cyrilzakka/clinical-trials huggingface dataset:
Impact of Osteopathic Manipulative Therapy on Hip Range of Motion

One way for runners to improve their performance and remain injury free is to preserve and improve joint mobility, especially at the hips. The femoroacetabular joints are a pivotal part of the running gait allowing the athlete to fully extend their leg to generate sufficient force in each stride. Improving hip range of motion can help reduce or prevent groin pain, make the runner more comfortable while running, improve running longevity, and prevent injuries. Thus, it is clear that a runner's commitment to improving the range of motion of their hips is crucial for both the enhancement of their performance and prevention of injury. Researchers assessed how the hip, and its biomechanics, can be impacted by Osteopathic medical treatment.

The primary research question investigated is how Spencer Technique for the hip impacts femoral acetabular active range of motion (AROM) in flexion, extension, abduction, adduction, internal rotation, and external rotation in those training 4 weeks for a 5K race. This study investigated the effect that 4 weeks of twice weekly, bilateral, Spencer Technique treatment had on femoroacetabular range of motion. During this 4-week period participant exercise and stretching habits in preparation for the 5k race were recorded.


Eligibility Criteria:
Inclusion Criteria:

* All LECOM-Bradenton students will be included in recruitment.

Exclusion Criteria:

* Subjects will be excluded from this research study if they cannot sign an informed consent. Additionally, subjects will be excluded if they are:

  * Pregnant or plan to become pregnant
  * Have a past medical history including:

    * Skin disorders or open wounds precluding skin contact
    * Neurological symptoms (i.e. numbness, tingling, weakness)
    * Recent bone fracture
    * Recent lower extremity ligamentous sprain
    * Recent lower extremity muscle strain
    * Adhesive capsulitis of the hip joint
    * Osteoarthritis of the lower extremity
    * Rheumatoid arthritis
    * History of hip or knee arthroplasty
    * 1 year history of any lower extremity surgery
    * Gout
    * Iliotibial band syndrome
    * Legg-Calve-Perthes disease
    * Slipped capital femoral epiphysis
    * Hip dysplasia
    * Avascular necrosis of the hip
    * Chronic hip bursitis
    * Hip dislocation
    * Osteoporosis/osteopenia
    * Severe Femoroacetabular impingement
    * Use of heel lift due to leg length discrepancy
    * Immunosuppressive syndromes
    * Radiation or chemotherapy within the past 3 years
    * Congestive heart failure
    * Unable to complete a 5 kilometer race after the 4 weeks of training
    * Down syndrome
    * Have been told by a physician or other medical professional that you should not participate in aerobic training activities.
    * Have medication changes in the last month
    * Run 30+ miles per week regularly
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers.

Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.

As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial dysfunction.

Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.

A normal healthy sub-population will be used as a control.

Eligibility Criteria:
Inclusion Criteria:

* Burn injury must be less than 24 hours old at time of initial sampling
* Burn must be 2nd or 3rd degree and at least 10% TBSA
* ISS (injury severity score) \> 15

Exclusion Criteria:

* Burn injury/trauma injury \> than 24hours old at time of initial sampling
* Burn \< 10% total body surface area.
* Evidence of active infection on admission in the burn subjects.
* \< 19 years of age and \> 70 years
A Registered Cohort Study on α-Synucleinopathy

α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom. The data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy.

α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom, including Parkinson's disease (PD), multiple system atrophy (MSA) and dementia with lewy bodies (DLB). The data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy. Datas will be accumulated retrospectively at research entry and prospectively during follow up.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a clinical diagnosis of primary α-synucleinopathy
* Unrelated healthy controls

Exclusion Criteria:

* Patients with secondary α-synucleinopathy that cannot be excluded.
* Patients with other neurological disorders.
* Pregnant or lactating women.
Investigating Cardiac Health of Adults With Trauma

This project examines the impact of a healthy lifestyle intervention, specifically designed for adults with posttraumatic stress and identified cardiovascular risks.

Considerable research has indicated strong associations between posttraumatic stress and cardiovascular disease (CVD) risk. Individuals with posttraumatic stress disorder (PTSD) tend to show patterns of elevated CVD risk earlier in life than in the general population. The need for developing effective interventions for CVD risk-reduction in PTSD is increasingly evident. In comparison to the cumulative evidence concerning elevated CVD risk in PTSD, relatively little research has addressed CVD risk-reduction in this population. Adjunctive treatments, such as health behavior interventions, may be necessary as supplements to traditional psychotherapy for PTSD in order to reduce CVD risks. The objective of the proposed project is to examine the effects of a healthy lifestyle intervention that addresses multiple CVD-related heath behaviors among civilian adults across genders (ages 18+), who evidence PTSD and CVD risk at baseline. The investigators will assess the intervention impact on both subjective and objective indices of health behaviors, cardiovascular risks and CVD markers over a one-year timeframe. The healthy lifestyle intervention addresses unique aspects of PTSD symptom presentation that serve as barriers to healthy behaviors (e.g., nightmares/sleep disruption, and cognitive responses to stress), while encouraging healthy lifestyle changes. The primary goal of the present study is to examine whether, compared to a usual care psychotherapy control condition, utilizing the healthy lifestyle intervention as an adjunct to psychotherapy will result in significantly reduced CVD risks and improved CVD markers among civilian adults with PTSD and elevated CVD risks. Therefore, participants will be randomly assigned to either a usual care psychotherapy-only control condition or a usual care psychotherapy plus healthy lifestyle intervention condition. Outcomes will be assessed at post-intervention (12 weeks), as well as 6-month and 12-month time points for follow-up evaluation.

Eligibility Criteria:
Inclusion Criteria:

* PTSD symptoms
* overweight OR less than 30 min. of moderate physical activity 5 times per week

Exclusion Criteria:

* cannot exercise at a low-moderate level (walking)
Short- and Medium-term Results of New Generation Aortic

Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.


Eligibility Criteria:
Inclusion Criteria:

* Retrospectively included all patients examined since 2010.
* Patients who have aortic valve surgery from the Cardiac Surgery Department of the University Hospital of Amiens.

Exclusion Criteria:

* Refusal to participate in the patient.
* Patients who have previously had aortic valve surgery.
Pharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male Subjects

The purpose of this study is to determine how the human body processes and eliminates the drug (BMS-690514.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Body mass index (BMS) of 18 - 30 kg/m², inclusive

Exclusion Criteria:

* Radiation exposure from diagnostic X-rays (except dental X-rays) in the last year or from clinical trials in the last 5 years
AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.

The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to identify cancer neoantigens, which are likely to elicit an immune response.

A key challenge to be solved using the technology is to predict for each patient which neoepitopes are not only likely to bind to HLA or be presented on the tumor cell surface, but also will be recognized by the T-cell receptor and create the immunogenic response. The presence of such epitopes is required for immunotherapy by immune checkpoint inhibition to have an effect on the disease. Knowledge of those epitopes enables therapeutic strategies to boost the immune response by designing personalized cancer vaccines and adoptive cell therapies.

The samples and data collected in this clinical study will be used for clinical validation of A.I.mmune technology. For all patients treated with immunotherapy (using anti-PD1 / anti-PDL1 and / or anti-CTLA-4 antibodies) peripheral blood samples (PBMC) and biopsy (FFPE) collection will be performed before treatment. Samples will be sequenced by next-generation sequencing platform. In parallel, the investigators will also collect samples of stool (one sample before the start of immunotherapy) and follow-up information of responses to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥18 years of age.
* Patients with non-small cell lung cancer.
* Patients with informed consent to participate in the study.
* Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
* The applied immunotherapy should be the first or second line of treatment.

Exclusion Criteria:

* Patients who are unable to understand, read and / or sign informed consent.
* Patients who can not collect stools.
* Patients with fecal transplant.
* The applied immunotherapy is not the first or second line of treatment.
Characteristics of Neonatal Covid-19 in Turkey

The investigators aimed to investigate the clinical and epidemiological characteristics of neonates who will be born to Covid-19 positive mothers in Turkey. It is a multicentric prospective cohort study designed and destined only in Turkey. The investigators are planning to admit more than 20 Neonatal Intensive Care Units into the survey; nevertheless, the total number may change according to the prevalence of Covid-19 in neonates.

The investigators will also inquire into vertical transmission by collecting cord blood, placental, and postnatal serum samples to test for Covid-19 PCR and Covid-19 Ig M and IgG values from the neonates.

The patients will be recruited by a secure database of "Trials Network" with individualized accounts. Plexus Corporation will hold data monitoring and primary analysis.

Eligibility Criteria:
Inclusion Criteria:

* Infants born to mothers with Covid-19 infection

Exclusion Criteria:

* If PCR values of mother negative, even though the clinic is preferable for Covid-19, the infant will not be recruited.
Flow Patterns and Stent Thrombosis

The goal of this observational study is to study the effect of haemodynamic forces on thrombus formation and identify haemodynamic markers that predict stent thrombosis events in patients who have undergone OCT-guided percutaneous coronary interventions.

The primary objective of the study is to examine the efficacy of blood flow patterns in predicting stent thrombosis. Researchers will compare the blood flow patterns of the stent thrombosis group with that of the control group to understand the influence of blood flow patterns on thrombus formation and progression.

The incidences of Stent Thrombosis (ST) remain high in complex lesions and in high-risk patients. The use of intravascular imaging seems to be able to identify causes of ST, enabling prompt correction, and its use has been associated with better clinical outcomes in this setting. However, the efficacy of intravascular imaging features in predicting ST is limited. Computational fluid dynamic studies have shown that the local hemodynamic forces distribution has an effect on thrombus formation and can be responsible for the ST events. However, none of the studies today has explored in vivo the value of the flow disturbances in predicting events. The investigators have recently developed a method that is able to reconstruct vessel geometry accurately using coronary angiography and optical coherence tomography (OCT) data. Validation of this method in vitro and in human data showed promising results in accurately measuring shear stress and shear rate distribution.

This study, aims to explore the value of this method in predicting patients undergoing stent implantation with OCT imaging guidance that will suffer a ST. The investigators aim to collect data from 40 patients who had an ST after OCT-guided revascularization and from a control group of 80 patients who had no event after having stent implantation under OCT guidance. Investigators will further reconstruct the stented vessel from the OCT and the angiographic images, perform blood flow simulation and measure the shear rate and the shear stress in these two groups to explore the value of these metrics in predicting stent occlusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
* Patients who have suffered thrombosis post-stent implantation

Exclusion Criteria:

-
Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia

Acetylsalicylic acid (Aspirin, ASA) is the most widely prescribed drug used in primary and secondary prevention of cardiovascular disease. However, aspirin resistance has been described, mostly in cardiac patients and is an independent predictive factor for a poor survival. Two frequent conditions in patients with cardiovascular diseases, diabetes and hypercholesterolemia, are also considered as risk factors for aspirin resistance. Among patients with peripheral arterial disease, those with critical limb ischemia have the worst cardiovascular prognosis. At one year, 23% are dead, 25% have a major cardiovascular event and 25% have a major amputation (which can be combined). Aspirin resistance is poorly studied in these patients, and to our knowledge no study has been made to assess the prognosis value of aspirin resistance on cardiovascular outcomes in critical limb ischaemia patients.

Hospitalized critical limb ischaemia patients will be tested for aspirin resistance using the bed-side point of care VerifyNow®, and will be followed during one year, including death, fatal and non-fatal acute coronary syndromes, cardiac decompensation, stroke, and major amputation.


Eligibility Criteria:
Inclusion Criteria:

* any adult patient hospitalized for critical limb ischaemia and already treated by aspirin for at least 4 days before the VerifyNow® test. Critical limb ischemia is defined by the TASC II criteria : chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease, confirmed by an ankle pressure subordinate or equal 50 mmHg and a toe pressure subordinate or equal 30 mmHg, or a transcutaneous oxygen tension subordinate or equal 30 mmHg

Exclusion Criteria:

* non observance to aspirin treatment, other drugs that could interact with platelets (NSAIDs, other anti-platelet agents), other peripheral vascular disease status than critical limb ischemia, acute limb ischemia, platelet number lower than 100 000/mm3, hematocrit lower than 29%, known primary hemostasis disorder.
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.

Primary Objective:

To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate \[PRP\]) and vaccine response rates to acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the three-dose primary vaccination.

All participants will receive three primary doses of their assigned study the vaccine, on Days 0, 60, and 120. They will be assessed for immunogenicity on Day 0 before vaccination and Day 150 post-vaccination. Safety will be assessed for all participants throughout the study, up to Day 157.

Eligibility Criteria:
Inclusion Criteria:

* Aged 2 months (56 to 70 days) inclusive on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
* Informed consent form signed by the parent(s) or other legal representative
* Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the trial inclusion
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood derived products received in the past or current or planned administration during the trial (including immunoglobulins).
* Any vaccination in the 3 weeks preceding the first trial vaccination.
* History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically).
* Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current major neurological diseases or seizures.
* Febrile illness (axillary temperature ≥ 38ºC) or acute illness on the day of inclusion.
* Known family history of congenital or genetic immuno-deficiency.
Effect of Exercise on MiR-126 in Individuals With Prediabetes

This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes.

This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes. The hypothesis of our study is that regular aerobic exercise will increase miR-126 expression. Determining the effect of exercise on miR-126 in individuals with prediabetes will contribute to the elucidation of the pathways through which exercise is effective in prediabetes via epigenetic mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who were newly diagnosed with prediabetes according to the Oral Glucose Tolerance Test (OGTT) and/or HbA1C criteria
* between the ages of 18-60
* were physically inactive (Level 1 according to the International Physical Activity Questionnaire)
* were motivated to exercise
* Individuals who had no obstacle to exercise as a result of the evaluation made by a cardiologist (ECG, exercise ECG test, etc.)
* and who did not show a change in body weight of more than ±2.5 kg in the last six months were included in the study.

Exclusion Criteria:

* presence of serious medical conditions (e.g. advanced cancer, major neurological or endocrine disorders, respiratory failure)
* current cardiovascular disease, BMI \<19 kg/m²
* history of metformin use within the last 6 months
* receiving hormone replacement therapy
* life expectancy less than one year
* HIV positivity
* substance use
* or orthopedic and cognitive disorders that may prevent exercise
A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers

The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.