louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00055432: Gemzar (Gemcitabine) and Alimta (Pemetrexed) in the Treatment of Patients With Recurrent Platinum-Sensitive and Platinum-Resistant Ovarian or Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Peritoneal Cancer
Keywords: recurrent ovarian cancer
platinum-resistant
platinum-sensitive
folate receptor antagonist
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2003-03-04
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study hopes to evaluate whether the combination of Gemzar plus Alimta will have any beneficial effects for patients with recurrent platinum-sensitive or platinum-resistant ovarian or peritoneal cancer. Treatments are weekly for two weeks, with the 3rd week off and will be repeated every 21 days. Side effects and the overall safety of the treatment will also be monitored and evaluated. In addition, a Quality of Life questionnaire is part of this study to help measure patient perceived benefits or drawbacks to this treatment regimen.


Eligibility criteria: Inclusion Criteria:

* Patients must have disease that can be measured.
* Patients must meet criteria for either platinum-resistant or platinum-sensitive ovarian or peritoneal cancer.
* Patients may only have had one prior platinum-based chemotherapy regimen.
* Patients must be willing and able to stop all aspirin and NSAID medications immediately before and for a time after each treatment cycle (approx. 5-8 days)
* Patients must have normal kidney function.

Exclusion Criteria:

* Patients may not have a Low Malignant Potential or Borderline Ovarian Tumor.
* Patients may not have received pelvic or abdominal radiotherapy.
* Patients must not have evidence of or received treatment for another cancer within the last 5 years.
* Patients must not have been diagnosed with a heart attack in the last 6 months.
* Patients who are unwilling or unable to take folic acid tablets, vitamin B12 injections or dexamethasone tablets.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
state: Georgia
Study officials:
References:
Clinical trial NCT00943332: Pediatric Femur Research Project
Official title: Pediatric Femur Research Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Fracture
Keywords: Orthopedic Procedures
Fracture Fixation, Internal
Fracture Fixation, External
femur fracture
pediatrics
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Missouri-Columbia
name: Children's Mercy Hospital Kansas City
First posted: 2009-07-22
Enrollment: 48
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will have undergone of the following interventions for the treatment of the femur fracture: spica casting, nancy nailing, or submuscular plating, by a participating physician in the trial. All of these treatments are considered standard of care for this pediatric population.

Brief summary: Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting for patients 6 years and younger and for patients over 6 years and older is percutaneous or open placement of titanium elastic intramedullary nails. The investigators would like to evaluate the current treatment protocol by comparing those patients 6 years and younger treated with closed reduction and spica casting to those 6 years and younger treated with percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The investigators will be comparing their post-operative functional level, pain management, impact on family and complications through chart and x-ray reviews. The goal is to improve patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6 years old and younger and increase the knowledge of those residents/physicians who care for this patient population.


Eligibility criteria: Inclusion Criteria:

* Child diagnosed with femur fracture between the ages of 2-6 years old
* Patient will undergo surgical intervention for a femur fracture (e.g., submuscular plating, Nancy nailing, casting )

Exclusion Criteria:

* Parent refusal to participate for any reason
* Children with neuromuscular disorders having a Gross Motor Function Classification greater than 3
* Pathologic fracture

Primary outcomes:
measure: Impact on family
timeFrame: 6 months
Secondary outcomes:
measure: post-operative functional level
timeFrame: 1 year
measure: pain management
timeFrame: 6 weeks
measure: complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Children's Hospital - University Missouri
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Childrens Hospital
state: Missouri
Study officials:
affiliation: Washington Univeristy
name: J. Eric Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00984932: Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension
Official title: The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis
pulmonary hypertension
rosuvastatin
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event and statins through their vasculoprotective effect might be of value in the treatment armamentarium of PAH related to SSc.

The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.

Detailed description: Background: Pulmonary arterial hypertension (PAH) is an acknowledged devastating complication of systemic sclerosis (SSc); difficult to manage with a poor prognosis.

Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event.

Statins, through their pleotropic effects might be of value in the treatment armamentarium of PAH related to SSc.

Objectives: The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.

Methods: Forty SSc patients fulfilling the ACR criteria for the classification of SSc diagnosis and having PAH were recruited.

All SSc patients underwent transthoracic echocardiography and the six minute walk test (SMWT).

Patients were randomized into 2 groups; the first group (n = 23) were assigned to receive 40mg of rosuvastatin and the second group (n = 23) received placebo for 6 months.

The levels of endothelial dysfunction and inflammatory markers were assayed at baseline and after 6 months of therapy. Outcome measures assessed included exercise capacity (SMWT), MPAP, WHO functional class change, tolerability and safety.

Eligibility criteria: Inclusion Criteria:

* New York Heart Association (NYHA) class III
* A mean pulmonary artery pressure (mPAP) of \> 30mmHg at rest

Exclusion Criteria:

* Smoking
* Diabetes mellitus
* Hypercholesterolemia
* Hypertension
* Cardiac insufficiency
* Coexisting hepatic and renal diseases
* Use of drugs known to interact with statins.
* Patients with severe interstitial lung fibrosis

Primary outcomes:
measure: exercise capacity measured by the SMWT, mPAP and WHO functional class change
timeFrame: At baseline and After 6 months of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, University of Alexandria
Study officials:
affiliation: University of Alexandria
name: Anna Abou-Raya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02431832: Exploration of microRNA and Metabolomics Biomarkers Predicting Drug Induced Liver Injury in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Elderly
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 17
Sex: MALE
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An open-label, one-sequence, multiple administration study for exploration of microRNA and metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean people.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects, as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations were eligible to participate in the study. Subjects had to be 65 to 84 years of age.

Exclusion Criteria:

* Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: up to 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT03695432: Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly
Official title: Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza-like Illness
Keywords: Influenza
Vaccine
Probiotic
Influenza-like Illness
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 910
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: To asses the effect of the probiotic and influenza vaccination alone and combination on enhancing immune response to influenza-like illness (ILI) and reducing ILI incidence in the elderly

Detailed description: To see percetange of subjects seroconvertion and seroprotection before and after intervention in the elderly (\>60 years), and monitored for 6 months.

Eligibility criteria: Inclusion Criteria:

* all health elderly aged ≥ 60 years
* who came to the vaccination and health education activities in the entire East Jakarta District Health Center
* with Body Mass Index (BMI) 17,5-29,9
* healthy mental status (MMSE score of 28-30)

Exclusion Criteria:

* subject who have contraindications to influenza vaccinations
* are undergoing treatment related to immune system modulation in the past 4 weeks
* therapy for immunossuppresants and/ or corticosteroids eqivalent to prednisone ≥ 20 mg/day that is being lived more than 2 weeks or has only been stopped less than 3 months before the study
* recieved influenza vaccination less than one year before
* Currently consuming probiotic agents, either in the form of a manufacturer or natural for more than 7 days.

Primary outcomes:
measure: The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of subjects with anti HI titer >=1:40
timeFrame: 6 months
measure: Percentage subjects with increasing antibody titer >=4 times
timeFrame: 6 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Integrated Health Post, at Pulo Gadung District
state: DKI Jakarta
Study officials:
affiliation: Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University
name: Sukamto Koesnoe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koesnoe S, Masjkuri N, Adisasmita A, Djauzi S, Kartasasmita C, Sundoro J, Nadjib M, Korib M, Muthia AN, Muzellina VN, Habibah U, Nursyirwan SA, Djaya KH, Bachtiar NS, Sari RM. A randomized controlled trial to evaluate the effect of influenza vaccination and probiotic supplementation on immune response and incidence of influenza-like illness in an elderly population in Indonesia. PLoS One. 2021 Dec 16;16(12):e0250234. doi: 10.1371/journal.pone.0250234. eCollection 2021.
Clinical trial NCT05480332: Defining the Role of Endothelial Function Assessment Using EndoPAT in Cardiovascular Risk Screening : Comparison to Traditional Risk Assessment Tools and CIMT Testing
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atherosclerosis
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \>/= 18 years consenting for participation are eligible. There are no speicifc exclusion critieria except age \< 18 years.

Brief summary: Our study aims to evaluate endothelial function using the non-invasive EndoPAT device, and compare this assessment to traditional cardiovascular risk calculation tools and carotid intima media thickness measurements. We look to determine whether the discovery of endothelial dysfunction provides incremental risk stratification over traditional and CIMT methods of cardiovascular risk assessment.

Detailed description: Atherosclerosis is a disease affecting the function of arteries, and is one of the underlying causes of stroke, heart attack and other cardiovascular diseases. These diseases are some of the highest causes of morbidity and mortality in North America. As an inflammatory disease that involves the endothelium of blood vessels, atherosclerosis causes arteries to stiffen and become blocked with plaques. This leads to decreased function of these arteries, which at first is asymptomatic, but at later stages can block blood supply to the heart or brain.

The Endo-PAT 2000 is a device designed to measure endothelial function using finger probes placed onto the finger tip of a patient. It is made to detect the presence of peripheral endothelial dysfunction, which develops under the same mechanisms as coronary disease. Risk factors for heart disease are well recognized, and include gender, race, weight, smoking status, and the presence of hypertension, diabetes, and elevated cholesterol. While these factors are monitored in the clinical setting, the actual damage to vascular endothelium has previously been difficult to quantify. The EndoPAT system offers a novel method of assessing endothelial function as an aggregate outcome of all of these risk factors.

Eligibility criteria: Inclusion Criteria:

* All patients 18 years of age and older are eligible

Exclusion Criteria:

* None except age \< 18 years

Primary outcomes:
measure: Endothelial Function as Indicated by the Reactive Hyperemia Index Score
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06850532: NMES Effects on Substrate Metabolism and IGF-1
Official title: Metabolic Health, IGF-1, and Cardiovascular Fitness Responses to High-intensity Interval Training and Moderate-intensity Continuous Training in Combination with Superimposed Neuromuscular Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Effects of Neuromuscular Electrical Stimulation on Exercise Performance
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to investigate whether neuromuscular electrostimulation (NMES) training coupled with high-intensity interval training (HIIT) and moderate intensity continuous aerobic training has an effect on the metabolic, cardiovascular and hormonal components compared to respective training protocols without concurrent NMES as a exercise performance enhancement strategy.


Eligibility criteria: Inclusion Criteria:

- All participants were healthy with no musculoskeletal injuries and had not participated in lower-body resistance training for six months prior to the study.

Exclusion Criteria:

* Individuals with musculoskeletal injuries and had participated in lower-body resistance training for six months prior to the study has been excluded from the enrollement for the current study.

Primary outcomes:
measure: Body composition via Bioelectrical Impedance Analysis (Tanita 418-MA, Japan)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Height (cm) via a stadiometer (Holtain Ltd., UK).
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Heart rate (bpm) via 12-lead ECG
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Blood Lactate Concentration (mmol/L) via Lactate Pro 2 analyzer
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: SERUM INSULIN-LIKE GROWTH FACTOR-1 (IGF-1 ng/mL)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: VO2 - Volume of oxygen (ml/kg/min) VCO2 - Volume of carbon dioxide (ml/kg/min)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Energy expenditure (L/min) via indirect calorimetry (CareFusion MasterScreen CPX).
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Neuromuscular Electrical Stimulation (NMES) Protocol
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Low-frequency Neuromuscular Electrical Stimulation (NMES)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: High-frequency Neuromuscular Electrical Stimulation (NMES)
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yenisehir
country: Turkey
facility: Mersin University
state: Mersin
Study officials:
affiliation: Mersin University
name: Nevzat Demirci, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00280332: A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy
Official title: A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Cancer
Keywords: colonic adenoma, colonic advanced neoplasm
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2006-01-23
Enrollment: 560
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are previously participated in one of our two screening colonoscopy studies \[Sung, Gastroenterol 2003; Leung, AJG 2004\]

Brief summary: * To determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy
* To determine the optimal time interval for re-screening in average risk individuals
* To determine potential baseline characteristics that predicts adenoma recurrence

Detailed description: Colorectal cancer (CRC) is the second commonest cancer in Hong Kong, and tends to be increasing. Screening for colorectal cancer can reduce the cancer incidence and mortality by detecting early lesions. However, the best interval for a follow up colonoscopy, particularly for those with normal baseline colonoscopy, remains largely unknown.

This study aim to determine the prevalence of colonic neoplasm in average-risk patients who had previously undergone screening colonoscopy and the optimal time interval for re-screening.

Eligibility criteria: Inclusion Criteria:

* Subjects who are previously participated in one of our two screening colonoscopy studies \[Sung, Gastroenterol 2003; Leung, AJG 2004\]
* Asymptomatic on first screening colonoscopy
* Age\>50and \<75
* No family history of CRC
* No other colonoscopy except the baseline screening colonoscopy

Exclusion Criteria:

* Subjects who refused consent
* Subjects who are not warrant follow up colonoscopy

Primary outcomes:
measure: The prevalence of advanced colonic adenoma in the re-screening population
timeFrame: 5 year from index colonoscopy
Secondary outcomes:
measure: The time to adenoma adenoma development according to different baseline characteristics of patients and colonoscopy findings
timeFrame: 5 years from index colonoscopy
Other outcomes:
Locations:
city: Hong Kong (SAR)
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: CUHK
name: Wai K Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01220232: Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Official title: Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Lersivirine
UK-453
061
NNRTI
Abacavir
Lamivudine
Combivir
Pharmacokinetics
Drug Interaction
HIV
AIDS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2010-10-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* History of hypersensitivity to abacavir, lamivudine and/or lersivirine.

Primary outcomes:
measure: To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine.
timeFrame: 17 days
Secondary outcomes:
measure: To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine.
timeFrame: 17 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: