louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03137407: Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Official title: A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plantar Fasciitis
Keywords: heel pain
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.


Eligibility criteria: Inclusion Criteria:

* Written informed consent, including authorization to release health information
* Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis
* Persistent heel pain for more than three months
* Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study

Exclusion Criteria:

* Previous surgery on the midfoot or hindfoot
* Neuromuscular disease
* Systemic muscle weakness
* Planning a pregnancy during the study
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit

Primary outcomes:
measure: Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
timeFrame: Week 8
Secondary outcomes:
measure: Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16
timeFrame: Weeks 1, 2, 4, 8, and 16
measure: Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)
timeFrame: Weeks 1, 2, 4, 8, and 16
measure: Change From Baseline Through Week 16 for the Foot and Ankle Disability Index
timeFrame: Weeks 1, 2, 4, 8, and 16
Other outcomes:
Locations:
city: Duluth
country: United States
facility: Village Podiatry Centers
state: Georgia
city: Des Plaines
country: United States
facility: Weil Foot and Ankle Institute
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Bone & Joint Clinic
state: Kansas
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: San Antonio
country: United States
facility: Element Research Group
state: Texas
Study officials:
References:
Clinical trial NCT06248307: Evaluation of Protein Bars on Weight Management and Osteoarthicular Health
Official title: Evaluación Del Efecto de la Ingesta de Una Barrita Con Alto Contenido de proteína Sobre el Peso y la Salud Osteoarticular
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Articular Disease
Keywords: Nutritional intervention
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Viscofan
First posted: 2024-02-08
Enrollment: 102
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel groups, double-blind, randomized intervention
Primary purpose: PREVENTION

Brief summary: The goal of this intervention study is to evaluate the efficacy in subjects with overweight or obesity of protein bars consumption. The main questions it aims to answer are:

* Does the regular consumption of these protein bars help to loose weight?
* Does the regular consumption of these protein bars help to improve the osteoarticular health? Participants will be asked to follow the indications of consumption of the bars togather with healthy nutritional advice during 16 weeks.

Researchers will compare exparimental Versus placebo groups to see if weight is lost in similar or different ways.

Detailed description: The intervention is designed to evaluate the efficacy of the consumption of a protein bar vs placebo on weight control and osteoarticular health.

For this purpose, a total of 102 subjects will be randomised to either the experimental group or the placebo group, the only stratification performed will be acording to sex.

Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 37.5 kg/m2
* Normal physical examination and vital signs according to clinical examiners.
* Chronic pharmacological treatment is permitted if dosage is stable within at least three months prior the start of the intervention.

Exclusion Criteria:

* Any funcitonal or structural impairment in digestive system (hitus hernia, ulcers, inflammatory bowel disease, etc.)
* Excessive alcohol consumption (\> 14 units/week in women and \> 20 units per week in men)
* Bariatric surgery or similar
* Arthritis, hepatic diseases, cancer.
* Alergy to any component of the products
* Subjects presenting any cognitive or psichiatric impairment, that may impel them to follow the protocol.
* Subjects following any weight loss program

Primary outcomes:
measure: Ponderal evolution
timeFrame: 16 weeks
measure: Change in fat mass
timeFrame: 16 weeks
measure: Change in fat-free mass
timeFrame: 16 weeks
Secondary outcomes:
measure: Osteoarticular changes
timeFrame: 16 weeks
measure: Plasma P2P and CTX-II levels
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Centro de Investigacion en Nutricion. Universidad de Navarra
state: Navarra
Study officials:
References:
Clinical trial NCT00237107: Debulking Effect of Curretage on Basal Cell Carcinomas - a Histological Assessment.
Official title: Relation of Basal Cell Carcinoma Tumour Thickness, Histologically Estimated, in Punch Biopsies Performed Before and After Curretage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Basal Cell
Keywords: Cytoreduction Surgical Procedures
Curretage
Photochemotherapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this study was to compare histologically observed tumour infitration of basal cell carcinoma (bcc) lesions before and after curretage.A significant reduction of tumour depth would enable further bcc's included for superficial non-invasive treatment modalities such as topical photodynamic therapy.


Eligibility criteria: Inclusion Criteria:

* bcc with tumour depth two mm.or more

Exclusion Criteria:

* bcc tumours smaller than three mm in mean diameter.

Primary outcomes:
measure: Reduction of tumour thickness 0,5mm or more after curretage
timeFrame: 1 hour
Secondary outcomes:
measure: Comparison of tumour thickness in punch biopsies performed on referral, before and after curretage.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: St. Olav University Hospital, Trondheim
name: Eidi Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensen E, Mork C, Foss OA. Pre-treatment deep curettage can significantly reduce tumour thickness in thick Basal cell carcinoma while maintaining a favourable cosmetic outcome when used in combination with topical photodynamic therapy. J Skin Cancer. 2011;2011:240340. doi: 10.1155/2011/240340. Epub 2011 Nov 15.
Clinical trial NCT03520907: The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block
Official title: The Effect of the Transversalis Fascia Plane Block on Postoperative Pain Behavior After Hernia Repair Surgery in Children - Comparison With Conventional Ilioinguinal/Iliohypogastric Nerve Block-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Inguinal Hernia Unilateral
Children, Only
Keywords: transversalis fascia
ilioinguinal/iliohypogastric nerve
inguinal hernia repair
children
Lead sponsor: Ibaraki Children's Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the transversalis fascia plane block with the ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery.

Half of participants will receive the transversalis fascia plane block, while the other will receive the ilioinguinal/iliohypogastric nerve block.

Detailed description: The ilioinguinal/iliohypogastric nerve block (II/IH B)is a widely used regional anesthesia technique in inguinal hernia repair surgery. However, this block provides limited analgesia during and after surgery, and the patients feel pain when walking. The transversalis fascia plane block (TFPB) is a recently developed technique and several case reports presented its efficacy for inguinal repair surgery in adult patients. It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the thoracolumbar fascia. Therefore, we compare the effect of the TFPB and II/IH B on postoperative pain and walking form.

Eligibility criteria: Inclusion Criteria:

* the patients undergoing unilateral open hernia repair surgery

Exclusion Criteria:

* known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage

Primary outcomes:
measure: walking appearance
timeFrame: 3 to 5 hours after surgery
Secondary outcomes:
measure: FLACC (face, legs, activity, cry, consolability) score
timeFrame: 3 to 5 hours after surgery
measure: Faces Pain Scale revised
timeFrame: 3 to 5 hours after surgery
measure: additional pain curer usage
timeFrame: up to 5 hours after surgery
Other outcomes:
measure: intraoperative heart rate changes
timeFrame: just before surgery start, one minute after incision, maximum value during surgery
measure: intraoperative respiratory rate changes
timeFrame: just before surgery start, one minute after incision, maximum value during surgery
Locations:
city: Mito
country: Japan
facility: Ibaraki Children's Hospital
state: Ibaraki
Study officials:
affiliation: Ibaraki Children's Hospital
name: Kazuhiko Okuyama, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02114788: Interactive Sections Of An Internet-Based Intervention Increase Patient Empowerment: A Study With Chronic Back Pain Patients
Official title: INTERACTIVE SECTIONS OF AN INTERNET-BASED INTERVENTION INCREASE PATIENT EMPOWERMENT: A RANDOMIZED CONTROLLED STUDY WITH CHRONIC BACK PAIN PATIENTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Group 1 (Control): Access to a Static Version of the Website Containing Only Static Features (i.e. Library, First Aid, and FAQ)
Group2 (Intervention) Access to an Interactive Version of the Website Containing Both Static and Interactive Features
Lead sponsor: University of Lugano
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are screened through their healthcare provider at selected clinics and rehabilitation centers in the Canton Ticino (Switzerland).

Brief summary: The aim of the study is to study how to improve patients' management of chronic back pain, particularly their management of prescription medication, through increasing health literacy and patient empowerment through an internet based intervention. We do this by designing both patient education materials and physician communication strategies to increase literacy and volitional components of patients. We will test two conditions using a website called Oneself: one providing only information (literacy-only control) and a second providing relational communications designed to increase both literacy and volitional empowerment. To test the self-management enhancing effects of empowerment and health literacy, we will conduct a longitudinal experiment with 51 chronich back pain patients over two months. This span of time is the minimum necessary to achieve a systematic change in self-management and literacy skills, increasing also the range of possible decisions to be made and actions to be real-ized by the patients.


Eligibility criteria: Inclusion Criteria:

1. aged \> 18 years,
2. having suffered from back pain for at least 3 months,
3. no concurrent involvement in other studies.

Exclusion Criteria:

1. No access/limited access to computer and internet
2. concurrent diseases

Primary outcomes:
measure: Empowerment level (psychological measure)
timeFrame: 8 weeks
Secondary outcomes:
measure: Medication misuse Physical exercise Pain burden
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Insitute of Communication nad Health, University of Lugano
state: Canton Ticino
Study officials:
References:
citation: Riva S, Camerini AL, Allam A, Schulz PJ. Interactive sections of an Internet-based intervention increase empowerment of chronic back pain patients: randomized controlled trial. J Med Internet Res. 2014 Aug 13;16(8):e180. doi: 10.2196/jmir.3474.
Clinical trial NCT00442988: Prediction of NODAT After Renal Transplantation
Official title: Early Prediction of New Onset Diabetes Mellitus After Transplantation (NODAT) in Renal Transplantation: Use of Oral Glucose Tolerance Test (OGTT) and Fasting Plasma Glucose (FPG).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplantation
Keywords: NODAT
OGTT
FPG
Renal Transplanation
Risk Factors
Predictive value
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2007-03-05
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: A statistical analysis of the predictive value of OGTT and FPG testing executed as part of standard clinical practice after renal transplantation for the diagosis of new-onset diabetes mellitus after transplantation.

Detailed description: All patients transplanted in our department receive a formal oral glucose tolerance test (and thus also fasting plasma glucose concentration) in the first week after renal transplantation. This testing for DM or Impaired Glucose Tolerance (IGT) is part of our standard clinical protocol and data are collected prospectively in all these patients in an electronic patient medical file. The development of diabetes mellitus in all transplant patients is documented, including DM therapy.

Eligibility criteria: Inclusion Criteria:

* Primary or secondary single kidney transplantation
* Age older than 18 years

Exclusion Criteria:

* Pre-existing DM or documented impaired glucose metabolism
* Combined organ transplantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Dpt of Nephrology and Renal Transplantation
Study officials:
affiliation: Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Belgium
name: Dirk R Kuypers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02871388: Addressing Modifiable Breast Cancer Risk Factors With Project CONECT
Official title: Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Breast Cancer Risk Factors
Keywords: Physical activity
Diet
Nutrition
Breast cancer prevention
Mammography screening
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 14
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change.


Eligibility criteria: Inclusion Criteria:

1. Female
2. 40-65 years of age,
3. Received a negative mammography screening result in the previous four weeks
4. Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),
5. Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).
6. BMI 25-40 kg/m2
7. Has access to a computer or mobile device with wireless internet
8. Able to speak and read English (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.)

Exclusion Criteria:

1. Previous history or current diagnosis of breast cancer
2. Pregnancy or lactation
3. Involvement in a weight loss program
4. Major co-morbidities (e.g.,diabetes, hypertension, etc.)
5. History of disordered eating
6. Currently taking medication that may impact weight (e.g., synthroid, metformin)

Primary outcomes:
measure: feasibility-participant engagement and retention
timeFrame: 12 weeks
measure: feasibility-intervention adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in autonomous motivation
timeFrame: 12 weeks and 24 weeks
measure: Steps per day
timeFrame: 12 and 24 weeks
measure: Total minutes of weekly physical activity
timeFrame: 12 and 24 weeks
measure: Daily caloric goals
timeFrame: 12 and 24 weeks
Other outcomes:
measure: change in waist circumference
timeFrame: 12 and 24 weeks
measure: weight loss
timeFrame: 12 weeks
measure: weight maintenance
timeFrame: 24 weeks
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Maria D Thomson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06877988: Artificial Intelligence (AI) - Assisted Visual Impairment Screening Model: Community-based Implementation and Evaluation of Performance, Feasibility and Costs.
Official title: Artificial Intelligence (AI) - Assisted Visual Impairment Screening Model: Community-based Implementation and Evaluation of Performance, Feasibility and Costs.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Visual Impairment
Keywords: Visual impairment
Community Screening
Randomized Controlled Trial (RCT)
Artificial Intelligence (AI)
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
Collaborators: name: Institute of High Performance Computing (IHPC), A*STAR Research Institutes
name: National University Polyclinics, Singapore
First posted: 2025-03-14
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this observational study is to evaluate the performance, operational efficiency, acceptability, feasibility, and cost-effectiveness of an AI-assisted screening model for visual impairment in a community setting. The main questions it aims to answer are:

* Can the AI-assisted screening model improve screening and referral accuracy compared to the current traditional screening approach?
* Does the AI-assisted model enhance operational efficiency and reduce healthcare costs in a community setting?

Researchers will compare the AI-assisted model with the current traditional screening approach to assess its impact on screening accuracy, operational efficiency, and cost-effectiveness.

Participants will:

* Undergo vision screening using either the AI-assisted model or the traditional model.
* Provide feedback on the acceptability of the screening approach.
* Contribute to evaluating the feasibility and costs associated with each screening method.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 50 years old and above.

Exclusion Criteria:

* Individuals aged below 50 years old.

Primary outcomes:
measure: Performance of AVIRI on the detection of visual impairment
timeFrame: through study completion, an average 1 year
Secondary outcomes:
measure: Operational efficiency
timeFrame: through study completion, an average 1 year
measure: Patient acceptability
timeFrame: through study completion, an average 1 year
measure: Perceptions of feasibility
timeFrame: through study completion, an average 1 year
measure: Cost savings of implementing the AI-assisted screening model
timeFrame: through study completion, an average 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pioneer Polyclinic
Study officials:
References:
Clinical trial NCT00831688: Efficacy of Local Overpressure Treatment for Meniere's Disease
Official title: Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meniere's Disease
Keywords: Meniere
vertigo
overpressure treatment
caloric irrigation
hearing levels
vertigo severity
functional disability scale
Lead sponsor: Klinikum der Universitaet Muenchen, Grosshadern
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to date, is that no causal therapy for Meniere's disease has been discovered. Local overpressure treatment for Meniere's disease is a new treatment form that has been shown in animal and human experiments to reduce the endolymphatic hydrops, a condition that is generally believed to be the pathologic hallmark of Meniere's disease. This study analyzes the efficacy of local overpressure treatment by measuring subjective vertigo severity and objective audiovestibular function parameters.

Detailed description: Randomized double-blind controlled trial. Patients with unilateral Meniere's disease that suffer from recurring vertigo attacks are allocated to either a verum or a placebo device and are treated for 4 months. Before during and after the treatment period, subjective and objective audiovestibular function parameters are measured.

Eligibility criteria: Inclusion Criteria:

* unilateral definite Meniere's disease according to the AAO-HNS criteria

Exclusion Criteria:

* previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Primary outcomes:
measure: Change in vertigo score from pre-therapy to post-therapy. (Vertigo score = summation of daily vertigo severity over 4 weeks. Daily vertigo score = a number between = and 4.)
timeFrame: 4 months
Secondary outcomes:
measure: Pure tone audiometric thresholds
timeFrame: 4 months
measure: Speech recognition hearing levels
timeFrame: 4 months
measure: Horizontal semicircular canal paresis
timeFrame: 4 Months
measure: Subjective Daily Activity levels (Number between 0 and 4)
timeFrame: 4 Months
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinik für Hals-Nasen-Ohrenheilkunde
state: Bayern
Study officials:
affiliation: LMU Munich, Department of ENT
name: Eike Krause, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LMU Munich, Department of ENT
name: Robert Gürkov, MD
role: PRINCIPAL_INVESTIGATOR
References: