louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00210223: Radiofrequency of Breast Cancers in Non Surgical Patients
Official title: Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Radiofrequency
Percutaneous technique
breast cancer
tolerance
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 15
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To treat breast tumors in non surgical patients with percutaneous technique (radiofrequency). Prospective evaluation of treatment efficiency and tolerance based on clinical and radiological evaluation


Eligibility criteria: Inclusion criteria:

* Patients more than 70 years old
* Breast tumors with estrogen receptors
* Non surgical patients
* Life expectancy more than 6 months

Exclusion criteria:

* Presence of a pace maker
* Tumors measuring more than 30 mm on ultrasound evaluation, located less than 10 mm from skin, nipple, or pectoral muscle
* Coagulation disorders
* Contra indications to magnetic resonance imaging or computed tomography with contrast medium injection
* Non visible lesions on magnetic resonance imaging or computed tomography with contrast medium injection

Primary outcomes:
measure: To know at 6 months the efficacy of radiofrequency based on
measure: - no local recurrence (detected with magnetic resonance imaging)
measure: - no palpable mass on clinical examination
Secondary outcomes:
measure: To evaluate every 2 months, until 6 months :
measure: - the late complications of the percutaneous technique
measure: - the pain felt by the patients, during and after the radiofrequency
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Study officials:
affiliation: Institut Bergonié
name: Fabienne VALENTIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05631223: Use of Telemedicine to Address 'Off Target' Symptoms in Psoriatic Arthritis (PsA)
Official title: Use of Telemedicine to Address 'Off Target' Symptoms in Psoriatic Arthritis (PsA): Implementation of PsOWellTM in PsA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriatic Arthritis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm, multisite pilot study
Primary purpose: TREATMENT

Brief summary: This will be a single-arm interventional study to test the acceptability, feasibility, and effectiveness of structured telemedicine visits to encourage lifestyle changes that will improve quality of life, disease impact, and disease activity in patients with psoriatic arthritis (PsA).

Detailed description: The proposed trial will be embedded within clinical care. This is a 2-year interventional trial that will enroll patients with active psoriatic arthritis despite stable therapy among three centers (the University of Pennsylvania, University of Utah, and University of Oxford). The intervention employs PsOWellTM, a program that trains clinicians to utilize motivational interviewing to help patients set goals and make lifestyle/behavior changes for holistic management of psoriasis.

Eligibility criteria: Inclusion Criteria:

* Population: Patients with Psoriatic Arthritis

  * Age 18-89.
  * Active symptoms of PsA as defined by a PsA Impact of Disease (PsAID) questionnaire score \>4 (range 0-10, 4 is the patient acceptable symptom state) or a patient global assessment of greater than 4 (scale 0-10).
  * Patients should be stable on therapy (i.e., not planning to switch therapy at the current visit).
  * Meet CASPAR criteria.
  * Provision of signed and dated informed consent form.
  * Willingness to comply with all study procedures and availability for duration of the study.
  * Has access to a mobile phone or other mobile device.

Exclusion Criteria:

* Inability to provide informed consent.
* Plan to change systemic treatment for psoriasis or PsA in the next 4-8 weeks.
* PsAID score ≤4

Primary outcomes:
measure: Acceptability
timeFrame: 4 Months
measure: Effectiveness
timeFrame: 4 Months
measure: Minimal Disease Activity
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Pennsylvania
name: Alexis Ogdie-Beatty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02725723: Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections
Official title: Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Spinal Stenosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Spinal stenosis is a prevalent diagnosis, which is handled in a heterogeneous manner by clinicians. Moreover, when using steroidal epidural injections, successful treatment is currently defined as the satisfaction of the patient from the treatments, a subjective and non-quantifiable indicator.

In this experiment, the investigators aim to evaluate thermographic images as an objective method for assessing the efficacy of steroidal epidural injections, the most common invasive treatment for pain associated with spinal stenosis


Eligibility criteria: Inclusion Criteria:

* Signed a valid, IRB/EC-approved informed consent form
* 18 years of age or older when written informed consent is obtained
* Diagnosis of spinal stenosis by MRI or CT imaging

Exclusion Criteria:

* Sensitivity to local anesthetics
* Skin infection at the site of needle insertion
* Had evidence of a peripheral neuropathy
* Had clinical signs of peripheral vascular disease
* Patient is pregnant
* Clinical diagnosis of blood clotting disorder
* Tumor or infection at spine as demonstrate at MRI Unbalanced Cardiac Insufficiency, hypertension \& Diabetes cataract Stomach Ulcer

Primary outcomes:
measure: Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region
timeFrame: Baseline and 30 min
Secondary outcomes:
measure: Change in Pain Intensity by a 0 - 10 numerical rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine".
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05042323: Short-term Intervention and Health Trajectories After Mass Trauma
Official title: The Landslide Disaster in Gjerdrum Municipality: Early Intervention and Health Trajectories After Mass Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Norwegian Center for Violence and Traumatic Stress Studies
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has two aims. The first is to understand more of what may be typical health trajectories after mass trauma for children and adults and what predicts these trajectories. The second is to understand what may be effective early interventions to prevent long-term health and psychosocial problems for youth (6-19). Participants are recruited from an outreach program implemented after a landslide killed 11 persons and destroyed 33 houses in Gjerdrum in Norway. One third of the inhabitants were evacuated. All evacuated are contacted and screened for trauma related difficulties. Those who have significant post-trauma reactions are offered trauma focused interventions.

Detailed description: Two short step-wise interventions are developed for this study as an early intervention after mass trauma based on components from TF-CBT to test the relative importance of dosage and the sequencing of components.

Eligibility criteria: Inclusion Criteria:

* Exposed to the landslide
* Between 6-19 years old
* A score of 15 or more on the CATS
* A score between 11 - 14 on the CATS and have additional problems that have started or worsened after the landslide.

Exclusion Criteria:

* Suicidal
* Psychotic

Primary outcomes:
measure: PTSD
timeFrame: Pre-treatment
measure: PTSD
timeFrame: After 5 weeks
measure: PTSD
timeFrame: After 9 weeks
measure: PTSD
timeFrame: After 21 weeks
measure: PTSD
timeFrame: After 33 weeks
measure: PTSD
timeFrame: After 45 weeks
measure: PTSD
timeFrame: After 57 weeks
Secondary outcomes:
measure: Depression
timeFrame: Pre-treatment
measure: Depression
timeFrame: After 5 weeks
measure: Depression
timeFrame: After 9 weeks
measure: Depression
timeFrame: After 21 weeks
measure: Depression
timeFrame: After 33 weeks
measure: Depression
timeFrame: After 45 weeks
measure: Depression
timeFrame: After 57 weeks
Other outcomes:
measure: Anxiety
timeFrame: Pre-treatment
measure: Anxiety
timeFrame: After 5 weeks
measure: Anxiety
timeFrame: After 9 weeks
measure: Anxiety
timeFrame: After 21 weeks
measure: Anxiety
timeFrame: After 33 weeks
measure: Anxiety
timeFrame: After 45 weeks
measure: Anxiety
timeFrame: After 57 weeks
Locations:
city: Oslo
country: Norway
facility: Norwegian center for violence and traumatic stress studies
Study officials:
affiliation: Norwegian Center for Violence and Traumatic Stress Studies
name: Tine K Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05267223: Experience of Rehabilitation Amongst Individuals With Paraplegia
Official title: Experience of Physical and Vocational Rehabilitation Amongst Individuals With Paraplegia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Keywords: qualitative research
paraplegia
rehabilitation
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic \& non-traumatic paraplegics having atleast 6 months of time since injury and are community dwelling so that their obstacles in community integration can be noted

Brief summary: This study is a qualitative study exploring the facilitators to physical and vocational rehabilitation and also explores the barriers in empowering individuals with paraplegia

Detailed description: Spinal cord injury is one of the most distressing medical conditions being encountered by today's health care system. In India incidence of Spinal cord injury accounts for 20 per million per years population with 20,000 cases added every year. Rehabilitation services are of utmost importance in empowering these individuals. So there is a need for more qualitative studies through which needs in rehabilitation services can be upgraded. The aim of the study is to explore the experience of physical and vocational rehabilitation amongst the individuals with paraplegia in India

Eligibility criteria: Inclusion Criteria:

* Traumatic \& Non-Traumatic paraplegics Both male \& female above 18 yrs of age Time since injury of minimum 6 months Community dwelling paraplegics

Exclusion Criteria:

* Communication problems Psychiatric problems or co morbidities like head injury

Primary outcomes:
measure: Semi-structured interview
timeFrame: 30minutes-45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ambāla
country: India
facility: Maharishi Markandeshwar institute of Medical Sciences and Research
state: Haryana
Study officials:
affiliation: MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY & REHABILITATION
name: AKANKSHA SAXENA, MPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00457223: To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
Official title: Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pterygium
Keywords: pterygium
pterygia
excision
amniotic membrane transplantation
fibrin glue
suture
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2007-04-06
Enrollment: 32
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 purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue.

Detailed description: There are few studies about use of fibrin glue in pterygium surgery with conjunctival auto-graft with promising outcome. Less recurrent rate, less discomfort and halve surgical time were reported.

Up to our knowledge,there is no report of fibrin glue in pterygium excision with amniotic membrane transplantation(AMT). There is conventional technique to use AMT in King Chulalongkorn Memorial Hospital because some benefits over conjunctival auto-graft e.g.

* Preserve healthy superior conjunctiva for future glaucoma filtering surgery
* Can use in big or 2-headed pterygium
* Not contract as conjunctival graft esp. in case of fibrin glue
* Potential easier to use with fibrin glue
* Available from Thai Red Cross Eye Bank Comparison(s): amniotic membrane transplantation using fibrin glue compare to suture after pterygium excision.

Eligibility criteria: Inclusion Criteria:

* primary pterygium

Exclusion Criteria:

* Pregnant women
* Recurrent pterygium
* Pseudopterygium
* Uncontrolled systemic disease.
* Known allergy to any of the study agents or preservatives used in the formulations.

Primary outcomes:
measure: Pain and discomfort during and after surgery using visual analog scale
timeFrame: during surgery and after surgery up to 30 days
Secondary outcomes:
measure: Surgical time
timeFrame: start and to the end of surgery
measure: Healing of epithelial defect on cornea and AMT
timeFrame: until 30 days
measure: Postoperative inflammation
timeFrame: up to 30 days
measure: Complications e.g. Recurrent, graft loss/dehiscent, re-operation
timeFrame: until last follow up
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Ophthalmology, King Chulalongkorn Memorial hospital
Study officials:
affiliation: Ophthalmology Department, Faculty of Medicine, Chulalongkorn University
name: Ngamjit Kasetsuwan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04353323: COVID 19-Caregivers IGg Seroconversion
Official title: Comparison of the Proportion of Covid19 Seroconversion of Caregivers Working or Not in the COVID Sector
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection, COVID-19
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 130
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: Caregivers staff assigned to a non-intensive care COVID service

* Or caregiversg staff assigned to a non-COVID adult service
* Or caregivers staff assigned to a non-COVID pediatric service

Brief summary: According to recent publications, the percentage of caregivers infected with COVID 19 is evaluated between 10 and 30% . This great variability is due, on the one hand to the intensity of the influx of covid plus patients and, on the other hand, to the disparity in the preparation of caregivers in the face of this emergency. Indeed, we can understand that the strict application of hygiene rules can be faulted in the face of the volume of patients, the lack of protective equipment and the lack of specific training for caregivers in this area. As a result, within healthcare teams, there are many questions that generate anxiety: will I be able to provide care properly while protecting myself from the risk of contamination? This anxiety is also present and sometimes manifests itself aggressively in the entourage or in the vicinity of caregivers, due to lack of scientific data adapted to the local ecology of the crisis.

Thus, the aim of this study is to show that the risk for caregivers of being contaminated by COVID in an area dedicated to COVID positive patients is no higher than being a caregiver in a non-COVID area that he either in the adult or pediatric sector.


Eligibility criteria: Inclusion Criteria:

* caregivers staff assigned to a non-intensive care COVID service
* or caregivers staff assigned to a non-COVID adult service
* or caregivers staff assigned to a non-COVID pediatric service
* Age \> = 18 years old
* With health insurance
* Express consent

Exclusion Criteria:

* Protected persons
* Refusal to participate

Primary outcomes:
measure: Seroconversion
timeFrame: Day1
measure: Seroconversion
timeFrame: Day 15
measure: Seroconversion
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
References:
Clinical trial NCT03599323: Study on the Safety of the Approved Product Empedic L Cream During Its Routine Use (Active Ingredient is Clotrimazole 1%)
Official title: Prospective, Non-interventional, Post-marketing, Multi-center, Single-cohort, Safety (Questionnaire) Investigation of Empecid L Cream (Clotrimazole 1%)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Candida
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: SATO PHARMACEUTICAL , Ltd.
First posted: 2018-07-26
Enrollment: 1033
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary population of interest is composed of subjects 15 years or older and under 60 years who purchase Empecid L Cream.

Brief summary: Researchers already did trials that showed Empecid L Cream worked for patients with Vaginal yeast infection who were in those trials. In this trial, they want to learn if consumers that use the cream under the guidance of a pharmacist have any medical problems during the trial


Eligibility criteria: Inclusion Criteria:

- Consumers who self-select and are then deemed appropriate users of the product by the pharmacist for treatment of Vulvar itching with rash due to recurrent vaginal candida (only in patients previously diagnosed and treated by a doctor).

Exclusion Criteria:

* Patient with first episode
* Patient with allergy to Empecid Cream (Clotrimazole)
* Patient under 15 years old/ beyond 60 years old
* Pregnant women or women who may possibly be pregnant
* Patient with diabetes
* Patient who repeats indicated symptom frequently, have recurrent episodes (once every month or two, or twice or more within 6 months).
* Patients who does not know whether it is a recurrence symptom
* Patients who have a fever, chills, lower abdominal pain, back or shoulder pain, colored or bloody vaginal discharge, fishy-smelling vaginal discharge, cessation of menses, irregular or abnormal bleeding from the vagina, or ulcer, edema or erosion in the vagina or vulva suggesting they may have a different disease.

Primary outcomes:
measure: Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream.
timeFrame: Up to one month
measure: Types of AE recorded in Questionnaire
timeFrame: Up to one month
Secondary outcomes:
measure: Patterns and way of use of Empecid L Cream recorded in Questionnaire
timeFrame: Up to one month
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
References:
Clinical trial NCT04180423: TKA Operating Room Efficiency for TKA Using Customized Implant Techniques
Official title: What Factors Affect Operating Room Efficiency When Performing TKA Using Customized Implant Techniques: Conformis iTotal (CR), (PS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Knee
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients receiving Total Knee Arthroplasty

Brief summary: This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age

Exclusion Criteria:

* Participation in another clinical study which would confound results
* Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
* Simultaneous bilateral Total Knee Arthroplasty cases

Primary outcomes:
measure: Operating Room Efficiency
timeFrame: Single time point - day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
Study officials:
References: