louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01196364: Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake in Boys
Official title: Effect of Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake After a Glucose Drink in Normal Weight Boys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body Weight
Keywords: Girls
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-09-08
Enrollment: 19
Sex: MALE
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, boys.

Detailed description: The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was investigated in normal weight (NW), boys were randomized into 4 treatments. Each boy consumed either a non-caloric sweetened control (CON) or GLU drink after either exercise (EXR) or sedentary activity. Subjects exercised at 25% above their ventilation threshold (VeT).

Eligibility criteria: Inclusion Criteria:

* Healthy boys with no emotional, behavioral or learning problems

Exclusion Criteria:

* Girls

Primary outcomes:
measure: food intake (kcal)
timeFrame: at 30-35 min after the treatment
Secondary outcomes:
measure: Subjective appetite
timeFrame: 0-80 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey G. Anderson, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bozinovski NC, Bellissimo N, Thomas SG, Pencharz PB, Goode RC, Anderson GH. The effect of duration of exercise at the ventilation threshold on subjective appetite and short-term food intake in 9 to 14 year old boys and girls. Int J Behav Nutr Phys Act. 2009 Oct 9;6:66. doi: 10.1186/1479-5868-6-66.
citation: Bellissimo N, Desantadina MV, Pencharz PB, Berall GB, Thomas SG, Anderson GH. A comparison of short-term appetite and energy intakes in normal weight and obese boys following glucose and whey-protein drinks. Int J Obes (Lond). 2008 Feb;32(2):362-71. doi: 10.1038/sj.ijo.0803709. Epub 2007 Aug 14.
citation: Bellissimo N, Thomas SG, Goode RC, Anderson GH. Effect of short-duration physical activity and ventilation threshold on subjective appetite and short-term energy intake in boys. Appetite. 2007 Nov;49(3):644-51. doi: 10.1016/j.appet.2007.04.004. Epub 2007 Apr 22.
Clinical trial NCT04881864: Study for Rural Innovations in the Delivery of Exercise
Official title: Adapting an Evidence-Based Exercise Program for Remote Delivery to Rural Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Physical Activity
Rural
Older Adults
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: : Falls are the primary cause of injury and a leading cause of disability and mortality among older adults. Risk factors for falling are common among older adults with knee osteoarthritis (OA) - a highly prevalent condition. Physical exercise is consistently the most efficacious intervention for preventing falls in older adults. However, access to these programs is severely limited in rural settings. Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA. Accordingly, the proposed project aims to refine a protocol for remote delivery of Enhance Fitness (EF). EF is an evidence-based, group exercise program involving strength, endurance, and balance training that is recommended for falls prevention and OA management


Eligibility criteria: Inclusion Criteria:

* Community-dwelling
* English-speaking
* Physician diagnosed knee osteoarthritis
* Knee pain that occurs almost daily for at least the past 3 months and is moderate to severe in intensity
* Knee pain-related difficulty with walking or climbing stairs
* resident of a rural county

Exclusion Criteria:

* cognitive impairment determined by a Mini Montreal Cognitive Assessment score of \<11
* any of the following in the past 6 months: cancer requiring treatment (except for non- melanoma skin cancer), heart attack, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus; and temporary exclusions
* hospitalization within the last month
* ≥3 falls within the past month

Primary outcomes:
measure: Feasibility and Acceptability of Tele-Enhance Fitness
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
timeFrame: Change from baseline PROMIS physical function score at 12 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale
timeFrame: Change from Baseline KOOS Physical Function Subscale score at 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT02935764: FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients
Official title: Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) Versus Irinotecan Monodrug as Second-line Treatment in Metastatic Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.


Eligibility criteria: Inclusion Criteria:

* aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
* Eastern Cooperative Oncology Group performance status of 0 to 2
* life expectancy of ≥ 3 months
* patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
* at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
* have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

* patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
* patients with symptomatic brain metastases
* active clinical severe infection
* previously received irinotecan
* dihydropyrimidine dehydrogenase (DPD) enzyme adequate

Primary outcomes:
measure: progression free survival
timeFrame: 2 months
Secondary outcomes:
measure: overall survival
timeFrame: 6 months
measure: overall response rate
timeFrame: 2 months
measure: Number of Participants with Adverse Events
timeFrame: 2 months
measure: quality of life questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang X, Duan R, Wang Y, Liu X, Zhang W, Zhu X, Chen Z, Shen W, He Y, Wang HQ, Huang M, Wang C, Zhang Z, Zhao X, Qiu L, Luo J, Sheng X, Guo W. FOLFIRI (folinic acid, fluorouracil, and irinotecan) increases not efficacy but toxicity compared with single-agent irinotecan as a second-line treatment in metastatic colorectal cancer patients: a randomized clinical trial. Ther Adv Med Oncol. 2022 Jan 13;14:17588359211068737. doi: 10.1177/17588359211068737. eCollection 2022.
Clinical trial NCT01123564: Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion
Official title: A Randomized, Controlled, Two-center Phase II Study Assessing the Efficacy and Safety of Intravitreal Lucentis Injections in Patients With Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Retinal Vein Occlusion
Macular Edema
Keywords: macular edema secondary to retinal vein occlusion
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: University of Debrecen
First posted: 2010-05-14
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: This study aims to assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to retinal vein occlusion


Eligibility criteria: Inclusion Criteria:

* Macular edema persisting for more than 3 months period despite conventional medication.
* Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).
* Patients randomized into ranibizumab-treated group do not receive macular laser treatment.
* Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 μm and/or retinal thickness is above 330 μm at any region of the macula calculated by retinal thickness analysis.
* Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent).

Exclusion Criteria:

* Diabetes mellitus
* Additional vitreoretinal diseases
* History of pars plana vitrectomy
* Previous macular grid laser treatment
* Intravitreal triamcinolone acetonid treatment
* Complicated cataract surgery
* Advanced glaucomatous damage of optic nerve head
* Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract)
* Age-related macular degeneration
* Pregnancy and lactation
* Women in childbearing potential who are not using double safe contraception

Primary outcomes:
measure: Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy assessed by change in macular thickness
timeFrame: 12 months with monthly assessment
Other outcomes:
Locations:
city: Debrecen
country: Hungary
facility: Debrecen Medical and Health Science Center Dept of Ophthalmology
city: Pecs
country: Hungary
facility: University of Pecs, Medical School, Department of Ophthalmology
Study officials:
affiliation: University of Pecs
name: Zsolt Balla, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00192764: High Dose CHOP in Lymphoma
Official title: Phase II Study of Short High-dose CHOP Chemotherapy for Aggressive Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: large cell lymphoma
CHOP
cyclophosphamide
high-dose
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that intensification of CHOP by dose escalation of the most active drugs in the combination will improve treatment outcome. Patients with diffuse large-cell lymphoma are treated by high cyclophosphamide containing CHOP. The planned dose is 3000 mg/m2 which is 4 times the atandard one. Only 4 cycles are given.


Eligibility criteria: Inclusion Criteria:

* large-cell non-Hodgkin's lymphoma
* IPI low-intermediate, high-intermediate and high or bulky mediastinum
* age 18-65

Exclusion Criteria:

* previous treatment for lymphoma
* serious concurrent systemic disease

Primary outcomes:
measure: Failure-free survival
Secondary outcomes:
measure: overall survival
measure: response rate
measure: toxicity
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Oncology, Rambam Medical Center
Study officials:
affiliation: nonaffiliated
name: Ron Epelbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00130364: Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis
Official title: Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
T-cell
pimecrolimus
children
facial
Facial atopic dermatitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States of America (USA).

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate facial atopic dermatitis
* Patients intolerant of, or dependent on, topical corticosteroids

Exclusion Criteria:

* Concurrent skin diseases (infections)
* Immunocompromised
* Recently received phototherapy or systemic therapy

Primary outcomes:
measure: The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Secondary outcomes:
measure: Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
measure: The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
measure: The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
measure: Time to clearance of facial IGA (score of 0 or 1)
Other outcomes:
Locations:
city: Novartis Pharmaceuticals
country: United States
facility: This study is not being conducted in the United States
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT02060864: Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals
Official title: Effect of the Enzyme AN-PEP on Gluten Degradation in the Stomach of Gluten-sensitive Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-coeliac Gluten Sensitivity
Keywords: enzyme
gluten
food intolerance
Lead sponsor: DSM Food Specialties
Sponsor class: INDUSTRY
First posted: 2014-02-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten. Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have completed 3 test days, a blind interim analysis is performed by a third party based on which it is decided whether to proceed with the low AN-PEP dose.


Eligibility criteria: Inclusion Criteria:

* Male/female
* Age ≥18 but \<70 yr
* Females: Hormonal contraceptive treatment
* Self-reported gluten-sensitive individuals fulfilling the Rome III criteria while consuming gluten
* Subject has read and understood the information provided on the study and given written informed consent

Exclusion Criteria:

* Coeliac disease serology while consuming gluten (serological test for tissue transglutaminase IgA antibodies and total IgA antibodies)
* Wheat allergy (serological test for wheat protein IgE antibodies)
* Medication or medical condition that affects gastric emptying or secretion
* Females: Pregnancy or breast-feeding
* Inability to swallow the gastroduodenal feeding tube
* Any medical condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant
* Any condition that in the opinion of the investigators may interfere with the study and may jeopardise the health status of the participant

Primary outcomes:
measure: Effect of 160.000 PPI AN-PEP on duodenal gluten
timeFrame: 3-hour
Secondary outcomes:
measure: Effect of 160.000 PPI AN-PEP on gastric gluten
timeFrame: 3-hour
measure: Effect of 80.000 PPI AN-PEP on duodenal gluten
timeFrame: 3-hour
measure: Effect of 80.000 PPI AN-PEP on gastric gluten AUC
timeFrame: 3-hour
measure: Effect of 160.000 PPI AN-PEP on percentage duodenal gluten reduction
timeFrame: 3-hour
measure: Effect of 160.000 PPI AN-PEP on percentage gastric gluten reduction
timeFrame: 3-hour
measure: Effect of 80.000 PPI AN-PEP on percentage duodenal gluten reduction
timeFrame: 3-hour
measure: Effect of 80.000 PPI AN-PEP on percentage gastric gluten reduction
timeFrame: 3-hour
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
References:
Clinical trial NCT03434964: Ev-AIFIB Preliminary Evaluation of the AIFib Software
Official title: Preliminary Evaluation of the AIFib Software in Real Time as a Medical Decision Aid for the Detection of Atrial Fibrillation Driver
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Software Performance Evaluation a Posteriori
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years with an indication of ablation of FA or TA

Brief summary: To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Etiology in the following list:
* Atrial fibrillation for which a conventional anatomical approach alone (pulmonary vein isolation) is not performed: persistent AF, long standing persistent AF paroxysmal AF (redo), paroxysmal AF
* Atrial tachycardia de novo or secondary to AF ablation.

Exclusion Criteria:

* Contraindication to AF ablation
* Major bleeding disorder

Primary outcomes:
measure: Software performance evaluation a posteriori
timeFrame: during the ablation procedure
Secondary outcomes:
measure: Indirect evaluation of the clinical effectiveness of the software
timeFrame: during the ablation procedure
Other outcomes:
Locations:
city: Lille
country: France
facility: Groupe Hopitaux Institut Catholique de Lille
city: Lyon
country: France
facility: Clinique de l'Infirmerie Protestante
city: Marseille
country: France
facility: Saint Joseph Hospital
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré, Neuilly
city: Nice
country: France
facility: CHU NICE Pasteur
city: Paris
country: France
facility: IHCPS Massy
city: Saint-Denis
country: France
facility: Centre de cardiologie du Nord
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
References:
Clinical trial NCT01244464: A Study of the Safety of IMOVAX Polio™ in China
Official title: Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Poliomyelitis
Polio
Keywords: Poliomyelitis
IMOVAX POLIO™
Polio
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 800
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China.

Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.

Detailed description: Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.

Eligibility criteria: Inclusion Criteria :

* Subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine.
* Subject's parents/legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio™ according to the schedule: one injection at 2, 3, 4 months old, respectively.
* Informed consent form obtained from the subject's parent/legal representative.
* Subject plan to live in the selected study sites for at least three months after inclusion.

Exclusion Criteria :

* Subject with a history of serious illness (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases)
* Known or suspected impairment of immunologic function
* Acute medical illness with or without fever within the last 72 hours
* Subject plan to leave the study sites for at least three months after inclusion
* Administration of immune globulin or other blood products within the last three months
* Participation in another clinical trial at the same time
* Contraindication to vaccination according to IMOVAX Polio™ leaflet.

Primary outcomes:
measure: The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.
timeFrame: Day 0 to Day 30 post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
Study officials:
affiliation: Sanofi Pasteur China
name: Medical Director
role: STUDY_DIRECTOR
References: