louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06103240: A Probiotic That Improve Intestinal Flora
Official title: Changes in the Gut Microbiota Composition of Healthy Young Volunteers After Administration of Lacticaseibacillus Rhamnosus LRa05: A Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Flora
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: to verify the physiological properties of Lactobacillus rhamnosus LRa05.

Bacterial count:100 billion Test Objective: to test and collect the changes of intestinal flora before and after the daily use of LRa05 product.

Detailed description: In order to validate the physiological properties of the 100 billion probiotic Lactobacillus rhamnosus LRa05 product and to gather sufficient evidence to test the changes in the intestinal flora before and after the daily use of the probiotic product, the test was conducted on 110 college students aged 18-25 years.

The primary outcome was to investigate the increase in the diversity of the gut flora and the increase in the peak levels of beneficial bacteria in the gut, and the secondary outcome was to investigate whether there was a significant improvement in the PSQI Pittsburgh Sleep Quality Index and the ISI Insomnia Severity Index.

Eligibility criteria: Inclusion Criteria:

1. PSQI Pittsburgh Sleep Quality Index scale score \>6 and \<18
2. ISI Insomnia Severity Index scale score \>8 and \<23

Exclusion Criteria:

1. People who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
2. people whose daily diet is too light or too oily are not recommended to participate in the test; people with special dietary structure (e.g. ketogenic diet, etc.) caused by weight loss or other reasons, such as muscle gain and fat loss, are not recommended to participate in the test;
3. others with special conditions are not recommended to participate, such as those who are allergic to probiotic products;
4. pregnant women, lactating women and people under 19 and over 45 years old should not experiment;
5. people with unhealthy stomach and intestines are not recommended to participate in the test;
6. people with low body fat and BMI \<23 are not recommended to participate in the test.

Primary outcomes:
measure: intestinal flora test
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan University of Technology
state: Henan
Study officials:
References:
Clinical trial NCT00752440: Inspiratory Muscle Training in Patients With Autonomic Neuropathic
Official title: Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Diabetic Autonomic Neuropathy
Keywords: Diabetes Mellitus
Autonomic Neuropathy
Inspiratory Muscle training
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2008-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.

Detailed description: The diabetic autonomic neuropathy (NAD) is a common complication of diabetes mellitus (DM), both of the type 1 diabetes mellitus (DM1) as of the type 2 diabetes mellitus (DM2). The results of this study, would help to reveal the degree of commitment generated by NAD in respiratory muscle strength, can also enable the development of a new therapeutic approach, such non-pharmacological (respiratory muscle training), with a view to improve the respiratory muscle strength and alleviate the autonomic dysfunction in these patients.

Eligibility criteria: Inclusion Criteria:

* Diabetic autonomic neuropathy
* Age between 36 and
* 70 years old and signed in informed consent form

Exclusion Criteria:

* Presence of congestive heart failure
* Chronic obstructive pulmonary disease (FEV1 \< 70% and/or FEV1%\< 80
* Class II or III obesity (body mass index \> 35)

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: eight
Secondary outcomes:
measure: Variability of heart rate
timeFrame: eight
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Institudo de Cardiologia do Rio Grande do Sul
state: RGS
Study officials:
affiliation: Institudo de cardiologia de Porto Alegre
name: Beatriz D Schann, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04430140: CT Scalar Localization
Official title: CT Scalar Localization of the Electrode Array Following Cochlear Implantation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cochlear Implant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic Patients

Brief summary: Comparing the location of cochlear implants to level of retained hearing.

Detailed description: Subjects who have undergone cochlear implant surgery will have a CT scan to determine the exact anatomical location of the implant. This location will then be compared with audio testing levels and operative reports to determine any advances in implantation technique that would result in more preserved hearing

Eligibility criteria: Inclusion Criteria:

* Currently scheduled for a cochlear implant or currently have a cochlear implant
* 18 years of age and over
* Male and female
* Capacity to consent for patients will be determined by review of the medical history of subject at screening and in concert with the referring physician. Consent will be signed after all questions have been answered and the participant indicates they understand

Exclusion Criteria:

* Younger than 18 years of age
* Current criteria for cochlear implantation
* Currently pregnant, all females will be asked to take a urine pregnancy test if of child bearing age, unless you cannot become pregnant

Primary outcomes:
measure: Implant Location
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: John Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00011440: Pollutant Altered Allergic Responses
Official title: Markers of Pollutant Altered Allergic Responses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Allergy
Keywords: Allergy
Air pollution
Lung function
Inflammation
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: This study is designed to investigate whether exposure to particulate air pollution increases the allergic response to allergens. Research studies suggest that symptoms in individuals with allergies may be aggravated by exposure to particulate air pollution. We sought to experimental determine this by exposing human volunteers to combustion particles, a component of air pollution, and then challenge them with an allergen such as ragweed or oak tree pollen. Using biological tests we can measure whether the allergen response is magnified by prior particulate exposure.

Detailed description: To study whether particulates enhance the allergic response, we chose the upper airway as a model of allergic inflammation and nasal lavage as a non-invasive method for obtaining samples. The nasal cavity is both an excellent model of allergic inflammation and provides an easily accessible site for study. We measured inflammatory cells and cytokines in the nasal lavage fluid. Our specific hypothesis was that particulate exposure prior to allergen challenge would enhance inflammatory cell recruitment and expression of inflammatory cytokines.

Eligibility criteria: Adult without a history of asthma or respiratory disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
References:
Clinical trial NCT00184340: Secured Internet-mediated Psychotherapy With Psychiatry Patients
Official title: Secured Internet-mediated Psychotherapy With Psychiatry Patients. Software Improvement, Clinical Trials and Development of Clinical Precautions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorders
Keywords: eTherapy supplementary
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Directorate of Health
First posted: 2005-09-16
Enrollment: 6
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clients in CAMH services

Brief summary: This is the second phase (Phase B) of the main project "Bank for Thoughts", which has the following aims:

1. Improvement of software for secured (encrypted and access-controlled) asynchronous text-based communication within health services. (Adjustments for use in psychiatry.)
2. Open clinical trials with Internet-mediated psychotherapy or counselling in out-patient child and adolescent psychiatry.
3. Development of indications and precautions for text-based Internet-mediated psychotherapy.

Detailed description: This phase (Phase B) concentrates on qualitative evaluation of open clinical single case trials using asynchronous Internet-mediated text-dialogue for psychotherapeutic purposes.

Single patients in differing treatment phases, conditions, age and sex categories are interviewed after using Internet-contact as a supplementary tool in psychotherapy. Their therapists are interviewed as well.

The purpose is systematically gathering single-case experiences with the tool, to build a hypothesis for research and preliminary guidelines for experimental clinical use of Internet-mediated psychotherapy.

Eligibility criteria: Inclusion Criteria:

* Motivation for e-mail contact
* Therapist evaluation for suitability

Exclusion Criteria:

* Paranoia
* Psychosis
* Eating disorders
* Addictive problems
* Denying or concealing symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Child Psychiatry Department, Levanger Hospital
city: Orkanger
country: Norway
facility: Child Psychiatry Department, St. Olav Hospital, Orkdal Site
Study officials:
affiliation: Norwegian University of Science and Technology (NTNU), Faculty of Medicine, Dept. of Neuroscience, Center for Child and Adolescent Mental Health
name: Tormod Rimehaug, Asst. Prof.
role: STUDY_DIRECTOR
References:
citation: Joraas T, Rimeheug T, Birkeland MS, Arefjord K. E-therapy as a follow-up supplement to outpatient treatment of adolescents: A qualitative study of therapist experiences. Tidsskrift for Norsk Psykologforening 46(4): 355-61, 2009
citation: Birkeland MS, Rimehaug T, Arefjord K, Joraas T. How clients experience e-therapy as a supplement to ordinary psychotherapy. Tidsskrift for Norsk Psykologforening 46(4): 348-358, 2009.
Clinical trial NCT00788840: Detemir Energy Expenditure Study
Official title: A 24-week, National, Single-centre, Open-labelled, Randomised, Parallel-group Trial Comparing Energy Expenditure With Insulin Detemir Versus NPH Insulin Using a Basal-bolus Regimen With Insulin Aspart as the Mealtime Insulin in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2008-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.


Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes
2. Treated with metformin
3. Already on treatment with a long-acting or intermediate insulin.
4. Over 18 years of age,
5. HbA1c \> 7.0%
6. BMI 27-40
7. Able and willing to perform self-blood glucose monitoring.
8. Able and willing to maintain consistent eating habits throughout the entire trial period.
9. Able and willing to maintain consistent physical activity level during the entire trial period

Exclusion Criteria:

1. Patients on sulphonylureas or thiazolidinediones
2. Proliferative retinopathy that has required acute treatment within the last six months.
3. Impaired hepatic or renal functions.
4. Cardiac problems.
5. Uncontrolled hypertension (treated or untreated).
6. Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.

Primary outcomes:
measure: Weight change
timeFrame: 6 months
Secondary outcomes:
measure: Energy Expenditure
timeFrame: 6 months
measure: Fat composition
timeFrame: 6 months
measure: Fat & muscle gene expression
timeFrame: 6 months
measure: Glycaemic control
timeFrame: 6 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Cedar Centre, Royal Surrey County Hospital
state: Surrey
Study officials:
affiliation: University of Surrey
name: David Russell-Jones, MB BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Clinical trial NCT05128240: Nutritional Study of Fish Oil in Skin Quality in Healthy Women
Official title: A Randomised, Two-armed, Double-blinded Nutritional Study of Fish Oil on Skin Quality in Healthy Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Health
Keywords: skin
inflammation
wrinkles
trans epithelial water loss
fish oil
LCMUFA
Lead sponsor: Epax Norway AS
Sponsor class: INDUSTRY
Collaborators: name: Møreforsking AS
First posted: 2021-11-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled, double blind intervention study.
Primary purpose: TREATMENT

Brief summary: The skin acts as a barrier against the external environment and prevents water loss from the body. Aging is a natural process leading to changes in the skin and fish oil has been shown to prevent inflammation, hyperpigmentation and UV-damage. This pilot study will determine skin characteristics after intervention with north atlantic fish oil.

Detailed description: Women will be recruited to a placebo or fish oil group and be examined at pre- and post for skin quality parameters such as wrinkles, fine lines and trans-epithelial water loss.

Eligibility criteria: Inclusion Criteria:

Healthy women in the age of 30-65

Able to follow the following dietary restriction for 4 months (4 weeks wash-out, 3 months intervention):

* Do not take omega-3 supplements
* do not take supplements containing vitamin A
* do not take supplements containing collagen
* try to avoid using skin products containing vitamin A
* do not undergo skin treatment

Exclusion Criteria:

Pregnancy or breast feeding known allergy to seafood skin treatment the last 6 months planned skin treatment during the study period

-

Primary outcomes:
measure: Determine the change in skin quality of healthy women after supplementation with fish oil compared to corn oil
timeFrame: 3 months
Secondary outcomes:
measure: Determine the change in omega-3 index (%EPA and DHA in red blood cells) after daily intake of 4g of north atlantic fish oil compared to placebo
timeFrame: 3 months
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Møreforsking AS
Study officials:
affiliation: Møreforsking AS
name: Lisa Midtbø, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007240: Antibacterial Properties of Silicon Incorporated With Quaternary Ammonium Polyethylenimine Nanoparticles
Official title: Clinical Study of the Antibacterial Properties of the Nano Particles Which Incorporated With the Soft Liner Silicone - in Obturators
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Carcinoma of Head and Neck
Keywords: head and neck carcinoma
obturators
maxillectomy
soft liner
nano particles
antibacterial properties
patients post maxillectomy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the antibacterial activity of crosslinked quaternary ammonium polyethylenimine (PEI) nanoparticles incorporated at 1-2% w/w in a commercial soft liner material when compared to the commercial soft liner material.

The investigators' results in vitro showed a significant delay in bacterial growth.

Therefore, the investigators assume to have the same delay in vivo- on patients.


Eligibility criteria: Inclusion Criteria:

* patients post maxillectomy, who are using obturators

Exclusion Criteria:

* patients who are not using obturators

Primary outcomes:
measure: bacterial growth
timeFrame: a week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: lecturer, department of maxillofacial rehabilitation, hadassah medical organiztion
name: anat b sharon, DMD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05111340: Securing the Immediate Perioperative Walk: Creating and Validating a Score.
Official title: Securing the Immediate Perioperative Walk: Creating and Validating a Score.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wandering Behavior
Anesthesia
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-11-08
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to set up a pre and postoperative ambulation score on a population of adult patients and undergoing outpatient surgery operated under locoregional anesthesia and sedation.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years-old
* Patient undergoing sedation with or without associated local anesthesia
* Patient having giver their consent
* Patient are benefiting from a social protection insurance
* Patient hospitalized as part of the outpatient for ophthalmologic surgery or upper limb surgery, plastic surgery or surgery for implantation of a vascular access device

Exclusion Criteria:

* Patient whose surgery is performed on the lower limbs
* Patient with psychiatric disorders
* Patient with dementia
* Patient who has already participated in this same study (ex: cataract the second eye is made a few weeks after the first)
* Patient's refusal to participate in the study
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.

Primary outcomes:
measure: The validity of the perioperative walk score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Arras
country: France
facility: Hôpital privé Arras les Bonnettes
Study officials:
References:
Clinical trial NCT01832740: Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Younger, Healthy Subjects
Official title: Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Younger, Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: young healthy subjects
brain stimulation
tSOS
tDCS
sleep
memory
memory consolidation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. In this study we investigate if the consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during nocturnal SWS.


Eligibility criteria: Inclusion Criteria:

* healthy Subjects
* unobtrusive, neuropsychological screening
* age: 18-35 years
* right handed

Exclusion Criteria:

* untreated severe internal or psychiatric diseases
* epilepsy
* other severe neurological diseases eg., previous major stroke, brain tumour
* contraindications to MRI

Primary outcomes:
measure: Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
timeFrame: 4 weeks
Secondary outcomes:
measure: 1. Amount of Slow wave Sleep
timeFrame: 4 weeks
measure: 2. sleep spindels
timeFrame: 4 weeks
measure: 3. EEG-correlates
timeFrame: 4 weeks
measure: 4. further memory systems
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite CCM Neurologie Berlin
Study officials:
affiliation: Charite Universitätsmedizin Berlin - Neurologie
name: Agnes Flöel, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.
citation: Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.