louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03990636: Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
Official title: Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Actinic Cheilitis
Leukoplakia
Erythroplakia
Keywords: PDT
Actinic Cheilitis
Phase 2 Clinical Trial
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2019-06-19
Enrollment: 40
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: Brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. Many Europeans migrated to Brazil escaping either war or economic crisis to live in the country searching for opportunities. Low phototype combined with high incidence of UV light is a combination that not only affect the skin but also the lips. The current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis with histopathological confirmation of actinic cheilitis
* Patients will be requested to respect the timeframe of clinical consultations
* No treatment for actinic cheilitis in the last 3 months

Exclusion Criteria:

* Histopathological diagnosis of squamous cell carcinoma (SCC)
* Patient presenting any type of immunosupression
* Recurrent crust of the lip vermilion (high risk of SCC)

Primary outcomes:
measure: Complete clinical response
timeFrame: 18 months
measure: Histological cure
timeFrame: 18 months
Secondary outcomes:
measure: IHC analysis
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06937736: Performance Evaluation by the User of BGM Contour Care According to ISO 15197:2015
Official title: Leistungsbewertung Durch Den Anwender. Evaluierung Des Blutglukose Monitoring Systems Contour Care Der Firma Ascensia gemäß DIN EN ISO 15197:2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 101
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: Performance Evaluation by the User of the Blood Glucose Monitoring SystemContour Care in accordance with DIN EN ISO 15197:2015


Eligibility criteria: Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose measurements (i.e. Diabetes mellitus)
* Male or female patients with hypo-, eu- or hyperglycemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion Criteria:

* Pregnancy or lactation
* Acute or chronic diseases that

  * pose a risk of aggravation by the measure
  * pose a health hazard to the personnel
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Eckhard Salzsieder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00059436: Mental Effort and Muscle Strength
Official title: Mental-effort Effect on Large Muscle Strengthening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aging
Muscle Strength
Keywords: Muscle strengthening
Skeletal muscle Contractions
Rehabilitative exercise
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-04-28
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of mental effort on improving muscle strength.

Detailed description: Training that involves heavy loads or resistance strengthens muscles. Recent data suggest that substantial voluntary strength gains can be achieved with training involving low resistance and strong mental effort. In contrast, individuals who train with the same low intensity contractions but with low mental effort show no improvement in strength.

This study will evaluate the relationship between mental effort muscle strength improvements by comparing the improvement in muscle strength in participants who have trained with different levels of mental effort. In addition to evaluating muscle strength, this study will also examine the neural mechanisms underlying muscle strength improvements.

Four groups of volunteers (65 years old and over) will participate in a training program directed at elbow-flexor muscles. One group will be trained with an intensity near the level of maximal voluntary contraction (MVC group); a second group will be trained with high mental effort, low muscle intensity contractions (HME group); a third group will be trained with low mental effort, low muscle intensity elbow-flexion contractions (LME group); and the fourth (control) group will not be trained but will participate in the strength tests. Training will be performed every weekday for 12 weeks. Participants will be evaluated by functional MRI (fMRI), EEG-derived motor activity-related cortical potential (MRCP), surface EMG signals, and the MRI T2 relaxation time.

Preliminary analysis of results shows that the HME group gained more than 13% strength, the LME group showed a statistically insignificant 6% change, and the no-practice control group did not show any change in elbow flexor muscle strength. We expect the MVC group to have the highest strength gains among the four groups.

Eligibility criteria: Inclusion Criteria

* Healthy individuals free of neurological impairment

Exclusion Criteria

* Already involved in regular physical training
* Neuromuscular disorders
* Medications known to affect neuromuscular system (other than moderate alcohol or caffeine)
* Left-hand dominant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Cleveland Clinic Foundation, Biomedical Engineering
name: Guang H. Yue, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05510336: Assessment of Concentric Needle Technique in Temporomandibular Joint (TMJ) Internal Derangement.
Official title: Assessment of Concentric Needle Technique for the Management of Temporomandibular Joint Internal Derangement Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TMJ Disc Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effectivenes of using two concentric needles in comaprsion with the normal traditional two distant needles.


Eligibility criteria: Inclusion Criteria:

1. Patients with age ranges from 18-60.
2. Patients with painful clicking.
3. Patients free of systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).

Exclusion Criteria:

1. Patients out of the specified range group
2. Patients with painless TMJ clicking.
3. Patients with osteo-arthritic changes of the TMJ.
4. Patients with systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).
5. Patients with previous TMJ surgeries.

Primary outcomes:
measure: Pain felt during the procedure TMJ arthrocentesis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04898036: Phototherapy For Treatment Of Raynaud's Phenomenon
Official title: Phototherapy For Treatment Of Raynaud's Phenomenon
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Raynaud Disease
Raynaud Phenomenon
Raynaud Syndrome
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine if blue light therapy can improve the symptoms of Raynaud's phenomenon, and provide parameters for ultimately designing commercial treatment devices, an investigational stationary phototherapy unit was designed and built.

Detailed description: The purpose of this study is to test the efficacy of blue light phototherapy for the treatment of Raynaud's phenomenon (RP) in human participants. The specific aim is to see if phototherapy treatment applied to the hands will reduce the symptoms that RP participants experience. This will be measured through the use of a visual analog scale (VAS) of both pain and numbness. This study will also help to infer whether blue light phototherapy causes vasodilation through infrared thermal imaging of the hands and continuous measurement of skin temperature with a surface thermistor. Together, the visual analog scale (VAS) and infrared thermal imaging contribute to the objective of deducing whether blue light phototherapy can lead to reduced RP symptoms due to vasodilation of blood vessels.

Eligibility criteria: Inclusion Criteria:

- Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome

Exclusion Criteria:

* Those with active ischemic digital ulcers or gangrene as the cold exposure can be a safety hazard for them.
* Inability of the subject to place their hands into the PTD portal because of physical size or discomfort.
* Inability of the subject to wear protective eyewear.
* Anyone, who in the judgement of any of the investigators, would be unable to safely complete the study procedures.
* Females who are pregnant.
* Adults unable to consent for any reason not explicitly stated herein.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) of Pain
timeFrame: 4 hours
measure: Change in Visual Analog Scale (VAS) of Numbness
timeFrame: 4 hours
Secondary outcomes:
measure: Skin Temperature
timeFrame: 4 hours
Other outcomes:
measure: Thermal Imaging
timeFrame: 4 hours
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jerry Molitor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05945836: Peri-implant Disease and Prosthetic Cement: Cross-sectional Study
Official title: Excess Cement and Peri-implant Disease: A Cross-sectional Clinical Endoscopic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-implant Mucositis
Peri-Implantitis
Keywords: Dental implants
Peri-implant diseases
Excess cement
Implant prosthesis
Endoscopy
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutively, all subjects over 18 years of age presenting at least one cemented single-implant restoration with clinical and radiographic signs of peri-implant disease were included in the study.

Brief summary: The main objective of the present clinical study project, of a cross-sectional observational nature, is to evaluate the presence of submucosal cement residues through endoscopic visualization in clinical situations with peri-implant disease.

The secondary objective is to investigate the potential correlation between the severity of the pathological condition and the spatial position of cement residues in relation to the implant-prosthetic unit.

For each subject, the following data were collected: gender, age, periodontal history, smoking habits, reasons for implant rehabilitation (trauma, caries, periodontitis, agenesis, other), the position of the implant in the oral cavity, elapsed time between prosthetic rehabilitation and pathological condition. If the deposit was recognized as cement residue, its presence was recorded, and the anatomical position of the cement residue (mesial, distal, lingual/palatal, vestibular) and the spatial position of cement residues in relation to the implant-prosthetic unit were collected.


Eligibility criteria: Inclusion Criteria:

* at least one single-implant with cemented restoration and clinical-radiographic signs of peri-implant disease
* patients with previous periodontitis had to have a healthy but reduced periodontium

Exclusion Criteria:

* neuromotor pathologies or morphological-dysfunctional alterations

Primary outcomes:
measure: Prevalence of submucosal cement
timeFrame: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.
Secondary outcomes:
measure: Spatial position of submucosal cement
timeFrame: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.
Study officials:
affiliation: Alma Mater Studiorum - University of Bologna
name: Marco Montevecchi, DDS
role: STUDY_CHAIR
References:
Clinical trial NCT03664336: Refractory Diffuse Large B-cell Lymphoma
Official title: Refractory Diffuse Large B-cell Lymphoma After First-line Immuno-CT: Treatment Options and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Keywords: diffuse large B-cell lymphoma
refractory
rituximab
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Man or woman diagnosed for a DLBCL from January 2002 to January 2017

Brief summary: In the rituximab era, one-third of diffuse large B-cell lymphoma (DLBCL) patients experience relapse/refractory disease after first-line anthracycline-based immunochemotherapy (IChemo). Optimal management remains an unmet medical need. The aim of this study was to report the outcomes of a cohort of refractory patients according to their patterns of refractoriness and the type of salvage option. The investigators performed a retrospective analysis, which included 104 DLBCL patients treated at Lyon Sud University Hospital (2002-2017) who presented with refractory disease. The investigators retrospectively evaluated the outcomes of a cohort of 104 refractory patients according to their patterns of refractoriness and the type of salvage option.


Eligibility criteria: Inclusion Criteria:

-≥18 years of age

* diagnosed with DLBCL at Lyon Sud University Hospital (LSUH) from January 2002 to January 2017
* presented with refractory disease in response to front-line therapies
* including anthracycline-based chemo and a monoclonal anti-CD20 antibody

Exclusion Criteria:

* Patients with a history of indolent lymphoma,
* Patients with a primary central nervous system (CNS) lymphoma or immunosuppression-related lymphoma

Primary outcomes:
measure: Outcome according to pattern of refractoriness
timeFrame: Up to 4 years
Secondary outcomes:
measure: Outcome according to pattern of refractoriness
timeFrame: Up tp 24 months
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Clémentine Sarkozy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02716636: Fast Versus Slow Tenaculum Placement
Official title: Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD Insertion Complication
Endometrial Diseases
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 121
Sex: FEMALE
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 the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.

Detailed description: IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.

Eligibility criteria: Inclusion Criteria:

* 18 years old and older
* Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
* English speaking and able to consent

Exclusion Criteria:

* Incarcerated
* Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix

Primary outcomes:
measure: Pain with tenaculum placement assessed using a VAS scale
timeFrame: procedure
Secondary outcomes:
measure: Overall pain perception assessed using a VAS scale
timeFrame: procedure
measure: Provider perception of patient pain assessed using a VAS scale
timeFrame: procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Abbey J Hardy-Fairbanks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05571436: iCan Diabetes Self-management and Prevention Program
Official title: iCan Diabetes Self-Management and Prevention Support Group
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
PreDiabetes
Keywords: Diabetes Mellitus, Type 2
Prediabetes
Self-management
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the feasibility and preliminary efficacy of the iCan Diabetes Self-Management and Prevention Support Group using a single arm clinical trial. The program is composed of six weekly sessions, and it will be implemented with 60 adults (aged 18 years or older) who have been diagnosed with type 2 diabetes or prediabetes and evaluated using mixed methods. A pre-test will be conducted before the program implementation and a post-test will be conducted three months after the pre-test. Focus groups will be conducted shortly after the last session to obtain feedback on the program. Between the last session and the post-test, weekly emails/texts will be sent to keep participants engaged and maximize retention rate.


Eligibility criteria: Inclusion Criteria:

* Adult aged 18 years or older
* Have been diagnosed with type 2 diabetes or prediabetes
* Can read, write, and speak in English

Exclusion Criteria:

* Attended a diabetes self-management program or diabetes prevention program within the last 3 months
* Plan to attend another diabetes self-management program or diabetes prevention program within 3 months

Primary outcomes:
measure: Hemoglobin A1c (A1C)
timeFrame: 3 months
measure: Diabetes self-management behavior
timeFrame: 3 months
Secondary outcomes:
measure: Self-efficacy related to diabetes self-management
timeFrame: 3 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Seung-Yeon Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05610436: Post-Covid Condition Cohort: Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors
Official title: Post-Covid Condition Monitoring Cohort: Evaluation of the Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long COVID
Post-Acute COVID-19
Post-Acute COVID19 Syndrome
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 500
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: outpatients treated in the Nancy University Hospital Long Covid Support and Care Center for post-Covid condition according to WHO definition

Brief summary: The aim of our cohort is to collect prospectively, in a standardized and exhaustive manner, the health data of patients referred to the CAPCoV, our holistic referal post covid clinics for post-covid condition in order to be able to identify typical profiles of patients suffering from post covid syndrome and to follow the evolution of their disease over time.


Eligibility criteria: Inclusion Criteria:

* outpatients treated in the Nancy University Hospital Long Covid Support and Care Center for post-Covid condition according to WHO definition

Exclusion Criteria:

* patient opposing the processing for research purposes of their data collected in routine care for their care

Primary outcomes:
measure: Symptoms
timeFrame: every 6 months up to 3 years
Secondary outcomes:
measure: Medical history
timeFrame: baseline
measure: fatigue
timeFrame: every 6 months up to 3 years
measure: Dyspnea
timeFrame: every 6 months up to 3 years
measure: Cognitive impairement
timeFrame: every 6 months up to 3 years
measure: inappropriate hyperventilation syndrome
timeFrame: every 6 months up to 3 years
measure: additional examinations
timeFrame: every 6 months up to 3 years
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Nancy University Hospital
state: Grand Est
Study officials:
affiliation: Infectious Diseases Department, Nancy University Hospital,F-54000 Nancy, France.
name: Francois GOEHRINGER, MD
role: PRINCIPAL_INVESTIGATOR
References: