cyrilzakka/clinical-trials huggingface dataset:
Loads, Injuries and Illnesses Among Elite Handball Players

Primary goal of the research is to determine whether injury/illness occurrence is influenced by the academic, training and competition loads, as well as the overall load (sum of academic/work, training and competition loads) in elite handball athletes To examine whether subjective measures of perceived overall stress correlate with objectively measured levels of stress.

Determine the benefits of certain biomarkers to monitor stress, load and injury/illness occurrence in athletes.

The current structure and organizational initiatives do not meet the needs of athletes as they face different challenges throughout their careers. There is a need for better health surveillance, load monitoring and support services with a focus on injury/illnesses prevention and rehabilitation. The main goal of the research is to determine how specific loads affect the occurrence of injuries and illnesses in elite handball players and how much of the total load an athlete can withstand before an injury/illness occurs. Thus, the study will attempt to identify athletes at risk of injury/illness by monitoring their workload with subjective (perceived stress) and objective (biomarkers, hours of workload) measurements. One of the goals is also to determine the correlation between objective measures of stress (biomarkers) and subjective measures of stress (athlete's stress assessment). The results will not only be important for the medical and sports community for development of new injury prevention and rehabilitation strategies, but also for structuring the correct policy recommendations for athletes' general health. The research will be carried out on approx. 250 elite handball players (the entire 1st men's handball league) during one handball season. In addition to other parameters (monitoring of load, injuries and illnesses), blood samples will be taken from athletes at five time points according to their training cycle.

Eligibility Criteria:
Inclusion Criteria:

* At least national-level handball players above 18 years of age, who are in a dual-career setting.
* Handball players older than 18 years old, who are competing at least at national level and are not in a dual-career setting will be matched by their demographic characteristics and included in the control group.

Exclusion Criteria:

* Not fulfilling inclusion critieria
RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs

The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.

This is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. In this study, the investigators propose to randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively. The primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based RSA. Secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
* Between the ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery
Coil Positioning in Navigated Transcranial Magnetic Stimulation Feasibility in Depression Patients Trial

The objective of this study is to evaluate the feasibility of adding a navigational system to traditional repetitive Transcranial Magnetic Stimulation (rTMS, referred to in this application as nTMS) as a way to establish and maintain precise coil positioning (contact, rotation, and tilt) and consistent brain region targeting throughout a nTMS treatment session and in subsequent nTMS sessions.

Objective: The objective of this study is to evaluate the feasibility of adding a navigational system to traditional repetitive Transcranial Magnetic Stimulation (rTMS, referred to in this application as nTMS) as a way to establish and maintain precise coil positioning (contact, rotation, and tilt) and consistent brain region targeting throughout a nTMS treatment session and in subsequent nTMS sessions. Success will be evaluated via data analysis of information captured during nTMS, which will evaluate coordinates, contact, rotation, and tilt parameters of the stimulation pulses delivered. The study will be conducted with patients who have been selected as traditional rTMS candidates and have met the criteria for rTMS, which includes, but is not limited to the following: Adults with Major Depressive Disorder (MDD) who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. For the purposes of this study, nTMS is referring to the use of a navigation device in combination with delivery of traditional rTMS.

Aim 1: Determine the percentage of successful nTMS treatment sessions. A successful nTMS treatment session is defined as the following: 80% of the TMS pulse trains are delivered while the coil is within acceptance criteria measured by tracking the following parameters: coil deviations from digitally saved target location, which includes contact (mm), rotation (°), and tilt (°) parameters. The acceptance criteria are met with coil position at the time of pulse delivery as follows: coil rotation within ±15° of target; coil tilt within ±15° of target; in-plane deviation within ±5mm of target; contact deviation within ±2mm of target.

Aim 2: Determine Patient Health Questionnaire (PHQ-9) change measured weekly from baseline to after 30 sessions of nTMS, collect Patient comfort data, measure Operator confidence and collect coil position data for nTMS sessions to determine future product improvements and clinical studies.

The goal of this proposal is to establish nTMS as a means of precise administration of transcranial magnetic stimulation. Ultimately, data from this study will be used to design larger, comparative studies to establish superior efficacy profiles in the treatment of MDD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of medication-resistant MDD,
* Age 18 years or older
* Normal findings in the medical history, physical, and neurological examination

Exclusion Criteria:

* History of seizure disorder
* History of neuroleptic medications/prior use of neuroleptics
* Presence of implanted medical pump, metal plate, or metal object in skull or eye
* Pregnant women
An Exploratory Study of a Wearable Robotic Hand Orthosis

Upper limb deficits usually remain in 75% of the stroke survivors despite completing full rehabilitation. This is due to lack of effectiveness of rehabilitation and the degree of support and resources available.

In this study, the investigators plan to study the use of assistive technologies in chronic stroke survivors.

Assistive technologies have shown promising results in immediate improvement in functional abilities.

RELab tenoexo is a fully wearable and portable robotic hand orthoses (RHO) used for functional training. Its design support end users with functional hand opening and closing and can be applied in therapy exercises or during functional activities. While prior research demonstrated its effectiveness for spinal cord injury, it hasn't been tailored for multi-ethnic stroke populations.

This study aims to determine the feasibility and extent to which the RELab tenoexo can complement therapy training in clinic and further be used as both a training and assistive device in the home environment. In addition, it also aims to investigate the amount of upper limb usage before, during and after the training period.

Eligibility Criteria:
Inclusion Criteria:

* Patient with first ever clinical stroke (ischaemic or haemorrhagic) with hemiplegic motor deficit(s) due to stroke as diagnosed by CT or MRI.
* Post stroke of at least 6 months with stable neurological status.
* Age 21 to 80 years of age.
* Hemiplegic pattern and shoulder abduction MRC motor power \> 2/5 and elbow extension \>2/5
* Has a stable home abode and a carer/NOK to assist with donning of device and supervise home based exercise
* MOCA \> or equal to 22/30
* Able to give and sign informed consent at research site.
* Able to speak English

Exclusion Criteria:

* Non-stroke related causes of arm motor impairment.
* Has unstable or terminal medical conditions which may affect participation (e.g.: unresolved sepsis, postural hypotension, end stage renal failure, cancer, retroviral disease, on immunosuppressive therapy) or anticipated life expectancy of \<1 year due to malignancy or neurodegenerative disorder.
* Local factors which may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain Pain Scale \>5/10, active/non-united fractures or arthritis or fixed joint/tissue flexion contractures of shoulder, elbow, wrist or fingers incompatible with tenoexo interface.
* Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation.
* Experiencing moderate to severe levels of pain (Numerical Vertical Pain Scale \> 5).
* Is pregnant or breast feeding. Neither the tenoexo nor the IMUs have been tested to evaluate the usage with pregnant and/or breast feeding mothers. Further, due to the length of the study, pregnancy may make it difficult to follow the study schedule.
* Have a pacemaker. Magnets are used throughout the system.
PK/PD of Caspofungin in Children Severe Infection

Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. There is little metabolism of caspofungin through the kidney and continuous renal replacement therapy and renal function have little influence on the pharmacokinetics of caspofungin. The study aim to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.

The current international recommended dose of caspofungin is 70 mg per square metre for load for children who is older than three months of age, followed by 50 mg per square metre for maintenance. For newborns and infants younger than 3 months of age，25 mg per square metre is also recommended.

Whether such a recommended dose can achieve an ideal PK/PD target in children with liver insufficiency, hypoproteinemia, ECMO treatment, or severe infection is still lacking in sufficient clinical data.

The objective of this study is to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.

Blood sampling time points of caspofungin are listed as follow:

Before administration (0 min); 1 h, 2 h, 4 h, 8 h , 12 h and 24 h after administration.

The concentration of caspofungin in whole blood will be analyzed at Huashan Hospital of Fudan University.

Eligibility Criteria:
Inclusion Criteria:

* Children receiving caspofungin in pediatric intensive care unit

Exclusion Criteria:

* No Informed Consent signed Participate in other clinical trials
Social Feedback and Dysfunctional Risk Taking in NSSI Adolescents

Nonsuicidal self-injury (NSSI) is defined as direct, intentional physical injury without suicidal intention. Problematic interpersonal relationships and decision-making have been demonstrated to play crucial roles in this maladaptive behavior, especially for adolescents. Accumulating evidence suggests that decision processes and risk-taking are strongly influenced by the affective state of the individual. However, whether these interactions are disrupted in NSSI adolescents has not been systematically examined. In the current study, the investigators modified one of the most widely used paradigms for measuring an individual's risk decision-making, the Balloon Analogue Risk Task (BART). The investigators combine social reward (green balloon), punishment (red balloon), and control feedback (yellow balloon), to investigate whether the NSSI adolescents have dysfunctional risk-taking behavior while facing different social outcomes. The investigators recruit one group of NSSI adolescents (n = 40) and one health control (HC) group (n = 40), to compare their risk-related decisions during the emotional BART. The investigators hypothesize that compared to HC, NSSI adolescents will show altered effects of social reward and punishment on risk-related decision-making, in particular higher risk avoidance in the context of social punishment.


Eligibility Criteria:
Inclusion Criteria:

* 15-18 years
* right-handed
* normal or corrected normal visual acuity
* meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)

Exclusion Criteria:

* diagnosis of borderline personality disorder, major depressive disorder, other
* psychiatric disorders, etc.
* high suicidal risk
* recent use of medications that can affect neural activity
* have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
* have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)
The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease

A prospective, single-blind, parallel-group, randomised trial was conducted in Sao Paulo, Brazil. Thrid eight People with Parkinson's Disease were recruited and randomly allocated in two groups: Experimental Group (EG), that performed the balance and gait training based on games from Microsoft Xbox Kinect System ® (MXKS) supported by manual and verbal guidance (MVG) provided by a PT and a control group (CG) that performed an identical training with no MVG during the training.

It were recruited PPD in the "Brazil Parkinson Association" (BPA), a no-government association of PD care, where the assessments and intervention were performed from December 2017 to June 2018. The PPD were recruited by randomization from the BPA list of active patients and waiting list for PT intervention.

Outcome measures were obtained at up to three time points: before intervention, after 1 week and after 8 weeks of the end of intervention, the last time point was considered as a follow-up assessment. This study is in agreement with CONSORT guidelines for developing randomised trials . Primary measures was the functional balance evaluation by the Balance Evaluation Systems Test (BESTest) and Rapid Turn Test (RT Test), and gait performance assessed in the six-minute walk test and Gait test in 30 seconds. As secondary measures were used: Unified Parkinson's Disease Rate Scale (UPDRS), 5-Step Standing Passing Test (ST-DP5), International Falls Efficiency Scale (FES-I), Brazilian Version of the Freezing Scale March (FOGQ), Parkinson's Disease Quality of Life Questionnaire (PDQ-39), Geriatric Depression Scale (GDS-15).

All patients performed 8 individual training sessions, under the supervision of a physiotherapist, twice a week for four weeks. Each session had 10 minutes of identical global exercises for both groups, consisting of stretching, muscle strengthening and axial mobility exercises, one serie per session. After these initial 10 minutes, both groups performed an additional 40 minutes of balance training using four XBOX games, four per session, under different conditions for MVG and NMVG.

While the Control Group will be trained by conventional Physical Therapy exercises.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London criteria
* Active treatment with levodopa
* Classification in stages 1, 2 and 3 according to Hoehn and Yahr Classification

Exclusion Criteria:

* Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment
* Severe respiratory and / or cardiovascular conditions
* Visual and / or auditory deficit that can not be corrected with orthotics;
* Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance;
* Previous experience with Microsoft XBOX Kinect® games;
* Be in rehab at another location concomitant with study training.
Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System

Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.

The purpose of this study is to assess the kinetics of antibodies against SARS-CoV-2 as well as the kinetics of the immune system's cell subpopulations and cytokines associated with the immune system in healthy volunteers receiving the BNT162b2 vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies or any other vaccine authorized and administered by the Ministry of Health. Immunoassays will be performed at serum collection points before and after vaccination, as set out in this study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine
* Age ≥ 18 years old

Exclusion Criteria:

* Serious allergy problems i.e. hospitalization due to a serious allergic reaction (anaphylaxis)
Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

There have been no published studies to date on the effects of backwards walking in persons with MS. Thus it is important that the investigators explore different methods for treatment to help improve balance and gait and prevent injury in persons with MS with gait disturbances and balance impairments.The overall goal of this research is to collect pilot data on the effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait and balance assessments in persons with Multiple Sclerosis compared to forward walking.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of MS
* Cognitively able to understand directions and complete protocol (score of 22 or greater on MMSE)
* Signed Consent form approved by the Saint Francis Institutional Review Board
* 18-65 years of age
* PDDS score of 3 to 5 during the past 12 months
* Completion of the 6 minute walk test
* Speaks English (in order to safely complete intervention)

Exclusion Criteria:

* Unwilling or unable to complete assessments and intervention
* Current participation in physical therapy
* Major changes in exercise habits in the past three months
* Has had a relapse, acute Solumedrol treatment, or Acthar treatment in the past two months
* Requires constant bilateral assistance (canes or crutches) for ambulation and/or cannot walk at least 100 meters without resting
* Current self-reported medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of DVT, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes \[11\]
* Participants that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the Principal Investigator
SARS-COV-2 Detection From Used Surgical Mask

The real-time reverse transcription-polymerase chain reaction (RT-PCR) test is regarded as the gold standard for SARS-CoV-2 detection. Proper specimen collection and obtaining a sufficient sample are the most important steps for laboratory diagnosis. The nasopharyngeal (NP) swab is recommended as the reference collection method. However, NP swab collection is invasive and uncomfortable for patients and poses some risk to healthcare workers. This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with the NP swab method using RT-PCR testing

Proper specimen collection and obtaining sufficient samples are the most important steps for laboratory diagnosis of an infectious disease. Improper collection may lead to false or inconclusive test results. During the early stages of the COVID-19 outbreak, the Center for Disease Prevention and Control recommended collecting and testing an upper respiratory specimen \[4\]. Nasopharyngeal (NP) and oropharyngeal (OP) swabs are the preferred choice for initial SARS-CoV-2 diagnostic testing.

This study aimed to compare the efficacy of SARS-CoV-2 RNA detection from used surgical masks with standard detection methods. We tested for SARS-CoV-2 RNA in masks from patients with COVID-19 that had been worn for eight hours and compared this with NP swabs using RT-PCR testing. Hospitalized patients with laboratory-confirmed COVID-19 were recruited to provide surgical masks. Collection of used surgical mask samples by patients themselves is easy, convenient, requires no sampling equipment and decreases the risk of healthcare personnel exposure to COVID-19. If SARS-CoV-2 RNA can be detected on used surgical mask samples, this may encourage patients to provide specimens for testing and help in early detection and transmission prevention. As an alternative method to NP swabs, it may facilitate timely diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Newly confirmed SARS-CoV-2 positive cases admitted to a field hospital within 48 hours or outpatient with a positive result for SARS-CoV-2
* Should be able to wear a mask for 8 h according to the protocol

Exclusion Criteria:

* require oxygen intubation or any breathing support devices