louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06276413: REgistRy BRAnch goRE EndopRosthEsis
Official title: Registry on Gore Branch Endoprosthesis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Aneurysm, Thoracic
Aortic Dissection
Keywords: endograft
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 50
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: All consecutive patients treated with the Gore TAG thoracic branched endograft in the participating centers

Brief summary: Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis

Detailed description: This is a multicenter, non-sponsored, physician-initiated multicenter registry on patients treated with the Gore thoracic branched endoprosthesis.

Inclusion of centers is on a voluntary basis; each participating center includes consecutive patients treated with this device.

Eligibility criteria: Inclusion Criteria:

* patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies

Exclusion Criteria:

* less than 18 years
* allergy to endograft components
* patients receiving other types of arch endografts

Primary outcomes:
measure: early mortality
timeFrame: 30 days
measure: device stability
timeFrame: 5 years
measure: technical success
timeFrame: 30 days
Secondary outcomes:
measure: early major adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Vascular and Endovascular Clinic - Padova University
Study officials:
References:
Clinical trial NCT01834313: Willingness to Pay for Patient-centred Care
Official title: Identifying Patients' and Healht Insurers' Preferences Regarding Patient-centred Care by Determining Their Willingness-to-pay for Patient-centred Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Willingness-to-pay
Patient-centredness
Keywords: Willingness-to-pay
Patient-centredness
Health insurers
Fertility care
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who are under treatment for their fertility problem and underwent at least one treatment in one of 10 Dutch clinics.

All healthcare purchasers from the 5 large Dutch health insurer companies

Brief summary: The purpose of this study is to evaluate the monetary value of patient-centrednes in health care by determining a willingness-to-pay for more patient-centredness care for both patients and health insurers

Detailed description: We perform our study in the area of fertility care, as it is known that infertile patients suffer from a high physical and physiological burden during treatment and could especially benefit from patient-centred care. Moreover, previous studies have clearly identified the concept of patient-centred fertility care and have shown that improvement is needed.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing MAR-treatment (ovulation induction, intra-uterine inseminations, in vitro fertilization, or intra-cytoplasmic sperm injection)
* All healthcare purchasers working at one of the 5 large Dutch health insurer companies.

Exclusion Criteria:

* None

Primary outcomes:
measure: Willingness-to-pay for patient-centred care
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Centre, Nijmegen
name: J AM Kremer, MD, PhD
role: STUDY_CHAIR
affiliation: Radboud University Medical Centre, Nijmegen
name: W L Nelen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Centre, Nijmegen
name: E MM Adang, PhD
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Centre, Nijmegen
name: A G Huppelschoten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huppelschoten AG, Verkerk EW, Appleby J, Groenewoud H, Adang EM, Nelen WL, Kremer JA. The monetary value of patient-centred care: results from a discrete choice experiment in Dutch fertility care. Hum Reprod. 2014 Aug;29(8):1712-20. doi: 10.1093/humrep/deu122. Epub 2014 Jun 4.
Clinical trial NCT00065013: Strength Training Following Gastric Bypass for Obesity
Official title: Strength Training Following Gastric Bypass for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: obesity
gastric bypass
obesity surgery
bariatric surgery
exercise
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-07-18
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: We will assess whether undesirable loss of lean tissue following gastric bypass surgery for obesity can be minimized by protein supplementation and exercise training.


Eligibility criteria: * clinically severe obesity
* candidate for bypass surgery
* new york city local address
* willing to visit hospital weekly

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Allan Geliebter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02571413: Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Allergic Rhinitis
Official title: Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Administration Technique Among Thai Children With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Allergic Rhinitis
Keywords: animated cartoon-aided teaching
oral presentation
allergic rhinitis
intranasal corticosteroid
how to use intranasal corticosteroid
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2015-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS administration was created to decrease workload of health care professionals. The aim of this study is to compare the achievement of the children with AR in using INCS between the group which were instructed by animated cartoon-aided teaching or oral presentation without demonstration.

Detailed description: The study was a prospective randomized control trial in children aged 5 - 16 years with moderate to severe intermittent or persistent AR who had never used INCS. The patients were randomly divided into 2 groups; 1) Teaching how to use INCS by oral presentation and 2) by animated cartoon-aided teaching. Successful achievements were recorded when the patients were able to use INCS (all five-point checklists) correctly. If they were unable to use the INCS correctly after the first teaching, the same instruction would be repeated and the second assessment would be performed.

Eligibility criteria: Inclusion Criteria:

* Children with 5 - 16 year old
* children with allergic rhinitis

Exclusion Criteria:

* history of intranasal corticosteroid use
* history of other underlying disease

Primary outcomes:
measure: Scores of the correct method of intranasal corticosteroid administration technique before and after teaching
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Nualanong Visitsunthorn, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02584413: Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma
Official title: Hypotonia as a Clinical Predictor of Optic Pathway Glioma in Children With Neurofibromatosis Type 1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurofibromatosis Type 1
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: St. Louis Children's Hospital
First posted: 2015-10-22
Enrollment: 29
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Currently, optic pathway gliomas (OPG) are detected based on abnormal findings made during annual ophthalmologic exams. However, because these exams are annual, it is possible for healthcare providers to miss the point at which a child's vision begins to decline (potentially indicating an OPG). If at-risk children are screened for hypotonia early in life, those children who are hypotonic may undergo magnetic resonance imaging (MRI) to evaluate for OPG before they are showing ophthalmologic symptoms. This would enable healthcare providers to discover vision loss earlier and treat symptomatic OPGs earlier, thereby allowing us a better chance of preventing further vision loss in children with OPGs.


Eligibility criteria: Inclusion Criteria:

* Patient must be seen at the St. Louis Children's Hospital NF Clinic
* Diagnosis of NF1
* Between 1 and 7 years of age, inclusive
* Diagnosed with hypotonia
* Legally authorized representative/guardian must be able to understand and willing to sign an IRB-approved informed consent document
* Must have an MRI scan ordered by a treating physician

Exclusion Criteria:

* Normal tone on clinical exam
* Known allergy to gadolinium or the sedative, propofol, used during MRI
* Poor kidney function defined as a known renal disease or elevated BUN and creatine
* Requiring intubation for anesthesia

Primary outcomes:
measure: Predictive accuracy of clinical diagnosis of hypotonia as an indicator of OPG in children with NF1
timeFrame: At the time of MRI (1 day)
Secondary outcomes:
measure: Other features that may be indicatory of OPG in children with NF1
timeFrame: At the time of MRI (1 day)
measure: Determine if a physical therapist (PT) can train another clinical professional to accurately diagnose hypotonia
timeFrame: 1 day
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine (St. Louis Children's Hospital)
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: David Gutmann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04947813: Genotype-Phenotype Correlations in Patients With Alport Syndrome
Official title: Association Analysis Between Variants of COL4A3/COL4A4/COL4A5 and Alport Syndrome in the Han Chinese Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alport Syndrome
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 8165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and other 26 hospitals of China Huadong Region.

Brief summary: Alport syndrome (AS) is caused by pathogenic variants in the type IV collagen genes COL4A3, COL4A4, and COL4A5. This study aims to enroll families and patients with a history of renal hematuria in 27 hospitals and detect these three genes for AS screening. This study also aims to analysis the effect of COL4A3/COL4A4/COL4A5 genotype on the development of kidney disease.

Detailed description: Alport syndrome (AS) is a genetically and phenotypically heterogeneous disorder caused by the mutations in the type IV collagen genes COL4A3, COL4A4, and COL4A5. In this study, next generation sequencing is used to screen AS on 8165 participants enrolled from families and patients with a history of renal hematuria in 27 hospitals of China Huadong Region. Genotype (variants in COL4A3/COL4A4/COL4A5)-phenotype (onset age of hearing loss, nephroticrange proteinuria, decline of eGFR, kidney survival and onset age of CKD5) correlations in AS were evaluated.

Eligibility criteria: Inclusion Criteria:

1. Age: up to 99 Years (Child, Adult, Older Adult)
2. Sex: All;
3. Families and patients with a history of renal hematuria;
4. Those who signed the informed consent.

Exclusion Criteria:

1. Polycystic kidney disease, hypertensive nephropathy, etc.;
2. Kidney biopsy is diagnosed as other primary/secondary kidney disease without type IV collagen-related kidney disease, including IgA nephropathy, membranous nephropathy, lupus nephritis, etc.
3. Incomplete medical history or clinical data.

Primary outcomes:
measure: Identification COL4A3/COL4A4/COL4A5 variants of Alport Syndrome
timeFrame: Up to 240 weeks
Secondary outcomes:
measure: Identification genotype-phenotype correlations of Alport Syndrome
timeFrame: Up to 240 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: China Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Study officials:
References:
Clinical trial NCT05729113: Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation.
Official title: Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Keywords: Arteriovenous Fistula
Renal Insufficiency Chronic
Quality of Life
Distraction
Lead sponsor: Instituto Politécnico de Leiria
Sponsor class: OTHER
Collaborators: name: Instituto Politécnico de Leiria
First posted: 2023-02-15
Enrollment: 47
Sex: ALL
Minimum age (years): 62
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pain in patients under hemodialysis affects chronic renal patients' quality of life. Distraction has been effective in controlling pain induced by the insertion of needles. Once applied adequately, distraction promotes endorphins' release, with efficacy in acute pain. This study aims to evaluate pain perception while puncturing the hemodialysis device using an anti-stress ball as a distraction strategy.


Eligibility criteria: Inclusion Criteria:

* adults over 18 years old
* able to read and write
* vascular access by a fistula or arteriovenous prosthesis, cannulated with a 15G needle
* vascular access at least with month old

Exclusion Criteria:

* patients under 18 years
* can't be able to read and/or write
* usage of topical anesthetics before treatment
* vascular access by a fistula or arteriovenous prosthesis, cannulated with smaller or larger 15G needles
* vascular access under one-month-old

Primary outcomes:
measure: Pain perception by hemodialysis patients
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Figueira Da Foz
country: Portugal
facility: Diaverum
Study officials:
affiliation: Instituto Politécnico de Leiria
name: Joana P Sousa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02609113: Static Magnetic Therapy for Carpal Tunnel Syndrome
Official title: A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 22
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 purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
* ≥ 18 years

Exclusion Criteria:

* Current use of magnets as therapy for Carpal Tunnel Syndrome
* Known allergy to silicone
* Unwillingness to wear wristband for 6 weeks
* Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.

Primary outcomes:
measure: Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake ForestUBMC
name: Vanessa Baute, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03146013: Dual Algorithm Post Market Clinical Study
Official title: Evaluation of the MP Diagnostics HTLV Blot 2.4
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HTLV-I Infections
HTLV-II Infections
Human T-lymphotropic Virus 1
Human T-lymphotropic Virus 2
HTLV I Associated T Cell Leukemia Lymphoma
HTLV I Associated Myelopathies
Keywords: HTLV
Confirmatory
Supplemental
Blot
HTLV-I
HTLV-II
Lead sponsor: MP Biomedicals, LLC
Sponsor class: INDUSTRY
Collaborators: name: MP Biomedicals Asia Pacific Pte. Ltd.
First posted: 2017-05-09
Enrollment: 100
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: All populations are from whole blood donors.

Brief summary: The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).

Detailed description: This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.

Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Completion of a health history evaluation for routine donor screening
3. Provided a routine blood donation
4. Tests repeat reactive by the Abbott PRISM HTLV assay and non-reactive on the AVIOQ Elisa HTLV assay

Exclusion Criteria:

1. Unwilling or unable to provide informed consent to blood donation
2. Inadequate sample volume for testing
3. Unable to provide samples that meet the suitability requirements for testing

Primary outcomes:
measure: Assess the HTLV dual algorithm testing in blood donor facilities
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: American Red Cross - National Testing Laboratory
state: North Carolina
Study officials:
affiliation: American National Red Cross
name: Susan Stramer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller L. Profile of the MP Diagnostics HTLV Blot 2.4 test: a supplemental assay for the confirmation and differentiation of antibodies to HTLV-1 and HTLV-2. Expert Rev Mol Diagn. 2016;16(2):135-45. doi: 10.1586/14737159.2016.1123622. Epub 2016 Jan 11.
Clinical trial NCT01430013: Trial of Endostar Combined With CHOPT for T Cell Lymphoma
Official title: Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: T Cell Lymphoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Simcere Pharmaceutical Co., Ltd
First posted: 2011-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T cell lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Male and female aged 18 to 70 years old.
2. Diagnosis of T cell lymphoma according to WHO Classification, without antitumor therapy
3. At least 1 measurable tumor mass (greater than 1.5cm in the longest dimension and greater than 1.0 in the short axis)
4. Eastern Cooperative Oncology Group status 0-2
5. White blood cell≥4.0×109cells/L; Absolute neutrophil count (ANC) ≥1.5×109cells /L; Platelets≥100×109cells/L
6. Alanine transaminase (ALT) ≤2×upper limit of normal(ULN); Aspartate transaminase (AST) ≤2×ULN; Total Bilirubin≤1.5×ULN; Creatinine in normal range

Exclusion Criteria:

1. No active central nervous system lymphoma or brain tumor
2. Suppurative inflammation,Chronic infection
3. Severe heart disease, conclusion: congestive heart failure; uncontrolled cardiac arrhythmia; myocardial infarction; refractory hypertension
4. psychiatric history
5. Primary cutaneous T cell lymphoma
6. Pregnant or lactating women
7. Concurrent treatment with another investigational agent
8. Accept radiotherapy

Primary outcomes:
measure: efficacy including overall response rate, progression free survival and overall survival
timeFrame: 1 year
Secondary outcomes:
measure: safety of Endostar combined with CHOPT chemotherapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institue and Hospital
name: Huaqing wang, MD
role: PRINCIPAL_INVESTIGATOR
References: