louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02575937: Low Glycemic Diet Intervention and Community Diabetic Patients
Official title: The Efficiency of Nutrition Education-based Low Glycemic Diet Intervention on Community Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: low glycemic diet
diabetes
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients.

Design: Randomized clinical trial.

Main measures: HbA1c,fasting blood glucose(FBG),2 hours postprandial blood glucose（2hPG）

Detailed description: Low glycemic diet can help to control Blood glucose levels，this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients,and to improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and diet controlling.

Eligibility criteria: Inclusion Criteria:

* subject has a fasting blood glucose between 6.1 and 6.9mmol/L or diagnosed of type 2 diabetes
* glycosylated hemoglobin(A1C) between 6 and 11%.
* subject's age≥18 years.

Exclusion Criteria:

* subject has kidney disease (defined as creatinine\>1.3 mg/dl)
* active liver or gallbladder disease
* significant heart disease
* a history of severe hypoglycemia, or use of weight loss medications.
* subject that is pregnant.

Primary outcomes:
measure: Change in Glycosylated hemoglobin (HbA1c)
timeFrame: Change from Baseline HbA1c at 12 months
Secondary outcomes:
measure: Weight
timeFrame: Baseline and 6, 12 months
measure: Body Mass Index (BMI)
timeFrame: Baseline and 6, 12 months
measure: Fasting blood-glucose
timeFrame: Baseline and 6, 12 months
measure: Total cholesterol level
timeFrame: Baseline and 6, 12 months
measure: HDL level
timeFrame: Baseline and 6, 12 months
measure: LDL level
timeFrame: Baseline and 6, 12 months
measure: Triglycerides
timeFrame: Baseline and 6, 12 months
measure: Food Frequency Questionnaire（FFQ）
timeFrame: Baseline and 6, 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Min Xia, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00872937: Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions
Official title: Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 800
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cervical cancer patients with HPVinfection

Brief summary: Human papillomavirus (HPV) infection plays a key role in the carcinogenesis of cervical cancer and pre-invasive lesions. There are hundred types of HPV, including high risk and low risk types, and it is proved the close association between the cervical cancer and high risk HPV. While HPV 16 and 18 are known to be the leading two genotypes detected in women with cervical neoplasm worldwide, there is considerable difference in the other prevalent high risk genotypes in different geographic areas. It is important to establish the local database about the cervical intraepithelial lesions and the related prevalent HPV genotypes. The investigators designed a retrospective study which included total 784 patients managed at our hospital from January 1, 2000 to December 31, 2007. The present study was to investigate the HPV genotypes in the Taiwanese female patients with abnormal cervical cytology and analyses the association between HPV types and cervical pre-invasive lesions. It could provide the guide for the clinicians in the management of patients with abnormal cytological change of Pap smear.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* People infected with HPV type 16 but without CIN lesions
* Patients with CIN lesions
* Patients with cervical cancer from National Taiwan University Hospital
* Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards.

Exclusion Criteria:

* None

Primary outcomes:
measure: overall survival
timeFrame: from disease diagnosis to death
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wen-Fang Cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04676737: TTHX1114(NM141) in Combination With DWEK/DSO
Official title: Phase 2 Study To Determine the Safety and Efficacy of TTHX1114(NM141) on the Regeneration and Migration of Corneal Endothelial Cells in Patients Undergoing DWEK/DSO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fuchs' Endothelial Dystrophy
Fuchs Dystrophy
Fuchs
Lead sponsor: Trefoil Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 49
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: Open label, single-treatment, with a concurrent non-treatment control


Eligibility criteria: Key Inclusion Criteria:

* Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months
* Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm
* Subjects in Group 2 must have a stable Fellow Eye with adequate function

Key Exclusion Criteria:

* Secondary corneal/ocular pathology in the Study Eye
* Prior refractive surgery in the Study Eye
* Prior exposure to TTHX1114

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Trefoil Investigational Site 124
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Deerfield Beach
country: United States
facility: Trefoil Investigational Site 123
state: Florida
city: Fort Myers
country: United States
facility: Trefoil Investigational Site 119
state: Florida
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Bozeman
country: United States
facility: Vance Thompson Vision - Bozeman
state: Montana
city: Omaha
country: United States
facility: Vance Thompson Vision - Omaha
state: Nebraska
city: W. Fargo
country: United States
facility: Vance Thompson Vision - Fargo
state: North Dakota
city: Cincinnati
country: United States
facility: Trefoil Investigational Site 120
state: Ohio
city: Sioux Falls
country: United States
facility: Vance Thompson Vision - Sioux Falls
state: South Dakota
Study officials:
affiliation: Trefoil Therapeutics.com
name: Thomas Tremblay
role: STUDY_DIRECTOR
References:
Clinical trial NCT00381537: Prediction of Childhood Epilepsy Outcome in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: childhood epilepsy
Active childhood epilepsy
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2006-09-28
Enrollment: 92
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects.


Eligibility criteria: Inclusion Criteria:

* Active epilepsy
* Aged 2-15 years

Exclusion Criteria:

* Excluded absence
* Myoclonic and malignant epilepsy syndromes
* Major motor and cognitive impairments
* Those currently receiving antiepilepsy drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sher-e-Bangla Nagar, Dhaka 1207
country: Bangladesh
facility: Children's Hospital Dhaka (Shishu) Bangladesh.
city: London
country: United Kingdom
facility: Institute of Child Health
Study officials:
affiliation: Institute of Child Health
name: Brian Neville, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Dhaka (Shishu) Bangladesh.
name: Selina Banu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banu SH, Jahan M, Koli UK, Ferdousi S, Khan NZ, Neville B. Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial. BMJ. 2007 Jun 9;334(7605):1207. doi: 10.1136/bmj.39022.436389.BE. Epub 2006 Dec 4.
Clinical trial NCT00767637: Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone
Official title: Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia
Dialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis


Eligibility criteria: Inclusion Criteria:

* Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

Exclusion Criteria:

* Patients with severe hypocalcemia (adjusted serum calcium level of \<7.5 mg/dL)

Primary outcomes:
measure: Changes in pre-dialysis serum phosphate levels
timeFrame: Every 2 weeks
Secondary outcomes:
measure: Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)
timeFrame: Every 2 weeks
measure: Changes in corrected serum calcium level
timeFrame: Every 2 weeks
measure: Changes in the product of serum calcium and phosphate
timeFrame: Every 2 weeks
measure: Changes in serum intact-PHT levels
timeFrame: Every 2 weeks
measure: Changes in bone metabolism markers
timeFrame: Every 2 weeks
Other outcomes:
Locations:
city: Isesaki
country: Japan
state: Gunma
city: Yonago
country: Japan
state: Tottori
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Shigematsu T, Tokumoto A, Nakaoka A, Arisaka H. Effect of lanthanum carbonate treatment on bone in Japanese dialysis patients with hyperphosphatemia. Ther Apher Dial. 2011 Apr;15(2):176-84. doi: 10.1111/j.1744-9987.2010.00898.x.
Clinical trial NCT00451152: Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
Official title: A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Keywords: glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-03-23
Enrollment: 89
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: The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pseudoexfoliation;
* Pigment dispersion component;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure (IOP)
timeFrame: 3 months
Secondary outcomes:
measure: Percent Treatment Failures
timeFrame: 3 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Texas
state: Texas
Study officials:
affiliation: Alcon Research
name: Theresa Landry, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00117052: SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
Official title: SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
End Stage Renal Disease
Keywords: Clinical trial
Amgen
Secondary HyperParaThyroidism (SHPT)
Dialysis
End Stage Renal Disease (ESRD)
KDOQI
Cinacalcet
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-04
Enrollment: 673
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit.


Eligibility criteria: Inclusion Criteria: - CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment - An iPTH determination within 14 days before randomisation must be greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) - A serum calcium determination (corrected for calcium) within 14 days before randomisation must be greater than or equal to 8.4 mg/dL \[2.1 mmol/L\] Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Are currently breast-feeding - Are performing peritoneal dialysis - Have had a parathyroidectomy in the 3 months before day 1 - Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets

Primary outcomes:
measure: Number of subjects with PTH less than or equal to 300pg/mL
timeFrame: 21 week dose optimisation phase
Secondary outcomes:
measure: Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes
timeFrame: Dose Optimisation phase 21 weeks
measure: Safety of cinacalcet
timeFrame: 21 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Schaefer RM, Bover J, Dellanna F, Sanz D, Asensio C, Sanchez Gonzalez MC, Gross P, Zani V, Carter D, Jehle PM. Efficacy of cinacalcet administered with the first meal after dialysis: the SENSOR Study. Clin Nephrol. 2008 Aug;70(2):126-34. doi: 10.5414/cnp70126.
Clinical trial NCT00422552: Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol
Official title: An Exploratory, Double-Blind Comparison of Inspiratory Capacity (IC) and FEV1 in COPD Patients Following Single Dose Administration of Indacaterol and Placebo and Open Label b.i.d. Administration of Formoterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COPD
Keywords: inspiratory capacity, FEV1, COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
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 assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and formoterol.


Eligibility criteria: Inclusion Criteria:

* Male and post-menopausal female adults aged 40-80 years inclusive.
* Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005)
* Smoking history of at least 10 pack years (either smokers or ex-smokers).
* Able to perform reproducible spirometry maneuvers.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Exclusion Criteria:

* COPD exacerbations within 6 weeks prior to dosing
* Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
* Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.
* Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours
Secondary outcomes:
measure: Percent predicted FEV1 time course change over 24 hours
measure: Mean maximal change in IC time course change over 24 hours
Other outcomes:
Locations:
city: Horsham
country: United Kingdom
facility: Novartis Investigative site
Study officials:
affiliation: Investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03857152: Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications
Official title: Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mammography
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 250
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Women who attend for their screening mammogram will be recalled if an abnormality is detected on the screening mammogram. Calcifications account for 20% of the women recalled to second stage screening. Currently there is no effective imaging tool to determine if the calcifications are cancer or not. Therefore, 90% of women will be subjected to a biopsy. 25-30% of the biopsies will show cancer. Contrast enhanced spectral mammography (CESM) is where contrast is given and then a mammogram performed. The theory is that high risk DCIS and invasive cancers have an increased blood supply and will therefore enhance more than benign lesions within the breast. If CESM can identify calcifications that are cancerous then we maybe able to reduce the number of women who have benign biopsies. This is patient focused as women would not require a biopsy and be able to be reassured at the same visit. This is also a cost-saving for the Trust by reducing unnecessary biopsies. This also supports the findings of the Marmot review by aiming to reduce harm by over-diagnosis.


Eligibility criteria: Inclusion Criteria:

1. Recalled for second stage screening due to microcalcifications on the mammogram
2. Renal function is within normal limits
3. No known allergies to contrast
4. Able to give informed consent

Exclusion Criteria:

1. Known allergy to contrast
2. Renal impairment
3. Unable to provide informed consent
4. Having radioactive iodine treatment for hyperthyroidism

Primary outcomes:
measure: Number of benign biopsies
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT02074852: Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Catheter
Cesarean Section
Urinary Infection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women admitted to the prenatal wards for primary or repeat elective cesarean section

Brief summary: The objective this trial is to compare immediate and 12 hours postoperative removal of urinary catheter after elective cesarean section; and whether early removal is associated with lower risk of urinary infection compared with delayed catheter removal.


Eligibility criteria: Inclusion Criteria:

- Women admitted to the prenatal wards for primary or repeat elective cesarean section

Exclusion Criteria:

* urinary infection (assessed clinically and by midstream urinalysis),
* significant vaginal bleeding,
* severe pre-eclampsia or eclampsia and/or any other conditions requiring postoperative monitoring of urinary output, and
* contraindications for general anesthesia.

Primary outcomes:
measure: Number of cases with significant bacteriuria and urinary symptoms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University
Study officials:
References: