louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02364635: Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Official title: PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I pharmacokinetics and safety study
Lead sponsor: Pronova BioPharma
Sponsor class: INDUSTRY
First posted: 2015-02-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

Objective:

* To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
* To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects


Eligibility criteria: Inclusion Criteria:

* males of females
* any ethnic origin
* Age 18-55 years
* BMI 18.0 - 33.0 kg/m2
* generally in good health
* signed informed consent

Exclusion Criteria:

* males or females not willing to use appropriate contraception
* recent blood donation
* recent blood received
* high consumption of alcohol
* high consumption of tobacco
* subjects who have engaged in heavy exercise last two weeks
* prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety
* other medication know to alter drug absorption or elimination
* abnormal heart rate or blood pressure or 12-lead ECG
* significant history of drug allergy, or hypersensitivity to treatment ingredients
* ocular disorder requiring topical ocular therapy, or recent allergic eye disease
* other significant medical history or physical findings

Primary outcomes:
measure: Pharmacokinetic assessments of icosabutate - AUC
timeFrame: 0-36 hour
measure: Pharmacokinetic assessments of icosabutate - Cmax
timeFrame: 0-36 hour
measure: Number of patients with Adverse Events
timeFrame: During the 36 hour assessment, and at post-study visit day 5-7
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit (CRU) Ltd.
Study officials:
affiliation: Covance
name: Ashley Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00986635: Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Differences in Laboratory Coagulation Parameters
Keywords: Activated partial thromboplastin time
Thrombin clotting Time
Anti-Xa-activity
Factor X-activity
Factor XIII-activity
Antithrombin (based on factor II)
Antithrombin (based on factor X<9
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 100
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: patients after hip or knee replacement surgery

Brief summary: Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Xarelto® on different coagulation parameters.

Detailed description: To validate the effects of Rivaroxaban on coagulation parameters plasma samples of patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d are investigated.

Plasma samples are obtained by blood collection before, after 2 hours and after 12 hours after Rivaroxaban dosing in steady state (on 3rd - 5th day).

Several techniques, including clot-based tests, chromogenic assays and ELISA´s are used for coagulation assays in our coagulation laboratory Frankfurt/Main. The influence of Rivaroxaban on different coagulation assays should be investigated in our coagulation laboratory.

Eligibility criteria: Inclusion Criteria:

* patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d
* must be able to accept blood sampling

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital Frankfurt/Main Germany
name: Helen Mani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mani H, Hesse C, Stratmann G, Lindhoff-Last E. Ex vivo effects of low-dose rivaroxaban on specific coagulation assays and coagulation factor activities in patients under real life conditions. Thromb Haemost. 2013 Jan;109(1):127-36. doi: 10.1160/TH12-04-0228. Epub 2012 Nov 8.
Clinical trial NCT01452035: Exercise Dose Response for Improving Insulin Sensitivity
Official title: Comparing the Effects Exercise Intensity and Energy Expended During a Single Exercise Session on Insulin Sensitivity and Fatty Acid Partitioning Within Skeletal Muscle the Next Day in Obese Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: insulin sensitivity
fatty acid metabolism
exercise
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-10-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Many of the beneficial metabolic effects of endurance exercise training are not due to adaptations to weeks, months, or even years of training, but rather much is due to the response to the most recent exercise session(s). Therefore, the investigators contend that lifestyle interventions for obese individuals should be tailored to optimize the metabolic effects of the most recent exercise session(s). But the "dose" of exercise necessary to evoke these beneficial responses is not known, and the mechanisms responsible for these improvements are poorly understood. The findings from these studies will: 1) establish the minimum "dose" of a single exercise session necessary to improve insulin sensitivity the next day in obese adults, 2) characterize the underlying metabolic factors responsible for the improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations that occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise program. Findings from these studies will provide valuable information for the development of lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise session in obese patients.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index \[BMI\] = 30-45 kg/m2, weight stable (± 5 lbs in the past month), fasting blood glucose concentration must be \<125 mg/dl.

Exclusion Criteria:

* pregnancy, evidence of cardiovascular or metabolic disease, taking medications know to influence metabolism.

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 2-3 hours
Secondary outcomes:
measure: Resting Metabolic Rate
timeFrame: 40-60 min
measure: Meal Tolerance Test
timeFrame: 2-3h
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Clincal Research Unit
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey F Horowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04137835: Non-invasive Evaluation of Upper and Lower Body Function With Showmotion
Official title: Non-invasive Evaluation of Upper and Lower Body Function With Showmotion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee
Osteoarthritis, Spine
Keywords: osteoarthritis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 60
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: SUPPORTIVE_CARE

Brief summary: It is very important to understand joint and body kinematics and muscles activity in clinical settings, which is relevant to identify issues related to the spine, the upper and lower limbs due to injury.

In this study, the investigators will use an innovative platform, Showmotion to establish baseline of shoulder, hip, knee and spine kinematics and muscles activity from 60 healthy volunteers.

Detailed description: Upper and lower body functional evaluation is challenging and relevant to identify the issues related to injury. Current technique still stays at visual observation.

Showmotion™ (NCS Lab, Carpi, Italy) is an innovative platform that provides a comprehensive analysis to monitor motion patterns of the whole body using WISE sensors, proprietary wireless inertial and magnetic units (MIMU) developed by NCS Lab (Italy).

Using the data acquired from MIMU and validated protocols for upper and lower limbs, Showmotion is able to measure, objectify and store three dimensional kinematic variables highlighting underlying information and allowing an in-depth analysis of the movement in real time.

Compared to the classic motion analysis performed with cameras in special research laboratories, the Showmotion™ technology allows the user to analyze the movements of the subjects in any place, quickly, and without the need to a long process of data analysis.

Eligibility criteria: Inclusion Criteria:

* Healthy people (without musculoskeletal pathologies of the joint of interest)
* Age \> 18, \<65
* Volunteers given written informed consent
* Ability to understand and execute instructions at all stages of the procedure

Exclusion Criteria:

* Age \> 65, \< 18
* Active infections
* Surgery at joint of interest
* BMI (Body Mass Index) \>30 kg/m2
* Pregnancy

Primary outcomes:
measure: range of motion
timeFrame: 1 HOUR
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Vikas Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01970735: Clinical, Genetic and Epigenetic Characterization of Patients With FSHD Type 1 and FSHD Type 2
Official title: Clinical, Genetic and Epigenetic Characterization of Patients With FSHD Type 1 and FSHD Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophy, Facioscapulohumeral
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study was to compare the severity of illness between groups of patients (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2).

Despite advances in research on the subject, answers are still needed on these diseases.

We also aim to determine whether the chromosomal genetic abnormality is involved in other diseases and the frequency of this mutation in the population of patients FSHD.

This study will increase our knowledge of the two forms of FSHD who present a common pathophysiological mechanism and may occur together in the same family with a worsening of the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1 and type 2 seems to have clinical consequences requiring appropriate management


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years and \<75 years
* FSHD patients 1 or 2 with or without genetic confirmation

Exclusion Criteria:

- Patient with all conditions considered by the investigator interfering with the proper conduct of the study.

Primary outcomes:
measure: Muscle damage measure
timeFrame: One time at the inclusion
measure: Level of muscle damage
timeFrame: One time at the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Archet 1
Study officials:
References:
citation: Sacconi S, Briand-Suleau A, Gros M, Baudoin C, Lemmers RJLF, Rondeau S, Lagha N, Nigumann P, Cambieri C, Puma A, Chapon F, Stojkovic T, Vial C, Bouhour F, Cao M, Pegoraro E, Petiot P, Behin A, Marc B, Eymard B, Echaniz-Laguna A, Laforet P, Salviati L, Jeanpierre M, Cristofari G, van der Maarel SM. FSHD1 and FSHD2 form a disease continuum. Neurology. 2019 May 7;92(19):e2273-e2285. doi: 10.1212/WNL.0000000000007456. Epub 2019 Apr 12.
Clinical trial NCT06749535: The Detection of Chronic Obstructive Pulmonary Disease in Patients With Diabetes Mellitus
Official title: The Detection of Chronic Obstructive Pulmonary Disease in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Aim is to access the Chronic Obstructive Pulmonary Disease in Patients With Diabetes Mellitus

Brief summary: "Background: Chronic obstructive pulmonary disease (COPD) is an ongoing lung condition caused by damage to the lungs. The damage results in swelling and irritation, also called inflammation, inside the airways that limit airflow into and out of the lungs. Diabetes can worsen the progression and prognosis of COPD.

Detailed description: If inflammation cause in lungs breathing process become disturbed. If damages the air sacs (alveoli) that cause emphysema. COPD mainly starts with asymptomatic patients who do not realize that they have it. It mostly affects older people or middle-aged. Its symptoms become develop slowly but with the time they become worsen, patient change their life style and treatment become helpful to prevent from chronic disease The Detection of Chronic Obstructive Pulmonary Disease in Patients with Diabetes Mellitus.

Methods: The Study design was cross sectional and carried out in hospital, Lahore from July 2024 to Jan 2024. All eligible patients who were Diabetes Mellitus in the study through random sampling technique.

Eligibility criteria: Inclusion Criteria:

* Age: 30-65 years Gender: Both
* Male and female
* At least 5-10 year history of Diabetes Mellitus
* Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

* Patients who smoke prolong.
* Patient having other diseased (asthma, lung carcinoma).
* Patients having Acute Respiratory Distress Syndrome (ARDS)."

Primary outcomes:
measure: copd
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Gulab devi hospital, Ferozepur Rd, Nishtar Town
state: Punjab
Study officials:
References:
Clinical trial NCT03448835: Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA)
Official title: Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stomach Cancer
Gastro Esophageal Junction Cancer
Keywords: short term immunotherapy
surgical resection
atezolizumab
capecitabine
oxaliplatin
docetaxel
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2018-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group, open label
Primary purpose: TREATMENT

Brief summary: In this explorative study, patients with resectabel cancer of the stomach or stomach-oesophagealjunction cancer will receive neoadjuvant treatment.

The treatment will be 1 cyle atzolizumab monotherapy, followed by 4 cycle of atezolizumab and capecitabine, oxaliplatin and docetaxel.

Detailed description: In this single-centre, open-label, monocenter study, the investigators will enroll 20 patients with resectable cancer of the stomach of GEJunction.

All patients will be treated with 1 cycle of atezolizumab monotherapy, followed by 4 cycles of combinationtherapy of atezolizumab, capecitabine, oxaliplatin and docetaxel, followed by surgery.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* patients age 18 and older
* primary resectable, histologically confirmed gastric or GEJ adenocarcinoma

Exclusion Criteria:

* no signs of distant metastases
* no active or history of autoimmune disease or immune deficiency
* no significant cardiovascular disease
* no major surgical procedure within 4 weeks prior to initiation of study treatment
* no current treatment with anti-viral therapy or HBV
* no pregnancy or breastfeeding
* no history of malignancy within 3 years prior to screening

Primary outcomes:
measure: Incidence of adverse events following treatment (safety)
timeFrame: until 100 days after last patient last study drug treatment
Secondary outcomes:
measure: pathological tumor regression grade
timeFrame: Within 6 months after last patient inclusion
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Marieke van de Belt
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
Study officials:
affiliation: Antoni van Leeuwenhoek
name: Myriam Chalabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Clinical trial NCT03137758: A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Official title: A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Castration-Resistant Prostate Cancer
Lead sponsor: Pellficure Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC


Eligibility criteria: Inclusion Criteria:

* histologically confirmed diagnosis of metastatic CRPC
* standard of care androgen deprivation treatment
* castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)
* progressive disease while receiving androgen deprivation therapy
* previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
* adequate hematologic, renal and hepatic function
* KPS of ≥ 70 or ECOG of 0 to 1

Exclusion Criteria:

* pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
* use of opiate analgesics for prostate cancer pain within 4 week of treatment start
* more than one sequential second generation AR-directed therapy
* received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks
* history of bleeding disorder
* history of seizure disorder
* concomitant use of therapeutic anticoagulation
* history of or current cardiac issues
* received external beam radiation therapy within 4 weeks
* CTCAE Grade \> 2 neuropathy

Primary outcomes:
measure: Toxicities and Adverse Events
timeFrame: 28 days
Secondary outcomes:
measure: Response
timeFrame: up to 2 years
measure: Toxicities and adverse events
timeFrame: up to 2 years
Other outcomes:
measure: Measurement of Serum Cytoine IL-6
timeFrame: up to 2 years
measure: Measurement of Urine Polyamines
timeFrame: up to 2 years
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
References:
Clinical trial NCT00162058: A Phase II Study of DMP 115 to Assess Focal Liver Lesions
Official title: An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Disease
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with 1 but \<7 focal liver lesions
* Scheduled for liver biopsy within 30 days of study
* Scheduled for CT or MR within 30 days of study

Exclusion Criteria:

* Critically ill subjects
* Subjects with right-to-left shunts

Primary outcomes:
measure: The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study.
Secondary outcomes:
measure: The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Scotland
Study officials:
affiliation: Consultant Radiologist, Royal Infirmary
name: Edward L.S. Leen, MD
role: PRINCIPAL_INVESTIGATOR
References: