louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00414219: Visual Prognosis in Non-Penetrating Corneal Blast Injuries
Official title: Visual Prognosis in Non-Penetrating Corneal Blast Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Foreign Body Following Blast Injury
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
First posted: 2006-12-21
Enrollment: 40
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: US Army patients age 18 years and older prsenting with corneal foreign bodies from non-penetrating ocular blast injuries

Brief summary: The purpose of this study is to assess visual quality of patients with non-penetrating, non-metallic, stable corneal foreign bodies. Visual quality will be assessed by examining visual acuity, wavefront analysis and contrast sensitivity. Drawings, photographs, and confocal microscopy will be used to document clinical examination of the cornea at baseline and on follow-up examinations.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Access to medical care at Walter Reed Army Medical Center
* Age 18 years or older
* Corneal foreign bodies from blast injuries
* Available for evaluation at Walter Reed

Exclusion Criteria:

* Residual, recurrent or active ocular disease in the designated eye as determined by exam and history.
* Penetrating ocular trauma or injury to the posterior segment
* Prior history of ocular surgery
* Any physical or mental impairment that would preclude participation in any of the examinations.
* Any ocular abnormality other than corneal foreign bodies that have any impact on vision (i.e. other abnormalities from trauma such as retinal detachment, corneal laceration, traumatic cataract, or abnormalities unrelated to trauma such as herpes.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Ophthalmology Service, Walter Reed Army Medical Center
name: Dain Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252119: High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
Official title: High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis, Viral
Lead sponsor: Chris Hani Baragwanath Academic Hospital
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled, and randomized to either "high flow humidified oxygen" or "standard therapy".

Detailed description: A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for enrollment shall be considered eligible. Informed consent from parents or legal guardians shall be obtained. Infants shall be randomized to either "standard therapy" or "high flow humidified oxygen". Measurements of heart rate, respiratory rate, work of breathing (Tal score and WCAS), oxygen saturation and oxygen requirements shall be recorded.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of viral bronchiolitis
* Not requiring intubation and ventilation
* Admitted to high care unit
* With moderate/severe respiratory distress (Tal score \>6)
* Saturations \<92% in room air

Exclusion Criteria:

* congenital cardiac disease
* presence of multiorgan failure/multisystemic disease
* previously ventilated
* craniofacial abnormalities
* nasal pathology
* decreased level of consciousness
* Ex-prem \<34 weeks
* Possible impending respiratory failure

Primary outcomes:
measure: Effect of high flow humidified oxygen therapy on work of breathing
timeFrame: during first 5 days post enrollment
measure: Effect of high flow humidified oxygen therapy on work of breathing
timeFrame: first 5 days post enrollment
measure: Effect of high flow humidified oxygen therapy on blood oxygen saturations
timeFrame: first 5 days post enrollment
measure: Effect of high flow humidified oxygen therapy on heart rate
timeFrame: first 5 days post enrollment
Secondary outcomes:
measure: Proportion of patients requiring intubation and ventilation
timeFrame: from time of enrollment to end of hospital stay (up to 6 months)
measure: Length of hospital stay
timeFrame: from time of enrollment to end of hospital stay (up to 6 months)
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: Gauteng
Study officials:
affiliation: University of the Witwatersrand, Johannesburg
name: Susan M Murphy, FCPaed (SA)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02508519: Study of Zonal and Balance Acupuncture Pain Relief Effect
Official title: Study of Zonal and Balance Acupuncture Pain Relief Effect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Syndrome
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate how effective is zonal acupuncture method compared to balance method to obtain a short coming pain relief effect, which takes place several minutes after needle insertion.

Detailed description: Main purpose of the study is to estimate the efficiency of the zonal acupuncture method compared to control group and the balance acupuncture method.

This study includes random completion of 3 groups of participants : zonal acupuncture, control group, balance acupuncture approximately 20 participants each.

The zonal acupuncture group will receive a treatment according to a zonal method and a pain level will be estimated by the investigator according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.

The control group will provide only the estimation of the the pain level according to a visual analog pain scale (VAS) but receive no acupuncture treatment. Then if possible the pain level will be measured again approximately 24 hours after the first measurement and the change of the pain level will be recorded for a control group too.

The balance acupuncture group will receive a treatment according to a balance method, and a pain level will be estimated according to a visual analog pain scale (VAS) before and 10 minutes and 15 minutes after the beginning of the treatment and the change of the pain level will be recorded. If possible the pain level will be measured again approximately 24 hours after the treatment and the change of the pain level will be again recorded.

These measurements are primary outcome of the experiment. Provided statistically consistent they will be treated to extract method efficiency estimation.

The participants from all tree groups may receive drug analgesia at some recorded moment of time before the procedure, however the investigators want to investigate the effect of acupuncture analgesia at the time when no other analgesia effect is present, so the investigators can exclude possible interference.

Eligibility criteria: Inclusion Criteria:

* post traumatic pain syndrome
* vertebrogenic pain syndrome

Exclusion Criteria:

* oncological diseases
* narcotic dependency
* psychiatric disorders

Primary outcomes:
measure: Change of the Pain level on the VAS scale
timeFrame: 10 minutes, 15 minutes, 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00333918: Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery
Official title: Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Inflammation
Keywords: Cataract Extraction
Anti-Inflammatory Agents, Non-Steroidal
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 522
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: The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.


Eligibility criteria: Inclusion Criteria:

* Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
* Agree to return for all required visits
* Agree to avoid disallowed medications

Exclusion Criteria:

* Known hypersensitivity to bromfenac and salicylates

Primary outcomes:
measure: Reduction of ocular inflammation
Secondary outcomes:
measure: Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free
Other outcomes:
Locations:
city: Irvine
country: United States
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Ralph Bianca, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03781518: Mandibular Ridge Splitting Versus Khoury Shell Technique
Official title: Mandibular Ridge Splitting With Complete Separation of the Buccal Cortical Plate Versus Khoury Shell Technique for Horizontal Augmentation of Atrophic Posterior Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Horizontal Augmentation of Atrophic Posterior Mandible
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mandibular ridge splitting with complete separation of the buccal cortical plate versus Khoury shell technique for horizontal augmentation of atrophic posterior mandible


Eligibility criteria: Inclusion Criteria:

* Patients with atrophic mandible with residual bone width 3 to 4 mm.
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* • Any pathology in the posterior mandible.

  * Heavy smokers more than 20 cigarettes per day.
  * Patients with systemic disease that may affect normal healing.
  * Psychiatric problems
  * Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Primary outcomes:
measure: Amount of horizontal bone gain (bone width)
timeFrame: 4 months
Secondary outcomes:
measure: Soft tissue healing
timeFrame: 1 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03963518: Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)
Official title: Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Treated With Immune-checkpoint Inhibitors
Keywords: cancer
trial
immune-checkpoint inhibitors
meta-analysis
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-05-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in phase III randomized clinical trials (RCT) / Metastatic melanoma

Brief summary: The objective of this research work is two-fold: (i) to conduct a systematic literature review to identify surrogate endpoints in this specific drug class (review registered in the PROSPERO database) and (ii) to assess the surrogate properties of candidate surrogate endpoints in the specific context of melanoma cancer.


Eligibility criteria: Inclusion Criteria:

* Patients included in phase III randomized clinical trials (RCT)
* Metastatic melanoma

Exclusion Criteria:

* N/A

Primary outcomes:
measure: overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié, Comprehensive Cancer Center
Study officials:
affiliation: Institut Bergonié
name: Carine A Bellera, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branchoux S, Bellera C, Italiano A, Rustand D, Gaudin AF, Rondeau V. Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review. Crit Rev Oncol Hematol. 2019 May;137:35-42. doi: 10.1016/j.critrevonc.2019.02.013. Epub 2019 Mar 1.
Clinical trial NCT06364618: Use of Wearables to Detect Infections in Kidney Transplant Recipients
Official title: Use of Continuous Biomonitoring for Detection of Infectious Complications in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Transplant Infection
Keywords: biometric data
continuous monitoring
machine learning
early alert system
infection
kidney transplantation
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2024-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients followed at the Institute for Clinical and Experimental Medicine.

Brief summary: The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies.

The main questions it aims to answer are:

1. What are the biometric data pattern changes in impending infections?
2. What accuracy the machine learning algorithm can achieve?

Participants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection.


Eligibility criteria: Inclusion Criteria:

* kidney transplant recipient
* age 18 years or more
* kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2)

Exclusion Criteria:

* recipient of another transplanted organ
* terminal failure of another organ (heart, liver, lung)
* diabetes mellitus type 1
* pregnant or breastfeeding woman
* refusal to give informed consent

Primary outcomes:
measure: Accuracy of the algorithm at detecting infections at presymptomatic stage
timeFrame: The primary endpoint will be assessed periodically throughout the study, up to 24 months.
Secondary outcomes:
Other outcomes:
measure: Rate of in-patient admissions
timeFrame: Periodically throughout the study, up to 24 months.
measure: Incidence of decrease/increase of Quality of Life
timeFrame: Periodically throughout the study, up to 24 months.
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
References:
Clinical trial NCT06623318: IV Ensure in Patients Receiving OPAT
Official title: IV Ensure in Patients Receiving OPAT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Determine If Adherence Rates with IV Antibiotics in OPAT Have a Correlation to Hospital Readmission Rates
Keywords: OPAT
IV antibiotic
Adherence
home infusion
readmission
Lead sponsor: IV Ensure
Sponsor class: INDUSTRY
Collaborators: name: University of Oklahoma
First posted: 2024-10-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigation will be designed as a retrospective cohort study, in which assignment to the IV Ensure device is determined based on patient discharge status (home IV for antimicrobial therapy) and current device allocation. Patients will be assigned to IV Ensure subsequent to their initial health encounter for their admitting diagnosis. The non-treatment group will be assigned to home infusion therapy using the current standard of care of OU Medicine. This group is required in order to assess whether the usage of the IV Ensure device is associated with a reduction in subsequent readmission risk due to infection.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of remote therapeutic monitoring is to provide oversight and evaluation of patients receiving IV medications in the home setting post-acute. The goal is to improve patient outcomes and decrease re-admission rates for related diagnoses due to poor adherence. Remote therapeutic monitoring provides data used in the determination of dates, times, and duration of doses administered in the home setting to support real-time intervention by dedicated care managers to support improved adherence with prescribed dosing regiments. The objectives of the study are to:

1. Determine adherence rates for IV medications administered in the home.
2. Assess re-admission against adherence rates.


Eligibility criteria: Inclusion Criteria:

* Adult patients enrolled in OPAT (IV antibiotic therapy) discharged to the home setting will be included in the study.

Exclusion Criteria:

* Patients enrolled in OPAT (IV antibiotic therapy) discharged to nursing homes, SNF (Skilled Nursing Facility), and pediatric patients will be excluded from the study.

Primary outcomes:
measure: Readmission due to subsequent related infection following the initial encounter.
timeFrame: From enrollment to 30 days after completion of prescribed IV medication.
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: The University of Oklahoma Health Sciences Center
name: Joseph Sassine, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06935318: Effects of High Functional Resistance Training Program on Arterial Stiffness
Official title: Effects of an 11-Week High Functional Resistance Training Program on Indices of Arterial Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Training Study
Keywords: pulse wave velocity
beta-stiffness index
central arterial blood pressure
CrossFit training
Lead sponsor: Salisbury University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Study examined the effects of CrossFit training on blood vessels. The results indicate long term CrossFit training does not harm blood vessel function.

Detailed description: Arterial stiffness is a systemic loss of elastic properties that significantly augment cardiovascular disease risk in adults. Chronic aerobic and anaerobic exercise activity has consistently been shown to attenuate or not affect markers of arterial stiffness in adults with chronic disease and otherwise healthy adults. Chronic high functional resistance training's effect on vascular compliance is less understood. The study aimed to determine the impact of a chronic high functional resistance training program on pulse wave velocity and beta-stiffness index. Accordingly, participants (18-40 years old) were placed in a non-randomized fashion into high functional resistance training (HIB) group (n = 9; \>6 months of CrossFit experience; 4 female) or control (CON) group (n = 8; \< 6 months of exercise experience; 6 female). Participants in the HIB group trained at the same local facility 4 -5 days a week, utilizing the same training program. CON group refrained from exercise during the study period. Body composition, 1,000-meter rowing test, deadlift 1 repetition maximum (1 RM), hemodynamic assessments, and vascular compliance were assessed at baseline and follow-up.

Eligibility criteria: Inclusion Criteria:

* body weight stability with no more than ± 2.5 kg fluctuations in last six month

Exclusion Criteria:

* hypertension
* heart disease
* cancer
* diabetes
* renal disease
* hepatic disorders
* history of tobacco use.

Primary outcomes:
measure: Pulse wave velocity
timeFrame: From enrollment to the end of treatment at 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salisbury
country: United States
facility: Salisbury University
state: Maryland
Study officials:
References:
citation: Garcia-Mateo P, Garcia-de-Alcaraz A, Rodriguez-Perez MA, Alcaraz-Ibanez M. Effects of Resistance Training on Arterial Stiffness in Healthy People: A Systematic Review. J Sports Sci Med. 2020 Aug 13;19(3):444-451. eCollection 2020 Sep.
Clinical trial NCT04986618: The Effect of Nordic Exercise on Children's Agility
Official title: Investigation of the Effects of One-Way and Two-Way Nordic Exercise on the Agility of Active Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Performance in Children
Keywords: soccer
child
agility
nordic
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 54
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this research is to investigate the effect of one-way and two-way Nordic exercise on the agility of active children. Children who meet the necessary criteria will be randomly assigned to one-way Nordic exercise group, two-way Nordic exercise group and control group by drawing lots. Volunteers in the training group will participate in a four-week training, two sessions per week. Agility will be assessed at baseline and after four weeks with the T-agility test. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 8-12
* To be actively participating in football training.

Exclusion Criteria:

* Those with orthopedic, neurological and congenital problems.
* Those with any systematic disease.
* Those who have experience taping before.
* Those who have undergone any surgery within the last 1 year.
* Those who have been absent from training for more than 2 weeks in the last three months.

Primary outcomes:
measure: T-Agility Test
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: