louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01887106: First-in-Human Single and Multiple Dose of GLPG1205
Official title: Randomized, Double-blind, Placebo-controlled, Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1205 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.


Eligibility criteria: Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: Safety and tolerability after single dose
timeFrame: Between screening and 7-10 days after the last dose
measure: Safety and tolerability after multiple doses
timeFrame: Between screening and 7-10 days after the last dose
Secondary outcomes:
measure: The amount of GLPG1205 in plasma and urine over time after a single oral dose
timeFrame: Between Day 1 predose and 48 hours post dose
measure: The amount of GLPG1205 in plasma and urine over time after multiple oral doses
timeFrame: Between Day 1 predose and Day 16 (48 hours after the last dose)
measure: Ratio of 6-b-hydroxycortisol/cortisol in urine
timeFrame: Twelve hours before dosing on Day 1 and Day 14
measure: Receptor occupancy by GLPG1205 on blood cells after a single dose
timeFrame: Day 1 predose up to 24 hours post dose
measure: Receptor occupancy by GLPG1205 on blood cells after multiple doses
timeFrame: Day 1 and Day 14, predose up to 24 hours post dose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00379106: Arm Function and Quality of Life Following Mastectomy.
Official title: Arm Function and Quality of Life Following Mastectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Supportive
Mastectomy
Quality of Life
Arm Function
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-09-21
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To measure arm function and quality of life of mastectomy patients.

Detailed description: Treatment: Randomized to one of two treatment arms. Group One: Basic active exercise program at home. Group Two: Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises. Range of Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year. Patients will complete demographic form, functional questionnaire, and QOL questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patients who have been referred from UNMH to CRTC for further treatment following mastectomy/lumpectomy surgery.

Exclusion Criteria:

* Not specified

Primary outcomes:
measure: Arm Function and Quality of Life Following Mastectomy
timeFrame: Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Kathy Dieruf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04154306: Effects of Fermented Red Clover on Muscle Strength and Muscle Mass
Official title: Effects of Fermented Red Clover on Muscle Strength and Muscle Protein Signaling in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Estrogen Deficiency
Keywords: Isoflavones
Red clover
Muscle Function
Postmenopausal women
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The project is designed as a randomized controlled, double-blinded, cross-over trial, including 10 healthy postmenopausal women consuming fermented red clover extract or placebo twice daily over a two-week period. After the first trial (two weeks), participants will undergo a two-week washout period, after which they will receive the opposite trial drink for two weeks. The trial period runs over six weeks. Before each of the two trial rounds, participants will meet in the laboratory and perform muscle strength tests (trial days 1 and 3). After each trial round (trial days 2 and 4), participants will meet fasting in the laboratory, and a blood test and a muscle biopsy will be taken initially. Next, the subject consumes the test drink (placebo or red clover extract) before the subject performs a strength training session with one leg. Right after the training session, the subject consumes a protein drink. Three hours after the protein drink, another muscle biopsy is taken. During the period from the protein drink to the final biopsy, the subject performs two muscle strength tests (respectively grip strength and maximum upper arm muscle strength (biceps)). The primary target parameter is muscle protein signaling measured in the muscle tissue samples using the western blotting method.


Eligibility criteria: Inclusion Criteria:

* maximum of 5 years since last menstrual bleeding
* Minimum of 6 months since last menstrual bleeding

Exclusion Criteria:

* Performed systematic resistance training within the last 6 months
* Smoker
* Using any form of medicine influencing the effects of resistance training

Primary outcomes:
measure: Muscle protein signalling measured by western blotting
timeFrame: Change from pre to 3 hours post training
Secondary outcomes:
measure: Forearm and biceps strength measured by maximal isometric muscle strength
timeFrame: Change from Pre to post intervention.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
References:
Clinical trial NCT05750706: Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative
Official title: Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukemia, Adult
Invasive Fungal Infections
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Asst Degli Spedali Civili Di Brescia
First posted: 2023-03-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with B or T acute lymphoblastic leukemia Ph negative

Brief summary: The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment


Eligibility criteria: Inclusion Criteria:

* diagnosis of acute lymphoblastic leukemia Ph negative
* age more than 18 yo

Exclusion Criteria:

* diagnosis of acute lymphoblastic leukemia Ph positive
* acute lymphoblastic leukemia relapsed/refractory
* lymphoblastic lymphoma

Primary outcomes:
measure: Incidence of invasive fungal infections during first week of chemotherapy
timeFrame: 18 months
Secondary outcomes:
measure: Mortality rate among patients with invasive fungal infections
timeFrame: 30 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References:
Clinical trial NCT04423406: The Changes in Carotid Plaque Neovascularization After Elovocumab Therapy
Official title: The Changes in Carotid Plaque Neovascularization After Long-term Elovocumab Injection Therapy: A Follow-Up Study by Contrast Enhanced Ultrasonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Diseases
Lead sponsor: Zibo Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 150 eligible coronary atherosclerosis disease patients were anticipated to include in this study.

Brief summary: 150 selected patients will be recruited, who have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography. For each of the plaques, standard ultrasonography will be used to evaluate lesion echogenicity, while contrast-enhanced ultrasonography (CEUS) will be used to perform the visual and quantitative analysis of neovascularization. Each technique will be applied at baseline (at the time of study enrollment) and following 0.5、1 year of Elococumab Injection treatment. During the study, these patients will be treated with Elococumab Injection (1ml:140mg),ih, every two weeks.


Eligibility criteria: Inclusion Criteria:

* 1. have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography;
* 2.patients were referred for optimal medical treatment;
* 3.patients agreed to undergo follow-up CEUS at half-year and 1-year interval.

Exclusion Criteria:

* 1.patients had previous history of cerebral thrombosis or cerebral embolism;
* 2.patients were contraindicated to the usage of contrast media;
* 3.image quality of baseline or follow-up CEUS was severely impaired (in presence of severe artifact, non-diagnostic);
* 4.patients withdrew the informed consents during follow-up;
* 5.patients experienced major adverse cerebrovascular events during follow-up;
* 6.patients refused to undergo follow-up CEUS;
* 7.lost follow-up

Primary outcomes:
measure: The Changes in Carotid Plaque Neovascularization
timeFrame: June 2020 to December 2021
Secondary outcomes:
Other outcomes:
measure: The Changes in Carotid Plaque Size
timeFrame: June 2020 to December 2021
Locations:
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
Study officials:
affiliation: Zibo Central Hospital
name: Bo Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05997706: Unraveling the Klinefelter's Disease Physiopathology
Official title: Unraveling the Klinefelter's Disease Physiopathology by Organoid Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Klinefelter Syndrome
Infertility, Male
Keywords: Klinefelter Syndrome
fertility preservation, male
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 20
Sex: MALE
Minimum age (years): 5
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Organoid Model to unravel Klinefelter Syndrome infertility

Klinefelter Syndrome (KS) is characterized by the presence of an extra chromosome X in male (47,XXY), it is the most frequent genetic cause of azoospermia in adult men. The investigators will isolate and expand spermatogonial cells from KS patients, then using an organoid model investigators will compare the behavior of these Spermatogonia from KS patients when interacting with four combinations of somatic cell types incorporated in the Extra Cellular Matrix hydrogel.

Detailed description: Men with Klinefelter Syndrome candidate for TESE or microTESE (testicular sperm extraction) for azoospermia.

One extra testicular biopsy (1-2 mm) will be cryopreserved and used later for the cells isolation and culture.

Eligibility criteria: Inclusion Criteria:

* Klinefelter

Exclusion Criteria:

* Mosaicism

Primary outcomes:
measure: Klinefelter's infertility physiopathology
timeFrame: Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
Study officials:
affiliation: Cliniques Universitaires St Luc
name: Christine Wyns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00311506: A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease
Official title: A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Pulmozyme
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-04-06
Enrollment: 25
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This is an observational study to be conducted at approximately 25 sites in the United States. Approximately 25 subjects with severe obstructive CF lung disease (FVC \<40% predicted) will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent
* Males or females who will be \>=14 years old at Visit 3
* A proven diagnosis of CF as evidenced by a positive sweat test (sweat sodium or chloride \>60 mEq/L by quantitative pilocarpine iontophoresis), or genotype and clinical symptoms consistent with the diagnosis of CF
* Able to perform reproducible spirometry maneuvers at Visit 1 in accordance with the American Thoracic Society (coefficient of variation for three FEV1 maneuvers \<=0.2)
* FVC \<40% predicted for height, age and sex at Visit 1
* On a stable regimen of chest physiotherapy (CPT) begun at least 7 days prior to Visit 1
* Able to complete the 6-minute walk test at Visit 1

Exclusion Criteria:

* Use of an investigational drug or device within 28 days prior to Visit 1
* Experiencing an episode of severe acute respiratory failure, as determined by the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Morris Cheeks, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06725706: Beta Amyloid PET/CT in Various Aβ-Related Disease
Official title: Beta Amyloid PET/CT in Various Aβ-Related Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyloid
Beta-Amyloid
Neurodegenerative Diseases
Keywords: PET/CT
MRI
Beta-Amyloid
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2024-12-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Aβ PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Brief summary: To evaluate the potential usefulness of 18F-92/AV45, 11C-PIB positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.

Detailed description: Subjects with various Tau-related disease patients underwent 18F-92/AV45, 11C-PIB PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-92/AV45, 11C-PIB PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Aβ PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: Anhui
city: Beijing
country: China
facility: Chinese PLA General Hospital,
state: Beijing
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04752306: The Integration of Sensor Technology in Disposable Pads: a Needs Assessment in Nursing Homes
Official title: The Integration of Sensor Technology in Disposable Pads: a Needs Assessment in Nursing Homes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence
Keywords: incontinence
pads
sensor technology
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 10 residents, 8 healthcare workers and 2 policymakers from 3 nursinghomes in Flandres (Belgium)

Brief summary: The aim of the study is to explore the criteria and conditions for the integration of sensor technology in disposable pads according to the needs and opinions of residents with incontinence, healthcare workers, and policymakers in nursing homes.


Eligibility criteria: Inclusion Criteria:

* Residents

  1. if they have worn absorbent incontinence products minimum one time for more than one week
  2. if they have a Mini-Mental State Examination (MMSE)-score of \>23
  3. if they are able to communicate verbally
* Health care workers
* if they are health care assistants or nurses
* Policymakers if they have a role in the financial decisions regarding incontinence material.

Exclusion Criteria:

-

Primary outcomes:
measure: requirements for sensor technology in disposable bodyworns measured with a semi-structured questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Residentie Vroonstalle
state: Oost-vlaanderen
city: Ledegem
country: Belgium
facility: Rustenhove
state: West-Vlaanderen
city: Gent
country: Belgium
facility: Residentie Brugse Vaart
Study officials:
References:
citation: Raepsaet C, Serraes B, Verhaeghe S, Beeckman D. Integrating Sensor Technology in Disposable Body-Worn Absorbent Products: A Qualitative Study to Define User Profile, (Technical) Criteria, Conditions, and Potential Benefits. J Wound Ostomy Continence Nurs. 2021 Nov-Dec 01;48(6):560-567. doi: 10.1097/WON.0000000000000812.
Clinical trial NCT03877406: Effect of Empagliflozin on Body Composition and Ketones
Official title: Decrease in Body Fat and Increase in Ketone Body After 6-month Treatment of Empagliflozin in Korean Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus
Fat; Intolerance, Pancreas
Keywords: Sodium-glucose transporter 2 inhibitor
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 20
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 evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).

Detailed description: Sodium-glucose cotransporter-2 (SGLT2) inhibitor increases urinary excretion of glucose, promoting glycemic control and weight loss. However, it is unclear whether weight loss is attributed to decrease in fat components and associated with favorable changes in metabolic profile. The purpose of this study is to evaluate changes of body composition induced by SGLT2 inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).

Eligibility criteria: Inclusion Criteria:

Patients with type 2 diabetes Age: 20-79 years BMI ≥ 20 kg/m2 eGFR ≥ 45

Exclusion Criteria:

Patients with type 1 diabetes Secondary diabetes due to Cushing diseases, acromegaly Insulin user BMI \< 20 kg/m2 eGFR \< 45 Malignancy

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Biochemical parameters
timeFrame: 6 months
measure: Body weight
timeFrame: 6 months
measure: Body fat
timeFrame: 6 months
measure: Systolic and diastolic blood pressures
timeFrame: 6 months
measure: Lipid profile
timeFrame: 6 months
measure: Insulin resistance
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo N Lim, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: