cyrilzakka/clinical-trials huggingface dataset:
Point-of-care Ultrasound for Clean-Catch Urine Collection in Young Children

Background:

The investigators recently evaluated a new bladder stimulation technique to obtain clean-catch urine in infants aged less than six months. In this study, the reported success rate was of 52%. Measuring the transversal bladder diameter prior to the procedure with emergency point-of-care ultrasound (ePOCUS) could likely increase success rates for this technique as it has been described for bladder scans prior to performing urethral catheterization.

Objective:

The aim of this study is to evaluate if using emergency point-of-care ultrasound to measure bladder volume improves clean-catch urine collection success in patients less than 6 months of age when compared to children undergoing this technique without a prior ultrasound.

Methods:

This will be a randomized controlled trial performed in a tertiary paediatric emergency department. Participants will include all infants younger than 6 months of age who need a urinary culture and/or analysis requested by the attending physician. The intervention will consist of the use of emergency point-of-care ultrasound by a trained research assistant. The primary outcome will be the rate of success of the procedure. Secondary objectives will be to evaluate time to collect urine samples and to determine which transversal bladder diameter correlates with more than a 90% success rate for the procedure. Independent variables will be sex and age. In both groups, trained research nurses will collect clean-catch urine samples using bladder stimulation techniques. The success rate of the CCU procedure in both groups will be calculated. The time required to collect urine samples will be analysed. In group 1, the investigators will determine the transversal bladder diameter corresponding to a success rate for the procedure of \> 80%. It is estimated that, in the worse-case scenario, the evaluation of 200 participants will provide a 95% confidence interval smaller than 10% for proportions. In addition, 20 participants with a successful CCU sample would allow to evaluate 2 risk factors using univariate and multivariate analysis.

Expected results:

This study will demonstrate that use of emergency point-of-care ultrasound increases success rates of stimulated clean-catch manoeuvres and may avoid invasive urethral catheterizations in young children.


Eligibility Criteria:
Inclusion Criteria:

* Children aged less than 6 months
* Urine sample ordered by the treating physician
* Presence of a research assistant

Exclusion Criteria:

* Any medical condition where obtaining a midstream urine sample is impossible (e.g. urostomy, anuria for 24h)
* Any serious illness or unstable infant (e.g. sepsis)
* Any medical situation where the infant cannot be fed (e.g NPO order, GCS\<15)
* Inability to obtain parental informed consent (language barrier, absence, etc.)
Cohort of IPF Patients Experiencing an Exacerbation

Extension of the PFBIO cohort which includes patients with newly diagnosed idiopathic pulmonary fibrosis (IPF) for longitudinal follow-up for up to 5 years.

In the PFBIO-EXA extension, patients are included if they experience an exacerbation, or other increase in respiratory symptoms requiring hospital admission, for further collection of clinical and biological data.

The aim of this study is to investigate the diagnostic and prognostic value of clinical and blood biomarkers during exacerbations, or other increase in respiratory symptoms requiring hospital admission in patients with IPF.

Patients that are already included in the PFBIO-cohort (NCT02755441) and who are admitted to hospital with an increase in respiratory symptoms, are also included in PFBIO-EXA.

Patients are recruited within 24 hrs. from hospital admission with respiratory worsening, where clinical data, and blood samples are collected. The blood samples are investigated for the same blood biomarkers as PFBIO.

Patient related outcomes are also collected, including quality-of-life questionnaires and outcomes of the exacerbations.

Eligibility Criteria:
Inclusion Criteria:

* Admitted with an increase in respiratory symptoms
* Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA
* Age at least 18 years

Exclusion Criteria:

* Unable to provide informed consent
A Comparative Study Between Preservative With Benzalkonium Chloride vs Preservative Free Eye Drops on the Ocular Surface

study the effect of different concentrations of benzalkonium chloride on the ocular surface of non-dry-eyed patients post cataract surgery.

60 eyes of will be included in this study.

* 20 eyes will receive regular Tobradex 0.1mg/ml BAK 5 times per day (Group 1).
* 20 eyes will receive Dexathalm multidose 0.05mg/ml BAK 5 times per day (Group 2).
* 20 eyes will receive single dose unit Dexathalm NO BAK 5 times per day (Group 3).

Preoperative assessment:

All selected patients will receive thorough explanation of the study design and aims, an informed consent will be obtained from all patients.

Tear break up time (TBUT) will be measured non-invasively by Ocular Surface analyzer.

Ocular Surface disease index will be calculated by filling a questionnaire. 12-item questionnaire provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.

Postoperative:

1. All patients will be examined at day1, 1 week and 3 week postoperative.
2. At 3 weeks re-evaluate I. TBUT by non-invasive ocular surface analyzer II. OSDI by filling the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing uncomplicated cataract surgery
* Cataract grade: (LOCSIII): NO2NC2,C3,P2

Exclusion Criteria:

Preoperative non-invasive TBUT\<10 seconds. Patients who have rheumatoid arthritis or autoimmune diseases affecting corneal surface.

Involutional entropion or ectropion preoperative Postoperative significant corneal edema requiring medication.
The Juice Study: Sensitivity of Skin Carotenoid Status to Detect Change in Intake

This study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids.

The US Dietary Guidelines for Americans recommends that individuals consume approximately 2-4 c of vegetables each day to reduce risk of chronic disease, but current methods for assessing intake are either inaccurate (self-report) or invasive (blood carotenoid levels). Recent research indicates that skin carotenoid status may be a useful biomarker of vegetable intake, but the sensitivity to dose in unknown. In this study, we propose to test the dose-response of skin carotenoids to consumption of 3 different levels of vegetable juice (with a control group receiving water). We will test skin carotenoids in two ways: using resonance Raman spectroscopy (RRS), which we have previously validated, and with a new technique, pressure mediated reflection spectroscopy (RS; the "Veggie Meter"). We will compare the two techniques during an 8-week provided tomato-based juice intervention. Skin carotenoid readings will be compared to blood carotenoid concentrations and single nucleotide polymorphisms (SNPs) of genes related to the uptake, transport, and metabolism of carotenoids will be examined in blood and saliva.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-29.9 kg/m2

Exclusion Criteria:

* weigh less than 110 lbs
* currently dieting to lose weight
* allergic to tomatoes or vegetables
* pregnant, lactating, or planning to become pregnant
* currently use tobacco products or vape
* eat more that 2 cups of vegetables per day
* have high blood sugar (≥200 mg/dL)
* have high blood pressure (≥140/90 mm Hg)
* have a medical condition such as diabetes or high blood pressure
* taking medication that lowers cholesterol or triglycerides
Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida

The study aims to investigate the effects of a combination of Lamaze breathing exercises and backside massage on the labor experiences of primigravidae in Pakistan. Labour pain, if left unaddressed, can lead to abnormal labor, hence the importance of effective pain management techniques. Lamaze breathing techniques are non-pharmacological methods aimed at psychologically and physically preparing mothers for drug-free childbirth. Backside massage therapy is another non-invasive intervention that can help to reduce pain and anxiety during labor. The study will involve a randomized controlled trial with two groups: an intervention group receiving backside massage and Lamaze breathing along with standard labor care, and a control group receiving only standard labor care. Primigravidae between 26 to 34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal departments. Eligible participants will be randomly allocated to either group to minimize bias. The backside massage therapy intervention will be administered by trained massage therapists. Outcome measures include level of labor pain and anxiety levels, maternal stress hormone levels (adrenocorticotropic hormone, cortisol, and oxytocin), maternal vital signs, fetal heart rate, labor duration, APGAR scores, and maternal satisfaction and self-efficacy. The sample size of 90 participants (45 in each group) has been determined to achieve a 95% power level with a 5% error rate, accounting for a 20% attrition rate. Data analysis will employ mixed-effect regression models, time series analyses, paired t-tests, or equivalent non-parametric tests to assess between-group and within-group outcome measures. The study aims to provide valuable insights into the efficacy of combining Lamaze breathing exercises and backside massage therapy as complementary interventions for managing labor pain and anxiety among primigravidae in Pakistan, potentially reducing the need for medically unnecessary cesarean sections and improving maternal and neonatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Primigravidae
* Age 20-35 years old
* Gestational age of 37-41 weeks
* First stage of labour
* Singleton pregnancy
* Cephalic presentation
* Regular contractions
* Cervical dilatation of at least 6 cm
* Minimum of three contractions every 10 minutes
* Contraction intensity of at least moderate
* Contraction duration between 30 seconds and 60 seconds

Exclusion Criteria:

* Diagnosis of underlying chronic diseases (e.g., cardiovascular disease, kidney disease, diabetes, asthma, mental health disorders, epilepsy or seizure)
* Pregnancy-related diseases (e.g., gestational diabetes, preeclampsia, cephalo-pelvic disproportion, polyhydramnios or oligohydramnios, deep venous thrombosis)
* Pregnancy complications (e.g., placenta praevia, antepartum haemorrhage, fetal distress, administration of analgesics)
Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis 1st MTJ Contracture following Bunionectomy

Exclusion Criteria:

* Current treatment with Botulinium Toxin-A (Botox), lower extremity
* Current treatment Fluoroquinolones (antibiotic medication)
* Current use of muscle relaxant medications
* Fibromyalgia
* Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
* Treatment with electrical stimulation assisting ambulation (i.e Bioness, WalkAide, Parastep, etc.)
Observational Cohort Study of Chronic Low Back Pain

This research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. The investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 175 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 175 non-OCC CLBP patients treated within Brigham and Women's Hospital. Outcomes will include assessment of functional status, symptom relief, satisfaction with care, health-related quality of life, and worker productivity, and will be measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3, 6, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* 3 months or more of chronic low back pain or 6 months or more of intermittent low back pain OR
* having at least one of a list of ICD-9 diagnostic codes for uncomplicated low back pain
* having two or more visits for back pain within the past two years; one of these visits must have happened within the past year (as a screening marker of chronicity)

Exclusion Criteria:

* under the age of 21
* unable to understand English
* have complicated low back pain (e.g. history of back pain related to cancer, fracture, or infection)
* unable to participate in the phone follow-up for the next one-year period.
Management of Postoperative Pain After Total Knee Replacement.

The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.

Patients undergoing total knee replacement will be assigned at random to receive one of two methods of postoperative pain management. Patients assigned to nerve block will receive regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block. Patients assigned to periarticular injection will receive periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all patients will be given a standardized combination of oral analgesic medications preoperatively and postoperatively. All patients will receive a posterior stabilized total knee replacement through an medial parapatellar approach.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary total knee replacement.
* Weight 50-125 kg.
* Age 18-79 years.
* Intact neurological exam to the surgical lower extremity.
* Cognitively intact with ability to sign informed consent.

Exclusion Criteria:

* Renal insufficiency with creatinine \>1.5 mg/dL.
* Allergy to medication used in the study.
* Using narcotic medication prior to surgery (morphine equivalents \>=20 mg/day for \>7 days.)
* Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.
Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20

The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneous (SC) injection of 20 units (U) with or without coadministration of recombinant human hyaluronidase PH20 (rHuPH20).

The study hypothesizes that the time required to reach maximum insulin concentration (tmax) when insulin is administered with rHuPH20 will be comparable or shorter than the time required without rHuPH20.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male participants aged 18 to 55 years.
2. Body mass index (BMI) 18 to 28 kilograms per meter squared (kg/m\^2) and total body weight \>70 kilograms (kg) (154 pounds \[lb\]).
3. Willingness and ability to comply with the protocol.
4. Vital signs within the normal range.
5. Within 7 days before the first injection, metabolic panel results and complete blood count (CBC) within the laboratory normal reference range.
6. Fasting plasma glucose within the normal range of 90 to 110 milligrams per deciliter (mg/dL) on the morning of the glucose clamp.
7. Agreement not to father a child or donate sperm and to use effective contraception during the study and for at least 30 days after study completion.
8. Willingness and ability to sign an informed consent form.

Exclusion Criteria:

1. Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic (to include history of seizures) or allergic disease, or history of hypoglycemic episodes.
2. Known history of diabetes mellitus.
3. Prior exposure to any insulin or insulin analogs.
4. Known allergy to hyaluronidase or any other ingredient in HYLENEX.
5. Known allergy to bee or vespid venom.
6. Positive urine drug screen results.
7. Positive human immunodeficiency virus (HIV) 1, HIV 2, hepatitis B, or hepatitis C antibody test result.
8. Any history or evidence of alcohol or drug abuse.
9. History or evidence of use of any tobacco- or nicotine-containing product within 6 months of screening, or screening urine nicotine concentration \>50 nanograms per milliliter (ng/mL).
10. Use of prescription or nonprescription drugs within 7 days or 5 half-lives, whichever was shorter, except acetaminophen at doses of less than or equal to 1 gram per day (g/day).
11. Donation of blood in excess of 500 milliliters (mL) within 56 days before dosing.
12. Failure to limit alcohol consumption and refrain from exercise within 48 hours before each injection.
13. Known clinically significant intercurrent illness or other major systemic disease that would unduly risk the participant's safety or interfere with the interpretation of results.
14. Participation in a study of any investigational drug or device 30 days before enrollment in this study.
15. Unfitness for the study, in the investigator's opinion.
Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18-75 years of age, inclusive, at screening;
* Intolerance to milk and other dairy products;
* Patient agrees to refrain from all other treatments and products used for lactose intolerance, to follow diet modifications required during periods of the study that include abstinence from all dairy in some periods and consuming dairy in other periods;
* Patient meets the defined minimum lactose intolerance symptom composite score; and
* Patient has positive Hydrogen Breath Test (HBT) results for lactase deficiency.

Exclusion Criteria:

* Patient has a disorder associated with abnormal gastrointestinal motility such as gastroparesis (from any cause), amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, uremia, or malnutrition;
* Patient has undergone bowel preparation for endoscopic or radiologic investigation within 4 weeks of Screening (example, colonoscopy preparation);
* Patient has a history of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: fundoplication, gastrointestinal bypass surgery, bariatric surgery, gastric banding, colostomy, vagotomy, pyloroplasty, colectomy or other surgery for Crohn's disease or ulcerative colitis; and
* Patient has received antibiotic treatment, or had a high colonic enema, colonic irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to or during Screening.
Effects of Glucose-fructose Drinks During Training on Lactate Transport

The purpose of this study is to determine whether glucose-fructose intake during training increases lactate transport and oxidation and improve endurance performance.

The study will enroll 24 healthy male volunteers. After baseline assessment of lactate transport and endurance performance, subjects will be randomized to either a 3-week intervention arm in which they will train with glucose-fructose intake during training, or to a control arm (water during training). After this 3-week intervention, lactate transport and endurance performance will be assessed again.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* age between 18 and 30 years
* sedentary
* BMI between 19 and 25
* blood pressure lower than 140/90 mmHg

Exclusion Criteria:

* smoking
* consumption of more than 10g alcohol per day
* cardiovascular history
* electrographic abnormalities at rest
* consumption of more than one can of soda per day or more than 60g sugars per day
* any current drug treatment
* consumption of drugs or illicit substances
* diabetes mellitus
* vegetarian
* food intolerance
* blood donation or participation to another study \<3 months before study inclusion
Anatomical Shoulder™ Inverse/Reverse Study

The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs.

Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided:

* Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.
* SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of twelve questions to assess the subject's physical and mental health status which must be answered by the patient.

This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria.

All patients will undergo pre-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge.

There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.

Eligibility Criteria:
Inclusion Criteria:

* Age - 18 years minimum.
* Sex - male and female.
* General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
* Informed Consent - patient or patient's legal representative has signed a Patient Informed Consent form.
* Indications - Diagnosis of disease or trauma in the affected joint, including cuff-tear arthropathy, failure of prior rotator cuff surgery and irreparable rotator cuff tears associated with loss of glenohumeral stability with the indication for total shoulder arthroplasty.
* The deltoid muscle has to be intact in all 3 parts (clavicular, acromial as well as spinal).

Exclusion Criteria:

* Patient is skeletally immature.
* Patient is pregnant.
* Patient is unwilling or unable to cooperate in a follow-up program.
* Patient shows one of the following medical conditions - Chronic fracture, Acute fracture, Axillary nerve lesion, Severe loss of humeral or glenoid bone, Paralysis of the deltoid muscle, Active Infection
* Patient requires one of the following medical interventions - Implant Revision, Glenoid bone grafting, Autografts