louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00602550: Bioequivalency Study of Zidovudine Under Fasting Conditions
Official title: A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory findings during screening.

Exclusion Criteria:

* Allergic or adverse responses to zidovudine or any other comparable or similar products.
* Participation in clinical trial within 30 days of study initiation.
* Positive blood screen for HIV, Hepatitis B and C.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Three day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Daniel V Freeland, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04510350: Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
Official title: Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After selection of the patients and volunteers of interest (number and type of clinical and biological data available, heterogeneity of the chosen group...), the medical and imaging data of the patients will be transmitted by OFSEP from the EDMUS database and for healthy volunteers, the data of interest will be retrieved from the ABCD-SEP database

Patients CIS+ :60 Healthy Volunters : 30

Brief summary: The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.


Eligibility criteria: Patients :

Inclusion Criteria:

* Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
* At least 18 years of age
* Diagnosed with MS according to criteria 2017 at the time of their last visit.
* Non-opposition to participation in the study
* Having had at least one visit in the year following collection
* Follow-up for at least 1 year after collection.
* Having signed the OFSEP consent

Exclusion Criteria:

* CIS patients with progressive MS

Healthy volunteers :

Inclusion Criteria:

* Age 18 years or older
* Having participated in the ABCD-SEP clinical trial promoted by the Rennes University Hospital (NCT03744351).
* Matched on age and sex to patients of interest in the OFSEP cohort
* Not having objected to participation in the study

Exclusion Criteria:

* Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty

Primary outcomes:
measure: Frequency of immune subpopulations
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of immune subpopulations correlated to EDSS score
timeFrame: 1 year
measure: Frequency of immune subpopulations correlated to disease progression delay
timeFrame: 1 year
measure: Frequency of immune subpopulations correlated to disease progression events
timeFrame: 1 year
measure: Frequency of immune subpopulations correlated to spinal lesions
timeFrame: 1 year
measure: Profiles of CIS+ patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Rennes University Hospital
name: Laure Michel, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02559050: Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia
Official title: Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arhinia
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Pohang University of Science and Technology
First posted: 2015-09-24
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A 7-year-old male patient with congenital arhinia with no history of previous treatment.

Brief summary: A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity constriction.

Detailed description: After reconstruction of a nasal cavity in the maxilla by burring using a navigation system, the patient required a nasal stent to prevent stenosis. However there was no conventional stent available. A 3D-printed silicone nasal stent was custom made for the cavity and inserted.

Eligibility criteria: Inclusion Criteria:

* Single patient
* 7-year-old male
* Congenital arhinia
* No history of previous treatment

Exclusion Criteria:

-

Primary outcomes:
measure: Nasal cavity diameter
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jung JW, Ha DH, Kim BY, Seo BF, Han HH, Kim DH, Rhie JW, Kim SW, Cho DW. Nasal Reconstruction Using a Customized Three-Dimensional-Printed Stent for Congenital Arhinia: Three-Year Follow-up. Laryngoscope. 2019 Mar;129(3):582-585. doi: 10.1002/lary.27335. Epub 2018 Sep 24.
Clinical trial NCT01858350: Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation
Official title: Comparison of the Effectiveness of Complementary and Alternative Medicine (CAM) Therapies in Pediatric Patients Undergoing Medical Resonance Imagining (MRI) Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Disorders
Keywords: CAM
Sedation
MRI
Music Therapy
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 471
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conducted a prospective open unblinded clinical four-arm evaluation of Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation. Children were assigned to active music therapy, passive music therapy, distraction therapy, and no intervention; measures included doses and numbers of sedation medications, time of sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines, before and immediately after the intervention was completed. The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (generally about 150 minutes). No further follow up was conducted.


Eligibility criteria: Inclusion Criteria:

* Children ages 1-12 years undergoing MRI studies

Exclusion Criteria:

* Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations

Primary outcomes:
measure: Need for sedation medications for MRI is reduced
timeFrame: The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (average about 150 minutes). No further follow up was conducted.
Secondary outcomes:
measure: To measure the effect of the interventions on salivary cortisol and inflammatory cytokines
timeFrame: Saliva samples were collected before the intervention and then after the MRI was performed (average about 150 minutes).
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University and Children's Hospital of Michigan
state: Michigan
Study officials:
affiliation: Wayne State University
name: Ambika MATHUR, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02071550: 10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Cholecystectomy
Keywords: laparoscopic cholecystectomy, near infrared spectroscopy, positive end expiratory pressure
Lead sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-02-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing laparoscopic cholecystectomy

Brief summary: In this study the investigators investigated changes in hemodynamic parameters and cerebral oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at the 30°head-up left side position, is compared with using two individual devices (INVOS-FORESIGHT).

Methods: Afterwards the ethics committee approval of the hospital and receiving the written patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the right side forehead region. Totally 11 evaluation periods were formed, respectively: Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10 cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data, hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.


Eligibility criteria: Inclusion Criteria:

* ASA(American Society of Anesthesiologist) class I and II
* Patients undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* ASA class III and IV
* Morbid obesity
* Emergency cases
* Cases returned to laparotomy

Primary outcomes:
measure: change in cerebral oxymetry during laparoscopy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic
Study officials:
References:
Clinical trial NCT02200250: Long Term Barrett's Endoscopic Mucosal Resection Study
Official title: Long Term Outcomes of Patients Undergoing Endoscopic Resection of Barrett's Oesophagus (BO) With High Grade Dysplasia (HGD) and Early Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Barretts Esophagus
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have or have had Barrett's Oesophagus with high grade dysplasia or adenocarcinoma.

Brief summary: Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).


Eligibility criteria: Inclusion Criteria:

* 18 years or over
* Have or have had Barrett's Oesophagus

Exclusion Criteria:

* Do not have Barrett's Oesophagus
* Have not had Barrett's Oesophagus resected at Westmead Hospital

Primary outcomes:
measure: Reviewing patients symptoms following resection
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Endoscopy Unit
state: New South Wales
Study officials:
affiliation: Western Sydney Local Health District
name: Michael J Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950650: GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus
Official title: GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-09-25
Enrollment: 1800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Insulin treated patients with diabetes (type 1 or 2), and physicians involved in the treatment, management of diabetes and care of patients with diabetes.

Brief summary: This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.


Eligibility criteria: Inclusion Criteria:

* PATIENTS WITH DIABETES:
* Age 18 years or older
* Treated with insulin
* Type 1 or Type 2 diabetes
* PHYSICIANS:
* In practice for more than 1 year since completing residency
* See a minimum number of patients with diabetes per week (primary care physicians 5, specialists 10)
* Initiate insulin treatment for patients with diabetes

Primary outcomes:
measure: Frequency of insulin omission/non-adherence
timeFrame: In the past 30 days prior to the day when responding to the survey (patient survey)
measure: Reasons for insulin omission/non-adherence reported by patient and physician
timeFrame: Day 1 (when responding to the survey)
Secondary outcomes:
measure: Impact of insulin treatment on life domains (patient survey)
timeFrame: Day 1 (when responding to the online questionnaire)
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Paris La défense cedex
country: France
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.
Clinical trial NCT01591655: Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Official title: The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Inflammation
Surgery
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 360
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 objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.


Eligibility criteria: Inclusion Criteria:

* Subjects who are candidates for routine, uncomplicated cataract surgery.
* Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
* Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

Exclusion Criteria:

* Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
* Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
* Presence of active external ocular disease: infection or inflammation of the study eye.
* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.

Primary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
timeFrame: 8 days
measure: Percentage of Participants With Grade 0 Pain
timeFrame: 8 days
Secondary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
timeFrame: 15 days
measure: Percentage of Participants With Grade 0 Pain
timeFrame: 15 days
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
timeFrame: 15 days
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.
timeFrame: 15 days
measure: Percentage of Treatment Failures
timeFrame: 8 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Quintus Ngumah, OD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05334355: Impact of a Family History of Hypertension and Physical Activity on Left Ventricular Mass
Official title: Impact of a Family History of Hypertension and Physical Activity on Left Ventricular Mass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Predisposition
Genetic Hypertension
Lead sponsor: Montclair State University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young healthy normotensive adults who are capable of self reporting family history of hypertension.

Brief summary: This is a retrospective analysis of data collected within two previous studies. The data has been combined and used to investigate the impact of having a family history of hypertension on left ventricular muscle mass with and without controlling for moderate and vigorous intensity physical activity frequency per week. The hypothesis was that in a sample of mostly active participants, no differences in left ventricular mass between family history of hypertension groups would be observed, but the positive family history of hypertension group would have elevated left ventricular mass compared to the negative family history of hypertension group following statistical control of activity frequency.

Detailed description: A positive family history of hypertension (FHH) (+FHH) is associated with elevated left ventricular mass (LVM). Regular physical activity (PA) may eliminate differences in LVM between +FHH and negative family history of hypertension (-FHH) adults. PURPOSE: To determine if a +FHH is associated with a greater LVM compared to a -FHH group within a sample of young, mostly active healthy adults with and without statistically controlling for PA. METHODS: Healthy young (18-32yrs) participants self-reported FHH status and habitual moderate and vigorous PA frequency. Participants then underwent an echocardiogram.

Eligibility criteria: Inclusion Criteria:

* Generally healthy

Exclusion Criteria:

* Known hypertension, cardiovascular disease, current pregnancy, current infectious disease, diabetes mellitus, kidney disease, a history of cancer, pulmonary disease, history of a stroke, obesity (for most people this means a body mass index greater than 30), or any life threatening chronic conditions

Primary outcomes:
measure: Left Ventricular Mass
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Montclair State University
name: Evan L Matthews, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Callaghan KN, Hosick PA, Brian MS, Matthews EL. Impact of a family history of hypertension and physical activity on left ventricular mass. J Sports Med Phys Fitness. 2023 Aug;63(8):949-956. doi: 10.23736/S0022-4707.23.14877-8. Epub 2023 May 9.