louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06535867: The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
Official title: The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Smoking
Smoking, Cigarette
Smoking, Tobacco
Betel Chewer's Mucosa
Tobacco Use
Tobacco Smoking
Alcohol Drinking
Smokeless Tobacco Hyperkeratosis
Keywords: smoking
smoking, cigarette
smoking, tobacco
smokeless tobacco
betel leaf
areca nut
paan masala
alcohol use
Memorial Sloan Kettering Cancer Center
24-148
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 5122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Field health personnel (FHP) with help of ASHA (a healthcare network in rural areas) will visit household and collect mobile phone numbers in Varanasi.

Brief summary: Mobile health (mHealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. This program is inclusive of long term surveillance to downstage oral cancer in India


Eligibility criteria: Inclusion Criteria:

Positive for any one or more of the following:

* All individuals aged above 18 years positive for habits (smoking and smokeless tobacco, chewing betel leaf, areca nut, paan masala, and/or regular use of alcohol)
* Clinical signs/symptoms (non-healing ulcers, white/ red/red \& white patches in the mouth, restriction of mouth opening and swelling of the neck)
* All individuals aged above 40 irrespective of habit/oral lesions

Exclusion Criteria:

* Individuals already diagnosed with oral cancer and undergoing treatment for oral cancer
* Under treatment for tuberculosis or suffering from any acute illness/ debilitating systemic disorders

Primary outcomes:
measure: Comparison of mHealth with conventional oral cancer screening
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Milind Rajadhyaksha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06853067: Effect of Dexmedetomidine and Remimazolam on Body Temperature in Patients Undergoing Spinal Anesthesia
Official title: Effect of Dexmedetomidine and Remimazolam on Body Temperature in Patients Undergoing Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temperature Change, Body
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to evaluate the effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective surgery under spinal anesthesia

Exclusion Criteria:

* Severe vascular disease
* Thyroid dysfunction

Primary outcomes:
measure: Incidence of hypothermia
timeFrame: Body temperature is monitored during spinal anesthesia.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02777567: KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)
Official title: Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or After EGFR Tyrosine Kinase Receptor (TKI) Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-05-19
Enrollment: 315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy

Brief summary: The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.


Eligibility criteria: Inclusion Criteria:

* 1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy
* 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

* 1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
* 2. Pregnancy and/or breast feeding
* 3. Current participation in any interventional trial

Primary outcomes:
measure: Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
timeFrame: up to one year
measure: Severity of (S)AEs
timeFrame: up to one year
Secondary outcomes:
measure: ORR (Objective response rate), if available
timeFrame: up to one year
measure: PFS (Progression free survival), if available
timeFrame: up to one year
Other outcomes:
Locations:
city: South Korea
country: Korea, Republic of
facility: Research Site
Study officials:
References:
Clinical trial NCT02322567: Left Ventricular Diastolic Dysfunction in Kidney Recipients
Official title: Influence of Left Ventricular Diastolic Dysfunction on Graft Function and Postoperative Complication in Patients Undergoing Elective Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 242
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective kidney transplantation patients

Brief summary: The purpose of this study is to examine the relationship between pre-operative LV diastolic function and post-operative complications and kidney function in living-donor kidney transplantation patients.


Eligibility criteria: Inclusion Criteria:

* Elective kidney transplantation patients

Exclusion Criteria:

* No data of preoperative echocardiography

Primary outcomes:
measure: Patients with postoperative cardiovascular complications
timeFrame: 30 days
Secondary outcomes:
measure: Patients with postoperative pulmonary edema
timeFrame: 30 days
Other outcomes:
measure: Postoperative graft function (graft failure, acute rejection, graft loss, serum creatinine)
timeFrame: 30 days
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: Yong Seon Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim EJ, Chang S, Kim SY, Huh KH, Kang S, Choi YS. Predictive Value of Echocardiographic Abnormalities and the Impact of Diastolic Dysfunction on In-hospital Major Cardiovascular Complications after Living Donor Kidney Transplantation. Int J Med Sci. 2016 Jul 18;13(8):620-8. doi: 10.7150/ijms.15745. eCollection 2016.
Clinical trial NCT00922467: Influence of Esmolol on a Closed-Loop Anesthesia System
Official title: Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil


Eligibility criteria: Inclusion Criteria:

* male patients scheduled for a general anesthesia

Exclusion Criteria:

* age lower than 18 years
* allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine, or to a myorelaxant or to an excipient,
* any other history of anaphylactic reaction,
* hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
* hypersensibility to esmolol or to an excipient,
* history of central nervous system disease,
* patients receiving a psychotropic treatment or an agonist-antagonist opiate,
* hypovolemic patients,
* patients receiving a cardio-vascular treatment,
* patients with a pacemaker,
* expected bleeding more than 20% of the blood volume,
* simultaneous general and loco-regional anesthesia,
* patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,
* patients with a heart rate less than 50/min and/or an arterial hypotension,
* neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.

Primary outcomes:
measure: administered doses of propofol and of remifentanil during anesthesia
timeFrame: end of anesthesia
Secondary outcomes:
measure: delay before recovery
timeFrame: at the end of anesthesia
measure: hemodynamic abnormalities requiring a treatment
timeFrame: end of anesthesia
measure: postoperative morphine requirement
timeFrame: Third post-anesthetic hour
measure: explicit memorisation
timeFrame: Second postoperative day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06213467: Using Diode Laser in 2nd Stage of Implant.
Official title: Pain Perception and Evaluated Injectable Anesthesia Needed by Using Pulsating Diode Laser 940nm in Second Stage Implant Exposure Versus Traditional Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Exposure Using Diode Laser
Keywords: diode laser
dental implant
local anasthesia
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 15 patients that have at least two dental implants in jaws.
Primary purpose: TREATMENT

Brief summary: Dental Implants that are teeth replacements usually place with two stages. In the second stage the implant fixture, (which is the body that inserted in the bone is exposed to place the artificial tooth), is exposed using surgical blade, however; an alternative method using diode laser may be used. This study aimed to compare the two methods in relation to pain anticipated by the patients and the need for local anesthesia usage.

Detailed description: Second-stage implant exposure involves removing soft tissue above the dental implant, as a part of the implant procedures to replace the missing teeth which can be done either by using diode laser or traditional method This study included fifteen patients, aged between 18 and 70 years old. Implant exposure was performed on 15 patients has at least two implants in two groups: group 1 with a diode laser at 940nm and group 2 with the traditional method performed either using a puncture, flap, or incision in 5 private clinics and one governmental run hospital in city of Baghdad/ Iraq.

Eligibility criteria: Inclusion Criteria:

- 1. Describe the target population and the criteria for their inclusion. Patients indicated for fixed implant treatment with conventional Implant procedure with implant insertd before (3-6) months by using two stage dental implant.

2. Treatment with two or more implant in same patient. 3. Patients aged from 18 to 70 years of both the gender with the presence of adequate osseointegration and healthy keratinized tissue surrounding the implant site.

Exclusion Criteria:

* 1. Patient have single implant. 2. Expose dental implant or already have gingival former. 3. Poor oral hygiene. 4. Failure implant osseointegration to bone.

Primary outcomes:
measure: Pain perceived by the patient.
timeFrame: recordings were done immediately at time of exposure , after 2 , 5 ,7 days postsurgical.
Secondary outcomes:
measure: need for injectable anesthesia
timeFrame: at time of operation treatment
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: laser institute for postgraduate studies, University of Baghdad
state: Al-Jadiriya
Study officials:
References:
Clinical trial NCT00115167: A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
Official title: A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Cancer
Keywords: Oncology
Cancer-related anemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-06-22
Enrollment: 371
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 purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.


Eligibility criteria: Inclusion Criteria:

- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol

Exclusion Criteria:

* Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
* Subjects who have other diagnoses not related to the cancer which can cause anemia
* Known history of seizure disorder
* Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
* Subject of reproductive potential who is not using adequate contraceptive precautions
* Concerns for subject's compliance with the protocol procedures

Primary outcomes:
measure: Incidence of adverse events
timeFrame: throughout study
Secondary outcomes:
measure: Confirmed antibody formation to investigational product
timeFrame: throughout study
measure: Deaths on study
timeFrame: on study
measure: Laboratory parameters
timeFrame: throughout study
measure: Vital signs (blood pressure)
timeFrame: throughout study
measure: Change in PRO scores
timeFrame: from baseline to end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Smith RE Jr, Aapro MS, Ludwig H, Pinter T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. doi: 10.1200/JCO.2007.14.2885. Epub 2008 Jan 28.
Clinical trial NCT02869867: Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
Official title: Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Localized Neuropathic Pain
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Nursing study, prospective, randomized, two-center open-label.

Patients will be randomized into two groups during their first laying Qutenza®:

* Patients receiving the laying of Qutenza® without refrigerated cushion
* Patients receiving the laying of Qutenza® associated with a refrigerated cushion

The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* Major
* Do not opposing the participation in the study
* Monitoring in the case of localized neuropathic pain
* Diagnostic with neuropathic pain score ≥ 4
* Neuropathic pain conventional treatment failure of first-line
* Front advantage of laying a first patch Qutenza®
* With ability to understand the proposed study

Exclusion Criteria:

* Patch Installation on the feet, face, mucous membranes
* Eutectic mixture of local anesthetics (EMLA) Pose premedication
* Having Already received prior to the installation of a patch of Qutenza®
* Allergy to components Qutenza®
* Known and poorly stabilized hypertension
* Known cryoglobulinaemia
* Pregnant or lactating women
* Patient enjoying a measure of legal protection (guardianship, guardianship ...)
* Private Patient freedom
* No affiliation to a social security scheme.
* Refusal to participate in the study

Primary outcomes:
measure: Visual Analogue Pain Scale (Burning Pain)
timeFrame: after 1 hour of installation of Qutenza patch
Secondary outcomes:
Other outcomes:
Locations:
city: Challans
country: France
facility: CHLVO de Challans
city: La Roche sur Yon
country: France
facility: CHD Vendée de la Roche sur Yon
city: Nantes
country: France
facility: Clinique Brétéché
Study officials:
References:
Clinical trial NCT06487767: The Validity of the Use of Imaging in Cervical Cancer Staging
Official title: The Validity of the Use of Imaging in Cervical Cancer Staging
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer Stage, Imaging Modalities
Keywords: Cervical cancer
Ultrasound
MRI
CT Scan
PET-CT scan
Lead sponsor: University of Pretoria
Sponsor class: OTHER
Collaborators: name: Dr Edwin Mnisi
name: Prof Mike Sathekge
name: Prof N Khan
First posted: 2024-07-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women diagnosed with cervical cancer scheduled for surgical treatment or intervention

Brief summary: The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer

Detailed description: Patients with cervical cancer undergoing surgery will also undergo PET-CT scan, CT scan, trans-abdominal ultrasound of the pelvis and abdomen to assess pelvic and para-aortic lymph node status, MRI and trans-vaginal ultrasound (TVUS) to assess tumour size and parametrial infiltration. As per the current unit protocol, patients will be assessed clinically for operability. The performance of the different imaging modalities will be measured against the histological status of the parametric and lymph nodes and tumour size as measured by the pathologists.

CT, PET-CT, MRI and abdominal ultrasound will be reported as per the usual departmental process. Staff in the radiology department will be blinded for the different imaging modalities performed. TVUS will be performed in the unit by different gynaecological oncologists and fellows and at the time of the investigation will be blinded with regards to clinical findings and the reports of other imaging studies performed.

The sensitivity, specificity, positive and negative predictive values will be calculated for the different imaging modalities.

Eligibility criteria: Inclusion Criteria:

- Women diagnosed with cervical cancer Able and willing to provide informed consent

Exclusion Criteria:

Previously treated for cervical cancer Unable to provide informed consent Patients with contra-indications to undergo surgical treatment

-

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Kalafong Provincial Tertiary Hospital
state: Gauteng Province
Study officials:
affiliation: Trial administrator
name: Cathy Visser, MSc
role: STUDY_DIRECTOR
References: