louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03243344: Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery
Official title: Randomized Medico-economic Assessment of Preventive Devices Used for Post-operative Hemorrhagic Risk in Endonasal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otorhinolaryngologic Diseases
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the efficiency and the cost of three medical devices and the abstention of the use of specific product for the post-operative haemostasis in endonasal surgery .

Detailed description: Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the post-operative bleeding of which one of the indications is in endonasal surgery.

Floseal® is a haemostatic frost(gel) containing of the thrombin.

Algosteril® is a lint tent of arginate of calcium.

Eligibility criteria: Inclusion Criteria:

* endonasal surgery schedule
* Surgical indications:

hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body, polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine,

Exclusion Criteria:

* Pregnant Woman
* Disorder of the haemostasis known or disrupted preoperative biological balance assessment
* Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K, AINS)
* Unchecked HTA by the treatment and/or preoperative \> mmHg 160/90
* Surgical Act including a septoplasty
* malignant tumoral surgical Indication, or mild overtaking the naso-sinusial system
* Dacryocystorhinostomy

Primary outcomes:
measure: Per-operative hemostasis
timeFrame: Hours 0
measure: Hemostasis in the 6 first hours
timeFrame: Hours 6
measure: Hemostasis at the 24th hour
timeFrame: Hours 24
measure: Spontaneous hemorrhagic events
timeFrame: from Hours 0 to Day 45
Secondary outcomes:
measure: Preoperative assessment
timeFrame: Before the endonasal surgery
measure: Preoperative assessment
timeFrame: Hours 0
measure: Device evaluation by the surgeon
timeFrame: Hours 0
measure: Device evaluation by the surgeon
timeFrame: Hours 0
Other outcomes:
Locations:
Study officials:
affiliation: CHU Besançon
name: Laurent TAVERNIER, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02905344: Effectiveness of Using 3D Printed Models to Educate Otolaryngology (Ear, Nose, Nose and Throat (ENT)) Patients About Surgery: A Survey
Official title: The Effectiveness of Using 3D Printed Anatomically Accurate Models to Educate Patients About Surgery: A Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pathological Conditions, Anatomical
Deviated Nasal Septum
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 adult patients considering sinus surgery

Brief summary: Within the Ear, Nose, and Throat (ENT) medical space, a relatively small number of patients follow through with elective surgeries to fix ailments like a deviated septum or occluded sinus passage. Patient understanding of their diagnosis and treatment plan is integral to compliance, which ultimately yields improved medical outcomes and better quality of life. Here the investigators report the usage of advanced inkjet 3D printing methods to develop a multimaterial replica of the patient's nasal sinus anatomy, derived from clinical X-ray Computed Tomography (CT) data. The final patient education model was developed over several iterations to optimize material properties, anatomical accuracy and overall display. A two arm, single center, randomized, prospective study was then performed in which 50 ENT surgical candidates (and an associated control group, n = 50) were given an explanation of their anatomy, disease state, and treatment options using the education model as an aid. Each patient was then surveyed for their self-rated understanding of their anatomy, disease, and treatment options.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects that are 18 years or older.
* Surgeon must have recommended nasal or sinus surgery
* Not excluded as a surgical candidate

Exclusion Criteria:

* Patients who or not able to read or understand English

Primary outcomes:
measure: Question: How did the doctor's visualization help you in your understanding of the surgery?
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: South Bend
country: United States
facility: Michiana ENT Specialty Center
state: Indiana
Study officials:
affiliation: Notre Dame
name: Douglas R Liepert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04935892: Slippers to Reduce Transfer From Floors to Surfaces
Official title: Impact of Wearing Slippers on Transfer of Bacteriophage MS2 From Floors in Patient Rooms to Bedding and Surfaces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transmission, Other/Miscellaneous
Keywords: Floor
Bacteriophage MS2
Contamination
Environment
Healthcare-associated pathogens
Lead sponsor: Louis Stokes VA Medical Center
Sponsor class: FED
First posted: 2021-06-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial
Primary purpose: PREVENTION

Brief summary: The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Subjects are randomized to wear slippers versus standard care and cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces, personal items, bedding, socks or feet, and hands of patients.

Detailed description: The goal of this study is to determine if wearing slippers will reduce transfer of bacteriophage MS2 from hospital room floors to surfaces in the room and hands of patients. Hospitalized patients are enrolled and randomized to wear slippers any time they are out of bed versus standard care. Bacteriophage MS2 is inoculated onto a site on the floor between the patient bed and the bathroom. Cultures are collected at 24 and 48 hours to assess transfer of bacteriophage MS2 from the floor to high-touch surfaces (bed rail, bedside table, telephone, call button), personal items, bedding, socks or feet, and hands of patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients of 18 years of age or older
* Ambulatory
* Able to demonstrate an understanding of study procedures

Exclusion Criteria:

* Unable or unwilling to fulfill study requirements.
* Expected length of stay less than 48 hours
* Any patient deemed not suitable for study participation at the discretion of the study investigator

Primary outcomes:
measure: Contamination of a composite of high-touch surfaces, personal items, socks/feet, bedding, and hands
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland VA Medical Center
state: Ohio
Study officials:
affiliation: Cleveland VA Medical Center
name: Curtis J Donskey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haq MF, Alhmidi H, Redmond SN, Cadnum JL, Silva SY, Wilson BM, Donskey CJ. A randomized trial to determine whether wearing slippers reduces transfer of bacteriophage MS2 from floors to patients and surfaces in hospital rooms. Infect Control Hosp Epidemiol. 2023 Apr;44(4):670-673. doi: 10.1017/ice.2021.475. Epub 2022 Aug 23.
Clinical trial NCT04725292: Rare Benign Lesion of Peins
Official title: Pseudoepitheliomatous Hyperplasia of the Penis a Very Rare Disease in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Diseases
Penile Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 1
Sex: MALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male healthy married

Brief summary: PEKMB was first named and described by Lortat-Jacob \& Civatte in 1961 and by Bart \& Kopf later. This rare condition is mostly reported in elderly males. The keratotic scales is usually micaceous and resembles psoriasis. Most patients are above 50 years of age and are circumcised later in life, but also reported in younger age group. This mica like scales contains keratin which gets dissolved in 10% potassium hydroxide solution. Disease progression may lead to phimosis. Differential diagnosis of this disease entity include moniliasis, wart, psoriasis ,penile horn, circinate balanitis, erythroplasia of Queyrat, squamous cell epithelioma and verrucous carcinoma. It is primarily a benign entity, it is capable of invasiveness. Bart and Kopf considered it to be in intermediate stage between benign hyperplasia and squamous cell carcinoma. However, the histological spectrum can range from hypertrophic-hyperplastic penile dystrophy to verrucous carcinoma. Fibro sarcoma has been reported developing in a same patient. Etiology is unclear. Despite search for a viral agent, Human Papilloma Virus (HPV) has not been demonstrated and its role in pathogenesis or its transformation to verrucous carcinoma has been proved. The treatment of PEKMB should be conservative when there is no histological evidence of malignancy. All such patients should be followed up. Treatment choices include potent topical steroids, topical 5% 5-flurouracil cream1, 2, cryotherapy, radiotherapy and shaving biopsy plus electro coagulation. When frank malignancy is observed, excision with wide margin is the rule.


Eligibility criteria: Inclusion Criteria:

* 40 years
* failed medical treatment

Exclusion Criteria:

* psoriasis
* allergy
* trauma

Primary outcomes:
measure: improvement of the skin lesion
timeFrame: 1 month after treatment
measure: improvement of associated lesion
timeFrame: 1 month after drug given
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit Medical School
state: Assuit
Study officials:
References:
Clinical trial NCT00674492: Hepatitis C Virus (HCV) Treatment Completion or Withdrawal
Official title: Patients' View of Hepatitis C Treatment Completion or Withdrawal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-05-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VHA patients who ever initiated antiviral treatment for hepatitis C.

Brief summary: Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C.

Detailed description: Qualitative pilot study of patient' views of their experiences with antiviral treatment for hepatitis C. Two groups of patients will be sampled: nine who completed a 24 or 48 week course of treatment and nine who withdrew from treatment prior to planned end. Interview data will be analyzed using narrative and grounded theory methods to identify attributes of treatment experience that may discriminate between completion and withdrawal.

Eligibility criteria: Inclusion Criteria:

Ever initiated anitiviral treatment for hepatitis C.

Exclusion Criteria:

none

Primary outcomes:
measure: Attributes of Treatment Experience
timeFrame: Zero to five years since ending treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
name: Jack A Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02487992: The Study of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
Official title: The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 1200
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: The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer.

Detailed description: 1200 patients with stage Ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive CIK plus S-1 and Bevacizumab ) or group B（just receive S-1 and Bevacizumab),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only S-1 and Bevacizumab (continuous) .

Eligibility criteria: Inclusion Criteria:

* Patients who can accept curative operations 18-70 years old
* Histologically confirmed with colorectal cancer at stage Ⅳ
* Patients who can accept oral drugs;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion Criteria:

* Hemoglobin\<8.0 g/dL,White blood cell \<3 X 10\^9/L;Platelet count \<75 X 10\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or lactating patients
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
* Patients who are suffering from serious autoimmune disease
* Patients who had used long time or are using immunosuppressant
* Patients who had active infection
* Patients who are suffering from serious organ dysfunction
* Patients who are suffering from other cancer
* Other situations that the researchers considered unsuitable for this study.

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: 3 months
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 months
Other outcomes:
measure: Adverse events
timeFrame: 1 months
Locations:
Study officials:
References:
Clinical trial NCT03615092: Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions
Official title: Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions. A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Acellular dermal matrix graft
Clinical Trial
Root coverage
Noncarious cervical lesion
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled Split-mouth clinical trial
Primary purpose: TREATMENT

Brief summary: Patients with high standards of oral hygiene frequently search for buccal gingival recession (GR) treatment due to cervical wear, root sensitivity and compromising aesthetics. The cervical lesion (NCCL) is commonly produced by improper toothbrushing techniques, sharing the same etiology of GR. Many different surgical approaches have been described. The association of a graft to the coronally advanced flap had demonstrated the best long-term outcome for root coverage. But, substitutes for the autogenous graft must be studied. Therefore, the aim of this clinical trial was to investigate the effectiveness of the acellular dermal matrix graft (ADMG) in root coverage associated with a previous restored cervical lesion or not.

Material and methods: Seventeen individuals with bilateral GR were included in the study. At one side, the GR must present a previously restored cervical lesion, as the test group (TG). The contralateral arch, must present GR with an intact root surface (CG). All patients were treated with the extended flap technique associated with the ADMG. All clinical parameters were assessed at baseline and 6-months postoperative.


Eligibility criteria: Inclusion Criteria:

* CEJ without significant damage;
* localized bilateral RT112 gingival recession ≥3 mm in the same arch, in which one had a non-carious cervical lesion (NCCL) restored with composite and the opposite one was intact

Exclusion Criteria:

* previous periodontal surgical treatment on the involved sites;
* smokers
* pregnants or lactating
* compromised systemic health and contraindications for periodontal surgery

Primary outcomes:
measure: Root coverage
timeFrame: 6 months
Secondary outcomes:
measure: Keratinized tissue
timeFrame: 6months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: School of Dentistry of Ribeirao Preto - University of Sao Paulo
state: Sao Paulo
Study officials:
References:
Clinical trial NCT06673992: Evaluation of Corneal Irregular Astigmatism and Visual Quality Following Bilateral Sequential Small Incision Lenticule Extraction (SMILE) and Laser Subepithelial Keratomileusis (LASEK): A Six-Year Comparative Study
Official title: Evaluation of Corneal Irregular Astigmatism and Visual Quality Following Bilateral Sequential Small Incision Lenticule Extraction (SMILE) and Laser Subepithelial Keratomileusis (LASEK): A Six-Year Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with mild to moderate myopia or myopic astigmatism who underwent SMILE or LASEK between October 2017 and May 2018 were enrolled

Brief summary: To compare the corneal spherical component (SC), regular astigmatism (RA), irregular astigmatism (IA, including Asymmetry and Irregularity) and visual quality six years after small incision lenticule extraction (SMILE) and laser subepithelial keratomileusis (LASEK) for mild to moderate myopia.


Eligibility criteria: Inclusion Criteria:

* (1) patients aged over 18 years; (2) absence of corneal, ocular, or systemic diseases; (3) stable refractive diopter maintained for the past 2 years with a change of ± 0.50 diopter; (4) discontinuation of soft contact lens wear for at least 2 weeks and rigid contact lenses for at least 4 weeks prior to surgery; (5) preoperative manifest refraction spherical equivalent (MRSE) less than -6.00 diopter (D)

Exclusion Criteria:

A history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery

Primary outcomes:
measure: Corneal Irregular Astigmatism
timeFrame: preoperative and 6 years postoperatively
measure: wavefront aberration
timeFrame: preoperative and 6 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
Study officials:
References:
Clinical trial NCT03829592: TheEffect of pH on Misoprostol in Induction of Labor
Official title: TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2019-02-04
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 paralle groups
Primary purpose: TREATMENT

Brief summary: Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .

Detailed description: Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation

Exclusion Criteria:

* 1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.

Primary outcomes:
measure: The number of women who will start lactive phase of labour after treatment
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References: