louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05588258: Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
Official title: Comparative, Randomised, Double-blind, Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomised, double-blind, cost-effectiveness clinical trial of two 10% urea creams purchased in pharmacies and supermarkets in patients with diabetic foot syndrome.

Detailed description: The aim of this study was to evaluate the cost-effectiveness of two 10% urea creams in patients with Diabetic Foot Syndrome.

The methodology was a prospective, longitudinal, single-centre, randomised, double-blind, longitudinal clinical trial that evaluated the skin quality of 20 participating feet belonging to 10 patients with Diabetic Foot Syndrome after the application of two 10% urea creams purchased in pharmacies and supermarkets.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years with Diabetic Foot Syndrome
* Deep or superficial sensory neurological involvement diagnosed by Semmes-Weinstein Monofilament and Rydel-Seiffer tuning fork
* ABI (Ankle Brachial Index) in normal range
* Metabolic Syndrome
* No cognitive impairment
* Patients who agreed to be included in the study by signing a written consent

Exclusion Criteria:

* Patients with hypersensitivity or allergy to any of the components of both creams.

Primary outcomes:
measure: Cost analysis of two 10% urea creams purchased in pharmacies and supermarkets.
timeFrame: 5 months
measure: Assessment of the skin quality of participants' feet before and after the cream application intervention using a validated questionnaire.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: José Luis Lázaro Martínez
Study officials:
affiliation: Universidad Complutense de Madrid
name: José Luis Lázaro Martínez, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02091258: Tooth Loss in Periodontitis Patients
Official title: Tooth Loss in Periodontitis Patients on Long-term Maintenance in Private Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 patients with periodontitis on maintenance therapy (after initial/ corrective periodontal therapy) will be included in the study

Brief summary: Tooth loss in periodontitis patients is associated with patient and site factors as well as with treatment provided. Not much is known about long-term tooth loss in periodontitis patients in private practice in the UK. The study plans to follow-up 200 subjects with periodontitis (and currently on maintenance therapy) for 5 years. The effect of treatment provided, site and patient risk factors on tooth loss will be studied.


Eligibility criteria: INCLUSION CRITERIA:

1. Initial diagnosis of chronic or aggressive periodontitis (Lindhe et al. 1999, Lang et al. 1999), with at least two sites with PPD and CAL ≥5mm
2. Diagnosed and treated by the same periodontist (LN)
3. Willing to give written informed consent for study participation
4. Willing to undergo SPT as per standard of care for at least 5 years

EXCLUSION CRITERIA:

1. Serious medical history that prevents patients from undergoing dental treatment
2. History of rheumatic fever, heart murmur, mitral valve prolapse, artificial heart valve or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
3. Current alcohol or drug abuse
4. Self-reported pregnancy or lactation
5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may compromise trial participation and/or interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial

Primary outcomes:
measure: Tooth loss
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bishop's Stortford
country: United Kingdom
facility: The Dentist
state: Herts
city: London
country: United Kingdom
facility: Ravenscourt Dental Practice
Study officials:
affiliation: UCL
name: Luigi Nibali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03616158: Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time
Official title: Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lung Diseases
Keywords: Rheumatoid arthritis
Interstitial Lung Disease
RA
ILD
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-08-06
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are selected for participation in the study because they are diagnosed with or without rheumatoid arthritis and lung disease.

Brief summary: The purpose of this study is to investigate the link between the lungs and rheumatoid arthritis (RA). Additionally, to understand why RA patients get lung disease, how to treat, and prevent the disease.

Detailed description: This study is to learn more about the risk factors for the development of lung disease among patients with rheumatoid arthritis (RA), an auto-immune disease. Additionally, those at heightened risk of developing RA such as in the pre-RA period. This is a prospective and retrospective study, which 420 patients will be enrolled into the study. In-person participation will be up to 4 years, completing different standard of care assessments yearly. Additionally, quality of life questionnaires will be completed every 6 months at 4 time points. Lastly, an extended follow-up will be performed yearly for an additional 6 years, an overall 10 year participation.

Eligibility criteria: Inclusion Criteria:

1. Age 18 - 80 years

Exclusion Criteria:

1. Subjects who do not speak English
2. Subjects without the capacity to sign the informed consent form (ICF)
3. Pregnant women

Primary outcomes:
measure: Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Joshua Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642096: Factorial Study of Metoprolol Succinate TOPROL-XL (324A)
Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Factorial Study of Metoprolol Succinate Extended Release Tablets (TOPROL-XL) Hydrochlorothiazide and Their Combination in Patients With Essential Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: High Blood Pressure (Hypertension).
Keywords: High blood pressure
hypertension
(TOPROL-XL)
metoprolol succinate
hydrochlorothiazide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. The study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.


Eligibility criteria: Inclusion Criteria:

* Diastolic blood pressure between 95 and 114 mm at screening and start of treatment

Exclusion Criteria:

* Significant conditions which in the opinion of the investigator place the subject at undue risk, eg Renal impairment, hepatitis
* Known secondary causes of hypertension, eg, Cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism
* Systolic blood pressure greater or equal to 180 mm Hg at start of trial

Primary outcomes:
measure: Change in trough sitting diastolic blood pressure
timeFrame: 3 readings determined at 8 weeks after treatment
Secondary outcomes:
measure: change in trough Sitting Systolic Blood pressure
timeFrame: 3 readings determined at 8 weeks after treatment
measure: change in trough Standing Systolic Blood Pressure
timeFrame: 6 readings determined at 8 weeks after treatment
measure: change in trough standing diastolic blood pressure
timeFrame: 6 readings determined at 8 weeks after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Georgetown University
name: Vasilios Papademetriou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00859196: Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Superficial Injuries
Official title: A Randomized, Double-blind, Single Centre, Placebo-controlled Pilot Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Previously Injured Skin by Investigation of Skin Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wound Healing
Cell Proliferation
Gene Expression
Keywords: Wound healing
Cell proliferation
Gene expression
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In previous in vitro studies it could be shown, that Dexpanthenol has an influence on the gene expression of fibroblasts. The genes which are influenced by Dexpanthenol play mainly a role during cell proliferating processes.The aim of this study is to investigate the molecular effect of Dexpanthenol on human living skin, during wound healing.


Eligibility criteria: Inclusion Criteria:

* Skin type I to IV
* Willingness to avoid intensive sunlight exposure two weeks before the start of the study and at least 2 months after removal of the stitches

Exclusion Criteria:

* Active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring
* History of keloids and hypertrophic scars
* Frequent visits of tanning booths
* Intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 30 days before day 1 as well as during the study.

Primary outcomes:
measure: Investigation of gene expression in dermal fibroblasts and keratinocytes on a molecular level.
timeFrame: Analysis of skin biopsies taken 24h, 72h and 144h after wounding
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00359996: Improving Diabetes Care Collaboratively in the Community
Official title: Improving Diabetes Care Collaboratively in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes
quality improvement
community health center
health disparities
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Robert Wood Johnson Foundation
First posted: 2006-08-03
Enrollment: 6993
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a quality improvement intervention including rapid quality improvement, a chronic care model, and best practices improves diabetes care in community health centers and whether more intensive interventions enhance care further.

Detailed description: In 1998 the Health Resources and Services Administration's Bureau of Primary Health Care began the Health Disparities Collaborative (HDC) to improve chronic disease management in community health centers (HC) nationwide. The HDC incorporates rapid quality improvement (QI), a chronic care model, and best practices. This study determines if the HDC improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.

Eligibility criteria: Inclusion Criteria:

- patients with diabetes age 18-75 years

Exclusion Criteria:

Pregnant women

-

Primary outcomes:
measure: hemoglobin A1c
timeFrame: 4 years
Secondary outcomes:
measure: Lipid levels
timeFrame: 4 years
measure: Blood pressure
timeFrame: 4 years
measure: Urine microalbumin levels
timeFrame: 4 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Marshall H Chin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chin MH, Drum ML, Guillen M, Rimington A, Levie JR, Kirchhoff AC, Quinn MT, Schaefer CT. Improving and sustaining diabetes care in community health centers with the health disparities collaboratives. Med Care. 2007 Dec;45(12):1135-43. doi: 10.1097/MLR.0b013e31812da80e.
Clinical trial NCT00608296: Functional and Neurochemical Brain Changes Bipolar Depression
Official title: Functional and Neurochemical Brain Changes Following Successful Treatment of Early Course Bipolar Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Bipolar
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-02-06
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: You are being asked to take part in this research study because you have been diagnosed with bipolar disorder and are currently experiencing a depressive episode. Bipolar disorder is an illness characterized by recurrent mood swings including mania, (periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and clinical depression (periods of depressed mood, loss of interest in activities and disruption of sleep, appetite and energy). To participate in this study you must be at least 12 years old, and no older than 35.

Brief summary: The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.


Eligibility criteria: Inclusion Criteria - Depressed bipolar patients (N=100; 15-20 patients/year):

1. Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138
2. Patient has experienced a maximum of three documented affective episodes.
3. Patient has been off medications for one week prior to study enrollment.
4. Patient has a Hamilton Depression Rating Scale (HDRS) total score ≥20
5. Patient is between the ages of 12 and 35 years.

Exclusion criteria: All subjects will be excluded from participation for the following reasons:

1. Any chemical use disorder within 3 months.
2. Any history of significant suicidality that would place the patient at risk to participate in this protocol.
3. Current score ≥3 on item 3 of the HDRS-17 (Suicide Item)
4. Any medical or neurological disorder that could influence fMRI results.
5. A history of mental retardation or an estimated IQ total score \<85.
6. An MRI scan is contraindicated in the subject for any reason.
7. The patient lives \>100 miles from the University of Cincinnati or cannot attend follow-up visits.
8. Meets DSM-IV criteria for a bipolar mixed episode

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Caleb M Adler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05743296: Differences in Brain Activity in the Application of Upper Limb Exercise Tasks Through Virtual Reality
Official title: Differences in Brain Activity in the Application of Upper Limb Exercise Tasks Through Virtual Reality in Chronic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients

Brief summary: This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients.

Detailed description: This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients. All participants will participate in tasks for upper limb exercise conducted for 26 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients aged 19 to 80 years
* FMA Upper scores more than 25 and less than 58
* Patients whose lesions do not include stimulation regions
* Patients with stroke with more than 6 months of onset
* K-MMSE scores more than 24
* patients who can Grasp \& release

Exclusion Criteria:

* Difficult to communicate due to severe language impairment.
* Accompanied by an existing serious neurogenic disease
* Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: Baseline
Secondary outcomes:
measure: Grip and Tip pinch strength test
timeFrame: Baseline
measure: Box & Block Test
timeFrame: Baseline
measure: 9-hole pegboard test
timeFrame: Baseline
measure: Jebsen-Taylor Hand Function test
timeFrame: Baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT04692896: Effect of Different Concentrations of Lidocaine in Relieving Pain in Wide Awake Hand Surgery Using Tumescence
Official title: Effect of Different Concentrations of Lidocaine in Relieving Pain Peroperatively and 24 Hours Postoperatively in Wide Awake Hand Surgery Using Tumescent Local Anesthesia Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lidocaine
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Lidocaine has been used along with adrenaline in tumescent anesthesia for a variety of procedures. This has been quite popular especially in wide awake surgery of the hand with no tourniquet. However, the appropriate lidocaine concentration is yet to be established. This randomized control trial will study the minimum effective lidocaine concentration in hand surgery using the tumescent technique.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 16 to 60 years of either gender
2. Patients with post burn/post traumatic contractures involving fingers \& palm
3. Patients with nerve injury or flexor/extensor tendons injury distal to mid forearm.

Exclusion Criteria:

1. Patients with history of ischemic heart disease, chronic liver disease (ALT/AST 40 IU/L), renal disease (creatinine 13mg/dl), bleeding disorder, peripheral arterial disease \& peripheral neuro3pathy .
2. Surgical site infection .
3. History of allergic hypersensitivity to epinephrine or lidocaine.

Primary outcomes:
measure: total duration of analgesia
timeFrame: Within 24 hours of randomization.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Department of plastic Surgery,Mayo Hospital King Edward Medical University
state: Pujab
Study officials:
References:
Clinical trial NCT01414296: Extended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
Official title: Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Progenics Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301EXT is an open-label, nonrandomized, phase 1 extension study of PSMA ADC administered IV in subjects with progressive CMPC that has progressed after prior taxane therapy. Subjects who have participated in PSMA ADC 1301 and who, in the opinion of the PI, are likely to benefit from continued treatment with PSMA ADC will be enrolled in PSMA ADC 1301EXT.


Eligibility criteria: Inclusion Criteria:

1. Subjects who have completed the PSMA ADC 1301 study and who, in the opinion of the investigator, have derived benefit from treatment with PSMA ADC.
2. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
3. Prior chemotherapy regimens, one of which contains taxane.
4. Eastern Cooperative Oncology Group status of 0 or 1

Exclusion Criteria:

1. Clinically significant cardiac disease or severe debilitation pulmonary disease
2. Evidence of an active infection requiring ongoing antibiotic therapy
3. History of drug and/or alcohol abuse

Primary outcomes:
measure: Number of subjects with Adverse Events
timeFrame: 39 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Robert J Israel, MD
role: STUDY_DIRECTOR
References: