cyrilzakka/clinical-trials huggingface dataset:
Impact on Functional Status in Older Adults Treated With L-Carnitine

This study evaluates the impact of the treatment with L-Carnitine on the function of adults over 65 years, in conjunction with regular exercise. Simple randomization will be performed, distributing patients in 3 treatment groups, with L-Carnitine or Placebo, and with physical exercise at home or supervised.

The supplemental intake of L-carnitine improves the physical functioning of the pre-fragile and fragile elder of the community.

Circulating L-carnitine levels increase after administration of the supplement. The impact on the function of L-carnitine in combination with physical exercise will be studied in a population of older adults in Montevideo.

The sample will be divided into 3 groups, according to the intervention:

Group 1: Patients who will receive L-Carnitine in addition to a manual to perform physical exercise at home.

Group 2: Patients receiving L-Carnitine plus supervised exercise plan. Group 3: Patients receiving placebo and supervised exercise plan. All three groups will be evaluated for functional and anthropometric parameters: prior, during and after intervention. In addition, the dosage of L-carnitine and acetylcarnitine will be evaluated before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet at least 2 criteria for the fragility phenotype of Linda Fried
* Ability to comply with aerobic physical activity of moderate intensity and basic resistance.
* Not depressed patients (Yesavage \<5 in patients without previous depression or Hamilton \<7 in patients in treatment for depression)
* MMSE (Mini-Mental State Examination) greater than 24 points.
* Independent or mildly dependent patients, Barthel\> 95 points.
* Patients without visual disturbances or with decreased visual acuity corrected.
* No pain or with VAS (Visual analogue scale) \<3/10.
* Patients without nutritional risk, MNA (Mini Nutritional Assessment \> 23.5 / 30 points) and BMI (Body Mass Index) \> 23 kg / m2.

Exclusion Criteria:

* Absolute contraindications for performing physical exercise: recent AMI or unstable angina, uncontrolled hypertension, acute HF and complete AV block.
* Patients with osteoarticular pathology that limits their physical activity.
* Previous neurological pathology (Stroke, Enf. Of Parkinson's).
* Acute or chronic diseases decompensated or with lymphedema that makes difficult the accomplishment of the bioimpedanciometry.
* Patients using orthopedic devices and prostheses or pacemakers that interfere with gait or impede the achievement of bioimpedanciometry.
* BMI less than 23 and / or an involuntary weight loss of 3kg or more in the last 3 months.
* Psychiatric disorders that hinder adherence to treatment.
* Moderate to severe Chronic Renal Disease
* Patient who does not agree to participate in the study.
Risk Factors of Outcomes Associated With Disease Progression in Patients With Atrial Fibrillation and Heart Failure (HF) Who Are Receiving a Direct Oral Anticoagulant (Rivaroxaban)

Evaluation of the risk factors associated with Heart Failure (HF) worsening (measured by hospitalizations and emergency visits because of HF exacerbations) in Spanish patients with Atrial Fibrilation and HF treated with rivaroxaban.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females aged 18 years or older.
* Patients with a diagnosis of nonvalvular Atrial Fibrilation (AF).
* Patients with a diagnosis of chronic Heart Failure, New York Heart Association (NYHA) class I-IV HF with preserved Ejection Fraction (HFpEF), HF with reduced EF (HFrEF) or HF with mid-range EF (HFmrEF).
* Patients receiving antithrombotic treatment because of AF, with rivaroxaban since at least 4 months before entering the study.
* Patients who have been given appropriate information about the study objectives and procedures and with the mental and physical capacity to give their informed consent to participate in the study.

Exclusion Criteria:

* Patients participating in a research program which involves some intervention beyond clinical practice.
* Patients who started rivaroxaban after the start of the inclusion period.
* Patients with significate mitral stenosis or other heart valvular diseases that requires or have needed specific treatment (prosthesis or valvuloplasty).
* Patients with severe cognitive impairment.
Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.

To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have traditionally been minimized with overnight fasting. However, prolonged fasting can also have some adverse consequences and has been abandoned for some procedures in several patient populations with the exception of obese and/or diabetic patients. The aim of this study was to assess RGV in morbidly obese diabetic patients after traditional or abbreviated fasting.

Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic.

All the endoscopic procedures began at 9 AM, and were performed by the same board-certified endoscopist, JMS, who was blinded as to the duration of the fast. The endoscopies were conducted at Gastroclinica, Cuiaba, MT, in the period from April to June, 2013. Sedation was performed by a board-certified anesthesiologist, who was also blinded as to the duration of the fast. The anesthetic regimem included a intravenous bolus of 2 ml of lidocaine hydrochloride (Astra Zeneca, São Paulo, Brazil) followed by 100 to 150mg of propofol before endoscopy. Digital oximetry was monitored throughout the procedure. Patients were positioned in the lateral recumbent position. A flexible electronic videoendoscope (EG2770K; Pentax Corporation, Tokyo, Japan) of 9 mm in outer diameter was used. The main outcome variable was the RGV measured by the endoscopist after aspiration of gastric residue.

Eligibility Criteria:
Inclusion Criteria: patients between 18 and 55 years of age, of both sexes, with Body Index Mass (BMI) which is equal or greater than 40 Kg/m2, and type II diabetic that were using oral drugs or insulin to control the disease.

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Exclusion Criteria: patients who were using medications for gastrointestinal symptoms and/or who had prior abdominal operations.

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Rhythmically Entrained Exercise in Community-Dwelling Older Adults

Researchers at the University of North Carolina at Greensboro conduct a single-arm intervention trial to investigate the efficacy of a music-based group exercise program for community-dwelling older adults. Up to forty participants will be recruited to participate in a music-based light-to-moderate intensity group exercise program for 20 weeks (30 - 40 min/day, up to 6 days/week), which is designed for older adults with or without functional limitations to exercise with chairs for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace. During the exercise sessions, participants will be trained to move in time with music playlists in synchronous tempos. Primary outcomes are cognitive performance, mobility, and health-related quality of life measured before and after the intervention. Secondary outcomes are adherence to the exercise program as a potential mediator of the treatment.

Researchers at the University of North Carolina at Greensboro are conducting a single-arm intervention trial to investigate the efficacy of a music-based group exercise program for community-dwelling older adults. Up to forty participants will be recruited to participate in a music-based light-to-moderate intensity group exercise program for 20 weeks (30 - 40 min/day, up to 6 days/week), which is designed for older adults with or without functional limitations to exercise with chairs for the improvement of aerobic capacity, upper and lower body strength, and balance control at a gradually increasing pace. During the exercise sessions, participants will be trained to move in time with music playlists in synchronous tempos. Primary outcomes are cognitive performance, mobility, and health-related quality of life measured before and after the intervention. Secondary outcomes are adherence to the exercise program as a potential mediator of the treatment. The research team aims to determine whether (1) a music-based light-to-moderate intensity group exercise intervention beneficially impacts mobility, cognitive function, and health-related quality of life in community-dwelling older adults; (2) the treatment effect is mediated by adherence to physical activity; and (3) the treatment effect is moderated by cognitive impairment or functional limitations.

Eligibility Criteria:
Inclusion Criteria:

* 55 - 99 years old
* Capable of being ambulatory with or without an assistive device.
* No cardiac or pulmonary conditions or any neurological or musculoskeletal comorbidity or pain that would make light-intensity exercise dangerous, determined by the Physical Activity Readiness Questionnaire for Everyone or confirmed by their local medical practitioner if necessary.
* Having adequate hearing for a conversation (including with hearing aids)
* Capable of following the study procedures
* No severe anxiety or depression
* Mild to moderate cognitive impairment

Exclusion Criteria:

* Age younger than 55 or older than 99
* Severe anxiety or depression
* Severe cognitive impairment
COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses

The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.

This study is to analyse the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.

The study aims to validate strategies to measure antibody levels with minimal intervention and to explore the antibody response and technical capacity for said measurement. The study will collect the minimally necessary samples to deduce a strategy for serum or saliva surveillance of the population of the canton Baselland. To achieve this, the study is designed to address the following points:

* determine specificity, sensitivity and general utility of point of care (POC) and ELISA tests to deduce a strategy for serum surveillance of the population of the canton Baselland
* especially validate different POC kits in regard of their use for continuous surveillance
* gain an understanding of seroconversion and antibody levels of patients and survivors
* gain an understanding of the individual antibody and T-cell repertoire of patients and survivors
* study whether patterns of convergent antibody evolution is generated in the surviving population or whether the diseases survivors generated an antibody pool recognizing a specific epitope
* develop the technology to correlate blood antibody levels with levels detected in the saliva
* develop high throughput technologies for the precise detection of immune cell Repertoire and binding epitopes

Eligibility Criteria:
Inclusion Criteria:

* tested positive for COVID-19 in Baselland
* tested negative for COVID-19 in Baselland. Specifically, needed to show symptoms to be able to deduce cross reactivities.

Exclusion Criteria:

* continuous steroid therapy / chemotherapy / immunsuppressiva
* subject is treated for cancer
* severe autoimmune disease
Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients

Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 68 years of age
* Confirmed diagnosis of Multiple Sclerosis
* Clinical history of pseudobulbar affect

Exclusion Criteria:

* Sensitivity to quinidine or opiate drugs
* Recent diagnosed within 2 months with Multiple Sclerosis
* Patient on anti-depressants
* Patient with liver or kidney disease
* Patient with hypotension
Using a Cartoon Questionnaire to Improve Consent of Children

In this study, a prospective, multicenter, randomized, and controlled trial will be performed to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation.

In this study, we will evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation. A prospective, multicenter, randomized, and controlled trial will be performed at some hospitals in China. Three hundred children will be randomly asked to participate in our survey to investigate the participants' willingness and attitudes for donating biospecific nonspecimen specimen.The participants will be randomly allocated to the AACQ group and the text questionnaire (TQ) group. A separate knowledge test to assess the amount of knowledge acquired is included in the questionnaires. Additionally, participants' demographic data and basic information will be also collected. In our present study, we aim to test whether an audio and animated cartoon could help the child to understand the information about our research of biospecific nonspecimen specimen donation, reduce differences in their understanding, and use that information to make an appropriate decision for themselves. Meanwhile, we will exam factors that may influence a Chinese child's willingness to donate biospecific nonspecimen specimen before pediatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients without obvious communication difficulties in the pediatric surgery wards were invited to participate in this survey.

Exclusion Criteria:

* Patients with obvious communication difficulties
Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants

Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).


Eligibility Criteria:
Inclusion Criteria:

* Born with up to 32(+6) weeks gestation
* Presence of hemodynamic insufficiency, defined as SVC flow \<51 ml/kg/min.
* Provision of signed and dated informed consent form by father/mother or legally designated representative, which can be given antenatally.

Exclusion Criteria:

* Neonates considered non-viable, with a clinical decision not to provide life support
* Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment
* Infants already on dobutamine treatment
* Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects)
* Infants with chromosomal anomalies
* Lack of parental signed informed consent
Complications of Mesh Procedures for Stress Urinary Incontinence

Complications from mesh procedures (i.e. insertion of tension-free vaginal tapes (TVT), trans-obturator tapes (TOT) and suprapubic slings (SS)) used during surgical treatment of stress urinary incontinence have caused major concern around the world.

The investigators aim to conduct a retrospective cohort study using administrative inpatient data from the Hospital Episode Statistics (HES) database to determine the complications of all first-time surgical mesh procedures in the treatment of stress urinary incontinence (SUI) in women treated in a National Health Service (NHS) hospital in England who were discharged from hospital between 1st April 2007 and 31st March 2015.

The primary outcome measure is the number and types of complications (occurring peri-procedurally, within 30 days of the mesh procedure and those occurring during follow-up). Additional outcomes recorded include: the numbers and types of mesh procedures, including those with potentially confounding concomitant procedures.


Eligibility Criteria:
Inclusion Criteria:

* Women with an Office of Population Censuses and Surveys Classification of Surgical Operations and Procedures 4th revision (OPCS-4) procedure code for an introduction of a Tension-free Vaginal Tape (TVT: M53.3), Trans-Obturator Tape (TOT: M53.6) or Supra-pubic Sling (SS: M52.1) surgical mesh procedure recorded in any of the 24 procedure fields captured in HES, and a recorded diagnosis of stress urinary incontinence based on International Classification of Diseases 10th revision (ICD-10) diagnoses: N39.3, N39.4, R32: T83.1, T83.4, T83.5, T83.6, T83.6, T83.8, T83.9, Z46.6, in any of the 20 diagnosis fields captured in HES.

Exclusion Criteria:

* Duplicate episode of care (exact match on patient identifier; admission date and method; discharge date, destination and method; hospital, gender, age, all procedure codes and all diagnostic codes)
* Male gender
* Missing age
* Aged less than 18 years
* Invalid or missing admission method
* Missing admission date
* Patients with recorded episodes of care in HES which appear after a reported date of death.
* Concomitant mesh surgery for pelvic organ prolapse surgery, or surgical mesh repair, removal, renewal or subsequent mesh insertion.
Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes

In a setting of acute cholecystitis (AC) one of the treatment option is percutaneous transhepatic cholangiography (PTHC) drainage. The goal of current study is to evaluate some radiology aspects and correlate with clinical patient outcomes in patients with acute cholecystitis severity grade III (presented as acute cholecystitis with organ dysfunction).


Eligibility Criteria:
Inclusion Criteria:

* clinical markers of acute cholecystitis
* diagnosis confirmed with some imaging technique: computed tomography (CT), ultrasound (US).

Exclusion Criteria:

* clinical diagnosis was not confirmed with imaging.
Functional Capacity in Anderson-Fabry Disease Patients

The goal of this observational study is to observe the relation between excercise parameters - assessed by CPET - and rest/stress hemodynamic parameters - assessed by echocardiogram and CMR - in patients with a genetic diagnosis of Anderson-Fabry Disease.

Participants will undergo:

* baseline evaluation: clinical evaluation, disease staging with FASTEX and MSSI, KCCQ for quality of life assessment, resting 12-leads ECG, 6MWT, CPET-ESE and contrast-enhanced CMR;
* before 36 months from baseline: resting 12-leads ECG, 2D rest and stress echocardiogram, CPET-ESE, contrast-enhanced CMR, disease staging with FASTEX and MSSI and KCCQ for quality of life assessment;
* up to 7 years from baseline: clinical follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a genetic diagnosis of AFD, according to current guidelines;
* Informed written consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care (for patients age \<18 years old, written consent from a caregiver is mandatory).

Exclusion Criteria:

* eGFR \<30 ml/min and other contraindications for CMR (relative controindication: patients with implantable device);
* Musculoskeletal limitation for exercise test on the cyclo ergometer;
* Pregnant or breastfeeding women;
* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a full comprehension of the written consent form.
Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals

The investigators aim to compare the clinical characteristics and outcomes of SLE between male and female Egyptian patients at Assuit University Hospital.

Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology and is characterized by a multifaceted clinical presentation and disease course. Female predominance is a well-known characteristic of SLE, particularly during the reproductive years. Sex differences are another peculiarity of SLE with respect to clinical manifestations and outcomes. Previous studies have recognized male patients with lupus as a distinct minority; such patients often exhibit a poorer prognosis, especially involving the renal, cardiovascular, and neurologic systems. Higher mortality rates in male than in female patients with SLE have also been reported. Andrade et al reported that multiple conditions (for example, severe skin lesions, serositis, thrombotic events, and seizures) are more frequent in males than females.

Lu et al investigated the frequency of renal failure and end-stage renal disease among both genders and found out that these conditions were more prevalent among males. Another study shows no difference in complications and prognosis between both genders.

The results of these previous studies may not be applicable to all ethnic groups. For example, Mok et al studied the males in the local Chinese population had different disease features in term of clinical features at diagnosis, rate, and severity of relapse, organ damage and cumulative damage score. They found through a retrospective review that at the time of diagnosis, there was a trend, however not statistically significant, that males had less Raynaud's, alopecia, arthritis, anti-Ro antibody, but more thrombocytopenia and discoid lesions. Also, a significantly higher number of males had impaired renal functions.

There are few studies that have assessed the differences between male and female Egyptian patients with SLE according to the presentation, complication, prognosis, and mortality. One of these studies shows a more aggressive disease detected in male patients. This was evident by a higher prevalence of nephritis, fever, cutaneous vasculitis in male patients. on the other hand, alopecia and arthritis were significantly higher in females.

Eligibility Criteria:
Inclusion Criteria:

• Any SLE patients between 18and 40 years old will be eligible to be included in our study.

Exclusion Criteria:

* Patients below the age of 18 or above 40.
* Any other autoimmune disease.
* Cardiovascular, neurological, renal complications due to other co-morbidity such as DM and HTN.