louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05027412: En Bloc TURBT With Collins Loop vs Conventional TURBT
Official title: Transurethral En Bloc Resection With Collins Loop vs Conventional Transurethral Resection for the Treatment of Urothelial Bladder Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Bladder Neoplasm
Bladder Urothelial Carcinoma
Bladder Cancer Stage
Urothelial Carcinoma Recurrent
Lead sponsor: Hospital Universitario de Fuenlabrada
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 80
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: This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized.

Detailed description: The main objective of the study is to assess the quality of the resection, defined as the presence of detrusor muscle in the resected tissue.

The secondary objetives are:

* Compare the surgical time, hospital stay, urinary catheterization time and incidence of complications.
* Compare tumor recurrence after one year of follow up.
* Determine the number of re-TURB as a consequence of the absence of muscle layer in the sample or artifacts (Tx)
* Establish the incidence of conversions as a consequence of difficulties in the technique or intraoperative bleeding.
* Compare the degree of satisfaction of the surgeon

Eligibility criteria: Inclusion Criteria:

* \>18 years old.
* Polypoid / sessile primary tumor.
* \< 3 tumors
* Tumor size 10 - 30 mm.

Exclusion Criteria:

* \> 4 tumors
* Size of the largest tumor \<1 cm and\> 4 cm.
* Tumor located in the bladder dome.
* No visualization of the ureteral meatus.
* Flat or in situ tumor.
* Non-urothelial tumors.
* Clotting disorder or treatment with oral anticoagulants.

Primary outcomes:
measure: presence of detrusor muscle in the resected sample
timeFrame: 1 year of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
Study officials:
affiliation: Hospital Universitario de Fuenlabrada
name: emilio f ripalda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482312: Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 70.
* History of end-of-day or low-humidity dryness with contact lenses.
* Healthy eyes.
* Best-corrected visual acuity of 20/50 or better for each eye.
* Usable pair of eye glasses.
* Willing and able to attend required study visits.
* Sign informed consent.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Ocular or systemic allergies or diseases which might interfere with contact lens wear.
* Clinically significant ocular findings which would contraindicate contact lens wear.
* Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
* Participation in another clinical study currently or within 30 days of study entry.
* Spectacle astigmatism of \>1.00 diopter.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Tear Osmolarity
timeFrame: 90 minutes
measure: Ocular Comfort
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research, San Antonio
name: Deepen Patel, MD, CCFP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03806712: Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)
Official title: Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Transfusion
Hematological Malignancy
Palliative Care
Keywords: social representation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with advanced hematological malignancies, transfused in platelet regulary, hematologist's nurses who practice platelet transfusion and hematologist who prescribe the transfusion.

Brief summary: Limited data is available for end of life care in hematologic malignancies, moreover with thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow involvement in those diseases or its treatments. Yet, a few studies was interested in, whereas platelet transfusion is the only treatment indicated. As it represent a scarce, limited resource, the ethical principles are in conflict in this setting and there's a lack of recommendation. The final decision is take by the clinician and his patient, but no study exist in representation of the two parts. We provide a qualitative study to understand what this decision is made of.


Eligibility criteria: Inclusion Criteria:

* major patient
* patient with advanced hematological malignancies
* patient transfused in platelet regularly (3 time at least in last month)
* medical practioner, hematologist, prescribing platelet transfusion at least one per week.
* nurse working in hematology, practicing platelet transfusion at lest one peer week.

Exclusion Criteria:

* minor patient
* non communicant patient
* non transfused platelet patient
* non voluntary patient or hematologist or nurses
* non graduated hematologist

Primary outcomes:
measure: measure the impact of social representation on platelet transfusion practice
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Moracchini
Study officials:
References:
citation: McGrath P, Leahy M. Catastrophic bleeds during end-of-life care in haematology: controversies from Australian research. Support Care Cancer. 2009 May;17(5):527-37. doi: 10.1007/s00520-008-0506-1. Epub 2008 Sep 23.
citation: McGrath P, Holewa H. Special considerations for haematology patients in relation to end-of-life care: Australian findings. Eur J Cancer Care (Engl). 2007 Mar;16(2):164-71. doi: 10.1111/j.1365-2354.2006.00745.x.
citation: Jeoffrion C, Dupont P, Tripodi D, Roland-Levy C. [Social representations of illness: Comparison of "expert" knowledge and "naive" knowledge]. Encephale. 2016 Jun;42(3):226-33. doi: 10.1016/j.encep.2015.12.007. Epub 2016 Jan 12. French.
Clinical trial NCT06866912: Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis
Official title: Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiomyopathy
Keywords: Cardiac amyloidosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes all adult patients referred to the participating centers with a diagnosis of amyloidosis or carriers of pathogenic mutations starting from 01/01/1981 diagnosed in accordance with current international guidelines.

Brief summary: observational epidemiological study of patients affected by systemic amyloidosis


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with amyloidosis or asymptomatic carriers of mutations in the transthyretin gene
* minimum age of 18 years at the time of diagnosis
* obtaining informed consent

Exclusion Criteria:

* nothing

Primary outcomes:
measure: prevalence of amyloidosis
timeFrame: throughout the study period until 10 years
measure: incidence of amyloidosis
timeFrame: throughout the study period until 10 years
measure: Observational epidemiological study of patients with systemic amyloidosis
timeFrame: throughout the study period until 10 years
measure: Types of cardiac clinical phenotype
timeFrame: throughout the study period until 10 years
measure: Incidence of mixed clinical phenotype
timeFrame: throughout the study period until 10 years
measure: Incidence of hospitalization for heart failure
timeFrame: throughout the study period until 10 years
measure: Incidence of hospitalization for onset of arrhythmias
timeFrame: throughout the study period until 10 years
measure: Incidence of hospitalization for stroke
timeFrame: throughout the study period until 10 years
measure: incidence of pacemaker implantation
timeFrame: throughout the study period until 10 years
measure: incidence of pacemaker implantation of defibrillator
timeFrame: throughout the study period until 10 years
measure: Incidence of cardiac transplantation
timeFrame: throughout the study period until 10 years
measure: Incidence of transplantation of other solid organs
timeFrame: throughout the study period until 10 years
measure: Mortality
timeFrame: throughout the study period until 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Simone Longhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06534112: Evaluation of the Know Your OQ™ Oral Health Literacy Tool in an Indian Population
Official title: Evaluation of Short-term Changes and Self-reported User Experiences Related to the Know Your OQ™ Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Health Literacy
Keywords: Oral Health Quotient
KYOQ
Oral Health Education
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 150 male and female adults were split into two groups: 100 regular subjects and 50 nurses. These groups were further stratified by educational qualification (Completed High School, Pursuing Graduation, Completed Graduation, Completed Post Graduation), sex (male and female), age group (18-24, 25-35, 36-45, 46-55, 56-65, \>65), experience with oral health problems (yes and no), and the cities they reside in (Mumbai, Delhi, Chennai, Kolkata, Bengaluru).

Brief summary: This was a research study to evaluate the effectiveness of the questionnaire "Know Your OQ™" (Know Your Oral Health Quotient™) in changing people's level of knowledge about oral health in India and to evaluate the readability, understanding and ease of completion of the questionnaire "Know Your OQ™".


Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent Form
* Male and female subjects aged ≥18 years old
* Availability of 10 days for completing the study
* Belong to NCCS (National Consumer Classification System) A,B
* Access to a cell phone, laptop, tablet or computer with internet/data connection
* Fluent in English

Primary outcomes:
measure: Changes in Knowledge, Attitude, Practice (KAP)
timeFrame: Baseline, Intervention, Immediate Follow-Up, 1 week Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: IPSOS Research Private Limited
Study officials:
References:
Clinical trial NCT01934712: A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
* Body mass index (BMI) 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Primary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0-1 hour
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0-12 hours
measure: Area under the glucose infusion rate (GIR) curve
timeFrame: From 0-1 hour
measure: Area under the glucose infusion rate (GIR) curve
timeFrame: From 0-12 hours
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Shiramoto M, Nishida T, Hansen AK, Haahr H. Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart. J Diabetes Investig. 2018 Mar;9(2):303-310. doi: 10.1111/jdi.12697. Epub 2017 Jul 7.
citation: Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
Clinical trial NCT03460912: Different Types of Electrostimulation Probes During IONM
Official title: Comparison of Different Types of Electrostimulation Probes for Intraoperative Nerve Monitoring During Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Diseases
Keywords: IONM
thyroidectomy
bipolar probe
monopolar probe
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consequtive patients who underwent thyroid surgery

Brief summary: Intraoperative nerve monitoring is often used in many centers during thyroidectomy. According to the investigators' knowledge, there's no study showing superiority between bipolar and monopolar stimulation probes used for nerve monitoring during thyroid surgery. In this study, the investigators aimed to compare two different types of probes and find out superiorities.Twenty-one patients who underwent primary total thyroidectomy or hemithyroidectomy were included in the study. During surgery, amplitude and latency values obtained in the same patient with both bipolar and monopolar stimulation probes from 10 different anatomical spots \[vagal nerve, recurrent laryngeal nerve inferior portion, recurrent laryngeal nerve superior portion, external branch of superior laryngeal nerve (EBSLN)\] were recorded prospectively, both when sheath was intact and after being dissected.


Eligibility criteria: Inclusion Criteria:

* who underwent thyroid surgery

Exclusion Criteria:

* Perioperative loss of electromyographic(EMG) signal (LOS) during intraoperative nerve monitorization
* patients with additional pathology that may affect vocal cord function,
* abnormal preoperative laryngeal examination
* history of thyroid, vocal cord or other neck surgery
* advanced cancer, RLN, esophageal or trachea invasion

Primary outcomes:
measure: Comparison of amplitude values of bipolar vs. monopolar stimulation
timeFrame: One week
measure: Comparison of Latency values of bipolar vs. monopolar stimulation
timeFrame: One week
Secondary outcomes:
measure: Comparison of stimulation with vs. without overlying fascia on nerve
timeFrame: One week
measure: Comparison of stimulation pre- vs. post-resection without overlying fascia on nerve
timeFrame: One week
measure: Comparison of stimulation of inferior vs. superior parts of recurrent nerve.
timeFrame: One week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00754312: A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
Official title: A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Syndax Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of the study is to evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.


Eligibility criteria: Inclusion criteria:

* Is scheduled for breast biopsy due to a suspicious mass palpable or ≥1 cm on mammogram
* Must be able to receive two doses of study medication 7 days apart prior to surgery
* Has histologically confirmed invasive breast cancer with ER positive, ER and/or PR negative histology or triple negative (for ER, PR, HER-2) histology
* Has an ECOG performance status ≤ 2
* Has no clinically significant laboratory or cardiac abnormalities
* Has a negative serum pregnancy test at Screening as is either post menopausal, sterile or willing to use an approved method of contraception.
* Is able to swallow and retain oral medication

Exclusion criteria:

* Has a concomitant medical condition that precludes adequate study treatment compliance or assessment, such as: a. Bleeding disorders that would increase risks of additional core biopsy for biomarkers b. Morbid obesity
* Is currently receiving treatment with a medication on the prohibited medication list
* Has allergy to benzamides or inactive components of study drug
* Is participating in another clinical trial or has received another investigational agent within 30 days prior to informed consent

Primary outcomes:
measure: Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration
timeFrame: 14 days
Secondary outcomes:
measure: Evaluate changes in gene and/or protein expression of exploratory biomarkers in invasive breast cancer tissue before and after SNDX-275 administration, as tissue sample permits.
timeFrame: 14 days
measure: Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters
timeFrame: 14 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Monet Bowling, MD
state: Indiana
Study officials:
affiliation: Indiana University
name: Monet Bowling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christie Hospital, UK
name: Andrew Baildam, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00764712: Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
Official title: Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: Tight glycemia control
cardiac surgery patients
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)

Detailed description: 120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour intervals as requested by protocols.

Eligibility criteria: Inclusion Criteria:

* patients admitted to the postoperative ICU after elective cardiac surgery

Exclusion Criteria:

* insulin allergy

Primary outcomes:
measure: The effectiveness of different TGC management protocols
timeFrame: ICU stay
Secondary outcomes:
measure: The safety with respect to hypoglycemia
timeFrame: ICU stay
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: University Hospital in Prague
Study officials:
affiliation: Charles University, Czech Republic
name: Jan Blaha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blaha J, Kopecky P, Kotulak T, Kunstyr J, Matias M, Rubes D, Dobias M, Romaniv S, Kubatova J, Porizka M et al: Blood glucose control in cardiac surgery patients: a comparative study of different insulin protocols. Journal of Cardiothoracic and Vascular Anesthesia 2008, 22(S3):S23.