louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06654986: Muscle Anabolic Response to β2-adrenergic Stimulation With Increased Amino Acid Availability.
Official title: The Importance of Amino Acid Availability in Modulating the Muscle Anabolic Response to β2-adrenergic Stimulation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Beta2-adrenergic stimulation
Amino acid availability
Skeletal muscle hypertophy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Thirty-six healthy, well-trained men and women will be randomized into three distinct groups, each receiving one of the following interventions: 1) salmeterol with amino acid availability, 2) salmeterol, or 3) a placebo, administered twice daily over a 6-week intervention period. This design aims to elucidate the impact of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the project is to investigate the effect of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation in young healthy men and women.


Eligibility criteria: Inclusion Criteria:

* Age 18-40
* Physically active \>5 hours a week
* Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

* Active smoker currently or within the past 5 years
* Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
* Chronic or acute illness deemed by the responsible study physician to affect the test parameters
* Deviation from the study protocol
* Lean mass index \>21 kg/m²
* Pregnancy
* Smoker
* Blood donation during the past 3 months

Primary outcomes:
measure: Skeletal muscle hypertrophy
timeFrame: Through study completion, an average on 7 weeks
Secondary outcomes:
measure: Quadriceps strength
timeFrame: Through study completion, an average on 7 weeks
measure: Power output during sprint testing
timeFrame: Through study completion, an average on 7 weeks
measure: Power output during time trial
timeFrame: Through study completion, an average on 7 weeks
Other outcomes:
measure: Maximal oxygen uptake
timeFrame: Through study completion, an average on 7 weeks
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT02103686: Study for Comparing The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects
Official title: A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Neuropathic pain
pregabalin
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to:

1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2).
2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.


Eligibility criteria: Inclusion Criteria:

* 19\~44 aged healthy adult.
* someone tho has at least 50kg body weight and ideal body weight ±20%

Exclusion Criteria:

* someone has acute symptom at screening phase
* someone has any disease or symptoms which is clinically significant
* someone had been determined during healthy examination in screening period
* AST or ALT \> 1.25 times than normal
* Total bilirubin \> 1.5 times than normal
* someone who has a history of allergy, anaphylaxis, drug abuse or misuse.
* someone who had enrolled to other clinical trial within the last 60 days.
* someone who had donated blood within the last 60 days.
* someone who can't take a meal derived from this trial.
* someone who has taken abnormal meals like which can affect to drug ADME
* someone who has taken other ETC drugs or oriental drugs within the last 14 days, Or OTC drugs within the last 7 days
* someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before.
* someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day.
* someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Primary outcomes:
measure: Cmax, AUC of pregabalin
timeFrame: 0~36h
Secondary outcomes:
measure: Safety evaluation
timeFrame: 0~24day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03936686: CVD Risk Factor Knowledge Across Age Groups
Official title: Assessment of the Knowledge Level Regarding Cardiovascular Disease Risk Factors: Comparison Across Age Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Education
Knowledge level
Lead sponsor: D'Youville College
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 381
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There were five participant groups evaluated based on age groupings. These groups were compared within group and against each other.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study was to examine the knowledge level regarding cardiovascular disease risk factors among participants of varying ages. Then to see if there was any type of previous education that led to greater knowledge levels.

Detailed description: This study used a survey tool that assessed the participants' method(s) of prior education regarding cardiovascular disease (CVD) risk factors. Then the participant was asked eleven questions regarding CVD risk factors which tested their knowledge of those factors. Analysis was done to evaluate overall knowledge level of each group and compare the knowledge levels across age groups. Then analysis was done to see if any method(s) led to better knowledge level within and/or between age groups.

Eligibility criteria: Inclusion Criteria:

* were specific to age for each participant group and then also included full completion of the survey for all groups.

Exclusion Criteria:

* age outside of specified population for each participant groups or incomplete survey for any participant regardless of group.

Primary outcomes:
measure: Cardiovascular disease risk factor knowledge
timeFrame: 10-15 minutes
measure: Method(s) of education
timeFrame: 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bartlo P, Irion G, Voorhees J. Assessment of the Knowledge Level Regarding Cardiovascular Disease Risk Factors: Comparison Across Age Groups. J Community Health. 2020 Oct;45(5):1030-1037. doi: 10.1007/s10900-020-00824-w.
Clinical trial NCT01197586: Evaluation of Surfactant Protein B in the Differential Diagnostics of Dyspnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Cardiac Disease
Pulmonary Disease
Keywords: surfactant protein B
differential diagnostics
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2010-09-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients presenting with the symptom "dyspnea" in a university hospital emergency room

Brief summary: Establishing new biochemical markers in the differential diagnostics and risk stratification in heterogeneous patient collectives is becoming more and more important. The markers should be objective, reliable, reproducible, quick and cost effective as well as specific and sensitive. Concerning the differential diagnostics of "dyspnea", NT-pro-BNP plays the most important role for the evaluation of a cardiac origin. However, a corresponding biochemical marker for pulmonary stress is lacking. The aim of the study at hand therefore was the evaluation of surfactant protein B in the differential diagnostics of pulmonary and cardiac diseases.


Eligibility criteria: Inclusion Criteria:

* patients presenting with dyspnea and giving informed consent

Exclusion Criteria:

* outpatients
* lack or doubt of legal competence
* indication for mechanical ventilation
* pregnancy
* palliative patients
* CPAP/LTOT
* BMI \> 30 kg/m2
* sepsis
* anemia
* dialysis

Primary outcomes:
measure: Surfactant protein B serum levels
timeFrame: Days 1, 3 and 7
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitaetsmedizin Mannheim
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Joachim Saur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004986: Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
Official title: Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cryptosporidiosis
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Cryptosporidiosis
Drug Evaluation
Antiprotozoal Agents
Treatment Failure
nitazoxanide
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.

Detailed description: Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a CD4 cell count of 50 cells/mm3 or less.
* Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry.
* Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment.
* Are able to take medications by mouth.
* Are at least 13 years old (consent of parent or guardian required if under 18).
* Agree to use an effective method of birth control (such as condoms) during the study.

Exclusion Criteria

Patients will not be eligible if they:

* Have certain diseases or infections of the intestines.
* Have ever taken nitazoxanide.
* Have taken certain experimental drugs within 14 days of enrollment.
* Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin.
* Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Julie Ryner
state: Florida
Study officials:
References:
Clinical trial NCT03800186: Influence of Age on Trauma Femoral Fractures
Official title: The Influence of Ageing on the Incidence and Site of Trauma Femoral Fractures: a Cross-sectional Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: FEMORAL FRACTURES
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 3859
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective study reviewed data from 27,462 trauma patients registered between January 1, 2009 and December 31, 2016. The inclusion criteria required patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients with incomplete data were excluded.

Brief summary: This study aimed to determine the influence of ageing on the incidence and site of femoral fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into account.

Detailed description: This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016. According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487), proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A multivariate logistic regression analysis was applied to identify independent effects of the univariate predictive variables on the occurrence of fracture at a specific site. The propensity score accounts for the risk of a fracture at a specific femoral site was calculated and presented visually with age in a two-dimensional plot.

Eligibility criteria: Inclusion Criteria:

* Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury

Exclusion Criteria:

* Patients with incomplete data were excluded

Primary outcomes:
measure: Locations of femoral fracture
timeFrame: up tp 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: TSANG-TANG Hsieh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00435786: Diabetic Patients With End-Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
End-Stage Renal Disease
Cardiovascular Diseases
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-02-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: In diabetic patients with end-stage renal disease to investigate the prevalence of diabetic complications and quality of life and to compare with non-diabetic patients with ESRD and diabetic patients with normal kidney function.


Eligibility criteria: Inclusion Criteria:

* Presence of diabetes and treatment with either dialysis or renal transplantation

Exclusion Criteria:

* Age \< 18
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nephrology, Rigshospitalet
name: Vibeke R Sørensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05007886: Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor
Official title: Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cochlear Hearing Loss
Hearing Loss
Keywords: cochlear implant
Advanced Bionics Marvel Processor
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Advanced Bionics cochlear implant users due for a sound processor upgrade in line with normal standard of care. Able to access the internet and undertake tests remotely.

Brief summary: Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups.

Detailed description: Within-subject comparison, standard of care CE marked Advanced Bionics device. Remote Evaluation of new CI Naida M sound processor through speech understanding in quiet and noise using standard clinical tests, subjective feedback on sound quality for a set of listening situations reflecting everyday use and a ease of use questionnaire. Two adult groups, one CI users and the other bimodal users. All tests completed remotely.

Eligibility criteria: Inclusion Criteria:

* CI users with a CI, HiRes90K (Advantage) or HiRes Ultra cochlear implant system
* Unilaterally implanted recipients using only a Naída Q sound processor
* Bimodal users: additionally using hearing aid on their contralateral ear

  * Minimum of 18 years of age
  * Minimum of five years' experience with their Naída Q sound processor
  * Minimum of six months experience with their contralateral hearing aid (if applicable)
  * Ability to give feedback on sound quality
  * Speech intelligibility with the BKB sentence test in noise at a +10 dB SNR \> 10% as obtained during previous visits in the clinical routine or BKB \>50% in quiet conditions if noise has previously not been tested
  * Fluent in English language

Exclusion Criteria:

* Difficulties additional to hearing impairment that would interfere with the study procedures
* Concurrent participation in any other clinical hearing study
* Not due to have their sound processor upgraded in line with normal clinical procedures

Primary outcomes:
measure: Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices
timeFrame: 12 months
Secondary outcomes:
measure: Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge Biomedical Campus, Addenbrookes Hospital
Study officials:
References:
Clinical trial NCT05986786: Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
Official title: Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Handling and Safety of AVT06 Pre-filled Syringe (PFS) in Subjects With Chorioretinal Vascular Disease Followed by an Optional Extension Phase of AVT06 Pre-filled Syringe (PFS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chorioretinal Vascular Disease
Lead sponsor: Alvotech Swiss AG
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS)


Eligibility criteria: Inclusion Criteria :

* Male or female ≥18 years old
* Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye
* Study eye considered by the Principal Investigator to be indicated for treatment with aflibercept
* Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures
* Willing and able to comply with all study procedures and be likely to complete the study
* Subjects must be able to follow the contraception requirements

Exclusion Criteria (selected):

* Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety
* Current systemic infectious disease or a therapy for active infectious disease Any condition that, in the Principal Investigator's opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the subject, or interfere with interpretation of study data

Primary outcomes:
measure: Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
timeFrame: Day 1
measure: Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4 to evaluate ocular safety of AVT06 delivered from the PFS
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: 4001
Study officials:
affiliation: University Clinic Freiburg
name: Hans-Juergen Agostini
role: PRINCIPAL_INVESTIGATOR
References: