louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03783208: Intrauterine G-CSF Administration in RIF
Official title: Intrauterine G-CSF Administration in Recurrent Implantation Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Endometrium
G-CSF
Recurrent implantation failure
Lead sponsor: Gurgan Clinic
Sponsor class: NETWORK
First posted: 2018-12-20
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group

Detailed description: This study was designed as a prospective randomized controlled trial with the involvement of 200 RIF group patients.The procedure will perform by administering 30 mIU of Leucostim®(Filgrastim \[G-CSF\] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL will be infused into the endometrial cavity in the same way in the control group. The standard ICSI procedure will use for all patients, and fresh cycle embryos will be transferred on the third or fifth day.

Eligibility criteria: Inclusion Criteria:

* Women under the age of 40 who met the RIF definition
* Follicle-stimulating hormone (FSH) levels were \<15 IU/mL

Exclusion Criteria:

* Patients with congenital uterine anomalies
* Patients with Asherman's syndrome
* Patients with uterine cavity distorted by myoma or endometrial polyps
* Patients with confirmed endometriosis or endometrioma
* Patients for whom G-CSF was contraindicated (active infections, kidney disease, sickle cell anemia, malignancies, chronic neutropenia)

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 1month
Secondary outcomes:
measure: Endometrial thickness
timeFrame: 1month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gurgan Clinic IVF and Women Health Center
state: Cankaya
Study officials:
affiliation: Gurgan Clinic IVF and Women Health Center
name: Ziya Kalem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06792708: Observational Study of LUMRYZ in Narcolepsy
Official title: A Prospective, Multicenter, Observational Study of LUMRYZ Used in Clinical Practice for the Treatment of Narcolepsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Narcolepsy
Lead sponsor: Avadel
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 years and older) with a diagnosis of Type 1 or Type 2 narcolepsy

Brief summary: This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ. The questionnaires ask about narcolepsy symptoms, experience with LUMRYZ, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Adults with narcolepsy
* Oxybate naive or prior treatment with twice-nightly oxybate
* Access to smart phone, tablet or laptop with reliable internet connection
* Able to read/understand English
* Written informed consent and ability to comply with schedule

Exclusion Criteria:

* Already using LUMRYZ
* Clinical or mental health condition excluded by LUMRYZ label
* Any other condition/situation that would adversely impact participation

Primary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: Baseline to Month 4
Secondary outcomes:
Other outcomes:
measure: Narcolepsy Severity Scale
timeFrame: Baseline to Month 4
measure: Sheehan Disability Scale
timeFrame: Baseline to Month 4
measure: Patient Global Impression of Change
timeFrame: Month 4
measure: Clinical Global Impression of Change
timeFrame: Month 4
measure: Adverse Reactions
timeFrame: Month 1, Month 2, Month 3, Month 4
Locations:
city: Bradenton
country: United States
facility: Jeremy D McConnell, MD PA
state: Florida
city: East Lansing
country: United States
facility: Comprehensive Sleep Center
state: Michigan
city: Middletown
country: United States
facility: Patient First MD
state: New Jersey
city: East Syracuse
country: United States
facility: Ghaly Sleep Management Services
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Wynnewood
country: United States
facility: Pulmonology Associates, Inc.
state: Pennsylvania
city: Wyomissing
country: United States
facility: Respiratory Specialists
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants
state: South Carolina
city: Sugar Land
country: United States
facility: Tricoastal Narcolepsy and Sleep Disorder Center
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Neurology
state: Texas
Study officials:
References:
Clinical trial NCT02853708: Epidemiology of ST131 in Besançon University Hospital
Official title: Epidemiology of ST131 in Besançon University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Escherichia Coli Infections
Keywords: E. coli
extended-spectrum beta-lactamase
molecular epidemiology
risk factors
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized at CHRU Besançon and infected with ESBL producing E. coli

Brief summary: The sequence type 131 (ST131) is a predominant lineage among extraintestinal pathogenic Escherichia coli. It plays a major role in the worldwide dissemination of E. coli that produce extended-spectrum beta-lactamase (ESBL). The aim of this study was to describe the epidemiology of ESBL producing ST131clonal group in our university hospital. All patients with an infection due to ESBL E. coli will be prospectively included for a 2-year period. ST131 isolates will be identified and risk factors associated to ST131 will be determined in comparison to non-ST131 ESBL E. coli.


Eligibility criteria: Inclusion Criteria:

* Patients infected with ESBL producing E. coli

Exclusion Criteria:

* Patients known to be carrier or infected in the previous year, patients only colonised with ESBL producing E. coli.

Primary outcomes:
measure: Risk factors associated to ESBL ST 131 infections
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
References:
citation: Nicolas-Chanoine MH, Bertrand X, Madec JY. Escherichia coli ST131, an intriguing clonal group. Clin Microbiol Rev. 2014 Jul;27(3):543-74. doi: 10.1128/CMR.00125-13.
citation: Lafolie J, Nicolas-Chanoine MH, Grenouillet F, Hocquet D, Bertrand X. Prevalence of Escherichia coli sequence type 131 and its H30 subclone among E. coli isolates in a French hospital. Int J Antimicrob Agents. 2014 Nov;44(5):466-8. doi: 10.1016/j.ijantimicag.2014.07.016. Epub 2014 Sep 3.
citation: Lafolie J, Sauget M, Cabrolier N, Hocquet D, Bertrand X. Detection of Escherichia coli sequence type 131 by matrix-assisted laser desorption ionization time-of-flight mass spectrometry: implications for infection control policies? J Hosp Infect. 2015 Jul;90(3):208-12. doi: 10.1016/j.jhin.2014.12.022. Epub 2015 Feb 28.
citation: Can F, Azap OK, Seref C, Ispir P, Arslan H, Ergonul O. Emerging Escherichia coli O25b/ST131 clone predicts treatment failure in urinary tract infections. Clin Infect Dis. 2015 Feb 15;60(4):523-7. doi: 10.1093/cid/ciu864. Epub 2014 Nov 6.
Clinical trial NCT02002208: Effect of OC000459 on Moderate to Severe Atopic Dermatitis
Official title: A Study of the Effect of OC000459 on Signs and Symptoms in Subjects With Moderate to Severe Atopic Dermatitis: A Randomised Double Blind Placebo Controlled Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Atopix Therapeutics, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-05
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether OC000459 is in reducing disease severity and preventing flares in people with moderate to severe atopic dermatitis (AD).

Detailed description: The study will include patients with a Th2 high eosinophilic phenotype who typically have more severe disease and are prone to flare.

Eligibility criteria: Inclusion Criteria:

1. Atopic dermatitis as defined by a score of at least 9 on the Nottingham Eczema Severity Score, stratified into moderate (score 9 to 11 inclusive) and severe (score 12 to 15 inclusive) disease.
2. Fully documented history of the use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI). Subjects without a fully documented history will be excluded from the study.
3. Male and female subjects with moderate to severe atopic dermatitis treated with by TCS and/or TCI (with or without emollients) at the time of screening and over the previous month.
4. Subjects must have had at least 1 AD flare in the previous 6 months.

Exclusion Criteria:

1. Receipt of any forbidden medication including over the counter preparations and herbal medicines within 14 days of the first dosing day with the exception of paracetamol up to a maximum of 2g daily.
2. Use of systemic steroids within 4 weeks of the screening visit, light therapy or immunosuppressants within 2 months of the screening visit.
3. Use of NSAIDs.
4. Subjects initially diagnosed with AD aged 2 years or over will be excluded unless they have either coexisting or a history of asthma and/or allergic rhinoconjunctivitis.
5. Subjects with contact dermatitis will be excluded.
6. Subjects with acute skin infection or acute disease flares. Subjects with active flares during the screening to randomisation period (visits 1 to 2) may be managed according to normal clinical practice and be rescreened once their flares are no longer active.

   -

Primary outcomes:
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16
timeFrame: EASI was measured at baseline (week 0) and 16 weeks after dosing.
Secondary outcomes:
measure: Rate of Flares
timeFrame: over 16 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
Study officials:
affiliation: University of Sheffield
name: Michael Cork, MB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02364908: Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus
Official title: Prospective Evaluation of Adherence to Antimalarials in Patients With Systemic Lupus and Role of Therapeutic Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: systemic lupus erythematosus
antimalarials
therapeutic education
Coping questionnaire
MASRI questionnaire
morisky medication adherence scale
lupus Quality Of Life
internal medicine
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Région Nord-Pas de Calais, France
First posted: 2015-02-18
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).

The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).


Eligibility criteria: Inclusion Criteria:

* patients with a systemic lupus with ACR criteria (at least 4 criterias)
* patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day.

Exclusion Criteria:

* patients who refuse to sign the informed consent
* patients who are under guardianship

Primary outcomes:
measure: measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment.
timeFrame: baseline, at 12 months
Secondary outcomes:
measure: hydroxychloroquinémie
timeFrame: between 6 months at 12 months
measure: number of non- adherent patients
timeFrame: at 12 months
measure: quality of life scale Coping
timeFrame: baseline, at 12 months
Other outcomes:
Locations:
city: Boulogne sur Mer
country: France
facility: CH Hôpital Duchenne
city: Douai
country: France
facility: CH Douai
city: Dunkerque
country: France
facility: CH Dunkerque
city: Lens
country: France
facility: CH du Dr Schaffner
city: Lille
country: France
facility: CHRU, Hôpital Huriez
city: Roubaix
country: France
facility: Victor Provo Hospital
city: Valenciennes
country: France
facility: Valenciennes hospital
Study officials:
affiliation: University Hospital, Lille
name: Eric Hachulla, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01440608: Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy
Official title: Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of High-dose Zinc Therapy and Albendazole in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteropathy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 225
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.


Eligibility criteria: Inclusion Criteria:

* 1-3 years of age
* Lives in study villages

Exclusion Criteria:

* Unable to drink 100 mL of sugar water
* Demonstrating evidence of severe acute malnutrition, WHZ \< or = -3, presence of bi-pedal pitting edema
* Apparent need for acute medical treatment for an illness or injury
* Parent refusal to participate and return for 7-week follow-up

Primary outcomes:
measure: Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
timeFrame: 4 weeks, 7 weeks
Secondary outcomes:
measure: Change in blood endoCAb
timeFrame: 7 weeks
measure: Change in fecal calprotectin mRNA
timeFrame: 4 weeks, 7 weeks
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Saint Louis Nutrition Project
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryan KN, Stephenson KB, Trehan I, Shulman RJ, Thakwalakwa C, Murray E, Maleta K, Manary MJ. Zinc or albendazole attenuates the progression of environmental enteropathy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1507-13.e1. doi: 10.1016/j.cgh.2014.01.024. Epub 2014 Jan 22.
Clinical trial NCT02080208: Which Place for High Flow Oxygen in ICU ?
Official title: Which Place for High Flow Oxygen in Intensive Care Unit ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Keywords: hypoxemia
high flow oxygen therapy
respiratory failure
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who need only oxygen support, usually received low flow oxygen (\< 15 Liters / min), as well as in respiratory weaning. Now new devices can be used. They provide high flow oxygen with different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2), allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of this study is that the high flow oxygen enable more efficient oxygen administration than conventional oxygen. In addition, it would improve the effectiveness of the ventilation of the patient, through flushing the dead space.

Detailed description: The investigators hypothesized that when using high flow oxygen therapy, respiratory failure is relieved, as well as ventilation failure, so accessories are less stressed muscles, and this can be demonstrated by the electromyography (EMG) of sterno-mastoid..

Eligibility criteria: Inclusion Criteria: patients with respiratory failure.

* Spontaneously breathing patient requiring administration at least 40% oxygen, or,
* Patient under mechanical ventilation, during respiratory weaning.

Exclusion Criteria:

* Facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients.
* Neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.

Primary outcomes:
measure: Change from baseline in Oxygenation criteria
timeFrame: 20 minutes
Secondary outcomes:
measure: Change from baseline in Ventilation criteria
timeFrame: 20 minutes
Other outcomes:
measure: change from baseline in hemodynamic criteria
timeFrame: 20 minutes
Locations:
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Emilie Bialais, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195208: Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis
Official title: A Randomized, 2-Period, Crossover, Pharmacodynamic Comparability Study Comparing A Pantoprazole Spheroid Formulation to the Currently Marketed Tablet Formulation in Subjects With GERD and a History of Erosive Esophagitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Esophagitis
Keywords: Gastroesophageal Reflux Disease (GERD)
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.


Eligibility criteria: Inclusion Criteria:

* GERD and a history of Erosive Esophagitis documented by endoscopy
* H. pylori negative

Exclusion Criteria:

* Gastrointestinal conditions such as esophageal stricture, esophageal varices, previous vagotomy
* Achlorhydria

Primary outcomes:
measure: Comparison of MAO between the two formulations.
Secondary outcomes:
measure: Comparison of BAO and pH parameters between the two formulations.
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05055908: Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors
Official title: Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 12000
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: The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.

Detailed description: The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.

Step 1: All the lung cancer patients treated with Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study.

Step 2: All the adverse events were evaluated by principal investigator. Step 3: All the blood and FFPE samples were collected for further anaysis. Step 4: Correlation between adverse events and gene profile was analysis. Step 4: Predict model was construted with AI.

Eligibility criteria: Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histologically or cytologically confirmed lung cancer.
4. Treated with Immune Checkpoint Inhibitors with or without chemotherapy.

6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria:

Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.

Primary outcomes:
measure: Correlation between Adverse events (AEs) and gene profile
timeFrame: Time from first subject dose to study completion, or up to 36 month
Secondary outcomes:
measure: Adverse events (AEs) rate according to CTCAE 5.0
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: Correlation between Adverse events (AEs) and survival outcome
timeFrame: Time from first subject dose to study completion, or up to 36 month
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: