cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction With Subdissociative Dose Ketamine Versus Morphine for Emergency Department Pain Control

The proposed research will be a single blinded (patient) randomized controlled prospective trial of adult patients receiving treatment for moderate to severe abdominal pain to test the hypothesis that patient satisfaction with pain control with Ketamine will be comparable to patient satisfaction with pain control using morphine when treating abdominal pain.

Informed consent will be obtained from patients presenting with chief complaint of moderate to severe abdominal pain in the emergency department who do not meet any exclusion criteria and who willingly agree to participate by signing the written consent form. Investigators will assess the patient's opioid tolerance by asking if they have use an opioid medication in the last week, prescription opioid use at home, and/or recreational opioid use. Patients in both groups will fill out the pre-treatment questionnaire, which will include demographic questions (age, sex, race, height, weight, etc.), a 10cm (100mm) VAS for pain, a 10cm (100mm) VAS to measure patient satisfaction, and a Likert Scale to measure patient satisfaction. Post-treatment survey will be given at 30 minutes after administration of medication. The physician will record whether the patient required additional pain medication after the 30 minutes, final emergency department diagnosis, and final emergency department disposition.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Initial presenting complaint of moderate to severe abdominal pain (five or higher on numerical rating scale \[NRS\]).
* Subjects will be enrolled into the project one (1) time only.

Exclusion Criteria:

* Under 18 years of age
* Pregnant patients
* Inability to provide written consent
* Evidence of traumatic brain injury
* Hemodynamic instability
* Procedures involving laryngeal manipulation
* History of laryngeal spasm
* History of adverse reaction to Ketamine or morphine
* Patients will not be excluded if they had received pain medications prior to enrollment (ie. Received pain medication from triage, non-physician provider (NPP), or emergency medical services (EMS) prior to being seen by physician
* History of opioid use in the last week, prescription opioid use, recreational opioid use
Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea

This research study is being performed to evaluate the photographic evidence of the efficacy and tolerability of Azelaic Acid Foam 15% in the treatment of papulopustular rosacea.

This is a single site, single arm open label study of Azelaic Acid foam 15% for the treatment of moderate to severe papulopustular rosacea. All patients will apply Azelaic Acid foam twice daily. At scheduled visits, high resolution equipment will be used to measure 3D topographical values for elevation of papules and pustules to objectively evaluate reduction of papulopustular lesions. Investigator and subject assessments will also be completed to assess the level of rosacea at weeks 4,8 and 12.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects age 18 or older.
2. Diagnosis of moderate to severe papulopustular rosacea with IGA of 3- moderate or 4-severe.
3. Presence of 12 - 50 inflammatory lesions and persistent erythema with or without telangiectasia.
4. Subjects must read, understand, and sign the Informed Consent.
5. Subjects must be willing and able to comply with study procedures and visit schedule requirements.
6. Women of childbearing potential that are willing to use an acceptable method of contraception during the study.

Exclusion Criteria:

1. Active or localized or systemic infections.
2. Subjects must not be immunocompromised.
3. Known unresponsiveness or allergy to azelaic acid.
4. Subjects unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g. drug or alcohol abuse).
5. Subjects must not be pregnant or breastfeeding.
6. Presence of dermatoses that might interfere with the ability to diagnose and/or evaluate rosacea.
7. Presence of other types of rosacea.
8. Laser surgery on the face for the treatment of telangiectasia or other conditions within 6 weeks of study enrollment.
9. Use of medications or products for the treatment of rosacea or other medical conditions within the following time periods prior to study enrollment. Use of these medications will be prohibited during the trial.

   Topical Prescription or Nonprescription medications 6 weeks Oral retinoids 6 months Tetracycline (ex. doxycycline, minocycline 2 months Corticosteroids 4 weeks Erythromycin or azithromycin 4 weeks Other systemic medications to treat rosacea 6 weeks
10. Refusal to sign the Informed Consent document or Photo Release document and/or refusal to comply with all follow-up requirements.
11. Use of medications that are known to cause flushing.
12. Dose changes in the last 90 days or initiation of beta-blockers, vasodilators, vasoconstrictors, nonsteroidal anti-inflammatory drugs, hormone therapy, and/or other drugs known to cause acneform eruptions.

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Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.


Eligibility Criteria:
Inclusion Criteria:

1. Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,
2. FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
3. Consent of participation signed,
4. Affiliation to a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria:

1. Non-optimal preparation (boston score \<7 or segment \<2),
2. Adenomatous polyposis, familial or assimilated (juvenile, etc.),
3. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,
4. Patient in emergency or deprived of liberty or placed under the authority of a tutor,
5. Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
Wearable Technology in Endoscopy

Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.

This is a prospective, non-blinded, exploratory study to assess the accuracy and safety of wearable devices in the endoscopy suite with patients undergoing procedures using anesthesia assisted sedation using smart watches. We will also simultaneously perform an assessment of patient and provider preferences using narrative-driven, qualitative evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age.
* Undergoing anesthesia-assisted endoscopic procedures.
* Able to give appropriate consent to the study or have an appropriate representative to do so.

Exclusion Criteria:

* Pregnancy.
* Physical deformity, wound, or dressing preventing placement of a wearable device on the wrist.
* Allergy to aluminum, nickel or acrylate.
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil

The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.


Eligibility Criteria:
Inclusion Criteria:

* Child 12-48 months of age
* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
* Signed informed consent

Exclusion Criteria:

* Child who is receiving predominantly breast-milk
* Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Child's z-score of weight for length/height \< -3 according to World Health Organization criteria
Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial

This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta.

This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta dispositioned for a scheduled delivery. The primary outcome will be assessed by comparing the composite neonatal morbidity and composite maternal morbidity between the two groups (delivery at 34 versus 36 weeks gestational age).

Eligibility Criteria:
Inclusion Criteria:

* Women with monographically morbidly adherent placenta with or without a placenta previa.
* Scheduled delivery via cesarean hysterectomy

Exclusion Criteria:

* Delivery planned prior to 36 weeks (e.g. non-reassuring fetal status, preterm labor, severe preeclampsia, other medical/fetal indication for delivery as determined by the managing physician).
Epidemiology of Sleep Disordered Breathing - SCOR in Cardiopulmonary Disorders of Sleep

To address the public health importance of sleep disordered breathing and ultimately reduce morbidity through information gained from longitudinal, population-based, epidemiologic studies.

BACKGROUND:

The investigators have shown that undiagnosed sleep disordered breathing is prevalent for both men and women throughout the range of middle age; multidisciplinary research findings suggest that untreated sleep disordered breathing may lead to significant behavioral and cardiovascular morbidity. The relative risks are of direct application to public health estimates of: How much behavioral and cardiovascular morbidity would be eliminated if prevalence of untreated sleep disordered breathing were significantly reduced? How much reduction in sleep disordered breathing prevalence could be achieved by eliminating the modifiable etiologic factors? Should high risk groups be targeted for early detection of risk factor reduction programs?

DESIGN NARRATIVE:

The study quantified the etiologic role of hypothesized risk factors for sleep disordered breathing, described progression of the pathophysiologic process, and tested causal hypotheses of adverse health outcomes. The study was conducted on a unique, established cohort of over 800 subjects, representative of middle-aged employed adults. Extensive baseline polysomnographic and other data were available on the established cohort of 800 subjects; additional cohorts of 50 perimenopausal women and 200 older adults were added for maximum study power. The research resulted in longitudinal data, over a 5-9 year period, on multiple parameters of sleep, breathing, risk factors and outcomes. The independent relative risks were calculated with multivariate techniques to express the temporal relationships for sleep disordered breathing etiologic factors and for consequences of sleep disordered breathing.

The study was renewed in 1993 and used longitudinal studies to focus on specific questions of greatest relevance to public health, namely: the roles of aging and menopause in the development of sleep-disordered breathing and the effect of sleep disordered breathing on hypersomnolence and systemic hypertension.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
No eligibility criteria
Plasma Pharmacological Monitoring of M Penicillins in Methicillin-sensitive Staphylococcus Aureus Bacteremia

The treatment of Methicillin-sensitive Staphylococcus aureus bacteremia is based on the first-line use of cefazolin or M penicillins (oxacillin and cloxacillin). The use of the latter is recommended at high doses (150-200 mg/kg/24h). In a study on infectious endocarditis, 52 of 56 patients with staphylococcal endocarditis treated with (cl)oxacillin were overdosed with the recommended doses. Although the main mechanism of renal toxicity described for M penicillins is immunoallergic, a frequent overdose is observed in cases of acute renal failure with M penicillins. There is also a significant association between overdose and risk of neurological toxicity. The currently recommended treatment duration is a minimum of 14 days of IV treatment from the first negative blood culture, which leaves room for carrying out a plasma assay and possible dosage adjustment subsequently.

Overdose is a risk factor for nephrotoxicity and neurotoxicity. Plasma level could be predictive of clinical success. Systematic plasma dosing would reduce the risk of toxicity and improve the clinical cure rate.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old)
* Having presented an infection with Staphylococcus aureus and treated at the University Hospitals of Strasbourg between January 1, 2019 and December 31, 2022.

Exclusion Criteria:

- Patient having expressed his opposition to the reuse of his data for scientific research purposes.
Dose Finding Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis

This is a single-center, open-label, multiple-dose study of the efficacy and long-term safety of Lamazym for the treatment of patients with alpha-mannosidosis.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must have a confirmed diagnosis of alpha-Mannosidosis as defined by alpha-mannosidase activity \< 10% of normal activity in blood leukocytes
2. The patient must have an age at the time of screening ≥ 5 year and ≤ 21 years
3. The patient must have physical ability to perform 6-minutes walk test (6MWT), 3 minute-stair climb test (3MSCT) and pulmonary lung function test (spirometry, body plethysmography).
4. The patient must have the ability to mentally cooperate in the cognitive and motor function tests
5. The patient must have the ability to hear and follow a request. Hearing aids can be worn.
6. Patient or patient's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject)
7. The patient and his/her guardian(s) must have the ability to comply with the protocol

Exclusion Criteria:

1. The patient cannot walk without support.
2. Presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-Mannosidosis
3. History of bone marrow transplantation
4. Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
5. Presence of an ECHO with abnormalities within half a year that, in the opinion of the Investigator, would preclude participation in the trial
6. Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial
7. Pregnancy
8. Psychosis within the last 3 months
Institut Paoli-Calmettes Pancreatic Neoplasms Database

Database of Institut Paoli Calmettes diagnosed with Pancreatic neoplasms


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of Pancreatic neoplasm

Exclusion Criteria:

* Patient with a diagnosis of cholangiocarcinoma
Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

The study is intended to test the image quality of the FICE system to the predicate device, Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.

No additional description required.

Eligibility Criteria:
Inclusion Criteria:

* Referred for diagnostic endoscopy or colonoscopy
* Ability to comply and willingness to partake in study

Exclusion Criteria:

* less than 21 years of age
* is an inmate
Study to Evaluate Blood Cell Lines From Patients With Gaucher Disease

The purpose of this study is to learn more about Gaucher disease. The information we collect from medical histories and a blood sample from people with Gaucher disease may help us pinpoint certain things that are different between people who have Gaucher disease and people who do not have Gaucher disease. This information may be useful in the future to help find new treatments for Gaucher disease.

This study is designed to evaluate the ex vivo response to pharmacological chaperone therapy by testing blood samples from previously treated and untreated patients with Gaucher disease. The study will include patients with non-neuropathic Gaucher disease (type I) and neuropathic Gaucher disease (types II and/or III).

All subjects will participate in one study visit. Clinical information will be collected retrospectively from medical records. Information collected will include Gaucher disease diagnosis and history, medical history, family history, assessments of clinical severity, and genotype. A blood sample will be collected and various cells will be isolated for laboratory testing and research.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent by subject or legal guardian
2. Male or female of any age
3. Confirmed diagnosis of Gaucher disease with known genotype
4. Clinically stable and either treatment naïve or on a stable dose of enzyme replacement therapy and/or substrate reduction therapy for at least 6 months prior to study entry
5. Available medical records for collection of retrospective clinical information

Exclusion Criteria:

1. Received any investigational product within 30 days prior to study entry
2. Other significant disease or be otherwise unsuitable for the study, as determined by the investigator
Obesity and Metabolic Surgery in Patients With Type I Diabetes

Obesity is the indication for bariatric surgery in type I diabetes. Interestingly postsurgery the patients improve remarkable in their need for insulin, not only in the daily total insulin dosage but also in the dosage of IU per kg.

The investigators performed a retrospective analysis on 16 patients undergoing weight loss surgery in obesity with concomitant type I diabetes. All patients were evaluated during Follow - Up to analyze insulin dosage and metabolic changes.

Eligibility Criteria:
Inclusion Criteria:

* type I diabetes
* BMI \> 40kg/m2

Exclusion Criteria:

* type II diabetes
Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:

1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
2. Frequency of incidence and its change in adverse events (AEs)
3. Factors on the safety profile of the study drug
4. Factors on the efficacy profile of the study drug


Eligibility Criteria:
Inclusion Criteria:

patients diagnosed with essential hypertension

Exclusion Criteria:

patients who took Micardis Plus before participating in this PMS study
Development Study of Pain Monitoring and Injury Impact Scale

This study introduced and validated the Pain Monitoring and Injury Impact Scale for Athletes (PAMIIS), developed to address the lack of a comprehensive tool in Turkish for assessing injury-related pain and its multidimensional impact on athletes.The development process involved expert consultations, literature review, and feedback from athletes, resulting in a 37-item pool that was refined through pilot testing. Psychometric analyses conducted with 148 athletes demonstrated strong internal consistency, high test-retest reliability, and substantial correlations with established tools such as the Visual Analog Scale, OSTRC-O, and OSTRC-H. The final scale structure, consisting of 32 items across four subscales, was confirmed through both exploratory and confirmatory factor analyses. PAMIIS is a psychometrically sound instrument for systematically monitoring athletes' health status and documenting the short- and long-term consequences of sports injuries.

ABSTRACT Aims: In Turkish, there is no valid and reliable measurement tool for monitoring the health status of athletes and evaluating the effects of injuries on them from various dimensions. With this study, we aimed to develop a measurement tool to detect pain associated with sports injuries and to investigate the consequences of injury. We created a measurement tool called Pain Monitoring and Injury Impact Scale for Athletes-PAMIIS, which consists of a Pain Detection Diagram and an Injury Impact Scale.

Methods: PAMIIS was designed and improved upon expert, partner, and participant opinions and a literature review. Initially, a pool of 37 items was created. The content and scope of the tool were checked with a pilot test on 30 athletes. In the main test phase, 148 participants (200 sample) were tested for item consistency, and 55 athletes (70 sample) were retested for stability to determine reliability. For concurrent validity, PAMIIS sub-scores were compared with the Visual Analog Scale, the Oslo Sports Trauma Research Center Overuse Injury Questionnaire (OSTRC-O), and the Oslo Sports Trauma Research Center on Health Problems (OSTRC-H) scores. Scale structure revealed with Exploratory Factor Analysis (EFA) for the construct validity. In the final phase, 90 (122 sample) athletes were administered the restructured scale, and its construct was tested with Confirmatory Factor Analysis (CFA).

Eligibility Criteria:
Inclusion Criteria:

* Engaged in regular participation in any form of sporting activity for a minimum duration of six months
* Aged 13 years or older
* Had sufficient proficiency in the Turkish language to comprehend and respond to the study materials
* Voluntarily agreed to participate in the study, with informed consent obtained

Exclusion Criteria:

* Pregnancy or illiteracy
Levosimendan in Acute Kidney Injury Study

We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.

The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed adult patients with AKI

Exclusion Criteria:

* Failure to obtain written consent to participate from patient or legal representative (by deferred consent)
* Patients entering the ICU for post-operative observation with an estimated length of stay less than 24 hrs.
* Moribund patients
* Patients under the age of 18
* Pregnancy
* Patients suffering from pre-existing renal failure (elevated NGAL values without apparent rise in creatinine values)
* Renal replacement therapy initiated before admission due to Chronic Kidney Disease
* Hypersensitivity to levosimendan experienced by previous treatments
* Severe hypotension and tachycardia
* Significant mechanical obstruction affecting ventricular filling or outflow or both.
* Severe hepatic impairment (ALAT/ASAT\>400U/L)
* Patients will be excluded if the treating physician judges that study participation is undesirable for medical, medical-ethical or other reasons
* Known history of Torsades de Pointes