louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04804826: Same Day Discharge Following Pelvic Reconstructive Surgery
Official title: Patient's Perceptions Regarding Same Day Discharge Following Pelvic Reconstructive Surgery: What do They Want Other Patients to Know?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Same Day Discharge
Pelvic Organ Prolapse
Total Vaginal Hysterectomy
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent a total vaginal hysterectomy with concurrent vaginal native tissue prolapse repairs, including an apical suspension procedure performed by one of the fellowship trained urogynecologists at TriHealth.

Brief summary: This is a prospective cross-sectional study in which patients undergoing major pelvic reconstructive surgery with total vaginal hysterectomy will be recruited and enrolled. At approximately 2 weeks and 12 weeks postoperatively, enrolled patients will be asked to complete a survey detailing their experience with SDD, surgical recovery, and advice for prospective patients.


Eligibility criteria: Inclusion Criteria:

* Total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy
* Apical repair with uterosacral ligament suspension or sacrospinous ligament fixation
* They may also have any of the following concurrent procedures: Anterior repair, Posterior repair, Enterocele repair, Suburethral sling for incontinence
* Surgery by one of the fellowship trained urogynecologists at TriHealth
* English speaking

Exclusion Criteria:

* Enrollment in the "Diazepam Research Study" (Protocol ID:19-130)
* Concomitant procedure with another surgeon
* Chronic pain conditions that require daily use of narcotic pain medications (including but not limited to: chronic back or pelvic pain, interstitial cystitis, fibromyalgia)
* Concomitant anal sphincteroplasty, mesh removal or use of mesh for prolapse (excluding sling procedures)

Primary outcomes:
measure: Number of subjects who satisfied with the results of the surgery
timeFrame: Approximately 2 weeks postoperatively
Secondary outcomes:
measure: Number of subjects who satisfied with the results of the surgery
timeFrame: Approximately 12 weeks postoperatively
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lloyd JC, Guzman-Negron J, Goldman HB. Feasibility of same day discharge after robotic assisted pelvic floor reconstruction. Can J Urol. 2018 Jun;25(3):9307-9312.
citation: Evans S, Myers EM, Vilasagar S. Patient perceptions of same-day discharge after minimally invasive gynecologic and pelvic reconstructive surgery. Am J Obstet Gynecol. 2019 Dec;221(6):621.e1-621.e7. doi: 10.1016/j.ajog.2019.06.046. Epub 2019 Jun 27.
Clinical trial NCT01008826: Cross-Over Broccoli Sprouts Trial
Official title: Cross-Over Broccoli Sprouts Trial - Qidong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: sulforaphane
pharmacokinetics
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Qidong Liver Cancer Institute
First posted: 2009-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study hypothesis tested is that broccoli sprouts are effective at altering the urinary levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the biomarkers.


Eligibility criteria: Inclusion Criteria:

* Adults aged 25-65 in good general health with no history of a chronic illness
* normal liver function tests (ALT, AST, bilirubin)
* normal renal function tests (creatinine, BUN, urinalysis)
* serum alpha-fetoprotein negative

Exclusion Criteria:

* personal history of cancer, except for non-melanoma skin cancer
* use of prescribed medications
* hepatomegaly by clinical exam
* unwillingness to avoid cruciferous vegetable consumption for the duration of the study
* for women, a positive pregnancy test.

Primary outcomes:
measure: Urinary levels of glucoraphanin or sulforaphane and metabolites.
timeFrame: Endpoints will be assessed on urine samples collected daily during the intervention.
Secondary outcomes:
measure: Urinary levels of aflatoxin-DNA adducts and mercapturic acids as well as mercapturic acids of air-borne pollutants
timeFrame: Endpoints will be assessed on urine samples collected daily during the intervention.
Other outcomes:
Locations:
city: Qidong
country: China
facility: Qidong Liver Cancer Institute
state: Jiangsu
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Thomas W Kensler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04401826: Micro-surgical Treatment of Gummy Smile
Official title: Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 24
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: Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.

Detailed description: The conventional approach: Anesthesia will be given followed by bone sounding using William graduated periodontal probe and measuring the pocket depth (using magnification loupes and microsurgical blades)

* Marking the bleeding points
* An internal bevel incision is made followed afterwards by a sulcular incision.
* The gingival collar is eliminated.
* Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery and an apical position of the bone 2-3mm beyond CEJ.
* Mattress suture (6.0) is made

The intervention approach:

Surgery is done the same as in the conventional approach but without opening a flap, gaining access via a tunneling instrument and piezo tips for osteoplasty

Eligibility criteria: Inclusion Criteria:

1. Patients with healthy systemic condition.
2. Adult patients ˃ 18 years old.
3. The presence of the six upper anterior teeth.
4. Patients who have short clinical crowns due to altered passive eruption classified as Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977).
5. Absence of sites with attachment loss and probing depth (PD) \>3 mm.
6. Keratinized gingiva of at least 2mm width (Pontoriero and Carnevale, 2001).
7. Compliance with good oral hygiene.
8. Patients accepts 6-months follow-up period (cooperative patients).
9. Patients provides an informed consent.

Exclusion Criteria:

1. Presence of prosthetic crowns
2. Extensive restorations
3. Extensive incisal edge attrition.
4. Smokers ˃ 10 cigarettes / day
5. Pregnant females

Primary outcomes:
measure: Pain VAS
timeFrame: 48 hours
Secondary outcomes:
measure: Mid-buccal gingival margin level
timeFrame: 6 months
measure: Post-Surgical Patient Satisfaction.
timeFrame: 6 months
measure: Pink Esthetic Score
timeFrame: 6 months
measure: Post-Surgical swelling
timeFrame: 14 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medecine-CU
Study officials:
References:
Clinical trial NCT04816526: Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Official title: Phase 2 Study of Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Myeloma Multiple
Lead sponsor: Cartesian Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess Minimal Residual Disease (MRD)-negative Complete Response (sCR) rate after consolidation treatment with Descartes-08 in patients with high-risk myeloma who have residual disease following induction therapy.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older at the time of enrollment
* High-risk multiple myeloma patients who complete pre-transplant induction treatment anti- myeloma drug combination (minimum 2 drugs).

Exclusion Criteria:

* Patients who are pregnant or lactating.
* Patients who have any active and uncontrolled infection. No blood cultures are necessary unless clinically indicated.

Primary outcomes:
measure: Rate of Stringent Complete Response
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Nashville
country: United States
facility: Sarah Cannon Research Institute at Tennessee Oncology
state: Tennessee
Study officials:
References:
Clinical trial NCT01900626: Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery
Official title: Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 2
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study comparing pain control utlilizing one or two epidural catheters, along with a hydromorphone PCA, for analgesia following surgery for correction of scoliosis.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing surgery via a posterior approach for AIS
2. Children ages 11-18
3. ASA physical status 1-2
4. Informed consent by legal guardian and assent by patient (for minors 11-17 years of age) or informed consent by subject (for patients 18 years of age)
5. Planned correction of at least 8 vertebral levels

Exclusion Criteria:

1. Patient refusal to participate
2. Patients on chronic narcotic medication
3. Allergy to standard of care drugs used in the study (Omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam)
4. Coagulopathy
5. Pre-existing neurological deficit
6. Inability to use a Numerical Rating Scale (NRS: 0-10 patient self-reported score) for pain assessment

Primary outcomes:
measure: Pain Scores With Activity
timeFrame: 72 hours
Secondary outcomes:
measure: Pain Scores at Rest
timeFrame: 72 hours
measure: Opioid Usage
timeFrame: 72 hours
measure: Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score
timeFrame: 3 months
measure: Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire
timeFrame: 3 months
measure: Functional Outcomes: The Owestry Disability Index(ODI)
timeFrame: 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
Study officials:
References:
Clinical trial NCT03173326: Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
Official title: Randomized Controlled Trial Evaluating Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Arthroscopy
General Anesthesia
Subarachnoid Block
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 1
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.

Detailed description: The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl. The study evaluates pain scores, opioid utilization and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patients with ASA physical status classification of I, II, or III
* Patients without a current diagnosis of chronic pain or chronic opioid use for \> 1-month prior to knee arthroscopy
* Patients who are scheduled to undergo unilateral knee arthroscopy
* Patients do not have a contraindication to receiving regional anesthesia

Exclusion Criteria:

* Preexisting sensory or motor deficit in operative extremity
* Patients with a contraindication to general anesthesia
* Patient undergoing meniscal or ligamentous repair

Primary outcomes:
measure: Pain score
timeFrame: Discharge from post anesthesia care unit (PACU) (usually one hour)
measure: Pain score
timeFrame: Post operative day one
measure: Pain score
timeFrame: One month postoperatively
measure: Pain score
timeFrame: Three months postoperatively
measure: Opioid utilization
timeFrame: Surgical completion to PACU discharge (usually one hour)
measure: Opioid utilization
timeFrame: Postoperative day one
measure: Opioid utilization
timeFrame: One month postoperatively
measure: Opioid utilization
timeFrame: Three months postoperatively
Secondary outcomes:
measure: Patient satisfaction with anesthetic
timeFrame: 24 hours after PACU discharge
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jenna Walters, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04712526: Endostapler Gastric Bypass Study
Official title: Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Lead sponsor: Lexington Medical Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 0
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: 25 subjects

Brief summary: The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.

Detailed description: Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
* Informed consent for study obtained and signed from each subject

Exclusion Criteria:

* Planned open surgical approach
* Use of staple line reinforcement material (buttress)
* Revision or other bariatric procedure
* Patients with a bleeding disorder: known coagulopathy, or Platelets \<100,000, or PTT \> 45sec, or PT\> 15sec, or INR\>1.5
* Patients with active HIV or Hepatitis B
* Patients under the age of 18 on the date of the surgery
* Patients who are pregnant
* Patients using tobacco products within the last 2 weeks prior to surgery date
* Patients using cortisone or related products within the last 2 weeks prior to surgery date

Primary outcomes:
measure: Incidence of reported device-related adverse events
timeFrame: Within 30-day post-operative period
Secondary outcomes:
measure: Endoscopic staple line bleeding
timeFrame: Within surgery
measure: Laparoscopic staple line bleeding
timeFrame: Within surgery
measure: Incidence of intraoperative or postoperative blood transfusion
timeFrame: Within 72 hours of surgery start time
measure: Incidence of product malfunction
timeFrame: Within surgery
Other outcomes:
Locations:
city: Holyoke
country: United States
facility: Holyoke Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT06884826: Evaluation of Desarda Technique in Management of Complicated Inguinal Hernia
Official title: Evaluation of Desarda Technique in Management of Complicated Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Desarda
Complicated
Inguinal Hernia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the desarda technique in management of complicated inguinal hernia.

Detailed description: Desarda technique is one of the best surgical methods suitable for emergency hernia surgery repair, but there is still limited consensus. The purpose of this study is to assess the Long-term outcome of the pure tissue Desarda technique for the treatment of emergency inguinal hernias repair (Incarcerated, Irreducible, and Obstructed Patients) regarding Postoperative Complications, Groin Pain, and recurrence rate.

Surgical techniques for emergency inguinal hernia surgery remain an important less documented area. Emergency inguinal hernia can have different presentations. Incarceration is characterized by the irreducibility of contents and strangulation by the compromise of the blood supply of the contents (e.g., bowel, omentum).

Eligibility criteria: Inclusion Criteria:

* Age above 14 years old.
* Irreducible, incarcerated \& obstructed inguinal or inguinoscrotal hernia; unilateral or bilateral

Exclusion Criteria:

* Recurrent Hernias.
* Intra-operative finding of separated thin and/or weak external oblique aponeurosis.

Primary outcomes:
measure: Incidence of postoperative complications
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Stop of postoperative analgesic
timeFrame: 6 days postoperatively
measure: Incidence of recurrence
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT02658526: Cognitive Changes in Childs After Anesthesia / Surgery
Official title: Role of Anesthesia / Surgery on Cognitive Function in Child
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Behavioral
Keywords: cognition
anesthesia
surgery
stress
child
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort study - children \<3 years

Brief summary: The role of surgical stress and anesthesia is unknown in the early childhood. In vitro and animal studies showed a risk for treatment with anesthesia in the developmental brain. Furthermore, stress is also an important risk factor for cognitive impairment. Therefore, the investigators want to investigate in a clinical prospective cohort study the role anesthesia and surgery on different cognitive parameters and self-controling mechanisms in children under 3 years.

Detailed description: In order to investigate the role of anesthesia and / or surgery on cognitive abilities the investigators want to perform a prospective cohort study in children under 3 years. Three groups should be compared: i) control without anesthesia / surgery, ii) children with only anesthesia, and iii) children with both surgery and anesthesia. All children will be investigate before and after intervention. Different behavioral scales will be used for detailed cognitive abilities and self-regulatory skills.

Eligibility criteria: Inclusion Criteria:

* Age 9 month to 3 years with or without anesthesia / surgery

Exclusion Criteria:

* Psychiatrical, neurological, oncological diseases

Primary outcomes:
measure: Global cognitive abilities
timeFrame: 4-6 weeks
measure: Global cognitive abilities
timeFrame: 4-6 weeks
measure: Global cognitive abilities
timeFrame: 4-6 weeks
measure: Global cognitive abilities
timeFrame: 4-6 weeks
Secondary outcomes:
measure: surgery-associated data
timeFrame: 1 - 3 days
measure: surgery-associated data
timeFrame: 1 day
measure: surgery-associated data
timeFrame: 1 day
measure: surgery-associated data
timeFrame: 1 day
measure: surgery-associated data
timeFrame: 1 day
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School
state: BW
Study officials:
References: