louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05467878: The Effect of Anesthesia on Pain in Percutaneous Nephrolithotomy
Official title: The Effect of Anesthesia on Perioperative Pain Level and Analgesic Effect in Patients With Percutaneous Nephrolithotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Nephrolithotomy
Keywords: general anesthesia
postoperative pain
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 patients

Brief summary: It is aimed to determine the ideal application by determining the effect of different anesthesia methods applied in percutaneous nephrolithotomy surgeries on analgesic consumption and pain level.

Detailed description: Different anesthesia methods are used in percutaneous nephrolithotomy.In addition to traditional analgesia methods such as intravenous paracetamol, NSAIDs, opioids, various methods such as epidiural analgesia or blocks added to general anesthesia are used.In this study, it was aimed to investigate whether central or peripheral block applications are preferred in percutaneous nephrolithotomy, and the need for intraoperative and postoperative analgesics in patients.In addition, it was aimed to investigate whether there was a change in analgesic consumption, recovery and pain level, and hospital stay in patients who were given general anesthesia or regional anesthesia, in a multicentric observational manner.

Eligibility criteria: Inclusion Criteria:

* patient giving consent
* accessing patient information

Exclusion Criteria:

* missing information in the patient file

Primary outcomes:
measure: Visual Analog Scala (VAS)
timeFrame: 1 days after the surgery
Secondary outcomes:
measure: Hospital stay
timeFrame: after the surgery to the discharge time until 10 days
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa YIEAH
state: Yildirim
Study officials:
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Şeyda Efsun ŞE Özgünay, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Serra S Topal, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Sedat S Öner, Assoc Prof
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Salim S Zengin, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Şermin Ş Eminoğlu, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Tuğba T Onur, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06289478: Efficacy and Safety of Retrograde Intraarticular Injection, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Femoral Neck Fractured Patients Undergoing Cementless Bipolar Hemiarthroplasty
Official title: Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Bipolar Hemiarthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoral Neck Fracture
Keywords: tranexamic acid
femoral neck fracture
bipolar hemiarthroplasty
topical
blood transfusion
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:

* The efficacy in reducing blood transfusion for topical tranexamic acid administration
* The safety of tranexemic acid, topically used

As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.

Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.


Eligibility criteria: Inclusion Criteria:

* Elderly patients (age \&gt; 60 years)
* Femoral neck fractures from low energy mechanism
* Household ambulator
* Undergoing cementless bipolar hemiarthroplasty at KCMH
* Informed consent

Exclusion Criteria:

* Allergy to TXA
* History of VTE
* History of hip surgery, pathological fracture, hip infection
* Congenital or acquired coagulopathy
* Hb \&lt; 10 g/dL or Platelet \&lt; 140,000

Primary outcomes:
measure: Rate of blood transfusion
timeFrame: 2 years, or until complete enrollment
Secondary outcomes:
measure: Volume of blood transfusion
timeFrame: 2 years, or until complete enrollment
measure: Calculated blood loss
timeFrame: 2 years, or until complete enrollment
measure: Any adverse events
timeFrame: 2 years, or until complete enrollment
measure: In-hospital mortality
timeFrame: During admission period
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00004278: Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Infections
Keywords: congenital cytomegalovirus infection
cytomegalovirus infection
herpesvirus infection
immunologic disorders and infectious disorders
neonatal disorders
rare disease
viral infection
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 1999-10-19
Enrollment: 130
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.

Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks.

Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Symptomatic cytomegalovirus (CMV) infection: Central nervous system disease, with or without other organ system involvement, e.g.: Microcephaly, i.e., less than 5% for age Radiologic changes indicating brain disease Cerebrospinal fluid exam abnormal for age Chorioretinitis Hearing defects
* CMV confirmed by urine, throat, buffy coat, and/or conjunctiva culture
* No hydroencephalopathy or other devastating brain involvement

--Prior/Concurrent Therapy--

* No concurrent antiviral agent No concurrent immune globulin

--Patient Characteristics--

* Age: Under 1 month (preferably under 2 weeks)
* Life expectancy: No imminent demise
* Renal: Creatinine no greater than 1.5 mg/dL
* Other: Birth weight at least 1200 g Gestational age at least 32 weeks No HIV infection No concurrent bacterial infection Eligible if resolved following 2-week treatment and CMV symptoms persist

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Richard J. Whitley
role: STUDY_CHAIR
References:
Clinical trial NCT05072678: Clinical and Radiological Evaluation of Two Mastoid Filling Products
Official title: Clinical and Radiological Evaluation of Two Mastoid Filling Products in Patients With Cholesteratoma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prospective Study
Keywords: osteoingration
surgery
cholesteatome
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with cholesteatoma surgery

Brief summary: to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma

Detailed description: Primary objective: To compare the radiological aspect in the petrous bone of two obliteration products in adults, one year after surgery (Bioactive Glass S53P4 and biological Hydroxy apatite) secondary objective : To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 and biological hydroxy apatite when used in the mastoid and epitympanic obliteration for chronic otitis surgery

Eligibility criteria: Inclusion Criteria:

* Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up

Exclusion Criteria:

* patient less than 18 years old

Primary outcomes:
measure: Hounsfield Unit
timeFrame: one year
Secondary outcomes:
measure: decibel
timeFrame: one year
measure: decibel
timeFrame: one year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU De Brest
Study officials:
References:
Clinical trial NCT05761678: Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort (e-QoL-Trans)
Official title: Quality of Life of Transgender People - Implementation and Monitoring of an Online Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgenderism
Gender Identity
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transgender people, whether they have transitioned or not, with or without reassignment surgery.

Brief summary: Transgender people have an identity or an expression gender that differs from the sex assigned to them at the birth. Transgender people and their needs remain misunderstood, and more generally by society. THE transgender populations express poor quality of life compared to the general population. However, very few of studies are interested in these people, in their diversity of paths, trajectories and characteristics of life. More of research is needed to study the quality of life, understand the experiences, in their diversity and in the health, social and life trajectories. Researches must be carried out, in particular on how to interrogate by the seeks out transgender people, in order to prevent stigmatization within population studies.

The main objective of this study is to assess the quality of life of people transgender people during their life trajectory and their transition path, based on validated questionnaires scientifically in French, for major themes of the population concerned (quality of life, social support perceived).


Eligibility criteria: Inclusion Criteria:

* Transgender people (having a gender identity or expression that differs from the sex assigned to them at birth);
* People with any of the following characteristics regarding their trans identity:

  * Consultant in one of the transgender reference centers and services for questions/information on the transition;
  * Integrated or having completed a course of care with or without gender reassignment surgery;
  * Not integrated into a health or care pathway.
* French-speaking people;
* Adults;
* People able to use the tools digital;
* People with Internet or 4G access (total or limited)

Exclusion Criteria:

* People who do not identify as transgender;
* Non-French speaking people;
* Minors
* People who do not know how to handle the tools digital data collection;
* People without Internet access.
* Non-French speaking people, unable to speak understand the research questions
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administrative

Primary outcomes:
measure: Quality of life estimated with a validated questionnaire administered over the Internet repeatedly every three months.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital privé Jean Mermoz
Study officials:
References:
Clinical trial NCT02002078: Caustic Esophageal Burns in Children and High Doses of Methylprednisolone
Official title: High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esophageal Diseases
Keywords: caustic
corticosteroid therapy
stricture
children
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 83
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. The role of corticosteroids in preventing corrosive-induced strictures is controversial. The investigators' aim is to study the influence of high doses of corticosteroids to prevent esophageal strictures.


Eligibility criteria: Inclusion Criteria:

-Corrosive substance ingested children with grade IIb esophageal burn

Exclusion Criteria:

* Caustic substance ingested chldren grade I, IIa and grade III esophageal burns
* Caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis
* Caustic substance ingested children with any chronic disease

Primary outcomes:
measure: Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Usta M, Erkan T, Cokugras FC, Urganci N, Onal Z, Gulcan M, Kutlu T. High doses of methylprednisolone in the management of caustic esophageal burns. Pediatrics. 2014 Jun;133(6):E1518-24. doi: 10.1542/peds.2013-3331.
Clinical trial NCT00741078: Additive Beneficial Effects of Atorvastatin Combined With Amlodipine In Treatment of Hypertension
Official title: Additive Beneficial Effects of Atorvastatin Combined With Amlodipine In Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: endothelial
function
insulin
sensitivity
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2008-08-26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized combination therapy would be superior to monotherapy.


Eligibility criteria: Inclusion Criteria:

* Hypertension

Exclusion Criteria:

* Chronic renal disease
* Severe hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
Clinical trial NCT05463978: Sculptra Chart Review
Official title: A Multi-center Retrospective Chart Review to Evaluate the Safety of Sculptra Aesthetic When Used in Non-facial Areas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-facial Skin Aesthetic Conditions
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females/males treated with Sculptra Aesthetic in non-facial areas

Brief summary: Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas


Eligibility criteria: Inclusion Criteria:

* Subjects who have been treated at the site with Sculptra Aesthetic in non-facial areas
* Subjects with available information about treatment dates and treatment procedures

Exclusion Criteria:

* Subject that have actively asked not to be involved in a study or registry
* Other conditions that in the Investigator's opinion would exclude the subject from participation ; the condition should be recorded.

Primary outcomes:
measure: To evaluate safety of Sculptra Aesthetic when used in non-facial areas
timeFrame: January 2018 to 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Galderma Research Site
state: California
city: San Diego
country: United States
facility: Galderma Research Site
state: California
city: Solana Beach
country: United States
facility: Galderma Research Site
state: California
city: Coral Gables
country: United States
facility: Galderma Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Galderma Research Site
state: Florida
city: New York
country: United States
facility: Site Coordinator
state: New York
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: New York
country: United States
facility: Galderma Research Site
state: New York
Study officials:
References:
Clinical trial NCT04066478: Does DHEA IVF Outcomes in Poor Responders?
Official title: Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Infertility, Female
Poor Response to Ovulation Induction
Lead sponsor: Homerton University Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 400
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, double-blind, placebo controlled study
Primary purpose: TREATMENT

Brief summary: This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment

Detailed description: Poor responders to ovarian stimulation for IVF may be either predicted or evidenced from previous treatment. The ESHRE criteria for poor responders will be used to select candidates for this trial. A power calculation determined that 200 subjects should be recruited to each arm to receive either DHEA or placebo.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 40 years
* Markers for poor ovarian reserve (AMH \<7 pmol/L(\<1.1 ng/ml) and/or AFC\< 7)
* Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol)

Exclusion Criteria:

* Women \> 42 years
* Women with premature ovarian failure / premature menopause (FSH\>40 U/L). Women already taking DHEA.
* Patients with a known allergy to the trial drug or any of the active ingredients in the placebo.

Primary outcomes:
measure: Clinical pregnancy rates
timeFrame: at 6-8 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Homerton Fertility Centre
Study officials:
References:
Clinical trial NCT01149278: Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Arterial Pressure
Hemodynamics
Mortality
Clinical Trial
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2010-06-23
Enrollment: 800
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: The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)


Eligibility criteria: Inclusion Criteria:

* patients with septic shock according criteria of Bone
* minimal dose of norepinephrine
* Written informed consent obtained from the patient or surrogate

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Participation in other trials with the same endpoints
* moribund
* absence of registration in french health care system
* patient protected by law

Primary outcomes:
measure: mortality
timeFrame: day 28
Secondary outcomes:
measure: decrease in mortality at day 90
timeFrame: day 90
measure: decrease in sequential organ failure assessment
timeFrame: day 1 to day 28
measure: extra renal replacement free days
timeFrame: day 28
measure: renal function
timeFrame: day 1 to day 28
measure: amount of fluids
timeFrame: day 1 to end of shock
measure: catecholamines free days
timeFrame: day 1 to day 28
Other outcomes:
Locations:
city: Angers
country: France
facility: University hospital Angers
Study officials:
References:
citation: Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.