louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05120999: Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
Official title: Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring: A Prospective, Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: neuromuscular blockade
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Qualified participants will be invited to participate in this study regardless of gender, sex, race, or religion.

Brief summary: The purpose of this research is to use 2 devices to compare the difference in the amount of time it takes for each device to register complete muscle relaxation after the muscle relaxing medication is given. The comparison will be made by using electromyographic (EMG), such as TetraGraph, and acceloromyographic (AMG), such as TOFScan, monitors at the time of insertion of breathing tube.


Eligibility criteria: Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents; i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm into the sterile field.
* Patients receiving a rapid sequence induction.

Primary outcomes:
measure: Time difference
timeFrame: During the initiation of anesthesia period
Secondary outcomes:
measure: Intubating conditions
timeFrame: During the initiation of anesthesia period
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: J. Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04788199: Novel Technique in Closure of Mesenteric Defects After Laparoscopic Roux-en-Y Gastric Bypass and Its Effect on Internal Hernia: a Case-control Study
Official title: Analytical Study of Internal Hernia Following Laparoscopic Roux-eny Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Keywords: Bypass, Gastric; Obesity, Morbid; Glue. Internal hernia; Laparoscopy.
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 928
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: patients with morbid obesity who were qualified to receive LRYGB in the period between September 2007 and January 2020

Brief summary: This study is to investigate the rate of internal hernia after laparoscopic Rox-en-Y gastric bypass when the defects are closed using cyano-acrylate glue.

Detailed description: Background Internal hernia complicated by bowel obstruction is a well-recognized complication of laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study aims to investigate the role of cyanoacrylate glue in the prevention of internal hernia (IH) after LRYGB and compare it with the open technique of managing mesenteric defects by leaving the mesentery intact without closure of mesenteric defects. Data from six UK hospitals have been involved in this study. Operations were done under the supervision of a single senior consultant surgeon of bariatric surgery.

Methods The prospectively collected data of 813 patients with morbid obesity who underwent LRYGB were retrospectively analyzed. Patients were subdivided into two groups: group I comprising 185 patients who had the mesenteric defects closed with cyanoacrylate glue and group II comprising 628 patients who were managed by the open technique of leaving the mesentery intact without closure of the mesenteric defects.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent antecolic LRYGB without closure of mesenteric defects using cyanoacrylate glue or without closure of the mesenteric defects.

Exclusion Criteria:

* Open RYGB, laparoscopic converted to open RYGB, laparoscopic retro-colic RYGB, laparoscopic ante-colic RYGB with closure of the defect using sutures or RYGB done for non-bariatric purposes e.g. idiopathic gastroparesis.

Primary outcomes:
measure: Number of participants with internal hernia after Laparoscopic Roux-en-Y gastric bypass
timeFrame: September 2007 to January 2020
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Mary's Hospital, Imperial College Healthcare NHS Trust
Study officials:
affiliation: Mansoura Faculty of Medicine, Imperial College Healthcare NHS Trust
name: Ahmed Ghanem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02917499: Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Lead sponsor: Sveti Ivan Psychiatric Hospital
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 228
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the efficacy and safety of transcranial magnetic stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and neurological disorders. Subjects will be randomized into two groups: experimental (treated with pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They and their clinicians will complete a battery of instruments that measure relevant symptoms, global functioning and quality of life. The first measurement will be done after the inclusion and before treatment. The second measurement will be made immediately after the end of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3 and 6 months.


Eligibility criteria: Inclusion Criteria:

* diagnosed psychiatric or neurological disorder, duration of disorder for at least 5 years, inpatients or outpatients treated in Psychiatric hospital Sveti Ivan

Exclusion Criteria:

* suicidality, psychosis, alcohol addiction, unable to complete the questionnaires

Primary outcomes:
measure: the proportion of patients who experienced complete remission of the disease
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: PB Sveti Ivan
Study officials:
References:
citation: Filipcic I, Simunovic Filipcic I, Milovac Z, Sucic S, Gajsak T, Ivezic E, Basic S, Bajic Z, Heilig M. Efficacy of repetitive transcranial magnetic stimulation using a figure-8-coil or an H1-Coil in treatment of major depressive disorder; A randomized clinical trial. J Psychiatr Res. 2019 Jul;114:113-119. doi: 10.1016/j.jpsychires.2019.04.020. Epub 2019 Apr 26.
Clinical trial NCT02695199: Doppler Ultrasound Assisted Varicocelectomy Improve Sperm Qualities
Official title: Comparison Between Laparoscopic Doppler Ultrasound Assisted Laparoscopic Varicocelectomy and Microscopic Subinguinal Varicocelectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicocele
Keywords: Doppler Ultrasound
Laparoscopic
Microscopic Subinguinal Varicocelectomy
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with varicoceles.

Detailed description: To compare the surgical outcomes such as semen parameters and the pregnancy rate and complications like postoperative varicocele recurrence and hydrocele between laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy and conventional microscopic subinguinal for infertile patients with varicoceles. To examine the microanatomy of the spermatic cord within suprainguinal portion.

Eligibility criteria: Inclusion Criteria:

1. 20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles;
2. impaired semen quality including sperm concentration \<15 million/ml or total motility \<40% or progressively motile \< 32% (a+b), the 5th edited World Health Organization criteria was referred;
3. with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, Thyroid hormones and prolactin;
4. patient's spouse was healthy in reproduction.

Exclusion Criteria:

1. with subclinical varicocele, recurrent varicoceles;
2. normal semen analyses;
3. other reasons of infertility than varicoceles;
4. refusing to enter randomization;
5. female partner older than 35 years;
6. with abnormal level of serum hormones;
7. female factor infertility;
8. with significant surgical diseases, congenital diseases or endocrine diseases.

Primary outcomes:
measure: Pregnancy rate
timeFrame: The pregnancy rate was calculated at 1 year of follow-up
Secondary outcomes:
measure: semen quality assessment
timeFrame: semen quality assessment were checked at 3, 6 and 12 months after surgery.
measure: postoperative complications
timeFrame: postoperative complications at 3, 6 and 12 months after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Second Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Second hospital of Shandong University
name: Mingzhen Yuan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02930499: Effect of Hyaluronic Acid ECM on Venous Ulcers
Official title: A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Hyaluronic Acid Extracellular Matrix (Hyalomatrix®) in the Management of Chronic Venous Ulcers
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Venous Ulcers
Lead sponsor: Calvary Hospital, Bronx, NY
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to compare the incidence and rate of wound healing in subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid plus compression therapy as compared to standard care. The study also intends to follow the subjects for a 16-week period in order to evaluate ulcer recurrence within treatment groups.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients 18-85 years of age with chronic venous insufficiency (CVI) and the presence of venous ulceration for longer than 2 months
2. Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages
3. Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period.

Exclusion Criteria:

1. Ulcers of non-venous etiology
2. Subject has a known sensitivity to hyaluronic acid
3. Presence of wound infection as determined by clinical signs and symptoms
4. Subject has any evidence of peripheral arterial disease (PAD)
5. Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
6. Pregnancy or lactation at time of treatment.
7. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
8. Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
9. History of alcohol or drug abuse.
10. Subject allergic to a broad spectrum of primary \& secondary dressing materials, including occlusive dressings and the adhesives on such dressings.

Primary outcomes:
measure: Effect of Hyalomatrix® plus standard care on the incidence of wound healing
timeFrame: 16 weeks
Secondary outcomes:
measure: Rate of wound healing by decrease in ulcer surface area Incidence of 50% wound healing by 4 weeks Reduced VLU recurrence after healing
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Vascular and Wound Care Center, University Hospital
state: New Jersey
Study officials:
affiliation: Program Director, Vascular and Wound Care Center, University Hospital, Newark, NJ
name: Oscar M Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04701099: Population Pharmacokinetics of Vancomycin, Meropenem, Milrinone, Dexmedetomidine and Fentanyl in Pediatric Patients During Extracorporeal Membrane Oxygenation
Official title: Population Pharmacokinetics of Vancomycin, Meropenem, Milrinone, Dexmedetomidine and Fentanyl in Pediatric Patients During Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under the age of 19 who are receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl while using VA ECMO in Severance Hospital, Yonsei University Health System.

Brief summary: Extracorporeal membrane oxygenation (ECMO) has been used primarily in newborns since it was first successfully implemented in the 1970s, and has recently increased use in infants and young children. Venoarterial ECMO (VA-ECMO) is a temporary mechanical circulatory support for patients with cardiac failure. Because ECMO is invasive, appropriate use of antimicrobial agent, analgesic and sedatives is important to promote recovery. However, a large variability in drugs pharmacokinetics is expected in pediatric ECMO patients due to the combination of ECMO, drug characteristics and disease factor. This study aimed to evaluate whether the PK of drugs is influenced by VA-ECMO and to recommend the optimal dosing strategies for proposed drugs in pediatric patients receiving VA-ECMO.


Eligibility criteria: Inclusion Criteria:

* \<19 years old
* receiving VA ECMO in Severance Hospital, Yonsei University Health System.
* receiving one of these drugs: vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
* agreed to participate

Exclusion Criteria:

* receiving drugs that could affect study drug's concentration due to drug-drug interaction

Primary outcomes:
measure: Serum or plasma concentration
timeFrame: Between day0 to day3 during ECMO
measure: Serum or plasma concentration
timeFrame: Between day0 to day3 after weaning off ECMO
measure: Pharmacokinetic parameter: Volume of distribution
timeFrame: Between day0 to day3 during ECMO
measure: Pharmacokinetic parameter: Volume of distribution
timeFrame: Between day0 to day3 after weaning off ECMO
measure: Pharmacokinetic parameter: Clearance
timeFrame: Between day0 to day3 during ECMO
measure: Pharmacokinetic parameter: Clearance
timeFrame: Between day0 to day3 after weaning off ECMO
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Thoracic and Cardiovascular Surgery, Yonsei University Health System
Study officials:
affiliation: Severance Hospital
name: Yu Rim Shin, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04426799: Effectiveness of Lemon Essential Oil of Aromatherapy in Reducing Test Anxiety in Nursing Students
Official title: Lemon Essential Oil in Reducing Test Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Student
Keywords: Lemon Essential Oil
Test Anxiety,
Student
Nurse
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: : A randomized, pre-test-post-test design was carried out to examine the effectiveness of lemon essential oil in reducing test anxiety in first-year students of the Faculty of Medical Sciences of a private university in Istanbul.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examines the effectiveness of lemon essential oil in reducing test anxiety in first-year nursing students.

Detailed description: While studies on the role of aromatherapy in reducing test anxiety exist, those evaluating the effects of lemon essential oil on test anxiety are extremely limited. In this study, the effect of a different aromatherapy application on reducing test anxiety was tried to be determined by using lemon essential oil. It is envisaged to provide an alternative aromatherapy application to students and educators to reduce test anxiety through the results obtained in the study.

Eligibility criteria: Inclusion Criteria:

* No respiratory system diseases (Asthma, Flu etc.)
* no allergy to any smell, no pregnancy status,
* absence of epilepsy discomfort,
* not having a condition that prevents smell, not using any medication that will affect heart rate and blood pressure,

exclusion criteria

* Any respiratory system disease (Asthma, Flu, etc.).
* have a known allergic response to essential oil to be used,
* Lack of smell, use of any medication affecting heart rate and blood pressure,
* to use other complementary medicine practices

Primary outcomes:
measure: Personal Information Form
timeFrame: 30 minutes
measure: Test Anxiety Scale (TAS)
timeFrame: 30 minutes
measure: State Test Anxiety Scale
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sabahattin Zaim University
state: Center
Study officials:
affiliation: Sabahattin Zaim University
name: Züfünaz Özer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06852599: Long-term Outcomes of Implants in Patients with Periodontitis
Official title: Long-term Outcomes of Implants in Patients with Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implant Health
Periodontitis
Peri-implant Mucositis
Peri-implantitis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study cohort is recruited from patients of the Department of Conservative Dentistry at Heidelberg University Hospital who have undergone systematic periodontal therapy, have a dental implant, and meet the other inclusion criteria.

Brief summary: The aim of the study is to examine potential influencing factors on the changes in the periodontal parameters probing pocket depth (PPD), bleeding on probing (BOP), and alveolar bone loss (ABL) on implants and control teeth (using a split-mouth design) over five (T-5), 7.5 (T-7), and ten years (T-10) of supportive periodontal care (SPC). For this purpose, 150 patients with periodontitis and implants are re-examined cross-sectionally (T0), and the changes in the main peri-implant and periodontal target parameters are compared retrospectively at the specified observation time points (T-5, T-7, T-10).

Potential influencing factors to peri-implant conditions include patient-related factors, therapy-related factors and implant-related factors. In addition, patients will be surveyed using validated questionnaires on oral health-related quality of life (OHIP-G14), and a number of common risk factors for periodontits and peri-implant conditions.


Eligibility criteria: Inclusion Criteria:

Patient-related:

* At least one dental implant present
* Age ≥ 18 years at the beginning of the observation period
* Verbal and written consent
* Complete periodontal and dental status at one of the defined observation time points with 6 probing sites per tooth/implant and bleeding on probing (BOP) recorded during the periodontal maintenance phase

Locally:

* a contralateral control tooth to the implant is present at the first defined observation time point
* BOP recorded on the implant

Exclusion Criteria:

* No written and verbal consent
* Younger than 18 years

Primary outcomes:
measure: changes in periodontal pocket depths
timeFrame: over five, 7.5, and ten years of supportive periodontal care
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT05227599: BRAVE: Building Resilience and Values Through E-health
Official title: BRAVE: Building Resilience and Values Through E-health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survivorship
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 56
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the feasibility and acceptability of tracking survivors' and their caregivers, stressors, affect, and symptoms using an electronic diary method, in the time period surrounding their routine check- up with their oncologist.


Eligibility criteria: Inclusion Criteria:

1. 11-25 years old
2. previously received a pediatric cancer diagnosis and treatment for such
3. completed cancer treatment \<5 years ago, in remission
4. Own a smart phone or tablet
5. are English proficient

Exclusion Criteria:

* no cognitive, motor, or sensory deficits that could preclude completion of study measures.

Primary outcomes:
measure: Online survey questionnaire
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Claudia Mueller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: