louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03139864: Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children.
Official title: Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Control
Physical activity
Substrate utilization
Hormonal regulation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.

Detailed description: The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.

Eligibility criteria: Inclusion Criteria:

* Children between 6 and 12 years
* Tanner stage \<T2
* Type 1 diabetes for more than 1 year for infants with type 1 diabetes

Exclusion Criteria:

* Tanner stage \> ou = T2
* Obesity
* Hormonal disease
* Disease who prevent doing exercise

Primary outcomes:
measure: Comparison of substrate utilization between infants with type 1 diabetes and infants without type 1 diabetes during exercise
timeFrame: at day 1
Secondary outcomes:
measure: hormonal regulation of blood glucose
timeFrame: at day 1
measure: lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry
timeFrame: at day 1
measure: Comparison between infants during 10 days before and 4 days after exercise of blood glucose modification
timeFrame: 10 days before and 4 days after exercise of blood glucose modification
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Daniel TERRAL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03991364: Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke
Official title: Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Robot-assisted gait training
stroke
gait speed
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2019-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training.


Eligibility criteria: Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Functional ambulation category score ≥ 3

Exclusion Criteria:

* History of surgery of affected lower limb
* Fracture of affected lower limb

Primary outcomes:
measure: Energy expenditure (EE)
timeFrame: 2 weeks after baseline
Secondary outcomes:
measure: Energy expenditure (EE)
timeFrame: baseline, 1 weeks after baseline, 3 weeks after baseline
measure: Heart rate (HR)
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: Volume of Oxygen (VO2)
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: Respiratory Quotient (R)
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: Metabolic equivalent (METS)
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: oxygenated hemoglobin (OxyHb)
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: deoxygenated hemoglobin (DeoxyHb)
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: Lower extremity Fugl-Meyer Assessment
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: Functional Ambulation Category
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: 10m walk test
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
measure: timed up and go test
timeFrame: baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00613964: The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure
Official title: The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Renal Failure
Keywords: Natriuretic Peptides
Heart Failure
Renal Failure
Lead sponsor: Nara Medical University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in patients with heart failure through a vasodilatory action, a natriuretic action, and inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan. However, a paucity of report is available on the effects of carperitide on short and long-term prognosis in patients with both cardiac and renal failure. The purpose of this study is to evaluate the effects of carperitide therapy on short and long-term prognosis in patients with both cardiac and renal failure, in comparison with standard therapy.


Eligibility criteria: Inclusion Criteria:

* Heart failure of any etiology, diagnosed according to Framingham criteria
* Estimated GFR \</= 60 ml/min/1.73 m2)

Exclusion Criteria:

* Severe heart failure required percutaneous cardiopulmonary bypass support (PCPS)
* End-stage renal failure on maintenance dialysis
* Severe hepatic dysfunction
* Severe anemia
* Allergic history of carperitide
* Pregnant women

Primary outcomes:
measure: Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation
timeFrame: at 6 months and 2 years
Secondary outcomes:
measure: All cause mortality
timeFrame: at discharge, 6 months, and 2 years
measure: Sudden death
timeFrame: at discharge, 6 months, and 2 years
measure: Cardiovascular death
timeFrame: at discharge, 6 months, and 2 years
measure: Plasma B-type natriuretic peptide concentration
timeFrame: at discharge, 6 months, and 2 years
measure: Estimated GFR
timeFrame: at discharge, 6 months, and 2 years
Other outcomes:
Locations:
city: Nara
country: Japan
facility: First Department of Internal Medicine, Nara Medical University
Study officials:
affiliation: First Department of Internal Medicine, Nara Medical University
name: Yoshihiko Saito, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03182764: Tobacco Control-Related Policy Survey
Official title: Policy-Related Survey - Territory-wide Telephone Survey on Tobacco Control
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Survey on Tobacco Control
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 5104
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All Hong Kong residents

Brief summary: Aim: to collect further information on issues related to tobacco control which should be addressed and advocated in further tobacco control measures in Hong Kong

The objectives of this policy-related survey are as follows:

1. to update information on trends and prevalence of secondhand smoke, smoking attributable health effects, cessation services, and e-cigarette;
2. to investigate the level of public support on current and future tobacco control measures and taxation;
3. to address the timely impacts of smoke-free policies, public support for further tobacco control measures and assist COSH in shaping policy direction for government.

Current study is a cross-sectional retrospective telephone survey based on questionnaires. In total, 5,104 subjects will be randomly selected for a telephone interview. The subjects will be categorized into three groups, i.e. never smokers (1,700), ex-smokers (1,700) and current smokers (1,704). They will be required to answer a questionnaire via telephone. All data shall be collected using a Computer Assisted Telephone Interview (CATI) system, which allows real-time data capture and consolidation. All interviews shall be conducted anonymously. Analysis of survey data will aim to identify current opinion on tobacco control policies and implications for future policies. Analyses will be controlled for confounding variables as required by stratification into sub-groups based on important pre-defined characteristics and/or by multivariate analysis. Comparison with past trends and, where possible, extrapolation of future trends will be explored. Weights will be applied to adjust for the sex and age of Hong Kong population, and to handle the over-sampling issues of current smokers. The data analysis will be conducted by statisticians.


Eligibility criteria: Inclusion Criteria:

* Aged 15 or above
* Cantonese or Mandarin speakers

Exclusion Criteria:

* Unable to provide a consent form
* Speak language other than Cantonese and Mandarin

Primary outcomes:
measure: Attitudes towards tobacco control policies
timeFrame: Finish all telephone survey by Sep 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Public Opinion Programme, the University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Man Ping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02526264: Evaluation of Quality of Life and Period of Hospitalization by Education
Official title: Clinical Trial to Evaluate Quality of Life, Period of Hospitalization and Complication Rates in Patients With Stoma Receiving Specific Preoperative Education vs. Standard Preoperative Education
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: stoma
quality of life
Lead sponsor: Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates.

Detailed description: The present study is initiated to evaluate quality of life, period of hospitalization and complication rates in patients with colorectal cancer receiving treatment with stoma surgery. Prior to surgery patients are randomized to different preoperative education programs. In Arm A patients receive a new specific education program (Krankenhaus Nordwest concept) conducted by a specialized therapist (stoma-therapist). In Arm B patients receive the standard preoperative education program. Standardized questionnaires are used to evaluate quality of life and period of hospitalization at baseline and four weeks after surgery in Arm A vs. Arm B

Eligibility criteria: Inclusion Criteria:

* Planned stoma
* colorectal cancer, from resection of left hemi-colon aboral A. colica media
* Patients speaking german and living in Germany
* ECOG ≤ 3
* Informed Consent
* standard education program

Exclusion Criteria:

* Patients treated with stoma by emergency
* patients with dementia
* status post stoma
* Patients in contact with a stoma-therapist
* recurrence of colorectal cancer

Primary outcomes:
measure: Quality of life
timeFrame: 9-15 days after surgery
measure: Quality of Life
timeFrame: 4 weeks after surgery
Secondary outcomes:
measure: Period of hospitalization
timeFrame: 9-15 days after surgery, 4 weeks after surgery
measure: Complication rates
timeFrame: 9-15 days after surgery, 4 weeks after surgery
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Offenbach
country: Germany
facility: Sana Klinikum
Study officials:
References:
Clinical trial NCT04489264: The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Official title: A Prospective Study of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral T Cell Lymphoma
Keywords: Autologous Stem Cell Transplantation
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lymphoma patients in several hospitals in China

Brief summary: The role of autologous stem cell transplantation (ASCT) in the first remission (CR1 \& PR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed pathological diagnosis of aggressive PTCL
* Age 18-65 years old
* Achieving CR or PR after first-line therapy

Exclusion Criteria:

* Subtypes with a more indolent course, including precursor T/natural killer neoplasms, T-cell large granular lymphocytic leukemia, mycosis fungoides other than transformed mycosis fungoides, Sézary syndrome, and primary cutaneous CD30-positive disorders.

Primary outcomes:
measure: PFS
timeFrame: 2-year PFS
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02909764: Shifting Salty Taste Preferences in Children
Official title: Salty Taste: Assessing a Strategy to Reduce Children's Preference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development
Keywords: Salty taste
Psychophysics
Genetics
Diet
Age
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 39
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goals of the proposed research are to determine whether repeated exposure to a low sodium food will result in reduced preference for salt in that food among children; and to determine whether such reductions in preference are related to dietary intake of salt, taste receptor genotype, and anthropometric and physiological measures.

Detailed description: This is a within- and between-subjects randomized controlled trial on children consuming either a low sodium or a higher sodium cereal over a 2-month period to determine if repeated exposure to the low sodium cereal is effective for reducing preference for salt in that food. Children will be genotyped for markers related to taste, dietary intake will be recorded, and anthropometric and physiological measures will be collected at baseline.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Willingness to consume no other cereals during intervention

Exclusion Criteria:

* Allergies and/or taking medication that affects taste

Primary outcomes:
measure: Most Preferred Level of Salt Taste
timeFrame: Baseline (time 0) and after 8-week intervention
measure: Relative Preference for Regular vs Low Sodium Cereal
timeFrame: At baseline and after 8-week intervention
Secondary outcomes:
measure: Salt Taste Detection Thresholds
timeFrame: Baseline and after 8-week intervention
measure: Most Preferred Level of Sucrose
timeFrame: At baseline and after 8-week intervention
measure: Intake of Cereal During Intervention Period
timeFrame: 28 days
measure: Blood Pressure
timeFrame: Baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Monell Chemical Senses Center
state: Pennsylvania
Study officials:
affiliation: Monell Chemical Senses Center
name: Julie A Mennella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bobowski N, Mennella JA. Repeated Exposure to Low-Sodium Cereal Affects Acceptance but Does not Shift Taste Preferences or Detection Thresholds of Children in a Randomized Clinical Trial. J Nutr. 2019 May 1;149(5):870-876. doi: 10.1093/jn/nxz014.
Clinical trial NCT04994964: Recurrent Nerve Monitoring During Aortic Arch Repair
Official title: Pilot Study of Recurrent Laryngeal Nerve Monitoring During Neonatal Aortic Arch Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Laryngeal Nerve Injuries
Aortic Arch Hypoplasia
Lead sponsor: Birmingham Women's and Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Almost half of newborns undergoing surgery to repair narrowing or interruption of the aortic arch will suffer injury to the recurrent laryngeal nerve. This causes a weak voice and can lead to problems with feeding including aspiration of milk feed after the surgery. As these children can have a vulnerable circulation, aspiration events can reduce survival and poor weight gain has been shown to correlate with poorer outcomes after surgery.

In other types of surgery in the neck, monitors can be used to alert the surgeon to when injury is occurring to the recurrent nerve. To date, this type of monitoring has not been possible in newborns. This study aims to investigate if this type of monitoring is feasible in newborns undergoing aortic arch repair, to prevent recurrent nerve injury.


Eligibility criteria: Inclusion Criteria:

* Only patients with parents/ carers able to give informed consent to participation in the trial will be included. • Male and female patients will be included
* Only Neonates (babies less than 28 days of age) will be included in the study.
* Only patients undergoing repair of the aortic arch via median sternotomy will be included in the study

Exclusion Criteria:

* Patients with severe abnormalities of the airway, such that they are unlikely to be extubated within 7 days of the aortic arch repair surgery will be excluded from participation, as assessment of vocal cord function will be difficult/ impossible in such patients.
* Patients with parents/ carers who are unable to give informed consent to participation in the trial will be excluded from participation.

Primary outcomes:
measure: Vocal cord EMG - Burst amplitude (mV)
timeFrame: Intra-operative (1 hour)
measure: Vocal cord EMG - Burst duration (ms)
timeFrame: Intra-operative (1 hour)
measure: Vocal cord EMG - Burst frequency (Hz)
timeFrame: Intra-operative (1 hour)
measure: Vocal cord EMG - Interburst interval (ms)
timeFrame: Intra-operative (1 hour)
measure: Vocal cord EMG - Signal to noise ratio (mV)
timeFrame: Intra-operative (1 hour)
measure: Correlation of Vocal cord EMG with post-operative palsy
timeFrame: Post extubation / 1 week post-operatively
Secondary outcomes:
measure: Neuromuscular blockade
timeFrame: Intra-operative (1 hour)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: West Midlands
Study officials:
affiliation: Birmingham Women's and Children's Hospital
name: Phil Botha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02822664: Analysis of Cerebral Correlates of Pedophilia With Neuroimaging Techniques
Official title: Analysis of Cerebral Correlates of Pedophilia With Neuroimaging Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pedophilia
Keywords: Brain, pedophilia, neuroimaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective is to identify cerebral correlated of pedophilia using neuroimaging techniques.


Eligibility criteria: Inclusion Criteria (for patients):

* Diagnosis of pedophilia
* Male
* Age between 18 and 65
* Informed consent signed

Inclusion Criteria (for healthy patients):

* Male
* Age between 18 and 65
* Informed consent signed

Exclusion Criteria (for patients):

* IQ \<70
* Ongoing treatment with cyprostrerone acetate or GnRH agonist or antidepressant treatment (5HT reuptake inhibitor)
* Ongoing detention

Exclusion Criteria (for healthy patients):

* psychiatric disorders
* IQ\<70
* Sexual disorders

Primary outcomes:
measure: BOLD contrast signal
timeFrame: 3 months
measure: Local cerebral blood flow
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Michel PUGEAT, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fonteille V, Redoute J, Lamothe P, Straub D, Lavenne F, Le Bars D, Raverot V, Moulier V, Marchand JJ, Vittoz A, Leriche C, Pugeat M, Stoleru S. Brain processing of pictures of children in men with pedophilic disorder: A positron emission tomography study. Neuroimage Clin. 2019;21:101647. doi: 10.1016/j.nicl.2018.101647. Epub 2018 Dec 24.