louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02050191: Community Web Health Portal for Diabetes Prevention
Official title: The Primary Goal of the Phase I Research Was to Demonstrate Feasibility of Creating and Running an Incentive-based Wellness Portal for a Local Community (Princeton, NJ) That Involved Designing the System, Building a Prototype, Testing the System, and Assessing User Acceptance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Health Knowledge
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
Collaborators: name: Viocare, Inc.
First posted: 2014-01-30
Enrollment: 20
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study supports the development of a diabetes prevention and control community web portal. The portal will feature an innovative personalized impediment profiling tool and reward program. The program, "Nutrition Navigation on-Line Edge," or NnoLEDGE, will be used by community consortiums for weight loss and diabetic health interventions within their communities.

The Specific Aims are:

1. Recruitment of local community organizations to participate as a community health consortium
2. Development of a comprehensive community health web portal consisting of a web portal, impediment profiler, community toolbox, and rewards system
3. Final evaluation of the system with regard to participants' attitudes and perceptions of using NnoLEDGE as a tool for weight control and diabetes prevention to determine feasibility.


Eligibility criteria: Inclusion Criteria:

* can read and write English

Exclusion Criteria:

* cannot read and write Engish

Primary outcomes:
measure: attitudes and perceptions re: feasibility of web portal
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Viocare, Inc.
name: Rick Weiss, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01762891: CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen
Official title: CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antiphospholipid Antibody Syndrome
Keywords: Coumadin
celecoxib
rofecoxib
acetaminophen
antiphospholipid syndrome and INR
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Coumadin drug-drug interactions (DDI) are frequent. Patients in permanent use of coumadin are advised to avoid traditional nonsteroidal antiinflammatory drugs to avoid risk of bleeding. New selctive cyclooxygesase 2 inhibitors arisen as potential option for treating pain and inflamation in these patients once interactions with coumadin are supposed to be lower. The CI(R)CA study was made to evaluate in a prospective fashion the occurrence of DDI with new cyclooxygenase antiinflammatory drugs and coumadin when compared to acetaminophen and placebo.

Detailed description: The CI(R)CA study included patient diagnosed with antiphospholipid syndrome in permanent use of coumadin. Eligible patients were invited to use in a prospective cross-over mode two weeks of celecoxib, rofecoxib, acetaminophen and placebo with two weeks of wash out between drugs. Their international normalized ratio (INR) were measured before and during the use of each study drug. The interaction with coumadin was evaluated according to increases or decreases on the INR after each medication.

Eligibility criteria: Inclusion Criteria:

* PAPS on contious stable dose of coumadin
* 18 years old or older
* Younger than 65 yo
* Signed informed consent.

Exclusion Criteria:

* Renal failure
* Heart failure
* Symptomatic gastritis or peptic ulcer
* Elevated liver enzymes (\>3 fold)
* Platelet count \< 100,000.

Primary outcomes:
measure: International Normalized Ratio
timeFrame: increase or decrease on the INR after coxibs or placebo use during 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Pedro Ernesto
name: Veronica S Vilela, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03695991: Effect of Per-cutaneous Nephrosotomy Drainage on Radioisotope Imaging of Hydronephrotic Kidneys
Official title: Effect of Per-cutaneous Nephrosotomy Drainage on Radioisotope Imaging of Hydronephrotic Kidneys
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydronephrosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital

Brief summary: Hydronephrosis describes a condition of urine-filled dilation of the collecting system. Normally, urine flows through the urinary tract with minimal or low pressure. If the build-up of excess fluid in the urinary collecting system continues, there will be an increase in pressure and atrophy of renal cortex. If hydronephrosis is left untreated for a long time, renal damage with permanent loss of function occurs


Eligibility criteria: Inclusion Criteria:

* 1) Patients for whom a percutaneous nephrostomy is indicated provided that the hydronephrosis is advanced ( parenchymal thickness not more than 5 mm ) 2) Patients for whom a nephrectomy is planned for a seemingly poorly functioning kidney along with either

Exclusion Criteria:

1. Target kidney is the only functioning or better functioning kidney or otherwise substantially contributing to the total renal function, so nephrectomy is not likely.
2. Emergency cases where the general condition of the patient cannot withstand the logistics of undergoing a radioisotope study eg
3. Malignancy in the target kidney
4. Patients unlikely to undergo a nephrectomy

Primary outcomes:
measure: The rate of increase in glomerular filtration rate after intervention
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04998994: The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy
Official title: The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Status, Immune Function, Quality of Life Uring the Progress of Chemotherapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Wenzhou Medical University
name: Quzhou Kecheng People's Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Jinhua Municipal Central Hospital
name: Zhejiang Cancer Hospital
First posted: 2021-08-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with breast cancer, receiving chemotherapy for the first time

Brief summary: To explore the effects of wheat sprouts supplements on the key health indicators of the patients with breast cancer after chemotherapy, Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy and nutritional status, immune function, quality of life were measured and evaluated. Through data analysis, we found that Maiji tablets may improve the symptoms of appetite loss, nausea and vomiting, and fatigue in patients with breast cancer during chemotherapy. Meanwhile it may help patients maintain weight, keep appetite and improve the food intake.


Eligibility criteria: Inclusion Criteria:

- patients diagnosed with breast cancer, receiving chemotherapy for the first time

Exclusion Criteria:

- Patients with severe liver or kidney disease or other infectious diseases

Primary outcomes:
measure: quality of life
timeFrame: 28 days
measure: weight
timeFrame: 28 days
measure: nutritional status
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06038994: Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction
Official title: Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction, Acute
Keywords: TRAF3IP2, Myocardial Infarction, Coronary angiography, MACEs
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with acute myocardial infarction who received coronary angiography well enrolled in Huai'an First People's Hospital

Brief summary: To evaluate the prognostic value of surem TRAF3IP2 levels in patients with acute myocardial infarction

Detailed description: Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients diagnosed with acute myocardial infarction who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the major adverse cardiac events will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients with acute myocardial infarction
2. patients received coronary angiography
3. invasive management within 72 h of hospital admission

Exclusion Criteria:

1. NYHA III-IV
2. malignant tumor
3. acute infection
4. thyroid dysfunction
5. Life expectancy of b1 y
6. Unsuitable for PCI

Primary outcomes:
measure: MACEs (major adverse cardiac events)
timeFrame: 1 year
Secondary outcomes:
measure: cardiac death
timeFrame: 1 year
measure: hospitalization for myocardial infarction or heart failure
timeFrame: 1 year
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
Study officials:
affiliation: NJMU
name: Shuren Ma, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05453994: Bismuth for PCAB-based H. Pylori Eradication
Official title: Efficacy of Bismuth Added to Potassium-competitive Acid Blocker-based Triple Regimen for First-line Helicobacter Pylori Eradication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: H. Pylori Infection
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: H. pylori-infected patients

Brief summary: Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB.

Bismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication rate by 30%-40% in resistant H. pylori strains.

Detailed description: The investigators aim to evaluate the success rate and adverse drug events of bismuth added to PCAB-based triple therapy as a first-line regimen for H. pylori infection.

Eligibility criteria: Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding

Primary outcomes:
measure: H. pylori infection status
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Digestive Disease Center, Soonchunhyang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Jun-Hyung Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03709394: Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion
Official title: Two Different Techniques for Ultrasound Guided Peripheral Venous Catheter Insertion in Pre-hospital Emergency Care - Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehospital
Keywords: ultrasound
peripheral venous catheter
Lead sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
Sponsor class: OTHER
Collaborators: name: Masaryk Hospital Usti nad Labem
First posted: 2018-10-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized study
Primary purpose: TREATMENT

Brief summary: This study evaluates two different techniques for ultrasound guided peripheral venous catheter insertion in pre-hospital emergency care in comparison with conventional approach without any ultrasound guidance.

Detailed description: Peripheral venous catheter placement is one of the most common interventions in emergency medicine. When performed by conventional approach, the failure of the first attempt occurs up to 22 % and cannulation time exceed 2 minutes in up to 15 %. Ultrasound guidance of peripheral venous catheter (PVC) insertion may improve both. However, this approach has not been verified in the setting of pre-hospital emergency care so far.

Eligibility criteria: Inclusion Criteria:

* Awake patient indicated for peripheral venous catheter placement while treated by emergency medical service

Exclusion Criteria:

1. Coma
2. Age \<18 years
3. Patient disagreement with the insertion of peripheral venous catheter
4. Disagreement of the patient with inclusion in a clinical trial
5. Contraindication of ultrasound examination of the venous system
6. Contraindication of the introduction of peripheral venous cannula on both upper limbs
7. Investigator's opinion that ultrasonic control cannulation would cause undue delay and a other procedure is required

Primary outcomes:
measure: Frequency of the patients with successful the first cannulation attempt of peripheral venous catheter insertion
timeFrame: 60 minutes
Secondary outcomes:
measure: Frequency of the patients with successful peripheral venous catheter insertion irrespective of the number of attempts
timeFrame: 60 minutes
measure: The number of attempts required for successful peripheral venous catheter insertion
timeFrame: 60 minutes
measure: Time required to introduce peripheral venous catheter
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Beroun
country: Czechia
facility: Emergency Medical Service of the Central Bohemian Region
state: Central Bohemian Region
Study officials:
affiliation: Emergency Medical Service of Central Bohemian Region, Kladno, Czech republic
name: Roman Skulec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05732194: Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ITI-333 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-02-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential ascending doses. Parallel (active, placebo) within each cohort
Primary purpose: TREATMENT

Brief summary: The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male and female subjects between 18 and 45 years old (inclusive);
* BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
* Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator.

Key Exclusion Criteria:

* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
* Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) \< 96% and respiratory rate \< 12 breaths per min;
* History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
* CRP, ESR, or fibrinogen that are above normal reference ranges at Screening or Day 1.

Primary outcomes:
measure: Pharmacokinetics: AUC0-tau
timeFrame: Day 14
measure: Pharmacokinetics: Cmax
timeFrame: Day 14
measure: Pharmacokinetics: Tmax
timeFrame: Day 14
measure: Percentage of subjects with treatment-emergent adverse events
timeFrame: up to 30 days after last dose
measure: Change from baseline in systolic and diastolic blood pressure
timeFrame: Day 17
measure: Change from baseline in SpO2
timeFrame: Day 17
measure: Change from baseline in ECG QT interval
timeFrame: Day 17
measure: Change from baseline in aspartate aminotransferase
timeFrame: Day 17
measure: Change from baseline in alanine aminotransferase
timeFrame: Day 17
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Site 1
state: Florida
Study officials:
References:
Clinical trial NCT02903394: Coherence Imaging of the Cervical Epithelium
Official title: Coherence Imaging of the Cervical Epithelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Epithelia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Jacobi Medical Center
First posted: 2016-09-16
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.


Eligibility criteria: Inclusion Criteria:

* able to provide informed consent
* willing to abstain from sexual intercourse for at least 24 hours before study visit

Exclusion Criteria:

* pregnant
* using an intrauterine device (IUD)
* have a current gynecological infection or discharge
* have had any cervical surgery
* had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
* currently enrolled in any research studies involving the application of vaginal formulations
* employed or supervised by the study investigators
* have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study

Primary outcomes:
measure: Number of Patients With Interferometric Data Acquired From Cervical Epithelium
timeFrame: day 1
Secondary outcomes:
measure: Number of Patients With Automated Classification of Cervical Epithelium
timeFrame: day 1
measure: Number and Frequency of Adverse Events
timeFrame: day 1
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: professor
name: Adam Wax, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00083694: Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
Official title: UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: Leukemia
Thalidomide
relapsed
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2004-05-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.

Detailed description: Patients will take Thalidomide tablets at bedtime daily until remission. The dose will be increased gradually and modified according to side-effects. The drug will be given daily up to the time of complete remission then as long as it is beneficial.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of refractory or relapsed leukemia: acute leukemia, CML, CLLm and MDS.
* Signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed
* Serum creatinine \< or = 2.5mg/dL
* Serum bilirubin\< or = 2.5mg/dL
* Negative pregnancy test
* Age 18 years or older
* Performance status \< or = 3

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent treatment with cytotoxic chemotherapy, or radiation
* History of seizures, neurotoxicity, or active CNS disease
* Serious infections not controlled by antibiotics

Primary outcomes:
measure: To evaluate the efficacy and safety of Thalidomide in patients with leukemia.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences/MIRT
state: Arkansas
Study officials:
affiliation: UAMS
name: Barthel Barlogie, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: