louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03246412: Nevus Doctor Clinical Decision Support for GPs
Official title: Nevus or Melanoma? Nevus Doctor - Computer Aided Clinical Decision Support in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma (Skin)
Non-melanoma Skin Cancer
Actinic Keratoses
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study investigates if a computer-based clinical decision support tool for skin cancer may improve the diagnostic accuracy of general practitioners (GPs). The aim of the program is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious skin lesions that need biopsy or referral to specialist health care for further assessment. Half of the physicians in the trial will have the clinical decision support tool available during consultations, while the other half has no such tool available. We hypothesize that general practitioners using the clinical decision support tool will have a higher number of correct classifications of skin lesions compared to doctors without the tool.

Detailed description: General practitioners (GPs) examine patients who attend a primary health care center. In the intervention group the computer-based clinical decision support tool "Nevus doctor" in a first step assists doctors in the process of selecting skin lesions that are suggestive of cancer. In the next step a given skin lesion is photographed using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program "Nevus doctor" and a preliminary result is presented. Finally the GP reviews the result and assesses the clinical significance of the output by using guidelines presented by "Nevus doctor". The patient is subsequently referred to a dermatologist and a complete skin examination is performed. The assessment of the dermatologist serves as the gold standard.

Eligibility criteria: Inclusion Criteria:

* Patients concerned about one or several skin lesion(s)
* Patients with any other condition if doctor has observed a skin lesion suspicious for skin cancer (incl. actinic keratosis)

Exclusion Criteria:

* Patients not able to give consent

Primary outcomes:
measure: Diagnostic classification of suspicious skin lesions
timeFrame: Up to 3 months
Secondary outcomes:
measure: Skin lesions not classified by GPs
timeFrame: Up to 3 months
measure: Biopsies and excisions
timeFrame: Up to 3 months
Other outcomes:
measure: User experience
timeFrame: Up to 12 months.
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North-Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Thomas Schopf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05504512: Percutaneous Nephroscopic Treatment of Parapelvic Cysts
Official title: Feasible Surgical Treatment of Peripelvic Cyst by Percutaneous Nephroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Stone
Parapelvic Cyst
Kidney Diseases
Recurrence
Keywords: Parapelvic Cyst
Recurrence
Kidney Diseases
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone percutaneous nephroscopic surgery for parapelvic cysts

Brief summary: Background of the project: The surgical treatment of parapelvic cysts is currently less researched and there is no gold standard for surgery. Previously, in percutaneous nephrolithotomy, we found that fenestration and fenestration drainage in the simultaneous treatment of pararenal pelvis cysts under nephroscopic nephroscopic surgery has clear curative effect, less trauma, and quicker recovery.

Objective: To clarify the safety, efficacy and long-term efficacy of percutaneous nephroscopy in the treatment of parapelvic cysts.

Nature: Retrospective case cohort study. Basic research process: Retrospective collection of cases in our hospital who underwent percutaneous nephroscopy for the treatment of parapelvic cysts, and comparison of preoperative and postoperative cyst size changes and long-term efficacy.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Has undergone percutaneous nephroscopic surgery for parapelvic cysts
* Ability to receive study follow-up

Exclusion Criteria:

* Patient refuses or is unable to give consent

Primary outcomes:
measure: cyst size
timeFrame: At least 1 year after percutaneous nephroscopy for parapelvic cysts
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya hospital of central south university
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yu Cui, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02563912: Pre-calculated Doses of Medication for Pediatric Resuscitation, a Simulation Experimental Trial
Official title: Pre-calculated Doses of Medication for Pediatric Resuscitation, a Simulation Cross-over Randomized Experimental Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Children
resuscitation
simulation
medication error
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Dosage errors are common in the stressful situation of a pediatric resuscitation. In addition to that, studies have reported that delays to provide medication is associated to worst survival rate for very sick children. To minimize delays and error, the investigators recently published a resuscitation handbook who provides drug dosages for each weight for children thus eliminating the need for dosage calculation. Once the weight of the patient is known, the physicians only have to open the book at the page corresponding to the weight and all the medications with their calculated dosage are provided. The primary goal of this study is to evaluate the number of dosage error during simulated pediatric resuscitation comparing residents using the handbook vs. utilisation of a chart providing non-calculated dosage. This will be an experimental crossover trial among 40 residents performing four simulated case-scenarios in a high-fidelity simulation lab.


Eligibility criteria: Inclusion Criteria:

* Residents doing a rotation in pediatrics emergency medicine

Exclusion Criteria:

* Resident who participated in a previous month

Primary outcomes:
measure: Having at least one dosage error in any of the medications during the case for a participant
timeFrame: During the simulation (10 minutes)
Secondary outcomes:
measure: Dosage error in any for all individual medications during the case for a participant
timeFrame: During the simulation (10 minutes)
measure: Time for first drug prescription for each case per participant
timeFrame: During the simulation (10 minutes)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT02994212: Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
Official title: Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Médecins Sans Frontières, France
First posted: 2016-12-15
Enrollment: 115
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss \> 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.


Eligibility criteria: Inclusion Criteria:

* a) being eligible for new admission to treatment of uncomplicated SAM
* b) being resident within 15 km of the study health center

Exclusion Criteria:

* previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits)
* considered a relapse case (e.g. re-admitted within three months of previous discharge)

Primary outcomes:
measure: weight gain
timeFrame: 4 weeks
measure: mid-upper arm circumference gain (mm/day)
timeFrame: 4 weeks
measure: weight loss > 5%
timeFrame: 4 weeks
measure: development of edema
timeFrame: 4 weeks
Secondary outcomes:
measure: correct utilization of RUTF
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Epicentre
name: Sheila Isanaka, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isanaka S, Kodish SR, Berthe F, Alley I, Nackers F, Hanson KE, Grais RF. Outpatient treatment of severe acute malnutrition: response to treatment with a reduced schedule of therapeutic food distribution. Am J Clin Nutr. 2017 May;105(5):1191-1197. doi: 10.3945/ajcn.116.148064. Epub 2017 Apr 12.
Clinical trial NCT01718912: Periodontal Disease Treatment of a Physically Challenged Population
Official title: The Effect of an Antibiotic-antifungal Rinse on Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Keywords: periodontal disease
bleeding on probing
periodontal pockets
disabled
Lead sponsor: Oravital Inc
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Many physically handicapped patients at the dental department, Toronto Rehabilitation Institute(TRI) have considerable gingival inflammation and breath odour because of the inability to effectively handle a toothbrush. These patients have considerable periodontal disease. There is a concern that these pathogens may have a detrimental effect on wound healing in other areas of the body.

Hypothesis: Patients attending the dental department at TRI that are treated with the antibiotic-antifungal rinse containing metronidazole and nystatin will show substantial decrease in periodontal disease as measured by bleeding points and pocket depth when compared to the group that continues to use their regular oral hygiene methods (control group).


Eligibility criteria: Inclusion Criteria:

Participants must be between the ages of 18 to 65 years Participants must have at least 6 teeth. Participants must have some indication of gingivitis and periodontal breakdown. -

Exclusion Criteria:

Patients who are taking Warfarin/Coumadin Patients who are allergic to Metronidazole or chlorhexidine. Edentulous patients will be excluded by those who have at least 6 teeth can be a participant

-

Primary outcomes:
measure: Evidence of healing of periodontal tissues as shown by a reduction of bleeding
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute, Dental Department
state: Ontario
Study officials:
References:
Clinical trial NCT01130012: Prevention of Gestational Diabetes
Official title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Gestational diabetes mellitus
Lifestyle intervention
Oral glucose tolerance test
Insulin treatment
Pregnancy outcomes
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: South Ostrobothnia Hospital District
First posted: 2010-05-25
Enrollment: 440
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Gestational diabetes mellitus (GDM)is a major health problem

* growing prevalence of obesity
* the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

* feasibility of an early intervention
* glucose tolerance at weeks 26-28

Detailed description: 1. A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12

   1. voluntary women in early pregnancy (n=96)
   2. 54 high risk mothers were randomized

      * lifestyle intervention group (n=27)
      * close follow-up (n=27)
2. An OGTT was performed again at weeks 26-28

   * the lifestyle intervention group (n=27)
   * the close follow-up group (n=27)
   * other high-risk women of the early care group (n=42)who were not randomized
3. An OGTT was also performed at weeks 26-28 in two neighboring municipalities

   * a standard care high-risk group(n=171)who did not undergo early intervention
4. Primary outcomes

   * number of at risk participants developing GDM during pregnancy in the two arms
5. Secondary outcomes

   * the effect of intervention on fetal growth

Eligibility criteria: Inclusion Criteria:

* high risk for gestational diabetes
* fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT \<7.8 mmol/l

Exclusion Criteria:

* normal glucose tolerance at weeks 8-12
* gestational diabetes at weeks 8-12

Primary outcomes:
measure: Number of at risk participants developing GDM during pregnancy
Secondary outcomes:
measure: The effect of intervention on fetal growth
Other outcomes:
Locations:
Study officials:
affiliation: South Ostrobothnia Hospital District
name: Eeva Korpi-Hyövälti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korpi-Hyovalti E, Heinonen S, Schwab U, Laaksonen DE, Niskanen L. Effect of intensive counselling on physical activity in pregnant women at high risk for gestational diabetes mellitus. A clinical study in primary care. Prim Care Diabetes. 2012 Dec;6(4):261-8. doi: 10.1016/j.pcd.2012.07.004. Epub 2012 Aug 13.
citation: Korpi-Hyovalti EA, Laaksonen DE, Schwab US, Vanhapiha TH, Vihla KR, Heinonen ST, Niskanen LK. Feasibility of a lifestyle intervention in early pregnancy to prevent deterioration of glucose tolerance. BMC Public Health. 2011 Mar 24;11:179. doi: 10.1186/1471-2458-11-179.
Clinical trial NCT01991912: Irrigation Endoscopic Decompressive Laminotomy
Official title: Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Unilateral Approach for Bilateral Lumbar Decompression: A Blinded Non-randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbosacral Spinal Stenosis
Keywords: irrigation endoscopic decompression
minimally invasive surgery
spinal stenosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity .This is further magnified by the disease being more common in elderly with associated medical comorbidities and being usually global involving multiple levels.The purpose of this study is to present and to evaluate a new endoscopic technique named Irrigation Endoscopic Decompressive Laminotomy (IEDL) for lumbar spinal canal decompression.

Detailed description: In the IEDL group,2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy and bilateral decompression under endoscopic vision is performed. In the microsurgical group, bilateral fenestration is performed in the usual manner

Eligibility criteria: Inclusion Criteria:

* neurogenic claudication,that correlated with moderate to severe spinal canal stenosis as shown on MRI and resistant to 3 months of conservative management .

Exclusion Criteria:

* predominant back pain or instability

Primary outcomes:
measure: oswestry disability index
timeFrame: 24 months
Secondary outcomes:
measure: postoperative hospital stay
timeFrame: 30 days
measure: time required following surgery before return to work
timeFrame: 30 days
measure: vas for back pain
timeFrame: 30 days
Other outcomes:
measure: complications
timeFrame: 24 months
Locations:
Study officials:
affiliation: Cairo University
name: hesham m soliman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462912: Evaluation of Software Generated Customized Foot Orthoses
Official title: Evaluation of Software Generated Customized Foot Orthoses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthropathy of Ankle or Foot
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Soleit
First posted: 2022-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether custom-made foot orthoses generate a significant decrease in the perception of pain among individuals with foot pain and/or ankle pain.

Detailed description: The investigators aim to enroll up to 60 participants over the course of 1-3 months. Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. Subsequently, consecutive surveys will be carried out at 0, 7, 30, 120, and 360 days from the first day of foot orthoses use to measure the change in pain and comfort with use of the foot orthoses. An interim analysis will be conducted after all subjects have completed the 30-day time point. This interim analysis will allow the sponsor to determine whether subjects are using the foot orthoses that the subjects have been provided. Complete primary analysis is estimated to be completed within 3 months after the termination of the study.

Eligibility criteria: Inclusion Criteria:

1. Foot/ankle pain or pathology OR diagnosed pes planus, pes cavus, pronator foot, supinator foot, metatarsalgia, Morton's neuroma, sesamoiditis, hallux valgus, intermetatarsal bursitis
2. Between 18 and 65 years of age
3. BMI is greater than 18.5 or less than 30

Exclusion Criteria:

1. Individuals who have had surgery in the lower limbs during this past year.
2. Individuals who already have custom-made orthopedic orthoses.
3. Patients with active diabetic ulcers or chronic foot pressure ulcers.

Primary outcomes:
measure: Successful patient use of a 3D printed Custom foot orthotic
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
Study officials:
affiliation: UC Davis Orthopaedic Surgery
name: Eric Giza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04356612: Barriers to Efficient PACU Discharge At a Major Academic Orthopaedic Ambulatory Surgery Center
Official title: Barriers to Efficient PACU Discharge At a Major Academic Orthopaedic Ambulatory Surgery Center
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Achilles Tendon Rupture
Database
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing ambulatory foot and ankle surgery

Brief summary: This is a retrospective chart review to determine the etiologies contributing to prolonged PACU discharge at a major Orthopedic Ambulatory Center

Detailed description: Increasing number of surgeries are now performed at ambulatory surgical centers including orthopaedic procedures. While healthier patients usually undergo non-major orthopaedic procedures using regional anesthesia to facilitate faster discharges, prolonged PACU discharges are frequently encountered necessitating characterization and identification of modifiable variables. This is a retrospective chart review to determine the etiologies contributing to prolonged PACU discharge at a major Orthopedic Ambulatory Center.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years and older) undergoing ambulatory foot and ankle surgery

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Time required for discharge
timeFrame: Day of surgery (Day 0) through discharge, average of 6 hours
Secondary outcomes:
measure: Supplemental Analgesics
timeFrame: Day of surgery (Day 0) through discharge, average of 6 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgey
name: Sang Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: