cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Post-operative Diet in Children Following Tonsillectomy and Adenoidectomy

This research is being done because it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. The purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.

Currently it is not known which dietary recommendations are best to help patients recover after a tonsillectomy and/or adenoidectomy. Traditional standard of care is to recommend that patients be restricted to a soft diet post-operatively. However, the investigators believe that there may be benefit in allowing patients to eat a restriction-free diet. In this study, the investigators will compare the current standard of care verse a non-restricted diet. The purpose of this study is to determine how diet after tonsil/adenoid surgery affects bleeding, pain, and oral intake.

Eligibility Criteria:
Inclusion Criteria:

* Patients 3-12 years undergoing tonsillectomy and/or adenoidectomy.

Exclusion Criteria:

-
Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block

The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)

The main objective is to assess the predictive value of the pre-TAVI infrahelic conduction time interval (infraheal conduction time measured before percutaneous aortic valve implantation) on the risk of Pacemaker implantation at 30 days post-TAVI, in patients with right bundle branch block prior to surgery.

The aim of the study is to identify a pre-interventional marker of the risk of rhythmological complication after the TAVI procedure (Transcatheter Aortic Valve Implantation), in order to better anticipate it.

This is an interventional, prospective, longitudinal (follow-up: 12 months), multicenter (4 centers) study.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ;
* Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles);
* Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ;
* Patient having signed a consent.

Exclusion Criteria:

* Contraindication to Transcatheter Aortic Valve Implantation ;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
ABI v Dry Needling for Plantar Fasciitis

To investigate whether a procedure of ultrasound-guided autologous blood injections (ABI), which includes a dry-needling component within the overall procedure, has any measureable clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar fasciitis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 or over who are being seen in the Department of Sports Medicine (all of whom are age 16 or over) with chronic plantar fasciitis of at least 6 months duration
2. Failure of previous conservative therapy - including physiotherapy, and podiatry input
3. Objective evidence of plantar fasciitis - either ultrasound or MRI investigations
4. No contraindications of injection therapy - anticoagulation, blood borne illness, strong needle phobia ...

Exclusion Criteria:

1. Patients with either partial or full-thickness tears of plantar fascia found on investigations
2. Subjects who are unable to give valid consent for study entry based on normal competency assessment
3. Subjects unable or unwilling to undergo the rehabilitation plan post-procedure
4. Subjects unable or unwilling to attend the follow-up appointments post-procedure
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1810631 in the Blood

The main objective of this trial is to investigate the effect of multiple doses of the strong CYP3A inhibitor and recommended Pglycoprotein (P-gp) inhibitor itraconazole on the pharmacokinetics of a single dose of BI 1810631 in plasma following oral administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Shoulder Position in Volleyball Players With Shoulder Pain

The aim of this study is to assess the relationship between shoulder position and the presence of pain in volleyball players. To do this, will be measured pain sensation and the position of acromion process

The position is defined as the alignment of body segments at a given time. The assessment of the position is part of the physical examination. Recent studies have shown that photometry can be a reliable method to assess posture. The measurement of angles can identify situations as the forward position of the head and shoulder protraction.

The aim of this study is to assess the position of the shoulder, using photometry by the measurement of angle between acromion process and seventh cervical vertebra, and the relationship with the presence of pain in volleyball players.

For this study will be recruited thirty nine volleyball players. The variables measured are pain sensation registered with a visual analog scale and the position of acromion process measurement with photometry

Eligibility Criteria:
Inclusion Criteria:

* over 16 years old
* minimum of 3 days per week of training
* with or without shoulder pain

Exclusion Criteria:

* less than 1 year practicing volleyball
Collecting Recorded Videos of Colonoscopy Screening Tests

The study shall mainly help to better evaluate the performance the APDS device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon Polyps.

Primary objectives • To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.

Secondary objectives

• When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all the criteria related to regular colonoscopy according to the standard of care at the Gastroenterolgy Department of the selected center. In addation, the following criteria have to be met to be eligible for the study:

1. Able to read, understand and provide written Informed Consent;
2. Females or males - older than 18 years old

Exclusion Criteria:

Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:

* Bleeding disorder or unacceptable risk of bleeding
* Terminal illness or life threatening malignancy
Management of Grades 3-5 Renal Trauma in Pediatrics

comparing conservative management versus interventional management in hemodynamically stable paediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of renal loss and blood transfusion in patients managed conservatively.


Eligibility Criteria:
Inclusion Criteria:

* Children ( age group 0-18) who are diagnosed to have renal tissue injury grade 3-5 by contrast CT

Exclusion Criteria:

* Age group more than 18 years
* Low grade renal trauma 1-2
* Patients who get explored due to extra urologic indication without proper urologic assessment
Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage

To date there are no data suggesting substantial effects of hormonal interaction after percutaneous closure of the left atrial appendage (LAA). Our hypothesis is that by excluding the LAA from blood flow physiologic stimuli for ANP and BNP produce may be impaired and consecutive release of the hormones may be reduced. Here, we present our experience of ANP and BNP secretion in the early postprocedural period after transcatheter closure of the LAA.


Eligibility Criteria:
Inclusion Criteria:

* non-valvular atrial fibrillation
* increased risk for thromboembolic complications (a minimum CHADS2Score of at least 2)

Exclusion Criteria:

* Valvular-atrial fibrillation
* Low risk for thromboembolic complications CHADS-2-Score \< 2
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).

Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.

The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.

The investigator has a hold on enrolling new subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of LEMS
2. Over 18 years old
3. Medically stable
4. If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study

Exclusion Criteria:

1. Known sensitivity to 3,4 DAP
2. History of past or current seizures
3. History of severe asthma
4. Believed by the investigator to be unable to comply with the protocol
5. Unable to provide informed consent
Point of Care Testing to Improve Monitoring of LVAD Patients

The purpose of this study is to develop and validate the accuracy of a low-cost "point-of-care" test (POCT) that allows monitoring of markers for anticoagulation and thrombosis (local coagulation or clotting of the blood), to be used by patients with advanced heart failure (AHF) on left ventricular assist device (LVAD) support. The investigators central hypothesis is that the fully-printed AT-POCT utilizing low-cost (printed) cassettes and detector will produce an inexpensive and convenient option for daily self-monitoring of PT/INR and LDH over existing methods.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* Subject has signed Informed Consent Form (ICF)
* For LVAD patient cohort, they are on LVAD support from 2 weeks to 10 years.

Exclusion Criteria:

* Patients with dementia, altered mental status, any psychiatric condition or mental disability that would prohibit the understanding or rendering of informed consent are not eligible
* Prisoners
Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)

This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years).


Eligibility Criteria:
* Children, 3 months through 17 years of age,
* with esophageal candidiasis or
* invasive candidiasis or
* children requiring salvage treatment of invasive aspergillosis.
Evaluation of Immersive Audiovisual Distraction Impact on Peroperative Opioid Consumption.

This study evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption for outpatient procedures with Remifentanil added to local anesthesia.

Half of patients will receive an audiovisual distraction device while the other half not.

Early recovery for patients undergoing surgery is the key factor for an outpatient procedure.

The technique of adding remifentanil to a local anesthesia is used in 22% of the procedures realized in The CHU de Caen Outpatient unit. Decreasing opioid dose, whose side effects are numerous and widely described, as well as reducing anxiety are daily challenges to ensure comfort and successful care.

We propose a prospective, randomized, monocentric, open label study to evaluate the impact of the use of an audiovisual distraction device on the intraoperative consumption of opioids, on the patient's pain and peroperative anxiety.

ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement. We will analyze if audiovisual distraction can integrate existing techniques such as hypnosis.

Finally, we will also assess the medico-economic impact of this technique in order to establish a benefit / cost ratio.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Signed consent
* Outpatient surgery eligibility
* Patient covered by social security

Exclusion Criteria:

* Unsigned consent
* Study participation refusal
* Deafness, blindness
* Claustrophobia
* ANI contraindication (atrial fibrillation, pace maker, severe autonomic system dysfunction)
* Contraindication or impossibility to use the audiovisual distraction device
Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) Intervention

The purpose of this study is to evaluate Cognitive Behavioral Intervention for Targeted Therapy Fatigue (CBT-TTF) with fatigued chronic myelogenous leukemia (CML) patients on tyrosine kinase inhibitors (TKIs) for feasibility, acceptability and potential efficacy relative to usual care only in a small-scale randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* able to speak/read English
* diagnosed with chronic phase CML
* not have been treated for other cancer (except non-melanoma skin cancer) in the past 5 years
* be under the care of a Moffitt Cancer Center (MCC) physician
* be on a stable dose of the same oral TKI for \>= 3 months
* new onset or worsening of fatigue since starting TKI
* report moderate-severe fatigue in past week (FSI average rating \>= 4 of 0-10)
* have no clinical history of disease (e.g., multiple sclerosis, fibromyalgia) that could account for their fatigue presentation

Exclusion Criteria:

* scheduled to discontinue their TKI under medical supervision within the next 3 months
Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods

The purpose of this study is to quantify the amount of diclofenac in rinse water after application of the test product (Voltaren® Schmerzgel forte; 2.32 percent \[%\]) containing 2.32% Diclofenac-N-Ethylethanamin either by hand or using an applicator and subsequent washing and/or wiping.

This will be an exploratory, open label, crossover study. Participants with healthy skin on the elbows and hands will be enrolled. The amount of diclofenac in rinse water after application of the test product (Voltaren® Schmerzgel forte; 2.32%) containing 2.32% Diclofenac-N-Ethylethanamin will be assessed after three different washing methods, with and without use of an applicator in a crossover design. There will be a wash-out period of at least 2 days in between each method. Approximately 40 participants will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study.
* Willingness to actively participate in the study and to come to the scheduled visits.
* Female and/or male.
* From 18 to 70 years of age.

Exclusion Criteria:

* Female participants: Pregnancy or lactation.
* Drug addicts, alcoholics.
* Acquired immunodeficiency syndrome (AIDS), human immunodeficiency virus (HIV)-positive or infectious hepatitis.
* Conditions which exclude a participation or might influence the test reaction/evaluation.
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
* A previous allergic reaction, sensitivity or intolerance to diclofenac or any of the other ingredients in Voltaren® Schmerzgel forte.
* Participants in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by acetyl salicylic acid or other non-steroidal anti-inflammatory drugs (example, ibuprofen, naproxen et cetera).
* Documented allergies to cosmetic products.
* Active skin disease at the test area.
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, et cetera, at the test area that could influence the investigation.
* Any topical medication at the test area within the last 3 days prior to the start of the study.
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb

A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.

A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (CMC1). The primary outcome is Patient Reported Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.

Eligibility Criteria:
Inclusion Criteria:

1. Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living
2. Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months.
3. Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)
4. Age \> 45 years
5. ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)
6. Ability to speak, understand and read in the language of the clinical site
7. Provision of informed consent from the participant

Exclusion Criteria:

1. Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy
2. Neurologic condition affecting the function or symptoms of the upper extremity
3. \<6 months from other surgical procedure of the upper extremities
4. Rheumatoid arthritis or other inflammatory joint disease
5. Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides
6. Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side
7. \>45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity)
8. Patient is unable to continue his/her current job due to thumb pain
Fast Assay for Pathogen Identification and Characterization - Prospective Study

The FAPIC project will develop a diagnostic system that will identify pathogens and charachterize virulence and resistance. A prospective study will be performed in which blood samples will be collected of patients with suspected sepsis in order to evaluate the diagnostic system. In routine care, blood is drawn of these patients for culture in order to identify the causative pathogen. This process takes 3-5 days. During the study, one extra blood sample will be collected with the same venipuncture, with each blood culture. Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to the research laboratories for determination of sensitivity and specificity. The system will not be used in the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Suspicion of bacteremia

Exclusion Criteria:

* Children (\<18 years)
Effects of L-arginine and L-citrulline Supplementation on Muscle Respiration

The objective of this trial is to determine the effects of dietary supplementation with the amino acids, L-arginine and L-citrulline, on endurance performance and mitochondrial respiration in healthy men compared to supplementation with L-arginine alone and a placebo supplement.

This study is a randomized, double-blind, cross over trial of L-arginine and L-citrulline supplementation, L-arginine supplementation alone and placebo supplementation in healthy men. The intervention period will be 8-11 weeks for each participant and a minimum of 15 individuals will be recruited and enrolled to complete the trial. Subjects will complete the experimental protocol described below over 3 individual 10 day supplementation periods, separated by washout periods of approximately 2 weeks. Subjects will ingest corn-starch as a placebo, L-arginine (3g/day) or L-arginine (1.5 g/day) + L-citrulline (1.5g/day). On day 7 of the supplementation period, a skeletal muscle biopsy and blood sample will be obtained from the subjects to investigate mitochondrial function and blood amino acid and nitric oxide levels. On day 10 of the supplementation period, subjects will complete a performance test on a cycle ergometer to investigate their endurance performance. These assessments will be performed to determine the effects of co-ingesting L-arginine and L-citrulline compared to L-arginine alone and placebo administration.

Eligibility Criteria:
Inclusion Criteria:

* healthy male, 18-40 years of age
* recreationally-active
* healthy BMI (≥18.5 and ≤24.9 kg/m2)

Exclusion Criteria:

* participating in other studies currently or in the past two months or has an intention to participate in other studies over the period of this study
* history of gastric, digestive, cardiovascular, renal disease or any other orthopaedic diseases related to motor organs
* lidocaine allergy
* use of medication that may affect study measures
* contraindication to the biopsy procedures
* on medications that affect the immune system
* on Aspirin or other drugs known to prolong bleeding
* smoker
* user of dietary supplements currently or in the past one month
* a heavy drinker