louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02387801: A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
Official title: Early Onset of Clinical Improvement With Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.


Eligibility criteria: Inclusion Criteria:

* Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
* Active psoriatic skin lesions of plaque psoriasis (Ps)
* Are a candidate for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Are unable to commit to the photography schedule for the duration of the study
* Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab
* Serious disorder or illness other than psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women

Primary outcomes:
measure: Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
timeFrame: Baseline through Week 12
Secondary outcomes:
measure: Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Percent Body Surface Area (%BSA)
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline, Week 12
measure: Time to at Least a 2 Point Improvement on the PatGA Score
timeFrame: Baseline though Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine Dermatology Clinical Trials
state: New York
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:
citation: Khattri S, Goldblum O, Solotkin K, Amir Y, Min MS, Ridenour T, Yang FE, Lebwohl M. Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 May;11(5):33-37. Epub 2018 May 1.
Clinical trial NCT01167101: Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?
Official title: Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Ulcer
Keywords: Rebamipide
gastric ulcer
healing rate
iatrogenic gastric ulcer after endoscopic submucosal dissection
Lead sponsor: Kangdong Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 290
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.


Eligibility criteria: Inclusion Criteria:

* patients underwent ESD for gastric adenoma or cancer

Exclusion Criteria:

* subjects with previous gastric surgery
* subjects taking aspirin, anticoagulant, or antiplatelet agent
* subjects having malignancy except gastric cancer
* pregnant or breast-feeding women

Primary outcomes:
measure: Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer
timeFrame: at 2month after endoscopic submucosal dissection (ESD)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
Study officials:
References:
citation: Shin WG, Kim SJ, Choi MH, Kim KO, Jang HJ, Park CH, Baek IH, Kim KH, Baik GH, Kae SH, Kim JH, Kim HY. Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study. Gastrointest Endosc. 2012 Apr;75(4):739-47. doi: 10.1016/j.gie.2011.11.004. Epub 2012 Jan 26.
Clinical trial NCT00350701: Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Official title: Effect of Androgel on Inflammatory Mediators and Oxidative Stress in Type 2 Diabetic Males With Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Keywords: DM type 2
Hypogonadism
Testosterone
AndroGel
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2006-07-11
Enrollment: 49
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

Detailed description: Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress. Hypogonadism( low testosterone) is also associated with increased levels of inflammatory mediators and atherosclerosis.

This project is about studying the effect of testosterone replacement on different inflammatory cells in blood and urine. It will also compare the dose dependent effect on inflammatory cells. This also involves comparing level of inflammation in hypogonadic diabetic males treated with testosterone with those not treated with any replacement therapy.

This study involves applying AndroGel for 8 wks and studying effects during this time and thereafter.

Eligibility criteria: Inclusion Criteria:

* Males with age 35-75 years inclusive.
* Evidence of hypogonadism: low free testosterone.
* Type 2 Diabetes
* People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
* If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
* BP under control even if on medication.

Exclusion Criteria:

* Coronary event or procedure in previous past 4 wks.
* High PSA
* H/O prostate cancer
* Hepatic or renal disease
* Participation in any other concurrent clinical trial
* Any other life- threatening , non cardiac disease.
* Uncontrolled BP
* Congestive heart failure
* High hemoglobin
* Use of investigational agent or therapeutic regimen within 30 days of study.

Primary outcomes:
measure: Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo
timeFrame: 8 weeks
measure: Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone
timeFrame: 8 week
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Diabetes-Endocrinology Center of Western NY, 115 flint road
state: New York
Study officials:
affiliation: Kaleida Health/Diabetes Endocrinology Center of WNY
name: Paresh Dandona, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06192901: Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses After Bilateral Cataract Surgery
Official title: A Limited Patient Cohort Follow-up Study to Assess the Long-term Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses in Bilateral Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Senile Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 20 eyes in 10 adult subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye and AT LISA tri 839MP in the second eye.

Brief summary: Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery

Detailed description: The main objective of this clinical investigation is to collect data on the IOLs AT ELANA 841P and AT LISA tri 839MP in subjects who underwent bilateral cataract surgery with the use of the two different types of IOLs to confirm the long-term performance and safety of the IOLs.

Retro-prospective, comparative, non-interventional, non-randomized, single center study on medical devices with one follow-up visit after more than 12 months of a bilateral cataract surgery.Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery.

Eligibility criteria: Inclusion Criteria:

1. Adult patient of any gender;
2. Patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery
3. Currently implanted with an IOL model AT ELANA 841P into the capsular bag in one eye and with the IOL model AT LISA tri 839MP into the capsular bag of the other eye.
4. The postoperative visit was scheduled to be conducted more than one year after the second eye surgery.
5. Given written informed consent by patient.

Exclusion Criteria:

1. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the study
2. Patient whose freedom is impaired by administrative or legal order
3. Concurrent participation in another drug or device investigation that could confound the outcome of this investigation.

Primary outcomes:
measure: Monocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 12 to 24 months after cataract surgery
measure: Slit Lamp Examination
timeFrame: 12 to 24 months after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Salvador
country: El Salvador
facility: Clinica Quesada
Study officials:
References:
Clinical trial NCT03037801: Intrapulmonary Percussive Ventilation for Children With Bronchiolitis on Non-Invasive Ventilation Support
Official title: Prospective Randomized Controlled Study of the Use of Intrapulmonary Percussive Ventilation (IPV) for Children With Bronchiolitis Admitted to the Pediatric Intensive Care Unit (PICU) and Are on Non-Invasive Ventilation Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiolitis
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 50
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized study of patients admitted to the Pediatric Intensive Care Unit suffering from Bronchiolitis and are supported on Non Invasive Positive Pressure Ventilation. The patient population will be divided into two groups, one group will receive conventional treatment and the other group will receive conventional treatment and three times a day of physiotherapy using Intrapulmonary Percussive Ventilation.


Eligibility criteria: Inclusion Criteria:

* Bronchiolitis
* PICU patients
* Non Invasive Pressure Support Ventilation
* Age \< 24 months

Exclusion Criteria:

* Age \> 24 months
* Invasive Ventilation
* No parental consent

Primary outcomes:
measure: Length of PICU Stay
timeFrame: 10 days
measure: Need for Invasive Ventilation Support
timeFrame: 10 days
Secondary outcomes:
measure: S/F ratio
timeFrame: Baseline, 15, 30 and 150 minutes after intervention
measure: Prevention of lung atelectasis
timeFrame: 10 days
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka UMC
name: Yuval Cavari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06556901: Management of Patients Who Claim to be Electrosensitive
Official title: Evaluation of the Feeling of General Practitioners in the Management of Patients Who Claim to be Electrosensitive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electromagnetic Field
Keywords: qualitative study
environmental exposure
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of general practitioners practicing in Brittany in 2018. Population assessed by the ODM between 3000 and 3200 liberal general practitioners

Brief summary: Know qualitatively the ways to deal with these patients, in general medicine in Brittany, and the difficulties encountered, through thematic and lexicometric analysis of responses

Detailed description: The Ministry of Health instructed the French society of medicine work (Dr Pougnet for the Brest CHRU) to coordinate the drafting of practical guides for the management of people claiming to have IEI-CEM (Intolerance Environmental Idiopathic in the Fields ElectroMagnetic) for care physicians primary (general practitioners). To meet this mission, it is necessary to know qualitatively the difficulties encountered by general practitioners during the management of these people.

Eligibility criteria: Inclusion Criteria: The inclusion criteria will be to be general practitioners, to have practiced between 01/01/2018 and 12/31/2018.

Exclusion Criteria:

* be other practionners

Primary outcomes:
measure: principal
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
citation: Vanderstraeten J, Verschaeve L. Biological effects of radiofrequency fields: Testing a paradigm shift in dosimetry. Environ Res. 2020 May;184:109387. doi: 10.1016/j.envres.2020.109387. Epub 2020 Mar 12.
Clinical trial NCT06335901: Clinical Characteristics and Outcomes of Coronary Heart Disease
Official title: Clinical Characteristics and Outcomes of Coronary Heart Disease: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary heart disease hospitalized at the First Affiliated Hospital of Xinjiang Medical University.

Brief summary: This study evaluated and compared the prognostic value of different Baseline data and clinical variables to develop predictive model in patients with CHD.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with Coronary Heart Disease (CHD) admitted to the First Affiliated Hospital of Xinjiang Medical University.
2. The diagnosis is based on clinical assessments, including symptomatic evaluation, electrocardiographic findings, and coronary angiography.

Exclusion Criteria:

We excluded patients who had serious heart failure, malignant tumor，rheumatic heart disease, valvular heart disease, congenital heart disease, pulmonary heart disease and serious dysfunction of the liver or kidney.

Primary outcomes:
measure: Death （All-cause mortality、Cardiac mortality ）
timeFrame: 5 years of follow-up deaths occurred during this period
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 5 years of follow-up deaths occurred during this period
Other outcomes:
Locations:
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References:
Clinical trial NCT00735501: Observational Study to Observe the Safety of Levemir® Treatment in Patients With Type 2 Diabetes
Official title: Safety of Levemir® (Insulin Detemir) Treatment in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 or above, with type 2 diabetes, who together with their physician, have decided to switch to Levemir® from human basal insulin treatment

Brief summary: This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.


Eligibility criteria: Inclusion Criteria:

* Any patient with type 2 diabetes
* Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin)
* Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products.
* Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months

Primary outcomes:
measure: Incidence of serious adverse drug reactions, including major hypoglycaemic events
timeFrame: After 26 weeks
Secondary outcomes:
measure: Number of all hypoglycaemic events
timeFrame: at 12 weeks and 26 weeks
measure: Number of all adverse drug reactions
timeFrame: after 12 and 26 weeks
measure: HbA1c
timeFrame: at 12 and 26 weeks
measure: Variability in fasting plasma glucose (FPG) values and average FPG levels at visits
timeFrame: at 12 and 26 weeks
measure: Weight changes
timeFrame: at 12 and 26 weeks
Other outcomes:
Locations:
city: Copenhagen S
country: Denmark
city: Stockholm
country: Sweden
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05546801: Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome
Official title: Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periventricular Pseudocysts
Keywords: periventricular pseudocysts
postnatal development
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 46
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: questionnaire on postnatal development
Primary purpose: OTHER

Brief summary: The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.

Detailed description: Antenatal ultrasound screening for periventricular pseudocysts is steadily increasing, enabled in part by technological advances in ultrasound equipment.

Most of studies dealing with periventricular pseudocysts and subsequent neurodevelopment are based on neonatal screening, mostly performed in neonatal units.

Current data in the literature on the postnatal outcome of children screened antenatally are scarce; there are only 5 cohort studies with small numbers on the subject.

The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.

Eligibility criteria: Inclusion Criteria:

* Adult patient diagnosed with a periventricular cyst during a prenatal ultrasound at Bordeaux University Hospital between January 1, 2016 and December 31, 2020.
* Patient affiliated with or benefiting from a social security plan.
* Oral informed consent.

Exclusion Criteria:

* Subarachnoid cyst
* Blake's pouch cyst
* Choroid plexus cyst
* Periventricular leukomalacia
* Poor understanding of French
* Patient under legal protection.

Primary outcomes:
measure: postnatal child development
timeFrame: Baseline
Secondary outcomes:
measure: mother's medical history
timeFrame: Baseline
measure: medical history of the child
timeFrame: Baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: