louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02236117: Aerobic Training on the Autonomic Modulation in Children
Official title: The Effects of 10 Weeks of Aerobic Training on the Autonomic Modulation in Prepubertal Children: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: heart rate variability
children
progressive test
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 160
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The heart rate variability is a tool used to asses non-invasive cardiac autonomic. In fact, many studies have been disseminated of heart rate variability in adults, however few results in a literature this parameters in pediatric population, mainly with children submitted the physical training. Thus, this Project aims to verify the effects of aerobic training, with 10 weeks, in prepubertal on the performance and heart rate variability in rest.

Detailed description: The randomized control trial in accordance with Consort - Statement (Moher et al., 2012) will be done. Will be included 160 children, 80 in an experimental group and 80 children with no intervention, of both genders.

Eligibility criteria: Inclusion Criteria:

* Children be with body weight and height between the 10th and 90th percentiles, according to criteria adopted by the Centers for Disease Control and Prevention (CDC, 2002).
* To characterize the infant state, all volunteers will conduct evaluation of secondary sexual characters by criteria of Tanner (Marshall and Tanner, 1970), through visual inspection by a single experienced paediatrician. Children must show the initial stage of pubertal development, for girls (1 breast) and boys (genital 1) to be included and characterized such prepubertal. Participants throughout the trial entering puberty will be excluded from the final analysis.
* The children will be healthy, without clinical or historical evidence of cardiovascular disease, hypertension, insulin-dependent diabetes mellitus or obesity, and were not taking any drugs.

Exclusion Criteria:

* The participants can be not linked to sports practices at least one year before the beginning the study, and can be involved only with the physical education classes two times a week for 50 minutes each class.

Primary outcomes:
measure: Rest Heart Rate Variability in short term
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Universidade Estadual de Londrina
state: Paraná
Study officials:
affiliation: Universidade Estadual de Londrina
name: Carla Silva, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01283217: Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer
Official title: A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Adenocarcinoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 166
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46\~56% and a median survival time of 14.0\~14.3 months.

Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).


Eligibility criteria: Inclusion Criteria:

* Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma
* ECOG performance status 0-1
* Curatively resected advanced gastric cancer patients of stage IIIb/IIIc
* D2 lymph node dissection with R0 surgery
* Signed informed consent

Exclusion Criteria:

* Subjects with documented distant metastasis.
* Malabsorption syndrome or disease significantly affecting gastrointestinal function
* Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled HTN
* History of other malignancy. Subjects who have been disease-free for 5 years or subjects with successfully treated in situ carcinoma are eligible.
* Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy, immunotherapy and radiotherapy

Primary outcomes:
measure: 3-year disease free survival(DFS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT00418717: Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA
Official title: An Open-label, Multicenter, Dose-regimen Study Evaluating the Efficacy and Safety of Etanercept 50 mg Once-weekly Dose in Japanese Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be more convenient for most patients. This once-weekly regimen is used in countries outside of Japan.


Eligibility criteria: Main Inclusion Criteria:

* Subjects of Japanese ancestry and living in Japan.
* Subjects who are receiving the approved dose of 25 mg etanercept BIW for at least 6 months and have stable disease activity, as determined by investigator's judgment for 3 months before test articles administration.
* Subjects who have mildly active rheumatoid arthritis as demonstrated by 5 swollen joints and 5 tender/painful joints.

Main Exclusion Criteria:

* Prior treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or methotrexate (MTX) within 6 months of the baseline visit.
* Subjects considered being in disease remission, per investigator's judgment.
* Received other biological drugs, rituximab, anti-CD-4 agents, or diphtheria interleukin-2 fusion protein (DAB-IL-2) within 6 months prior to baseline.

Primary outcomes:
measure: Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.
timeFrame: weeks 4 and 12
Secondary outcomes:
measure: Area Under the Concentration-Time Curve (AUC)
timeFrame: 7 days after week 4 and 7 days after week 12
Other outcomes:
Locations:
city: Nunoya-cho Goshogawara
country: Japan
state: Aomori
city: Kokubu, Kurume
country: Japan
state: Fukuoka
city: Inomachi Takasaki
country: Japan
state: Gunma
city: Higashiuneno Kawanishi
country: Japan
state: Hyogo
city: Mukogawa-cho, Nishinomiya
country: Japan
state: Hyogo
city: Kamiyokoba, Tsukuba
country: Japan
state: Ibaraki
city: Douhaku, Suzuka
country: Japan
state: Mie
city: Hazama, Isobe-cho, Shima
country: Japan
state: Mie
city: Hisai Myojin-cho, Tsu
country: Japan
state: Mie
city: Yamato, Sasebo
country: Japan
state: Nagasaki
city: Higashizuka, Kurashiki
country: Japan
state: Okayama
city: Toranomon, Minato-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01455441: The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes
Official title: Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: GLP-1
Training
Exercise
Type 2 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.

Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.


Eligibility criteria: Inclusion Criteria:

* Informed oral and written consent
* Diagnosed with type 2 diabetes according to the criteria of the WHO
* HbA1C: 7-11% (doing treatment with diet and/or metformin)
* Age \>18 years
* BMI \>25 kg/m2 \<40 kg/m2
* Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies

Exclusion Criteria:

* Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures.
* Subjects treated with sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, insulin or glitazones
* Ongoing abuse of alcohol or narcotics
* Impaired hepatic function (liver transaminases \>2 times upper normal limit)
* Impaired renal function (se-creatinine \>150μM and/or albuminuria)
* Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg)
* Anaemia
* Any condition that the investigators feels would interfere with trial participation
* Receiving any investigational drug within the last 3 months

Primary outcomes:
measure: HbA1c
timeFrame: 16 weeks
Secondary outcomes:
measure: Maximal oxygen uptake (VO2peak)
timeFrame: 16 weeks
measure: Body weight
timeFrame: 16 weeks
measure: Blood pressure
timeFrame: 16 weeks
measure: Glycaemic control
timeFrame: 16 weeks
measure: Meal test
timeFrame: 16 weeks
measure: Myocardial echocardiography
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Internal Medicine, Gentofte Hospital
Study officials:
References:
Clinical trial NCT06522841: 16SRDNA Sequencing of 30 Samples of Human Oral Microbial Samples by Tianjin Medical University
Official title: 16SRDNA Sequencing of 30 Samples of Human Oral Microbial Samples by Tianjin Medical University: Analysis of the Microbial Community Diversity in Various Regions of the Healthy Oral Cavity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Microbiome
Sampling Methods
Epidemiological Studies
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: According to WHO-related standards, we have selected adults who are orally healthy, free from systemic diseases, and non-smokers.

Brief summary: Study Objective:

To explore suitable sampling sites and methods for oral epidemiological surveys in large populations, we aim to compare the distribution of the oral core microbiome at different sites and using different sampling methods in a small sample of healthy individuals.

Main Question:

What is the distribution of the oral core microbiome at different sampling sites and using different sampling methods in orally healthy individuals?

Study Design:

Participants will be randomly selected from a population of orally healthy individuals. After explaining the study to the participants and obtaining informed consent, they will complete a consent form and be informed of the precautions. Samples will be collected using cotton swabs and curettes from the buccal surface of the lower right first molar and using cotton swabs from the left and right buccal mucosa. The samples will be placed in pre-numbered test tubes and sent to the laboratory for microbiome analysis.


Eligibility criteria: Inclusion Criteria:

* (1) People who had no oral diseases particularly caries, periodontitis, and oral mucosal diseases. (2) Teeth without previous restorations.

Exclusion Criteria:

* (1) People who are pregnant. (2) People who suffer from severe systematic diseases, such as diabetes, immune system diseases, and genetic diseases. (3) People who have taken antibiotics within two weeks before sampling.(4) People who have had or currently receiving radiotherapy or chemotherapy. (5) People with complete or incomplete absence of dentition. (6) Individuals who smoke or have smoked within the past six months

Primary outcomes:
measure: 16SRDNA sequencing of 30 samples of human oral microbial samples by Tianjin Medical University
timeFrame: 2021.07 - 2021.12 Finalize research topic. 2021.12 - 2022.06 Complete bibliometric analysis. 2022.06 - 2022.12 Acquire data for analysis. 2022.12 - 2023.06 Obtain analysis results. 2023.06 - 2024.01 Complete and submit the thesis.
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University School of Stomatology
state: Tianjin
Study officials:
References:
Clinical trial NCT04999241: Combined Application of EEN in the Induction of Remission in PUC
Official title: The Role of Combined Application of Exclusive Enteral Nutrition in the Induction of Remission for Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Exclusive Enteral Nutrition
Ulcerative Colitis
Children
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease had been well documented. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week12 will be compared between the two groups (combine with EEN group VS non-combine group).

Detailed description: The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease(CD) had been well documented. Several randomized controlled trial studies found that the overall induction of remission was equipotent with EEN compared to corticosteroids for pediatric CD. However, in promoting mucosal healing and improving the nutritional status, EEN was much better than corticosteroids. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week 12 will be compared between the two groups (combine with EEN group VS non-combine group).The sustained corticosteroid-free clinical remission rate and treatment modification rate during the first year will also be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed UC
2. Years 6 to 18
3. Moderate to severe disease activity at diagnosis

Exclusion Criteria:

1. With mild disease activity at diagnosis
2. Had been treated with corticosteroids or biologics

Primary outcomes:
measure: The mucosal healing rate
timeFrame: 12 week after intervention
Secondary outcomes:
measure: sustained corticosteroid-free clinical remission rate
timeFrame: 1 year after intervention
measure: Treatment modification rate
timeFrame: 1 year after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Huang
role: STUDY_DIRECTOR
References:
Clinical trial NCT02239341: Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
Official title: Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-Risk Pregnancy
Keywords: hospitalized
activity restriction
bed rest
antepartum
pregnant
high risk
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current standard of care for pregnant women deemed to be high-risk often involves recommending varying levels of activity-restriction, up to and including hospitalization. High levels of activity-restriction can lead to physical deconditioning of the mother, which can be difficult to recover from after birth. The proposed study will investigate whether a mild muscular conditioning program conducted in bed and given to hospitalized activity-restricted high-risk pregnant women will improve functional ability, cardiovascular deconditioning and overall quality of life in the postpartum period compared to a control group with no in hospital bed-rest exercise program. We hypothesize that women with a in-hospital muscle conditioning program will be better able to perform functional ability tasks and activities of daily living than a control group with no exercise program.


Eligibility criteria: Inclusion Criteria:

* Hospitalized high-risk pregnant women in hospital for at least 7 days
* Diagnosed with gestational hypertension
* Diagnosed with preeclampsia (mild to moderate)
* Diagnosed with intrauterine growth restriction
* Single baby
* Expecting twins
* Expecting triplets
* Diagnosed with shortened cervix
* Diagnosed with threatened pre-term labour (not actively contracting)

Exclusion Criteria:

* Diagnosed with symptomatic placenta previa (bleeding)
* Diagnosed with severe pre-eclampsia (immediate delivery)
* Diagnosed with conditions indicating a short term hospital stays of less than 7 days
* Diagnosed with infections
* Diagnosed with heart and renal disease
* Diagnosed with diabetes
* Diagnosed with metabolic bone disease
* Diagnosed with hyper-or-hypo-thyroidism
* Diagnosed with Cushing disease and anemia
* Women carrying more than 3 babies

Primary outcomes:
measure: Score on the Functional Mobility Assessment Tool
timeFrame: 2 weeks post delivery
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery
measure: Follow up to Primary outcome Score for Functional Mobility Assessment Tool
timeFrame: 2, 6 and 12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Michelle F Mottola, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00795041: Temporally Splitting Ovarian Stimulation and Embryo Transfer
Official title: Temporally Splitting Ovarian Stimulation and Embryo Transfer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Splitting of Ovarianstimulation and Embryotransfer
Keywords: vitrification
ovarian stimulation
reproductive medicine
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with indication for ART with ICSI or IVF

Brief summary: The purpose of this study is to explore the concept of temporally splitting ovarian stimulation and embryo transfer.


Eligibility criteria: Inclusion Criteria:

* Indication for IVF/ICSI
* Age 18-36 years
* \<= three earlier unsuccessful IVF/ICSI treatments with embryo transfer
* BMI 20-30
* Regular cycle with ovulation (28-35 days)
* Progesterone \>7ng/ml at the beginning of stimulation
* Informed consents

Exclusion Criteria:

* PCOS (polycystic ovarian syndrome
* Endometrioses \>= grade 3
* Known poor response syndrome
* History of ovariectomy
* Severe endocrinopathie

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: November 2008- May 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University Hospital of Schleswig Holstein, Campus Luebeck, Department of Obstetrics and Gynecology
state: Schleswig-Holstein
Study officials:
affiliation: University of Schleswig-Holstein, Campus Luebeck, Department of Obstetrics and Gynecology
name: Georg Griesinger, PD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buendgen NK, Schultze-Mosgau A, Cordes T, Diedrich K, Griesinger G. Initiation of ovarian stimulation independent of the menstrual cycle: a case-control study. Arch Gynecol Obstet. 2013 Oct;288(4):901-4. doi: 10.1007/s00404-013-2794-z. Epub 2013 Apr 3.