louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05561582: The Effects of Intensity on Exercise-Induced Hypoalgesia During a Knee Extension Exercise
Official title: The Effects of Intensity on Exercise-Induced Hypoalgesia During a Knee Extension Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to to compare immediate changes in pressure pain threshold at the exercising muscle (quadriceps) and a non-exercising muscle (upper trapezius) during low and high weight knee extension exercise. Participants will attend one session that consists of pain sensitivity testing, completion of pain-related psychological questionnaires, and random assignment to one of three interventions: 1) knee extension exercise with a high weight, 2) knee extension exercise with a low weight, or 3) quiet rest.


Eligibility criteria: Inclusion Criteria:

* Pain-free
* 18-60 years old
* Participant can appropriately perform the knee extension exercise (assessed during screening)

Exclusion Criteria:

* Non-English speaking
* Regular use of prescription pain medications
* Current or history of chronic pain condition
* Currently taking blood-thinning medication
* Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
* Any contraindication to the application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
* Known presence of cardiovascular, pulmonary, or metabolic disease
* Current use of tobacco products
* Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* Surgery, injury, or fracture to the lower back or lower extremity within the past 6 months

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: 1 day
Secondary outcomes:
measure: Conditioned Pain Modulation
timeFrame: 1 day
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Abigail Wilson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03761082: Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy
Official title: Post Marketing Surveillance of PIRESPA® TAB 200mg (Pirfenidone) for Evaluating the Safety and Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 258
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents of Korea, in real-world practice

Brief summary: Post-marketing surveillance of Pirfenidone

Detailed description: Pirfenidone (Pirespa®) is an anti fibrotic drug, which was approved in 2012 in the Republic of Korea for the treatment of patients with idiopathic pulmonary fibrosis (IPF). A post-marketing survey was conducted following the approval to obtain data on the safety and efficacy of pirfenidone for IPF treatment in real-world practice.

Eligibility criteria: Inclusion Criteria:

* Among patients diagnosed as idiopathic pulmonary fibrosis, only those who have used the testing drug under the general medical conditions for a certain investigation period after the beginning of the investigation and also signed a the "Personal Information Utilization Agreement" form. However, for those who have already received the drug before the beginning of the investigation, only the subjects whose medical record can be used are included.

Exclusion Criteria:

1. Subjects who is hypersensitive to the active ingredient or additives of this drug
2. Subjects who have severe hepatopathy
3. Subjects who have severe renal disorder (creatinine clearance\<30mL/min) or a terminal renal disease treated by dialysis
4. Subjects who received a combined treatment of fluvoxamine
5. Subjects who have genetic problems, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Primary outcomes:
measure: The change from baseline to week 48 in the percentage of the predicted FVC
timeFrame: up to 48 weeks
Secondary outcomes:
measure: Incidence of adverse event after this drug administration in general medical
timeFrame: 48 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Chung MP, Park MS, Oh IJ, Lee HB, Kim YW, Park JS, Uh ST, Kim YS, Jegal Y, Song JW. Safety and Efficacy of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis: A Nationwide Post-Marketing Surveillance Study in Korean Patients. Adv Ther. 2020 May;37(5):2303-2316. doi: 10.1007/s12325-020-01328-8. Epub 2020 Apr 15.
Clinical trial NCT03385720: Submandibular Gland Preservation in Neck Dissection
Official title: Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Dislocation
Oral Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
name: Peking University School of Stomatology
First posted: 2017-12-28
Enrollment: 200
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trial design: a randomized controlled trial.

Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.

Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.

Primary Parameters: survival rate, mortality rate


Eligibility criteria: Inclusion Criteria:

Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).

Exclusion Criteria:

Cancer of the floor of the mouth.

Primary outcomes:
measure: 5-year survival rate
timeFrame: 5-year after operation
measure: 3-year survival rate
timeFrame: 3-year after operation
measure: 5-year regional recurrence rate
timeFrame: 5-year after operation
measure: 3-year regional recurrence rate
timeFrame: 3-year after operation
measure: 1-year regional recurrence rate
timeFrame: 1-year after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University School of Stomatology
state: Beijing
Study officials:
References:
Clinical trial NCT03537820: Noise Impact in the Post-anesthesia Care Unit
Official title: Relationship Between Noise Level and Patients Satisfaction in Post Anesthesia Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Surgery
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 816
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with scheduled surgery

Brief summary: World health organization recommends noise level should be less than 30db in hospital. However many analysis conclude to an average of 67dB in the post anesthesia care unit. No many studies were reported about noise impact in a post-anesthesia care unit. Only one was published by B.Allaouchiche in 2002. However, noise is a complaint reported by patients and it could be responsible for physiological and psychological troubles. In this prospective study, the main objective is to determine patients' satisfaction in the post anesthesia care unit, before and after installation of a noise warning device. Between the two parts, a short training about noise consequences on health will be presented to nurses. Improvement off anti-noise actions on patient's satisfaction will analysed.

Detailed description: Although the post- anesthesia care unit can be noisy, the effect of noise on patients recovering from anesthesia is unknown. Indeed, many studies are achieved in reanimation or ICU. That's why this prospective study is about patients' satisfaction after their stay in the post-anesthesia care unit. In a first part, noise is just measured with a sound level meter and patients are asked about their experience. Before the second part, during few days, nurses will be informed about noise consequences on heath. With some precaution, a decrease of the sound level in a room (ex: decrease scope alarms, speaking quietly, not slamming the drawer, noise warning device...) will be expected. The main objective is to determine the patient's satisfaction in the post-anesthesia care unit before and after installation of a noise warning device.

Eligibility criteria: inclusion criteria :

* patient who have a scheduled surgery in University hospital of Reims
* patient who stay in the post-anesthesia care unit
* patient consenting to participate to the study
* patient older than 18 years

exclusion criteria :

* Emergency surgery
* Patients who have been hearing disorders (notice in the preoperative consultation)
* Patients who have cognitive disorders (notice in the preoperative consultation)
* Patients who have a medical history of ear/cerebral surgery

Primary outcomes:
measure: patient's unpleasantness due to the noise
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT03021720: Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial
Official title: Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroid
Keywords: Uterine fibroid embolization
Uterine artery embolization
Arterial access
Radial access
Interventional radiology
Quality of life
Patient Satisfaction
Patient centered care
Uterine fibroid
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access

Detailed description: 1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus radial arterial access for uterine fibroid embolization

Eligibility criteria: Inclusion Criteria:

* Meeting standard eligibility criteria for uterine fibroid embolization
* Satisfactory ulnopalmar arch patency

Exclusion Criteria:

* Unable to provide informed consent
* Unable or unwilling to complete the study questionnaires
* Failed Barbeau test

Primary outcomes:
measure: Patient satisfaction
timeFrame: From date of procedure to one month after procedure
Secondary outcomes:
measure: Procedure related complication rate
timeFrame: Up to one month after procedure
measure: Procedure time
timeFrame: Duration of intra-procedural time
measure: Fluoroscopy Time
timeFrame: Duration of intra-procedural fluoroscopy
measure: Procedure equipment cost
timeFrame: Procedure
measure: Health related quality of life
timeFrame: 1 month post procedure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, University Health Network
name: John Kachura
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06208020: Cortical Function Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome
Official title: Cortical Activation and Functional Connectivity Changes During Swallowing in Patients With Dysphagia in Lateral Medullary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deglutition Disorders
Lateral Medullary Syndrome
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dysphagia in LMS and healthy adults will be enrolled.

Brief summary: The goal of this observational study is to detect the alteration of cortical activation and functional connectivity during swallowing in patients with Lateral Medullary Syndrome (LMS) dysphagia by functional near infrared spectroscopy (fNIRS). The main questions it aims to answer are:

* The alteration of cortical activation during swallowing in patients with LMS compared with healthy subjects.
* The alteration of cortical functional connectivity during swallowing in patients with LMS compared with healthy subjects.

fNIRS will be used to detect cortical activation and functional connectivity during swallowing tasks in LMS patients and healthy subjects, and to compare the differences between patients and healthy subjects.


Eligibility criteria: Inclusion Criteria:

* The first ischemic stroke was confirmed by head MRI as LMS;
* 18-80 years old, right-handed;
* Dysphagia was confirmed by video fluoroscopic swallow study(VFSS);
* Conscious enough to cooperate with fNIRS testing;
* No previous neurological or mental illness.

Exclusion Criteria:

* Other central nervous system diseases (Parkinson's disease, Alzheimer's disease, intracranial tumors, etc.);
* Other diseases causing dysphagia (tumors of the esophagus, larynx, nasopharynx, etc.);
* Serious physical diseases (cancer, fracture, etc.);
* Other mental disorders (mania, schizophrenia, etc.);
* Unconscious, unable to cooperate with the examination

Primary outcomes:
measure: cortical activation during swallowing
timeFrame: day 1
Secondary outcomes:
measure: functional connectivity during swallowing
timeFrame: day 1
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Yi Li
role: STUDY_CHAIR
References:
Clinical trial NCT00545220: Problem Solving Training and Low Vision Rehabilitation
Official title: Problem Solving Training and Low Vision Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Vision
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2007-10-17
Enrollment: 430
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vision loss can result in feelings of frustration, helplessness, anxiety, depression, and anger, which compromise a person's activities of everyday living. While emotional distress may resolve in some persons without intervention, unmanaged and persistent distress places the person at risk for continued decrements in health status and the potential development of more severe conditions (i.e., depression, poor health outcomes). Persons with low vision will be recruited and randomly assigned to either an innovative, problem-solving training (PST) intervention group designed specifically for persons with low vision or a sham intervention/control group. Primary and secondary outcomes will be assessed at baseline prior to intervention and at 3 month follow-up, 7 month follow-up, 12 month follow-up, and 24 month follow-up by a research interviewer masked to participants' randomization. This project will: (1) demonstrate how specified physical and emotional outcomes of persons with low vision change across time, (2) evaluate the effectiveness of a PST intervention that will be delivered to persons with low vision; and (3) identify persons with low vision who are at risk for adverse emotional and health outcomes.


Eligibility criteria: Inclusion Criteria:

* +19 yrs of age
* Underwent a low vision rehabilitation initial eye exam
* No more than 2 errors on cognitive on cognitive screening measure (SPBS)
* Must have access to telephone
* No significant hearing problems
* No significant communication problems
* Speaks fluent English

Primary outcomes:
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: baseline, 3months, 6 months, 12 months, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Dreer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940820: Clinical Research of ROBO1 Specific CAR-NK Cells on Patients With Solid Tumors
Official title: Clinical Research of ROBO1 Specific CAR-NK Cells on Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Asclepius Technology Company Group (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. We have developed anti-ROBO1 CAR-NK cells that can target tumor cells highly expressing ROBO1. The purpose of this study is to evaluate the safety and effectiveness of cell therapy using ROBO1 CAR-NK cells to treat solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Age 18 \~ 75 years old, male or female
2. Life expectancy ≥ 6 months
3. ECOG score: 0 - 3
4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
5. Advanced solid tumor was diagnosed by pathological or clinical physicians
6. Laboratory examination: white blood cell ≥ 3 x 10\*9/L, blood platelet count ≥ 60 x 10\*/L, hemoglobin ≥ 85g/L; lymphocyte count ≥ 15%, total bilirubin ≤ 100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level
7. Signed informed consent
8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion

Exclusion Criteria:

1. Expected overall survival \< 6 months
2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months
3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%
4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements

Primary outcomes:
measure: Occurrence of treatment related adverse events as assessed by CTCAE v4.03
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Radiation Therapy Department, Suzhou Cancer Center, Suzhou Hospital Affiliated to Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01660620: Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Official title: Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Development of Side Effects From Betaxolol
Keywords: betaxolol/ retinopathy of prematurity
Lead sponsor: Smith-Kettlewell Eye Research Institute
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: University of Minnesota
name: University of Oklahoma
name: The University of Texas Health Science Center, Houston
First posted: 2012-08-08
Enrollment: 23
Sex: ALL
Minimum age (years): 32
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.

Detailed description: The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when ROP is most likely to arise.

Eligibility criteria: Inclusion Criteria:

* \<1251 grms birth weight

Exclusion Criteria:

* ocular defect

Primary outcomes:
measure: development of apnea and or bradycardia
timeFrame: 3 weeks
Secondary outcomes:
measure: development of ROP requiring treatment
timeFrame: 7 weeks
Other outcomes:
Locations:
Study officials:
References: