louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06646705: Biochemical Evaluation of Periodontal Effects of Orthodontic Treatment with Aligners
Official title: Biochemical Evaluation of the Effect of Orthodontic Treatment with Aligner on Periodontal Parameters and OPG and RANKL Salivary Values
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aligner Treatment
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to determine the effect of orthodontic treatment with aligner on changes in osteoprotegerin (OPG) and receptor activator of NF-κB ligand (RANKL) levels in saliva samples and to investigate the possible relationship between periodontal clinical parameters. Materials and Methods: A total of 25 (n=25) saliva samples were taken from systemically healthy non-smoking individuals who were planned to receive orthodontic treatment with aligner before treatment. Whole mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded and repeated at 1 and 3 months. Enzyme-linked immunosorbent assay (ELISA) was used to determine OPG and RANKL levels in biological samples.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
* Must receive orthodontic treatment with aligners and must have accepted the treatment
* Non-smoker
* No medication for continuous use
* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
* Not in pregnancy or lactation period.

Exclusion Criteria:

* Any oral or systemic disease
* Regularly using a systemic medication
* During pregnancy or lactation
* Received periodontal treatment within the last 6 months.
* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
* Smokers are not included in the study

Primary outcomes:
measure: The total amount of OPG in saliva
timeFrame: 24 hours after taking the clinical measurements
Secondary outcomes:
measure: The total amount of RANKL in saliva
timeFrame: 24 hours after taking the clinical measurements
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Katip Çelebi University Faculty of Dentistry
state: Cigli
Study officials:
References:
Clinical trial NCT00102505: A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
Official title: Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small-Cell Lung Carcinoma
Carcinoma, Bronchogenic
Keywords: Non-Small Cell Lung Cancer
Lung Cancer
Metastatic lung cancer
Inoperable lung cancer
Advanced lung cancer
Large-cell lung cancer
Adenocarcinoma, lung
Squamous cell carcinoma, lung
Squamous cell lung cancer
Large cell carcinoma, lung
Bronchogenic
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
First posted: 2005-01-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.

A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.

Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* ECOG score of 0, 1, or 2
* Histologically confirmed diagnosis of non-small cell lung cancer

Exclusion Criteria:

Laboratory values demonstrating inadequate function of the following:

* Bone marrow
* Kidneys
* Liver

and

* Peripheral neuropathy Grade 2 or higher
* Greater than 2 prior chemotherapy regimens

Primary outcomes:
measure: Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
measure: Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
Secondary outcomes:
measure: Tumor response
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT04487405: A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
Official title: A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adnexal Mass
Lead sponsor: Aspira Women's Health
Sponsor class: INDUSTRY
First posted: 2020-07-27
Enrollment: 721
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women with an ovarian adnexal mass, or in follow up due to the presence of BRCA1/2 and other germline DNA variants.

Brief summary: The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.


Eligibility criteria: Inclusion Criteria:

* Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.
* Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.

Exclusion Criteria:

* Patient is less than 18 years of age
* Patient is not being treated in the U.S.

Primary outcomes:
measure: OVAnex
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Women's Health Arizona
state: Arizona
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Columbus
country: United States
facility: MidTown OBGYN
state: Georgia
city: Eden Prairie
country: United States
facility: Premier OBGYN of Minnesota
state: Minnesota
city: New Hyde Park
country: United States
facility: Square Care Health
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Cincinnati
country: United States
facility: Seven Hills Clinical Research Group
state: Ohio
city: Lancaster
country: United States
facility: May Grant OB/GYN
state: Pennsylvania
city: Austin
country: United States
facility: Hill Country OBGYN Associates
state: Texas
Study officials:
affiliation: Aspira Women's Health
name: Todd Pappas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06948305: Evaluate the Effectiveness of the Mobile Instant Messaging Intervention
Official title: Exploring the Care Needs of Spouses of Gynecological Cancer Patients and Evaluating the Development of Care Plans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gynecological Cancer
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study explores the caregiving needs of male spouses and develops an instant messaging software intervention to provide effective support. The goal is to help male spouses better adjust to their caregiving roles, reduce psychological stress and emotional distress, and improve overall health.

A randomized controlled trial will be conducted to evaluate the effectiveness of the mobile instant messaging intervention, analyzing its impact on reducing psychological distress and improving the quality of life of male spouses.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older, with a diagnosis of gynecological cancer (including cancers of the cervix, endometrium, fallopian tubes, ovaries, uterus, or vagina), and whose spouse has not been diagnosed with any other type of cancer;
2. The spouse has undergone cancer treatment, including surgery, chemotherapy, or radiotherapy;
3. Clear consciousness and ability to communicate in Mandarin or Taiwanese;
4. Willingness to participate in the study after being informed of the study purpose and procedures.

Exclusion Criteria:

Individuals with psychiatric disorders.

Primary outcomes:
measure: Supportive Care Needs -Partners & Caregivers 45, SCNS-P&C45
timeFrame: Post-intervention assessments will be conducted at 1 month, 3 months, and 6 months after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Shin Kong Memorial Wu Ho-Su Hospital
Study officials:
References:
Clinical trial NCT06831305: Bacterial Colonization on Nails Covered With a Methacrylic Coating
Official title: Bacterial Colonization of Nails With Methacrylic Coating in Relation to the Formation of Biofilms and Healthcare-associated Infections
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bacterial Colonization
Keywords: methacrylates
nails
desinfection
transmission of infections
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: In the research, the investigators will monitor the bacterial colonization of nails coated with a methacrylic coating

Detailed description: It is known that the hand hygiene of healthcare workers is extremely important in order to prevent health-related infections. The effectiveness of hand disinfection can be affected by aspects of hand hygiene such as long nails and fingernail applications. In order to determine whether and to what extent fingernails applied among healthcare workers pose a risk of transmission of potentially pathogenic bacteria, and until what day artificial fingernails are safe in healthcare workers, the investigators will monitor bacterial colonization on nails with UV-cured methacrylic fingernails lamp and compared it with a control group of natural nails without application.

Eligibility criteria: Inclusion Criteria:

* nurses, doctors and respiratory physiotherapists employed in high-risk wards for patients
* healthy nail surface and cuticle

Exclusion Criteria:

* subjects with damaged nails or cuticles
* operating room staff using surgical hand brushing and staff in general nursing wards.

Primary outcomes:
measure: Comparison of microbial colonization between natural and methacrylate nails
timeFrame: From day 1st to the end of treatment on day 14th
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References:
Clinical trial NCT01809405: Validation of Sexual Function Scale in Female Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexuality
Cancer
Healthy Women
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-03-12
Enrollment: 1130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 1130 adult women living in Korea

Brief summary: To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.

Detailed description: Due to the observational nature of the study which aims to evaluate the internal consistency and validity of the Korean version of Questionnaire, formal sample size and power calculations were not performed. When the number of observations (items) per subject ranges from 4 to 6, roughly 152-199 patients are required to show 10% increase in intraclass correlation from baseline ICC of 30% with 85% power and 5% type I error rate. The sample size was determined based on this calculation and practical considerations.

The pilot study will be performed based on 30 people (include reference), and the main study will include 1100 people (considering 10% drop-out from 200 people in each group) cancer type (ovary, cervix, endometrium, and breast) and healthy female. Total 1130 patients.

Eligibility criteria: Inclusion Criteria:

* Healthy women

  * Female without history of cancer
  * Cancer free as of the most recent linkage
  * At least 18 years of age
  * Able to speak and read Korean
  * Sexual activity within 3months.
* Female cancer patient

  * History of gynecological or breast cancer
  * At least 18 years of age
  * Able to speak and read Korean
  * Sexual activity within 3months.

Exclusion Criteria:

* Women who are unable to complete the questionnaires.
* Refuse to participate in the survey.

Primary outcomes:
measure: sexuality
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04431505: Anaesthesia and Apoptosis
Official title: Effect of Anaesthesia on Apoptosis During Congenital Heart
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apoptosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing congenital heart corrective surgery

Brief summary: Anesthetics cause widespread apoptosis in the developing brain, resulting in neurocognitive abnormalities. However, it is unknown whether anesthesia-induced neurotoxicity occurs in humans because there is currently no modality to assess for neuronal apoptosis in vivo


Eligibility criteria: Inclusion Criteria:

* congenital heart corrective surgery

Exclusion Criteria:

* none

Primary outcomes:
measure: apoptotis during anaesthesia
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT03365505: Frailty Assessment in Elderly Patients With Acute Coronary Syndrome
Official title: Frailty Assessment in Elderly Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frail Elderly Syndrome
Acute Coronary Syndrome
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 80
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly patient admitted to our hospital with acute coronary syndrome: unstable angina or non ST elevation myocardial infarction who are aged 80 and above and are hemodinamically stable.

Brief summary: Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients . It is an important factor on the cardiologist decision between conservative and invasive treatment in older patient with acute coronary syndrome, and is usually made subjectively by the cardiologist known in the literature as eyeball testing.

in this study the investigators will compare the cardiologists eye ball testing to objective frailty assessment based on Fried score and Edmonton frailty scale.

Detailed description: elderly patients admitted to Meir hospital with acute coronary syndrome will be assessed for frailty twice: the first frailty assessment will be a subjective eye ball testing made by the cardiologist, the second assessment will be an objective one based on Fried frailty score and Edmonton frail scale.

The cardiologist will not be aware of the objective frailty assessment result.

The eye ball testing will be compared to the objective frailty assessment (Fried score and Edmonton frailty scale).

Eligibility criteria: Inclusion Criteria:

* patient admitted to Meir hospital with acute coronary syndrome
* Age: 80 years old and older
* eligible for signing an informed concent

Exclusion Criteria:

* uncontrolled heart failure ( pulmonary edema or the use of iv diuretics)
* cardiogenic shock
* fever st elevation myocardial infarction

Primary outcomes:
measure: A subjective eye ball frailty assessment will be compared to an objective frailty assessment based on Fried score and Edmonton frailty scale
timeFrame: Through hospitalization , an average of 1 week
measure: An objective frailty assessment using Fried score and Edmonton frailty scale will be compared to a subjective eye ball frailty assessment
timeFrame: Through hospitalization , an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00080405: Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma
Official title: Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Relapsed
Multiple Myeloma
Pharmacokinetic
Pharmacodynamic
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2004-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to participate in the pharmacogenetic portion of the study, an additional blood sample will be collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug metabolizing enzymes.


Eligibility criteria: Male and female adult patients 18 years or older with a diagnosis of relapsed multiple myeloma requiring therapy will be eligible for this study.

Key inclusion criteria include:

Karnofsky Performance Status (KPS) equal to or greater then 70%, normal liver function tests (aspartate transaminase \[AST\] or alanine transaminase \[ALT\] equal to or less then 2 x upper limit of normal \[ULN\], total bilirubin equal to or less then 1.5 x ULN), hemoglobin equal to or greater then 10 g/dL, platelets equal to greater then 50 x 10 to ninth power/L, and absolute neutrophil count (ANC) equal to or greater then 1000/uL; calculated creatinine clearance equal to or greater then 50 mL/min, and normal serum calcium.

Key exclusion criteria include:

Patients with significant cardiac disease, equal to or greater then Grade 2 neuropathy, active hepatitis, HIV infection, secondary malignancy, POEMS syndrome, plasma cell leukemia, or who are transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment will be excluded. Patients taking concurrent medications at entry that may act as inducers or inhibitors of CYP 3A4 are excluded. Patients receiving thalidomide must discontinue that drug at least 2 weeks prior to enrollment. Patients receiving concurrent corticosteroids must have tapered their dose of corticosteroid to to equal to or less then 10 mg/day of prednisone or prednisone equivalent at least 2 weeks prior to enrollment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00905905: Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction
Official title: Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: myocardial infarction
systemic inflammatory activity
endothelial function
Lead sponsor: Brasilia Heart Study Group
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: During acute coronary syndromes (ACS), the generation of inflammatory mediators negatively influences arterial wall remodeling and the endothelium-dependent vasomotor function in the coronary and systemic arterial systems. In fact, the intensity of the inflammatory upregulation is strongly related to the incidence of recurrent coronary events. The investigators previously demonstrated that high dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. In addition, such statin treatment attenuates the post-discharge endothelial dysfunction of these patients. By inference, it is plausible to hypothesize that these beneficial effects during ACS may be intensified by an additive lowering of plasma cholesterol through the treatment with ezetimibe. So far, data is unavailable to verify this assumption. In parallel, data from animal models have suggested that both statins and ezetimibe may reduce insulin sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in liver cells. In this context, the present study aims to investigate the role of the addition of ezetimibe upon statin treatment on stress-induced insulin resistance and on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation.


Eligibility criteria: Inclusion Criteria:

* less than 24 hours after the onset of myocardial infarction symptoms
* ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads
* myocardial necrosis, as evidenced by increased CK-MB and troponin levels

Exclusion Criteria:

* use of statins for the last 6 months before myocardial infarction

Primary outcomes:
measure: C- reactive Protein (CRP) elevation during the first 7 days after myocardial infarction
timeFrame: 5th day
Secondary outcomes:
measure: Endothelial function 30 days after myocardial infarction
timeFrame: 30th day
measure: Stress Insulin Resistance
timeFrame: 5th day
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital de Base do Distrito Federal
state: DF
Study officials:
affiliation: University of Brasilia Medical School
name: Andrei C Sposito, MD, PhD
role: STUDY_CHAIR
References: