louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00486928: Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis
Official title: Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Keywords: Valves, heart disease, prosthesis.
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2007-06-15
Enrollment: 816
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients undegoing AVR during inclusion period

Brief summary: Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet HF in the period 1977-87. In the present study we followed all 816 patients undergoing aortic valve replacement (AVR) over a 25-year period.

Detailed description: The Medtronic-Hall (MH) tilting valve disk was first implanted in Oslo in June 1977. From 1977 through 1987, the valve was used as the only valve of choice and inserted in a total of 1,104 consecutive patients at our department.

The MH valve is made of a single piece of titanium with no welds. The disk is made of tungsten impregnated graphite with a carbon pyrolytic coating. The tungsten renders the disk radiopaque. In the aortic position the maximal opening is 75˚. A central aperture in the disk allows free rotation. The valve is rotatable in the sewing ring. The sewing ring is made of Teflon. Aortic sizes are 20-31 mm (outer diameter).

The initial clinical results were published in 1979 (1). The cohort of patients has been followed-up and analysed at 5, 10 and 15 years (2-5). In the present study we report our 25-year follow-up data for the 816 patients undergoing aortic valve replacement (AVR) with special reference to survival, functional status, valve-related complications and the impact of concomitant surgery.

Eligibility criteria: Inclusion Criteria:

* All patients with aortic valve replacement 1977-87

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet
Study officials:
affiliation: Rikshospitalet, Oslo
name: Jan L Svennevig, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238328: Hematopoietic Stem Cell Transplantation for Mucopolysaccharidosis
Official title: Hematopoietic Stem Cell Transplantation for Mucopolysaccharidosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Mucopolysaccharidosis
Keywords: Mucopolysaccharidosis
HSCT
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 10
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic cells using chemotherapy regimen without total-body irradiation in children undergoing a hematopoietic stem cell transplant for Mucopolysaccharidosis. The blood stem cells will be derived from either related donor or unrelated umbilical cord blood or haploidentical donor.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Mucopolysaccharidosis type 1, 6 and 7 confirm by leukocyte enzyme assay
* Age up to 8 year old
* Have suitable donor

Exclusion Criteria:

* Creatinine clearance ≤ 40ml/min/1.73m\^2
* Bilirubin ≥ 3mg/dL
* SGPT ≥ 500 U/L
* Current severe infection
* Evidence of CNS involvement
* Morbidity such as blindness or deafness

Primary outcomes:
measure: Overall Survival and Progressive Free Survival in patient with Mucopolysaccharidosis who receive allogeneic Hematopoietic stem cell transplantation (HSCT)
timeFrame: 1 year
Secondary outcomes:
measure: One year overall survival after allogeneic hematopoietic stem cell transplantation (HSCT)
timeFrame: 1 year
measure: One year Progressive Free Survival after allogeneic hematopoietic stem cell transplantation (HSCT)
timeFrame: 1 year
measure: Transplantation Related Mortality (TRM) after allogeneic hematopoietic stem cell transplantation (HSCT)
timeFrame: 1 year
measure: Acute and chronic Graft-versus-host disease (GVHD) rate after allogeneic hematopoietic stem cell transplantation (HSCT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Teharn
country: Iran, Islamic Republic of
facility: Hematology-Oncology & SCT Research Center
state: Tehran
Study officials:
References:
Clinical trial NCT01357928: Thromboelastography (TEG) Reference Range Study
Official title: Procedure for the Reference Range Study for Haemoscope Reagents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation
Keywords: TEG
Thromboelastography
Coagulation
Lead sponsor: Haemonetics Corporation
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 159
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: community sample

Brief summary: As part of a system wide reagent verification plan Haemoscope Corporation will be running a study to verify the reference intervals of many of the reagents. Reference intervals will be constructed following the guidelines set out in CLSI document C28-A3c. This guideline calls for a reference interval to be constructed from at least 120 donors. Some reagents currently have ranges in place based on fewer donors than that stated in the guideline. This procedure will provide additional testing results to meet the requirements outlined in the CLSI guideline. Reagents that currently have no reference intervals will be tested and will include a minimum of 146 donors.


Eligibility criteria: Inclusion Criteria:

* Male or Female over the age of 18 years.

Exclusion Criteria:

* Genetic bleeding disorders
* Currently Pregnant
* Oral Contraceptives
* On anti-coagulants or anti-platelet therapy
* Took ASA (Acetylsalicylic Acid)within 1 week prior
* Recent surgery (within 4 weeks)
* Recent injury leading to substantial bruising (within 2 weeks)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore-Long Island Jewish Health System
state: New York
Study officials:
affiliation: NSLIJ Health System
name: William A Heaton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06951828: A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects
Official title: A Phase I, Randomized, Open-label, Two-Arm, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2025-04-30
Enrollment: 160
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 in Healthy Male Subjects.

Detailed description: CT-P43, containing the active ingredient ustekinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Stelara. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 will be evaluated in Healthy Male Subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, between the ages of 19 and 55 years, both inclusive.
* Subject has a body weight between 60 to 90 kg, both inclusive, and a BMI between 18.5 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth.

Exclusion Criteria:

* A medical history and/or condition that is considered significant
* Clinically significant allergic reactions, hypersensitivity
* History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
* Active or latent Tuberculosis
* History of malignancy
* Previous exposure to ustekinumab or a biosimilar of ustekinumab or any drug that directly targets interleukin (IL)-12, IL-17 or IL-23

Primary outcomes:
measure: PK similarity demonstration by AUC 0-inf
timeFrame: Day113
measure: PK similarity demonstration by Cmax
timeFrame: Day113
Secondary outcomes:
measure: Additional PK evaluation
timeFrame: Day113
measure: Safety evaluation by AEs
timeFrame: Day113
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
Study officials:
affiliation: Korea University Guro Hospital (Department of Clinical Pharmacology)
name: Hyewon Chung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06684028: PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors
Official title: PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Solid Malignancies
Keywords: FAP
FAPI
PET
cancer
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values.

Detailed description: PET/CT imaging was performed about 1 hour after the patient was injected with the novel tracer 68Ga-FAPI-JNU. SUVmax and SUVmean values of the area of interest were mapped by two diagnostic physicians with more than 5 years of experience after the imaging was completed.

Eligibility criteria: Inclusion Criteria:

1. The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
2. Age 18-85 years old, male or female;
3. Clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as CT and MRI;
4. ECOG score is 0-3 points;

Exclusion Criteria:

1. Patients with a history or allergic constitution to any component of the developer, including alcohol;
2. pregnant or lactating women;
3. Patients with mental illness or related history;
4. Patients who cannot or cannot undergo a PET/CT scan;

Primary outcomes:
measure: Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues
timeFrame: 4 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiated Hospital of Jiangnan University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00918528: Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Urethral Stricture
Keywords: Urethral stricture
Mitomycin C
Internal Urethrotomy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-06-11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.


Eligibility criteria: Inclusion Criteria:

* Male urethral stricture suitable for internal urethrotomy
* Stricture length less than 10 mm

Exclusion Criteria:

* Stricture length over 10 mm
* Benign prostate enlargement

Primary outcomes:
measure: Urethral stricture recurrence
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00200928: Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
Official title: Asthma, a Disease Due to a Lack of Bacterial Infections in Childhood.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Atopic Dermatitis
Asthma
Rhinitis
Keywords: prospective
randomised
intervention
BCG
atopy
Lead sponsor: The Netherlands Asthma Foundation
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The degree of TH1-skewing by mycobacteria is controlles by NRAMP1 gene polymorphisms and related to the degree of inhibition of TH2-mediated disease.

Detailed description: A randomised single blinded intervention study in high-risk newborns vaccinated at the age of 6 weeks with BCG or placebo.

Inclusion: high-risk was defined as either a mother or a father and a sibling with present or past atopic disease.

Exclusion: maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother), the use of antibiotics directly post-partum (newborn)

Eligibility criteria: Inclusion Criteria:

high-risk was defined as either a mother or a father plus a sibling with present or past atopic disease.

Exclusion Criteria:

maternal infection in the last week of pregnancy, the use of immunomodulatory drugs or antibiotics during pregnancy (mother) or directly post partum (newborn)

Primary outcomes:
measure: Incidence and severity of atopic disease.
Secondary outcomes:
measure: SCORAD, lung function, IgE, cytokine production by PBMNC's, NRAMP-polymorphisms.
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Wilhelmina Children's Hospital (UMCU)
Study officials:
affiliation: Wilhelmina Children's Hospital Utrecht (UMCU)
name: Maarten O Hoekstra, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04315428: Study of Swaddling on Tactile Learning in Premature Infants
Official title: Study of Swaddling on Tactile Learning in Premature Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Newborn
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: GeneveUniversity
First posted: 2020-03-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born prematurely and hospitalized in the neonatal and neonatal resuscitation unit at the University Hospital of Grenoble

Brief summary: Explore the sensorially of the premature newborn that is fundamental to adapting the care environment to these hospitalized babies

Detailed description: Indeed, the challenge is to offer them an environment adapted to their sensory skills, so as not to alter their development.

This is in line with the customized care development, better known as the Anglo-Saxon term of Neonatal Individualised Developmental Care and Assessment Program.

The aim is thus to promote later the cognitive development of these children

Eligibility criteria: Inclusion Criteria:

* Children born prematurely and aged 28 to 35 Weeks of Amenorrhoea, regardless of their postnatal age

Exclusion Criteria:

premature newborns with

* associated anomalies syndrome
* abnormal cranial ultrasonography with stage III or IV intraventricular hemorrhage or periventricular cavitary leukaemia
* those receiving sedative or convulsive treatment during the experiment
* those whose grasping reflex is absent

Primary outcomes:
measure: time required to habituate a first object (corresponding to a time when the object is held repeatedly) and time required to present a new object (corresponding to the property of discrimination)
timeFrame: up to 3 months max
Secondary outcomes:
measure: Compare cognitive development at 2 years in both groups
timeFrame: between first evaluation and 2 years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Leïla MARCUS, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lejeune F, Delacroix E, Gentaz E, Berne-Audeoud F, Marcus L, Debillon T. Influence of swaddling on tactile manual learning in preterm infants. Early Hum Dev. 2021 Feb;153:105288. doi: 10.1016/j.earlhumdev.2020.105288. Epub 2020 Dec 3.
Clinical trial NCT02891928: Evaluation of Rocker sOles in Diabetis
Official title: Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Neuropathy
Keywords: Type 2 diabetes
Diabetic neuropathy
Disorders of equilibrium
"Rocker sole" shoes
Walking
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.

Detailed description: Diabetes is a public health problem. The functional prognosis is partly conditioned by the occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy. Preventive measures are necessary to avoid such complications: education, pedicure, suitable footwear, insoles. There are many types of orthopedic shoes, standard or custom-made. A key objective is to avoid excessive pressure found at the level of the front-foot, favoring the appearance of lesions like ulcers. In this context, the Anglo-Saxons have developed a type of shoe ( "rocker sole"), allowing to decrease the pressures on the front-foot with a rigid sole system associated with an elevation of the front-foot. Some, however, have shown that this type of shoe may be responsible for disorders of equilibrium to the healthy subject, what about at the diabetic patients, already at higher risk of postural disorders and falls?

Eligibility criteria: Inclusion Criteria:

* Patient with Type 2 Diabetes
* Patients suffering from diabetic neuropathy diagnosed by the test in the monostrand
* Can walk without technical assistance
* Age from 18 to 75
* Having made his non-opposition

Exclusion Criteria:

* Presence of ulceration of the foot (or a history of this type)
* History of pathologies that could disturb the balance and walking independently of diabetes: vestibular diseases, ophthalmic diseases with decreased of visual acuity, neurological, musculoskeletal and rheumatic diseases.

Primary outcomes:
measure: Anteroposterior displacement amount of the center of pressure with regard to the center of mass.
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Olivier Remy-Neris, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476228: EEG Objectification in Neuropsychiatry
Official title: EEG Objectification in Neuropsychiatry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Personality Disorder
Depression
Neurodegeneration
Alzheimer's Disease
Epilepsy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the study is to evaluate the use of EEG in the management and follow-up of neuropsychiatric disorders. Secondary objectives are therefore better understanding of the pathological activations in neural network during neuropsychiatric disorders, their clinical evolution and response to therapies.

Detailed description: Patients are having EEG recordings as a routine part of their clinical evaluation and diagnosis. EEG recording is harmless, has no side effects, any radiation or any mechanical or electrical influence. It is of short duration and may be done in the EEG institute or the patient's room.

Eligibility criteria: Inclusion Criteria:

* diagnosis of the investigated neuropsychiatric disease

Exclusion Criteria:

* Other co-existing neuropsychiatric conditions
* Refusal to participate in the study

Primary outcomes:
measure: percentage of fitting (0-100%) of EEG pattern to a previously identified electrophysiological "key"
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: HMO
Study officials:
affiliation: HMO
name: shahar arzy, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arzy S, Collette S, Wissmeyer M, Lazeyras F, Kaplan PW, Blanke O. Psychogenic amnesia and self-identity: a multimodal functional investigation. Eur J Neurol. 2011 Dec;18(12):1422-5. doi: 10.1111/j.1468-1331.2011.03423.x. Epub 2011 May 7.
citation: Arzy S, Allali G, Brunet D, Michel CM, Kaplan PW, Seeck M. Antiepileptic drugs modify power of high EEG frequencies and their neural generators. Eur J Neurol. 2010 Oct;17(10):1308-12. doi: 10.1111/j.1468-1331.2010.03018.x.