louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05062733: SEBBIN Round, Anatomical and Biconvex Gluteal Implants
Official title: Prospective Observational Study About SEBBIN Gluteal Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complication
Prosthesis Durability
Lead sponsor: Groupe SEBBIN
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 60
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: The intended target population for the gluteal Implants is women or men, who desire an increase in volume of the gluteal region for aesthetic or reconstruction reason.

Brief summary: This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.


Eligibility criteria: Inclusion Criteria:

* The patient is a man or a woman ≥ 18 years old at the time of inclusion.
* The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision
* The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing.

Exclusion Criteria:

* Patient implanted with silicone implants somewhere else in the body.
* Patient candidate for implantation with custom-designed implants.
* Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.

Primary outcomes:
measure: Complication rate
timeFrame: At 10 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Istituto Estetico Italiano
city: Den Haag
country: Netherlands
facility: Medical Clinic "Essential Aesthetics"
Study officials:
References:
Clinical trial NCT05643833: Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma
Official title: Impact of Gender on the Outcome of Liver Transplantation for Hepatocellular Carcinoma: A Multicenter Retrospective Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Liver
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 3769
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 3769 HCC patients underwent liver transplant with the age between 18-65 years old were studied.

Brief summary: This is a large-scale study in China to provide evidence and insights in the role of gender in LT for HCC by analyzing the data of 3769 recipients with HCC registered in the China Liver Transplant Registry.


Eligibility criteria: Inclusion Criteria:

The patients with liver transplants performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR.

Exclusion Criteria:

Patients with following features were excluded: with concurrent other malignancies, pathologically-confirmed tumor types other than HCC, such as intrahepatic cholangiocarcinoma (ICC), combined hepatocellular cholangiocarcinoma (cHCC-CC), fibrolamellar hepatocellular carcinoma (FLC) or secondary metastatic tumor; without histological confirmation of HCC for transplantation. The patients who received living donor liver transplantation, split liver transplantation, reduced-size liver transplantation or simultaneous transplantation were also excluded. Next, pediatric patients (\<18 years) or senile patients (\>65 years) and those patients who died within six months after transplantation were also excluded. Finally, the patients with type-1 and type-2 portal vein tumor thrombus (PVTT), tumor metastasis, having doubtful or contradictory data or missing essential data for analysis, re-transplantation during follow-up time were excluded as well.

Primary outcomes:
measure: Overall survival
timeFrame: January 2015 to December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT01797133: A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization
Official title: A Comparative Study of ID Fellow-based Pre-authorization VS. Pharmacist-based Pre-authorization in Reducing Antibiotic Consumptions and Hospital Expenditures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: All Hospitalzied Patients
No Specific Conditions Requires
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2013-02-22
Enrollment: 984
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will conduct a cluster randomized controlled trial to compare two antibiotic pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and duration of antibiotic consumption would be lower in the pharmacist group while the clinical outcome would be equivalent between two groups.

Detailed description: Study design: A cluster randomized controlled trial Settings: 6 general medical wards at Siriraj Hospital, Bangkok, Thailand

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients
* Received at least one dose of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem or Doripenem)
* Each patient may be enrolled more than once, if he/she receives the controlled antibiotic for a new episode of infection (at least 48 hour apart)

Exclusion Criteria:

* Died prior to receive the controlled antibiotic

Primary outcomes:
measure: Defined Daily Dose (DDD) of antibiotics
timeFrame: Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks
Secondary outcomes:
measure: Total duration of antibiotic use
timeFrame: Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks
Other outcomes:
measure: Clinical response
timeFrame: at the end of therapy and at discharge (an average duration of antibiotic therapy is 2 weeks, an average length of stay is 3 weeks)
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Pinyo Rattanaumpawan, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rattanaumpawan P, Upapan P, Thamlikitkul V. A noninferiority cluster-randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows. Infect Control Hosp Epidemiol. 2018 Oct;39(10):1154-1162. doi: 10.1017/ice.2018.198. Epub 2018 Aug 29.
Clinical trial NCT00763633: B6 Treatment for Nausea and Vomiting in Pregnancy
Official title: Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nausea and Vomiting Complain in Early Pregnancy
Keywords: nausea
vomiting
pregnancy
B6
Lead sponsor: Showa University
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2008-10-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.


Eligibility criteria: Inclusion Criteria:

* Nausea and vomiting of pregnancy

Exclusion Criteria:

* Other medical condition causing nausea and vomiting of pregnancy

Primary outcomes:
measure: Nausea and vomiting score
timeFrame: 2 weeks
Secondary outcomes:
measure: Vitamin B6 concentration in nausea and vomiting of pregnancy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dept. Obstetric Gynecology Univ. Indonesia
Study officials:
affiliation: Dept. Obstetric Gynecology Univ. Indonesia
name: Noroyono Wibowo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06274333: Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort
Official title: The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Percutaneous Nephrolithotripsy (PCNL)
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2024-02-23
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Age from 20 - 50 years
* ASA (The American Society of Anesthesiologists) I or II,
* undergo percutaneous nephrolithotomy (PCNL)

Exclusion Criteria:

* Patients with history of psychotic illnesses
* Opioid users
* Bladder obstruction,
* Benign prostatic hyperplasia
* Overactive bladder (OAB) defined as frequency _3 times at night or _8 times within 24 hours.

Primary outcomes:
measure: The incidence of catheter-related bladder discomfort (CRBD)
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 hours postoperatively
measure: Meperidine requirement
timeFrame: 24 hours postoperatively
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
measure: Surgeon satisfaction
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Neveen Kohaf
Study officials:
References:
Clinical trial NCT01542333: Studying Biomarkers in Samples From Younger Patients With Wilms Tumor
Official title: Biological Analysis of Ethnic Variations in Wilms Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: recurrent Wilms tumor and other childhood kidney tumors
stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-02
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with Wilms tumor

Brief summary: RATIONALE: Studying samples of tissue and urine from patients with cancer in the laboratory may help doctor learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Detailed description: OBJECTIVES:

* To determine a unique molecular "finger print" of primary Wilms tumor arising in ethnically diverse children who are at increased risk to develop this lethal malignancy and subsequently relapse.
* To determine a unique protein "finger print" from the urine of ethnically diverse children who develop Wilms tumor and subsequent relapse.

OUTLINE: Formalin-fixed paraffin-embedded and snap-frozen primary tissue samples, and urine samples collected at the time of diagnosis and before treatment, are analyzed for molecular and protein profile by MALDI-TOF mass spectroscopy, western blotting, immunohistochemistry, and reverse-transcriptase polymerase chain reaction (RT-PCR) assays.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with Wilms tumor
* Specimens from African-American and from Caucasian children
* Specimens from each ethnicity who relapsed
* Specimens from each ethnicity who did NOT relapse

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Molecular "finger print" of primary Wilms tumor in ethnically diverse children
measure: Protein "finger print" from the urine of ethnically diverse children
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt Children's Hospital
name: Harold N. Lovvorn, III, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00306033: Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis
Official title: IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myasthenia Gravis
Keywords: myasthenia gravis
immunoglobulin
intravenous immunoglobulin
treatment
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2006-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a double-blind, placebo-controlled, randomized clinical trial to determine whether IVIG is effective in improving motor scores in patients with myasthenia gravis and worsening weakness.

Detailed description: Patients aged 18 years or older with a diagnosis of myasthenia gravis (MG) and worsening weakness were enrolled in the study after providing informed consent. Fifty-two patients were recruited to the study, but one withdrew consent prior to starting so that 51 patients were recruited. Baseline clinical assessments using the Quantitative MG Score for Disease Severity (QMGS) were repeated at 2 and 4 weeks after treatment with IVIG or saline infusion. The Post-Intervention Status was assessed at 2 and 4 weeks after treatment. The treatment was randomized and double-masked. Electrophysiological and immunological tests were done at baseline and after 2 weeks. Baseline characteristics were compared by the Student's t test for continuous variables or Chi-square test for categorical variables. An analysis of covariance was performed for the primary outcome measure, the change in QMGS.

Eligibility criteria: Inclusion Criteria:

* age \> or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and worsening weakness

Exclusion Criteria:

* age \<18; severe myasthenia gravis requiring intensive care admission; change in immunosuppresive medication in previous 3 months; patients with severe bulbar weakness at risk for aspiration and respiratory failure; patients with other serious underlying medical conditions (renal failure, congestive heart failure); unwilling to provide informed consent.

Primary outcomes:
measure: change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity
Secondary outcomes:
measure: MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Vera Bril, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02961933: Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation
Official title: Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation
Keywords: hypoxemia
intubation
apneic oxygenation
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2016-11-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will determine rates of first pass success without hypoxemia in emergency department intubations with and without the use of apneic oxygenation by nasal cannula.


Eligibility criteria: Inclusion Criteria:

- Patients requiring emergent Rapid Sequence or Delayed Sequence endotracheal intubation with administration of a neuromuscular blocker (Succinylcholine, Rocuronium)

Exclusion Criteria:

* Known prisoners
* Patients in cardiac arrest
* Patients who are intubated without the use of neuromuscular blockade (i.e., cardiac arrest, awake intubation).

Primary outcomes:
measure: First pass success without hypoxemia
timeFrame: 10 minutes
Secondary outcomes:
measure: Change in peri-intubation saturation
timeFrame: 0, 30, 60 and 120 seconds
measure: Saturation at time of tube placement
timeFrame: 10 minutes
measure: Time to desaturation <93%
timeFrame: measured time until saturations drop below 93% during the peri-intubation period, up to 10 minutes
measure: Saturation at post intubation
timeFrame: 0, 30, 60, and 120 seconds
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Robert Bryant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04423133: Bilingual Family Literacy Program Pilot
Official title: Bilingual Family Literacy Program Pilot: Ready and Healthy for Kindergarten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Development
Literacy
Health Behavior
Keywords: Language development
Health routines
Literacy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will examine the feasibility of implementing a virtual bilingual health-focused family literacy program.

Detailed description: "Ready and Healthy for Kindergarten" is a bilingual family literacy program that uses anticipatory guidance on important health routines to introduce critical language and literacy skills to young Latino children entering Kindergarten and their families.

The objectives of this study are 1) To assess the feasibility of implementing the bilingual family literacy program online via video conference by collecting information on family attendance and participation, 2) To examine the acceptability of the program, and 3) To explore preliminary effects of the program on the family health and language routines as well as child language and literacy skill acquisition.

Eligibility criteria: Inclusion Criteria:

* Preferred language either Spanish or bilingual (English and Spanish)
* Parent or legal guardian of the child
* Parent Age ≥ 18

Exclusion Criteria:

* Children not entering Kindergarten.

Primary outcomes:
measure: Number of sessions attended by participants
timeFrame: 8 weeks
measure: Acceptability of the program
timeFrame: 8 weeks
Secondary outcomes:
measure: StimQ Reading Scale
timeFrame: Baseline, 8 weeks
measure: StimQ Parental Verbal Responsivity Scale
timeFrame: Baseline, 8 weeks
measure: Child Literacy Skills
timeFrame: Baseline, 8 weeks
measure: Family Health Routines Assessment
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Child Health Institute of NJ
state: New Jersey
Study officials:
affiliation: Rutgers Biomedical Health Sciences
name: Manuel E Jimenez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04341233: Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis
Official title: Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spondylitis, Ankylosing
Psoriatic Arthritis
Keywords: Nurse-Led Service
Enhanced Clinics
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2020-04-10
Enrollment: 0
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 with a diagnosis of ankylosing spondylitis or psoriatic arthritis requiring initiation of biologic therapy.

Brief summary: The 19.5 months project will pilot the introduction of a hospital-based, nurse-led ankylosing spondylitis (AS) and psoriatic arthritis (PsA) service for patients being initiated on biologic therapy in NHS Lothian Edinburgh Western General Hospital.

It is anticipated that this new model of care will improve:

1. The time from referral for biologic therapy to initiation of treatment with a biological therapy due to the dedicated nurse to see patients
2. The management and monitoring of AS and PsA patients post commencement of treatment , in line with The National Institute for Health and Care Excellence (NICE) guidelines


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of AS or PsA
* Referral for initiation of biological therapy by patients regular consultant
* Age 18 years or older
* Willing and able to give informed consent

Exclusion Criteria:

· Unable to comply with study procedures

Primary outcomes:
measure: Setup a nurse-led clinic
timeFrame: 3 months
measure: Develop and setup a tool, an NHS Lothian Excel database
timeFrame: 19.5 months
measure: Develop and setup a tool, an NHS Lothian Excel database
timeFrame: 19.5 months
measure: Develop and setup a tool, an NHS Lothian Excel database
timeFrame: 19.5 months
measure: Develop and setup a tool, an NHS Lothian Excel database
timeFrame: 19.5 months
measure: Develop and setup a tool, an NHS Lothian Excel database
timeFrame: 19.5 months
measure: Develop and setup a tool, an NHS Lothian Excel database
timeFrame: 19.5 months
measure: Develop and setup a tool, an NHS Lothian Excel database
timeFrame: 19.5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NHS Lothian
name: Neil McKay, Dr
role: PRINCIPAL_INVESTIGATOR
References: