louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05190484: bIosimilar of aDalimumab, an European evAluation
Official title: An International, Prospective, Observational Study of Patients With Chronic Inflammatory Diseases, to Assess 12-months Persistence Drivers After Switching to an Adalimumab Biosimilar, Idacio®, in a Real World Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Crohn Disease
Ulcerative Colitis
Keywords: adalimumab
biosimilar
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 1050
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 study population will include male and female adult patients with an IMID who were prescribed FK adalimumab, meet all the study inclusion criteria and none of the exclusion criteria and provide written informed consent to participate.

Brief summary: The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years, male or female.
2. Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases.
3. Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar.
4. Patients who have been prescribed FK adalimumab according to the SmPC prior to the inclusion.
5. Patients able to understand and complete the study questionnaires in local language during the study visits.
6. Patients willing to sign informed consent to meet data protection requirements

Exclusion Criteria:

1. Unwillingness to provide written informed consent.
2. Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab.
3. Patients not expected to be available for study visits during 12 months.

Primary outcomes:
measure: TREATMENT DISCONTINUATION
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01801579: Reproducibility of Ankle Brachial Index After Maximal Exercise
Official title: Reproducibility of the Ankle-Brachial Index Measurements After a Maximal Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Subjects
Keywords: Ankle Brachial Index
Maximal exercise
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Institut de formation en éducation physique et en sport d'Angers/Les Ponts de Cé
First posted: 2013-03-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: health volunteers over 18 years old

Brief summary: Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method.

Detailed description: Two methods are mainly used to determine the blood pressure at rest, in a non-invasive way, in order to calculate the Ankle-Brachial Index (ABI). The first method, using a manual sphygmomanometer coupled with a Doppler probe, is considered as the reference method. The second method requires at least one automatic sphygmomanometer. Data from the literature show that these two methods are reproducible to assess ABI at rest. Some authors have reported a better reproducibility of measurements with automatic tool. Others consider that the current accuracy of automatic measurement is insufficient to replace the reference method Doppler. Thus, the aime of the present study is to evaluate whether automatic assessment of ABI is as reliable and reproducible as the manual method.

Eligibility criteria: Inclusion Criteria:

* Participant between 18 and 40 years old
* Informed consent signed
* Exclusion Criteria:
* Do not want to participate to the protocol
* Pregnant woman
* Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
* Being in a period of exclusion from another biomedical study
* Amputee or with a member dysgenesis
* Not allowed to perform a maximal exercise

Primary outcomes:
measure: Test-retest difference in ankle to brachial pressure index
timeFrame: up to 2 week
Secondary outcomes:
measure: Duration of recordings.
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Angers
name: Antoine BRUNEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01889979: Tramadol for Labour Analgesia in Low Risk Primiparous Women
Official title: Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain During Labour
Keywords: Pain during labour
Duration of labour
Apgar score
Umbilical cord pH
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). The purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.


Eligibility criteria: Inclusion Criteria:

* Gestational age between 37 and 40 6/7 weeks
* Primiparous patient
* Singleton
* 4 to 5 cms of dilation
* Intact membranes or spontaneous rupture of membranes less than 2 hours
* Fetus in a vertex presentation
* Gynecoid pelvis by clinical examination

Exclusion Criteria:

* Multiparous
* Multiple pregnancies
* Any pathology
* Induction of labour with prostaglandins

Primary outcomes:
measure: Pain during labour
timeFrame: 6 hours
Secondary outcomes:
measure: Duration of labour
timeFrame: 12 hours
measure: Neonatal outcomes
timeFrame: 48 hours
measure: Side effects
timeFrame: 48 hours
measure: Requirements of oxytocin
timeFrame: 12 hours
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Maternity Hospital
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Maternity Hospital
name: Riggie Castillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03492879: Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
Official title: Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Liver Disease
Fibrosis, Liver
Non-Alcoholic Fatty Liver Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-04-10
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aims of this study are to assess the performance of the non-invasive Electrical Impedance Technology (EIT) in evaluating the liver fibrosis stage in patients with chronic liver diseases, in comparisons with a liver biopsy and/or Shear wave elastography and Liver Ultrasonography.

The second aim is comparing between Liver Ultrasonography and Electrical Impedance Technology (EIT) to quantify the hepatic steatosis grade in patients with Non Alcoholic Fatty Liver Disease (NAFLD) .

Detailed description: The study will include 210 patients with chronic liver diseases. Relevant clinical data such as sex, age, weight, height, alcohol intake, medical history and routine lab results will be collected.

The study will include three groups:

1. Patients with indication for liver biopsy will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT) (70 patients).
2. Patients with chronic liver diseases will undergo routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT) (70 patients).
3. Patients with Non Alcoholic Fatty Liver Disease will undergo routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT) (70 patients).

Eligibility criteria: Inclusion Criteria:

* Patients with chronic liver diseases

Exclusion Criteria:

* Patients who don't have chronic liver diseases

Primary outcomes:
measure: Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT)
timeFrame: Each technology will be performed once in 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Ziv Ben-Ari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01359579: A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
Official title: A Phase 1, Open-label, Pharmacokinetic, Safety, and Tolerability Study of a Single Oral Dose of Varespladib Methyl in Subjects With Normal Renal Function, and Subjects With Mild, Moderate, or Severe Renal Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: renal impairment
phase 1
healthy volunteers
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive.
* Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae

Exclusion Criteria:

* Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk
* Evidence of significant respiratory, gastrointestinal or hepatic disease at screening
* Positive screen for hepatitis B surface antigen, or HIV
* Positive test in drugs of abuse screens or alcohol on admission to the clinic

Primary outcomes:
measure: Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
timeFrame: PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose
Secondary outcomes:
measure: Safety measures to include adverse events and changes in clinical laboratory results
timeFrame: From admistration of study drug through follow-up on Day 8
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Investigator Site 101
state: Florida
city: Minneapolis
country: United States
facility: Investigator Site 102
state: Minnesota
city: Knoxville
country: United States
facility: Investigator Site 103
state: Tennessee
Study officials:
References:
Clinical trial NCT03966079: Thrombolysis Endovascular Treatment of Pulmonary Embolism
Official title: Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Embolism
Acute Pulmonary Embolism
Keywords: Acute Pulmonary Embolism
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Single Group Assignment
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA

Detailed description: The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.

Eligibility criteria: Inclusion Criteria:

* CT evidence of proximal PE
* Age ≥ 18 years
* Pulmonary embolism symptom duration ≤14 days
* Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT)

Exclusion Criteria:

* Age \<18 years
* PE symptom duration \>14 days
* Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
* Recent (within one month) or active bleeding from a major organ
* Pregnancy
* Chronic pulmonary hypertension or severe chronic obstructive pulmonary disease
* Administration of thrombolytic agents within the previous 3 days
* Life expectancy \< 30 days
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
* Inability to follow protocol requirements

Primary outcomes:
measure: Change of RV to LV Diameter Ratio
timeFrame: baseline and 30days after baseline
Secondary outcomes:
measure: Rate of death
timeFrame: 30days
measure: Rate of major Bleeding
timeFrame: 30days
measure: Pulmonary embolism recurrence
timeFrame: 30days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
state: Beijing
Study officials:
affiliation: Director of department
name: Wu weiwei, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06768879: Sonographic Evaluation Of Uterine Fibroids At Different Locations In Patient With Irregular Menstrul Cycle
Official title: Sonographic Evaluation Of Uterine Fibroids At Different Locations In Patient With Irregular Menstrul Cycle
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Menstrual Irregularity
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 97
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aim is to check Irregular Menstrul Cycle with Sonographic Evaluation Of Uterine Fibroids

Brief summary: Uterine fibroids are a major cause of illness in women of a reproductive age. There are many factors involved in the growth and reduction of these common tumors. The most likely cause of fibroids is their effect on a woman's menstrual cycle. For accurate diagnosis numerous diagnostic markers on ultrasound are present which increases the efficacy of ultrasound to diagnose uterine fibroids.

Detailed description: To evaluate the different location of uterine fibroids in patient with disturbed menstrual cycle on Ultrasound.

The descriptive and cross-sectional study was conducted. A total of 97 patient data were collected. All the patients with uterine fibroids due to heavy bleeding, abdominal pain, pelvic pain, disturbance in menstrual cycle undergoing ultrasound were included.

Eligibility criteria: Inclusion Criteria:

* Patient with Pelvic pain
* Patient with Abdominal pain
* Patient with heavy bleeding
* Patient with Dysmenorrhea
* Polymenorrhea

Exclusion Criteria:

* Patient with H/O Cystectomy
* Patient with H/O cyst

Primary outcomes:
measure: two-dimensional ultrasound scan (GE Loginq P7 convex probe.3.5-5MHz)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Pattoki
country: Pakistan
facility: THQ hospital Pattoki/ Siddique medical center Pattoki
state: Punjab
Study officials:
References:
Clinical trial NCT04656379: The Incidence and Risk Factors of Postoperative Delirium
Official title: The Incidence and Risk Factors of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium in Old Age
Keywords: postoperative delirium
elderly
spine surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥65 and underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital

Brief summary: Delirium is known to be one of the most common postoperative complications in elderly patients undergoing surgery. Because postoperative delirium can affect the length of hospital stay and prognosis significantly, it is important to identify the risk factors for postoperative delirium in advance. However, there have been few reports concerning intraoperative modifiable risk factors, such as postoperative pain, for postoperative delirium.

Detailed description: In this observational study, we will review the electronic medical records of elderly patients underwent spine surgery and assess the incidence and risk factors for postoperative delirium.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital

Exclusion Criteria:

* Patients who had no information on postoperative care and managements.

Primary outcomes:
measure: Incidence of delirium
timeFrame: through study completion, postoperative period up to 2 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03152279: Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance
Official title: Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Celiac disease patients will be identified in the Celiac Disease Clinic at Vanderbilt. Patients will be asked if they would like to participate in the study during their clinic visit and will undergo consent for the study at the time of procedure. Control subjects will be asked about participation at the time of routine endoscopy.

Brief summary: Increased intestinal permeability can represent compromise of the epithelium's integrity and is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune response. In this study, the investigators propose to use a novel, minimally invasive technology to detect mucosal damage (i.e. barrier dysfunction) in the duodenal epithelium. The primary aim of this study is to identify if there is a difference in duodenal mucosal impedance between CeD and control patients.


Eligibility criteria: Inclusion Criteria:

* scheduled for endoscopy as part of routine care with or without suspected Celiac Disease based upon at least 1 positive serologic marker of CeD
* consuming gluten at time of endoscopy

Exclusion Criteria:

* Already on a gluten free diet or unwilling to undergo a gluten challenge
* Undergoing upper endoscopy for an urgent indication such as unstable gastrointestinal bleed or food impaction
* Patients with inflammatory bowel disease
* Patients on blood thinners other than aspirin at time of endoscopy
* Patient unable to give informed consent
* Patient less than 18 years old

Primary outcomes:
measure: mucosal impedance values
timeFrame: Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes
Secondary outcomes:
measure: Marsh Score
timeFrame: 1 week
measure: IFABP
timeFrame: 1 week
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Endoscopy Laboratory
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Dhyanesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: