louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01450371: Interferential Electrical Stimulation and Vasodilatation in Healthy Individuals
Official title: Interferential Electrical Stimulation Improves Peripheral Vasodilatation in Healthy Individuals: A Randomized Crossover Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decreased Vascular Flow
Keywords: Autonomic Nervous System
Neuromodulation
Blood flow control
Exercise
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: University of Brasilia
First posted: 2011-10-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects without degenerative diseases.

Brief summary: Interferential electrical stimulation (IES) increases local blood flow. It is not known whether increases in blood flow may be caused by inhibition of sympathetic activity, mediated by muscle metaboreflex activity. The purpose of this study was to evaluate the effect of IES on metaboreflex activation in healthy subjects.

Detailed description: The study sample consisted of 11 healthy young individuals. All subjects were non-smokers, non-obese and free of any signs or symptoms of disease, as revealed by medical history, physical examination and electrocardiogram at rest and during cardiopulmonary exercise testing. Exclusion criteria were pregnancy, breast-feeding, alcohol or drug abuse, and any medication with potential effects on cardiovascular variables. Subjects were asked not to drink caffeine-containing drinks or exercise for at least 12 and 48 hours, respectively, before the experimental protocols.

Eligibility criteria: Inclusion Criteria:

* Subjects are non-smokers
* non-obese
* and free of any signs or symptoms of disease

Exclusion Criteria:

* Pregnancy
* breast-feeding
* alcohol or drug abuse
* medication with potential effects on cardiovascular variables

Primary outcomes:
measure: Muscle Metaboreflex Reflex
timeFrame: Participants will be followed for the duration of metaboreflex activity (up to 30 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University of Brasilia
state: DF
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Gaspar Rogério da Silva Chiappa
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Gaspar R Chiappa, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vieira PJ, Ribeiro JP, Cipriano G Jr, Umpierre D, Cahalin LP, Moraes RS, Chiappa GR. Effect of transcutaneous electrical nerve stimulation on muscle metaboreflex in healthy young and older subjects. Eur J Appl Physiol. 2012 Apr;112(4):1327-34. doi: 10.1007/s00421-011-2084-z. Epub 2011 Jul 28.
Clinical trial NCT02521571: The Resilience Alliance
Official title: The Resilience Alliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Traumatic Stress
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Resilience Alliance is a skill-based staff development intervention for child protective staff that focuses on improving job satisfaction, resilience, optimism and social support, while decreasing attrition, stress reactivity and burnout. The investigators believe that the intervention will enhance the capacity of child welfare workers to care for themselves, which will result in them providing better care for the children and families involved with the child welfare system.

The Resiliance Alliance will be implemented in two child protective offices, Manhattan Zone C and Brooklyn Zone B. Staff from two additional offices (Staten Island Zone A and Brooklyn Zone C) will serve as a control group. A web-based survey will be administered in the group receiving the Resiliance Alliance intervention prior to intervention, at completion of the intervention, and 3 months post completion. The control group will be given a two-part training (3 hours in total) on secondary traumatic stress. The control group will then be asked to complete the same survey as the intervention group.


Eligibility criteria: Inclusion Criteria:

* Administration for Children's Services (ACS) employees working at one of four offices: Manhattan Zone C, Brooklyn Zone B, Staten Island Zone A and Brooklyn Zone C
* Adults aged 18 years or older
* English-speaking

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Survey Over Time
timeFrame: At baseline, upon conclusion of the intervention (6 months), and 3 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx ACS Borough Office
state: New York
city: Brooklyn
country: United States
facility: Brooklyn ACS Borough Office
state: New York
city: New York
country: United States
facility: Manhattan ACS Borough Office
state: New York
city: Staten Island
country: United States
facility: Staten Island ACS Borough Office
state: New York
Study officials:
affiliation: NYU MEDICAL CENTER
name: Claude Chemtob
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01748071: The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl
Official title: Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Individuality
Keywords: fentanyl
sufentanil
individual variation
pain threshold
nacro-trend index
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 Chinese female patients receiving elective surgery under general anesthesia

Brief summary: Purpose: This study aimed to find a quick and timely way to investigate the individual variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries. Methods: 120 female patients receiving elective surgery under general anesthesia were recruited into this study. At the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.

Detailed description: Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Eligibility criteria: Inclusion Criteria:

* Aged 20-65 years
* Anesthesiologists (ASA) physical status I or II;
* Within ±20% of ideal body weight;
* Agreed to participate the research

Exclusion Criteria:

* History of chronic pain;
* Psychiatric diseases;
* Diabetes mellitus;
* Severe cardiovascular diseases;
* Kidney or liver diseases;
* Alcohol or drug abuse (according to the criteria of DSM-IV);
* Pregnancy or at lactation period;
* Disagree to participate to the research

Primary outcomes:
measure: Mean Pressure Pain Threshold
timeFrame: 10 minutes after the procedure
measure: Mean Value of Narco-trend Index
timeFrame: 10 minutes after the procedure
Secondary outcomes:
measure: Mean Arterial Pressure
timeFrame: 10 minutes after the procedure
measure: Mean Heart Rate
timeFrame: 10 minutes after the procedure
measure: Mean Respiratory Frequency
timeFrame: 10 minutes after the procedure
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Zhang Xianwei, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03444571: PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
Official title: PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prosthesis-Related Infections
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2018-02-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Implantation of joint prostheses is currently the second largest diagnosis-related group in the Danish health service, and in view of the demographic development and spread of lifestyle diseases, this type of intervention is expected to continue to increase.

Unfortunately, 5% of patients experience significant discomforts and complications. The second most frequent and serious complication is infection. While the established laboratory analyses (culture of tissue biopsies) are good at diagnosing acute infections, they are not satisfactory to diagnose a large group of patients especially with chronic infections. This can lead to prolonged diagnosing time and even to wrong diagnosis.

Several studies have shown that analyses of prosthetic parts and the use of molecular biological methods for detecting infecting microorganisms can significantly improve diagnostics accuracy.

The purpose of this project is primarily to demonstrate that analyses of bacterial specific DNA (16S rRNA genes) can confirm or rule out infection as fast (or faster) as cultivation methods. Rapid clarification can promote targeted treatment and in order to demonstrate this, the trial is conducted as a randomized study. .


Eligibility criteria: Inclusion Criteria:

* revision of hip platelets (THA) or knee replacement (TKA) on indication of likely infection

Exclusion Criteria:

* surgery within the last 4 months. The same applies to patients with short history of illness, pronounced acute symptoms and systemic response (reducing the likelihood of biofilm infection).

Primary outcomes:
measure: Improved diagnostic accuracy
timeFrame: 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Orthopedic surgery
state: Northern Jutland
Study officials:
References:
Clinical trial NCT04329871: Medtronic 670G Insulin Pump and the Impact on Glycemic Control, Quality of Life, and Compliance
Official title: An Analysis of Medtronic 670G Insulin Pump Use in Clinical Practice and the Impact on Glycemic Control, Quality of Life, and Compliance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Metabolic Research Institute, Inc.
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who enter the study at Visit 1 and meet all the inclusion criteria and none of the exclusion criteria will be eligible to sign informed consent to have their data collected and analyzed

Brief summary: Analyze the Medtronic 670g pump on glycemic control

Detailed description: An Analysis of the Medtronic 670g Insulin pump use in clinical practice and the impact on glycemic control , quality of life, and compliance

Eligibility criteria: Inclusion Criteria:

* age 18 or older
* Documented History of Type 1 Diabetes Mellitus
* 3 months continuous use of the Medtronic 670g pump system
* given written informed consent

Exclusion Criteria:

* Less than 3 months use of the Medtronic 670g pump system
* Taking any other medication, other than the insulin used in the Medtronic 670g pump, to manage their diabetes
* having medical conditions or taking medications that would preclude subject involvement or affect the outcomes being measured, in the opinion of the Investigator

Primary outcomes:
measure: Glycemic control while using the Medtronic MiniMed 670g system
timeFrame: through study completion, an average of 1 year.
Secondary outcomes:
measure: Efficacy of Quality of Life and satisfaction while using the MiniMed 670g system
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
Study officials:
affiliation: Metabolic Research Institute, Inc.
name: Barry S Horowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: There are no Citations
Clinical trial NCT05531071: Effect of Acupuncture Combined With Biofeedback Electrical Stimulation on SUI
Official title: Clinical Observation of Acupuncture Combined With Biofeedback Electrical Stimulation in the Treatment of Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence
Acupuncture
Biofeedback electrical stimulation
Lead sponsor: Hebei General Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To investigate the clinical efficacy of acupuncture combined with biofeedback electrical stimulation on female stress urinary incontinence. Methods: 90 patients diagnosed in a hospital from January 2020 to January 2021 were randomly divided into three groups A, B and C, and group A was treated with biofeedback electrical stimulation, 3 times a week for 30 minutes for 15 times. Group B used acupuncture treatment, including Guanyuan, Qihai, Zhongji, Zusanli, Sanyinjiao and Yinlingquan, once a day, Monday to Friday, 30 minutes each, a total of 10 times. Group C was treated with acupuncture combined with biofeedback electrical stimulation. All three groups were combined with pelvic floor muscle training. After treatment, the changes in class I, II muscle fiber, ICI-Q-SF score, and urine leakage in the 1h pad test were compared.


Eligibility criteria: Inclusion Criteria:

* meet the diagnostic criteria of SUI
* Aged over 18 years old and have a history of sexual life
* No treatment related to SUI within three months
* Mental illness without cognitive dysfunction, able to cooperate with examination and treatment
* Voluntarily participate and sign the informed consent

Exclusion Criteria:

* combined with urge urinary incontinence, uterine prolapse, vaginal anterior and posterior wall prolapse
* pregnancy, postpartum lochia or abnormal vaginal bleeding
* Acute phase of inflammation (pelvic cavity, vagina, urinary system)
* There are metal substances such as pacemakers and metal stents in the body
* Denervation of pelvic floor muscles (no sensation, no contraction)
* coagulation dysfunction

Primary outcomes:
measure: Pelvic floor muscle strength
timeFrame: Before treatment
measure: Pelvic floor muscle strength
timeFrame: 4 weeks
measure: 1 hours urine pad test
timeFrame: Before treatment
measure: 1 hours urine pad test
timeFrame: 4 weeks
measure: International Consultation on Incontinence Questionnaire short form
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Caiqing Ji
state: Hebei
Study officials:
References:
Clinical trial NCT00585871: Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Official title: Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: ICD patients with 5 VTs per 3 month period
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiac arrest or sustained VT (ventricular tachycardia) in patients with heart disease is best treated with an ICD (implantable cardioverter defibrillator). However, the ICD alone is not appropriate therapy for patients with frequent VT episodes. In fact frequent shocks for VT may predict a poorer prognosis. Anti-arrhythmic drugs are co-administered with ICDs in up to 50% of patients to prevent VT episodes, but antiarrhythmic drugs may have harmful effects. Thus improved drugs to prevent VT without interfering with ICD function are needed. Recent data including our own suggest that clonidine may be a new therapy to prevent ICD shocks. It may act centrally on sympathetic outflow and peripherally and selectively on cardiac Purkinje, to suppress and control VT occurring in patients. Our purpose is to test the hypothesis that clonidine reduces frequent VT better than beta blocker in patients with ICDs. After informed consent patients will be randomized in a single blind fashion to either clonidine or metoprolol given three times per day. Other prescribed drugs may be adjusted to promote toleration of the study drug. ICD interrogations of episodes of VT will be the primary endpoint. Device based NIPS (non-invasive programmed stimulation) testing in a subset of these patients will allow mechanistic understanding of the clonidine effect. All of the procedural techniques are in place as performed clinically; preliminary data are given showing feasibility of the project.

Detailed description: we had wanted very commonly occurring VT episodes on ICD interrogation: 5 episodes/ 3 months. We could not enroll more than 2 patients most of which have interventions to prevent episodes. Thus we could not enroll patients and discontinued the study in the first year.

Eligibility criteria: Inclusion Criteria:

* Implantable defibrillator treated patients with 5 episodes of ventricular tachycardia per 3 month period

Exclusion Criteria:

* No more than one shock/3 months
* No contraindication to clonidine
* Non-compliance
* Asthma

Primary outcomes:
measure: episodes of non-sustained ventricular tachycardia
timeFrame: one year
Secondary outcomes:
measure: defibrillator shocks
timeFrame: one year
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: UIHC
state: Iowa
Study officials:
affiliation: University of Iowa
name: james b martins, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05246371: Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury
Official title: Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hepatectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.

Detailed description: Postoperative impairment of liver function is common after hepatectomy. It may be caused by surgical trauma, loss of hepatic mass, stress response, hepatic oxygen deprivation, infection and drug toxicity.

Anesthetic agents used in general anesthesia for liver surgery have a big effect on hepatic blood flow, oxygen delivery and liver function This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.

Eligibility criteria: Inclusion Criteria:

1. Patients American Society of Anesthesiologists physical status (ASA) I to II.
2. Patients Child Pugh classification A to B.
3. Both sexes.
4. Aged between 18 years and 70 years
5. Scheduled for more than 1 segment hepatectomy.

Exclusion Criteria:

1. Patients with Child Pugh classification C.
2. Patients younger than18 years old or older than 70 years old
3. Patients performed additional ablation therapies (cryosurgery or radiofrequency ablation).
4. Prior liver resection for donation.
5. Scheduled resection not requiring inflow occlusion (Pringle's maneuver).
6. Hypersensitivity to any of the used drugs.

Primary outcomes:
measure: aspartate aminotransferase (AST)
timeFrame: 1 week
measure: alanine aminotransferase (ALT)
timeFrame: 1 week
measure: bilirubin
timeFrame: 1 week
measure: albumin
timeFrame: 1 week
measure: prothrombin time
timeFrame: 1 week
measure: INR
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Hany Alzahaby, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01698671: InterGard Synergy Post-Marketing Surveillance Study
Official title: InterGard Synergy Post-Marketing Surveillance Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Occlusive Disease of Artery of Lower Extremity
Lead sponsor: Maquet Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.

Detailed description: Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.

Eligibility criteria: Inclusion Criteria:

* Patients requiring an InterGard Synergy Vascular Graft

Exclusion Criteria:

* Patients with contra-indications per InterGard Synergy Vascular Graft
* Patients with current graft infection
* Patients with a known allergy to collagen, triclosan or silver acetate
* Patients who require urgent or emergent surgery

Primary outcomes:
measure: Graft Patency and Complications
timeFrame: 6 months
Secondary outcomes:
measure: Mortality rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Graz, Vienna
country: Austria
facility: Study Centers
city: Frankfurt, Karlsruhe
country: Germany
facility: Study Centers
city: Heidelberg, Hamburg, Hanau
country: Germany
facility: Study Centers
Study officials:
affiliation: Krankenhaus Nordwest
name: Max Zegelman, MD
role: PRINCIPAL_INVESTIGATOR
References: