cyrilzakka/clinical-trials huggingface dataset:
The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes

The goal of this clinical trial is to compare the effects of acute aerobic exercise at two different intensities on psychological measures, symptomology, and time to symptom free in collegiate student athletes with concussion. The main questions it aims to answer are:

* Does prescribed, acute aerobic exercise influence measures of pain related fear, anxiety, depression, symptoms, and recovery time?
* Does the intensity of the exercise prescription also influence the aforementioned outcomes?

Participants will be randomly assigned into either a light intensity or moderate intensity aerobic exercise (treadmill walking) group. They will initiate the exercise protocol 48 hours following their concussion diagnosis, and complete exercise sessions 5 times per week until they report symptom-free. Researchers will compare the light intensity group to the moderate intensity group to see if intensity of exercise influences psychological measures of pain related fear, anxiety, depression, symptomology, and time to symptom-free.


Eligibility Criteria:
Inclusion Criteria:

* Collegiate athlete (varsity)
* Symptomatic at time of exercise prescription

Exclusion Criteria:

* If advanced neuroimaging was performed, any subject with a structural abnormality will be excluded
* History of traumatic brain injury requiring hospitalization
* Not cleared to play their sport by a physician due to some other injury such as an ankle sprain or muscle strain
* If individual is diagnosed with any condition that is a contraindication to aerobic exercise. Please note that all participants will have already been cleared to participate in their respective collegiate sport after extensive pre-participation physical examinations upon entering the university.
Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome

Mannose-binding lectin (MBL) plays an important role in the innate immune response. In addition to activating the complement, MBL can induce cytokine production and contribute to a deleterious inflammatory response with severe A(H1N1)pdm09 virus infection. The aim was to determine if serum MBL levels correlate with the risk of mortality in intensive care units (ICU) patients with A(H1N1)pdm09 infection.

Prospective observational study was performed in ICU patients with acute respiratory distress syndrome due to influenza A(H1N1)pdm09 virus. Demographic characteristics and severity indices were recorded at ICU admission. MBL was assayed from blood drawn at influenza diagnosis within 24-48 h following the ICU admission. Outcomes were compared according to MBL levels.

Mannose-binding lectin (MBL) plays an important role in the innate immune response. In addition to activating the complement, MBL can induce cytokine production and contribute to a deleterious inflammatory response with severe A(H1N1)pdm09 virus infection. The aim was to determine if serum MBL levels correlate with the risk of mortality in intensive care units (ICU) patients with A(H1N1)pdm09 infection.

Prospective observational study was performed in ICU patients with acute respiratory distress syndrome due to influenza A(H1N1)pdm09 virus. Demographic and clinical data at admission and during the ICU stay were recorded from the medical files of each patient and collected in a database to evaluate variables potentially associated with in-hospital mortality. Data baselines were recorded at admission. Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) requirements, and the use of vasopressor drugs were noted during ICU stay. To determine illness severity, SAPSII and SOFA scoring systems were applied to all patients within 24 h of ICU admission.Demographic characteristics and severity indices were recorded at ICU admission. MBL was assayed from blood drawn at influenza diagnosis within 24-48 h following the ICU admission. Outcomes were compared according to MBL levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients who developed moderate-to-severe ARDS defined by the presence of bilateral alveolar images, a PaO2 / FiO2 ratio \<200 mmHg and the absence of an obvious cardiac cause, with or without the need for mechanical respiratory support extracorporeal circulation or decarboxylation.
* Patient benefiting from nitric oxide.
* Patient requiring continuous curarization.

Exclusion Criteria:

* Chronic renal insufficiency dialysis.
* Severe hepatic insufficiency.
* Patient under guardianship or curatorship or deprived of liberty.
* "light" ARDS
Value of Platelet-Rich Plasma in Post Severe Acute Respiratory Syndrome Coronavirus 2

The study will be conducted to evaluate :

The efficacy of Platelet Rich plasma in treatment of smell disorders post severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via the growth factors involved in accelerating and enhancing healing.

Smell is essential sensory function for good quality of life as its preservation helps in identifying several harmful odors .

Viral URTIs can lead to olfactory disorders of varying degree and duration 70% of URTI caused by rhinovirus, adenovirus ,influenza and parainfluanza virus Smell disorders are divided into two types Quantitative (anosmia and hyposmia) Qualitative (parosmia and phantosmia) Anosmia is a total loss of smell . hyposmia is a decrease in the sense of smell. parosmia is a distortion of the smell in presence of an existing stimulus . Phantosmia (Cacosmia) is distortion of the smell in absence of an existing stimulus severe acute respiratory syndrome coronavirus2 (SARS-coV-2)which is a global pandemic started in china 2019 one of respiratory tract infection that affect olfaction and cause varying types of smell impairment.

Smell disorders seem to be more common in SARS-coV2 than other respiratory infections as in some patient persist for long time after resolution of respiratory symptoms Current evidence suggest that olfactory impairment results from propensity of SARS-coV2 for neuroinvasion and neurotrophic activities .

Majority of patients experience some level of smell impairment most often temporary as olfactory neuroepithelium has regenerative power .

European study published on 16 July 2020 reported that some patient affected by SARS -coV2 come solely with olfactory symptoms and most of patient recovered within 2 weeks ,smell not recovered in one quarter of patient 15 Once olfactory dysfunction persists more than 2 weeks a therapy should be considered to avoid persistent impairment of smell One of therapies can be used in ttt of smell disorders ( Platelet _rich plasma) PRP is a process in which a small amount of blood from test subject is separated by special centrifugation process.

PRP contains many growth factor which have a neuroregenerative feature as well as therapeutic effect

Eligibility Criteria:
Inclusion Criteria:

1. patient age above 18 who suffer from anosmia post severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 more than two weeks
2. Normal airway passage
3. CT Nose and Para nasal sinuses does not show any nasal lesion

Exclusion Criteria:

1. Lesions obstruct airway as nasal polyps, tumors, chronic sinusitis and severe nasal septum deviation
2. Previous Sino nasal surgery
3. Atrophic rhinitis
4. Diabetic patients and those with medical history of bleeding disorders
5. Recieving any medication affect platelets or bone marrow function for 2 weeks prior to testing
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for enrollment, the subject must:

* Be female, greater or equal to 18 years of age
* Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant
* Have previously had or be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
* Be in good health other than breast pathology and be suited to general anesthesia and planned treatments.

Exclusion Criteria:

The subject must not:

* Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study
* Have a known allergy to silk
* Have collagen-vascular, connective disease, or bleeding disorders
* Have a Body Mass Index (BMI) that is greater than or equal to 35
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
* Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer
* Have smoked within the last 12 months
* Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
* Be pregnant, lactating, or expecting to be within the next 24 months
* Have concomitant unrelated condition of breast/chest wall/skin
* Have an abscess or infection at the time of surgery
* Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation
* Have had a prior soft tissue support device implanted in the breast
* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods

Intra-articular and peri-articular glucocorticoid (GC) injections are common in sports medicine. However, from 1st January 2022, all injectable GC routes (including intra-articular administration (IA)) will be prohibited in-competition by World Anti-Doping Agency (WADA). Due to these rules, an IA GC treatment out-of-competition could result in an adverse analytical finding (AAF) in-competition if the washout period is not clearly defined. The aim of this study is to determine the urinary excretion profile of triamcinolone acetonide following IA to help in the definition of the washout periods.


Eligibility Criteria:
Inclusion Criteria:

* Sports practice at least 4h / week
* No comorbidities against indicating intra-articular knee injection
* Subject with a knee disease requiring intra-articular injection of GCs

Exclusion Criteria:

* Subject with glucocorticoid (GC) allergy or GC medical contraindication
* Pregnant women or women of childbearing potential without effective contraception
* Washout period of all injectable routes and systemic use of GCs less than 3 months
Hydroxychloroquine May be Beneficial for Preeclampsia

The purpose of this research is to investigate the impact of hydroxychloroquine on the incidence of hypertensive pregnancy disorders in women with a history of recurrent spontaneous abortion (RSA).

Preeclampsia affects about 3-5% of all pregnancies and is estimated to cause at least 42 000 maternal deaths annually, remaining an important cause of death and complications for the mother and baby. However, no treatment yet has been found that affects disease progression except for termination of pregnancy which may cause iatrogenic preterm labor. Therefore, keenly sought for approaches to improving clinical outcomes in pre-eclampsia would be needed.

Hydroxychloroquine (HCQ), an antimalarial drug, is commonly used in the treatment of pregnant women with RSA and has proven to be safe for both the mother and the fetus. Because of the antioxidant effect, anti-inflammatory effect, and vasculoprotective effect of HCQ, it has been thought to be beneficial in the prevention of preeclampsia.

Therefore, we conducted a retrospective cohort study to evaluate the impact of HCQ treatment on the prevention of preeclampsia in RSA pregnancies.

Eligibility Criteria:
Inclusion Criteria:

1. singleton pregnant women
2. with a history of two or more miscarriages

Exclusion Criteria:

1. indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, malignancy,
2. major malformation of the fetus diagnosed at 11-13 weeks of gestation.
3. Known paternal, maternal, or embryo chromosome abnormality;
4. Abnormal uterine anatomy at hysterosalpingography/hysteroscopy or hydrosonography that might explain RM in the first trimester of pregnancy;
5. Maternal endocrine dysfunction: premature ovarian failure, hyperprolactinemia, corpus luteal insufficiency, untreated diabetes mellitus or untreated thyroid dysfunction.
Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Humeral Stem.

Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular Metal Humeral Stem.

Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the SF-12 as well as AEs and radiographic parameters by analysis of x-rays.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \>18 years of age;
* Patient is skeletally mature;
* Patient qualifies for primary unilateral or bilateral total or hemi shoulder arthroplasty based on physical exam and medical history including the following: Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis
* Patient is willing and able to provide written informed consent;
* Patient is willing and able to cooperate in the required post-operative therapy;
* Patient is will and able to complete scheduled follow-up evaluations/questionnaires as described in the Informed Consent;
* Patient has participated in the Informed Consent process and has signed the IRB/ERB approved informed consent;

Exclusion Criteria:

* The patient is a prisoner;
* The patient is mentally incompetent or unable to understand what participation in the study entails;
* The patient is a known alcohol or drug abuser;
* The patient is anticipated to be non-compliant;
* The patient has one of the following compromising the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
* The patient has a local/systemic infection;
* The patient is known to be pregnant;
* The patient has marked bone loss;
* The patient has a known sensitivity or allergic reaction to one or more of the implanted materials;
* The patient is unwilling or unable to give consent or to comply with the follow-up program.
Antiviral Therapy for Influenza A H1N1

The aims of this study are to characterise the clinical efficacy and virological clearance dynamics of orally administered oseltamivir in patients with influenza caused by novel influenza A(H1N1). This research will also contribute to enhancing research capacity in affected countries.

The objectives are to assess the:

* viral replication levels over time in affected patients
* antiviral efficacy of oral oseltamivir
* patterns and compartments of viral shedding, tissue distribution
* innate inflammatory response and relation to viral replication
* kinetics of antibody response
* antiviral sensitivity of influenza viruses at baseline and during oseltamivir treatment using in vitro and molecular methods
* pharmacokinetic characteristics of oseltamivir and oseltamivir carboxylate
* all cause in hospital mortality
* clinical and radiological features, disease course and outcome
* length of stay in hospital
* risk factors associated with development of severe disease and death

Any patient over 1 year of age who presents to a participating institution with confirmed influenza A and who meets the study inclusion/exclusion criteria may be approached for informed consent. Choice of antiviral is up to the study physician. Children aged 1-6 years and asthmatics should receive oseltamivir. The weight- and age-adjusted dosage used will be that approved for treatment of uncomplicated seasonal influenza, and doses will be administered twice daily for 5 days for patients with normal renal function. All patients who are clinical and/or virologic failures at day 5 will be treated for an additional 5 days of antivirals. After coming off antiviral therapy patients can be discharged at day 10 if deemed ready by study physicians and they are virologically negative.

During the course of treatment study evaluations will be performed to determine primary efficacy end points including viral clearance on Day 5 on all collected nasopharyngeal samples, assessed by RT PCR for novel H1N1 influenza AND no clinical features of clinical failure. Evaluations will also be performed to determine secondary viral, serological, clinical efficacy, safety and pharmacokinetic endpoints.

Patients will be followed up for up to 6 months after discharge for a clinical assessment, pulmonary function and outcome of pregnancy.

The protocol will be reviewed after 6 months from starting or after 100 patients with Influenza A are recruited.

Eligibility Criteria:
Inclusion Criteria:

* Adults, including pregnant and breast feeding women, and Children aged ≥ 12 months when first seen with an acute febrile respiratory tract illness (ARI) of any severity and influenza A, virologically proven on a respiratory specimen according to hospital procedure, which is suspected to be novel influenza A(H1N1)
* A positive influenza A H1 swine screening reverse transcriptase polymerase chain reaction (RT PCR) or conventional PCR assay on one respiratory specimen : NPA, NP swab, nasal wash, nasal swab and throat swab
* Underlying illnesses including HIV
* Prescribed oseltamivir prior to presentation

Exclusion Criteria:

* Lack of informed consent
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Sweden, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.

Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during normally scheduled visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit'(V1) if in line with local clinical practice
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Short Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers

Compare the effect of Xalatan with benzalkonium chloride on the ocular surface to those effects observed with Travatan Z without benzalkonium chloride after a single dose


Eligibility Criteria:
Inclusion Criteria:

* Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma

Exclusion Criteria:

* Age
Clinical Efficacy of Cooperative Parent-Mediated Therapy (C-PMT_in_ASD)

The research highlights the lack of studies assessing the effectiveness of evidence-based interventions for ASD in community services. This RCT study aims to evaluate the effectiveness of Cooperative Parent Mediated Therapy (CPMT), a parent coaching program previously shown to be effective in tertiary care settings.

Fifty participants with ASD (aged 2-10 years) and their parents were randomized into two groups: both groups received treatment as usual (TAU), but only the experimental group participated in CPMT. The primary outcomes indicated significant improvements in parent-child interaction and benefits in adaptive skills, ASD symptom severity, and parental stress levels in the CPMT group, whereas the TAU group showed no notable changes. The study suggests that the CPMT model is effective in community healthcare settings, representing a significant advancement for ASD therapy.

Eligibility Criteria:
Inclusion Criteria:

* age between 2 and 10 years;
* clinical diagnosis of ASD based on DSM-5 criteria ;
* scores above the autism spectrum cut-off on the Autism Diagnostic Observation Schedule Generic-ADOS-2 ;

Exclusion Criteria:

* 2 years \> age \< 10 years;
* not received clinical diagnosi for ASD in line with DSM-5 criteria;
* absence of other major medical diagnoses (i.e., epilepsy, genetic syndromes);
* absence of psychosocial treatment during the trial.