louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05208437: Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants
Official title: Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants Whose Corrected Gestational Age Are Less Than 32 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Keywords: premature infants
oral feeding
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 148
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants

Detailed description: In order to improve the feeding of premature infants \<32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale.

Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. The whole intervention stops until the premature infant achieves the full oral feeding. Length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants \<32 weeks of gestation.

Eligibility criteria: Inclusion Criteria:

* Gestational age \<32w;
* Admit within 72 hours of birth;
* The guardian signs the informed consent;
* OI (oxygenation index \>300)

Exclusion Criteria:

* Newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
* Newborns who die during the study;
* Newborns who drop out of the study;
* Newborns who have NEC during hospitalization

Primary outcomes:
measure: Transition time from the initiation oral feeding to full oral feeding
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiaojing Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05997537: Dynamic Web-Based Interventions to Improve Update of Preventive Health Recommendations in IBD
Official title: Dynamic Web-Based Interventions to Improve Update of Preventive Health Recommendations in IBD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBD
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 1056
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: Patients enrolled in IBD Partners, age 18 and older who have agreed to be contacted for future studies.

Brief summary: To understand patient knowledge, attitudes, and beliefs around the uptake of vaccinations and malignancy screening through patient focus groups/qualitative interviews. To develop and pilot an interactive website that will provide customized recommendations for individual patients with IBD and direct them as relevant to five 60-90 second customized, animated videos (influenza, pneumococcal, and zoster vaccinations, bone health, and skin cancer screening). This content will be pilot-tested with patients to fine-tune the educational modules.


Eligibility criteria: Inclusion Criteria:

* enrollees in the internet-based cohort IBD Partners, age 18 and older

Exclusion Criteria:

-

Primary outcomes:
measure: Uptake of influenza vaccination
timeFrame: Through study completion, no later than March 31, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Gil Melmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04061837: MitralStitch Mitral Valve Repair System for Mitral Regurgitation
Official title: To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System - a Clinical Application of New Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 10
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 main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.


Eligibility criteria: Inclusion Criteria:

1. The age of patient is ≥18yrs;
2. Severe mitral regurgitation patients (The area of central regurgitation exceeds 40% of left atrial area or holosystolic eccentric regurgitation; VC≥0.07cm；regurgitant volume ≥60ml；RF ≥50%; EROA≥0.4cm2 (Satisfy any condition).
3. LVESD≤60mm, LVEF≥25%, small incision surgery of chest can be tolerated.
4. The subject was informed of the clinical application nature of the new technology and agreed to participate in all requirements of the clinical application of the new technology, signed the ICF and agreed to complete the follow-up and the inspection required during the follow-up period.

Exclusion Criteria:

1. Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
2. Subjects with active endocarditis or rheumatic mitral valve disease.
3. Life expectancy \<1 year for cardiac or other malignant tumors.
4. Participate in other clinical trial
5. In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.

Primary outcomes:
measure: The occurrence rate of major adverse event after 30 days of the intervention
timeFrame: 30days
Secondary outcomes:
measure: The success of device
timeFrame: Immediately after repair
measure: The success rate of operation
timeFrame: Before discharge, an average of 7 days
measure: Incidence of major adverse events after device implantation
timeFrame: 12months
measure: The classification of mitral regurgitation
timeFrame: 1/6/12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Shiqiang Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Xijing Hospital
name: Jian Yang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05802537: Home-Based Exergame Program for Community-Dwelling Older Adults
Official title: Home-Based Exergame Program for Community-Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exergaming
Frail Elderly
Lead sponsor: Kyungdong University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate the effect of a home-based exergame program on physical function, fall efficacy, depression, and quality of life in older adults. For the purpose of the study, the investigators established the following hypotheses. Older adults who participate in a home-based exergame program will experience significant improvements in physical function, fall efficacy, depression, and quality of life compared to those who do not participate in the program.


Eligibility criteria: Inclusion Criteria:

* 75 years or older
* the ability to walk independently with or without a walking aid
* a mini-mental state examination score ≥ 24.

Exclusion Criteria:

* musculoskeletal disorders such as fractures or dislocations
* neurological impairment
* mental disorders
* uncontrolled endocrine, cardiovascular, or urinary system diseases

Primary outcomes:
measure: One-leg standing test
timeFrame: Change from baseline after intervention at 8 weeks
measure: Berg balance scale
timeFrame: Change from baseline after intervention at 8 weeks
measure: Functional reaching test
timeFrame: Change from baseline after intervention at 8 weeks
measure: Timed up-and-go test
timeFrame: Change from baseline after intervention at 8 weeks
measure: Five-times sit-to-stand test
timeFrame: Change from baseline after intervention at 8 weeks
Secondary outcomes:
measure: Falls Efficacy
timeFrame: Change from baseline after intervention at 8 weeks
measure: Depression
timeFrame: Change from baseline after intervention at 8 weeks
measure: Health-Related Quality of Life
timeFrame: Change from baseline after intervention at 8 weeks
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Kyungdong University
state: Gangwon-do
Study officials:
References:
Clinical trial NCT05012137: The MEV of 0.5% Ropivacaine in Ultrasound-guided SASIS-FICB
Official title: The Minimum Effective Volume (MEV) of 0.5% Ropivacaine in Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Keywords: Minimum Effective volume
Ropivacaine
Fascia Iliaca Compartment Block
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a dosing exploratory study.
Primary purpose: TREATMENT

Brief summary: The Aim of This Study is to Determine the Minimum Effective Volume of Local Anesthetic (Ropivacaine 0.5%) Required to Produce an Effective Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block（SASIS-FICB） for Surgical Anesthesia in 90% of Patients Scheduled for Elective Surgery of One Lower Limbs.

Detailed description: The study is based on biased coin design, and the volume of Local Anesthetic (Ropivacaine 0.5%) for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2.5ml. Conversely, block success will result in either a reduction in volume by 2.5ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the femoral, obturator and lateral femoral cutaneous nerves) at 5-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.

Eligibility criteria: Inclusion Criteria:

* patients undergoing hip/knee surgery

Exclusion Criteria:

* age \<18 years
* body mass index \>35
* inability to consent to the study
* allergy to local anesthetics
* a history of liver or renal insufficiency, coagulopathy
* clinical evidence of peripheral neuropathies, abnormalities of sensory or motor function of the FN, ON or LFCN.

Primary outcomes:
measure: The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Director of Anesthesiology Department,Peking Union Medical College Hospital
name: Yuguang Huang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05857137: Psychosis TMS Study
Official title: Investigational TMS Study of Cognitive Impairment in Early Psychosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychosis
Keywords: Cognitive impairment
Transcranial Magnetic Stimulation
Attention
Short-term memory
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of this study is to investigate the neural mechanisms of working memory function in patients with early psychosis using Transcranial Magnetic Stimulation (TMS) in conjunction with functional MRI. TMS is a noninvasive method used to modulate brain activity via changing magnetic fields applied over the surface of the scalp.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of psychosis, psychosis not otherwise specified, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder with psychosis, and schizophreniform disorder within first ten years of onset of psychotic symptoms.
* Ability to provide informed consent

Exclusion Criteria:

* TMS incompatibility including metallic implants in head and neck, cardiac pacemakers, history of seizures, pregnancy.
* MRI-incompatibility including implanted aneurism clips, cardiac pacemakers, metal implants, intrauterine devices, tattoos containing metal ink, pregnancy, and claustrophobia
* Severe substance abuse within 3 months (nicotine allowed)
* Unstable medical or neurologic illness that would preclude participation in study procedures

Primary outcomes:
measure: Working memory accuracy
timeFrame: 2 hours
measure: Reaction time during working memory
timeFrame: 2 hours
measure: Resting state functional connectivity between the left inferior parietal lobule and the regions of the frontoparietal control network
timeFrame: 2 hours
measure: Resting state functional connectivity within the default mode network
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Martinos Center for Biomedical Imaging
state: Massachusetts
Study officials:
References:
Clinical trial NCT03922737: Telehealth Following Orthopaedic Procedures
Official title: Evaluation of Telehealth Follow-up Appointments Following Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Op Complication
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 198
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: This study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.


Eligibility criteria: Inclusion Criteria:

1. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet).

Exclusion Criteria:

1. Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
2. Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
3. Subjects with workman's compensation or automotive claims or other ongoing litigation
4. Subjects that are unable or unwilling to consent for enrollment
5. Patients under the age of 18 years
6. Pregnant or breastfeeding women
7. Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures
8. Patients without English-language proficiency
9. Patients with unforeseen intra-operative or perioperative complications

Primary outcomes:
measure: Patient Satisfaction: Likert Score
timeFrame: 2 mont post-operative period following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01973699: Visualization in Shoulder Arthroscopy With and Without Epinephrine
Official title: Surgeon Determined Visualization in Shoulder Arthroscopy: A Randomized, Blinded, Controlled Trial Comparing Irrigation Fluid With and Without Epinephrine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visualization in Shoulder Arthroscopy
Keywords: shoulder arthroscopy, epinephrine, visualization
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adequate visualization during shoulder arthroscopy is of great importance for the procedure to be efficiently and effectively performed. The use of dilute epinephrine in irrigation fluid has been historically utilized to help with visualization. Given the potential safety issues documented in the literature related to epinephrine use, as well as the significant improvements in technique and instrumentation over the last decade, the need for this additive should be reexamined. The objective of the current study was to compare surgeon determined visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine.


Eligibility criteria: Inclusion Criteria:

All patients requiring shoulder arthroscopy

Exclusion Criteria:

none

Primary outcomes:
measure: Visualization
timeFrame: November 1, 2012- April 1, 2013 (5 months)
Secondary outcomes:
measure: Fluid Use
timeFrame: November 1, 2012-April 1, 2013 (5 months)
measure: Operative time
timeFrame: November 1, 2012-April 1, 2013 (5 months)
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's University Hospital
state: Pennsylvania
Study officials:
affiliation: St. Luke's University Hospital and Health Network
name: Gregory F Carolan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03064399: Microfracture Technique for Talar Articular Cartilage Lesions With or Without Lateral Ligament Repairment
Official title: Microfracture Technique for the Treatment of Articular Cartilage Lesions of the Talus With or Without Lateral Ligament Repairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Ligament Repair
Talar Cartilage Lesion
Microfracture
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the clinical efficacy of microfracture combined with lateral ligament repairment for cartilage lesions of talus through the comparison between microfracture with and without lateral ligament repairment.


Eligibility criteria: Inclusion Criteria:

Full - thickness cartilage injury

Exclusion Criteria:

Age: \> 40 years old or \< 18 years old; BMI \> 30; lesion \> 4 cm2

Primary outcomes:
measure: Function score
timeFrame: One year after surgery
Secondary outcomes:
measure: Imaging result
timeFrame: One year after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02237599: Somatosensory Evoked Potential Algorithm for Detection of Intraoperative Positional Neuropraxia
Official title: A Feasibility Study of Integrated SSEP and Detection Algorithm for Detection of Intraoperative Positional Neuropraxia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropraxia
Keywords: SSEP
neuropraxia
intraoperative
automated
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intraoperative adult patients undergoing surgical procedure

Brief summary: This study hypothesizes that an automated device using small electronic impulses can detect nerve impairment in unconscious patients.

Detailed description: Application of SSEP probes to bilateral ulnar and popliteal nerve areas with sensors at (1) bilateral brachial plexus (clavicles), (2) Erb's point (posterior C8 cervical spine) and (3) on forehead will permit microvolt current to to be detected and analyzed against a proprietary algorithm. Neuropraxia will be detected based on abnormalities developing in received SSEP signals.

Eligibility criteria: Inclusion Criteria:

* elective surgery

Exclusion Criteria:

* neuromuscular disease stroke

Primary outcomes:
measure: Neuropraxia
timeFrame: postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: Western University
name: John M Murkin, MD
role: PRINCIPAL_INVESTIGATOR
References: