louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00723463: Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissue
Official title: Retrospective - Prospective - Study to Determine if Apparent Diffusion Coefficient (ADC) Values Can Differentiate Tumors From Normal Tissues at 3T MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Brain Cancer
Neck Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine normal measurements (ADC values) from the head and neck of healthy volunteers using 3T MRI.

Detailed description: The purpose of this study is to determine normal measurements (ADC values) from the head and necks of healthy subjects using 3T MRI.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects 18 years of age or older.

Exclusion Criteria:

* Under 18 years of age
* Women of child bearing potential
* Pregnant or lactating women
* All potential volunteers will be pre-screened by MRI personnel to determine if there is any medical reason that you should not be included in this study.

Primary outcomes:
measure: To determine if ADC values determined at 3T are different between normal tissues and tumors arising from the extracranial head and neck.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ashok Srinivasan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06187363: Redo Repair in Disrupted Hypospadias
Official title: Tubularized Incised Plate (TIP) Procedure Versus Other Procedures in the Repair of Disrupted Hypospadias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypospadias
Keywords: Hypospadias
Redo repair
Disruption
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2024-01-02
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty patients were included in our study; all of them have disrupted repair of hypospadias. Half of those patients were treated by TIP procedure and the other half were treated by other procedures

Brief summary: Redo hypospadias repair is a challenging situation and its success depends on many factors. Several procedures could be used in such situations with variable outcomes. The investigator in this study aimed at comparing the results of these procedures

Detailed description: Purpose: Our study compared the outcome of the tubularized incised plate urethroplasty procedure and other procedures in the case of redo hypospadias repair. Methods: The participants were categorized into those who were treated by the tubularized incised plate procedure (Group A) and those who were treated by other procedures (Group B) and the collected data were compared between the two groups. The patients were examined regularly during the postoperative period for urethral-cutaneous fistula, meatal stenosis, penile curvature, penile skin coverage, and re-disruption.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with disrupted hypospadias repair

Exclusion Criteria:

* Fresh cases of hypospadias

Primary outcomes:
measure: The number of participants who developed post-operative meatal stricture
timeFrame: at 1 month, 3 months, 6 months, and at the end of the 1st year
measure: The rate of development of recurrent post-operative chordae
timeFrame: at 1 month, 3 months, 6 months, and at the end of the 1st year
measure: The incidence of development of postoperative penile skin scarring
timeFrame: at 1 month, 3 months, 6 months, and at the end of the 1st year
measure: The incidence of the development of failed repair as discovered by the position of the neo-meatus
timeFrame: at 1 month, 3 months, 6 months, and at the end of the 1st year
measure: The incidence of the development of post-operative urethral-cutaneous fistula
timeFrame: at 1 month, 3 months, 6 months, and at the end of the 1st year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Pediatric Surgery department
name: Ahmed Elrouby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05519163: A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients.
Official title: A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients: A Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Keywords: Diabetes Mellitus, Type 2
Diabetic Foot
Predictive model
cohort study
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 6301
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2016 and December 31, 2021.

Brief summary: A retrospective cohort study was constructed based on hospitalized patients with type 2 diabetes, aiming to explore the related factors for new-onset diabetic foot and conducted a robust prediction model by Cox proportional hazards model.

Detailed description: Diabetic foot is an infection of lower extremity, ulceration and/or deep tissue damage due to neuropathy and varying degrees of vascular disease in diabetic patients, including diabetic foot ulcerations or infections. Diabetic foot can lead to adverse consequences such as amputation and death,which seriously endangering the physical and mental health and quality of life for patients. Early identification of risk factors for diabetes foot is useful to reduce the risk of hospitalization, amputation or even mortality.

Most prediction models for diabetic foot focus on recurrent diabetic foot, however there is little published information on new-onset diabetic foot. This study aims to conduct a retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform and build a prediction model for the new-onset diabetic foot using the related risk factors, which is of guidance significance for clinical prevention and treatment of diabetic foot.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of type 2 diabetes
2. Hospitalized patients
3. The interval between two records is more than one year

Exclusion Criteria:

1. Any history of ulcer or amputation previously
2. The patients with type 1 diabetes
3. Pregnant during the study
4. Patients with malignant tumors
5. Complicated with serious organ dysfunction, such as heart, liver and kidney

Primary outcomes:
measure: New-onset diabetic foot
timeFrame: through study completion, an average of 32 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
name: Wang Yibing, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01922063: Physiotherapy Following Disc Surgery: Long Term Follow-up of a RCT
Official title: Long Term Follow-up of Comprehensive Physiotherapy Following Disc Herniation Operation: Results of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intervertebral Disc Displacement
Keywords: disc herniation surgery
physiotherapy, exercise therapy
randomized
long term
follow up
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained from survivors of disc surgery that would have considered the type of postoperative care.

Objectives: 1) To evaluate the long-term effects of postoperative comprehensive physiotherapy starting 1 week after lumbar disc surgery. 2) To assess the relative risk of segmental instability in the operated segment 12 years following lumbar disc surgery.

Detailed description: Design: Twelve years' follow-up of a three-armed, randomized, controlled, single blinded clinical trial. Setting: Outpatient department of Physical Medicine \& Rehabilitation. Participants: Of 120 patients following first-time, uncomplicated lumbar disc surgery who participated in the original study are invited to a 12 years follow-up examination. Interventions: In the original study, patients had been randomly assigned to "comprehensive physiotherapy", "sham intervention" (neck massage), or no therapy. Measurements: Low Back Pain Rating Score (LBPRS; Manniche 1993), functional X-rays of the lumbar spine. All data are collected by blinded students and physicians at the Department of PM\&R, Vienna Medical University.

Eligibility criteria: Inclusion Criteria:

* all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had completed the treatment originally allocated
* all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had not completed the treatment originally allocated

Exclusion Criteria:

* n.a.

Primary outcomes:
measure: Low back pain rating scale (LBP-RS)
timeFrame: 12 years after Randomization
Secondary outcomes:
measure: Satisfaction with treatment
timeFrame: 12 years
measure: Use of health care resources
timeFrame: 12 years
measure: Psychological questionnaires
timeFrame: 12 years
Other outcomes:
measure: X Rays
timeFrame: 12 years
Locations:
city: Vienna
country: Austria
facility: Dept Physical Medicine & Rehabilitation, MUV, AKH
Study officials:
affiliation: Medical University of Vienna
name: Gerold Ebenbichler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03225963: Application of Proteome Profiler Antibody Arrays to Find Angiogenetic Predictors in Glioma Paitents.
Official title: Application of Proteome Profiler Antibody Arrays to Find Angiogenetic Predictors in Glioma Paitents.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma Multiforme
Angiogenesis
Keywords: Glioblastoma
Bevacizumab
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obtain peripheral blood pre-chemotherapy, mid-chemoradition and post-chemoraidtion

Brief summary: Bevacizumab has become the standard of care of recurrent glioblastoma based on promising clinical trial results with with response rates up to 50% and progression-free survival up to 9 months. In our study, we set to find the serum angiogenesis biomarkers of bevacizumab response.

Detailed description: Pre-chemoradiation and post-chemoradiation peripheral blood will be obtained to see if there are some angiogenesis biomarker available for prediction of bevacizumab response later.

Eligibility criteria: Inclusion Criteria:

* Age older than 20 year old.
* Glioblastoma patients who will receive chemoradiation treatment.

Exclusion Criteria:

* None

Primary outcomes:
measure: Response of bevacizumab therapy.
timeFrame: 3 months after bevacizumab therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: The Institutional Review Board of Taichung Veterans General Hospital
name: Weir Chiang You, M.D. Ph.D.
role: STUDY_CHAIR
References:
citation: Lamszus K, Ulbricht U, Matschke J, Brockmann MA, Fillbrandt R, Westphal M. Levels of soluble vascular endothelial growth factor (VEGF) receptor 1 in astrocytic tumors and its relation to malignancy, vascularity, and VEGF-A. Clin Cancer Res. 2003 Apr;9(4):1399-405.
citation: Reynes G, Vila V, Martin M, Parada A, Fleitas T, Reganon E, Martinez-Sales V. Circulating markers of angiogenesis, inflammation, and coagulation in patients with glioblastoma. J Neurooncol. 2011 Mar;102(1):35-41. doi: 10.1007/s11060-010-0290-x. Epub 2010 Jul 6.
Clinical trial NCT01876563: the Effect of Vitamin D on the Serum Thioredoxin, TBP-2, Thioredoxin Reductase, Gene Expression of TBP-2 in Patients With Type II Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: thioredoxin
TBP-2
thioredoxin reductase
vitamin D
DIABETES
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the comparision between the effects of vitamin D or placebo supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase activity in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -

Exclusion Criteria:

people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers

-

Primary outcomes:
measure: serum total cholesterol
timeFrame: change from baseline at 2 months
measure: serum HDL cholesterol
timeFrame: change from baseline at 2 months
measure: serum triglycerides level
timeFrame: change from baseline at 2 months
measure: fasting plasma glucose
timeFrame: change from baseline at 2 months
measure: serum LDL cholesterol
timeFrame: change from baseline at 2 months
measure: complete blood count (CBC)
timeFrame: change from baseline at 2 months
measure: HbA1c
timeFrame: change from baseline at 2 months
measure: serum insulin
timeFrame: change from baseline at 2 months
measure: serum calcidiol
timeFrame: change from baseline at 2 months
measure: thioredoxin
timeFrame: change from baseline at 2 months
measure: thioredoxin binding protein 2 (TBP-2)
timeFrame: change from baseline at 2 months
measure: erytrocyte thioredoxin reductase
timeFrame: change from baseline at 2 months
Secondary outcomes:
measure: GENE EXPRESSION OF TBP-2
timeFrame: change from baseline at 2 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
References:
Clinical trial NCT00618163: Bioequivalency Study of Meloxicam Tablets Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 15 mg Meloxicam Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Anti-inflammatory
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 47
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 the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) 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 the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Meloxicam or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06078163: Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
Official title: Combined Rehabilitation With ALA, ALC, Resveratrol and Vitamin D in Discogenic Sciatica in Young People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatic Radiculopathy
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 130
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 Interventional case-control clinical study is to evaluate the effectiveness of physiotherapy combined with the administration of Alpha Lipoic Acid, L-acetylcarnitine, Resvelatrol, Vit D3 in the treatment of sciatica due to herniated disc in young patients.

The main questions we intend to answer are:

* Is this combined treatment more effective in reducing pain?
* Is the combined treatment useful for improving postural alterations, reducing the intake of painkillers and the number of days of absence from work and improving the quality of life?


Eligibility criteria: Inclusion Criteria:

* age 18-45 years
* pain with NRS scale score between 5 and 7 points
* symptoms attributable to lumbosciatica which occurred no more than 4 weeks ago
* pharmacological wash out of NSAIDs and corticosteroids for at least a week
* presence of L4-L5, L5-S1 disc herniation diagnosed with lumbar MRI performed within 3 months
* absence of ongoing infectious episodes;
* written consent for participation in the study.

Exclusion Criteria:

* Altered states of consciousness;
* Sciatica not of disc origin
* Neurological disorders
* Presence of scoliosis \>20° of Cobb
* Previous spinal surgery
* Pregnancy and/or breastfeeding

Primary outcomes:
measure: extent of pain.
timeFrame: at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2)
Secondary outcomes:
measure: degree of disability of low back pain
timeFrame: at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2)
measure: quality of life in relation to low back pain
timeFrame: at the time of recruitment (T0); after 30 days from the start of treatment (T1); and after 60 days from the end of treatment (T2)
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Study officials:
References:
Clinical trial NCT02386163: Large-scale ex Vivo Expansion and Characterization of Two Kinds of MSC From Knee for Clinical Application
Official title: Large-scale ex Vivo Expansion and Characterization of Synovial Membrane MSC (SM-MSC) and Infrapatellar Fat Pad MSC (IF-MSC) for Clinical Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injuries
Lead sponsor: EMO Biomedicine Corporation
Sponsor class: INDUSTRY
Collaborators: name: Far Eastern Memorial Hospital
First posted: 2015-03-11
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For patients who have an operation of total knee replacement.

Brief summary: According to many researches, mesenchymal stem cells (MSC) isolated from synovial membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and ability to undergo chondrogenesis.

Based on this concept, the investigators plan to get two removed tissues (synovial membrane and infrapatellar fat pad) from patients who have an operation of TKR (Total Knee Replacement). The investigators are going to isolate and expand MSC from these two tissues respectively, and then compare their characterization and potential for clinical application. In the other hand, the investigators plan to build techniques and procedures which comply with "Good Tissue Practices (GTP)".


Eligibility criteria: Inclusion Criteria:

Patient who have an total knee replacement surgery

Exclusion Criteria:

Patient who don't sign the agreement

Primary outcomes:
measure: Compare MSCs from synovial membrane and infrapatellar fat pad
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Chih-Hung Chang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: EMO Biomedicine Corp.
name: Shing-Mou Lee
role: STUDY_CHAIR
References: