louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03135223: Participatory Research to Promote Physical Activity
Official title: Development of Intervention Strategies to Increase Physical Activity and Reduce Sedentary Behaviour in Secondary Schoolgirls by Means of Participatory Health Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Physical activity
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 196
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One intervention and one control condition
Primary purpose: PREVENTION

Brief summary: Secondary schoolgirls have the most unhealthy profile regarding physical activity and sedentary behaviour of all age groups. Since both behaviours independently contribute to various health outcomes, an effective intervention to promote physical activity and to reduce sedentary behaviour needs to be developed.

Many interventions fail to induce changes in health behaviour, as they often use a top-down approach with limited input from the end-users (i.e. the secondary schoolgirls) of the intervention programmes. This project uses a participatory health research approach by actively involving the girls in the entire research process. A co-creation group was set up per intervention school (n=3), including girls and a researcher which co-created a school-specific intervention, tailored to the needs and interests of those girls.

The effect of participatory process were evaluated via a clustered randomized controlled trial using an intervention and control condition and a pre- and post-test design. Effects on physical activity and related determinants (e.g. self-efficacy, attitude, etcetera) were evaluated. The hypothesis was that girls from the intervention condition would improve their physical activity levels and related determinants compared to no changes among girls from the control schools. The process was evaluated as well using focus group research and the hypothesis was that girls who participate in the co-creation groups would be positive about the process and will feel empowered.


Eligibility criteria: Inclusion Criteria:

* Healthy, female pupils of secondary schools (aim: 10th grade) who volunteer to participate in the study

Primary outcomes:
measure: Increase in the mean overall physical activity level of adolescent girls
timeFrame: one schoolyear
Secondary outcomes:
measure: Increase in the mean value of determinants related to physical activity
timeFrame: one schoolyear
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01606423: The Effect of LY2409021 on Blood Sugar Levels When Glucagon Levels Are Increased in Healthy Male Participants
Official title: The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 21
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a study to measure the effect that various doses of LY2409021 have on blood sugar levels and on the amount of glucose released by the liver, when glucagon is given to increase these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study periods, with a minimum 13-day washout between dosing periods. This study is approximately 9 weeks long, not including screening. A screening appointment is required within 6 weeks prior to the start of the study.


Eligibility criteria: Inclusion Criteria:

* Must be a healthy male
* Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m\^2 inclusive
* Have a fasting blood glucose between 3.0-6.0 millimoles/liter (mmol/L) (inclusive) at screening

Exclusion Criteria:

* Are allergic to LY2409021, insulin, glucagon, somatostatin, or similar drugs
* Have a regular alcohol intake greater than 21 units/week, or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
* Are currently smokers or have used tobacco products on a regular basis in the 6 months prior to screening
* Have received any medication known to affect glucose metabolism in the 1 month before the study
* Have a significant blood disorder and/or donated blood (450 mL or more) in the last 3 months

Primary outcomes:
measure: Maximum glucose response during a 3-hour glucagon infusion
timeFrame: During a 3-hour glucagon infusion
Secondary outcomes:
measure: Total glucose released from the liver during a 3-hour glucagon infusion
timeFrame: During a 3-hour glucagon infusion
measure: Maximum glucose release from the liver during a 3-hour glucagon infusion
timeFrame: During a 3-hour glucagon infusion
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01411423: Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan
Official title: Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: Nexavar
Unresectable or advanced renal cell carcinoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 3305
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is all cases investigation of which the enrollment period is 15 months, and all patients who received Nexavar for unresectable or advanced RCC will be recruited.

Brief summary: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.


Eligibility criteria: Inclusion Criteria:

* Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
timeFrame: After Nexavar administration, up to 1 year
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]
timeFrame: After Nexavar administration, up to 1 year
measure: Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]
timeFrame: After Nexavar administration, up to 1 year
measure: The status of therapy with Nexavar [duration of treatment, daily dose]
timeFrame: After Nexavar administration, up to 1 year
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Inamoto T, Azuma H, Tatsugami K, Oya M, Adachi M, Okayama Y, Sunaya T, Akaza H. Real-world use of sorafenib for advanced renal cell carcinoma patients with cardiovascular disease: nationwide survey in Japan. Expert Rev Anticancer Ther. 2020 Jul;20(7):615-623. doi: 10.1080/14737140.2020.1773805. Epub 2020 Jun 16.
Clinical trial NCT00992823: Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure
Official title: Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Iron
anemia
supplementation
preschoolers
prevalence
preschoolers children from public day care centers
Lead sponsor: Sao Jose do Rio Preto Medical School
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 99
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the mean life of red blood cells compared to weekly supplementation, in reducing the prevalence of preschool anemia.

Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period. Group 1 received once weekly supplementation and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

Detailed description: The prevalence of anemia after the supplementation regimens reduced from 20.20% to 5.05% (P \< 0.0005); the reduction was not significantly different between the two groups (P = 0.35). The mean hemoglobin concentration increased in both groups (Group 1: 0.27 g/dL; P \< 0.016 and Group 2: 0.47 g/dL; P \< 0.0005) without significant differences between the groups (P = 0.17).

Eligibility criteria: Inclusion Criteria:

* The participants of the study were children with ages ranging from 24 to 59 months old that attended four local public day care centers

Exclusion Criteria:

* Presence of infection or reported infections within two weeks prior to the intervention
* Anemia lower than 7.0 g/dL and children taking medications containing ferrous sulfate

Primary outcomes:
measure: Initial and final blood hemoglobin concentration
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Badi Bassit
country: Brazil
facility: Public Day Care Centers
state: Sao Paulo
Study officials:
affiliation: FAMEP
name: Patricia M Cury, MDPhD
role: STUDY_DIRECTOR
affiliation: Sao Jose do Rio Preto Medical School
name: Geraldo PL Coutinho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coutinho GG, Cury PM, Cordeiro JA. Cyclical iron supplementation to reduce anemia among Brazilian preschoolers: a randomized controlled trial. BMC Public Health. 2013 Jan 10;13:21. doi: 10.1186/1471-2458-13-21.
Clinical trial NCT04337723: Implementation of ABI and WIfI in Rural Health Clinics
Official title: Implementation of Ankle Brachial Index Measurements and Wound, Ischemia, and Foot Infection Testing in Rural Health Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Diabetic Foot
Diabetes Mellitus
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this project is to assess the fidelity and sustainability of in improving provider performance with Ankle Brachial Index (ABI) assessment and ulcer staging with the would ischemia foot infection (WIfI) tool for new patients with lower extremity ulcers due to peripheral artery disease (PAD) and diabetes mellitus (DM) at RHCs in the telemedicine network through a rural provider education program that is aligned with preexisting continuing medical education activities.


Eligibility criteria: Inclusion Criteria:

To be eligible for the educational program, an RHC must:

* already have telemedicine capabilities with the UC Davis CHT,
* be within 3 hours driving time form UC Davis Medical Center,
* have a lead practitioner willing to act as the clinic's point person for the proposed educational project, and
* have seen at least 10 patients in the prior 3 months with foot ulcers due to DM, PAD or combined disease.

Exclusion Criteria:

To be eligible for the project, a RHC must NOT:

* have a dedicated foot ulcer assessment program with on-site measurement of arterial perfusion, and
* be located within a 45 minute drive of a vascular surgeon

Primary outcomes:
measure: ABI/WIFI adoption
timeFrame: 6 months
Secondary outcomes:
measure: ABI/WIFI adaption and fidelity
timeFrame: 6 months
measure: ABI/WIFI sustainability
timeFrame: 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Misty D Humphries
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03869723: Virtual Surgical Planning Systems in Mandibular Reconstruction
Official title: Evaluation of Virtual Surgical Planning Systems and Customized Devices in Fibula Free Flap Mandibular Recontruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mandibular Neoplasms
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 30
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: Patients who underwent fibula free flap for mandibular reconstruction

Brief summary: The purpose of this study was to evaluate the accuracy of virtual planning using customized surgical devices (VP3D) in fibula free flap mandibular reconstruction. Virtual planning was compared to postoperative scans using cephalometric and three-dimensional (3D) measurements. Operative times of both VP3D and conventional surgery groups were compared.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent fibula free flap for mandibular reconstruction
* Patient ≥18 years old
* patient alive 6 months after completion of treatment

Exclusion Criteria:

* Patient without post-operative scan evaluation
* Patient with a chirurgical contraindication
* Pregnant or nursing woman
* Adult requiring protection (guardianship, supervision)

Primary outcomes:
measure: Comparison of the cephalometrics measurements between the virtual model and postoperative outcomes
timeFrame: Six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse Hospital - Hospices Civils de Lyon
Study officials:
References:
citation: Blanc J, Fuchsmann C, Nistiriuc-Muntean V, Jacquenot P, Philouze P, Ceruse P. Evaluation of virtual surgical planning systems and customized devices in fibula free flap mandibular reconstruction. Eur Arch Otorhinolaryngol. 2019 Dec;276(12):3477-3486. doi: 10.1007/s00405-019-05625-z. Epub 2019 Sep 9.
Clinical trial NCT01908023: Exercise and Radiotherapy, a Good Combination?
Official title: Exercise and Radiotherapy, a Good Combination? A Pilot Study of Group Exercise for Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: exercise therapy
oxygen consumption
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-07-25
Enrollment: 15
Sex: FEMALE
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: TREATMENT

Brief summary: Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of short-and long-term side effects may be experienced, such as physical deterioration, reduced quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all out-patients undergoing post operative radiotherapy are currently offered participation in group exercise training sessions. The main purpose of this study is to evaluate these out-patient group exercise sessions.


Eligibility criteria: Inclusion Criteria:

* Surgery for breast cancer.
* Completed chemotherapy treatment.
* Radiotherapy is scheduled.

Exclusion Criteria:

* metastatic disease
* pregnancy
* drug abuse

Primary outcomes:
measure: changes in physical performance
timeFrame: from baseline to 6 weeks
Secondary outcomes:
measure: perceived coping
timeFrame: from baseline to 6 weeks
measure: Range of motion
timeFrame: from baseline to 6 weeks
measure: quality of life
timeFrame: from baseline to 6 weeks
measure: activity level
timeFrame: from baseline to 6 weeks
measure: balance
timeFrame: from baseline to 6 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, Klinikk for Kliniske Servicefunksjoner
Study officials:
affiliation: Norwegian University of Science and Technology
name: Inger L Aamot, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006323: Neurobehavioral Consequences of Sleep Apnea in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Sleep Apnea Syndromes
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-10-03
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To identify physiological and clinical measures of obstructive sleep-disordered breathing that are associated with increased morbidity in children.

Detailed description: BACKGROUND:

The study is in response to a Request for Applications (RFA) on Obstructive Sleep Apnea in Children. NHLBI issued the RFA in December, 1997, with co-sponsorship from the National Institute of Dental and Craniofacial Research and the National Institute of Child Health and Human Development.

DESIGN NARRATIVE:

This cross-sectional study recruited a population-based sample of young children from among the more than 8000 children in Massachusetts enrolled in the on-going Infant Care Practices Study. Stratified sampling was used to assemble a cohort of 250 children with habitual snoring (\> 3 nights/week), 100 children with occasional snoring (\<3 nights/week), and 100 non-snoring children. These children were studied within 3 months of their fourth birthday using overnight laboratory polysomnography and a detailed neurobehavioral evaluation, in order to test the hypothesis that, after adjusting for potential confounding variables, both parent-reported snoring and polysomnographic measures were associated with standardized measures of the following neurobehavioral domains: immediate attention, sustained attention, working memory, and symptoms of hyperactivity. These data also provided an opportunity to determine normal values for polysomnographic measures in 4-year-old children and to determine the prevalence of snoring and polysomnographic abnormalities among 4-year-old children.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Daniel Gottlieb
References:
citation: Gottlieb DJ, Vezina RM, Chase C, Lesko SM, Heeren TC, Weese-Mayer DE, Auerbach SH, Corwin MJ. Symptoms of sleep-disordered breathing in 5-year-old children are associated with sleepiness and problem behaviors. Pediatrics. 2003 Oct;112(4):870-7. doi: 10.1542/peds.112.4.870.
citation: Gottlieb DJ, Chase C, Vezina RM, Heeren TC, Corwin MJ, Auerbach SH, Weese-Mayer DE, Lesko SM. Sleep-disordered breathing symptoms are associated with poorer cognitive function in 5-year-old children. J Pediatr. 2004 Oct;145(4):458-64. doi: 10.1016/j.jpeds.2004.05.039.
Clinical trial NCT01306123: Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration
Official title: An Open, Randomized, Single-dose, Two-way Crossover Study to Characterize the Pharmacokinetic Properties of Cyanocobalamin When Administered as an Intranasal Spray and an Intramuscular Injection to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Focus: Bioavailability
Keywords: bioavailability
pharmacokinetics
cyanocobalamin
intranasal
intramuscular
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product).

Detailed description: This is an open-label, randomized, single-dose, two-way crossover study. The study consists of a screening visit, two 4-days confinement periods and a follow-up telephone call. The two confinement periods will be separated by a washout period of at least 28 days.

Eligibility criteria: Inclusion Criteria:

* Healthy female and male voluteers
* 18-40 years of age
* BMI between 18.5 and 30.0 kg/m2

Exclusion Criteria:

* Females who are pregnant or lactating
* History of clinically significant metabolic, hepatic, renal, haematological, pulmondary, cardiovascular, gastrointestinal, urological, neurological or phychiatric disorders
* Serum vitamin B12 \<=250 pmol/L or MMA \>=0.40 umol/L
* Evidence of significant intranasal pathology
* Nasal congestion, allergic rhinitis or upper respiratory tract infection

Primary outcomes:
measure: Relative bioavailability
timeFrame: 0-72 hours
Secondary outcomes:
measure: Additional PK characteristics
timeFrame: 0-72h
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, Karolinska University Hospital, Huddinge
Study officials:
affiliation: Karolinska Trial Alliance
name: Nabil Al-Tawil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: