louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06893991: The Effect of Symbiotic Beverage Consumption on Lipid Profile
Official title: The Effect of Symbiotic Beverage Consumption on Lipid Profile and Nutritional Status in Overweight and Hypercholesterolemia Adults Aged Above 18 Years
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lipid Profile
Fasting Blood Sugar Above Normal
Body Mass Index
Keywords: Symbiotic Beverages
Lipid Profile
Body Mass Index
Lead sponsor: Politeknik Kesehatan Kemenkes Padang
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This trial is a controlled clinical studies conducted to evaluate the effectiveness of the symbiotic drink for improving lipid profiles, blood sugar and nutritional status in participants with hypercholesterolemia or overweight under study and to determine the common short-term side effects and risks.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate whether the synbiotic beverage "Daygurt" can improve lipid profiles, blood sugar levels, blood pressure, and body weight in individuals diagnosed with dyslipidemia. The main questions it aims to answer are:

Does "Daygurt" significantly reduce total cholesterol and LDL levels compared to nutrition counseling alone? Does "Daygurt" increase HDL levels and reduce triglycerides more effectively than nutrition counseling? Does "Daygurt" lead to greater improvements in fasting blood sugar, blood pressure, and body weight compared to nutrition counseling?

The intervention group (receiving "Daygurt" plus nutrition counseling) will be compared to the comparison group (receiving nutrition counseling without "Daygurt") to see if "Daygurt" provides additional benefits beyond standard dietary advice.

Participants will be divided into 2 groups:

Intervention group: Consume "Daygurt" daily for 8 weeks. Comparison group: Receive nutrition counseling sessions focused on managing dyslipidemia but will not consume "Daygurt."

Both groups will undergo health parameter measurements before and after the intervention, including:

Total cholesterol, LDL, HDL, and triglyceride levels. Fasting blood sugar. Blood pressure. Body mass index (BMI).


Eligibility criteria: Inclusion Criteria:

* Cholesterol total above 200 mg/dl, or LDL Cholesterol above 100, or BMI above 25 kg/m2
* Agree to study protocols

Exclusion Criteria:

* Has Allergic to dairy product
* Having any drug lowering cholesterol

Primary outcomes:
measure: Lipid profile
timeFrame: 6 weeks (before and after intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Padang
country: Indonesia
facility: Health Ministry Polytechnic of Padang
state: West Sumatra
Study officials:
References:
Clinical trial NCT00811291: Influence of Vitamin-B-complex on Cognitive Ability of Kindergarten Kids
Official title: SIMBA-Study Investigating Mental Acuity Effects of B-vitamins in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: B-vitamins
Folic-Acid
kindergarten kids
cognitive tests
Healthy kids
second part low urine vitamine-B-metabolites
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: European Union
name: Unilever R&D
First posted: 2008-12-18
Enrollment: 250
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin-B and Folic intake of Kindergarten kids in Germany is only 50-70% of the official recommendations. In studies with adults it has been found that for example providing people suffering from Alzheimer´s disease improved their mental and cognitive abilities when provided with a high intake of these vitamins.The hypothesis is, that kindergarten kids, 4-6 years of age, could also improve mentally from a recommended intake of B-vitamins and Folic Acid.

1. screening study: The urine of 1200 kindergarten kids will be analyzed for metabolites of these vitamins, and the 250 kids with the lowest results will be invited for a randomized double blind intervention study.
2. intervention study: Participating kids will get an one hour mental and cognitive testing before and after the intervention. The intervention will be one portion of the recommended dosage of a vitamin B complex and folic acid , given in a drink (milk, tea, etc). The assumption is, that the treatment group will perform better than the placebo group in the second test phase.


Eligibility criteria: Inclusion Criteria:

* age: 4-6 years
* kindergarten kids in Munich
* fluent in German
* healthy
* no medication

Exclusion Criteria:

* not fluent in German
* chronic illness
* intake of multivitamin supplements

Primary outcomes:
measure: change in outcome of cognitive testing of kindergarten kids after intervention
timeFrame: August 2009
Secondary outcomes:
measure: Analysis of Vitamine-B-metabolites in urine of kindergarten kids via a new method
timeFrame: September 2008-December 2008
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dr. von Hauner Children´s Hospital
Study officials:
affiliation: Dr. von Hauner Children´s Hospital, Ludwig-Maximilians-University, Munich
name: Berthold V Koletzko, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04648891: Spasmodic Dysphonia Pain
Official title: Spasmodic Dysphonia Pain Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Spasmodic Dysphonia
Keywords: Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.

Detailed description: Hypothesis:

The use of local anesthetic or vibrating instrument will decrease overall pain experienced by a patient with spasmodic dysphonia undergoing Botox injections.

Aims, purpose, or objectives:

To identify adjuvant methods to improve patient comfort during in-office laryngology procedures. Results demonstrated here should be transferrable to other transcutaneous in-office procedures in laryngology.

Background:

Spasmodic dysphonia is a vocal disorder characterized by uncontrollable voice breaks. Injection of botulinum neurotoxin into the laryngeal muscles is the mainstay of treatment. Patients require repeated treatments due to the temporary effect of botulinum neurotoxin. Laryngeal injections are commonly performed through the skin of the neck and can be associated with pain and discomfort. Local anesthetic administration prior to laryngeal injection is commonly performed in clinical practice, however its efficacy hasn't been evaluated and a third of surveyed otolaryngologists do not administer local anesthesia prior to the laryngeal injection of botulinum neurotoxin. Vibratory anesthesia involves the application of a local vibratory stimulus and has been found to reduce pain during various needle-related procedures. Vibratory anesthesia has not previous been evaluated for laryngeal injections.

This study will utilize the need for spasmodic dysphonia patients to receive repeated injections to incorporate a crossover design where patients receive three consecutive laryngeal injections of botulinum toxin experiencing injection without additional anesthesia, with local anesthesia, and with vibration anesthesia in a randomized order.

Eligibility criteria: Inclusion Criteria:

* Spasmodic dysphonia with or without tremor
* Receiving botox as treatment via a transcricothyroid approach

Exclusion Criteria:

- Allergy to lidocaine

Primary outcomes:
measure: Pain Experienced
timeFrame: 6 months
Secondary outcomes:
measure: Subject Preference
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: David Lott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00932191: Endothelial Cell Loss After Cataract Surgery
Official title: Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Cataracts
Keywords: Cataract
Corneal endothelial cell loss
Ultrasound power
Corneal endothelium
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-07-03
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two cataract surgical technique variations for removing the nucleus of the lens (central part of the lens) in terms of damage to the inner layer of the cornea which is called the endothelium. One variation uses more ultrasound energy and the other more mechanical force to break up the nucleus.


Eligibility criteria: Inclusion Criteria:

* Visually significant moderate density cataract

Exclusion Criteria:

* Corneal or retinal pathology limiting visual potential to worse than 20/40
* Lens pathology including pseudoexfoliation or lens dislocation
* Prior intraocular surgery
* Age less than 40

Primary outcomes:
measure: Corneal endothelial cell loss by specular microscopy after cataract surgery
timeFrame: 3 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: David Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02754791: Reducing Blood Culture Contamination:
Official title: Reducing Blood Culture Contamination: a Prospective Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preventing Blood Culture Contamination
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
Collaborators: name: Magnolia Medical Technologies, Inc.
name: 3M
First posted: 2016-04-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Bloodstream infections cause significant morbidity and mortality and their prompt identification is an essential part of modern medicine. False positive results in blood cultures are primarily due to contaminants. It has been estimated that up to 50% of positive blood cultures represent contamination. These false positive cultures, at the microbiological laboratory level, require significant additional resources for workup. Additionally, they result in unnecessary antibiotic treatment and hospitalization days, causing needless harm to patients. Various methods have been implemented in order to reduce blood culture contaminants, including modifying the solution used for sterilizing the skin and feedback on contamination rates. However, it has been shown that the bacteria which colonize the human skin are not only on the surface but in fact colonize deeper surfaces as well. The SteriPath device diverts the initial 1-2 ml blood so as to remove any potential skin plug with contaminants. Thus, the principle object of this study is the determination of the rate of contamination of blood culture taken prior to initiating intervention versus the rate of contamination using three interventions: Monthly feedback via departmental report card, a chlorhexidine plus alcohol wipe and the SteriPath device. Secondary objectives will include ease of use of the wipes and the SteriPath device and an estimate of the sensitivity of SteriPath device use to true bacteremia. If the various interventions will be shown to reduce contamination, researchers will also attempt to estimate the financial effects of those reductions, comparing intervention cost to estimated savings related to reduced contamination.


Eligibility criteria: Inclusion Criteria:

* adult patients hospitalized in our institution in whom blood cultures are taken

Exclusion Criteria:

* none

Primary outcomes:
measure: Percentage of contaminated blood cultures relative to overall blood cultures as compared to percentage in historical and parallel control groups
timeFrame: 6 months
Secondary outcomes:
measure: Ease of use of SteriPath device as evaluated by resident physicians and phlebotomists using a questionaire
timeFrame: 6 months
measure: Cost effectiveness of Steripath device and chlorhexidine wipes in measured as cost of devices in dollars versus reduction of cost in dollars associated with reduced blood culture contamination
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05305391: Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk
Official title: Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Milk Intolerance
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to reveal how different forms of milk casein, lactose and moderate breakdown of proteins affect the symptoms that may arise from milk and markers of inflammation in volunteers receiving symptoms from milk. Research hypotheses are: 1) Protein hydrolyzed milk is as tolerated or better tolerated than A2 milk, and 2) Lactose is the main causative agent of stomach symptoms in milk-sensitive individuals.


Eligibility criteria: Inclusion Criteria:

* Perceive disturbing gut symptoms from regular milk
* Commits to the research diet for the whole research period
* Age: 18-65
* BMI: 18.5-30
* Healthy (normal kidney, liver and thyroid function and self-reported)

Exclusion Criteria:

* Milk allergy
* Regular medication (other than contraceptives) or medication affecting the gut
* Recent course of antibiotics (\< 3 months prior the study)
* Pregnancy or lactation
* Diagnosed bowel disease

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: day 0 - day 3
measure: Inflammation markers
timeFrame: day 4
measure: Calpro
timeFrame: day 4
measure: Stool quality and defecation regularity
timeFrame: day 0 - day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Food Chemistry and Food Development, Department of Life Technologies, University of Turku
Study officials:
References:
Clinical trial NCT04937491: Detection of Minor Changes in Fluid Volume or Tonicity in Healthy Volunteers.
Official title: Detection of Minor Changes in Fluid Volume or Tonicity in Healthy Volunteers.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Healthy Nutrition
Keywords: dehyration
Lead sponsor: Mode Sensors AS
Sponsor class: INDUSTRY
Collaborators: name: University of Tromso
First posted: 2021-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult healthy volunteers (students), 20 years or older.

Brief summary: This study is aimed at detecting minor changes in hydration volume and tonicity. We will use healthy students of both sexes who will ingest fluids and nutrition that should lead to specific changes in both intracellular and extracellular volumes. The protocol is based on laboratory exercises previously carried out at The Arctic University of Norway (UiT).


Eligibility criteria: Inclusion Criteria:

- Healthy volunteer

Exclusion Criteria:

* Kidney disease,
* neurological,
* heart or endocrine disease,
* hypertension.
* Eating disorder

Primary outcomes:
measure: Ability to detect tonicity or volume change
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Arctic University of Norway
Study officials:
References:
Clinical trial NCT04114591: Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study
Official title: Contributing Factors to Anterior Resection Syndrome and Its Impact on Quality of Life: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Anterior Resection Syndrome
Cancer
Quality of Life
Lead sponsor: University of Malta
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients \>18 years, under the care of all surgical firms at Mater Dei Hospital, who had undergone anterior resection for rectal cancer between January 2014 and December 2016

Brief summary: This study adds to the understanding of the contributing factors leading to LARS, the long term effects of this syndrome post-operatively and its impact on quality of life.


Eligibility criteria: Inclusion Criteria:

* All adult patients \>18 years, under the care of all surgical firms at Mater Dei Hospital, who had undergone anterior resection for rectal cancer between January 2014 and December 2016

Exclusion Criteria:

* colorectal cancer (\>15cm) from anal verge
* permanent stoma
* known disseminated or recurrent disease,
* patient without restitution of bowel continuity after 1 year

Primary outcomes:
measure: LARS incidence
timeFrame: 1 year
measure: Risk factors
timeFrame: 1 year
measure: Life
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Valletta
country: Malta
facility: Mater Dei Hospital
Study officials:
affiliation: Mater Dei Hospital
name: Svetlana Doris Brincat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812591: Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 Diabetic Patients
Official title: Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study seeks to use microdialysis and microperfusion techniques to assess the feasibility of combining insulin delivery and glucose sensing at a single subcutaneous tissue site.

Detailed description: Current treatment of in type 1 diabetes comprises the measurement of glucose in capillary blood obtained by fingersticking and administration of exogenous insulin in the form of a subcutaneous bolus injection or subcutaneous infusion. This treatment could be simplified if there were a stable ratio between blood glucose concentration and tissue glucose level at the site of insulin delivery so that tissue glucose levels could be used to estimate blood glucose levels, thereby circumventing the need for fingerstick blood glucose monitoring.

The aim of this study is to ascertain whether a stable ratio between the blood glucose concentration and the glucose levels at the tissue site of insulin infusion exists when this tissue site is exposed to variable insulin infusion rates. To achieve this, microdialysis and microperfusion probes are applied in healthy and type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site during euglycemic clamps and oral glucose tolerance tests.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus patients aged 18 - 65
* Healthy subjects aged 18 - 65
* Informed consent obtained before any trial-related activities.

Diabetic subjects:

* C-peptide negative (≤ 0.05 nmol/L)
* HbA1c (glycosylated haemoglobin A1c) \< 10%

Exclusion Criteria:

* Severe diabetic complications (e.g., proliferative retinopathy, severe nephropathy)
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
* Subject with mental incapacity or language barriers

Primary outcomes:
measure: Ratio between the plasma glucose level and the glucose concentration at the subcutaneous insulin delivery site
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz, Internal Medicine, Endocrinology and Nuclear Medicine
name: Thomas R. Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01059591: First Study in Humans With GSK424887
Official title: A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK424887 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin- Receceptor Occupancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder and Anxiety Disorders
Keywords: NK1 antagonist and SSRI
Healthy subjects
Safety
First time in Human
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-02-01
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology


Eligibility criteria: Inclusion Criteria:

* Healthy males aged 18-45 years, limited to 25-40 years for PET section

Exclusion Criteria:

* The subject has a positive: drug/alcohol, Hepatitis, HIV screen
* The subject has a history of psychiatric illness suicidal attempts or behaviour.
* Abuse of alcohol.
* Clinically significant laboratory, ECG abnormality;
* The subject has recently received an investigational.
* Use of prescription or non-prescription drugs,
* History or presence of allergy to the study drug or drugs of this class,.
* Donation of more than 500 mL blood within the 90 days before dosing.
* An unwillingness of male subjects to comply with contraceptive requirements
* Average daily caffeine intake exceeding Protocol requirements.

Primary outcomes:
measure: Adverse event monitoring, vital signs (blood pressure, heart rate, ECGs, clinical laboratory assessments (standard laboratory parameters); Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) , tmax
timeFrame: 12 weeks
Secondary outcomes:
measure: Brain receptor occupancy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: