louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04712604: Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
Official title: Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Sleep disturbance in GI cancer patients and their sleep partner
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.


Eligibility criteria: Inclusion Criteria:

Patients:

1. newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
2. 18 years or older
3. able to speak/read English at the 5th grade level
4. having a consistent partner who is involved in daily activities including sleep
5. having 5 or greater score on the Pittsburgh Sleep Quality Index.

Sleep partners:

1. 18 years or older
2. able to speak/read English at the 5th grade level
3. a partner of the patient who is involved in the patient's daily activities including sleep
4. having similar circadian rhythm/sleep patterns with the patient
5. having 5 or greater score on the Pittsburgh Sleep Quality Index.

Exclusion Criteria:

Patients and their sleep partners:

1. having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
2. having active suicidality in the past year
3. currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
4. currently having have a poor physical functioning status as measured by an Eastern Cooperative Oncology Group (ECOG) score of 3 or higher and Karnofsky grade of 50 or lower
5. having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
6. unable to see or hear
7. at the end of life (life expectancy of less than a month)
8. unwilling to change their current sleep-related habits in near future.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: 4 weeks
measure: Acceptability of the intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in sleep disturbance
timeFrame: Baseline, 4 weeks
measure: Change in quality of life
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Youngmee Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06336304: NXT Post-Market Clinical Follow-up
Official title: NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Incontinence
Urinary Obstruction
Urinary Bladder, Overactive
Urinary Bladder, Neurogenic
Urinary Incontinence, Urge
Lead sponsor: Laborie Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 180
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: Male, Female and Pediatric subjects who have been medically indicated for UDS testing.

Brief summary: NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

Detailed description: The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.

Eligibility criteria: Inclusion Criteria:

* Patients medically indicated for urodynamic study
* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Exclusion Criteria:

* Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire
* Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)
* Pregnant women
* Patients with recent (less than 2 weeks) pelvic floor surgery
* Requires use of suprapubic catheter

Primary outcomes:
measure: Assess NXT system performance
timeFrame: 120 Minutes
measure: Assess NXT system safety
timeFrame: 120 Minutes
Secondary outcomes:
measure: Assess NXT system performance
timeFrame: 120 Minutes
Other outcomes:
Locations:
city: Hanover
country: United States
facility: Chesapeake Urology Hanover
state: Maryland
city: Owing Mills
country: United States
facility: Chesapeake Urology Owing Mills
state: Maryland
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT02663804: Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry
Official title: Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Knee Arthroplasty
Patient Satisfaction
PROMs
Implant Design
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2016-01-26
Enrollment: 380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.


Eligibility criteria: Inclusion Criteria:

* Male and female patients of all ages, scheduled for TKA
* Primary osteoarthritis of the knee joint
* post traumatic arthritis
* rheumatoid arthritis

Exclusion Criteria:

* previous TKA in same joint
* evidence of neuromuscular or neurosensory deficiency
* immunologic suppression

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Preop
measure: Patient Satisfaction
timeFrame: 3 months postoperative
measure: Patient Satisfaction
timeFrame: 6 months postoperative
measure: Patient Satisfaction
timeFrame: 1 year postoperative
measure: Patient Satisfaction
timeFrame: 2 years postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
Clinical trial NCT05851404: Management of Indeterminate Thyroid Nodules Across Different World Regions
Official title: Management of Indeterminate Thyroid Nodules Across Different World Regions: a Multicentric International Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Indeterminate Thyroid Nodules
Keywords: Indeterminate thyroid nodule
Thyroid carcinoma
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to investigate different approaches to indeterminate thyroid nodules across different countries worldwide

Brief summary: Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Fine needle aspiration cytology (FNAC) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. Nevertheless, FNAC is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class III and class IV according to Bethesda Classification\[2\]). In fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. Thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems.

We aim to evaluate different approaches to indeterminate nodules across different countries in the world.


Eligibility criteria: Inclusion Criteria:

* Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion Criteria:

* Patients with preoperative diagnosis of lymph node metastases

Primary outcomes:
measure: Rate of malignancy
timeFrame: 36 months
measure: Surgical approach to indeterminate thyroid nodules
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: AOU Cagliari
state: CA
Study officials:
References:
Clinical trial NCT03382704: Lanugo Hair Loss as a Marker for Peri-ocular Malignancy
Official title: Lanugo Hair Loss as a Marker for Peri-ocular Malignancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Cancer Face
Keywords: Peri-ocular
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
Collaborators: name: Moorfields Eye Hospital NHS Foundation Trust
First posted: 2017-12-26
Enrollment: 100
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: All cases undergoing incision or excision biopsy of peri-ocular lesions at the two participating centres

Brief summary: Skin cancers around the eye are common, but so are other lid lumps. It is useful to be able to tell which lumps are likely to be cancer.

This study looks at whether the loss of fine hairs (lanugo hairs) on the skin are a good indicator of whether a lump is a skin cancer or not.

The investigators are recruiting patients who have lid lumps who haven't had a biopsy before, who would be having a biopsy as part of their treatment, and seeing whether those who have loss of the fine skin hairs are the same as those who have skin cancer confirmed on their biopsy.

The study doesn't involve any extra examinations or treatments for participants. The investigators look at the patients before the biopsy as part of their usual care, and take a note of whether or not they have lost the fine hairs at this stage.

The main benefit of participating is that the medical community has better evidence about which lid lumps are likely to represent skin cancer, helping future diagnosis.

There are no additional risks to participating. The risks of biopsy are unchanged whether patients participate in the study or not.

The study is run from the Princess Alexandra Eye Pavilion in Edinburgh, in conjunction with Moorfields Eye Hospital, London

The investigators aim to start the study in Spring 2018, and will most likely recruit for 6 months depending on the number of participants recruited.

There is no additional funding from any source at present - the work will be undertaken by doctors in their research time.


Eligibility criteria: Inclusion Criteria:

* patients undergoing biopsy for peri-ocular lesion

Exclusion Criteria:

* Age under 18; previous biopsy or excision on the same lid

Primary outcomes:
measure: Lanugo hair presence/absence
timeFrame: Examination on day of biopsy
measure: Biopsy result
timeFrame: Typically reported within a week of biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Princess Alexandra Eye Pavilion
state: Midlothian
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: NHS Lothian
name: Robert G Peden, MA; MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04994704: Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam
Official title: Comparison of Postoperative Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics (Propofol vs. Remimazolam) During Total Intravenous Anesthesia in the Spine Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Spine Surgery
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. In addition, it has no injection pain and infusion syndrome compared with propofol. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. Therefore, rhe purpose of the study is to compare poetoperative quality of recovery (QoR)-15 scores according to the use of anesthetics for total intravenous anesthesia in the cervical spine surgery with intraoperative neurophysiological monitoring.


Eligibility criteria: Inclusion Criteria:

* Adult patients who aged 20-70 years with ASA-PS 1-3,
* diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy
* intraoperative neurophysiological monitoring.

Exclusion Criteria:

* Tolerance or hypersensitivity to benzodiazepine or propofol
* Dependence or addiction to psychotropic drugs or alcohol
* Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions

Primary outcomes:
measure: The difference of QoR-15 scores between two groups (propofol vs. remimazolam)
timeFrame: postoperative day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT01625104: Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI
Official title: Randomized Trial of Aggressive Process of Care Quality Improvement Intervention to Decrease Door to Balloon Time in Primary PCI for Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STEMI
Keywords: Myocardial Infarction
Time to Treatment
Door to Balloon Time
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2012-06-21
Enrollment: 882
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were randomized to either aggressive intervention or control. The intervention consisted of Grand Rounds at each hospital, sharing of best practices, and coordinating center staff working closely with staff at each intervention hospital to discuss solutions to barriers to rapid treatment for STEMI patients.

Detailed description: The participating hospitals randomized to the aggressive intervention strategy actively worked to create teams to analyze processes of care for STEMI patients, identify areas needing improvement, and implemented strategies to streamline treatment.

Hospitals randomized to control were instructed to conduct "business as usual".

Eligibility criteria: Inclusion Criteria:

* Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.

Exclusion Criteria:

* Patients transferred from one facility to another,
* non ST segment myocardial infarction patients.

Primary outcomes:
measure: Percentage of Sites With Reduction in Door to Balloon Time
timeFrame: Arrival to balloon inflation, measured in minutes (generally less than 120 mins)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mauro Moscucci, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Eva M Kline-Rogers, MS, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02914704: Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
Official title: Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Fibroids
Adenomyosis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-09-26
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire.

Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.


Eligibility criteria: Inclusion Criteria:

* BMI \< 35
* Premenopausal
* Uterine size \<20 gw
* Willingness to participate to the research
* Uterine fibroids with typical symptoms
* Maximum of 4 treated fibroids
* Dominant fibroid \>2.5cm
* \>50% of the fibroid is treatable

Exclusion criteria

* Unspecified pelvic tumours or ovarian masses, PID
* Major corrective surgery to uterus (simple myomectomy excluded)
* Major uterine anomalies
* Unability to calculate the volume of uterine fibroids
* Marked uterine calcification
* Marked scarring of the lower abdomen
* Suspicion of malignancy
* Marked general health problem contraindicating MRI
* Claustrophobia

Primary outcomes:
measure: Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
timeFrame: 12 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Kirsi M Joronen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05818904: Ultrasound Imaging of Fibrotic Tissue
Official title: Ultrasound Imaging of Fibrotic Tissue Using Machine Learning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthrofibrosis of Knee
Arthrofibrosis of Shoulder
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Joint stiffness patients

Brief summary: This project intends to collect the ultrasonic spectrum information of shoulder and knee joint fibrotic tissue, and use machine learning to study the mechanism of fibrosis tissue ultrasound imaging, and then build a model and finally establish the relationship between joint stiffness and fibrosis formation. In this study, the broadband ultrasound imaging method for joint fibrosis has the potential to create a method for ultrasonic localization, staining and evaluation of joint fibrosis, laying the foundation for the research of new conservative treatment methods and surgical positioning for fibrosis, and for reducing the occurrence of joint fibrosis rate, improve joint function of patients, and return to family and society earlier and better


Eligibility criteria: Inclusion Criteria:

1. Unilateral shoulder or knee joint stiffness and normal on the opposite side
2. The course of the disease is longer than 3 months
3. Good cognitive function, able to understand the content of this experiment, willing to cooperate with follow-up
4. Over 18 years old, voluntarily participate in this study, and sign the informed consent

Exclusion Criteria:

1. Wound non-healing, joint dislocation or unstable fracture fixation, pseudarthrosis, joint purulent infection and other contraindications for joint range of motion examination
2. There are skin lesions, wounds or allergies to the coupling agent on the joint surface and other conditions that cannot be used for ultrasound examination

Primary outcomes:
measure: KOOS score
timeFrame: 3-month
measure: CM score
timeFrame: 3-month
Secondary outcomes:
measure: SF-36
timeFrame: 3-month
measure: WOMAC
timeFrame: 3-month
measure: HSS-KS
timeFrame: 3-month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: