cyrilzakka/clinical-trials huggingface dataset:
Grinding Versus Standard Methods for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis

The main objective of this study was to compare the diagnostic capability (sensitivity and specificity) of standard bacteriological analysis made from one or other of the two sampling processing techniques and perioperative management of samples : the Ultra Turrax method that uses grinding versus the standard method.

The secondary objectives of this study are to:

A. Compare the two techniques in terms of bacterial species identified.

B. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of analyzed samples (soft tissue, bone tissue) (subgroup analysis).

C. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of joint (subgroup analysis).

D. Compare the diagnostic capabilities (sensitivity and specificity) of the two sample processing techniques depending on the type of implanted materials (prosthesis versus other equipment) (subgroup analysis).

E. Develop a culture collection of bacteria isolated from infection osteo-articular protheses.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be insured or beneficiary of a health insurance plan
* The patient is cared for in the operating theater because of a suspicion of an osteo-articular infection involving any type of material (protheses, screws, plates) and requiring bacteriological sampling
* The patient has not taken any antibiotics within the past 15 days

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The subject presents with an osteo-articulaire infection without material
* Systematic samplings from reversals of aseptic prostheses
* Second intervention for the same patient
Wearable Technology for Hospital Inpatients

This study will address the feasibility of using wrist-worn fitness trackers to monitor hospital inpatients. The study is being conducted in the Intensive Care Unit where patients are closely monitored, in order to provide gold standard measurements of heart rate, and accurate estimates of sleep quality.

Overall Hypothesis:

The use of wearable personal fitness trackers to monitor physiologic signals in hospital inpatients is feasible, reliable, secure, and cost effective.

Specific Objectives:

1. To evaluate the feasibility of applying a wrist-worn personal fitness tracker to hospital inpatients for the purpose of monitoring heart rate and sleep quality during the night.
2. To determine the accuracy and completeness of high-frequency heart rate measurements recorded from personal fitness trackers in hospital inpatients.
3. To compare measurements of sleep quality generated by personal fitness trackers with clinical assessments by nursing staff among hospital inpatients.
4. To develop a workflow and data analysis pipeline for downloading, storing, analyzing, and visualizing data generated by personal fitness trackers worn by hospital inpatients.
5. To evaluate the feasibility of a larger prospective multicenter trial examining the utility of personal fitness trackers among hospital inpatients, including recruitment rates, inclusion/exclusion criteria, data management protocols, and outcomes measures.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age \> 18 years)
2. Spontaneously breathing (i.e. no invasive or non-invasive mechanical ventilation, with the exception of nocturnal non-invasive ventilation at stable home settings)
3. Cardiac telemetry and/or continuous SpO2 monitoring in place

Exclusion Criteria:

1. Continuous sedation or analgesia
2. Known upper extremity deep venous thrombosis
3. Dialysis fistula
4. Radial arterial line in the non-dominant arm
5. Peripherally inserted central venous catheter in the non-dominant arm
6. Severe upper extremity trauma or fracture
7. History of upper extremity amputation
8. Skin breakdown at application site
9. Contact precautions (methicillin resistant Staph aureus, C. difficile, vancomycin resistant Enterococcus)
Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial

Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.

newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners.

the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.

Eligibility Criteria:
Inclusion Criteria:

* Non-syndromic Infants with complete unilateral cleft lip and palate
* Infants less than 3 months of age
* Males and females.
* Infants with displaced alveolus
* Patients whose parents provided written consent for the study.

Exclusion Criteria:

* Patients above 3 months of age
* Syndromic, malnourished and systemically ill infants.
* Patients with bilateral cleft lip and palate.
* Incomplete Cleft lip.
* Medically compromised patients
* Patient's/guardians who will be unwilling to go through the PNAM therapy
Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis

To date, two devices to measure nitric oxide lung diffusing capacity (DLNO) are commercially available in Europe. Previous research has shown systematic between-device differences in lung diffusing capacity outcomes in healthy people (Radtke et al. ERJ Open Res. 2021 Sep 13;7(3)). The extent and magnitude of between-device differences in people with lung function impairment and ventilation inhomogeneities is unknown.

The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO) in people with systemic sclerosis and proven interstitial lung disease.

1. "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
2. "HypAir" ("HA", Medisoft, Dinant, Belgium).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of systemic sclerosis by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR1) criteria (≥ 9 points)
* Interstitial lung disease proven with high-resolution computed tomography (HRCT)
* Written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Unstable clinical condition affecting lung function testing (i.e., major hemoptoe/-tysis or pneumothorax within the last 3 months, acute respiratory tract infection in the past two weeks), others according to the assessment of the treating physician
* Pregnancy
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM) device and (2) to collect data to characterize the performance of arrhythmia detection algorithms. Data was also collected to characterize the ICM system related safety events.


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated to be implanted with the LUX-Dx ICM for one of the following reasons (grouped in three "Reason for Monitoring" subgroups): 1) Cryptogenic stroke, 2) Syncope, 3) AF management, Post-AF ablation, or Suspected AF
* Patient is willing to enroll and be monitored in LATITUDE Clarity.
* Patient is willing and able to be followed remotely via the ICM patient mobile app.
* Patient is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and agrees to participate in all protocol required activities.
* Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law.

The following inclusion criterion is applicable for patients participating in the Holter study:

• Patient can tolerate the adhesive used in the Holter monitoring for an extended period of time.

Exclusion Criteria:

* Patient is indicated for implantation of, or is currently implanted with an active implantable cardiac device (e.g., LVAD, ICD, CRT D, PPM\*).
* Patient cannot tolerate a subcutaneous, chronically-inserted device due to medical condition.
* Patient has a documented life expectancy of less than 12 months (per investigator's discretion).
* Patient is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion).
* Patient is currently enrolled in another clinical study including observational studies/registries, unless prior written approval from BSC is obtained. Mandatory governmental registries are accepted for co-enrollment without approval by BSC.

The following exclusion criteria are applicable for patients participating in the Holter study:

* Patient has known allergies to the adhesive materials or hydrogel used in the extended Holter monitoring.
* Patient has broken, damaged, or irritated skin over the chest area where the extended Holter monitor will be attached.
Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

The purpose of this study is to help understand the benefits of eating food supplemented with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on glucose metabolism and body weight.

The investigators will employ a double-blind randomized controlled study design with 3 arms such that obese, insulin resistant adults will be randomly selected to receive food made with 1) sugarcane bagasse, 2) non-caloric, non-fermentable fiber, or 3) a similar product with minimal fiber for 4 weeks. The intervention will be in the form of brownies and cookies and will look and taste nearly identical to each other. Caloric value will be constant with all three delivery systems. Subjects will have blood testing and body composition analysis before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18-50 years
* Body Mass Index ≥ 30 kg/m2 (a ratio of weight to height)
* Fasting insulin level \>5 µIU/mL, as determined by tests performed during screening

Exclusion Criteria:

* Women who are pregnant
* Past medical history of diabetes
* History of intestinal surgery such as removal of bowel
* History of problems with absorbing food such as celiac disease, inflammatory bowel disease, malabsorption syndrome
* Taking chronic medications for any medical conditions such as diabetes, hypertension, cholesterol, thyroid hormone, etc.
* Any food allergies
Levothyroxine Supplementation for Heart Transplant Recipients

This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.

Studies have shown that thyroid hormone results in a higher number of organs available for transplant. Increasingly, thyroid hormone supplementation is used amongst transplant donors. However, it is not the current standard of practice to supplement recipients without a prior medical history of hypothyroidism with levothyroxine. Two large retrospective studies have demonstrated improved 30-days survival and lower risk of all-cause mortality for heart transplant recipients who receive levothyroxine in the post-operative context. No randomized trials have tested this hypothesis and so the investigators aim to trial the use of levothyroxine for heart transplant recipients at University of California San Francisco using a double-blinded and placebo controlled randomized control trial study design. This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be listed for heart transplantation
2. Age ≥18 years
3. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy
2. Patients with a known allergy or intolerance to levothyroxine
3. Patients participating in another study evaluating an investigational drug within the past 30 days.
Oral Versus Intravenous Antibiotic Prophylaxis Before Obstetric and Gynecological Procedures

Oral versus intravenous antimicrobial prophylaxis for the prevention of surgical site infection for elective cesarean section and gynacological procedures

the aim of the current study is to compare the efficacy of prophylactic intravenous (cephradine) and oral antibiotic (cephradine) for the prevention of surgical site infection in the elective obctetric and gynecological procedures

Eligibility Criteria:
Inclusion Criteria:

- Cesarean section Gynaecological procedure Exclusion Criteria Immunocompromised patient

-
Tesetaxel for Previously Treated Patients With Bladder Cancer

The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients.

Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
* Measurable disease (revised RECIST; Version 1.1)
* Karnofsky performance status ≥ 60%
* Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
* Adequate bone marrow, hepatic, and renal function, as specified in the protocol
* At least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent
* Ability to swallow an oral solid-dosage form of medication

Exclusion Criteria:

* Known metastasis or symptoms of metastasis to the central nervous system
* Significant medical disease other than cancer
* Presence of neuropathy \> Grade 1 (NCI CTC, Version 4.0)
* Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Pain Management After Shoulder Arthroplasty

Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. Current trends in pain management are morphing and multimodal opioid sparing protocols are now being evaluated and implemented, with results showing a decrease in the amount of opioids being prescribed. Despite all efforts, most patients experience pain and, in order to control it, multiple medications have been tried with variable results. The most commonly prescribed medications are opioids, but side effects associated with their use as well as their addictive potential are making them a less desirable option for patients. Currently there is a trend towards diminishing opioids consumption and prescribing alternative pain control regimens.Caffeine is a well known molecule that when associated with non-steroidal anti-inflammatory drugs (NSAIDS) potentiates their analgesic effect and decreases the amount of doses required to control pain. Little is known about the effect of caffeine over pain relief in patients undergoing total joint arthroplasty, but preliminary results in other fields make us believe it could have a potential benefit for patients undergoing total joint arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who undergo primary Total Shoulder Arthroplasty or Reverse Total Shoulder Arthroplasty
* Patient willing and able to complete postoperative surveys
* Post-Menopausal Women and Men over the age of 55

Exclusion Criteria:

* Patients reporting caffeine consumption in excess of 300mg daily
* Patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse.
* Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
* Patient has a known allergy to aspirin or caffeine.
* Patient has history of cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including pain.
* Patient has history of anxiety disorder
* Patients with known sleep disturbances that would otherwise be affected by caffeine
* Patients undergoing revision surgery
* Patients who require alternate DVT prophylaxis other than ASA.
* Patients undergoing inpatient arthroplasty
* Workman's comp patient or patient has current litigation pending
A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis

The purpose of this study is to investigate the impact of the probiotic Lactobacillus rhamnosus (LGG) on proton pump inhibitor (PPI)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. PPI medicines reduce stomach acid and are commonly used to treat acid reflux disease.


Eligibility Criteria:
Inclusion Criteria:

* Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.).
* Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.
* Only those with an absence of symptoms will eligible to participate.

Exclusion Criteria:

* For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy).
* Chronic daily use of medications affecting GI secretion or motor function.
* The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease.
* Pregnancy.
Gastric Decompression After Sub-total Gastrectomy

The purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as "guardian" of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or according Roux.

A silastic naso-gastric tube (Rusch® distributed by Teleflex Medical Srl) is used in the naso-gastric/jejunal tube group

Eligibility Criteria:
Inclusion Criteria:

* All people subjected to subtotal gastrectomy for distal gastric adenocarcinoma.

Exclusion Criteria:

* People undergoing enteral nutrition through naso-jejunal tube
Web-based Training and Telephone Follow-up of Patients With Heart Failure: Randomized Controlled Trial

Web-based training and telephone monitoring have an effect on reducing symptom burden in patients with heart failure.

Web-based training and telephone monitoring have an effect on improving the quality of life of patients with heart failure.

Web-based training and telephone follow-up have an effect on reducing recurrent hospitalizations of patients with heart failure.

Web-based training and telephone follow-up have a positive effect on the clinical parameters (weight, waist circumference, blood pressure, creatinine) of patients with heart failure.

The aim of this study was to determine the effect of web-based training and telephone monitoring on symptom management and quality of life in patients with heart failure. Study was conducted with the participation of 32 intervention and 32 control patients who have heart failure, in Akdeniz University Hospital Cardiology Clinic, between April 2018 and July 2019. Data were collected using the Patient Information Form, Left Ventricular Dysfunction Scale and Memorial Symptom Rating Scale-Heart Failure Scale, Website Analysis and Measurement Inventory. The patients in the intervention group received web-based training after discharge, and were followed up by telephone at the first, fourth, eighth and 12 weeks. The scale data were collected before the patient was discharged from hospital and at the third month of discharge.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing treatment at the Cardiology Clinic of Akdeniz University Hospital with a diagnosis of heart failure.
* Class I, II, III according to NYHA classification
* Has internet access and can use a computer / tablet or smartphone
* Agree to participate in the research

Exclusion Criteria:

* Functional class IV according to NYHA classification
* Diagnosed with psychiatric illness
* Malignancy diagnosed
* Visually and hearing impaired
* Diagnosed with chronic obstructive pulmonary disease
PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY

Ten year longitudinal survey following children with disabilities who have participated in Sports and Recreation from a young age (5 to 10), and the parents of children who have participated in Sports and Recreation at a young age (5 to 10). These children will be followed for 10 years with surveys every 6 months, whether they are currently participating in sports and recreation activities or not.

The purpose of this longitudinal study is to examine the effects of early participation in organized sports and recreation activities (S\&R) on self-reported health and health-related quality of life of children and youth (C\&Y) with disabilities and their parent-reported social participation. This project will examine child and parent reported differences between:

1. C\&Y with disabilities who participate in S\&R and those who have discontinued participation in S\&R programs
2. C\&Y with disabilities who participate in sports vs. those who participate in recreation, and
3. C\&Y with disabilities who participate in S\&R and normative data on C\&Y with disabilities and those without disabilities.


Eligibility Criteria:
Inclusion Criteria:

* At the time of enrollment, the child must be between the ages of 5 and 10 and be participating in an adapted sports and recreation program.
* At the time of enrollment, the parent must have a child between the ages of 5 and 10, who is participating in an adapted sports and recreation program.
* Children and parents who are enrolled in the study will continue to participate in the study for 10 years.

Exclusion Criteria:

* Children who are younger than 5 or older than 10 will not be entered into the study, nor will parents whose children are younger than 5 or older than 10 be entered into the study. .
* Individuals who do not read and write in English will be excluded from the study.
* Children who are wards of the state, or in foster care will be excluded from the study.