louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05705739: Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block
Official title: Comparison Between the Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block for Postoperative Pain in Patients Undergoing Hepatobiliary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Analgesia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.

the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.


Eligibility criteria: Inclusion Criteria:

1. Age18-60.
2. Both genders.
3. hepatobiliary surgery.
4. ASA I-III.

Exclusion Criteria:

1. Drug allergy.
2. Morbid obesity (BMI \>40 kg/m2).
3. Psychiatric disorder.
4. Opiod dependence.

Primary outcomes:
measure: Visual analogue pain scale
timeFrame: 24 hour
Secondary outcomes:
measure: Time of first post operative analgesic request.
timeFrame: 24 hour
measure: Total analgesic consumption
timeFrame: 24 hour
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
state: Minia
Study officials:
References:
Clinical trial NCT01293539: Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
Official title: Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Retinoblastoma
Keywords: Retinoblastoma
intra-arterial chemotherapy
angiography
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 10
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show that chemotherapy delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment alternative to conventional systemic chemotherapy, external beam radiation, and surgical removal of the eye.

Detailed description: Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Administration of the drug directly to the targeted site thus avoids the complications and adverse events associated with toxicity from systemic, rather than local, chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients newborn to 18 years old.
* Patients with intraocular retinoblastoma, unilateral or bilateral, who would be treated either by systemic chemotherapy, EBR, or enucleation would be considered for this study.

Exclusion Criteria:

* Patients over the age of 18.
* Patients with small, localized intraocular Rb amenable to focal therapy (laser or cryotherapy).
* Patients with extraocular disease evident on MRI (extension into the optic nerve), massive choroidal/uveal invasion (grade IIC or IID per ARET0332) or disease outside the globe evident on MRI or physical examination.
* Documented hypercoagulable disorders or vasculopathies.
* Laboratory exclusion criteria: GFR \< 60 mL/min/1.73 m2

Primary outcomes:
measure: Number of Patients Who Complete Therapy Without the Need for Additional Treatment Including Systemic Chemotherapy, External Beam Radiation, or Enucleation.
timeFrame: Within the first six months after the initial treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Monica Pearl, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abramson DH, Dunkel IJ, Brodie SE, Kim JW, Gobin YP. A phase I/II study of direct intraarterial (ophthalmic artery) chemotherapy with melphalan for intraocular retinoblastoma initial results. Ophthalmology. 2008 Aug;115(8):1398-404, 1404.e1. doi: 10.1016/j.ophtha.2007.12.014. Epub 2008 Mar 14.
citation: Abramson DH. Chemosurgery for retinoblastoma: what we know after 5 years. Arch Ophthalmol. 2011 Nov;129(11):1492-4. doi: 10.1001/archophthalmol.2011.354. No abstract available.
Clinical trial NCT04994639: Hypotension Prediction Effect on AKI
Official title: Effect of Use of Hypotension Prediction System in Prevention of Postoperative Acute Kidney Injury in Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is a single-center randomized controlled trial that aims to figure out the effect of the hypotension prediction index (HPI) on the prevention of acute kidney injury (AKI) after radical cystectomy. The primary hypothesis is that HPI software guidance prevents postoperative AKI by reducing the duration and severity of intraoperative hypotension (IOH).


Eligibility criteria: Inclusion Criteria:

* Age ≧ 19
* Patients undergoing radical cystectomy with neobladder reconstruction
* Patients undergoing radical cystectomy with ileal conduit urinary diversion

Exclusion Criteria:

* Unable to voluntarily give consent
* Unable to use both radial arteries due to such reasons: prior surgery on the radial artery, breast cancer history with axillary LN dissection, AV fistula for renal replacement therapy, or abnormal Allen's test.

Primary outcomes:
measure: Acute kidney injury
timeFrame: Seven day after the operation
Secondary outcomes:
measure: Depth and duration of hypotension
timeFrame: From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
measure: Hypotension prediction index
timeFrame: From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Sooyoung Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02926339: Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative
Official title: Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking Behavior
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: El Paso Independent School District
name: Paso del Norte Health Foundation
First posted: 2016-10-06
Enrollment: 639
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to either receive 3 anti-tobacco presentations or 3 presentations on a different topic, unrelated to tobacco.

Detailed description: The investigators will collaborate with Austin High School, Wiggs Middle School, and Guillen Middle School of the El Paso Independent School District to implement smoke free youth coalitions as an after school activity. The coalitions will follow the Teens Against Tobacco Use (TATU) model developed by the American Lung Association, the American Cancer Society, and the American Heart Association. Participating youth will be trained to develop and deliver anti-tobacco presentations to younger students. Each school will have a separate youth coalition operating under the guidance of an adult coordinator. High school youth will present to middle school classes, whereas middle school youth will present to 4th and 5th graders.

To evaluate the efficacy of the TATU program, we will randomly assign students in physical education classes to receive TATU presentations or a control condition. Confidential surveys about tobacco will be administered at the beginning and end of the school year. Analyses will compare intervention and control students on smoking susceptibility, perceptions of harm from tobacco use, tobacco industry perceptions, and social norms on tobacco use.

Eligibility criteria: Inclusion Criteria:

* Students from participating schools
* 6th to 8th grade students
* Classes must be willing to receive presentations in the fall and spring semesters.

Exclusion Criteria:

* Students from non-participating schools
* Students not able to read English or Spanish

Primary outcomes:
measure: Tobacco Susceptibility assessed by Likert scale questions drawn primarily from the global youth tobacco survey
timeFrame: Change from Baseline Tobacco Susceptibility at 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: The University of Texas Health Science Center at Houston, School of Public Health, El Paso Regional Campus
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Louis D Brown, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02481739: Laparoscopic Surgical Management of Endometriosis on Fertility
Official title: Study of the Impact of Laparoscopic Surgical Management of Endometriosis on Fertility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: endometriosis
fertility
endometriosis surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This work concerns patients aged 18-38 years, operated by laparoscopy for endometriosis in our department between 2006 and 2014

Brief summary: The aim of the investigators study is to know the results of the endometriosis surgery and particularly to highlight a benefit of this surgery on fertility.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014.

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: benefit of endometriosis surgery on fertility : occurrence of pregnancy or live birth, spontaneous or after use of a MPA technical
timeFrame: after surgery, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Arnaud WATTIEZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02901639: Postpartum Contraception Counseling on the Rate of Unintended Pregnancy
Official title: Influence of Immediate Postpartum Contraception Counseling on the Rate of Unintended Pregnancy in Primigravida: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Improving Quality of Life
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Unwanted pregnancies are not only the major cause of maternal mortality and morbidity but are also a great social and financial burden on societies and countries. According to World-health-organization statistics, there are an estimated 200 million pregnancies around the world each year, and a third of these, 75 million, are unwanted. Unintended pregnancy also is a major health problem in the United States of America. In the 2002 National Survey of Family Growth assessment, 1.22 million, or 31%, were reported as unintended. When abortions were included, unintended pregnancies increased to 2.65 million, or 49% of all pregnancies


Eligibility criteria: Inclusion Criteria:

1. Age: above 18 years
2. Primigravida
3. Women who will accept to participate in

Exclusion Criteria:

1. Women who are not intended to use contraception
2. Multiparous
3. Women who refuse to participate in the study

Primary outcomes:
measure: The difference in the rate of unintended pregnancy in both groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT01768039: Vitamine D in Multiple Sclerosis
Official title: Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Vitamin D
EDSS
ARR
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial.

They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.


Eligibility criteria: Inclusion Criteria:

* BMI:18-30kg/m2
* caucasian race
* Relapsing remitting multiple sclerosis
* treatment with interferon beta

Exclusion Criteria:

* Recent vitamin D supplement therapy
* Restricted fat diet
* nephrolithiasis in recent 5 years
* Past history of hyperparathyroidism, sarcoidosis, cancer
* Past history of hepatic disease
* Past history of gastrointestinal disease
* Past history of mycobacterial infection
* Past history of hypercalcemia and hypercalciuria
* serum creatinine\>1.5
* Smoking, drug abuse and corticosteroid therapy in recent year
* treatment with thiazides or other drugs that inhibit vitamin D absorption
* Disease attack in recent 2 months
* Serum Ca\>2.6mm0l/L
* Serum 25(OH)D\>85mmol/L
* hypersensitivity to cholecalciferol
* Past history of heart disease
* Major depression
* Uncontrolled hypertension (BP\>180/110)
* Immunosuppressive therapy

Primary outcomes:
measure: Expanded disability state scale score (EDSS)
timeFrame: Changes in EDSS from baseline to 6 months
Secondary outcomes:
measure: Annual relapse rate(ARR)
timeFrame: Changes in ARR from baseline to 12 months
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Mazandaran University of medical sciences
state: Mazandaran
Study officials:
References:
Clinical trial NCT03968939: Total Joint Arthroplasty and Sleep
Official title: Postoperative Sleep Quality Following Total Joint Arthroplasty: A Prospective, Randomized, Controlled Trial of Diphenhydramine and Melatonin Versus Sleep Skills Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Total Hip Arthroplasty
Primary Total Knee Arthroplasty
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.


Eligibility criteria: Inclusion Criteria:

All patients undergoing elective primary total hip or knee arthroplasty

Exclusion Criteria:

1. History of substance abuse
2. Workman's compensation patients
3. Revision joint replacement
4. History of prescription or over-the- counter sleep aid use

Primary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
measure: Visual Analogue Scale (VAS) for Pain
timeFrame: Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Vicki L Jones
state: Missouri
Study officials:
References:
Clinical trial NCT05011539: Thiol-disulfide Homeostasis in Patients With Ovarian Cancer
Official title: Thiol-disulfide Homeostasis in Patients With Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 115
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ovarian cancer patients who applied to Izmir Tepecik Training and Research Hospital

Brief summary: Ovarian cancer is the third most common after endometrial and cervical cancer in societies with a high standard of living; It is the second most common type of gynecological cancer after cervical cancer in societies with a low standard of living, and it is also the deadliest among gynecological cancers. Dynamic thiol-disulfide homeostasis is an antioxidant system that minimizes oxidative damage and prevents cell damage. In the presence of oxidative stress, the thiol groups combine to form the disulfide structure, and when the oxidative stress condition is over, they are separated into thiol groups again. This homeostasis is impaired in conditions that cause oxidative processes such as diabetes, cardiovascular diseases, cancers, rheumatoid arthritis, and chronic kidney failure. This can be determined by measuring the total thiol and native thiol levels. Likewise, the level of ischemia modified albumin increases in the case of oxidative stress. There are studies on this homeostasis in the literature on many types of cancer; There are studies on endometrial cancer and cervical cancer, which are gynecological cancers In this study, the usability of these tests together with other diagnostic tests in the diagnosis of ovarian cancer will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Histopathological diagnosis of ovarian cancer

Exclusion Criteria:

* Having an acute or chronic disease that will cause oxidative stress
* Using alcohol/cigarettes/drugs
* Using antioxidant agents (such as vitamins A, C, E)

Primary outcomes:
measure: thiol - disulfide levels
timeFrame: April 2021 - January 2022
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Tepecik Training and Research Hospital
state: Konak
Study officials:
References:
citation: Sezgin B, Kinci MF, Pirincci F, Camuzcuoglu A, Erel O, Neselioglu S, Camuzcuoglu H. Thiol-disulfide status of patients with cervical cancer. J Obstet Gynaecol Res. 2020 Nov;46(11):2423-2429. doi: 10.1111/jog.14480. Epub 2020 Sep 9.
Clinical trial NCT04447339: Open Nipple Sparing Mastectomy (NSM)
Official title: A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nipple Sparing Mastectomy
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 75
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: Consecutive subjects that have undergone open NSM procedures for prophylaxis between January 1 2018 through 42 days prior to IRB approval will be included in this retrospective chart review.

Brief summary: This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Detailed description: This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Eligibility criteria: Inclusion Criteria:

All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval

Exclusion Criteria:

-

Primary outcomes:
measure: Safety Endpoint: complication rate
timeFrame: IntraOperative period through 42 days postoperatively
measure: Effectiveness
timeFrame: IntraOperative period through 42 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic Hosp - Methodist Campus - MN
state: Minnesota
city: Queens
country: United States
facility: Northwell Health
state: New York
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Univ. of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: