louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02805348: Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease
Official title: Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Kiklin
Bixalomer
Chronic Kidney Disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time

Brief summary: The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.


Eligibility criteria: Inclusion Criteria:

* Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time

Primary outcomes:
measure: Change from baseline in the serum concentrations of phosphate
timeFrame: Baseline and up to Month 12
measure: Change from baseline in the corrected serum concentrations of calcium
timeFrame: Baseline and up to Month 12
measure: Change from baseline in the serum concentrations of intact parathyroid hormone
timeFrame: Baseline and up to Month 12
measure: Safety assessed by incidence of adverse events
timeFrame: Up to Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP00006
city: Ehime
country: Japan
facility: Site JP00010
city: Fukuoka
country: Japan
facility: Site JP00012
city: Gifu
country: Japan
facility: Site JP00004
city: Ibaraki
country: Japan
facility: Site JP00001
city: Kagawa
country: Japan
facility: Site JP00009
city: Kanagawa
country: Japan
facility: Site JP00003
city: Kochi
country: Japan
facility: Site JP00011
city: Kumamoto
country: Japan
facility: Site JP00014
city: Nagasaki
country: Japan
facility: Site JP00013
city: Osaka
country: Japan
facility: Site JP00007
city: Shizuoka
country: Japan
facility: Site JP00005
city: Tochigi
country: Japan
facility: Site JP00002
city: Wakayama
country: Japan
facility: Site JP00008
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT02362048: ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
Official title: A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-02-12
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer


Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 18 years of age
* ECOG performance status of 0 or 1
* Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic
* Prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy

Exclusion Criteria:

* Prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years.
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction
* Breastfeeding or pregnant

Primary outcomes:
measure: Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.
timeFrame: Every 12 weeks for up to 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
Study officials:
affiliation: 1-888-292-9613; acertamc@dlss.com
name: Acerta Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Overman M, Javle M, Davis RE, Vats P, Kumar-Sinha C, Xiao L, Mettu NB, Parra ER, Benson AB, Lopez CD, Munugalavadla V, Patel P, Tao L, Neelapu S, Maitra A. Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer. J Immunother Cancer. 2020 Feb;8(1):e000587. doi: 10.1136/jitc-2020-000587.
Clinical trial NCT00891748: Safety Study on AdCD40L Gene Therapy for Bladder Cancer
Official title: A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bladder Cancer
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2009-05-01
Enrollment: 12
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 study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of transitional cell carcinoma of the bladder
* ECOG 0-2
* 18 years of age or older
* signed informed consent
* for the Phase I part: patient scheduled for cystectomy

Exclusion Criteria:

* Woman of childbearing potential (fertile woman)
* Other malignancy within 5 years of study, except for non-melanoma skin cancer
* Metastatic disease
* Previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for BCG therapy.
* Previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study.
* Clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders in the opinion of the investigator.
* Chronic urinary tract infections.
* Serous infection of G.U. surgery, except for bladder cancer, within 1 month of study requiring more than 3 days of hospital care.
* Vesical capacity \<150mL and/or vesical obstruction with residual \>150 mL after spontaneous voiding.
* Previous exposure to any experimental drug within 3 months from enrolment.
* Any significant medical or psychiatric illness that would prevent the patient from giving informed consent of from following the study procedures.
* Patients who presently have urothelial cell carcinoma of the upper G.U. tract
* Patients with systemic autoimmune disease
* Patients that do not consent to that tissue and blood samples are stored in a biobank
* Treatment with systemically administered corticosteroids and NSAID within 4 weeks prior to first study treatment

Primary outcomes:
measure: Toxicity
timeFrame: Continously during therapy and at follow up 30d
Secondary outcomes:
measure: Inflammation
timeFrame: Continously during treatment and at follow up 30d
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital, Uppsala, Sweden
name: Per-Uno Malmstrom, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05679648: Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients
Official title: Evaluation of Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients: a Cross-sectional Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients
Keywords: hepatic steatosis
rheumatoid arthritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The outpatient clinic of the Rheumatology Department in Sohag University

Brief summary: studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls


Eligibility criteria: Inclusion Criteria:

1. RA according to the American College of Rheumatology (ACR)/EULAR 2010 criteria (Aletaha et al., 2010)
2. Age≥18 years

Exclusion Criteria:

* History of hepatitis B and C virus infection.
* Receiving hepatotoxic drugs other than RA-specific drugs.
* Alcohol abuse (i30 g/day in men and ⩾20 g/day in women).
* Diagnosis of Wilson's disease, α1-antitrypsin deficiency or hemochromatosis.
* Autoimmune liver disease.
* Cancer.
* Pregnancy.

Primary outcomes:
measure: degree of hepatic steatosis
timeFrame: 1 day during examination
measure: degree of hepatic fibrosis
timeFrame: 1 day during examination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00159848: Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra
Official title: Effectiveness Of An Educational Program To Improve Patients' Satisfaction Regarding Their Management Of Erectile Dysfunction With Sildenafil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 8000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will demonstrate if a treatment optimization program has an impact on the satisfaction with Viagra treatment in men with erectile dysfunction


Eligibility criteria: Inclusion Criteria:

* Male subjects above age of majority for whom sildenafil is prescribed for the first time within the usual practice of medicine

Exclusion Criteria:

* Male subjects who have used any ED medical treatments over the last month, with the exception of testosterone and/or herbal therapies
* Subjects who do not have the possibility of viewing the video either through a computer, VCR or a DVD

Primary outcomes:
measure: Assess the impact of a sildenafil educational program versus usual care on subjects' satisfaction regarding their management of ED with sildenafil as assessed through the validated EDITS questionnnaire after 3 months of treatment
Secondary outcomes:
measure: Describe the relationship between the administration of an educational program and the effectiveness of sildenafil; Evaluate the educational program as a tool to help physicians in their management of ED; Estimate the intracluster correlation coefficient
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02882048: Auricular Acupuncture to Facilitate Outpatient Opioid Weaning
Official title: A Randomized Controlled Trial of Auricular Acupuncture to Facilitate Outpatient Opioid Weaning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Narcotic Addiction
Keywords: Opioid addiction
Opioid weaning
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare two groups undergoing opioid weaning as ordered by their referring physicians. One group will undergo the standard opioid weaning process and the other group will have the addition of the NADA Protocol to the weaning process.

Detailed description: The NADA (National Acupuncture Detoxification Association) Protocol is a standardized acupuncture technique in which five designated points in the ear are needled (+/-beads/seeds at points for home acupressure therapy in between treatments). The NADA Protocol is indicated for treatment of the following conditions: detoxification, withdrawal, emotional trauma, craving, stress syndromes, relapse prevention, rehabilitation \& recovery maintenance. It is also commonly used for PTSD and addiction; however it has not been studied as an adjunct to outpatient opioid weaning protocols for pain.

It is cited in the literature as yielding improvements in engagement, retention, decreased cravings, anxiety, and physical symptoms. Given these documented results, it seems feasible the outpatient opioid weaning patient would likely benefit from this procedure.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and older
* Referral to the VUMC Interventional Pain Clinic for opioid weaning and discontinuation.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change from baseline in clinical institute narcotic assessment scale (CINA) for withdrawal
timeFrame: time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months)
Secondary outcomes:
measure: Off-opioids rate
timeFrame: time from beginning of opioid withdrawal intervention to opioid cessation(approximately 6 months)
measure: Change from baseline assessment of psychological distress of weaning, assessed using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 9 months
measure: Time to cessation of opioids
timeFrame: time from of beginning of opioid withdrawal intervention to opioid cessation (approximately 6 months)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Heather Jackson, MSN, APRN-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson HJ, Walters J, Raman R. Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study. Med Acupunct. 2021 Apr 1;33(2):153-158. doi: 10.1089/acu.2020.1450. Epub 2021 Apr 19.
Clinical trial NCT03655548: Optimization Management Study of Community Urinary Tract Infections Spectrum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Resistant Infection
Community-Acquired Infections
Beta Lactam Resistant Bacterial Infection
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 108
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: Adult patient who were prescribed by a GP a CBEU during the 2 inclusion periods (from 1/10/2016 to 28/02/2017 with a first period from 01/10/2016 to 30/11/2016 and a second period from 02/01/2016 to 28/02/2017)

* CBEU analyzed by Labazur laboratory
* CBEU positive for a spectrum β-lactamase-producing Enterobacteriaceae (ESBLE)
* Ambulatory management of the infection by the GP

Brief summary: Urinary tract infections are the second most common community-acquired infections. Even if extended spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) cause fewer urinary tract infections, their proportion is increasing. New recommendations were published by ANSM in 2015, with specific recommendations for infections due to ESBL-producing Enterobacteriaceae. In this study, we wanted to evaluate the effectiveness of a recall of the 2015 recommendations in the form of a table attached to the ECBU report, associated with hygiene recommendations.

Methodology: This prospective, multi-center, non-interventional study was conducted in collaboration with the Labazur laboratory over two 2-month periods, one without modification of the laboratory's practices, the other with the addition of documents on the CBEU report. The primary endpoint was the adequacy of prescriptions to ANSM 2015 recommendations.


Eligibility criteria: Inclusion Criteria:

* Adult patient who were prescribed by a GP a CBEU during the 2 inclusion periods (from 1/10/2016 to 28/02/2017 with a first period from 01/10/2016 to 30/11/2016 and a second period from 02/01/2016 to 28/02/2017)
* CBEU analyzed by Labazur laboratory
* CBEU positive for a spectrum β-lactamase-producing Enterobacteriaceae (ESBLE)

Exclusion Criteria:

* Children
* Refusal of consent
* CBEU prescribed by a specialist
* patient hospitalised for management of the infection

Primary outcomes:
measure: percentage of adequation to ANSM 2015 guidelines of antibotics prescription for community acquired urinary tract infection before and after CBEU report
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005548: Green Tea Consumption and Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine the prospective association of green tea consumption to the incidence and mortality of coronary heart disease (CHD) using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.

Detailed description: BACKGROUND:

Both in vivo and in vitro experiments have show that flavonoids, antioxidants which are rich in green tea, are potentially as beneficial as vitamin E, beta-carotene and vitamin C in reducing the risk of cardiovascular disease. Thus, the possible preventive effects of green tea on CHD have begun to raise research interests in green tea sufficiently to inquire about its beneficial effects formally in humans. However, few epidemiologic studies have been carried out to directly examine the effects of green tea on CHD. The Honolulu Heart Program (HHP) is a 30 year longitudinal study of CHD and stroke among 8,006 Japanese American men living on Oahu Hawaii. Until the end of 1992, 1,888 men from this cohort were defined as having incident CHD; this includes 396 deaths due to CHD. The baseline examination for the HHP was conducted during 1965-68. A comprehensive physical examination and 24 hour dietary recall interview were administered. Within the original cohort more than 75 percent men reported to have drunk green tea daily. The amount consumed per day varied considerably from low to high doses. The high prevalence of green tea consumption coupled with dose information (i.e low, moderate and high consumption) provides good opportunities to examine the relationships of green tea consumption and CHD.

DESIGN NARRATIVE:

The study uses the Honolulu Heart Program data to examine the prospective association of green tea consumption to the incidence and mortality of CHD using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Toledo
name: Boji Huang
References:
Clinical trial NCT05956548: Lead Migration During the Spinal Cord Stimulation Trial Period and Therapeutic Response
Official title: Contrasting Lead Migration During Spinal Stimulation Trial Period Against Therapeutic Response - Evaluating Securement Methods During the Trial Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to compare lead migration distance and therapeutic response for participants receiving a spinal cord stimulator during the trial period. Of note- scs trial period is a procedure name, not to be confused with this clinical trial study.

The main question\[s\] it aims to answer are:

* Is there a difference in migration distance and/or rate for those with external leads secured by an anchor device versus and anchor device with suture?
* How does participant activity levels during the trial period compare to migration rates? ° Does the temperature, heat index, and humidity during the trial period impact migration rates? Participants will come in for the scs trial procedure as normal. They will be asked to complete an activity survey upon return to the clinic for lead pull after the scs trial. They will also have an additional image upon return to the clinic to document lead position prior to lead pull.

Researchers will compare two groups- those with securement via anchor and those with securement via anchor and suture to see if there is an impact on therapeutic effect (percentage of pain relief) form the scs trial.


Eligibility criteria: Inclusion Criteria:

Adults ages 18 and over without a failed spinal stimulation trial or implant will be accepted into the study. Patients must have a diagnosis of chronic back pain and must be patients of the identified anesthesiologists and have their procedures performed at AUHS pain clinic.

Exclusion Criteria:

Patients will be excluded if they have a history of local anesthetic allergy (lidocaine), current skin infections at the procedure site, or a diagnosis of diaphoresis/ secondary hyperhidrosis (chronic over sweating).

Primary outcomes:
measure: Therapeutic Response
timeFrame: SCS trial periods are 3-6 days at our facilty.
measure: Lead position changes (migration)
timeFrame: the last day of the trial period which could be day 3 up to day 6, depending on length
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University Health System Pain Clinic
state: Georgia
Study officials:
affiliation: Augusta University
name: Jeane Silva, PhD
role: STUDY_CHAIR
affiliation: Augusta University
name: Stephanie C Jones, Grad Student
role: PRINCIPAL_INVESTIGATOR
References: