louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03338712: Micro-RNA Expression Profiles in Localised Prostate Cancer
Official title: Micro-RNA Expression Profiles in Localised Prostate Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Radical Prostatectomy
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 0
Sex: MALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Male
* Patients with clinically localised high risk prostate cancer

Brief summary: Recurrence free survival The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly for until death.


Eligibility criteria: Inclusion Criteria:

* 35 Years to 80 Years
* Male
* Patients with clinically localised high risk prostate cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Recurrence free survival
timeFrame: Up to 120 months. From date of inclusion until date of death from any cause
Secondary outcomes:
measure: Cancer specific survival
timeFrame: Up to 120 months. From date of inclusion until date of death from any cause
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04900012: Prospective Snapshot Audit of Distal Pancreatectomy in Spain
Official title: SPAnish DIStal PANcreatectomy Snapshot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery--Complications
Pancreas Disease
Pancreatic Fistula
Lead sponsor: Hospital General Universitario de Alicante
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All scheduled distal pancreatectomies performed in on year in each Unit.

Brief summary: Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.

Detailed description: Snapshot observational study including most of the Spanish pancreatic units that perform distal pancreatectomy. One year consecutive cases.

Main objectives.

1. percentage of laparoscopic approach in Spain
2. Morbidity at 90 days measured by CCI and Clavien Dindo
3. Percentage of pancreatic fistula
4. Impact of new device to decrease pancreatic fistula

Eligibility criteria: Inclusion Criteria:

-All distal pancreatectomies performed in involved Units

Exclusion Criteria:

* No sign of informed consent for entering in the study
* Emergency procedures

Primary outcomes:
measure: Morbidity at 90 days
timeFrame: 90 days
measure: Laparoscopic approach
timeFrame: 1 year
Secondary outcomes:
measure: Pancreatic fistula
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04343612: Different Montages of Transcranial Direct Current Stimulation Tongue Strength
Official title: The Effects of Different Montages of Transcranial Direct Current Stimulation on Tongue Strength in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: tDCS
IOPI
Tongue Strength
Healthy
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4 groups, each group receives one of three treatments or the sham treatment. Double-blinded, sham controlled, crossover study
Primary purpose: TREATMENT

Brief summary: 20 healthy subjects will be split into 4 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal or placebo Subjects will receive 2mA for 20 mins of their attributed tDCS. The evaluation is a maximal strength test measured with the IOPI and will take place prior to, immediately following and 30 minutes after stimulation


Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)

Primary outcomes:
measure: Change Tongue Maximal Strength
timeFrame: Baseline, immediately after, and 30 minutes after tDCS
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Liege Univeristy
Study officials:
References:
citation: Bornheim S, Croisier JL, Maquet P, Kaux JF. Proposal of a New Transcranial Direct Current Stimulation Safety Screening Tool. Am J Phys Med Rehabil. 2019 Jul;98(7):e77-e78. doi: 10.1097/PHM.0000000000001096. No abstract available.
Clinical trial NCT00743912: Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
Official title: A Phase 1, Single Arm, Open-Label Study to Evaluate the Effect of Rifaximin 550 MG Tablets TID on the Pharmacokinetics of Orally Administered Midazolam in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic
Keywords: rifaximin
midazolam
pharmacokinetics
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this study is to determine if rifaximin, administered daily has an effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.

Detailed description: This is a single-site, single-arm, open-label, drug-interaction study that examines the effect of rifaximin (RFX), 550 mg 3 times daily (TID; 1650 mg/day), on orally administered (PO) midazolam (MDZ) 2 mg (administered as a 2 mg dose in 1 mL of midazolam HCL Syrup; 2 mg/mL) when dosed for 7 and 14 consecutive days, respectively.

Eligibility criteria: Inclusion Criteria:

* Patient is medically normal
* Patient has normal laboratory values
* Patient has the ability to understand the requirements of the study

Exclusion Criteria:

* HIV
* Hepatitis B
* Hepatitis C
* History of renal, hepatic, endocrine, oncological, gastrointestinal or cardiovascular disease.
* History of epilepsy, asthma, diabetes, psychosis, glaucoma or severe head injury.

Primary outcomes:
measure: Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized.
timeFrame: 21 to 38 days (including a 21 day screening period)
Secondary outcomes:
measure: Overall safety assessments will include the incidence, intensity, and type of adverse events, and clinically significant changes in the patient's physical examination, vital signs and laboratory results.
timeFrame: 21 tyo 38 days
Other outcomes:
Locations:
Study officials:
affiliation: Covance CRU, Inc
name: William Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587412: Treatment of Lateral Epicondylalgia With Shock Waves
Official title: Radial Shock Waves Versus Focal Shock Waves in the Treatment of Lateral Epicondylalgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epicondylitis of the Elbow
Epicondylitis, Lateral
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lateral epicondylalgia (LET) is characterized by pain, decreased muscle strength of the wrist extensor muscles, and disability. Among the treatments proposed in the literature, both focal shockwave therapy and radial shockwave therapy have been considered effective in the management of this musculoskeletal disorder. The objective of this study is to compare the safety and effectiveness of these two shockwave applications on the signs and symptoms of subjects with lateral epicondylalgia. In this clinical trial, subjects will be evaluated for elbow pain using a Visual Analog Scale (VAS), grip strength using a handheld dynamometer, and degree of disability using the Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE). A six-month follow-up will be performed.

Patients will be randomly divided into three groups. The first group will receive radial shock waves (rESWT), the second group will receive focal shock waves (fESWT), and the third group, which will act as a control, will receive a placebo treatment with very low energy parameters according to the literature.

Subjects will receive three sessions, one session per week.


Eligibility criteria: Inclusion Criteria:

* Pain in the lateral epicondyle \>3 months
* Pain when performing resisted grip
* Positive Cozen test
* Positive Maudsley test

Exclusion Criteria:

* Pregnancy
* Systemic diseases (Fibromyalgia, Diabetes, Arthritis)
* Local infection or Cancer
* Recent treatments (Physiotherapy, Corticosteroids)-

Primary outcomes:
measure: Pain with Visual Analogue Scale (VAS)
timeFrame: Change from Baseline pain at 6 month
Secondary outcomes:
measure: Grip strength
timeFrame: Change from Baseline pain at 6 month
measure: Patient Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: Change from Baseline pain at 6 month
measure: The Global Rating of Change (GROC)
timeFrame: Change from Baseline pain at 6 month
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Centro Investigación Fisioterapia y Dolor
state: Madrid
Study officials:
References:
Clinical trial NCT06930612: A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-1）
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Rhinosinusitis With Nasal Polyposis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Detailed description: The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period) and Safety Follow-up Period (12 weeks).

Eligibility criteria: Inclusion Criteria:

* with chronic rhinosinusitis with nasal polyposis (CRSwNP).
* Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
* Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline.
* Contraception.

Exclusion Criteria:

* Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.
* Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.

Primary outcomes:
measure: Nasal Polyps Score (NPS)
timeFrame: at week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tong-Ren hospital
Study officials:
affiliation: Beijing Tong-Ren hospital
name: Luo Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517112: 3D Ballistocardiography in Microgravity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab D2 missions on a single astronaut. The results from this experiment have been published in the literature: the influence of respiration have been demonstrated and the signal processing methodology for the reconstruction of the displacement in one cardiac cycle have been developed. A 3D-BCG sensor has been developed and a collaboration to perform a sustained microgravity experiment onboard the Russian segment of ISS has been initiated. To be integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity before implemented on ISS.

The aim of the present parabolic flight study is to serve as a feasibility demonstrator and test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to test whether the sensitivity of the developed 3D-BCG sensor is appropriate


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Whose 4 chamber view of the heart during a breath hold is easy to get during a routine cardiac echocardiography (M-Mode - apical view).
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Difficulty to obtain a clear echocardiography.
* Pregnant women

Primary outcomes:
measure: Heart rate
timeFrame: baseline
measure: stroke volume
timeFrame: baseline
measure: ejection fraction
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT03917212: Energy Metabolism in Branched-chain Organic Acidemias
Official title: Non-invasive Measurement of Energy Metabolism in Patients With Primary and Secondary Mitochondrial Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Energy Metabolism
Metabolic Syndrome
Insulin Resistance
Keywords: Organic acidemias
Mitochondria
Oxidative stress
Fatty liver
Dyslipidemia
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
Collaborators: name: University Children's Hospital, Düsseldorf
First posted: 2019-04-16
Enrollment: 57
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with known propionic acidemia, methylmalonic acidemia or isovaleric acidemia were enrolled as well as healthy humans of comparable age, sex and BMI

Brief summary: Energy metabolism and insulin sensitivity were assessed in a case-control study in patients with branched-chain organic acidemias.

Detailed description: Children and adults with branched-chain organic acidemias and matched healthy humans underwent deep metabolic phenotyping using non-invasive magnetic resonance spectroscopy, oral glucose tolerance tests and measurements of leucocyte respirometry in order to assess changes in energy metabolism and insulin sensitivity.

Eligibility criteria: Inclusion Criteria:

* known branched-chain organic acidemia diagnosed by enzymatic or genetic test
* age\>5 years

Exclusion Criteria:

* acute inflammatory conditions with fever, cold symptoms, gastro-intestinal infection within the last 24 hours
* contraindications for an oral glucose tolerance test such as fasting blood glucose \>126 mg/dl, severe chronic gastrointestinal conditions, allergy against black currant
* contraindications for magnetic resonance tomography (MRT) such as claustrophobia, metallic implants which are not MRT compatible

Primary outcomes:
measure: Hepatic and skeletal muscle energy metabolism
timeFrame: At baseline
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: At baseline
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of General Pediatrics, Neonatology and Pediatric Cardiology of the University Children's Hospital Düsseldorf
state: NRW
city: Düsseldorf
country: Germany
facility: Institute for Clinical Diabetology, German Diabetes Center
state: NRW
Study officials:
affiliation: German Diabetes Center
name: Michael Roden, Professeor
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Düsseldorf
name: Regina Ensenauer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06166212: Changes in Angle Kappa and Corneal Back Elevations After Laser in Situ Keratomileusis in Myopic Astigmatism
Official title: Changes in Angle Kappa and Corneal Back Elevations After Laser in Situ Keratomileusis in Myopic Astigmatism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Refractive Errors
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 groups

Brief summary: Refractive errors and corneal astigmatism are associated with changes in angle kappa and corneal back elevation at the thinnest point in Pentacam.

The purpose of this study is to track:

The effect of anterior corneal astigmatism treatment on angle kappa and corneal back elevation.

Detailed description: This prospective observational study will be settled in Ain Shams University Hospital, Cairo, Egypt.

Eligibility criteria: Inclusion Criteria:

Myopic astigmatism

Exclusion Criteria:

Corneal scar

Primary outcomes:
measure: Track changes in angle kappa
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04846712: Interest of Ultrasound in the Diagnosis of Severity of Lateral Ankle Sprain
Official title: Interest of Ultrasound in the Diagnosis of Severity of Lateral Ankle Sprain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Sprains
Keywords: Ankle
sprain
diagnosis
ultrasound
MRI
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a first ankle sprain will be included.

Brief summary: Ankle sprain is a frequent and widely trivialized trauma. Misdiagnosed or poorly treated, it can recur and thus develop into chronic ankle instability. It can be associated with complications which, if not detected early, can lead to long-term sequelae.

Detailed description: The hypothesis of this study is that ultrasound can better characterize the severity stages of the sprain and can diagnose complications that may have gone unnoticed on physical examination.

Patients were assessed clinically: demographics, history, clinical examination, functional scores. An ultrasound and an MRI were done during the first month to check for complications. The main objective is to assess the value of ultrasound in the diagnosis of the severity of the lateral ankle sprain. The secondary objective is to compare an ultrasound assessment of severity with a clinical assessment and Magnetic Resonance Imaging (MRI).

Eligibility criteria: Inclusion Criteria:

* First ankle sprain with sport or work disability

Exclusion Criteria:

* Patient with fractures, dislocation or hyperlaxity
* Previous ankle sprain

Primary outcomes:
measure: Severity score by ultrasound (US) assesment
timeFrame: Day: 14 after Ankle Sprain.
Secondary outcomes:
measure: Severity score by Magnetic Resonance Imaging (MRI) assesment
timeFrame: Day: 14 after Ankle Sprain.
measure: Severity score by radiologist assesment
timeFrame: Day: 30, 90, 180, 365 after Ankle Sprain.
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thomas NERI, MD
role: PRINCIPAL_INVESTIGATOR
References: