louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03955809: Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.
Official title: Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroscopy
Keywords: Injection
Intra-Articular
arthroscopy
ketamine
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 75
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy

Detailed description: All pateints are going to be operated under general anesthesia. At the end of the study patients are going to be randomyl seperated into 3 groups. The surgeon is going the following drugs intraarticulary.

Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled analgesia with morphine.

VAS scores and total analgesic requirement is going to be evaluated.

Eligibility criteria: Inclusion Criteria:

* Artroscopic surgery
* ASA I-II

Exclusion Criteria:

* Long time NSAID use
* Travmatic knee injury
* Long ter analgesic use
* Intraartiular catheter insertion at the end of surgery

Primary outcomes:
measure: Change in postoperative pain scores throughout time evaluated by VAS
timeFrame: VAS scores at rest and during activity will be evaluated for 24 hours. The first measurement will be recorded immediately after surgery and at 30 minutes interval for the first hour. Afterwards at 2.4.6.12.24.hours postoperatively.
measure: Difference in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.
timeFrame: Total amount off delivered morphine will be recorded for 24 hours.
Secondary outcomes:
measure: Time for discharge measured by eligible for discharge criteria
timeFrame: Discharge criterias will be evaluated every three hours until postoperative 24. hour. In patients who did not complete the discharge criteria in the postoperative 24 hours period, they will be defined as prolonged discharge.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03473509: Primary Care CKD Registry
Official title: Impact of a Safety-Net Primary Care CKD Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Chronic Kidney Diseases
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines whether a safety-net primary care CKD registry directed at the entire primary care team can enhance the delivery of guideline concordant CKD care, including BP control, ACEi/ARB use and albuminuria quantification.


Eligibility criteria: Inclusion Criteria:

All PCPs who worked in practice teams and provided longitudinal primary care to patients were eligible to participate in this study. Practice teams that consisted of several physicians (+/- trainees), one nurse, nurse practitioners, medical assistants and behaviorists, were randomized 1:1 to one of two arms with a random number generator: access to an electronic CKD registry or a usual care registry for 12 months.

Exclusion Criteria:

PCPs who solely provided specialty care, for example HIV services or urgent care, were excluded.

Primary outcomes:
measure: Change in clinic systolic
timeFrame: 12 months
Secondary outcomes:
measure: Change in proportion of patients with BP control
timeFrame: 12 months
measure: Change in proportion fo patients with urine albuminuria quantification
timeFrame: 12 months
measure: Change in albuminuria severity
timeFrame: 12 months
measure: Change in proportion of patients with ACEi/ARB prescription
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01314209: Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)
Official title: Dexmedetomidine Pharmacokinetics During Continuous Venovenous Hemodialysis in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury
Keywords: dexmedetomidine
pharmacokinetics
critical illness
continuous renal replacement therapy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2011-03-14
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 purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous renal replacement therapy on critically ill patients.

Detailed description: Dexmedetomidine is a selective alpha-2-adrenergic agonist with sedative properties indicated for sedation of patients in the intensive care setting. ICU patients with acute kidney injury requiring renal replacement therapies frequently have changes in volume status causing alterations in drug pharmacokinetics. Although dexmedetomidine pharmacokinetics have been studied earlier on ICU patients, there is no information on its pharmacokinetics in critically ill patients needing continuous renal replacement therapy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Clinical need for sedation
* Acute kidney injury requiring renal replacement therapy (according to ICUs standard operating procedures)

Exclusion Criteria:

* Severe bradycardia (HR \< 50/min)
* AV conduction block II-III (unless pacemaker installed)
* Severe hepatic impairment (bilirubin \> 101 umol/l)
* Pregnancy or lactation
* Age \< 18

Primary outcomes:
measure: Dexmedetomidine clearance by continuous venovenous hemodialysis
timeFrame: 10 hours from the start of the dexmedetomidine infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Meilahti Hospital, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital
Study officials:
affiliation: Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, HUCH
name: Kirsi-Maija Kaukonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01842009: Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
Official title: Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Keywords: transcranial stimulation
direct current
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: ElMindA Ltd
First posted: 2013-04-29
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: TREATMENT

Brief summary: The purpose of this study is to investigate the mean number of stimulation (high definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS) for pain. These data will be important in defining the optimal number of sessions for future fibromyalgia subjects in Phase III trials.


Eligibility criteria: Inclusion Criteria:

* Providing informed consent to participate in the study
* 18 to 85 years old, both male and female
* Have a diagnosis of Fibromyalgia
* Existing pain for more than 3 months with an average of at least 4 on a 0-10 VAS scale
* Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex and Codeine.

Exclusion Criteria:

* Pregnancy
* Contraindications to tDCS: metal in the head or implanted brain medical devices
* History of alcohol or drug abuse within the past 6 months as self-reported
* Use of carbamazepine within the past 6 months as self-reported
* Severe depression (with a score of \>30 in the Beck Depression Inventory)
* Any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
* History of unexplained fainting spells as self-reported
* Neurosurgery as self-reported

Primary outcomes:
measure: Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS)
timeFrame: approximately 4.5 months
Secondary outcomes:
measure: Number of subjects who achieve clinical response
timeFrame: Approximately 4.5 months
measure: Measurement of sensory and auditory evoked potentials
timeFrame: Approximately 4.5 months
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castillo-Saavedra L, Gebodh N, Bikson M, Diaz-Cruz C, Brandao R, Coutinho L, Truong D, Datta A, Shani-Hershkovich R, Weiss M, Laufer I, Reches A, Peremen Z, Geva A, Parra LC, Fregni F. Clinically Effective Treatment of Fibromyalgia Pain With High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization. J Pain. 2016 Jan;17(1):14-26. doi: 10.1016/j.jpain.2015.09.009. Epub 2015 Oct 9.
Clinical trial NCT05450809: Performance and Accuracy of an AI Enhanced Smart Watch Single Lead ECG
Official title: PeRfOrmance and ACcuracy of an artifiCial Intelligence Enhanced Smart Watch Single Lead ECG (PROCESS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: electrocardiogram
wearable
artificial intellegence
Apple Watch
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory patients who are undergoing a clinically ordered electrocardiogram in the Mayo Clinic outpatient ECG lab.

Brief summary: The purpose of this study is to show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG.

Detailed description: 1. Ambulatory patients undergoing ECG recording in the Mayo Clinic outpatient ECG lab will be asked to consent for this study.
2. Those who consent for the study will be asked to record a ECG using a single-lead watch-based (Apple Watch series 5) recording at a visit for a clinically scheduled 12 lead ECG recording.
3. This watch-based ECG data will be recorded and analyzed in comparison to the near-simultaneously recorded outpatient 12 Lead ECG

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 89.
* Able to give verbal consent.
* Able to complete routine clinical 12 lead ECG tracing and single lead Apple Watch ECG tracing.

Exclusion Criteria:

* Individuals \< 18 and \> 89 years of age.
* Unable to given verbal consent.

Primary outcomes:
measure: Comparison of 12 lead ECG features to single-lead watch-based ECG features
timeFrame: 12 months
measure: Arrhythmia comparison of 12 lead ECG to single-lead watch-based ECG
timeFrame: 12 months
Secondary outcomes:
measure: Arrhythmia classification by physician overread of single-lead watch-based ECG
timeFrame: 12 months
Other outcomes:
measure: Artificial intelligence detection of heart failure by single-lead watch-based ECG
timeFrame: 12 months
measure: Artificial intelligence detection of silent/paroxysmal atrial fibrillation by single-lead watch-based ECG
timeFrame: 12 months
measure: Artificial intelligence detection of aortic stenosis by single-lead watch-based ECG
timeFrame: 12 months
measure: Artificial intelligence determination of patient age by single-lead watch-based ECG
timeFrame: 12 months
measure: Artificial intelligence detection of amyloidosis by single-lead watch-based ECG
timeFrame: 12 months
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Itzhak Zachi Attia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06028009: PRP Injections for Genitourinary Syndrome of Menopause
Official title: Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PRP
Sexual Function Disturbances
Genitourinary Syndrome of Menopause
Postmenopausal Symptoms
Vaginal Atrophy
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.


Eligibility criteria: Inclusion Criteria:

* Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM
* Sexually active with at least one episode of sexual activity per week in the preceding 4 weeks defined as follows: Partnered or solo penetrative or non-penetrative stimulation of the clitoris or vagina
* English-speaking
* Willingness and able to comply with the study requirements

Exclusion Criteria:

* Symptomatic pelvic organ prolapse protruding beyond the hymen)
* History of prior vaginal mesh or midurethral mesh sling surgery
* History of pelvic radiation or genital tract malignancy
* Current symptomatic pelvic organ prolapse (stage II or greater)
* Active vulvar dermatoses or genitourinary infection
* Unable to hold anticoagulation
* Hormonal replacement therapy (systemic, local, or vaginal) within 3 months of participation
* Pregnancy or pre-menopausal status

Primary outcomes:
measure: Female Sexual Function Index
timeFrame: Assessed at baseline and at 6 weeks and 6 months post-procedure
Secondary outcomes:
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: Assessed at 6 weeks and 6 months post-intervention
measure: Visual analog scale for vaginal dryness (VAS)
timeFrame: Assessed at 6 weeks and 6 months post-intervention
measure: Urinary Distress Inventory (short form) (UDI-6)
timeFrame: Assessed at baseline and 6 weeks/6 months post-intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Lafayette Medical Centre
state: District of Columbia
Study officials:
References:
Clinical trial NCT05228509: Portal Vein Flow Velocity as a Screening Tool for Oesophageal Varices in Cirrhotic Patients
Official title: Portal Vein Flow Velocity as a Screening Tool for Oesophageal Varices in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis Portal
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cirrhotic patients with or without E

Brief summary: Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy

Detailed description: Portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy with its high cost \& complications Using portal vein flow velocity and the relation between it \& presence of oesophageal varices in cirrhotic patient \& its efficacy as a primary tool for these cases

Eligibility criteria: Inclusion Criteria:

* cirrhotic patients with oesophageal varices
* cirrhotic patients without oesophageal varices

Exclusion Criteria:

* Patients with hepato-cellular carcinomas \[HCCs\], portal vein thrombosis, hepatic encephalopathy.
* Patients with positive HCV antibody, but without liver cirrhosis diagnostic criteria

Primary outcomes:
measure: Using upper GIT endoscopy to detect the presence or absence of oesophageal varices
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: 43
state: Manfalout
city: Assiut
country: Egypt
facility: Egypt .assiut.manfalout
state: Manfalout
Study officials:
affiliation: Assiut University
name: Peter At Munir, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02871609: Assessment of Longterm Ureteral Stenting
Official title: Longterm Ureteral Stenting: Assessment of Stent- Associated Morbidity, Associated Costs and Impact of Biofilms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Longterm Indwelling Ureteral Stent
Keywords: Biofilm
Morbidity
Ureteral Catheterization
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with longterm indwelling ureteral stent undergoing regular changes in an inpatient or outpatient setting at the department of urology of KSSG.

Brief summary: This study is performed to analyze various aspects of biofilms on ureteral stents in a longterm setting.

Detailed description: The study is performed to provide a better understanding of the influence of biofilms on ureteral stents on the entire spectrum of stent-associated morbidity in a longterm setting.

In addition, the trial is intended to give an overview of the incidence of complaints, the occurrence of complications and their economic aspects.

The influence of biofilms on the morbidity associated with longterm ureteral stenting is assessed.

Eligibility criteria: Inclusion Criteria:

* Patients with longterm indwelling ureteral stent (minimum of 2 months) undergoing regular changes
* Informed consent
* responsible patients

Exclusion Criteria:

* ongoing therapy: OAB, LUTS, urinary incontinence, chronic prostatitis, chronic pelvic pain syndrome
* insufficient language skills
* cognitive limitation

Primary outcomes:
measure: Total biofilm mass on ureteral stents
timeFrame: Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change
measure: Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change
Secondary outcomes:
measure: Urine Culture
timeFrame: 2-6 months after stent insertion
measure: Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents
timeFrame: 2-6 months after stent insertion
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 2-6 months after stent insertion
measure: Assessment of costs arising from complications
timeFrame: 2-6 months after stent insertion
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Urological Department, Cantonal Hospital of St. Gallen
Study officials:
affiliation: Department of Urology
name: Patrick Betschart, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04193709: Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
Official title: Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Bladder, Neurogenic
Blood Pressure
Autonomic Dysreflexia
Bowel Incontinence
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-12-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross-sectional and observational (Arm 1) Prospective, cohort, and interventional (Arm 2).
Primary purpose: OTHER

Brief summary: This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.


Eligibility criteria: Arm 1 Inclusion Criteria:

* At least 18 years of age;
* AIS A to D;
* Neurogenic bladder and bowel dysfunction;
* Stable medical condition

Arm 2 Inclusion Criteria:

* At least 18 years of age;
* AIS A to D;
* Neurogenic bladder and bowel dysfunction;
* Use of intermittent catheterization for bladder emptying;
* Prior implantation of a Medtronic scES array

Arms 1 and 2 Exclusion Criteria:

* Prior Botox injections of the bladder and/or bladder augmentation surgery;
* Colostomy bag,
* Ventilator dependent;
* Any implanted pump (i.e. Baclofen pump, pain pump, etc.);
* Pregnant at the time of enrollment or planning to become pregnant during the time course of the study

Primary outcomes:
measure: Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)
timeFrame: Baseline, 80 sessions (6 months)
Secondary outcomes:
measure: Change from baseline in bladder capacity after 80 sessions (6 months)
timeFrame: Baseline, 80 sessions (6 months)
measure: Change from baseline in detrusor pressure after 80 sessions (6 months)
timeFrame: Baseline, 80 sessions (6 months)
measure: Change from baseline in mean resting anal pressure after 80 sessions (6 months)
timeFrame: Baseline, 80 sessions (6 months)
measure: Change from baseline in mean squeeze pressure after 80 sessions (6 months)
timeFrame: Baseline, 80 sessions (6 months)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Charles Hubscher, PhD
role: PRINCIPAL_INVESTIGATOR
References: