louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03451305: Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture
Official title: Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Compression Fracture Spine
Osteoporosis Fracture
Keywords: Compression fracture, postural reduction, vertebroplasty
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients with single level osteoporotic compression fracture
Primary purpose: TREATMENT

Brief summary: Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.


Eligibility criteria: Inclusion Criteria:

* Single level osteoporotic compression fracture of thoracic and lumbar spine

Exclusion Criteria:

* Can't tolerate the postural reduction by pillow
* Pathological spine fracture caused by tumor, infection.
* Multiple spine fractures
* Patient presented with neurological. deficits

Primary outcomes:
measure: Sagittal plane contour
timeFrame: 6 months of post-operative follow up
Secondary outcomes:
measure: Functional outcome
timeFrame: 6 months of post-operative follow up
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
citation: Rao RD, Singrakhia MD. Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty and kyphoplasty in its management. J Bone Joint Surg Am. 2003 Oct;85(10):2010-22. No abstract available.
citation: Lee JH, Lee DO, Lee JH, Lee HS. Comparison of radiological and clinical results of balloon kyphoplasty according to anterior height loss in the osteoporotic vertebral fracture. Spine J. 2014 Oct 1;14(10):2281-9. doi: 10.1016/j.spinee.2014.01.028. Epub 2014 Jan 23.
citation: Chin DK, Kim YS, Cho YE, Shin JJ. Efficacy of postural reduction in osteoporotic vertebral compression fractures followed by percutaneous vertebroplasty. Neurosurgery. 2006 Apr;58(4):695-700; discussion 695-700. doi: 10.1227/01.NEU.0000204313.36531.79.
Clinical trial NCT06141005: Feasibility of Bronchial Washing Fluid for Molecular Testing with Next Generation Sequencing in Lung Cancer
Official title: Feasibility of Bronchial Washing Fluid for Molecular Testing with Next Generation Sequencing in Patients with Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Bronchoscopy
Liquid biopsy
Lung Cancer
Next Generation Sequencing
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.

Detailed description: This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of genetic alterations using Next Generation Sequencing in patients with NSCLC.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years
* Obtained written informed consent
* No contraindication to bronchoscopy
* Subjects suspected of having lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
* Subjects planning to undergo tissue or liquid biopsy for genetic alteration with Next Generation Sequencing

Exclusion Criteria:

* Subjects who withdraw informed consent
* Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement
* Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion
* Subjects diagnosed with a benign lesion from the lung tissue lesion

Primary outcomes:
measure: Comparison of the detection rate of druggable genetic alteration using Next Generation Sequencing in bronchial washing fluid, tissue, and plasma across the full patient set
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The concordance rate for the detection of druggable genetic mutations among bronchial washing fluid, plasma, and tissue samples using Next Generation Sequencing in the analysis intent group
timeFrame: through study completion, an average of 1 year
measure: Comparisons of the detection rates of representative co-occurring genetic alterations in bronchial washing, plasma, and tissue samples across the full patient set
timeFrame: through study completion, an average of 1 year
measure: The incidence of adverse events associated with the bronchial washing procedure
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University hospital
Study officials:
affiliation: Pusan National University Hospital
name: Jung-Seop Eom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01012505: The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
Official title: The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Preterm Infants With no Active Disease
Human Milk Nutrition
Incubator Stay
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2009-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: preterm infants at least 1 weekk of age no active disease or treatment (like respiratory support) place in incubator

Brief summary: Mammalian fetal sensory development comes in an invariant series, with the tactile/kinesthetic and chemosensory systems the earliest functioning and responsive to stimulation, implicating the importance of these foundational sensory systems for later development. Olfaction is essential for neonatal behavioral adaptation in many mammals, including humans. Experiments show that newborns recognize, and are soothed by, the smell of amniotic fluid. Provision of the mother's smell with breast pads, handkerchiefs she has worn, breast milk on a cotton ball or cotton applicator, or other means of providing odor and taste input can facilitate recognition by the infant's mother at a later time and does not appear to be detrimental to the stability of the infant.

Provision of the odor and taste of the mother's milk has been shown to facilitate the infant's mouthing, sucking, arousal, and calming from irritability, especially in preparation for oral feeding. Using 24 hour monitor analysis and cortisol saliva measurements, we will provide quantitive analysis to the effect of smell.


Eligibility criteria: Inclusion Criteria:

* preterm infants at least 1 week of age
* no active disease or treatment (like respiratory support)
* place in incubator

Exclusion Criteria:

* active disease or treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat - Gan
country: Israel
facility: Sheba medical center
Study officials:
References:
Clinical trial NCT01015105: Troponin Elevation in Consecutive Patients With Hip Fracture
Official title: Troponin Elevation in Consecutive Patients With Hip Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Keywords: patients with hip fracture
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2009-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 patients with hip fracture

Brief summary: The aims of this study is to study the occurrence of the troponin elevations, ECG changes, and cardiac symptoms in unselected consecutive patients with hip fracture.

Followup will be carried out up to one year period.


Eligibility criteria: Inclusion Criterion:

* Hip fracture diagnosed in Turku Univeristy Hospital between October 2009 and May 2010

Exclusion Criterion:

* Patient refusal

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
citation: Nordling P, Kiviniemi T, Strandberg M, Strandberg N, Airaksinen J. Predicting the outcome of hip fracture patients by using N-terminal fragment of pro-B-type natriuretic peptide. BMJ Open. 2016 Feb 24;6(2):e009416. doi: 10.1136/bmjopen-2015-009416.
Clinical trial NCT01925105: Comprehensive Geriatric Assessment - Can it Improve Quality of Life
Official title: Comprehensive Geriatric Assessment - Can it Improve Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Keywords: Polypharmacy
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
First posted: 2013-08-19
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Like most developed countries the population of Sweden is getting older and consequently the number of individuals with chronic diseases will be an increasing challenge for its healthcare system. To improve care of the frail elderly, wards with a coordinated multidisciplinary team and multidisciplinary mobile teams were established several years ago. Treatment and follow up is planned in accordance to the patients' medical, psychological and functional capabilities (Comprehensive Geriatric Assessment = CGA). There are to our knowledge only few studies concerning CGA applicable to Swedish conditions. We plan to conduct a Swedish study that evaluates if care and treatment with a modified CGA-model in an outpatient setting can improve quality of life for frail older people.


Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* Live in own home
* Reason to believe that the health condition is not optimal or could be optimized
* Meet at least 2/6 of the following criteria: cognitive impairment, general tiredness or dyspnea, have fallen often/afraid to fall, need help with activities of daily living, hospital care ≥3 times within the last 12 months, care problems at home

Exclusion Criteria:

* Psychosis
* Not understand the Swedish language

Primary outcomes:
measure: Retained or increased quality of life of at least 20% measured by EQ-5D (EuroQOL) after 1 year from baseline.
timeFrame: 1 year from baseline
Secondary outcomes:
measure: Readmission to hospital
timeFrame: 1 year from baseline
Other outcomes:
measure: The quality of drug treatment
timeFrame: 1 year from baseline
Locations:
city: Örebro
country: Sweden
facility: Örebro County Council
Study officials:
affiliation: Allmänmedicinskt forskningscentrum, AFC, Örebro läns landsting, Box 1613, 70116 Örebro
name: Peter Engfeldt, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02144805: Closure of Uterine Incision by Single or Double Layer Technique
Official title: Evaluation of Single Versus Double-layer Technique by Closure of Cesarean Uterine Incision. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Region Zealand
First posted: 2014-05-22
Enrollment: 77
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Detailed description: Objective: To compare short-term and long-term effects on myometrial thickness in women sutured by single- or double-layer technique by closure of cesarean uterine incision. The study is a randomized clinically controlled study.

Design:Follow-up by ultra sound of a randomised controlled trial. Surgical technique was blinded for the investigator.

Setting: An obstetric department in a tertiary referral hospital, 2008-2013. Participants: Healthy nulliparous scheduled for elective caesarean section randomly assigned to closure of the uterine incision by single- or double layer techniques.

Intervention: A modified version of the Misgav-Ladach surgical technique was used. The women were examined by abdominal ultra sound before discharge from the maternity ward, and by vaginal ultra sound and hysterosonography minimum five month post partum.

Main outcome measure: Thickness of the remaining myometrium corresponding to the former cesarean uterine incision measured by ultra sound.

Eligibility criteria: Inclusion Criteria:

* Women submitted to cesarean sectio

Exclusion Criteria:

* Exclusion criteria were: Former uterine operations such as myomectomy or surgery resulting in entering the cavity, fibroids located in the cervix or the cervicalcorporal border, inflammatory bowel disease, SLE, rheumatoid arthritis, IDDM, re-operations after inclusion or the cesarean section and more than three additional single sutures for hemostasis.

Primary outcomes:
measure: Myometrial thickness
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Department of Obstetrics and Gynecology
Study officials:
affiliation: Zealand University Hospital
name: Gitte Bennich, consultant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00788905: Comparison of Conventional Dialysis and the Allient System
Official title: Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Chronic Kidney Failure
Keywords: Hemodialysis
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
Collaborators: name: Renal Solutions, Inc.
First posted: 2008-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Maintenance in-center hemodialysis
* Age greater than or equal to 18 years
* Has been on hemodialysis for at least 4 months
* Uses a standard single-pass dialysis machine with a high-flux dialyzer

Exclusion Criteria:

* Hospitalization during the 8 weeks preceding enrollment
* Infection requiring antibiotic treatment during the 8 weeks preceding enrollment
* Central venous cather as dialysis access
* Uncontrollable blood coagulation anomalies
* Smokers
* Dialysis regimen other than 3 times weekly
* In ability to understand the English language and give informed consent for participation in the study

Primary outcomes:
measure: Clearance of specific waste products from blood determined through subject blood and dialysate samples
timeFrame: 3 weeks
Secondary outcomes:
measure: Inflammation as determined by levels of specific inflammatory markers
timeFrame: 3 weeks
measure: Red blood cell lifespan determined through a measurement of CO in the subject's breath
timeFrame: 3 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Irving Place Dialysis Center
state: New York
city: New York
country: United States
facility: Upper Manhattan Dialysis Center
state: New York
city: New York
country: United States
facility: Yorkville Dialysis Center
state: New York
Study officials:
affiliation: Renal Research Institute
name: Nathan W. Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: STUDY_DIRECTOR
References:
citation: Rosales L, Thijssen S, Kruse A, Sipahioglu MH, Hirachan P, Raimann JG, Kuntsevich V, Carter M, Levin NW, Kotanko P. Inflammatory Response to Sorbent Hemodialysis. ASAIO J. 2015 Jul-Aug;61(4):463-7. doi: 10.1097/MAT.0000000000000212.
Clinical trial NCT04158505: Real World Study of Pyrotinib in Human Epidermal Growth Factor Receptor-2 (HER2) Positive Breast Cancer
Official title: Real World Study on the Efficacy and Safety of Pyrotinib in the Treatment of HER2 Positive Breast Cancer: An Observational,Multi-center,Prospective Study (Real Pretty Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER2-positive Breast Cancer
Keywords: pyrotinib
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-11-08
Enrollment: 3000
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: HER2+ breast cancer patients whose treatment decision with pyrotinib has been made by their physician and who meet the eligibility criteria will be invited to participate in the study

Brief summary: This Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years old with histologically confirmed HER2 positive breast cancer.
2. Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive.
3. Physician has determined that treatment with pyrotinib is indicated.
4. Traceable medical record available.

Exclusion Criteria:

1. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent .
2. Pregnant or breast feeding patients
3. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment.
4. Patients not suitable for this study under investigators' consideration.

Primary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 12 months
measure: Pathological Complete Response（pCR）Rate
timeFrame: through study completion, an average of 1 year
measure: Incidences of adverse events and toxicities
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center, Cancer Hospital/Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT03656705: CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
Official title: Clinical Investigation of Chimeric Costimulatory Converting Receptor(CCCR)-Modified NK92 Cells in Previously Treated Advanced Non-small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Xinxiang medical university
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical investigation is to evaluate the safety and effects of CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung carcinoma(NSCLC).


Eligibility criteria: Inclusion Criteria:

* 1.Male and female subjects with non-small cell lung carcinoma in patients with no available curative treatment options who have limited prognosis(≧3 months)with currently available therapies will be enrolled.
* 2.The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
* 3.HB≧90g/L, ANC≧1.5×10e9/L, PLT≧80×10e9/L, TBIL≦1.5×upper limit of nomal, ALT/AST≦2.5×upper limit of nomal, ALT/AST≦5×upper limit of nomal if have liver metastasis, Cr≦1.5×upper limit of nomal or CCr≧60ml/min.

Exclusion Criteria:

* 1.Pregnancy or breastfeeding.
* 2.Known HIV, HBV or HCV infection.
* 3.Active antoimmune disease.
* 4.History of severe immediate hypersensitivity to any of the biological products including penicillin.
* 5.Severe psychiatric disorder which might interfere with the study treatment or examination.
* 6.Chronic heart failure NYHA≧III.
* 7.Simultaneous participation in another clinical trial within 4 weeks.

Primary outcomes:
measure: Number of participants with adverse events evaluated with CTCAE,version 4.0
timeFrame: 3 months
measure: Objective Response Rate
timeFrame: up to one year
Secondary outcomes:
measure: Disease Control Rate
timeFrame: up to one year
measure: Progression-free Survival
timeFrame: up to one year
measure: Overall Survival
timeFrame: up to one year
Other outcomes:
Locations:
city: Xinxiang
country: China
facility: The first Affiliated Hospital of Xinxiang Medical University
state: Henan
Study officials:
References: