louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02891681: Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
Official title: Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Tumors
Cancer of Breast
Cancer of the Breast
Malignant Neoplasm of Breast
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2016-09-07
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response.


Eligibility criteria: Inclusion Criteria:

* Scheduled to receive neoadjuvant chemotherapy for the treatment of newly diagnosed, locally advanced breast cancer or scheduled to receive neoadjuvant endocrine therapy with the eventual goal of surgery of newly diagnosed clinical stage II-III ER+ HER2- breast cancer (for the endocrine therapy cohort)
* At least 18 years of age
* Female
* Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Pregnant and/or breastfeeding
* Prior history of breast cancer
* Prior history of chest wall radiation
* Prior history of breast reconstruction, reduction, or augmentation

Primary outcomes:
measure: Pathologic Response Based on Miller-Payne Grading System
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Quing Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu Q, Ademuyiwa FO, Young C, Appleton C, Covington MF, Ma C, Sanati S, Hagemann IS, Mostafa A, Uddin KMS, Grigsby I, Frith AE, Hernandez-Aya LF, Poplack SS. Early Assessment Window for Predicting Breast Cancer Neoadjuvant Therapy using Biomarkers, Ultrasound, and Diffuse Optical Tomography. Breast Cancer Res Treat. 2021 Aug;188(3):615-630. doi: 10.1007/s10549-021-06239-y. Epub 2021 May 10.
Clinical trial NCT03035981: Gastric Emptying of Rice With Different Starch Properties
Official title: Assessment of Gastric Emptying and Fullness of Rice With Different Starch Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes, due to rapid digestion of starch into glucose. The specific properties of starch within these foods has been studied for the purpose of slowing their digestion rate and improving related physiological outcomes, such as gastric emptying rate. The current study investigated the relationship among starch digestion, gastric emptying rate and satiety in white and brown rice.

Detailed description: Studies have indicated that starch-based foods with somewhat high amylose content have slower in vitro starch digestion rates, which relate to a low glycemic response. Low glycemic response is associated with delayed gastric emptying rate as well. Therefore, we hypothesized that rice with a slow starch digesting property would delay gastric emptying. White and brown rice with varying amylose contents were used in this study. A 13C-labeled octanoic acid breath test method was used to measure gastric emptying rate, and questionnaires were used to assess hunger and fullness during the testing sessions. Twelve healthy volunteers were recruited to participate in a crossover design study with six rice treatments and outcome measurements were gastric emptying and satiety assessments. One fermentable carbohydrate (fructooligosaccharide, FOS) solution was used to validate the production of breath hydrogen.

Eligibility criteria: Inclusion Criteria:

* Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)

Exclusion Criteria:

* Under any medication
* History of any gastrointestinal disease or surgery
* Diabetes
* Smoker

Primary outcomes:
measure: Gastric emptying
timeFrame: Acute study, 4 hours after consumption of test food
measure: Appetitive response
timeFrame: Acute study, 4 hours after consumption of test food
Secondary outcomes:
measure: Breath hydrogen
timeFrame: Acute study, 4 hours after consumption of test food
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05118581: Safety and Efficacy of Ultrasound Guided Vascular Access
Official title: Safety and Efficacy of Ultrasound Guided Vascular Access
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access
Ultrasound Guided Vascular Access
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Vascular access involves central and peripheral vein accesses and arterial accesses. Central venous catheterization is widely used in clinical practice for diverse purposes, including hemodialysis for end stage renal failure, invasive hemodynamic monitoring, radiological studies, infusion of drugs that cannot be administered via peripheral vessels, administration of parenteral nutrition, vascular access in patients whose peripheral veins are difficult to be catheterized and for miscellaneous purposes that require access to large caliber vessels.

Arterial cannulation is used for invasive arterial pressure monitoring and to ensure access for diagnostic and therapeutic interventions.

In the United States and United Kingdom, guidelines have recommended the use of ultrasound guidance to reduce complications and improve success in central venous catheterization.


Eligibility criteria: Inclusion Criteria:

* · Adult patients who need vascular access (arterial or venous)

Exclusion Criteria:

* · Patients with local infection in the area targeted for vascular access.

  * Patients with severe generalized infection and other skin diseases or lesions.
  * patients with history of DVT of the target vein and or pulmonary embolism.
  * Patients with untreated coagulopathy (INR \>1.5 or platelets \<50000mm3)

Primary outcomes:
measure: Incidence of adverse effects of ultrasound guided vascular access
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00875381: Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin
Official title: Immunohistochemical Analysis of Melanocytes in Sun-Exposed Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Keywords: Melanocytes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 100
Sex: ALL
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: A total of 50 patients from Mayo Clinic Jacksonville and 50 Mayo Clinic Rochester will be enrolled in this study.

Brief summary: The purpose of this study is to estimate and define the mean number, degree of confluence, and depth of penetration of melanocytes in chronically sun exposed skin of the head and neck using Mart-1 immunostains on frozen sections. The study was conducted to confirm whether similar results were found using permanent sections. The present study used hematoxaline and eosin (H\&E) staining as well as Mart-1 staining, and included patients from both Mayo Clinic Jacksonville and Rochester.

Detailed description: For each study participant we recorded their age, sex, state they lived in, tumor type, tumor location, recent sun exposure (during the two weeks prior to the surgery), whether or not a follicle was present on the slide, and if so the follicular extension (mm) from the granular layer, presence of atypia, nesting, pagetoid spread. Two slides were obtained; one stained with Mart-1; the other with H\&E. For both, melanocyte counts per high power field (400 X HPF magnification) were obtained in three locations of the slide. The mean of the 3 counts was used for analysis, though the individual counts were considered in some data summaries (see below). Classification of photo-aging according to the Glogau scale was noted by the surgeon as type1: "no wrinkles"; type II "wrinkles in motion"; type III "wrinkles at rest" and type IV "only wrinkles." Confluence was categorized by the number of adjacent melanocytes as none, mild (2 side-by-side), moderate (3-6), or severe (7 or more).

Eligibility criteria: Inclusion Criteria:

* Participants undergoing Mohs and reconstructive surgery for basal cell and squamous cell carcinoma of the face and neck

Exclusion Criteria:

* Participants with a history of radiation to the head and neck were excluded.

Primary outcomes:
measure: The mean number of melanocytes per high power field for Mart-1 was 12.7 in FL and 11.2 in MN. Using H&E, the means were 10.3 and 8.3 for FL and MN respectively.
timeFrame: one year
Secondary outcomes:
measure: Evidence of higher means in FL than in MN after adjusting for age and gender (p<0.001 for H&E, p=0.08 for Mart-1) and strong evidence of an increase in observed numbers of melanocytes with use of the Mart-1 stain compared to the H&E stain (p<0.001)
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Lawrence E Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02158481: Effects of Dietary Ingredients on Vascular Function
Official title: Investigating the Effects of Dietary Ingredients on Vascular Function During Acute Glucose Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Impaired Glucose Tolerance
Keywords: Vascular function
Dietary ingredients
Acute glucose load
Oxidative stress
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Aspect Clinical
First posted: 2014-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the study is to investigate the effects of dietary ingredients (polyphenols and carotenoids) on vascular function during acute glucose load. Each subject will receive 4 weeks of intervention with test product or placebo product after a dietary restriction run-in period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT) immediately after the run-in phase and at the end of the intervention phase. During the OGTT, blood samples will be taken at regular intervals.

The study will be conducted in subjects with impaired glucose tolerance.


Eligibility criteria: Inclusion Criteria:

* Males or females confirmed with IGT;
* Age ≥ 35 and ≤ 65 year at screening;
* Body Mass Index (BMI) \> 25 and \<40 kg/m2;
* Reported intense sporting activities ≤ 10h/w;
* Reported alcohol consumption ≤ 14 units/week (female volunteers) or ≤ 21 units/week (male volunteers)
* Currently not smoking and being a non-smoker for at least six months

Exclusion Criteria:

* Any medical condition or use of over-the-counter and prescribed medication which might affect study measurement (judged by the study physician);
* No reported participation in another nutritional or biomedical trial 3 months before screening;
* Reported weight loss or gain of 10% or more during a period of 6 months prior to screening;
* Anti-hyperglycemic drug or other medication which interferes with study measurements;
* No blood donation 1 month prior to screening;
* Reported allergy or intolerance to test products or other food products provided during the study;

Primary outcomes:
measure: Interleukin-6 (IL-6) levels.
timeFrame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Secondary outcomes:
measure: Pro-inflammatory and oxidative stress biomarkers
timeFrame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
measure: Cell stress-defence responses
timeFrame: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
measure: Clinical chemistry parameters
timeFrame: At baseline (after run-in period of 2 weeks) and after 4 weeks intervention
Other outcomes:
Locations:
city: Ledbury
country: United Kingdom
facility: Aspect Clinical
Study officials:
affiliation: Aspect Clinical
name: Alex Thompson, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01783795: Dent Disease Mutation Genotyping
Official title: Screening for Dent Disease Mutations in Patients With Proteinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dent Disease
Keywords: Dent
Dents
Dent Disease
Dent genetic testing
CLCN5
OCRL1
Genetic testing for Dent Disease
Hereditary study for Dent Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-02-05
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study will help the investigator determine whether certain genetic mutations, more than others, are a cause of more severe disease in Dent Disease.

Detailed description: During this study visit, the investigator will draw one tube, about two teaspoonfuls (1 to 1 ½ teaspoons for children), of blood from the subject's arm to obtain white blood cells. These white blood cells will be used as a source of DNA for genetic testing. The investigator will use the isolated DNA to try to identify the gene that is defective in Dent Disease by comparing it with the structure of genes in normal individuals, patients with Dent Disease, and family members for Dent Disease.

Eligibility criteria: Inclusion Criteria:

* The patient has been diagnosed, or in the process of being diagnosed with Dent Disease.
* The patient has a family member diagnosed with Dent Disease.

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of subjects with genetic mutations in either the CLCN5 or ORCL1 gene
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John C. Lieske, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05215795: Validity and Reliability of Modified Box and Block Test and Targeted Box and Block Test in Patients With Stroke
Official title: Validity and Reliability of Modified Box and Block Test and Targeted Box and Block Test in Patients With Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Validity
Reliability
Modified Box and Block Test
Targeted Box and Block Test
Upper Extremity
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stroke

Brief summary: The aim of our study is investigated validity and reliabilty of Modified Box and Block Test and Targeted Box and Block Test in patients with stroke.

Detailed description: Fifty patients with stroke will included in the study. Box and Block Test, Modified Box and Block Test, Targeted Box and Block Test, 9 Hole Peg Test, Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. To evaluate validity between Modified and Targeted Box and Block Tests and Box and Block Test, 9 Hole Peg Test, Fugl-Meyer Assessment will used to correlation analysis tests. The investigator will evaluate after one week to test-retest reliability to patients. Other pyhsiotherapist will evaluate to patients inter-rater reliability.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with stroke and in the chronic phase (having been diagnosed with stroke at least 6 months ago),
* Over 18 years old,
* Mini Mental Test score ≥ 24 points,
* Able to grasp and release a 2.5 cm cube on both upper extremities,
* Brunnstrom Upper Extremity Staging ≥ 3
* Modified Ashworth Scale ≤ 2,
* Able to sit independently in a chair for 2 minutes

Exclusion Criteria:

* Having a neurological disease other than stroke
* Have had surgery in the last 6 months
* Severely affected upper extremity
* Uncooperative with physiotherapist
* Patients with neglect, aphasia and hemianopsia

Primary outcomes:
measure: Modified Box and Block Test
timeFrame: 10 minute
measure: Targeted Box and Block Test
timeFrame: 10 minute
Secondary outcomes:
measure: 9 Hole Peg Test
timeFrame: 10 minute
measure: Fugl-Meyer Assessment for Upper Extremity
timeFrame: 15 minutes
measure: Box and Block Test
timeFrame: 5 minute
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Lütfiye AKKURT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Kutahya Health Sciences University
name: Cihan Caner AKSOY, PhD
role: STUDY_DIRECTOR
affiliation: Kutahya Health Sciences University
name: Fatıma YAMAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06598995: Myocardial Bridging in Obstructive Hypertrophic Cardiomyopathy
Official title: The Association Between Myocardial Bridging and Atrial Fibrillation in Patients With Obstructive Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Bridging
Obstructive Hypertrophic Cardiomyopathy
Atrial Fibrillation (AF)
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 968
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with obstructive hypertrophic cardiomyopathy who underwent septal myectomy.

Brief summary: This study investigated the impact of myocardial bridging (MB) and its characteristics on preoperative atrial fibrillation and survival in patients with obstructive hypertrophic cardiomyopathy (oHCM). We recruited 968 consecutive patients with oHCM who underwent myectomy at our institution between January 2015 and December 2019, including 144 patients with MB and 824 patients without MB. All patients received angiography before surgery. The diagnosis of preoperative atrial fibrillation was based on 12-lead electrocardiography, 24-hour Holter electrocardiography, or in-hospital electrocardiogram monitoring, which was extracted from patients' medical records. Surgical details and follow-up data were also collected.


Eligibility criteria: Inclusion Criteria:I(i) age ≥ 18 years and (ii) diagnosis of oHCM based on clinical and echocardiographic evaluation.

-

Exclusion Criteria: (i) a history of heart surgery (ii) Patients who had coronary atherosclerosis or myocardial infraction; (iii) Patients who had no angiography records.

-

Primary outcomes:
measure: All-cause death
timeFrame: One month after discharge
Secondary outcomes:
measure: New-onset AF
timeFrame: One month after discharge.
measure: Composite endpoints
timeFrame: One month after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Please Select
Study officials:
References:
Clinical trial NCT01284595: Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931
Official title: [14C] AZD8931 - A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Radioactive carbon
Absorption
Distribution
Metabolism
Excretion
Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Study to Assess the Absorption, Metabolism and Excretion of \[14C\]AZD8931 after a Single-Dose Oral Administration


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) of ≥19 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
* Regular daily bowel movements (ie, production of at least 1 stool per day).
* Non-smokers or ex-smokers who have stopped smoking for \>3 months before Visit 1 and have not used nicotine products for \>3 months
* Healthy Male volunteers aged 50 to 65 years, inclusive

Exclusion Criteria:

* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life
* Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1).
* History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)

Primary outcomes:
measure: To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects
timeFrame: Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose
measure: To investigate the pharmacokinetic variable of AZD8931 in plasma
timeFrame: Multiple PK blood samples from pre-dose until 240 hours post last dose
Secondary outcomes:
measure: To investigate the safety and tolerability of AZD8931 given orally
timeFrame: Frequent safety measurements during the study from screening period to follow-up
measure: To investigate the AZD8931 metabolites variables in plasma
timeFrame: Multiple PK blood samples from pre-dose until 240 hours post last dose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: Darren Wilbraham, MBBS, DCPSA
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mary Stuart
role: STUDY_DIRECTOR
References:
citation: Ballard P, Swaisland HC, Malone MD, Sarda S, Ghiorghiu S, Wilbraham D. Metabolic disposition of AZD8931, an oral equipotent inhibitor of EGFR, HER2 and HER3 signalling, in rat, dog and man. Xenobiotica. 2014 Dec;44(12):1083-98. doi: 10.3109/00498254.2014.938257. Epub 2014 Jul 9.