cyrilzakka/clinical-trials huggingface dataset:
Influence of Using Physical Therapy Resources for Knee Osteoarthritis

Osteoarthritis is a chronic, multifactorial characterization, which changes in bone alignment, cartilage and structures that provide joint stability appear to be strongly correlated with the origin of this disease.This project will aim to verify the effectiveness of interferential current, short wave and low level laser therapy on an exercise program for mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups: exercise group, exercise group + Ultrasound therapy, exercise group + interferential current, exercise group + short-wave diathermy, exercise group + Low level laser therapy. Before and after the trial protocol by the following instruments: Western Ontario and McMaster Universities osteoarthritis index (WOMAC), numerical scale of pain assessment (END), Visual Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of life of the World Health Organization (WHOQOL-100) test sitting and standing + numerical rating pain scale, algometry. This project hypothesizes that the inclusion of photothermal and electrical agents in an exercise program will provide an improvement in pain, mobility and knee function in individuals diagnosed with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* knee pain to at least six months and minimum of 4 points in pain scale
* Diagnosed with osteoarthritis in unilateral knee according to the criteria established by the American College of Rheumatology and confirmed by radiographic examination for identification Kellgren-Lawrence grade 2 or 3 (Kellgren \& Lawrence, 1957).

Exclusion Criteria:

* Any type of physical therapy
* therapy with intra-articular corticosteroids or therapeutic chondroprotective drugs last year, before the start of the study.
* history of trauma on his knees, cognitive disorder or psychological disorder,
* neurological (sensory or motor)
* cancer
* diabetes,
* or any state of adverse acute health osteoarthritis signs of hip
* cardiopulmonary disease that prevents the conducting exercises
* require auxiliary device for performing gait.
* Yet who undertake physical activity in the last two months. Physical activity is defined as strength training and / or more than 20 minutes of aerobic activity twice a week.
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)

A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
* Subject is in good health and is a non-smoker
* Subject is willing to avoid strenuous physical activity during the study
* Subject agrees to refrain from eating grapefruit or grapefruit products during the study

Exclusion Criteria:

* Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Subject consumes excessive amounts of alcohol or caffeinated beverages
* Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
* Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food
* Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin
* Subject is a regular user or past abuser of any illicit drugs
* Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study.
* Subject is a nursing mother
Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction.

Adverse cutaneous drug reactions are undesirable and typically unanticipated reactions independent of the intended therapeutic purpose of a medication. It may be either immunologic (eg, drug allergy) or non-immunologic. Adverse cutaneous drug reaction produce a wide range of clinical manifestations such as pruritus, maculopapular eruptions, urticaria, angioedema, phototoxic and photo allergic reactions, fixed drug reactions, erythema multiforme,vesiculobullous reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) and serum sickness .They must be considered in the differential diagnosis of sudden symmetric eruption

Erythema multiforme is an acute immune mediated disorder It is a type IV hypersensitivity reaction leading to dermal vasculitis. Erythema multiforme major usually as a result of medications such as sulphonamides, non-steroidal anti-inflammatories and penicillin and there is skin and mucosal involvement.

Steven-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are considered a spectrum of acute life-threatening mucocutaneous reactions that differ only in severity. Both diseases are characterized by mucous membrane and skin involvement, are often caused by medications and are collectively known as epidermal necrolysis or scalded skin syndrome.Stevens-Johnson syndrome (SJS) is classified as an epidermal loss \<10% of the body surface area.Toxic Epidermal Necrolysis (TEN) is indicated by \>30% body surface area erosion. The range of epidermal loss between 10% and 30% is called Stevens-Johnson syndrome-Toxic Epidermal Necrolysis (SJS-TEN) overlap. Severity of illness score \[Score of Toxic Epidermal Necrolysis(TEN) \] has been devised to predict prognosis in patients with Epidermal Necrolysis.This scoring system addresses 7 prognostic factors: age, malignancy, heart rate,Body Surface Area involved, serum urea, serum glucose and serum bicarbonate levels.

Interleukin-21 regulates both innate and adaptive immune responses and it is not only has key roles in antitumour and antiviral responses that promote the development of autoimmune diseases and inflammatory disorders. It is recently discovered member of the type 1 cytokine family which is produced by activated clusters of differentiation 4+ T cells ,Natural killer cells and follicular helper T cells.

Eligibility Criteria:
Inclusion Criteria:

* 20 patients presenting with adverse cutaneous drug reaction (Erythema multiforme, SJS and TEN )
* Patients with definite drug history.
* Both sex will be included.

Exclusion Criteria:

* Patients with a history of topical or systemic treatment (corticosteroids, intralesional steroid injection, immunosuppressive therapy).
* Patients within 4 weeks of the study.
* Patients receiving phototherapy within 6 months of the study.
* Diabetic patients
* Anaemic patients
* Thyroid disorders,
* Chronic liver or Renal diseases
* Atopy and Parathyroid disorders.
* Patients with known autoimmune diseases or cancer.
* Pregnant or lactating womens.
Emotional Proactive Brain Study in Adults With Autism Spectrum Condition

This project aims:

* to study behavioral and cerebral activity specificity (latency and amplitude of evoked potentials, time frequency maps and cerebral connectivity) in predictive process (top-down regulation) during visual recognition of static and dynamic stimuli in adults participants with autism spectrum conditions compared to typically developed participants.
* to study the relation between predictive process and autonomous response (heart activity and electrodermal activity)
* to explore potential sex differences between autistic males and females

Once eligibility criteria would have been verified, information on the study will be given and non opposition of the participant will be collected.Then, the participant will be comfortably installed in order to pass the Landolt C task (visual acuity task) on a computer. If his vision is normal, electroencephalogram (EEG), electrocardiogram (ECG) and electrodermal activity (EDA) of participants, will be recorded during visual processing and recognition tasks. Stimuli will include emotional and non emotional pictures and films, filtered in coarse-to-fine versus fine-to-coarse sequences in order to stimulate or not predictive process described by Bar (2007).

The participant will also have to complete an abbreviated version of the Wechsler Adult Intelligence Scale, IVth edition (Wechsler, 2003), and the Autism Spectrum Quotient (Baron-Cohen et al., 2001) if he never did it before. The aim is to pair as much as possible group by IQ and to verify that control participants don't present autistic traits above the Autism Spectrum Quotient cutoff. Groups will also be paired by age and education level.

Eligibility Criteria:
Inclusion Criteria:

* affiliation to the french social protection care
* information and non opposition of the participant
* information and non opposition of tutor/curator if the case presented
* normal or corrected to normal vision
* capacity to understand and apply instruction required by the task
* no participation in another research
* for autistic person: formal diagnosis of autism spectrum condition (autism/asperger/PDD-NS) according to CIM-10/DSM-IV/DSM-5 criteria

Exclusion Criteria:

* adults with no ability to express their consent
* adults on judiciary protection
* perceptive/motor/neurological/psychiatric issue
* major health issue (cardiac, metabolic ...)
* alcohol or drug consumption
Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae

The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years old or older.
2. Native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed.
3. Patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for PTA procedure.
4. Patient who is willing and able to sign a written informed consent and that complies with procedures (including adherence to follow-up visits).

Exclusion Criteria:

1. Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
2. Previous participation in another study with any investigational drug or device within the past 30 days.
3. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult.
4. Known hypersensitivity to paclitaxel or structurally-related compounds.
5. Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
6. Stenosis with corresponding thrombosis treated within 7 days before enrollment.
7. Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
8. Infected grafts/fistulae.
BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition

The purpose of this study is to determine whether BRAND'S® Essence of Chicken are effective in the promotion of resilience and resistance to stress-associated cognitive inhibition.

This is a placebo-controlled, randomized, double-blind trial. There will be 100 subjects. Subjects are randomly assigned into either placebo or BRAND'S® Essence of Chicken (BEC), 70cc daily for 2 weeks, group.

Stress test, cognitive function assessment and blood tests will be carried out at Week 0, Week 2, and Week 4 (2 weeks after termination of supplementation).

The primary end-point is the better improvement of cognitive function after supplement with BEC than placebo. The second endpoints include improvement of global health survey and changes of biomarkers related to stress and immunity.

Eligibility Criteria:
Inclusion Criteria:

* aged over 20 years,
* mildly stressed with Perceive Stress Scale (PSS) score higher than 25
* All the participants should not require medication for their mood disturbance affected by stress during the trial.

Exclusion Criteria:

* history of chronic diseases
* any psychiatric or neurological diseases (e.g. depression)
* other medical illnesses (e.g. stroke, diabetes, other cardiovascular diseases)
* allergy history to chicken
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.

Approximately 750 study subjects received different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* A female who enrolled in the HPV-012 (NCT00337818) study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).
* Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
* Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Conservative Intervention of Femoroacetabular Impingement Syndrome

1. Purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (FAI), and 2) analyze functional outcome comparatively across groups.
2. Interventions will be provided based on randomized assignment. Group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. Group 2 will receive only the prescriptive exercise program. Group 3 will be a control group (supervised neglect)
3. Primary outcomes data analysis will involve a mixed design (repeated measures) ANOVA for assessment of the primary outcome measure of the HAGOS. Secondary analyses will include chi square analyses (PASS, surgery at 6 months, adverse events), ANCOVA (PPMs, and expectations measures), or other appropriate comparative measures. None of the proposed treatment is considered outside of 'standard of practice'.


Eligibility Criteria:
Inclusion Criteria:

* Individuals age 18 to 60 years,
* diagnosed with FAI by an orthopedic surgeon and exhibiting
* hip/groin symptoms for at least 3 months (symptomatic); and
* signs, symptoms and imaging findings conducive to FAI will be recruited from a surgical practice of an orthopedic surgeon in Durham, North Carolina.

Exclusion Criteria:

* subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis \>grade 1 or Kellgren-Lawrence \>2;
* have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures;
* exhibit hip dysplasia (center edge angle \<20 degrees on AP radiograph
* are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the PT group;
* are unable to understand English.
Ceftobiprole in Hospital Acquired Pneumonia

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.

Ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00248) and another similar study (BAP00307, see NCT00210964) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248 Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia
* Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening

Exclusion Criteria:

* Known or suspected hypersensitivity to any related antibiotic medications
* Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
* Treatment with any investigational drug within 30 days before enrollment
* Prior enrollment to this study
Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)

The aim of this randomized, double-blind, controlled intervention study with parallel groups is to investigate the effect of resistance training (2x/week for 10 weeks) with and without different goals of vitamin D intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons. Participants (n = 100) will be community-dwelling older adults. After a preparticipation screening and a vitamin D blood investigation (vitamin D status below 75 nmol/L) participants will be distributed randomly but stratified by sex, age and initial vitamin D plasma levels to one of the 3 groups (Vitamin D daily + strength training, Vitamin D monthly + strength training, no Vitamin D + strength training).

Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs, a regular strength training during the last six months and a vitamin D plasma concentration of 75nmol/L or above.

Primary outcome measure is the change in the handgrip strength. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, DNA/Chromosomal damage microbiota, metabolomics and the nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between the age of 65 and 85 years
* Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State \>23)
* Independently mobile

Exclusion Criteria:

* Chronic diseases, which contraindicate a training participation
* Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
* Diabetic retinopathy
* Manifest osteoporosis
* Regular use of cortisone-containing drugs
* Regular strength training (\> 1x / week) in the last 6 months before inclusion
* Vitamin D plasma level of 75 nmol/l or above
The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach

The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in adipose tissue will be studied in 50 subjects.

Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with coronary heart disease, cancer and immunological diseases, and also with obesity, hypertension and glucose intolerance. However, to see the full effect of vitamin D, one should not only look at single diseases or risk factors, but have a global approach using a combined clinical index. A similar line of thinking can be applied to genetic, proteomic and metabolomic studies on vitamin D. Thus, in the present study 50 subjects will be included and randomized to vitamin D 40.000 IU per week versus placebo for 2 months. Blood and adipose tissue samples will be collected before and after the intervention and analyzed for gene expression. Based on these results the investigators will proceed with the relevant proteomic and metabolomic profile analyses. If successful, this may reveal new aspects of vitamin D's physiology and metabolic effects.

Eligibility Criteria:
Inclusion Criteria:

* serum 25OHD in the range 20 - 40 nmol/L
* no change in medication last 4 weeks

Exclusion Criteria:

* women \< 60 yrs of age (to avoid influence of menstrual cycle)
* reduced kidney function
* serious diseases (cardio-vascular, diabetes, etc)
* taking vitamin d supplementation