louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01963104: Community-Based Kiosks for Hearing Screening and Education
Official title: Community-Based Kiosks for Hearing Screening and Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: hearing test, audiology, healthcare utilization,
patient education, hearing screening
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
First posted: 2013-10-16
Enrollment: 2048
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The overall goal of the project is to evaluate innovative, cost-effective, community-based automated hearing screening and education methods to motivate individuals with mild-to-moderate hearing loss to enter the hearing healthcare system.


Eligibility criteria: Inclusion Criteria: :

* Some subjects will have a complaint of hearing difficulty without a recent hearing evaluation

Exclusion Criteria:

* For all groups: minimum age 18 years. No current hearing aid use

Primary outcomes:
measure: Record number of participants who sought hearing healthcare 6 months after the initial visit.
timeFrame: 4 years
Secondary outcomes:
measure: Record number of participants whose attitude about hearing health care has changed 6 months after the initial visit.
timeFrame: 4 years
Other outcomes:
measure: Record which hearing screening method was best at motivating subjects to pursue hearing healthcare.
timeFrame: 4 years
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VAHCS
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Portland VA Medical Center, National Center for Rehabilitative Auditory Research
state: Oregon
Study officials:
affiliation: Portland VA Medical Center, National Center for Rehabilitative Auditory Research
name: Martin P Feeney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269904: Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.
Official title: Fluorouracil Implants（SinoFuan®）Used for Intraperitoneal Chemotherapy During Operation for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer, Randomized, Controlled, Multicentres Open Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: DSF
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.


Eligibility criteria: Inclusion Criteria:

1. primary gastric cancer, Phase III
2. D2 radical gastrectomy(R0)
3. 18 year old or above
4. KPS≥70%；
5. suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L
6. suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.
7. suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment .

9. the authorized ICF must be signed

Exclusion Criteria:

1. non-initial gastric cancer；
2. having the other uncontrolled diseases.
3. obvious loss of weight ( more than 10% within 6 weeks )
4. the female in pregnancy or feeding.
5. contraindication to study drug
6. participating in other clinical trial and at the time of treatment period.

Primary outcomes:
measure: DFS (Disease Free Survival)
timeFrame: 3 year
Secondary outcomes:
measure: adverse event
timeFrame: 3 years
Other outcomes:
Locations:
city: Harebin
country: China
facility: Heilongjiang Cancer Hospital
state: Heilongjiang
Study officials:
References:
citation: Xu Y, Zhang R, Li C, Sun Z, Deng J, Wang X, Ding X, Wang B, Xue Q, Ke B, Zhan H, Liu N, Liu Y, Wang X, Liang H, Xue Y, Xu H. Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study. Front Oncol. 2021 Jul 8;11:670651. doi: 10.3389/fonc.2021.670651. eCollection 2021.
Clinical trial NCT06068504: Shear Stress in the Arteries of the Lower Limbs During Exercise in Patients With Peripheral Arterial Disease
Official title: Shear Stress in the Arteries of the Lower Limbs During Arm Cranking Exercise in Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: exercise
arm-cranking
vascular function
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study will be to evaluate shear stress and blood flow parameters in lower limb arteries during arm cycle ergometer exercise in participants with peripheral artery disease. Twenty patients participants with peripheral artery disease and claudication symptoms will be recruited. Participants will perform 3 experimental sessions in random order. Iarm-cranking (15 sets of two minutes exercise), warm water foot immersion, and control. During the interventions, blood pressure and heart rate will be assessed every 6 minutes. Measurements of arterial diameter, blood flow, anterograde and retrograde shear stress of the femoral artery will be evaluated using a two-dimensional ultrasound device with spectral Doppler.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of peripheral artery disease or ankle-brachial index less than 0.90 in one or both limbs
* do not present peripheral neuropathy;
* be able to exercise after medical approval
* aged 50 or over.

Exclusion Criteria:

* Medication change during the study
* Health problems that contraindicates the practice of physical exercise.

Primary outcomes:
measure: Femoral artery diameter [mm]
timeFrame: Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention
measure: Femoral artery shear rate [sec.-1]
timeFrame: Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention
measure: Femoral artery Blood flow [mL/min]
timeFrame: Before the intervention and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 minutes into the intervention
Secondary outcomes:
measure: Brachial systolic and diastolic blood pressure [mmHg]
timeFrame: Before the intervention and at 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, and 29 minutes into the intervention
measure: Heart rate [bpm]
timeFrame: Before and up to 30 minutes into the intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Raphael Dias
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00807404: Optical Coherence Tomography in Tissue Samples From Women Undergoing Mastectomy for the Treatment or Prevention of Breast Ductal Intraepithelial Neoplasia
Official title: Forward Image Guided Ductoscopy for Early Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precancerous Condition
Keywords: ductal intraepithelial neoplasia
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells.

PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia.

Detailed description: OBJECTIVES:

* To design and construct a portable forward imaging optical coherence tomography (OCT) needle probe.
* To compare OCT imaging of ex-vivo breast tumor tissue sections with histology to form the basis of an image library for in-vivo work.
* To initiate development of an OCT needle probe that is capable of acquiring core biopsy samples.

OUTLINE: Breast tissue samples are obtained during mastectomy and analyzed ex-vivo by optical coherence tomography (OCT) and by histopathological examination. Once routine pathological evaluation and tissue sampling are completed, OCT imaging is performed using a portable forward imaging needle probe that is inserted through the ducts of the tissue sample. OCT images of the surface of the closest margin to the tumor (if present) as well as images of the duct(s) in the nipple areola complex (after dilation) are obtained. Images of a cross section of the tumor (after the sample has been sliced by the pathologist) are also obtained. The OCT images are then correlated with tissue histology. The images are used to create a correlation histology-OCT atlas for the evaluation of subsequent images and for future reference.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Undergoing mastectomy at the City of Hope Breast Center for the treatment or prevention of breast ductal intraepithelial neoplasia

PATIENT CHARACTERISTICS:

* Fertile and/or pregnant patients allowed

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Design of a portable forward imaging optical coherence tomography (OCT) needle probe
measure: Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology
measure: Development of an OCT needle probe that is capable of acquiring core biopsy samples
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: I. B. Paz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06874504: Clinical Validation of the Norbert Health Device for Pulse Rate Measurement
Official title: Clinical Validation of the Norbert Health Device for Pulse Rate Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Norbert Health
Sponsor class: INDUSTRY
Collaborators: name: Integrative Clinical Trials, LLC
First posted: 2025-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects 18 years of age or older with the ability to consent to study and follow instructions needed for data collection. Data will be collected on enrolled patients including but not limited to diabetes, hypertension, cardiac conditions, circulation problems, medications, and other health issues that would affect blood circulation to skin. Subject enrollment for these comorbidities and others will be based on incidental enrollment from the pool of available subjects per site.

Brief summary: The study will evaluate the measuring pulse rate (PR) using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

Detailed description: The study design is to validate the pulse rate accuracy. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of subjects.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 years or older
* Ability to comprehend written consent and provide informed consent
* Ability to commit to and complete study related paperwork and activities (i.e. subject forms, have de-identified pictures taken, comply with periods of no movement, etc.)

Exclusion Criteria:

* Pregnant women
* Diagnosis of essential tremor or any medical condition causing tremors of the head or hands
* Facial tattoos, scars, large moles, beards/hair growth, birthmarks, vitiligo, skin conditions, facial discoloration, or heavy makeup within the areas of interest
* Inability for subject to avoid extreme movement during measurement reading windows
* Inability for subject to raise their hand during measurement reading windows
* No heart arrythmias
* Discretion of the Principal investigator or clinical study staff

Primary outcomes:
measure: Primary Objective
timeFrame: Approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
Study officials:
References:
Clinical trial NCT00981604: Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
Official title: Single Incision Versus Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Biliary Dyskinesia
Keywords: SILS
Laparoscopic Cholecystectomy
Children
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.

Detailed description: This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

Eligibility criteria: Inclusion Criteria:

* Need for cholecystectomy

Exclusion Criteria:

* Need for cholangiogram

Primary outcomes:
measure: Operative Time
timeFrame: 1 day
Secondary outcomes:
measure: Operative complications
timeFrame: 2 weeks
measure: length of hospitalization
timeFrame: 1 week
measure: doses of analgesics
timeFrame: 1 week
measure: hospital/operation charges
timeFrame: 1 week
measure: surgeon perception of difficulty
timeFrame: 1 day
measure: cosmetic scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Daniel J Ostlie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostlie DJ, Juang OO, Iqbal CW, Sharp SW, Snyder CL, Andrews WS, Sharp RJ, Holcomb GW 3rd, St Peter SD. Single incision versus standard 4-port laparoscopic cholecystectomy: a prospective randomized trial. J Pediatr Surg. 2013 Jan;48(1):209-14. doi: 10.1016/j.jpedsurg.2012.10.039.
Clinical trial NCT06892704: Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.
Official title: Olfactory Cleft Obstruction and Electrophysiological Olfactory Bulb Generated Beta Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
Smell Loss
Keywords: Dupilumab
Chronic Rhinosinusitis with Nasal Polyps
Smell Loss
Electrophysiology
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2025-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a well documented history of CRSwNP who had prior endoscopic sinus surgery who experience and are assessed to have olfactory deficit.

Brief summary: The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are:

1. Does obstruction of the olfactory cleft predict return of the sense of smell?
2. Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?

Participants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.


Eligibility criteria: * Well documented history of CRSwNP
* BSIT age/sex classified as "abnormal" score
* Self-reported stable olfactory deficit of moderate to severe quality \> 3 months
* Prior endoscopic sinus surgery \>3 months, \<10 years prior

Primary outcomes:
measure: Status change of the Brief Smell Identification Test
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References:
Clinical trial NCT03668704: Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty
Official title: Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Keywords: osteoarthritis
medial
bicompartmental
patellofemoral
Lead sponsor: St. Helena Hospital Coon Joint Replacement Institute
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2018-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 21 years of age who require a primary robotic-arm assisted medial bicompartmental arthroplasty.

Brief summary: The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

Detailed description: The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

Eligibility criteria: Inclusion Criteria:

* All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative.
* Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation.
* Patient is willing to comply with follow up

Exclusion Criteria:

* Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms.
* Patient had active infection
* Implants were implanted without bone cement
* Patients did not have sufficient bone stock to allow for insertion and fixation of components
* Patient did not have sufficient soft tissue integrity to allow for stability
* Patient had a neurological or muscular deformity that did not allow for control of the knee.

Primary outcomes:
measure: % of patients with Revisions
timeFrame: 10 years after surgery
Secondary outcomes:
measure: % of patients with Revisions
timeFrame: 2 years after surgery
Other outcomes:
measure: % of patients with revisions
timeFrame: 5 years after surgery
measure: % of patients with revisions
timeFrame: 7 years after surgery
Locations:
city: Saint Helena
country: United States
facility: St. Helena Hospital Coon Joint Replacement Institute
state: California
Study officials:
affiliation: St. Helena Hospital Coon Joint Replacement Institute
name: Thomas Coon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01605604: Effectiveness of Buddhist Intergrated Group Intervention on Minefulness in Adolescents
Official title: Department of Orthopedic Surgery, Faculty of Medicine Siriraj Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Conditions That May Be A Focus of Clinical Attention
Keywords: mindfulness EQ adolescents
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The pupose of the study is to determine the effectiveness of the Buddhist integrated group intervention improve the mindfulness in adolescents by a randomized controlled trial.The study divede the adolescents in two groups group A recieved the 8 time Buddhist group interventions.Group recieved nothing.The measurement were done pre and post intervention at week1 and week8.The mindfulness score ,the EQ,the MASS score were compared between both groups.

Detailed description: Adolescence behavioural problems are increasing including learning disabilities,game addiction,intolerance etc.The improvement of mindfulness ,the emotional quotient(EQ) proved to be effective to reduce the problems.The original teaching methods in school or in the temple are inadequate from increasing number of adolescent problems. The new technique integrated between Buddhism and group intervention is proposed to improve the mindfulness and EQ in adolescence.

Eligibility criteria: Inclusion Criteria:

* adolescents

Exclusion Criteria:

* incomplete qeustionaire and intervention

Primary outcomes:
measure: The mindfulness score,The EQ score,the MASS score of the participants after intervention.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital Mahidol University
Study officials:
affiliation: Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand
name: Kamolporn - Kaewpornsawan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: