louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03042650: Intensive Referral to Reduce Smoking in Probationers
Official title: Intensive Referral to Reduce Smoking in Probationers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Substance Use Disorder
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 46
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: The purpose of this study is to determine if Intensive Referral Intervention increases motivation to quit cigarette smoking and quitting-related behaviors in probationers and also to determine if Intensive Referral Intervention improves short-term substance use outcomes in probationers with substance use disorder.

Detailed description: This is a longitudinal study of adults on probation who have a Substance Use Disorder (SUD) and smoke cigarettes. One-half of probation officers will be trained in the Intensive Referral Intervention (IRI) while one-half will deliver Standard Practice which is to encourage support group attendance. Research staff will assess fidelity to the IRI in trained probation officers. The investigators propose to enroll 150 probationers over a four month period and complete 3 and 6-month follow-up interviews to assess smoking and substance use measures.

Eligibility criteria: Inclusion Criteria:

* CBR-MH Probationers in Douglas County, NE
* SUD
* daily cigarette smoker

Exclusion Criteria:

* Under guardianship
* unwilling to provide personal contact information
* unable to pass Mini-Cog

Primary outcomes:
measure: Motivation measured by Fagerstrom Test
timeFrame: 6 Months
Secondary outcomes:
measure: Change in Timeline Follow-back Calendar
timeFrame: 6 Months
Other outcomes:
measure: Motivation measured by Readiness to Quit Ladder
timeFrame: 6 Months
measure: Motivation measured by QSU-Brief Questionnaire for Smoking Urges
timeFrame: 6 Months
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Kathleen M Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540150: Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy
Official title: Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy in a Randomized Study Depending on Mite-Depot Supplement in Children and Adolescents With Allergic Bronchial Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immunotherapy
Keywords: Immunotherapy
Mite
Asthma
bronchial provocation
SIT
specific immunotherapy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Allergopharma GmbH & Co. KG
First posted: 2007-10-05
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy.

Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* informed consent of patient and/or parents
* age \>6 and \<18 years
* bronchial asthma I° or II°
* allergy on house dust-mite

Exclusion Criteria:

* age \<6 and \>18 years
* vital capacity \<80% or FEV1 \<70%
* pregnancy
* inhalative or systemic steroid use
* bronchial asthma III° or IV°
* heavy exacerbation during the last 3 months

Primary outcomes:
measure: Safety of the shortened specific immunotherapy.
timeFrame: may 2004 - march 2005
Secondary outcomes:
measure: Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.
timeFrame: may 2004 - march 2005
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University, Department of Pulmonology
state: Hessen
Study officials:
affiliation: Goethe University, Department of Pulmonology
name: Stefan Zielen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen I, Hormann K, Stuck BA, Schneider-Gene S, Mosges R, Klimek L. [Cluster-immunotherapy in seasonal allergic rhinitis: safety aspects of induction therapy with depot allergoids (Purethal)]. Laryngorhinootologie. 2003 Aug;82(8):558-63. doi: 10.1055/s-2003-41234. German.
citation: Tabar AI, Echechipia S, Garcia BE, Olaguibel JM, Lizaso MT, Gomez B, Aldunate MT, Martin S, Marcotegui F. Double-blind comparative study of cluster and conventional immunotherapy schedules with Dermatophagoides pteronyssinus. J Allergy Clin Immunol. 2005 Jul;116(1):109-18. doi: 10.1016/j.jaci.2005.05.005.
Clinical trial NCT00837850: SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty
Official title: A Randomised Prospective Trial of SmartSet HV and Palacos R Bone Cements in Primary Total Hip Arthroplasty. A Radiostereometric Analysis of the Charnley Femoral Component.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: total hip arthroplasty
Charnley stem
RSA
non-inflammatory arthritis
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: DePuy International
First posted: 2009-02-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.

Detailed description: The fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. Bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. However, there are significant differences in cement behaviour among differing types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity.

Studies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. RSA is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants.

Eligibility criteria: Inclusion Criteria:

* patients in need for total hip arthroplasty

Exclusion Criteria:

* patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips),
* patients on corticosteroid treatment,
* patients who had already participated in a clinical study with an investigational product in the last 6 months.

Primary outcomes:
measure: Distal migration of the charnley femoral stem
timeFrame: 2010
Secondary outcomes:
measure: Rotational movements of the charnley femoral stem
timeFrame: 2010
Other outcomes:
Locations:
Study officials:
affiliation: St.Olavs hospital HF
name: Otto S. Husby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Husby OS, Haugan K, Benum P, Foss OA. A prospective randomised radiostereometric analysis trial of SmartSet HV and Palacos R bone cements in primary total hip arthroplasty. J Orthop Traumatol. 2010 Mar;11(1):29-35. doi: 10.1007/s10195-010-0087-x. Epub 2010 Mar 3.
Clinical trial NCT02891655: KERatoconus and Metalloproteinases InvesTigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with keratoconus and controls subjects without keratoconus

Brief summary: Corneal stromal thinning observed in keratoconic eyes could result from an increased synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3 by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases (MMP) may be observed between the apex of the keratoconus and the peripheral cornea. Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of specific inhibitors to slow or to stop keratoconus evolution.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* Patient with keratoconus undergoing corneal collagen cross-linking (epithelium-off methods)
* Patient with keratoconus undergoing his first corneal graft for optical indication (control)

Exclusion Criteria:

* Patient with keratoconus undergoing corneal graft for tectonic indication
* Patient undergoing corneal refractive surgery (refractive photokeratectomy) with a normal topography, a normal slit lamp examination and no previous ophthalmic condition (control)
* pregnant or breast feeding patient
* patient under judiciary protection
* patient opposition to participate in the study

Primary outcomes:
measure: expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Opthalmologique A de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Eric GABISON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06562855: Tension-Type Headache Gene Expression and Methylation
Official title: Gene Expression-methylation Profiling
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Tension-Type Headache, Unspecified, Intractable
Keywords: Tension-Type Headache
Gene expression
Gene methylation
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2024-08-20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 82
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Tension-type headache (TTH) refers to pain radiating from the forehead to the back of the head as a bilateral band. It often occurs without warning and spreads to the neck muscles. Patients describe it as tension, pressure, or dull pain. It is usually triggered by stress. The complexity of the processes is the biggest difficulty in diagnosing and treating TTH. Although there are genetic connections, there are no single responsible genes.

Detailed description: 130 TTH patients and 117 healthy controls were included in the study. Serum markers of the patients were measured. WNT5A, responsible for the Wnt-B catenin signaling pathway, and its receptor FZD3 were examined in the pathogenesis of TTH. Expression changes and methylation profiles of genes were obtained. Genetic and serum parameters were compared. Diagnostic powers were determined by ROC analyses.

Eligibility criteria: Inclusion Criteria:

* (ICHD)-3 criteria
* Male and female
* 17-82 years
* not diagnosed with tension-type or other primary headaches

Exclusion Criteria:

* Tension-type headache not diagnosed
* below 16 ages
* pregnant woman
* subdural hematoma
* intracranial mass

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University Şahinbey Research and Application Hospital
state: Şehitkamil
city: Gaziantep
country: Turkey
facility: Medicine
state: Şehitkamil
Study officials:
References:
Clinical trial NCT06111755: Quit Smoking Text Message Study
Official title: Evaluating Digital Health Interventions To Promote Smoking Cessation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2023-11-01
Enrollment: 200
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: This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.

Detailed description: Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction.

Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.

Outcomes will be evaluated for those who complete enrollment, defined as those who complete study onboarding.

Eligibility criteria: Inclusion Criteria:

* daily smokers for at least 6 months
* report an interest in quitting smoking.

Exclusion Criteria:

* reporting being currently enrolled in another quit smoking program

Primary outcomes:
measure: Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in cigarettes smoked per day
timeFrame: baseline, 4 weeks and 8 weeks
measure: Percent days smoke-free
timeFrame: up to 8 weeks
measure: Average number of days to relapse
timeFrame: 2 weeks post quit date
measure: Treatment satisfaction assessed using the Mobile Application Rating Scale User version
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: National online recruitment
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen A Garrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05169450: Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke
Official title: Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Ischemic Stroke
Nervous System Diseases
Cerebral Infarction
Brain Ischemia
Brain Infarction
Keywords: Diterpene Ginkgolides Meglumine Injection
acute ischemic stroke
effectiveness
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 998
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized positived-controlled study of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) was conducted between7/2013 and 4/2014. The study was designed to test efficacy of DGMI for IS. Post hoc analysis of this trial was conducted to evaluate the efficacy of DGMI in elderly (aged≥65 years) IS patients.

Detailed description: To examine the efficacy of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) by age subgroups. The efficacy analysis was a post hoc analysis of data from a large randomized, controlled study was performed in a cohort of 998 IS patients. Patients were pooled and grouped by age (elderly aged ≥ 65 years and non-elderly aged \< 65 years).Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90days is the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* 35 years of age or older, and gender not limited;
* Between 2 and 4 weeks onset of ischemic stroke;
* The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
* Understand and voluntarily signed informed consent.

Exclusion Criteria:

* Known severe liver or kidney dysfunction;
* Known allergies for ingredients in the investigational product;
* Known medical condition likely to limit survival to less than 3 months;
* Known dementia, mental impairment, or unsuitability for participation as judged by the investigators;
* Hemorrhage transformation after infarction, or bleeding tendency;
* Pregnancy or breastfeeding;
* Known lower extremity venous thrombosis;
* Having participated in others clinical trial within 1 month before randomization.

Primary outcomes:
measure: Excellent functional outcome
timeFrame: 90 days
Secondary outcomes:
measure: Neurological deficit amelioration
timeFrame: 14 post-randomization days, 90days
measure: Patient quality of life
timeFrame: 14 post-randomization days, 90days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing University of Chinese Medicine
Study officials:
References:
Clinical trial NCT06620250: A Study of the Impact of Digital Intervention on Parents/primary Caregivers' Myopia Prevention and Control Health Literacy on Preschoolers' Myopia and Physical and Mental Health
Official title: A Randomized Controlled Trial：a Study of the Impact of Digital Intervention on Parents/primary Caregivers' Myopia Prevention and Control Health Literacy on Preschoolers' Myopia and Physical and Mental Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia
Mental Health
Obesity
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 882
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a Randomized controlled trial based on digital interventions, involving pre-school children and their parents or major caregivers. To compare the myopia and physical and mental health status of preschool children before and after intervention between intervention group and control group, to confirm the effect of digital intervention on prevention and control of Myopia and physical and mental health of preschool children.

Detailed description: In this study, wechat, online courses, live broadcast and SMS were used to transfer the knowledge of myopia prevention and control to parents/primary caregivers, and to promote their attitude and behavior change. The intervention period was from October to December 2025. The control group did not 2024 any intervention. The prevention and control of Myopia and health literacy of the parents and main adopters were collected at baseline and after the intervention respectively, visual data and physical and mental health status of preschool children were collected every six months.

Eligibility criteria: Inclusion Criteria:

* No cognitive impairment and communication impairment
* Volunteer and sign the informed consent
* Fill in the questionnaire
* Skilled in using electronic equipment

Exclusion Criteria:

* Children with congenital glaucoma, cataract, strabismus and other congenital eye diseases
* Children with a history of ocular trauma, eye surgery, or complications of myopia
* Do not cooperate with the investigation

Primary outcomes:
measure: Prevention and control of Myopia Health Literacy Rating Scale
timeFrame: 0,6month，12month
measure: Myopia screening
timeFrame: 0,6month,12month
measure: BMI
timeFrame: 0, 6month，12month
measure: Strength and Difficulties Questionnaire
timeFrame: 0,6month,12month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05519150: Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.
Official title: Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stones
Keywords: transplant
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90 participants who were evaluated to donate a kidney at Indiana University (IU) School of Medicine /IU Health Transplant \> 2 years ago.

Brief summary: We believe that kidney donors with kidney stones accepted for a donation do not have an increased risk of loss of kidney function and will not be at increased risk of symptomatic kidney stone events compared to donors without a history of kidney stones.

Detailed description: Indiana University Health center has a large nephrology and transplant service which is well versed in taking care of kidney donors with history of kidney stones. We believe that kidney donors with kidney stones accepted for a donation do not have an increased risk of loss of kidney function and will not be at increased risk of symptomatic kidney stone events compared to donors without a history of kidney stones. In this study we are contacting past kidney donors and participants with kidney stone who were declined as kidney donors. We will use blood tests, 24-hour urine tests, computed tomography (CT) scan, patient reported medical history and medical history in the patient's chart to gather data. This data will help us compare non stone donors, stone donors, and participants with kidney stone who were declined as kidney donors.

Eligibility criteria: Inclusion Criteria:

* Age \> 18,
* Evaluation for kidney donation \> 2 years ago, with A) no history of kidney stones, or kidney stones on Imaging and successfully donated a kidney B) either had history of kidney stones or kidney stones on imaging and either i) successfully donated a kidney or ii) were declined for donation due to history of kidney stones, Litholink abnormalities or Imaging findings
* Willing to participate and sign an informed consent.

Exclusion Criteria:

* Subjects who are currently pregnant or breast feeding.

Primary outcomes:
measure: changes in eGFR and urine protein to urine creatinine ratio
timeFrame: >2 years
Secondary outcomes:
measure: changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies
timeFrame: >2 years
measure: assess formation of new kidney stones by imaging
timeFrame: >2 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
References: