louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01002807: Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
Official title: Bioavailability Study of Two Prototype Fixed Dose Combination (FDC) Formulations of 10 mg Dapagliflozin and 1000 mg Metformin Extended Release (XR) Tablet Relative to Dapagliflozin 10 mg Tablet and Glucophage® XR 2 X 500 mg Tablets Coadministered to Healthy Subjects in a Fasted State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-10-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.


Eligibility criteria: Inclusion Criteria:

* Men and women ages 18 to 45 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2

Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Glucosuria at screening
* Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
* Presence of edema on physical exam
* History of diabetes mellitus
* History of heart failure
* History of renal insufficiency
* History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
* History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
* Estimated creatinine clearance (ClCR) of \< 80 mL/min using the Cockcroft Gault formula
* History of allergy or intolerance to metformin or other similar agents

Primary outcomes:
measure: Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone
timeFrame: 48 hours post-dose
Secondary outcomes:
measure: Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments)
timeFrame: 15 timepoints in 48 hours time interval
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development, Lp
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04666207: Viral Shedding, Symptoms and Exposure of SARS-CoV-2 in Non-hospitalized Children With COVID-19
Official title: A Cohort Study of Non-hospitalized SARS-CoV-2 Positive Children in Denmark: Viral Shedding, Symptoms and Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 24
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SARS-CoV-2 PCR-positive children from two test centers in the Capital Region of Denmark

Brief summary: Data on COVID-19 in children are still scarce, and their role in SARS-CoV-2 transmission is poorly described. Furthermore, documentation of the best SARS-CoV-2 sampling methods in children are limited. In adults, saliva seems like a promising specimen to collect by noninvasive procedure to diagnose and monitor viral load of SARS-CoV-2, but this has not been tested in children yet.

We want to test the following hypothesis:

1. Shedding load and duration of SARS-CoV-2 in children are related to age, gender, clinical symptoms and exposure
2. Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2
3. Parental home testing of saliva and feces is feasible in children

The study is a prospective cohort study of SARS-CoV-2 PCR-positive children from two test centers in the Capital Region of Denmark. Children aged 0-17 years with a PCR-positive SARS-CoV-2 test from a nasal or pharyngeal swab is included from May 2020 to January 2021 and followed-up for a period of 28 days with weekly sample collection and questionnaires.

Samples include a saliva sample, a nasal swap and a rectal swap for children under four years of age. A semiquantitative RT-PCR method, will identify positive and negative samples and provide a Ct value estimating viral load. Saliva and fecal samples will be analyzed from November 2020-February 2021.

Shedding duration will be related to medial history, clinical presentation, exposure, gender and age.


Eligibility criteria: Inclusion Criteria:

* a PCR-positive SARS-CoV-2 test

Exclusion Criteria:

-

Primary outcomes:
measure: Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2
timeFrame: 1 year
Secondary outcomes:
measure: Parental home testing of saliva and feces is feasible in children
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Ulrikka Nygaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02552407: Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis
Official title: Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Acute Coronary Syndromes
Keywords: thrombectomy
acute coronary syndromes
percutaneous coronary intervention
STEMI
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Region Örebro County
name: University Medical Center Groningen
name: University of Groningen
First posted: 2015-09-17
Enrollment: 18000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ST elevation myocardial infarction undergoing emergency percutaneous coronary intervention

Brief summary: During primary percutaneous coronary intervention, distal embolization of thrombus and impaired microvascular perfusion has been associated with an increased mortality. Thrombectomy devices during primary percutaneous coronary intervention may prevent distal embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce mortality.

Detailed description: An individual patient meta-analysis of large randomized controlled trials comparing manual thrombectomy versus percutaneous coronary intervention alone in patients with ST elevation myocardial infarction will provide significantly more power to detect differences in mortality as well as important but rare events such as stroke and to assess benefits in pre-defined subgroups.

Eligibility criteria: Inclusion Criteria:

* Randomized controlled trials comparing manual thrombectomy vs. percutaneous coronary intervention alone in patients with ST elevation myocardial infarction published between January 1980 and April 2015.
* Large trials randomizing more than 1000 patients.
* Trials must have had at least 30 day follow up.

Exclusion Criteria:

-

Primary outcomes:
measure: Occurrence of Cardiovascular death
timeFrame: up to 30 days
Secondary outcomes:
measure: Occurrence of Cardiovascular death
timeFrame: up to 180 days
Other outcomes:
measure: Occurrence of Stroke
timeFrame: up to 30 days
Locations:
Study officials:
affiliation: Population Health Research Institute
name: Sanjit S Jolly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jolly SS, James S, Dzavik V, Cairns JA, Mahmoud KD, Zijlstra F, Yusuf S, Olivecrona GK, Renlund H, Gao P, Lagerqvist B, Alazzoni A, Kedev S, Stankovic G, Meeks B, Frobert O. Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation. 2017 Jan 10;135(2):143-152. doi: 10.1161/CIRCULATIONAHA.116.025371. Epub 2016 Dec 9.
Clinical trial NCT00768807: Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
Official title: Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 450
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.

Detailed description: Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function. It may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional left ventricular changes might be reverted after treatment with Continuous positive airway pressure.

Eligibility criteria: Inclusion Criteria:

* Apnea-hypopnea index higher than 5 events per hour

Exclusion Criteria:

* Body mass index higher than 40 kg/m2

Primary outcomes:
measure: Improvement of left ventricular diastolic echo variable
timeFrame: 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Sono/AFIP
Study officials:
References:
citation: Oliveira W, Campos O, Cintra F, Matos L, Vieira ML, Rollim B, Fujita L, Tufik S, Poyares D. Impact of continuous positive airway pressure treatment on left atrial volume and function in patients with obstructive sleep apnoea assessed by real-time three-dimensional echocardiography. Heart. 2009 Nov;95(22):1872-8. doi: 10.1136/hrt.2009.173625. Epub 2009 Jul 29.
Clinical trial NCT01439607: Cellular and Molecular Mechanisms Governing Bone Marrow Stem Cells in Gaucher Disease
Official title: Cellular and Molecular Mechanisms Governing Bone Marrow Stem Cells, Macrophages and Plasma Cell Biology in Gaucher Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gaucher Disease
Keywords: Gaucher disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside particularly in cells of the macrophage lineage. Clinical manifestations associate hematological, neurological and bone disorders.

Detailed description: Gaucher disease is an inherited autosomal recessive lysosomal storage disorder caused by the defective activity of the glucocerebrosidase, leading to accumulation of glucocerebroside particularly in cells of the macrophage lineage. Clinical manifestations associate hematological, neurological and bone disorders.

In this project, the investigators aimed to study the cellular and molecular mechanisms governing the biology of various cell populations of the bone marrow and blood in these patients in order to define their potential role in the physiopathology of the disease. The main research topics the investigators plan will then be focused on characterization and functional analysis of hematopoietic stem cells, mesenchymal stem cells (with a special focus on osteogenic differentiation), macrophages and osteoclastic differentiation, B lymphocytes and plasma cells.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* Gaucher disease
* clinical examination written consent

Exclusion Criteria:

* pregnancy
* HIV seropositive
* contraindication to bone marrow sampling

Primary outcomes:
measure: stem cells
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Bertrand Arnulf
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bertrabd Arnulf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06684509: Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia
Official title: Using of Atorvastatin for Anthracyclin _ Associated Cardiotoxicity in Hemetological Malignancies Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Leukemia
Hodgkin Disease
Keywords: Cardiotoxicity
Atrovastatin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The research proposal focuses on evaluating the efficacy of atorvastatin in reducing cardiotoxicity caused by anthracycline chemotherapy in patients with hematologic malignancies, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). The study will be conducted at Assiut University Hospitals and will include patients aged 18 or older receiving anthracycline-based treatments (3+7 regimen for AML and CHOP regimen for NHL).

The background highlights that anthracyclines, a class of chemotherapeutic agents, can cause serious side effects, particularly cardiotoxicity. The research aims to investigate whether atorvastatin, a statin used to lower cholesterol, can mitigate this risk by improving cardiac function in patients undergoing chemotherapy.

The study will be a randomized controlled trial with a sample size of 46 participants. It will assess left ventricular ejection fraction (LVEF) as the primary outcome to determine the effect of atorvastatin on reducing cardiotoxicity. Secondary outcomes include identifying high-risk patients and further understanding the impact of atorvastatin.

The study also adheres to ethical guidelines, ensuring patient consent and confidentiality. Data analysis will be performed using IBM SPSS, and results will be disseminated in scientific journals, with support from Assiut Medical School's Grants Office if funding is approved.


Eligibility criteria: Inclusion Criteria:

Age \>18 years Patient with hematologic malignany ( Acute myeloid leukemia on 3,7 regimen or non-Hodkin Lymphoma on CHOP regimen) Cardiac function with EF ≥60%

Exclusion criteria:

Cardiac dysfunction with EF \< 60% Other hematologic malignancies Pregnant women and breastfeeding Patients refuse participate in research

Primary outcomes:
measure: Cardiotoxicity
timeFrame: During the study period along 12 months
Secondary outcomes:
measure: Cardiotoxicity events correlation to high risk patients
timeFrame: along 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT00982709: The Effects of Treadmill Versus Agility Training in Parkinson's Disease
Official title: The Effects of Treadmill Versus Agility Training in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Parkinson's Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim:

To determine the Responsiveness of the iMOBILITY in response to intensive physical therapy exercise programs. (Is it sensitive to change?) Although exercise is thought to be the most effective intervention for balance and gait in PD (compared to dopaminergic medication or DBS surgery), the best exercise program for mobility in PD is unknown. The iMOBILITY will be used to quantify balance and gait performance before and after two PT-supervised, intensive, exercise programs, expected to improve balance and gait. The first program is a published Treadmill training program and the second is the investigators new Agility training program with sensorimotor progressions, targeted at specific impairments that underlie the abnormalities of balance and gait in PD (developed for the Kinetics Foundation). This pilot clinical trial will randomize 40 PD subjects into the two exercise programs at OHSU in preparation for a larger clinical trial to determine the most effective exercise for mobility disability in PD. The effects of exercise will be compared with no treatment during a 5-week delay prior to start of exercise.

This trial will also determine the relative responsiveness (compared to traditional clinical scales) of the iMOBILITY for testing the hypothesis that intensive exercise can improve mobility in PD. We will use existing instruments (Berg Balance Scale, BEST of dynamic balance, UPDRS, PDQ-39, 5 times sit-to-stand time and the Functional Performance Battery) to show there is a difference between the exercise groups. Superior responsiveness of the iMOBILITY system will be determined by larger differences with exercise intervention with the iMOBILITY system than with traditional clinical measures of mobility in PD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Idiopathic PD

Exclusion Criteria:

* Other neurological conditions, artificial joints

Primary outcomes:
measure: Dynamic Posturography
timeFrame: pre and post intervention
Secondary outcomes:
measure: UPDRS
timeFrame: pre and post intervention
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
Clinical trial NCT02359409: Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy
Official title: Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Redundant Colon
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to look if use of goggle balloon can help to complete colonoscopy in patients with very redundant colons.

Detailed description: About 5% of colonoscopies are technically difficult because the colon is elongated or redundant. There is an increased risk of the colonoscope not reaching the cecum in these cases. One solution to this is to try to keep the colon shorter by not insufflating it with gas. In order to achieve that, in these cases the investigators typically fill the colon with water, which does not distend the colon as much. Another technique, which can improve visualization, is to use a device called the goggle balloon. This is a small balloon filled with a few mL of water which fits over the end of the colonoscope and pushes the colonic mucosa away from the end of the scope so that the luminal direction can be visualized with minimal insufflation. In patients with normal colons, the goggle balloon can be used to insert the colonoscope to the cecum with virtually no air or water filling. We aim to study if the goggle balloon can be used to help complete the colonoscopy in patients with redundant colons.

Eligibility criteria: Inclusion Criteria:

Referral for incomplete colonoscopy

Exclusion Criteria:

Known stricture or narrowing of the colon, prior colon resection

Primary outcomes:
measure: number of subjects with complete colonoscopy in each arm
timeFrame: 2 years
Secondary outcomes:
measure: Time to cecal intubation in each arm
timeFrame: 2 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: IU Medical Center
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395209: Muscle Strength Loss In Stroke Individuals - Control Study
Official title: Muscle Strength Loss In Stroke Individuals - Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: individuals with stroke and healthy subject
Primary purpose: OTHER

Brief summary: ABSTRACT The muscle strength (MS) is necessary to overcome the resistance encountered during the activity. The present study aims to determine MS loss in stroke individuals (SI). 33 SI and 33 healthy individuals (HI) were included in this study. MS and handgrip force were assessed using a power track dynamometer and Jamar hand dynamometer, respectively. The total MS of the HI was calculated by summing the muscle strength of the trunk, lower and upper extremities. In the SI, the muscle strength of the trunk, unaffected upper and lower extremities were summed to calculate the total MS. To compare MS of unaffected sides (US) between groups, 27 SI who was dominant and not affected on the right side and 33 HI who was dominant on the right side were used.


Eligibility criteria: Inclusion Criteria:

* for patient with stroke
* Between 30-65 ages
* Diagnosed with stroke chronic stroke patients (diagnosed with a stroke at least 6 months ago)

for healthy individuals

* 30-65 ages
* healthy individuals

Exclusion Criteria for patient with stroke

* patient with an additional neurological disease to stroke
* patients with orthopedic problems,
* patients with mental and communication impairments
* patients who scored more than 3 points for the Modified Rankin Scale for healthy individuals;
* who had active sporting life

Primary outcomes:
measure: Muscle Strength Loss In Stroke Individuals - Control Study
timeFrame: 24 week
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: University Address
state: Pamukkale
Study officials:
References: