louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02197507: Digitized Grip Strength
Official title: Evaluation of Grip Strength With Digitized Sensor in Adults With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults. Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also validated questionnaires for self-assessment of the disease by the patient. Grip strength measured using a digitized sensor used by the patient could be an additional tool to the remote monitoring of patients with RA.

Main Objective : To evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28

Secondary objective : Evaluate the correlation between grip strength of the dominant hand and :

* scores of fatigue and pain (VAS and FACIT)
* the self-assessment scores known in RA : functional index Health Assessment Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5.

It is a cross-sectional study involving 150 patients followed in our department for RA. Grip strength of the dominant hand will be measured by a digitalized sensor during a single visit integrating into the routine monitoring of patients.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis whatever its activity
* Above 18 years old patients

Exclusion Criteria:

* Other condition that may affect the level of fatigue and / or grip strength
* Insufficient level of understanding to perform the measurement and self-report questionnaires

Primary outcomes:
measure: grip strength
timeFrame: visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
References:
Clinical trial NCT02583607: Brava and Fat Transfer for Breast Reconstruction
Official title: Brava and Fat Transfer for Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Fat Necrosis of Breast
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Breast reconstruction is one of the most challenging aspects in plastic surgery. One of the most sophisticated methods of breast reconstruction is using of autologous fat grafting. Brava is a device that invented by Dr Roger Khouri, and is intended to improve the final results of fat grafting.

Detailed description: The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.

Eligibility criteria: Inclusion Criteria:

* woman after mastectomy

Exclusion Criteria:

* smokers
* collagen disease
* low compliance

Primary outcomes:
measure: Number of patients satisfied with breast reconstruction using Brava and fat transfer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shaare Zedek Medical Center
name: Yoav Gronovich, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01433107: Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of Terbinafine Film Forming Solution, 1% (as Hydrochloride), in Patients With Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Keywords: Tinea pedis
Terbinafine film forming solution
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 290
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: This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy

Exclusion Criteria:

* Allergy to the allylamine class of antimycotics or excipients in the formulation.
* Chronic, hyperkeratotic plantar (moccasin) tinea pedis
* Other fungal disease or intertrigo
* Other abnormal findings on the affected foot
* Systemic antifungal or antimicrobial treatment within the last 3 months
* Topical treatment for skin lesions on feet within the last 3 months
* Diabetes mellitus and peripheral artery occlusive disease

Primary outcomes:
measure: Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)
timeFrame: week 6
Secondary outcomes:
measure: Total Clinical Signs and Symptoms (S/S) Scores
timeFrame: week 6
measure: Number of Subjects With Adverse Event
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing University Hospital N°3
city: Guangdong
country: China
facility: The Second Affiliated Hospital of Sun Yat-sen University Guangzhou
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
city: Jiangsu
country: China
facility: Chinese Academy of Medical Sciences
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
Study officials:
References:
Clinical trial NCT04950907: Uniportal Tubeless VATS for the Evaluation of Biopsy for Second-generation Sequencing in Patients With Advanced NSCLC
Official title: A Randomized Controlled Study of Single Port Tubeless VATS for the Evaluation of Qualified Rate of Biopsy for Second-generation Tibial Specimens in Patients With Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NSCLC
Biopsy Technique
VATS
CT Guided Puncture Biopsy
NGS
Keywords: NSCLC
biopsy technique
VATS
CT guided puncture biopsy
NGS
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study is a single-center, prospective, open-label randomized controlled study. This study evaluates the eligibility rate of different biopsy methods (tubeless tubeless VATS vs. CT guided fine needle aspiration) for the detection of molecular genetic characteristics of peripheral NSCLC next-generation sequencing, and its main purpose is to evaluate the use of tumor gene profiling (NGS) The best biopsy technique, the First Affiliated Hospital of Guangzhou Medical University is the research center. It is expected to be completed between 2021-3-1 and 2023-3-1.


Eligibility criteria: Inclusion Criteria:

* Informed consent is obtained
* Assessed by more than 2 surgeons, patients whose lesions can be achieved by tubeless single-port thoracoscopic surgical biopsy

Exclusion Criteria:

* History of other malignant tumors.
* The general condition is not suitable for puncture, bronchoscopy, or surgery (such as cardiopulmonary dysfunction, high risk of bleeding, allergy to anesthetics, confusion, inability to exercise, etc.)
* History of lung surgery, tuberculosis and coal mine work experience, etc. may cause severe chest adhesions; other situations that conflict with the biopsy process

Primary outcomes:
measure: Qualified Rate of Biopsy for Second-generation Tibial Specimens
timeFrame: up to 2 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: up to 2 years
measure: Overall Survival
timeFrame: up to 2 years
measure: Tumor Content Size
timeFrame: up to 2 years
measure: Gene Mutation Rate
timeFrame: up to 2 years
measure: Drug sensitive mutation detection rate
timeFrame: up to 2 years
measure: Detection of PD-L1 expression
timeFrame: up to 2 years
measure: TMB detection situation
timeFrame: up to 2 years
measure: Correlation between tumor cell content and detection rate of sensitive mutations
timeFrame: up to 2 years
measure: Perioperative complications
timeFrame: up to 2 years
measure: Postoperative patient experience score
timeFrame: up to 2 years
measure: Usage rate of targeted drug
timeFrame: up to 2 years
measure: Success rate of enrollment
timeFrame: up to 2 years
measure: Postoperative MRD detection
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00902707: Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung
Official title: An Open-Label, 2-way Crossover Placebo-Controlled , Radio-Labeled Tracer Study Evaluating the Effect of MUCINEX® 1200 mg on Mucociliary and Cough Clearance From The Human Lung In Healthy, Non-Smoking Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mucociliary Clearance
Keywords: healthy nonsmokers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Reckitt Benckiser Inc.
First posted: 2009-05-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Non smoker
* BMI 19-29
* Normal lung function

Exclusion Criteria:

* Pregnant
* Smokers
* Any illness

Primary outcomes:
measure: Difference between drug and placebo in the percentage of particles cleared from the lung.
timeFrame: Measurements at 60, 90 and 180 min
measure: Difference between drug and placebo as an estimate of small airway clearance.
timeFrame: Measurements at 60, 90 and 180 min
measure: Difference between drug and placebo between study days.
timeFrame: Measurements at 60, 90 and 180 min
Secondary outcomes:
measure: Blood will be drawn to determination of guaifenesin in the serum.
timeFrame: at baseline and every 30 min x8
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Environmental Medicine, Asthma and Lung Biology
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: William Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03407807: Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution
Official title: Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Keywords: Fetal Splenic cyst
Differential Diagnosis
Evolution and complication
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 5450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnent women with an isolated suspected fetal splenic cyst

Brief summary: The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst

Detailed description: The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst. The investigators performed a retrospective study in the Montpellier Prenatal Diagnosis Centre between 2007 and 2017. All pregnant women referred to this unit after routine ultrasound examination with a suspected splenic cyst were included. Participant all benefit a reference ultrasound to perform a detailed morphological examination. In any doubt about diagnosis, a MRI exam wad proposed. Then patient were followed regularly. At birth, all newborn babys had medical examination to search early complication. Then, children had a surgical consultation and regular ultrasound examinations were performed.

Eligibility criteria: Inclusion Criteria:

* Pregnent women with an isolated suspected fetal splenic cyst between 2007 and 2017 in Montpellier Prenatal Diagnosis Center

Exclusion Criteria:

* All others fetal diagnosis

Primary outcomes:
measure: Prenatal ultrasound evolution of fetal splenic cysts during pregnancy
timeFrame: 1 day
Secondary outcomes:
measure: Prenatal Magnetic Resonance imaging (MRI) evolution of fetal splenic cyst
timeFrame: 1 year
measure: Post natal ultrasound evolution at birth of the cyst
timeFrame: 1 year
measure: Post natal MRI evolution at birth of the cyst
timeFrame: 1 year
measure: 1 year ultrasound evolution of the cyst
timeFrame: 1 year
measure: 1 year MRI evolution of the cyst
timeFrame: 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
References:
Clinical trial NCT02191007: Efficacy and Safety Study of Calcipotriol Betamethasone Plus Calcipotriol in Sequential Therapy to Psoriasis
Official title: Multi-center,Single Blind, Parallel-Controlled Study of the Efficacy and Safety of Calcipotriol Betamethasone Ointment Plus Calcipotriol Ointment in Sequential Therapy to Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 230
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: Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol Ointment in sequential therapy

Detailed description: 1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12 weeks after the beginning of treatment.

Eligibility criteria: Inclusion Criteria:

1. Subjects who signed Informed Consent Form；
2. Male or female subjects 18-65 years of age；
3. Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for psoriasis vulgaris specified in Clinical Dermatology.
4. Involved area 1-10% of the body surface area.

Exclusion Criteria:

1. Incompliance with the diagnosis of plaque psoriasis or plaque area \> 10% of the body surface area.
2. Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;
3. Known allergy to any component of the test or control drug；
4. Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or other serious and/or extensive skin disease；
5. Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study initiation；
6. Topical use of external drug for psoriasis within 2 weeks prior to study initiation；
7. Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
8. Glucocorticoid or immunodepressant, or hypoleukemia due to tumor or chemotherapy within the last 4 weeks；
9. Serious life-threatening condition that allows a life expectancy of less than 2 months；
10. Inability to guarantee taking medications and completing visits as scheduled during the study;
11. Serious infection that is not suitable for external treatment；
12. Any other condition that the investigator deems unsuitable for entering the study.

Primary outcomes:
measure: Psoriasis Area and Severity Index 50 ,75 and 90
timeFrame: week0 and week12
Secondary outcomes:
measure: Time to recurrence
timeFrame: Any Point In Time after 4 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT03296007: Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task
Official title: Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task on Individuals With Clinically Significant Symptoms of Chronic Pain, Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depression, Anxiety
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 2016
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the psychophysiological effects of a smart phone based mindfulness meditation app (MMA) for individuals with clinically significant symptoms of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present awareness, mood symptoms, and breath focus in groups of participants who self-report clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms (CP), as well as control participants who do not meet our criteria for either (Controls (C). All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a mindfulness meditation condition without the app (MMA-) after a brief stress-induction procedure.


Eligibility criteria: Inclusion Criteria:

* York University students

Exclusion Criteria:

* Individuals with diagnosed cardiac conditions (e.g. coronary artery disease, arrhythmias etc) will be excluded due to confounds with heart rate variability assessment

Primary outcomes:
measure: Heart Rate Variability
timeFrame: 22 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Joel Katz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azam MA, Latman VV, Katz J. Effects of a 12-Minute Smartphone-Based Mindful Breathing Task on Heart Rate Variability for Students With Clinically Relevant Chronic Pain, Depression, and Anxiety: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 2;8(12):e14119. doi: 10.2196/14119.
Clinical trial NCT01833507: Physical Activity and Health Outcomes
Official title: Relationship Between Physical Activity and Health Outcomes in Overweight and Obese Medically Complex Adults, a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Overweight
Obese
Keywords: increased activity
weight loss
obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 130
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: Obesity is common in adults with complex medical problems with ensuing complications afterwards. Obese patients suffer higher mortality and impaired functional status often as a result of their obesity. One primary goal to reduce both obesity and improve functional status is exercise. The investigators hypothesize that a simple exercise intervention with limited behavioral goal-setting will reduce weight and increase functional status compared to usual care. As a secondary measure, the investigators hypothesize that using this intervention will reduce hospital admissions and ER visits.

Detailed description: We are enrolling up to 150 subjects where half will receive a pedometer and behavioral goal-setting at enrollment and half will receive a pedometer and goal-setting 2 months later. It is a 4 month study. Our aims are as follows:

Primary Aim: Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients.

Second Primary aim: To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.

Secondary Aim: Determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.

Eligibility criteria: Inclusion Criteria:

1. Patients will be over the age of 18
2. Have a BMI over 25.0 kg/m2.
3. Have a Minnesota Medical Tiering concerning medical complexity of 3-4.

Exclusion Criteria:

1. Patients will be excluded if they have clinically documented dementia.
2. Subjects will be community dwelling and patients living in skilled nursing facilities will be excluded.
3. Subjects residing within a correctional institution will be excluded.
4. Subject is a female patient who is currently pregnant.

Primary outcomes:
measure: Gait, Grip and Walking
timeFrame: 4 months
measure: weight loss
timeFrame: 4 months
Secondary outcomes:
measure: number of hospitalizations
timeFrame: 4 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul Y Takahashi, MD
role: PRINCIPAL_INVESTIGATOR
References: