cyrilzakka/clinical-trials huggingface dataset:
Intervention of Virtual Reality on Oculomotor Muscles and Balance

Prospective, controlled, randomized, non-masked longitudinal research project for the realization of a doctoral thesis, based on an intervention with virtual reality in order to assess whether the influence on balance and the oculomotor muscles is positive.

The introduction of new technologies in the field of medicine in all fields, and in particular the rehabilitation is fully in place and under development. There are numerous examples like these technologies, including virtual reality (VR), have helped different health fields such as surgery or physiotherapy.

The main aim of the study is to analyze these factors and analyze the way in which virtual reality (VR) can modulate the convergence of the gaze and can influence the center of pressure (COP). As secondary objectives es proposes to analyze the interrelationship between the VR and the COP to analyze the clinical possibilities of application in the field of rehabilitation, whether due to a downward (oculomotor) or upward alteration (COP alteration), as well as if physical activity or gender can also influence.

The center of pressure (COP) is the point where the resultant of the ground reaction forces is applied to the base of support. The oscillation of the individual with respect to the ground is projected in an anteroposterior line (AP) and another mediolateral (ML). With these two parameters you can define the total route covered by the COP. The population general presents a small area: parameters of short distance and fast and precise displacements. An alteration of the balance can be objectified by measuring an increase in the same area; reflecting a loss of axis control AP and ML and a slowing in the perception of this loss.

The oculomotor muscles are responsible for maintaining horizontal gaze; given the position bipedal, the brain seeks to maintain this premise to allow carrying out the usual activities in it position A good response of this musculature, specifically, the ability to accommodate the convergence of the look, will guarantee optimal function.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 25 years old.
* No visual alteration.
* No history of vertigo.
* No pathology that compromises balance.
* Physically active (where the first two questions are affirmative and are 3 days and 3 hours, respectively.

Exclusion Criteria:

* Taking medication that affects the nervous and/or motor system.
* Smoking, alcoholism, taking illicit drugs or neurologically active medications.
A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ

The purpose of the study is to obtain recurrence rates and long-term safety data for patients who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a previous study.


Eligibility Criteria:
Inclusion Criteria:

* 100% clearance of Actinic Keratosis (AK) lesions in the 1487 IMIQ study

Exclusion Criteria:

* used any treatments in the previous treatment area within 24 hours prior to the follow-up visit
Race, Class, and Gender--Studies of Health Effects

To improve understanding of three important and intertwined social determinants of health: social class, race/ethnicity, and gender.

DESIGN NARRATIVE:

The first component of the study investigated associations among discrimination, blood pressure, and cardiovascular risk factors, and used data from Exam IV (1992-1993) of CARDIA, a multi-site longitudinal study of cardiovascular risk factors among Black and white men and women. Analyses examined the association between blood pressure and discrimination based on race/ethnicity, gender, social class, sexual orientation, and religion, and took into account response to unfair treatment. To assess for effect modification, separate analyses were performed for the eight strata defined by the sampling strategy: Black/white x male/female x equal to or less than high school/more than high school. Additional multivariate analyses examined whether, within the four gender/education strata, discrimination contributed to Black/white differences in blood pressure, adjusting for relevant covariates. Other analyses explored the relationship between discrimination, response to unfair treatment, and other possible cardiovascular risk factors, including hostility, body fat distribution, lipid fractions, blood glucose, skin color, substance use (tobacco, alcohol, and illegal drugs), and body self-image.

The second component concerned appropriate measures of social class for studies of women's health. It used data on 718 women who participated in Examination II of the Kaiser Permanente Women Twins Study (1989-1990) . Socioeconomic information existed on: adult individual and household class (which took into account the individual class position of both the respondent and her partner or head-of-household, if present), childhood household class, and class trajectory (comparing childhood and adult household class). Data on health characteristics included: blood pressure, body mass index, waist-hip ratio, lipoprotein fractions, fasting and postload insulin and glucose serum concentrations, self-assessed health status, age at first completed pregnancy, total number of childbirths, duration of breast feeding, physical activity, and smoking status. Analyses evaluated whether different magnitudes of class-based differences in these health characteristics were detected with these diverse measures of social class, using multivariate techniques that corrected for the correlation of errors within twin pairs. The effects of using these different class measures were also examined for analyses testing the hypothesis that social class was inversely related to risk of hypertension among women, adjusting for relevant covariates.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase

This extension trial of SP668 consists of two phases: double-blind treatment and open-label extension. The trial provides subjects the option of long-term treatment with sustained release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and efficacy.

Double-Blind: Subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their dose assignment in SP668. Previous SP668 placebo subjects received fesoterodine 4mg.

Open-Label: Subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg.

The primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in ECG, physical and urological examinations and subject's assessment of treatment tolerance.

Secondary efficacy variables include various parameters derived from micturition diaries, count of subjects and their dose choice throughout the trial and subject's assessment of treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder
A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)

This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participant is not on a statin or other lipid-modifying therapy
* Low or moderate risk participant
* Male participants, and female participants not of reproductive potential

Exclusion Criteria:

* Female participant of reproductive potential
* Participant is pregnant, breastfeeding, or expecting to conceive during the study
* Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer)
* Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse
* Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study
* Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week
* Participant is currently experiencing menopausal hot flashes
* Participant currently engages in vigorous exercise or an aggressive diet regimen
* Participant is at high risk for heart conditions
* Participant has Type 1 or Type 2 diabetes mellitus
* Participant has poorly controlled cardiac arrhythmias
* Participant has a history of stroke or other hemorrhage
* Participant has poorly controlled high blood pressure
* Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids
* Participant has a disease of the kidney or liver
* Participant has an ulcer within 3 months of screening
* Participant is Human Immunodeficiency Virus (HIV) positive
* Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy
* Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening
* Participant has taken an anti-obesity medication within 3 months of screening
* Participant is taking coumarins
* Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed)
* Participant is taking more than 100 mg aspirin per day
* Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents
Fatal Cerebral Infarction After Nasal Augmentation With Hyaluronic Acid

this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for Aisan induced by hyalruonic acid filler injection.

Intra-arterial thrombolysis and retrobulbar injection of hyaluronidase have been used for HA-induced ophthalmic artery obstruction.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cerebral infarction

Exclusion Criteria:

* fat embolism
Adolescents' Response to Hepatitis B Vaccine Booster Dose

The aims of this study are to determine:

1. the degree of immunity against hepatitis B,
2. factors associated with immunity against hepatitis B,
3. if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and
4. if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents.

Study subjects eligible for enrollment will:

* have blood drawn for baseline serologies
* receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug dose)
* have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine)

The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.


Eligibility Criteria:
Inclusion Criteria:

* 16-19 years of age
* born in the United States
* received the full hepatitis B vaccination series by 12 months of age
* received the third dose of hepatitis B vaccine within 10 months of the first dose

Exclusion Criteria:

* a history of hepatitis B disease
* being born to a mother with hepatitis B at the time of the participant's birth
* having received hepatitis B immune globulin as an infant
* immunosuppression including HIV or chronic/current steroid use (use \> 10 days duration within the 3 months of enrollment)
* renal insufficiency or dialysis
* pregnancy (due to theoretical risk of different immune response among pregnant females)
* ever receiving a booster (fourth) dose of hepatitis B vaccine
* history of allergy to the hepatitis B vaccine
* receipt of blood products or IgG within 3 months of enrollment
* having received another vaccine within 2 weeks of enrollment
A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients

The purpose of this study is to determine whether the development of antibodies to laronidase in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented diagnosis of MPS I confirmed by measurable signs and symptoms and deficient α-L-iduronidase activity (\<10% of the lower limit of normal).
* For a patients receiving Aldurazyme therapy prior to study entry: Have available as baseline data the results of urinary GAG levels and IgG antibody titers collected prior to the patient's first Aldurazyme infusion.
* Provide signed, written informed consent prior to any protocol-related procedures being performed. Consent of a legally authorized guardian(s) is (are) required for patients under 18 years.

Exclusion Criteria:

* Have previously received Aldurazyme without the collection of baseline samples as specified.
* Have a suspected hypersensitivity to Aldurazyme or a know hypersensitivity to components of infusion solution.
* Have received a Hematopoietic Stem Cell Transplantation, injection fibroblast therapy, or major organ transplant.
* Are receiving chronic immunosuppressant therapy.
* Have a medical condition, serious intercurrent illness, or other extenuating circumstances that may interfere with study compliance including all prescribed evaluations and follow-up activities.
* Are pregnant or lactating
* Have received investigational drug within 30 days prior to study enrollment
A Clinical Study to Investigate How Safe and Tolerable the Study Drug MT-2990 is and How MT-2990 is Taken up by the Body in Healthy Volunteers

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are able and willing to provide written informed consent to participate in this study
* Healthy male subjects aged 18 to 55 years (inclusive)
* Free from clinically significant (CS) illness or disease
* Body weight of 60 to 100 kg (inclusive)
* Body mass index (Quetelet index) ranging from 18 to 30 kg/m2 (inclusive).

Exclusion Criteria:

* A CS endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological (including history of seizures), renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness or disorder (including anxiety, depression and reactive depression)
* Presence or history of any known malignancy with the exception of basal cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
* A history of bacterial or viral infections that led to hospitalisation and IV antibiotic or antiviral treatment within 3 months prior to Screening, or any recent infection requiring antibiotic or antiviral treatment within 4 weeks of Day -1
* A history of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic infection is two episodes within 6 months)
* A history of tuberculosis (TB) or malaria; history or any evidence of active infection or febrile illness within 7 days of dosing (e.g., bronchopulmonary, urinary, or gastrointestinal)
* An active, or history of, parasitic infections; any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (e.g., history of splenectomy)
* Presence or history of severe adverse reaction or allergy to any drug or allergy that is of clinical significance to the Investigational Medicinal Product (IMP)
* A positive test result for QuantiFERON-TB Gold® Plus, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at Screening.
Effect Of Counselıng

This study aims to determine the effect of counseling on quality of life and self-care agency for patients who are scheduled for TKR.

This is a quantitative study and has a quasi-experimental design with a control group. The sample of the study consisted of 79 patients including intervention (n=39) and control (n=40). The data are collected by the face-to-face interview method using Patient Identification Form, Quality of Life Scale, and Self-Care Agency Scale before surgery, and 6-8th weeks after discharge. Face-to-face and telephone counseling were applied to individuals in the intervention group. The x2, t-test, one-factor variance analysis, and two-factor variance analysis were used in the analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

* undergoing TKA for the first time, being scheduled to have unilateral TKA, having surgery for osteoarthritis, having no postoperative complications, fulfilment of discharge criteria after surgery, being aged 18 years or older, being conscious, orientation to place and time, having no hearing or speech problems, ability to understand and speak Turkish, being at least literate, not being diagnosed with any psychiatric diseases and not having a history of cancer.

Exclusion Criteria:

* diagnoses of neurological (e.g. Alzheimer's disease) and psychiatric disorders (e.g. schizophrenia) likely to affect cognitive functions, first accepting to participate in the study and then dropping out of the study, development of complications during follow-up (e.g. infection), unavailability when called and lost to follow-up.
ABSORB EXTEND Clinical Investigation

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System

ABSORB BVS is currently in development at Abbott Vascular.


Eligibility Criteria:
Inclusion Criteria:

* Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
* Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
* Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1.
* If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
* Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
* Percutaneous intervention for lesions in the target vessel are allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure.

Exclusion Criteria:

* Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
* Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation.
* Total occlusion (TIMI flow 0), prior to wire passing.
* Target vessel(s) contains visible thrombus.
* Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
* Subject has received brachytherapy in any epicardial vessel (including side branches).
Hyperoxia and Pulmonary Complications After Cardiac Surgery

The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old)
* Patient operated heart surgery with extra-corporal life support
* Hospitalization in Cardiology intensive and critical care unit
* Patient operated in HUS between 01/01/2015 and 31/12/2019
* Subject consent, after information, to the reuse of its data for the purposes of this study

Exclusion Criteria:

* Non-consent patient
* Hypoxemic patient
* Emergency surgery
* Patient with post-operative cardiac assist device
* Patient with guardianship
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection

The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection

After providing informed consent, patients will undergo to a screening visit. If they meet the inclusion criteria and none of the exclusion will be included in this trial. Patients will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-65 years
* ART naïve
* HIV infection of less than 100 days post-infection (documented 3 month previous negative serology or incomplete WB test with negative p31 band)
* Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner.

Exclusion Criteria:

* Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen
* AST \>5 times UNL
* Creatinine Clearance \<30 mL/min/1.73m2
* Any end-stage organ disease
* Acute or chronic HCV co-infection
* Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of acquired-drug resistance to FCT or TDF).
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.


Eligibility Criteria:
Inclusion Criteria:

* knee pain
* diagnosis of osteoarthritis in affected knee

Exclusion Criteria:

* intraarticular corticosteroids in affected knee within past three months
* primary inflammatory connective tissue disease (ie rheumatoid arthritis)
* currently taking oral corticosteroids
Behavior of the Upper Cervical Spine in Rugby Players

Rugby players are often exposed to destabilisation of the upper cervical spine.This kind of trauma may lead to dramatic injuries, due to lesion of spinal cord.

CerviStab© is a device which evaluate the bio-mechanical and neuromuscular behavior of the upper cervical spine in rugby situation.

The aim of this study, is to evaluate the dynamic stabilization of the upper cervical spine in reaction to unexpected impact.


Eligibility Criteria:
Inclusion Criteria:

* Rugby players at least since 5 years
* Amateurs or professionals players
* Able to play in rugby competition

Exclusion Criteria:

* Medical history of cervical spine injury requiring surgical intervention
* Active cervical symptomatology
* Medical history of migraine or epilepsy