louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02595736: A Study of LY3200327 in Healthy Participants
Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3200327 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body.

The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).


Eligibility criteria: Inclusion Criteria:

* At the time of initial screening, in general good health
* First-generation healthy Japanese (age 20 to 65 years) will be included

Exclusion Criteria:

* Pregnancy or breastfeeding during the study
* Chronic infection
* Treatment with prohibited medications

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline to study completion (approximately 12 weeks)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327
timeFrame: Pre-dose up to 84 days post dose
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327
timeFrame: Pre-dose up to 84 days post dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Parexel International/ California Clinical Trials
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00905736: Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow
Official title: Influence of Microcurrent Parameters on Effectiveness of Treatment of Chronic Tennis Elbow - a Preliminary Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tennis Elbow
Keywords: tendon
healing
microcurrent
chronic tennis elbow
Lead sponsor: University of Hertfordshire
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies have investigated its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.

A clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study is comparing the effects of two different forms of microcurrent treatment.


Eligibility criteria: Inclusion Criteria:

* symptoms of tennis elbow for at least 3 months
* clinical diagnosis of tennis elbow

Exclusion Criteria:

* significant symptom improvement in previous month
* receipt of any active treatment for the condition in the previous month
* currently under the care of another health professional for tennis elbow
* current cervical radiculopathy

Primary outcomes:
measure: Tissue healing as indicated by sonography
timeFrame: baseline, 3 weeks, 6 weeks, 4 months
Secondary outcomes:
measure: Patient rating global change
timeFrame: baseline, 3 weeks, 6 weeks, 4 months
measure: Pain free grip strength
timeFrame: baseline, 3 weeks, 6 weeks, 4 months
measure: Patient rated tennis elbow questionnaire
timeFrame: baseline, 3 weeks, 6 weeks, 4 months
measure: Adverse events
timeFrame: 3 weeks, 6 weeks, 4 months
Other outcomes:
Locations:
city: Hatfield
country: United Kingdom
facility: University of Hertfordshire
state: Hertfordshire
Study officials:
References:
Clinical trial NCT06747936: A Study to Evaluate the Efficacy and Safety of Co-administration of AD-2281 and AD-2282
Official title: A Randomized, Double-blind, Active-controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combined Administration of AD-2281 and AD-2282 in Patients with Primary Hypercholesterolemia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safetyof co-administration of AD-2281 and AD-2282 in patients with Primary Hypercholesterolemia


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Patients with Primary Hypercholesterolemia
* Other inclusions applied

Exclusion Criteria:

* Patients with Secondary Hypercholesterolemia
* Other exclusions applied

Primary outcomes:
measure: Change rate of LDL-C
timeFrame: from baseline at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02893436: Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation
Official title: Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Surgery
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient curarised at Nancy Hospital

Brief summary: The purpose is to calculate the time for an optimal recovery (T4/T1 \> 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.

Detailed description: Neuromuscular monitoring is a basic monitoring for all curarised patients. Acceleromiography is used to supervise neuromuscular blockade and allow measuring in an objective and quantitative manner the curarisation level during surgery and phase of recovery from neuromuscular blockade. Various parameters are usually measured during surgery:

* T4/T1 ratio: ratio between the 4th and 1st response to "train of four" stimulation (TOF, 4 stimulations of 0.2 ms in 2 s). Neuromuscular recovery is considered appropriate if T4/T1 ratio is \> 0.9
* Double burst stimulation (DBS): 2 short tetanic stimulations separated by an interval of 750 ms.

It is known that when DBSs induce the same visual and/or tactile response, T4/T1 recovery time is \> 0.6. However, for an optimal recovery, T4/T1 ratio must be \> 0.9.

This study will analyze the interval between the moment when DBSs are visually identical and the T4/T1 ratio is \> 0.9, from anesthesia sheet of patients undergone surgery with tracheal intubation curarisation.

Results will define a minimum time to have an optimal recovery after having visually identical DBS responses.

Eligibility criteria: Inclusion Criteria:

* ASA score 1-3
* Needing a surgery with tracheal intubation curarisation

Exclusion Criteria:

* none

Primary outcomes:
measure: Time interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy, France
name: Denis Schmartz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00947336: Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics
Official title: Evaluation of Safety and Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis in Cirrhotics: A Randomized, Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cirrhosis With Ascites
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Jhaver Research Foundation Limited
First posted: 2009-07-28
Enrollment: 110
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background: Spontaneous bacterial peritonitis (SBP) is a serious complication in patients of cirrhosis with ascites and may occur despite antibiotic prophylaxis. Small bowel dysmotility and bacterial overgrowth have been documented to be related to SBP. Aims: To investigate whether addition of prebiotic plus probiotics (synbiotics) to norfloxacin enhances the efficacy of norfloxacin in prevention of SBP in high risk patients with ascites.

Methods: A prospective, double blind, randomized controlled trial was conducted in consecutive high-risk cirrhotic patients with ascites who had either recovered from an episode of SBP (secondary prophylaxis) or who never had SBP but were at high risk for development of SBP (low ascitic fluid protein or serum bilirubin ≥2.5 mg/dL; primary prophylaxis). Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million, Lactobacillus sporogenes 50 million spores) 2 t.i.d. (group I) or norfloxacin 400 mg once daily with placebo (group II) was given and occurrence of SBP within a period of 6 months (primary endpoint) or side-effects of therapy and mortality (secondary endpoints) were recorded. Every patient received IV albumin to maintain a serum albumin level of \>3.2 g/dl. SBP was treated with intravenous antibiotics with albumin.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis with ascites with any one of following:

  * History of at least one episode of SBP, or
  * Ascitic fluid protein less than or equal to 1g/dL, or
  * Serum bilirubin more than or equal to 2.5 mg/dL

Exclusion Criteria:

* Renal failure
* HCC
* Hepatic encephalopathy
* No consent

Primary outcomes:
measure: Development of SBP
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Gastroenterology, G B Pant Hospital
state: Delhi
Study officials:
References:
Clinical trial NCT01437436: The Effect of Obesity on Ventilation Tube Insertion
Official title: The Effect of Obesity on Ventilation Tube Insertion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Otitis Media
Obesity
Keywords: otitis media
obesity
ventilation tube
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of bucheon city in South Korea

Brief summary: Obesity is associated with increased risk of surgical complications. Ventilation tube insertion is one of the most frequent surgical procedures performed on children. However, the impact of obesity on surgical results or surgical related complication following ventilation tube insertion remains poorly understood. The aim of this study was to investigate the effect of obesity on the surgical results of ventilation tube insertion for otitis media with effusion (OME) in pediatric patients.

Detailed description: OME was diagnosed by the presence of fluid in the middle ear on otoscopy or tympanometry according to clinical practice guidelines . The diagnostic findings of pneumatic otoscopy and otomicroscopy include the tympanic membrane dullness, impaired mobility, and an air-fluid level or bubble. In addition, the type B or C tympanogram was considered positive for OME.

Indication for ventilation tub insertion includes history of OME lasting 3 months or longer, structural damage to tympanic membrane or middle ear and risk for speech, language learning difficulties. Adenoidectomy is also performed when adenoid hypertrophy is founded during preoperative assessment.

Body weight and height were measured before ventilation tube insertion at hospital. Body mass index (BMI) was calculated using the formula weight/ height2 (Kg/m2).

Eligibility criteria: Inclusion Criteria:

* Children aged 2-15 years with a diagnosis of OME who underwent ventilation tube insertion

Exclusion Criteria:

* Children with a previous history of ventilation tube insertion
* Use of ventilation tubes other than Paparella type I
* Head and neck anomalies
* Chronic or systemic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03644836: Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease
Official title: Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease. Randomized Study Against Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Broncho Chronic Obstructive Pulmonary Disease
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Respiratory rehabilitation is one of the main treatments for COPD in the early stages of the disease (Stage 2 of GOLD) with a recognized effect on improving the capacity of the patients to exert effort by fighting against deconditioning. the effort. This treatment also improves the quality of life of patients and reduces the risk of respiratory exacerbations. The patients are very often malnourished and various studies have proposed the addition of oral supplementation such as hormone therapy (testosterone) to improve the exercise performance of these atrophied muscles. The use of branched-chain amino acids (AARs) such as valine, leucine, isoleucine in this indication can be fully justified because they stimulate protein synthesis and promote muscle maintenance and repair.


Eligibility criteria: Inclusion Criteria:

* Patients Broncho Chronic Obstructive Pulmonary Disease in stages 2 and 3 of the GOLD classification, whose Maximum Expiratory Volume on the first second is between 30% and 80% of the expected theoretical value, associated with a maximal expiratory volume ratio on the first Second / Vital Capacity less than or equal to 70% of the expected theoretical value.
* Patients of both sexes, aged 40 to 80 years
* In case of active smoking, patients must commit to interrupting it during the respiratory rehabilitation program that will be proposed to them in this study

Exclusion Criteria:

* - Age \<40 years or\> 80 years
* Patients with a contraindication to exercise,
* Phenylketonuria
* Patients treated with long-term oxygen therapy and / or home ventilation will not be included.
* Patients with acute respiratory decompensation in the three months prior to inclusion.
* Patients with known allergy to milk, gluten, soy, egg and nuts
* Patients taking part in another clinical trial or who have participated in a clinical trial in the 3 months preceding this study.

Primary outcomes:
measure: maximum oxygene uptake
timeFrame: after 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Jean-Claude MEURICE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00515736: Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome
Official title: Influence Of Early Antioxidant Supplements On Clinical Evolution And Organ Function In Critically Ill Cardiac Surgery, Major Trauma And Subarachnoid Hemorrhage Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Critically Ill Patients
Cardiac Surgery
Trauma
Subarachnoid Hemorrhage
Keywords: selenium
oxidative stress
glutathione peroxidase
critically ill
outcome
supplementation
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi
First posted: 2007-08-14
Enrollment: 200
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: SUPPORTIVE_CARE

Brief summary: Critically ill patients are generally exposed to an increased oxidative stress, which is proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are depleted particularly in those patients with intense inflammatory response. The hypothesis tested is that early I:V: administration of a combination of AOX micronutrient supplements (Se, Zn, Vit C, Vit E, Vit B1) would improve clinical outcome in selected critically ill patients, by reinforcing the endogenous AOX defenses and reducing organ failure.

Detailed description: Prospective randomized, double-blind, placebo-controlled, single-center trial. Patients admitted to ICU after complicated cardiac surgery, major trauma with or without brain injury, subarachnoid hemorrhage, and predicted by the clinicians to require \>48 hours of ICU treatment.

Supplements: provided IV for 5 days

Eligibility criteria: Inclusion Criteria:

* adult patients admitted for above diagnosis assessed on admission by the medical team likely to require more than 48 hours of ICU

Exclusion Criteria:

* absence of consent, participation in another study, liver cirrhosis or major burns and life expectancy \< 24 hours or a lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the 48 hours

Primary outcomes:
measure: Organ function (SOFA) with special additional attention to renal function
timeFrame: 3 months
Secondary outcomes:
measure: Pneumonia, Length of mechanical ventilation-ICU stay-hospital stay, Mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Dpt of Adult Intensive Care - CHUV
state: VD
Study officials:
affiliation: Dpt of Adult Intensive Care, CHUV
name: Mette M Berger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger MM, Soguel L, Shenkin A, Revelly JP, Pinget C, Baines M, Chiolero RL. Influence of early antioxidant supplements on clinical evolution and organ function in critically ill cardiac surgery, major trauma, and subarachnoid hemorrhage patients. Crit Care. 2008;12(4):R101. doi: 10.1186/cc6981. Epub 2008 Aug 7.
Clinical trial NCT06740136: Genetic Determinants of Exercise-Induced Muscle Damage (POLYGENDOMUS)
Official title: Genetic Determinants of Exercise-Induced Muscle Damage (POLYGENDOMUS) / Déterminants Génétiques Des Dommages Musculaires Induits Par L'exercice (POLYGENDOMUS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Muscle damage
Single nucleotide polymorphism
exercise
Lead sponsor: Lille University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention model
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the association between the evolution of plasma CPK levels and genetic polymorphisms, both before the muscle-damaging exercise and at three post-exercise time points. The investigators aim to include 300 participants in this research.

Detailed description: Elite-level sports expose athletes to training loads designed to induce muscle damage, aiming to achieve optimal physiological adaptations. However, the repetitive nature of such damage increases the risk of injury. The ability to assess an athlete's susceptibility to fragility is therefore crucial for optimizing their training and performance. Genetic factors appear to play a significant role in the occurrence of these injuries, particularly through subtle variations in DNA sequences. Depending on the location of these variations within a gene, they may or may not alter the expression or function of the associated protein. The investigators aimed to investigate the relationship between genetic polymorphisms and biological parameters in the context of exercise-induced muscle damage.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged between 18 and 35
* Weighing more than 50 kg
* Member of a sports club affiliated to an Olympic federation
* Socially insured
* Willing to comply with all study procedures and duration of the study

Exclusion Criteria:

* Medical history contraindicating sporting activities
* Current medical treatment
* Not a member of a sports club affiliated to an Olympic federation
* Administrative reasons: impossibility of receiving informed information, impossibility of participating in the entire study, absence of social security coverage, refusal to sign consent form.

Primary outcomes:
measure: The association between single nucleotide polymorphisms and exercise induced blood creatine kinase variation
timeFrame: Evolution of kinetics from Day 0 to Day 3 post experiment
Secondary outcomes:
Other outcomes:
Locations:
city: Loos
country: France
facility: Eurasport
Study officials:
References: