louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04193917: Confounding Factors in Ocular Surface Microbiome Research
Official title: Confounding Factors in Ocular Surface Microbiome Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Surface Microbiome
Keywords: Ocular surface microbiome
Temporal stability
Confounding factors
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A conjunctival swab will be taken from healthy volunteers
Primary purpose: DIAGNOSTIC

Brief summary: To elucidate confounding factors in ocular surface microbiome research and to confirm the presence of a core ocular surface microbiome and its temporal stability.

Detailed description: The investigator will take a conjunctival sample of both eyes of a group of volunteers together with an extensive questionnaire. Furthermore, 50 volunteers will be sampled repeatedly during one year or two years.

Eligibility criteria: Inclusion Criteria:

* The subject is fluent in written and verbal Dutch
* The subject is capable of giving informed consent

Exclusion Criteria:

* Use of glaucoma drops
* Use of antibiotic drops \< 1 month before sampling

Primary outcomes:
measure: Richness and evenness of distribution of the microbial flora measured as operational taxonomic units on a single moment
timeFrame: 20 minutes for samples and filling the questionnaires
measure: Change in richness and evenness of distribution of the microbial flora, measured as operational taxonomic units, over time
timeFrame: 20 minutes for the first sample and questionnaire, 5 minutes for all other visits
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, Department of Ophthalmology
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Heleen Delbeke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03329417: Neurorehabilitation Using a Virtual Reality-based Mirror Therapy
Official title: Effects of a Virtual Reality-Based Mirror NeuroRehabilitation System (VR-based MNRS) on Functional Performance of Upper Extremity for Unilateral Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation, Mirror Neurons, Stroke
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 134
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the proposed study, the investigators assumed that mirror therapy combined with virtual reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either virtual reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of stroke with unilateral side involved;
2. A score of Mini-mental state examination greater than 24 for proving higher mental function;
3. Time of onset \> 6 months before treatment begins, and
4. Premorbid right-handedness.

Exclusion Criteria:

1. Vision loss;
2. Major cognitive-perceptual deficit;
3. Other brain disease.

Primary outcomes:
measure: Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
timeFrame: baseline, 6 weeks and 18 weeks
measure: Change in the result of Modified Ashworth scale (MAS)
timeFrame: baseline, 6 weeks and 18 weeks
measure: Change in the result of Box and blocks test
timeFrame: baseline, 6 weeks and 18 weeks
measure: Change in the result of Semmes-Weinstein monofilament (SWM) test
timeFrame: baseline, 6 weeks and 18 weeks
measure: Change in the result of Motor Activity Log
timeFrame: baseline, 6 weeks and 18 weeks
Secondary outcomes:
measure: Change in Power Spectrum of the Electroencephalography (EEG)
timeFrame: baseline and 6 weeks
measure: Changes in Cortical Excitability Assessed by Transcranial Magnetic Stimulation
timeFrame: baseline and 6 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
citation: Hsu HY, Kuo LC, Lin YC, Su FC, Yang TH, Lin CW. Effects of a Virtual Reality-Based Mirror Therapy Program on Improving Sensorimotor Function of Hands in Chronic Stroke Patients: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Jun;36(6):335-345. doi: 10.1177/15459683221081430. Epub 2022 Mar 28.
Clinical trial NCT02035917: Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tibial Fracture
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-01-14
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: this study will perform to compare the results and functional outcomes of tibial plateau fractures treated with non-locking and locking plate fixation.


Eligibility criteria: Inclusion Criteria:

* unilateral closed tibia plateau fracture

Exclusion Criteria:

* patients who have been treated with casting or screw
* history of diabetes mellitus
* evidences of pathological fractures

Primary outcomes:
measure: knee society knee score
timeFrame: ten months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
Study officials:
affiliation: Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran
name: Mohammad Ali Tahririan, Orthopedic surgeon
role: STUDY_DIRECTOR
affiliation: Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran
name: Mohsen Derakhshan, Orthopedic surgery resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05766917: Peer Education on Core Health Outcomes Specific for Burn Patients
Official title: Effectiveness of Peer Education on Core Health Outcomes Specific for Burn Patients: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Burn Specific Health Scale
Burn patients
Peer education
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluate the Effectiveness of Peer Education on Core Health Outcomes Specific for Burn Patients

Detailed description: A randomized controlled study will done in the Plastic \& Reconstructive Burn Center at Mansoura University Hospitals. the first phase includes the systematic collection of data to assess patient's health status and determine any actual or potential health problems after necessary permission taken.

The researcher will design the proposed peer education and educational media based on the findings of the assessment.

After peers training, implementing peer education for the study group. The final step of data collection is evaluating the patient's response to the proposed program and the extent to which the outcomes have been achieved.

Eligibility criteria: Inclusion Criteria for patients:

Recently admitted patients

* Hemodynamically stable and Free from chronic disease
* Conscious, able to communicate

Inclusion criteria for peer:

* old burns injury patients at least have a diploma degree

Exclusion Criteria:

-

Primary outcomes:
measure: change in Burn Specific Health Scale measurements
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Heba Abubakr Salama
Study officials:
affiliation: Mansoura University, Faculty of Nursing
name: Ola E Elsherbiny, pHD
role: STUDY_CHAIR
References:
Clinical trial NCT03932617: Correlation Between Changes in End-Tidal Carbon Dioxide and Stroke Volume Variation Detected by Electrical Cardiometry as A Predictor of Fluid Volume Responsiveness in Hemodynamically Unstable Patients in the Intensive Care
Official title: Correlation Between Changes in End-Tidal Carbon Dioxide and Stroke Volume Variation Detected by Electrical Cardiometry as A Predictor of Fluid Volume Responsiveness in Hemodynamically Unstable Patients in the Intensive Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Tidal Carbon Dioxide
Cardiometry
Fluid Responsiveness
Shock
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tanta University Hospital at surgical intensive care unit (SICU).

Brief summary: This study will be conducted to assess the role of end-tidal carbon dioxide (PETCO2) monitoring to predict the fluid volume responsiveness in correlation with stroke volume variation detected by electrical cardiometry in patients with hemodynamic instability.


Eligibility criteria: Inclusion criteria:

* Patients who will be 18 years or older.
* Patients on mechanical ventilation in the intensive care.
* Patients developing hypotension (MABP) \<65 mmHg.

Exclusion Criteria:

* Patients with organ/s failure at presentation.
* Patients with deep venous thrombosis.
* Patients with limb and pelvic fractures.
* Pregnant patients

Primary outcomes:
measure: Assessment of sensitivity and specificity of end tidal carbon dioxide monitoring in predicting fluid responsiveness in correlation with stoke volume variation detected by cardiometry
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT05633017: Breathing With a Facemask Exercise Performance
Official title: Measuring Exercise Performance and Perception With Facemask Resistance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: CereVu Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: John Muir Health
First posted: 2022-12-01
Enrollment: 100
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: Patients undergoing respiratory therapy at John Muir Health which encompasses a variety of pulmonary conditions

Brief summary: This study will determine the dyspnea response in chronic lung disease volunteers during treadmill walking with and without added inspiratory resistance. This study will also determine the level of dyspnea and exercise sense of effort in individuals walking on a treadmill when elevations occur. Comparisons will be made of a participant's exercise response with and without increased inspiratory resistance. In this study, exercise performance will be analyzed based on physiological and perceptual measures. The participant will undergo two sessions: one session will be a standard exercise walking test without an inspiratory resistance; the other session will be the same standard exercise walking test while breathing with an inspiratory resistance equal to a N95 facemask (R=10-15 cmH2O/L/sec). Performance will be determined by physiological measures. Perception will be determined by scores based on numerical scales and automatically with the forehead Vitality remote monitoring sensor.


Eligibility criteria: Inclusion Criteria:

* Former pulmonary rehabilitation patients that are now participating in maintenance exercise classes
* Males and females with an age range of 18 years or older
* Subjects must be able to walk on treadmill for multiple sessions

Exclusion Criteria:

* The subjects in each experiment will be recruited for a distribution of gender, ethnicity and age

Primary outcomes:
measure: Correlation between dyspnea as measured by the device and reported dyspnea by subjects
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pleasant Hill
country: United States
facility: John Muir Health
state: California
Study officials:
affiliation: CereVu Medical
name: Alireza Akhbardeh, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03451617: Alpine vs. Xpedition: Evaluation of Stent Delivery System
Official title: Randomized Clinical Evaluation of Alpine® vs. Xpedition® Stent Delivery System of the XIENCE® Everolimus-eluting Stent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Coronary Intervention
Lead sponsor: University of Groningen
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2018-03-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate and compare the performance of two stent delivery systems for percutaneous coronary intervention with everolimus-eluting stent.

Detailed description: Rationale: The current gold standard for percutaneous coronary intervention (PCI) is the second generation drug-eluting stent (DES). The most commonly used DES is the everolimus-eluting stent (EES). New stent delivery systems for PCI with EES are developed to optimize strength, flexibility and pushability of the catheter. The effect on procedural time of new stent delivery systems has not yet been investigated in clinical practice.

Objective: To evaluate and compare the performance of two stent delivery systems for PCI with EES.

Study design: Randomized comparative trial with 500 patients in the University Medical Center Groningen (UMCG).

Study population: All patients undergoing PCI with EES, aged 18 years or older, will be considered for eligibility. Patients will be excluded when scheduled for chronic total occlusion (CTO) PCI or if verbal informed consent cannot be obtained.

Intervention: The first group will undergo PCI with the XIENCE EES using the Alpine stent delivery system, the second group will undergo PCI with the Xpedition stent delivery system.

Main study parameters/endpoints: The primary endpoint is the proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes. Secondary endpoints include procedural time (from heparin administration to removal of catheter sheath, mins), use of additional materials, total procedural costs, radiation dose (μGym2), radiation time (mins), and contrast dose (ml).

Eligibility criteria: Inclusion Criteria:

* All patients undergoing PCI with EES, aged 18 years or older

Exclusion Criteria:

* Chronic total occlusion (CTO) PCI
* Inability to obtain (verbal) informed consent

Primary outcomes:
measure: Crossing time
timeFrame: During PCI procedure
Secondary outcomes:
measure: Procedural time
timeFrame: During PCI procedure
measure: Total procedural costs
timeFrame: During PCI procedure
measure: Radiation dose
timeFrame: During PCI procedure
measure: Radiation time
timeFrame: During PCI procedure
measure: Contrast dose
timeFrame: During PCI procedure
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT04544917: SmartManage Stress Management for HIV+ Cancer Survivors
Official title: Development of an eHealth-based Cognitive Behavioral Stress and Self-Management Intervention to Reduce Symptom Burden in HIV+ Gay and Bisexual Men Who Have Sex With Men (MSM) Treated for Non-Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Hiv
Stress
Keywords: Symptom burden
Cognitive behavioral stress management
Intervention development
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2020-09-10
Enrollment: 32
Sex: MALE
Minimum age (years): 18
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 design and refine a web-based platform developed for managing symptom burden in men who have sex who are HIV+ cancer survivors.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 years or older
2. Fluent in English
3. Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer
4. Be at least 30 days post active primary cancer treatment
5. Self identify as a sexual minority cisgender man
6. Self-report having been diagnosed with HIV
7. Have reliable access to a computer/device with internet accessibility

Exclusion Criteria:

1. Have had one of the following exclusionary cancer types: Non-melanoma skin cancer, brain cancer, eye cancer, history of some form of pediatric cancer (if that is participant's only cancer diagnosis)
2. History of advanced (metastatic) cancer of any type
3. Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk
4. Appears actively intoxicated or otherwise unable to provide full informed consent
5. Have any other medical condition resulting in predicted live expectancy of less than 12 months

Primary outcomes:
measure: Proportion of eligible SMM that agree to participate
timeFrame: Up to one year
Secondary outcomes:
measure: USE Questionnaire Scores
timeFrame: Week 10
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Frank J Penedo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00626717: Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
Official title: Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Keratoconus
Keywords: Keratoconus
Cross linking
Riboflavin
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Peschke Meditrade, GmbH
First posted: 2008-02-29
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression.

Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be.

Methods: Randomised, placebo controlled, double blinded, multicenter trial.


Eligibility criteria: Inclusion Criteria:

* Only early Keratoconus (Contact lens fitting)
* Progression of Ametropia.
* Corneal thickness \> 450µm

Exclusion Criteria:

* Further ophthalmic diseases
* History of ocular surgery
* Pregnancy, brest feeding
* Allergy against Riboflavin
* End stage Keratoconus

Primary outcomes:
measure: Keratoconus progression
timeFrame: 3 years
measure: Endothelial cell loss
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Eye Hospital Freiburg
state: Baden-Württemberg
Study officials:
affiliation: University Eye Hospital, Freiburg
name: Philip Maier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang SJ, Messmer EM, Geerling G, Mackert MJ, Brunner T, Dollak S, Kutchoukov B, Bohringer D, Reinhard T, Maier P. Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus. BMC Ophthalmol. 2015 Jul 21;15:78. doi: 10.1186/s12886-015-0070-7.
Clinical trial NCT06993324: Awareness of Families With Down Syndrome Children About the Role of Physical Therapy in Egypt
Official title: Awareness of Family With Down Syndrome Children About the Role of Physical Therapy Amongst Egyptian People
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Down Syndrome (DS)
Keywords: Awareness
Genetic Disorders
Physical Therapy
Egypt
Down Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes family members and primary caregivers of children with Down Syndrome in Egypt. The participants will complete a questionnaire designed to assess their awareness of the role of physical therapy in managing developmental challenges.

Brief summary: This study explores how much families with children who have Down Syndrome in Egypt know about the benefits and role of physical therapy. By understanding their awareness, hope to improve education and support so that these families can better access physical therapy services that can help improve their children's quality of life.

Detailed description: This cross-sectional study aims to assess the awareness of families with children who have Down Syndrome regarding the role of physical therapy in Egypt. Data will be collected via a validated questionnaire distributed to family members to evaluate their knowledge and perceptions about physical therapy interventions. The study seeks to identify gaps in awareness and inform strategies for improving educational outreach and support for these families.

Eligibility criteria: Inclusion Criteria:

* Parents/guardians of children diagnosed with DS.
* Egyptian residents.
* Consent to participate in the study
* Aged 18 years or older

Exclusion Criteria:

* Families with children who have conditions other than DS.
* Participants who do not provide informed consent.

Primary outcomes:
measure: Awareness Level of Families About the Role of Physical Therapy
timeFrame: "Baseline (single assessment using questionnaire at the beginning of the study)"
Secondary outcomes:
measure: Factors Influencing Awareness of Physical Therapy Among Families
timeFrame: "Baseline (single assessment using questionnaire at the beginning of the study)"
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Cairo
Study officials:
affiliation: Cairo University
name: Maya G Aly, Assistant Professor
role: STUDY_DIRECTOR
References: