louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01476176: A Pharmacokinetic Study of an Experimental Paracetamol Formulation
Official title: A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Headache, Tension-Type
Keywords: Bioequivalence
Pharmacokinetics
Healthy volunteers
paracetamol
caffeine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This PK study is designed to show bioequivalence between the study treatments.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

-

Primary outcomes:
measure: PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
timeFrame: 10 hours
Secondary outcomes:
measure: PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)
timeFrame: 10 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services ARIZONA
state: Arizona
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02591576: Long Term Excess Mortality of Acute Myocardial Infarction in Patients With and Without Diabetes: A Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Diabetes on Long Term Excess Mortality Following Acute Myocardial Infarction
Keywords: Diabetes
ST-elevation myocardial infarction (STEMI)
non-STEMI
Excess mortality
Relative survival
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 700000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI and NSTEMI were eligible for analysis if they have been hospitalised following AMI between the period of 2003-2013 and were aged at least 18 years. Only records of the first admission were considered for analyses.

Brief summary: Diabetes is key risk factor for death following acute myocardial infarction. However, the long-term excess risk of death associated with diabetes following acute myocardial infarction not known. Investigators aimed to determine the long-term excess risk of death associated with diabetes among patients with ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) after adjustment for multimorbidity, risk factors and cardiac treatments.


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction
* Both sex
* 18 years

Exclusion Criteria:

Primary outcomes:
measure: Long term excess mortality
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Alabas OA, Hall M, Dondo TB, Rutherford MJ, Timmis AD, Batin PD, Deanfield JE, Hemingway H, Gale CP. Long-term excess mortality associated with diabetes following acute myocardial infarction: a population-based cohort study. J Epidemiol Community Health. 2017 Jan;71(1):25-32. doi: 10.1136/jech-2016-207402. Epub 2016 Jun 15.
Clinical trial NCT00428376: Does Block Play Improve Language Acquisition: A Randomized Trial
Official title: Clinical Trial of Building Block Distribution in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Megablocks
First posted: 2007-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years of age to see if language acquisition improves.

Detailed description: Children in age group are randomized to get two sets of blocks or not. Outcomes include language development assessed using the Macarthur Bates CDI 6 months after enrollment.

Eligibility criteria: Inclusion Criteria:

* healthy children

Exclusion Criteria:

* developmental delay, non-English

Primary outcomes:
measure: Macarthur Bates Language Inventory
Secondary outcomes:
measure: TV viewing
measure: Block play
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Dimitri Christakis, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01359176: Capnography Data Collection From Healthy Participants
Official title: The Capnography Library: Data Collection From Healthy Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric healthy volunteers

Brief summary: Capnography is the non-invasive monitoring of the concentration or partial pressure of carbon dioxide (CO2) in the expired respiratory gases; it is thus a non-invasive monitoring technique which allows fast and reliable insight into ventilation, circulation and metabolism. The capnogram is a direct monitor of the inhaled and exhaled concentration or partial pressure of CO2, and an indirect monitor of the CO2 partial pressure in the arterial blood. The purpose of this study is to create a waveform library by collecting CO2 waveform data from healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Consent to participate in the trial by volunteer themself or by their legal guardian

Exclusion Criteria:

* Any individual who does not consent themselves or their legal guardian does not grant consent to participate in the trial
* A medical history of heart disease, lung disease, smoking, hypertension, pregnancy, diabetes or any other illness that excludes the participant from enrolling in the trial in the opinion of the PI

Primary outcomes:
measure: To gather data received from monitoring healthy participants as reference for the creation of a capnography waveform library.
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Centre
name: Sharon Einav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03592576: Expanded Access to Navitoclax
Official title: Expanded Access to Navitoclax
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Myelofibrosis
Acute Lymphocytic Leukemia (ALL)
Lymphoblastic Lymphoma
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-07-19
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to navitoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01344876: Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
Official title: A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Chronic Myeloid Leukemia
Keywords: multiple myeloma [MM]
non-Hodgkin lymphoma [NHL]
acute myeloid leukemia [AML]
acute lymphoid leukemia [ALL]
chronic myeloid leukemia [CML]
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the maximum tolerated dose (MTD) of OPB-51602


Eligibility criteria: Inclusion Criteria:

1. Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
2. Patients who are responsive or have relapsed following standard treatment
3. Patients capable of providing written informed consent
4. Japanese patients age 20 to 75 years (inclusive) at time of informed consent
5. ECOG performance status score of 0-1
6. Life expectancy of at least 3 months
7. Adequate vital organ function
8. Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration

Exclusion Criteria:

1. Patients with other primary malignant tumors
2. Symptomatic CNS involvement
3. Ongoing or active infection, or complication that is not controllable by medication or other means
4. Complication of uncontrolled cardiac disease
5. Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
6. Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment

Primary outcomes:
measure: Subjects With Treatment Emergent Adverse Events
timeFrame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
measure: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
timeFrame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Secondary outcomes:
measure: Treatment Response
timeFrame: From first dose of study medication to withdrawal examination
Other outcomes:
Locations:
city: Nagoya
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT06934876: Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults
Official title: Waveform Capnography and Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Failure
Keywords: tracheal intubation
emergency intubation
waveform capnography
end-tidal CO2
exhaled carbon dioxide
colorimetric detection of exhaled carbon dioxide
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 1332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill adult patients undergoing emergency intubation

Brief summary: This study will compare the sensitivity and specificity of waveform capnography versus colorimetric carbon dioxide detection to identify tracheal placement of the endotracheal tube during intubation of critically ill adults.


Eligibility criteria: Inclusion Criteria:

1. Patient is located in a participating unit (ED or ICU)
2. Patient is undergoing tracheal intubation.
3. The clinician intends to use an exhaled CO2 detection device to confirm tracheal placement of the tube.

Exclusion Criteria:

1. Patient is known to be a prisoner
2. Patient is known to be \< 18 years old
3. A responsible clinician has determined that sole use of either waveform capnography or colorimetric testing is required for optimal care of the patient.

Primary outcomes:
measure: Sensitivity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned in the trachea.
timeFrame: From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute
measure: Specificity of the test of exhaled carbon dioxide to detect a endotracheal tube positioned outside of the trachea.
timeFrame: From intubation until 7 breaths from the ventilator are delivered, approximately 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
Study officials:
References:
Clinical trial NCT04359576: Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers
Official title: Impact of Frozen-thawed Embryo Transfers and Hormone Substitution on Thrombotic Risk Markers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frozen Embryo Transfer
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2020-04-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women receiving FET

Brief summary: The study focus on the impact of estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in women undertaking assisted reproductive technology treatment (ART).

Detailed description: The aim is to investigate whether the coagulation is activated in women undergoing estrogen/progesterone substitution during artificial cycle frozen embryo transfer (AC-FET) in assisted reproductive technology treatment (ART). An activation of the coagulation might induce an increased thromboembolic risk in these women. Thus, the present study may lead to improvement of the current treatment protocol for women receiving AC-FET and ultimately prevent thromboembolic complications for woman in fertility treatment.

Eligibility criteria: Inclusion Criteria:

* Women receiving FET with or without estrogen/progesterone substitution

Exclusion Criteria:

* Known bleeding disorder
* Indication for thromboprophylaxis during ART treatment
* Treatment with anti-platelet medication including non-steroid-anti-inflammatory drugs (NSAIDs) within the last week
* Donor recipients

Primary outcomes:
measure: coagulation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
Study officials:
References:
Clinical trial NCT00170976: A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension
Official title: A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HYPERTENSION
Keywords: HYPERTENSION, VALSARTAN, AMLODIPINE< SAFETY
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.


Eligibility criteria: Inclusion Criteria:

* SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL
* VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion Criteria:

* PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Adverse events and serious adverse events at each study visit for 6 or 12 months
Secondary outcomes:
measure: Change from baseline in diastolic blood pressure from baseline after 6 or 12 months
measure: Change from baseline in systolic blood pressure from baseline after 6 or 12 months
measure: Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months
measure: Change from baseline in sitting and standing pulse after 6 or 12 months
measure: Hematology and blood chemistry after 6 or 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Sites in germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04438876: The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore
Official title: The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Muscle Weakness
Lead sponsor: Geriatric Education and Research Institute
Sponsor class: OTHER_GOV
First posted: 2020-06-19
Enrollment: 61
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail and frail community-dwelling older adults in Singapore for the management of physical frailty. The proposed study will provide information on the benefits of FPT on physical performances of older adults and help to shape future exercise recommendations to slow or reverse the onset and severity of physical frailty.


Eligibility criteria: Inclusion Criteria:

* aged 55 years and above
* low muscle strength - handgrip strength less than 26kg for men and 18kg for women
* ambulate without human assistance
* able to understand basic instructions

Exclusion Criteria:

* currently enrolled in another study
* acute musculoskeletal injury
* unable to participate in the full duration of the study
* unwilling to participate if not assigned to the intervention group
* deemed not suitable to participate in exercise by a medical doctor

Primary outcomes:
measure: Change of Frail status at 12 and 24 weeks
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change of hand grip strength at 12 and 24 weeks
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change of knee extensor strength at 12 and 24 weeks
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change of Timed up and go (TUG) at 12 and 24 weeks
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change of SPPB at 12 and 24 weeks
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Exercise adherence
timeFrame: baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Geriatric Education & Research Institute
Study officials:
affiliation: Geriatric Education & Research Institute
name: Shiou-Liang Wee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tou NX, Wee SL, Seah WT, Ng DHM, Pang BWJ, Lau LK, Ng TP. Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study. Prev Sci. 2021 Nov;22(8):1048-1059. doi: 10.1007/s11121-021-01221-y. Epub 2021 Mar 19.
Clinical trial NCT00987376: Novel PET/CT Agents and MRS/MRI in Prostate CA and High Risk Prostate Cancer: An Inter-SPORE Collaboration
Official title: Comparison of Novel PET/CT Imaging Agents and MRS/MRI in Metastatic and High Risk Prostate Cancer: An Inter-SPORE Collaboration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-30
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate cancer imaging using traditional anatomic modalities including CT, MR, and ultrasound is limited. Improvement in current imaging modalities or development of new ones should be a priority in prostate cancer research. Optimal treatment varies considerably for patients with different staging characterizations and new imaging methods that more accurately stage patients could lead to more appropriate treatment. The objective of this study is to obtain preliminary, comparative data on new, promising imaging methods for prostate cancer. PET/CT imaging using 11C-choline,11C-acetate, and Y86 or 18F-Adenosylcobalamin and MRI spectroscopy (MRS) of prostate cancer will be compared. Direct comparison of these imaging methods has never been done and Mayo Clinic and Johns Hopkins are uniquely able to conduct such a trial as an inter-SPORE collaboration.


Eligibility criteria: Inclusion Criteria:

* Males 18 years of age or older
* Patients who have completed staging CT and/or bone scan as part of their routine workup
* Patients with bulky metastatic prostate cancer who have 5 or more lesions suspicious for distant metastases as determined by routine CT and/or bone scans that are untreated by radiation

Exclusion Criteria:

* Patients who are less than 6 weeks post operative for Greenfield filter placement
* Patients with metallic surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at Mayo and only those inserted after October of 1994 and /or metal fragments in the body including metal fragments in the eyes

Primary outcomes:
measure: Test accuracy
timeFrame: 2 years
Secondary outcomes:
measure: Test comparative accuracy of PET and MRI
timeFrame: 2years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
References: