louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06606496: Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index
Official title: Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index and Other Parameters in General Anesthesia: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: General Anesthesia
Testosterone
BIS
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 22
Sex: MALE
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing hypospadias repair surgery

Brief summary: The aim of this observational study is to learn the effects of hormone therapy (testosterone) applied in micropenis hypospadias surgery on the depth of anesthesia under general anesthesia. The main question it aims to answer is: The effect of testosterone therapy on the depth of general anesthesia. Based on these, to comment on the depth of anesthesia of patients who have just started using testosterone for sex change. To follow the depth of anesthesia of patients who have undergone hypospadias surgery with BIS monitoring and to record respiratory parameters under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Ages 1-16
* Patients with ASA I (Normal healthy patients except for surgery)
* Patients who will undergo surgery for hypospadias repair

Exclusion Criteria:

* Morbidly obese patients (body mass index \> 40kg/m2)
* ASA II-III-IV patients (other groups of patients with additional diseases)
* Volunteers who do not want to participate in the study

Primary outcomes:
measure: BIS values
timeFrame: 4 months
Secondary outcomes:
measure: sex change and anesthesia
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04027296: Development and Validation of the GLORI-COPD Score
Official title: Screening of COPD Patients at Risk of Complications in General Practice:
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
name: Assistance Publique - Hôpitaux de Paris
First posted: 2019-07-19
Enrollment: 462
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be any patient consulting a general practitioner over 35 years of age with smoking (active or weaned) in excess of 10 pack-years.

Brief summary: The objective of this study is to evaluate the diagnostic accuracy of the GLORI-COPD score in ambulatory care, to enable the screening of COPD patients at risk of complications, requiring early management

Detailed description: Chronic obstructive pulmonary disease (COPD) is a chronic disease with a high prevalence in France, but which remains under-diagnosed due to the trivialization of symptoms and difficulty in accessing diagnostic investigations. It is associated with other co-morbidities, with an impact on the occurrence of complications and quality of life. Early management of the most severe patients would allow better control of these risks of complications. Our objective is to better identify patients with COPD at risk of complications in general practice, taking into account the totality of the patient, to improve their management.

Eligibility criteria: Inclusion Criteria:

* age ≥ 35 yo
* smoker or former smoker ≥ 10 Pack Years

Exclusion Criteria:

* Patients who have already been diagnosed with COPD by spirometry,
* have a contraindication to spirometry,
* have an estimated life expectancy of less than 5 years
* are under protective measures

Primary outcomes:
measure: diagnostic accuracy of the score
timeFrame: 12 months
Secondary outcomes:
measure: COPD diagnosis
timeFrame: Baseline
measure: complications
timeFrame: 6 and 12 months
measure: death
timeFrame: 12 months
measure: Modified Medical Research Council Dyspnea scale score (mMRC)
timeFrame: baseline, 6 and 12 months
measure: COPD Assessment test (CAT)
timeFrame: baseline, 6 and 12 months
measure: ADO index (Age, Dyspnea, Obstruction)
timeFrame: baseline, 6 and 12 months
measure: GOLD stage
timeFrame: baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Université Paris Cité
Study officials:
References:
citation: Malmartel A, Eap D, Ghasarossian C. [Spotting the GLObalRIsk of severe outcomes in undiagnosed COPD patients (GLORI-COPD)]. Rev Mal Respir. 2018 Mar;35(3):347-352. doi: 10.1016/j.rmr.2017.10.663. Epub 2018 Mar 27. French.
Clinical trial NCT03067116: Posturography Changes During Pregnancy
Official title: Posturography Changes During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Keywords: balance, postural
fall risk
anthropometrics
blood pressure
SpO2
heart rate
heart rate variability
stance width
Lead sponsor: Caps Research Network
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, healthy pregnant women

Brief summary: Determine balance changes during pregnancy

Detailed description: The subjects will be tested at enrollment and during weeks 20, 24, 28, 32, 36, 40 of their pregnancy, as well every 4 weeks postpartum up to 6 months. The following protocol will be used:

1. Subjects will also be asked to answer a short health questionnaire.
2. The following data will be recorded each time: height, minimum stance width, circumference measurements of the chest, abdomen, hip and each thigh as well as a supine fundal height. A full body side-profile photo was also taken to determine the curvature of the spine.
3. A session questionnaire will be used to determine if the subject had fallen or noticed any changes in their daily activity.
4. In a seated position, the following measurements will be recorded: 1-minute heart rate variability (HRV) with paced breathing, temporal scan body temperature, respiration rate, heart rate, blood pressure and SpO2 (these last three will be measured bilaterally).
5. Subject will undergo posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: four 30 s tests in the following conditions: eyes open on a rigid surface (NSEO), eyes closed on a rigid surface (NSEC), eyes open on a compliant surface (PSEO), and eyes closed on a compliant surface (PSEC).
6. At the end of the posturography testing, heart rate, blood pressure and SpO2 will be re-measured bilaterally in the standing and then seated positions, as will be the seated HRV.

Eligibility criteria: Inclusion Criteria:

* healthy women less than 20 weeks pregnant

Exclusion Criteria:

* women affected by any pathology and/or more than 20 weeks pregnant

Primary outcomes:
measure: Stability Score
timeFrame: From enrollment to 6 month post partum
Secondary outcomes:
measure: Center of Pressure (CoP) coordinates
timeFrame: From enrollment to 6 month post partum
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Innova Brain Rehabilitation
state: Georgia
Study officials:
affiliation: Caps Research Network
name: Elena Oggero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: C.C. Keiser, N.D. Keiser, G. Pagnacco, E. Oggero "REPEATED EVALUATIONS OF FALL RISK AND POSTUROGRAPHIC CHANGES DURING PREGNANCY AND POST-PARTUM: A FEASIBILITY STUDY", Biomedical Sciences Instrumentation, 2017, Vol. 53, pp 269-75.
Clinical trial NCT04655716: Urine Alkalinisation to Prevent AKI in COVID-19
Official title: Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.

Detailed description: Severe acute kidney injury appears to a major part of the SARS-CoV-2 syndrome. Preventing early acute kidney injury may reduce severe AKI as the disease progresses. Urine alkalinisation to prevent binding of SARS-COV-2 to renal tubular epithelial cells is a novel concept that could be used to design other therapies to reduce viral binding. Showing feasibility with this safe and available strategy could be the first step toward other related efforts.

Eligibility criteria: Inclusion Criteria:

* Confirmed Covid-19 positive
* Admission to Critical Care Unit
* Bladder catheter in situ
* Central line in place (including PICC line)
* Age ≥18y
* Written informed consent to participate in the study

Exclusion Criteria:

* Stage 3 AKI (as defined by KDIGO criteria)
* Chronic kidney disease stage 4 or 5
* Contraindications to NaHCO3 therapy (e.g. risk of serious drug interaction, systemic metabolic alkalosis, congestive heart failure)
* Urine pH \> 7.0
* Serum sodium \>150mmol/L
* Blood pressure \>180/100mgHg
* Severe hypokalaemia (K\<3.0mmol/L)
* Inability to grant informed consent
* Severe hypocalcaemia (Cai \<0.8 mmol/L)
* Pregnant or lactating and breast-feeding women
* Unwilling to use contraception
* Patient is on a medication that may interact with sodium bicarbonate

Primary outcomes:
measure: proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
timeFrame: up to 10 days after intensive care unit admission
Secondary outcomes:
measure: number of days alive and free of stage 2-3 AKI (up to day 28) in each group
timeFrame: up to day 28 after randomisation
measure: proportion of patients developing stage 2-3 AKI
timeFrame: up to day 28 after randomisation
measure: ventilator-free days
timeFrame: up to day 28 after randomisation
measure: hospital-free days
timeFrame: up to day 60 after randomisation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Marlies Ostermann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02021916: Louisville Cooperative Tissue Biorepository
Official title: Louisville Cooperative Tissue Biorepository of the James Graham Brown Cancer Center Tissue Collection Consent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal and Abnormal Tissue
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 17499
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing surgery for removal of normal or abnormal tissues that are removed from the human body as part of standard medical and surgical practice at the University of Louisville Hospital, Norton Hospital downtown, Jewish Hospital downtown and Kosair Children's Hospital.

Brief summary: To provide appropriate collection, storage, and distribution of specimens and medical data to local investigators who have approved IRB protocols for their specific research purposes.

Detailed description: The mission of the Louisville Cooperative Tissue Biorepository is to appropriately collect normal and abnormal tissues that are removed from the human body as a part of standard medical and surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. The LCTB securely stores appropriately collected human samples for research purposes and appropriately allocates these samples to local investigators for research purposes. The LCTB team appropriately documents all points in the process of obtaining informed consent, collection, storage, and allocation of tissues.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery for removal or normal and abnormal tissues as part of standard medical and surgical practice

Exclusion Criteria:

* Patients with known systematic infections including septic patients with bacterial and viral infections, hepatitis, HIV, TB and other defined pathogens will not be included.

Primary outcomes:
measure: Collect normal and abnormal tissues that are removed from the human body as a part of standard surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made.
timeFrame: 15 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06792916: This Study Evaluates the Clinical Effect of Adding Spermidine Gel to Minimally Invasive Non-surgical Periodontal Therapy (MINST) to Improve Periodontal Health.
Official title: Evaluation of Subgingival Mechanical Periodontal Therapy with the Additional Local Application of a Spermidine-Based Gel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Peridontitis
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effectiveness of using a spermidine-based gel as an adjunct to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis. The primary outcome is to assess whether the addition of spermidine gel reduces pocket depth (PPD) compared to MINST alone. Secondary outcome include evaluating other periodontal parameters like bleeding on probing, FMBS and FMPS and CAL over a 12-month period.


Eligibility criteria: Inclusion Criteria:

Age 18 years or older. Presence of untreated periodontitis with at least 2 sites showing clinical attachment loss (CAL) \> 2 mm and probing depth (PD) \> 4 mm.

Voluntary signing of informed consent.

Exclusion Criteria:

Presence of systemic diseases (e.g., diabetes mellitus, cardiovascular, renal, hepatic, or pulmonary conditions).

Smokers (≥10 cigarettes per day). Pregnancy or breastfeeding. Allergy to any ingredients in the products used in the study. Diseases affecting bone and/or connective tissue metabolism.

Primary outcomes:
measure: Probing depth (PD)
timeFrame: From non surgical periodontal therapy to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: AOU Federico II
Study officials:
References:
Clinical trial NCT01249716: Follow-up Home Visits With Nutrition
Official title: Follow-up Home Visits With Nutrition (OHE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: follow-up home visit
Geriatric Disorder
rehabilitation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 152
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect on geriatric patients of follow-up home visit including nutrition.

The hypothesis is that this can prevent hospital readmissions, and has a positive impact on functional abilities and quality of life

Detailed description: Before and after the intervention the participants nutritional status, hand grip strength, functional abilities, well-being, dietary intake, level of tiredness,and activities of daily living will be assessed

Eligibility criteria: Inclusion Criteria:

* Geriatric patients in nutritional risk

Exclusion Criteria:

* Dementia
* Expected readmissions
* Terminal disease
* Non-Danish speaking

Primary outcomes:
measure: hospital readmissions
timeFrame: one year
Secondary outcomes:
measure: body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Geriatric department
Study officials:
References:
citation: Beck AM, Kjaer S, Hansen BS, Storm RL, Thal-Jantzen K. Study protocol: follow-up home visits with nutrition: a randomised controlled trial. BMC Geriatr. 2011 Dec 28;11:90. doi: 10.1186/1471-2318-11-90.
citation: Baldwin C, de van der Schueren MA, Kruizenga HM, Weekes CE. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002008. doi: 10.1002/14651858.CD002008.pub5.
citation: Beck AM, Kjaer S, Hansen BS, Storm RL, Thal-Jantzen K, Bitz C. Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge: a randomized controlled trial. Clin Rehabil. 2013 Jun;27(6):483-93. doi: 10.1177/0269215512469384. Epub 2012 Dec 20.
Clinical trial NCT05162716: Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.
Official title: Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pacing-Induced Cardiomyopathy
Keywords: left bundle branch area pacing; atrial fibrillation; atrioventricular ablation; pacing-induced cardiomyopathy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Dr Arnaud BISSON
First posted: 2021-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated with pacemaker implantation and atrioventricular junction ablation for symptomatic chronic atrial arrhythmia.

Brief summary: Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing.

Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.

They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.

They will be prospectively followed during 6 months.

Detailed description: Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.

They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing confirmed according to electrocardiographic parameters. Atrioventricular node ablation will be performed the following day through a femoral venous approach.

Perioperative data and potential complications will be collected. Patients will be prospectively followed during 6 months. They will have clinical examination, 12-lead ECG, and an echocardiography.

Eligibility criteria: Inclusion Criteria:

* Permanent atrial arrhythmia
* Symptoms related to an insufficient rate control under optimal medical therapy

Exclusion Criteria:

* Indication of prophylactic defibrillator
* Already implanted with a cardiac device

Primary outcomes:
measure: Heart failure hospitalization
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
measure: Electrical remodeling
timeFrame: 6 months
measure: Complications
timeFrame: 30 days
measure: Volumetric response
timeFrame: 6 months
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
state: Please Select...
Study officials:
References:
Clinical trial NCT06077916: Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy
Official title: The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will test the hypothesis that azythromycin is efficient and safe in cleansing the upper gastrointestinal tract for endoscopic examination in the case of acute bleeding.

Detailed description: In this study patients with upper GI bleeding will be randomzied to either i.v. azythromycin or placebo in order to evaluate the efficiency and safety of azythromycin for upper GI cleanliness during diagnostic endoscopy. A validated upper GI cleanliness score (Toronto score with values up to 10) and a visual analog scale will be used to evaluate cleanliness. Need for repeat endoscopy due to poor preparation, duration of hospitalization and requirement for blood transfusions during hospitalization will also be assessed. Adverse venets due to medication will also be recorded carefully.

Eligibility criteria: Inclusion Criteria:

* acute upper GI bleeding (\<12 hours)

Exclusion Criteria:

* prokinetics \<12 hours
* allergy to azithromycin
* use of contraindicated drugs (due to interactions)
* pregnancy
* physician option

Primary outcomes:
measure: Toronto Upper Gastrointestinal Cleaning Score
timeFrame: up to 12 hours after admission
measure: Need for second look endoscopy
timeFrame: up to 48 hours after endoscopy
Secondary outcomes:
measure: Toronto Upper Gastrointestinal Cleaning Score
timeFrame: up to 12 hours
measure: Total hospitalization
timeFrame: one month
measure: Number of blood units transfused
timeFrame: one month
measure: Adverse events
timeFrame: one month
measure: Duration of endoscopy
timeFrame: up to 12 hours after admission
measure: Score of endoscopist satisfaction on a 4-item scale
timeFrame: up to 12 hours
Other outcomes:
Locations:
city: Bucuresti
country: Romania
facility: Colentina Clinical Hospital
state: Bucharest
Study officials:
affiliation: Clinical Hospital Colentina
name: Bogdan Mateescu, Prof
role: PRINCIPAL_INVESTIGATOR
References: