louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04847115: Treatment of Fifth Metatarsal Zone 3 Fractures
Official title: Treatment of Fifth Metatarsal Zone 3 Fractures - A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fractures, Stress
Metatarsal Fracture
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University Hospital, Akershus
First posted: 2021-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospecitve, randomized trial
Primary purpose: TREATMENT

Brief summary: The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.


Eligibility criteria: Inclusion Criteria:

* Zone 3 fracture

Exclusion Criteria:

* Neuropathy
* Open fractures
* High energy injuries
* Associated injury in the same or opposite extremity that may affect treatment or rehabilitation
* Pressure ulcer(s)
* Lack of consent competence
* Fracture radiologically confirmed more than six months ago
* No possibility of follow-up at one of the study centers
* Established pseudarthrosis
* Medical condition that contraindicates surgery
* Non-compliance

Primary outcomes:
measure: Pain free weight bearing
timeFrame: 2 years
Secondary outcomes:
measure: Palpatory pain
timeFrame: 2 years
measure: Radiological healing
timeFrame: 2 years
measure: Work status
timeFrame: 2 years
measure: Refracture
timeFrame: 2 years
measure: Delayed union
timeFrame: 2 years
measure: Nonunions
timeFrame: 2 years
measure: Level of activity
timeFrame: 2 years
Other outcomes:
Locations:
city: Grålum
country: Norway
facility: Østfold Hospital Trust
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Ostfold HT
name: Marius Molund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03703544: The Glycaemic Response of Local Foods Using the Continuous Glucose Monitoring System
Official title: The Glycaemic Response of Local Foods Using the Continuous Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: Health Promotion Board, Singapore
First posted: 2018-10-12
Enrollment: 15
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is carried out to determine the effect of high and low GI of local foods using Continuous Glucose Monitoring System (CGMS™) on 24 hour blood glucose profiles.

Detailed description: Glycemic Index (GI) is a method of classifying foods based on the food's ability to raise the blood glucose level. Low GI foods are recommended as Participants will have a lower impact on blood glucose concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose profiles in healthy Chinese male participants. There will be two test sessions where participants will consume either a high or low GI breakfast, lunch, snack and dinner. Participants will take part in two test sessions (each spanning over 3 days and to monitor the participants' glycemic response using a Continuous Glucose Monitoring System (CGMS) throughout the period.This study specifically attempts to see how having high and low GI locally consumed meals impact on blood glucose.

Eligibility criteria: Inclusion Criteria:

* Chinese, male
* Age between 21-50 years
* Body mass index between 18 to 25 kg/m2
* Normal blood pressure (\<140/90 Hgmm)
* Fasting blood glucose \< 6 mmol/L

Exclusion Criteria:

* Current Smoker
* Have any metabolic diseases (such as diabetes, hypertension etc)
* Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
* Have an ongoing infection or currently undergoing treatment at the time of screening
* Known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)• Have active Tuberculosis (TB) or currently receiving treatment for TB
* Have intolerances or allergies to any foods
* Partake in sports at the competitive and/or endurance levels

Primary outcomes:
measure: Daily blood glucose profile
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References:
Clinical trial NCT02545244: Effectiveness of Black Tea Mouthwash on Plaque Formation
Official title: "Effectiveness of Black Tea Mouthwash on Plaque Formation:A Randomized Controlled Clinical Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Keywords: Gingivitis, Black Tea, Green Tea,Chlorhexidine, Biofilm,
Lead sponsor: Sri Hasanamba Dental College and Hospital
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was conducted to measure the effectiveness of Black Tea in reducing the deposits on teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical trial among adults of 18-40 years of age.

Detailed description: The study titled "Effectiveness of Black Tea Mouthwash on Plaque formation: A Randomized Controlled Clinical Trial" conducted at Department of Periodontics,during February 2015 till July 2015 included three interventional arms with 15 subjects each who had chronic generalized plaque-induced gingivitis. All subjects underwent scaling and randomly allocated into three groups as Black tea,Green tea and Chlorhexidine. Those in black tea, green tea and Chlorhexidine groups advised to rinse with 0.5% Black tea, 0.5% green tea and 0.12% Chlorhexidine aqueous based solutions for 30 seconds twice daily half an hour after brushing teeth respectively. Gingival Index (Loe and Silness 1963) and Plaque Index (Silness and Loe, 1964) recorded at baseline and 2 weeks after intervention in all subjects. Results were analyzed using SPSS Statistical software version 20.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old. subjects with at least 20 natural teeth. diagnosed with chronic generalized plaque induced gingivitis.

Exclusion Criteria:

* subjects with systemic illness. subjects on antibiotic in the previous six months. subjects with allergy to tea. subjects on medications with effect on periodontium (Eg:anti-osteoporotic drugs).

Primary outcomes:
measure: Plaque Index (Silness and Loe 1964)
timeFrame: two weeks
Secondary outcomes:
measure: Gingival Index(Loe and Silness 1963)
timeFrame: two weeks
Other outcomes:
Locations:
city: Hassan
country: India
facility: Sri Hasanamba Dental College and Hospital
state: Karnataka
Study officials:
affiliation: Sri Hasanamba Dental College and Hospital
name: ShivaMurthy Ravindra, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04397744: Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso
Official title: Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Keywords: Mammogram
Pap test
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2020-05-21
Enrollment: 660
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in El Paso County and to increase repeat screening among those currently overdue.


Eligibility criteria: Inclusion Criteria:

* overdue for a repeat mammogram
* overdue for repeat cervical screening

Exclusion Criteria:

-

Primary outcomes:
measure: Number of participants who uptake clinical breast exam (CBE)
timeFrame: 6 months
measure: Number of participants who uptake mammography
timeFrame: 6 months
measure: Number of participants who uptake pap test
timeFrame: 6 months
measure: Number of participants who repeat mammography
timeFrame: 6 months
measure: Number of participants who repeat pap test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria E Fernandez
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savas LS, Atkinson JS, Figueroa-Solis E, Valdes A, Morales P, Castle PE, Fernandez ME. A lay health worker intervention to improve breast and cervical cancer screening among Latinas in El Paso, Texas: A randomized control trial. Prev Med. 2021 Apr;145:106446. doi: 10.1016/j.ypmed.2021.106446. Epub 2021 Feb 4.
Clinical trial NCT01078844: Memantine in Adult Autism Spectrum Disorder
Official title: Memantine in Adult Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism
Asperger's Disorder
Pervasive Developmental Disorder NOS
Keywords: Autism
Asperger's Disorder
Pervasive Developmental Disorder NOS
Adult
Memantine
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2010-03-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).


Eligibility criteria: Inclusion criteria

* Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)
* Participant has a diagnosis of:

  * Autistic Disorder
  * Asperger's Disorder
  * Pervasive Developmental Disorder (PDD) NOS
* Participant meets one of the following criteria:

  * CGI-S \>= 4 (CGI-S: ________)
  * Participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine:

    1. _____________________________________________
    2. _____________________________________________
    3. _____________________________________________

Exclusion criteria

The patient meets none of the following criteria (mark if absent):

* Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible).
* Rett's Syndrome or Childhood Disintegrative Disorder
* Active treatment with an acetylcholinesterase inhibitor
* Prior or current treatment with memantine
* Current treatment with lamotrigine
* Genetic, metabolic or degenerative disorder (excepting Fragile X).
* Brain malformation or known severe brain trauma
* Pregnancy or breastfeeding
* Glomerular Filtration Rate (GFR) \< 30 mL/min

Primary outcomes:
measure: Clinical Global Impression-Scale(CGI-S)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric Samstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.
Clinical trial NCT06336044: Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'
Official title: "Clinical and Instrumental Evaluation of the Safety and Bio-revitalizing Effect on the Face of the Medical Device 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wrinkle
Scar
Laxity; Skin
Keywords: hyaluronic acid
Collagen
Filler
Wrinkles
Lead sponsor: Taumedika s.r.l.
Sponsor class: INDUSTRY
Collaborators: name: Nextrasearch S.r.l.s.
First posted: 2024-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 patients for face and 20 for lips will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks
Primary purpose: TREATMENT

Brief summary: Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events

Detailed description: The patients chosen with facial laxity characteristics, at the first visit will be assessed and will receive the treatment (microinjections) in the cheekbone area, over the lips and in the marionette lines. After 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements.

Eligibility criteria: Inclusion Criteria:

* all sexes
* caucasic
* 18 to 70 years
* non smoker

Exclusion Criteria:

* Pregnancy
* milking
* smoker
* alcohol or drugs abuse
* change of BMI during the study
* previous facial surgery, implants, permanent treatments
* sensitivity to the product
* dermatological difficult frame
* health weakness
* treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results

Primary outcomes:
measure: Safety: no adverse events
timeFrame: 16 weeks
measure: Efficacy: change of wrinkles and scars
timeFrame: 16 weeks
measure: Efficacy: change of wrinkles and scars
timeFrame: 16 weeks
measure: Efficacy: change of wrinkles and scars
timeFrame: 16 weeks
measure: Efficacy: change of wrinkles and scars
timeFrame: 16 weeks
Secondary outcomes:
measure: Duration of the efficacy
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nextrasearch S.r.l.s.
name: Adolfo Gasparetto, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01761344: Intraoperative Analysis of Cortisol During Adrenal Vein Sampling
Official title: Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hyperaldosteronism
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 21
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: Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary hypertension. The overproduction of aldosteron might in some cases be due to unilateral hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these cases the adrenal can be removed and the patient cured of hypertension. The clinical evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective sampling of blood from the adrenal veins to determine lateralization of overproduction. This is executed as an interventional radiological procedure.

The adrenal vein sampling is challenging, and success is determined by measuring another adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample. By routine laboratory assays the procedure is evaluated after the patient has been discharged from the hospital. In the study a rapid assay of cortisol will be evaluated, allowing the radiologist to draw new samples during the same procedure if the first set of samples is unsuccessful. The study hypothesis is that intraoperative measurement of cortisol is a useful tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.


Eligibility criteria: Inclusion Criteria:

* Primary hyperaldosteronism
* Motivated for surgery if applicable
* Able to give informed consent

Exclusion Criteria:

* Not able to give informed consent
* Severe kidney failure

Primary outcomes:
measure: Representative blood sample from adrenal veins bilaterally.
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: Hormonlaboratoriet, Haukeland Universitetssykehus
name: Gunnar Mellgren, MD.PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04006444: Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital
Official title: Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iatrogenic Drug Risk
Chronic Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged at least 65 years consulting at the pain centre of the Nîmes University Hospital for chronic pain

Brief summary: Chronic pain may be an additional risk factor for drug iatrogeny due to its management and also drug non-compliance in the geriatric population.

it seems interesting to carry out an inventory of the iatrogenic risk before and after the consultation at the pain centre to enable us to identify the patients most at risk. This study would make it possible to characterize elderly patients with chronic pain, in order to consider, in a future study, setting up a pharmaceutical consultation.


Eligibility criteria: Inclusion Criteria:

* The patient must be affiliated or beneficiary of a health insurance
* Patient ≥ 65 years old
* Having an outpatient consultation at the pain centre of the Nîmes University hospital of for chronic pain
* Available for pharmaceutical consultation about 30 minutes

Exclusion Criteria:

* It is impossible to give information
* The patient objects to participating in this study

Primary outcomes:
measure: Evolution of the ADE Geriatric risk score
timeFrame: 2018
Secondary outcomes:
measure: rate of patients with a low, medium or high risk level calculated by ADE Geriatric risk score according to the type of pain
timeFrame: 2018
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU NIMES
name: geraldine leguelinel, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jambon J, Choukroun C, Roux-Marson C, Viel E, Leguelinel-Blache G. What Is the Medication Iatrogenic Risk in Elderly Outpatients for Chronic Pain? Clin Neuropharmacol. 2022 May-Jun 01;45(3):65-71. doi: 10.1097/WNF.0000000000000505.
Clinical trial NCT00616044: Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block
Official title: Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Knee Arthroplasty
Femur Fracture
Keywords: Spinal Anesthesia
Epidural Anesthesia
Orthopedic procedures
Lead sponsor: Sao Jose do Rio Preto Medical School
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (CSA) and combined spinal epidural anesthesia (CSE) are safe and reliable anaesthesia methods. Our results suggest that both continuous spinal anesthesia and combined spinal epidural anesthesia provide good surgical conditions with a low incidence of complications. The sensory block level and hemodynamic changes were lesser with CSA.

Detailed description: 240 patients scheduled for hip, knee arthroplasty or fracture of the femur were randomly assigned to receive either CSA or CSE. Blocks were performed in the lateral position at L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor block, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and post dural puncture headache were registered. At the end of the surgery, the catheter was removed and CSF leak was evaluated.

Eligibility criteria: Inclusion Criteria:

* Fractures repair of femur, or arthroplasty of either knee or hip

Exclusion Criteria:

* Hypovolemia
* Preexisting neurologic disease
* Coagulation disorders and/or administration of thromboprophylaxis less than eight hours before the start of surgery
* Infection at the puncture site
* Agitation or delirium and the presence of a urinary bladder catheter.

Primary outcomes:
measure: Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: São José do Rio Preto
country: Brazil
facility: SaoJoseRPU
state: São Paulo
Study officials:
affiliation: Sao Jose do Rio Preto Medical School
name: Luiz E Imbelloni, MD
role: PRINCIPAL_INVESTIGATOR
References: