louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02389855: Laser Ablation in Stereotactic Neurosurgery (LAISE): NeuroBlate® Retrospective Registry
Official title: Laser Ablation in Stereotactic Neurosurgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Brain Tumor
Keywords: Progression
Quality of Life
Lead sponsor: Monteris Medical
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously treated with NBS (up to 300)

Brief summary: The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. Since receiving FDA clearance in April 2013, the NBS has been used in nearly 300 procedures conducted at approximately 20 leading institutions across the United States. This post-market, multi-center retrospective study is designed to collect long-term follow-up data on patients who were treated previously with NBS.


Eligibility criteria: Inclusion Criteria:

* Patient was previously treated with NBS
* Patient is willing and able to provide informed consent and authorization for release of personal health information or IRB waiver is granted to collect study information without patient consent

Exclusion Criteria: There are no exclusion criteria for this study.

Primary outcomes:
measure: Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status
timeFrame: up to 24 months
Secondary outcomes:
measure: Adverse Events
timeFrame: up to 24 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sujit Prabu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Andrew Sloan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03540355: Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment
Official title: Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 20 Association on the Dyslipidemia Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dyslipidemias
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 312
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: The purpose of this study is to evaluate the efficacy of Cipros 20 association in the treatment of dyslipidemia treatment.


Eligibility criteria: Inclusion Criteria:

* Participants of both sexes, aged 18 years or more;
* Participants with the diagnosed of dyslipidemia and with high or very high cardiovascular risk, according to the Brazillian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
* Signed consent.

Exclusion Criteria:

* Using medications that may interfere with the metabolism or serum levels of triglycerides;
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Presence of concomitant cardiovascular disease, renal failure and hepatic failure;
* Decompensated diabetes;
* Current smoking;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* History of alcohol abuse or illicit drug use;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Reduction of serum triglyceride levels
timeFrame: 12 weeks vs baseline
measure: Reduction of serum LDL-c
timeFrame: 12 weeks vs baseline
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
References:
Clinical trial NCT01004055: Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Official title: Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wound Healing
Wound Infection
Keywords: Wound
Skin lesion
Antimicrobial
Bioelectric
Lead sponsor: Vomaris Innovations
Sponsor class: INDUSTRY
First posted: 2009-10-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.


Eligibility criteria: Inclusion Criteria:

* If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test
* Wound size greater than 1x1cm
* Wound must be ≥5 cm away from all other wounds
* Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
* Participant agrees to participate in follow-up evaluation
* Participant must be able to read and understand informed consent, and sign the informed consent

Exclusion Criteria:

* Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
* Participant is to receive another topical antimicrobial agent other than the study dressing
* Participant with sensitivity or adverse reactions to silver or zinc
* Pregnancy or nursing an infant or child
* Immunosuppression
* Active or systemic infection
* Collagen vascular disease
* Diabetes
* Venous stasis ulcers
* Participant undergoing active cancer chemotherapy
* Chronic steroid use
* Decision impairment

Primary outcomes:
measure: Wound healing over time
timeFrame: July 2008-October 2009
Secondary outcomes:
measure: Comparing three FDA cleared products for pain reduction and incidence of infection
timeFrame: July 2008-October 2009
Other outcomes:
Locations:
city: Oro Valley
country: United States
facility: Sheftel Associates Dermatology, LLC
state: Arizona
city: Tucson
country: United States
facility: Sheftel Associates Dermatology, LLC
state: Arizona
Study officials:
affiliation: Sheftel Associates Dermatology, LLC
name: Scott N Sheftel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00101855: Can Parental Activation Over the Internet Improve Pediatric Preventive Care?
Official title: Parent Initiated Prevention Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Well Child Preventive Care
Keywords: prevention
internet
quality of care
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2005-01-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial of an evidence based, patient specific web site's ability to improve preventive practices in pediatric care. Parents visit the website within 2 weeks of a scheduled well child visit and are presented with a menu of age specific topics that they can read about as they wish.


Eligibility criteria: Inclusion Criteria:

* \<11 years

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Prevention Practices
measure: Satisfaction with care
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT06061055: Comparison of VentiBroncTM Anchor With Conventional Double-lumen Endobronchial Tube in Patients With High Risk of Malposition
Official title: Comparison of VentiBroncTM Anchor With Conventional Double-lumen Endobronchial Tube in Patients With High Risk of Malposition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators intend to compare the group using triple-cuffed endobronchial tube (VentiBroncTM Anchor) with the group using the conventional double-lumen endotracheal tube (Shiley®) in patients at high risk of malposition of the double-lumen endotracheal tube. The aim of this study is to determine if the use of VentiBroncTM Anchor increases the success rate of optimal double-lumen intubation to left main bronchus.


Eligibility criteria: Inclusion Criteria:

Patients requiring left double-lumen endotracheal tube intubation for thoracic surgery.

ASA physical status classification 2-4. Female patients aged 20-85 with a height of 160cm or less and a body mass index (BMI) of 25.0 kg/m2 or higher.

Patients requiring VentiBroncTM Anchor 33Fr or Shiley® 32Fr intubation due to a left mainstem bronchus diameter of 11mm or less on chest CT.

Exclusion Criteria:

Intraluminal lesions in the left or right mainstem bronchi. History of airway surgery. Emergency surgery.

Primary outcomes:
measure: Success rate of endobronchial intubation
timeFrame: Immediately after double-lumen tube intubation, with flexible fiberoptic bronchoscope
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
name: Kyuho Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142855: Structural and Metabolic Determinants of Sarcopenia and the Efficacy of Concentric vs. Eccentric Exercise Training
Official title: Structural and Metabolic Determinants of Sarcopenia and the Efficacy of Concentric vs. Eccentric Exercise Training: a Novel Temporospatial Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
young (18-30 y)
older (65-75 y)
age groups
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Biotechnology and Biological Sciences Research Council
First posted: 2014-05-20
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The first goal of this study is the follow young and older people over a period of 8 weeks to define the processes responsible for loss of muscle length and width in age-related muscle wasting (sarcopenia) and allow us to look at age-related differences in tendon. Secondly, we will assess two different exercise interventions for reversing human sarcopenia; one which involves shortening of the muscle and the other which involves lengthening, whilst also studying why these exercises work the way they do. This project will have significant implications for our understanding of the control of skeletal muscle and tendon size in humans, particularly in relation to sarcopenia and the surrounding health issues.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* Body mass index 18-30 kg/m2
* Aged 18-35 and 65-75 years

Exclusion Criteria:

* Participation in a formal exercise regime,
* A BMI \< 18 or \> 30 kg/m2,
* Active cardiovascular disease,
* Taking beta-adrenergic blocking agents, statins or non-steroidal anti-inflammatory drugs,
* Cerebrovascular disease,
* Respiratory disease,
* Metabolic disease,
* Active inflammatory bowel or renal disease,
* Malignancy,
* Recent steroid treatment (within 6 months) or hormone replacement therapy,
* Clotting dysfunction,
* Musculoskeletal or neurological disorders,
* Family history of early (\<55y) death from cardiovascular disease

Primary outcomes:
measure: Muscle protein synthesis
timeFrame: 0 - 8 weeks
Secondary outcomes:
measure: Tendon protein synthesis
timeFrame: 0 - 8 weeks
Other outcomes:
measure: Muscle function
timeFrame: 0 - 8 weeks
Locations:
city: Derby
country: United Kingdom
facility: University of Nottingham
state: Derbyshire
Study officials:
affiliation: University of Nottingham
name: Marco V Narici, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02868255: Myeloid Derived Suppressor Cells Control by Signal Regulatory Protein-alpha: Investigation in Hepatocellular Carcinoma
Official title: Myeloid Derived Suppressor Cells Control by SIRP-alpha: Investigation in Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Biobank analyses
Effect evaluation of the drug
patient-derived cells
SIRPα/CD47 expression
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Several types of samples will be used to test the effect of the drug candidate: 30 inflammatory ascites of HCC patients, 30 HCC resections (both from CHU de Nantes), 30 HCC patient blood samples.

Brief summary: project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a new immunotherapy strategy in cancer.

Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* adult
* HCC patients (all BCLC stages accepted)
* patient consent for the use of their biological samples

Exclusion Criteria:

* patient with other cancers
* hepatitis C or B positive
* HCC treatment by chemo-embolization under 3 months
* under Sorafenib treatment within the month prior to collection
* underage or under guardianship patients

Primary outcomes:
measure: evaluation of the SIRP/CD47 expression
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Isabelle ARCHAMBEAUD, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00578955: Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
Official title: A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blepharoconjunctivitis
Keywords: Blepharoconjunctivitis, Ophthalmology
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 417
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.


Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of blepharoconjunctivitis
* Must be willing to discontinue contact lens wear for the duration of the study
* Additional inclusion criteria also apply.

Exclusion Criteria:

* Have known sensitivity or poor tolerance to any component of the study medications.
* Have any clinically significant cardiovascular disorders
* Have any history of liver or kidney disease resulting in persisting dysfunction
* Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.
* Additional exclusion criteria also apply.

Primary outcomes:
measure: The resolution of the clinical signs and symptoms.
timeFrame: 2 weeks
Secondary outcomes:
measure: Bacterial eradication
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03663855: Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria
Official title: Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystinuria
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the minimum effective dose of the cysteine binding thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine solubility in the urine, in patients with cystinuria to evaluate the effect of escalating doses of cystine binding thiol drugs on the cystine capacity of the urine. The overall goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by larger dosages.

Cystinuria is a rare genetic disease that can lead to significant morbidity in affected patients due to the recurrent nature of the disease. This study will follow the levels of urine cystine capacity in order to help guide treatment and to use lower than usually prescribed Tiopronin doses to decrease the potential side effects while maintaining therapeutic benefit. This will increase adherence with the medications by decreasing the burden of the large number of pills that need to be taken daily.


Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed laboratory diagnosis of cystinuria who meet the following criteria: (1) stone analysis demonstrating cystine as a component, or (2) increased urinary cystine excretion (\>250mg/24hrs in adults).
* A medical regimen that includes Tiopronin.
* Willing to use a medically accepted form of birth control, if female and of child bearing- potential
* Ability to reliably urinate in a collection vessel and measure urine volume.
* Ability to give informed consent.
* Documentation of a stable complete blood count (CBC) and urinalysis (UA) in the six month period prior to the date of enrollment.
* Enrollment in Rare Kidney Stone Consortium (RKSC) Protocol 6401 (Cystinuria Registry)

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or trying to become pregnant
* Patients with renal colic
* Patients who are scheduled to undergo a surgical procedure
* Inability to give informed consent

Primary outcomes:
measure: Change in Cystine Capacity From Baseline
timeFrame: Baseline; Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01213355: Scopolamine Challenge Study
Official title: A Randomized, Double-Blind, Sponsor Unblinded, Placebo Controlled, 5-Way, Crossover Study To Evaluate The Effects Of Single Oral Administrations of PF-05212377 (SAM-760), A 5-HT6 Antagonist, On Scopolamine Induced Deficits In Psychomotor And Cognitive Function In Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Randomized
double-blind
placebo-controlled
5-way crossover
single oral administrations of PF 05212377
scopolamine induced deficits in healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive impairments in healthy adults subjects.

Detailed description: Proof of mechanism

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive.
* Body Mass index (BMI) of between 17.5 to 30.5 kg/m2 inclusive; and a total body weight greater than or equal to 50 kg (110 lbs).

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Primary outcomes:
measure: Groton Maze Learning Task (Total Errors); included in CogState Battery of Tests.
timeFrame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
Secondary outcomes:
measure: Detection Task (Speed; included in CogState Test Battery)
timeFrame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
measure: One Card Learning Task (Accuracy of performance; included in CogState Test Battery)
timeFrame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
measure: Continuous Paired Associate Learning Task (Number of errors; included in CogState Test Battery)
timeFrame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
measure: Bond-Lader Visual Analog Scales (included in CogState Test Battery)
timeFrame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
measure: Identification Task (Speed; included in CogState Test Battery)
timeFrame: Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: