louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03278652: Use of Analgesic Drugs in Renal Colic in Emergency Room
Official title: Use of Analgesic Drugs in Renal Colic in Emergency Room
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Colic
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-11
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: Patient with renal colic

Brief summary: A prospective non-interventional study on the use of analgesic drugs in renal colic in emergency rooms


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Suspicion of renal colic (pain in a lumbar pit radiating to the external genital organs, rapidly progressive onset, non-febrile)

Exclusion Criteria:

* Shock
* Glasgow score less than 15
* Oxygen saturation less than 93% in ambient air
* Signs of intracranial hypertension (headache associated with vomiting)
* Suspicion of pneumothorax
* History of emphysema or chronic obstructive pulmonary disease
* Diving accident or suspicion of gas embolism
* Trauma of the face of interest in the area of application of the mask
* Abdominal gas distension
* Contraindication in Nonsteroidal anti-inflammatory drugs
* Pregnancy

Primary outcomes:
measure: Number of analgesic drug used in the context of renal colic in emergency rooms by following the recommended and validated service protocol
timeFrame: During hospitalisation in emergency rooms
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT04048252: Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy
Official title: Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy: Construction and Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 18
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: Patients with metastatic prostate cancer and receiving next-generation hormone therapy

Brief summary: The development of a personalized therapeutic education program dedicated to patients with metastatic prostate cancer and receiving next-generation hormone therapy would improve their knowledge of the disease, medication adherence and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic prostate cancer treated with enzalutamide or abiraterone acetate for at least 3 months
* The patient must have given their free and informed consent and signed the consent form
* The patient must be insured or the beneficiary of an insurance policy

Exclusion Criteria:

* The subject is not in a fit state to express their consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship

Primary outcomes:
measure: Create a focus group
timeFrame: Day 0
measure: Patient satisfaction
timeFrame: End of workshops (max 2 months)
measure: Successful running of workshop
timeFrame: End of workshops (max 2 months)
Secondary outcomes:
measure: Patient participation rate in workshops
timeFrame: End of workshops (max 2 months)
measure: Patient-reported acceptability of programme
timeFrame: End of workshops (max 2 months)
measure: Patient-reported satisfaction of programme
timeFrame: End of workshops (max 2 months)
measure: Patient knowledge of their disease
timeFrame: End of workshops (max 2 months)
measure: Patient quality of life
timeFrame: 1 month after last workshop
measure: Patient medication adherence
timeFrame: End of workshops (max 2 months)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Nadine Houede
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02090452: Mobile Transmission of Prehospital Vital Signs to the Emergency Department
Official title: Telemedical Solutions in Medical Emergencies, Advantages and Disadvantages for Patients, Healthcare Professionals, and the Healthcare System: Study 1: "Mobile Transmission of Prehospital Vital Signs to the Emergency Department - Effect on Patient Outcomes, Treatment and Diagnosis"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Triage
Emergency Medical Service
Keywords: Telemedicine
Mobile
Vital signs
Prehospital care
Emergency medicine
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Central Denmark Region
First posted: 2014-03-18
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine if real time transmission of vital signs, ECG and chat communication between the prehospital ambulances and the emergency department has an effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to treatment and time to diagnostics


Eligibility criteria: Inclusion Criteria:

* All patients transported with ambulance to the emergency department

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to physician
timeFrame: Time from arrival to first patient-physician contact, assessed up to 36 months
Secondary outcomes:
measure: All cause mortality
timeFrame: 30 days, assessed up to 36 months
measure: Time to treatment
timeFrame: Time from arrival to administration of first iv. antibiotics, assessed up to 36 months
measure: Time to x-ray
timeFrame: Time form arrival at the emergency department to completion of x-ray requisition form, assessed up to 36 months
measure: Time to ICU
timeFrame: Time from arrival to admission to the ICU, assessed up to 36 months
measure: Number of ICU admissions
timeFrame: During present hospitalization, assessed up to 36 months
Other outcomes:
measure: Emergency department staff evaluation of usability of equipment
timeFrame: At the time of using the equipment, assessed up to 36 months
measure: Ambulance staff evaluation of usability of equipment
timeFrame: At the time of using the equipment, assessed up to 36 months
Locations:
city: Aarhus N
country: Denmark
facility: Prehospital Emergency Medical Services, Aarhus, Central Denmark Region
city: Horsens
country: Denmark
facility: Horsens Regional Hospital, Central Region Denmark
city: Horsens
country: Denmark
facility: Responce A/S
Study officials:
affiliation: Central Denmark Region
name: Erika F. Christensen, MD, Medical director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06910852: Hepatic and Portal Vein Transection by Vascular Stapler in Open Living Donor Hepatectomy
Official title: Hepatic and Portal Vein Transection by Vascular Stapler in Open Living Donor Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatectomy
Lead sponsor: Jordan Hospital
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing open living donor hepatectomy at Jordan Hospital.

Brief summary: To enhance donor safety in living donor liver transplantation (LDLT), the use of vascular staplers for the division of the right portal and hepatic veins in patients undergoing right lobe liver donation has been introduced. This study examines the application of vascular staplers in LDLT and assesses the subsequent feasibility and safety outcomes for donors.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing open living donor hepatectomy
* Age ≥ 18 years, ≤ 80 years
* Written informed consent

Exclusion Criteria:

* None.

Primary outcomes:
measure: Post-operative complications (Clavien-Dindo classification)
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan Hospital Amman
Study officials:
References:
Clinical trial NCT00347100: Insulin Glargine in Type 2 Diabetic Patients
Official title: Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary:

* To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c \< 7%)

Secondary:

* To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia)
* To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patients with first OAD (Sulfonylurea \[SU\] or Metformin) failure
* Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
* Serum creatinine ≤ 1.5mg/dL
* BMI: 21-41 kg/m²
* 7.5%\< A1c \<11%
* Fasting plasma glucose \> 7.5mmol/L
* On diet and exercise therapy and stable OAD treatment (SU or metformin \> ½ maximal dose)for more than 1 month prior to enrolment
* Women not of childbearing potential (sterilization procedure done or menopausal \> 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
* Able and willing to monitor blood glucose
* Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
* Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin

Exclusion Criteria:

* Type 1 diabetes
* Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
* Pregnancy, breast-feeding
* People who work night shifts
* Hypersensitivity to investigational drugs or its additives, or intolerability to metformin
* Need for use of medications prohibited by the protocol during the study for treatment purpose
* Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
* Drugs or alcohol abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: A1c values
timeFrame: At baseline and 24 weeks
Secondary outcomes:
measure: Adverse events including hypoglycemia
timeFrame: From the beginning to the end of the study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Bruno Jolain
role: STUDY_DIRECTOR
References:
Clinical trial NCT04370652: Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum
Official title: Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum (CCH or Xiapex®): Sexual and Psychological Impact and Results From 156 Patients' Questionnaires Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peyronie Disease
Keywords: Collagenase Clostridium Histolyticum
Xiapex®
Peyronie's Disease Questionnaire (PDQ)
Sexual dysfunction
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution

Brief summary: Peyronie's disease is the appearance of a fibrosis plaque on the albuginea of the corpora cavernosa, which produces mechanical traction at the time of erection, inducing a deformation/curvature of the erect penis. The physiopathology is largely unknown.

There is a significant sexual and psychological impact on patients. Historically, the only possible treatment was surgical. The only drug treatment that was FDA approved for this disease was Collagenase from Clostridium Histolyticum marketed under the name Xiapex® until 31/12/2019 by Sobi laboratory. Marketing was stopped on that date for economic reasons and restricted to the US market only.

The investigators propose a retrospective evaluation of the largest French monocentric series of this treatment from the perspective of the sexual and psychological evaluation of patients.


Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years old
* Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
* Angle of penis deformation ≥ 30°

Exclusion criteria:

* Surgery for Peyronie's disease before
* Anticoagulation

Primary outcomes:
measure: Peyronie's Disease Questionnaire (PDQ)
timeFrame: every 4 weeks for 2 years
Secondary outcomes:
measure: Penile curvature angulation
timeFrame: every 4 weeks for 2 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Edouard Fortier, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00523952: Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients
Official title: A 12-week, Exploratory, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Keywords: dermatitis, atopic
tacrolimus
adult
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 303
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared

Detailed description: The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).

Eligibility criteria: Inclusion Criteria:

* Male or female, any ethnic group, age ≥16
* Moderate to severe atopic dermatitis
* Has given informed consent

Exclusion Criteria:

* Erythroderma
* Pregnant or breast-feeding
* Skin infection on the affected area

Primary outcomes:
measure: Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study Visit
timeFrame: 12 weeks
Secondary outcomes:
measure: Physician's evaluation of clinical response
timeFrame: 12 weeks
measure: Patient's assessment of global response
timeFrame: 12 weeks
measure: Affected body surface area
timeFrame: 12 weeks
measure: Quality of Life at Baseline/Day 1 and Week 12/End of study
timeFrame: 12 weeks
measure: Changes of mEASI
timeFrame: 12 weeks
measure: Incidence of adverse events during the study, including all clinically significant laboratory values
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Prague
country: Czech Republic
city: Tabor
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Györ
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Bialystok
country: Poland
city: Czestochowa
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Sopot
country: Poland
city: Szczecin
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: Astellas Pharma GmbH
name: Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT06862752: Erector Spinae Plane Block Versus Serratus Anterior Plane Block
Official title: Bilateral Ultrasound-Guided Erector Spinae Plane Block or Serratus Anterior Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Opioid-Related Disorders
Keywords: post operative pain
opioid consumption
erector spinae block
serratus anterior plane block
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the study compare the analgesic effect of erector spinae block and serratus anterior block in breast surgery

Detailed description: Breast reduction surgery is a common cosmetic surgical procedure. Providing effective analgesia has a crucial role in reducing side effects, catalyzing postoperative recovery, and increasing patient satisfaction. Regional anesthesia techniques are generally used for postoperative analgesia to decrease opioid-related side effects. Fascial plane block has gained popularity for breast analgesia. The investigator aimed to consider the effects of ESP block or Serratus Anterior Plane block on postoperative analgesia in breast reduction surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II,
* 18-65 years of age, adult,
* female patients
* undergoing elective breast reduction surgery

Exclusion Criteria:

* Allergy to amide-type local anesthetics
* Infection at the block injection site
* Severe obesity (BMI \> 35 kg/m2)
* Liver or renal deficiency
* Patients with anatomical deformities
* Recent use of analgesic drugs
* Patient refusal or inability to consent

Primary outcomes:
measure: Opioid consumption
timeFrame: 24 hour
Secondary outcomes:
measure: Pain assessed by NRS
timeFrame: 24 hour
measure: Rate of opioid related side effects
timeFrame: 24 hour
measure: Blooad loss
timeFrame: during surgery
measure: Remifentanil consumption
timeFrame: during surgery
measure: Length of stay in hospital
timeFrame: 30 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli etfal research and training hospital
Study officials:
affiliation: SISLI HAMIDIYE ETFAL RESEARCH AND TRAINING
name: AYSE SURHAN CINAR
role: STUDY_CHAIR
References:
Clinical trial NCT00572052: Comparison of Glycemic Control Achieved With 2 Different Needles
Official title: Comparison of Glycemic Control Achieved With a 31 Gauge x 6 mm NovoFine® Needle vs. a BD 29 Gauge x 12.7 mm Ultra-Fine® Needle in Subjects With Diabetes Mellitus and a BMI Exceeding 30 kg/m2: An Open Label, Randomized, Two-Period Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the 29 gauge x 12.7 mm needle in obese subjects with diabetes.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* Current treatment with insulin or insulin analogues for the last 6 months
* BMI greater than or equal to 30.0 kg/m2
* Currently injecting in the thigh or abdomen
* HbA1c below 10%

Exclusion Criteria:

* Severe, uncontrolled hypertension
* Self-mixing insulin
* Unwillingness to monitor blood glucose
* Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures

Primary outcomes:
measure: HbA1c
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Subject preference and handling
measure: Frequency of hypoglycaemic episodes
measure: Quality of Life
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Berlin
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Kettering
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Schwartz S, Hassman D, Shelmet J, Sievers R, Weinstein R, Liang J, Lyness W. A multicenter, open-label, randomized, two-period crossover trial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge x 6 mm needle versus a 29 gauge x 12.7 mm needle in obese patients with diabetes mellitus. Clin Ther. 2004 Oct;26(10):1663-78. doi: 10.1016/j.clinthera.2004.10.007.