cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.

To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital.

Background: Hyponatremia is the most common electrolyte imbalance in clinical practice, associated with increased mortality and length of stay. In 2014,European guideline have recommended promp infusion of 3%NaCl 150 ml in 20 minutes to raise plasma Na to 5 mmol/L and improve symptoms. The recommendation was the result of studies with small numbers of patients, and expert opinions.

Methods: A single center opened-label randomized controlled-trial,we will randomly assign 40 patients with severe symptomatic hyponatremia (plasmaNa\<125mmol/L) in Rajavithi Hospital into two groups:

First group receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and follow plasma sodium until achieve target of goal plasma sodium = 5 mmol/L in 6 hours (no more than 12 mmol/L in 24 hr and 18 mmol/L in 48 hr),another receive traditional continuous drip of 3%NaCl start with rate = 1ml/kg/hr and follow plasma sodium every 1 hour until achieve target of plasma sodium 5 mmol/L in 6 hours .The primary end point is change in plasma sodium in 6 hours and improvement of glasglow coma scale.The secondary end points are change in plasma sodium in 24,48 hours,overcorrection rate in 24 and 48 hours ,ODS rate ,hospitality days and mortality rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients in Rajavithi Hospital
* Age from 18 years
* Plasma Na \< 125 mmol/l with glucose-corrected
* Severe symptomatic hyponatremia (Vomitting ,Coma ,Somnolence)

Exclusion Criteria:

* Systolic BP \< 90 mmHg Or MAP\< 70 mmHg
* Pregnancy or Lactation
* Congestive Heart Failure or Volume overload
* Lung congestionfrom CXR
* Chronic renal failure patients with edema
* Cirrhosis patients with edema
* Patients with coronary artery disease
* Patients with brain injuries
* Deny consent
The Effects of Dairy Products on Energy Balance

The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* men and women,
* medium overweight (body mass index 28-36 kg/m2),
* 18-60 years old,
* low habitual calcium intake (\<800 mg/d)

Exclusion Criteria:

* milk allergy, infection diseases and diabetes,
* intake of dietary supplements,
* smoking,
* pregnancy and/or breast feeding,
* any medications known to affect the outcome measurements,
* weigh reducing diet,
* gastrointestinal diseases,
* participation in other intervention studies
Comparing X-3 To N2vac Polyethylene With the Triathlon Total Knee System

Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system.

Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total duration

Multi-centre study

Objectives

Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when X3 polyethylene components are used to the same knee system when N2Vac components are used.

Secondary: To compare pain, function, radiographic outcomes, and health related quality of life of subjects in both treatment groups. Safety will be assessed by comparison of adverse events between the groups.

Number of Subjects 384 cases (197 each group)


Eligibility Criteria:
Inclusion Criteria:

* The subject requires a primary cemented total knee replacement.
* The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
* The subject has intact collateral ligaments.
* The subject has signed the ethic committee approved, study specific Informed Patient Consent Form.
* The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* The subject has inflammatory arthritis.
* The subject is morbidly obese, BMI \> 40.
* The subject has a history of total or unicompartmental reconstruction of the affected joint.
* The subject has had a high tibial osteotomy or femoral osteotomy.
* The subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
* The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
* The subject is immunologically suppressed, or receiving chronic steroids (\>30 days duration).
* The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
* The subject has had a knee fusion at the affected joint.
* The subject has an active or suspected latent infection in or about the knee joint.
* The subject is a prisoner.
Exercise Training in Postmenopausal Patients With Breast Cancer

This randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program.

All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized.

All patients are to receive identical counseling for ideal nutritional, life-style and physical activity.

Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Postmenopausal women with hormone receptor positive breast cancer (as defined by HR \>= ++ and/or PR \>= ++) who are treated with aromatase inhibitors
* ECOG performance status \<= 2
* all age groups

Exclusion Criteria:

* Pathologic ergometry
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* COPD \> II
* Active opportunistic infection
* NYHA heart failure III or IV
Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease

The purpose of this research study is to learn if a very low carbohydrate (sugar) diet or traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux disease (GERD) in people who are overweight. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. In this study, the investigators also hope to find out if acid in the esophagus is reduced more by a low carbohydrate diet than a low fat diet.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old
* BMI between 30 kg/m2 and 45 kg/m2

Exclusion Criteria:

* Known history of Barrett's esophagus or esophageal adenocarcinoma
* Previous surgical anti-reflux procedure
* Previous weight loss surgery, including gastric bypass
* Diabetes
* Pregnancy
* Heart Disease
* Unwillingness to discontinue use of proton pump inhibitors (PPI's) or H2-receptor antagonists per study protocol
Ultrasound and Psychobiological Correlates of Female Sexual Function

Monocentric pilot interventional study. The aim of the study is to assess clitoral doppler ultrasonographic parameters in a population of sexually healthy volunteer women in order to obtain reference values. Psychobiological correlates of female sexual function will also be studied through hormonal testing and psychological evaluation.


Eligibility Criteria:
Inclusion Criteria:

* sexually healthy
* evidence of a personally signed and dated informed consent.

Exclusion Criteria:

* any uncontrolled or unstable, acute or chronic disease
* alcohol or drugs abuse
* sexual dysfunction
* any overt psychiatric or psychological condition assessed through psychological evaluation and/or self-administered validated questionnaires.
Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea

Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type I - IIII
* Self-identified rosacea or no history of flushing/blushing for controls
* Able to provide medical history and list of medications -- control subjects will not be allowed to take medications that are known to be photosensitizers.

Exclusion Criteria:

* Using imipramine, amitriptyline or any other tricyclic antidepressant (oral or topical)
* Using topical anti-inflammatory (within 1 week) or systemic agents (e.g. prednisone)
* Large tattoos in the designated testing areas
* Tanning bed use within last 3 months
* Photodynamic Therapy or UCB treatments in past 3 months
* Female Subjects: pregnant or nursing
A Pilot Study to Evaluate the Role of High-dose Ranibizumab (2.0mg) in the Management of AMD in Patients With Persistent/Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy (the LAST Study)

This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to their treatment assignment.

The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 50 years
* Subfoveal neovascularization secondary to AMD
* Best corrected visual acuity in the study eye between 20/30 to 20/400 using an ETDRS chart
* Documentation of the presence of subretinal fluid and/or cystoid macular edema on SD-OCT less than 30 days following at least six months of anti-VEGF therapy
* Presence of fibrosis, hemorrhage, or other hypofluorescent lesions should not obscure greater than 50% of the CNV lesion

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Participation in another simultaneous medical investigation or trial
* Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL
* Prior treatment with triamcinolone in the study eye within 6 months of BSL.
* Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
* Past treatment with PDT or thermal laser in the study eye
* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding BSL
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous hemorrhage in the study eye
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
* History of allergy to fluorescein, not amenable to treatment
The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children

Background: How best to improve iron status among infants in low-income settings is of continued concern in many countries, including Brazil

Objective:

Design: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with 23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on the correct dosage of iron drops and to feed their children (including whether and how much rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and at 5 mo.


Eligibility Criteria:
Inclusion Criteria:

* anemia

Exclusion Criteria:

* non anemic
Fase I Clinical Trial on NK Cells for COVID-19

Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available.

This study aims to investigate the safety and efficacy of intravenous infusion of natural killer cells patients with COVID-19.

In March 2020, the World Health Organization secreted COVID-19 as a pandemic. Although most infected individuals can develop effective immunity, the population at risk (elderly, obese and individual with comorbidities) develop a rapid and frequently fatal disease, with severe acute respiratory syndrome, cytokine storm and coagulopathies; for those who recover, severe pulmonary sequels are frequently observed. We propose a phase I clinical trial to test safety and feasibility of NK cells adoptive immunotherapy for COVID-19. Natural Killer cells are innate granular lymphocytes able to rapidly recognize and kill, without previous exposition, altered cells; it is widely recognized as immune effectors specialized in lysing virus infected cells releasing antigens and activating cytokines to antigen presenting cells and, by doing so, stimulating effective adaptive immunity. We hypothesize that the early infusion of highly activated NK cells will activate adaptive immune effectors preventing the severe clinical evolution of COVID-19 infection. Adoptive NK cell immunotherapy for severe virus infections is innovative. Our proposition is in line with the Brazilian Public Health system purposes, which is to offer secure and effective therapies for all COVID-19 infected individuals. Upon proving NK cell immunotherapy effectiveness for serious virus infections, we can evolve to test this strategy for common viruses that cause epidemics and endemics such as the ones caused by Dengue, Zika, Chikungunya, C and B hepatitis and HIV.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR);
* The patient or legal donor agrees to participate in the study and signs the informed consent;
* Patients with white or yellow criteria according to the score proposed by Liao et al (2020).

Exclusion Criteria:

* Patient with pregnancy, are planning to become pregnant or breastfeeding;
* Patients with malignant blood-borne diseases such as HIV or syphilis;
* Not consenting for clinical trial;
* Patients with other than white or yellow criteria according to the score proposed by Liao et al (2020).
Alpha MSH in Ocular Disease

The purpose of this study is gain a better understanding of a molecule called alpha melanocyte stimulating hormone (alpha MSH) and its potential role in your retinal disease. Alpha MSH has been shown to have an important role in the regulation of ocular immunity in animal models of inflammatory retinal diseases and retinal dystrophies, and there may be a protective effect of alpha MSH. By studying the levels of alpha MSH in your eye we may better understand its role in advanced dry macular degeneration. By studying the levels of this molecule we hope to better understand if it may be a good target for future treatment.

A small amount (0.1 mL) of aqueous humor would be removed from the study eye in the clinic setting. This sample will be processed and then sent off for measurement of alpha MSH levels.

Eligibility Criteria:
Inclusion Criteria:

* 60 years or older
* diagnosis of advanced dry macular degeneration with foveal geographic atrophy
* limited vision or blindness (20/100 or worse) in that eye
* pseudophakia (prior cataract surgery in that eye)

Exclusion Criteria:
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening.
* Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening.
* Both cohorts match by age, gender, race and CFTR genotype severity.

Exclusion Criteria:

* No prior solid organ transplantation
* No initiation of an investigation drug within 28 days prior to and including Visit 1
* No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1.
* No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including Visit 1.
* For the BIA sub-study - Individuals with an implanted pacemaker will be excluded.
* No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit.
* Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.
Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia After Elective Laparoscopic Cholecystectomy

This study aimed to assess the efficiency of dexmedetomidine against magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia in individuals having elective laparoscopic cholecystectomy.

Pain after laparoscopy is less intense than after laparotomy, but laparoscopy is not pain free and analgesia after this type of surgery is inadequately studied. Intraperitoneal (IP) instillation/nebulization of local anesthetics has been used as a method for reducing postoperative pain and opioid use following laparoscopy through acting on visceral nociceptors of the peritoneum.

Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. It is available mixed with a small amount of epinephrine to increase the duration of its action. It typically begins working within 15 minutes and lasts for 2 to 8 hours.

Dexmedetomidine is a selective alpha-2 (α2) adrenergic agonist known to have analgesic and sedative characteristics that can augment the duration of action of local anesthetics.

Magnesium is an N-methyl-D-aspartate receptor antagonist in addition to its effects on calcium influx. The anti-inflammatory and opioid-sparing effects make it a popular component of opioid free anaesthesia. It is extensively used for perioperative analgesia in a dose of 30- to 50-mg/kg intravascular bolus followed by a 10- to 15-mg/kg/h infusion.

Eligibility Criteria:
Inclusion Criteria:

* Age from 21 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) class I-III.
* Scheduled to undergo elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Patient refusal.
* Body mass index ≥40.
* Allergy to the study drugs.
* Advanced cardiac, renal and hepatic diseases.
* Patients with peritoneal drain or peritoneal wash after surgery.
* Uncooperative patients.
* Chronic pain medications.
* Hypomagnesaemia or hypermagnesaemia.
Airway Microbiota Based Treatment of Asthma in Preschool Children

Airway microbiota pattern may related the preschool asthma exacerbation. This is a single-center, randomized-controlled trial, the study will compare the management of preschool wheeze determined by airway microbiota phenotype and blood eosinophils level to the management using current clinical guidelines.

In this study, participants will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of two treatment groups, either current clinical care or airway microbiota and blood eosinophils phenotype based management for 3 months.They will be followed up for one year after the intervention. The primary outcome is the frequency of unscheduled healthcare visit for wheezing, the secondary outcome parameters are events of severe wheezing requiring oral or intravenous steroids, events of emergency department visit and hospital admissions, the changes of Test for Respiratory and Asthma Control in Kids (TRACK) score and Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) score.

Eligibility Criteria:
Inclusion Criteria:

* physician diagnosed recurrent wheeze（at least 3 episodes of wheezing or at least one course of oral steroids in the last 6 months）

Exclusion Criteria:

* Any congenital heart disease diagnosed by a physician
* Any chronic respiratory condition other than preschool wheeze (bronchopulmonary dysplasia, bronchiolitis obliteran, congenital airway and lung malformations, bronchomalacia, chronic aspiration) diagnosed by a physician
* Received antibiotic last 6 weeks
Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement

The aim of this study is to assess the effect of systematic lateral retinacular release on anterior knee pain, as well as its impact on the functional and radiological outcomes after total knee arthroplasty with patellar resurfacing.

Anterior knee pain is an important cause of persistent pain after total knee arthroplasty. Lateral retinacular release has been proposed as a procedure to prevent anterior knee pain syndrome, based on the reduction of lateral tension and improving patellar tracking.

However, its effect on anterior knee pain after total knee arthroplasty is not clear when it is not strictly needed to correct maltracking.

The purpose of this trial is to evaluate the effect of systematic lateral retinaculare release on anterior knee pain, peformed during a total knee arthroplasty with patellar resurfacing.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of knee osteoarthritis

Exclusion Criteria:

* prior major surgery on the same knee (high tibial or distal femoral osteotomy, patellar realignment)
* important preoperative malalignment (varus or valgus \>15º or flexion deformity \>15º)
* inability to sign informed consent