louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06078943: ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood
Official title: ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Blood gas
Lead sponsor: Radiometer Medical ApS
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 612
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.

Detailed description: The main question it aims to answer is:

To quantify the relationship using comparison measurement from the same sample between the test device and the predicate device within the reportable range for ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode (S65, SP65) and heparinized mixed venous/arterial whole blood samples in capillary measuring mode (C65).

Eligibility criteria: Inclusion Criteria:

* The following are the inclusion criteria for the neonatal subjects:

  * The age of the subject must be ≤28 days.
  * Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
  * Subjects having a sample drawn as part of standard of care that meets the requirements for samples in this study.

The following are the inclusion criteria for the subjects providing placenta for cord blood:

• Delivery ≥38 weeks of gestation.

Exclusion Criteria:

* The following are the exclusion criteria for the neonatal subjects:

  * Subject who has already provided successful results from arterial, venous and mixed venous/arterial samples, to cover both syringe modes and the capillary mode and parameters.
  * Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.
  * Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).

The following are the exclusion criteria for the subjects providing placenta for cord blood:

• Subjects positive of HIV or Hepatitis C

Primary outcomes:
measure: Slope, R^2 and bias
timeFrame: 6-9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St Louis Children's Hospital
state: Missouri
Study officials:
affiliation: St. Louis Children's Hospital
name: Dennis Dietzen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06297343: Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
Official title: Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Renal Failure
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-03-07
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned.

Brief summary: The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.

Detailed description: This is a non-interventional, prospective, non-randomised, descriptive, single-centre study with no comparator.

The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned.

Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation, during which the surgeon will explain the principle of the operation and the expected benefits/risks. On the day of surgery, patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day. Patients will be reviewed during post-operative follow-up visits at 1, 6 and 12 months as in standard practice. All the data collected in the study were collected in routine medical practice.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Stage 5 chronic kidney disease, on dialysis or not on dialysis;
* Requiring the creation of an arteriovenous fistula;
* Membership of a social insurance scheme;
* Patient having been informed and having formulated his/her oral non-opposition to participate in the research.

Exclusion Criteria:

* Contraindication to the proposed surgery ;
* Reduced life expectancy in the opinion of the investigator;
* Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient;
* Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre;
* Other surgical or medical intervention planned during the study;
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient under guardianship or deprived of liberty.

Primary outcomes:
measure: Occurrence of ischaemia of the hand
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Privé des Peupliers
Study officials:
References:
Clinical trial NCT03677843: Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline
Official title: Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy, Spastic
Keywords: hip dislocation
GMFCS level 3,4,5
scoliosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Serious cerebral palsy children(GMFCS 3,4,5) have secondary problems such as hip dislocation and scoliosis. and There are many preliminary reports that hip dislocation occurs from 2 years of age or older.

Brief summary: In children with cerebral palsy, secondary problems lead to hip dislocation and scoliosis. But There is no definite evidence for the dislocation of hip and scoliosis. The investigators want to verify evidence of scoliosis and dislocation of hip.

Detailed description: Observation cohort study. The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor muscles pressure test and electromyography(EMG test) test of hip adductor and spine muscles

Eligibility criteria: Inclusion Criteria:

* Severe cerebral palsy patients(GMFCS level 3,4,5)
* 2 to 10 years old

Exclusion Criteria:

* Those who disagree with the study.
* other than cerebral palsy.

Primary outcomes:
measure: hip adductor and spin muscles electromyography(EMG) test
timeFrame: once at study, when patient enrolled
Secondary outcomes:
measure: Whole spine AP and total Hip AP X-ray photograph
timeFrame: once at study, when patient enrolled and after once every six months for three years
measure: hip adductor muscles pressure meter test
timeFrame: once at study, when patient enrolled
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01852643: Spreader Graft and Lateral Crural Overlay Technique in Rhinoplasty
Official title: Determine and Compare the Finding of Rhinomanometry Before and After Treatment in Two Ways of Rhinoplasty Surgery (Spreader Graft and Lateral Crural Over Lapping)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rhinoplasty Techniques
Keywords: Rhinoplasty
Spreader graft technique
Lateral crural overlay technique
Rhinomanometry
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-05-14
Enrollment: 50
Sex: ALL
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: Most of the studies performed to compare the present techniques of rhinoplasty have been based on the clinical examination and change of postoperative complaints that cannot be very precise in evaluating the advantages of one technique over another. Therefore, in this study the investigators are going to compare the efficacy of spreader graft and lateral crural overlay techniques by an objective method, rhinomanometry.


Eligibility criteria: Inclusion Criteria:

* Candidates of rhinoplasty
* Willingness to participate

Exclusion Criteria:

* Having structural problems such as nasal obstruction
* History of the deformity requiring rhinoplasty of the deviated septum
* Hardening surgery
* New clinical conditions or a change in therapeutic technique
* Unwillingness to continue participating in the study
* Having no access to subjects after the operation

Primary outcomes:
measure: Nasal flow
timeFrame: Up to 3 months
measure: Nasal resistance
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Department of Plastic Surgery, Alzahra Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Amiryousef Ahmadnia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01924143: TD-9855 Mass Balance Study
Official title: An Open-Label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-9855 Following a Single Oral Dose Containing Approximately 100 µCi [14C]-Labeled TD-9855 (20 mg) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: ADHD
Fibromyalgia
Keywords: ADHD
Fibromyalgia
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2013-08-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of \[14C\]TD-9855


Eligibility criteria: Inclusion Criteria:

* Healthy, nonsmoking male subjects or healthy, nonsmoking female subjects not of childbearing potential, 18 to 50 years old, inclusive. Women are considered to be not of childbearing potential if they have had a hysterectomy or tubal ligation or are at least 2 years postmenopausal (follicle-stimulating hormone \[FSH\] \>40 IU/mL)
* Body mass index 19 to 31 kg/m2, inclusive, and weight at least 55 kg
* Negative for hepatitis B, hepatitis C, and HIV antibody

Exclusion Criteria:

* Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, dermatologic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
* Subjects who, in the opinion of the investigator, are at risk for suicide or risk of harming others, or who score positive on the C-SSRS (item 2 or higher on ideation). Subjects with any history of suicide attempts
* Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\])
* Infrequent bowel movements (less than once per 24 hours) in the last 7 days prior to Day -1. Subject is unable to provide a fecal sample prior to study drug dosing on Day -1 or Day 1.

Primary outcomes:
measure: To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855
timeFrame: 1-21 Days
Secondary outcomes:
measure: Pharmacokinetics of total drug-related material and TD-9855: Cmax
timeFrame: 1-21 Days
measure: PK: Tmax
timeFrame: 1-21 Days
measure: PK: AUCt
timeFrame: 1-21 Days
measure: PK: AUCinf
timeFrame: 1-21 Days
measure: PK: CL/F (Renal clearance)
timeFrame: 1-21 Days
measure: PK: Vz/F (oral volume of distribution during the terminal phase)
timeFrame: 1-21 Days
measure: PK: amount excreted in urine (Ae)
timeFrame: 1-21 Days
measure: PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)
timeFrame: 8-21 Days
measure: Metabolic profiles in plasma and excreta
timeFrame: 1-21 days
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04958343: Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male
Official title: Application and Clinical Effectiveness of Pelvic Reconstruction in Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder in the Male
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: The Seventh Affiliated Hospital of Sun Yat-sen University
First posted: 2021-07-12
Enrollment: 100
Sex: MALE
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: Enroll patients who received RARC.

Brief summary: To study the effect of pelvic reconstruction on early return of continence after robot-assisted radical cystectomy-orthotopic ileal neobladder in the male.

Detailed description: This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy-orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to whether received pelvic reconstruction or not. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
4. Patients those who are able to cooperate and complete the follow-up.
5. Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion Criteria:

1. Patients thsoe who are diagnosed distant metastasis before surgery.
2. Patients those who are diagnosed with other malignancies.
3. Patients those who had received pelvic radiotherapy or major pelvic operation.

Primary outcomes:
measure: day-time and night-time continence rate
timeFrame: 6 months
Secondary outcomes:
measure: perioperative complication rate
timeFrame: 3 months
measure: operative time
timeFrame: 24 hours
measure: estimated blood loss
timeFrame: 24 hours
measure: overall survival
timeFrame: 1 year
measure: recurrence-free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05726643: Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors
Official title: Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Fatigue
Quality of Life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study will be to investigate the effect of kinesotaping augmented by resistive exercise on fatigue, muscle strength, and QoL in breast cancer survivors.

Detailed description: The present study will provide an evidence base to women's health care providers about the effect of strength training augmented by kinesotaping on fatigue, QoL and muscle strength in breast cancer women compared to strength training alone

Eligibility criteria: Inclusion Criteria:

* Patient's age will range from 40- 55 years.
* Their body mass index (BMI) will be from 25 to 29,9 Kg/m2.
* They suffer from breast cancer.
* They will receive chemotherapy within previous 3 months.
* They complain from fatigue, deterioration in their daily living activity (ADL) and feeling of weakness in their muscles.

Exclusion Criteria:

* Respiratory or heart problems affecting mobility
* Marked skeletal deformity.
* Visual system affection.
* Cognition problems.
* Previous surgeries at their back and/or lower limbs.

Primary outcomes:
measure: Assessing the change in fatigue
timeFrame: at baseline and after 12 weeks of intervention
measure: Assessing the change in quality of life
timeFrame: at baseline and after 12 weeks of intervention
measure: Assessing the change in muscle strength
timeFrame: at baseline and after 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physica therapy cairo university
Study officials:
affiliation: Cairo University
name: Alaa Negm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01484743: Risk Factors for Morbidity After Parastomal Hernia Repair
Official title: Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Parastomal Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parastomal Hernia
Keywords: recurrence
readmission
reoperation
mortality
morbidity
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 199
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: All incisional hernia repairs registered in the Danish National Hernia Database from January 1st 2007 to December 31st 2010

Brief summary: The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair.

Detailed description: All principal parastomal hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility criteria: Inclusion Criteria:

* All parastomal hernia repairs registered in the Danish National Ventral Hernia Database

Primary outcomes:
measure: Recurrence repair
timeFrame: up to 4 years after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Køge Hospital
state: Region Sjælland
Study officials:
affiliation: Dept. surgery Koege hospital
name: Frederik Helgstrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04481243: A Study to Evaluate Pneumococcal Polysaccharide Vaccine Effectiveness in Children With Type 1 Diabetes
Official title: Vaccine Effectiveness and Seroconversion to 23 Valent Pneumococcal Polysaccharide Vaccination in Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 29
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Will study immunological response to vaccination
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if children with type 1 diabetes have adequate immune response to PPSV23 vaccination and to assess factors affecting immune response.


Eligibility criteria: Inclusion Criteria:

* Children ages 3-18 years old.
* Clinical diagnosis of Type 1 diabetes.

Exclusion Criteria:

* Newly diagnosed with Type 1 diabetes with in the past month of study date.
* Contraindications to receiving 23 valent pneumococcal vaccines.
* Other conditions associated with compromised immunity and vaccine response.
* Primary or Secondary Immune deficiency.
* Previous receipt of PPSV-23 vaccination.

Primary outcomes:
measure: Immunoglobulin G (IgG) Antibodies
timeFrame: 6 months post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ana Creo, MD
role: PRINCIPAL_INVESTIGATOR
References: