louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01612884: Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Official title: Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Thrombosis
Coronary Artery Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 67
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. This study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting


Eligibility criteria: Inclusion Criteria:

* Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction) and referred for coronary angiography.
* Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for \>5 days)
* Age range 21-75 years.

Exclusion Criteria:

* Unable to give consent
* Age younger than 21 years, greater than 75 years
* History of stroke
* Body weight \<60 kg
* Acute STEMI,
* Thrombocytopenia\<100'000,
* requirement for chronic warfarin therapy

Primary outcomes:
measure: Thrombelastography (TEG) MA
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants With Ischemic Events
timeFrame: 6 months
measure: Number of Participants With Bleeding Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT06036784: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects
Official title: A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postbariatric Hypoglycemia
Lead sponsor: MBX Biosciences
Sponsor class: INDUSTRY
Collaborators: name: ProSciento, Inc.
First posted: 2023-09-14
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and Drug Drug Interaction of MBX 1416 in healthy volunteers

This study includes 3 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part C involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of MBX 1416.


Eligibility criteria: Part A/B/C Inclusion Criteria:

1. Female and male adults, ages ≥ 18 and ≤ 65 years with a body mass index (BMI) ≥ 18 kg/m² to ≤ 30.0 kg/m² and fasting glucose \< 100 mg/dL and HbA1c \< 5.7%.
2. Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.

Part A/B/C Exclusion Criteria:

1. Pregnant, lactating or intending to become pregnant during the study.
2. Use of weight-lowering pharmacotherapy or participation in a clinical weight control study within the previous 3 months prior to the first dose of study drug.
3. Presence of clinically significant ECG findings
4. Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
5. Abnormal laboratory results at Screening.
6. History of renal disease or abnormal kidney function tests at Screening
7. Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.

Primary outcomes:
measure: Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)
timeFrame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: MBX Biosciences Investigational Site
state: California
Study officials:
References:
Clinical trial NCT06246084: INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy
Official title: INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Cancer Female
Breast Carcinoma
Keywords: Breast Cancer
Breast Cancer Female
Breast Carcinoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy.

The name of the intervention used in this research study is:

Endocrine Therapy Education Program (a brief, video-based intervention)

Detailed description: This research study is a randomized pilot study to determine whether a brief-video based intervention program can improve experiences of Endocrine Therapy (ET). Participants will be randomized into one of two groups: Group A: Endocrine Therapy Education Intervention vs. Group B Wait-list Control Group. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-clinic visits, and survey questionnaires.

Participation in this research study is expected to last 3 months.

It is expected that about 60 people will take part in this research study.

Eligibility criteria: Inclusion Criteria:

* Biologically female
* About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)
* 18 years of age or older
* English fluency for reading and writing.
* Computer literacy (ability to watch videos and fill out questionnaires online)

Exclusion Criteria:

* Adults unable to consent
* Individuals with metastatic cancer
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Engagement Rate of Intervention
timeFrame: 6 weeks
measure: Intervention Satisfaction Questionnaire Mean Score Group A
timeFrame: At 6 weeks
measure: Intervention Satisfaction Questionnaire Mean Score Group B
timeFrame: At 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ann Partridge, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01066884: A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>= 18 years of age;
* inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
* ECOG performance status of 0-3;
* previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.

Exclusion Criteria:

* prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
* unstable systemic disease;
* any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
* any significant ophthalmologic abnormality.

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Length of patient on study (length of time of patient on study determined by investigator)
Secondary outcomes:
measure: Best Response Rate per investigator assessment
timeFrame: Length of patient on study (length of time of patient on study determined by investigator)
measure: Time to Progression (TTP)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
measure: Overall survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Other outcomes:
Locations:
city: Balashikha
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00848484: Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Add-On Therapy, 2-Period Cross-Over Clinical Trial to Evaluate the Safety and Efficacy of MK5757 for the Treatment of Cognitive Impairment in Men With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 54
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patient is male between 21 and 55 years of age
* Duration of the illness must be longer than 1 year
* Patient's current antipsychotic medication regimen must be stable
* Patient is negative for selected drugs of abuse at Screening
* Must be in a stable living arrangement for at least 3 months prior to screening (not a homeless shelter)

Exclusion Criteria:

* Patient has mental retardation
* Undergone Electroconvulsive Therapy (ECT) treatment within 6 months prior to screening
* Has suicidal attempts or ideation within the last 12 months
* Patient has a history of alcohol/drug dependence within 1 year or alcohol/drug abuse within 12 months of starting the study

Primary outcomes:
measure: Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score
timeFrame: Baseline and week 2
measure: Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score
timeFrame: Baseline and Week 2
measure: Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00141284: An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C
Official title: A Phase Iv Single-Arm Open-Label Non-Randomized Study To Evaluate The Safety And Pharmacokinetics Of Nelfinavir (Viracept, A430) 1250mg Twice Daily (250mg Or 625mg Forms) With Lamivudine/Zidovudine (Combivir) Background Therapy In Hiv/Hepatitis C Virus (Hcv) Co-Infected Subjects With Hepatic Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Hepatitis C
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the safety, efficacy and delineate the pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child Pugh A compensated cirrhosis and or Hepatic fibrosis


Eligibility criteria: Inclusion Criteria:

* HIV/ Hepatitic C co infected with documented HCV viremia evidence for cirrhosis and or hepatic fibrosis on liver biopsy, positive fibrosis index, stable health

Exclusion Criteria:

* Decompensated cirrhosis (Child Pugh B or C)
* Pregnant or lactating women
* History of previous antiretrovirals \> 14 days

Primary outcomes:
measure: To Evaluate the safety of nelfinavir 1,250 mg orally taken twice daily in HIV/HCV co infected adult subjects with compensated cirrhosis (Child Pugh A) or hepatic fibrosis.
Secondary outcomes:
measure: To evaluate the pharmacokinetics of nelfinavir and M8, the major metabolite.
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05115084: The Effect of the COVID-19 Epidemic Process on the Nutritional Habits and Body Weights of Adults
Official title: The Effect of the COVID-19 Epidemic Process on the Nutritional Habits and Body Weights of Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pandemic
Eating Habit
Weight Gain
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals between the ages of 19 and 70 who agreed to participate in the study.

Brief summary: During the COVID-19 epidemic, the time spent by adults on the stomach has increased. Therefore, the likelihood of adverse changes in lifestyles has increased. In this study, the changes in nutritional habits, physical activities and body weights of adult individuals during the epidemic will be evaluated. A questionnaire including questions about nutritional habits, physical activity status and changes in body weights will be administered to individuals. The results will be evaluated with the appropriate statistical method. The survey will be administered once. The estimated time to reach the total number is 3 months.


Eligibility criteria: Inclusion Criteria: Adult individuals wishing to participate in the study -

Exclusion Criteria: Individuals outside the age range of 19-70 years, all individuals who did not agree to participate in the study.

-

Primary outcomes:
measure: Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00302484: Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation
Official title: Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Liver Transplantation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-03-14
Enrollment: 96
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: Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate, slows down the destruction of bone. The purpose of this study is to determine whether bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive therapy after liver transplantation.


Eligibility criteria: Inclusion Criteria:

* primary liver transplantation
* retransplantation within two weeks
* written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* chronic kidney disease:
* Creatinine Clearance \< 35 ml/min or Serum Creatinine \> 2,5 mg/dl
* known hypersensitivity to Zoledronate, or any of the recipients of the drug
* bone specific medication (Bisphosphonate, Fluoride, Calcitonin) within the last three months before liver transplantation

Primary outcomes:
measure: first bone fracture or death within 24 months after liver transplantation
Secondary outcomes:
measure: bone mineral density (pre-transplant, 6 and 12 months post-transplant)
measure: serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
measure: histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Surgery, Division of Transplantation
Study officials:
affiliation: Medical University of Vienna
name: Ferdinand Mühlbacher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05065684: Effect of rhBMP-2 or rhBMP-7 on Long Bone Fractures and Non-unions.
Official title: Effect of rhBMP-2 or rhBMP-7 on Long Bone Fractures and Non-unions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long Bone Non-union
Keywords: Long bone non-union
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 150
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: Patients with an acute fracture or non-union of a long-bone

Brief summary: Delayed fracture healing continues to cause significant patient morbidity and economic burden to society. Biological stimulation of acute fractures and non-unions includes application of rhBMP-2 and rhBMP-7. However, BMP use continues to be a matter of controversy as literature shows scarce evidence for treatment effectiveness. The aim of this study is to compare acute fractures and non-unions in the long bones humerus, femur and tibia with and without BMP treatment of acute fractures. Furthermore, the investigators want to identify complications and risk factors on union-rate and time to union.

Detailed description: Primary Objective:

The primary objective is to assess time to union and union rate after rhBMP-2 and rhBMP-7 application at long bone fractures and non-unions.

Secondary Objective(s):

* Analysis of secondary complications
* Analysis of risk factors

Hypothesis and Statistical considerations and estimated enrollment:

The investigators hypothesize that with the use of rhBMP-2 and rhBMP-7 there will be a faster timer to union and higher union rate compared to no-BMP. Outcomes will be assessed prospectively.

This study is exploratory in nature. Therefore, there is no formal statistical hypothesis and no formal sample size calculation. Approximately 150 long-bone fractures and non-unions are expected.

Data will be analyzed with the use of simple summary statistics. Depending on the volume and quality of the collected data, different statistical analyses will be applied. Exploratory analyses will be conducted to investigate relationships between the different treatment options and the outcomes.

Eligibility criteria: Inclusion Criteria:

* Long bone fracture or long bone non-union.
* Signed informed consent, if required by IRB/EC

Exclusion Criteria:

Prisoner at date of inclusion

Primary outcomes:
measure: Time to Union
timeFrame: 24 months
measure: Union-rate
timeFrame: 24 months
Secondary outcomes:
measure: Risk factor analysis
timeFrame: 24 months
measure: complications/Adverse Events related to implant or surgery
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Muenster
name: Michael J. Raschke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: