louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05002920: Correlation Between Body Mass Index and Progressive Grafted Bone in Cleft Patients
Official title: Correlation Between Body Mass Index and Progressive Bone Mineral Density in Cleft Patients After Secondary Alveolar Bone Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Bone Graft; Complications
Keywords: alveolar bone grafting
body mass index
bone mineral density
cone beam computed tomography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 39
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients with unilateral and bilateral cleft lip and palate received alveolar bone graft at their 9 year of age.

Brief summary: The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. The study was to analyze the correlation between BMI and post-operative bone mineral density.

Detailed description: Although childhood obesity is a growing issue, the association between BMI and the progressive bone mineral density (BMD) in grafted tissue after secondar alveolar grafting (ABG) remains little reviewed. This study compared the correlation between BMI and the progressive BMD after ABG procedure. Thirty-nine patients with unilateral or bilateral clefts were enrolled. ABG was performed at mixed-dentition age. Patient were classified into underweight, normal weight, and overweight or obese based on age- and sex-adjusted BMI. BMD was expressed in Hounsfield unit (HU) on cone-beam computed tomography (CBCT), which was obtained at 6 months (T1) and 2 years (T2) postoperatively. Calibrated BMD (HUgrafted tissue/HUpogonion¬, BMDc) was used for further analysis.

Eligibility criteria: Inclusion Criteria:

* nonsyndromic unilateral or bilateral cleft lip and alveolus with or without palate patients
* received secondary ABG at Chang Gung Craniofacial Center
* received team managements based on our current treatment protocol for cleft lip and palate

Exclusion Criteria:

* syndromic cleft
* patients with failed grafted tissue

Primary outcomes:
measure: bone mineral density
timeFrame: post-ABG six months
measure: bone mineral density
timeFrame: post-ABG two years
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Pangyun Chou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03502720: A Personalised Percutaneous External 3D Guide for Scaphoid Fixation
Official title: Analysis of a Customized Percutaneous External Guidance System for Scaphoid Fracture Fixation Using 3D Printing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scaphoid Bone Fracture
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an Scaphoid acute fracture that requires surgery

Brief summary: The investigators want to analyse the advantages of using a 3D constructed prototype from a previous CT Scan to model an external customised guide por percutaneous Scaphoid fixation.

The investigators hypothesise that the usage of this device will shorten surgery time, radiation for the surgery team and optimise the percutaneous screw trajectory inside of the scaphoid bone.

Detailed description: To carry out this analysis the investigators will recruit 10 patients who present with an acute fracture of the Scaphoid bone type B1 and B2 (Herbert Classification).

A CT Scan will be performed and a 3D exoesqueleton model printed, previously deciding the position of the fixation screw inside of the bone and adding a cannulated sleeve in the volar aspect of the exoesqueleton to insert the initial positional guide wire for surgery.

Surgery time, surgery radiation exposure and screw positioning will be recorded and compared to 10 control patients operated following standard procedure.

Eligibility criteria: Inclusion Criteria:

* Acute scaphoid fracture (Herbert B1 B2)

Exclusion Criteria:

* Concomitant fractures

Primary outcomes:
measure: Screw Position
timeFrame: 1st day Xray
Secondary outcomes:
measure: Surgery time
timeFrame: 1st day
measure: xray exposure
timeFrame: 1st day
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporación sanitaria Parc Taulí de Sabadell
state: Barcelona
Study officials:
affiliation: Hospital parc tauli Sabadell
name: Francesc A Marcano Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03487120: Open Facet Joint Denervation in the Treatment of Low Back Pain
Official title: Open Facet Joint Denervation in the Treatment of Low Back Pain -A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Both groups had their back pain and functional limitations measured using a 10 cm visual analogue scale and the Oswestry disability index (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up clinic visit.


Eligibility criteria: Inclusion Criteria:

* aged 19 or older
* a diagnosis of spinal stenosis
* having neurogenic claudication
* complained of back pain for at least 3 months

Exclusion Criteria:

* previous surgery on their spine,
* fracture, systemic inflammatory disease,
* malignancies or an infection affecting their spine

Primary outcomes:
measure: Change in Visual analog scale for pain (VAS)
timeFrame: change from baseline score at 24 weeks
Secondary outcomes:
measure: Change in Modified Oswestry Disability score (ODI)
timeFrame: change from baseline score at 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03351920: Ventilation's Parameters Applied in Emergency Medicine. A Prospective Observational Study
Official title: Ventilation's Parameters Applied in Emergency Medicine. Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Acute Respiratory Distress Syndrome
Protective Ventilation
Survival
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician

Brief summary: To prospectively assess the mechanical ventilation management when its provided by Emergency Physicians in French Hospital, and to assess complications and outcome of these patients.

The study could be measure the proportion of patients developing an Acute Respiratory Failure Distress after a take care of by French Emergency Departments.


Eligibility criteria: Inclusion Criteria:

* Age equal or over 18 years old
* Needing a invasive or noninvasive mechanical ventilation
* Mechanical ventilation initiated in Prehospital or IntraHospital Emergency Department by an Emergency Physician

Exclusion Criteria:

- Age under 18 years old

Primary outcomes:
measure: Proportion of patients benefiting of a early low-volume ventilation initiated Emergency Department or Prehospital Care.
timeFrame: Day 1
Secondary outcomes:
measure: Proportion of patients benefiting of an early protective ventilation in Emergency Departments
timeFrame: Day 1
measure: Proportion of patients with acute respiratory distress syndrome according to the Berlin Definition during the first eight days of following.
timeFrame: from Day 1 to Day 8 and Day 28
measure: Proportion of survival from day 1 to Day 8, and to day 28
timeFrame: from Day 1 to Day 8 and Day 28
measure: Indication to mechanical ventilation in Prehospital care and Emergency Departments
timeFrame: Day 1
measure: Mechanical Ventilation Duration in Emergency Departments
timeFrame: Day 1
measure: Mechanical ventilation settings in Emergency Departments
timeFrame: Day 1
Other outcomes:
Locations:
city: Agen
country: France
facility: Pierre-Arnaud Fort
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: Pierre-Marie Noël
city: La Rochelle
country: France
facility: Paul Fievet
city: Lorient
country: France
facility: Thomas Lenormand
city: Niort
country: France
facility: CH de Niort
city: Poitiers
country: France
facility: Marjanovic Nicolas
Study officials:
References:
Clinical trial NCT01840020: BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Official title: Changes in Bioavailability of Ethanol Following Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Keywords: bariatric surgery
alcohol drinking
alcoholism
ethanol
metabolism
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-04-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: persons eligible for bariatric surgery in the Obesity policlinic, St Olavs Hospital, Trondheim, Norway

Brief summary: The first-pass metabolism (FPM) is a barrier to the toxicity of ethanol. Changes to the size and function of the stomach may alter FPM. Bariatric surgery, like the gastric bypass procedure, involves significant changes to the size and function of the stomach and leads to more rapid gastric emptying. Consequences will be faster absorption and higher peak concentration of ethanol after surgery than before. There are growing concerns that surgery for obesity in this way may cause alcohol abuse.

In this study the investigators compare changes in FPM of ethanol following two different bariatric surgical procedures.


Eligibility criteria: Inclusion Criteria:

* volunteers from Central Norway
* morbid obese BMI \> 40 kg/m2)
* morbid obese BMI \> 35 kg/m2 given a obesity related disease that qualifies for bariatric surgery

Exclusion Criteria:

* previous or current alcohol abuse
* risk for alcohol harm as assessed by AUDIT
* alcohol abstinence
* liver disease except fatty liver, which occurs in more than 50% of those who seek bariatric surgery
* previous colon resection
* not/insufficiently able to informed consent
* drugs that interact with alcohol dehydrogenase
* drugs that slow down emptying of the stomach
* pregnancy

Primary outcomes:
measure: Change in bioavailability of ethanol
timeFrame: from baseline to 3 months, 1 year, and 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Namsos
country: Norway
facility: Sykehuset Namsos
city: Trondheim
country: Norway
facility: Obesity policlinic of St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Magnus Strommen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059720: Haplo-SCT vs ASCT With or Without Decitabine in AML CR1
Official title: Haplo-mismatch Donor Stem Cell Transplantation (SCT) Versus Autologous SCT Followed or Not by Maintenance Therapy, for Patients With Acute Myeloid Leukemia (AML) in First Remission: A Chinese Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
allogeneic hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation
maintenance treatment
hematopoietic stem cell transplantation
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: European Society for Blood and Marrow Transplantation
First posted: 2014-02-11
Enrollment: 212
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: A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18y
* Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time
* Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping)
* Presence of an available haplo-mismatch related donor

Exclusion Criteria:

* Contra-indications of chemotherapy or hematopoietic stem cell transplantation
* Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor
* Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT
* No effective contraception
* Pregnant or lactating females
* Other causes which are not suitable for the trial in investigator's consideration

Primary outcomes:
measure: Leukemia-Free Survival
timeFrame: Five years
Secondary outcomes:
measure: Overall survival
timeFrame: Five years
measure: Cumulative relapse incidence
timeFrame: Five years
measure: Non-relapse Mortality
timeFrame: Five years
measure: Cumulative incidence of engraftment
timeFrame: 180 days
Other outcomes:
measure: Quality of Life
timeFrame: Five years
Locations:
city: Suzhou
country: China
facility: The Fisrt Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05043220: Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy
Official title: COVID-19-Prädiktoren: Klinische Studie Zur Sicherheit Von Gynäkologisch Onkologischen Patientinnen Unter Onkologischer Systemtherapie - CO-SI-ONKO-Studie
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Telemedicine
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.


Eligibility criteria: Inclusion Criteria:

* gynecological cancer
* indication for systemic cancer therapy
* patients who are legally competent and able to understand and follow instructions of the study staff
* present informed consent

Exclusion Criteria:

* no use if internet or applications
* persons who are in a dependency or employment relationship with the study center
* positive proof of COVID-19
* affection of the external auditory canal

Primary outcomes:
measure: Compliance
timeFrame: 3 months
measure: robustness of the ppg-signal
timeFrame: 3 months
Secondary outcomes:
measure: number of correct- and false-positive alerts
timeFrame: 3 months
measure: number of contacts and hospitalization rates
timeFrame: 3 months
measure: infections
timeFrame: 3 months
measure: therapy modifications
timeFrame: 3 months
measure: effect on quality of life
timeFrame: 3 months
measure: OS; PFS
timeFrame: 3 months
measure: health-related costs
timeFrame: 3 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Frauenklinik, Technische Universität München
Study officials:
affiliation: Technical University of Munich
name: Heike Jansen, Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Marion Kiechle, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03358420: Inflammation and Steatosis: the Role of Alpha-defensin
Official title: Inflammation and Steatosis: the Role of Alpha-defensin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammation
Fatty Liver
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending our liver unit who underwent a liver biopsy with proven fatty liver disease

Brief summary: The aim of this study is to examine the correlation between the severity of non-alcoholic steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV) positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver biopsy.


Eligibility criteria: Inclusion Criteria:

* Fatty liver disease patients with liver biopsy

Exclusion Criteria:

* None

Primary outcomes:
measure: Amplitude of immunohistochemical stain
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rami Abu Fanne, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02816320: Validity of Information Employed to Generate Standardized Mortality Ratios Using Hospital Administrative Databases (RNMH)
Official title: Validity of Information Employed to Generate Standardized Mortality Ratios Using Hospital Administrative Databases (RNMH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Condition
Obstetrical Condition
Hospitalization in Acute Care
Keywords: hospital mortality
standardized mortality ratios
patient safety
healthcare quality
hospital performance
administrative data
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 715
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A random sample of patients who were hospitalized in 24 participating hospitals during the study period.

Brief summary: In a retrospective cross-sectional study, investigators aimed to valid the variables employed to generate standardized mortality ratio from hospital administrative databases. For this purpose, investigators have compared those variables collected in administrative databases with the information available in patient medical record.


Eligibility criteria: Inclusion Criteria:

* All inpatients stays in acute care from high mortality diagnosis related groups (DRGs) registered in administrative databases of participating hospitals from January to December 2010.

Exclusion Criteria:

* Hospital participation refusal

Primary outcomes:
measure: In-hospital mortality
timeFrame: within 90 days of admission (D90)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01314820: Effects of Joint Effusion on Quadriceps Muscle
Official title: Effects of Joint Effusion on Quadriceps Muscle in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
Effusion.
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study investigated whether the presence of fluid in the joint affected peak torque and the root mean square (RMS) values of surface electromyography (EMG) in patients symptomatic for osteoarthritis (OA).

Detailed description: Several studies have shown that knee effusion influenced quadriceps muscle activity and induced quadriceps arthrogenic muscle inhibition in normal volunteers. However, the effect of joint effusion on the quadriceps of patients with OA is controversial,and few patients with OA have been included in studies of joint effusion.

Eligibility criteria: Inclusion Criteria:

* 50 years old or older with knee osteoarthritis
* knee pain without joint effusion confirmed by ultrasonography

Exclusion Criteria:

* the presence of knee joint effusion determined using US
* a history of knee injury or surgery
* a history of knee injection within 3 months
* a history of inflammatory arthritis
* taking anticoagulants
* balance or gait disturbance
* diabetes mellitus

Primary outcomes:
measure: the peak torque of the knee extensors
timeFrame: within 5 minutes after intervention
Secondary outcomes:
measure: the root mean square values of the vastus medialis and vastus lateralis muscles
timeFrame: within 5 minutes after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Study officials:
affiliation: Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
name: Jongin Lee, M.D
role: STUDY_DIRECTOR
References:
citation: Fahrer H, Rentsch HU, Gerber NJ, Beyeler C, Hess CW, Grunig B. Knee effusion and reflex inhibition of the quadriceps. A bar to effective retraining. J Bone Joint Surg Br. 1988 Aug;70(4):635-8. doi: 10.1302/0301-620X.70B4.3403614.
citation: Jones DW, Jones DA, Newham DJ. Chronic knee effusion and aspiration: the effect on quadriceps inhibition. Br J Rheumatol. 1987 Oct;26(5):370-4. doi: 10.1093/rheumatology/26.5.370.
citation: Rice D, McNair PJ, Dalbeth N. Effects of cryotherapy on arthrogenic muscle inhibition using an experimental model of knee swelling. Arthritis Rheum. 2009 Jan 15;61(1):78-83. doi: 10.1002/art.24168.