louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01631643: One Touch® Verio®IQ European Clinical Outcomes Study
Official title: One Touch® Verio®IQ European Clinical Outcomes Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetes
Keywords: Blood glucose monitor
Pattern management
Pattern guide
Education
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
First posted: 2012-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the clinical benefits of One Touch VerioIQ system.

Detailed description: Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.

Eligibility criteria: Inclusion Criteria:

* male or female at least 18 to 80 years old
* ADA guidelines for FPG and PPG appropriate
* A1C greater or equal to 8.0% and less than or equal to 10.5%
* lab A1C greater than or equal to 8.0% in the last 6-12mths
* Diagnosed with type 1 or 2 in at least last 1 year
* on stable dose of OADs for at least 3mths prior to screening
* willingness to test 7 BGM tests per day
* willing to remain on same therapy as baseline (MDI) for duration of study

Exclusion Criteria:

* unlikely to be compliant to study procedures
* has or has currently used One Touch VerioIQ
* Is on fixed doses of insulin for MDI therapy

Primary outcomes:
measure: Change in A1C from baseline to week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in A1C from baseline to week 12
timeFrame: 12 weeks
measure: Change in FPG from baseline to 24 weeks
timeFrame: 24 weeks
measure: Change in proportion of subjects with A1C less than or equal to 7.0% at week 24
timeFrame: 24 weeks
measure: Change in 30 day mean glucose comparing first month to last month after 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Lyon Sud
name: Charles Thivolet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05968443: Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery
Official title: Observational, Retrospective Clinical Study in Patients Undergoing Ophthalmic Surgery Using Dafilon® Suture Material (Dafilon® USP (United States Pharmacopeia) Sizes From 8/0 to 11/0)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Diseases
Keywords: Ophthalmologic Surgery
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2023-08-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent any ophthalmic surgery using Dafilon® suture in the participating centre between 2018 and 2020.

Brief summary: This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample size can be given but the planned sample size shall be at least 200 eyes (around 100 patients depending on the number of operated eyes per patient) to conduct meaningful subgroup analysis.


Eligibility criteria: Inclusion Criteria:

* Patient operated between 2018 - 2020 undergoing any ophthalmic surgery using Dafilon® suture material (Dafilon® USP (United States Pharmacopeia) sizes from 8/0 to 11/0) at the participating hospital

Exclusion Criteria:

* No exclusion criteria have been set

Primary outcomes:
measure: Number of Suture material complications
timeFrame: up to the retrospective examination (2 to 4 years postoperatively)
Secondary outcomes:
measure: Number of Intra-operative complications
timeFrame: intraoperatively
measure: Number of Post-operative complications
timeFrame: up to the retrospective examination (2 to 4 years postoperatively)
measure: Incidence of recurrence
timeFrame: up to the retrospective examination (2 to 4 years postoperatively)
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: KPJ Tawakkal KL Specialist Hospital
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: KPJ Tawakkal KL Specialist Hospital
name: Hamidah H Budin, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238743: Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.
Official title: A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Determined by surgeon

Brief summary: The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair.

Detailed description: The ADOPT- Ventral Hernia project is designed as a prospective, single arm, case series. The proctor will select a limited number of licensed surgeon trainees (up to 5) as agreed upon by Covidien and the proctor. The proctor will then train through clinical immersions, hands on proctorship and video training for proper technique on minimally invasive surgical (MIS) repair of ventral hernia. After the training, the data will be collected on the trainee's next 10 MIS ventral hernia repair cases, pending subject consent to collect data. Procedural and Post-Operative details will be captured for each of these subjects who have undergone the laparoscopic ventral hernia repair.

Eligibility criteria: Inclusion Criteria:

* Determined by surgeon's standard of care

Exclusion Criteria:

* Determined by surgeon's standard of care

Primary outcomes:
measure: Number of complications during independent cases post proctorship
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Jonathan Pearl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04004143: Micronutrients and Health in Adult Chinese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysglycemia
Dyslipidemia
Lead sponsor: Shenzhen Center for Chronic Disease Control
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Shenzhen Qilinshan Sanatorium
First posted: 2019-07-01
Enrollment: 1520
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult volunteers visiting a health examination center were randomly recruited with their consent to particiapate the study.

Brief summary: Adult subjects were recruited from a health examination center. Their fasting blood samples were collected for laboratory analyses of multiple measures including mineral, glucose, lipids, etc.


Eligibility criteria: Inclusion Criteria:

* adult volunteer
* Han population
* living in Shenzhen City for \> 2 y

Exclusion Criteria:

* caught by organic diseases
* in pregnancy

Primary outcomes:
measure: circulation concentration of glucose
timeFrame: less than 4 hours
measure: circulation concentrations of 4 types of lipids
timeFrame: less than 4 hours
measure: circulation concentrations of 5 minerals
timeFrame: less than 3 years
Secondary outcomes:
measure: body mass index
timeFrame: less than 1 month
measure: circulation concentration of 25OHD
timeFrame: less than 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03806543: The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level
Official title: The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level in Critically Ill Patients: A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vancomycin
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (age≥18 years) treated with intravenous vancomycin were included. Exclusion criteria were chronic renal dysfunction and acute renal injury patients treated with Renal Replacement therapy, VTL was not retained at steady-state, vancomycin treatment time≤48h, vancomycin dose did not meet study definitions, palliative care.

Brief summary: The aim of this study was to assess factors that may influence vancomycin trough level and the rate achieving the target trough level in critically ill patients.

Detailed description: This retrospective observational study included adult patients treated with intravenous vancomycin in intensive care unit of Zhongda Hospital from January 2015 to December 2017. Vancomycin dose was based on international consensus and adjusted according to estimated glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault equation. vancomycin trough level (VTL) was retained at steady state (after the third dose). Linear regression was performed to determine the correlation between factors prior to the first vancomycin dose and VTL. Distribution of VTL and percentage of patients achieving the target trough level (15-20mg/L) was observed in different renal function.

Eligibility criteria: Inclusion Criteria:

* Adult ICU patients (age≥18 years) treated with intravenous vancomycin were included

Exclusion Criteria:

* Chronic renal dysfunction and acute renal injury patients treated with Renal Replacement therapy
* VTL was not retained at steady-state
* Vancomycin treatment time≤48h
* Vancomycin dose did not meet study definitions
* Palliative care

Primary outcomes:
measure: Rate of patients achieving the target vancomycin trough（15-20mg/L）
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southeast University
name: Jingyuan Xu, PHD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03693443: Knowledge and Behavior Toward Early Childhood Caries
Official title: Oral Health Beliefs, Knowledge, and Behavioral Attitudes of Egyptian Mothers Towards Early Childhood Caries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Childhood Caries
Keywords: knowledge
behaviors
Early childhood caries
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Mothers are at least 18 years of age who have at least a child with minimum age of 6 years or even younger will be selected from the outpatient clinics of October University for Modern Sciences and arts, Cairo city, the capital of Egypt.

Brief summary: 400 mothers are at least 18 years of age who have at least a child with minimum age of 6 years or even younger will be selected from the outpatient clinics of October University for Modern Sciences and arts (MSA). The questionnaire will be administrated to obtain socio demographic information and to assess their oral health beliefs, knowledge, behaviors and the possible barriers for their accessing oral health care.


Eligibility criteria: Inclusion Criteria:

* mothers are at least 18 years of age who have at least a child with minimum age of 6 years or even younger

Exclusion Criteria:

* mothers are refuse to participate in the study or sign the consent

Primary outcomes:
measure: evaluation of the oral health beliefs, knowledge, and behavioral attitudes towards early childhood caries
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October University of Modern Sciences and Arts
Study officials:
affiliation: October University for Modern Sciences and Arts
name: Naglaa I Ezz El Din, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00174343: Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients
Official title: Phase II Study Evaluating The Role Of Exemestane On Clinical And Pathologic Response Rates, And Its Aromatase Activity As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 46
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)


Eligibility criteria: Inclusion Criteria:

* Post-menopausal patients with unilateral breast cancer T2 to T4, N0-1, M0, non inflammatory, operable, hormonal receptors positive

Exclusion Criteria:

* Patients with bilateral breast cancer T4d, inflammatory, non operable, hormonal receptors negative

Primary outcomes:
measure: To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)
Secondary outcomes:
measure: To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Clermont Ferrand
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Poitiers Cedex
country: France
facility: Pfizer Investigational Site
city: St. Cloud
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03896243: Serum Antimullerian Hormone Levels in Patients Who Underwent Uterine Artery Ligation
Official title: Serum Antimullerian Hormone Levels in Patients Who Underwent Uterine Artery Ligation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Artery Ligation
Ovarian Reserve
Keywords: Uterine atony
amh
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had uterine artery ligation during C-section. Control group is age-matched postpartum patients.

Brief summary: Investigators would like to see the amh values after uterine artery ligation

Detailed description: Group/cohort:

Uterine artery ligation (UAL) Investigators would like to invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.

Participants would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

Control Group:

Investigators would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication.

Participants would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

Eligibility criteria: Inclusion Criteria:

* age 18- 35 years
* no systemic or endocrine diseases
* patients who had uterine artery ligation due to atony
* healthy postpartum patients as controls

Exclusion Criteria:

* patients with PCOS

  * Pregnancy with IVF or oosit donation
  * Patients with endocrinopathy, diseases which require radiotherapy and chemotherapy etc.
  * Patients with BMI \>40

Primary outcomes:
measure: 1.ovarian reserve in patients with uterine artery ligation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT02427243: A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose
Official title: A Phase 1, Single-Dose, Randomized, Open-Label, Parallel Group Study to Assess the Relative Bioavailability and Tolerability of Two Formulations of Crenezumab in Healthy Subjects Following Subcutaneous Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female 18 to 65 years of age at Screening, inclusive
* Body mass index (BMI) 18.5 to 32 kg/m\^2, inclusive
* Body weight 50 to 100 kg, inclusive
* Females must be of non-childbearing potential
* Males of reproductive potential must agree to remain abstinent or must be using highly effective contraception and must avoid sperm donation, from Screening until at least 8 weeks after the last study drug administration or until study completion, whichever is later

Exclusion Criteria:

* Significant medical history, psychiatric disorder, or acute infection at Screening (as determined by Investigator)
* History of alcoholism or drug addiction within 6 months prior to CRU Check-in
* Use of tobacco or nicotine-containing products from 6 months prior to CRU Check-in and during the study
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred wtihin 30 days or 5 half-lives, whichever is longer, prior to CRU Check-in

Primary outcomes:
measure: Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2)
timeFrame: Day 1 through Day 85 or early termination
Secondary outcomes:
measure: Incidence, nature, and severity of adverse events
timeFrame: Consent through Day 85 or early termination
measure: Incidence of anti-therapeutic antibodies (ATAs) to crenezumab
timeFrame: From Day 1 (Predose) through Day 85 or early termination
Other outcomes:
Locations:
city: Evansville
country: United States
state: Indiana
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02155543: A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-06-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Weight at least 110 lbs

Exclusion Criteria:

* Use of contact lenses within 14 days, or planned use during the study
* Use of any ocular eye medications within 30 days, or anticipated use during the study
* Anticipated use of any artificial tears product during the study

Primary outcomes:
measure: Maximal Plasma Concentration (Cmax) of AGN-223575
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05436743: Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery
Official title: Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Sore Throat
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2022-06-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative sore throat (POST) is a fairly common side effect of general anesthesia which is caused by the mucosal injury and nerve compression associated with tracheal intubation or laryngeal mask airway device insertion. In this randomized study, the authors evaluate the effect of K-Y jelly-soaked nasopharyngeal packs on POST and postoperative nausea and vomiting in patients subjected to nasal surgery.

Detailed description: Postoperative sore throat (POST) is a fairly common side effect of general anesthesia which is caused by the mucosal injury and nerve compression associated with tracheal intubation or laryngeal mask airway device insertion. In this randomized study, the authors evaluate the effect of K-Y jelly-soaked nasopharyngeal packs on POST and postoperative nausea and vomiting in patients subjected to nasal surgery.

The present double-blinded randomized controlled study was conducted at Al-Azhar University Hospitals, Cairo, Egypt. The study protocol was approved by the local ethical committee of Al-Azhar Faculty of Medicine and all patients provided informed consent before enrollment in the study.

Eligibility criteria: Inclusion Criteria:

* Patients submitted to nasal surgery under general anesthesia.

Exclusion Criteria:

* Acute of chronic nasopharyngeal conditions,
* Gastroesophageal reflux, regurgitation,
* History of postoperative sore throat,
* nasal surgery for malignant disease,
* concurrent or recent use of systemic or topical agents used for sore throat or
* Mallampati grade more than 2.

Primary outcomes:
measure: Postoperative sore throat
timeFrame: up to 6 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University Hospitals
Study officials:
affiliation: Al-Azhar University
name: Ahmed Algarhy
role: PRINCIPAL_INVESTIGATOR
References: