louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05683860: Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)
Official title: A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: ALS
FTD
Lead sponsor: Wave Life Sciences Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an OLE study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of WVE-004 in adult patients with ALS, FTD, or mixed ALS/FTD phenotype with a documented mutation in the C9orf72 gene. To participate in the study, patients must have successfully completed Phase 1b/2a WVE-004-001 study.


Eligibility criteria: Inclusion Criteria:

* Patient successfully completed the Phase 1b/2a study with WVE-004, WVE-004-001.

Exclusion Criteria:

* Patient has a clinically significant medical finding on the physical examination other than C9orf72-associated ALS or FTD that, in the judgment of the Investigator or Sponsor, will make the patient unsuitable for participation in and/or completion of the trial procedures.
* Patient received any other investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Patient received an investigational oligonucleotide within the past 6 months or 5 half-lives of the drug, whichever is longer.

Primary outcomes:
measure: Safety: Number of patients with adverse events (AEs)
timeFrame: Day 1 to Week 120 (end of study)
measure: Safety: Number of patients with a severe AE
timeFrame: Day 1 to Week 120 (end of study)
measure: Safety: Number of patients with serious AEs (SAEs)
timeFrame: Day 1 to Week 120 (end of study)
measure: Safety: Number of patients who withdraw due to AEs
timeFrame: Day 1 to Week 120 (end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Oxford
country: United Kingdom
facility: University of Oxford - Nuffield Department of Clinical Neurosciences
Study officials:
affiliation: Wave Life Sciences
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00044460: Efficacy and Safety In Poorly Controlled Type 2 Diabetics
Official title: A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes drug-naive
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-08-30
Enrollment: 142
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: The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.


Eligibility criteria: Inclusion criteria:

* Type 2 diabetes
* Drug-naive.
* Laboratory test result for HbA1c of greater than or equal to 10%.
* Written informed consent.

Exclusion criteria:

* Prior use of antidiabetic medications within 3 months of screening.
* Fluid retention (edema).
* Significant liver disease.
* Low red blood cells (anemia).
* Severe or unstable angina (chest pain).
* Congestive heart failure.
* Severe high blood pressure.
* Alcohol or drug abuse.
* Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Primary outcomes:
measure: Change in HbA1c from baseline to Week 24.
Secondary outcomes:
measure: Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Abstract: The Effects of Rosiglitazone in Poorly-Controlled, Drug-Naive Patients with Type 2 Diabetes Mellitus, KATHLEEN L. WYNE, ALEXANDER R. COBITZ, BRIAN R. WATERHOUSE, LEANNE J. STROW. Dallas, TX; King of Prussia, PA; Orlando, FL; USA. 64th Annual Scientific Sessions of the American Diabetes Association. 6/4/2004
citation: Wyne KL, Cobitz AR, Waterhouse BR, Strow LJ. The effects of rosiglitazone in poorly-controlled drug-naive patients with type 2 diabetes mellitus. Diabetes 2004;53(Suppl 2):A152. Poster 639 presented at ADA
Clinical trial NCT04706260: Clinical Evolution and Becoming of Adult Patients Infected With Covid-19 Hospitalized at Strasbourg University Hospitals
Official title: Clinical Evolution and Becoming of Adult Patients Infected With Covid-19 Hospitalized at the University Hospitals of Strasbourg : A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: COVID-19
COVID-19 Pandemic
Sars-cov-2
Emergency Department
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with covid-19 hospitalized at HUS between 06/03/2020 and 05/04/2020.

Brief summary: A SARS-CoV-2 infection emerged in China in December 2019, the severity of which is linked to acute respiratory distress syndrome1. The rate of emergency visits in Bas-Rhin for suspected Covid-19 increased, compared to the French average, at the end of the 10th week of 2020.

Compared to the onset of symptoms, Chinese studies estimate the onset of dyspnea on the 7th day3 and admission to the emergency room between the 5th and the 9th day4. But this duration varies according to the epidemic period5, the geographical location6 and a later emergency admission is associated with an increase in mortality in the Chinese population7.

The need for oxygen, which is not noted in Chinese studies8, is a reflection of the onset of respiratory worsening and a major factor in hospitalization. There is no study on the changing profile of the French population to date its onset.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 or over
* Admitted to the NHC emergency room and hospitalized at the Strasbourg University Hospitals (HUS) between 06/03/2020 and 05/04/2020.
* With SARS-CoV-2 RT-PCR on a positive nasopharyngeal sample taken at the SU.

Exclusion Criteria:

* Refusal to participate in the study
* Return home from the SU
* Transfer to another establishment
* Patient under the protection of justice
* Patient under guardianship, curatorship

Primary outcomes:
measure: Retrospective evaluation of the clinical evolution and becoming of adult patients infected with Covid-19 hospitalized at the University Hospitals of Strasbourg from the Emergency Structure
timeFrame: Files analysed retrospectily from March 06, 2020 to April 05, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Adult Emergency Department - Strasbourg University Hospitals
Study officials:
affiliation: Adult Emergency Department - Strasbourg University Hospitals
name: Mathieu OBERLIN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03229460: High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure
Official title: High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure With Hypercapnia
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy ang noninvasive ventilation.

Detailed description: Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

Eligibility criteria: Inclusion Criteria:

* Hypoxemic and no hypercapnic acute respiratory failure :
* severe dyspnea at rest with a respiratory rate \>25 breaths/min
* PaO2/FiO2 \<300
* PaCO2 \<45 mmHg,

Exclusion Criteria:

* age \<18 years
* NPPV contraindications
* past history of respiratory chronic disease (COPD, cystic fibrosis...)
* cardiac pulmonary edema
* Pre-defined intubation
* other than respiratory organ failure : systolic pressure \<90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
* profound aplasia (white cells count \<1000/mm 3)

Primary outcomes:
measure: the number of patients in each group who require endotracheal intubation with mechanical ventilation
timeFrame: 28days
Secondary outcomes:
measure: mechanical ventilation-free to day 28
timeFrame: 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Xinhua Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05527860: Evolution of the State of Health of Patients Undergoing Surgery for Osteoarticular Surgery
Official title: Evolution of the State of Health of Patients Undergoing Surgery for Osteoarticular Surgery: Retrospective Study Based on the Point of View of Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Chronic pain
Osteoarticular surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged ≥18 years underwent osteoarticular surgery between 01/01/2019 and 31/12/2022.

Brief summary: Osteoarticular surgery is frequently associated with the occurrence of moderate to severe postoperative pain. This pain can persist and become chronic post-surgical pain that is often debilitating. The transition between early postoperative pain and chronic pain is poorly understood, which complicates treatment.


Eligibility criteria: Inclusion criteria:

* Patient aged ≥18 years
* Underwent osteoarticular surgery between 01/01/2019 and 31/12/2022.
* Having been followed up with the administration of at least 1 QoR-15F questionnaire postoperatively
* Subject who has not expressed his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

- Subject who expressed their opposition to participating in the study has

Primary outcomes:
measure: Score measurement of the QoR-15F questionnaire
timeFrame: Score measured on D1, D3, D14 and D28 postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
Study officials:
affiliation: Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
name: Eric NOLL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01876160: Analysis of Sensory and Motor Thresholds During Transcutaneous Electrical Stimulation in Different Sexes and Ages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Individuals
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The sensory and motor perception thresholds can influence the therapeutic effects of Transcutaneous Electrical Nerve Stimulation. This study aimed to determine the threshold of sensory perception and the threshold of motor response in young and elderly subjects of both sexes. Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal groups of young and elderly subjects. Half of the individuals in each group were stimulated with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on the flexor muscle bellies of the wrist and fingers. The threshold of sensory perception was identified as the first sensation of increased current intensity and the threshold of motor response as the minimum muscle contraction detected. The results were submitted to ANOVA test, followed by the Tukey test, with a significance level of 5%.


Eligibility criteria: Inclusion Criteria:

* healthy individuals

Exclusion Criteria:

* not present: previous circulatory, nervous or metabolic diseases, metal implants in areas to be studied; fracture on upper limb studied; history of pain or injury in areas to be studied.
* are not in menstrual period or a week before it
* not be making use of drugs that affect the nervous system

Primary outcomes:
measure: Analysis of sensory thresholds
timeFrame: 1 years
measure: Analysis of Motor thresholds
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01669460: Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
Official title: A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatigue
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate cancer
* Currently receiving LHRH-agonist therapy for greater than 6 months
* Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale
* Able to swallow Red Bull™ Sugar-Free Drink
* Life expectancy of at least 1 year
* Able to read and write in English
* Willing to limit consumption of alcohol to one drink per day

Exclusion Criteria:

* Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)
* Myocardial infarction within past 6 months
* Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders
* Evidence of drug or alcohol abuse
* Known hypersensitivity to caffeine
* Known history of liver and kidney insufficiencies
* Known contraindications to Red Bull™ use

Primary outcomes:
measure: Reduction in overall fatigue as measured by Bruera global fatigue severity scale.
timeFrame: Within 4 days after completion of intervention (28 days of Red Bull™)
Secondary outcomes:
measure: Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)
timeFrame: Within 4 days after completion of intervention (28 days of Red Bull™)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Neil Fleshner, MD, FRCSC, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02106260: First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts
Official title: A Phase I/IIa Open-label First-in-Human Study to Assess Safety and Pharmacokinetics and Explore Biomarker Effects of Topical Ionic Contra-viral Therapy (ICVT) Comprised of CLS003 in Subjects With Cutaneous Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cutaneous Warts
Keywords: safety
pharmacokinetics (PK)
pharmacodynamics (PD)
CLS003
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 12
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: TREATMENT

Brief summary: This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of topically applied CLS003 in healthy subjects with cutaneous warts.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
* Body mass index (BMI) between 18 and 30kg/m2, inclusive
* Fitzpatrick skin type I-II-III-IV
* At least 4 cutaneous warts on the hands, separated by at least 1cm of skin

Exclusion Criteria:

* For women, a positive pregnancy test and/or nursing at screening
* A positive test for drugs of abuse at screening
* History of alcohol or illicit drug abuse
* Positive test results for Hepatitis B, Hepatitis C or HIV
* Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
* Have received cryotherapy in the treatment area within 60 days prior to enrollment
* Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of CLS003
timeFrame: 7 days
measure: Number of participants with adverse events
timeFrame: 7 days
measure: Peak Plasma Concentration (Cmax) of CLS003
timeFrame: 7 days
measure: Time to reach Cmax (Tmax)
timeFrame: 7 days
Secondary outcomes:
measure: Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load
timeFrame: 7 days
Other outcomes:
Locations:
city: Zernikedreef 8
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Centre for Human Drug Research
name: J. (Koos) Burggraaf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01683760: Pharmacokinetic Study of Fluconazole in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Very Low Birth Weight Infant
Keywords: Fluconazole
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 80
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.


Eligibility criteria: Inclusion Criteria:

* very low birth weight infant (birth weight \< 1,500 g) who were admitted to the NICU before day 3 of life
* Informed consent from the parents

Exclusion Criteria:

* Major congenital anomaly
* Expired within 72 hours of life
* Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher)
* Proven congenital or intrauterine fungal infection

Primary outcomes:
measure: drug level of fluconazole
timeFrame: 30min later, 10-12hr later, at routine lab with interval of 1week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han-Suk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YK, Lee J, Oh J, Rhee SJ, Shin SH, Yoon SH, Lee S, Kim HS, Yu KS. Population Pharmacokinetic Study of Prophylactic Fluconazole in Preterm Infants for Prevention of Invasive Candidiasis. Antimicrob Agents Chemother. 2019 May 24;63(6):e01960-18. doi: 10.1128/AAC.01960-18. Print 2019 Jun.