louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06840639: The Impact of Dental Health on Complications During and Following Radiotherapy in the Head and Neck Region.
Official title: The Impact of Dental Health on Complications During and Following Radiotherapy in the Head and Neck Region.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasms
Radiotherapy; Complications
Extracting Own Teeth
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients receiving radiotherapy for malignant diagnosis (oral and oropharyngeal cancers)

Brief summary: Study the risk of complications after dental extractions in patients recieving radiotherapy.

Detailed description: Dental extractions before radiotherapy in the head and neck region is an established part of the treatment plan for patients with malignant disease. There are contradictory results in the literature regarding the importance timing and magnitude of extractions. It is important to minimize complications in this patient group since the regular therapy is already detrimental to the affected tissues. Patients were extracted from the ARTSCAN register were the population was followed for 4 years for several factors, including development of osteoradionecrosis. The aim is to evaluate which diagnoses are more prone to develop complications after extraction. If there is a relationship between occurrence of complication and magnitude of dental pathology.

Eligibility criteria: Inclusion Criteria:

* Malignant diagnosis
* radiotherapy pre or postoperative

Exclusion Criteria:

-

Primary outcomes:
measure: Does dental extractions increase the risk for complications such as osteoradionecrosis?
timeFrame: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
measure: Does dental pathology in extracted teeth correlate with development of osteoradionecrosis?
timeFrame: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Oral and Maxillofacial department
state: Skåne
Study officials:
affiliation: Lund University Hospital
name: Philip Fransson, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03326739: Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
Official title: Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Critically ill patients in the emergency department commonly require arterial line placement for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and frequent blood sampling. Trans-radial catheterization has been shown to reduce access site complications and increase patient comfort compared to trans-femoral access. Radial artery access on the first attempt is optimal; attempts at reentry delay care and increase the risk of vascular spasm, hematoma, infection, neurovascular injury, and pain. The traditional pulse palpation method of radial artery cannulation can be challenging, especially in patients with weak pulses (i.e. morbidly obese or hypotensive individuals).

A review of literature suggests that ultrasound guided trans-radial catheterization compared to standard pulse palpation reduces access time and increases rate of first-entry success when performed by physicians trained in ultrasound. Thus, complications ascribed to reentry are prevented and timely care is provided.

To the investigator's knowledge, only one other prospective study has been conducted to assess the utility of ultrasound guided radial artery cannulation in the emergency department. Due to the paucity of literature to support the use of ultrasound guided trans-radial catheterization in critically ill patients, the study will aim to provide further data on the topic. Both techniques are considered standard of care.

Detailed description: Patients presenting to the Emergency Department 18 years old or greater, who do not belong to a vulnerable group, requiring arterial line placement will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts, success rate, and time for procedure to be completed. PGY-1 residents will perform the arterial line placement.

Eligibility criteria: Inclusion Criteria:

* Patients requiring arterial line placement.

Exclusion Criteria:

* Adults Unable to Consent
* Members of Vulnerable Populations

Primary outcomes:
measure: Superiority of Method of arterial line placement
timeFrame: 1 day
Secondary outcomes:
measure: Success of method
timeFrame: 1 day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Lewis Katz School of Medicine at Temple University
state: Pennsylvania
Study officials:
affiliation: Lewis Katz School of Medicine at Temple University
name: Ryan C Gibbons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04816539: Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function
Official title: Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function : a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuromuscular Blockade
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing an electrive surgical procedure with non emergency and that requires use of Rocuronium, and willing to participate and provide an informed consent

Brief summary: Assess the values of train-of-four ratios with the TetraGraph and thoses obtained with the TOFscan during recovery of neuromusculat function in surgical patients who have been administred rocuronium.

Primary outcome : value of TOFratio with the TetraGraph when TOFratio of TOFscan is greater than or equal to 90% Pilot study : no hypothesis


Eligibility criteria: Inclusion Criteria:

* age greater than or equal to 18 years old
* patients willing to participate and provide an informed consent
* elective surgical procedures, without emergency, administration of rocuronium for neuromuscular blockade, and recovery of complete neuromuscular function at the end of the surgery

Exclusion Criteria:

* patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or similar wrist injury
* patients with systemic neuromuscular diseases such as myasthenia gravis
* renal insufficiency or renal failure
* significant liver disease
* patients having surgery that would involve prepping the arm into the sterile field
* allergy to rocuronium

Primary outcomes:
measure: Train-of-four ratios
timeFrame: baseline (J0)
Secondary outcomes:
measure: Train-of-four ratios
timeFrame: baseline (J0)
measure: Train-of-four ratios
timeFrame: baseline (J0)
measure: Train-of-four count
timeFrame: baseline (J0)
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Chu Nancy
Study officials:
affiliation: CHU NANCY
name: Claude Meistelman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01839539: Study of DC-CIK to Treat Colorectal Cancer
Official title: Phase Ⅱ Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Stage Ⅲ Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: colorectal cancer
DC-CIK
CRC
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 60
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 evaluate the efficacy of dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).

Detailed description: 60 patients with stage Ⅲ CRC, who had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, and got complete response (CR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients ≥ 18 years of age;
2. CRC with histological diagnose, and had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy and got complete response (CR) with imaging;
3. Patients who have a life expectancy of at least 3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
5. The bone marrow functioned normally (WBC \> 4.0×109/L, Hb \> 120 g/L, PLT \> 100×109/L);
6. The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients who had distant metastases;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;
5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Quality of life (QOL)
timeFrame: 5 years
measure: Laboratory findings (The number of CD3+ (or CD8+ or CD4+ or CD56+)T cell)
timeFrame: 1 month
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Medical University
state: Guangxi
Study officials:
References:
Clinical trial NCT02935439: A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure
Official title: A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Mobile Phone
Self-efficacy
Quality of Life
Knowledge
Feasibility
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
First posted: 2016-10-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this research study is to learn about the use of a cell phone for monitoring patients with heart failure. Participants will be asked questions about their heart failure daily and participants will need to answer them. The investigator will try to assess if the questions are easily understood by the participants. The investigator will also assess if the phone-based system for monitoring is easy to use by the participants. The investigator will also assess if the daily questions and interactions increase the self-efficacy, knowledge, and quality of life of participants related to their heart failure.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of heart failure
* Have an anticipated survival ≥ 6 months
* Receive care at the University of Miami or Jackson Healthcare system
* 18 years or older
* Able to communicate in English and/or Spanish
* Able to operate a cell phone, read, understand, and respond to the questions on the cell phone, and are able to use the weight scale.

Exclusion Criteria:

* Previous history of unstable coronary syndromes
* History of end-stage heart failure or heart transplantation

Primary outcomes:
measure: Self-Efficacy for Managing Chronic Disease
timeFrame: 90 days
Secondary outcomes:
measure: Health Distress Scale
timeFrame: 90 days
measure: Communication with Physicians
timeFrame: 90 days
measure: Fatigue Visual Numeric
timeFrame: 90 days
measure: Shortness of Breath Visual Numeric
timeFrame: 90 days
measure: Heart Failure Self-Efficacy Scale-30
timeFrame: 90 days
measure: European Heart Failure Self-Care Behavior Scale
timeFrame: 90 days
measure: Dutch Heart Failure Knowledge Scale
timeFrame: 90 days
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: 90 days
measure: The Medical Outcome Study 36-Item Short Form
timeFrame: 90 days
measure: Usability survey
timeFrame: 90 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
Study officials:
affiliation: University of Miami
name: Stuti Dang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205439: Surveillance For New Lung Primaries
Official title: Fluorescence Bronchoscopic Surveillance For New Lung Primaries After Curative Therapy for Squamous Cell Carcinoma of the Aerodigestive Tract"
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Study population: Patients with new lung primaries after curative therapy for squamous cell carcinoma of the aerodigestive tract

Brief summary: The primary goal of this study is to determine the prevalence of tracheobronchial carcinomas in patients with a history of squamous cell cancer of the aerodigestive tract who have been treated with a curative intent and remain disease free. Detection of pre-invasive and invasive lesions (moderate to severe dysplasia, CIS) with fluorescence bronchoscopic surveillance may help to define the natural history of these lesions and allow earlier intervention should they progress to invasive lesions.


Eligibility criteria: Inclusion Criteria:

* History squamous cell NSCLC who have undergone complete resection or definitive chemotherapy

Exclusion Criteria:

* History of an aerodigestive tract carcinoma of non-squamous histology
* Patients who have Stage IIIA, IIIB or IV squamous cell lung cancer that have undergone resection or chemotherapy within three years
* Patients who have Stage I or II squamous cell lung cancer that have undergone resection or chemotherapy within one year
* Patients who have received external beam radiation therapy for treatment of a squamous cell cancer of the lung

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Medical School
name: Tracey Weigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03846739: Dose-dependent Effects of Oxytocin on the Amygdala and Reward System
Official title: Dose-dependent Effects of Oxytocin on the Amygdala and Reward System Vary Between Women and Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: amygdala
reward
oxytocin
dose
emotion processing
sex differences
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala and reward system responses vary as a function of treatment dose in women in comparison to men.

Detailed description: The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala and striatal regions (putamen, nucleus accumbens, caudate, pallidum) vary as a function of dose. In particular, the investigators plan to compare effects of three different IN-OXT doses (6, 12, and 24 international units, IU) on established neural and behavioural correlates of emotion processing in women. Results will be discussed in comparison to a previous study of OXT kinetics in men.

Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers
* Right-handed
* Non-smoker

Exclusion Criteria:

* Current psychiatric or physical illness
* Hormonal contraception
* Psychoactive medication
* MRI contraindication (e.g. metal in body, claustrophobia)
* Pregnancy

Primary outcomes:
measure: Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala
timeFrame: 45 min after nasal spray administration
measure: Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in striatal regions (putamen, nucleus accumbens, caudate, pallidum)
timeFrame: 45 min after nasal spray administration
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
Study officials:
affiliation: University of Bonn
name: Rene Hurlemann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04535739: PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
Official title: A Prospective Randomized Controlled Study for Prophylactic Cranial Irradiation After Chemotherapy and Thoracic Radiation Therapy in Patients With Extensive-stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Small-cell Lung Cancer
Keywords: small cell lung cancer
Brain Metastases
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-09-02
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: prophylactic cranial irradiation （PCI）was verified to decrease the brain metastases rates and improve the overall survival（OS）for patients with limited stage small cell lung cancer.We hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from PCI.

Detailed description: Patients with extensive-stage small cell lung cancer achieving CR or PR after chemotherapy and thoracic radiation therapy were randomly divided into observation group and prophylactic cranial irradiation (PCI) group to evaluate the effect of PCI on survival after radiation therapy for thoracic lesions. To preliminarily analyze the clinical characteristics of patients who would benefit from thoracic radiation therapy plus PCI. To explore the optimal treatment modality after chemotherapy + thoracic radiation therapy in patients with extensive-stage SCLC.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old,KPS≥70
* Pathological or cytological diagnosis of stage IV small cell lung cancer (by using AJCC 7th edition staging criteria);
* 1-3 extra-cranial metastatic organs before chemotherapy; 4-6 cycles of CE or EP ；
* CR or PR after chemotherapy；
* no grade ≥II side effects;
* the estimated overall survival time ≥ 3 months;
* no serious medical disease or major organ dysfunction.

Exclusion Criteria:

* Patients with brain or nervous system metastases;
* Presence of high grade radiation comorbidities;
* Patients who are pregnant or lactating

Primary outcomes:
measure: overall survival
timeFrame: 2 year
Secondary outcomes:
measure: progression-free survival
timeFrame: 2 year
measure: brain metastases rates
timeFrame: 2 year
measure: side effect
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT02475525: Oral Nutritional Supplement in Reducing Surgical Site Infections
Official title: The Role of an Arginine Enriched Oral Nutritional Supplement in the Prevention of Wound Complication in Patients Undergoing Lower Limb Revascularization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Vascular Disease
Claudication
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: UL Hospitals, Limerick
First posted: 2015-06-18
Enrollment: 6
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: The study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement in the prevention of wound complications in the the wounds of patients post lower limb revascularization.

Detailed description: Surgical incisions are associated with a number of possible complications. The reported incidence of surgical site infections at the groin after vascular procedures is between 3% and 30%. This incidence is up to five times higher than the expected incidence of infection in clean cases. Risk factors for postoperative surgical site infection in patients undergoing vascular surgery may include age, co-morbidities, use of prosthetic grafts and repeat operations.

A systematic review in 2011 concluded that arginine supplemented diets among perioperative patients were associated with a reduced rate of surgical infection and reduced overall length of hospital stay.

The study aims are to determine if taking an oral nutritional supplement reduces the rate of wound complications post lower limb revascularization.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective lower limb revascularization surgery
* patients aged \>18 years.

Exclusion Criteria:

* Patients unable to provide informed consent,
* emergency cases,
* seriously ill patients/unconscious patients,
* chronic renal disease,
* known inflammatory bowel disease,
* known lactose intolerance and not using lactase,
* known galactosemia,
* pregnancy,
* cows milk allergy.

Primary outcomes:
measure: The number of incidents of wound infections in both groups of patients undergoing lower limb re vascularization.
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient acceptability of the oral nutritional supplement.
timeFrame: 4 weeks
measure: Duration of post operative hospital stay
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
Study officials:
affiliation: University of Limerick
name: Mary Clarke Moloney
role: PRINCIPAL_INVESTIGATOR
affiliation: UL Hospitals
name: Paul Burke
role: PRINCIPAL_INVESTIGATOR
References: