louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02379312: Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams
Official title: Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety
Appetite
Keywords: Foams
Satiety
Appetite
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Eurofins Optimed
First posted: 2015-03-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very low energy aerated beverage with normal energy aerated beverages in healthy subjects.

Detailed description: The primary objective of this study is to assess if a very low energy foam has the same effect on satiety as the same volume of a reference normal energy foam, by testing for equivalence of these two foams. Treatment equivalence, is met if the 90% confidence interval (CI) of between-treatment differences in appetite AUC is within the range of -5 to +5 mm/min of the reference . Two other normal energy foams with slightly different compositions are also compared to the reference foam to test for possible effects of differences in composition (carbohydrate type, emulsifier) other than energy per se.

On each test day, volunteers will arrive at the clinic in a fasted state where they consume a standardized 250 kcal breakfast. Subjects receive one of the four test products 2.5 hours after start of breakfast and consume 400 ml of the test products with a spoon within 10 minutes. Each subject will be randomized to a treatment order according to a balanced (Williams type) design, and receive one of four test products each week for 4 weeks, separated by a one-week washout period (consumed on the same week day).

Eligibility criteria: Inclusion Criteria:

* BMI between 20 and 30 kg/m² (inclusive)
* Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).

Exclusion Criteria:

* Dislike, allergy or intolerance to test products
* Eating disorder (measured by SCOFF questionnaire, \> 2 "yes" responses)
* High or very high restrained eater measured by Three factor eating questionnaire TFEQ, restriction score \> 14
* Reported medical treatment that may affect eating habits/satiety

Primary outcomes:
measure: Hunger and satiety questions
timeFrame: Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min
Secondary outcomes:
measure: Electronic Visual Analogue Scale (EVAS) for liking questions
timeFrame: Time point 15 min
Other outcomes:
Locations:
Study officials:
affiliation: Eurofins Optimed
name: Isabelle Blanc, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06257212: Live Vaccines and Innate Immune Training in COPD.
Official title: Using Live Vaccines to Induce Beneficial Innate Immune Training and Reduce Systemic Inflammation in COPD Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Trained Innate Immunity
COPD
Lead sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex.
Primary purpose: TREATMENT

Brief summary: A randomized, single-blinded clinical pilot study to assess whether vaccination with live attenuated vaccines can induce trained immunity and cause beneficial changes in patients with COPD.

Detailed description: Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex. A total of 60 participants will be recruited and randomly assigned with 20 in each treatment arm. Separated by three months, the participants will receive two doses of one of the following three treatments:

1. MMR vaccine (M-M-R VaxPro)
2. BCG vaccine (Danish strain 1331)
3. Saline (placebo)

Eligibility criteria: Inclusion Criteria:

* Specialist verified and spirometry-confirmed COPD
* Age \> 40 years.
* Negative HIV-test.
* Able to give informed consent.

Exclusion Criteria:

* Acute febrile illness.
* Known allergy to BCG or MMR vaccines or serious adverse effects at previous vaccination.
* Allergy to MMR vaccine components, neomycin, or egg proteins.
* Known prior, active, or latent infection with mycobacterium tuberculosis.
* Pregnancy or breastfeeding.
* Vaccination with a live vaccine within the last 4 weeks.
* Being severely immunocompromised (HIV-1 infection, organ- or bone marrow transplantation, chemotherapy, primary immune defect, anti-cytokine therapy, immunosuppressant treatment).
* Oral or intravenous corticosteroid at dose of ≥10 mg/day with duration over 3 months.
* Active solid or non-solid malignancy or lymphoma, excluding basal cell carcinoma within 2 years.
* Treatment with immunoglobulins within the last 3 months or expected treatment with immunoglobulins for the duration of the trial.

Primary outcomes:
measure: Innate immune training.
timeFrame: From inclusion to 4 months post-inclusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Internal Medicine, Section of Respiratory Medicine
state: Copenhagen
Study officials:
affiliation: Herlev Gentofte Hospital
name: Jens-Ulrik Stæhr S Jensen, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304212: Effectiveness of Analgesia in Total Knee Arthroplasty
Official title: Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: total knee arthroplasty
intraarticular infiltration
femoral block
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 137
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the performance multimodal postoperative pain KA combining two analgesic techniques to obtain better analgesia than when applied separately.


Eligibility criteria: Inclusion Criteria:

* intervention program for total knee arthroplasty
* ASA I, II, III
* over 65 years old

Exclusion Criteria:

* ASA \> III
* patients who refuse the realization of technical loco-regional anesthesia
* presence of coagulopathy or impaired hemostatic function
* BMI \> 35
* Serious intraoperative complications
* patients undergoing bypass and aortic-femoral or femoro popliteal bypass operated leg
* patients treated for chronic pain diagnosed processes, different knee osteoarthritis

Primary outcomes:
measure: postoperative pain
timeFrame: 48 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: José Antonio Bernia Gil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02771912: Patient-controlled Sedation With Propofol During Cataract Surgery Under Topical Anesthesia
Official title: Randomised Study of Propofol Versus Placebo for Sedation During Cataract Surgery Under Topical Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-05-13
Enrollment: 60
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: Controversies exist about the use of propofol in sedation of patients for cataract surgery. This prospective randomised double-blind study evaluates the efficacy of patient-controlled sedation compared with placebo using the same device.


Eligibility criteria: Inclusion Criteria:

* Patients should be operated of cataract under topical anesthesia

Exclusion Criteria:

* Contra-indication to sedation
* Complicated cataract
* Hypersensitivity to propofol, known or suspected hypersensitivity to egg phospholipid, soybean or peanut protein
* State of acute shock, severe dyslipidemia, severe liver failure, serious bleeding disorders
* Comprehension and language impairment
* Written and signed informed consent by the patient to participate in the study

Primary outcomes:
measure: Number of self administered bolus
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT04391712: Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Official title: Multiwave Locked System (MLS) Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID
Laser
Pulmonary
Lead sponsor: Lowell General Hospital
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will utilize a randomized parallel assignment
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.

Detailed description: Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.

Eligibility criteria: Inclusion Criteria:

* COVID-19 positive
* Pulmonary compromise requiring oxygen support of approximately 2-6 liters
* Able to self prone, or support in self-sitting position

Exclusion Criteria:

* Ventilator management
* Patients with autoimmune disorders or inflammatory conditions not related to COVID-19
* Pregnant women

Primary outcomes:
measure: Patient Disposition Post treatment
timeFrame: 7 days
measure: oxygenation
timeFrame: Daily for 4 days
measure: IL-6 levels
timeFrame: First four days of trial
measure: Chest Xray radiographic results
timeFrame: 7 Days
measure: Brescia-COVID Respiratory Severity Scale
timeFrame: 7 days
measure: SMART-COP Score
timeFrame: 7 days
measure: PSI Score
timeFrame: 7 days
measure: CRP levels
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lowell
country: United States
facility: Lowell General Hospital
state: Massachusetts
Study officials:
affiliation: Lowell General Hospital
name: Scott Sigman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06742112: The 6-minute Pegboard and Ring Test in Overweight and Obese Individuals
Official title: Validity and Reliability of the 6-minute Pegboard and Ring Test in Assessing Upper Extremity Function in Overweight and Obese Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overweight or Obese Adults
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese individuals will be included in the study.

Brief summary: The aim of our study is to investigate the validity and reliability of the 6-minute pegboard and ring test in overweight and obese individuals.


Eligibility criteria: Inclusion Criteria:

* Body mass index ≥ 25 kg/m2
* Volunteering for the study

Exclusion Criteria:

* Having uncontrolled hypertension, diabetes mellitus
* Having comorbidities that may affect physical functions
* Failure to cooperate with tests to be performed
* Liver disease, kidney disease, cancer, lung diseases and serious cardiomyopathies, neurological diseases
* Pregnancy
* Having a history of bariatric surgery
* Presence of contraindications to exercise testing

Primary outcomes:
measure: Arm exercise capacity
timeFrame: 1st day
measure: Exercise capacity
timeFrame: 1st day
measure: Hand grip strength
timeFrame: 1st day
measure: Muscle endurance
timeFrame: 1st day
Secondary outcomes:
measure: Upper extremity functional status
timeFrame: 1st day
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
References:
Clinical trial NCT00914212: A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)
Official title: A Functional Magnetic Resonance Imaging (fMRI) Study of the Reproducibility and the Effect of Sibutramine During Fasted and Fed Conditions in Healthy Overweight and Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by sibutramine.


Eligibility criteria: Inclusion Criteria:

* Subject is a male between 18 and 45 years of age
* Subject has a body mass index (BMI) between 28 and 35 kg/m\^2
* Subject does not weigh more than 140 kg (309 lbs) at the screening visit
* Subject is right-handed
* Subject is a non-smoker
* Subject is in generally good health
* Subject has normal or corrected to normal vision

Exclusion Criteria:

* Subject works a night shift within 3 days of each treatment visit
* Subject has permanent cosmetic or metallic objects in his body
* Subject has attention deficit hyperactivity disorder (ADHD)
* Subject has or had sleep apnea
* Subject has a history of neurological disorders
* Subject has a history of any clinically significant disease or condition
* Subject is vegan or vegetarian
* Subject has a history of eating disorders
* Subject has had previous bariatric surgery

Primary outcomes:
measure: Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI)
timeFrame: Day 1
Secondary outcomes:
measure: Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs
timeFrame: Day 1
measure: Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs
timeFrame: Day 1
measure: AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs
timeFrame: Day 1
measure: Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs
timeFrame: Day 1
measure: rCBF during the fed condition with placebo or sibutramine in the six ROIs
timeFrame: Day 1
measure: Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs
timeFrame: Day 1
measure: Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01863212: The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects
Official title: Investigating the Role of the FTO Gene in Reward System Activation During Visual Presentation of Food Images With fMRI Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Eating Behavior
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In order to investigate if individuals, carrying genetic variants predisposing to obesity, respond differently to visual presented food images than non-carriers the investigators aim to screen 500 people for a common risk variant in the FTO gene. From those 500 screened 40 subjects, 20 homozygous for the risk allele and 20 homozygous for a non risk allele will be selected for the second step in the study. This part involves the fMRI technique to visualize the brain response, focus on reward system activation, when food images are visually presented in the scanner. Factors regarding eating behavior, sleep, physical exercise and relation to food are investigated in the first part of the study as well as clinical parameters such as BMI.


Eligibility criteria: Inclusion Criteria:

* No medications (except contraceptives including estrogen)
* No metabolic disorders/diseases
* Right handed
* Color vision
* Normal sleep-wake rhythm (eg. shift workers can not participate)

Exclusion Criteria:

* Specific preferences of food, for example vegetarians
* Grandparents originating from country outside the Nordic area
* Metallic implants

Primary outcomes:
measure: Genotyping for variants in the FTO gene associated with overweight and obesity
timeFrame: Blood sampling for genetic analyse is performed at the initiation visit
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
state: Uppsala County
city: Uppsala
country: Sweden
facility: dep. Neuroscience, Uppsala University
state: Uppsala County
Study officials:
affiliation: dep. Neuroscience, Uppsala University
name: Christian Benedict, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiemerslage L, Islam R, van der Kamp C, Cao H, Olivo G, Ence-Eriksson F, Castillo S, Larsen AL, Bandstein M, Dahlberg LS, Perland E, Gustavsson V, Nilsson J, Vogel H, Schurmann A, Larsson EM, Rask-Andersen M, Benedict C, Schioth HB. A DNA methylation site within the KLF13 gene is associated with orexigenic processes based on neural responses and ghrelin levels. Int J Obes (Lond). 2017 Jun;41(6):990-994. doi: 10.1038/ijo.2017.43. Epub 2017 Feb 14.
Clinical trial NCT02437812: Study of Paclitaxel, Carboplatin and Oral Metformin in the Treatment of Advanced Stage Ovarian Carcinoma
Official title: A Phase II, Open-Label, Non-Randomized, Pilot Study of Paclitaxel, Carboplatin and Oral Metformin for Patients Newly Diagnosed With Stage II-IV Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epithelial Ovarian Carcinoma
Lead sponsor: Gynecologic Oncology Associates
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2015-05-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Initially, the prospect of metformin as a neoplastic treatment was considered for malignancies of the prostate, colon and pancreas. However, only select clinical studies involving the use of metformin in the treatment of ovarian cancer have documented improved survival rates. Since no first line regimen has demonstrated compelling superiority in the management of advanced stage ovarian carcinoma, the combination of paclitaxel, carboplatin, and metformin is of particular interest given the triplet's prospect for achieving increased synergy without compromising patient tolerability.

Detailed description: A phase II, open-label, non-randomized, pilot study assessing the safety, toxicity, and progression free survival of advanced stage ovarian carcinoma patients who underwent treatment with paclitaxel, carboplatin and metformin. An estimated 30 patients will be required for this study.

Eligibility criteria: Inclusion Criteria:

Female Gender

Age greater than 18 years

Advanced stage epithelial ovarian, fallopian tube, or primary peritoneal cancer

Adequate bone marrow function

ECOG performance score of 2 or greater

Patients must be able to swallow oral medication.

Exclusion Criteria:

Subjects must NOT be taking metformin or have been on metformin in the past 6 months.

Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas)

Subjects with concomitant malignancy or a previous malignancy within the past three years, melanoma skin cancer excepted

Primary outcomes:
measure: Progression free survival
timeFrame: 5 years
Secondary outcomes:
measure: Metabolic biomarker evaluation
timeFrame: 3 months
measure: Metabolic biomarker evaluation
timeFrame: 3 months
measure: Metabolic biomarker evaluation
timeFrame: 3 months
measure: Metabolic biomarker evaluation
timeFrame: 3 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
Study officials:
affiliation: Gynecologic Oncology Associates
name: Lisa N Abaid, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: