louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04267328: Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery
Official title: Post-Operative Cognitive Dysfunction in Normal Aging Patients Undergoing Elective Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Cognitive Dysfunction
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to Regions Hospital orthopedics center in Saint Paul, MN with a scheduled surgery fitting the diagnostic codes listed in the eligibility criteria.

Brief summary: Post-operative cognitive dysfunction (POCD) is a common concern for aging patients undergoing elective orthopedic surgery and significantly effects health outcomes. This study aims to evaluate the incidence of and risk factors associated with post-operative cognitive dysfunction in aging patients without prior history for mild cognitive impairment or dementia.


Eligibility criteria: Inclusion Criteria:

* Age ≥50 and ≤90
* Any patient undergoing elective orthopedic surgery for hip, knee, or shoulder replacement (as defined by diagnostic codes: M16.0, M16.12, M16.11, M17.0, M17.12, M17.11, M19.011, M19.012)

Exclusion Criteria:

* History of cognitive impairment of dementia
* Montreal cognitive assessment (MoCA) \<26
* History of Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, normal pressure hydrocephalus, Huntington's disease, stroke, seizure disorder, brain tumor, or brain surgery
* History of surgery requiring anesthesia within the past 3 months

Primary outcomes:
measure: Presence of Post Operative Cognitive Dysfunction (POCD)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Neurology
name: Michael H Rosenbloom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04485728: Sleep Improvement Intervention for Hospitalized Antepartum Patients
Official title: Sleep Improvement Intervention for Hospitalized Antepartum Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance in Hospitalized Antepartum Patients
Lead sponsor: Sam Houston State University
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
name: Memorial Hermann Texas Medical Center
First posted: 2020-07-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).


Eligibility criteria: Inclusion Criteria:

* speak, read, and write English
* medically stable
* 20 weeks' gestation or greater
* viable fetus
* hospitalized at least 24 hours

Exclusion Criteria:

* Do not speak, read, and write English
* Medically unstable
* Less than 20 weeks' gestation
* Nonviable fetus
* Hospitalized less than 24 hours

Primary outcomes:
measure: Number of patients who use the sleep improvement intervention
timeFrame: Day 7
measure: Level of satisfaction with the intervention as assessed by a Likert assessment
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
Study officials:
affiliation: Sam Houston State University
name: Andrea M Smith, Ph.D., RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00380328: HKI-272 Ketoconazole Drug Interaction Study
Official title: An Open-label, Randomized, 2-period Crossover, Drug Interaction Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of HKI-272 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetic
healthy subjects
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-administered.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

Primary outcomes:
measure: Pharmacokinetics; safety and tolerability
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
Clinical trial NCT03058861: Mitigating ACEs in Pediatric Primary Care
Official title: Mitigating ACEs in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Parenting
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.

Detailed description: The goal of the project is to affect policy and practice related to Adverse Childhood Experiences (ACEs) screening and intervention in pediatric primary care. First, the investigators will develop and test a new ACEs screening tool that is brief, has a pediatric perspective, builds on parents' strengths, and measures parenting-related ACEs that can be treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration, mental illness). A research assistant will invite approximately 1000 parents to complete the survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior problems that the investigators hypothesize will be associated with elevated parenting scores. The second part of the project will be to recruit English and Spanish-speaking parents for a randomized controlled trial (RCT) to determine if educational interventions can help educate parents about ACEs and decrease parenting-related ACE scores two months post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to participate in the study. Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will receive routine primary care. Follow up data will be obtained 2 months after enrollment.

Eligibility criteria: Inclusion Criteria:

* Parents of 2-10 year old children presenting for a well visit.

Exclusion Criteria:

* Parents do not speak English, Spanish, or Arabic.

Primary outcomes:
measure: Change from baseline Parenting Survey at 2 months
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Change from baseline Attitudes Toward Spanking scale at 2 months
timeFrame: Baseline and 2 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Pediatric Primary Care Clinic
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Seth Scholer, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05504161: Detection of Tumor DNA Through Cervical Smear and Liquid Biopsy in Endometrial Cancer Patients and Evaluation of Prognostic and Predictive Values of Tumor DNA Assay
Official title: Detection of Tumor DNA Through Cervical Smear and Liquid Biopsy in Endometrial Cancer Patients and Evaluation of Prognostic and Predictive Values of Tumor DNA Assay
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed endometrial cancer (case) and benign gynecological disease (control)

Brief summary: Circulating tumor DNA (ctDNA) may help detect and prognosis-stratify patients with endometrial cancer. Both cervical swab-based genomic DNA (gDNA) and whole blood-based ctDNA can be utilized for this goal. Our objective is to utilize cervical swab and whole blood samples to analyze tumor-derived ctDNA from patients with endometrial cancer. These samples will be collected prospectively, and prior to staging operation. Samples from patients without cancer, who undergo hysterectomy for benign gynecological cause, will be utilized as controls. Variants called by next generation sequencing were classified into four-tiers based on ASCO/AMP system. These initially captured samples will be used to compare performance in terms of detection rate and to stratify patients based on the mutational profile. Additionally, in patients with advanced disease, we plan to collect whole blood samples every 3 months to assess any changes in mutational landscape. Clinical data including age, cormorbidities, treatment methods, date of diagnosis and recurrence, response evaluation for chemotherapy or radiotherapy, survival data will be used to contextualize our findings.


Eligibility criteria: Inclusion Criteria:

1. Female, over 19 years of age
2. Patients with endometrial cancer or benign gynecological diseases

Exclusion Criteria:

1. Patients in pregnancy
2. Patients being treated for cancer of other organs, including gynecological cancer.
3. Patients who has difficulty reading and understanding Korean.
4. The tester's determination that the patient will not be able to comply with the clinical trial procedures.
5. Patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.

Primary outcomes:
measure: Detection rate
timeFrame: Detection rate based on two different modalities at the time of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Yonsei University College of Medicine
name: Jung-Yun Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00193661: Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
Official title: A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary or Secondary Hypogonadism
Constitutional Delay in Growth and Puberty (CDGP)
Keywords: Hypogonadism
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Unimed Pharmaceuticals
First posted: 2005-09-19
Sex: MALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).


Eligibility criteria: Inclusion Criteria:

* Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion Criteria:

* Skin intolerance to alcohol or allergy to soy
* Generalized skin disease
* Contraindication to testosterone or androgen products

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 130
state: Alabama
city: Los Angeles
country: United States
facility: Site 107
state: California
city: Sacramento
country: United States
facility: Site 113
state: California
city: Torrance
country: United States
facility: Site 114
state: California
city: Gainesville
country: United States
facility: Site 121
state: Florida
city: Jacksonville
country: United States
facility: Site 127
state: Florida
city: Jacksonville
country: United States
facility: Site 128
state: Florida
city: Indianapolis
country: United States
facility: Site 117
state: Indiana
city: Kansas City
country: United States
facility: Site 111
state: Missouri
city: Brooklyn
country: United States
facility: Site 129
state: New York
city: New York
country: United States
facility: Site 123
state: New York
city: Cincinnati
country: United States
facility: Site 131
state: Ohio
city: Columbus
country: United States
facility: Site 124
state: Ohio
city: Portland
country: United States
facility: Site 103
state: Oregon
city: Hershey
country: United States
facility: Site 109
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 125
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 126
state: Pennsylvania
city: Memphis
country: United States
facility: Site 104
state: Tennessee
city: Seattle
country: United States
facility: Site 205
state: Washington
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT04501861: Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:
Official title: Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients: a Comparative-effectiveness Quality Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Disease
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 153
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cluster crossover study
Primary purpose: TREATMENT

Brief summary: The relative increase in the mPAP with the same unit increase in MAP adjusted for baseline, and RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery.

Detailed description: The specific aims of our study are to compare 1) the relative increase in the mPAP with the same unit increase in MAP adjusted for baseline and 2) RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery. We hypothesize that the use of vasopressin compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support. Second, we will test the hypothesis that vasopressin is associated with improved right ventricular global longitudinal strain compared to norepinephrine in patients requiring vasopressor support during cardiac surgery.

Eligibility criteria: Inclusion criteria:

Adults\> 18 years of age

* Elective cardiac surgery with the use of CPB
* Patients with pulmonary artery catheter insertion
* Systemic hypotension (MAP \< 70 mmHg) requiring continuous infusion of vasopressor

Exclusion Criteria:

* Transplant surgery
* Ventricular assist device implantation other than intra-aortic balloon counter-pulsation
* Pulmonary endarterectomy
* Thoracoabdominal aneurysm repair
* Inhalational pulmonary vasodilators (e.g. Epoprostenol) administration before insertion of pulmonary artery catheter
* Vasopressin is started as the first choice of pressor per clinical staff discretion

Primary outcomes:
measure: mPAP-to-MAP Ratio
timeFrame: during 20 minute period after chest closure
Secondary outcomes:
measure: RV Free Wall Strain
timeFrame: during 20 minutes period after chest closure
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mariya Geube, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05284461: Effect of Shape and Surface Treatment of the Transmucosal Abutments on Peri-implant Health.
Official title: Effect of Shape and Surface Treatment of the Transmucosal Abutments on the Bone-implant-contact and the Peri-implant Health, .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.


Eligibility criteria: Inclusion Criteria:

* totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders

Exclusion Criteria:

* evidence of systemic or psychic pathology that contraindicates implant treatment.

Primary outcomes:
measure: Bone to implant contact
timeFrame: 3 months after healing
measure: Peri-implant inflammation of the soft tissues
timeFrame: 3 months after healing
measure: Density of the peri-implant soft tissues
timeFrame: 3 months after healing
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Clinica Odontológica de la Universidad de Salamanca
Study officials:
References:
Clinical trial NCT05976061: High- and Low-risk Actinic Keratosis Referrals to Secondary Care
Official title: High- and Low-risk Actinic Keratosis Referrals to Secondary Care. Implementation of the General Practitioners Guidelines for Actinic Keratosis Patients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Actinic Keratoses
Keywords: General Practitioners guidelines
actinic keratosis
general physician
dermatology
low-risk patients
referrals
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Tergooi Hospital
First posted: 2023-08-04
Enrollment: 3379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from patients are collected retrospectively using the Electronic health records. Patients were selected based on the diagnosis-treatment-combination (DTC) 17 (premalignant lesion) and DTC 14 (cutaneous malignancy) that was registered from January 2018 to December 2019 by the dermatologist.

Brief summary: This study evaluates the implementation of the General Practitioners guidelines 'Suspicious Skin Lesions' and investigated whether their publication and implementation has led to a reduction in the proportion of referrals of low-risk patients with actinic keratosis to secondary care, after publication of the General Practitioners guidelines and implementation activities.

Detailed description: In the Dutch healthcare system, patients are first examined by the general practitioner who decides whether a referral to a dermatologist is indicated. Both general practitioners and dermatologists can diagnose and treat patients with actinic keratosis. Therefore, it is necessary to distinguish which patients the general practitioner should refer to a dermatologist and which patients are suitable to be treated by the general practitioner.

This retrospective data study evaluates the proportion of low risk actinic keratosis patients in 2019 en 2018.

Eligibility criteria: Inclusion Criteria:

* patients of 18 years and older
* referred to dermatologist for suspicion of actinic keratosis and diagnosed as actinic keratosis by the dermatologist
* treated at MaastrichtUMC+ or TergooiHospital

Exclusion Criteria:

* different diagnosis than actinic keratosis
* referred by a different specialist than the general practitioner
* referred with multiple problems
* referred for a second opinion
* if the patients was treated as different diagnosis than actinic keratosis by general practitioner

Primary outcomes:
measure: Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients.
timeFrame: 2018 compared to 2019 (2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Ellen Oyen
Study officials:
affiliation: Maastricht UMC+
name: Klara Mosterd, prof.dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht UMC+
name: Maud Jansen, dr.
role: PRINCIPAL_INVESTIGATOR
References: