louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03653936: Neuro-ocular Baselines in a Sports Setting
Official title: Neuro-ocular Baselines in a Sports Setting: Feasibility Study for Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wave Form Signals Coming From the Eye in a Healthy Cohort
Lead sponsor: Rebiscan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BlueGrass Orthopaedics Surgery & Hand Care
First posted: 2018-08-31
Enrollment: 63
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort study of individuals tested with the Rebion device followed by SCAT3 examination. Two data sets will be taken and compared: a cohort with non-contact sport athletes (swimmers, tennis, track) and a cohort of contact sport athletes (lacrosse, spring football, and spring soccer).

Brief summary: Rebion (Rebiscan, Inc) has developed a noninvasive, handheld device that uses retinal birefringence scanning (RBS) to rapidly assess eye fixation and retinal integrity in adults and children. The proprietary technology uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. The project described herein aims to provide accurate assessment of brain dysfunction in TBI (Traumatic Brain Injury) patients through the use of the developed device, which is called the Head and Intraocular Trauma Test (HITT) device.


Eligibility criteria: Inclusion Criteria:

* Student-athletes who present to schools affiliated with the Bluegrass Sports Clinica
* Engaged in sports
* Older or equal to 11 years of age, and less than 21 years of age.
* Provide informed consent; youths must have their parents sign the informed consent document. Children will be presented with a written assent statement and that they will be asked to sign the assent document.

Exclusion Criteria:

* Catastrophic polytrauma that would interfere with follow-up and outcome assessment
* Amblyopia/strabismus
* Pregnancy in female subjects
* Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
* History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
* Intoxication or chemical impairment at time of examination (upon initial presentation)

Primary outcomes:
measure: Capturing of wave forms from the eye
timeFrame: Screenings will be performed during a normally scheduled visit to the sports facility by the research group enrolling in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: BlueGrass Orthopaedics
state: Kentucky
Study officials:
affiliation: Bluegrass Orthopaedics
name: Harry Lockstadt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00480636: Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
Official title: Fragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Deep Vein Thrombosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients are identified in primary care setting.

Brief summary: To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

Detailed description: Method: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Eligibility criteria: Inclusion Criteria:

* Male or female patient of 18 - 70 years of age.
* Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.

Exclusion Criteria:

* Bleeding
* Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.
* Serum creatinine level \> 150 umol/l.
* Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy.
* Patient on oral anticoagulation therapy in the last 7 days.

Primary outcomes:
measure: Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
timeFrame: Month 6 or End of Treatment (EOT) (up to Month 6)
Secondary outcomes:
measure: Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood
timeFrame: Baseline through Month 6 or EOT (up to Month 6)
measure: Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)
timeFrame: Baseline through Month 6 or EOT (up to Month 6)
measure: Percent of Participants With and Without Pulmonary Embolism (PE)
timeFrame: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)
measure: Number of Participants With Recurrent DVT
timeFrame: Month 6 or EOT (up to Month 6)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04163549: Evaluating the Effectiveness of the Safe at Home Program
Official title: Evaluating the Effectiveness of the Safe at Home Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Functioning
Domestic Violence
Child Abuse
Lead sponsor: International Rescue Committee
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of the pilot RCT examining the potential effectiveness of the Safe at Home program in DRC are to:

1. Determine the potential effectiveness of Safe at Home program on improvements of family functioning and secondary outcomes of reductions in intimate partner violence and child maltreatment
2. Determine the potential effectiveness of the Safe at Home program on changes in pathway outcomes such as attitudes towards harsh discipline, gender attitudes, power-sharing, positive parenting practices, etc.

Detailed description: For the pilot RTC, quantitative data will be collected from up to 420 individuals participating in the Safe at Home program in the North Kivu, DRC. The 420 individuals comprising the study population will be 210 couples, of which both the male and female partners will be asked to participate in the study. After baseline data collection is completed, within each of the four sites where the program will occur in North Kivu, DRC, two groups of couples will be formed (n=8 groups total). Each group will be formed based on geographical proximity and will mirror real-life implementation of the program and ensure high fidelity to program design and limit contamination or spillover of Safe at Home to the control groups. Groups will then be randomized to receive Safe at Home in Cycle 1 or be waitlisted to receive Safe at Home in Cycle 2. After randomization is completed the Cycle 1 programming will commence. Following a waiting period of 3 months after the program ends, the endline survey will be administered. Subsequently Cycle 2 cohort will receive programming.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* registered for the Safe at Home program
* living with intimate partner who is also registered for the program and at least one child aged 6-12
* speaker of Swahili, Kinyarwanda, or French

Exclusion criteria includes:

* \< 18 years of age
* being of a polygamous household
* not registered for program
* obvious mental, or cognitive, or communication difficulties.

Primary outcomes:
measure: Family functioning
timeFrame: Three months after intervention completion
Secondary outcomes:
measure: Intimate partner violence
timeFrame: Three months after intervention completion
measure: Harsh discipline
timeFrame: Three months after intervention completion
Other outcomes:
Locations:
city: New York
country: United States
facility: International Rescue Committee
state: New York
Study officials:
affiliation: International Rescue Committee
name: Kathryn Falb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01130649: Remote Tracking of Epilepsy Patients
Official title: Pilot Study of Real-time Automated Tracking System for Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Epilepsy
Keywords: Epilepsy
Tracking
Electronic diary
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
First posted: 2010-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from the UCSF and VAMC Outpatient Epilepsy Centers. All study participants must have a confirmed diagnosis of epilepsy (defined by two or more unprovoked seizures) for at least 6 months.

Brief summary: The investigators propose a novel method for tracking the seizure frequency, side effect burden, and medication compliance for patients with epilepsy. The investigators intend to utilize a table-top device currently for tracking other chronic disease to collect remote data from epilepsy patients. The hypothesis is that the use of this device will lead to better longterm treatment outcomes than the standard outpatient mechanism of following patients longitudinally.


Eligibility criteria: Inclusion Criteria:

* Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded.

Patient can range in age from birth to 65 years old; in cases of child participants, the parents are responsible for data reporting.

* Patients must have a seizure frequency of at least two seizures in a 6 month period of time.
* Patients must be on at least one anti-epileptic medication.
* Patients and/or legal guardian must be able to report seizure frequency with either a paper or electronic diary.
* Patients and/or legal guardians must be able to read and understand either English or Spanish.
* Patients and/or legal guardians must be able to complete questionnaires and provide informed consent to this study.

Exclusion Criteria:

* Exclusion criteria include: a diagnosis of psychogenic nonepileptic seizures; severe depression, anxiety, or psychosis
* Recent problem with substance abuse.

Primary outcomes:
measure: Seizure frequency per month
timeFrame: 1 year
measure: Medication compliance
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Univ of California San Fran
state: California
Study officials:
affiliation: University of California, San Francisco
name: John Hixson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04038749: Satisfaction of Patients With the Chosen Method of Inhibition of Lactation
Official title: Satisfaction of Patients With the Chosen Method of Inhibition of Lactation: With the Use of Drugs Lowering the Level of Prolactin or Without the Use of Pharmacological Agents in Postnatal Period, Taking Into Account Individual Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lactation Suppressed
Lead sponsor: Żelazna Medical Centre, LLC
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to improve the standard of care in case of the inhibition of lactation.

The participant qualified for the study will answer the questions contained in the survey. The patient will have her breast palpated and then will be instructed on the possible options for the inhibition of lactation. The participant, who decides to inhibit lactation with medications, will be consulted by a doctor.

Each patient will receive information of the possible ways to relieve the symptoms of overfilled breast and be able to contact with lactation consultant. The participant will also receive a card to assess the severity of symptoms in the following days. The investigators will call the patient between the third and fifth day by phone.

Once again, after 2 weeks from the beginning of the inhibition of lactation in order to ask questions contained in the survey (the course of the process, problems that occurred and the level of satisfaction with the chosen method).


Eligibility criteria: Inclusion Criteria:

* Mother during the period of six weeks after childbirth
* Decision to inhibit lactation
* Patient's age at the time of enrollment (at least 18 years old)

Exclusion Criteria:

* Less than 18 years of age
* Lack of patient's consent
* To the pharmacotherapy group- contraindications for the use of the medication

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: from the 1st day of the inhibition of lactation to 14th day of process
measure: Evaluation of breast status
timeFrame: from the 1st day of the inhibition of lactation to 14th day of process
measure: Symptoms in association with the ingestion of medicines that inhibit lactation.
timeFrame: from the 1st day of the inhibition of lactation to 14th day of process
measure: Breast palpation
timeFrame: 1st day of including in the study
measure: Survey: 1st day of including in the study
timeFrame: 1st day of including in the study
Secondary outcomes:
measure: Survey: 3rd-5th day of lactation suppression
timeFrame: 3rd-5th day of lactation suppression
measure: Survey: 14th-16th day of lactation suppression
timeFrame: 14th-16th day of lactation suppression
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Żelazna Medical Centre
Study officials:
affiliation: Centre of Postgraduate Medical Education
name: Dorota Sys, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02454049: Influence of Dietary Nitrate on Time Trial Performance in Swiss Paracycling Athletes
Official title: Influence of Dietary Nitrate on Paralympics 2016 Time Trial Performance in Swiss Elite Paracycling Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Nutritional Physiology
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2015-05-27
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate wether beetroot juice or sodium nitrate enhances time trial performance in Swiss paracycling athletes compared to the ingestion of a placebo supplement. Furthermore, the effects of beetroot juice and sodium nitrate on performance will be investigated in spinal cord injured and non-injured athletes.

Detailed description: The influence of dietary nitrate on performance will be tested performing a time trial on a handbike. The time trial will be the same as in the Paralympics 2016 in Rio. The subjects perform three trials and receive another supplement for each trial: beetroot juice with 6mmol nitrate, 6mmol sodium nitrate or plain water (placebo supplement). The time to complete the time trial will be the main outcome parameter.

Eligibility criteria: Inclusion Criteria:

* healthy paracycling athletes
* healthy, able-bodied, upper-body trained individuals

Exclusion Criteria:

* female
* smoking
* any medication affecting performance
* medical conditions affecting performance

Primary outcomes:
measure: time to perform trial
timeFrame: 3 hours after supplement ingestion
Secondary outcomes:
measure: oxygen consumption during time trial performance measured by a metabolic cart (Oxycon Pro) in ml/min/kg
timeFrame: 3 hours after supplement ingestion
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Centre
name: Claudio Perret, PD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05310149: Measuring the Influence of Maxillary Obturator Prosthesis on Facial Morphology in Patient With Unilateral Maxillary Defects Using Stereophotogrammetry
Official title: Measuring the Influence of Maxillary Obturator Prosthesis on Facial Morphology in Patient With Unilateral Maxillary Defects Using Stereophotogrammetry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Asymmetry
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Functional rehabilitation and quality of life after maxillofacial surgery have been emphasized in recent years. It depends mainly on outcomes of maxillofacial reconstruction and rehabilitation involving functions, esthetics, psychology acceptance and resocialization.

Tooth loss, alveolar and maxillary bone resorption or changes of the hard palate cause facial asymmetry in patient with maxillofacial surgery. The facial soft tissue over the defect become recessed as a result of loss of lip and buccal support which lead to decrease the quality of life and psychological disorders. Prosthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. The purpose of this study is to investigate the influence of maxillary obturator on facial morphology in patient with unilateral maxillary defect by using 3 dimensional digital stereophotogrammetry compared to the intact side of the same patient


Eligibility criteria: Inclusion Criteria:

* adult patient of both sexes, 6 months after partial maxillectomy with good periodontal condition of remaining tooth especially abutment tooth.

Exclusion Criteria:

* patient with history of radiotherapy, bad oral hygiene patient with tumor recurrence, patient with mental instability, patient with systemic disorders like uncontrolled diabetes, compromised heart function

Primary outcomes:
measure: Facial morphology
timeFrame: after 6 months of maxillofacial surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Hoor Nafade
Study officials:
References:
Clinical trial NCT01723449: Predictors for Admission to Emergency Department More Than 48 Hours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Length of Admission
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 730
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all admissions to Emergency department

Brief summary: In Demark acutely admitted patients are supposed to stay in the Emergency Department (ED) bed ward if the anticipated duration of stay is less than 48 hours.

However, it is not a trivial matter to estimate duration of stay for emergency patients. a number of factors affect this, eg. social background, disease, hospital organisation.

The aim of this study is to analyse whom are the best among the health staff to predict the length of stay: ED nurses, admitting doctors og the specialist, and to analyse if a number of variables can be used to improve the prediction.


Eligibility criteria: Inclusion Criteria:

all patients admitted to the Emergency Department -

Exclusion Criteria:

Children less than 15 years patients transferred from other hospitals

-

Primary outcomes:
measure: length of admission in hours
timeFrame: admission to discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Aabenraa Sygehus Emergency Department
Study officials:
References: