louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02867475: REduction of Physical Inactivity Facing the CAncer
Official title: Physical Activity in Patients With Cancer: Epidemiological Study of Patients' Beliefs and Promotional Messages Efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study 1:

The investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in AP.

Detailed description: Study 2:

Because of a recent research, it is shown that a narrative message from a peer generates an identification, a sense of self-efficacy and intention to practice in sedentary patients with breast cancer.

The investigator hypothesize that a promotional message about physical activity, issued by a self-determined peer (intrinsic motivation), compared to a non-self-determined peer (extrinsic motivation), generate higher scores of positive beliefs about physical activity and intention to engage in a physical activity program for sedentary patients.

These promotional messages will be delivered through two videos, one featuring the self-determined pair, the other featuring the non-self-determined pair.

Eligibility criteria: Inclusion Criteria:

* PS 0-3
* Patients with breast cancer undergoing chemotherapy treatment
* neoadjuvant, adjuvant, metastatic, any histological type, any stage breast cancer
* Sedentary Patients (physical activity score of Dijon less than or equal to 20)

Exclusion Criteria:

* Patients with PS greater than 3
* Patients with cognitive disorders not allowing them to understand the questionnaires and study procedures

Primary outcomes:
measure: CaBES
timeFrame: 1 day
Secondary outcomes:
measure: Multidimensional Fatigue Inventory
timeFrame: 1 day
measure: Dijon's Score
timeFrame: 1 day
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
Study officials:
affiliation: Centre Antoine Lacassagne
name: Véronique MARI, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00468975: A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
Official title: A Phase IIA Randomised, Double-blind, Double Dummy, Placebo and Active Controlled 5-Way Cross-over Trial to Examine the Bronchodilator Effects of PF-610,355 and to Test for Superiority Versus Placebo in Reversible Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to determine the ability of different doses of PF-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.


Eligibility criteria: Inclusion Criteria:

* Reversible asthmatic patients (\>15% increase in FEV1 following 200ug salbutamol).
* FEV1 greater than or equal to 60% predicted
* Stable disease for at least the previous 3 months

Exclusion Criteria:

* Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to screening
* Subjects with a history of pulmonary disease other than asthma.

Primary outcomes:
measure: Peak and Trough (24 hour post dose) FEV1.
Secondary outcomes:
measure: Peak and trough (24 hour post dose) PEFR
measure: FEV1 and PEFR measurements to 32 hours post dose.
measure: Pharmacokinetics of PF-610,355 and salmeterol
measure: Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Großhansdorf
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01666275: The Metabolomics of Anaphylaxis
Official title: The Metabolomics of Anaphylaxis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Patients With AERD Undergoing Aspirin Desensitization
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ages 18-75, history of an allergic reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for aspirin exacerbated respiratory disease (AERD)

Brief summary: Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined.

Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin during challenge/desensitization is equivalent to an allergic drug reaction however we are able to evaluate these specific reactions in a controlled, clinical environment. This population of patients undergoing aspirin desensitization is ideal for studying metabolomics as serial blood sampling can be performed in patients before, during a reaction, and after aspirin desensitization, thereby allowing each patient to serve as his or her own biological control. The investigator hopes that this study of metabolomics will allow for better methods of identifying anaphylaxis in the future.


Eligibility criteria: Inclusion Criteria:

* Patients ages 18-75 with a history of aspirin anaphylaxis or a history of hypersensitivity reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for AERD.

Exclusion Criteria:

* Pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin desensitization.

Primary outcomes:
measure: Change in metabolic profile of blood serum metabolites from Baseline to 1 week post-desensitization
timeFrame: before start of aspirin desensitization, 2 hours into desensitization, at time of reaction(s) - an expected average of 6 hours into desensitization, 1 week post-desensitization
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital - Allergy Associates
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Aleena S Banerji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05034575: Eye Tracking in Laryngology
Official title: A Study to Assess Eye Tracking and Visual Gaze Patterns in Laryngology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess whether eye-tracking technology can be used to differentiate the visual gaze patterns of experienced and novice laryngoscopists while reviewing prerecorded laryngeal videos with both normal and abnormal findings and to characterize any differences arising between level of training groups.

Detailed description: Novice and experienced participants will be recruited to take part in this study. Novices include medical students without practical experience in otorhinolaryngology and resident physicians at different stages in training. Trainees, residents and experts from fields of gastroenterology and pulmonology will also be included. The experienced group will be defined as consultants and speech pathologists.

This study will look at multiple areas within otolaryngology including laryngology, rhinology, facial plastic surgery, head and neck oncology, and otology. Participants will view prerecorded videos and/or still pictures absent of patient identifiers.

There will be two tasks each taking approximately 10 minutes. Task order will be alternated between subjects with one task asking participants to view 7 still images from video laryngoscopy examinations. After each image participants will rate how likely the image is to represent glottic cancer and what portion of the image they deemed most important to their decision. For the second task, participants will be asked to view a 5 second video of a flexible laryngoscope exam, after which, they will be asked to identify the presence and side of vocal fold paralysis as well as note the location they deemed most important to their decision.

Eligibility criteria: Inclusion Criteria:

* Adults, age 18 and over.
* Already professionals in a laryngology related field, residents in a related field or students considering a related field.
* Related fields include otolaryngology, laryngology, and speech language pathology.

Exclusion Criteria:

- Anyone not meeting the inclusion criteria or anyone not wishing to participate.

Primary outcomes:
measure: Time to Fixation Fixation Point
timeFrame: 15 minutes
measure: Percent of Fixation Time on pre determined area of interest
timeFrame: 15 minutes
measure: Count of Fixations
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Diana Orbelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01776359: Effects of High Protein Intake With Intense Exercise and Energy Deficit
Official title: Effects of High Protein Intake With Intense Exercise and Energy Deficit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Muscle
Protein
Diet
Exercise
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A four week intervention will take place with the participants. They will undergo 6 days a week of high intensity training. They will also be at a 40% energy deficiency. One group will have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our thesis that the participants with the higher protein will retain more lean mass.


Eligibility criteria: Inclusion Criteria:

* 18-30 males
* Healthy

Exclusion Criteria:

* more than 15% body fat
* 35-50ml/kg/min VO2
* BMI grater than 27

Primary outcomes:
measure: Body Composition
timeFrame: 4 weeks
Secondary outcomes:
measure: Psychological state
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Stuart M Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mettler S, Mitchell N, Tipton KD. Increased protein intake reduces lean body mass loss during weight loss in athletes. Med Sci Sports Exerc. 2010 Feb;42(2):326-37. doi: 10.1249/MSS.0b013e3181b2ef8e.
citation: Demling RH, DeSanti L. Effect of a hypocaloric diet, increased protein intake and resistance training on lean mass gains and fat mass loss in overweight police officers. Ann Nutr Metab. 2000;44(1):21-9. doi: 10.1159/000012817.
citation: Butterfield GE, Calloway DH. Physical activity improves protein utilization in young men. Br J Nutr. 1984 Mar;51(2):171-84. doi: 10.1079/bjn19840021.
citation: Longland TM, Oikawa SY, Mitchell CJ, Devries MC, Phillips SM. Higher compared with lower dietary protein during an energy deficit combined with intense exercise promotes greater lean mass gain and fat mass loss: a randomized trial. Am J Clin Nutr. 2016 Mar;103(3):738-46. doi: 10.3945/ajcn.115.119339. Epub 2016 Jan 27.
Clinical trial NCT02857959: One Dose Versus Three Weekly Doses of Benzathine Penicillin G for Patients With Early Syphilis
Official title: Doctor of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Syphilis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the serological response to 1 or 3 weekly doses of benzathine penicillin G in patients with early syphilis.


Eligibility criteria: Inclusion Criteria:

1. Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis
2. A rapid plasma reagin (RPR) test was positive, with a titer were 1:4 or higher. In addition, Treponema pallidum particle agglutination assay and/or fluorescent treponemal antibody absorption test were reactive.

Exclusion Criteria:

1.Patients who were pregnancy, known allergy to penicillin, use of antibiotics active against syphilis during the preceding six months for symptomatic cases or during the preceding two years for asymptomatic cases, and concurrent illnesses requiring treatment with antibiotics effective against syphilis. 2. if RPR titers were found to be 1:4 or less or the T. pallidum particle agglutination test was nonreactive, participants were retrospectively excluded from the trial unless primary syphilis was confirmed by the finding of T. pallidum in ulcer exudates on direct immunofluorescence

-

Primary outcomes:
measure: Rapid plasma reagin titers
timeFrame: up to 9 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Study officials:
References:
Clinical trial NCT03333759: Treatment of Acne Scars With Erbium:Yttrium Aluminum Garnet (Er:YAG) Laser Examined Under OCT
Official title: Treatment of Atrophic Facial Acne Scars With Er:YAG Laser Examined Under Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: laser
Er:YAG laser
acne
acne vulgaris
optical coherence tomography
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is examining the effects of the 2940 nm Er:YAG on atrophic facial acne scars under optical coherence tomography in terms of blood flow, vessel shape, skin roughness, collagen content, and epidermal thickness.


Eligibility criteria: Inclusion Criteria:

1. Patients should be 18-90 years of age
2. Patients should have Fitzpatrick skin types of I-III
3. Patients should have at least mild acne

Exclusion Criteria:

1. The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
2. Pregnant or lactating females
3. Fitzpatrick skin type of IV-VI
4. A history of keloids or hypertrophic scars
5. Scleroderma
6. Photosensitivity
7. Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months
8. Subjects with a known history of herpes simplex

Primary outcomes:
measure: Change in blood flow
timeFrame: During 8 weeks
measure: Change in epidermal thickness
timeFrame: During 8 weeks
measure: Change in collagen content
timeFrame: During 8 weeks
measure: Change in skin roughness
timeFrame: During 8 weeks
Secondary outcomes:
measure: The Patient Scar Assessment Scale
timeFrame: During 8 weeks
measure: The Observer Scar Assessment Scale
timeFrame: During 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: Keyvan Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02126059: Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research
Official title: The Health Effects of Cognitive Stimulation, Reminiscence, and Aroma-massage Complementary Interventions on Different Behavior Patterns of Patients With Dementia: Comparative and Longitudinal Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
behavioral and psychological symptoms
quality of life
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2014-04-29
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cognitive function, behavioral and psychological symptoms, and quality of life will improve after administration of cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy in patients with dementia.

Detailed description: This study will base on the pattern of behavioral and psychological symptoms of dementia, to verify and compare the effectiveness of the three non-pharmacological complementary interventions, cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy on patients' cognitive function, behavior and psychological symptoms, and quality of life.

Eligibility criteria: Inclusion Criteria:

* been diagnosed with dementia (all stages) or MMSE below 23 for high school educated and 17 for less than high school education
* able to communicate verbally or nonverbally
* able to understand short sentences
* can sit for at least 50 mins.

Exclusion Criteria:

* no hospitalization within the past two weeks
* not under severe acute illness
* no psychiatric disorders.

Primary outcomes:
measure: behavioral and psychological symptoms of dementia
timeFrame: 2 years
Secondary outcomes:
measure: quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Dementia center
Study officials:
affiliation: National Cheng Kung University
name: Jing-Jy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ball EL, Owen-Booth B, Gray A, Shenkin SD, Hewitt J, McCleery J. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020 Aug 19;8(8):CD003150. doi: 10.1002/14651858.CD003150.pub3.
Clinical trial NCT03019159: Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis
Official title: Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Renal Failure
Peritoneal Dialysis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence Regionale de Sante d'Ile de France
First posted: 2017-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with renal failure under peritoneal dialysis

Brief summary: The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event


Eligibility criteria: Inclusion Criteria:

* Patient under peritoneal dialysis for more than three month
* Patient thought to be able to perform peritoneal dialysis alone or with the help of health care professionnals
* Patients or health care professionnals thought to be able to use telemedicine

Exclusion Criteria:

* No DSL Network
* No GSM Network
* Patients who can not express their opposition to the participation to this study because of limited mental abilities

Primary outcomes:
measure: Severe adverse events
timeFrame: Within 2 years after enrollment
Secondary outcomes:
measure: Number of hospitalisations
timeFrame: Within 2 years after enrollment
measure: Number of consultations
timeFrame: Within 2 years after enrollment
measure: Number of sanitary transportation
timeFrame: Within 2 years after enrollment
measure: Mean length of hospital stay
timeFrame: Within 2 years after enrollment
measure: Global costs
timeFrame: 6 months after the first patient enrollment
measure: Patients satisfaction
timeFrame: 1 year after enrollment
measure: Satisfaction of the professionnals
timeFrame: 6 months after enrollment of the first patient
Other outcomes:
Locations:
city: Saint Maurice
country: France
facility: CTIRC - Hôpitaux Saint Maurice
Study officials:
affiliation: Pôle CTIRC. Hôpitaux Saint Maurice
name: Stéphane Roueff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
name: Isabelle Durand-Zaleski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906.
citation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.