louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04905134: Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase
Official title: Partnership to Establish a Practice Based Network to Assess for Head and Neck Cancers Using a Low-Cost Portable Flexible Nasopharyngoscope - Optimization Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Oral Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2021-05-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to develop and evaluate a low-cost, portable, flexible nasopharyngeal scope (FNS) used to assess head and neck cancers (HNC) in low resource settings. The FNS will be compared to an endoscope that is used as standard of care (SOC) in terms of ease of use, image quality, and perceived pain. The ultimate goal is to compare the ease of use between the FNS to what is used in SOC.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged 18 or older
* Patients who clinical meet clinical criteria for SOC scope examination of the upper aerodigestive tract. This includes signs and symptoms such as dysphagia, nasal obstruction, neck mass, throat pain, and hoarseness.

Exclusion Criteria:

* Withdrawal of consent during the study duration
* Subjects who have complications from the SOC exam
* Anyone unable to under the SOC exam

Primary outcomes:
measure: Number of Participant Exams in Which Providers Reported the FNS (Flexible Nasopharyngoscope) is Easy to Use
timeFrame: up to 15 minutes
Secondary outcomes:
measure: Image Quality of the Standard of Care (SOC) Scope as Measured on a 5-point Scale
timeFrame: Day 1
measure: Image Quality of the Flexible Scope as Measured on a 5-point Scale
timeFrame: Day 1
measure: Number of Patients Who Experienced an Adverse Event Following the Use of the Flexible Scope
timeFrame: Day 1
measure: Number of Patients Who Experienced More, the Same, or Less Pain/Discomfort With the Flexible Scope Compared With the Standard of Care (SOC) Scope
timeFrame: Day 1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Walter Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06857734: Analgesic and Anti-inflamatory Effect of Vit. B
Official title: The Analgesic and Anti-inflamatory Effect of Vitamin B Versus Vitamin C Infusion in Patients Undergoing Laparoscopic Cholecystectomy ; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain, Acute
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin C, also known as ascorbic acid, is a potent reducing agent and antioxidant that plays a crucial role in various metabolic processes.Vitamin B complex, a group of eight essential B vitamins, plays a crucial role in cellular metabolism, energy production, and maintaining nervous system health. There are few available studies on the effects of vitamin B injection on plasma inflammatory markers and its adjuvant analgesic effect along with the routine multimodal analgesia. Considering limited research and existing controversies in this field, the aim of present study is to evaluate the effects of preoperative and intraoperative vitamin B12 administration compared to vitamin C when used as a component of the multimodal analgesic technique in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age 18-60 years)
* American Society of Anesthesiologists (ASA) classification I-II
* Patients undergoing laparoscopic cholecystectomy under general anaesthesia

Exclusion Criteria:

* Hypersensitivity to vitamin B complex or vitamin C
* History of chronic pain or use of opioids within the last month
* Patient with inflammatory conditions
* Severe renal or hepatic impairment
* Patient with intellectual disabilities.

Primary outcomes:
measure: The total dose of analgesics required postoperatively
timeFrame: within the first 24 hours and the time to first request
Secondary outcomes:
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Benha university
Study officials:
References:
Clinical trial NCT00638716: A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin
Lead sponsor: ConjuChem
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 122
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.

The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin monotherapy.


Eligibility criteria: Major Inclusion Criteria:

* BMI: 27 to 45 kg/m2
* Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator
* Stable life-style, i.e. diet \& physical activity, as determined by the Investigator
* Stable metformin daily dose ≥1000 mg for at least 3 months
* Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%

Primary outcomes:
measure: Reduction of HbA1c From Baseline
timeFrame: Screening and Day 85
Secondary outcomes:
measure: Reduction in FPG From Baseline
timeFrame: Screening and Day 85
measure: Reduction in Fasting Body Weight From Baseline
timeFrame: Screening and Day 85
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: ConjuChem Biotechnologies Inc.
state: Quebec
Study officials:
References:
Clinical trial NCT01934816: Incretin and KATP Channels
Official title: Effects of KATP Channel Blockers on GLP-1 and Its Analogues' Mediated Microvascular Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Subjects
Keywords: Incretins, KATP channels, intradermal injection
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2013-09-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to examine the involvement of KATP channels on the microvascular actions of the incretin GLP-1 and its analogues in healthy individuals and to determine whether the acute oral administration of different KATP channel blockers which are oral medications for Type 2 diabetes such as Glibenclamide and Glimepiride differentially modulate the microvascular responses in these individuals.

Detailed description: In addition to the glucose lowering effect, incretin based therapies have also an effect on the vascular system. Previous animal work and initial human studies suggest that incretins may be cardioprotective and act as vasodilators through opening of KATP channels.

Initial evidence suggests that beneficial vascular effects of incretin modifying agents may be nullified by the co-current treatment of the sulfonylurea (SU) drug glibenclamide. The investigators hypothesis is that the GLP-1 and SUs may have conflicting effects on the KATP channels and thus vascular function.

Interestingly the vascular actions of GLP-1 were not modified by a different treatment SUs called glimepiride, thereby raising the possibility that SUs differentially modulating the vascular actions of GLP-1 though this remains controversial.

Eligibility criteria: Inclusion Criteria:

* BMI ≤ 25 kg/m2

Exclusion Criteria:

* current or past history of diabetes (HbA1C more or equal 45mmol/mol)
* history of postprandial hypoglycaemia and dumping syndrome
* established cardiovascular disease
* established cerebrovascular disease
* blood pressure ≥ 140/85 mmHg
* Raynaud's disease
* severe impairment of renalhepatic, thyroid or adrenocortical function
* current treatment with any anti-hypertensive treatment
* lipid lowering therapy or systemic steroids
* lactation, pregnancy
* established vascular disease
* bariatric surgery
* significant weight change within the last 3 months

Primary outcomes:
measure: Change in skin blood flow to GLP-1 and its analogues
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
Study officials:
affiliation: University of Exeter
name: Katarina Kos, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05070416: Lithium Disilicate Crowns Study
Official title: Clinical Evaluation of Lithium Disilicate CAD/CAM Crowns
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caries
Dental Trauma
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2021-10-07
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: CAD-CAM crowns made of lithium disilicate are placed in patients by using either a dual-curing adhesive or a self-adhesive luting material in combination with total etch/universal bonding agent.


Eligibility criteria: Inclusion Criteria:

* Patients will be at least 18 years of age, of either gender, and of any ethnic background.
* Each patient should have at least one carious lesion or defective restoration to be restored on a maxillary or mandibular premolar or molar tooth.
* Each lesion or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
* The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact.
* All teeth will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient.

Exclusion Criteria:

* Devital or sensitive teeth
* Teeth with prior endodontic treatment of any kind
* Teeth with a history of direct or indirect pulp capping procedures
* Patients with significant untreated dental disease to include periodontitis and/or rampant caries
* Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
* Patients with a self-reported past history of allergies to the materials to be used in the study including composite resin cements or ceramic restorative materials
* Patients unable to return for the recall appointments

Primary outcomes:
measure: short-term post-operative sensitivity
timeFrame: 4 weeks
Secondary outcomes:
measure: Quality Criteria (modified FDI criteria)
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan School of Dentistry, Department of Cariology, Restorative Sciences & Endodontics
name: Dennis J. Fasbinder, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05762016: Outcomes of a Novel Technique of Mini- Incision and Self-Express (MISE) for Breast Abscess
Official title: A Comparison of the Outcomes of a Novel Technique of Mini- Incision and Self-Express (MISE) for Breast Abscess With the Conventional Techniques: A Retrospective Comparative Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Infection
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: females with breast abscess

Brief summary: Conventional techniques for treatment of breast abscess, such as incision and drainage/percutaneous drainage, have disadvantages. Bedside Mini-Incision and Self-Express (MISE) is a novel technique for breast abscess. The outcomes of MISE were compared to the conventional techniques.

Detailed description: outcomes such as recovery time, duration of antibiotics use etc will be compared between the various groups of intervention.

Eligibility criteria: Inclusion Criteria:

* Patients with a pathologically confirmed breast abscess and
* presenting at KK Women's and Children's Hospital, Singapore

Exclusion Criteria: Patients with:

* mastitis
* granulomatous mastitis
* breast fillers with infection
* ruptured abscess prior to intervention
* other interventions or bilateral breast infection

Primary outcomes:
measure: recovery time
timeFrame: from diagnosis to date of documented recovery defined as resolution of abscess, assessed up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
Clinical trial NCT04688216: Developing a Risk Assessment System of Multidrug-resistant Organisms Infection
Official title: Developing the Best Risk Assessment System of Multidrug-resistant Organisms Infection in Critically Ill Patients Based on Big Data Analysis Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Keywords: risk assessment system
multidrug-resistant organisms
ICU
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ①Length of stay in ICU is more than 48h; ② no less than 18 years old.

Brief summary: 1. A retrospective analysis was performed to determine the prevalence of multidrug- resistant organisms infection in ICU from October 2017 to October 2019.
2. Non-MDRO patients were selected by random sampling in a ratio of 1:1 to the final MDRO group during the same period , and select the risk factors of infection with multi-drug resistant bacteria by comparing the two groups.
3. Randomly select 30% of the sample size as the validation set, and the remaining 70% for the training set to establish a model. Using multi-factor Logistic regression, decision tree classification, artificial neural network, support vector machine, Bayesian network Method to establish risk assessment system for multidrug-resistant organisms infection respectively.Using validation set data to calculate the area under the ROC curve (AUC) and sensitivity, specificity of models and comparing the prediction accuracy of several models. Finally, choose a more suitable risk assessment system for multidrug-resistant organisms infection.
4. Predict the patient's infection risk level according to the best risk assessment system and develop a low-to-high intervention plan.


Eligibility criteria: Inclusion Criteria：

* Duration of ICU admission ≥ 48h
* no less than 18 years old

Exclusion Criteria:

* Patients with MDRO infection at the time of admission
* Lack of case data
* MDRO colonized patients

Primary outcomes:
measure: multidrug-resistant organisms infection
timeFrame: From date of ICU admissions until the date of ICU discharge or date of diagnosis of multidrug-resistant organisms infection , whichever came first, assessed up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06106516: Vital Sign Monitor Device Validation - WARD
Official title: Vital Sign Monitor Device Validation - WARD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery-Complications
Medical Complication
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2023-10-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Humans with or without medical or surgical complications in or out of hospital

Brief summary: Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.

Patients: up to 1000 medical and/or surgical patients will be included Intervention: Studies with various wirless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device.

Detailed description: Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting.

Patients: up to 1000 medical and/or surgical patients will be included. Intervention: Studies with various wireless or novel vital sign monitor devices control: Golden standard measurements or clinical standard devices Outcome: Agreement assessed by bias and limits of agreement between Intervention and control device. Other statistical assessments of agreement may be chosen as secondary outcomes, dependent on the data-structure

Setting: the study will be carried out in up to 76 hours with collection of vital sign data pre-, intra or postoperatively.

Eligibility criteria: No inclusion or exclusion criteria

Primary outcomes:
measure: Agreement between vital sign data from novel device and golden standard
timeFrame: 76 hours
Secondary outcomes:
measure: Description of data from novel device and golden standard
timeFrame: 76 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Eske Kvanner Aasvang
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT05446116: Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism
Official title: Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersplenism
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-07-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aimes at comparing the transradial and transfemoral approaches for partial splenic embolization in patients with hypersplenism.

Detailed description: Since its development in 1979, partial splenic embolization (PSE) has been universally accepted to treat patients with hypersplenism in preference to surgical splenectomy. The spleen is the primary source of antibodies, lymphocyte production, and responsible for phagocytosis of white cells. Additionally, it plays an essential role in the immune system. Unlike splenectomy, partial splenic embolization (PSE) maintained partial splenic function and was thought to be an effective alternative to treat thrombocytopenia and leukopenia resulted from hypersplenism with fewer complications.

PSE is usually performed using a femoral artery approach that requires bed rest for a few hours. Recently, the transradial approach, with less obvious need for bed rest, has been more widely applied for cardiovascular intervention.

Eligibility criteria: Inclusion Criteria:

1. Patients with hypersplenism and severe thrombocytopenia (platelet count \< 50,000/mm3).
2. the functional status of the liver should be Child A or early B according to Child-Pugh classification (5-7 points) (albumin ≥ 2.8 g/dL, bilirubin ≤ 3 mg/dL, prothrombin time ≤ 4 or INR \< 1.7, no ascites, no encephalopathy).
3. Eligible for both femoral and radial puncture.

Exclusion Criteria:

1. Patients referred for embolization as treatment of traumatic splenic injury.
2. Patients lost during follow-up.

Primary outcomes:
measure: Technical Success of the Procedure
timeFrame: Immediately after the procedure is complete
measure: Average number of punctures
timeFrame: Immediately after the procedure is complete
measure: Procedural time
timeFrame: Immediately after the procedure is complete
measure: X-ray exposure duration
timeFrame: Immediately after the procedure is complete
measure: Length of hospital stay
timeFrame: 7 days
measure: Complications at access site
timeFrame: 30 days
Secondary outcomes:
measure: Procedural complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of medicine, Zagazig university
Study officials:
affiliation: Zagazig University Radiology Department
name: Mohamed MA Zaitoun, MD
role: PRINCIPAL_INVESTIGATOR
References: