louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04629859: Orthognathic Surgeries and Pharyngeal Airway Space
Official title: Malocclusion Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Prognathism
Keywords: Orthognathic surgery
Pharyngeal airway space
skeletal class III patients.
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: twenty-four patients with dentoskeletal deformity of class III will be divided equally into two groups and will be subjected to orthognathic surgeries group A; will be treated by mandibular setback surgery while group B will be treated with bimaxillary orthognathic surgery in the form of mandibular setback and maxillary advancement surgeries. the total pharyngeal airway will be measured on lateral cephalometric radiographs, integrating retro-palatal and retro-glossal area, and statistically will be compared preoperative, immediate postoperative, and at 6 months post-surgically


Eligibility criteria: Inclusion Criteria:

* dento-skeletal class III malocclusion which needed a surgical intervention with maxillary advancement surgery and/or mandibular set-back orthognathic surgery in the form of bilateral sagittal split osteotomy
* no previous orthognathic surgery

Exclusion Criteria:

* Patients with craniofacial syndromes.
* Medically compromised patients and patients with bone anomalies

Primary outcomes:
measure: total pharyngeal airway space surface area
timeFrame: 6 months
Secondary outcomes:
measure: Epworth sleepiness scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
affiliation: Cairo University
name: hussien hatem, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04384159: Combination Diagnostic Strategies in NAFLD
Official title: Transient Versus Bidimensional Shear Wave Elastography in Serial Combination Strategy to Diagnose Advanced Fibrosis in NAFLD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Chronic Liver Disease
Keywords: Liver elastography
Liver fibrosis
Non-invasive diagnosis
NAFLD
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 577
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: Patients who underwent liver biopsy for the diagnosis of a NAFLD

Brief summary: Serial combination of biological and elastography tests is accurate to diagnosing advanced fibrosis in non-alcoholic fatty liver disease (NAFLD) patients. In this study, the investigators compared the diagnostic performances of a 2-step strategy using either vibration-controlled transient elastography (VCTE) or bidimensional shear wave elastography with Supersonic imagine (2D-SWE-SSI), and analysed the added-value of a 3-step strategy.

Detailed description: The investigators retrospectively selected all consecutive adult patients with suspicion of NAFLD who had undergone liver biopsy from November 2011 to July 2019 in 2 French academic centers, Angers and Bordeaux university hospitals. A total of 577 patients were included. Among them, 291 had been previously included in a prospective study comparing diagnostic performances of several non-invasive tests in NAFLD patients. Inclusion criteria were: Age≥18yo, 2D-SWE-SSI and VCTE performed within the two weeks prior to liver biopsy. Exclusion criteria were high alcohol consumption (i.e., \>21 drinks, on average, per week in men and \>14 drinks, on average, per week in women), associated causes of liver disease (alcoholic, viral, or other causes of liver injury), other aetiologies than NAFLD on pathological examination, and a liver biopsy length of less than 10 mm and/or fewer than 6 portal spaces and/or more than 2 fragments, except for in cases of cirrhosis.

Eligibility criteria: Inclusion criteria:

- PAtients who underwent a liver biopsy for a suspicion of NAFLD, and liver stiffness evaluation with either Fiborscan and Bidimensional shear wave elastography

Exclusion criteria:

* Other aetiologies of chronic liver disease
* biopsy length under 10mm

Primary outcomes:
measure: Diagnostic accuracyclassification
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: Christophe Cassinotto, PU-PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01806259: Ketorolac in Breast Cancer Surgery
Official title: Perioperative Ketorolac in High Risk Breast Cancer Patients With and Without Inflammation. A Prospective Randomized Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Curative Breast Cancer Surgery
Inflammatory Positive/Negative Status
Pre Surgical Incision Administration
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Anticancer Fund, Belgium
First posted: 2013-03-07
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.


Eligibility criteria: Inclusion Criteria:

Written informed Consent age : 18-85 years weight: 50-100 kg Neutrophils / Lymphocytes ratio \>4 and/or "triple negative" histological status and/or Positive lymph nodes

Exclusion Criteria:

Previous cancer (behalf of basocellular skin cancer and in situ uterine cervix cancer) Non compliance or refusal of the protocol Positive Pregnancy test Childbearing or breastfeeding mothers Contra-indication for NSAIDs NSAIDs intake in the 5 days before randomisation NSAIDs use planned in the 30 days after randomisation Non curative surgery (T4 or M1 tumor classification )

Primary outcomes:
measure: Recurrence-free Survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
measure: Overall Survival
timeFrame: 5 years
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Patrice Forget, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forget P, Vandenhende J, Berliere M, Machiels JP, Nussbaum B, Legrand C, De Kock M. Do intraoperative analgesics influence breast cancer recurrence after mastectomy? A retrospective analysis. Anesth Analg. 2010 Jun 1;110(6):1630-5. doi: 10.1213/ANE.0b013e3181d2ad07. Epub 2010 Apr 30.
citation: Forget P, Bouche G, Duhoux FP, Coulie PG, Decloedt J, Dekleermaker A, Guillaume JE, Ledent M, Machiels JP, Mustin V, Swinnen W, van Maanen A, Vander Essen L, Verougstraete JC, De Kock M, Berliere M. Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial. PLoS One. 2019 Dec 4;14(12):e0225748. doi: 10.1371/journal.pone.0225748. eCollection 2019.
citation: Forget P, Berliere M, van Maanen A, Duhoux FP, Machiels JP, Coulie PG, Bouche G, De Kock M; Ketorolac in Breast Cancer trial (KBCtrial) group. Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial. Med Hypotheses. 2013 Oct;81(4):707-12. doi: 10.1016/j.mehy.2013.07.033. Epub 2013 Aug 9.
Clinical trial NCT03596359: Teach-Back Method on Quality of Life in Heart Failure Patients
Official title: Effect of Self-care Education With Teach-Back Method on Quality of Life in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Self Care
Heart Failure
Quality of Life
Teach-Back
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study determines effect of education with Teach-Back method in patients with Heart failure. In this randomized clinical trial, 70 patients with Heart failure hospitalized in year 2016-17 were selected and they were randomly divided into control group and test group.Self-care behaviors training with Teach-Back method within 15 to 45 minutes was done on the case group, and control group received routine treatment. Information have collected whit Demographic questionnaire and SF36 questionnaire before and after training. Data were analyzed by Spss version18 And there were analyzed by descriptive statistics and Chi-square, Independent T-test, Paired T-test and Co-variance tests.


Eligibility criteria: Inclusion Criteria:

* Age from 45 to 85
* Heart failure diagnosed six months ago
* The Ejection Fraction less than 45
* Have reading and writing skills
* Have perfect consciousness
* Fluency in Persian

Exclusion Criteria:

* Patient do not cooperate with researchers
* The inability of each sample to continue cooperation during the study because of the problem or acute disease.

Primary outcomes:
measure: SF 36 questionnaire
timeFrame: Up to 48 hours
measure: Demographic questionnaire
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03078959: Prognostic Value of PD-L1 in NSCLC
Official title: The Prognostic Value of the Expression of Programmed Death Ligand 1 (PD-L1) in Early Stage Non-small-cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Fondazione Ricerca Traslazionale
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 350
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: 350 patients with stagi I-III NSCLC

Brief summary: This is an observational retrospective study. The primary objective is to investigate the expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor samples from 350 patients with early stage treatment-naive non-small-cell lung cancer (NSCLC).

Tissue samples were embedded in a tissue microarray. PD-L1 will be studied by immunohistochemistry using the SP263 antibody. Stained samples will be evaluated independently by two operators. A tumor will be defined as positive when = or \>50% of tumor cells express the ligand.

The investigators will investigate the relationship between PD-L1 protein expression and overall survival and other clinical characteristics with appropriate statistical methods.


Eligibility criteria: Inclusion Criteria:

* Early stage treatment-naive NSCLC

Exclusion Criteria:

* Received any pre-surgical treatment
* no OS data available

Primary outcomes:
measure: Expression
timeFrame: 15 days
measure: Prognostic value
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02558959: Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer
Official title: Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Neoplasms
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 64
Sex: ALL
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: This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
* Age 18 years or older
* Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
* Karnofsky performance status (KPS) of at least 70%
* Adequate renal function, adequate hepatic function, adequate bone marrow function

Exclusion Criteria:

* The presence of any severe concomitant disease that could interrupt the planned treatment
* Intractable pain
* Hypersensitivity to study drugs
* Serious cardiovascular disease
* If female, pregnancy or breastfeeding

Primary outcomes:
measure: Progression Free Survival
timeFrame: within 1 year
Secondary outcomes:
measure: Overall Survival
timeFrame: within 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First affiliated hospital, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03783559: TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)
Official title: TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Adenocarcinoma Metastatic to the Liver
Keywords: colorectal cancer liver metastasis
Transarterial chemoembolization
conversion resection rates
chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 168
Sex: ALL
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: To date no randomized controlled trials have been completed that demonstrated whether TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for patients who failed with first-line chemotherapy.The primary objective of this trial is to determine conversion resection rates and survival for patients with colorectal cancer liver metastasis are treated with TACE plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd line.


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically confirmed CRLM
* disease limited to the liver Unresectable disease by surgery or other local therapies
* Age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2,child pugh A or B
* Expected survival ≥ 3 months
* Adequate hematological, hepatic and renal function
* PD(progressive disease) after first line chemotherapy

Exclusion Criteria:

* pregnant or lactating women
* patients with severe organ dysfunction or failure
* with severe cardiovascular or mental disease

Primary outcomes:
measure: Progression free survival
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 6 months
measure: conversion resection rates
timeFrame: 2-4months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of General Surgery, Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: Jianmin Xu, PhD
role: STUDY_CHAIR
References:
citation: Liu Y, Chang W, Zhou B, Wei Y, Tang W, Liang F, Chen Y, Yan Z, Lv M, Ren L, Xu J. Conventional transarterial chemoembolization combined with systemic therapy versus systemic therapy alone as second-line treatment for unresectable colorectal liver metastases: randomized clinical trial. Br J Surg. 2021 Apr 30;108(4):373-379. doi: 10.1093/bjs/znaa155.
citation: Swierz MJ, Storman D, Riemsma RP, Wolff R, Mitus JW, Pedziwiatr M, Kleijnen J, Bala MM. Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases. Cochrane Database Syst Rev. 2020 Mar 12;3(3):CD009498. doi: 10.1002/14651858.CD009498.pub4.
Clinical trial NCT02293759: Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency
Official title: Prospective Non-randomized Trial Comparing Holmium Laser Enucleation of the Prostate Versus Greenlight Laser Photoselective Vaporization of the Prostate in Treating Benign Prostate Hyperplasia in Patients With Bleeding Tendency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH- LASER- PROSTATE- BLEEDING TENDENCY
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile.

Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated with greenlight PVP

Detailed description: Elderly patients with bleeding tendency either secondary;

1. Strict antiplatelet intake
2. Strict anticoagulant intake
3. uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery.

Laser prostate surery was introduced to overcome this difficulty. However, till now there is no head to head comparision of different types of laser procedures in treating this subset of patients In the current study patients presented for BPH surgery in a tertiarry referral prostate unit will be assessed for bleeding tendency and will be treated either by Holmium laser enucleatiuon of the prostate or Greenlight laser vaporization of the prostate Single surgeon will perform all cases

Eligibility criteria: Inclusion Criteria:

* BPH patients candidate for transurethral prostate surgery after failure of medical treatment
* Perioperative uncorrected Blleding tendency

  1. patients with naturally induced uncorrectable bleeding tendency;

     1. platelet count less than 100000/mm3
     2. INR more than 1.5
  2. Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist
  3. Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist

Exclusion Criteria:

* Correctable bleeding tendency

Primary outcomes:
measure: perioperative blood loss
timeFrame: 48 hours
Secondary outcomes:
measure: readmission
timeFrame: 30 days
measure: blood transfusion
timeFrame: 30 days
measure: flow rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Mansoura University
name: Ahmed m Elshal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00216359: Cohort Study for Patients Using Fuzeon (Enfuvirtide)
Official title: The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Antiretroviral Treatment
Keywords: Treatment Experienced
Lead sponsor: Institute for Interdisciplinary Infectiology
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: The Radata-Fuzeon cohort is an observational cohort study to gain a better understanding of Fuzeon (Enfuvirtide) in daily clinical practice. Patients planned to take this drug in a new antiretroviral combination therapy (ART) are eligible to participate in this observation.

Physicians may register patients online via the internet. They are offered to get an expert advice suggesting therapeutics for a new ART.

Observation interval is every three month. However physicians are allowed to initiate new diagnostics, expert advice and therapeutic changes independently from these intervals if necessary.

Total observation time for each patients is planned for two years.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HIV-Infection
* Planned to switch to a Fuzeon-containing antiretroviral therapy

Exclusion Criteria:

* Inability to understand or sign inform consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Ifi-Institute for Interdisciplinary Infectiology
Study officials:
affiliation: ifi-Institute for Interdisciplinary Infectiology
name: Andreas Plettenberg, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03702959: Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia
Official title: Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoglycemia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This is a retrospective study at Rambam Health Care Campus.

Brief summary: A single "supraphysiological" course of exogenous corticosteroids is recommended between 24-34 weeks' gestation to minimize the adverse sequelae associated with prematurity. The 24-hour profile of endogenous corticosteroids normally follows a diurnal rhythm with the highest serum level occurs between 5am-11am and nadir over 12 hours.

Detailed description: A retrospective study from January 2010 to December 2017. Eligible for analysis are: singleton pregnancies between 24 - 34 weeks' gestation who were given a single course of intramuscular betamethasone. Single course comprised of two separate doses of 12 mg given 24 hours apart. Each woman was allocated into one of the four pre-defined groups based on the time the intramuscular betamethasone was administered; Group 1 (5am-11am), group 2 (11am-5pm), group 3 (5pm-11pm) and group 4 (11pm-5am). The investigators hypothesized that exogenous corticosteroids given during the nadir state of endogenous corticosteroids activity could alter maternal and fetal glucose homeostasis.

Eligibility criteria: Inclusion Criteria:

• women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution

Exclusion Criteria:

* higher order multiple pregnancies
* women who were given more than one course of betamethasone during the course of the current pregnancy
* known major congenital anomalies.

Primary outcomes:
measure: Incidence of neonatal hypoglycemia
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Yaniv Zipori, M.D
role: PRINCIPAL_INVESTIGATOR
References: