louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01236729: Disability and Self-rated Health Following Primary Knee Replacement
Official title: The Effects of Primary Knee Replacement for Osteoarthritis on Disability in Activities of Daily Living and Self-rated Health in Older People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Knee Replacement
Keywords: knee replacement
disability
older people
Lead sponsor: Coxa, Hospital for Joint Replacement
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2010-11-09
Enrollment: 460
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients refererred to or operated on with primary knee replacement in a population-based tertiary care hospital

Brief summary: Knee replacement is an effective treatment in late-stage osteoarthritis. It reduces pain and improves quality of life. There is, however, limited data concerning its results in older people and on its effect on how patients survive in regular activities of daily living (ADL), such as bathing and shopping. In this study, the results of knee replacement are evaluated from the point of view of disability in everyday activities and self-rated health. Moreover, association with ADL performance and clinical knee scores and severity of osteoarthritis are assessed.

Detailed description: This is a cross-sectional study with a 12 month follow-up for recruited patients. Most data are gathered by a postal questionnaire.

Eligibility criteria: Inclusion Criteria:

* age 75 years or more at the time of operation
* diagnosis of knee osteoarthritis
* scheduled for or operated on with primary knee replacement

Exclusion Criteria:

* died during the follow-up
* inflammatory arthritides

Primary outcomes:
measure: Disability in activities of daily living
timeFrame: Baseline (recruitment) and at 12 months
Secondary outcomes:
measure: Overall self-rated health
timeFrame: Baseline (recruitment) and at 12 months
measure: Health-related quality of life (WOMAC)
timeFrame: Baseline and 12 months postoperatively
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Coxa, Hospital for Joint Replacement
Study officials:
affiliation: Coxa, Hospital for Joint Replacement
name: Esa Jämsen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Limnell K, Jamsen E, Huhtala H, Jantti P, Puolakka T, Jylha M. Functional ability, mobility, and pain before and after knee replacement in patients aged 75 and older: a cross-sectional study. Aging Clin Exp Res. 2012 Dec;24(6):699-706. doi: 10.3275/8718. Epub 2012 Nov 12.
citation: Vekama L, Puolakka T, Honkasalo M, Huhtala H, Moilanen T, Jamsen E. Functional gain following knee replacement in patients aged 75 and older: a prospective follow-up study. Aging Clin Exp Res. 2015 Dec;27(6):865-76. doi: 10.1007/s40520-015-0348-x. Epub 2015 Mar 24.
Clinical trial NCT04874129: Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506
Official title: Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dyslipidemias
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: ramdomized, open-label, single-dose, two-way crossover study
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Detailed description: Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.

Eligibility criteria: Inclusion Criteria:

* Over 19 ages healthy men
* Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2
* Men who don't have congenital disease and other cronic disease need to be cared. etc.

Exclusion Criteria:

* Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
* Men who have drunken or eatten something including caffeine within 24 hours before. etc.

Primary outcomes:
measure: Pharmacokinetic parameters: Cmax
timeFrame: Until 48 hours
measure: Pharmacokinetic parameters: AUC
timeFrame: Until 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National Unviersity Hosipital
Study officials:
affiliation: Chungbuk National University Hosipital.
name: Min Kyu Park, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00461929: Chromosome Abnormalities in Chronic Myeloid Leukemia (CML) on Imatinib. GIST Patients on Imatinib
Official title: Are the Secondary Chromosome Abnormalities Seen in Chronic Myeloid Leukemia (CML) Cells Induced to Ph-Chromosome Negativity by Imatinib a Result of Chromosome Instability or a Side Effect of the Therapy - a Study in GIST (Gastrointestinal Stromal Cell Tumors) Patients Treated With Imatinib.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Myeloid Leukemia
Gastrointestinal Stromal Cell Tumors
Chromosome Abnormality
Keywords: chronic myeloid leukemia
gastrointestinal stromal cell tumors
chromosome abnormality
imatinib
bone marrow aspiration
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: Mount Sinai Hospital, Canada
name: Novartis
First posted: 2007-04-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In order to distinguish between clonal instability driven by imatinib in CML and actual changes with secondary clones induced by imatinib we would like to investigate the karyotype of non-CML patients treated with imatinib such as GIST patients.

Detailed description: Chronic myeloid leukemia (CML) is a myeloproliferative disorder characterized by the presence of the Philadelphia (Ph) chromosome - a t(9:22) translocation that results in the production of a BCR/ABL fusion protein with Abl kinase activity.

Imatinib mesylate (Gleevec) specifically targets a limited set of protein tyrosine kinases - ABL, Arg (Abl-related gene), c-Kit, platelet-derived growth factor receptor (PDGF-R) - and their oncogenic forms, most notably BCR/ABL Imatinib is also a potent inhibitor of a receptor-type c-Kit tyrosine kinase. Therefore imatinib was examined for therapeutic efficacy against malignant gastro-intestinal stromal tumors (GIST) Recent articles have drawn attention to the development of new Ph-negative, cytogenetically unrelated clones after therapy of Ph-positive CML with imatinib. Trisomy 8 and monosomy 7 are the most frequent defects, but other aberrations have also been reported. Some of these cytogenetic abnormalities are associated with acute myeloid leukemia and MDS.

Eligibility criteria: Inclusion Criteria:

* GIST patient on Imatinib for more than 12 months

Exclusion Criteria:

* nil

Primary outcomes:
measure: ~ presence or absence of genetic abnormality as seen in CML patients on imatinib
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, DMOH
name: Jeff Lipton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Martin Blackstein, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04274829: Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid
Official title: Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Lymph Node Metastases
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with papillary thyroid carcinoma

Brief summary: Papillary thyroid microcarcinoma (PTMC), defined as a tumor with larger diameter ≤ 1 cm, is considered a tumor with an indolent course and an excellent prognosis. Nevertheless, the incidence of lymph node metastasis in PTMC is not negligible, reaching up to 65% in some series. The aim of this study was to assess the incidence of lymph node metastasis in patients with PTMC and to evaluate predictive factors for lymph node metastasis.


Eligibility criteria: Inclusion Criteria:

Patients with papillary microcarcinoma of the thyroid

Exclusion Criteria:

Patients with thyroid nodules \> 1 cm; incomplete data

Primary outcomes:
measure: Incidence of lymph node metastasis
timeFrame: 1 year
Secondary outcomes:
measure: Predicrive factors of lymph node metastasis
timeFrame: 1 year
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: AOU Cagliari
state: CA
Study officials:
References:
citation: Medas F, Canu GL, Cappellacci F, Boi F, Lai ML, Erdas E, Calo PG. Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid: Retrospective Analysis on 293 Cases. Front Endocrinol (Lausanne). 2020 Aug 25;11:551. doi: 10.3389/fendo.2020.00551. eCollection 2020.
Clinical trial NCT04606329: To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)
Official title: A Multicenter, Randomized, Open-label, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. Versus Charcotrace Inj. in Patients With Nonpalpable Breast Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Diseases
Keywords: Nonpalpable Breast Lesions
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-28
Enrollment: 109
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 weeks for screening, once Investigational product injection, Follow up visit.

Detailed description: The purpose of this study is to evaluate the efficacy and safety of LuminoMark inj. (Conc. for fluorescence) localization in patients with nonpalpable breast lesions.

Eligibility criteria: Inclusion Criteria:

1. 19 years ≤ age ≥ 80 years
2. Those who have lesion vial mammography and breast ultrasound
3. Those who be expected to do operation about non palpable breast lesion excision
4. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients who be expected to do mastectomy
2. Patients with multiple tumor or diffuse microcalcification
3. Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection
4. Patients who were treated with moderate to severe radiotherapy
5. Patients who were treated with neoadjuvant Chemotherapy
6. Patients with active invading skin connective tissue disease
7. Patients with local progressing breast cancer or inflammatory local progressing breast cancer
8. Patients who have an allergy to investigational product or any of the component with the Investigational product
9. Patients who disagree about contraception for this clinical trial
10. A pregnant women or lactating women
11. Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent
12. Patients who investigators determines unsuitable for this clinical trial

Primary outcomes:
measure: Negative Resection margin rate
timeFrame: Visit 5 (Day 14 ~Day 24)
Secondary outcomes:
measure: Technical success rate
timeFrame: Visit 3 (Day 0)
measure: Coloring confirmation rate of excision lesion
timeFrame: Visit 3 (Day 0)
measure: Pathologic perfection
timeFrame: Visit 5 (Day 14 ~Day 24)
measure: Pigmentation rate
timeFrame: Visit 5 (Day 14 ~Day 24)
measure: Re-operation rate
timeFrame: Visit 5 (Day 14 ~Day 24)
measure: Procedure complication rate
timeFrame: Visit 4, 5 (Day 1, Day 14 ~Day 24)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01659229: Fluoroscopic Analysis of PFC CR 150 Versus Standard PFC CR Total Knee Arthroplasty Implants in Deep Flexion
Official title: Fluoroscopic Analysis Comparing the Dynamic Flexion of 2 Different Knee Arthroplasty Implants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: DePuy International
First posted: 2012-08-07
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant

Brief summary: The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.

Detailed description: Both sets of patients will undergo routine post-operative follow up in clinic. The study involves patients who had their surgery more than 2 years ago. We assess their range of movement using fluoroscopy. They are asked to perform lunges, squats and climbing up and down 3 steps. The fluoroscopic images are then analysed to assess their individual range of movements.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent total knee replacement surgery who received either the PFC CR 150 knee implants or the PFC CR standard knee implant
* Surgery more than 2 years
* Able to walk, climb stairs

Exclusion Criteria:

* Knee stiffness with less than 100 degrees of knee range of movement
* Patients who required revision surgery
* Patients who received an all polyethylene tibial insert
* Patients who received rotating platform tibial tray

Primary outcomes:
measure: Flexion-extension range of movement of operated knee
timeFrame: 2 years after their total knee replacement surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Dr Seng Jin Yeo, MBBS FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nicholls RL, Schirm AC, Jeffcote BO, Kuster MS. Tibiofemoral force following total knee arthroplasty: comparison of four prosthesis designs in vitro. J Orthop Res. 2007 Nov;25(11):1506-12. doi: 10.1002/jor.20438.
Clinical trial NCT00806429: Transvaginal Appendectomy
Official title: Transvaginal Appendectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: appendicitis
surgery
laparoscopy
natural orifice transluminal surgery
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility and safety of transvaginal appendectomy and determine and compare the postoperative pain and quality of life after surgery to standard laparoscopic transabdominal appendectomy.


Eligibility criteria: Inclusion Criteria:

* ultrasound or CT-based diagnosis of acute or chronic appendicitis
* ASA classification 1 or 2

Exclusion Criteria:

* BMI \>35
* on Immunosuppressive meds or immunocompromised
* on blood thinners or aspirin or abnormal coagulation tests
* h/o ectopic pregnancy, PID or endometriosis
* prior open abdominal surgery or transvaginal surgery
* with diffuse peritonitis
* evidence of abscess
* retroflexed uterus
* non english speaking

Primary outcomes:
measure: feasibility of transvaginal appendectomy
timeFrame: 1 year
Secondary outcomes:
measure: pain
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Kurt E Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts KE, Solomon D, Mirensky T, Silasi DA, Duffy AJ, Rutherford T, Longo WE, Bell RL. Pure transvaginal appendectomy versus traditional laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Ann Surg. 2012 Feb;255(2):266-9. doi: 10.1097/SLA.0b013e31823b2748.
Clinical trial NCT03024229: Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine
Official title: The Importance of Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine Before Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplantation
Keywords: Transplantation;perfusion machine
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Laboratory of Biochemistry, University François Rabelais of TOURS
First posted: 2017-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Metabolic assessment in Urine and perfusion liquids
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

Detailed description: The quality of the renal transplant prior to transplantation is essential for the recovery of graft function in the days following transplantation and its long-term survival. When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

Eligibility criteria: Inclusion Criteria:

* Donors aged 18 years or more in brain death or who died of cardiac arrest collected locally in Tours, associated with the major local recipients of the grafts over the same period.

Exclusion Criteria:

* Kidney transplant removed but stored in a static preservative.
* Kidney grafts of donors aged 18 years or more, removed and not retained on a LifePort® perfusion machine.

Primary outcomes:
measure: IGF
timeFrame: 7 days
Secondary outcomes:
measure: DGF
timeFrame: 7 days
measure: BANFF-1
timeFrame: PRE-OPERATIONAL
measure: BANFF-2
timeFrame: 3 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Urology CHRU-TOURS
state: I&L
city: Orléans
country: France
facility: CHR-ORLEANS Service d'Urologie
state: Loiret
Study officials:
affiliation: University François Rabelais of TOURS
name: Franck BRUYERE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faucher Q, Alarcan H, Sauvage FL, Forestier L, Miquelestorena-Standley E, Nadal-Desbarats L, Arnion H, Venhard JC, Brichart N, Bruyere F, Marquet P, Barin-Le Guellec C. Perfusate Metabolomics Content and Expression of Tubular Transporters During Human Kidney Graft Preservation by Hypothermic Machine Perfusion. Transplantation. 2022 Sep 1;106(9):1831-1843. doi: 10.1097/TP.0000000000004129. Epub 2022 Apr 20.
Clinical trial NCT02716129: The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section
Official title: Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.

Detailed description: The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.

Eligibility criteria: Inclusion Criteria:

* Female patients
* age between 16 to 40 years
* ASA physical status I - II

Exclusion Criteria:

* Infection at the site of injection.
* Coagulopathy or other bleeding diathesis.
* Preexisting neurologic deficits.
* History of hypersensitivity to any of the given the drugs.
* Inability to communicate with the investigator and the hospital staff.
* History of chronic opioid us

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of postoperative itching
timeFrame: 24 hours
measure: number of participants with incidence of postoperative nausea
timeFrame: 24 hours
measure: number of participants with incidence of postoperative vomiting
timeFrame: 24 hours
measure: number of participants with incidence of postoperative postdural puncture headache
timeFrame: 24 hours
measure: number of participants with incidence of postoperative respiratory depression
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assistant professor of anesthesia and intensive care
name: Abdelrady S Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5. doi: 10.1097/00000539-200009000-00019.