cyrilzakka/clinical-trials huggingface dataset:
Effect of Prebiotic and Synbiotic Supplementation in Individuals Undergoing Roux-en-y Gastric Bypass.

The study will recruit patients submitted to bariatric surgery. Individuals will be supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days. Immunological, metabolic and anthropometric parameters will be assessed before and after the supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate plasma concentrations of immunological and metabolic parameters and anthropometric measures of subjects undergoing gastric bypass Roux-Y.

The study will recruit patients submitted to roux-en-y gastric bypass. Individuals that meet the inclusion criteria will be randomized by means of a computer program on three study groups: 1) Prebiotic group: Oral supplementation with 6g/day of prebiotic for 15 days. 2) Synbiotic group: Oral supplementation with 6g/day of synbiotic for 15 days. 3) Placebo group (control): Oral supplementation with 6g/day of placebo (maltodextrin) for 15 days. Will be assessed the effects of supplementation on the plasma cytokines, plasma lipopolysaccharide (bacterial endotoxin), plasma cellular fatty acid profile, metabolic parameters (lipid profile, glycemic status and insulin resistance) and nutritional status. Blood samples will be collected before the surgery and the supplementation will begin 30 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years and less than 65 years
* Body mass index (BMI)\> 40kg/m2 or\> 35kg/m2 with at least one comorbidity
* Failure in the non-pharmacological and pharmacological treatment.

Exclusion Criteria:

* Significant intellectual limitations without adequate family support.
* Uncontrolled psychiatric disorder.
* Alcohol dependence and / or illicit drugs dependence.
* Current use of anti-inflammatory drugs and / or antibiotics and / or immunosuppressants
* Display intolerance prebiotics and / or probiotics and / or symbiotic
* Having made use of prebiotic and / or probiotic and / or symbiotic prior to the study period.
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI

Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD. This same phenomenom has not been clearly mapped in patients with CAD that goes through a transcatheter aortic valve implantation procedure.

A narrowing of the aortic valve, aortic stenosis, is a relatively common condition among the elderly. When the narrowing gets too severe, symptoms such as loss of breath, angina and fainting can occur, so called symptomatic aortic stenosis. Since the 60's, surgical aortic valve replacement (sAVR) has been the treatment of choice for severe aortic stenosis. A large setback of this method is that a third of these patients could not undergo the treatment due to too high surgical risk.

Transcatheter aortic valve implantation (TAVI) have steadily gained ground in the treatment of severe aortic valve stenosis during the last decade. The procedure, which is a minimal invasive type of surgery, introduces a new aortic valve through a catheter, usually transfemorally. Patients with an underlying coronary artery disease (CAD) undergoing sAVR is known to have higher mortality rates postoperatively. However, it is not clearly known how an underlying CAD affects the long term results after a TAVI-surgery. It is therefore our goal to contribute with the mapping of how a CAD affects the long term results for patients with a severe aortic valve stenosis that undergoes TAVI.

Eligibility Criteria:
Inclusion Criteria:

* All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019.

Exclusion Criteria:

* Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from the study.
CORona (COVID-19) Follow Up Study: Epidemiology, Pathophysiology, Prediction, and Communication

The CORFU study, funded by ZonMW, is a prospective, multiple, cohort study with a maximum follow-up of 24 months after COVID-19. Dutch COVID-19 patients from 7 existing prospective cohorts, aiming and designed to conduct COVID-19 research, will be included in this study.

The CORFU study has 5 aims, divided into 4 work packages (WPs):

1. To describe the nature, severity, pattern and duration of long COVID complaints up to a maximum of two years after infection and its relationship with quality of life (WP1);
2. To describe the rehabilitation and corresponding activities for the treatment and improvement of complaints and quality of life (WP1);
3. To describe the pathophysiological processes that cause long COVID complaints, and the role of vulnerability/resilience factors (WP2);
4. To develop a prediction model for the persistence of complaints, with distinction between patients with and without pre-existing morbidity (WP3);
5. To develop a patient platform prototype in which patients can digitally consult their answers and compare their answers with reference populations (WP4, in collaboration with the EuroQol foundation).

The 7 cohorts participating in the CORFU study are: POPCOrn, COVAS, ELVIS, MaastrICCht, DC\&TC, CAPACITY-COVID, and Adelante cohort.

(Clinical) baseline and follow-up data has been collected in these cohorts and will be used/aggregated to investigate CORFU study aims. In addition, questionnaires will be send to the (former) patients of the existing cohorts and patients will be asked about several domains such as persisting complaints and quality of life, at several moments, depending on when the patients have experienced COVID-19. Within this study a patient platform prototype will be developed, together with the EuroQol foundation, to be able to inform patients about the individual situation and course of disease.


Eligibility Criteria:
All 7 existing cohorts have specific inclusion and exclusion criteria.

For the CORFU study, in general, the criteria are:

Patients with proven or suspected COVID-19:

* Confirmed (or suspected) COVID-19 - both home-isolated patients and patients who were admitted to the hospital ward and/or ICU;
* Included in one of the seven cohorts from March 2020 onwards;
* Aged 18 years or older;
* Mastering the Dutch language sufficiently to answer the questionnaires;
* Informed consent.

Controls who did not experience COVID-19:

* Aged 18 years or older;
* Mastering the Dutch language sufficiently to answer the questionnaires;
* Informed consent.

There were no exclusion criteria.
Brief Integrative Alcohol Interventions for Adolescents

The primary aim of this research is to test the efficacy of innovative, brief alcohol abuse prevention strategies that integrate positive youth development messages and health risk messages for adolescents in high school settings. A secondary aim is to examine these strategies in various combinations as interventions and re-interventions (i.e., boosters) for sustaining or enhancing behavior change over time. These strategies are founded upon an emerging conceptual framework titled the Behavior-Image Model emanating from findings of our recent trials examining multiple behavior health interventions. The long-term objective of this project is to reduce alcohol abuse and problems among older high-risk adolescents for whom alcohol and drug use disparities exist, yet who are often overlooked in prevention research and services.

A total of 921 adolescents from two diverse high schools in northeast Florida were randomized to receive either the: 1) in-person consult, 2) parent-youth letter, 3) adolescent newsletter, or 4) standard care control . Three-month, one-year and 18-month follow-ups are planned, with interventions to be implemented in rotating fashion as re-interventions immediately after three-month and one-year data collections. Plans for following year include the following: 1) collecting and analyzing 3-month post-intervention data to determine the effects of the initial consult, parent-youth and adolescent print strategies, intervention costs, and assess possible mediators and moderators of outcomes; 2) implementing the first round of re-interventions; 3) collecting and analyzing one-year post-baseline effects of re-interventions, determining costs and cost-effectiveness of the interventions/re-interventions, and assessing possible mediators and moderators of outcomes; and 4) implementing the second round of re-interventions.

Eligibility Criteria:
Inclusion Criteria:

* Can read English
* 10th and 11th grade high school students at participating sites

Exclusion Criteria:

* Cannot read English
* Not in 10th and 11th grade high school students at participating sites
Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors plan treatment and help patients live more comfortably.

PURPOSE: This observational epidemiologic cohort is designed to study arthralgia, patient-reported outcomes, and medication adherence in postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors.

OBJECTIVES:

Primary

* Estimate the incidence, time to onset, prevalence, and clinical and demographic predictors of arthralgia in post-menopausal women with early-stage breast cancer receiving aromatase inhibitors (AI).
* Chart the trajectory of arthralgia symptom severity over the course of AI treatment in these patients.

Secondary

* Measure the impact of arthralgia on sleep quality, depression, and physical function in these patients.
* Develop a roster of current physician-advised or prescribed treatments, including self-management techniques being used for AI-induced arthralgia, for intervention development.

OUTLINE: Patients complete questionnaires about joint pain and stiffness, sleep, depression, physical function, medications and treatment, exercise and social support, demographics, comorbidities, body mass index (BMI), and performance status at baseline and then periodically for approximately 1 year after beginning aromatase inhibitor (AI) therapy.

Patient medical records are reviewed for comorbidities, BMI, use of prior hormone replacement therapy, vitamin D levels and deficiency, performance status, histological stage, prior treatment, and medications at baseline and then periodically for approximately 1 year after beginning AI therapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Planning to begin aromatase inhibitor (AI) therapy or taken fewer than 10 doses of adjuvant AI therapy
* Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

* Postmenopausal
* ECOG performance status 0-1
* Able to understand and respond to questions in English
* No condition that would impair the ability to provide informed consent
* No other non-breast cancer condition

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No more than 9 prior doses of AI
Clinical Performance of Nanohybrid Resin Composite Lined With PRG Barrier Coat Compared to Resin Modified Glass Ionomer in Class V Carious Cavities Over 18 Months: Randomized Clinical Trial

Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Class V carious lesions will be restored using two different restorative materials either resin modified glass ionomer or nanohybrid resin composite lined by PRG barrier coat.Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 3 months, 6 months, 12 months and at 18 months. The restorations will be clinically examined according to modified USPHS criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years Males or females. Patients with untreated cervical carious lesion that need restoration. Participants available for recall Patients with moderate to high caries risk

Teeth Inclusion Criteria No spontaneous pain Absence of tooth mobility

Exclusion Criteria:

* Patients with para-functional habits Experience with allergic reactions against any component of used materials. Teeth Exclusion Criteria Non-vital teeth Teeth with orthodontic appliance Teeth with advanced periodontal diseases.
The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass

This study evaluates the enhanced recovery after surgery (ERAS) concept over conventional postoperative care in patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass. Half of participants will adherence to the ERAS, while the other half will under the conventional postoperative care.

Enhanced recovery after surgery (ERAS) or fast-track surgery is a perioperative and postoperative care concept initiated in the early 1990s aiming to reduce the length of hospital stays following elective abdominal surgery. The success of ERAS depends highly on multidisciplinary teamwork and patient compliance.

This study intends to compare the Enhanced Recovery After Surgery (ERAS) concept applied to patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass under traditional perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an effective perioperative management during cardiopulmonary bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely.

Eligibility Criteria:
Inclusion Criteria:

* Heart function grade II - III (Using the cardiac function classification method formulated by American Heart Disease Institute)
* The in - hospital was treated with extracorporeal circulation operation and general anesthesia.
* Had a good cognition, and signed the informed consent.
* Aged between 18 and 70.
* The age, clinical examination and other generally situation of the two groups of patients had no statistical significance.

Exclusion Criteria:

* Combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease.
* Patients with severe mental disorders cannot cooperate with the treatment.
* Emergency operation
* Have taboo of Echocardiography and pulmonary catheterization by echocardiography.
* Patients have been fitted with a pacemaker.
* Allergic to erythropoietin.
* Suspected or had alcohol, drug abuse history.
* Spinal deformity or paravertebral lesions.
High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture

The purpose of the study is to compare between the efficacy of high intensity LASER therapy and scapular stabilization exercises on ventilatory functions in forward head posture patients

Neck pain is a common complaint in the population, with a considerable impact on individuals and their families, communities, health-care systems and businesses. The estimated 1-year incidence of neck pain ranges between 10.4 and 21.3%, and the overall prevalence of neck pain in general population can be as high as 86.8%.

The photothermic and the photochemical effects of high intensity LASER therapy may increase blood flow and stimulate collagen production within tendons; in addition, high intensity LASER therapy may increase vascular permeability and has an anti-inflammatory effect, thus removing the pain stimulus.

Scapular stabilization exercise is used as an effective way to recover the imbalance in posture and the muscles. It is also effective in increasing muscle activation in the serratus anterior and lower trapezius, through decreasing the compensatory movement, which is caused by the forward head posture, and in decreasing muscle activation on the upper trapezius. Furthermore, it brings about a spinal curve change and upper crossed syndrome improvement.

Therefore, this study will compare the difference between the effect of high intensity laser therapy and scapular stabilization as a modality of treatment on ventilatory function in forward head posture patients.

Eligibility Criteria:
Inclusion Criteria:

1. Their ages ranged from 30 -40 years.
2. All patients were diagnosed with forward head posture. - Diagnostic criteria for forward head posture by craniovertebral angle that detected by radiography and was less than 49° using specific goniometer.
3. Patients with abnormal values of decreased Forced vital capacity (FVC), forced expiratory volume at one second (FEV1), FEV1/FVC, MVV and TLC due to forward head posture.
4. All patients are medically and psychologically stable
5. They had a score more than 40% at neck disability index.

Exclusion Criteria:

1. Patients who had congenital anomalies in the neck and the thoracic cage.
2. Patients with pulmonary diseases (with restrictive lung disease or with obstructive lung disease).
3. Patients with BMI \> 30 kg/m2.
4. patients with Contraindications for HILT: malignancies and potential precancerous growths, patients with cochlear implants, endocrine glands disease, patients with febrile conditions, epilepsy, pregnancy, freckles or tattoos, photosensitive medication.
5. Uncontrolled diabetes.
SoundBite Hearing System Long Term Multi Site Patient Use Study

This study is designed to collect data about the SoundBite™ Hearing System to answer specific questions. The hearing system has been cleared for commercial distribution by the Food and Drug Administration (FDA). Sonitus hopes to learn from a larger group of users what features and settings of this device provide the best hearing ability for people diagnosed with Single Sided Deafness (SSD) or Conductive Hearing Loss (CHL).

The Sonitus SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus SoundBite Hearing System consists of an In the Mouth (ITM) component an external microphone component, worn behind the ear (BTE), a calibration interface cable and PC-controlled calibration software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this multi-sites observational study is to assess the long-term patient use of the Sonitus SoundBite Hearing System.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years or older
* Clinical diagnosis of a Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL)
* Patients diagnosed with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL.
* At least two contiguous molar or premolar teeth with no untreated tooth decay. -Patients with tooth decay present are to first have restorations before being fitted for SoundBite
* Healthy attachment to those teeth with tooth pockets limited to no more than 5mm
* No mobile teeth
* Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn.

Exclusion Criteria:

* The SoundBite Hearing System and all portions of it are contraindicated for use in an MRI Environment and should be removed prior to MRI exposure
* The SoundBite Hearing System is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers.
* The SoundBite Hearing system is contraindicated for vulnerable populations that are unable to sue their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.
IMPACT OF KIDNEY FAILURE ON THE REGULATION OF HUMORAL RESPONSE TO VACCINATION

The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.

Researchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.

Participants will:

* Be enrolled at the time of influenza vaccination
* Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination
* Be asked to provide relevant clinical information and a blood sample at each visit


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Patients undergoing thrice-weekly hemodialysis / peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency
* Subjects eligible to receive a seasonal influenza vaccine
* Signed informed consent for participation in the study

Exclusion Criteria:

* Recent influenza infection (clinically resolved less than 3 months ago).
* Administration of immunosuppressive drugs in the two weeks prior to vaccination.
* Administration of another vaccine in the three weeks prior to enrollment (co-administration of other vaccines with those under study does not contraindicate participation).
* Systemic infection clinically resolved less than two weeks before enrollment.
Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced Lung Cancer

The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced NSCLC (IIIB/IV) and extensive disease SCLC with pathology/cytology record between 1-Dec-2013 and 30-Nov-2014
* Received inpatient treatment more than twice (inclusive) at a selected site. For hospitals with outpatient records, patients receiving oral TKI therapy and routinely (more than twice a year) followed up outpatient will be included although no inpatient records. For hospitals with outpatient chemotherapy center, patients will be include if they were prescribed with chemotherapy and routinely (more than twice a year, inclusive) followed up outpatient in the hospital
* 18 years of age or older at initial diagnosis of IIIB/IV NSCLC and extensive disease SCLC

Exclusion Criteria:

* Patients who have participated in or are attending clinical trials receiving active LC therapy
* Unknown initial diagnosis time and initial treatment time.
* For hospitals without outpatient chemo therapy center, patients who were prescribed with chemo therapy but with no inpatient records will be excluded
* Patients who received inpatient therapy for one time and were not routinely (more than twice a year, inclusive) followed up outpatient will be excluded

Other protocol defined inclusion/exclusion criteria could apply