louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00631358: Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sjogren's Syndrome
Keywords: Ocular inflammation
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 97
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.


Eligibility criteria: Inclusion Criteria of Sjorgren's Population:

Inclusion Criteria:

* 17 years or older
* LogMar visual acuity of 0.6 or better
* Ocular inflammation associated with Sjogren's Syndrome

Exclusion Criteria:

* Has had an adverse reaction to either topical of systemic steroids in the past
* Has diabetes (type 1 or 2)
* Has glaucoma or evidence of ocular hypertension in either eye or treatment of either within six months of Visit 1
* Has worn contact lenses within one week prior to Visit 1
* Has received ocular prescription therapy in the last 30 days
* Has active ocular infections or inflammation not associated with Sjogren's Syndrome.
* Has any finding in the vitreous, macula, retina or choroid that show signs of inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant

Primary outcomes:
measure: Change in Levels of Biomarkers After Dosing With Maxidex
timeFrame: Baseline to 2 weeks
Secondary outcomes:
measure: Correlation Between Biomarker Expression and Ocular Symptoms
timeFrame: Baseline to 2 weeks
measure: Correlation Between Biomarker Expression and Tear Film Break up Time
timeFrame: Baseline to 2 weeks
measure: Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining
timeFrame: Baseline to 2 weeks
measure: Correlation Between Biomarker Expression and the Schirmer Test
timeFrame: Baseline to 2 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto
city: Waterloo
country: Canada
facility: Waterloo
Study officials:
References:
Clinical trial NCT04246658: Effect of Platform Swing Walkway on Locomotor Behavior in Diplegic Children
Official title: Effect of Platform Swing Walkway on Locomotor Behavior in Children With Diaplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Rehabilitation
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Locomotor activity is accompanied by a number of sensory stimuli: visual, auditory, olfactory, vestibular, and somatosensory. When improving motor skills, incorporating postural reflexes, creating synchronized eye movements, and visual attention skills, the vestibular system is particularly important.

Detailed description: Thirty diaplegic cerebral palsied children of both sexes, ranged in age from 3 to 6 years enrolled in this study. They randomly assigned into two groups of equal number; control group (A), study group (B). Group (A) groups received the conventional physical therapy program based on neurodevelopmental approach for such cases. Whereas study group (B) received the same conventional physical therapy program given to group (A) in addition to gait training on platform swing walkway for 30 minute. All children were assessed before and after the treatment program by using 2D video based gait assessment system to measure the percentage of swing and stance phase, also GMFM was used to assess standing and walking, running, and jumping abilities, domains (D) and (E).

Eligibility criteria: Inclusion Criteria:

* were cognitively competent
* able to understand and follow instructions.

Exclusion Criteria:

* if they had fixed contractures
* deformities of the spine, upper or lower extremities,
* visual or respiratory disorders.

Primary outcomes:
measure: Growth Motor Function Measure Scale (GMFM).
timeFrame: pre intervension and after three months of the intervention to asses the improvent in standing and walking .the highest score indicate improvementg
measure: 2D, video based gait assessment system:
timeFrame: 2D, video based gait assessment system asses the change in the stance in swing phase before and after three months of the intervention program .
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr Univesity in Cairo (BUC)
Study officials:
References:
Clinical trial NCT03989258: Personalised Risk-based Breast Cancer Prevention and Screening
Official title: Implementation of a Model for Personalised Risk-Based Breast Cancer Prevention and Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Screening
Genetic risk
Polygenic risk score
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
Collaborators: name: University of Tartu
name: North Estonia Medical Centre
First posted: 2019-06-18
Enrollment: 28389
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a cohort study, applied research and T3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. The study group base consists of 28 389 female participants, currently in the age-group 22-79, in the Biobank of Estonian Genome Centre. The study is aimed to demonstrate the usability of personalised approach for adjusting and stratifying screening recommendations, based on predicted genetic risk estimates for breast cancer in the situation, where the genome data could be available from all women who have given informed consent for that. The project includes both the detection of moderate and high hereditary breast cancer risk carriers as well as high risk polygenic risk-score (consisting several single nucleotide polymorphisms) carriers among healthy individuals for application of personalised prevention and screening strategies.


Eligibility criteria: Inclusion Criteria:

Cohort 1:

* Available NGS (WGS or WES) data for detection of breast cancer moderate to high genetic risk variants in BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
* Available genetic (WGS, genotyping) data for PRS calculation, participants in age 40-74 will be further selected;

Cohort 2:

* Available genotyping data;
* No available NGS data for BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
* Participants in the age group 40-74 with available genetic data for PRS calculation;

Cohort StMG:

• Female participants in Estonian Biobank in the age group 50-69 participating at least once in the current Estonian population-based screening program during 2016-2020.

Exclusion Criteria:

Cohort 1: breast cancer in the medical history; Cohort 2: breast cancer in the medical history. Cohort StMG: none.

Primary outcomes:
measure: Proportion of women in the population with genetically higher risk for breast cancer
timeFrame: 3 years
Secondary outcomes:
measure: Number of screen-detected breast cancers in different risk groups
timeFrame: 3-years
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
city: Tallinn
country: Estonia
facility: The North Estonia Medical Centre
Study officials:
References:
Clinical trial NCT01823458: Behavioral Economics Incentives for Health Management
Official title: Evaluation of Behavioral Economics Patient Incentive Strategies for Health Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Keywords: behavioral economics
incentives
health behavior
exercise
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2013-04-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Incentives are increasingly being used to motivate health behavior in medical studies. Small cash payments conditional on certain health and welfare promoting behaviors have shown efficacy in both real world and experimental settings. Furthermore, in incentive studies, behavioral economics has been shown to amplify behavior change beyond what is possible with simple cash payments, but little is known about how varying incentive payment design may impact health behavior. The goal of the present study is to evaluate a new incentive payment instrument, lottery insurance, to determine its impact on adherence to the target health behavior, attendance at free exercise classes provided by QueensCare Family Clinics, a safety-net medical clinic.


Eligibility criteria: Inclusion Criteria:

* 18 to 64 years of age
* BMI between 25-40
* Receiving care in QueensCare Family Clinics

Exclusion Criteria:

* Failure to obtain exercise clearance from physician

Primary outcomes:
measure: Attendance at exercise classes
timeFrame: 12 weeks
Secondary outcomes:
measure: Body Mass Index
timeFrame: Change from Baseline Body Mass Index at 12 weeks
measure: HbA1c
timeFrame: Change from Baseline HbA1c at 12 weeks
measure: Blood Pressure
timeFrame: Change from Baseline Blood Pressure at 12 weeks
measure: LDL cholesterol
timeFrame: Change from Baseline LDL at 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: QueensCare Family Clinics
state: California
Study officials:
affiliation: University of Southern California
name: Jason N Doctor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05648058: Role of Nefopam in Rituximab Transfusion Reaction
Official title: Role of Nefopam in Rituximab Transfusion Reaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nefopam
Lead sponsor: Ministry Of Health / Nineveh Health Directorate
Sponsor class: OTHER_GOV
First posted: 2022-12-13
Enrollment: 100
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 patients will be taken nefopam ampule 50 mg before rituximab in the first group while the second group will be taken diphenhydramine ampule 10 mg before rituximab in the second group

Detailed description: the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab

Eligibility criteria: Inclusion Criteria:

* 18 - 80 years old male and female will be taken rituximab

Exclusion Criteria:

* less than 18 years old more than 80 years old diabetic patients

Primary outcomes:
measure: transfusion reaction
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ministry Of Health / Nineveh Health Directorate
name: moataz alani
role: STUDY_CHAIR
References:
Clinical trial NCT00793858: A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray
Official title: A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patients (18 Years or Older) With Documented Perennial Allergic Rhinitis (PAR).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2008-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose


Eligibility criteria: Inclusion Criteria:

1. Males and females 18 years of age or older.
2. History of perennial allergic rhinitis for at least 1 year prior to screening.
3. Positive skin test to perennial allergen.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
4. Active asthma requiring treatment with inhaled or systemic steroids.
5. Use of any form of nasal spray during the previous month.

Primary outcomes:
measure: levels of ciclesonide in biopsy tissue
timeFrame: 2 hours post study drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT04653558: Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis
Official title: Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis According to Diagnostic Certainty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lyme Disease
Keywords: Lyme neuroborreliosis
post-Lyme borreliosis symptoms
antibiotic therapy
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with definite or possible early Lyme neuroborreliosis

Brief summary: In this retrospective cohort study of patients with early Lyme neuroborreliosis (LNB), clinical and microbiologic characteristics and long-term outcome of definite vs. possible LNB were evaluated at a single university medical center in Slovenia. Severity of acute disease and long-term outcome during a 12-month follow-up were assessed using a composite clinical score based on objective clinical findings and subjective complaints.


Eligibility criteria: Inclusion Criteria:

* early Lyme neuroborreliosis

Exclusion Criteria:

* Not fulfilling study criteria for definite or possible Lyme neuroborreliosis
* Alternative diagnosis during follow-up
* Concomitant tick-borne encephalitis
* Clinical symptoms/signs present for \>6 months
* Data not available

Primary outcomes:
measure: composite clinical score
timeFrame: follow-up for 12 months-post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical center Ljubljana
Study officials:
References:
Clinical trial NCT06495658: Impact of Prebiotics in Ulcerative Colitis
Official title: The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.

Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.


Eligibility criteria: Inclusion Criteria:

* Ages 18 to 85 years old
* History of biopsy-proven ulcerative colitis (UC)
* Active symptoms (SCCAI \>2)
* Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment.
* Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.
* Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial

Exclusion Criteria:

* Prior colectomy
* Hospitalization
* Urgent need for abdominal surgery
* Unstable major medical condition
* Active malignancy under treatment
* Active alcohol or non-cannabinoid substance abuse
* Pregnancy or lactation
* Concerns for non-compliance

Primary outcomes:
measure: Clinical response
timeFrame: Week 8
measure: Microbial composition
timeFrame: Week 8
Secondary outcomes:
measure: Clinical remission
timeFrame: Week 8
measure: Clinical response
timeFrame: Week 16
measure: Clinical remission
timeFrame: Week 16
measure: Microbial composition
timeFrame: Week 16
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References:
Clinical trial NCT05836558: Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term?
Official title: Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Disease
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated with mitral valve repair in right minithoracotomy to treat degenerative mitral valve disease

Brief summary: Mitral regurgitation (MR) is a disease affecting the mitral valve that it causes a volumetric and pressure overload in the left chambers due to the leak of the unidirectionality normally guaranteed by the heart valve system.

The gold standard for severe mitral regurgitation is currently surgical mitral valve repair (PLM) using longitudinal median sternotomy to expose the heart Since the mid-1990s, the right mini-thoracotomy, ie a surgical access with cut in the 3rd or 4th intercostal space that would allow to reduce the size of the surgical site making it less traumatic and more aesthetic, addressing mainly a young target population.

Since the 2000s this method has spread more and more, expanding all over the world and spreading especially in the United States and Germany. This method has been progressively used in the treatment of the whole mitral valve surgery starting from valve repair up to prosthetic replacements.

Mitral valve repair through minimally invasive access in degenerative pathology has made it possible to obtain excellent long-term results, with low recurrence rates of regurgitation. In our center the results on the first 48 patients have been published in 2005 by Lapenna et al. Over the years this method has been adopted in thousands of patients worldwide, however the data present in the literature they stop at a follow-up of about 10 years. In 2017 De Bonis et al. of the San Raffaele Hospital have published the outcome of a particular subgroup of patients (bileaflet prolapse) treated with minimally invasive access, comparing them with as many subjects subjected to the same method of mitral repair ("edge-to-edge technique or Alfieri stitch"), obtaining superimposable long-term results (about 14 years old).

The goal of the present study is to analyze very long-lasting results in patients treated with mitral valve surgery with access in right mini-thoractotomy.


Eligibility criteria: Inclusion Criteria:

* patients with degenerative mitral regurgitation
* patients treated with mitral valve repair in right minithoracotomy

Exclusion Criteria:

* median sternotomy

Primary outcomes:
measure: Mortality
timeFrame: through study completion, a minimum of 16 years
Secondary outcomes:
measure: Reintervention
timeFrame: through study completion, a minimum of 16 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT03410758: Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus
Official title: Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Esophageal Surgery Cancer
Overall Survival
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 245
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: Adult patients undergoing esophagectomy for esophageal cancer

Brief summary: Prospective study of Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus


Eligibility criteria: Inclusion Criteria:

* Patients undergoing during inclusion time carcinologic esophagectomy for esophageal cancer (Adenocarcinoma or epidermoid carcinoma)

Exclusion Criteria: Mortality within 90 postoperative days

-

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: