louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02248935: Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy
Official title: Prospective Cohort Study Comparing Two Lightweight Y Meshes After Robotic-Assisted Laparoscopic Sacrocolpopexy Longterm Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Robotic Assisted Laparoscopic Sacrocolpopexy
Y Mesh
Pelvic Organ Prolapse
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 316
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who had a robotic-assisted laparoscopic sacrocolpopexy using either mentioned Y-mesh during the listed timeframe. All of the index cases were performed by fellowship-trained FPMRS specialists.

Brief summary: The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh

Exclusion Criteria:

* Refusal to participate in our long-term outcome study

Primary outcomes:
measure: Clinical Cure Rate
timeFrame: 5-6 years
Secondary outcomes:
measure: Objective Anatomic Outcome
timeFrame: 5-6 year
measure: Mesh exposure/erosion
timeFrame: 5-6 years
measure: Complications
timeFrame: 5-6 years
measure: Symptom Comparison
timeFrame: 5-6 years
measure: Surgical Satisfaction
timeFrame: 5-6 years
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Department of Urogynecology-Atlantic Health System
state: New Jersey
Study officials:
References:
citation: Culligan PJ, Lewis C, Priestley J, Mushonga N. Long-Term Outcomes of Robotic-Assisted Laparoscopic Sacrocolpopexy Using Lightweight Y-Mesh. Female Pelvic Med Reconstr Surg. 2020 Mar;26(3):202-206. doi: 10.1097/SPV.0000000000000788.
Clinical trial NCT03039335: The Impact of Delayed Diagnosis of Alpha-1 Antitrypsin Deficiency
Official title: The Impact of Delayed Diagnosis of Alpha-1 Antitrypsin Deficiency: Assessing the Association Between Diagnostic Delay and Worsened Clinical Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alpha 1-Antitrypsin Deficiency
Lead sponsor: Biocerna LLC
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AATD Positive Adult Subjects

Brief summary: The objective of this study is to prospectively assess whether there is any interval between first symptom and initial diagnosis that is experienced by patients with newly diagnosed alpha-1 antitrypsin deficiency (AATD) and then to assess whether this diagnostic interval is associated with worsened clinical status at the time of initial diagnosis.

Detailed description: The study protocol proposes to assess participants' clinical status based on the results of spirometry tests that are performed by the patient's managing physician as a routine part of clinical care of individuals with AATD within +/- 6 months of the initial diagnosis, subjects' St. George's Respiratory Questionnaire (SGRQ) at the time of initial diagnosis, and their COPD Assessment Test (CAT) result at the time of initial diagnosis of AATD (hereafter called "time zero" or T0 defined as the day on which the patient's test shows AATD from the blood work submitted for testing to Biocerna LLC by the patients' managing physicians as part of their routine clinical management). After offering verbal consent, subjects will complete a survey that assesses various clinical domains, including demographic features, how was AATD ascertained, initial symptom ascribable to AATD, the number of healthcare providers (and specific types of providers) seen before initial diagnosis, and clinical status at T0 or within a defined, relatively narrow temporal window (+/- 6 months) of T0. As in prior studies, the diagnostic interval will be defined as the duration between self-reported initial symptom of AATD (usually dyspnea in \> 80% of cases3) and initial confirmed diagnosis of AATD (T0).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Positive AATD Test Result

Exclusion Criteria:

* Previous Positive AATD Test Result
* Negative Test Result for AATD

Primary outcomes:
measure: Recruitment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fulton
country: United States
facility: Biocerna LLC
state: Maryland
Study officials:
affiliation: CEO of Biocerna LLC
name: Christopher Sanders
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06954935: Periorbital Massage for Nausea and Vomiting After Laparoscopic Surgery
Official title: Effectiveness of Periorbital Massage in the Management of Nausea and Vomiting After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nausea
Vomiting
Laparoscopic Cholecystectomy
Keywords: nausea
voming
periorbital massage
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laparoscopic cholecystectomy is one of the commonly used surgical treatment methods for gallbladder diseases. However, many patients experience significant nausea and vomiting after laparoscopic cholecystectomy. It is observed that approximately 20% to 30% of patients experience postoperative nausea and vomiting as the most common complaint after laparoscopic cholecystectomy. This study aims to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.

Detailed description: This study aimed to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. One group received periorbital massage, while the other group did not receive massage.

Eligibility criteria: Inclusion Criteria:

Those who have laparoscopic cholecystectomy surgery under general anesthesia,

* Those between the ages of 18-70,
* Those who do not have a psychiatric disease,
* Those who understand what they read and volunteer patients,
* Those who do not have a hearing or speech problem,

Exclusion Criteria:

* Patients undergoing emergency surgery,

  * Patients with psychiatric disorders
  * Patients who have taken another antiemetic drug within 24 hours before surgery

Primary outcomes:
measure: Apfel risk score
timeFrame: It will be filled half an hour before you go down for surgery.
measure: Numerical Scale of Nausea
timeFrame: 0, 2, 6, 12 and 24 hours after surgery
measure: Postoperative Nausea and Vomiting Impact Scale
timeFrame: 0, 2, 6, 12 and 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Tuğba Albayram
Study officials:
References:
Clinical trial NCT06806735: Measuring the Volumes of Hypertrophic Scars and Keloids, Two Specific Kind of Scars, Over Different Points in Time in Patients Who Have Undergone Surgery and Evaluate 3D-cameras As a Possible Measuring and Documenting Tool Including Volumetry
Official title: Quantification of Hypertrophic Scar Tissue or Keloid Using a 3D-Camera
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Keloid Scar Following Surgery
Scars, Hypertrophic
Scar Keloid
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypertrophic scars or keloids of the University Hospital Zurich

Brief summary: Measuring the volumes of hypertrophic scars and keloids, two specific kind of scars, over different points in time in patients who have undergone surgery and evaluate 3D-cameras as a possible measuring and documenting tool including volumetry.

Detailed description: The objective of this study is to utilize a 3D camera to measure the volumes of hypertrophic scars and keloids in patients at specified time points. The time points for measurement include day 0, as well as 3, 6, and 12 months. The 3D camera will be evaluated for their efficacy in measuring and documenting the volumes of the scars. This evaluation will include volumetry, which is the measurement of the three-dimensional space occupied by an object.

Eligibility criteria: Inclusion Criteria:

* All patients with hypertrophic scars or keloids, written consent to participate in the study, minimum age of 18 years.

Exclusion Criteria:

* Absence of written consent, unwillingness to contribute data, inability to understand the study protocol.
* lack of hypertrophic scars or keloid

Primary outcomes:
measure: Measurability
timeFrame: Day 0, Month 3, 6 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
References:
Clinical trial NCT01669135: Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery
Keywords: cerebral oximetry
cesarean delivery
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.


Eligibility criteria: Inclusion Criteria:

* Term healthy parturients

Exclusion Criteria:

* Body Mass Index \> 35
* preeclampsia
* neurological,cardiovascular, respiratory disease

Primary outcomes:
measure: cerebral oxygen saturation of the right frontal lobe
timeFrame: Change from the performing of spinal anesthesia untill 1 minute after delivery
Secondary outcomes:
measure: cerebral oxygen saturation of the left frontal lobe
timeFrame: 5, 10, 50 min after spinal,1 minute after delivery
measure: Thigh oxygen saturation
timeFrame: 5, 10, 50 min after spinal, 1 minute after delivery
measure: Arterial Oxygenation
timeFrame: 5, 10, 50 min after spinal, 1 minute after delivery
Other outcomes:
measure: Hemodynamic changes (Changes in Blood Pressure (mmHg) and Heart rate (beats/min)
timeFrame: 5, 10, 50 min after spinal, 1 minute after delivery
Locations:
city: Athens
country: Greece
facility: Department of Anesthesiology, Aretaieio Hospital
Study officials:
References:
citation: Fassoulaki A, Paraskeva A, Tsaroucha A. Cesarean delivery under spinal anesthesia is associated with decreases in cerebral oxygen saturation as assessed by NIRS: an observational study. Curr Med Res Opin. 2014 Mar;30(3):331-7. doi: 10.1185/03007995.2013.852526. Epub 2013 Nov 8.
Clinical trial NCT00803335: The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse
Official title: The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Vaginal Atrophy
Keywords: pelvic organ prolapse
vaginal atrophy
atrophic vaginitis
postmenopausal
posthysterectomy
vaginal health
vaginal cytology
vaginal maturity index
vaginal histology
quality of life questionnaires
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 54
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

Detailed description: Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Women aged 45 years or older
* Postmenopausal (\>55 if natural menopause)
* Clinical atrophic vaginitis (at least mild atrophy)
* Pelvic organ prolapse(at least stage 2 or greater)
* Posthysterectomy
* Surgery date between 2-12 weeks after recruitment

Exclusion Criteria:

* Uterus present
* Well-estrogenized appearing vagina
* Known or suspected history of breast carcinoma
* Hormone-dependent tumor
* Genital bleeding of unknown cause
* Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
* Vaginal infection requiring treatment
* Allergy to estrogen or its constituents
* Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.
* Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment
* Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)

Primary outcomes:
measure: Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.
timeFrame: baseline and 2-12 weeks after treatment (at time of surgery)
Secondary outcomes:
measure: Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.
timeFrame: baseline and 2-12 weeks after treatment (at time of surgery)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
state: Ohio
Study officials:
affiliation: Good Samaritan Hospital
name: Christine M Vaccaro, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04664335: Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study
Official title: Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Pregnancy Complications
Delivery Complication
Complication
Miscarriage
Keywords: endometriosis
pregnancy
delivery
miscarriage
cesarian section
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 1762
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016

Brief summary: Purpose:

To study the impact of endometriosis on subsequent pregnancy and delivery.

Methods:

retrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016; analysis of pregnancy rate, mode of delivery and complications using Clavien-Dindo-classification, role of deep infiltrating endometriosis using ENZIAN classification; data analysis using t-test with p \< 0.050% being considered significant.


Eligibility criteria: Inclusion Criteria:

* cases: Operation because of endometriosis at the endometriosis Center, University Hospital Muenster, child wish, wants to participate, correct age group
* controls: Operation because of sterility, exclusion of endometriosis during this Operation, child wish, wants to participate, correct age group

Exclusion Criteria:

* cases / controls: declines participation, incorrect age Group, no child wish

Primary outcomes:
measure: pregnancy rate
timeFrame: through study completion, an average of 1 year
measure: complications
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster Germany
state: NRW
Study officials:
affiliation: University Hospital Muenster, Germany
name: Sebastian D Schaefer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01614535: Comparison of the Effect Site Concentration of Remifentanil for Preventing Cough During Emergence Between Male and Female Patients With Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Thyroidectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 46
Sex: ALL
Minimum age (years): 25
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The clinical studies demonstrate more powerful analgesic effect among female to both μ- and κ-opioid agonist (Fillingim et al. 2004). The antitussive effect of opioid is mediated predominantly by μ-, κ-opioid receptors (Kamei J. 1996). Therefore, the investigators hypothesized that there are sex differences in the antitussive responses to opioid.

It has been reported that target-controlled infusion (TCI) of remifentanil can reduce cough against endotracheal tube during emergence from general anesthesia. Some studies, reporting the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in different sex and surgeries (B. Lee et al. 2009, E.M.Choi et al. 2012), showed differences in EC50 and EC95.

The purpose of this study was to find out EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in each sex and to evaluate whether there were sex differences in EC50 and EC95 of remifentanil in effect-site TCI or not.


Eligibility criteria: Inclusion Criteria:

* aged 20-46
* ASA classification I\~II
* patients undergoing thyroidectomy

Exclusion Criteria:

* patient who has signs of a difficult airway
* patient who has smoking history
* patient who has upper respiratory infection or sore throat in the previous two weeks
* patient who has hypertension, DM
* female patients who were pregnant, breast-feeding or menopausal

Primary outcomes:
measure: occurrence of cough
timeFrame: 20 minutes after sevoflurane off
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine
Study officials:
affiliation: Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine
name: Wyun Kon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03200535: Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
Official title: Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 6588
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals with a body mass index between 25 and 30 are randomized 1:1 to the Usual Care or EHR Gap arms. Individuals with a body mass index \>=30 are randomized to all 4 arms, with n=1000 for the Personalized Outreach arm and 1:1:1 for the other three arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser Permanente Colorado members in these activities is low. The purpose of this study is to determine which of three outreach methods is most effective in increasing engagement in these activities.


Eligibility criteria: Inclusion Criteria:

* Kaiser Permanente Member
* Age 18-75
* Prediabetes
* BMI \>= 25
* A1c 6.1-6.4%
* No dietitian visit within the past 3 years

Exclusion Criteria:

- Pregnancy

Primary outcomes:
measure: Enrollment in Diabetes Prevention or Weight Management Class (Online)
timeFrame: 4.5 months (6/26/2017-11/10/2017)
Secondary outcomes:
measure: Enrollment in Diabetes Prevention or Weight Management Class (in Person)
timeFrame: 4.5 months (6/26/2017-11/10/2017)
Other outcomes:
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Coloado
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Emily Schroeder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: