louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01700920: PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
Official title: PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteonecrosis of the Femoral Head
Keywords: Osteonecrosis of the femoral head
Stem Cell
Mesenchymal Stem Cells
Femoral Head
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
name: Spanish National Health System
First posted: 2012-10-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years
* Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
* Stadiums \<IIIC ARCO ranking

Exclusion Criteria:

* Those on investigator judgment not in a good position to tolerate the procedure.
* Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
* Serious illness uncontrolled
* Pregnant women
* Patients with HIV infection +
* Acute infection (in the previous 15 days) or chronic (other than HIV)
* Previous treatments of osteonecrosis
* Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.
* Lack of informed consent or revocation thereof.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University Hospital of Salamanca
state: Castilla y León
Study officials:
References:
Clinical trial NCT03826420: Swift, Certain, and Fair: Reducing Recidivism and Improving Outcomes for Alcohol and Drug Users on State Parole
Official title: Swift, Certain, and Fair: Reducing Recidivism and Improving Outcomes for Alcohol and Drug Users on State Parole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Abuse
Criminal Behavior
Lead sponsor: Botec Analysis, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pennsylvania Department of Corrections
name: Bureau of Justice Assistance
First posted: 2019-02-01
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research project will study the outcomes of medium- to high-risk parolees with a history of substance abuse in Alleghany County, Pennsylvania supervised under Swift-Certain-Fair parole.

The research goals are to:

* Determine the effectiveness of SCF parole in reducing recidivism among medium- to high-risk parolees with a history of substance abuse in Pennsylvania.
* Determine the minimum effective sanction in response to a violation that will bring parolees into compliance with the conditions of their parole.


Eligibility criteria: Inclusion Criteria:

* Assigned to the Pittsburgh District
* Allegheny County resident
* Has at least 2 years left on supervision
* Had a prior drug or alcohol related sanction

Exclusion Criteria:

* Sex offender
* Reentrants assigned to the Special Needs Unit

Primary outcomes:
measure: Revocation Rate
timeFrame: 9 Months
Secondary outcomes:
measure: Days Incarcerated
timeFrame: 9 Months
measure: New Charges
timeFrame: 9 Months
measure: Percent Positive Drug Tests
timeFrame: 9 Months
Other outcomes:
Locations:
Study officials:
affiliation: BOTEC Analysis
name: Mark AR Kleiman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179620: Certoparin in Renal Patients Undergoing Hemodialysis
Official title: A Multi-center, Prospective, Open-label, 8-weeks Study to Investigate the Efficacy, Safety and Pharmacokinetics of Certoparin (3000 IU Anti-Xa Bolus, With the Option to Titrate Dose)in the Prophylaxis of Clotting in the Extracorporeal Circuit in Patients Undergoing Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Dialysis
Keywords: Hemodialysis, Certoparin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Patients requiring hemodialysis
* Patients requiring anticoagulation therapy during hemodialysis
* Written informed consent

Exclusion Criteria:

* Hypersensitivity to study medication
* Genetic abnormality or disease of clotting system
* Prior major surgery or bleeding
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of patients requiring uptitration
timeFrame: Week 8
Secondary outcomes:
measure: Pharmacokinetics of Certoparin
timeFrame: Day 1, Week 4
measure: Safety and tolerability of Certoparin
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Darmstadt,
country: Germany
facility: Novartis Investigative Site Darmstadt
city: Elsenfeld
country: Germany
facility: Novartis Investigative Site Elsenfeld
city: Flensburg
country: Germany
facility: Novartis Investigative Site Flensburg
city: Heringen
country: Germany
facility: Novartis Investigative Site Heringen
city: Hoyerswerda
country: Germany
facility: Novartis Investigative Site Hoyerswerda,
city: Kronach
country: Germany
facility: Novartis Investigative Site Kronach
city: Magdeburg
country: Germany
facility: Novartis Investigative Site Magdeburg
city: München
country: Germany
facility: Novartis Investigative Site München
city: Münster
country: Germany
facility: Novartis Investigative Site Münster
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Dorsch O, Krieter DH, Lemke HD, Fischer S, Melzer N, Sieder C, Bramlage P, Harenberg J. A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis--the membrane study. BMC Nephrol. 2012 Jun 28;13:50. doi: 10.1186/1471-2369-13-50.
Clinical trial NCT06205420: Injection Molding Technique: a Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children
Official title: Injection Molding Technique: a Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Enamel Hypoplasia
Keywords: composite resin restoration
giomer
injectable restorations
injection molding
developmental enamel defects
Permanent Anterior teeth
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 14
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This treatment involves the use of two different injectable restorations for the esthetic treatment of hypoplastic anterior teeth.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate and compare the clinical performance of the injectable giomer restoration versus an injectable composite resin restoration using the injection molding technique for veneering hypoplastic permanent maxillary and mandibular anterior teeth using the FDI criteria. Follow up will be done every 6 months for 2 years.

Detailed description: The aim of this study is to evaluate and compare the two-year clinical performance of injectable giomer restoration to an injectable composite resin restoration using the injection molding technique for veneering permanent maxillary and mandibular anterior teeth affected with enamel hypoplasia in children using the FDI criteria.

Injection molding technique using injectable composite resin restoration and injectable giomer restoration will be implemented for the esthetic management of permanent anterior teeth affected with enamel hypoplasia in children after removal of the defective enamel, its etching and bonding. Evaluation of their performance will be done using FDI criteria and will be followed up for 2 years.

Eligibility criteria: Inclusion Criteria:

* Healthy patients: Class I according to the American Society of Anaesthesiologists (ASA class I).
* Teeth scored code 3 according to Modified Developmental Defects of enamel (mDDE) index.
* Maxillary and mandibular permanent anterior teeth

Exclusion Criteria:

* Refusal of the parents to sign the informed consent.
* Signs and symptoms of reversible or irreversible pulpitis, as well as necrosis affecting the permanent anterior teeth.
* Enamel hypomineralization

Primary outcomes:
measure: Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations.
timeFrame: every 6months for 2 years
Secondary outcomes:
measure: The Mean Annual Failure rate using the World Dental Federation (FDI) criteria.
timeFrame: 1 year
measure: Measuring the impact of enamel hypoplasia on children's daily life from children's and parents' perspectives
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
Study officials:
References:
Clinical trial NCT01421420: Alzheimer's Disease Core Center
Official title: Arizona Alzheimer's Disease Core Center
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Age-Related Memory Disorders
Keywords: Alzheimer's
Dementia
Mild Cognitive Impairment
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Banner Health
name: Barrow Neurological Foundation
name: Mayo Clinic
name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2011-08-22
Enrollment: 900
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Alzheimer's disease, mild cognitive impairment, other forms of dementia, and normal elderly individuals.

Brief summary: The main objective of this research project is to provide a comprehensive clinical database of patients with Alzheimer's disease (AD) and other forms of dementia, individuals with mild cognitive impairment (MCI), and age-matched normal controls. The study will also attempt to identify cognitively normal individuals at genetically defined risk for Alzheimer's disease through genetic screening.

All participants are seen annually. Autopsies to establish diagnoses in patients with dementia, patients with mild MCI, and cognitively normal elderly control subjects will also be conducted.

Detailed description: All participants are seen annually. In addition to a detailed neurological examination, participants will receive a standardized battery of neuropsychological tests and will undergo genetic testing. The investigators will provide standardized periodic longitudinal assessment of the research participants. Autopsies to establish neurohistopathological diagnoses in clinically well-characterized patients with dementia, patients with mild MCI, and cognitively normal elderly control subjects will also be conducted.

Eligibility criteria: Inclusion Criteria:

For patients with MCI, or dementia, the presence of cognitive deficits including memory, language, and executive function.

Exclusion Criteria:

Presence of non-neurological medical conditions interfering with cognition.

Primary outcomes:
measure: Neuropsychological Test Scores
timeFrame: Up to 20 years
Secondary outcomes:
measure: Neurological Exam
timeFrame: Up to 20 Years
measure: Brain Tissue
timeFrame: From date of entry until date of death assessed up to 20 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona, University Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Steven Z Rapcsak, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01442220: Genome-wide Association Study of Pituitary Tumors
Official title: Genome-wide Association Study of Pituitary Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Adenomas
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 12500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with pituitary adenomas and healthy controls will be included.

Brief summary: Pituitary adenomas is a very common disease, but the cause and genetics hasn't been identified. The investigators are going to use genome-wide association study to identify genes that may be related to pituitary adenomas.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with pituitary adenomas

Exclusion Criteria:

* patients with a family history of endocrine tumors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Yao Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03964220: Impact of Tiotropium Add-on Therapy in Patients With Asthma
Official title: The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 7857
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatics 6 years and above on ICS/LABA at baselineIMS Pharmetrics (IMS or Database I); EMRClaims+ (Database II)

Brief summary: To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy


Eligibility criteria: Inclusion Criteria:

* Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.
* Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).
* Patients will be required to have available records 12 months prior to the index date.

Exclusion Criteria:

* Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.
* Patients with a diagnosis of COPD at any time during the study period will be excluded.
* Those who are on biologics at baseline will be removed.
* After the PSM process, unmatched patients will be excluded.

Primary outcomes:
measure: Time to First Exacerbation
timeFrame: From baseline until end of follow-up, up to 3 years
Secondary outcomes:
measure: Rate of Exacerbation at 6 Months and 1 Year of Follow-up
timeFrame: At 6 month and 1 year of follow-up
measure: Health Care Resource Utilization (HCRU) During Follow-up
timeFrame: During follow-up period, From baseline until end of follow-up, up to 3 years
measure: Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period
timeFrame: From baseline until end of follow-up, up to 3 years
measure: Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period
timeFrame: From baseline until end of follow-up, up to 3 years
Other outcomes:
Locations:
city: White Plains
country: United States
facility: eMax Health
state: New York
Study officials:
References:
Clinical trial NCT03571620: Safety and Efficacy Study of Q301 in Mild to Moderate Adolescents and Adults Atopic Dermatitis Patients
Official title: A Multicenter, Randomized, Phase 2, Double-blind, Vehicle-controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of Q301 Cream in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Qurient Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-27
Enrollment: 258
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adolescent and adult subjects with mild to moderate AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.


Eligibility criteria: Inclusion Criteria:

* Patient, for a period of at least three months, has had a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist.
* Patient has an Investigator's Global Assessment (IGA) score of 2 or 3 corresponding to mild or moderate AD
* Patient is in good general health and free of any disease state or physical condition that might impair evaluation of AD or which, in the investigator's opinion, exposes the patient to an unacceptable risk by study participation.

Exclusion Criteria:

* Patient has used within four weeks prior to randomization, systemic treatment with: 1) corticosteroids, 2) cyclosporine, 3) other immunosuppressive treatment or any medication known to affect AD (e.g., JAK inhibitors, etc.).

Primary outcomes:
measure: proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) and at least a two grade improvement in IGA score
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine Department of Dermatology
state: North Carolina
Study officials:
References:
Clinical trial NCT02071420: Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
Official title: Efficacy of a Combined Ergonomic Health Promotion Intervention on Employee Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary
Overweight
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our objective in this pilot study is to test the combined effect of a) replacing office workers' sedentary workstations with active workstations (LifeBalance Station) and b) optimizing computer workstation ergonomics on daily occupational sedentary time, cardiometabolic risk factors, musculoskeletal symptom health outcomes and work productivity.

Detailed description: Primary Aim: To compare the effects of providing sedentary employees with seated active workstations in combination with an ergonomic intervention and regular motivational emails (experimental group) against the ergonomic intervention and regular emails only (active control group) on occupational sedentary behavior over 16 weeks.

Hypothesis: The addition of a seated active workstation will result in significant reductions in daily occupational sedentary time compared to the active control group.

Secondary Aims: To compare the effects of the experimental group against the active control group on secondary measures of cardiometabolic disease risk factors, musculoskeletal discomfort, cognitive function and work productivity.

Hypothesis 1: The experimental group will result in reduced cardiometabolic disease risk, musculoskeletal discomfort and work limitations compared to the active control group.

Eligibility criteria: Inclusion Criteria:

* We will recruit overweight/obese (body mass index 25.0-40.0 kg/m2) adults (18-65 years) working in full-time (minimum 35 hours/week), sedentary (self-report sitting \>75% work time) occupations at an independent work site.

Exclusion Criteria:

* Working in an office that will not meet the space or electrical requirements of the active workstation, acute or chronic illness not under treatment of a provider, orthopedic limitations that prohibit physical activity, current or planned pregnancy, hospitalization from a physical or mental disorder in the past six months and/or taking medication that may impair physical activity

Primary outcomes:
measure: Change in Occupational Physical Activity From Baseline to 16 Weeks
timeFrame: Baseline and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Lucas Carr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carr LJ, Leonhard C, Tucker S, Fethke N, Benzo R, Gerr F. Total Worker Health Intervention Increases Activity of Sedentary Workers. Am J Prev Med. 2016 Jan;50(1):9-17. doi: 10.1016/j.amepre.2015.06.022. Epub 2015 Aug 7.