louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01696838: Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With fMRI
Official title: Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
CAM
Keywords: Crohn's disease
acupuncture
moxibustion
fMRI
Gut
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging.

Detailed description: The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of Crohn's disease. meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging.

Through treating quiescent Crohn's disease by electroacupuncture or moxibustion therapies for 12 weeks, Compare the different brain activation by the different therapies and observe the correlation between brain activation and efficacy.

Eligibility criteria: Inclusion Criteria:

* age 18-50 years;
* right-handed;
* clinical remission (Crohn's Disease Activity Index \[CDAI\]≤150) for at least 6 months prior to the study;
* C-reactive protein(CRP)\<10 mg/l;
* erythrocyte sedimentation rate (ESR) \<20 mm/h
* signing awritten informed consent form.

Exclusion Criteria:

* use of corticosteroids and psychotropic medications in the previous 30 days;
* current or prior history of neurological or psychiatric disease based
* on physicians' examination and questionnaires;
* current or prior history of neurosurgery, head injury, cerebrovascular
* insult, or brain trauma involving loss of consciousness;
* learning disability;
* claustrophobia;
* presence of metallic implants in the body;
* being pregnant or during lactation.

Primary outcomes:
measure: CDAI
timeFrame: 1 year
Secondary outcomes:
measure: fMRI
timeFrame: 1 year
measure: IBDQ
timeFrame: 1 year
measure: Inflammatory factors
timeFrame: 1 and a half years
measure: Neurotransmitter
timeFrame: 1 and a half years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture-Moxibustion and Merdian
state: Shanghai
Study officials:
affiliation: Shanghai Institute of Acupuncture, Moxibustion and Meridian
name: Wu Huangan, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02688738: Does Preoperative Administration of Oral Doxycycline Decrease the Colonization Rate of Propionibacterium Acnes in the Dermis of the Shoulder?
Official title: Does Preoperative Administration of Oral Doxycycline Decrease the Colonization Rate of Propionibacterium Acnes in the Dermis of the Shoulder?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Propionibacterium
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2016-02-23
Standard ages: CHILD
ADULT
OLDER_ADULT
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the ability of oral doxycycline to decrease the colonization of Propionibacterium acnes in the dermis of the shoulder.


Eligibility criteria: Inclusion Criteria:

-All male patients (\>18 years of age) undergoing shoulder arthroscopy

Exclusion Criteria:

* Female patients
* patients with active acne
* patients who have taken antibiotics in the past month
* doxycycline allergy
* benzoyl peroxide allergy
* clindamycin allergy
* patients with psoriatic/eczematous or other lesions on the shoulder girdle.

Primary outcomes:
measure: Quantification of P acnes grown from anaerobic or aerobic culture
timeFrame: within 14 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04329338: Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
Official title: Effects of Lactobacillus Pentosus KCA1 on the Gut and Vaginal Microbiome of Women With Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginoses
Keywords: Lactobacillus
Microbiota
Nigerian women
Gut
Vagina
16S rRNA
Sequencing
Metagenomics
Lead sponsor: Nnamdi Azikiwe University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In this case each participant served as control as we collected sample before and after intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bacterial vaginosis (BV) is under-reported, misdiagnosed and inappropriately treated in Nigeria. Treatment option rely on antibiotics that eliminates both good and pathogenic bacteria, with gross impact on the gut and vaginal microbiome. Our primary objective in this study is to determine the effects of Lactobacillus on the gut and vagina when taken orally.

Detailed description: Antibiotics reduces in considerable proportion both the healthy bacteria especially Lactobacilli and those associated with BV, thus the vaginal microecology and gut is adversely affected. It is widely acknowledged that Lactobacilli and other genera that produces some metabolites such as lactic acid, contributes to vaginal health by maintaining the low pH of the vagina.

The objectives of this study are three folds, first to determine the effects before and after 14 days oral feeding of Lactobacillus pentosus KCA1 on the vaginal and gut microbiota compositions of women diagnosed with BV. Second to measure the level of two proinflammatory cytokines IL-1 beta and IL-6 before and after KCA1 consumption and third to determine in silico, the relative abundance of microbial genes involved in metabolic functions using the 16S rRNA datasets.

Eligibility criteria: Inclusion Criteria:

* Not on antibiotic therapy within the last one month
* Not menstruating at the time of inclusion.

Exclusion Criteria:

Pregnant, use of antibiotic medication, declined informed consent, menstruating and those that used douches, sprays, spermicides in the last 48 hours

-

Primary outcomes:
measure: Nugent score
timeFrame: 14 days
measure: Gut and Vaginal microbiota
timeFrame: 14 days
Secondary outcomes:
measure: IL-6 Proinflammatory cytokine
timeFrame: 14 days
measure: IL-1beta Proinflammatory cytokine
timeFrame: 14 days
Other outcomes:
Locations:
city: Nnewi
country: Nigeria
facility: Nnamdi Azikiwe University Teaching Hospital
state: Anambra
Study officials:
References:
citation: Anukam KC, Macklaim JM, Gloor GB, Reid G, Boekhorst J, Renckens B, van Hijum SA, Siezen RJ. Genome sequence of Lactobacillus pentosus KCA1: vaginal isolate from a healthy premenopausal woman. PLoS One. 2013;8(3):e59239. doi: 10.1371/journal.pone.0059239. Epub 2013 Mar 19.
Clinical trial NCT05141838: Vitamin D Status and Bone Metabolism Status in Children With Congenital Epidermolysis Bullosa
Official title: Vitamin D Status and Bone Metabolism Status in Children With Congenital Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bullosa Epidermolysis
Vitamin D Deficiency
Osteoporosis
Osteopenia
Phosphorus and Calcium Disorders
Keywords: Children, Only
Lead sponsor: National Medical Research Center for Children's Health, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2021-12-02
Enrollment: 110
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This retrospective prospective study is aimed at studying the level of vitamin D supply and identifying markers of bone tissue remodeling in order to develop approaches to the prevention of osteopenia and osteoporosis in children with congenital epidermolysis bullosa.

Detailed description: This retrospective prospective interventional study will examine vitamin D availability and its relationship with clinical disease, patient gender and age, and season. The mechanisms of impairment of phosphorus-calcium metabolism and bone tissue metabolism will be analyzed on the basis of biochemical parameters and instrumental research methods in children with dystrophic epidermolysis bullosa in order to develop personalized approaches for correcting vitamin D status and bone metabolism disorders in children with epidermolysis bullosa, followed by an assessment of their clinical efficacy.

Eligibility criteria: Inclusion Criteria:

* Verified diagnosis of epidermolysis bullosa;
* Signing by parents (legal representatives) of informed consent to participate in the study and fulfill the requirements of the study

Exclusion Criteria:

* not planned

Primary outcomes:
measure: Vitamin D level
timeFrame: Baseline
measure: Vitamin D level
timeFrame: 24 week
measure: Phosphorus-calcium metabolism assessment
timeFrame: Baseline
measure: Phosphorus-calcium metabolism assessment
timeFrame: 24 week
measure: Assessment of the state of bone tissue
timeFrame: Baseline
measure: Assessment of the state of bone tissue
timeFrame: 24 week
measure: Assessment of indicators of physical development
timeFrame: Baseline
measure: Assessment of indicators of physical development
timeFrame: 24 wee
Secondary outcomes:
measure: Assessment of bone mineral density
timeFrame: Baseline
measure: Assessment of bone mineral density
timeFrame: 24 week
measure: Bone age assessment
timeFrame: Baseline
measure: Bone age assessment
timeFrame: 24 week
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Children's Health
Study officials:
References:
Clinical trial NCT04127838: Low Vision Occupational Therapy in Parkinson's Disease
Official title: Low Vision Occupational Therapy in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this study is to determine whether low-vision occupational therapy improves quality of life in Parkinson's Disease (PD) patients. Low-vision occupational therapy has not been previously studied in PD patients, and we suspect that this is a beneficial treatment option for PD patients as vision impairment is common in the PD patient population. Our primary objective will assess whether quality of life was improved following a low-vision occupational therapy session.

Detailed description: This project will be an exploratory study that will evaluate the benefits of low vision occupational therapy in the treatment of PD using the Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP) as the primary outcome measure. This tool assesses 33 vision-dependent ADLs ranging from personal care, leisurely activities, clothing management, meal preparation, etc. Patients are able to rank their ability to complete these tasks as independent, minimally difficult, moderately difficult, greatly difficult, unable, or not applicable. This will allow us to capture potential changes in the patient's ability to complete vision-specific ADLs following low vision occupational therapy. In addition, we will also evaluate quality of life using the Parkinson's Disease Questionnaire (PDQ-39), to compare this broad outcome measure with the R-SRAFVP.

Eligibility criteria: Inclusion Criteria:

* 18 and older
* seen at UAB Movement Disorders Clinic
* diagnosis of idiopathic Parkinson's Disease
* able to read, speak, and understand spoken English.

Exclusion Criteria:

* minors
* cognitively impaired

Primary outcomes:
measure: Change in Activities of Daily Living
timeFrame: Changes measured in the R-SRAFVP from the initial visit as compared to the visit six months later.
Secondary outcomes:
measure: Change in quality of life
timeFrame: Changes measured in the PDQ-39 from the initial visit as compared to the visit six months later.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Marissa Dean, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05891938: Effects of Hydrogen Gas Inhalation on Adults of Various Ages
Official title: Effects of Hydrogen Gas Inhalation on Community-Dwelling Adults of Various Ages: A Single-Arm, Open-Label, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: PREVENTION

Brief summary: Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages.

Detailed description: Molecular hydrogen (H2) is a versatile therapeutic agent. H2 gas inhalation is reportedly safe and has a positive impact on a range of illnesses, including Alzheimer's disease (AD). Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages. Fifty-four participants including those dropped out (5%) were screened and enrolled. The selected participants were treated as a single group without randomization. Evaluated the association between total and differential white blood cell (WBC) counts and AD risk at individual levels after 4 weeks of H2 gas inhalation treatment. Furthermore, evaluation of dementia-related biomarkers such as beta-site APP cleaving enzyme 1 (BACE-1), amyloid beta (Aβ), brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor A (VEGF-A), T-tau, monocyte chemotactic protein-1 (MCP-1), and inflammatory cytokines (interleukin-6).

Eligibility criteria: Inclusion

* Age ranges 40-70 years
* Healthy participants
* Patients who are willing or able to follow the doctor's instructions
* Fully understand the purpose and procedure of this clinical trial

Exclusion Criteria

* Participants excluded those who have any disease
* Pregnant and lactating women

Primary outcomes:
measure: Measurement of white blood cell and its differential counts such as neutrophils (%), basophils (%)
timeFrame: 4 weeks
measure: Measurement of oxidative stress markers such as reactive oxygen species (µM), and nitric oxide (µM)
timeFrame: 4 weeks
Secondary outcomes:
measure: Measurement of dementia biomarkers such as brain-derived neurotrophic factor (BDNF ng/mL)
timeFrame: 4 weeks
measure: Measurement of dementia biomarkers such as brain-derived neurotrophic factor amyloid beta (Aβ (pg/mL))
timeFrame: 4 weeks
measure: Measurement of inflammatory markers such as interleukin 6 (pg/mL)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju College of Medicine
state: Ganwon-do
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gwando
Study officials:
affiliation: Wonju College of Medicine
name: Prof. Kyu Jae Lee, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01829438: Influence of Music on 6 Minutes Walking Distance in Healthy Children
Official title: Influence of a Distractive Auditory Stimulus on 6 Minute Walking Test in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Children
Keywords: exercise tolerance
6MWT
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 97
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred) on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen saturation) in healthy children.


Eligibility criteria: Inclusion Criteria:

* the participation to the physical education program after the annual medical investigation

Exclusion Criteria:

* a lung disease
* an overweight
* a motor disability based on parent's answers to a questionnaire

Primary outcomes:
measure: Walked distance
timeFrame: After 6 minutes
Secondary outcomes:
measure: Dyspnea
timeFrame: At the end of the 6MWT
Other outcomes:
measure: cardio-respiratory parameters
timeFrame: at the begining and the end of the 6MWT
Locations:
city: Brussels
country: Belgium
facility: UCL
Study officials:
affiliation: UCL
name: Lux Amandine, Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00962338: Pain and Convalescence After Laparoscopic Groin Hernia Repair
Official title: Pain and Convalescence After Laparoscopic Groin Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Convalescence
Keywords: convalescence
pain
nausea
vomiting
sexual dysfunction
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2009-08-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population are from Region Sjaelland and are planned for laparoscopic inguinal or femoral herniorrhaphy. Single university hospital department i Denmark.

Brief summary: The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. This is also done first 3 days after operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and 6 months.


Eligibility criteria: Inclusion Criteria:

* planned laparoscopic inguinal or femoral herniorrhaphy
* ASA class I-II
* speak and read danish

Exclusion Criteria:

* converting to open operation
* low compliance (dementia, psychiatric disorder)
* use of morphine or similar drugs daily in the last month
* complications to the operation

Primary outcomes:
measure: duration of convalescence
timeFrame: 3 weeks in average
Secondary outcomes:
measure: Pain scores on visual analog scale and verbal rating scale
timeFrame: 6 months
measure: fatigue scores on numeric rating scale (1-10)
timeFrame: 6 months
measure: sexual dysfunction
timeFrame: 6 months
measure: nausea scores on verbal rating scale
timeFrame: 3 days
measure: vomiting
timeFrame: 3 days
measure: wellbeing scores on visual analog scale
timeFrame: 6 months
measure: Hospital anxiety and depression scale (HAD)
timeFrame: Baseline (before operation)
measure: Pain catastrophizing scale (PCS)
timeFrame: Baseline (before operation)
measure: Activity assessment scale (AAS)
timeFrame: Baseline (before operation)
Other outcomes:
Locations:
city: Koege
country: Denmark
facility: University Hospital Køge
state: Region Sjaelland
Study officials:
affiliation: University Hospital Køge
name: Mette A Tolver, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tolver MA, Rosenberg J. Pain during sexual activity before and after laparoscopic inguinal hernia repair. Surg Endosc. 2015 Dec;29(12):3722-5. doi: 10.1007/s00464-015-4143-8. Epub 2015 Mar 18.
citation: Tolver MA, Strandfelt P, Rosenberg J, Bisgaard T. Female gender is a risk factor for pain, discomfort, and fatigue after laparoscopic groin hernia repair. Hernia. 2013 Jun;17(3):321-7. doi: 10.1007/s10029-012-0956-8. Epub 2012 Jul 12.
Clinical trial NCT03982238: Effects of Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients
Official title: Effects of Continuous Subcutaneous Insulin Infusion and Oral Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the total testosterone and sex hormone-binding globulin levels in men with type 2 diabetes before and after continuous subcutaneous insulin infusion and hypoglycemic drugs treatment.


Eligibility criteria: Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs.
* HbA1c \> 9%.
* subjects are able and willing to eat and exercise regularly.

Exclusion Criteria:

* patients with insulin allergy.
* impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.● drug abuse and alcohol dependence in the past 5 years.
* systemic hormone therapy was used in the last three months.
* patients with poor compliance and irregular diet and exercise.
* patients with infection and stress within 4 weeks.
* any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Primary outcomes:
measure: total testosterone levels
timeFrame: 1 month
Secondary outcomes:
measure: bioavailable testosterone
timeFrame: 1 month
measure: free testosterone
timeFrame: 1 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
Study officials:
References:
citation: Hu Y, Ding B, Shen Y, Yan RN, Li FF, Sun R, Jing T, Lee KO, Ma JH. Rapid Changes in Serum Testosterone in Men With Newly Diagnosed Type 2 Diabetes With Intensive Insulin and Metformin. Diabetes Care. 2021 Apr;44(4):1059-1061. doi: 10.2337/dc20-1558. Epub 2021 Feb 3.