louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01682473: A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
Official title: A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: PI3K inhibitor
clinical trial
Lead sponsor: Zenyaku Kogyo Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.

Detailed description: Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21 days on drug and 7 days off drug).

Eligibility criteria: Inclusion Criteria:

* Japanese males or females \>= 20 years old
* Advanced (metastatic or unresectable) solid tumor
* ECOG performance status score of 0 or 1 and expected survival \>12 weeks
* Recovered from hematological toxicities of prior cancer therapies

Exclusion Criteria:

* Previous treatment with PI3K inhibitor
* Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease.
* Other investigational agent within previous 4 weeks
* Participating in another clinical study

Primary outcomes:
measure: Number of participants with dose-limiting toxicities
timeFrame: 28 days
Secondary outcomes:
measure: Pharmacokinetics (Cmax, tmax, t½, AUC)
timeFrame: 28 days
Other outcomes:
Locations:
city: Kashiwa-city
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
Study officials:
affiliation: National Cancer Center Hospital East
name: Toshihiko Doi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cancer Institute Hospital of JFCR
name: Shunji Takahashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00307073: Adapta Pacing System Clinical Study
Official title: Adapta Clinical Study to Evaluate the Overall System Safety and Clinical Performance of the Adapta Pacing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker
Bradycardia
Keywords: Pacemaker
Managed Ventricular Pacing
Ventricular Pacing
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (MVP) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system.


Eligibility criteria: Inclusion Criteria:

* Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines
* Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form

Exclusion Criteria:

* Subjects with a mechanical tricuspid valve
* Subjects with a life expectancy less than two years
* Subjects with a Class III indication for permanent pacing
* Subjects with lead integrity problems, unless leads are being replaced

Primary outcomes:
measure: Freedom from adverse device effects
Secondary outcomes:
measure: To assess right ventricular (lower right chamber of the heart) pacing
measure: To summarize all adverse events reported in the study
measure: To describe Adapta system performance as observed during Holter recording, save-to disk-files and technical observations
measure: To evaluate the user acceptance of TherapyGuide via questionnaire data
Other outcomes:
Locations:
city: Graz
country: Austria
city: Prague
country: Czech Republic
city: Belgrade
country: Former Serbia and Montenegro
city: Bad Nauheim
country: Germany
city: Hamburg
country: Germany
city: Heerlen
country: Netherlands
city: Lund
country: Sweden
Study officials:
affiliation: Medtronic
name: Adapta Study Team
role: STUDY_CHAIR
References:
Clinical trial NCT03810573: Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Official title: A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety And Preliminary Effectiveness Of NB1 Bone Graft In Subjects With Degenerative Disc Disease Undergoing Transforaminal Lumbar Interbody Fusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Spondylolisthesis
Lead sponsor: Bone Biologics Corp
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion.

It is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays and CT scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of degenerative disc disease
* Up to Grade I spondylolisthesis
* Eligible to undergo a single vertebral level spine fusion (L2 to S1)

Exclusion Criteria:

* Previous spinal instrumentation or previous interbody fusion procedure at the involved level
* Grade II or greater spondylolisthesis
* Systemic or local infection at the site of surgery

Primary outcomes:
measure: Fusion
timeFrame: 12 months
Secondary outcomes:
measure: Removal, revision, or supplemental fixation
timeFrame: 12 months
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Medical Center
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent Melbourne
city: Kogarah
country: Australia
facility: St George Hospital
Study officials:
affiliation: Monash Health
name: Tony Goldschlager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02427373: A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
Official title: A Parallel Bioavailability Study of Fish Oil-Ethyl Ester Versus Fish Oil-Triglyceride Versus Krill Oil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: bioavailability
fish oil
krill oil
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A multiple-dose, double-blind, randomized, four-week, three-treatment, parallel study in which 66 healthy adult subjects will receive 6 capsules/d, administered as a dose of 1.3 g/d eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) in fish oil ethyl ester (EE), or fish oil triglyceride (TG) or krill oil for a total of 4 weeks. The objective of the study is to compare the oral bioavailability of EPA+DHA in total plasma across the three formulations at the end of the 4 week study.


Eligibility criteria: Inclusion Criteria:

* Healthy,
* adult female who is neither pregnant nor breastfeeding, or
* a healthy, adult male
* with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and
* with a minimum weight of 50 kg (110 lbs).

Exclusion Criteria:

* history or presence of diabetes, high triglycerides (≥240 mg/dL), or high cholesterol (≥240 mg/dL);
* clinically significant abnormal finding on the physical exam, medical history, vital signs, or clinical laboratory results at screening;
* history or presence of allergic response to omega-3-fatty acids or sensitivity or allergy to fish or shellfish;
* history of coagulation disorder or current anticoagulation therapy;
* has used any nutritional supplements, omega-3 supplements, fish oil, chia, krill oil, flaxseed or foods supplemented with omega-3s within 3 months prior to the first dose of study medication;
* has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.

Primary outcomes:
measure: Comparison of total plasma DHA+EPA levels across 3 treatment groups
timeFrame: 4 weeks
Secondary outcomes:
measure: Comparison of RBC DHA+EPA levels across 3 treatment groups
timeFrame: 4 weeks
measure: pharmacokinetic parameter: AUC to 672hr
timeFrame: 4 weeks
measure: pharmacokinetic parameter: AUC to 336hr
timeFrame: 2 weeks
measure: pharmacokinetic parameter: Cmax
timeFrame: 4 weeks
measure: pharmacokinetic parameter: Tmax
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Worldwide Clinical Trials
name: Vanessa Smeberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yurko-Mauro K, Kralovec J, Bailey-Hall E, Smeberg V, Stark JG, Salem N Jr. Similar eicosapentaenoic acid and docosahexaenoic acid plasma levels achieved with fish oil or krill oil in a randomized double-blind four-week bioavailability study. Lipids Health Dis. 2015 Sep 2;14:99. doi: 10.1186/s12944-015-0109-z.
Clinical trial NCT04838873: Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
Official title: Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Laparoscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University.

Detailed description: The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy. The focus of the study will be a comparison of both approaches on the patients' peri-operative outcome.

Eligibility criteria: Inclusion Criteria:

* Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma.
* Patients fit for surgery (ECOG Performance Status 0,1).

Exclusion Criteria:

* Patients with medical comorbidities that preclude surgical management or minimally invasive techniques.
* Patients with advanced hydronephrosis or renal failure.
* Patients refusing surgery.
* Patients with urinary bladder cancer invading bladder neck or prostatic urethra.
* Patients with metastatic urinary bladder cancer.
* Patients who received prior pelvic radiotherapy.
* Patients refusing randomization and/or participation in the trial.

Primary outcomes:
measure: Operative time
timeFrame: During surgery
measure: Blood loss
timeFrame: During surgery
measure: Length of hospital stay
timeFrame: Immediate post-operative period.
measure: Time to oral intake
timeFrame: Immediate post-operative period
measure: Conversion rate
timeFrame: During surgery
measure: Re-admission rate.
timeFrame: Intra-operative to sixth months.
measure: Opioid requirements.
timeFrame: During surgery through first post-operative week.
measure: Visceral injury
timeFrame: During surgery
measure: Urine leak
timeFrame: Up to 4 weeks
measure: Wound dehiscence, infection.
timeFrame: Up to 4 weeks
measure: Enteric fistula
timeFrame: Up to 4 weeks
measure: Sepsis
timeFrame: Up to 4 weeks
measure: Venous thromboembolism
timeFrame: Up to 2 months
Secondary outcomes:
measure: pT stage
timeFrame: Within 10 days post surgery.
measure: Lymph node retrieval
timeFrame: Within 10 days post surgery.
measure: pN stage
timeFrame: Within 10 days post surgery.
measure: Surgical margins
timeFrame: Within 10 days post surgery
measure: Histological grade
timeFrame: Within 10 days post surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute, Cairo University
name: Hatem Aboulkassem, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730873: Fatty Liver and Obstructive Sleep Apnea
Official title: Fatty Liver and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Obstructive Sleep Apnea
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-08-08
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes. We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this reduction can be evident using computerized tomography


Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnea, defined as AHI\>5/h

Exclusion Criteria:

* Consumption of more than 20 grams of alcohol per 24 h
* Known autoimmune disease
* Usage of known hepatotoxic drugs
* Medical history positive for viral hepatitis or other chronic liver disease

Primary outcomes:
measure: Reduction in fatty liver changes on computerized tomography
timeFrame: Within 1-2 years
Secondary outcomes:
measure: Improved liver enzymes abnormalities
timeFrame: Within 1-2 years
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: The pulmonary institute, Asaf Harofeh Medical Center
Study officials:
References:
Clinical trial NCT04545073: Outcomes of a Trifocal IOL in Post-refractive Patients
Official title: Outcomes of a Trifocal IOL in Post-refractive Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractive Errors
Lead sponsor: Vance Thompson Vision ND
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Charts from up to 200 myopic post-refractive patients who have received PanOptix will be reviewed at at least two Vance Thompson Vision sites (Fargo, ND and Sioux Falls, SD). All patients will have had ORA used during the cataract surgery.

Brief summary: To compare the prediction error of ORA vs formula for post-LASIK cataract patients when PanOptix IOL was implanted. Using post-operative outcomes to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.

Detailed description: The study will be non-interventional with data being collected prospectively and retrospectively between at least two surgical sites. All subjects will have previous LASIK and be at least 3 months post op PanOptix implantation. The study will enroll up to 200 patients and a statistical database will be created.

Eligibility criteria: Inclusion Criteria:

* Previous myopic refractive surgery
* At least 3 months post op cataract surgery with a trifocal IOL

Exclusion Criteria:

* Pre-existing or subsequent eye condition that interferes with accurate data collection (retinal detachment, etc.)

Primary outcomes:
measure: To determine if preoperative IOL calculations or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.
timeFrame: Pre-op to 9 month visit
Secondary outcomes:
measure: Post-operative monocular visual acuity
timeFrame: 3 to 9 month visit
measure: Post-operative best corrected visual acuity
timeFrame: 3 to 9 month visit
measure: Post-operative uncorrected visual acuity
timeFrame: 3 to 9 month visit
measure: Post-operative visual acuity
timeFrame: 3 to 9 month visit
measure: Post-operative visual acuity
timeFrame: 3 to 9 month visit
measure: Post-operative visual acuity
timeFrame: 3 to 9 month visit
measure: Patient's quality of vision and reported side-effects
timeFrame: 3 to 9 month visit
Other outcomes:
Locations:
city: W. Fargo
country: United States
facility: Vance Thompson Vision ND
state: North Dakota
Study officials:
affiliation: Vance Thompson Vision ND
name: Michael Greenwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397773: Pentraxin-3 in Chronic Renal Failure
Official title: The Role Pentraxin-3 in the Inflammatory Process in Chronic Renal Failure, and the Association With Other Inflammatory Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Chronic Kidney Disease
Keywords: Hemodialysis
peritoneal dialysis
chronic kidney disease
inflammation
carotis intima media thickness
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 85
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected among those who are followed up in our clinic.

Brief summary: The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers and carotis intima media thickness.

Detailed description: The investigators planned to involve four group of patients: Hemodialysis, peritoneal dialysis, pre-dialysis and the control group; with about 25 patients planned to be involved in each group. The laboratory parameters to be measured are Pentraxin-3, C-reactive protein (CRP), high sensitive CRP, fibrinogen and interleukin-6. Concomitantly, carotis intima media thickness will be measured in the radiology clinic. Statistical analysis will be carried on by Statistical Package for Social Sciences (SPSS) for Windows 13.0. The variables acting on the inflammatory parameters and the correlation between them and carotis intima media thickness will be studied.

Eligibility criteria: Inclusion Criteria:

* To give informed consent
* Hemodialysis or peritoneal dialysis for more than 3 months
* Creatinin clearance less than 30 ml/min for the pre-dialysis group

Exclusion Criteria:

* Not to give informed concent
* Active infection within the last 3 months
* Known chronic inflammatory disease

Primary outcomes:
measure: Pentraxin-3 level
timeFrame: Five months
Secondary outcomes:
measure: Carotis intima media thickness
timeFrame: Five months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
References:
Clinical trial NCT03325673: Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control
Official title: Randomized, Double-arm, Controlled Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control (CORIANDER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-10-30
Enrollment: 84
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the increase in comfort and comfortable contact lens (CL) wear time associated with application of TrueTear (active intranasal neurostimulation) compared with application of TrueTear sham control (intranasal application which is not electrically active) in symptomatic CL wearers.


Eligibility criteria: Inclusion Criteria:

A person is eligible for inclusion if he/she

* In at least one eye, has a cotton swab nasal stimulation Schirmer test score at least 4 mm greater than 3 minute Schirmer with anesthesia basal score in the same eye at the Screening Visit
* Is an adapted soft contact lens wearer and currently wears lenses an average of at least 2 days per week, with an average minimum wearing time of 3 hours each day over the past month and is able and willing to wear lenses for at least 6 hours on four study day visits
* Has at least 20/40 visual acuity in both eyes with CL correction
* Is symptomatic according to Young's categorization

Exclusion Criteria:

* Refractive error surgery
* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
* History of nasal or sinus surgery
* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head

Primary outcomes:
measure: Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye
timeFrame: Day 28
measure: Comfort Rating Score in the Study Eye
timeFrame: CL Insertion, After 2 hours and the End of Day on Day 24
measure: Comfortable Wear Time (CWT) in the Study Eye
timeFrame: Day 24
measure: Total Wear Time (Total WT) in the Study Eye
timeFrame: Day 24
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research School of Optometry & Vision Science, University of Waterloo
state: Ontario
Study officials:
affiliation: Allergan
name: Michelle Senchyna
role: STUDY_CHAIR
References: