louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04780737: Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis
Official title: Prophylactic Cholecystectomy is Not Mandatory in Patients Candidate to the Resection for Small Intestine Neuroendocrine Neoplasms: a Propensity Score-matched and Cost-minimization Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Surgery
Gut Tumor
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For each patient sex, age, comorbidity, presence of symptoms, type of surgery (emergency or elective), ENETS TNM stage, WHO 2019 grading of the primary tumor, type of resection (R0/1 vs. R2), administration of SSA therapy, duration of follow-up, were collected

Brief summary: To evaluate two competitive strategies in patients undergoing resection of Small-intestine Neuroendocrine neoplasms (Si-NEN): Prophylactic Cholecystectomy (PC) versus On-demand delayed cholecystectomy

Detailed description: This is a retrospective study based on 230 Si-NENs candidates to the primary tumor resection. Patients were divided into two arms: PC and OC. Propensity score matching was performed, reporting the d value. The primary outcome was the re-hospitalization rate for any cause. The secondary endpoints were the re-hospitalization rate for biliary stone disease (BSD), the mean number of re-hospitalization (any cause and BSD), the complication rate (all and severe), and the total costs. A P-value \< 0.05 was considered significant, and NNT\< 10 was considered clinically relevant.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of Si-NEN;
* resection of the primary tumor with or without concomitant cholecystectomy;
* absence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis

Exclusion Criteria:

- presence of a history of a biliary stone disease or cholecystectomy before Si-NEN diagnosis

Primary outcomes:
measure: re-hospitalization rate for any cause
timeFrame: through study completion, an average of 7 years
Secondary outcomes:
measure: re-hospitalization rate for biliary stone disease
timeFrame: through study completion, an average of 7 years
measure: mean number of re-hospitalization any cause
timeFrame: through study completion, an average of 7 years
measure: mean number of re-hospitalization biliary stone disease
timeFrame: through study completion, an average of 7 years
measure: total costs
timeFrame: through study completion, an average of 7 years
measure: COmplication rate
timeFrame: through study completion, an average of 7 years
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliero Universitaria, Ospedale S.Orsola Malpighi
name: Carlo Ingaldi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05794737: Immunohistochemical Expression of Inhibin Beta A (INHBA) in Colorectal Carcinoma
Official title: Immunohistochemical Expression of Inhibin Beta A (INHBA) in Colorectal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Inhibin Beta A
Colorectal Carcinoma
Immunohistochemistry
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Archived Formalin-fixed, Paraffin-embedded tissue blocks belonged to patients suffered from colonic and/or rectal cancers. Patients were admitted to sohag university hospital and underwent colectomy and their colonic specimens were sent to Pathology Laboratory of the same hospital to ascertain diagnosis and tumor phenotype, from period Janurary 2021 to December 2022.

Brief summary: A retrospective observational study to evaluate immunohistochemical expression of Inhibin Beta A (INHBA) in 60 cases of Colorectal Carcinoma, and compare levels of its expression to different clinicopathological criteria.

Detailed description: Colorectal Carcinoma is an aggressive malignant epithelial tumor with an observable high incidence. Tumor invasion and metastasis to distant sites are two important issues which determine patient's outcome, so detecting novel biological markers that are involved in tumor proliferation and invasion with subsequent targeting by future medical drugs will positively improve patient's prognosis.

Inhibin Beta A (INHBA) is a glycoprotein molecule that has a role in tumor cells proliferation and invasion in different human malignancies. The aim of this study is to detect expression of INHBA in 60 archived formalin-fixed Paraffin-embedded tissue blocks of patients suffered from Colorectal Carcinoma, and to correlate different levels of its expression to some studied clinical and pathological criteria (Age, Sex, Tumor size, location, depth of tumor invasion, status of regional lymph nodes, vascular and perineural invasion).

Eligibility criteria: Inclusion Criteria:

Specimens from patients with Colorectal Carcinoma. Tissue blocks with sufficient material. Specimens with sufficient clinical data.

Exclusion Criteria:

Tissue blocks with insufficient, destroyed or necrotic material. Specimens with insufficient clinical data.

Primary outcomes:
measure: Detection of INHBA in Colorectal Carcinoma.
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between INHBA expression in Colorectal Carcinoma and clinicopathological parameters.
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
Clinical trial NCT01062737: Evaluation of the Structure Modifying Effect of Avocado-Soybean Unsaponifiables in Hip Osteoarthritis
Official title: Evaluation of the Structure-modifying Effect and Safety of Avocado-Soybean Unsaponifiable (Piascledine 300) in Hip Osteoarthritis (OA) a 3 Years Multicenter Randomized, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Osteoarthritis
Lead sponsor: Laboratoires Expanscience S.A.
Sponsor class: INDUSTRY
First posted: 2010-02-04
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study aims to assess the long term (three years) ability of ASU (Avocado Soya unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study versus placebo.

Detailed description: Inclusion criteria:

Primary hip OA, fulfilling ACR criteria, patient over 45 y, painful \> 1 year, Lequesne's index \> or equal to 3, with minimum JSW at the target hip \> 1 mm and \< 4 mm on pelvic radiograph.

Primary criterion of efficacy:

The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader.

Randomisation is stratified according JSW at baseline (\< 2,5 mm or \> or equal to 2,5 mm).

Statistical analysis:

The Full Analysis Set (FAS) is defined by patients with at least one baseline value and one post baseline value.

The main analysis is scheduled on FAS using a Missing At Random (MAR)with a multiple model repeated measure (MMRM)to take in account missing value.

SAP (Statistical Analysis Plan) schedule to analyse JSW change as quantitative variable using an ANCOVA and as qualitative variable (progressors defined as JSW loss upper than 0,5 mm) using Mantel Haentzel test.

Eligibility criteria: Inclusion Criteria:

* primary OA of hip,
* ACR criteria,
* older than 45 years,
* symptomatic painful \> 1 an,
* Lequesne's index \> or equal to 3,
* JSW between 1 and 4 mm on pelvic radiograph.

Exclusion Criteria:

* secondary OA.

Primary outcomes:
measure: The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader.
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Multiple locations
Study officials:
References:
citation: Maheu E, Cadet C, Marty M, Moyse D, Kerloch I, Coste P, Dougados M, Mazieres B, Spector TD, Halhol H, Grouin JM, Lequesne M. Randomised, controlled trial of avocado-soybean unsaponifiable (Piascledine) effect on structure modification in hip osteoarthritis: the ERADIAS study. Ann Rheum Dis. 2014 Feb;73(2):376-84. doi: 10.1136/annrheumdis-2012-202485. Epub 2013 Jan 23.
Clinical trial NCT03258437: Efficacy and Safety of DA-9401 on Improvement of Sperm Motility
Official title: A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. and Cuscuta Chinensis Lam. Extract Mixtures (DA-9401) on Improvement of Sperm Motility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spermatocele
Keywords: sperm motility, Clinical Trial , DA-9401
Lead sponsor: Korean Society for Sexual Medicine and Andrology
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 27
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.

Detailed description: This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Age 20-55 years
* sperm motility 40\~69%

Exclusion Criteria:

* History of alcohol or substance abuse
* Participation in any other clinical trials within past 1 months
* intense constipation

Primary outcomes:
measure: Changes of Sperm motility
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of Sperm count
timeFrame: 12 weeks
measure: Changes of Ejaculated volume
timeFrame: 12 weeks
measure: Changes of Sperm morphology
timeFrame: 12 weeks
measure: Changes of Ejaculated pH
timeFrame: 12 weeks
measure: Changes of hormone(Total testosterone, FSH, LH)
timeFrame: 12 weeks
measure: Changes of IIEF(International Index of Erectile Function)
timeFrame: 12 weeks
measure: Changes of MFS(Multidimensional Fatigue Scale)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital of urology
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT05247437: Digital Lifestyle Intervention For Diabetes/Pre-Diabetes
Official title: A Pilot Cluster Randomized Controlled Trial of a Digital Lifestyle Intervention for Individuals With Prediabetes or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
PreDiabetes
Obesity
Keywords: Intensive Lifestyle Intervention
mHealth
eHealth
digital intervention
efficacy
RCT
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 120
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 study aims to evaluate the acceptability, feasibility, and preliminary efficacy of a digital lifestyle intervention, called Fitness Digital (FitD), for individuals with prediabetes or type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Age 18+
* Hong Kong resident
* Can understand Chinese and Cantonese
* Have self-reported diagnosis of type 2 diabetes or prediabetes
* Have a smart phone and able to use a mobile app

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA)
timeFrame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
measure: Changes in weight from baseline (week 0) to posttreatment (week 9)
timeFrame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Secondary outcomes:
measure: Changes in the scores on the Weight Control Strategy Scale
timeFrame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
measure: Changes in the scores on the Physical activity acceptance and action questionnaire
timeFrame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
measure: Changes in the scores on the Weight loss self-efficacy scale
timeFrame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Wai Sze Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108937: Effects of Dexmedetomidine on Breast Cancer Cell Function in Vitro
Official title: Effects of Serum From Patients Received Dexmedetomidine During General Anesthesia on Breast Cancer Cell Function in Vitro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery. Previous studies in cells and animals show that dexmedetomidine may promote cancer growth. Using serum from breast cancer surgery patients randomized to receive dexmedetomidine or saline during surgery, we investigated the effects of dexmedetomidine on proliferation, migration and metastasis in MCF-7 breast cancer cells in vitro.

Detailed description: Women diagnosed with breast cancer undergoing elective surgery under general anesthesia will be randomly allocated to dexmedetomidine group or control group. Patients from both groups will receive midazolam, propofol, fentanyl, remifentanil and CIS atracurium for total intravenous anesthesia. BIS value will be controlled between 40-60 during surgery. Patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery. Patients of control group will receive same amount of normal saline. Serum will be collected from patients of both groups at before induction and 1h post-surgery. The MCF-7 breast cancer cell line will be treated with patient serum from both groups. The effects of dexmedetomidine on cellular proliferation, migration and metastasis will be measured.

Eligibility criteria: Inclusion Criteria:

* ASA grade I-III Age range of 18 to75 Patients diagnosed primary breast cancer(T2-3, N0-2, M0) Patients will have elective adenomammectomy

Exclusion Criteria:

* with history of breast operation Patients diagnosed carcinoma erysipelatodes Severe liver, renal, brain or lung disease with history of opioid addiction Patients diagnosed metastatic breast cancer

Primary outcomes:
measure: cell proliferation
timeFrame: 24 hour post-surgery
Secondary outcomes:
measure: cell migration
timeFrame: 24 hour post-surgery
measure: cell metastasis
timeFrame: 24 hour post-surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Jie Tian
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu Y, Sun J, Wu T, Lu X, Du Y, Duan H, Yu W, Su D, Lu J, Tian J. Effects of serum from breast cancer surgery patients receiving perioperative dexmedetomidine on breast cancer cell malignancy: A prospective randomized controlled trial. Cancer Med. 2019 Dec;8(18):7603-7612. doi: 10.1002/cam4.2654. Epub 2019 Oct 30.
Clinical trial NCT04340037: Prediction of Sepsis After Percutaneous Nephrolithotomy
Official title: A Pre-operative Nomogram for Sepsis After Percutaneous Nephrolithotomy Treating Solitary, Unilateral, and Proximal Ureteral Stones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Percutaneous Nephrolithotomy
Infection
Urolithiasis
Albumin Globulin Ratio
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 745
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 745 patients who underwent PCNL from January 2012 to December 2018 were enrolled when meeting eligibility criteria

Brief summary: We aim to determine the preoperative predictors of sepsis after percutaneous nephrolithotomy (PCNL) in patients with unilateral, solitary and proximal ureteral stones.


Eligibility criteria: Inclusion Criteria:

* (1) PCNL was performed to treat unilateral, solitary, and proximal ureteral stones; and (2) age ≥18 years

Exclusion Criteria:

* anatomical renal abnormalities (horseshoe kidney, solitary kidney, transplant kidney and kidney duplication)

Primary outcomes:
measure: sepsis
timeFrame: within 48 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT04545437: The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study
Official title: The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Myocardial Infarction
Stroke
Atrium; Fibrillation
Atrial Flutter
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 80000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023.

Brief summary: The aim this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk.

Detailed description: Undertake a retrospective observational cohort study of patients admitted to intensive care units between 2006 and 2023.

Study Participants: Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023.

Objectives:

To determine the short and long-term cardiovascular consequences of critical illness and identify in-ICU factors that affect them.

To identify the risk factors for new-onset atrial fibrillation/flutter occurring during critical illness.

To study the association between poor cardiovascular function during critical illness and long-term cardiovascular disease.

This study will provide new knowledge about the associations between baseline cardiovascular risk, the disease resulting in ICU admission and therapies / events on ICU with subsequent major adverse cardiac events (MACE), to allow the ongoing risk of these events to be determined. If clinicans can idetnify who is at risk, then risk factors can potentially be modified .

Eligibility criteria: Inclusion Criteria:

* Aged 16 years or above.
* Admitted to an intensive care unit at a study site from 2006 onwards

Exclusion Criteria:

* Patients that have informed their participating site that they do not wish their electronic records would be used for future research
* Patients who inform us directly that they don't wish their records used in this research study

Primary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Major adverse cardiovascular and vascular events
timeFrame: 5 years
measure: Arrhythmia
timeFrame: 5 years
Secondary outcomes:
measure: Hospital re-admission
timeFrame: 5 years
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
state: Berkshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
state: Oxfordshire
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: University of Oxford
name: Peter Watkinson
role: STUDY_DIRECTOR
References:
Clinical trial NCT03483337: New MRI Biomarkers in Head and Neck Cancers
Official title: Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Thyroid Cancer
Keywords: (DW)-MRI
oncological biomarkers
metastatic
recurrent
18-063
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 200
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: MSK clinics in the medicine, surgery and radiation oncology departments.

Brief summary: Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.

The purpose of this study is to see if new MRI methods can give us more information about the tumor.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region.
* Group 2 patients:

  * Biopsy proven recurrent or metastatic or definitive head and neck cancer or (differentiated and undifferentiated) thyroid cancers in the head and neck region only.
  * Patients planning to undergo reatment at MSK

Exclusion Criteria:

* Patient would require anesthesia for the study
* Patients who are claustrophobic
* Patients selecting treatment outside of MSK
* Known reaction to Gd based contrast agent
* Patients who have presence of a known contradiction to MRI

  * Pacemaker
  * Aneurysm clips
  * Patients with implants that are contradicted for MR imaging will be excluded
  * Pregnant
  * Age and mental status wherein he /she is unable to cooperate for MRI study

Primary outcomes:
measure: For group 1: number of patients that have biomarkers that maybe early response to therapy indicators
timeFrame: 1 year
measure: For group 2: number of patients response to treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Amita Dave, PhD
role: PRINCIPAL_INVESTIGATOR
References: