38°C
* cardiac frequency \> 100 bpm at rest
* systolic blood pressure \< 100 mmHg
* exacerbation during the study
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety

The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 year of age
* Major Depressive Disorder (MDD) with symptoms of anxiety
* Stable treatment with less than 50% improvement

Exclusion Criteria:

* Contraindicated to perform fMRI scan
* Previous exposure to brexpiprazole
Person-Centered Assessment and Monitoring Systems

The proposed study will include an analysis of data for residents of Pennsylvania who are age 21 and older, have a diagnosis of Autism Spectrum Disorder (ASD), and are enrolled in the Commonwealth's Adult Community Autism Program (ACAP). The individuals enrolled in the program will be administered a standardized assessment battery quarterly for two years. The proposed study will analyze the data gathered during each of the assessment periods in order to aid in service/treatment planning, assess for individual improvements, and ultimately measure treatment outcomes.

The proposed study seeks to more closely monitor the changing needs and challenges of adults with ASD, which will be facilitated through a battery of assessments given over quarterly time points in a two year time period. Investigators seek to address whether increased frequency of behaviorally driven assessments will inform treatment. More specifically, investigators are interested in knowing if the assessment data influences treatment planning with providers or if it is guiding any decisions about treatment once data is returned to participants in a meaningful way which is easily understood. If data prompts treatment changes, the study will examine whether improvements are being shown months or even years later.

An "elected reporter", a family member, is asked to take part in the research study with the participant. An elected reporter is asked to complete several questionnaires quarterly, both reporting on themself and the participant.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Pennsylvania's Adult Community Autism Program (ACAP), \> 18 years of age
* English as primary language spoken
* Ability to self-report (i.e. understand and answer assessment questions written at a third grade comprehension level)
* Have an Elected Reporter

Exclusion Criteria:

-Inability to provide consent
HFIP Ex-vivo Study

Sepsis, a multi organ failure caused by infectious diseases, is a major health burden with an average mortality rate of 26%. Cells of the innate immune system of hosts recognize specific patterns of pathogenic bacteria and trigger an inflammatory response. In case of sepsis, this inflammatory response takes a deregulated course, expressing an overwhelming amount of pro-inflammatory cytokines leading to a loosening of endothelial tight junctions, evasion of intravasal fluids and proteins into the interstitium, as well as direct tissue damage throughout an overproduction of reactive oxygen species by neutrophils. These pathological changes of the host's proper immune system lead to a multi organ failure, which characterize a clinical pathomechanism of sepsis. Several studies confirmed an immunomodulatory effect of sevoflurane's primary metabolite hexafluoroisopropanol (HFIP) attenuating pro-inflammatory cytokine expression with a consecutive improvement of organ function and survival in rodent models of sepsis. Until now, there are no data available confirming this effect in septic patients as well. With this study, the direct impact of sevoflurane's primary metabolite HFIP on cytokine expression in the blood of septic patients will be investigated for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency ward with suspicion of infection and a qSOFA Score ≥ 2 points (Respiratory frequency \> 22/minute, Systolic blood pressure \< 100 mmHg, Glasgow Coma Scale \< 15).
* Male and Female subjects with at least 18 years of age.
* Written informed consent by the participant after information about the project. In emergency cases where a written consent cannot be obtained immediately, due to the patient's medical conditions, the existence of a patient decree and of a representative in the emergency situation is evaluated according to the Swiss Civil Code. Informed consent will be obtained from the representative. A medical doctor, furthermore, not participating in the investigation, guarantees the medical care of the patient by the defending of his/her interests. After recovery, the patient will be informed as soon as possible about the trial and consent is requested.

Exclusion Criteria:

* Acquired Immune Deficiency Syndrome
* Anti-IL-6 therapy (e.g. Kevzara®) within the last 60 days
* Application of a cytokine absorber
* Pregnancy and/or Breast feeding
Effects of Exercise and Insole on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Pes Planus

The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus.

The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus. Forty-two individuals with flexible pes planus will be recruited into the study according to the inclusion criteria. Participants will be randomly divided into three groups: (1) Exercise, (2) Insole, (3) Exercise plus Insole. Exercises will be performed three times per week for six weeks, also custom-made insoles will be worn for six weeks. Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6. Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal and fast speeds, (3) Walking just after the heel-rise test for endurance. Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA). The assessments will be made pre/post intervention and at 6-weeks follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. being between 18 and 40 years of age,
2. having Navicular drop test greater than 10 mm,
3. having Foot posture index-6 greater than or equal to 6,
4. having bilateral flexible pes planus.

Exclusion Criteria:

1. a lack of anatomical integrity of the foot,
2. a history of surgery or trauma in the foot region,
3. other musculoskeletal or neurological problems which may affect balance and gait performance.
4. having received any treatment for lower extremity disorders including pes planus within the last 1 year
5. having a body mass index equal to or greater than 30.
Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population

Children with chronic diseases, particularly those who have received transplantation (e.g. cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as venipuncture multiple times per week. There is currently no standard of care for pain reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an outpatient. The study aims to determine the efficacy of distraction in reducing procedural pain and distress associated with venipuncture in pediatric post-transplant patients.

Children with chronic illnesses experience frequent painful experiences over extended periods of time, and may develop long-term physiological, psychological and behavioral sequelae including increased sensitivity to pain and higher levels of anxiety before painful procedures. There is strong evidence to show that distraction is effective in reducing children's pain and distress during painful procedures. However, the evidence to support distraction, as well as other methods of pain reduction during venipuncture (i.e. vibration, topical anesthetics, sucrose), has primarily focused on children who are previously well, as those with chronic disease are an understudied population with regards to pain reduction during simple procedures. Children with chronic disease or pathology, particularly those who have received transplantation (e.g. cardiac, renal, liver), are a population who undergo frequent painful procedures, such as venipuncture multiple times per week. There is currently no standard of care for pain reduction during venipuncture for pediatric patients having blood drawn in phlebotomy or in the transplant clinics as an outpatient.

The investigators will conduct a randomized control trial comparing two groups: Distraction versus standard of care (i.e. no distraction). The intervention (distraction) will be administered using an iPad and allowing the child to self-select a developmentally appropriate distraction (e.g. game, movie, music). Participants will be videotaped for approximately 1 minute, starting from the time of the venipuncture. This video will be viewed at a later date by two trained study investigators to assess the patient's pain and distress associated with venipuncture, as measured by the OSBD-r, CHEOPS, and FLACC.

Eligibility Criteria:
Inclusion Criteria:

* History of solid organ transplantation
* Undergoing venipuncture

Exclusion Criteria:

* Blood being drawn from a central line
A Family-Based Weight Loss Intervention for Youth With Intellectual Disability

The purpose of this randomized controlled trial is twofold. First, to examine the efficacy of a 24-session, 6-month family-based behavioral intervention (FBBI) - as compared to a waitlist FBBI group, which later receives the same FBBI - that targets weight loss in adolescents/young adults with intellectual disability aged 14-22 years. Second, to examine the efficacy of a 12-session, 6-month Maintenance intervention that targets maintenance of weight loss in the same population of adolescents/young adults with intellectual disability. The Maintenance condition follows the completion of each FBBI group and involves a re-randomization to either the Maintenance intervention or no further intervention. Primary outcome measures include body weight and Body Mass Index (BMI). Secondary outcome measures include physical activity/sedentary behavior (measured via accelerometry), dietary patterns (3-Day Food Records), and self-efficacy (brief questionnaire). Hypotheses are that: (1) participants in the FBBI condition will lose more weight (and reduced BMI) than participants in the waitlist treatment condition, and that (2) participants in the Maintenance condition will maintain weight lost (and reductions in BMI) or experience less weight regain, as compared with participants who receive no further intervention following FBBI.


Eligibility Criteria:
Inclusion Criteria: Inclusion criteria for the adolescents with intellectual disability (ID) will be:

1. Age 14-22 years
2. Clinically overweight or obese, as indicated by BMI guidelines set by the Centers for Disease Control and Prevention
3. Scores of ≤ 75 on the Kaufman Brief Intelligence Test (KBIT) and Vineland Adaptive Behavior Scales, 2nd Edition to establish criteria for the presence of an intellectual disability
4. Living at home in a single- or two-parent family with no plans to leave home in the next year
5. Verbal ability and necessary behavioral/social skills to participate in a group classroom-based educational program (determined by clinical observation and judgment accomplished through a structured interview during enrollment)
6. Signed approval to participate by the adolescent's primary care provider (and by other specialists such as cardiologists or neurologists if the participant has a heart condition or neurological disorder).

Exclusion Criteria: Exclusion criteria will be:

1. Cardiac problems that preclude participation in moderate-to-vigorous-physical-activity (MVPA)
2. Insulin-dependent diabetes
3. An active seizure disorder not stabilized on medication
4. Non-ambulatory, i.e. uses a wheelchair, or orthopedic injuries/deformities that prohibit moderate walking and other exercise
5. Colitis, Crohn's Disease, and Inflammatory Bowel Disease
6. Prader Willi syndrome
7. Unwillingness to wear the accelerometer at screening or enrollment
8. Recent history of disruptive, inappropriate or dangerous behaviors (e.g., self-injury, aggression/injury to others, property destruction, and extreme and ongoing use of inappropriate language).
Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2 FSHD study. For this, the investigators relied on observational components: FSHD2 patients appear more often present with psychiatric comorbidities and seem to have lower cognitive performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small sample population of patients. It seems to exist mainly executive dysfunction associated with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low in relation to their socio-educational and compared with patients FSHD1 level.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years and \<75 years
* FSHD patients 1 or 2 with genetic confirmation

Exclusion Criteria:

* Phosphokinase creatine level \> 5 time of the normal
* Patient as medical history :

  * A history or active neurological disease likely to interfere with the interpretation of results
  * a history of head trauma
  * an infectious disease, hormonal, inflammatory or some deficiency may induce cognitive and / or psychiatric troubles
  * Patient with cons-indication for performing a brain MRI
* Pregnant, parturient and lactating (producing a serum pregnancy test)