louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03020940: The Clinical Trial of Cefuroxime Axetil Dispersible Tablets
Official title: 100000 Cases Real World Research of the Safety and Efficacy Revaluation of Cefuroxime Axetil Dispersible Tablets After Listing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infectious Disease
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prescription of cefuroxime axetil dispersible tablets in patients

Brief summary: 1. National, large-scale, standardized, standardized, real-world research;
2. Prospective, single - arm open, non - interventional, registration, multi - center clinical study;
3. in the use of cefuroxime axetil dispersible tablets in the hospital, according to the principle of voluntary selection of 200;
4. registration of the use of cefuroxime axetil dispersion tablets patients;
5. Target sample size of 100,000 cases;
6. Exemption from informed consent for ethical review applications;
7. Antibiotic drug safety re-evaluation of large data.

Detailed description: Research purposes

1. To evaluate the safety of cefuroxime axetil dispersible tablets in the real world of the widely used population,

   Rare or even very rare, new, unanticipated adverse reactions, while revealing adverse reactions

   Should be susceptible to risk factors and susceptible populations.
2. To evaluate the efficacy of cefuroxime axetil dispersible tablets in the treatment of the relevant site of infection, including

   Including empirical therapy and targeted therapy, to further evaluate the widespread use of cefuroxime dispersible tablets

   The validity of the crowd in the real world.
3. To investigate the clinical application of cefuroxime axetil dispersible tablets for the safety management of drug use.

   Clinical management should provide more clinical clues and basis.
4. For the relevant treatment areas of guidance and consensus revision, clinical pathway design provides a reference.
5. To further improve the safety of cefuroxime axetil dispersion tablets level, the basic medical security capabilities and Market vitality.

Study end point

1. The main study endpoint:

   * Security;
   * Effectiveness.
2. Secondary study endpoint:

   * Extensive use of population characteristics;
   * Clinical drug characteristics;
   * Appropriate characteristics of the crowd;
   * Adverse reactions susceptible population characteristics.

Eligibility criteria: Inclusion Criteria:

* Prescription of cefuroxime axetil dispersible tablets in patients

Exclusion Criteria:

* no

Primary outcomes:
measure: Bacterial clearance
timeFrame: 1 to 14 days after the use of Cefuroxime Axetil Dispersible Tablets，
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03130140: MOSE to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions
Official title: Macroscopic On-site Quality Evaluation of Biopsy Specimens to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions: a Multicenter Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 244
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: DIAGNOSTIC

Brief summary: The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a 19-gauge needle. How it compares to the conventional technique of tissue acquisition during EUS-FNA is uncertain.

The objective of this study is to evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis.

Detailed description: To evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis in a randomized controlled study.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients (aged between 18 and 80 years) referred for EUS-guided tissue acquisition for intestinal or extra-intestinal solid lesions more than 2cm in the largest diameter would be included.

Exclusion Criteria:

* Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.

Primary outcomes:
measure: Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
References:
citation: Chong CCN, Lakhtakia S, Nguyen N, Hara K, Chan WK, Puri R, Almadi MA, Ang TL, Kwek A, Yasuda I, Doi S, Kida M, Wang HP, Cheng TY, Jiang Q, Yang A, Chan AWH, Chan S, Tang R, Iwashita T, Teoh AYB. Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial. Endoscopy. 2020 Oct;52(10):856-863. doi: 10.1055/a-1172-6027. Epub 2020 Jun 4.
Clinical trial NCT05047744: Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis
Official title: Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhizarthrosis
Keywords: CMC I Osteoarthritis, Total Joint Replacement, Hand Surgery
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective non randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

Detailed description: The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

The Study is designed to give clinical results after one year, 2 years and also long time results in the future.

Eligibility criteria: Inclusion Criteria:

* CMC I Osteoarthritis /Stage III)

Exclusion Criteria:

* CMC I (osteoarthritis / Other Stage than III)
* Anticoagulation

Primary outcomes:
measure: DASH Score (Disability of Arm Shoulder and Hand Score)
timeFrame: 24 months
Secondary outcomes:
measure: Subjective Pain
timeFrame: 24 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitaetsklinikum GmbH
Study officials:
References:
Clinical trial NCT00138944: Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
Official title: Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Essential hypertension
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 85
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: Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not below 140/90 mmHg) with the use of adequate doses of at least three different anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible mechanism of resistance is the aldosterone-escape phenomenon.

During aldosterone escape, aldosterone plasma levels are normal or even elevated despite therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH), local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood pressure independent effects on cardiac, vascular and renal damage.

Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients with resistant hypertension.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* Casual blood pressure \>=140/90 despite effective triple therapy including an ACEI/ARB and a diuretic

Exclusion Criteria:

* Contraindication for eplerenone
* Creatinine-Clearance \< 60 ml/min
* Diabetes mellitus

Primary outcomes:
measure: Change of left ventricular mass
timeFrame: 3 months vs. baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: CRC Medical Department IV
Study officials:
affiliation: University Erlangen-Nuremberg
name: Roland E Schmieder, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05774444: Investigating the Effects of Krill Oil and Krill Protein on Post-exercise Muscle Protein Metabolism
Official title: Investigating the Effects of Krill Oil and Krill Protein on Post-exercise Muscle Protein Metabolism: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophy
Keywords: Omega-3
Krill oil
Protein
Exercise
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Aker BioMarine
First posted: 2023-03-17
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel 2x2 factorial design
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to find out if krill oil can increase muscle building processes in response to resistance (weightlifting) type exercise. Others aim are to determine the effects of krill protein, and the interaction of krill oil and protein, on muscle building processes in response to resistance (weightlifting) type exercise.


Eligibility criteria: Inclusion Criteria:

* Be 60 years old or older
* Have a BMI of less than 35kg/m2
* Be participating in structured exercise for less than 2h per week

Exclusion Criteria:

* Diabetes
* Severe cardiovascular disease
* Seizure disorders,
* Uncontrolled hypertension (\>150/90mmHg at baseline measurement)
* Cancer or cancer that has been in remission \<5 years
* Ambulatory impairments which would limit ability to perform assessments of muscle function
* Dementia
* Taking medication known to affect muscle (e.g., steroids)
* Have an implanted electronic device (e.g., pacemaker/defibrillator/insulin pump),
* Anticoagulant therapy
* Allergies to seafood
* Regular consumption of more than 1 portion of oily fish per week.

Primary outcomes:
measure: Post-exercise muscle protein synthesis
timeFrame: 3-7 hours
Secondary outcomes:
measure: Change in Muscle thickness
timeFrame: Change from baseline to 8 weeks
measure: Change in grip strength
timeFrame: Change from baseline to 8 weeks
measure: Change in fat mass
timeFrame: Change from baseline to 8 weeks
measure: Change in lean mass
timeFrame: Change from baseline to 8 weeks
measure: Change in muscle strength
timeFrame: Change from baseline to 8 weeks
measure: Change in Chair rise time
timeFrame: Change from baseline to 8 weeks
measure: Change in balance
timeFrame: Change from baseline to 8 weeks
measure: Change in gait speed
timeFrame: Change from baseline to 8 weeks
measure: Basal muscle protein synthesis
timeFrame: 0-3 hours
measure: Change in Erythrocyte fatty acid profile
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Stuart Robert Gray
Study officials:
References:
Clinical trial NCT06892444: Sweet Corn and Carotenoids
Official title: Effects of Sweet Corn Intake on Carotenoid Levels and Gastrointestinal Wellness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carotenoids
Keywords: sweet corn
lutein
zeaxanthin
carotenoid
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will assess the effect of daily yellow and white sweet corn intake on serum lutein and zeaxanthin concentrations. Skin carotenoid levels using the Veggie Meter will be assessed, and gastrointestinal symptoms and changes in fecal microbiota during a 4-week intervention period will be monitored.


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years of age
* Able to provide written consent in English
* Baseline Veggie Meter score of ≤ 250 (Scale from 0 to 850)
* Willing to adhere to study procedures

Exclusion Criteria:

* Baseline Veggie Meter score of \>250
* Corn allergy
* Current use of laxatives or antidiarrheal medications
* Previously or currently being treated for intestinal disease, including irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer
* Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection)
* Current cancer treatment
* Current pregnancy
* Vegetarian diet
* Elite athletes or long-distance runners.
* Use of antibiotic drugs within 1 month of the screening visit.

Primary outcomes:
measure: Serum concentration of lutein + zeaxanthin
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT02563444: Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology
Official title: Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissular Lesion
Keywords: Diagnostic (Biopsy) or Therapeutic Procedure (Infiltration, Ablation)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by comparing the path indicated by the ultrasound fusion (virtual line) and the path actually obtained on the control CT scan (real line).

Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more accurate, saving time and irradiation (not evaluated here).


Eligibility criteria: Inclusion Criteria:

* age\>18 years
* male or female
* women of childbearing potential should use effective contraceptive measures and indicate the date of the last menstrual
* Patient requiring the use of computed tomographic guidance to perform a diagnostic (biopsy) or therapeutic procedure (infiltration, ablation) on a mobile organ
* patient signed an informed consent

Exclusion Criteria:

* Contraindications to the use of X-rays (pregnancy)
* Patients using vital electronic devices (eg: pacemaker or defibrillator)
* Subject under judicial protection
* Subject under tutorship or curatorship
* Inability to give informed informations (subject in emergency situations, comprehension difficulties of the subject, ...)

Primary outcomes:
measure: Measure of the averages (m) errors of the coordinates in the three planes of space, between the virtual and the real line of the spinal needle (comparison of ultrasound fusion data with control CT scan data achieved once the spinal needle is placed)
timeFrame: time of the procedure
Secondary outcomes:
measure: distance between the center of the target and the extension of the spinal needle (perpendicular line to this projection through the center of the lesion)
timeFrame: time of the procedure
measure: overall satisfaction score
timeFrame: time of the procedure
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
state: Alsace
Study officials:
affiliation: Strasbourg's University Hospitals
name: Afshin GANGI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01211444: US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Official title: US Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
OSA
Hypoglossal nerve stimulation
Sleep apnea
Lead sponsor: Apnex Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).


Eligibility criteria: Eligibility Criteria

1. Previously diagnosed with moderate-to-severe obstructive sleep apnea.
2. Subject has failed or does not tolerate CPAP treatment.
3. Age between 21 and 70 years.
4. Body mass index (BMI) less than or equal to 37.

Primary outcomes:
measure: Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
timeFrame: 6 months post-implant
measure: Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline
timeFrame: 6 months post-implant
measure: The frequency of serious adverse events.
timeFrame: One month post-implant.
measure: The frequency of serious adverse events.
timeFrame: 3 months post-implant.
measure: The frequency of serious adverse events.
timeFrame: 6 months post-implant.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Indianapolis
country: United States
facility: Saint Vincent Hospital
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Clinilabs, Inc.
state: New York
Study officials:
affiliation: Clinilabs, Inc. West Side ENT, NY, NY
name: Jon Freeman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Ear, Nose, Throat and Allegery, PC (Centa), Carmel, IN
name: Tod Huntley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Neurology, University of Minnesota
name: Con Iber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Califoprnia - San Francisco
name: Eric Kezirian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00460044: ADMA and Mechanical Ventilation in Preterm Infants
Official title: Plasma ADMA Concentrations at Birth and Mechanical Ventilation in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: ADMA
Preterms
infants
mechanical ventilation
Preterm infants
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2007-04-13
Enrollment: 35
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to study the relation between mechanical ventilation and ADMA concentrations at birth.

Detailed description: Nitric oxide (NO) plays an important role in the normal development and maturation of the lungs. In addition, NO is an important mediator of vascular smooth muscle relaxation, ventilation perfusion matching, neurotransmission and host defence and bacteriostasis. Asymmetric dimethylarginine (ADMA) is an endogenous derivative of arginine that inhibits NOS and thereby the bioavailability of NO. Preterm infants have increased concentrations of ADMA. Therefore, inhibition of NO by increased concentrations of ADMA which could be associated with reduced pulmonary functioning.

Eligibility criteria: Inclusion Criteria:

* Gestational age \< 32 weeks
* Birth weight \< 1500 gram
* Written informed consent of parents

Exclusion Criteria:

* Congenital abnormalities
* Chromosomal abnormalities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: R M van Elburg, MD, PhD
role: STUDY_DIRECTOR
References: