louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01493375: Surgical Field Bacterial Contamination in Primary Total Hip (THA) and Knee (TKA) Arthroplasty
Official title: Surgical Field Bacterial Contamination in Primary Hip and Knee Replacement Surgery
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Prosthetic Infections
Keywords: Contamination, hip operation, knee operation
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: University of Aarhus
name: Aalborg University
First posted: 2011-12-16
Enrollment: 60
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: Patients from Northern Orthopaedic Division, Clinic Frederikshavn.

Brief summary: In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection is a very serious condition and despite extensive prophylactic measures, prosthetic infections appear in 1-2 percent of the operated patients.

It is difficult to diagnose prosthetic infection with the techniques applied so far and incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections might lead to prolonged pain and invalidity.

The purpose of this study is to examine the value of these three techniques applied as a supplement to the existing technology and on this basis to prepare an algorithm for the examination of joint prosthesis infection.


Eligibility criteria: Inclusion Criteria:

* Patients who have been through an alloplastic operation in hip og knee.

Exclusion Criteria:

* Patients with cancer or a bilateral disease
* Former patients who have been through an operation with implants in hip or knee.
* Patients who might be infected in the joint due to operation in hip or knee.
* Lack of informed consent or inability to read/understand Danish

Primary outcomes:
measure: Contamination of the operation area
timeFrame: 12 months
Secondary outcomes:
measure: Description of the bacterial culture
timeFrame: 12 months
Other outcomes:
Locations:
city: Frederikshavn
country: Denmark
facility: Northern Orthopaedic Division, Clinic Frederikshavn
state: Northern Jutland
Study officials:
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital
name: Eileen Kohler, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Orthopaedic Division, Aalborg University Hospital
name: Sten Rasmussen, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02920775: Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Related Disorders
Opiate Addiction
Narcotic Abuse
Drug Abuse
Lead sponsor: ER/LA Opioid REMS Program Companies (RPC)
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 360000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects filling a prescription for a product of interest as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™

Brief summary: Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could have greater impact on prescribing (e.g., dentists). Trends and changes in monthly prescription volume and average monthly prescription volume will be evaluated by prescriber specialty.


Eligibility criteria: Inclusion Criteria:

* Changes in number of prescriptions for prescriber types with less or more compelling reasons to prescriber ER/LA opioid analgesics

Exclusion Criteria:

* None

Primary outcomes:
measure: Monthly volume of prescriptions by specialty
timeFrame: July 2010-December 2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01183975: Swedish Adjustable Gastric Banding Observational Cohort Study
Official title: Prospective National Cohort Study on Swedish Adjustable Gastric Band (SAGB) for Gastroplasty (Étude de Cohorte Nationale Prospective de l'Implant Annulaire Ajustable Pour Gastroplastie SAGB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Lead sponsor: Ethicon Endo-Surgery (Europe) GmbH
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 517
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: The study population is that of morbidly obese patients currently treated in France by gastroplasty (gastric banding with an SAGB). The CEPP notices define the indications in which this treatment is covered by health insurance.

Brief summary: Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.

Verification by means of a screening log (exhaustive list of all bariatric procedures performed by participating surgeons between the beginning and end of the cohort inclusion period) requested from all centers.

No comparator group. No randomization or blinding techniques

Detailed description: Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.

The study is originated in collaboration with HAS in France and has a target of 500 patients treated with gastric banding because of morbid obesity.

Eligibility criteria: Inclusion Criteria:

* morbidly obese patients (BMI\>35 with comorbidities or BMI\>40 without comorbidities) in France selected for gastric banding based on standard local clinical practice

Exclusion Criteria:

* lower BMI, contraindications based on local clinical assessment

Primary outcomes:
measure: Mean BMI Change
timeFrame: 3 years follow-up
measure: Mean Excess Weight Change
timeFrame: 3 years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Rillieux-La-Pape
country: France
facility: Polyclinique Rillieux
Study officials:
affiliation: Ethicon Endo-Surgery (Europe) GmbH
name: Goran Ribaric, MD,MSC,PhD
role: STUDY_DIRECTOR
References:
citation: Ribaric G, Buchwald J. Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients. Croat Med J. 2014 Aug 28;55(4):405-15. doi: 10.3325/cmj.2014.55.405.
Clinical trial NCT05150275: Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy
Official title: Retrospective Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hysterotomy
Keywords: Hysterotomy
vNOTES
Laparoscopy
Vaginal route
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021

Brief summary: vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route.

The aim of the research is to analyze postoperative pain


Eligibility criteria: Inclusion criteria:

* Adult woman (≥18 years old)
* Woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021
* Woman who did not express her opposition to the reuse of her data for the purposes of this research.

Exclusion criteria:

* Woman who expressed her opposition to participating in the study
* Surgical procedure associated with hysterectomy

Primary outcomes:
measure: Analysis of postoperative pain in patients who have had a vaginal hysterectomy
timeFrame: Files analysed retrospectively from January 01, 2017 to May 31, 2021 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de chirurgie gynécologique - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
name: Olivier GARBIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05340075: Staged Bilateral Percutaneous Nephrolithotomy
Official title: Staged Bilateral Percutaneous Nephrolithotomy: When to Operate for a Contralateral Kidney?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stone, Kidney
Urolithiasis
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stones of 2 cm or more in each kidney

Brief summary: To determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. Patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared.

Detailed description: The aim of the study is to determine the optimal time between the first and second operations in patients with bilateral kidney stones and scheduled percutaneous nephrolithotomy for the contralateral kidney. In our study, patients who underwent percutaneous nephrolithotomy to the contralateral kidney 2-4 weeks and 4-6 weeks after the first operation will be compared. With the guidance of preoperative and postoperative data, it is aimed to determine the optimal time with the lowest complication and highest operational success.

Eligibility criteria: Inclusion Criteria:

* Patients with stones of 2 cm or more in each kidney

Exclusion Criteria:

* Renal Failure
* Coagulopathy
* Pregnancy

Primary outcomes:
measure: BMI in kg/m^2
timeFrame: 3 Months
measure: rates of intraoperative blood transfusion, operation time(minute)
timeFrame: 3 Months
Secondary outcomes:
measure: mm size of the stone,
timeFrame: 3 Months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
state: Altindag
Study officials:
References:
citation: Wollin DA, Preminger GM. Percutaneous nephrolithotomy: complications and how to deal with them. Urolithiasis. 2018 Feb;46(1):87-97. doi: 10.1007/s00240-017-1022-x. Epub 2017 Nov 17.
citation: ElSheemy MS, Ghoneima W, Elmarakbi AA, Al-Kandari AM, Ibrahim H, Shrestha S, Khadgi S. Bilateral Single-session vs Staged Mini-percutaneous Nephrolithotomy for Renal Stones: A Comparative Study. Urology. 2018 Oct;120:62-67. doi: 10.1016/j.urology.2018.07.015. Epub 2018 Jul 20.
citation: Torricelli FCM, Carvalho RS, Marchini GS, Danilovic A, Vicentini FC, Batagello CA, Srougi M, Nahas WC, Mazzucchi E. Bilateral simultaneous percutaneous nephrolithotomy versus staged approach: a critical analysis of complications and renal function. Rev Assoc Med Bras (1992). 2020 Dec;66(12):1696-1701. doi: 10.1590/1806-9282.66.12.1696.
Clinical trial NCT00566475: School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
Official title: School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: New York State Department of Health
name: Children's Miracle Network
First posted: 2007-12-03
Enrollment: 41
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if using school-based telemedicine for diabetes support and education in students with type 1 diabetes in grades K-8 can lead to improvement in control of diabetes and improved satisfaction of all caregivers.

Detailed description: Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included medical visits every 3 months and communication between school nurse and diabetes team as needed by phone. The intervention group received usual care plus a telemedicine unit in the school nurse office to videoconference between the school nurse, child, and diabetes team every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1 year. Analyses used multilevel modeling.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes under care of Joslin Diabetes Center in Syracuse NY
* Grade K-8
* Age 5-14 at time of enrollment
* Consent of student, parent and school

Primary outcomes:
measure: hemoglobin A1c
timeFrame: 1 year
Secondary outcomes:
measure: glucose levels, hypoglycemia, quality of life, satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Ruth S Weinstock, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York - Upstate Medical University
name: Roberto E Izquierdo, MD
role: STUDY_DIRECTOR
References:
citation: Izquierdo R, Morin PC, Bratt K, Moreau Z, Meyer S, Ploutz-Snyder R, Wade M, Weinstock RS. School-centered telemedicine for children with type 1 diabetes mellitus. J Pediatr. 2009 Sep;155(3):374-9. doi: 10.1016/j.jpeds.2009.03.014. Epub 2009 May 21.
Clinical trial NCT04946175: National Survey Among Egyptian Pain Practitioners
Official title: The Rate of Interventional Pain Procedures During Covid 19: A National Survey Among Egyptian Pain Practitioners
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Survey
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: registered pain practitioners in Egypt.

Brief summary: Coronavirus pandemic health restrictions has deleteriously affected the rates of all interventional procedures even for emergency cases. This study tried to evaluate the impact of the outbreak of SARS-CoV-19 infection on rates of interventional pain therapy (IPT).

Detailed description: Background: Coronavirus pandemic health restrictions has deleteriously affected the rates of all interventional procedures even for emergency cases. This study tried to evaluate the impact of the outbreak of SARS-CoV-19 infection on rates of interventional pain therapy (IPT).

Methods: Setting: Multicenter Study. Design: Prospective observational study, approved by the Local Ethical Committee (RC:2-1-21). Materials: Two 20-item questionnaires with five choices for probable answer using a Likert-5 point scale were constructed as self-assessment questionnaire. The questionnaires were uploaded to the Google drive, and the links and identification codes were sent using the WhatsApp to 500 IPT providers. The feedback answers were scored and statistically analyzed. Statistical analyses will be performed using IBM® SPSS® Statistics (Version 22, 2015; Armonk, USA) for Windows statistical package. P value \<0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

registered pain practitioners in Egypt.

-

Exclusion Criteria:

Non registered pain practitioners

Primary outcomes:
measure: number of interventional pain procedures
timeFrame: June 1st 2020 till June 1st 2021
Secondary outcomes:
measure: wearing protective clothing
timeFrame: june 1st 2020 to june 1st 2021
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University Hospitals
state: Qina
city: Qinā
country: Egypt
facility: South Valley University
Study officials:
References:
Clinical trial NCT00443170: A Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Oral GSK626616AC in Healthy Subjects
Official title: A Randomized, Blinded, Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Single and Repeat Dose Escalation of the Oral YAK3/DYRK3 Inhibitor GSK626616AC in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Anaemia
Keywords: repeat dose,
GSK626616AC,
pharmacokinetic,
single dose,
cytochrome P450,
First time in human,
healthy volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 55 years healthy subjects
* Hemoglobin values of 13.5-17.0 g/dL for males or 12.0-15.5 g/dL for females.
* Females cannot be pregnant.

Exclusion Criteria:

* Cannot have exposure to greater than 4 new chemical entities within 12 months.
* Cannot have a clinical history of current alcohol, or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule.
* Cannot have a history of regular use of tobacco- or nicotine-containing products within 3 months.
* Must not have received a blood transfusion or had a donation of blood within 3 months prior to study entry.
* Cannot use be taking prescription, non-prescription or illicit drugs.

Primary outcomes:
measure: adverse events at end of each cohort
timeFrame: end of each cohort
measure: hematology/chemistry/urinalysis at end of each cohort
timeFrame: end of each cohort
measure: physical examination at end of each cohort
timeFrame: end of each cohort
measure: vital signs and electrocardiogram (ECG) at end of each cohort
timeFrame: end of each cohort
Secondary outcomes:
measure: GSK626616 pharmacokinetics at end of each cohort
timeFrame: end of each cohort
measure: hemoglobin at end of each cohort
timeFrame: end of each cohort
measure: red blood cell measurements at end of each cohort
timeFrame: end of each cohort
measure: estimates of CYP enzyme activity at end of study
timeFrame: end of study
measure: mRNA levels in peripheral blood at end of study
timeFrame: end of study
Other outcomes:
Locations:
city: Randwick, Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05004870: Home Examinations Researching and Understanding Submucosal Evaluations
Official title: Home Examinations Researching and Understanding Submucosal Evaluations: Prospective, Virtual Study to Demonstrate Sensitivity of Submucosal Fibroids on At-home Ultrasound (Follow up to SELF-HELP Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fertility Issues
Lead sponsor: Turtle Health, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to generate further data for sensitivity. This will be a single visit study, with participants scanning themselves at home with healthcare professional (HCP) supervision. Targeted population is women with previously diagnosed submucosal fibroids that have not been removed. The study will be single-blinded to the image raters.


Eligibility criteria: Inclusion Criteria:

* Women with one or more submucosal fibroid, with appropriate attestation (see more detail below)
* Women between the ages of 18 and 49 inclusive (women 38 and younger can also receive their antral follicle count, or AFC; 39 and older will participate in uterine scanning only)
* Women with BMI up to 40
* Women located in states where the PI or sub-PI licensure is valid
* Women able to freely give consent electronically, given COVID. For the purposes of this study, this is defined as women who speak native or fluent English; and have a high school degree or equivalent, and who are otherwise, in the professional judgement of the PI, able to give informed consent

Exclusion Criteria:

* Women with expert ultrasound experience, e.g., ultrasound technologists, radiologists, OB/GYNs, Reproductive Endocrinologists
* Women with BMI over 40
* Women who do not speak English natively or fluently
* Women who have recently given birth, and have had fewer than 3 postpartum menstrual cycles
* Women who have recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles
* Women who are currently pregnant or may be pregnant
* Any woman the PI believes is not capable of giving independent, informed consent
* Turtle Health employees

Primary outcomes:
measure: Sensitivity of the at-home ultrasound for submucosal fibroids
timeFrame: Up to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Virtual metasite
state: Massachusetts
Study officials:
References: