louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05104879: The Patient's Experience With Physician Assistant Providers (PEPAP)
Official title: The Patient's Experience With Physician Assistant Providers: a Descriptive Survey and Randomized Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Joint Diseases, Midlevel Providers, Nurse Practitioners, Physician Assistants, Patient Perceptions, Patient Preferences
Lead sponsor: Desert Orthopedic Center
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our investigation was a prospective cross-sectional survey evaluating the patient experience to new patients that presented to an outpatient private practice specialized in total joint reconstruction. New patients seeing a PA during their initial visit were randomized to intervention and control groups and all were given a descriptive survey at checkout. Inclusion criteria (1) new patient (2) English speaking (3) appointment with PA. There was no exclusion criteria. Eligible patients were randomized to the intervention group (received biosketch card) or the control group (no card) using random number generator. Patients within the intervention group received a biosketch card during rooming, pre-clinician encounter, and were not informed about involvement. Both groups received standard care that was independent of the study. To blind the outcome measure, the research assistant did not explain the reason for the card upon rooming. The provider PA was not informed which patient received the card. Upon discharge, the patient completed a five-question survey regarding the clinic visit.


Eligibility criteria: Inclusion Criteria:

* New Patient
* Appointment with a PA

Exclusion Criteria:

* Non-English Speaker

Primary outcomes:
measure: Survey
timeFrame: Immediately following the visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01457079: Keloid Radiation Registry
Official title: Keloid Radiation Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keloid
Keywords: Keloid
Radiation Therapy
Hypertrophic Scar
Lead sponsor: Tirgan, Michael H., M.D.
Sponsor class: INDIV
First posted: 2011-10-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study intends to enroll all patients who have had, or will be receiving radiation therapy for their keloid(s).

Brief summary: Radiation therapy has been, and is being used in treatment of patients with keloid. Radiation is typically used as an adjunct to surgery in order to reduce the recurrence rate of keloid.

Radiation therapy is not free of long term side effects. Radiation Therapy is known to cause secondary cancers. The investigators also do not have a good understanding as to how effective radiation therapy is in preventing recurrence of keloid.

Purposes of this study are to determine the long term safety as well as efficacy of radiation therapy when used for treatment of keloid.

Detailed description: The Keloid-Radiation project is a clinical registry of patients with keloid who have been treated with Radiation Therapy. This registry aims to monitor the at least 1,000 keloid patients who received radiation therapy to their keloid and to collect epidemiological and clinical data about these patients in order to assess the long term safety and effectiveness of radiation therapy.

Radiation is currently being used in the treatment of keloid, thus enabling the epidemiological characteristics of patients, analysis of treatment response, modeling the influence of risk factors on patients´ risk of developing long term complications such as a cancer, as well as the detailed analysis of the dose delivered, equipment used and radiation planning. This study intends to gather data about the long term efficacy and safety of radiation therapy and rate of developing secondary cancers in patients who have received radiation therapy for treatment of their keloid.

Eligibility criteria: Inclusion Criteria:

1. Clinically confirmed diagnosis of keloid
2. History of radiation therapy for treatment of keloid
3. All Ages
4. Signed informed consent form ( by parent or legal guardian if patient is under the age of 18)

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Michael H. Tirgan, MD
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Michael H Tirgan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04592679: Cost-Effectiveness Analysis of a Rehabilitation Protocol With FES Cycling in Persons With Complete SCI
Official title: FES Cycling Cost-Effectiveness Analysis in Rehabilitation for Persons Affected by Complete Spinal Cord Injury, an Experience From Two Italian Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: FESD
Rehabilitation
Spinal Cord Injuries
Complete Spinal Cord Injury
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 20 patients were recruited by two hospitals (AOUP and AOUC) in Italy from January 2015 to January 2018. The participants have been addressed to two different groups: the ones recruited by the AOUP were submitted to an experimental protocol of rehabilitation with FES Cycling, the ones recruited by the AOUC were submitted to a standard protocol of manual mobilization.

The primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20 cm) from the superior margin of the patella, while the secondary outcomes were the muscle tone evaluated with Modified Ashworth Scale (MAS) and the sensation of pain registered with International Spinal Cord Injury - Pain Basic Data Set (ISCI-P).

From these outcomes the Quality Adjusted Life Years (QALYs) was obtained. The costs of the two treatments were calculated through a consultation process with the Competent Offices of the two hospitals. The QALYs and the costs were used to calculate the Incremental Cost-Effectiveness Ratio (ICER) in order to verify the cost-effectiveness ratio of the two treatments.


Eligibility criteria: Inclusion Criteria:

* complete spinal cord injury
* loss of gait function
* any episode of autonomic dysreflexia
* any important range of motion limitation to hips, knees or ankles
* eccitability of the muscles
* FES tollerability

Exclusion Criteria:

* cognitive deficits
* psychiatric diseases
* cancer
* recent fractures

Primary outcomes:
measure: Incremental Cost-Effectiveness Ratio
timeFrame: 3 years
measure: Thigh Circumferences
timeFrame: 3 years
Secondary outcomes:
measure: Quality Adjusted Life Years (QALYs)
timeFrame: 3 years
measure: Costs
timeFrame: 3 years
measure: Muscle tone
timeFrame: 3 years
measure: Sensation of pain
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01044979: Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma
Official title: Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma, a Methodological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colloid Osmotic Pressure
Keywords: Colloid osmotic pressure in interstitial fluid
Colloid osmotic pressure in plasma
Protein fractions in interstitial fluid
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers over 18 years.

Brief summary: The purpose of this study is to evaluate a method of sampling interstitial fluid from subcutaneous sewn wicks.

Detailed description: Fluid loss from circulating plasma volume is one of the contributors of oedema formation. Measurement of colloid osmotic pressure (COP) both in plasma and in interstitial fluid can be utilised in planing of fluid therapy in patients with oedema. Different methods of sampling interstitial fluid are well validated in animal models, but not in human. Sampling of interstitial fluid by subcutaneous sewn wicks is a well-known method and can be painful. Local anaesthetics can reduce pain. By comparing interstitial fluid taken from areas with or without application of local anaesthetics, a possible influence in COP values can be detected.

Eligibility criteria: Inclusion Criteria:

* Adults over 18 years

Exclusion Criteria:

* Ongoing illness
* Medication

Primary outcomes:
measure: Colloid osmotic pressure
timeFrame: 60 and 90 minuttes after implanting wicks
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Hans Joergen T Guthe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guthe HJ, Nedrebo T, Tenstad O, Wiig H, Berg A. Effect of topical anaesthetics on interstitial colloid osmotic pressure in human subcutaneous tissue sampled by wick technique. PLoS One. 2012;7(2):e31332. doi: 10.1371/journal.pone.0031332. Epub 2012 Feb 14.
Clinical trial NCT02855879: Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft (CABG)
Official title: Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft, Consequences for Morbi/Mortality in the Short and Medium Term
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anomalies in Glucose Metabolism
Coronary Artery Bypass Graft
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients about to undergo coronary artery bypass grafting

Brief summary: The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients about to undergo coronary artery bypass grafting (CABG).

In addition, the effect of these anomalies on post CABG morbi/mortality in the short term will be evaluated.


Eligibility criteria: Inclusion Criteria:

* persons who have provided oral consent
* patients about to undergo coronary artery bypass grafting
* age \>18 years

Exclusion Criteria:

* persons without national health insurance cover
* Adults under guardianship
* Pregnant or breast-feeding women

Primary outcomes:
measure: Percentage of glucose anomalies (non-diabetic fasting hyperglycaemia, glucose intolerance, diabetes) in CAD patients about to undergo coronary artery bypass grafting.
timeFrame: Change from inclusion to week 2 and up to month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05983679: Prevalence of Sexually Transmitted Infections (STIs) and Coinfections in the General Population
Official title: Prevalence of Sexually Transmitted Infections (STIs) and Co-infections in the General Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infections
Lead sponsor: CerbaXpert
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of 9,000 participants meeting all the inclusion criteria will be recruited. A participant identification list will be created and maintained at clinical investigation sites, linking the participant's personal data to the code assigned in the research. The identification list of participants will be kept on the research site in paper or digital format classified in the investigator binder.

Brief summary: Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population


Eligibility criteria: Inclusion Criteria:

* Subject, male or female, 18 years of age or older
* Subject capable of understanding the purpose of the research having given their free and informed written consent
* Subject presenting to the laboratory for a biological examination
* Affiliated subject or beneficiary of a social security scheme

Exclusion Criteria:

- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: The prevalence of each STI will be assessed by the participant's positive or negative status for each pathogen, determined by the following screening tests:
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06790979: Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Traumatic Brain Injury
Official title: Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Mild to Moderate Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury (TBI); Concussion, Initial Encounter
Keywords: Traumatic brain injury
Sleep
Prognosis of trauma
Wearable devices
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Qualified inpatients hospitalized in our hospital

Brief summary: In patients with traumatic brain injury, post-traumatic sleep patterns have the potential to impact clinical prognosis. While some progress has been made in the study of sleep and prognosis in patients with traumatic brain injury, there is still lack of research on the relationship between sleep and clinical prognosis in post-traumatic patients due to differences in study design, patient age, severity of trauma, and definitions of sleep disorders. Additionally, the primary data collection methods employed in most studies have been self-reported sleep assessments, which are subject to potential biases and inaccuracies. Therefore, explore the impact of sleep patterns on clinical prognosis in post-traumatic patients, with potential to advance our comprehension of recovery outcomes in this patient group.


Eligibility criteria: Inclusion Criteria:

1. 18\~60 years old.
2. The patient had no sleep disturbance problems prior to traumatic brain injury.
3. The patient has a definite diagnosis of traumatic brain injury and the Glasgow score is \>8.
4. The patient had abnormal imaging scans.
5. It has complete preclinical data.

Exclusion Criteria:

1. Patients with a previous history of traumatic brain injury, mental illness, alcohol abuse or sleep disorders.
2. Patients admitted for surgical intervention.
3. Patients with a combination of other heavy visceral injuries.
4. Women during pregnancy and lactation.
5. The patents' use of medications that interfere with sleep

Primary outcomes:
measure: Change of cognitive function
timeFrame: 1st day and 30th day
measure: Change of executive function
timeFrame: 1st day and 30th day
Secondary outcomes:
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: The General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Zhanfeng Niu, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05755984: 3D Printed Breast Models in the Surgical Management of Breast Cancer
Official title: 3D Printed Breast Models in the Surgical Management of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: University Cancer Foundation via the Institutional Research Grant program at the University of Texas MD Anderson Cancer Center
First posted: 2023-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To learn if providing a 3-D printed model of the breast can help breast cancer patients make decisions related to their care. During this study, some study participants will receive the 3-D printed model and some study participants will receive traditional breast imaging scans to learn if the 3-D printed model

Detailed description: Primary Objective:

•The objective of this prospective study is to determine the impact of 3D printed breast models, compared to 2D imaging, on breast cancer patients' decisional conflict related to treatment decision-making.

Secondary Objective:

* To observe if patients will change their initial desired surgical option (mastectomy versus lumpectomy) after viewing the 3D printed models
* To evaluate the quality of the communication between surgical providers and patients with and without the 3D printed models
* To assess the surgical outcome including the margin status
* To evaluate patient satisfaction and well-being post-surgery between the 3D printed model group and the control group as well as mastectomy versus lumpectomy subgroups
* To assess surgical providers' response to the acceptability and utility of the model

Eligibility criteria: Inclusion Criteria:

* Age 18 or older female
* Patient must have histologically confirmed breast malignancy
* Patient is a candidate for surgical management
* Patient has a surgeon at MDACC (main campus and/or Houston Area Locations)
* Patient has a breast MRI for extent of disease assessment at MDACC (main campus and/or Houston Area Locations).
* Patient is able to speak, read or write English
* Patient is willing to be randomized to the control or 3D printed breast model groups and is willing to sign the consent form.

Exclusion Criteria:

* Pregnant and breastfeeding patients
* Patients who had history of mastectomy, have recurrent malignancies on the mastectomy side
* Patients for whom it is not feasible to create a 3D printed breast model from breast MRI

Primary outcomes:
measure: Decision Conflict Scale (DCS) score questionnaires
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lauren Chang Sen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04488679: Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials
Official title: Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Direct Pulp Capping
Keywords: platelet Rich fibrin , MTA
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 108
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: eligible carious teeth with exposed pulp by the undergraduate students will be randomly divided into two groups to be treated with direct pulp capping (A), where (A1) represents the comparator group where teeth will be treated with direct application of MTA over the exposed pulp, (A2) represents teeth to be treated with the application of PRF directly over exposed pulp followed by MTA application. clinical and radiographic assessment of tooth vitality, history of pain, pain on percussion, and dentin bridge formation will be performed at baseline, 6 months, and 1 year


Eligibility criteria: Inclusion Criteria:

* Patient aged 15:40 years old.
* Patients exhibiting pulp exposure (carious, traumatic, or mechanical) during management of active carious lesions with less than 2 mm of carious exposure.
* Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test.
* periapical radiograph showing closed apex and normal periapex

Exclusion Criteria:

* Teeth with spontaneous pain or sensitivity to percussion (signs of irreversible pulpitis).
* Teeth with periodontal lesions, internal or external root resorption, calcified canals, mobility of tooth, sinus opening, or abscessed tooth.
* Non restorable tooth.
* Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
* Pulp bleeding that could not be controlled within 10 minutes using 2.5% sodium hypochlorite
* Immune-compromised patients or with systemic medical disorders.
* pregnant females

Primary outcomes:
measure: clinical success rate
timeFrame: 6 months
measure: clinical success rate
timeFrame: 6 months
measure: clinical success rate
timeFrame: 6 months
measure: clinical success rate
timeFrame: 6 months
measure: clinical success rate
timeFrame: 1 year
measure: clinical success rate
timeFrame: 1 year
measure: clinical success rate
timeFrame: 1 year
measure: clinical success rate
timeFrame: 1 year
Secondary outcomes:
measure: radiographic assessment of incidence of regenerative dentin (dentin bridge)
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Manial
Study officials:
References: