louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03427788: BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect
Official title: Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY2328065 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY2328065 in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-02-09
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, aged 18 - 45 years
* Body mass index (BMI): 18 ≤ BMI ≤ 30 kg/m²
* Smoking less than 10 cigarettes / day
* Signed informed consent
* Use of an accepted method of contraception for the duration of the study.

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, thyroid disorders or malignant tumors
* Known severe allergies, non allergic drug reactions, or multiple drug allergies
* Medication history: any regular medication, esp. drugs known to induce/inhibit liver enzymes or transporters
* Clinically relevant findings in physical examination; ECG, blood pressure; laboratory values

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: Up to 8 days
measure: Severity of treatment-emergent adverse events
timeFrame: Up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
References:
Clinical trial NCT01609088: Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Official title: Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: endothelium
diabetes mellitus
oxidative stress
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Cargill
First posted: 2012-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Otherwise healthy

Exclusion Criteria:

* Pregnant
* BMI\>35 kg/m2
* Long acting insulin treatment
* Other major illness, drug abuse
* Treatment with an investigational drug within 12 weeks
* Treatment with dietary or vitamin supplements
* Smoking within 3 months

Primary outcomes:
measure: Brachial artery flow mediated dilation
timeFrame: Change from baseline at 28 days
Secondary outcomes:
measure: Brachial artery flow-mediated dilation
timeFrame: Change from baseline at 2 hours
measure: Reactive hyperemia
timeFrame: Change from baseline at 2 hours and 28 days
measure: Carotid femoral pulse wave velocity
timeFrame: Change from baseline at 28 days
measure: Fingertip tonometry
timeFrame: Change from baseline at 2 hours and 28 days
measure: Urine F2 isoprostanes
timeFrame: Change from baseline at 28 days
measure: C-reactive protein
timeFrame: Change from baseline at 28 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University
name: Joseph A. Vita, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flint N, Hamburg NM, Holbrook M, Dorsey PG, LeLeiko RM, Berger A, de Cock P, Bosscher D, Vita JA. Effects of erythritol on endothelial function in patients with type 2 diabetes mellitus: a pilot study. Acta Diabetol. 2014;51(3):513-6. doi: 10.1007/s00592-013-0534-2. Epub 2013 Dec 24.
Clinical trial NCT05980988: Effectiveness and Safety of Probiotic in Regulating Chronic Constipation
Official title: Efficacy and Safety of Probiotic BLa80 in Modulating Bowel Habits in Subjects With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Constipation
Keywords: Probiotics；Chronic constipation
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Methodex
First posted: 2023-08-08
Enrollment: 46
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: TREATMENT

Brief summary: To evaluate the effectiveness and safety of the use of probiotics as food supplements in regulating the intestinal habit of subjects with chronic constipation, in comparison with placebo.


Eligibility criteria: Inclusion Criteria:

Patients with chronic constipation (duration more than 3 months with less than three bowel movements per week and/or Bristol Scale 1 and 2).

Exclusion Criteria:

1. Diabetic patients.
2. Pregnant patients.
3. Breastfeeding patients.
4. Patients requiring antibiotic treatment.
5. Patients requiring treatment with tricyclic antidepressants, antiepileptics, antihistamines, antiparkinsonians, antipsychotics, antispasmodics, verapamil, monoamine oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and calcium), antidiarrheals and nonsteroidal anti-inflammatory drugs.
6. Patients who change the type of diet during the study.
7. Patients with allergy or intolerance to any of the ingredients in the formulation of the product under study.
8. Subjects with a history of pharmacological, alcoholic, or other substance abuse, or other factors that limit their ability to cooperate during the study.
9. Excessive alcohol consumption (\>3 glasses of wine or beer/day).
10. Subjects whose condition does not make them eligible for the study, according to the researcher.

Primary outcomes:
measure: changes in fecal state
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: CAP Can Bou Castelldefels and CAP Corbera de Llobregat
city: Barcelona
country: Spain
facility: Family and Community Medicine CAP Roger
Study officials:
affiliation: Methodex
name: METHODEX SL
role: STUDY_CHAIR
References:
Clinical trial NCT00422578: Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction
Official title: Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction (ED) Patients Previously Treated With Other Oral ED Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Erectile Dysfunction
Keywords: erectile dysfunction
tadalafil
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-01-17
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study is a clinical study assessing the effect of oral tadalafil 10mg or 20 mg on psychosocial aspects and quality of life of erectile dysfunction patients and to compare tadalafil with previous oral erectile dysfunction medication. Study period is 13 weeks. Study patients fill in quality of life questionnaires and treatment satisfaction questionnaires.


Eligibility criteria: Inclusion Criteria:

* have a history of erectile dysfunction (defined as a consistent change in the quality of erection that adversely affects the patient's satisfaction with sexual intercourse)of at least 3 months duration
* have been using any oral prescription medication,but not tadalafil, for erectile dysfunction for a minimum period of 3 months before visit 1
* have responded to previous erectile dysfunction medication as assessed by the investigator

Exclusion Criteria:

* exhibit evidence of clinically significant hepatobiliary disease (including jaundice) at visit 1
* cardiovascular exclusion criteria: history of chronic stable angina treated with nitrates, recent acute cardiovascular events or procedures (myocardial infarction, coronary interventions, stroke, etc.), history of other serious cardiovascular events (e.g. arrhythmias, sudden cardiac arrest, congestive heart failure, etc.), systolic blood pressure \<90mmHg or diastolic blood pressure \<50mmHg at screening
* receiving treatment with cancer chemotherapy

Primary outcomes:
measure: On-demand therapy with tadalafil, as measured by the spontaneity domain of the PAIRS questionnaire increases the possibility to spontaneous sexual activity in ED patients compared with any other previous oral ED treatment.
Secondary outcomes:
measure: Estimate the level of quality of life (15D and LiSat-11)in treated ED patients in order to be able to compare it with existing data of the general population and patients suffering from other diseases and symptoms.
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05488678: Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
Official title: VNRX-7145-103: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-08-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will enroll approximately 32 participants assigned to groups based on renal function.
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-82 years
* Males or non-pregnant, non-lactating females
* Body mass index (BMI): ≥18.5 kg/m2 and ≤40.0 kg/m2
* Laboratory values meeting defined entry criteria

Subjects with normal renal function (Group 1) must also meet the following criteria:

• Match to one or more participants with renal impairment by gender, age, and BMI

Subjects with renal impairment (Groups 2-5) must also meet the following criteria:

• Stable, pre-existing renal impairment

Exclusion Criteria:

* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
* Congenital or acquired immunodeficiency syndrome
* Major adverse cardiovascular event within one year of dosing
* Positive alcohol, drug, or tobacco use/test

Primary outcomes:
measure: Cmax
timeFrame: 0-120 hours post dose
measure: AUC0-inf
timeFrame: 0-120 hours post dose
measure: Number of subjects with adverse events
timeFrame: 8 days post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Advanced Pharma
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Saint Paul
country: United States
facility: Nucleus Network
state: Minnesota
Study officials:
References:
Clinical trial NCT03499678: Lung Cancer Screening Using DNA Methylation Changes in Circulated Tumor and PBMC DNA
Official title: Clinical Trials on Detection of Lung Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Lung Cancer, Nonsmall Cell
Lung Cancer, Small Cell
Lead sponsor: HKGepitherapeutics
Sponsor class: INDUSTRY
Collaborators: name: Kazakh Research Institute of Oncology & Radiology
First posted: 2018-04-17
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be assigned an ID that will be kept confidential according to hospital regulations. IDs will be randomized so that identity will not be revealed except to the approved hospital personnel. Methylation data will be returned to the hospital for follow up of progression of disease and for assessing early prediction of progression of lung cancer and will be entered into the data base. Other clinical follow up data will be entered into the electronic data base. All data will be captured in case report form.

Brief summary: A central challenge in the fight against lung cancers is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast and lung cancers, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of lung cancer is urgently needed.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in lung cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histological confirmed lung cancer

Exclusion Criteria:

* Pregnant women
* Minors (subjects less than 18 years of age)
* Prisoners
* Patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
* Patients having other than one cancer
* Subjects unable to consent for themselves

Primary outcomes:
measure: DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of lung cancer
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh Institute of Oncology and Radiology
Study officials:
References:
Clinical trial NCT05265078: A Study on Estimated Risks of Certain Adverse Events in Adults With Von Willebrand Disease (VWD) Treated With Veyvondi
Official title: Estimating Risk of Selected Adverse Events in Patients With Von Willebrand Disease Treated With VEYVONDI® (Vonicog Alfa; Recombinant Von Willebrand Factor)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Von Willebrand Disease (VWD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been diagnosed with VWD and were prescribed VEYVONDI in Europe.

Brief summary: The main aim of this study is to estimate the risks of certain adverse events in adults with Von Willebrand Disease treated with VEYVONDI. No study medicines will be provided to participants in this study.

Data from medical records of participants diagnosed with Von Willebrand Disease and treated with VEYVONDI will be evaluated during this study.


Eligibility criteria: Inclusion criteria:

1. Participants with 18 years of age or older
2. Participants with diagnosis of congenital VWD.
3. Participants received VEYVONDI with or without a FVIII concentrate.
4. Participants must have at least 7 days of observation time after the index dose.
5. Provides informed consent, if required, in accordance with local ethical and institutional requirements. All medical record data will be abstracted retrospectively; therefore, an exemption or waiver of informed consent will be sought from all associated independent ethics committees (IECs) and institutional review boards (IRBs).

Exclusion criteria:

1. History of any other coagulation or platelet disorder (including acquired VWD).
2. History of neutralizing antibodies / inhibitors to VWF or FVIII.

Primary outcomes:
measure: Percentage of Participants With Hypersensitivity Reactions
timeFrame: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)
measure: Percentage of Participants With Thromboembolic Events
timeFrame: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)
measure: Percentage of Participants With VWF or Factor VIII (FVIII) Inhibitor Formation
timeFrame: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Homburg vor der Höhe
country: Germany
facility: MVZ Gerinnungszentrum Hochtaunus
state: Hessen
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03473678: Dietary Nitrate and Healthy Older Adults
Official title: Influence of Dietary Nitrate Supplementation on Blood Pressure, Walking Economy, Functional Physical Capacity and Cognitive Function in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Cognitive Change
Functional Capacity
Brain Metabolism
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study investigates the influence of dietary nitrate supplementation on cardiovascular health and physical and cognitive performance in older adults. Participants will receive both a nitrate containing beetroot juice for 10 days and a nitrate depleted beetroot juice for 10 days

Detailed description: A recent exciting finding is that dietary nitrate supplementation (in the form of beetroot juice) appears to reduce the amount of oxygen needed to complete moderate intensity walking in healthy, young individuals. Nitrate is known to be converted in the body to nitric oxide (NO), a substance which reduces blood pressure and may affect the energy-producing mechanisms inside muscle cells. Exercise tolerance and muscle function typically declines with age and nitrate supplementation therefore may help improve cardiovascular health and the ability to carry out low-intensity daily activities in aging populations. The purpose of this study is to see if healthy, elderly individuals benefit from beetroot juice intake similarly to the effects seen in young adults. If this is indeed the case, then it may suggest that dietary supplementation with a relatively cheap, widely available, and natural food product may improve the ability of healthy elderly individuals to undergo everyday tasks and ultimately improve their quality of life.

Eligibility criteria: Inclusion Criteria:

1. 70 - 80 years of age
2. male or female

Exclusion Criteria:

1. involved in regular structured exercise
2. receiving medication for:

   * pulmonary conditions
   * cardiovascular conditions
   * metabolic conditions
   * musculoskeletal conditions
   * ulcerative colitis
   * renal disease

Primary outcomes:
measure: Blood pressure
timeFrame: 10 days
Secondary outcomes:
measure: Oxygen cost of exercise
timeFrame: 10 days
measure: Serial Subtraction test
timeFrame: 10 days
measure: Microbiome
timeFrame: 10 days
measure: Brain metabolism
timeFrame: 10 days
measure: 6 minute walk test
timeFrame: 10 days
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport and Health Sciences, University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Andrew M Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06411678: Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer
Official title: Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 50
Sex: FEMALE
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: DIAGNOSTIC

Brief summary: The investigators plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study in breast cancer patients to observe the binding of the tracer to tumor lesions and evaluate CD73 expression. As part of the study design, a subset of patients will initially undergo dynamic PET/CT imaging to evaluate the safety profile and pharmacokinetic distribution of the radiotracer in vivo. Subsequently, static PET/CT imaging will be performed on additional patients to assess the diagnostic effectiveness of 68Ga-DOTA-dPNE. Imaging results will be correlated with relevant clinical indicators to evaluate the potential of this tracer in diagnosing breast cancer, guiding therapeutic decisions, and predicting responses to targeted therapies.


Eligibility criteria: Inclusion Criteria:

Female patients aged ≥18 years with an expected survival of at least 12 weeks No prior radiotherapy or chemotherapy; surgery or biopsy is feasible for pathological diagnosis At least one measurable target lesion as defined by RECIST v1.1 Able to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

Severe hepatic or renal dysfunction Pregnant, breastfeeding, planning to become pregnant, or planning to have children during the study period; women of childbearing potential must use effective contraception during the study Unable to lie flat for 30 minutes History of claustrophobia or other psychiatric disorders Any other condition deemed unsuitable for participation by the investigator Refusal to participate in the clinical study

Primary outcomes:
measure: The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dongcheng
country: China
facility: PUMCH
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xianzhong ZHANG
role: PRINCIPAL_INVESTIGATOR
References: