louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02359682: Population Research of Sublingual Microcirculation Data of Healthy Volunteers
Official title: Population Research of Sublingual Microcirculation Data of Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: This study will enrolled 90 healthy volunteers. The sublingual microcirculation will be examined by sidestreamdark-field videomicroscopy (MicroScan;Microvision Medical, Amsterdam, The Netherlands). Five video sequences (20 s) was obtained from different sublingual sites, and digitally stored the images with code numbers that did not reflect volunteers' information for later offline analysis by automated analysis software (AVA 3.0; Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands).


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged from 20 to 79 years old
* BMI ranged from 18.5 to 27 kg/m2

Exclusion Criteria:

* Systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 95 mm Hg, or systolic blood pressure \< 90 mm Hg at enrollment
* Body temperature \> 37.5 ℃ or \< 35.5 ℃ at enrollment
* had been diagnose with any one of the following diseases
* hypertension
* diabetes mellitus
* peripheral arterial occlusive disease
* coronary arterial disease
* liver cirrhosis
* chronic kidney disease
* stroke
* anemia
* asthma
* chronic bronchitis
* any metabolic diseases
* any hematologic disease
* uncured cancer
* chronic uncontrolled infection
* other disease may limit daily activities
* non-native speakers

Primary outcomes:
measure: Total small vessel density of sublingual small vessels
timeFrame: Once at enrollment
Secondary outcomes:
measure: Perfused small vessel density of sublingual small vessels
timeFrame: Once at enrollment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, anesthesiology department
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04567082: Proteome- and Methylation Profiles in Oropharyngeal Cancer
Official title: Proteome- and Methylation Profiles in Oropharyngeal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharynx Cancer
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancergroup:

Patients from the Northern Region of Denmark referred to the Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital with suspected or verified oropharyngeal cancer. Only patients with verified cancer after diagnostic work-up will be included in the analyses.

Control group:

Patients referred to the Department of Otolaryngology - Head and neck surgery, Aalborg University Hospital or a private clinic for Oral- and Maxillofacial surgery in Aalborg.

Brief summary: This clinical study aims to evaluate proteome- and methylation profiles in saliva in patients with oropharyngeal cancers


Eligibility criteria: Cancer group:

Inclusion Criteria:

* Written informed consent
* Verified oropharyngeal squamous cell carcinoma

Exclusion Criteria:

* Other active cancer
* Uncontrolled comorbidity
* Unable to give informed consent

Control group:

Inclusion Criteria:

* Written informed consent
* Normal ENT examination

Exclusion Criteria:

* Active cancer
* Uncontrolled comorbidity
* Unable to give informed consent

Primary outcomes:
measure: Differences in proteome and methylation profiles
timeFrame: At diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Otolaryngology - Head and Neck Surgery
Study officials:
affiliation: Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital
name: Michael Gaihede, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219582: GLucobay M OBservation Study for Efficacy and Safety in Treatment of Type-2 Diabetes Patients
Official title: Open, Prospective, Multicentric, Single-arm, Non-interventional Study to Evaluate the Effectiveness & Safety of Oral Glucobay®-M Tablets in Type 2 Diabetes Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus Type-2
Acarbose
Metformin
Drug Therapy, Combination
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 9364
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: Type 2 Diabetes

Brief summary: An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M under daily life treatment of type-2 diabetes patients.The study objectives are to investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body - weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus, where investigator feels that addition of Glucobay®-M would be beneficial to patients will be included in non- interventional study. The routine investigation suggested by the attending physician will be done in diabetic patients. No additional investigation will be done for the study purpose. The uncontrolled diabetic patient on existing treatment and prescribed Glucobay®-M will be included in study after taking the informed consent. The patient will be asked to attend 2 follow up visit each after 6 weeks. All patients receiving at least one tablet will be included in the safety analysis.The study is planned to be carried out in 10000 patients from 320-350 trial sites in India.


Eligibility criteria: Inclusion Criteria:

* Female and male patients ≥ 18 years of age with Type 2 Diabetes where investigator feels that addition of Glucobay®-M would be beneficial to patients.
* The diagnosis will be made based on the ADA criteria by the attending physician.
* Patients will be defined as included in the study if they have a documented prescription of Glucobay-M by the physician.
* Patients willing to provide signed \& dated informed consent.
* Patients willing to comply with study requirements.

Exclusion Criteria:

* According to the local product information

Primary outcomes:
measure: Change in fasting blood glucose levels
timeFrame: 12 weeks
measure: Change in post-prandial glucose values
timeFrame: 12 weeks
measure: Change in Hemoglobin A1c (HbA1c) levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of patient with adverse events
timeFrame: 12 weeks
measure: Percentage of patients with satisfaction of treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Many Locations
country: India
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01853982: Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
Official title: A Multicenter, Open-Label, Randomized Study to Compare the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam With That of Piperacillin/Tazobactam in Ventilator Associated Pneumonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ventilator-Associated Pneumonia (VAP)
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 4
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: This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants .


Eligibility criteria: Key Inclusion Criteria:

* Participant has received mechanical ventilation for \> 48 hours
* Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35
* Presence of a new or progressive infiltrate on chest x-ray
* Presence of clinical criteria consistent with VAP

Key Exclusion Criteria:

* History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
* Known end stage renal disease or requirement for dialysis

Primary outcomes:
measure: Clinical Response at the End of Therapy Visit
timeFrame: 24 hours after last dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Duluth
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Bronx
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Abington
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Herston
country: Australia
state: Queensland
city: Meadowbrook
country: Australia
state: Queensland
city: Nambour
country: Australia
state: Queensland
city: Southport
country: Australia
state: Queensland
city: Woolloongabba
country: Australia
state: Queensland
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Wellington
country: New Zealand
Study officials:
affiliation: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
name: Obiamiwe Umeh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00453882: Uretal Flow Assessment During Gynecological Procedures
Official title: An Evaluation of Ureteral Flow After Temporary Bilateral Uterine Artery Occlusion During Conservative Gynecological Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conservative Gynecological Procedures
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-29
Enrollment: 7
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective is to evaluate the feasibility of using color Doppler ultrasound in ureteral flow assessment after uterine artery occlusion during a conservative gynecological procedure.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for conservative gynecological procedure
* At least 25 years of age
* Cervix suitable for tenaculum placement
* Provides written informed consent.

Exclusion Criteria:

* Pregnancy
* One or more lower uterine segment fibroids
* Hydronephrosis as determined by renal ultrasound pre-procedurally
* Clinical diagnosis of urinary tract infection (UTI)
* In the medical judgment of the physician, such a procedure may compromise the patient's condition
* Inability to achieve bilateral occlusion with the clamp placement during the procedure.

Primary outcomes:
measure: Ability to evaluate ureteric jets
measure: Adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Medical Group
state: Florida
Study officials:
affiliation: Ethicon, Inc.
name: David Robinson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01773382: The Effects of Weight Reduction in IgA Nephropathy
Official title: The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Proteinuria
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight reduction. The investigators hypothesized that benefits of weight loss may reduce proteinuria.

Detailed description: This is a prospective randomized study in adult IgA nephropathy. The investigators enrolled 30 patients who have proteinuria exceeds 1 g per day with biopsy proven IgA nephropathy. The experimental arm recieves the non-pharmacological treatment, weight reduction protocol. All patients in this arm must be reduce their body weight in 3-5 % from baseline as protocol. Another arm is control group which recieves standard treatment of IgA nephropathy including ACEIs/ARBs for blood pressure control (target \< 130/80 mmHg). The primary outcome is proteinuria level. The secondary outcome is cytokines and inflammatory markers level including interleukin-6, resistin, adiponectin, leptin and monocyte chemoattractant protein-1.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven IgA nephropathy
* body mass index more than 23 Kg/m2
* 24 hours urine protein more than 1 g
* estimated GFR more than 20 ml/min

Exclusion Criteria:

* pregnancy and lactation
* rapidly renal function decline
* crescent formation in renal biopsy more than 10%

Primary outcomes:
measure: Percentage change of 24-hour proteinuria
timeFrame: 6 months
Secondary outcomes:
measure: plasma concentration of IL-6, adiponectin, resistin, leptin, MCP-1
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of medicine, Chulalongkorn university
Study officials:
affiliation: Chulalongkorn University
name: Piyawan Kittiskulnam, M.D.
role: STUDY_DIRECTOR
References:
citation: Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.
Clinical trial NCT03699982: Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study
Official title: Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cystic fibrosis is an inherited disorder that causes severe damage to the lungs, digestive system, and other organs in the body. Individuals with cystic fibrosis often have poor weight gain and growth that can negatively impact health further by worsening lung function. Additionally, persons with the disease typically need more than the usual calories on a daily basis.

Most institutions estimate these patients' caloric needs using weight, age, and sex based mathematical formulae. However, numerous studies show that use of these formulae often yields inaccurate caloric values. Use of indirect calorimetry may give more accurate estimates of caloric needs in patients with cystic fibrosis.

The aim of our study is to assess the accuracy of caloric estimates generated using one such widely used mathematical formula, the Harris-Benedict equation, and to compare this calorie value with that obtained from indirect calorimetry testing in pediatric and adult patients with cystic fibrosis.

Study investigators will use the newly calculated caloric requirements in dietary counseling. Changes in weight and lung function after 3 months will be compared to participants' historical changes.


Eligibility criteria: Inclusion Criteria:

* Patients with cystic fibrosis who are equal to or older than six years of age presenting to West Virginia University-Charleston Cystic Fibrosis Center for their regularly scheduled appointments/check-ups.
* Patients at the Cystic Fibrosis Center for at least 12 months.

Exclusion Criteria:

* Patients with cystic fibrosis who are younger than 6 years of age.
* Patients without cystic fibrosis.
* Patients currently pregnant.
* Cystic fibrosis patients with significant disease exacerbation (such as needing oral steroids or antibiotics, hospital admission within 30 days) or patients who currently having the flu or a serious upper respiratory infection.

Primary outcomes:
measure: Resting energy expenditure estimation
timeFrame: 1 hour
measure: Morphological variable changes
timeFrame: 3 months
measure: Changes in pulmonary function status
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: CAMC - Women and Children's Hospital
state: West Virginia
Study officials:
affiliation: CAMC and WVU-Charleston
name: Amanda Dye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01465282: Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris
Official title: A Randomized, Placebo-controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Keywords: psoriasis vulgaris
topical ointment
Lead sponsor: Creabilis SA
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 160
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 evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged at least 18 years.
* Stable psoriasis vulgaris

Exclusion Criteria:

* Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.

Primary outcomes:
measure: Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.
timeFrame: Week 8
Secondary outcomes:
measure: Local and systemic toleration
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hotsprings
country: United States
state: Arkansas
city: San Ramon
country: United States
state: California
city: Bay City
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: South Euclid
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: San Antonio
country: United States
state: Texas
city: Spanish Fork
country: United States
state: Utah
city: Birmingham
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Manchester
country: United Kingdom
city: Merseyside
country: United Kingdom
Study officials:
References:
Clinical trial NCT02464982: Psycho-esthetic Impact of Tattoo Technology as Part of Mammary Reconstruction After Surgery Against Breast Cancer
Official title: Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Right or Left Breast Mammary Reconstruction
Malignant Neoplasm Reconstruction by Tattoo of Areola of Female Breast
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 107
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with 1 year non-invasive technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer.

Brief summary: Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode.

The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.

Detailed description: Tattoo is realized as standard car as part of mammary reconstruction after surgery of patient suffering from breast cancer. We try to measured :

* Tattooed patient's satisfaction degree with qualitative questionnaire using four level satisfaction scale (very satisfied, satisfied, dissatisfied, very dissatisfied)
* Evaluate from patient and jury, the tall, form, color and areola position defects
* Evaluate professional jury's satisfaction degree regarding this areola tattoo technology, with the same patient criteria

Eligibility criteria: Inclusion Criteria:

* technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer

Exclusion Criteria:

* Two breasts operated patient
* surgical reconstruction

Primary outcomes:
measure: Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment
timeFrame: 1 year after areola tattoo have been realized following standard care
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: esthetic, reconstruction and maxillo-facial surgery department, University Hospital
Study officials:
affiliation: esthetic, reconstruction and maxillo-facial surgery department, University Hospital, Strasbourg
name: Sylvie DUGUET
role: PRINCIPAL_INVESTIGATOR
References: