louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01532401: Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers
Official title: Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Blood pressure
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: The primary objective of this study is to analyze the sensitivity of blood pressure to oral salt intake. Matched male and female participants will be selected as normal weight, overweight, and obese.

Participating subjects will have a first visit with blood pressure measurement and a blood sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6 grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age 18-45 for adults and 6-8 for children

Exclusion Criteria:

* African ethnicity (known to affect blood pressure sensitivity to salt)
* Chronic condition affecting blood pressure
* Diabetes (known to affect blood pressure sensitivity to salt)
* Hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
Study officials:
affiliation: CHU DE POITIERS-Service d'endocrinologie
name: Samy HADJADJ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00313001: Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.
Official title: Effects of NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) BID and QD vs. Byetta™ Exenatide) BID on Glycemic Control: A Multicenter, 24-Week, Open-Label, Parallel Group Study in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets With Metformin and a Sulfonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-04-11
Enrollment: 373
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: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The study will compare A1C reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to patients receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1C: At least 8%
* Patients that were never treated with insulin before
* Current therapy with metformin and a sulfonylurea.

Exclusion Criteria:

* History of recurrent, severe hypoglycemia
* Hepatic insufficiency: ALT, AST or alkaline phosphatase \> 2.5 times upper limits of laboratory's normal
* Renal insufficiency: serum creatinine \> 1.3 mg/dL (males) or \> 1.2 mg/dL (females)
* Severe gastrointestinal disease, including gastroparesis

Primary outcomes:
measure: Superiority as assessed by HbA1c reduction
timeFrame: at 24 weeks
Secondary outcomes:
measure: Safety variables
measure: Patient satisfaction
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V; NovoLog Mix-vs.-Exenatide Study Group. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Curr Med Res Opin. 2009 Jan;25(1):65-75. doi: 10.1185/03007990802597951.
Clinical trial NCT03085901: Comparison of Clinical Outcomes of Toric Intraocular Lens
Official title: Comparison of Clinical Outcomes of Toric Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL.

Detailed description: In cataract surgery, after phacoemulsification, intraocular lens should be implanted for patient's better visual acuity. When patient has large amount of corneal astigmatism, toric intraocular lens are recommended to correct the preexisting astigmatism.

Eligibility criteria: Inclusion Criteria:

* Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface)

Exclusion Criteria:

* Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery

Primary outcomes:
measure: Postoperative refractive astigmatism
timeFrame: postoperative 3 months
Secondary outcomes:
measure: Postoperative visual acuity
timeFrame: postoperative 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.
Clinical trial NCT01155401: Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding
Official title: Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Bleeding
Keywords: acute upper gastrointestinal bleeding
patients with drug-induced upper gastrointestinal bleeding
routine management
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 300
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: Primary Care Clinic

Brief summary: The purpose of this study is to determine and analyse the incidence, severity, risk factors and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the population of Russian patients


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract
* Written informed consent provided prior the start of participation in the study.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.

Primary outcomes:
measure: Number and percentage of patients with drug-induced upper gastrointestinal bleeding
timeFrame: About 1 year
Secondary outcomes:
measure: Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding
timeFrame: About 1 year
measure: Number and percentage of patients with concomitant diseases contributing to drug-induced upper gastrointestinal bleeding and those who receive NSAIDs, antiplatelet agents, anticoagulants, steroids or combination therapy
timeFrame: About 1 year
measure: Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapy
timeFrame: About 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Department of the Russian State Medical University
name: Boris R Gelfand, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05682001: The Molecular Pathogenesis Study of Cataract
Official title: The Molecular Pathogenesis Study of Cataract
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Pathogenesis
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2023-01-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anterior lens capsule tissues from cataract patients with diabetes mellitus more than 10 years, patients with age related cataract, and transparent crystals of cadaveric eyes.

Brief summary: To study the molecular pathogenesis of cataract and explore possible treatments，anterior lens capsules were collected from cataract patients

Detailed description: Anterior lens capsules were collected from the patients with DC and ARC, and transparent crystals of cadaveric eyes. M6A epitranscriptomic microarray was performed to investigate the altered m6A modifications and determine the differentially expressed mRNAs. The potential role of dysregulated m6A modification levels was predicted through Gene Ontology and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analyses. Real-time polymerase chain reaction was performed to identify the dysregulated expression of RNA methyltransferases, demethylases, and readers.

Eligibility criteria: Inclusion Criteria:

* diabetic cataract
* underwent cataract surgery

Exclusion Criteria:

* Combined with other eye diseases
* underwent other eye surgery

Primary outcomes:
measure: m6A modification of mRNAs
timeFrame: 1 month
measure: expression level of mRNAs
timeFrame: 1 month
measure: levels of methylated mRNA
timeFrame: 1 month
measure: levels of RNA methyltransferase
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital
name: Jin Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173901: Adverse Drug Reactions of Different Brands of Ceftazidime Injection
Official title: Adverse Drug Reactions of Different Brands of Ceftazidime Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infection
Keywords: ceftazidime
safety
infection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 536
Sex: ALL
Minimum age (years): 1
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Detailed description: Ceftazidime is a third generation cephalosporins that should be reserved for severe bacterial infections. Substitution of the brand ceftazidime with a generic ceftazidime raised some concerns.

The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Eligibility criteria: Inclusion Criteria:

* patients in surgical intensive care unit who require ceftazidime treatment

Exclusion Criteria:

* less than 1 year old

Primary outcomes:
measure: The adverse drug reactions of ceftazidime
Secondary outcomes:
measure: The effectiveness of ceftazidime
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shan-Chwen Chang, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06438601: A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses
Official title: A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Astigmatism
Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to compare the short-term clinical performance of the two study contact lenses.

Detailed description: The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.

Eligibility criteria: Inclusion Criteria:

1. They are aged 35 years or over and have capacity to volunteer.
2. They understand their rights as a subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They agree not to participate in other clinical research for the duration of this study.
5. They are currently wearing soft contact lenses or have done so within the past 12 months.
6. They have a spherical prescription between +10.00 and -10.00DS inclusive, (based on the ocular refraction).
7. They have astigmatism of between -0.75 and -5.75DC (based on the ocular refraction) in each eye.
8. They have a reading addition component to their spectacle refraction of between +0.75 and +2.50DS.
9. They can be satisfactorily fitted with the study lenses.
10. They own a wearable pair of spectacles.

Exclusion Criteria:

1. They have an ocular disorder which would normally contraindicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medications such as eye drops or ointment.
4. They have had cataract surgery.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
8. They have eye or health conditions including immunosuppressive or infectious diseases which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
9. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Subjective Distance Vision
timeFrame: At the end of 15 minutes of daily wear
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
affiliation: Eurolens Research
name: Carole Maldonado-Codina, PhD,MCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205201: The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
Official title: The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients
Lead sponsor: Chittagong Medical College
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.


Eligibility criteria: Inclusion Criteria:

* IOP 22_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients.

Exclusion Criteria:

* pregnant and lactating women, infection, any eye surgery.

Primary outcomes:
measure: More than 20% IOP reduction
timeFrame: 0_3 months
Secondary outcomes:
measure: Adverse reaction
timeFrame: O_3 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Facuity of basic science and para clinical science
state: Chittagong
city: Chittagong
country: Bangladesh
facility: Facuity of basic scienceand para clinican science
state: Chokhbazar
Study officials:
References:
Clinical trial NCT01519401: Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
Official title: Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Estro-progestin Drugs
Keywords: PCOS
drospirenone ethinylestradiol
androgens
metabolism
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).

The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.


Eligibility criteria: Inclusion Criteria:

* normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.

Exclusion Criteria:

* pregnancy
* past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension
* significant liver or renal impairment
* other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
* neoplasms
* unstable mental illness

Primary outcomes:
measure: To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women
timeFrame: twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
References:
citation: Romualdi D, De Cicco S, Busacca M, Gagliano D, Lanzone A, Guido M. Clinical efficacy and metabolic impact of two different dosages of ethinyl-estradiol in association with drospirenone in normal-weight women with polycystic ovary syndrome: a randomized study. J Endocrinol Invest. 2013 Sep;36(8):636-41. doi: 10.1007/BF03346756.
Clinical trial NCT02165501: Jena Sepsis Registry
Official title: Jena Sepsis Registry - a Sepsis-registry for Long Term Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Sepsis or Septic Shock (ICD-10-GM, R65.0, R65.1)
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 1995
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: patients will be selected from Jena University Hospital, Germany

Brief summary: Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis management are recognized. Investigators present a population-based registry with easy feasibility as part of German Center for Sepsis Control \& Care (CSCC). All ICU patients of the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU discharge. The primary outcome is change in all-cause mortality from baseline to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected from the primary care provider of the patient. The registry may provide valid data on quality in sepsis care.


Eligibility criteria: Inclusion Criteria:

* Patients treated in one of the ICUs will be enrolled if they were 18 years or older and fulfill the diagnostic criteria of severe sepsis or septic shock (ICD-10-GM, R65.0, R65.1) (19), (20).
* Diagnosis of severe sepsis or septic shock requires the following criteria: a microbiologically documented and/or clinically evident infection, at least two of the four criteria of the systemic inflammatory response syndrome (SIRS) and at least one new organ dysfunction, remote from the site of infection.

Exclusion Criteria:

-

Primary outcomes:
measure: all cause mortality
timeFrame: change from baseline to 6,12, 24, 36, 48 and 60 months after ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Jena University Hospital
Study officials:
References:
Clinical trial NCT00372801: Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee
Official title: A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Pilot Study to Investigate the Efficacy of Ibuprofen in Patients With Osteoarthritis of the Knee Following Administration of a Single Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Ibuprofen
COX2
VAS
knee
single dose
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 36
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.


Eligibility criteria: Inclusion criteria:

* Subjects diagnosed with primary Osteoarthritis of the knee.
* Have at least 3 months in symptom duration prior to screening visit.
* Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
* Pain walking on flat surface within specific interval prior to study start.

Exclusion criteria:

* History of hypersensitivity to NSAIDS.
* Allergy to Ibuprofen.
* Use of assistive devices other than a cane or knee brace.
* History of specified diseases/illnesses.
* Abnormal blood tests pre-study.

Primary outcomes:
measure: Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).
Secondary outcomes:
measure: Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)
Other outcomes:
Locations:
city: Randwick, Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: