louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04672850: The Effect of Probiotic and Zinc Supplementation on the Common Cold
Official title: The Effect of Probiotic and Zinc Supplementation on the Common Cold in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Common Cold
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Coradil AB
First posted: 2020-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose with this study is to investigate the preventative effect of a supplement containing a combination of probiotic bacteria and fungi as well as zinc on the common cold. The hypothesis is that it will shorten the duration, alleviate the severity of symptoms or even decrease the number of infectons during the intervention period. This study is a randomzed placebo controlled human study were healthy adults will consume the supplement for three months.


Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Diagnosed gastrointestinal disorders
* Autoimmune diseases or immuno compromized
* Antibiotic treatment in the last month

Primary outcomes:
measure: Symptoms severity
timeFrame: Three months
Secondary outcomes:
measure: Composition of gut and oral microbiome
timeFrame: Three months
measure: IgA
timeFrame: Three months
measure: Duration of symptoms
timeFrame: Three months
measure: Number of colds
timeFrame: Three months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lunds universitet
Study officials:
References:
Clinical trial NCT02231450: Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Official title: Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heptic Impairment
Keywords: AE58054
Hepatic impairment
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 40 and 65 years (inclusive) with a body mass index between 19 and 32 kg/m2 (inclusive).
* Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6)
* Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score 7-9)
* Group 3: Healthy subjects with normal hepatic function

Other pre-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
timeFrame: 0 to 96 hours
measure: Maximum observed plasma concentration (Cmax) of Lu AE58054
timeFrame: 0 to 96 hours
Secondary outcomes:
measure: Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)
timeFrame: Screening to day 11
Other outcomes:
Locations:
city: Munich
country: Germany
facility: APEX GmbH
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT06469450: KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
Official title: KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pharmacodynamics
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2024-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A majority of high-risk patients does not achieve their cholesterol target levels and most of these patients do not receive more effective combination therapy, which goes beyond statin monotherapy. Large interindividual differences in treatment outcomes have been observed for patients receiving statins. Statins block cholesterol synthesis and increase cellular low-density lipoprotein (LDL) uptake. Importantly, LDL uptake is highly divergent in individuals.The aim of this trial is to investigate how atorvastatin influences leukocyte readouts of LDL uptake and lipid storage in humans. The trial is a single-arm, open-label, interventional trial. A total of 15 healthy volunteers will receive 40 mg atorvastatin once a day for 4 weeks. The participants will provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin, and one week after the end of the intervention for the measurement of leukocyte readouts of LDL uptake and lipid storage.


Eligibility criteria: Inclusion Criteria:

1. a signed written informed consent
2. age 18-40 years
3. healthy, and
4. Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
5. Fully vaccinated against COVID-19.

Exclusion Criteria:

1. significant disease
2. smoking
3. SLCO1B1 poor function genotype
4. oral contraception or other continuous medication
5. pregnancy, planning of pregnancy or breastfeeding
6. participating in a clinical trial less than 3 months ago
7. donating blood less than 3 months ago
8. marked obesity
9. anticipated difficulties in drawing blood samples
10. weight less than 45 kg
11. BMI less than 18.5 kg/m2 or
12. inadequate Finnish language skills

Primary outcomes:
measure: Lipid trafficking score LT-Mo
timeFrame: Baseline and once a week for 5 weeks
Secondary outcomes:
measure: Leukocyte LDL uptake
timeFrame: Baseline and once a week for 5 weeks
measure: Leukocyte lipid storage
timeFrame: Baseline and once a week for 5 weeks
measure: Atorvastatin plasma concentration
timeFrame: Once a week during the 4 week atorvastatin treatment
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Clinical Pharmacology
Study officials:
References:
Clinical trial NCT02230150: ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF
Official title: ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE - ADhesion-HF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Adhesion, Knowledge, Nursing
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to verify the impact of the educational intervention in the adhesion to therapeutic strategies for patients with heart failure.

Detailed description: 1. Characterize the socio-demographic and clinical aspects of heart failure patients;
2. Awareness before and after nursing consultation, in relation to diet for heart failure, liquid and weight, general heart failure information, medication, physical activity, measures to improve disease control, signs of decompensated heart failure;
3. Adhesion of patients before and after nursing consultation, related to medication, liquid and weight, use of alcohol and importance of returning for consultation and exams.
4. Evaluated the impact of educational intervention at the levels of NT-proBNP, urea, creatinine, sodium, potassium, before and after nursing consultation;
5. The 6 minute walk test performance before and after nursing consultation;
6. The distance covered and time of the 6 minute walk test, until fatigue in heart failure patients before and after nursing consultation;

Eligibility criteria: Inclusion Criteria:

* During the first phase of the study all the heart failure patients with ventricular ejection fraction of up to 49% shall be included (confirmed through ECOTT performed during the past year). All patients inserted had systolic heart failure and were scheduled and which agreed to take part of the research, signing a term of informed consent.

Exclusion Criteria:

* Individuals with cognitive deficit, first outpatient medical consultation, suffered AMI (acute myocardial infarction) within the last 3 months or a stroke, post-operative of cardiac surgery, patients with chronic obstructive pulmonary disease (COPD), orthopedic problems, patients over the age of 80 and those that do not accept to participate of the research.

Primary outcomes:
measure: ADHESION TO THERAPEUTIC STRATEGIES FOR OUTPATIENTS WITH HEART FAILURE
timeFrame: 1 month
Secondary outcomes:
measure: changes in biomarkers: Nt-proBNP, sodium, potassium, urea and creatinine
timeFrame: 1 month
Other outcomes:
measure: performance in the six minutes walk test
timeFrame: 1 month
Locations:
city: Salvador
country: Brazil
facility: Hospital Ana Nery
state: BA
Study officials:
name: Márcia M Carneiro Oliveira
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198950: Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis
Official title: Combined Determination of sTREM-1, PCT and CD64 in Diagnosing Sepsis: a Prospective, Bicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Patients
Keywords: sepsis
diagnosis
biomarker
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient admitted into the ICU

Brief summary: The purpose of this study is to determine wether the combined measurement of the soluble form of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients admitted into the ICU

Exclusion Criteria:

* absence of social protection

Primary outcomes:
measure: Accuracy of sTREM-1, PCT, and CD64, taken alone or in combination in diagnosing sepsis in ICU patients as defined by the expert panel
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Bocage Hospital
city: Nancy
country: France
facility: Central hospital
Study officials:
affiliation: Central Hospital, Nancy, France
name: Sebastien Gibot, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06130150: Sexual Function in High-risk Pregnant Women
Official title: Evaluation of Sexual Function in High-risk Pregnant Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Risk Pregnancy
Sexual Dysfunction
Anxiety
Female Sexual Function
Keywords: high-risk pregnancy
perinatology
sexual dysfunction
female sexual function
fsfi
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between the ages of 18-40 who were diagnosed with risky pregnancy for any reason during their pregnancy.

Brief summary: Our aim with this study is to evaluate the sexual functions of pregnant women whose pregnancies are defined as high-risk pregnancies and whose pregnancies are followed by perinatology specialists.


Eligibility criteria: Inclusion Criteria: - Pregnant women over 18 years old, -Pregnant women 39 years old and under, -Pregnant women in their 3rd trimester.

Exclusion Criteria: - Pregnant women under 18 years old, -Pregnant women over 40 years old, -Pregnant women in their 1st or 2nd trimester.

Primary outcomes:
measure: 1
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
state: Sisli
Study officials:
References:
Clinical trial NCT03101150: Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
Official title: Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Vitamin D Deficiency
Pre-Eclampsia
Keywords: Maternal vitamin D
Deficiency
Insufficiency
Pregnancy
Pre-eclampsia
IUGR
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2017-04-04
Enrollment: 179
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.

Detailed description: Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage.

Investigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.

Eligibility criteria: Inclusion Criteria:

* Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent.
* Planned to receive antenatal care in King Fahad Medical City antenatal clinic.
* The ability to provide written informed consent at the first visit.
* Low risk pregnancy; and Serum vitamin D3 levels less than \< 25nmol/L.

Exclusion Criteria:

* Mothers with pregnancy with abnormal foetus.
* Previous history of hypertension, pre-eclampsia, recurrent miscarriages.
* Chronic kidney disease, chronic liver disease, and malignancy.

Primary outcomes:
measure: Number of Participants With Pre-eclampsia in Both Arms
timeFrame: From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.
Secondary outcomes:
measure: Change in Vitamin D Level
timeFrame: At 36th week of pregnancy
measure: Number of Patients With Intrauterine Growth Retardation
timeFrame: At delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05641350: Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design
Official title: Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Eating
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to evaluate the efficacy of a group intervention program, based on the Barlow's protocol, in patients with emotional eating with the aim of improving the emotional eating pattern.

The design is quasi-experimental pre-post with a control group (waiting list) and evaluation of the maintenance of the response after 6 months of the end of the program.

Includes outpatients from the Eating Disorders Unit and the Psychiatry Unit of a Hospital. A sample size of 26 participants is considered in the experimental group, and another 26 more in the control group.


Eligibility criteria: Inclusion Criteria:

* Outpatients from eating behavior disorder outpatient clinics and psychiatric outpatient clinics.
* Age between 18 and 65 years.
* Score of more than 2.46 on the "emotional eating" subscale of the DEBQ scale

Exclusion Criteria:

* Diagnosis of active Eating Disorder, that is, without at least 6 months of symptomatic remission or that exceed the cut-off point on the EAT-26 scale.
* Patients with severe mental disorder with or without psychotic symptoms (schizophreniform disorders, bipolar spectrum disorders, major depression)
* Patients with some other medical disorder that presents with impulse dysregulation, such as epilepsy, frontal-type dementia...
* Patients with an IQ \< 85
* Patients who do not give consent.
* Patients who do not understand or speak Spanish or Catalan.

Primary outcomes:
measure: Emotional eating score assessed by the Emotional eating sub-scale of the Dutch Eating Behavior Questionnaire (DEBQ-EE)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT03383250: Metabolomic Response to Meal Ingestion
Official title: Factors to Determine the Responses to Meal Ingestion: Circulating Metabolites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
postprandial sensations
circulating metabolites
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators have recently shown that postprandial sensations correlate with changes in circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with a meal load up to the level of tolerance which involved an unpleasant fullness sensation. The aim of the present study is to determine changes in circulating metabolites of a satiating pleasurable meal. Healthy men (n = 32) will be evaluated after a 5 h fast. Perception measurements and blood samples will be taken before and 20 minutes after ingestion of a palatable probe meal (juice and warm ham and cheese sandwich, total 300 ml, 440 kcal). NMR spectroscopy will be performed to determine plasmatic Low Molecular Weight Metabolites (LMWM) and to characterize lipoprotein profiles (number of particles, lipid content and size of the main three lipoprotein classes (VLDL, LDL and HDL). Homeostatic (satiety, fullness) and hedonic sensations (digestive well-being, mood) will be measured by 10 cm analogical scales.


Eligibility criteria: Inclusion Criteria:

* non obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Metabolomic response in serum
timeFrame: 30 min
Secondary outcomes:
measure: Change in digestive well-being measured after the test meal
timeFrame: 1 day
measure: Change in satiety measured after the test meal
timeFrame: 1 day
measure: Change in fullness sensation measured after the test meal
timeFrame: 1 day
measure: Change in abdominal discomfort/pain sensation measured after the test meal
timeFrame: 1 day
measure: Change in mood measured after the test meal
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01558050: the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels
Official title: The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholesterol Level
HDL Level
LDL Level
TG Level
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators investigate the effect of a red rice product on plasma lipids in a sample of physicians and/or their family members.

After a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to receive a commercially available red rice product or placebo. After a period of 8 weeks, lipid levels are measured again.


Eligibility criteria: Inclusion Criteria:

* total fasting cholesterol \> 200mg/dl

Primary outcomes:
measure: fasting cholesterol, LDL, HDL, TG level
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: University of Antwerp
Study officials:
References:
citation: Verhoeven V, Lopez Hartmann M, Remmen R, Wens J, Apers S, Van Royen P. Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial. BMC Complement Altern Med. 2013 Jul 18;13:178. doi: 10.1186/1472-6882-13-178.