louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00379730: Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-blind Study of Treatment With a Known Anti-inflammatory (Prednisolone) to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: CT scan
breathing tests
lung function tests
biomarkers
prednisolone
IOS
COPD
clinical outcomes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prednisolone will be used as a model medication to identify new clinical outcomes for future evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* An established clinical history of COPD
* Evidence of bronchitis
* Current or ex-smoker

Exclusion Criteria:

* COPD exacerbation requiring steroid and/or antibiotics in the last month
* Taking oral or inhaled steroids for more than 14 days in the last 6 months
* Unable to withhold salbutamol/albuterol for a 6 hour period
* History of alcohol, substance or drug abuse within the last year.
* Other significant medical condition e.g. diabetes
* Cancer that has not been in complete remission for at least 5 years
* As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.

Primary outcomes:
measure: lung function tests using a system called Impulse oscillometry (IOS). CT scans to measure the thickness of the tubes in the lungs Blood, sputum and breath samples to measure chemical products in the lungs and body that relate to COPD
Secondary outcomes:
measure: Traditional lung function tests & Symptom Questionnaires
Other outcomes:
Locations:
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Mowbray
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lomas DA, Silverman EK, Edwards LD, Locantore NW, Miller BE, Horstman DH, Tal-Singer R; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints study investigators. Serum surfactant protein D is steroid sensitive and associated with exacerbations of COPD. Eur Respir J. 2009 Jul;34(1):95-102. doi: 10.1183/09031936.00156508. Epub 2009 Jan 22.
Clinical trial NCT02636530: Effect of Two Exercise Programs on Bone Strength and Architecture
Official title: Effect of Two Exercise Programs on Bone Strength and Architecture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: VA Eastern Colorado Health Care System
First posted: 2015-12-21
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Bone responds according to the load placed on it. In this study, investigators want to know if exercise that loads the body in exercises, like walking or jogging (Ground Reaction Forces: GRF), affects bone differently than exercises that load the joints, like weight lifting (Joint Reaction Forces: JRF). Participants will exercise at least 3 times a week for 6 months. Measures of bone strength and mass, muscular strength, and aerobic fitness will be taken at the beginning and the end of the 6 month program. Period blood samples will be taken for future analysis of blood markers.


Eligibility criteria: Inclusion Criteria:

* non-smoker
* in generally good health
* not physically active (less than 60 minutes of purposeful exercise/week)
* able to travel to the exercise facility a minimum of 3 times/week

Exclusion Criteria:

* use of glucocorticoids
* abnormal resting EKG
* angina and/or evidence of acute myocardial ischemia during a treadmill test
* resting blood pressure above 150 mmHg systolic of 90 mmHg diastolic
* anti-resorptive drug use in the last 2 years
* initiation of treatments that could impact bone metabolism (diuretics, hormones, bine anabolic agents) in the prior 6 months
* dual-energy x-ray absorptiometry (DXA) t-score \<+ -2.5 at the femoral neck and/or lumbar spine
* serum vitamin D concentration \<20 ng/mL
* uncontrolled thyroid disease
* any contraindications to regular exercise

Primary outcomes:
measure: Change in Volumetric Bone Mineral Density (vBMD)
timeFrame: Baseline and 6 month
measure: Change in Areal Bone Mineral Density (aBMD)
timeFrame: Baseline and 6 month
measure: Change in Bone Strength
timeFrame: Baseline and 6 month
Secondary outcomes:
measure: Change in 1-Repetition Maximum (1RM)
timeFrame: Baseline and 6 month
measure: Change in Maximal Oxygen Uptake (cardiovascular fitness)
timeFrame: Baseline and 6 month
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Denver
country: United States
facility: Veteran's Affairs Eastern Colorado Healthcare System
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Wendy Kohrt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00643630: Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials
Official title: A Study to Determine the Skin Barrier Effect of Tetrix Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Tetrix crea
skin barrier
antigen reaction
prevention
The efficacy of Tetrix Cream to prevent an antigen reaction on the skin.
Lead sponsor: Coria Laboratories, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin


Eligibility criteria: Inclusion Criteria:

* Normal subjects who are sensitized to nickel, neomycin, or fragrance mix.

Exclusion Criteria:

* Under 18 years of age.

Primary outcomes:
measure: Prevention of delayed bype hypersensitivity reaction following application of antigen
timeFrame: up to 96 hours after antigen application
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Dermatolgoy Specialists, LLC
state: Kentucky
Study officials:
affiliation: Dermatology Specialists
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04788030: Reconstruction of Digital Nerve Lesions With Muscle-in-Vein Conduits
Official title: Outcome After Reconstruction of 43 Digital Nerve Lesions With Muscle-in-Vein Conduits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Nerve Injury Upper Limb
Lead sponsor: BG Trauma Center Tuebingen
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The mean age of all patients was 38.0 years (SD 18.4, range 6-72). All patients aged younger than 18 years were males whereas patients older than 60 years tend to be females.

Brief summary: Muscle-in-vein conduits (MVCs) provide an alternative for bridging digital nerve defects when tension-free suture is not possible. Low donor site morbidity and absence of additional costs are favorable advantages compared to autografts or conduits. 37 patients with 43 defects of proper palmar digital nerves were retrospectively enrolled. Primary repair by MVCs was performed in 22 cases while 21 underwent secondary reconstruction. Recovery of sensibility was assessed by static and moving two-point discrimination (2PDs, 2PDm) and Semmes-Weinstein monofilaments (SWM). Results were compared with contralateral side serving as intraindividual control. Outcome data were stratified according to international guidelines and evaluated for differences in terms of age, gap length, time of reconstruction and concomitant injuries.


Eligibility criteria: Inclusion Criteria:

- Patients with reconstruction of digital nerves with muscle-in-vein conduits

Exclusion Criteria:

* Subtotal or total amputations
* pre-existing neurological disorders (e.g. polyneuropathy)
* symptoms of nerve entrapment

Primary outcomes:
measure: Two-point discrimination
timeFrame: Six months after reconstruction or later
measure: Semmes-Weinstein-Monofilament test
timeFrame: Six months after reconstruction or later
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Gap length
timeFrame: Baseline
measure: Time of reconstruction
timeFrame: Baseline
measure: Concomitant injuries
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05253430: D1 vs D2 Lymphadenectomy in Gastric Cancer
Official title: Prognostic Implications of D1 vs D2 Lymphadenectomy in Gastric Cancer: a Propensity Score Matched Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer
lymphadenectomy
outcomes
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective study was carried out in all consecutive patients diagnosed with GC who underwent curative-intent surgery between April 1999 and October 2019

Brief summary: This study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with D1 and D2 lymphadenectomy for gastric cancer.The main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (GC) who underwent D1 and D2 gastrectomy.

Detailed description: In this propensity score-matched analysis of 128 patients, D2 lymphadenectomy improved long-term outcomes compared with D1 in patients with curative intent surgery for gastric cancer except for the group of patients older than 75 years and with early tumors.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with GC stage I-III who underwent a curative gastrectomy +/- perioperative chemotherapy

Exclusion Criteria:

* patients with adenocarcinoma Siewert type I/II, palliative surgery, R1/R2 resections and pathological stage (pStage) IV.

Primary outcomes:
measure: Disease-free survival
timeFrame: percentage of patients without disease recurrence alive at 3 and 5 years after surgery
Secondary outcomes:
measure: Overall survival
timeFrame: percentage of patients alive at 3 and 5 years after surgery
measure: Postoperative morbidity
timeFrame: from the surgery up to 90 days after the surgery
measure: Postoperative mortality
timeFrame: from the surgery up to 90 days after the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00655330: Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy
Official title: A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Nephropathy
Keywords: Type 2 diabetes mellitus
Nephropathy
valsartan
probucol
Proteinuria
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2008-04-09
Enrollment: 170
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks.

Detailed description: a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy

* Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day)
* Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes nephropathy
* Urinary albumin excretion 1-3g/24hours
* Serum creatinine \< 3mg/dl

Exclusion Criteria:

* Type 1 diabetes mellitus
* Renal diseases other than type 2 Diabetes nephropathy
* Renal artery stenosis
* Severe heart diseases
* Tuberculosis

Primary outcomes:
measure: urinary albumin excretion or proteinuria at week 48
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Nephrology Dept.,Guangdong General Hospital
name: Shi Wei, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01518530: Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neck Pain
Keywords: Chronic Neck Pain, Occiflex, Computerized Mobilization
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. This is a third continuation study aimed at examining the Occiflex Robotic System. This time we will be studying tailored or personalized three dimensional movement of the neck.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain

Exclusion Criteria:

* Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders Cervical disc herniation

Primary outcomes:
measure: Occiflex Device Safety
timeFrame: 6 weeks
Secondary outcomes:
measure: Efficacy as Per the NDI-Neck Disability Index
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT06805630: Urine Methylation Markers in UTUC
Official title: Urine-based Methylation Markers in the Diagnosis and Surveillance of Upper Tract Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Tract Urothelial Cancer
Keywords: UTUC
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Urine samples will be de-identified and sent to Zymo/Pangea Research Corporation for analysis. The results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.


Eligibility criteria: Inclusion Criteria:

* \>=18 years
* Primary UTUC

Exclusion Criteria:

* Patients who do not understand and/or are unwilling to sign a written informed consent

Primary outcomes:
measure: Methylation level of urothelial-specific biomarker TRNA-Cys
timeFrame: Baseline, 3 months, 6 months
measure: Methylation level of urothelial-specific biomarker SIM2
timeFrame: Baseline, 3 months, 6 months
measure: Methylation level of urothelial-specific biomarker NKX1-1
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Abern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06663930: New Approach for Ovarian PRP Injection for Poor Responders
Official title: New Approach for Ovarian PRP Injection for Poor Responders ; Aiming At the Highest Response Rate
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Poor Responders
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 21
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women attending their attempt of IVF/ICSI at Assaf Fertility center, after poor ovarian response in a previous trial, during the period March 2024 to June 2025

Brief summary: New Approach For Ovarian PRP Injection for poor responders

Detailed description: Poor ovarian responders are at high risk of unsuccessful IVF/ICSI trials. In the last few years, many studies showed significant improvement of ovarian reserve parameters after PRP injection. There was no consensus regarding the route of injection, the volume injected, the location of PRP injection inside the ovary, the number of injection and the number of the cycle in which PRP is injected.

Eligibility criteria: Inclusion Criteria:

* AMH : \< 0.5 ng/ml
* FSH: \> 10 miu but \< 25 miu.
* AFC : \< 5 in both ovaries
* Poor ovarian response, in a previous IVF/ICSI trial , resulting in 3 or fewer oocytes.
* Normal uterine cavity , demonstrated by a recent hysteroscopy

Exclusion Criteria:

* Primary ovarian insufficiency with FSH \> 25 miu.
* Previous ovarian surgery or Chemotherapy.
* On going Anticoagulant use.
* Carcinomas or a history of chronic pelvic pain.
* Present infection.
* Hemoglobin level lower than 11 g/L
* platelet count lower than 150 x 10³/μL.

Primary outcomes:
measure: PRP effect on ovary for better fertility outcome
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Benha University
Study officials:
References:
Clinical trial NCT05314530: The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector
Official title: Validation of the ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burnout
Keywords: Healthcare
Burnout
Stress
Return to work
Intervention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care.

Detailed description: The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care.

Eligibility criteria: Inclusion Criteria:

* currently on sick leave for burnout
* employed in the Swedish healthcare services as a nurse or as a physician

Exclusion Criteria:

-

Primary outcomes:
measure: Return to work
timeFrame: 12 months
measure: Karolinska Exhaustion Disorder Scale KEDS
timeFrame: 12 months
measure: Symptom Checklist - 6
timeFrame: 12 months
measure: Montgomery Åsberg Depression Rating Scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Outside U.S. And Canada
Study officials:
affiliation: Karolinska Institutet
name: Emma Hagqvist
role: PRINCIPAL_INVESTIGATOR
References: