louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02487368: Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
Official title: Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Recurrent Low Back Pain
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Siemens-Betriebskrankenkasse
First posted: 2015-07-01
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. The aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment.

Patients with non-specific chronic or recurrent low back pain were selected from a large health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week 2; secondary outcome measures included the Oswestry disability index (ODI), health-related quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic medication consumption and safety.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* chronic or recurrent low back pain in the past 12 months
* average pain intensity 4 out of 10 points

Exclusion Criteria:

* malignant back pain
* congenital deformities of the spine
* dystonia or other movement disorders
* spinal surgery within 12 months prior
* pregnancy
* dermatological diseases in the areas treated
* tendency for hemorrhages
* severe mental illness
* recent treatment with anticoagulation, corticoid medication, acupuncture

Primary outcomes:
measure: Pain intensity
timeFrame: day 14
Secondary outcomes:
measure: Pain intensity
timeFrame: Week 14
measure: Oswestry Low Back Pain Disability Index
timeFrame: Day 14
measure: Oswestry Low Back Pain Disability Index
timeFrame: Week 14
measure: Short Form 36 Health Survey Questionnaire (SF-36)
timeFrame: Day 14
measure: Short Form 36 Health Survey Questionnaire (SF-36)
timeFrame: Week 14
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Day 14
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Week 14
measure: Experiences with the intervention
timeFrame: Day 14
measure: Medication use
timeFrame: Day 14
measure: Number of any adverse events
timeFrame: Day 14
measure: Pain intensity measured immediately after the application, visual analogue scale
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Duisburg-Essen
name: Gustav Dobos, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04731168: Prevention of Sleep Apnea After General Anaesthesia With a MAD
Official title: Prevention of Sleep Apnea After General Anaesthesia With a Mandibular Advancement Device: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-operative Medicine
Sleep Apnea
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sleep apneic episodes increase after general anaesthesia up to the third postoperative night. A mandibular advancement device, called MAD, is a small device that is inserted in the patient's mouth during the night and allows the advancement of the mandible, preventing sleep apneic episodes. The objective of this randomized controlled trial is to determine whether a MAD reduces the impact of general anaesthesia on the increase of the sleep apneic episodes in the postoperative period. All patients will have their sleep-related respiratory data measured using a portable respiratory polygraphy recorder (ResMed Embletta® system). This portable recorder allows a non-invasive recording of nasal airflow through a nasal cannula, oxygen saturation (SpO2) via finger pulse oximetry, respiratory efforts through thoracic and abdominal belts, and body position.


Eligibility criteria: Inclusion Criteria:

- adult patient undergoing any lower limb surgery

Exclusion Criteria:

* continuous positive airway pressure (CPAP) treatment for obstructive sleep apnoea,
* presence of severe respiratory or cardiovascular disease
* preoperative consumption of benzodiazepine,
* chronic use of opioids \> 30 mg/day morphine equivalent
* no tooth
* patient known for malignant hyperthermia

Primary outcomes:
measure: Supine AHI
timeFrame: Postoperative night 1
Secondary outcomes:
measure: Global AHI
timeFrame: Postoperative night 1
measure: OAI
timeFrame: Postoperative night 1
measure: CAI
timeFrame: Postoperative night 1
measure: Hypopnea index
timeFrame: Postoperative night 1
measure: ODI
timeFrame: Postoperative night 1
measure: Respiratory Rate
timeFrame: Postoperative night 1
measure: Percentage of supine time
timeFrame: Postoperative night 1
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois and University of Lausanne
state: Vaud
Study officials:
References:
Clinical trial NCT03375268: Predictive Model for Postoperative Complications in Hemi-hip Arthroplasty
Official title: Predictive Model for Postoperative Complications in Elderly Patients With Hip Arthroplasty: Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication
Risk Factor
Elderly Patient
Arthroplasty
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 460
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2011 to December 2015, we will enroll adult patients aged 60 years or older who underwent Hemi-hip Arthroplasty at our institution.

Brief summary: The purpose of this study was to identify the major complications and their risk factors of elderly patients who had undergone Hemi-hip Arthroplasty.

Detailed description: We retrospectively reviewed the medical records and reviewed the major complications and identify risk factors of elderly patients who had undergone Hemi-hip Arthroplasty for adults aged 60 years or older from January 2011 to December 2015.

Eligibility criteria: Inclusion Criteria:

* A patient scheduled to undergo spinal anesthesia for Hemi-hip Arthroplasty

Exclusion Criteria:

* 1) Patients with acute infectious disease before surgery 2) Patients with fractures around the implant 3) Patients who underwent reoperation during hospitalization 4) During the study period, Duplicate patient who underwent the opposite side of the hip during hospitalization

Primary outcomes:
measure: postoperative complications
timeFrame: from operation day to postoperative 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eulji university hospital
Study officials:
affiliation: Eulji University Hospital
name: Eunsu Choi, pf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06893068: Clinical Intelligent Management System Pragmatic RCT
Official title: Evaluation of a Multimodal Model-Based Clinical Intelligent Management System: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Care Diseases
Lead sponsor: Tsinghua University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of a clinical intelligent management system, based on a multimodal foundational model, in improving the quality of primary care at a community health service center.

Using a prospective, randomized controlled, single-blind study design, the trial will include primary care physicians and adult patients seeking care at the Tiantongyuanbei Community Health Service Center and Shanghai Health and Medical Center.

Physicians in the intervention group will utilize the intelligent management system with AR glasses to aid in diagnosis and treatment, while patients will engage with the system's patient interface to access health education, follow-up reminders, and AI-powered home consultation features. In contrast, physicians in the control group will provide routine diagnoses and treatments, with their patients receiving standard health education and follow-up care. The trial was designed with the assistance of a digital twin-based clinical research system (termed X Town).

By comprehensively evaluating diagnostic quality, physicians' clinical abilities, patient-reported outcomes, and system appraisals, this study will assess the effectiveness of the clinical intelligent management system in enhancing the quality of primary care and patient management.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Receiving care at a community health service center
* Able to understand and comply with the study procedures
* Agrees to participate in the study and signs the informed consent form

Exclusion Criteria:

* Patients with severe mental illness
* Patients unable to independently complete the questionnaire
* Patients expected to be unable to complete follow-ups within three months

Primary outcomes:
measure: Comprehensive Assessment of clinical performance
timeFrame: From enrollment to the end of treatment at 3 months of all recruited cases
Secondary outcomes:
measure: AI-System's appraisal
timeFrame: At the end of 3 months
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Shanghai Health and Medical Center
state: Jiang Su
Study officials:
affiliation: Tsinghua University
name: Tien Yin Wong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05100368: The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma
Official title: The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma, Ewing
Keywords: sarcoma; ewing
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Ewing's sarcoma or osteosarcoma

Brief summary: Extraction of laboratory data from blood tests prior to surgical and chemotherapy and other histological, clinical and instrumental data related to the patient's history from the digitized medical Digitized medical records and analysis of the same. The medical records of 1000 patients from January 1, 2000, until December 31, 2020


Eligibility criteria: Inclusion Criteria:

* Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis;
* Patients with age ≥ 2 years;
* Minimum follow-up duration of 2 years;
* Medical records, complete blood work and instrumental examinations; Regular follow-up.

Exclusion Criteria:

* Patients with Ewing's sarcoma or osteosarcoma who have received medical treatment (surgery radiotherapy or chemotherapy) in other institutions prior to admission to the Rizzoli Orthopaedic Institute.

Primary outcomes:
measure: 5-year survival
timeFrame: at baseline (Day0)
Secondary outcomes:
measure: Rate of local recurrence
timeFrame: at baseline (Day0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Nakamura T, Grimer RJ, Gaston CL, Watanuki M, Sudo A, Jeys L. The prognostic value of the serum level of C-reactive protein for the survival of patients with a primary sarcoma of bone. Bone Joint J. 2013 Mar;95-B(3):411-8. doi: 10.1302/0301-620X.95B3.30344.
citation: Li YJ, Yang X, Zhang WB, Yi C, Wang F, Li P. Clinical implications of six inflammatory biomarkers as prognostic indicators in Ewing sarcoma. Cancer Manag Res. 2017 Sep 28;9:443-451. doi: 10.2147/CMAR.S146827. eCollection 2017.
citation: Aggerholm-Pedersen N, Maretty-Kongstad K, Keller J, Baerentzen S, Safwat A. The Prognostic Value of Serum Biomarkers in Localized Bone Sarcoma. Transl Oncol. 2016 Aug;9(4):322-8. doi: 10.1016/j.tranon.2016.05.006.
Clinical trial NCT01738568: Effects of Aging and Aerobic Exercise Training on Brain Glucose Metabolism
Official title: Effect of Aging and Aerobic Exercise Training on Brain Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: High intensity aerobic training
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Aging is associated with a loss of brain function and conditions such as dementia and Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the progression of age related degenerative diseases. Aerobic exercise training can increase brain volumes and is associated with decreased risk for degenerative brain conditions. However, little is know about the changes that occur to brain metabolism with aerobic training and aging.


Eligibility criteria: Healthy sedentary adults aged 18-30 or 65-80 years of all ethnicities will be eligible. Pregnant women, children, prisoners or other at risk populations will not be recruited.

Inclusion Criteria:

* Age 18-30 years or 65-80 years

Exclusion Criteria:

* Body mass index (BMI) \>31 kg/m2
* Smoking
* Pregnancy
* Participation in structured exercise (\>2 times per week for 30 minutes or longer)
* Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease
* Orthopedic problems that would keep them from being able to ride an exercise bicycle, lift weights or do a combination of these exercise
* Medications that are known to impact on mitochondrial function: Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist)
* Claustrophobia

Primary outcomes:
measure: Change in Brain Glucose Uptake
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Val Lowe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson MM, Lowe VJ, Nair KS. Increased Brain Glucose Uptake After 12 Weeks of Aerobic High-Intensity Interval Training in Young and Older Adults. J Clin Endocrinol Metab. 2018 Jan 1;103(1):221-227. doi: 10.1210/jc.2017-01571.
Clinical trial NCT00218868: Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunwald-giemsa Stained Tissue Smear
Official title: Cytodiagnosis of Basal Cell Carcinoma and Actinic Keratosis Using Papanicolaou and May-grunvald-giemsa Stained Cutaneous Tissue Smear in Relation to Photodynamic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Basal Cell
Porokeratosis, Disseminated Superficial Actinic
Keywords: Cytodiagnosis
Skin Scrape
Touch Imprint
Papanicolaou
May-Grunvald-Giemsa
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 66
Sex: ALL
Minimum age (years): 0
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 BCC and 28 AK histologically verified lesions, from 41 and 25 patients, respectively

Brief summary: The purpose of this study is to compare and evaluate the diagnostic performance of scrape cytology using two different cytological staining techniques, and to evaluate additional touch imprint cytology with that of histopathology of superficial basal cell carcinoma and actinic keratosis.


Eligibility criteria: Inclusion Criteria:

Histologically verified basal call carcinoma and actinic keratosis

Exclusion Criteria:

Morphea form of basal cell carcinoma. Pigmented form of basal cell carcinoma.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olav University Hospital
Study officials:
affiliation: St. Olav, University Hospital, Trondheim
name: Eidi Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensen E, Bofin A, Gudmundsdottir I, Skogvoll E. Cytological diagnosis of basal cell carcinoma and actinic keratosis, using Papanicolaou and May-Grunwald-Giemsa stained cutaneous tissue smear. Cytopathology. 2008 Oct;19(5):316-22. doi: 10.1111/j.1365-2303.2007.00483.x. Epub 2007 Oct 4.
Clinical trial NCT06051968: Effects of an Online Hearing Support for First-time Hearing Aid Users
Official title: Effects of an Online Hearing Rehabilitation Support for First-time Hearing Aid Users: A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Loss
Hearing Impairment
Hearing Disorders
Hearing Disability
Ear Diseases
Sensation Disorders
Otorhinolaryngologic Diseases
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Horselvarden Region Ostergotland
First posted: 2023-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.


Eligibility criteria: Inclusion Criteria:

* Adults \> 20 years of age that are eligible for hearing aids
* Access to a computer, tablet and/or smartphone with internet
* Access to a Swedish BankID or equivalent

Exclusion Criteria:

* Inability to read and understand Swedish

Primary outcomes:
measure: The Hearing Handicap Inventory for the Elderly (HHIE)
timeFrame: Baseline, directly post intervention and 6 months post intervention.
Secondary outcomes:
measure: The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
timeFrame: Baseline, directly post intervention and 6 months post intervention.
measure: Communication Strategies Scale (CSS)
timeFrame: Baseline, directly post intervention and 6 months post intervention.
measure: The International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: Directly post intervention and 6 months post intervention.
Other outcomes:
measure: Subjective impact of the intervention, reported by the users: Memory of the intervention
timeFrame: 6 months post intervention
measure: Subjective impact of the intervention, reported by the users: Seeking more or other information
timeFrame: 6 months post intervention
measure: Subjective impact of the intervention, reported by the users: Adverse effects
timeFrame: 6 months post intervention
Locations:
city: Lund
country: Sweden
facility: Audiologimottagningen Lund
Study officials:
affiliation: Horselvarden Region Ostergotland
name: Marie Öberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105168: Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment
Official title: Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment in Patients With Lung Cancer or Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melanoma
Non Small Cell Lung Cancer
Small Cell Lung Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value.


Eligibility criteria: Inclusion Criteria:

1. Cytological or histological diagnosis of SCLC, NSCLC or melanoma
2. Patients age \>/= 18 years old
3. Indication of treatment using platinum salts for lung cancer except for patient with NSCLC treated by surgery for whom platinum salts is not indicated
4. If a biopsy is proposed, lesion lust be easily accessible
5. Signed informed consent

Exclusion Criteria:

1. Patients unable to follow the protocol
2. Consent refusal

Primary outcomes:
measure: Mutation rate on tumorous material
timeFrame: Assessed at the time of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
state: Val de Marne
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Benjamin Besse, MD
role: STUDY_CHAIR
References:
citation: Mezquita L, Preeshagul I, Auclin E, Saravia D, Hendriks L, Rizvi H, Park W, Nadal E, Martin-Romano P, Ruffinelli JC, Ponce S, Audigier-Valette C, Carnio S, Blanc-Durand F, Bironzo P, Tabbo F, Reale ML, Novello S, Hellmann MD, Sawan P, Girshman J, Plodkowski AJ, Zalcman G, Majem M, Charrier M, Naigeon M, Rossoni C, Mariniello A, Paz-Ares L, Dingemans AM, Planchard D, Cozic N, Cassard L, Lopes G, Chaput N, Arbour K, Besse B. Predicting immunotherapy outcomes under therapy in patients with advanced NSCLC using dNLR and its early dynamics. Eur J Cancer. 2021 Jul;151:211-220. doi: 10.1016/j.ejca.2021.03.011. Epub 2021 May 19.