cyrilzakka/clinical-trials huggingface dataset:
Blood Biomarkers for the Management of Concussion in Professional Rugby Players

In the past 20 years, the incidence of concussion in direct contact sports has significantly increased. The incidence of concussion in rugby players ranges between 8 to 17 episodes / 1000 playing hours. A recent study published by the French Rugby Federation (FFR) and the National Rugby League (LNR) showed similar results. The latter study was performed analyzing the French "TOP14", which includes 14 teams participating in professional rugby championships. At least two concussions were diagnosed each week. Despite the recent evidence, cognitive assessment remains the only means to determine whether or not players experiencing concussions can return to the game or not.

The possible evolution of neuro-vascular damage and its biological consequences are currently overlooked. The Head Injury Assessment (HIA) is the current gold standard used by the national Rugby Medical Authorities in accordance with international safety protocols. The HIA protocol relies on neurological or neuropsychological endpoints, potentially subjective or not ensuring sufficient sensitivity. As a result, defining the immediate and long-term pathophysiological consequences of concussions remains challenging. The introduction of an objective blood test to detect the presence and the evolution overtime of neuro-vascular damage could represent a pairing approach filling a sensitive gap in the management of concussed players. Recent evidence has proposed the use of serum biomarkers aiding post-concussion management . Remarkably, serum biomarkers of neuro-vascular functions are currently being used in emergency room settings. Serum levels of the brain protein S100β were demonstrated to have an excellent negative predictive value for neurovascular damage after mild traumatic brain injury (mTBI). Measurement of blood S100β was proposed as a tool to grade TBI, limiting unnecessary CT scan examinations in emergency cases . However, whether the use of serum makers of neuro-vascular damage could benefit the management of sport-related concussion remains unclear. Moreover, repeated concussions have been linked to an increased risk of Alzheimer's disease, Multiple Sclerosis and Parkinson's disease . Serum biomarkers could be of diagnostic and prognostic value, facilitating return to play decisions or predicting lingering risks of cognitive decline.

Eligibility Criteria:
Inclusion Criteria:

* Players age \> 18 years old.
* Players routinely managed by the medical staff of collaborative rugby teams. Availability of clinical data, age, body mass index, brain performance, previous HIA scores, history of concussions.
* Players must agree with all of the aspects of the research. Players must consent for a baseline blood draw before the season starts and follow up sampling after concussions

Exclusion Criteria:

* Adverse players' life style (e.g., alcohol consumption, medications or chronic drug regimens) or pathological conditions associated with abnormal S100β levels (e.g., S100 genetic variants, cutaneous infections, brain tumor, auto-immune disorders, or hyper-lymphocytosis).
Incidence of Various Types of Systemic Reactions Related to Spinal Steroid Injection: A Prospective Study

Many systemic reactions occur commonly after spinal steroid injections, especially in patients, and may be associated with underlying disease, such as hypertension and diabetes mellitus, as well as steroid dose and repetition of spinal steroid injection.

Evaluate the incidence and types of systemic reactions after spinal steroid injections and to investigate the association of spinal steroid injection with patient demographics, history of previous injections, type and dose of steroid, and method and site of previous and current injections.

Eligibility Criteria:
Inclusion Criteria:

* Indicaion of steroid injction.

Exclusion Criteria:

* Contraindiation of steroid injction.
Minimal Invasive Versus Traditional Transgluteal Approach in Total Hip Arthroplasty: a Comparative Gait Analysis

The hypothesis for the present study was that patients receiving a minimally invasive total hip arthroplasty will show a faster improvement on walking ability and mobilization in the immediate postoperative period compared to patients with the standard Hardinge approach. Therefore, the main goal was to evaluate the differences in early rehabilitation of these two different surgical approaches by gait analysis and electromyographical examination as objective methods.


Eligibility Criteria:
Inclusion Criteria:

* unilateral osteoarthritis of the hip
* BMI below 30

Exclusion Criteria:

* previous surgery on the evaluated hip,
* previous arthroplasties on other joints,
* a leg length discrepancy of more than 0.5cm,
* rheumatoid osteoarthritis
* decreased mobility due to non joint related factors
Dexmedetomidine vs. Ketorolac/ Midazolam for Retinal Surgery

To evaluate and compare the effect of administration of intravenous ketorolac- midazolam or dexmedetomidine as adjuvants to general anesthesia on perioperative outcome during retinal surgery.

regarding patient registry; G power analysis was done was done to estimate the sample size. Assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 18 patients per group would be sufficient to detect a difference 20 % in hemodynamics indices among the groups. A drop out 10% of cases was expected therefore 20 patients were required in each group to detect the difference.

- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Kolmogorov-Smirnov test. Data is presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, one way ANOVA test will be used to compare between mean values of three groups with post hoc Bonferroni test for paired comparisons. Repeated measures ANOVA with post hock Bonferroni will be used for intra-groupal comparisons. For non-parametric data, Kruskal Wallis H test to compare between median values of 3 groups with Mann Whitney U test for paired comparisons. Chi Square test will be used for testing significance of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status \|or \|\|

Exclusion Criteria:

* Mental disorders.
* Psychological disorders.
* Neurological disorders.
* Hyper reactive airway disease.
* History of sleep apnoea.
* Severe cardiovascular disease.
* Respiratory disease.
* Hepatic disease.
* Renal impairment.
* Known sensitivity to any of study drugs.
* History of alcohol.
* History of drug abuse.
* Morbid obesity (body mass index \>35).
* Pregnancy.
* Lactating women.
* Patient refusal.
Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes

The purpose of this randomized control trial will be to determine whether the duration of bridge plate fixation of distal radius fractures can be reduced to 6-8 weeks without worsening of functional outcomes relative to the current standard of greater than 12 weeks of fixation. The secondary aim of the study is to determine whether a reduced duration of bridge plate fixation leads to an increase in wrist range of motion following plate removal compared to the standard duration of fixation. 100 patients with comminuted distal radius fractures that are indicated for bridge plate fixation will be randomized to the Accelerated Removal arm (n = 50) or the Standard Removal arm (n = 50).


Eligibility Criteria:
Inclusion Criteria:

1. Fracture of the distal radius indicated for operative treatment using bridge plate fixation
2. Age 18 years or greater
3. Capacity to provide informed consent

Exclusion Criteria:

1. Bridge plate fixation in the setting of revision surgery for prior nonunion or malunion
2. Bilateral distal radius fractures (prevents accurate measurement of postoperative range of motion and strength of the injured extremity without a normal contralateral extremity for comparison)
3. Pathologic fractures
4. Patients that will be unable to complete the necessary follow up, including incarcerated patients
Development of a Celiac Safe Food Additive

The goal of this clinical trial was to investigate if intestinal deamidation of gliadin from wheat bread could be hindered by adding a E304i/zinc additive. The study was a randomized double-blind 4-week crossover intervention in 20 healthy volunteers in which the participants ingested 2 bread rolls a day during the intervention weeks.

The question it aimed to answer was if there was a difference in blood levels of deamidated gliadin peptides after ingestion of the reference wheat bread compared with the wheat bread containing the food additive.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Body mass index between 18.5 to 32
* Age between 18-50 years
* No tobacco use

Exclusion Criteria:

* Celiac disease and other diagnosed enteropathies
* Gluten-free diet
* Dietary supplementation (minerals (calcium, zinc, vitamin D) and proteolytic enzymes, probiotics)
* Pregnancy or lactation
* Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or the project PI.
* Withdrawn consent: Participant withdraws consent.
* Non-compliance: Participant fails repeatedly to comply with study protocol (diet, study visits and provide samples)
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis

Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.


Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed AD
* almost clear to mild AD (local IGA \[target lesions face and cubital areas\] score of 1-3)
* clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use
* Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas

Exclusion Criteria:

* Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry
* Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry
* Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation
The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults

This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in combination in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female 18 to 50 years of age, inclusive.
* The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
* The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at screening.
* The subject agrees to comply with all protocol requirements.
* The subject is able to provide written informed consent.

Exclusion Criteria:

* The subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator.
* The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
* The subject has an estimated glomerular filtration rate (eGFR) of \<90 (mL/min)/1.73 m2.
* The subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol \[up to 2 g per day\]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study.
* The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study.
* The subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
* The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake \>21 units per week for male subjects and \>14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint \[200 mL\] of beer, 1 small glass \[100 mL\] of wine, or 1 measure \[25 mL\] of spirits).
* The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Adult males able to provide consent and complete a survey in English
* Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain
* Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained
* Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

Exclusion Criteria:

* Previous participation in this study
ATAC - Quality of Life Sub-Protocol

To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for entry into the main ATAC trial 1033IL/0029
* Completion of a baseline questionnaire

Exclusion Criteria:

* Excluded from entry into the main ATAC trial (1033IL/0029)
* If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons
Cognitive Decline in Non-demented PD

The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD).

Cognitive dysfunction can occur in early stage of Parkinson's disease (PD) and increases as PD progresses. Attention deficits in PD patients with dementia strongly predict the impairment of their daily living activities.

Previous studies have shown that atomoxetine improves PD executive dysfunction and rivastigmine improves attention deficits in PD patients with dementia without worsening the motor symptoms.

The aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in PD patients without disabling cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease
* Respond to levodopa therapy

Exclusion Criteria:

* Dementia
* Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD
* Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization
* Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);
* Currently using any of the study drugs;
* Colorblindness
Perceptions of Passive Heating in Individuals With T2DM

Current treatments for type 2 diabetes (e.g., lifestyle changes and clinical interventions such as medication), have been shown to be unsustainable due to low levels of physical activity and increasing clinical costs. Therefore, scientists have been looking for new treatments to address this issue. One such treatment that is being investigated is passive heating (e.g., hot baths, saunas, etc.). In this study the investigators want to ascertain what passive heating, if any, individuals with T2DM currently do, what their perceptions of passive heating would be if it were to become a treatment, what may make it easier or more difficult for them to engage in passive heating, and how this might impact other areas of their life such as physical activity.

This study employs an interpretivist approach through semi-structured interviews to highlight participants' perceptions of and experiences with passive heating. To date, this topic has not been explored in-depth - this approach should bring nuance and context to light, aiding in future advocacy work which explores the potential of passive heating as a viable treatment for adults with T2DM.

Semi-structured interviews will be facilitated by an interview guide consisting of four main topic areas aiming to explore an individual's perception of and experience with passive heating as a treatment for T2DM and to ascertain whether engaging in this behaviour may affect physical activity. As no two conversations are ever the same, the approach to the interviews is one of flexibility through the use of open-ended questions and potential probes as the situation dictates - remaining open to following particular lines of participant thought.

Interviews will all be conducted by the Principal investigator, Mr Thomas James, a doctoral researcher who has been trained in the required skills. He has also undertaken necessary training in Good Clinical Practice and Valid Informed Consent. Interviews will be conducted virtually, by telephone or in person and will take place either at home or in a laboratory setting, dependent upon the individual's wishes. The interviews will be audio recorded and subsequently transcribed verbatim by a member of the research team. Transcriptions will be analysed via thematic analysis to determine the main themes expressed by participants. All data analysis will be conducted by a trained member of the research team.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Willing and able to undertake the interview process
* Able to give informed consent

Exclusion Criteria:

* Age \< 18 years
* Does not provide written informed consent
* Any neurological/psychiatric diagnoses
* Lack of fluency in English
Drug-drug Interaction Study (CKD-501, Ketoconazole)

The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.

From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1. After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not Ketoconazole administered.

Group 2 is administered in reverse order.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 45 years old in healthy males
* 18.5 ≤ IBW \< 25
* Agreement with written informed consent

Exclusion Criteria:

* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
* Medication with drug-mediated induction/inhibition metabolic enzyme such as Midazolam within 1 month or with may affect the clinical trial
* Subject has taken abnormal meals which affects the ADME of drug
* Subject has a history(such as gastric or duodenal ulcer, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
* Substance abuse, or a history of drug abuse showed a positive for the party
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* Previously participated in other trial within 60 days
* Previously donate whole blood within 60 days or component blood within 30 days
* Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
* SBP \>140 mmHg, SBP \< 90 mmHg or DBP \> 90 mmHg, DBP \< 50 mmHg or Pulse \> 100 per/min, Pulse \< 50 per/min
* 12-lead ECG, QTc \> 450 msec
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Women Abuse and the Role of the Family Doctor.

The study tested a training to improve recognition of abused female patients in family practice.Effect measures of the training were: number of reported cases wherein the doctor suspected and discussed partner abuse and the number of non-obviuos reasons to suspect partner abuse.We assumed that following a training would improve the recognition of abused women.

Secondary to this trial we explored gender differences of family doctors in discussing partner abuse and we interviewed women recently identified by their family doctor. Medical histories of recently identified abused women were studied to assess health problems and health-care utilisation.


Eligibility Criteria:
Inclusion Criteria:women consulting in family practice, age 18 years and older -

Exclusion Criteria:we excluded only for the interviews: women who were assessed by their family doctor to be in danger because of the abusive situation, women with a psychiatric condition.

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