louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00236990: An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland
Official title: A Double-Blind, Randomized, Placebo-Controlled Trial of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Prostatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatitis
Keywords: prostatitis
Elmiron
pentosan polysulfate sodium
Lead sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Alza Corporation, DE, USA
First posted: 2005-10-12
Enrollment: 283
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of ELMIRONÂ® in the treatment of chronic non-bacterial inflammation of the prostate gland.

Detailed description: The objective of this randomized, double-blind, placebo-controlled study is to determine the effectiveness and safety of ELMIRON® 100 mg three times per day for 12 weeks, as compared with placebo, in patients with chronic non-bacterial inflammation of the prostate gland. Safety evaluations will be assessed throughout the study. The hypothesis of the study is that ELMIRON® will be more effective than placebo, as based on the change in the total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline to the final visit (Week 12) and is generally well-tolerated. Patients will receive oral ELMIRON® 100 mg three times per day orally or matching placebo three times per day for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic non-bacterial prostatitis/chronic pelvic pain syndrome
* symptoms of discomfort or pain in the perineal and/or pelvic region (lower abdomen) for at least three of the last six months for which there is no recognized cause
* symptoms persist despite treatment with antibiotics for non-bacterial prostatitis in the past six months.

Exclusion Criteria:

* Clinically significant medical problems or other organ abnormalities
* psychiatric disorders
* urinary tract infection during the last three months
* history of bladder, urethral or prostate cancer
* Prostate Specific Antigen (PSA) greater than or equal to 4 ng/mL
* diagnosis or treatment for genital herpes or herpes flare within the last year.

Primary outcomes:
measure: The change in total NIH-CPSI score from baseline to Week 12
Secondary outcomes:
measure: Participant-reported Global Response Assessment at Week 12. Brief Male Sexual Function Index at Weeks 4, 8, and 12. Pelvic Pain Urgency and Frequency symptom scale at Weeks 4, 8, and 12.
Other outcomes:
Locations:
Study officials:
affiliation: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
name: McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00827190: Study Evaluating Single Ascending Doses Of ILS-920
Official title: Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ILS-920 Administered Intravenously To Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first-in-human study of ILS-920. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after administration of ascending single intravenous (IV) doses to healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women of nonchildbearing potential
* Aged 18 to 50 years inclusive at screening.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* History of drug abuse within 1 year before study day 1.

Primary outcomes:
measure: Safety based on vital sign evaluations, 12-lead ECGs, cardiac rhythm monitoring and routine lab tests.
timeFrame: 48 hours after study drug administration
Secondary outcomes:
measure: Pharmacokinetics will measure the extent and rate of Absorption, Distribution, Metabolism and Excretion of the drug in the body.
timeFrame: 48 hours after study drug administration
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00173290: Cytokine Regulation of Natural Killer Receptors in Inhibiting Activated T Cell Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Breast Cancer
Endometrial Cancer
Cancer
Keywords: Cervical cancer
Breast cancer
T lymphocyte
NK receptor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: In this study proposal, the investigators will extend their previous studies and examine the kinetic cytotoxic activity with concordant expression of inhibitory natural killer (NK) receptors (iNKR) on activated T cells. The inhibitory role of cytokines will be defined by utilizing the investigators' previously established models of mixed lymphocytes and tumor cells coculture to analyze the expression and activity of cytokines involved in the regulation of iNKRs on cancer-encountered T cells.

Detailed description: In our extended studies, we have directly examined the expressions of various inhibitory natural killer cell Receptors (iNKRs) on Tumor-infiltrating lymphocytes (TILs) derived from human Cervical cancer (CC) by triple-color flow cytometry with combination of different surface markers. We found up-regulated expression of certain iNKRs (CD94/NKG2A) in TILs and in mixed lymphocyte-cancer cell cocultures. In our previous studies, we demonstrated that certain cytokines, including IL-10, TGF-beta (Sheu et al, Journal of Immunology, 2001, 167:2972-2978), and IL-15 (Sheu et al, Cancer Research, 2005, 65:2921-2929) can be expressed by CC cells. We further demonstrated that activated T cells bear iNKRs which inhibit cytotoxic activity. iNKRs are proposed to restrain the T cell receptor (TCR)-mediated cytolysis. We found that CC cells had altered HLA-A, -B, and -C molecules in a cancer microenvironment. The acquisition of both NK-like activity and expression of iNKRs by these T cells is parallel to prevent damage to normal host cells. However, there is also limited knowledge about the regulatory role of iNKR expression in T cell cytotoxicity.

Eligibility criteria: Inclusion Criteria:

* Cancer patients
* Healthy volunteers

Exclusion Criteria:

* Immunosuppression
* HIV carrier

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, National Taiwan University Hospital
name: Bor-Ching Sheu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheu BC, Chiou SH, Lin HH, Chow SN, Huang SC, Ho HN, Hsu SM. Up-regulation of inhibitory natural killer receptors CD94/NKG2A with suppressed intracellular perforin expression of tumor-infiltrating CD8+ T lymphocytes in human cervical carcinoma. Cancer Res. 2005 Apr 1;65(7):2921-9. doi: 10.1158/0008-5472.CAN-04-2108.
Clinical trial NCT00187590: A Case Management Intervention to Prevent ER Visits in HIV-infected Persons
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV
Keywords: HIV
case management
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Case management has become an integral part of HIV care. There is little science however demonstrating its effectiveness. This is a randomized, controlled trial of a phone call intervention after an ER visit to see if this can reduce further ER visits, hospitalizations, deaths, and cost.

Detailed description: One year retrospective look at outcome measures followed by a one year trial of a phone call after each ER visit in half of the group. Outcomes measured are cost, ER visits, hospitalizations, death, length of stay. Adults only, English or Spanish, questionnaire on depression, appointments, drug use with referral to case management services, drug rehab services, or followup appointments. Time for intervention is recorded to estimate cost.

Eligibility criteria: Inclusion Criteria:

* Patient in our clinic as of 4-1-04

Exclusion Criteria:

* \<18 years old

Primary outcomes:
measure: Death, hospitalizations, ER visits, LOS
timeFrame: 1 year
Secondary outcomes:
measure: Cost
timeFrame: 1 year
Other outcomes:
Locations:
city: Fresno
country: United States
facility: University Medical Center
state: California
Study officials:
affiliation: UCSF-Fresno Medical Eduction Program
name: Roger B Mortimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01140490: Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients
Official title: Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis
Keywords: Hemodialysis
Sub-total Parathyroidectomy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate whether successful sub-total parathyroidectomy retards cardiovascular calcification in patients with hemodialysis and to investigate the mechanism .

Detailed description: Hyperparathyroidism (PHPT) in patients with end-stage renal disease have been shown to have an increased morbidity and mortality mainly due to cardiovascular disease. The precise mechanism of cardiovascular disease in PHPT is not well understood . The excess in cardiovascular mortality is significantly and independently related to serum calcium, the connection between the biochemical disturbances and the cardiovascular disorders in PHPT patients is not necessarily a cause-and-effect relationship. Indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular risk factors and mortality is controversial. Some studies suggest that cardiovascular risk markers remained unaltered after Sub-total Parathyroidectomy.

Eligibility criteria: Inclusion Criteria:

* The patients receiving hemodialysis treatment, with elevated intact parathyroid hormone (iPTH) levels \> 800pg/ml on two or more occasions.
* Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.

Exclusion Criteria:

* Patients with significant background valvular heart disease
* Patients who are unfit for general anaesthesia
* Patients with acute myocardial infarction within recent two months
* Patients with poor general condition
* Patients with plans for living related kidney transplant within 1 year
* Patients with previous history of parathyroidectomy

Primary outcomes:
measure: Change in vascular calcium scores
timeFrame: 12 months
Secondary outcomes:
measure: Change in left ventricular systolic and diastolic function
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Chinese Nephrology Committee
name: Shi wei, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04023890: Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients
Official title: Ventricular Electrical Synchronization by Stimulating Left and Right Bundle Branches Area in Pacing-indicated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Pacing
Pacing Therapy
Pacemaker
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll subjects who have pacing indications or indications for CRT.

Brief summary: This is a prospective, single-site, non-randomized, acute feasibility clinical study. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle branches area.

Detailed description: Many pacemaker patients have cardiac conduction system disease and thus need ventricular pacing. Traditional ventricular pacing causes ventricular dyssynchrony that in turn causes cardiac contraction dysfunction. CRT pacing provides better ventricular synchronization, but not the optimal, especially in patients with narrow QRS. CRT non-response rate is at 30%. His bundle pacing utilizes naturel His bundle-Purkinjie system to provide optimal physiological pacing. But many pacing-indicated patients have abnormal His bundle-Purkinje system, thus His bundle pacing cannot provide optimal pacing in patients with abnormal cardiac conduction system. Moreover, the pacing threshold is high during His bundle pacing. More recently, left bundle branch pacing is proposed. However, LBBP will generate right bundle branch block pattern, another kind of weak ventricular synchronization. Thus, the investigators propose to excite the left and right bundle branches area simultaneously to normalize ventricular synchronization. The purpose of this study is to explore the electrocardiogram (ECG) characteristics of simultaneous stimulation of right and left bundle branches area.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 80 years old
* Subjects who are willing to provide Informed Consent
* Subjects who have pacing indications or indications for CRT, and will receive pacemaker or CRT therapy

Exclusion Criteria:

* Subjects who have contra-indications for pacing therapy or CRT
* CRT up-graded subjects
* Ventricular hypertrophy
* Subjects who have medical conditions that would limit study participation
* Subjects who are pregnant or have a plan for pregnancy during the study
* Subjects who are not willing to provide Informed Consent

Primary outcomes:
measure: QRS duration
timeFrame: During implant
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Medtronic
name: Xiaohong Zhou, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02881203: Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
Official title: BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
radiation
DIBH
cardiac toxicity
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 45
Sex: FEMALE
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 investigates the Breathe Well device to test whether it is superior to the existing treatment standard of the Varian Realtime Position Management (RPM) system in assisting patients with deep inspiration breath hold.

Detailed description: Recent studies have demonstrated an increased risks of cardiac disease in breast cancer radiotherapy patients. For patients diagnosed \<50 years old, the risks for cardiovascular diseases/events were increased by 24-82% comparing left and right breast radiotherapy. The deep inspiration breath hold (DIBH) technique addresses this problem by reducing the heart dose by up to half, thus potentially reducing the increased rate of major coronary events by 20%. Providing patients with visual feedback in addition to audio guidance has been demonstrated to improve the reproducibility of the DIBH technique by 95% and stability by 80%.

Breathe Well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing DIBH for breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* Left-sided breast cancer patients (invasive and in situ)
* Supine positioning of the patients.
* Ability to perform a ≥20s breath hold
* \>18 years old
* An ECOG score in the range of 0 to 2
* Able to give written informed consent and willingness to participate and comply with the study
* Patients must be able to read and complete questionnaires in English

Exclusion Criteria:

* Involvement or at risk regional lymph nodes
* Pregnant / lactating women

Primary outcomes:
measure: Accuracy of Breathe Well
timeFrame: 2 years
Secondary outcomes:
measure: Difference in set up times for Breathe Well vs RPM
timeFrame: 2 years
measure: Patient comfort
timeFrame: 2 years
measure: Staff perception of Breathe Well
timeFrame: 2 years
measure: To develop the use of EPID for real time MLC tracking during breast radiotherapy
timeFrame: 2 years
measure: To compare actual and planned doses
timeFrame: 2 years
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Royal North Shore Hospital
name: Gillian Lamoury, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04165603: Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
Official title: Fluorescence-navigated Thoracoscopy for Detection of Small Pulmonary Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Fluorescence-navigated thoracoscopic imaging with indocyanine green (ICG) is a novel technique for detection of small pulmonary nodules other than traditional radiography or intraoperative palpation. As a non-targeted fluorescent contrast agent, ICG accumulates in tumors by the enhanced permeability and retention effect (EPR), making the lesions fluoresce under fluorescent imaging. However, the optimal dosage and injection time of ICG are still under exploration. Hence, we perform this study in humans made up of four groups to determine the optimal time and dose.


Eligibility criteria: Inclusion Criteria:

* Peripheral pulmonary solid nodules, with diameter 1-3 cm.
* Suitable for surgery and signed informed consent.

Exclusion Criteria:

* Liver dysfunction.
* Allergic to indocyanine green.
* Can't tolerate thoracoscopic surgery.

Primary outcomes:
measure: Signal-to-background Ratio (SBR) of the Tumor and Normal Parenchyma
timeFrame: within 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Wang Jun, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01037803: Perioperative Observation of the Sublingual Microcirculation With SDF
Official title: Visualisation of Changes in the Sublingual Microcirculation During Major Surgery Using Sidestream Darkfield Imaging (SDF).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: perioperative sublingual microcirculation SDF
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing major surgery at one university hospital

Brief summary: Does sublingual SDF-imaging results correlate with other haemodynamic parameters measured perioperatively and with postoperative morbidity/complications.


Eligibility criteria: Inclusion:

* major surgery \> 3h requiring arterial cannulation and central venous access

Exclusion Criteria:

* denied patient consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: University of Lund and Lund University Hospital
state: Skane
Study officials:
affiliation: Dep for Anesthesia and Intensive Care, Lund University Hospital
name: Peter Bentzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: