louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05779397: Clinical Performance of Masimo Rad-GT
Official title: Clinical Performance of Masimo Rad-GT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-03-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.

Detailed description: Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05779397, NCT05787782, and NCT05674344).

Eligibility criteria: Inclusion Criteria:

* Subject is 18 to 80 years of age.
* Subjects are able to read and communicate in English as well as understand the study and the risks involved.

Exclusion Criteria:

* Subject is pregnant or nursing.
* Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. \*
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

(\* = Per study staff discretion)

Primary outcomes:
measure: Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius)
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT00580697: Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management
Official title: Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lower Urinary Tract Symptoms
Gynecologic Malignancy
Keywords: Lower urinary tract symptoms
Gynecologic malignancy
Urinary incontinence
Fecal incontinence
Frequency
Voiding dysfunction
Sexual dysfunction
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Have a diagnosis of a gynecologic malignancy: cervical, endometrial, or ovarian cancer, and plan to have surgry for the cancer treatment.

Brief summary: This study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for gynecologic malignancy.

Detailed description: Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, is directly affected by gynecologic malignancies and the surgical and medical management of those malignancies. Increased risk of injury to the urinary tract is a recognized complication of surgical and medical therapy of gynecologic malignancies. To date, only a few studies have looked at the incidence of lower urinary tract symptoms at the time of diagnosis of gynecologic malignancy and prior to treatment, and there have been no published studies describing the incidence of sexual dysfunction at the time of diagnosis and prior to therapy of gynecologic malignancies. However, sexual dysfunction has been described in patients with urinary incontinence and pelvic organ prolapse and following surgery for incontinence and pelvic organ prolapse.

Eligibility criteria: Inclusion Criteria:

* Subjects with a new diagnosis of gynecologic malignancy who plan to undergo surgical management, including cervical, endometrial, and ovarian cancer.

Exclusion Criteria:

* Subjects less than 18 years of age
* Subjects unable to give informed consent

Primary outcomes:
measure: The outcome will be measured using validated general and condition-specific questionnaires.
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Karen L Noblett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771497: Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring
Official title: Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast CT
Lead sponsor: Koning Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
First posted: 2013-01-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twelve female patients at least 18 years of age undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy will be recruited for this study. Inclusion of those patients 18 years or older is important since as it is the younger patients who present with breast cancer that often end up receiving neoadjuvant treatment.

Brief summary: The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes.


Eligibility criteria: Inclusion Criteria:

* Female gender
* Age 18 years or older
* Any ethnicity
* Are undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy
* Is able to provide informed consent.

Exclusion Criteria:

* Pregnancy
* Lactation
* Women who are unable or unwilling to understand or to provide informed consent
* Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
* Women who are unable to tolerate study constraints.
* Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to):
* Treatment for enlarged thymus gland as an infant
* Irradiation for benign breast conditions, including breast inflammation after giving birth
* Treatment for Hodgkin's disease
* Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to):
* Tuberculosis
* Severe scoliosis

Primary outcomes:
measure: Tumor volume change from baseline during neoadjuvant treatment
timeFrame: Baseline, mid-point (~3 months), and end of therapy (4-6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center Highland Breast Imaging Center
state: New York
Study officials:
References:
Clinical trial NCT00188097: Diagnosis of Variceal Bleeding and Its Control in Cirrhosis
Official title: Diagnosis of Variceal Bleeding and Its Control in Cirrhosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study was to determine the independent predictors of variceal bleeding and control of bleeding in cirrhosis as no scientific assessment have been perfomed until now


Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients admitted for an acute complication of cirrhosis
* admission ≤ 6 hours of inclusion

Exclusion Criteria:

* Child-Pugh score \> 13
* Digestive hemorrhage
* Non cirrhotic portal hypertension

Primary outcomes:
measure: variceal bleeding
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UH Angers
name: Paul Cales, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05661097: Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
Official title: Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Wall Hernia
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: random control trail
Primary purpose: TREATMENT

Brief summary: By comparing the time of closing the hernia ring, the degree of pain, and the recovery of gastrointestinal tract in different groups Intervening, infection, recurrence and medical cost, to find out whether patients with abdominal wall hernia have different hernias It is the best way to close the hernia ring under laparoscopy and provide evidence based medicine. with In the research process of the research group, a database on abdominal wall hernia will be established for the future Further study of hernia has laid a solid foundation.


Eligibility criteria: Inclusion Criteria:

* Conform to the diagnostic criteria of abdominal wall hernia;

  * Patients with general physical condition and can tolerate general anesthesia and laparoscopic surgery; ③ After explaining the situation to the patients and their families, they agreed to join the research group.

Exclusion Criteria:

* The diagnostic criteria of abdominal wall hernia were not met; ② Patients who have serious medical diseases and cannot tolerate laparoscopic surgery; ③ Patients with mental illness; ④ The judgment is affected by incomplete data.

Primary outcomes:
measure: recrudescence
timeFrame: 24 months after operation
Secondary outcomes:
measure: Time to close the hernia ring
timeFrame: during operation
measure: Bleeding volume
timeFrame: during operation
measure: Pain level
timeFrame: immediately after the surgery
measure: Gastrointestinal recovery time
timeFrame: immediately after the surgery
measure: Seroma
timeFrame: immediately after the surgery
measure: Infected
timeFrame: immediately after the surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital)
state: Shandong
Study officials:
References:
Clinical trial NCT01181505: STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study
Official title: STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Genotype Guided(HNF4a)
Healthy Subjects
Keywords: HNF4a
CYP2D6
Toterodine
Genetic polymorphism
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in healthy subject in relation to the presence of HNF-4A G60D variant.

Detailed description: After a single oral administration of 2 mg tolterodine in 31 healthy subjects (6 with the heterozygous mutation of HNF-4A G60D vs 25 subjects with wild type of that whose CYP2D6 genotype and gender were matched with variant group), blood were collected for 24hrs. Assay of tolterodine and the metabolite, 5-hyroxymethyl tolterodine was conducted using LC/MS/MS.

Eligibility criteria: Inclusion Criteria:

* Healthy subject whose HNF4a and CYP2D6 genotype ware determined

Exclusion Criteria:

* Subject whose HNF4a and CYP2D6 genotype ware not determined

Primary outcomes:
measure: Cmax, AUC, CL, Vd, T1/2
timeFrame: 24hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inje University
name: Jae-Gook Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179205: Complementary Intradialytic Nutritional Supplementation in Dialysis Patients
Official title: Complementary Intradialytic Nutritional Supplementation in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Ross Laboratories
First posted: 2005-09-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, the investigators hypothesize that long-term administration of adequate intradialytic oral nutritional supplementation will increase visceral protein concentrations and somatic protein stores in malnourished chronic hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

1. On hemodialysis for more than 6 months
2. Optimally dialyzed with a biocompatible membrane (URR \> 70% and/or delivered Kt/V \> 1.2)
3. Suboptimal nutritional status identified by:

   * Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:

     * Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months
     * Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight over the past 6 months and/or patients who are less than 90% of standard body weight
     * Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements over the consecutive two months prior to inclusion:

       * Serum transferrin concentration less than 225 mg/dl
       * Serum prealbumin concentration less than 32 mg/dl

Exclusion Criteria:

1. Active auto-immune, inflammatory or infectious disease
2. Documented malignancy within the last 12 months
3. Patients on unusual dietary restrictions
4. Life-expectancy less than 6 months
5. Inability to tolerate nutritional supplements

Primary outcomes:
measure: increase in serum albumin
timeFrame: 6 months
Secondary outcomes:
measure: increase in lean body mass
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
Clinical trial NCT00848705: Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed)
Official title: Adolescent Self-Management of Type 1 Diabetes: an Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Adolescent Type 1 Diabetes
Keywords: type 1 diabetes, adolescent, self-management
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2009-02-20
Enrollment: 72
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goals of this R21 exploratory pilot and feasibility study were to: 1) design an Internet-based self-management intervention for adolescents with type 1 diabetes; 2) test that intervention in a small randomized trial to establish technical feasibility, intervention acceptability, and competence in completing the necessary recruitment and research procedures. Although not powered to detect statistically significant changes, possible outcomes of this study include improvements in problem-solving, coping, and self-management behaviors.


Eligibility criteria: Inclusion Criteria:diagnosed for at least 6 months, age 13-17; Internet access, parental consent -

Exclusion Criteria: Any sensory deficits that would preclude seeing or hearing.

-

Primary outcomes:
measure: Self-management behaviors
timeFrame: End of intervention
Secondary outcomes:
measure: Self-management Problem solving
timeFrame: end of study period
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT04274205: Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome in Intensive Cardiac Care Unit
Official title: Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome Patients in Intensive Cardiac Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Brief Supportive Psychotherapy
Intensive Cardiac Care Unit
Keywords: Brief supportive psychotherapy, acute coronary syndrome, major adverse cardiovascular events, neutrophil-lymphocytes ratio, psychological symptoms
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups Acute coronary syndrome group who got brief psychotherapy in five session in 5 days.. 30 minutes in 1 session Acute coronary syndrome group who did not get brief supportive psychotherapy as control Double opened RCT
Primary purpose: TREATMENT

Brief summary: There was no MACE in both groups, but there was stroke-major adverse vascular event lower in brief supportive psychotherapy group. There was neutrophil-lymphocytes ratio change better in brief supportive psychotherapy group and significantly in acute coronary syndrome patients without chronic heart failure or coronary arterial disease, also there was psychological symptom (depression) change better in brief supportive psychotherapy and significantly in acute coronary syndrome patients with chronic heart failure or coronary arterial disease.


Eligibility criteria: Inclusion Criteria:

* acute coronary syndrome
* 》 18 years old
* have got pharmacological treatment in cardiology standard with or without anxiolytic drug and had got or had not yet got PCI
* be able to communicate and ready to have interview, fill the questioners and psychotherapy

Exclusion Criteria:

* stroke
* cardiogenic shock at admission time
* psychosis
* reject to involve in study

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 5 days
Secondary outcomes:
measure: Neutrophil-lymphocytes ratio
timeFrame: 5 days
measure: Psychological symptoms (Hospital anxiety depression scale)
timeFrame: 5 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Medical Faculty
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT02438605: Dynamic CT Imaging After Nellix Endoprosthesis Implantation
Official title: Dynamic CT Imaging After Nellix Endoprosthesis Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm
Keywords: Nellix
EVAS
EVAR
Dynamic CT
Dyna CT
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for endovascular aortic repair using the Nellix endovascular sealing system

Brief summary: The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.


Eligibility criteria: Inclusion Criteria:

* Nellix implantation

Exclusion Criteria:

* Use of chimneys or combined with other stent graft material

Primary outcomes:
measure: Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS
timeFrame: 1 month
Secondary outcomes:
measure: Dynamic changes in neck morphology after EVAS
timeFrame: 1 month
measure: Dynamic changes in common iliac artery morphology after EVAS.
timeFrame: 1 month
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
References: