louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01261637: Abdominal Wall Local Anesthesia to Maximize Postoperative Pain Control After Cesarean Delivery
Official title: Ultrasound Guided 0.25% Ropivacaine Transversus Abdominis Plane Block in Addition to Intrathecal Morphine and Multimodal Analgesia for the Management of Postoperative Pain Among Women Undergoing Cesarean Delivery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: cesarean, pain, transversus abdominus plane block
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.


Eligibility criteria: Inclusion Criteria:

* Non-emergent CD with planned spinal anesthesia
* American Society of Anesthesia physical status class I \& II
* Age ≥ 18 years
* Term gestational age (≥ 37 weeks)
* English-speaking

Exclusion Criteria:

* Morbid Obesity (BMI³ 45 kg/m2)
* Laboring women
* Emergency CD
* Severe maternal cardiac disease
* Subjects with significant obstetric co-morbidities
* Failed spinal anesthesia
* Patient enrollment in another study involving medication within 30 days of CD
* Any other condition which may impair ability to cooperate with data collection
* Height less than 152 cm (5'0")
* Fetal anomalies or intrauterine fetal death

Primary outcomes:
measure: The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period.
timeFrame: 24 hours
Secondary outcomes:
measure: NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
timeFrame: 48 hours
measure: TAP block success rates and duration of block effect will be assessed using a patient diary completed every 2 hours while the patient is awake.
timeFrame: 24 hours
measure: Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.
timeFrame: 6 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Dolores McKeen, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKeen DM, George RB, Boyd JC, Allen VM, Pink A. Transversus abdominis plane block does not improve early or late pain outcomes after Cesarean delivery: a randomized controlled trial. Can J Anaesth. 2014 Jul;61(7):631-40. doi: 10.1007/s12630-014-0162-5. Epub 2014 Apr 24.
Clinical trial NCT03081637: FLNA in HCC Patients
Official title: Filamin A Expression in HCC Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 115
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: HCC patients submitted to hepatectomy at our unit in the above mentioned frame time.

Brief summary: The risk of recurrence after hepatectomy for hepatocellular carcinoma (HCC) is very high. Having a predictive marker of early recurrence (ER) would be desirable to personalize the follow-up and possibly develop new targeted therapy. The aim of this study was to test the expression of Filamin A (FLNA) in a cohort of patients operated for HCC.

Detailed description: A consecutive cohort of resected HCC patients will be analyzed. Several different prognostic factors, including FLNA expression, will be tested against the risk of ER. FLNA expression will be analyzed with immunohistochemistry in the intra-tumoral and extra-tumoral tissue compartments using a dedicated tissue microarray.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were represented by the histological positivity for HCC with complete clinical, surgical, pathological, and follow-up data.

Exclusion Criteria:

* Patients preoperatively treated with chemotherapy or trans-arterial therapy were excluded.
* Similarly, patients operated for recurrent HCC or with non-radical surgery or with missing data were excluded.

Primary outcomes:
measure: Rate of expression of Filamin A (FLNA) in HCC specimens from patients resected for HCC.
timeFrame: 2 years after surgery as a minimum follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00502437: The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antiggaging Effect
Antiemetic
Granisetron
Gag Reflex
Dental Situations
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-07-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER

Brief summary: Antigagging effect of kytril (granisetron) an antiemetic drug in dental situations

Gagging in dental situations can be a problem to the patient and the operating dentist. There are not proven methods of eliminating this reflex which sometimes will not allow routine quality dental care.

Pharmacological and behavioral approaches to eliminate this reflex have been tried with limited success.

This suggested study will test a potent antiemetic drug used in other clinical situations such as antineoplastic treatment. Granisetron is a potential antagonist for the 5-hydroxytryptamine3-receptor - 5HT(3), The drug binds to the receptor and blocks the effect of nausea and vomiting. Kytril mechanism of action was successfully proven for various medical situations as a potential antiemetic agent. Our Center for dental sedation and anesthesia in the oral medicine department have received approval to use Granisetron as an antigagging drug in dental situations based on several pilot studies conducted in other medical centers in different clinical situations such as strabismus corrections, post hysterectomy and others. Our preliminary clinical impression is that pre-emptive IV administration of this drug to patients with increased gag reflex is beneficial.

In our research we try to investigate the possibility of using kytril in dental situations.

In the first stage of this research we will study the INTRAVENOUS use of this drug and its effects On normal subjects compare them to themselves with placebo. According to the results of this study we will go on to the second stage of the research and try the same drug under oral administration.

The purpose of this study is to test the antigagging effect of this drug in a controlled manner in dental situations.

Our working hypothesis is that administration of this drug in dental situations with success, will allow many patients to receive good dental care


Eligibility criteria: Inclusion Criteria:

* normal subjects

Exclusion Criteria:

* presence of systemic disease
* subjects under medication or drug or food complementary agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Eliezer Kaufman, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02806037: Utility of Intra-operative Image Guidance System for Missing Metastases
Official title: Utility of Intra-operative Image Guidance System for Missing Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Metastatic to the Liver
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Hepatobiliary Clinic at Memorial Sloan-Kettering Cancer Center.

Brief summary: Intraoperatively, the surgeon will interrogate the liver with ultrasound. The time spent by the surgeon using the ultrasound is recorded. If all lesions seen on pre-op imaging were found, the patient does not have the Pathfinder Explorer system applied. If one or more lesions cannot be found, then the Pathfinder Explorer system is calibrated and a tracking device is attached to the ultrasound probe, which the surgeon will use to reattempt localization of the missing tumor. The Pathfinder Explorer system operates in real-time in conjunction with the ultrasound.


Eligibility criteria: Inclusion Criteria:

* patient has one or more colorectal liver metastases, at least one of which is ≤1.5cm in maximal diameter on pre-operative cross sectional imaging
* undergoing liver resection and/or ablation

Exclusion Criteria:

* none

Primary outcomes:
measure: localization rate of liver tumor
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Peter Kingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kingham TP, Pak LM, Simpson AL, Leung U, Doussot A, D'Angelica MI, DeMatteo RP, Allen PJ, Jarnagin WR. 3D image guidance assisted identification of colorectal cancer liver metastases not seen on intraoperative ultrasound: results from a prospective trial. HPB (Oxford). 2018 Mar;20(3):260-267. doi: 10.1016/j.hpb.2017.08.035. Epub 2017 Sep 19.
Clinical trial NCT04338737: Post Operative Feeding After Cesarean Section
Official title: A Randomized Controlled Study of Early Versus Delayed Oral Post Operative Feeding After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Feeding Patterns
Keywords: early feeding ,late feeding
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 3 different post ceseraen secton feeding regmen are compared

Detailed description: 300 women admitted to the labor and delivery unit in kasr Elainy teaching hospital, Following the decision to perform a cesarean section because of obstetric indications. The study involved only elective cesarean sections.

The 300 patients participated in this work and will be randomly and equally divided into three groups:

1. Group A :

   It consists of 100 patients that will be allocated for early post-operative oral feeding receiving water and clear fluid approximately 2 hours after surgery, followed by soft food and regular diet 4 hours later irrespective to intestinal sounds, flatus or stool.
2. Group B :

   It consists of 100 patients that will be allocated for early Postoperative oral feeding receiving water and clear fluid approximately 2 hours after surgery till the return of intestinal sounds, then soft food and regular diet later on.
3. Group C :

It consists of 100 patients that will receive no oral feeding till passage of flatus instead 2 to 3 Litres of intravenous fluid will be used for feeding. Water and fluid will be then offered, followed by soft foods and then a regular diet.

Eligibility criteria: Inclusion Criteria:

* Maternal age from 20 to 40.
* Primigravida and previous 1 or two cesarean section.
* Elective cesarean section.
* Regional anaesthesia.
* Singleton pregnancy

Exclusion Criteria:

* Medical disorders as (sever preeclampsia, diabetes, liver or kidney diseases).
* Intraoperative intestinal injury.
* Previous major abdominal surgery except cesarean section.
* Obstructed labor with

Primary outcomes:
measure: duration minutes till return of bowel sound
timeFrame: time interval in minutes from the end of surgery till the return of intestinal sound
measure: maternal satisfaction from time of initiation of oral feeding after caesarean section.
timeFrame: before discharge from hospital (range of 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02115737: Group Treatment for Adolescents With Depression
Official title: Group Treatment for Adolescents With Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 11
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Youth with depressive symptoms are at risk for a range of problems later in life. This includes problematic interpersonal relationships, occupational stress, and the occurrence of adult mental disorders. The main purpose of this study is to test how effective two types of group therapy are at reducing depressive symptoms in youth. A focus on group therapy is important because group therapy allows for many youth to be treated in a short amount of time. Group therapy is also helpful because youth can get social support and feel less alone in their symptoms when they participate in group. This study compares two groups, one that targets skills for managing difficult emotional experiences (dialectical behavior therapy skills group) and another group focuses on psychoeducation and is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh. The results of this study will provide insights regarding the comparative efficacy of these two treatments, and regarding predictors of treatment response.


Eligibility criteria: Inclusion Criteria:

* English speaking
* male or female, ages 14 to 19, all races and ethnicities
* Current depression as assessed by an ALIFE - PSR score equal to or greater than 4
* Has a treating psychiatrist at Sunnybrook Health Sciences Centre

Exclusion Criteria:

* Current manic episode
* current psychosis

Primary outcomes:
measure: Children's Depression Rating Scale - Revise (CDRS-R)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 12, 24)
measure: The Longitudinal Interval Follow-up Evaluation for adolescents (A-LIFE)
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 12 and 24)
Secondary outcomes:
measure: The Adverse Childhood Experiences
timeFrame: Assessed at baseline
measure: The Children's Affective Lability Scale
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24)
measure: The Stressful Life Events Schedule
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
measure: The DBT Ways of Coping Checklist
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
measure: The Life Problems Inventory
timeFrame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Science Centre
name: Benjamin I Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02543437: Large Head X3 Study
Official title: The Effect of Large Diameter Head to Prevent Dislocation, and of 3 rd Generation Highly Crosslinked Polyethylene to Reduce Wear in Computer Assisted Total Hip Arthroplasty.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Joint Disease
Lead sponsor: Stryker Japan K.K.
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is to observe wear resistance performance of X3 over historical liner existing highly crosslinked polyethylene.


Eligibility criteria: Inclusion Criteria:

1. Patient who is a candidate for primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
2. Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease.
3. Patient whose age is 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing and able to comply with postoperative scheduled evaluations.

Exclusion Criteria:

1. Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
2. Patient who requires revision surgery of a previously implanted total hip arthroplasty.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 45.
4. Patient who is or may be pregnant female.
5. Patient who has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.

Primary outcomes:
measure: Range of Motion(ROM) (Degree)
timeFrame: Intraoperative
measure: Lift Off Distance in Dislocation Maneuver(mm)
timeFrame: Intraoperative
Secondary outcomes:
measure: Wear Rate(%)
timeFrame: 1 year, 2 years, 3 years and 5 years after surgery
Other outcomes:
Locations:
city: Nagoya City
country: Japan
facility: Nagoya Kyoritsu Hospital
state: Aichi
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Suita City
country: Japan
facility: Kyowakai Hospital.
state: Osaka
city: Osaka
country: Japan
facility: Osaka City General Hospital.
Study officials:
References:
Clinical trial NCT03411837: Dupilumab Phase 4 Study
Official title: Dupilumab Registry Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis, dupilumab
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 46
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with moderate-to-severe atopic dermatitis on dupilumab

Brief summary: The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.

Detailed description: The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care.
* Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD.

Exclusion Criteria:

* Patients not on dupilumab
* Those who do not comply with the study requirements
* Those who do not provide informed consent

Primary outcomes:
measure: Quantified Itch Survey
timeFrame: 1 to 3 months
measure: Quantified Sleep Survey
timeFrame: 1 to 3 months
measure: Quantified Quality of Life Survey
timeFrame: 1 to 3 months
Secondary outcomes:
measure: Occurrence of any AEs by 24 months
timeFrame: 24 months
measure: Occurrence of any infections by 24 months
timeFrame: 24 months
measure: Occurrence of any SAEs by 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
References: