louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02467712: Fungal Infection on a Joint Prosthesis
Official title: Change in Joint Prosthesis in One Step Due to Fungal Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fongal Infection
Keywords: Fongal infection
joint prosthesis
prosthetic reconstruction
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years having surgery for the management of fungal infection after change in one step in joint replacement prothesis in the participating services in 2014.

Brief summary: It is generally accepted that the fungal infection on a joint prosthesis is to be treated in two surgical time: implant removal and prosthetic reconstruction. The service took the option for over 10 years to treat bacterial infections in joint replacement by a change in time. In four recent cases the diagnosis initially suspected of bacterial infection has been restated on intraoperative bacteriological examinations fungal infection. It is therefore a potentially harmful side effect of the chosen treatment option, but 4 patients in question were all cured of their fungal infection after a postoperative antifungal therapy. The objective of this study is to report these cases for discussion on the therapeutic choices in fungal infections on joint replacement.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patient having surgery for the management of fungal infection after change in one step in joint replacement prothesis in the participating services in 2014.

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: Fungal infection
timeFrame: for the duration of hospital stay, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jean-Yves JENNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111812: Prediction of Weight Gain by Children and Adolescents
Official title: Prediction of Weight Gain by Children and Adolescents That Participate in a Multi-disciplinary Intervention Program for Treatment of Overweight and Obese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Keywords: overweight
obese
children
weighing
weight
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 530
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: overweight and obese children and adolescence, boys and girls, ages 5-18

Brief summary: The 'Meir children's sport and health center' runs a multi-disciplinary intervention program for the treatment of overweight and obese children and adolescents. The program includes physical activity, dietary guidelines, medical supervision and behavioral treatment. The participants are routinely weighed once a week, at the same day and time, in order to supervise their progress. According to our experience, the child can predict his weight change, based on his "behavior" in the previous week. To our knowledge the overweight/obese child's ability to predict his weekly weight change, while participating in a multi-disciplinary intervention program, has never been tested.

Detailed description: The aim of this study is to examine whether a child participating in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center, can predict his weight change during intervention before the actual weighing.

This study will include 1000 weight measurements of children and adolescents, boys and girls, ages 5-18 years. A patient might be measured several times.

The data will be collected during 6 mounts. in this period the program participants will be asked, discretely, before being weighed if, in there opinion, they had lost or gained weight in the past week, and how mach and why.

Eligibility criteria: Inclusion Criteria:

* Overweight and obese children and adolescence
* Boys and girls
* Ages 5-18
* That taking pat in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center

Primary outcomes:
measure: Participants will be able to predict their weight change
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: 'Meir children's sport and health center'
Study officials:
References:
Clinical trial NCT02157012: Evaluation of the Condition of Rheumatoid Arthritis After Treatment
Official title: Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Shinshu University
Sponsor class: OTHER
Collaborators: name: Showa Inan General Hospital
First posted: 2014-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis

Exclusion Criteria:

* Other connective tissue disease

Primary outcomes:
measure: Change from baseline of clinical evaluation in rheumatoid arthritis
timeFrame: Every month
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Every month
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
Clinical trial NCT02783612: Digital Glucose Monitoring in Gestational Diabetes
Official title: Improvement of Compliance by Digital Blood Glucose Monitoring of Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-05-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Assessing blood glucose control in women with gestational diabetes can be challenging. The standard of care remains visual inspection of blood glucose paper diaries of self-performed capillary monitoring during regular meeting in High Risk pregnancy clinics.

The researchers are interested in preforming a randomized control trial comparing women with the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital monitoring using an application in a Smart-phone and submitting those values via email in addition to the regular clinic appointments.

The Primary outcome of the trial is to assess the compliance of the research group as compared to the control group.


Eligibility criteria: Inclusion Criteria:

* gestational diabetes

Exclusion Criteria:

* pre-gestational diabetes

Primary outcomes:
measure: Assessing the compliance of the research group compared to the control group.
timeFrame: 18 month
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson medical center
Study officials:
References:
Clinical trial NCT04503512: Surgical Excision of the Fat Pad
Official title: Effect of Excision of the Fat Pad in Total Knee Replacement Surgery. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-08-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction:

The infrapatellar fat pad (Hoffa's fat pad) is a structure which is located intra-articularly. Its function is not well known. During knee replacement surgery, some surgeons would prefer removing the whole of the fat pad as this can improve exposure of the knee joint, as it can affect exposure of the knee joint which will in turn make the procedure slightly more efficient. Other surgeons would rather resect the minimum amount and preserve the bulk of the structure as anecdotally this is thought to decrease the level of post operative pain. This surgical step fat pad resection is a very small part of the whole total knee replacement procedure.

A previous retrospective review of patients whose fat pad had been removed showed that they were nearly twice as likely to experience postoperative pain (P = 0.0005), while another study showed that they are at a slight risk of patellar tendon shortening.

A randomised controlled trial of 68 patients did not show any difference in patella tendon length at six months and no difference in pain relief in both groups 3. However this study did not evaluate the functional outcome in both groups.

To our knowledge, there are no RCT looking at the effect of the excision or preservation of the fat pad in TKR and the functional outcomes post operatively.

Study Hypothesis:

Excision of Hoffa's fat pad during total knee replacement surgery does not affect functional outcome, pain level after surgery or the patella tendon length at either one or two years.

Detailed description: RCT of excision or preservation of fat pad in TKR and the functional outcomes post operatively

Eligibility criteria: Inclusion Criteria:

* 1- Primary total knee replacement for knee osteoarthritis

Exclusion Criteria:

1. Revision Surgery.
2. Primary Knee Replacement for pathologies other than Osteoarthritis.
3. Previous knee fractures around the knee.
4. Previous confirmed intra-articular infections.
5. Non English speaking/reading patients.

Primary outcomes:
measure: Koos Knee Score
timeFrame: 3 months post op,
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Broadgreen Hospital
Study officials:
affiliation: Liverpool University Hospitals NHS Foundation Trust
name: A Howard
role: STUDY_DIRECTOR
References:
Clinical trial NCT02199912: Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery
Official title: ANC2 Pilot Study Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Tumor
Keywords: cachexia
nutrition
cancer
colorectal tumor
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 59
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Cachexia associated with cancer is a grave and most of the time irreversible common situation. It seems independent from the size of the tumor or from its metastatic character. The consequences for the management of the patient are major and exceed widely the frame of the nutrition.

Undernutrition of patients with cancer is described by a decrease of the energy contributions and a loss of muscular and fat mass, leading to a progressive functional deficiency which can go to the cachectic state.

Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia but it remain too indistinct to allow an early and efficient screening and set up effective measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast iron of the energy reserves.

It is necessary to have clinical and biological markers with diagnostic aim and forecasts during the situations precedents the appearance of cachexia.

The present study will allow calibrating a longitudinal study, which could confirm the value of measures made for the diagnosis of pre-cachexia.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 70 years
* Colorectal tumor resection with/without synchronous metastases

Exclusion Criteria:

* Emergency resection of colorectal tumor
* Unresectable colorectal tumor with/without synchronous metastases

Primary outcomes:
measure: biological and radiological markers
timeFrame: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
Secondary outcomes:
measure: activity of the ATGL
timeFrame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
measure: Body composition
timeFrame: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
measure: metabolic phenotype
timeFrame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
measure: loss of fat body mass and/or lean body mass
timeFrame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Groupement Hospitalier Sud - Service de Médecine Gériatrique
Study officials:
References:
Clinical trial NCT04196712: Essen Coronary Artery Disease Registry
Official title: Essen Coronary Artery Disease Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 55000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This registry includes all consecutive patients undergoing invasive coronary angiography at the West German Heart and Vascular Center, starting from 2003.

Brief summary: The ECAD registry is a registry of patients undergoing coronary angiography at the West German Heart and Vascular Center. The registry anticipates to determine predictors of patient outcome after coronary angiography.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing invasive coronary angiography at the West German Heart and Vascular Center

Exclusion Criteria:

* None

Primary outcomes:
measure: All-cause mortality
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
affiliation: University Hospital Essen, Deparment of Cardiology and Vascular Medicine
name: Tienush Rassaf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00641446: Varicella Vaccination With Pulmicort
Official title: Rates of Seroconversion Following Varicella Vaccination of Asthmatic Children Between the Ages of One and Eight Years Treated With Pulmicort Respules® Versus Non-Steroidal Conventional Asthma Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Children
Asthma
Varivax
varicella
Pulmicort
budesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 250
Sex: ALL
Minimum age (years): 10
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine


Eligibility criteria: Inclusion Criteria:

* Children between the age of 10 months and 8 years,
* have asthma or shown recent signs suggesting asthma,
* have a parent or guardian willing to comply with study requirements

Exclusion Criteria:

* Varicella zoster immune globulin (VZIG) within 5 months prior to immunization,
* Previous varicella immunization,
* an immunization or allergy immunotherapy 4 weeks prior to immunization,
* Severe asthma,
* have another persistent lung disease,
* have a planned hospitalization for the duration of study

Primary outcomes:
measure: Seroconversion level
timeFrame: Week 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca employee
name: Bertill Andersson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02575846: Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
Official title: Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroschisis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 4
Sex: ALL
Minimum age (years): 2
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis.


Eligibility criteria: Inclusion Criteria:

* 1) neonates born with gastroschisis
* 2) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study

Exclusion Criteria:

* 1) associated anomaly or medical concern that impacts hospital length of stay (i.e. intestinal atresia, very low birth weight(\<1500 grams))
* 2) known major chromosomal abnormality

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: One month
Secondary outcomes:
measure: Time to Full Enteral Feeds
timeFrame: Three weeks
measure: Time on Total Parenteral Nutrition
timeFrame: Three weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Obinna O Adibe, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohler JA Sr, Perkins AM, Bass WT. Human milk versus formula after gastroschisis repair: effects on time to full feeds and time to discharge. J Perinatol. 2013 Aug;33(8):627-30. doi: 10.1038/jp.2013.27. Epub 2013 Mar 21.
citation: Sydorak RM, Nijagal A, Sbragia L, Hirose S, Tsao K, Phibbs RH, Schmitt SK, Lee H, Farmer DL, Harrison MR, Albanese CT. Gastroschisis: small hole, big cost. J Pediatr Surg. 2002 Dec;37(12):1669-72. doi: 10.1053/jpsu.2002.36689.
citation: Mastromarino P, Capobianco D, Campagna G, Laforgia N, Drimaco P, Dileone A, Baldassarre ME. Correlation between lactoferrin and beneficial microbiota in breast milk and infant's feces. Biometals. 2014 Oct;27(5):1077-86. doi: 10.1007/s10534-014-9762-3. Epub 2014 Jun 27.
citation: Gomez-Llorente C, Plaza-Diaz J, Aguilera M, Munoz-Quezada S, Bermudez-Brito M, Peso-Echarri P, Martinez-Silla R, Vasallo-Morillas MI, Campana-Martin L, Vives-Pinera I, Ballesta-Martinez MJ, Gil A. Three main factors define changes in fecal microbiota associated with feeding modality in infants. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):461-6. doi: 10.1097/MPG.0b013e31829d519a.
Clinical trial NCT05075746: Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
Official title: Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2021-10-13
Enrollment: 302
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: The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL in patients with pre-op corneal astigmatism \<1.0D. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.

Brief summary: The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.

Detailed description: The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.

This is a retrospective chart review for preoperative and postoperative data conducted at least 4 weeks after IOL implantation.

Eligibility criteria: Inclusion Criteria:

* Males and Females subjects age 18 or older on the date of surgery
* Implant of enVista Toric IOL and/or enVista non-Toric (spherical) IOL in at least one eye
* Data available at least 4 weeks after IOL implantation
* Eyes must qualify for the 0.9D toric lens based on the Barrett Toric Calculator (flipped axis must be less than 0.2D) (https://ascrs.org/tools/barrett-toric-calculator)

  * Study eyes were implanted with the 0.9D toric lens
  * Control eyes were not implanted with the 0.9D toric lens and implanted with a spherical (non-toric) equivalent instead

Exclusion Criteria:

* History of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) before the surgery (e.g., dry eyes, retinal pathology, etc.)
* BCDVA of 20/25 or worse for the treated eye(s) after the surgery
* Excessive IOL rotation \> 10 degrees (Toric IOLs only) for the treated eye(s) after the surgery

Primary outcomes:
measure: Mean Reduction in Cylindrical Power of the Eye
timeFrame: 4 weeks after IOL implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Bausch Site 01
state: Alberta
city: Langley
country: Canada
facility: Bausch Site 03
state: British Columbia
city: Toronto
country: Canada
facility: Bausch Site 02
state: Ontario
Study officials:
affiliation: Bausch Health
name: Anya Loncaric
role: STUDY_DIRECTOR
References: