louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02617121: The Effects of Gabapentin and Ramosetron on Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
Official title: Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.

Detailed description: Postoperative nausea and vomiting (PONV) in the postanesthesia care unit is a common occurrence after general anesthesia. And laparoscopic gynecological surgery is associated with a high incidence of PONV. Several antiemetic agents such as dopaminergic, histaminic and 5-HT3 antagonist (including ondansetron, ramosetron, granisetron) have been used to prevent PONV. Gabapentin, anti-convulsant, has been shown to decrease PONV, as well as chemotherapy induced nausea and vomiting in recent studies, although the exact mechanism against PONV is not known. The purpose of this study was to compare the efficacy of gabapentin and ramosetron in preventing PONV in patients undergoing laparoscopic gynecological surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with ASA physical status 1 and 2 between 20 and 65 years undergoing laparoscopic gynecological surgery with patient-controlled analgesia for postoperative pain control.

Exclusion Criteria:

* Pregnant women
* Patients who took sedatives, antiemetics, hypnotics, analgesics, steroid, or gabapentin
* Patients with neurological deficits
* Patients with history of drug abuse and allergy of study drugs

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: Severity of nausea
timeFrame: 48 hours postoperative
measure: pain score
timeFrame: 48 hours postoperative
measure: sedation score
timeFrame: 48 hours postoperative
measure: patient's overall satisfaction score
timeFrame: 48 hours postoperative
measure: side effects
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Kim KM, Huh J, Lee SK, Park EY, Lee JM, Kim HJ. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study. BMC Anesthesiol. 2017 May 19;17(1):65. doi: 10.1186/s12871-017-0357-8.
Clinical trial NCT05916521: A Three Month Bleeding-Model Clinical Study
Official title: A Three-Month Bleeding-Model Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 90
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: The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 20 gradable teeth;
* Have established gingivitis with 10-70% bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
* Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having known hypersensitivity to the test products;
* Having removable oral appliances;
* Having fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Having any diseases or condition that might interfere with the safe participation in the study;
* Having an inability to undergo study procedures.

Primary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Baseline
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Week 4
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Silverstone Research Group
state: Nevada
Study officials:
References:
Clinical trial NCT04188821: Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
Official title: Reduction of Seroma and Improvement of Quality of Life After Early Drain Removal in Immediate Breast Reconstruction With Tissue Expander. Preliminary Report of a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Quality of Life
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving clinical outcomes and quality of life (QoL). The mechanism of action underlying the proposed approach was intuitive. The early drain removal allows to: 1) avoid continuous seroma development caused by active suction of drain (stopping the circle "drain itself may perpetuate the drainage" with vacuum mechanism); 2) reduce the risks connected to "foreign body reaction" as tissue inflammation and infection; 3) improve QoL reducing pain, length of hospital stay and limitations of daily activities.


Eligibility criteria: Inclusion Criteria:

* SNS (skin nipple sparing) or SS (skin sparing) mastectomy for breast cancer and immediate positioning of breast expander (without mesh) with placement of suction drain, regardless of TNM classification

Exclusion Criteria:

* skin reducing mastectomy, reconstruction with flap, direct to implant reconstruction (with or without mesh or ADM) and axillary dissection

Primary outcomes:
measure: total fluid volume (ml)
timeFrame: 21 days
measure: days with drainage
timeFrame: 21 days
measure: days of seroma formation
timeFrame: 21 days
measure: time until wound healing (days)
timeFrame: 21 days
measure: infection (yes or not)
timeFrame: 21 days
measure: complicated wound healing (yes or not)
timeFrame: 21 days
Secondary outcomes:
measure: pain (using Visual Analogic Score scale to measure intensity)
timeFrame: 21 days
measure: disturbance in quality of sleep (yes or not)
timeFrame: 21 days
measure: limitation in personal care, daily activities and social life (yes or not)
timeFrame: 21 days
measure: disturbance in mobility (yes or not)
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02468921: Goitres Influence on Voice Function - The Impact of Surgery
Official title: The Impact of Surgical Treatment of Benign Non-toxic Goiter on the Voice Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Goiter
Keywords: Goitre
thyroid disease
struma
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2015-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing hemi- or total thyroidectomy at Odense University Hospital for benign symptomatic non-toxic goiter

Brief summary: The aim of the study is to investigate the influence benign non-toxic goitre and the surgical treatment hereof on the voice function before and 6 months following surgery.


Eligibility criteria: Inclusion criteria:

* Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms
* The patients must be able to understand, write and read Danish

Exclusion criteria:

* Previous surgery to the neck
* Diabetes or any neuromuscular disorders.
* Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof.

Primary outcomes:
measure: Number of patients with changed frequency range in voice function following thyroidectomy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Christian Godballe, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02361021: Lung Aeration During WEANing From Mechanical Ventilation Determined by Electrical Impedance Tomography and Lung Ultrasound
Official title: Lung Aeration During WEANing From Mechanical Ventilation Determined by Electrical Impedance Tomography and Lung Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Care
Weaning From Mechanical Ventilation
Electrical Impedance Tomography
End Expiratory Lung Volume
Lung Ultrasound Score
Keywords: Critical Care
Non invasive ventilation
Electrical impedance tomography
End expiratory lung volume
Lung ultrasound score
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Estaing
First posted: 2015-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patients

Brief summary: Evaluation of lung aeration during weaning from mechanical ventilation determined by electrical impedance tomography and lung ultrasound

Detailed description: Prospective clinical study in ICU with patients during weaning from mechanical ventilation comparing lung aeration determined by electrical impedance tomography and lung ultrasound.

Duration of weaning test is 60 minutes.

Eligibility criteria: Inclusion Criteria:

* Adult ICU patients during weaning test from mechanical ventilation
* Consent of patients or family
* Arterial line

Exclusion Criteria:

* Tracheotomized patients
* Dressings in the thoracic area

Primary outcomes:
measure: End-expiratory lung volume (EELV)
timeFrame: at baseline
measure: End-expiratory lung volume (EELV)
timeFrame: at hour 1
Secondary outcomes:
measure: Anterior, medio-anterior, medio-posterior and posterior EELV
timeFrame: at baseline (start of the weaning test)
measure: Lung ultrasound score
timeFrame: at baseline (start of the weaning test)
measure: Anterior, medio-anterior, medio-posterior and posterior EELV
timeFrame: at Hour 1 (end of the weaning test)..
measure: Lung ultrasound score
timeFrame: at Hour 1 (end of the weaning test)..
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
References:
Clinical trial NCT04457921: Deep Tissue Massage on Pain and Comfort After Cesarean
Official title: Effects of Deep Tissue Massage on Pain and Comfort After Cesarean: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Pain, Postoperative
Massage
Comfort
Midwifery
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study to determine the effect of deep tissue massage applied to the back on pain and comfort after cesarean section. Personal information form was used as data collection form, Visual Analog Scala was used to assess pain, and Postpartum Comfort Questionnaire was used to assess comfort.

Detailed description: Material and Method

This research was conducted between May 2019 and November 2019 in Inonu University Turgut Ozal Medical Center Training and Research Hospital. When power analysis was performed, the sample size was calculated to be at least 81 women for each group (81 experiments, 81 controls). Experimental group received deep tissue massage twice at 11st and 23rd hours after cesarean section. Data collection form for experimental and control groups before the first massage; Visual Analog Scala was applied four times before and after both massages. After the second massage, both groups were re-administered. Descriptive statistics and independent t-test were used for data analysis.

Eligibility criteria: Inclusion Criteria:

* Pain severity is 45 mm or more according to the Visual Analogue Scale (VAS),
* Having a single and healthy newborn,
* Does not respond negatively to any attempt to touch like massage,
* Women whose tissue integrity is complete and healthy in the area to be massaged were included in the sample.

Exclusion Criteria:

* Those with cesarean section with general anesthesia,
* Any problems diagnosed before birth and at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
* Any complications related to the mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.),
* Those who received repeat doses other than routine narcotic analgesics (0.5 mg in the first 30 minutes) were not included in the study.

Primary outcomes:
measure: pain scores
timeFrame: at 11st hours cesarean section
measure: pain scores
timeFrame: at 23rd hours cesarean section
Secondary outcomes:
measure: comfort scores
timeFrame: at 23rd hours cesarean section
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: ESRA GUNEY
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simonelli MC, Doyle LT, Columbia M, Wells PD, Benson KV, Lee CS. Effects of Connective Tissue Massage on Pain in Primiparous Women After Cesarean Birth. J Obstet Gynecol Neonatal Nurs. 2018 Sep;47(5):591-601. doi: 10.1016/j.jogn.2018.07.006. Epub 2018 Aug 11.
Clinical trial NCT04636021: Restoring Non-Emergent Cardiovascular Care in the Peri- COVID-19 Era
Official title: Restoring Non-Emergent Cardiovascular Care in the Peri-COVID 19 Era
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corona Virus Infection
Keywords: COVID-19 testing
outpatient procedures
Lead sponsor: Pinnacle Health Cardiovascular Institute
Sponsor class: NETWORK
First posted: 2020-11-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac procedures in the time of COVID- 19

Brief summary: Pre-procedure and Short-Term COVID-19 Testing of Outpatients Undergoing Non-emergent Invasive Cardiovascular Procedures


Eligibility criteria: Inclusion Criteria:

• Outpatients undergoing non-emergent invasive cardiac diagnostic, cardiac interventional, peripheral diagnostic, peripheral interventional, structural heart interventional, electrophysiology diagnostic, ablation, or device implantation procedures

Exclusion Criteria:

* Previous positive COVID-19 test result
* Patients with symptoms concerning for COVID-19, including (but not limited to):

Fever \> 38˚C, shortness of breath and/or cough in greater severity from baseline, sore throat, anosmia / dysgeusia, vomiting/diarrhea within 24 hours prior to procedure

* Emergent status including (but not limited to) acute coronary syndromes, acute limb ischemia, stroke, need of temporary pacemaker
* Non-outpatient status including (but not limited to) patients evaluated in the hospital, observational unit, or emergency department

Primary outcomes:
measure: Number of subjects who contract COVID-19 while hospitalized for elective outpatient procedures
timeFrame: Through 30 day follow up period
Secondary outcomes:
measure: Patient perception of the effect of pre and post procedure COVID-19 testing on risk of contracting COVID-19 while hospitalized for an elective outpatient procedure.
timeFrame: Through 30 day follow up period
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: UPMC Pinnacle Harrisburg
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03770221: Coordinating Access to Care for People Experiencing Homelessness (CATCH-FI)
Official title: Coordinating Access to Care for People Experiencing Homelessness: The Role and Impact of Financial Incentives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2018-12-10
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Coordinating Access to Care for the Homeless (CATCH) initiative is a multidisciplinary brief intervention for homeless adults with mental health needs discharged from hospital in Toronto, Canada. The study aims to evaluate the effect of financial incentives in facilitating treatment engagement of homeless people with mental illness, as well as in improving health, health service use and housing outcomes, compared to usual CATCH care, over 6 months, a critical time of transition from hospital to community care.


Eligibility criteria: Inclusion Criteria:

* able to give informed consent
* a new client of the CATCH team, recently admitted or readmitted
* at least one contact with the CATCH team

Exclusion Criteria:

-

Primary outcomes:
measure: Number of contacts with CATCH service providers
timeFrame: 6 months
Secondary outcomes:
measure: Number of hospitalizations
timeFrame: 1 year prior to enrolment, 1 year post-enrolment
measure: Days in hospital
timeFrame: 1 year prior to enrolment, 1 year post-enrolment
measure: Number of emergency department visits
timeFrame: 1 year prior to enrolment, 1 year post-enrolment
measure: Mental health symptom severity
timeFrame: Baseline, 6 months
measure: Health status
timeFrame: Baseline, 6 months
measure: Working Alliance
timeFrame: 6 months
measure: Substance use
timeFrame: Baseline, 6 months
measure: Housing stability
timeFrame: Baseline, 6 months
measure: Disease-Specific Quality of Life: Lehman Quality of Life scale
timeFrame: Baseline, 6 months
measure: Health-related quality of life: EQ-5D-5L
timeFrame: Baseline, 6 months
measure: Income support
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Vicky Stergiopoulos, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reid N, Nisenbaum R, Hwang SW, Durbin A, Kozloff N, Wang R, Stergiopoulos V. The Impact of Financial Incentives on Service Engagement Among Adults Experiencing Homelessness and Mental Illness: A Pragmatic Trial Protocol. Front Psychiatry. 2021 Aug 3;12:722485. doi: 10.3389/fpsyt.2021.722485. eCollection 2021.
Clinical trial NCT02809521: Increasing Spontaneous Non-exercise Activity (The Sitting Study)
Official title: Increasing Spontaneous Non-exercise Activity (The Sitting Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2016-06-22
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to see if one's liking and awareness of different types of activities is related to one's activity pattern.


Eligibility criteria: Inclusion Criteria:

* Sedentary lifestyle

Exclusion Criteria:

* 5% weight loss within the past 2 months
* Active job or lifestyle
* Participation in an exercise program
* Pregnant and/or lactating
* Uncontrolled hypertension
* Alcohol or drug abuse
* Presence of acute illness
* Major limitation of physical movement

Primary outcomes:
measure: Change in liking of activity
timeFrame: Baseline, week 1, week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Shanon Casperson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05165121: Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids
Official title: Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: MDHearingAid
Sponsor class: INDUSTRY
Collaborators: name: Central Michigan University
First posted: 2021-12-21
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hearing aids are commonly used to help people with hearing loss hear better in daily listening environments. MDHearing Smart hearing aids are designed to use the MDHearing app to adjust hearing aids to each individual's hearing loss. This study intends to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve good aided benefit, which will be compared to those fitted by audiology professionals. This study includes three components: human factor study, self-fit study, and professional-fit study. The information obtained will be useful for both audiology professionals and people with impaired hearing.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* At least one air conduction threshold above 15dB HL.
* All air conduction thresholds must be under 60dB HL

Exclusion Criteria:

* Signs of outer or middle ear pathology
* Greater than 60db HL hearing loss at any frequency.

Primary outcomes:
measure: Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale.
timeFrame: 1 month
measure: Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Mount Pleasant
country: United States
facility: Central Michigan University
state: Michigan
Study officials:
affiliation: Central Michigan University
name: Yunfang Zheng, Sc.D. CCC-A
role: PRINCIPAL_INVESTIGATOR
References: