louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05233527: Novosyn® Quick in Patients Undergoing Episiotomy Closure
Official title: Observational, Retrospective, Monocentric Clinical Study on the Safety of Novosyn® Quick in Women With a Spontaneous Vaginal Delivery Who Required an Indicated Episiotomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Episiotomy Wound
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2022-02-10
Enrollment: 300
Sex: FEMALE
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: women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.

Brief summary: Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.

Detailed description: The study design is a retrospective, consecutive series of women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.

All women treated with Novosyn® Quick between January 2020 - December 2020 at the Hospital General de Catalunya will be analyzed. The investigator team will access medical records for the cohort of patients identified.

Eligibility criteria: Inclusion Criteria:

* Women who underwent an indicated episiotomy between January 2020 - December 2020 at the Hospital General de Catalunya (Sant Cugat del Vallès, Spain) and received Novosyn® Quick

Exclusion Criteria:

* No exclusion criteria have been set

Primary outcomes:
measure: Wound dehiscence rate
timeFrame: up to 1 month postpartum
Secondary outcomes:
measure: Rate of Re-suturing
timeFrame: up to 1 month postpartum
measure: Rate of Suture removal due to wound problems
timeFrame: up to 1 month postpartum
measure: Surgical Site Infection rate
timeFrame: up to 1 month postpartum
measure: Bleeding
timeFrame: up to 1 month postpartum
measure: Hematoma
timeFrame: up to 1 month postpartum
measure: Abscess formation
timeFrame: up to 1 month postpartum
measure: Rectovaginal fistula
timeFrame: up to 1 month postpartum
measure: Short-term perineal pain (VAS)
timeFrame: after 48 hours postpartum
measure: Long-term perineal pain (VAS)
timeFrame: up to 1 month postpartum
measure: Short-term Pain in daily living (VAS)
timeFrame: 24-48 hours postpartum
measure: Long-term Pain in daily living (VAS)
timeFrame: up to 1 month postpartum
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: IDC Hospital General de Catalunya
state: Catalunya
Study officials:
References:
Clinical trial NCT04003727: Glottic Visualisation During Laryngoscopy
Official title: The Effect of Head Position on Glottic Visualisation and Intubation Success With Videolaryngoscope in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this study, we aimed to investigate the effects of head and neck positions on the visualization of glottis and the success of intubation during videolaryngoscopy in obese patients.

Detailed description: Tree different head and neck positions will compare for glottic visualization and intubation success rates in obese patients (BMI\> 30 kg / m2) who required endotracheal intubation for general anesthesia between 18-65 years of age.

Eligibility criteria: Inclusion Criteria:

* Being 18-65 aged
* Being obese
* Undergoing surgery under general anesthesia

Exclusion Criteria:

* Having difficult airway
* Being American Society of Anesthesiologist (ASA) 4 physical status
* Undergoing emergency surgery

Primary outcomes:
measure: Glottic view
timeFrame: During laryngoscopy
measure: Intubation Success
timeFrame: During intubation
Secondary outcomes:
measure: Intubation difficulty
timeFrame: During Laryngoscopy
measure: Intubation time
timeFrame: During Intubation
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Hospital
state: Merkez
Study officials:
affiliation: Tokat Gaziosmanpasa University
name: Tugba Karaman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04515927: To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
Official title: An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipemia
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 31
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.

Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent.
2. Age ≥12 and ≤75 years old;
3. Weight ≥40kg at the time of screening
4. Patients diagnosed with HoFH
5. Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
6. Fasting triglycerides ≤4.5 mmol/L;

Exclusion Criteria:

1. History of NYHA class III-IV heart failure or EF\<30%
2. History of uncontrolled arrhythmia within 3 months
3. History of MI,UA, PCI or CABG, stroke within 3 months.
4. History of DVT or pulmonary embolism within 3 months.
5. Planned cardiac surgery or revascularization.
6. Uncontrolled hypertension.
7. Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
8. Other conditions that the researchers considered inappropriate to participate in the study.

Primary outcomes:
measure: The primary endpoint of effectiveness
timeFrame: JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT02179827: Performance of Non-Invasive Monitors During ANH
Official title: The Evaluation of Minimally Invasive Hemodynamic Monitors for the Assessment of Volume Responsiveness to Various Standard Replacement Fluids During Acute Normovolemic Hemodilution
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Baseline
Hemodilution
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective procedures requiring normovolemic hemodilution

Brief summary: The aim of this study is to assess the responsiveness of the standard minimally invasive hemodynamic monitors used in the operating room to known changes in the intravascular volume status that occur during blood removal and volume replacement with three different standard fluids used during ANH.


Eligibility criteria: Inclusion Criteria:

* Those surgical procedures where ANH is included in the surgical plan and consent is obtained

Exclusion Criteria:

* Severe or symptomatic COPD, emphysema, renal, hepatic or coronary artery disease as defined by the American College of Cardiology (Cannon et al., 2001).
* Esophageal pathology (diverticulum, hiatal hernia, esophageal cancer, esophageal surgery), which introduces risks associated with the placement of the esophageal Doppler.
* Ascites.
* BMI \>35
* Pregnancy

Primary outcomes:
measure: Change in cardiac output
timeFrame: Baseline (Supine) Volume Replaced (S/P ANH)
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
Study officials:
References:
Clinical trial NCT01736527: Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation
Official title: Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% at 6, 9, 12, and 24 Hours Following a Single Instillation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Subjects must have a best-corrected visual acuity of 20/20 or better in each eye.
* Subjects must have no active ocular disease or allergic conjunctivitis.
* Subjects must have a Schirmer test (without anesthesia) of ≥ 10mm in 5 minutes.
* Subjects must not be using any topical ocular medications or systemic medication other than acetaminophen.
* Male subjects or female subjects who are not of childbearing potential. Female subjects are considered to not be of childbearing potential if they are postmenopausal for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)

Exclusion Criteria:

* Subjects having an intraocular pressure less than 5 mmHg or greater than 22 mmHg or any type of glaucoma.
* Subjects with a history of ocular trauma, infection, or inflammation within the last 3 months.
* Subjects having any contraindication to the use of, or known sensitivity or allergy to, the study drug(s) or their components.
* Subjects wearing contact lenses on the day of Visit 2 and/or Visit 3 of the study
* Subjects having, at the Investigator's discretion, the presence of any significant illness that could be expected to interfere with the study.

Primary outcomes:
measure: Tear Fluid Levels
timeFrame: 6 hours
measure: Tear Fluid Levels
timeFrame: 9 hours
measure: Tear Fluid Levels
timeFrame: 12 hours
measure: Tear Fluid Levels
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Research Clinic
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jeffery Schafer, OD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Bausch & Lomb Incorporated
name: Raphaele Siou Mermet, MD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06083727: Primary Cesarean Section in Primigravida and Muligravida in Sohag and Al Balyana Cities
Official title: Primary Cesarean Section in Primigravida and Muligravida in Sohag and Al Balyana Cities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Cesarean Section
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all primigravida with gestational age more than 28 weeks and above who have come for delivery

* multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery
* women between 18 and 45 years

Brief summary: cesarean section and vaginal delivery are two methods of delivery, cesarean section somtimes indicated for obstetrical reason but primary cesarean section especially in primigravida might have a preference of the mode of delivery


Eligibility criteria: Inclusion Criteria:

* all primigravida with gestational age more than 28 weeks and above who have come for delivery
* multigravida upto gravida 4 with gestational age more than 28 weeks and above who has had one previous viable vaginal delivery
* women between 18 and 45 years

Exclusion Criteria:

* primigravida women \<28 weeks
* multigravida \<28 weeks
* patient having previous history of myomectomy or hystrotomy
* gravida 5 and more

Primary outcomes:
measure: rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
Clinical trial NCT05574127: A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Official title: Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Survivorship
Keywords: Older Adult Cancer Survivors
history of cancer
22-248
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)


Eligibility criteria: Inclusion Criteria:

* As per self-report or medical record, ≥65 years old
* As per self-report or medical record, has a history of cancer
* As per medical record and/or clinician confirmation:

  * a patient in MSK Survivorship Clinics AND/OR
  * no evidence of disease (NED) AND/OR
  * 6 months or more post-treatment (patients on maintenance hormonal therapies are eligible)
* Fluent in English, as per self-reported fluency of "well" or "very well"\*
* As per self-report, able to communicate over video-conference and/or phone for sessions
* Elevated score on the PHQ-9: ≥5 (N/A for Training Case participants)
* Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for Training Case participants)

Exclusion Criteria:

* As per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of \> 0 on item 9 of the PHQ-9, they will be referred to study PI for further evaluation. They will be excluded from participation in this study if the PI determines they would be appropriate for a higher level of care than BA may be able to provide.
* As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
* As per self-report or medical record, currently taking antidepressant medication for \< 3 month
* As per medical record, patient has impaired decision-making capacity

Primary outcomes:
measure: Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups
timeFrame: 2 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Rebecca Saracino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04968327: Micro-osteoperforations on the Rate of Canine Retraction
Official title: Effect of Micro-osteoperforations on the Rate of Canine Retraction; A Split-mouth Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split-mouth
Primary purpose: TREATMENT

Brief summary: the study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction.

Detailed description: Ten adult patients requiring maxillary first premolars' extraction were enrolled in this split-mouth randomized controlled clinical trial.

Micro-osteoperforations were randomly assigned to one side of the maxillary arch at the canine-premolar region, and the contralateral side served as the control.

Mini-screws were used for anchorage reinforcement, and canine retraction was performed using nickel-titanium closed coil springs, delivering a force of 150 grams per side.

The primary outcome was the measurement of canine retraction rate throughout the study period from digital dental models obtained every 3 weeks.

The secondary outcome was the detection of possible canine tipping during retraction.

Eligibility criteria: Inclusion Criteria:

* healthy systemic condition with no chronic diseases
* no previous orthodontic treatment
* adequate oral hygiene
* have a healthy periodontium
* signed an informed consent

Exclusion Criteria:

* have a chronic disease
* previous orthodontic treatment
* poor oral hygiene or periodontal conidition

Primary outcomes:
measure: Rate of canine retraction
timeFrame: 12 weeks
Secondary outcomes:
measure: Measurment of canine tipping
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00419627: Proteomic Analysis of HLA Complex in Solid Cancers: Breast, Ovary, Colon, Rectum, Stomach, and Pancreas
Official title: Proteomic Analysis of Serology and Peptides Presented on the HLA Complex of Breast, Ovarian, Colon, Rectal, Gastric and Pancreatic Adenocarcinoma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Breast Neoplasms
Ovarian Cancer
Keywords: proteomics of solid tumors
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2007-01-08
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to evaluate the presence of proteins in solid tumors which may lead to an immune response

Detailed description: The main objective of the study is to evaluate which proteins are presented by the HLA complex of solid tumors. Secondary objectives include to evaluate whether an immune response specific to these proteins has actually been provoked and whether there is a similar immune response following recurrence. Real specimens will be evaluated using PCR and mass spectrometry.

Eligibility criteria: Inclusion Criteria:

* Patients with adenocarcinoma of breast, colon, rectum, ovary , stomach, pancreas

Exclusion Criteria:

* Withdrawal of consent
* Small specimen which does not allow to retrieve tissue without interfering with pathologic evaluation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Itamar Ashkenazi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03007927: Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
Official title: Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: pain
hernia repair
Dexamethasone
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Sebastián Roche, MD
name: Santiago Bertone, MD
name: Claudio Brandi, MD
First posted: 2017-01-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia Repair Mesh

Detailed description: This study will be: controlled, prospective, randomized and double blind.

Randomized experimental study in which all patients scheduled to undergo unilateral inguinal hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be invited to participate. At the time of admission to the study, they were assigned randomly to one of the two branches of intervention:

(Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in physiological solution to a final volume of 30 ml.

(Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight + dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.

Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24 hours, 48 hours and at 8 days .

It will also evaluate analgesic consumption, complications and labor return

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years.
2. Unilateral inguinal hernioplasty.
3. That the surgery is performed in the Ambulatory Surgery Unit (UCA).

Exclusion Criteria:

1. Recurrent hernia.
2. allergies, ongoing infections, diabetes.
3. Background of rejection of prosthetic material (mesh).

Primary outcomes:
measure: pain postoperative
timeFrame: 3 month
Secondary outcomes:
measure: take analgesic
timeFrame: 1 month
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires, Peron 4190
state: Capital Federal
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Sebastian SR Roche, doctor
role: PRINCIPAL_INVESTIGATOR
References: