louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04761640: The Impact of Polynuclear Neutrophils' Intra-tumoral Rate and the Mutational Status in Pulmonary Adenocarcinomas on Survival
Official title: Study Concerning the Impact of Polynuclear Neutrophils' Intra-tumoral Rate and the Mutational Status in Pulmonary Adenocarcinomas on Chance of Survival.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Adenocarcinoma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stages I to III lung adenocarcinoma (TNM UICC 8ème édition) who went through a first surgery with a lymph node dissection at the CHRU of Nancy.

Brief summary: Lung cancer is one of the most frequent cancer concerning human beings and it represents, worldwide, one of the first cause of death. Most of patients with this cancer are males and 85% of lung cancers are non-small cells type (NSCLC) with adenocarcinoma being the most common histologic subtype.

Patients with pulmonary cancer have a poor long-term prognosis with an overall 5 years of survival which is less than 25% for all stages.

The natural immune system, with polynuclear neutrophils (PNN) is involved in carcinogenesis. The impact of PNN localized within the tumor as a prognostic biomarker has not been really studied in non-small cells lung cancers.

According to some studies, an increase in the number of PNN (labelled by the CD66b antibody) within the tumor is associated to a greater risk of relapse and a poor overall survival rate.

The intra-tumoral ratio PNN over Lymphocytes T CD8 + (iNTR) is an independent factor of the poor prognosis concerning the overall survival rate and concerning risk of relapse with patients who went through a first surgery for a non-small cells lung cancer.

With this study we will initially concentrate on lung adenocarcinoma and attempt to evaluate the PNN's rate within the tumor and its impact on an overall survival rate and progression-free survival.

Secondly, we will explore the role of iNTR and the mutational profile of tumors concerning this survival.


Eligibility criteria: Inclusion Criteria:

* Patients with stages I to III lung adenocarcinoma (TNM UICC 8ème édition)
* Patients who went through a first surgery with a lymph node dissection at the CHRU of Nancy between 01/01/2010 and 01/01/2012
* Patients included in the CRB CHRU-INSERM bronchial collection

Exclusion Criteria:

* patients who received neoadjuvant therapy.
* Stage IV patients (TNM UICC 8ème édition)
* Patients whose surgical resection was incomplete

Primary outcomes:
measure: Study concerning the association between the rates of intra tumoral PNN and overall survival rate (and without recurrence).
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02719340: Short Segment Fixation in Thoracolumbar Osteoporotic Fracture
Official title: Short-segment Decompression and Reconstruction for Thoracolumbar Osteoporotic Fractures With Neurological Deficits: Clinical and Radiological Results of Minimum 2-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fractures
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty elderly patients (60-89 years, mean 73.2 years) with osteoporotic thoracolumbar burst fractures and neurological compromise

Brief summary: Although long-segment posterior spinal fixation might provide more rigid fixation, the procedure increases perioperative morbidities in the elderly. The present study reviews the results of short-segment decompression and reconstruction in thoracolumbar fragile fractures.

Detailed description: This study included 20 elderly patients with osteoporotic thoracolumbar burst fractures and neurological compromise. The participants were followed-up for a period of 40.6 (24-68) months. A visual analog scale (VAS) and the Oswestry Disability Index (ODI) were used to measure back pain and disability. Radiologic assessment and neurological status were also analyzed.

Eligibility criteria: Inclusion Criteria

* osteoporotic burst fracture at a single level of the thoracolumbar region
* dual-energy X-ray absorptiometry and T-score value less than -2.5

Exclusion Criteria

* translational displacement at the fracture site (fracture-dislocation)
* loss of structural integrity within the posterior osteoligamentous complex (such as flexion-distraction ligament disruption)
* spondylolisthesis of the adjacent vertebrae
* malignancy
* chronic steroid administration
* previous spinal surgery
* prior vertebroplasty and infection

Primary outcomes:
measure: The Oswestry Disability Index (ODI)
timeFrame: at least 2 years
Secondary outcomes:
measure: Frankel's grade system
timeFrame: at least 2 years
measure: Local kyphosis and vertebral wedge angle were measured as radiologic assessment (units of measure: degree)
timeFrame: at least 2 years
measure: anterior vertebral height
timeFrame: at least 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04640740: Isokinetic Performance and Function After Total Hip Arthroplasty
Official title: Isokinetic Performance and Function Are Similar 12 Months After Total Hip Arthroplasty Applied With a Posterior or Anterolateral Approach: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: anterolateral approach
posterior approach
isokinetic test
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-11-23
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are ongoing debates on the effects of the surgical approach on outcome after total hip arthroplasty. It was hypothesized that with the anterolateral approach, trauma to the abductor arm can be occured and related detrimental effects can diminish the post-operative outcomes. In this first randomized controlled trial in the literature on this subject, isokinetic performance and patient-reported functional outcomes were evaluated in patients undergoing total hip arthroplasty. with a posterior approach (PA) and a anterolateral approach (ALA), at 6 and 12 months postoperatively.

Detailed description: Patients undergoing total hip arthroplasty are randomized to posterior approach (PA) and anterolateral approach (ALA) groups. The patients are evaluated preoperatively and at 6 and 12 months postoperatively, with flexion, extension and abduction strength measurements and the Harris Hip Score (HHS). The physiatrist performing isokinetic tests and the patients are blinded to the study groups.All data are calculated as mean and standard deviation values. The Student's t-test is used for statistical analysis of the patient data. Statistical calculations are performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).

Eligibility criteria: Inclusion Criteria:

Patients aged 55 to 80 years unilateral primary hip osteoarthritis -

Exclusion Criteria:

bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous hip surgery neuromuscular diseases

Primary outcomes:
measure: isokinetic test
timeFrame: Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
Secondary outcomes:
measure: Harris Hip Score
timeFrame: Change from preoperativeHarris Hip Score results at 6th months and 12th months iHarris Hip Score results
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Teaching and Research Hospital
Study officials:
References:
citation: Cankaya D, Inci F, Karakus D, Turker HB, Kahve Y, Neyisci C. Isokinetic performance and function are similar after total hip arthroplasty applied with a posterior or anterolateral approach: a randomised controlled trial. Hip Int. 2023 Jan;33(1):67-72. doi: 10.1177/11207000211012989. Epub 2021 Apr 26.
Clinical trial NCT05692440: Basivertebral Nerve Ablation With the Intracept Procedure
Official title: Prospective, Single-Arm, Cohort Study on Basivertebral Nerve Ablation With the Intracept Procedure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Basivertebral nerve radiofrequency ablation
Chronic low back pain
Vertebrogenic pain
Lead sponsor: Neuro Spine and Pain Center of Key West
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

Brief summary: This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.

Detailed description: Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months.

Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36).

Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18 years of age
* Patients who have experienced chronic low back pain for ≥6 months.
* Patients who have not responded to at least 6 months of conservative care.
* Patients with Modic type 1 or 2 changes.

Exclusion Criteria:

* Patients with severe cardiac or pulmonary disease.
* Patients with active systemic infection or localized infection in the treatment area.

Primary outcomes:
measure: Oswestry Disability Index (ODI) Change- 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Oswestry Disability Index (ODI) Change-12 Months
timeFrame: 12 Months
measure: Visual Analog Scale (VAS)- 6 Months
timeFrame: 6 Months
measure: Visual Analog Scale (VAS)- 12 Months
timeFrame: 12 Months
measure: ODI Responder Rate- 6 Months
timeFrame: 6 Months
measure: ODI Responder Rate- 12 Months
timeFrame: 12 Months
measure: VAS Responder Rate- 6 Months
timeFrame: 6 Months
measure: VAS Responder Rate-12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Key West
country: United States
facility: Neuro Spine and Pain Center of Key West
state: Florida
Study officials:
affiliation: Owner
name: William Schnapp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04959240: Expanded Access to Velmanase Alfa
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Alpha-Mannosidosis
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2021-07-13
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Individual patient expanded access requests may be considered for patients who have no other treatment options.

Detailed description: Expanded access may provide access for treatment prior to approval by the local regulatory agency.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01493440: Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure
Official title: Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Repeated Implantation Failure
Keywords: atosiban
clinical pregnancy
implantation rate
uterine contractility
IVF-ET
Lead sponsor: An Sinh Hospital
Sponsor class: OTHER
Collaborators: name: Vietnam National University
First posted: 2011-12-16
Enrollment: 71
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro fertilization and embryo transfer).

Detailed description: Atosiban is a mixed oxytocin and vasopressin V1A receptor antagonist.Combined antagonism at oxytocin and vasopressin V1A receptors reduces uterine contractions with a corresponding decrease in intrauterine production of prostaglandin F2alpha and improved uterine blood supply. These effects are of potential benefit for implantation support during IVF-ET cycles.

Eligibility criteria: Inclusion Criteria:

* had repeated implantation failure
* have at least 1 good quality embryo for transfer

Exclusion Criteria:

* uterine abnormalities that could compromise the implantation process (e.g. fibroids, endometrial polyp, bicornuate uterus, adhesion of uterine cavity)

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 5 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: IVFAS, An Sinh Hospital
state: Ho Chi Minh
Study officials:
affiliation: University of Medicine and Pharmacy of Ho Chi Minh City
name: Lan TN Vuong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moraloglu O, Tonguc E, Var T, Zeyrek T, Batioglu S. Treatment with oxytocin antagonists before embryo transfer may increase implantation rates after IVF. Reprod Biomed Online. 2010 Sep;21(3):338-43. doi: 10.1016/j.rbmo.2010.04.009. Epub 2010 Apr 18.
Clinical trial NCT02084940: Long Acting GnRH Antagonist in PCOS Women Undergoing IVF
Official title: The Use of a Long Acting GnRH Antagonist (Degarelix) in Controlled Ovarian Hyperstimulation in PCOS Women at a Risk to Developing OHSS Undergoing IVF : a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovarian Syndrome
Ovarian Hyperstimulation Syndrome
Invitro Fertilization
Keywords: PCOS
OHSS
GnRH antagonist
IVF
COH
Lead sponsor: Bioroma
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with PCOS with a previous IVF attempt cancelled due to the risk of OHSS

Brief summary: PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.


Eligibility criteria: Inclusion Criteria:

* regular menstrual cycle (26-39 days)
* primary infertility
* BMI \< 30

Exclusion Criteria:

* women with diabetes and other metabolic disease
* women with heart disease
* women with inflammatory or autoimmune disease

Primary outcomes:
measure: Pregnancy rate
timeFrame: Time Frame: until 12th gestational week
measure: Incidence of OHSS
timeFrame: Time frame: until 7th gestational week
Secondary outcomes:
measure: Number of collected oocytes
timeFrame: Time Frame: until 12th gestational week
measure: Estradiol level at HCG day
timeFrame: time frame: until 12th gestational week
measure: Total dose of FSH administered
timeFrame: Time frame: until 12th gestational week
measure: Total days of stimulation
timeFrame: Time frame: until 12th gestational week
measure: implantation rate
timeFrame: time frame: until 12th gestational week
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bioroma
Study officials:
References:
Clinical trial NCT00491140: Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab
Official title: Retrospective Study Assessing Molecular Features Predicting Response or Resistance to Cetuximab Therapy in Metastatic Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: EGFR
KRAS
BRAF
MET
IGFR1
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2007-06-25
Enrollment: 85
Sex: ALL
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: Colorectal cancer patients treated with Cetuximab

Brief summary: The primary objective is to identify molecular features predicting response or resistance to cetuximab

Detailed description: Secondary objective is to investigate association of genomic status of EGFR and HER-2 genes with clinical outcome, including objective response, time to progression and survival

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of colorectal cancer with available tumor tissue and clinical data; presence of at least one measurable lesion.

Exclusion Criteria:

* Less than 3 weeks after completion of previous radiotherapy

Primary outcomes:
measure: Association of different biomarkers with Cetuximab sensitivity
timeFrame: Assessment every two months
Secondary outcomes:
measure: Association of different biomarkers with time to progression and survival
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: STUDY_DIRECTOR
References:
citation: Chung KY, Shia J, Kemeny NE, Shah M, Schwartz GK, Tse A, Hamilton A, Pan D, Schrag D, Schwartz L, Klimstra DS, Fridman D, Kelsen DP, Saltz LB. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol. 2005 Mar 20;23(9):1803-10. doi: 10.1200/JCO.2005.08.037. Epub 2005 Jan 27.
Clinical trial NCT03659240: Prebiotic Effects of a Polyphenol-rich Food Product
Official title: Prebiotic Effects of a Polyphenol-rich Food Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysbiosis
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.


Eligibility criteria: Inclusion Criteria:

* BMI 27-35 kg/m2
* High waist circumference (men \>102 cm and women \>88 cm)

Exclusion Criteria:

* Cigarette smoking
* Regular intensive exercise
* Pregnancy or lactation
* Chronic diarrhea, constipation, or other gastrointestinal complaint
* Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota
* Use of medications that affect inflammation or the gut microbiota
* Use of prebiotics, probiotics, synbiotics, vitamins, or other dietary supplements known to affect the gut microbiota
* Aversion to cranberries
* Food allergies
* Lactose intolerance
* Vegetarianism

Primary outcomes:
measure: Fecal microbial community composition and structure
timeFrame: Changes in the fecal microbiota will be measured after a 20-day intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Ames
country: United States
facility: Nutrition and Wellness Research Center
state: Iowa
Study officials:
References:
Clinical trial NCT05459740: Self-management Behaviors and Resilience Among Chronic Obstructive Pulmonary Disease Patients
Official title: The Relations of Resilience to Self-management Behaviors Among Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Self-management Behavior
Resilience
Keywords: chronic obstructive pulmonary disease
self-management behavior
resilience
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The age ranged from 39-90 years old for all the population. The proportions of BMI \< 18.5 kg/m2, 18.5-24.9 kg/m2, and ≥ 24.9 kg/m2 were 8%, 58%, and 34%, respectively. Overall, only 14% of the COPD subjects were educated with a university degree or higher, which was associated with higher self-management scores compared to those educated with below university degree. Half of the subjects were former smokers.

Brief summary: This study conducted an assessment of the influencing factors and correlations that affect self-management behaviors and resilience in the COPD population.

Detailed description: A total of 100 participants with COPD from a medical center in Northern Taiwan were recruited from February 2020 to January 2021 in this cross-sectional study. Each subject completed self-reported questionnaires through face-to-face interviews, including 20-item COPD Self-Management Scale (CSMS-20) and a 25-item Connor-Davidson Resilience Scale (CD-RISC-25). A multiple linear regression model was used to examine the relationship between the levels of self-management behavior and resilience, controlling for sociodemographic and clinical factors.

Eligibility criteria: Inclusion Criteria:

The recruited participants have been diagnosed with COPD for at least a month by thoracic physicians based on the guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

Exclusion Criteria:

Participants who were diagnosed with serious mental disorders, cancer, terminal illness, or end-stage diseases were excluded from this study.

Primary outcomes:
measure: Levels of COPD self-management behavior
timeFrame: 2020-02-01 to 2021-01-30
measure: Levels of COPD psychological resilience
timeFrame: 2020-02-01 to 2021-01-30
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Respiratory therapist
name: EN-MING CHANG, master
role: STUDY_CHAIR
References: