louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04622852: Pegs for Osteofixation of Proximal Humeral Fractures
Official title: Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Complication
Proximal Humeral Fracture
Avascular Necrosis of Humerus
Keywords: Humeral head
Screw penetration
Peg penetration
Avascular necrosis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 38
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to hospital with an acute PHF for surgical treatment

Brief summary: Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)

Detailed description: From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events:

1. Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and
2. Avascular head necrosis / sinking / need of re-surgery
3. Clinical PROMS

Eligibility criteria: Inclusion Criterion:

* Acute proximal humeral fracture
* AO/OTA type 11-B2 or 11C2

Exclusion Criteria:

* Not eligible to surgical treatment
* Non-compliant
* Former shoulder fracture or symptomatic shoulder illness
* Drug abuser

Primary outcomes:
measure: Peg penetration into glenohumeral joint
timeFrame: 12 months
measure: Screw penetration into glenohumeral joint
timeFrame: 12 months
Secondary outcomes:
measure: Humeral head deformation
timeFrame: 12 months
measure: Shoulder function
timeFrame: 12 months
measure: Self reported shoulder function
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Ortophaedic Dept.
name: Tore Fjalestad, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bones I, Karlberg AC, Liljeholm M, Fraser AN, Madsen JE, Fjalestad T. Pegs not superior to screws for fixation of fractures of the proximal humerus. J Orthop Surg Res. 2022 Feb 2;17(1):66. doi: 10.1186/s13018-022-02947-3.
Clinical trial NCT06914752: TENS for Endometriosis Pain in Adolescents and Young Adults
Official title: TENS for Endometriosis Pain in Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis (Diagnosis)
Keywords: endometriosis
TENS
transcutaneous electrical nerve stimulation
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Delayed intervention trial. Individuals will be randomized to immediate or delayed treatment with the intervention.
Primary purpose: TREATMENT

Brief summary: The goal of this project is plan to investigate the utility of Transcutaneous Electrical Nerve Stimulators (TENS) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis.


Eligibility criteria: Inclusion Criteria:

* Adolescent girls and young women (13-25)
* Diagnosis of endometriosis,
* Current pelvic pain (score ≥ 3 on Visual Analog Scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for ≥ 14 days/month over the 2 months prior to study enrollment.
* Personal smart phone or mobile device
* Speak either English or Spanish.

Primary outcomes:
measure: Pain - Visual Acuity Scale
timeFrame: 6 months
Secondary outcomes:
measure: Endometriosis Health Profile 30 (EHP-30)
timeFrame: 6 months
measure: Missed school/work
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03775252: A Ketogenic Diet Acts on Cortical But Not Subcortical Responsivity in Migraineurs
Official title: A Ketogenic Diet Normalizes Interictal Cortical But Not Subcortical Responsivity in Migraineurs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Keywords: Ketogenic Diet
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 18
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
Primary purpose: BASIC_SCIENCE

Brief summary: A short ketogenic diet (KD) treatment can prevent migraine attacks and correct excessive cortical response. Here, investigators aim to prove if the KD-related changes of cortical excitability are primarily due to cerebral cortex activity or are modulated by the brainstem.

Through the stimulation of the right supraorbital division of the trigeminal nerve, there will be concurrently interictally recorded the nociceptive blink reflex (nBR) and the pain-related evoked potentials (PREP) in 18 migraineurs patients without aura before and after 1-month on KD, while in metabolic ketosis. nBR and PREP reflect distinct brain structures activation: the brainstem and the cerebral cortex respectively. It will be estimated nBR R2 component area-under-the-curve as well as PREP amplitude habituation as the slope of the linear regression between the 1st and the 2nd block of 5 averaged responses.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of migraine
* Kept a headache diary for at least 1 month
* Headache onset before the age of 50

Exclusion Criteria:

* over consumption of acute pain-killers (triptan, analgesic, or ergotamine)
* pregnancy or lactation
* type I diabetes
* serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.

Primary outcomes:
measure: Trigeminal neurophysiological changes (amplitude)
timeFrame: one month
measure: Trigeminal neurophysiological changes (latencies)
timeFrame: one month
measure: Trigeminal neurophysiological changes (slope)
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Umberto I
Study officials:
affiliation: University of Roma La Sapienza
name: francesco Pierelli, MD
role: STUDY_CHAIR
References:
citation: Di Lorenzo C, Coppola G, Bracaglia M, Di Lenola D, Evangelista M, Sirianni G, Rossi P, Di Lorenzo G, Serrao M, Parisi V, Pierelli F. Cortical functional correlates of responsiveness to short-lasting preventive intervention with ketogenic diet in migraine: a multimodal evoked potentials study. J Headache Pain. 2016;17:58. doi: 10.1186/s10194-016-0650-9. Epub 2016 May 31.
citation: Di Lorenzo C, Coppola G, Bracaglia M, Di Lenola D, Sirianni G, Rossi P, Di Lorenzo G, Parisi V, Serrao M, Cervenka MC, Pierelli F. A ketogenic diet normalizes interictal cortical but not subcortical responsivity in migraineurs. BMC Neurol. 2019 Jun 22;19(1):136. doi: 10.1186/s12883-019-1351-1.
Clinical trial NCT02821052: Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®
Official title: Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 1355
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

Brief summary: This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* Patients with diabetes mellitus requiring insulin therapy for whom the physician has decided to start treatment with Ryzodeg®
* Male or female, no age limitation

Exclusion Criteria:

* Patients who are or have previously been treated with Ryzodeg®
* Previous participation in this study. Participation is defined as having given informed consent in this study
* Patients with a history of hypersensitivity to study product components
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Primary outcomes:
measure: Incidence of AEs (adverse event)
timeFrame: Year 0-1
Secondary outcomes:
measure: Incidence of SADRs (Serious Adverse Drug Reactions)
timeFrame: Year 0-1
measure: Severe hypoglycaemic episodes
timeFrame: Year 0-1
measure: Incidence of Serious allergic reactions (systemic or localized, including injection site reactions)
timeFrame: Year 0-1
measure: Change in Glycosylated haemoglobin A1c (HbA1c)
timeFrame: Week 0, week 52
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Katabami T, Eriksen KT, Yamamoto Y, Ishigaki Y. Long-Term Safety and Clinical Outcomes with Insulin Degludec/Insulin Aspart Treatment in Japanese Patients with Diabetes: A Real-World, Prospective, Observational Study. Adv Ther. 2022 Jan;39(1):544-561. doi: 10.1007/s12325-021-01978-2. Epub 2021 Nov 20.
Clinical trial NCT06671652: Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk
Official title: Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a two phase project. Phase I is an online convenience sample to collect health and preference data for the intervention phase, as well as a partnership with community to co-create an intervention; Phase II. Phase II is an intervention to improve community connection and historical knowledge within Cherokee communities within the Cherokee Nation reservation involving consultation with Cherokee cultural and historical experts.

Detailed description: 1. Identify necessary program enhancements to maximize reach and acceptability of the intervention for primary prevention of CVD in Cherokee Nation adults. The new intervention will have a broad reach, and thus, potentially greater public health impact. By building on the well-established and popular intervention, RTR, the goal is to maximize the likelihood that this intervention will be culturally acceptable, logistically feasible, and financially sustainable.
2. Conduct a pilot study (n = 40) to demonstrate acceptability and feasibility of the adapted intervention and research methods. The expectation is that the intervention will be culturally acceptable to participants, and retention and data collection protocols will support feasibility of a larger randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Citizen of Cherokee tribe

Exclusion Criteria:

* Under the age of 18

Primary outcomes:
measure: Blood Pressure
timeFrame: Pre; Post (study completion; within 6 months)
Secondary outcomes:
measure: Positive Mental Health Scale
timeFrame: Pre; Post (study completion; within 6 months)
measure: "Cultural Efficacy"
timeFrame: Pre; Post (study completion; within 6 months)
Other outcomes:
Locations:
city: Tahlequah
country: United States
facility: Cherokee Nation
state: Oklahoma
Study officials:
affiliation: University of Missouri School of Medicine
name: Melissa Lewis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01584752: Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas
Official title: Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anal Fistula
Fecal Incontinence
Surgery
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inhabitants of Finland

Brief summary: This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months

Detailed description: Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years, male or female
* High cryptoglandular perianal fistula
* Written approval for the study
* Sufficient co-operation for the study
* Localization of the fistula by ultrasound or MRI

Exclusion Criteria:

* Crohns disease
* Immunosuppressive treatment
* Anovaginal fistula
* Radiation therapy 6 months before study
* Chemotherapy 6 months before study
* Low- or intersphincteric fistula

Primary outcomes:
measure: Healing of the fistula
timeFrame: 6 months
Secondary outcomes:
measure: Symptoms of fecal incontinence
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Joensuu
country: Finland
facility: Central Hospital
city: Jyväskylä
country: Finland
facility: Central Hospital
city: Lahti
country: Finland
facility: Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Central Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Central Hospital, Jyväskylä, Finland
name: Matti V Kairaluoma, ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04845152: Migraine in Electrohypersensitive Patients
Official title: Prevalence of Migraine Disease in Electrohypersensitive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Migraine
Keywords: Electrohypersensitivity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An adult declaring himself electrohypersensitive

Brief summary: The investigators propose here by the use of the French version of the migraine disease screening questionnaire (ID Migraine ™) to study the prevalence of migraine disease in a population of electrohypersensitive patients


Eligibility criteria: Inclusion criteria:

* Informed Consent
* 18 years or older at the time of informed consent

With all these criteria :

* the perception by the subjects of various non-specific functional symptoms
* the absence of clinical and biological evidence to explain the symptoms
* the attribution by the subjects themselves of these symptoms to exposure to electromagnetic fields, which are themselves diverse
* the symptoms are chronic (more than 3 months)
* the symptoms appear during an exposure to a source of electromagnetic radiation and cease after the exposure is stopped
* the symptoms are reproducible

Exclusion criteria:

- age under 18 years old

Primary outcomes:
measure: Possible migraine attack
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Frédéric GRECO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05670652: Assessment of the Occlusal Characteristics
Official title: Assessment of the Occlusal Characteristics of the Primary Dentition Among Egyptian Pre-School Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tooth Development Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 362
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian children aged from 3-6 years old

Brief summary: The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.

Detailed description: This cross-sectional study was based on examination of the primary dentition of healthy preschool Egyptian children ,The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.

Eligibility criteria: Inclusion Criteria:

* Egyptian children.
* Children are medically free.
* Children with a complete set of primary dentition without any permanent teeth. -Teeth free of extensive caries which affect the mesio- distal and occluso- gingival dimension.

Exclusion Criteria:

* Children with developmental anomalies.
* Children with any oral habits.
* Children with cognition problems.
* Children with a history of an obvious alternative cause for malocclusion (e.g. trauma, syndromes).
* Participant's caregivers refuse to give consent.

Primary outcomes:
measure: Primary molar relationship
timeFrame: Day 1
Secondary outcomes:
measure: Primary canine relationship
timeFrame: Day 1
measure: Physiological spaces (Upper and lower)
timeFrame: Day 1
measure: Primate spaces (Upper and lower)
timeFrame: Day 1
measure: Crowding (upper and lower)
timeFrame: Day 1
measure: Midline discrepancy
timeFrame: Day 1
measure: Posterior Crossbite (unilateral/bilateral)
timeFrame: Day 1
measure: Degree of overbite
timeFrame: Day 1
measure: Degree of overjet
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Sherine Badr Youness, prof dr
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Shereen Hassan El-Shamy, dr
role: STUDY_DIRECTOR
References:
citation: Davidopoulou S, Arapostathis K, Berdouses ED, Kavvadia K, Oulis C. Occlusal features of 5-year-old Greek children: a cross-sectional national study. BMC Oral Health. 2022 Jul 9;22(1):281. doi: 10.1186/s12903-022-02303-1.
citation: BY Badr, S. and H Yahfoufi, S. (2020) 'ASSESSMENT OF THE OCCLUSALCHARACTERISTICS OF THE PRIMARY DENTITION AMONG LEBANESE PRE-SCHOOL CHILDREN: A BASE LINE STUDY CROSS-SECTIONAL STUDY', BAU Journal-Health and Wellbeing, 2(2), p. 5.
citation: El-Attar, H., Salama, R. and Hussien, A. (2020) 'Prevalence of malocclusion and common occlusal traits among adolescent school children in Dakahliya, Egypt and Makkah, Saudi Arabia (A comparative study)', Egyptian Orthodontic Journal, 57(June 2020), pp. 1-9.
Clinical trial NCT03452852: Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
Official title: Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Cancer
Keywords: Split thickness skin graft
Lower leg
Compression therapy
PICO
Coban 2 lite
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The single center, prospective, randomized trial includes in total 60 patients. We want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. The patients are randomized to compression therapy with NPWT (negative pressure wound therapy) using the device PICO or using the compression bandage with Coban 2 lite.

Primary outcome is complete healing of the skin transplant 30 days postoperatively. Secondary outcomes will be to note frequency of infection, bleeding, loss of transplant etc.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Signed informed consent
* Surgical wound (excision of skin cancer)

Exclusion Criteria:

* Malignant melanoma
* Signs of infection
* Exposed tendon/bone in wound
* Burn/chronic wound

Primary outcomes:
measure: Healing of skin graft between the two Methods
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Percentage of healing between the two Methods
timeFrame: 30 days postoperatively
measure: Evaluation of pain with VAS (Visual analogic scale)
timeFrame: 0, 5-7, 10-14 and 30 days postoperatively
measure: Level of function
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet
Study officials:
affiliation: Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway
name: Thomas Moe Berg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: