louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00862017: Effect of Monosodium Glutamate Supplementation on Gastric Emptying and Postprandial Nitrogen Kinetics
Official title: Effect of Monosodium Glutamate on Gastric Emptying and Postprandial Nitrogen in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Physiology
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: AgroParisTech
First posted: 2009-03-16
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: There are receptors to free glutamate in the oral cavity and stomach that may mediate effects of this amino acid on gastrointestinal physiology. The investigators hypothesize that a chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the further metabolism of dietary protein in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* BMI 23 to 28

Exclusion Criteria:

* pregnancy
* allergy to milk protein
* gastrointestinal diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Centre de recherche sur volontaires
Study officials:
References:
citation: Boutry C, Matsumoto H, Airinei G, Benamouzig R, Tome D, Blachier F, Bos C. Monosodium glutamate raises antral distension and plasma amino acid after a standard meal in humans. Am J Physiol Gastrointest Liver Physiol. 2011 Jan;300(1):G137-45. doi: 10.1152/ajpgi.00299.2010. Epub 2010 Oct 28.
Clinical trial NCT06514417: External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries
Official title: Efficacy of Ultrasound - Guided External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Ayman Ahmed Rady
name: Ahmed Mohamed Helwa
First posted: 2024-07-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Ithe study will evaluate the analgesic efficacy of external oblique intercostal block for patients undergoing upper abdominal surgeries

Detailed description: Patients will be randomly divided into two equal groups using SPSS. Group A: will receive US-guided external oblique intercostal block after induction Group B: will receive postoperative morphine on patient request. Study design: prospective controlled randomized study.

Eligibility criteria: Inclusion Criteria:

* Selected patients will be more than 21 years old with ASA physical status I \& II scheduled for upper abdominal surgeries

Exclusion Criteria:

Uncooperative patients.

* Patients who have allergy to any of the used drugs.
* Patients who are on opioids.
* Known abuse of alcohol or medication.
* Local infection at the site of injection or systemic infection.
* Pregnancy
* Patients with coagulation disorders or on anticoagulation therapy

Primary outcomes:
measure: Visual analogue pain scale .
timeFrame: 24 hours
Secondary outcomes:
measure: total perioperative analgesics requirements
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menoufia university
state: Shibin Elkom
Study officials:
References:
Clinical trial NCT05850117: Efficacies of Tetracycline-levofloxacin, Standard Bismuth, Amoxicillin-levofloxacin Quadruple Therapy for H.p
Official title: Efficacies of Tetracycline-levofloxacin Quadruple Therapy, Standard Bismuth Quadruple Therapy and Amoxicillin-levofloxacin Quadruple Therapy in the Second-line Treatment of H Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Eradication
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1.Tetracycline combined with levofloxacin quadruple therapy 2. standard tincture quadruple therapy 2. amoxicillin combined with levofloxacin quadruple therapy
Primary purpose: TREATMENT

Brief summary: 1. Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization.
2. To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.

Detailed description: The "standard tincture quadruple therapy" and the "proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy" recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a "Tetracycline combined with levofloxacin quadruple therapy" for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (\> 95%). A randomized controlled trial confirmed that the elimination rate of "Tetracycline combined with levofloxacin quadruple therapy" was better than "proton pump inhibitor combined with fluoroquinolone" after "standard triple therapy" and "non-tank tetratherapy" sterilization failure. Triple therapy with amoxicillin.

Eligibility criteria: Inclusion Criteria:

1. at least 20 years old
2. subject was failure for the first line therapy of Helicobacter pylori

Exclusion Criteria:

1. Those who are allergic to the drugs used in this study
2. Those who have had a stomach surgery
3. Those who have antibiotics within four weeks of treatment
4. Those who have severe cirrhosis, uremia or malignancy
5. Those who are a pregnant woman or a woman who breastfeeds

Primary outcomes:
measure: the rate of Helicobacter pylori
timeFrame: 6 week after finish study drugs
Secondary outcomes:
measure: genotype analysis
timeFrame: 2 weeks after finishing study drgus
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
Clinical trial NCT00927017: The Effect of Liquorice on Plasma Potassium
Official title: Lakritsin Vaikutus Kaliumpitoisuuteen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2009-06-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The hypothesis is that liquorice lowers plasma potassium. This study aims to elucidate the dose-response of this effect with two doses of liquorice (66 grams or 102 grams) per day for two weeks.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* age 18-40

Exclusion Criteria:

* any continuous medication
* hypertension or hypotension
* allergy to liquorice
* pregnancy or lactation
* difficult venipuncture
* drug or alcohol abuse
* participation in pharmaceutical trial

Primary outcomes:
measure: Change in plasma potassium
timeFrame: 1 week, 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital, Department of Internal Medicine
name: Janne Hukkanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02662517: Growth Hormones and Cells in Human Milk Depending on Gestational Age
Official title: Growth Hormones and Cells in Human Milk Depending on Gestational Age and Lactation Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactation
Keywords: Neurotrophins
Stem Cells
Prematurity
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breastfeeding mothers

Brief summary: Human breast milk contains growth factors including neurotrophins and cells with neuroprotective potential. Concerning growth factors milk of preterms differs significantly from term milk. The aim of this study is to give a profile of human milk concerning non-nutritive factors depending on gestational age and lactation phase.

Detailed description: Neurotrophins (epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF)) as well as amount of cells, especially positive for sex-determining transformer protein (TRA)-1-81 and stage-specific embryonic antigen (SSEA)-4, are planned to be quantified in human breast milk of extremely preterm newborns as well as term newborns at different stages of lactation.

Eligibility criteria: Inclusion Criteria:

* the newborn infant is being fed with own mothers milk

Exclusion Criteria:

* low amount of breast milk

Primary outcomes:
measure: neurotrophins composition
timeFrame: day 7
Secondary outcomes:
measure: Amount of cells positive for surface markers TRA-1-81 and SSEA-4
timeFrame: day 7
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Neonatology at the University Hospital of Cologne
Study officials:
affiliation: Neonatology, University Hospital of Cologne
name: Titus Keller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keller T, Wengenroth L, Smorra D, Probst K, Kurian L, Kribs A, Brachvogel B. Novel DRAQ5/SYTOX(R) Blue Based Flow Cytometric Strategy to Identify and Characterize Stem Cells in Human Breast Milk. Cytometry B Clin Cytom. 2019 Nov;96(6):480-489. doi: 10.1002/cyto.b.21748. Epub 2018 Nov 26.
Clinical trial NCT06939517: Acupressure Wristbands for GLP-1RA Related Nausea
Official title: Antiemetic Effect of Acupressure Wristbands for GLP-1RA Related Nausea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nausea
Keywords: nausea relief
acupressure wristbands
glp-1 medication
obesity
Lead sponsor: Evexia Medical
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective interventional study of four weeks duration evaluating the antiemetic effect of wristbands for nausea related to GLP-1RA medication.
Primary purpose: TREATMENT

Brief summary: Nausea is a common side effect of GLP-1RA medications used for treatment of Type 2 diabetes mellitus and obesity. Current recommendations for nausea relief include the use of dietary changes and prescription anti-emetics. Acupressure wristbands Sea-Band are FDA cleared for nausea relief in other indications such as motion sickness, morning sickness in pregnancy, post-operative nausea, chemotherapy associated nausea. We hypothesized that acupressure wristbands could alleviate nausea in persons taking GLP-1RA.

Detailed description: Nausea is the most commonly reported side effect of the class of drugs collectively known as glucagon like peptide-1 receptor agonists (GLP-1RA). GLP-1RAs are FDA approved to treat Type 2 diabetes mellitus (T2DM) and Obesity. Sea-Band is an FDA-cleared set of drug-free elastic wristbands used for nausea relief in several indications including motion sickness, morning sickness in pregnancy, post-operative nausea, chemotherapy associated nausea in persons ages 3 years old and up. The elastic wristbands have a plastic skin facing knob that apples pressure to an acupressure point called pericardium 6 (P6) located below the crease of the wrist. We hypothesize that Sea-Band can alleviate nausea in persons taking GLP-1RA. Participants on GLP-1RA medication with nausea were offered a set of Acupressure wristbands, and followed for four weeks. Weekly touch points assessed the response to nausea relief of the bands. Eligibility for the study included Adults taking GLP-1RA experiencing nausea.

Eligibility criteria: Inclusion Criteria:

* Adults taking GLp-1RA with nausea

Exclusion Criteria:

* Adults on GLP-1RA without nausea
* Uncontrolled GERD
* Hx of Gastroparesis
* Other nausea related conditions such as vertigo
* History of chronic use of antiemetic medication for other reasons

Primary outcomes:
measure: Nausea relief
timeFrame: Nausea relief with use of wristbands for every recorded episode, reviewed weekly, for a total of four weeks
Secondary outcomes:
measure: Time to onset of relief
timeFrame: Time to nausea relief with use of wristbands for every recorded episode, reviewed weekly, for a total of four weeks
Other outcomes:
Locations:
city: Jupiter
country: United States
facility: Evexia Medical
state: Florida
Study officials:
References:
Clinical trial NCT01359917: Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome
Official title: Psychological Morbidity and Facial Volume in HIV Lipodystrophy:
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-Associated Lipodystrophy Syndrome
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2011-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with HIV facial lipoatrophy

Brief summary: The hypotheses of this study were that:

1. HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression.
2. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or Bio-alcamid, is associated with an improvement in psychological morbidity and anatomical volume of treated areas.
3. The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.

Detailed description: as above

Eligibility criteria: Inclusion Criteria:

* HIV facial lipoatrophy
* concurrent antiretrovirals

Exclusion Criteria:

* known psychological disorder
* skin allergies
* significant medical problems precluding anaesthesia

Primary outcomes:
measure: measurement of 3-D facial volume
timeFrame: 2 years
Secondary outcomes:
measure: psychological outcome
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: NHS Lothian
name: Kenneth J Stewart, FRCSPlast
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson L, Stewart KJ. Psychological morbidity and facial volume in HIV lipodystrophy: quantification of treatment outcome. J Plast Reconstr Aesthet Surg. 2012 Apr;65(4):439-47. doi: 10.1016/j.bjps.2011.11.024. Epub 2011 Dec 5.
Clinical trial NCT01790217: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)
Official title: GERMAN TARCEVA NON-INTERVENTIONAL STUDY in 1st Line Treatment of NSCLC EGFR Mutation Positive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic EGFR mutation positive non-small cell lung cancer

Brief summary: This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer
* Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Progression-free survival rate at 18 months
timeFrame: 3.5 years
Secondary outcomes:
measure: Response rate (complete response/partial response) by type of mutation
timeFrame: 3.5 years
measure: Percentage of patients with remission
timeFrame: 3.5 years
measure: Progression-free survival (overall/stratified)
timeFrame: 3.5 years
measure: Overall survival (overall/stratified)
timeFrame: 3.5 years
measure: Tolerability: Incidence of fatigue, rash, diarrhea
timeFrame: 3.5 years
measure: Safety: Incidence of serious adverse events
timeFrame: 3.5 years
measure: Dose modifications/withdrawals
timeFrame: 3.5 years
measure: Symptom control (cough, dyspnea)
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Oldenburg
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06146517: A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products
Official title: A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Mood
Caffeine Withdrawal
Anxiety
Productivity
Lead sponsor: Clevr Blends
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-24
Enrollment: 32
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Participants will complete questionnaires at Baseline and Week 2, 4, 6, 8, 10, and 12. In addition to data will be collected from participants' sleep tracking devices at Baseline, Week 2, and Week 4.


Eligibility criteria: Inclusion Criteria:

* Female.
* Age 28-42.
* Generally healthy without any uncontrolled or chronic disease.
* Must consume a beverage containing low to moderate amount of caffeine once daily, defined as consuming the caffeine equivalent of less than or equal to one cup of coffee daily.
* Looking for healthier alternatives to caffeine.
* Currently owns a wearable sleep tracking device (e.g. Fitbit, Whoop, Oura etc) and has been wearing consistently for 4 weeks.
* Resident of the USA.

Exclusion Criteria:

* Allergies to any of the ingredients in the three products.
* Anyone with a formal diagnosis of insomnia.
* Any pre-existing or chronic conditions that would prevent participants from adhering to the protocol.
* Women that are pregnant, breastfeeding or attempting to conceive during the duration of the trial.
* Unwilling to follow the protocol.
* Participants that consume more than two caffeinated drinks daily.
* Participants that have little to no caffeine daily, equivalent to less than 1 cup of coffee daily.
* Is not a resident of the USA.

Primary outcomes:
measure: Change in sleep quantity as recorded by wearable sleep tracking device. [Timeframe Baseline to Week 4]
timeFrame: 4 weeks
measure: Changes in scores on the Sleep Quality Scale (SQS). [Timeframe Baseline to Week 4]
timeFrame: 4 weeks
measure: Changes in self-reported energy levels. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in self-reported cognitive function. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in self-reported caffeine side effects,
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT03072641: Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Official title: Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Probiotics
Epigenetics
Microbiota
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: DuPont Nutrition and Health
First posted: 2017-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine if probiotic bacteria have a beneficial effect on the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.


Eligibility criteria: Inclusion Criteria:

* At least one malignant tumor in the colon

Exclusion Criteria:

* Study subjects with adenomas, or
* who received recent antibiotic therapy or
* consumed probiotics regularly were excluded.

Primary outcomes:
measure: Changes in microbiota composition after probiotics use
timeFrame: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor
Secondary outcomes:
measure: Epigenetic changes after probiotics use
timeFrame: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden
name: Yvonne A Wettergren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keane S, Herring M, Rolny P, Wettergren Y, Ejeskar K. Inflammation suppresses DLG2 expression decreasing inflammasome formation. J Cancer Res Clin Oncol. 2022 Sep;148(9):2295-2311. doi: 10.1007/s00432-022-04029-7. Epub 2022 May 2.
citation: Hibberd AA, Lyra A, Ouwehand AC, Rolny P, Lindegren H, Cedgard L, Wettergren Y. Intestinal microbiota is altered in patients with colon cancer and modified by probiotic intervention. BMJ Open Gastroenterol. 2017 Jul 3;4(1):e000145. doi: 10.1136/bmjgast-2017-000145. eCollection 2017.