louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04277559: The Effect of Music on Postoperative Anxiety
Official title: Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Postoperative
Keywords: Patient preferential music
Postoperative anxiety
Classical music
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music on postoperative anxiety.

Detailed description: Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 225 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into three groups as preoperative patient preferential music, classical music and not played. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones. The STAI will be repeated at postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at postoperative.

Eligibility criteria: Inclusion Criteria:

* Undergo inguinal hernia surgery under general anesthesia,
* Being the ability to speak, read and write the Turkish language

Exclusion Criteria:

* Poor vision
* Significant hearing loss
* Dementia
* Active opioid use
* Regular use of anxiolytics or discontinuation of them on the day of surgery
* Unwillingness to participate in the study
* Unwillingness to listening to music

Primary outcomes:
measure: Spielberg State-Trait Anxiety Inventory (STAI) score
timeFrame: 4 hours
Secondary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: 24 hours
measure: The quality of postoperative functional recovery (QoR-40) score
timeFrame: 24 hours
measure: Patient satisfaction score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dışkapı Yıldırım Beyazıt Training and Research Hospital
state: Gölbaşı
Study officials:
References:
Clinical trial NCT04168359: Semi-barbed Suture for Pulmonary Small Nodules Localization
Official title: A Clinical Application Study of a CT Guided Small Pulmonary Nodule Puncture and Positioning Device Based on Pre-filled Absorbable Semi-barbed Wire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture
Nodule, Solitary Pulmonary
Video-Assisted Thoracoscopic Surgery
Lead sponsor: Beijing Aerospace General Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Hookwire and microcoil are currently the most widely used localization instruments. Although their success rate is relatively high in preoperative localization attempts, they may lead to consequences that negatively affect patient outcomes, such as pain because of the metal's hardness, localization failure due to wire detachment, and the presence of permanent traces of metal and foreign bodies .

To overcome these disadvantages, we designed an absorbable semi-barbed suture to localize small intrapulmonary nodules (patent number: ZL201821444387.X).

The results of the previous animal experiments were satisfactory, and it is now necessary to recruit 10 patients for clinical trials.


Eligibility criteria: Inclusion Criteria:

1. solid nodules with a diameter2cm and distance to visceral pleura 0.5cm；
2. GGN；
3. part-solid GGN, with a solid portion1cm and distance to the visceral pleura 1cm；
4. Patients with nodules at a deep location, who underwent localization to facilitate localization in the resected specimen by a pathologist

Exclusion Criteria:

1. The lesion site is not suitable for percutaneous lung puncture;
2. those who have pneumothorax and pleural effusion;
3. Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery;
4. Those who refuse surgery;
5. Those who did not sign the informed consent form.

Primary outcomes:
measure: Success rate
timeFrame: half an hour after locating
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing aerospace general hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01872559: 3 Dimensional Sonography Imaging
Official title: 3D Sonographic Volumetric Analysis of Ovarian Follicles.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: New Imaging Modality
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In Vitro fertilization patients and donor egg patients of the Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine who at the day of monitoring (having an ultrasound and blood work drawn) have an estradiol level greater than 2000pg/ML.

Brief summary: The study is designed to evaluate a new imaging modality, 3-dimmensional sonographic volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is currently in place. Those patients who are scheduled to have an ultrasound as part of their infertility treatment will be offered the opportunity to have additional measurements done at the time of their ultrasound; these additional measurements will take less than 2 minutes and do no require any additional sonograms, tests, or interventions. All patients are eligible (oocyte donors and autologous oocyte patients) and only patients with a serum estradiol \> 2000pg/ML will be enrolled in the study. After the additional measurements are obtained, the results will be digitally stored. The results of the 3D sonographic volumetric analysis will then be correlated with the patients' IVF performance.

Detailed description: The benefits of the study is that 3-dimensional sonographic volumetric analysis may be a superior imaging modality for sonographically assessing oocyte maturity and may lead to change in clinical practice. The lone risk of the study is rooted in protecting the patients' protected health information.

Eligibility criteria: Inclusion Criteria:

* All patients (oocyte donors and autologous oocyte patients)with a serum estradiol \> 2000pg/ML.

Exclusion Criteria:

* All patients not meeting the estradiol criteria.

Primary outcomes:
measure: IVF performance
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Glenn Schattman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02527759: Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes
Official title: Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure

Brief summary: The purpose of this study is to examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with HF. The primary hypothesis is that variables in the monitoring instrument, individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure, mental condition, medication adherence, and overall well-being will be reported by participants on a daily basis and considered indicators for 30-day outcomes of stability, re-hospitalization, or mortality.


Eligibility criteria: Inclusion Criteria:

1. \> 65 years of age
2. male and female patients admitted to the hospital with the primary diagnosis of HF with hospitalization \> 24 hours
3. able to read and write in English
4. discharged to home environment

Exclusion Criteria:

1. a cardiac transplant candidate
2. experienced an acute coronary event within the previous 30 days of index hospitalization
3. experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization
4. end stage renal disease/hemodialysis
5. have a left ventricular assist device
6. \> 400 lbs
7. unable to stand for 90 seconds independently

Primary outcomes:
measure: Number of participants with adverse events of rehospitalization and/or mortality.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Medstar, Washington Hospital Center
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Medstar, Georgetown University Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT02093559: Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Drug Overdose
Keywords: Clinical Trial
Naloxone
Motivational Interviewing
Lead sponsor: San Francisco Department of Public Health
Sponsor class: OTHER_GOV
First posted: 2014-03-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed and already received take-home naloxone (the opioid antagonist used to reverse overdose).


Eligibility criteria: Inclusion Criteria:

* age 18-65 years;
* current opioid dependence by SCID
* urine positive for opioids during screening, excluding prescribed agonist maintenance therapy
* history of prior opioid overdose
* previously received take-home naloxone
* no serious illnesses likely to progress clinically during trial
* able and willing to provide informed consent, provide locator information, communicate in English, adhere to visit schedule

Exclusion Criteria:

* suicidal ideation by concise health risk tracking (CHRT)
* currently participating in another interventional research study that could possible impact the study's outcomes of interest
* any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures

Primary outcomes:
measure: Feasibility of a randomized trial with REBOOT
timeFrame: 16 months
measure: Acceptability of REBOOT
timeFrame: 16 months
measure: Influence of egocentric social network characteristics on overdose events and naloxone use
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Substance Use Research Unit
state: California
Study officials:
affiliation: San Francisco Department of Public Health
name: Phillip Coffin, MD, MIA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coffin PO, Santos GM, Matheson T, Behar E, Rowe C, Rubin T, Silvis J, Vittinghoff E. Behavioral intervention to reduce opioid overdose among high-risk persons with opioid use disorder: A pilot randomized controlled trial. PLoS One. 2017 Oct 19;12(10):e0183354. doi: 10.1371/journal.pone.0183354. eCollection 2017.
Clinical trial NCT00997659: Chromium's Effect on Insulin Resistance in Obesity
Official title: Efficacy and Safety of Chromium as a Therapeutic Intervention for Insulin Resistance Associated With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Obesity
Keywords: chromium picolinate
insulin resistance
obesity
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is to investigate the nutritional supplement chromium picolinate. A large number of people use chromium picolinate from health food stores to improve the function of the hormone insulin. The investigators are testing how effective this supplement is and are also monitoring its safety. In patients with diabetes, chromium has been shown to increase sensitivity to the hormone insulin. Since obesity can cause insensitivity or resistance to insulin, the investigators are studying obese individuals with documented insulin resistance. The investigators would like to know if chromium is also effective in treating the insulin resistance associated with obesity.


Eligibility criteria: Inclusion Criteria:

1. age \> 18 years;
2. a BMI greater or equal to 30; AND
3. an abnormal 2 hour postprandial glucose (greater than 140 mg/dl but less than 200 mg/dl) following 75 grams of a glucose load.

Exclusion Criteria:

1. positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
2. diagnosis of cancer;
3. acute illness of any sort, however, patients may be enrolled once they are stable;
4. hemoglobin less than 11.0 g/dl or hemodynamically unstable;
5. creatinine greater than or equal to 1.5 mg/dl;
6. liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
7. use of certain medications within the past month (e.g., glucocorticoids).
8. untreated hypertension (systolic BP \> 150 mmHG, diastolic BP\>IOO mmHG);
9. patients with diabetes mellitus;
10. hypogonadism;
11. abnormal thyroid function (serum T4 \< 4 or \> 12; TSH \< 0.35 or \> 5.5) (12) any chronic liver or kidney disease; OR
12. polycystic ovarian syndrome.

Primary outcomes:
measure: The primary outcome measure used for sample size evaluations is the (before and after) change in the rate of glucose disposal during infusion of insulin (Rd, in mg of glucose/kg lean body mass/minute)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University GCRC
state: New York
Study officials:
References:
Clinical trial NCT06287359: Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain?
Official title: What is the Day-to-day Experience of Parents/Carers of Children or Adolescents With Severe Motor Disabilities Suffering From Spinal Pain?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Low Back Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 15
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: Parents or carers of children with severe motor disabilities complaining of spinal pain

Brief summary: Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering.

For patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management.

The investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities.

To achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain.

With this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents.


Eligibility criteria: Inclusion Criteria:

* Parents or carers of children with severe motor disabilities complaining of spinal pain

Exclusion Criteria:

* Parent/carer refusing to participate

Primary outcomes:
measure: Individual interviews
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
Clinical trial NCT04432259: Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty
Official title: Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Arthritis Knee
Postoperative Nausea
Postoperative Pain
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
Primary purpose: TREATMENT

Brief summary: This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.

Detailed description: Protocols in perioperative pain management during total joint arthroplasty (TJA) have contributed to early discharge after surgery. As practices move to favor ambulatory surgery in total joint arthroplasty changes must be made to postoperative pain and nausea management. Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea and vomiting are known detrimental side effects. The use of systemic steroids has also been shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and increase the distance of ambulation without increasing the rate of surgical site infection or prosthetic joint infection. As more same-day total joint replacement is incorporated into practice, an oral alternative may prove beneficial.

Eligibility criteria: Inclusion Criteria:

* adult patients age 18 and older who will be undergoing joint replacement

Exclusion Criteria:

* Patients with uncontrolled diabetes ( HbA1C, \>7.5%), impaired hepatic function (Child class, \>B), impaired renal failure (Glomerular filtration rate \<60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.

Primary outcomes:
measure: Postoperative Pain
timeFrame: 3 weeks following surgery
measure: Postoperative Nausea
timeFrame: 3 weeks following surgery
measure: Opioid Consumption
timeFrame: 6 months
measure: Antiemetic Consumption
timeFrame: 6 months
measure: Episodes of Nausea
timeFrame: 3 weeks
Secondary outcomes:
measure: Postoperative complications
timeFrame: 6 months
measure: Patient-reported outcome scores (PROMS)
timeFrame: 6 months
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Henry Ford Health System
name: Jason Davis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03959059: PKP Assisted With MR Technology in OVCF With IVC
Official title: Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder of Spine
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.

Detailed description: The study is to prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC. Forty cases of OVCF with IVC undergoing PKP were randomized into a MR technology assisted group (group A) and a traditional C-arm fluoroscopy group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores, radiological evidence of vertebral body height and kyphotic angle(KA) at pre-operation and post-operation. The volume of injected cement and Operation time was recorded. And whether cement touching both endplates or not(non-PMMA-endplates-contact, NPEC) in radiological evidence were also recorded postoperatively. The clinical outcomes and complications were evaluated afterwards. All patients received 10 to 14 months' follow-up, with an average of 12 months.

Eligibility criteria: Inclusion Criteria:

* Single level OVCF in the thoracic and lumbar levels (T10-L4), suffering with severe back pain.;
* OVCF without damaged vertebral posterior wall and nerve lesion;
* The patient was over 50 years old and , the diagnosis of osteopenia or osteoporosis was confirmed by bone densitometry ;
* All patients underwent（received） plain radiography, computed tomography (CT) and MRI before surgery, and with IVC presented in MRI.

Exclusion Criteria:

-

Primary outcomes:
measure: visual analog scale
timeFrame: 1 year
measure: Oswestry Disability Index
timeFrame: 1 year
measure: Vertebral height
timeFrame: 1 year
measure: Kyphotic angle
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Mixed Reality
state: Jiangsu
Study officials:
References:
citation: Wei P, Yao Q, Xu Y, Zhang H, Gu Y, Wang L. Percutaneous kyphoplasty assisted with/without mixed reality technology in treatment of OVCF with IVC: a prospective study. J Orthop Surg Res. 2019 Aug 8;14(1):255. doi: 10.1186/s13018-019-1303-x.