louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04080960: Dining With Diabetes in Pennsylvania
Official title: Dining With Diabetes in Pennsylvania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults residents of Pennsylvania

Brief summary: Penn State Extension's Dining with Diabetes program is an evidence-based community education program for people with or at risk for type 2 diabetes. The program teaches participants how to prevent or manage their disease by providing practical knowledge and strategies to make the necessary lifestyle changes that will lead to healthier living and reduction in the risk of complications. The overall goals and objectives of the program are as follows:

Increasing knowledge of healthy food choices for families with or at risk for diabetes Promoting behavior changes by offering demonstrations and tasting of healthy food.

Increasing knowledge of essential medical tests associated with diabetes management.

Promoting physical activity as a component of diabetes control. Encouraging self-management and self-efficacy skill. Connecting participants to their healthcare providers for long-term follow-up. The program is designed to meet 4 consecutive weeks and then a 3 month follow-up. Participants A1c and blood pressure are taking at the first and follow-up classes. Classes consist of a nutrition lesson, physical activity, cooking demonstration and food tasting.


Eligibility criteria: Inclusion Criteria:

* Individuals with type 2 diabetes individuals with pre-diabetes individuals at risk of developing type 2 diabetes healthy family members/caretakers healthy volunteers

Exclusion Criteria:

* under age 18

Primary outcomes:
measure: hemoglobin A1C
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
References:
citation: Griffie D, James L, Goetz S, Balotti B, Shr YH, Corbin M, Kelsey TW. Outcomes and Economic Benefits of Penn State Extension's Dining With Diabetes Program. Prev Chronic Dis. 2018 May 3;15:E50. doi: 10.5888/pcd15.170407.
Clinical trial NCT05449860: Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma With Twin Cooled-wet Electrodes
Official title: Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Bipolar and Monopolar Energy Deliver With Twin Cooled-Wet Electrodes: A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Local Recurrence of Malignant Tumor of Liver
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: RF medical
First posted: 2022-07-08
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the therapeutic effects and treatment results of radiofrequency ablation using combined bipolar and monopolar energy deliver with twin cooled-wet electrodes for recurrent tumor after locoregional treatment in patients with hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or chronic hepatitis C or liver cirrhosis
* presence of recurrent hepatocellular carcinoma (HCC) after locoregional treatment confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
* single lesion less than or equal to 5 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment

Exclusion Criteria:

* number of recurrent HCCs, equal or more than 3
* largest recurrent HCC size over 3 cm
* presence of vascular invasion by HCC
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis

Primary outcomes:
measure: Local tumor progression rate
timeFrame: 12 months after radiofrequency ablation
Secondary outcomes:
measure: Safety margin evaluation
timeFrame: Immediately after radiofrequency ablation
measure: Technical success rate
timeFrame: 1 month after radiofrequency ablation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02081560: Colistin Pharmacokinetics in Continuous Renal Replacement Therapy
Official title: Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infection
Keywords: pharmacokinetics
antibiotic
Gram negative
continuous renal replacement therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 10
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: The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.

Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.

Detailed description: After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.

Patients are monitored for signs of neuro- and nephrotoxicity

Eligibility criteria: Inclusion Criteria:

* male or female aged 18 years or older
* hospitalised on the ICU
* gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care
* clinical necessity for continuous venovenous renal replacement therapy

Exclusion Criteria:

* History of hypersensitivity to colistin or to other polymyxins
* Personal or family history of Myasthenia Gravis

Primary outcomes:
measure: Area under the curve (AUC)
timeFrame: predose, and 0.5, 1, 2, 4, 6, 8 hours after administration
Secondary outcomes:
measure: Sings of neurotoxicity and nephrotoxicity
timeFrame: Expected average of follow up is about 14 days.
measure: Sings of neurotoxicity and nephrotoxicity
timeFrame: Expected average of follow up is about 14 days.
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich, Dept. of Pharmacology and Toxicology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Dept. of Pharmacology and Toxicology
name: Natascia Corti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leuppi-Taegtmeyer AB, Decosterd L, Osthoff M, Mueller NJ, Buclin T, Corti N. Multicenter Population Pharmacokinetic Study of Colistimethate Sodium and Colistin Dosed as in Normal Renal Function in Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01957-18. doi: 10.1128/AAC.01957-18. Print 2019 Feb.
Clinical trial NCT01230060: One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
Official title: A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of a Bausch + Lomb One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aphakia
Cataract
Keywords: ocular surgery
phacoemulsification
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-28
Enrollment: 122
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: The objective of this study is to evaluate the safety and effectiveness of the enVista® One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens has been removed by an extracapsular cataract extraction method (eg, small incision phacoemulsification).


Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
* Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in the study eye, with or without a glare source.
* Subjects must have a BCVA projected to be better than 20/30 after IOL implantation in the study eye.

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with any other serious ocular pathology, or underlying serious medical conditions, which based on the Investigator's medical judgment, could confound the results of the study.

Primary outcomes:
measure: Visual Acuity
timeFrame: 120-180 days (visit 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Aliso Viejo
country: United States
facility: Bausch & Lomb
state: California
Study officials:
affiliation: Drs. Fine, Hoffman & Packer
name: Mark Packer, MD,FACS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01652560: Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy
Official title: Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Bevacizumab
Neoadjuvant Chemotherapy
Molecular Targeted Therapy
Keywords: bevacizumab
neoadjuvant chemotherapy
HER2-negative breast cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2012-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients of vascular endocrine surgery department in Xijing Hospital

Brief summary: - The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.


Eligibility criteria: Inclusion Criteria:

* HER2-negative breast cancer patients
* Without surgery
* Plans to neoadjuvant chemotherapy

Exclusion Criteria:

* HER2-positive breast cancer patients
* Post-operative patients

Primary outcomes:
measure: Objective Response Rate
timeFrame: From enrollment to disease progression
Secondary outcomes:
measure: overall response
timeFrame: From enrollment to disease progression
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital ， Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT03354780: Endometriosis and Risk of Miscarriage
Official title: Impact of Endometriosis on the Risk of Miscarriage in Spontaneous Pregnancy: a Multicentric Italian Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Miscarriage
Lead sponsor: Endometriosis Treatment Italian Club
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2017-11-28
Enrollment: 844
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All continous women attending endometriosis clinics or undergoing a routine gynecological examination matching the inclusion criteria

Brief summary: The aim of this study is to compare the rate of miscarriage at first spontaneous pregnancy among women with endometriosis with the rate of miscarriage at first spontaneous pregnancy among women without endometriosis.

Detailed description: All women followed up for a surgical or sonographic diagnosis of endometriosis in 11 italian referral Centres for the treatment of endometriosis completed a questionnaire regarding their previous pregnancies. The same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or vaginal examination and pelvic ultrasonography excluded endometriosis.

Eligibility criteria: Inclusion Criteria:

* 30 to 50 years old women
* with at least one previous spontaneous pregnancy
* with surgical or clinical/sonographic diagnosis of endometriosis or
* in whom surgical or clinical/sonographic evaluation ruled out endometriosis

Exclusion Criteria:

* Pregnancy achieved by Assisted Reproductive technology
* Biochemical pregnancy
* Non corrected uterine malformation, poliabortivity, lupus like anticoagulant

Primary outcomes:
measure: Rate of miscarriage
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Endometriosis Treatment Italian Club
name: Nicola Berlanda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05957380: Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
Official title: A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of DA-2803 in chronic hepatitis B subjects


Eligibility criteria: Inclusion Criteria:

* Adult male and female subjects of ages in the range over 19
* The subjects HBsAg positive for at least 6 months or has history of Chronic Hepatitis B
* The subjects whose HBV DNA above 20,000 IU/mL when HBeAg positive or above 2,000 IU/mL when HBeAg negative or positive when has history of Chronic Hepatitis B
* The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent

Exclusion Criteria:

* The subjects who have been infected with HCV, HDV, HIV
* The subjects who have Hemochromatosis, Wilson's disease, autoimmune liver disease, and α-1 antitrypsin deficiency
* The subjects whose α-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma

Primary outcomes:
measure: HBV DNA(log10 IU/mL) change
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul
Study officials:
References:
Clinical trial NCT03384680: Symptom Collection of Lung Cancer Patients
Official title: A Study on Symptom Collection of Patients With Lung Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung cancer who are scheduled for surgery will be enrolled.

Brief summary: This study is conducted to collect the symptoms of lung cancer patients and to observe the relationship with proteomics.


Eligibility criteria: Inclusion Criteria:

* Adult over 18 years old
* Patients are scheduled for surgery with lung cancer diagnosis.
* ECOG status score 0 to 2
* Individual who can read and understand Korean
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Patient who was diagnosed with lung cancer in the past.
* Individuals who are judged inappropriate for the study

Primary outcomes:
measure: Pattern identification
timeFrame: For 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
citation: Cho W, Kim JH, Jeong M, Kim MS, Lee J, Son H, Cheon C, Park S, Ko SG. Pattern identification of lung cancer patients based on body constitution questionnaires (BCQ) and glycoproteomics for precision medicine. Medicine (Baltimore). 2019 Jun;98(24):e16035. doi: 10.1097/MD.0000000000016035.
Clinical trial NCT02820480: Design of an Affordable Gym for Post Stroke Rehabilitation
Official title: Design of an Affordable Gym for Post Stroke Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Cerebral Palsy
Healthy
Keywords: stroke
rehabilitation
robotics
cerebral palsy
therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Therapists and patients with neuro-rehab. Patients with neural injury

Brief summary: Rehab in a Crate is a therapy gym designed to be affordable, compact and easily transportable. The purpose of this particular study is to gain feedback on the initial design of the Rehab in a Crate system. This will be accomplished by using qualitative ethnographic research methods (i.e. human centered design) in the form of surveys that have been carefully designed by members of the research team. The eligibility criteria of this survey research reflects the intended user base of an eventual finished product, which is survivors of stroke and cerebral palsy across the globe. And while healthcare professionals are not the user base per se, their expertise and feedback should be instrumental in the design of future iterations of the Rehab in a Crate. Ease of use, utility, design, and various features, both existing and intended, will all be surveyed items.

Detailed description: The investigators aim to survey stroke survivors and healthcare professionals on the design, ease of use, utility, and various features of, both existing and those yet-to-be-developed. This feedback will help to fine tune further development of this therapy gym, Rehab in a Crate, and move forward in the iteration process.

Note: The device is not being used at this moment for diagnostic or evaluation.

Eligibility criteria: Inclusion Criteria:

* Stroke survivors who are more than 3 months post stroke and persons with cerebral palsy adults - have hemiplegia or diplegia
* Health professionals who have considerable experience in stroke rehabilitation.

Exclusion Criteria:

* Anyone who is not 18 years of age.
* More than mild spasticity in the upper of lower extremities.
* A cognitive score on the Montreal Cognitive Assessment that indicates that the participant is cognitively impaired.
* Motor impairment that precludes interaction with the Rehab in a Crate (e.g. unable to grip a handle).

Primary outcomes:
measure: Acceptability of Rehab system
timeFrame: 1 session, about 1.5 hours in length
Secondary outcomes:
measure: Usability of Rehab System
timeFrame: 1 session, about 1.5 hours in length
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine Rittenhouse
state: Pennsylvania
Study officials:
affiliation: Penn Medicine Rittenhouse
name: Michelle J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818480: An Extension Study Administering YM155 to Subjects Previously Enrolled in Another Protocol Administering YM155
Official title: Phase II: An Open-Label Extension Study of 168-Hour Continuous Infusion of YM155 in Subjects Previously Enrolled in a Phase I or Phase II Protocol Administering YM155
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Melanoma
Non-Hodgkin's Lymphoma
Keywords: prostate cancer
melanoma
lymphoma
YM155
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol is open to subjects previously enrolled in and who had completed a Phase I or Phase II study administering YM155. Subjects who are receiving benefit from treatment with YM155 are eligible after completing the previous study.

Detailed description: The main objective of the study is to continue to evaluate the safety and efficacy of YM155.

Each subject will be treated at the dose he/she was receiving at the completion of his/her previous phase I or phase II YM155 study.

Eligibility criteria: Inclusion Criteria:

* Completed a Phase I or II YM155 study with at least stable disease and continues to meet the criteria as stated in the previous YM155 study that allows for additional treatment with YM155
* Lack of progression based on the most recent radiological imaging, biochemical assessments and/or physical examination
* Negative pregnancy test result (females of child-bearing potential)

Exclusion Criteria:

* More than 21 days (or 14 days depending on the study of origin) between the time the last infusion of YM155 was stopped in the previous study and the proposed start of the first infusion in this study

Primary outcomes:
measure: Assess Response Rate
timeFrame: End of Study up to 77 months
measure: Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
timeFrame: End of Study up to 77 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Institute for Drug Development
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
Study officials:
affiliation: Astellas Pharma Global Development
name: Sr. Medical Director
role: STUDY_DIRECTOR
References: