louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04547426: Effects of Snuff and/or Red Wine om Metabolic Rate
Official title: Metabolic Effects of Snuff and Red Wine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Rate
Hunger
Insulin Sensitivity
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: About 14 healthy participants, consume a standardized breakfast combined with either using regular or nicotine-free moist snuff. The metabolic rate is measured every hour for four hours on each occasion starting in the morning. Participants are also randomized to get red wine or non-alcoholic red wine to the meal.

Detailed description: About 14 healthy participants, consume a standardized breakfast combined with either using regular or nicotine-free moist snuff. The metabolic rate is measured measured before the meal and then every hour for a total of four hours on each occasion that starts in the morning. Participants are also randomized to get red wine or non-alcoholic red wine to the meal. Since there are four possible combinations of the wine and the snuff, all participants do the test on four occasions. Except for metabolic rate we will also analyze hormone responses regarding appetite or hunger.

Eligibility criteria: Inclusion Criteria: No significant disease -

Exclusion Criteria: known illnesses, thyroid disease, need to take prednisolone, psychiatric disease,inability to understand Swedish

-

Primary outcomes:
measure: level of metabolic rate
timeFrame: 4 hours
Secondary outcomes:
measure: sense of appetite
timeFrame: 4 hours
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Faculty of Medicine and Health Sciences
state: Sverige
Study officials:
References:
Clinical trial NCT02971826: Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke
Official title: Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
thrombectomy
REVIVETM SE
MRI
Computed Tomography
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 15
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 last marketed thrombectomy devices, named stentretriever, permit a better and faster recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is not widely use in Europe and in France. The objective of this study is to assess the interest of using this device in the standard care of ischemic stroke in the radiology unit of the hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be collected in order to determine whether or not this device is useful for the practice of the radiology unit.


Eligibility criteria: Inclusion Criteria:

* Patient with an ischemic stroke detected by Computed Tomography (CT) or Magnetic Resonance Image (MRI)
* Large proximal arterial occlusion : M1 segment of the Middle cerebral artery (MCA), Internal Carotid Artery (ICA) or Basilar Artery (BA)
* Last known well (without neurological symptoms) ≤ 8 hours of treatment initiation
* Score NIHSS ≥4
* Eligibility on an endovascular procedure using REVIVETM SE device
* No opposition of the patient to participate at the study

Exclusion Criteria:

* Diagnostic cerebral imaging impossible
* Distal occlusion
* Tortuous vessel or other specificity preventing the access of device
* Vessel diameter \< 1.5 mm
* Known hypersensibility or allergy to nitinol
* Subjects not covered by or having the right to social security
* Deprivation of civil rights (guardianship, safeguard justice)

Primary outcomes:
measure: number of patients with a TICI score of 2b or 3 just after the thrombectomy
timeFrame: up to 2 days
Secondary outcomes:
measure: Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)
timeFrame: up to 2 days
measure: Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)
timeFrame: Day 0
measure: Time to obtain the appropriate recanalization (TICI 2b or 3)
timeFrame: At the end of the procedure - Day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Neuroradiology unit
Study officials:
affiliation: Hospices Civils de Lyon
name: Françis TURJMAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03477526: Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation
Official title: Status and Develepment Mental Quality of Life in Lung Fibrosis in Comparison of COPD Inpatients Before and After Pulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis and COPD
Keywords: pulmonary fibrosis
COPD
pulmonary rehabilitation
mental status (anxiety and depression)
quality of life
physical activity
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: Lungenfibrose e.V.
First posted: 2018-03-26
Enrollment: 1
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: As the result of our last study "Long Term effects of an Inpatient Pulmonary Program in Patients with Pulmonary Fibrosis" already demonstrated the positive effects of a Pulmonary Rehabiliation on the mental status. In this current study the aim will be to analyse the personality type regarding anxiety and depression


Eligibility criteria: Inclusion Criteria:

* COPD GOLD III-IV
* IPF according Pulmonary Guidelines

Exclusion Criteria:

\< 30% FVC comorbidities with a negativ influence on the prognosis neurological and orthopaedic deficits, which make the participation of the pulmonary rehabilitation impossible non-compliance no written informed consent of the patient

Primary outcomes:
measure: Anxiety score
timeFrame: 3 weeks
Secondary outcomes:
measure: Anxiety score
timeFrame: 3 months
Other outcomes:
Locations:
city: Schönau a.Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
Study officials:
References:
Clinical trial NCT04065126: Physical Activity Intervention for Trauma Afflicted Refugees
Official title: Physical Activity Intervention for Trauma Afflicted Refugees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Depression, Anxiety
Physical Activity
Keywords: Mental health
Physical activity
Lead sponsor: Swedish Red Cross University College
Sponsor class: OTHER
Collaborators: name: Swedish Red Cross
First posted: 2019-08-22
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of a 10-session physical activity intervention for trauma afflicted refugees. Half of participants will receive this 10-session physical activity intervention and half of the participants will be allocated to the control group.

Detailed description: Physical activity, particularly when performed in social settings, has been found to constitute an effective stress reliever and has been associated with improved physical and mental well-being, functional capacity and overall life satisfaction, as well as decreased risk of lifestyle diseases in various populations. Physical activity can also revert symptoms of psychiatric disorders such as depression, anxiety, social isolation and dissociation, which is common among trauma afflicted refugees. Many refugees also suffer from PTSD, and so the investigator's aim is to evaluate what effect a 10-session physical activity intervention will have on the mental and physical health of trauma afflicted refugees in a northern European country. The sessions will include physical exercise as well as psychoeducational components, and will be held by a physiotherapist over a period of ten weeks. The physical activity intervention group will be compared to a control-group, who receives two brief lectures on psycho-education in connection to baseline-assessment and follow-up.

Eligibility criteria: Inclusion Criteria:

* Arabic/Persian speaking persons.
* Persons with refugee background referred to the Swedish Red Cross Treatment Center for trauma related to war and/or torture.
* Person able to undertake physical activity in a group setting.

Exclusion Criteria:

* Current serious suicidal ideation, psychosis, serious cognitive impairments, current substance abuse, acute physical injuries or other health conditions that constrain physical activity.

Primary outcomes:
measure: Change in symptoms of PTSD
timeFrame: Baseline, 10 weeks, and six months
Secondary outcomes:
measure: Emotional distress
timeFrame: Baseline, 10 weeks, and six months
measure: Subjective well-being
timeFrame: Baseline, 10 weeks, and six months
measure: Health related quality of life
timeFrame: Baseline, 10 weeks, and six months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: The Swedish Red Cross Treatment Center for Persons affected by War and Torture (SRCTC)
Study officials:
affiliation: Swedish Red Cross University College
name: Fredrik Saboonchi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830426: Circulating Tumor Cells in Non-Small Cell Lung Carcinoma
Official title: Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Lung Cancer
Lead sponsor: Epic Sciences
Sponsor class: INDUSTRY
Collaborators: name: Yale University
name: Billings Clinic
name: University of California, San Diego
name: National Cancer Institute (NCI)
First posted: 2013-04-12
Enrollment: 232
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A primary lung cancer bearing population will be studied. Eligible patients will include those presenting to the specified clinical centers with a tissue confirmed primary lung cancer or radiographic abnormality deemed highly suspicious for primary lung cancer by collaborating clinical team, in whom definitive tissue diagnosis is planned. All stages of primary lung cancer will considered.

Brief summary: The purpose of this study is to establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer. This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.


Eligibility criteria: Inclusion Criteria:

* Suspected lung cancer
* Planned to undergo tissue biopsy. Tissue biopsy does not need to be limited to an intrathoracic structures. Biopsies of the supraclavicular lymph nodes are allowed
* Age \>18

Exclusion Criteria:

* Patients with history of a separate (not a primary lung cancer) malignancy within past two years.
* Recent history (past two weeks) of trauma (INCLUDING diagnostic surgery, biopsy, etc)
* Prior lung cancer treatment chemotherapy, radiation, surgery, etc. in past two years.
* Inability to provide informed consent.
* Hgb less than 8.

Primary outcomes:
measure: CTC Enumeration
timeFrame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
Secondary outcomes:
measure: Lung Cancer Subtyping
timeFrame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
measure: Nodal Staging
timeFrame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
measure: Establish the Prognostic Value by measuring CTC count over time.
timeFrame: Baseline, 3 months, 24 months and 66 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores Cancer Center
state: California
city: New haven
country: United States
facility: Yale University
state: Connecticut
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
Study officials:
affiliation: Epic Sciences
name: Ryan Dittamore, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01073826: Role of Interleukin-6 in Exercise
Official title: A Lifestyle Intervention Study Investigating the Role of Interleukin-6 in the Beneficial Effect of Exercise on Beta-cell Function in Obese People and Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: European Foundation for the Study of Diabetes
First posted: 2010-02-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to understand the role of interleukin-6 during physical activity in patients with type 2 diabetes.


Eligibility criteria: Inclusion criteria:

* Obesity group: BMI 30-40 kg/m2, fasting plasma glucose \<6.4 mmol/l.
* Diabetes group: Type 2 diabetes according to American Diabetes Association criteria

Exclusion criteria:

* Anti-diabetic drug other than metformin
* Diabetes duration of more than 5 years
* Inflammatory diseases
* Current infection
* Liver disease (transaminases \>2x upper normal range)
* kidney disease (creatinine \>1.5 mg/dl for men and 1.4 mg/dl for women)
* pregnancy or breast-feeding, women of child bearing potential not using an acceptable form of contraception
* immunosuppressive disease
* corticosteroid use
* regular non-steroidal antinflammatory drug usage
* history of carcinoma
* history of tuberculosis
* anemia, bleeding disorders
* obstructive pulmonary disease.

Primary outcomes:
measure: Glucagon like peptide- 1 (GLP-1)
timeFrame: Change in GLP-1 secretion compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Ellingsgaard H, Seelig E, Timper K, Coslovsky M, Soederlund L, Lyngbaek MP, Wewer Albrechtsen NJ, Schmidt-Trucksass A, Hanssen H, Frey WO, Karstoft K, Pedersen BK, Boni-Schnetzler M, Donath MY. GLP-1 secretion is regulated by IL-6 signalling: a randomised, placebo-controlled study. Diabetologia. 2020 Feb;63(2):362-373. doi: 10.1007/s00125-019-05045-y. Epub 2019 Dec 3.
Clinical trial NCT02152826: Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity
Official title: A Clinical Study Comparing the Safety and Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Existing Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Sensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent to participate in the study
* Be at least 18 years of age
* Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
* Agree to refrain from participating in any other oral/dental product studies for the duration of the study
* Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
* Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
* Agree to comply with study/product usage instructions; and
* Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria:

* Gross oral neglect or urgent dental treatment needs
* Severe periodontal disease and/or generalized mobility
* Active treatment for periodontitis
* Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
* Self-reported pregnancy or nursing

Primary outcomes:
measure: Change From Baseline for Air Challenge
timeFrame: 36 days
Secondary outcomes:
measure: Change From Baseline in Dentin Sensitivity
timeFrame: 36 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Dental Medicine
name: Athena Papas, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02603926: Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone
Official title: Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fragile X-associated Tremor/Ataxia Syndrome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).

Detailed description: This study includes a screening visit with several assessments, followed by an open-label medication trial of Allopregnanolone for 12 weeks and an end-point evaluation to assess for changes. Assessments include blood draws for genetic and safety laboratory testing, neurological and physical exam and medical history, cognitive testing, and motor testing.

Study record was updated in October 2018 to include adverse events and outcome measure reporting. Study record was updated in November 2018 in response to requests to (1) specify time frame of reported outcome measures, (2) clarify that the RASS was a safety monitoring tool, not a prespecified outcome measure, and as such will not be reported as an outcome measure, and (3) upload a version of the study protocol and statistical analysis plan with the required title page and statistical analysis plan information.

Eligibility criteria: Inclusion Criteria

* Fragile X premutation carrier status (55 to 200 CGG repeats in FMR1),
* Diagnosis of FXTAS including an intention tremor and/or ataxia and/or deficits on the BDS-2 demonstrating executive function deficits.

Exclusion Criteria

* other genetic problems in addition to the premutation
* a history of significant brain trauma
* significant substance abuse
* inability to follow the protocol
* liver or kidney disease
* heart failure
* active cancer
* other serious systemic disease
* current use of phenytoin

Primary outcomes:
measure: California Verbal Learning Test II (CVLT2) Trial 1-5 Free Recall Total Raw Score
timeFrame: Baseline/pre-treatment and 14 weeks/post-treatment
Secondary outcomes:
measure: Behavioral Dyscontrol Scale - 2 (BDS-2) Total Score
timeFrame: Baseline/pre-treatment and 14 weeks/post-treatment
measure: CATSYS Dot-to-Dot Tremor Intensity (CATSYS DTD TI)
timeFrame: Baseline/pre-treatment and 14 weeks/post-treatment
measure: Hippocampal Volume, as Measured by Structural MRI
timeFrame: Baseline/pre-treatment and 14 weeks/post-treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
Study officials:
affiliation: UC Davis MIND Institute
name: Randi J Hagerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06082726: The Systemic Concentration of Short-Chain Fatty Acids After Delivery in the Small and Large Intestine of Healthy Volunteers
Official title: The Systemic Availability of Short-Chain Fatty Acids After Delivery in the Small Intestine and the Colon
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Availability
Intestinal Absorption
Metabolism
Short-chain Fatty Acids
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this crossover study is to evaluate the systemic availability of short-chain fatty acids (SCFA) that are either administered in the small intestine or the colon in healthy volunteers. The main question it aims to answer is whether the site of administration affects the amount of SCFA that reaches the systemic circulation. On two test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. After ingestion, blood samples will be collected at regular time points.


Eligibility criteria: Inclusion Criteria:

* female and male
* healthy participants
* age within 18 - 50 years
* normal BMI (18.5-25 kg/m\^2)

Exclusion Criteria:

* Chronic gastrointestinal disorders such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, chronic constipation (less than 3 stools a week) and chronic frequent diarrhoea (more than 3 stools a day)
* Previous abdominal surgery, except from appendectomy
* Being on a weight loss, gluten-free, lactose-free, or vegan diet
* The donation of blood during the last 3 months or suffering from low blood haemoglobin levels
* The use of antibiotics or other medication that affects the gastrointestinal tract 3 months preceding the study and/or during the study
* The use of prebiotics or probiotics 2 weeks preceding the study and/or during the study
* Pregnancy, lactation or wish to become pregnant during the study period
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)

Primary outcomes:
measure: Concentration of 13C-short-chain fatty acids in blood
timeFrame: up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References: