louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00044798: Magnetic Stimulation Therapy for Treating Vascular Depression
Official title: Vascular Depression and Magnetic Stimulation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Depression
Keywords: Aged
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-09-06
Enrollment: 132
Sex: ALL
Minimum age (years): 51
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 12-week study will evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the brain, followed by citalopram (Celexa®), for treatment of depression associated with small vascular lesions in the brain (vascular depression).

Detailed description: Vascular depression is a condition that typically affects the elderly and is associated with small vascular lesions. It is more resistant to treatment and has a poorer outcome than nonvascular depression. By altering excitability in the cortical area of the brain, rTMS may be an effective treatment neuropsychiatric conditions, particularly depression.

Participants in this study will be randomly assigned to 15 treatments of either rTMS or sham rTMS for 3 weeks. Following treatment, participants will receive citalopram for 9 weeks. Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy will be measured. Improvements in activities of daily living, quality of life, and cognitive function will also be also measured.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of unipolar major or minor depressive disorder
* Hamilton Depression Rating Scale score of at least 18
* Depression that is associated with cerebrovascular disease
* Failed at least 1 treatment for vascular depression

Primary outcomes:
measure: Response rates to treatment; relapse rates; the size, number, and location of the vascular lesions; and the amount of regional brain atrophy
timeFrame: Measured at Week 12
Secondary outcomes:
measure: Improvements in activities of daily living, quality of life, and cognitive function
timeFrame: Measured at Week 12
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
Study officials:
References:
Clinical trial NCT05168098: Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy
Official title: Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effect of the olfactory stimulation intervention on the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed with mild to moderate dementia from 2 day care centers in Taipei. They are randomly assigned to three groups, including the olfactory intervention group, game comparison group, and control group. Beside the control group, the participant with two other groups were required to attend twelve weeks intervention (twice a week, thirty minutes for one section). Every participants completed the olfactory test, both paper-pencil and computer-based examination for cognition, blood test and psychological measurement before and after the intervention. The results showed that the participant in olfactory intervention group significant improved score in the LOTCA-G examination, and the Aβ1-42 concentration of the blood test significant increase in the control group; furthermore, the olfactory intervention group is lowest concentration among three groups in the Tau concentration of the blood test via ANCOVA analysis.


Eligibility criteria: Inclusion Criteria:

* ages \>50 years with a diagnosis of mild or moderate dementia
* being admitted to the day care center and living in the community
* being willing to do blood test with a family member's consent.

Exclusion Criteria:

* experience in chronic rhinitis or sinusitis, which causes loss of smell; inability to perform the cognitive exam or olfactory test (e.g., having a severe hearing impairment)
* inability to attend group activities due to severe emotional or aggressive behaviors

Primary outcomes:
measure: ImmunoMaggnetic-Reduction (IMR) blood tests
timeFrame: 60 min
Secondary outcomes:
measure: Mini-mental State Examination
timeFrame: 60 min.
measure: Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
timeFrame: 60 min.
measure: The Top International Biotech Smell Identification Test (TIBSIT)
timeFrame: 60 min.
measure: Geriatric Depression Scale (GDS-15)
timeFrame: 60 min.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
References:
citation: Lin LJ, Li KY. Comparing the effects of olfactory-based sensory stimulation and board game training on cognition, emotion, and blood biomarkers among individuals with dementia: A pilot randomized controlled trial. Front Psychol. 2022 Sep 20;13:1003325. doi: 10.3389/fpsyg.2022.1003325. eCollection 2022.
Clinical trial NCT06664398: Preventive Effects of Different Volumes of High-Intensity Interval Training on Risk Factors for MS in Overweight Young Women
Official title: Preventive Effects of Different Volumes of High-Intensity Interval Training on Risk Factors for Metabolic Syndrome in Overweight Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: high-intensity interval training
overweight
metabolic syndrome
risk factor
prevention
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effects of different volumes of high-intensity interval training on risk factors for metabolic syndrome in overweight young women.

Detailed description: The sedentary and inactive female overweight subjects, aged 18 to 30 years, were randomly divided into three groups: high volume high-intensity interval training group (4HIIT group), low volume high-intensity interval training group (1HIIT group) and control group (CON group). Human morphological measures, blood pressure, insulin resistance, blood analysis, and cardiorespiratory fitness were measured at baseline and after exercise intervention.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-30 years;
* BMI≥24kg/m2, indicating overweight and high risk of metabolic syndrome;
* Maintaining a stable body weight for the three months prior to the study.

Exclusion Criteria:

* Regular participation in physical exercise (≥3 times/week, exercise time≥30min/time);
* Any respiratory, musculoskeletal, or cardiovascular diseases;
* Medical or other contraindications for exercise;
* Taking medications that affect metabolism;
* Smoking and/or drinking habits.

Primary outcomes:
measure: Weight
timeFrame: 8 weeks
measure: Body Mass Index (BMI)
timeFrame: 8 weeks
measure: body fat percentage
timeFrame: 8 weeks
measure: waist circumference (WC)
timeFrame: 8 weeks
measure: Systolic blood pressure (SBP)
timeFrame: 8 weeks
measure: Diastolic blood pressure (DBP)
timeFrame: 8 weeks
measure: Fasting plasma glucose (FPG)
timeFrame: 8 weeks
measure: Triglyceride (TG)
timeFrame: 8 weeks
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: 8 weeks
Secondary outcomes:
measure: Non high-density lipoprotein cholesterol (Non HDL-C)
timeFrame: 8 weeks
measure: Insulin
timeFrame: 8 weeks
measure: Homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: 8 weeks
measure: Triglyceride-glucose (TyG) index
timeFrame: 8 weeks
measure: Triglyceride-to-high density lipoprotein cholesterol ratio (TG/HDL-C ratio)
timeFrame: 8 weeks
measure: Visceral fat area (VFA)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
Study officials:
References:
Clinical trial NCT06728098: Akkermansia Muciniphila Akk11 Impact on Obesity and Metabolic Health
Official title: An Open-Label Healthy Adult Control, Double-Blind Randomized Placebo-Controlled Clinical Trial of Akkermansia Muciniphila Akk11 on Body Weight and Metabolic Health in Obese Adult Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in adult obesity.


Eligibility criteria: Inclusion Criteria:

1. Male or female, aged 18-50 years
2. For healthy subjects: Must have a BMI between 18.5 and 24.9 kg/m2 and normal lipid profile (Cholesterol total \<200 mg/dL; LDL-C \<100 mg/dL; HDL-C ≥ 40 mg/dL; and triglyceride \< 150 mg/dL)
3. For obese subjects: Must have a BMI ≥ 30 kg/m2, weight stable for at least 3 months (± 2 kg)
4. Subjects must be either of non-childbearing potential, or if of childbearing potential, must be abstinent or have practiced adequate contraception for the entire study
5. Subjects who have not smoked in the past 1 month prior to screening
6. Subjects or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any study-related activities) -

Exclusion Criteria:

1. Male or female, aged 18-50 years
2. For healthy subjects: Must have a BMI between 18.5 and 24.9 kg/m2 and normal lipid profile (Cholesterol total \<200 mg/dL; LDL-C \<100 mg/dL; HDL-C ≥ 40 mg/dL; and triglyceride \< 150 mg/dL)
3. For obese subjects: Must have a BMI ≥ 30 kg/m2, weight stable for at least 3 months (± 2 kg)
4. Subjects must be either of non-childbearing potential, or if of childbearing potential, must be abstinent or have practiced adequate contraception for the entire study
5. Subjects who have not smoked in the past 1 month prior to screening
6. Subjects or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any study-related activities) -

Primary outcomes:
measure: Change in Body Weight
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: Jakarta
Study officials:
References:
Clinical trial NCT02158598: Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Khlôros Technology
name: Anne-Sophie Morisset
First posted: 2014-06-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D concentration following vitamin D supplementation with chewable tablets versus pills. Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet supplement. Questionnaires on physical activity, sunlight exposure and dairy product consumption will be administered to adjust for confounding factors. A questionnaire will be administered to assess satisfaction and pill count to evaluate adherence to treatment. This research intends to test the hypothesis that the vitamin D chewable tablet supplement is as effective as a traditional vitamin D pill supplement to increase serum 25(OH)D concentrations.


Eligibility criteria: Inclusion Criteria:

* Caucasian men and women;
* Aged 18 years and older;
* Having a serum 25(OH)D concentration of 75 nmol/L or less.

Exclusion Criteria:

* Regular consumption of a supplement containing \> 400 IU/d of vitamin D over the last 2 months;
* Intestinal malabsorption;
* Cirrhosis;
* Renal insufficiency (creatinine clearance \<60 ml/min);
* Hypercalcemia;
* Pregnancy;
* Breastfeeding;
* Inability to provide informed consent.

Primary outcomes:
measure: Change in Serum 25(OH)D concentration
timeFrame: 0 and 2 months, 4 and 6 months
Secondary outcomes:
measure: Satisfaction with the vitamin D chewable tablets and pills.
timeFrame: 0 and 2 months, 4 and 6 months
measure: Adherence to the vitamin D chewable tablets and pills.
timeFrame: 0 and 2 months, 4 and 6 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHU de Québec Research Centre, Laval University
state: Quebec
Study officials:
affiliation: CHU de Québec Research Centre and Laval University
name: Claudia Gagnon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573998: Study on the Mechanism of lcn2 in Obesity
Official title: Study on the Mechanism of lcn2 in Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity; Endocrine
Keywords: obesity
lcn2
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 Patients from Shanghai Tenth People's Hospital were enrolled in this study.

Brief summary: Obesity is now becoming a worldwide serious problem. Obesity is associated with a spectrum of severe diseases, including diabetes, cardiovascular diseases, and cancers. Lipocalin 2 (LCN2), also known as neutrophil gelatinase associated lipocalin (NGAL), is a member of the lipocalin family. Due to its upregulated expression in infection, LCN2 is originally considered to be a key regulator of immune response. Subsequent investigations revealed that LCN2 is expressed in many tissues and is related to a variety of diseases, including obesity. LCN2 was reported to be increased in obesity individuals. Thus, the investigators decide to investigate the relationship between LCN2 and obesity.


Eligibility criteria: Inclusion Criteria:

1) age ranged from 16-65 years old, 2) BMI over 37.5kg/m2, or BMI over 32.5kg/m2 with diabetes which meets the recommended cut off bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.

Exclusion Criteria:

1) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc.,2)pregnancy or location, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.

Primary outcomes:
measure: LCN2 level
timeFrame: 2019-2024
measure: meet the criteria of metabolism in the 2017 Chinese guideline
timeFrame: 2019-2024
Secondary outcomes:
measure: FBG
timeFrame: 2019-2024
measure: PBG
timeFrame: 2019-2024
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Shen Qu, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02432898: Non-Invasive Imaging of the Human Eye
Official title: Non-Invasive Imaging of the Human Eye
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Willing and Able Subjects for Ocular Imaging
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal subjects will be recruited from Topcon Medical Systems.

Brief summary: Evaluate the clinical information obtained from the use of the machines.

Detailed description: Evaluate the clinical information provided by these devices and determine their clinical utility and efficacy and safety.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed.
2. Subjects who can follow the instructions by the clinical staff at the clinical site and can attend examinations on the scheduled examination date.

Exclusion Criteria:

1. History of ocular pathology.
2. History of cataract of ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
3. History of systemic disease
4. fixation problems which may prevent obtaining good quality images in the eye.

Primary outcomes:
measure: Device Evaluation
timeFrame: 1 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems, Inc.
state: New Jersey
Study officials:
affiliation: Topcon Corporation
name: Danny Leung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00727298: Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)
Official title: Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Spondylitis, Ankylosing
Arthritis, Psoriatic
Psoriasis
Crohn's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Centocor, Inc.
First posted: 2008-08-01
Enrollment: 4485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.

Brief summary: This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.

Detailed description: The study population was chosen from a non-probability sample.

The safety population consisted of all participants with at least one documented infusion of infliximab.

The evaluable population consisted of all participants that were \>=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.

Eligibility criteria: Inclusion Criteria:

* Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants Experiencing at Least One Adverse Event
timeFrame: Baseline to Month 24
Secondary outcomes:
measure: Clinicians' Impression of Disease Severity From Baseline to Week 102
timeFrame: Baseline, Week 6, Week 14, Week 22, Week 54, Week 102
measure: Clinicians' Impression of Therapeutic Efficacy
timeFrame: Week 6, Week 14, Week 22, Week 54, Week 102
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04489498: Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Official title: Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 196
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is difficult to find the basis for calculation because there are no papers that measure the body size of children with cerebral palsy and papers that compare with normal children. In particular, children with cerebral palsy are rare diseases, and it is difficult to recruit a large number of subjects.

Brief summary: The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2) seek ways to simplify the data for clinical application, 3) progress of hip dislocation, presence or absence of hip surgery, and The purpose of this study is to compare differences in body development according to severity and nutritional methods.


Eligibility criteria: Inclusion Criteria:

* aged 1 to 13
* Experiment group: Children with cerebral palsy, Control group: Normal children
* Patients who agreed to participate in the study

Exclusion Criteria:

* do not agree with the study
* Those who find it difficult to participate under the judgment of the research director

Primary outcomes:
measure: Anthropometric data (body length)
timeFrame: through study completion, an average of 1 year
measure: Anthropometric data (BMI)
timeFrame: through study completion, an average of 1 year
measure: Anthropometric data (body circumference )
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Progression of hip dislocation
timeFrame: Use simple x-ray within 1 year prior to participation
measure: Progression of scoliosis
timeFrame: Use simple x-ray within 1 year prior to participation
measure: Have hip dislocation surgery
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national university bundang hospital
state: Bundang-gu
Study officials:
References: