louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00138567: Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Official title: Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Only patients successfully completing study CLAF237A2309 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from CLAF237A2309
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Safety during 104 weeks of treatment
measure: Change from baseline in HbA1c at 104 weeks
Secondary outcomes:
measure: Change in HbA1c between 52 weeks and 104 weeks
measure: Change in fasting plasma glucose between 52 weeks and 104 weeks
measure: Change from baseline in fasting plasma glucose at 104 weeks
measure: Change from baseline in HOMA B at 104 weeks
measure: Change in HOMA B between 52 weeks and 104 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Investigative Centers
country: Germany
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Goke B, Hershon K, Kerr D, Calle Pascual A, Schweizer A, Foley J, Shao Q, Dejager S. Efficacy and safety of vildagliptin monotherapy during 2-year treatment of drug-naive patients with type 2 diabetes: comparison with metformin. Horm Metab Res. 2008 Dec;40(12):892-5. doi: 10.1055/s-0028-1082334. Epub 2008 Aug 22.
citation: Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Clinical trial NCT02517567: DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation
Official title: Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
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 evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

Detailed description: This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Eligibility criteria: Inclusion Criteria:

* Sign an informed consent document;
* Adapted, current soft contact lens wearer;
* Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
* Can be successfully fitted with study lenses;
* Willing to wear lenses for a minimum of 8 hours prior to each study visit;
* Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only one lens;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Known pregnancy and lactation;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Tear Film Evaporation Rate
timeFrame: Day 1, Hour 8, each product
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT05538767: Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm
Official title: Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hookworm Infections
Keywords: Hookworm
Emodepside
Efficacy
Safety
Confirmatory Stage
Soil Transmitted Helminth
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Public Health Laboratory Ivo de Carneri
First posted: 2022-09-14
Enrollment: 320
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.


Eligibility criteria: Inclusion Criteria:

* Male or female adults aged between 12 and 60 years;
* Written and signed informed consent;
* Was examined by a study physician before treatment;
* Provided two stool samples at baseline;
* Hookworm EPG \> 48 and at least two Kato-Katz thick smears slides with more than one hookworm eggs.

Exclusion Criteria:

* Pregnant or lactating and/or planning to become pregnant within three months after drug treatment;
* Type 1 and/or 2 diabetes;
* Psychiatric disorders;
* History of ophthalmological conditions;
* Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment;
* Suffers from severe anaemia (Hb \< 80 g/l);
* Received anthelminthic treatment within past four weeks;
* Attending other clinical trials during the study;
* Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin;
* Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir.
* Participated in stage I trials of this protocol

Primary outcomes:
measure: Cure rate (CR) of emodepside against hookworm
timeFrame: In the week between 14 and 21 days post-treatment
Secondary outcomes:
measure: Geometric Mean Egg Reduction Rate (ERR) of the emodepside against hookworm.
timeFrame: In the week between 14 and 21 days post-treatment
measure: CR of emodepside against Trichuris trichiura and Ascaris lumbricoides
timeFrame: In the week between 14 and 21 days post-treatment
measure: ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides.
timeFrame: In the week between 14 and 21 days post-treatment
measure: Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.
timeFrame: At baseline and 14-21 days post-treatment
Other outcomes:
Locations:
city: Chake Chake
country: Tanzania
facility: Public Health Laboratory Ivo de Carneri
state: Pemba
Study officials:
References:
Clinical trial NCT02819167: Brain and Cognitive Reserve
Official title: Neuro-anatomical Correlates on Volumetric MRI on the Impact of Brain Reserve and Cognitive Reserve on Ischemic Strokes in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Ischemia
Keywords: ischemic stroke
brain reserve
cognitive reserve
cognitive prognosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ischemic strokes are one of the leading causes of handicap and death in elderly people in France.

Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual activities and other environmental factors that explain differential susceptibility to functional impairment in the presence of pathology or other neurological insult. CR is estimated using variables for cognitive activity: years of education, professional status, socioeconomic status... Furthermore, brain reverse (BR) is a passive and quantitative model that depend on brain size and other quantitative aspects of the brain that explain differential susceptibility to functional impairment in the presence of pathology.

Firstly, volume and localization of ischemic strokes have a great impact on CR and BR due to brain injury. On the other hand, CR influences the severity and the expression of cognitive diseases.

The investigators realize a prospective study in order to assess the impact of CR and BR on cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.


Eligibility criteria: Inclusion Criteria:

* ≥70 years old
* right middle cerebral artery ischemic stroke
* hospitalized in neurovascular unit of Pierre Wertheimer hospital between January 2015 to January 2016

Exclusion Criteria:

* Contraindication for MRI
* Hemorrhagic stroke
* Aphasia

Primary outcomes:
measure: evaluation of cognitive prognosis
timeFrame: one year post Ischemic stroke
Secondary outcomes:
measure: Volume of leucoencephalopathy
timeFrame: one year post Ischemic stroke
measure: volume of hippocampic
timeFrame: one year post Ischemic stroke
measure: brain injury
timeFrame: one year post Ischemic stroke
measure: volume of ischemic stroke
timeFrame: one year post Ischemic stroke
measure: evaluation of cognitive reserve
timeFrame: one year post Ischemic stroke
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital des Charpennes
Study officials:
affiliation: Hospices Civils de Lyon
name: Pierre Krolak Salmon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209167: Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty
Official title: Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Donor Site Complication
Satisfaction, Personal
Breast Cancer
Keywords: Breast reconstruction; abdominoplasty; patient satisfaction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 44
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.

Detailed description: 34 patients reconstructed with a DIEAP flap (DIEAP group) and 30 patients who had undergone a conventional abdominoplasty (AP group) were asked to complete two study-specific questionnaires. One questionnaire covered general and specific aspects concerning abdominal outcomes and morbidity. The other covered general outcomes such as satisfaction with surgery and change of body image, self-confidence, social and intimate relations. In addition, all patients performed an abdominal muscle function test.

Eligibility criteria: Inclusion Criteria:

* unilateral DIEAP flap, abdominoplasty

Exclusion Criteria:

* bilateral DIEAP flap, progressive cancer disease

Primary outcomes:
measure: Comparing patient satisfaction of the abdomen after DIEAP procedure and conventional abdominoplasty
timeFrame: 2001 to 2004.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01027767: Effect of Surgery and Radiation Therapy on Tc-99M Sestamibi Uptake Patterns in Molecular Breast Imaging
Official title: Effect of Surgery and Radiation Therapy on Tc-99M Sestamibi Uptake Patterns in Molecular Breast Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast
MBI
Molecular
Molecular Breast Imaging
Dense breast tissue
Surgery
Radiation
BCT
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are seen in the Mayo Clinic Breast Clinic

Brief summary: The investigators hope to prove that radiation and surgical scarring does not result in changes that affect the MBI pattern 6-12 months after completion of treatment.

Detailed description: The study will allow us to evaluate whether surgery and radiation have persistent effects on the breast tissue with regards to whether and how such changes impact MBI images and to determine whether the inflammatory changes due to treatment resolve within 6-12 months of completing treatment.

Eligibility criteria: Inclusion Criteria:

* Women who have planned surgical excision of a lesion or have had a baseline MBI study as part of another MBI research protocol who are within 6-12 months of completing breast surgery who are able and willing to return to Mayo Clinic for a follow up MBI study once the 6-12 month interval is complete.
* Women who plan BCT for a malignant lesion or who are within 6-12 months of completing breast conserving treatment and have had a baseline MBI study as part of another MBI research protocol and are able and willing to return to Mayo Clinic for a follow up MBI study.

Exclusion Criteria:

* Women who do not require surgical excision of a breast lesion or breast conserving treatment for breast cancer.
* Patients undergoing mastectomy.
* Women who are pregnant or lactating.
* Women who are taking hormonal contraception or hormone replacement therapy (vaginal estrogen is permitted), or have used these agents within the previous 3 months.
* Women who have received chemotherapy within the previous 6 months or receive chemotherapy as part of their cancer treatment.
* Men (due to the very low incidence of male breast cancer and the lack of any available data regarding the use of scintimammography or MBI in men).
* Women under the age of 18 years.
* Women unable to sit comfortably during image acquisition.
* Women who are unable to return to Mayo Clinic for a follow up MBI scan 6-12 months after surgical excision or 6-12 months after completing radiation therapy for breast conservation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicole Sandhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01549067: The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey
Official title: The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Malignant Neoplasm
Colorectal Cancer
Keywords: Advanced
Colorectal Cancer
Targeted chemotherapy
Surgery
Radiotherapy
Lead sponsor: Chinese Medical Doctor Association
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 3700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced Colorectal Cancer

Brief summary: Collect the real clinical background of advanced colorectal cancer c of China.

Detailed description: The Primary Objectives of this study is collect the real clinical background of advanced colorectal cancer treatment situation of China. The Secondary Objectives is the mutation of K-ras , targeting therapy , use present situation of cetuximab and liver metastases treatment situation of colorectal cancer patients.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed diagnosis of metastatic colorectal cancer.

Exclusion Criteria:

* Patients with histologically or cytologically confirmed diagnosis other than metastatic colorectal cancer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Zhongshan
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangzhou
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Lin Shen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Ruihua Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155167: Topical Radial Artery Vasodilation
Official title: The Effect of Topical Administration of Lidocaine/Nitroglycerin Combination Versus Placebo on Radial Artery Access in Patients Undergoing Cardiac Catheterization Via the Radial Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cardiac Catheterization
Spasm
Keywords: radial artery spasm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to facilitate radial artery access for cardiac catheterization. The investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.

Detailed description: The aim of the study is to facilitate radial artery access for cardiac catheterization. The investigators hypothesize that topical nitroglycerin and lidocaine will reduce radial artery spasm. Patients undergoing cardiac catheterization via the radial artery will be randomized to topical nitroglycerin + lidocaine versus placebo.

Eligibility criteria: Inclusion Criteria:

* Undergoing trans-radial cardiac catheterization

Exclusion Criteria:

* inability to receive nitroglycerin or lidocaine due to allergy or medication interactions

Primary outcomes:
measure: Change in Radial Artery Diameter
timeFrame: Baseline and after 30 minutes of drug application
Secondary outcomes:
measure: Radial Artery Spasm During Catheterization
timeFrame: 2 hours
measure: Radial Artery Patency
timeFrame: 24 hours
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Andrew Boyle, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10.
Clinical trial NCT02464267: Developing and Validating a Patient-reported Outcome Instrument to Monitor Symptom Management in Pulmonary Exacerbation in CF
Official title: Developing and Validating a Patient-reported Outcome Instrument to Monitor Symptom Management in Pulmonary Exacerbation of Patients Living With Cystic Fibrosis - Item Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: patient reported outcome instrument
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2015-06-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic Fibrosis

Brief summary: The aim of this study is to develop a reliable and valid instrument to measure symptom management (experience and / or management strategies) during exacerbation episodes in CF patients. For the development a sequential exploratory two phase mixed-method study will be applied. In a first step, up to 25 CF patients will be interviewed: approximately 15 CF patients who experienced at least one episode of exacerbation in the past year and approximately CF 10 patients who are currently experiencing an exacerbation. The latter group will be interviewed up to 3 times during and after the antibiotic treatment. The instruments initial item list will be developed on basis of the interviews. Up to five health professionals will rate the items' relevance. In a further step, items' clarity and relevance will be assessed by cognitive debriefing interviews with no more than 10 patients. In the last step (part III), the instrument's preliminary construct and concurrent validity and reliability will be tested in a larger sample up to 150 patients experiencing exacerbation. Patients will be asked to complete the newly developed questionnaires and a set of other questionnaires at one time point. For part III, ethic approval will be asked at a later date (2015).


Eligibility criteria: Inclusion Criteria:

Part I A \& II:

1. Patients with a confirmed diagnosis of cystic fibrosis
2. Age ≥ 18
3. Experience of at least one exacerbation during the last year requiring antibiotic treatment (oral or intravenous)

Part I B:

1. Patients with a confirmed diagnosis of cystic fibrosis
2. Age ≥ 18
3. Experience of an acute exacerbation requiring antibiotic treatment (oral or intravenous)

Exclusion Criteria:

Part I \& II

1. Do not speak or understand German
2. Inability to verbally communicate
3. Cognitive impairment

Primary outcomes:
measure: Change in patient experience of symptom management
timeFrame: Patients will be followed up for 4 weeks after start of antibiotic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Centre of Clinical Nursing,
name: Gabriela Schmid-Mohler
role: PRINCIPAL_INVESTIGATOR
References: