louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04400344: Approaches to Foot Complication Prevention: A Survey of Diabetes Educators
Official title: Approaches to Foot Complication Prevention: A Survey of Diabetes Educators
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Foot Ulcer, Diabetic
Keywords: Diabetic Foot
Ulcer
Care recommendation
Foot Diseases
Diabetic Neuropathies
Diabetes Education
Diabetes
Diabetes Educator
Diabetes Mellitus
Diabetes Complication
Care and treatment
Lead sponsor: Podimetrics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: American Association of Diabetes Educators
First posted: 2020-05-22
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Respondents are members of the American Association of Diabetes Educators (AADE) recruited via an introductory email sent out by the AADE on behalf of Podimetrics.

Brief summary: The purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.

Detailed description: Podimetrics is a care management company with a temperature-based foot monitoring solution to help prevent diabetic foot ulcers, one of the most debilitating and costly complications of diabetes.

Diabetes educators within the AADE/ADCES encompass a wide array of medical disciplines including nurses, physicians, dieticians, and pharmacists. Diabetes researchers want to better understand the degree to which diabetic foot care and prevention is incorporated into the diabetes education curriculum. To what extent are these topics discussed between diabetes educators and the patients they interact with? And how comfortable are educators in discussing these topics?

To gain insight into these questions Podimetrics researchers have designed an online questionnaire survey for completion by AADE members. The general purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.

The specific aim is to collect generalizable data to characterize the current state of diabetic foot education and identify any gaps in knowledge that may be present. Furthermore, if it is found that educators are lacking important knowledge which supports ample diabetic foot health education, approaches to bridge these gaps may be suggested through published recommendations.

Eligibility criteria: Inclusion Criteria:

* American Association of Diabetes Educators (AADE) member with accurate email address on file with the AADE.

Exclusion Criteria:

* AADE member with an inability to read English.

Primary outcomes:
measure: Current state of diabetic foot care education and knowledge base among diabetic educators
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Somerville
country: United States
facility: Podimetrics,Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT00185744: Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Official title: Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Carcinoma, Ductal
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 121
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.


Eligibility criteria: Inclusion Criteria:

1. Women \>= 40 with invasive ductal carcinoma or ductal carcinoma in situ
2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
3. Tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.

Exclusion Criteria:

1. Men
2. Prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years
3. Pregnant women
4. Immunocompromised
5. Poorly controlled insulin dependent diabetes
6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
7. Breast cancer that involves skin or chest wall
8. Multifocal or Multicentric breast cancer
9. Invasive lobular carcinoma
10. Diffuse microcalcifications on mammography
11. Invasive carcinoma with extensive intraductal component (EIC)
12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
15. Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)

Primary outcomes:
measure: In-breast tumor recurrence (IBTR)
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Frederick M. Dirbas
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horst KC, Fasola C, Ikeda D, Daniel B, Ognibene G, Goffinet DR, Dirbas FM. Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. Breast. 2016 Aug;28:178-83. doi: 10.1016/j.breast.2016.06.001. Epub 2016 Jun 17.
Clinical trial NCT03431844: Humanin Isoforms in Cardiac Muscle and Blood Plasma and Major Complications After Cardiac Operation
Official title: Prospective Clinical Observational Study of Humanin Isoforms in Cardiac Muscle and Blood Plasma and Their Association to Major Complications After Cardiac Operation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Coronary Artery Bypass Surgery
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: Tartu University Hospital
name: North Estonia Medical Centre
First posted: 2018-02-13
Enrollment: 106
Sex: ALL
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: All adult patients who have a history of ischemic heart disease and who are going to have an elective on-pump CABG operation.

Brief summary: Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation.

Hypothesis of the study is that previously described elements are related to each other.

Detailed description: Data collection: Historical medical and preoperative data, operation data (type of operation performed and its details), detailed postoperative course (occurrence of complications).

Specimen collection:

* Tissue sample is taken during the operation from the right atrial appendage of the heart and the sample is frozen at -80 C.
* Blood samples are taken just before the operation, one hour after aortic cross-clamp removal and the next morning after the operation. Samples are processed and blood plasma is frozen at -80 C.

Eligibility criteria: Inclusion Criteria:

* Age at least 18 years
* Ischemic heart disease in medical history
* Planned on-pump coronary artery bypass graft (CABG) operation
* Signed informed consent by patient

Exclusion Criteria:

* Age \<18 years
* Planned isolate valve or aortic operation
* Patient is in another study with an intervention
* Absence of signed informed consent

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Major complications: myocardial infarction.
timeFrame: 30 days
measure: Major complications: acute kidney injury.
timeFrame: 30 days
measure: Major complications: stroke.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
state: Harjumaa
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
Study officials:
affiliation: Tartu University Hospital
name: Joel Starkopf, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04999644: Reduced Nicotine Cigarette Purchasing Decisions
Official title: Reduced Nicotine Cigarette Purchasing Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Tobacco Use Disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-08-11
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this project is to experimentally evaluate how expectations about reduced-nicotine cigarettes as well as actual nicotine content interact to determine behavioral and subjective response for these novel products.


Eligibility criteria: Inclusion criteria:

* 21 years or older
* Smoke five or more cigarettes per day for the past six months
* Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 8 ppm and a urinary cotinine level of more than 100 ng per milliliter at screening

Exclusion criteria:

* Intention to quit smoking in the next 30 days
* Weekly use of nicotine-containing products other than machine-manufactured combustible cigarettes
* Serious medical or psychiatric disorder precluding participation by study physician guidance
* Positive urine screening for illicit drugs other than cannabis or current substance use disorder
* Women who are pregnant, plan to become pregnant, or are breast-feeding
* Medical contraindications to receiving tobacco products

Primary outcomes:
measure: Demand Intensity
timeFrame: Four times over approximately two weeks
measure: Demand Elasticity
timeFrame: Four times over approximately two weeks
Secondary outcomes:
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Post-cigarette administration four times over approximately two weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Matthew Johnson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05878392: Immediate Implant With Different Filling Materials
Official title: Comparison Between Different Filling Materials in Immediate Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implant
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 36 patients, were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant.


Eligibility criteria: Inclusion Criteria:

* Patient medically free from systemic diseases.
* Age above 18 years.
* A single maxillary anterior or premolar tooth that cannot be restored.
* No acute infection is present.
* Patients with sufficient quality and quantity of bone.
* Free from history of bruxism.

Exclusion Criteria:

* A medical condition that would prevent implant surgery.
* Existence of non-treated generalized progressive periodontitis.
* Patients who are smokers.

Primary outcomes:
measure: marginal bone loss
timeFrame: 1 year
Secondary outcomes:
measure: Implant Stability:
timeFrame: 1 year
measure: Peri-implant Pocket depth
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura, Egypt
country: Egypt
facility: Heba Elsheikh
Study officials:
References:
Clinical trial NCT02058992: Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
Official title: Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 3339
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Insomnia

Brief summary: The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.

Detailed description: This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000)

The usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.

Eligibility criteria: Inclusion Criteria:

1. Sleep-onset difficulty associated with insomnia

Exclusion Criteria:

1. Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
2. Patients with severe liver dysfunction
3. Patients taking fluvoxamine maleate

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to 6 weeks
measure: Number of Participants Reporting One or More Serious Adverse Drug Reactions
timeFrame: Baseline up to 6 weeks
Secondary outcomes:
measure: Sleep Status: Sleep Onset Latency
timeFrame: Baseline and Week 4
measure: Sleep Status: Total Sleep Time
timeFrame: Baseline and Week 4
measure: Sleep Status: Number of Awakenings
timeFrame: Baseline and Week 4
measure: Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4
timeFrame: Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References:
Clinical trial NCT00326092: A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Official title: A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 88
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 assess the comfort of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Adults of either sex and any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: Ocular discomfort
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Fort Worth and Other Sites
state: Texas
Study officials:
affiliation: Study Director
name: Julia White
role: STUDY_DIRECTOR
References:
citation: Vold SD, Evans RM, Stewart RH, Walters T, Mallick S. A one-week comfort study of BID-dosed brinzolamide 1%/timolol 0.5% ophthalmic suspension fixed combination compared to BID-dosed dorzolamide 2%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2008 Dec;24(6):601-5. doi: 10.1089/jop.2008.0030.
Clinical trial NCT00357292: Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers
Official title: Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eye Infections, Bacterial
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2006-07-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation

Detailed description: The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Male or female aged from 18 to 45 years old;
* Written informed consent;
* Healthy volunteers (without any ocular symptom);
* Normal ocular examination in both eyes (corrected visual acuity (VA) \>= 6/10 - Slit lamp examination without clinical relevant abnormalities - Tear break-up time (BUT) ≥10 seconds - Lachrymal secretion in the Schirmer test \>= 10 mm in 5 minutes - Lissamine green test total score \< 4 +).

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* Blepharitis;
* Conjunctival hyperaemia (score \>= 2 +);
* Watering (score \>= 2);
* Contact lenses;
* Ocular surgery, including LASIK and PRK, within the last 12 months;
* Topical ocular treatment within the last month;
* Systemic antibiotics within the last 7 days;
* Any medication during the study (except: Paracetamol and contraceptives).

Primary outcomes:
measure: Ocular subjective symptoms
measure: Ocular objective symptoms
Secondary outcomes:
measure: Ocular pharmacokinetic.
measure: Ocular and systemic adverse events.
Other outcomes:
Locations:
Study officials:
affiliation: The Eye Center, Riyadh (Saudi Arabia)
name: Khalid TABBARA, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06745492: Low-dose Neostigmine at TOF Ratio of 0.7 Improves Neuromuscular Recovery
Official title: Low-dose Neostigmine at TOF Ratio of 0.7 Accelerates Neuromuscular Recovery Without Adverse Effects: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recovery Time
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective thyroid surgery under general anesthesia were screened and included in this study

Brief summary: This study is a prospective observational study. A total of 54 patients were included in this study. We observed the time from neostigmine administration to TOF ratio of 1.0.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective thyroid surgery under general anesthesia
* a body mass index of 18.5-25 kg/m2
* Age ≥ 20

Exclusion Criteria:

* Refused to participate
* history of hypersensitivity to acetylcholinesterase inhibitor
* neuromuscular disease
* hepatic or renal dysfunction

Primary outcomes:
measure: Recovery time
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hoon Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05817292: Study of the Vaginal Microbiota in Women Under Fertile Age
Official title: Characterization of the Vaginal Microbiota in Fertile Age: Correlations Clinical and Pathogenetic Correlations Among Gynecological Disorders.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Disease
Lead sponsor: Universita degli Studi di Catania
Sponsor class: OTHER
Collaborators: name: ProBioEtna
First posted: 2023-04-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volunteers with vaginal microbiota imbalance

Brief summary: Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders

Detailed description: The study aimed to characterize, in women under fertile age, the composition and dynamics of the vaginal microbiota as well as to in-depth study correlations among microbiota and gynecological disorders

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45 years;
* Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, and subjective vaginal discomfort);
* Presence of at least 3 Amsel criteria;
* Nugent score ≥ 7;
* lactobacillary grade ≥ 2 (LBG) (according to Donders classification);
* presence of blastospores and/or pseudohyphae evaluated by fresh mount microscopy

Exclusion Criteria:

* Age \< 18 years;
* Nugent score \< 7;
* presence of sexually transmitted disease due to Chlamydia, Neisseria gonorrhoeae, or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;
* Clinically apparent herpes simplex infection;
* Human papillomavirus or human immunodeficiency virus infections;
* Use of antibiotic, antifungal, probiotic, or immunosuppressive drugs during the past four weeks;
* Use of vaginal contraceptives;
* Pregnancy or breastfeeding, chronic diseases, neoplastic disease, diabetes, genital tract bleeding)

Primary outcomes:
measure: Microbiota
timeFrame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
measure: Signs
timeFrame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
measure: Signs
timeFrame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
measure: Symptomatology
timeFrame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Secondary outcomes:
measure: Wellbeing
timeFrame: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
Study officials:
affiliation: University of Catania
name: Antonio Cianci, Prof
role: STUDY_DIRECTOR
References: