louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06094205: Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
Official title: Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anarthria
Dysarthria
Tetraplegia
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis
Brain Stem Infarctions
Locked-in Syndrome
Muscular Dystrophies
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-10-23
Enrollment: 2
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: OTHER

Brief summary: The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

Detailed description: The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 80 years of age
* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
* Complete or incomplete tetraplegia (quadriplegia)
* Must live within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

(There are additional inclusion criteria)

Exclusion Criteria:

* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study

(There are additional exclusion criteria)

Primary outcomes:
measure: Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
timeFrame: 1 year
Secondary outcomes:
measure: Decoded speech output accuracy
timeFrame: At participant exit from study, or up to 5 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Sergey Stavisky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02495805: Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
Official title: Ultrasound-guided Continuous Proximal Adductor Canal Versus Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: a continuous proximal adductor canal block (ACB)
continuous femoral nerve block (FNB)
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation.

Detailed description: Patients meeting the criteria: American Society of Anesthesiologists (ASA) class I and II, that are scheduled for elective total knee arthroplasty, will be recruited into the study. Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).

Eligibility criteria: Inclusion Criteria:

* Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.
* The patient will need to be able to have decision-making capacity and ability to consent for the study.

Exclusion Criteria:

* Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.
* Patients unable to have decision-making capacity and ability to consent for the study.

Primary outcomes:
measure: Motor effects
timeFrame: 24 hours (postoperatively)
Secondary outcomes:
measure: Pain score
timeFrame: On average between 6 and 8 hours postoperatively
measure: Pain score
timeFrame: 24 hours (postoperatively)
measure: Opioid consumption
timeFrame: On average between 6 and 8 hours postoperatively
measure: Opioid consumption
timeFrame: 24 hours (postoperatively)
measure: Motor effects
timeFrame: On average between 6 and 8 hours postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Richa Wardham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05526105: Gastric US in ICU Patient
Official title: Gastric Ultrasound in Critically Ill Patients for Evaluation of Gastric Volume Residuals; A Comparison of NPO Protocols
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Surgery
Aspiration Pneumonia
Keywords: NPO Protocols
Intensive Care Unit
Gastric Ultrasound
Ultrasound
Surgical Intensive Care Unit
NPO
Nasogastric Tube
Orogastric Tube
Enteral Nutrition
Parenteral Nutrition
Gastric Residual Volume
Aspiration
Critical Illness Nutrition
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to be NPO after midnight (standard protocol) or feed up until call to OR then decompressed (liberal protocol).
Primary purpose: SCREENING

Brief summary: This is a case series study using gastric ultrasound in critically ill patients to quantify gastric residual volumes to compare the efficacy of different NPO protocols.


Eligibility criteria: Inclusion Criteria:

* Patients age 18 or older, admitted to the ICU, requiring general anesthesia or sedation for a procedure with a pre-existing, cuffed endotracheal or tracheostomy tube. Most patients admitted to the ICU would be unable to consent.

Exclusion Criteria:

* Known upper gastrointestinal anatomical problem that would prevent accurate estimation of gastric volume, gastric perforation, pregnancy beyond the first trimester.
* Lack of a pre-existing, cuffed endotracheal or tracheostomy tube.

Primary outcomes:
measure: Gastric Residual Volumes
timeFrame: Within one hour of operative intervention.
Secondary outcomes:
measure: Comparison of two different NPO protocol populations
timeFrame: Within four months of study completion, 16 months from study start
measure: Peri-operative aspiration events
timeFrame: Within four months of study completion, 16 months from study start
measure: Estimation of the amount of enteral nutrition lost prior to surgery using the different NPO protocols
timeFrame: Zero to sixteen hours prior to surgery
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Laura M Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00190905: Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.
Official title: Study of Duloxetine HCl in Women of Different Demographic Characteristics and Co-Morbidities With Stress Urinary Incontinence: Evaluation of Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Urinary Incontinence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-09-19
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical conditions.


Eligibility criteria: Inclusion Criteria:

* Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week.
* Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception.
* Must provide informed consent.
* Must not have urinary tract infection at screening.

Exclusion Criteria:

* Sensitivity to duloxetine
* Unstable medical conditions
* Pregnancy
* Acute liver damage
* Suicidal in the opinion of the investigator

Primary outcomes:
measure: Percent change in weekly incontinence episode frequency as noted by patient diaries from baseline to endpoint in Hispanic women and also in African American women with SUI or stress predominant mixed urinary incontinence
Secondary outcomes:
measure: Baseline to endpoint analysis for the Patient Global Impression of Improvement, Incontinence Quality of Life, and pad use as noted by patient diaries
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04032405: Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.
Official title: Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects. A Controlled Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: connective tissue graft
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: The aim of this study was to determine whether the combined connective tissue graft (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF) improved root coverage of deep Miller Class I or II gingival recessions compared to CTG alone with CAF.

Methods: Seventy-two patients with Miller class I and II gingival recessions were enrolled. Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-prf) or control group (CAF+CTG). Clinical evaluations were made at 6 months


Eligibility criteria: Inclusion Criteria:

* ≥19 years of age,
* Periodontally and systemically healthy,
* FMPS and FMBS \<15%,
* Presence of deep Miller class I and II gingival recession defect (≥3 mm in depth) at the buccal aspect of incisors,

Exclusion Criteria:

Smoking,

* Contraindications for surgery,
* Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.

Primary outcomes:
measure: gingival recession depth
timeFrame: six months
measure: Keratized tissue height
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Balcalı
Study officials:
affiliation: CukurovaU Prof.
name: onur ucak Turer
role: STUDY_DIRECTOR
References:
Clinical trial NCT00604305: Comperative Trial Between an Accommodative Iol and Monofocal Iol
Official title: A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: CATARACT SURGERY
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a comparison of two intraocular lenses in regard of accommodative power.

Detailed description: A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.

Eligibility criteria: Inclusion Criteria:

* Age between 30 and 65
* Required cataract operation in one or both eyes
* BCVA potetial at least 20/30
* Clear intraoccular media
* Willing to participate in study as evidenced by signing a written Informed Consent

Exclusion Criteria:Main

* Prior surgery at the selected eye
* No light perception or poor potential for improvement
* Phacodonesis and damaged zonules
* Pupil size at least 6 mm.
* History of uveitis
* Macular disease decreasing vision below 20/30
* Amblyopia
* Axial length shorter than 21 mm and longer than 25 mm

Primary outcomes:
measure: distance and near visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: centration pco
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00385905: Excel Drug-Eluting Stent Pilot Clinical Registry
Official title: Excel Drug-Eluting Stent Pilot Clinical Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Stenosis
Lead sponsor: JW Medical Systems Ltd
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.

Detailed description: 30-day, 6-month, and 12-month clinical follow-up and 6 to 9-month IVUS or SCA follow-up to measure long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.

Eligibility criteria: Inclusion Criteria:

* Patients who should fulfill with criteria of implanting Excel stents.
* Each patient enrolled is only allowed to implant Excel stents.
* Each patient are not allowed to be implanted more than 6 Excel stents.Also, 3 over-lapped stents are not allowed to be implanted in the same vessel(3-5mm overlapping needed; length of stents totally are not allowed to be over 80mm; fully post-dilated is essential for overlapping).
* Patients acknowlegement to the trial is essential.

Exclusion Criteria:

* AMI withine 1 week.
* Patients who do not suitable to Excel stenting.(For example, non-tolerant to anti-platelet drug or cardiac/non-cardiac surgery undergoing recently.)
* Patients who have multiple branch lesions can not apply single Excel stenting.
* Patients who refuse to sign the Trial Acknowledgement.
* Patients with intra-stent restenosis.

Primary outcomes:
measure: 12-month MACE
Secondary outcomes:
measure: 30-day or 6-month MACE
measure: 6 to 9-month restenosis rate by SCA follow-up
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenyang Nothern Hospital
state: Liaoning
Study officials:
affiliation: Shenyang Northern Hospital
name: Yaling Han, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03429205: The Efficacy of External Warming During Laparoscopic Bariatric Surgery
Official title: The Efficacy of External Warming During Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypothermia
Morbid Obesity
Bariatric Surgery Candidate
Keywords: Sleeve gastrectomy
Roux-Y gastric bypass
Single anastomosis gastric bypass
Hypothermia
External heating blanket
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-02-12
Enrollment: 20
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: TREATMENT

Brief summary: External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump.

The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered.

The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last \<2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.


Eligibility criteria: Inclusion Criteria:

* Eligible for bariatric surgery
* Surgery time estimated to be \< 2 hours

Exclusion Criteria:

* Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies).
* Surgery time estimated to be more than 2 hours

Primary outcomes:
measure: Intraoperative core-temperature decline
timeFrame: Surgery duration, up to 2 hours from surgery start-time
measure: Arrival temperature at post anesthesia care unit (PACU)
timeFrame: arrival to recovery room, up to 2 h from surgery start-time
Secondary outcomes:
measure: Hypothermia events
timeFrame: 3 hours from surgery start-time
measure: Intraoperative blood loss
timeFrame: Surgery duration, up to 2 hours from surgery start-time
measure: Post operative complications
timeFrame: 30 days postoperatively
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT01692405: Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Official title: Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: UC Care, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 436
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:

1. Biopsy core length obtained (i.e. collecting all tissue fragments)
2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
3. Pathologist interpretability
4. Processing time
5. Prostate cancer detection.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure.
* Signed informed consent.

Exclusion Criteria:

* Patient's unwilling to participate.

Primary outcomes:
measure: percent of tissue loss
timeFrame: 1 year
Secondary outcomes:
measure: prostate cancer detection rate
timeFrame: 1 year
measure: processing time
timeFrame: 1 year
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek madical center
Study officials:
References:
citation: Obek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11.
Clinical trial NCT06398405: A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer
Official title: Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Esophageal Cancer
Dysphagia, Esophageal
Epigallocatechin Gallate
Keywords: Esophageal Cancer
Dysphagia, Esophageal
Epigallocatechin gallate
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 72
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 investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.


Eligibility criteria: Inclusion Criteria:

* confirmed pathological esophageal squamous cell carcinoma
* ≥18 years old
* the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* no previous anti-tumor treatment
* no esophageal bleeding or fistula
* adequate hemocyte count, normal hepatic and renal functions
* Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score

Exclusion Criteria:

* lactating or pregnant women
* known hypersensitivity or allergy to any kind green tea extract
* placement of small intestinal feeding tube or endoscopic stent treatment
* unable or refusing to take oral liquids

Primary outcomes:
measure: Choking symptom objective response rate
timeFrame: baseline and up to 7 days post-treatment
measure: Pain symptom objective response rate
timeFrame: baseline and up to 7 days post-treatment
measure: Imaging objective response rate
timeFrame: Change from Baseline esophageal stenosis size at 7 days
Secondary outcomes:
measure: prealbumin change
timeFrame: baseline and up to 7 days post-treatment
measure: Albumin change
timeFrame: baseline and up to 7 days post-treatment
measure: Number of Participants with Adverse Events
timeFrame: baseline and up to 7 days post-treatment
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
Study officials:
References: