cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain

Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus muscles is the most important cause of the chronic nonspecific low back pain (CNLBP). Recently, applications sre developed that generates audio and vibrant stimuli in response to anteroposterior and mediolateral rotations and can be adapted according to subject-specific movement sensitivity.

Objective. The objective of this study was to compare effects of a biofeedback application that is alternative to physiotherapist feedback in core stabilization training of patients with chronic nonspecific low back pain.

Design. This study was a parallel group randomized controlled trial with outcome assessment.

Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back pain.

Interventions. Patients were randomly assigned to receive either physiotherapist feedback or Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12 sessions, 30 minutes of three weekly graded functional core education trial.

Measurements. Primary outcome measures were muscle strength (transversus abdominus and multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry Disability Index); secondary outcomes were flexibility (modified Schober test), range of motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs (Fear Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and quality of life(36 Item Short-Form Health Survey questionnaire \[SF-36\]).

Limitations. Outcome measures for muscle strength did not include objective assesment.

Keywords. Chronic low back, core stabilization training, biofeedback, pain, function


Eligibility Criteria:
Inclusion Criteria:

* Age between 25 and 65 years
* Continuous or recurrent episodes of pain in the lower back lasting for more than 12 weeks (chronic)
* No specific cause for pain complaints
* No other pathologic complaints or immobility
* Sufficient auditory and visual communication skills and
* Sufficient knowledge of the Turkish language

Exclusion Criteria:

* Any chronic disorder that may prevent exercise,
* Personal history of neurologic or rheumatologic disease,
* Pregnant or lactating women,
* Patients with malignancy or a lumbar comorbidity
* Terminal or progressive disease and any other musculoskeletal condition
* Surgery in the last 6 months and
* Any type of treatment for low back pain within past 6 months
The Effect of Pnemoperitoneum on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Surgery According to Anesthesia Agents: Propofol Based Total Intravenous Anesthesia vs Desflurane Anesthesia

The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy undergoing general anesthesia

Exclusion Criteria:

* Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
Detection of Pressure Areas for Two Elastomeric Impressions

Forty completely edentulous patients were selected and randomly distributed into two groups 20 patients each.Group I received complete dentures constructed from elastomeric impression with wax spacer,group II received complete dentures constructed from elastomeric impression with no wax spacer.then on time of denture insertion pressure areas were detected using pressure indicating paste and the denture retention was detected.The results showed less pressure areas in group I and more denture retention values than group II.

This study was conducted to evaluate the significance of using wax spacer in the impression technique regarding the pressure areas and retention of the complete dentures constructed. Forty patients with edentulous maxillary arches were selected from the outpatient clinic of removable prosthodontics department, faculty of oral and dental medicine, Cairo university .The patients were randomly divided into two groups. Group I received dentures constructed from impression technique with wax spacer while group II received dentures constructed from impression technique with no spacer. On the day of denture insertion pressure areas were detected using pressure indicating paste and denture retention was measured using force gauge. The data was collected and analyzed using student's t-test.

Eligibility Criteria:
Inclusion Criteria:

- completely edentulous upper and lower arches. well to moderately developed ridges saliva of average viscosity and amount with normal temporomandibular joint

Exclusion Criteria:

diabetic patients radiation therapy signs of inflammation, ulceration or hyperplasia neurological disorders clicking or mandibular deviation.
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection

This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Individuals at least 16 years of age infected with HIV-1
* CD4 lymphocyte count less than equal to (\<=) 100 cells per cubic millimeter (cells/mm\^3) and HIV-1 ribonucleic acid (RNA) viral load greater than equal to (\>=) 10,000 copies/mL while on highly active antiretroviral therapy (HAART)
* Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens

Exclusion Criteria:

* Evidence of ongoing alcohol and/or drug or substance abuse
* Prior non-adherence to antiretroviral treatment regimens
* Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.
Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old

Primary objectives:

To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.

Secondary objectives:

•Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)

•Secondary safety objective: To describe the safety profile after vaccination in each group


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥60 years
* At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years
* No influenza vaccine administered during the last 6 months

Exclusion Criteria:

* Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years
* Receipt of pertussis-containing vaccine or pertussis disease within the last 10 years
* Receipt of medication / vaccine that may interfere with study assessments
* Febrile illness or moderate or severe acute illness/infection
* History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
* History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
* History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or unstable neurological disorders
* Known or suspected immune dysfunction
* Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
* Chronic disease that is unstable or any intercurrent illness that might interfere with the ability to participate fully in the study; or interfere with evaluation of the vaccine
Effect of Short-term Annatto Carotenoids Supplementation on Oxidative Stress Status in Healthy Individuals

Low-density lipoprotein (LDL) oxidation has a pivotal role in atherosclerosis development. There is a relationship between carotenoids serum concentration and cardiovascular (CV) benefits, mainly in oxidized LDL (oxLDL) reduction. Despite cardio protective effects of annatto carotenoids, bixin and norbixin, in vitro and in animal studies, its short or long-term supplementation effect on humans are not know. Objective: To analyse CV benefits of annatto carotenoids short-term supplementation in healthy individuals, comparing to lycopene effect. Methods: 16 healthy volunteers (8 men and 8 women) consumed 0.05 mg/kg b.w. of each treatment (bixin, norbixin, lycopene or placebo) through capsules, during 7 days. It was analysed the susceptibility of LDL to Cu2+-induced oxidation, biochemical parameters and oxidative stress biomarkers at the beginning and end of each treatment.

Graduate and post-graduate students were recruited in Federal University of Santa Maria to study participation. First, the health status of volunteers was analysed by questioner application (to evaluate lifestyle, family history, individual characteristics), anthropometric (height, weight, waist circumference) and biochemical parameters (glucose, lipid profile, transaminases, urea, creatinine) measurements. According to inclusion criteria, 18 volunteers were able to study participation, but just 16 people remained until the end of the study.

Each treatment was composed by 7 capsules (containing 0.05 mg carotenoid or placebo/kg b.w.) which should be consumed once a day (preferably in the morning), during 7 days. It was conducted a randomized, double blind, placebo-controlled crossover clinical trial, where 16 participants received 4 proposed treatments (bixin, norbixin, lycopene and placebo) in different periods. To plasma, serum and red blood cells (RBC) obtainment, 2 fasting blood collections were made, in the beginning (Day 0) and the end (Day 7) of each treatment. These samples were used for evaluating the ex vivo oxidation of LDL induced by copper sulphate and biochemical and oxidative biomarkers measurements.

Eligibility Criteria:
Inclusion Criteria:

* Normal levels of glucose, lipid profile, transaminases, urea and creatine
* Normal blood pressure, weight and body mass index (BMI)

Exclusion Criteria:

* Chronic diseases (diabetes, dyslipiademia, hypertension cancer, etc.)
* Drug, alcohol and cigarette consumption/addiction
* Medication, vitamins or suplements consumption (except oral contraceptive used by women)
* Recent inflammatory/infectious diseases
An Exploratory Trial of a Health Education Programme Based on the Social and Emotional Competence in Children

The purpose of this study was to evaluate whether an intervention based on the social and emotional competence development improves the healthy lifestyles adoption in young children.

This study has designed, implemented and evaluated an intervention to promote healthy lifestyles in children addressing the development of the social and emotional competence. This research followed the first three stages of the Medical Research Council framework for complex interventions: the theoretical, modeling phase and the exploratory trial. A randomised control trial with 37 children (5 y 6 years old) was conducted at the exploratory trial. The first unit was implemented in 8 sessions. A multi-method and multi-informant approach was used to assess the preliminary efficacy, acceptability and feasibility of the programme.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5 and 6 enrolled in a public school in the north of Spain

Exclusion Criteria:

* Children with severe cognitive or language special needs
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR

The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.

This study was a randomized, double-blind, placebo-controlled, phase III study with 2 parallel arms in adults and adolescents with HDM-associated allergic rhinitis (AR) for at least one year.

The primary objective was to assess the efficacy of STG320 sublingual tablets at a daily dosage of 300 IR when administered for 12 months to adults and adolescents with HDM-associated AR. The primary efficacy variable was the average Total Combined Score.

Eligibility Criteria:
Main Inclusion Criteria:

* Patients with HDM-associated allergic rhinitis (AR) for at least 1 year
* Patients sensitized to D. pteronyssinus (D. pte) and/or D. farinae (D. far) defined on skin prick test and HDM-specific serum IgE

Main Exclusion Criteria:

* A history of rhinitis, rhinoconjunctivitis or asthma to allergens other than HDM, likely to result in rhinitis symptoms during the evaluation periods
* Partly controlled or uncontrolled asthma
* Controlled asthma requiring controller treatment(s) consistent with GINA 2014 treatment Steps 3 to 5
"Cognitus & Moi": a New Cognitive Remediation Tool

Holders children with intellectual disabilities have great difficulty in adapting to social situations and relationships.Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved.Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are children with intellectual disabilities manner in their daily functioning.

Cognitus \& ME is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among children with intellectual disabilities.The main objective is to validate the effectiveness of Cognitus \& ME program on behavioral disorders in children with intellectual disabilities (with or without autism spectrum disorder associated).

Eligibility Criteria:
Inclusion Criteria:

* Children with intellectual deficiency (5-13 years) (40 \< total IQ \< 75) with or without autism spectrum disorders
* Native French speaker
* Clinically stable
* Parental consent

Exclusion Criteria:

* visual or auditory disorder
* history of neurological illness or trauma
* Absence of language
Evaluation of the Impact of Psychomotricity on the Patients Body Experience in Palliative Care

Palliative care is part of a comprehensive approach to the person, in the advanced phase of a serious illness. The purpose of this care is to relieve painful symptoms, to promote comfort and quality of life. In the context of a serious illness, the sick person is confronted with body modifications that have an impact on his body experience, that is, on his feelings and on the image that he has of his body.

Psychomotricity is a paramedical discipline that focuses on body-psyche links. The psychomotor therapist is authorized to take care of psychomotor disorders, as defined in the decree of competences. These psychomotor disorders appear in connection with the evolution of the serious illness and the presence of symptoms in these patients (ex: disorders of the tonic regulation, psychomotor disharmony, disorders of the representation of the body, etc.). In palliative care, the psychomotor therapist seeks to regulate these psychomotor disorders and thus to promote a more satisfying physical experience in the patient, through the use of different bodily approaches.

Several studies have shown the beneficial effects of touching and moving the body in cancer patients, but no work evaluating the effects of the psychomotor approach (involving various body mediations) on the body experience of patients with cancer in palliative situation


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Man or woman
* Subject who has agreed to participate in the research and to use the data collected for research purposes
* Patient with solid cancer or hematological malignancy in palliative stage, that is to say a cancerous disease for which no curative treatment is no longer envisaged, with committed vital prognosis
* Hospitalize patient in palliative care unit
* Patient with indication of care in psychomotricity defined by the decree of competence Decree n ° 88-659 of May 6, 1988
* Patient with a minimum score of 4 on an item or a minimum score of 4 on several cumulative items (with a minimum of 2 on at least one of the items), on the ESAS scale, among the following themes: pain, anxiety, depression, uneasy feeling

Exclusion Criteria:

* Patient whose clinical condition (left to the decision of the investigator) does not allow to perform a psychomotor care and / or participate in a recorded interview (extreme fatigue, confusion, painful uncontrolled symptoms)
* Communication difficulties, patient not speaking or not understanding French
* Impossibility of giving the patient informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
* Patient under guardianship, curatorship
* Patient not affiliated to social welfare regime
Electrocardiogram Clinical Validation Study

The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.


Eligibility Criteria:
Inclusion Criteria:

* Able to read, understand, and provide written informed consent;
* Willing and able to participate in the study procedures as described in the consent form;
* Individuals who are 22 years of age and older;
* Able to communicate effectively with and follow instructions from the study staff;
* Have a wrist circumference that fits within the device band; and
* For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening.

Exclusion Criteria:

* Physical disability that precludes safe and adequate testing;
* Mental impairment resulting in limited ability to cooperate;
* Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD);
* Acute myocardial infarction within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable;
* Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening;
* Stroke or transient ischemic attack within 90 days of screening;
* Subjects taking rhythm control drugs;
* Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis, or allergic contact dermatitis on both wrists or over electrode attachment sites, including known allergy or sensitivity to silicone bands primarily used in wrist-worn fitness devices;
* Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or ECG electrodes;
* A history of abnormal life-threatening rhythms as determined by the Investigator;
* Significant tremor that prevents subject from being able to hold still;
* Women who are pregnant at the time of study participation; and
* Subjects enrolled into the SR population must not have any diagnosis of AF.
Comparison of Different Methods of Nasogastric Tube Insertion in Anesthetized and Intubated Patients

The primary aim of this study is to investigate the difference in the first attempt and overall success rate of different techniques for insertion of nasogastric tube. Secondary aim is to investigate the difference of the duration of insertion using the selected technique, complications during insertion such as kinking, knotting, mucosal bleeding

Two hundred adult patients, who received general anaesthesia for elective abdominal surgeries that required nasogastric tube insertion, will be randomized by means of a computer-generated randomization order into four groups: Conventional group (Group C), head in the lateral position group (Group L), endotracheal tube assisted group (group ET) and video laryngoscope group (group MG).

Success rate of the selected technique (first attempt, second attempt and overall), duration of insertion for selected technique, complications such as kinking and mucosal bleeding will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received general anaesthesia for elective abdominal surgeries that required nasogastric tube insertion.

Exclusion Criteria:

* Patients with a history of coagulopathy,
* nasal stenosis,
* upper respiratory tract diseases or anomalies,
* esophageal varix, esophageal hiatus hernia,
* base of skull fracture,
* loose teeth,
* Cormack and Lehane and/or Mallampati scores of 3 or 4,
* patients younger than 18 years and older than 70 years