louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04249934: The Effects of Caffeine on Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion
Official title: The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Reconstruction
Deep Inferior Epigastric Perforator
Microvascular Free Flap Transfer
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Women that require breast reconstruction and meet eligibility will be enrolled in this study. The study is being completed to determine the effect of caffeine in deep inferior epigastric perforator (DIEP) flap perfusion using the Vioptix tissue oximeter monitor and to determine if caffeine in the acute postoperative period affects overall flap complication or loss (complete loss from anastomotic issue).

The researchers hypothesize that a single 8 ounce cup of regular coffee will not affect free flap perfusion as indicated by the Vioptix, and that it will not affect overall free flap survival at thirty days.


Eligibility criteria: Inclusion Criteria:

* regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System

Exclusion Criteria:

* smokers
* hepatic or renal disease (comorbidities that affect caffeine metabolism)
* male

Primary outcomes:
measure: Analysis of feasibility
timeFrame: approximately 6 months after recruitment starts
measure: Absolute value of tissue oxygenation saturation (StO2)
timeFrame: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
measure: Absolute value of tissue oxygenation saturation (StO2) rate of change
timeFrame: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
measure: Absolute value of tissue oxygenation saturation (StO2) amount of change
timeFrame: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
Secondary outcomes:
measure: Incidence of minor flap complications in the caffeine and non-caffeine groups
timeFrame: up to 30 days post-operatively
measure: Incidence of major flap complications in the caffeine and non-caffeine groups
timeFrame: up to 30 days post-operatively
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Adeyiza Momoh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Theodore A Kung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06760234: Multimodal Deep Learning Model Predicts Pancreatic Cancer Prognosis
Official title: Prediction of Pancreatic Cancer Prognosis Using a Multimodal Deep Learning Model Based on Intratumoral Immune Microenvironment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Adenocarcinoma
Keywords: Deep Learning Model
Pancreatic adenocarcinoma
prognosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: the fourth affiliated hospital, Zhejiang university school of medcine
name: Hangzhou Hospital of Traditional Chinese Medicine
First posted: 2025-01-06
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic cancer patients who were undergo surgery and received adjuvant chemotherapy after surgery.

Brief summary: This study describes the development and validation of a deep learning prediction model, which extracts deep learning features from preoperative enhanced CT scans and analyzes postoperative pathological specimens of pancreatic cancer patients. The aim is to predict patient prognosis and response to chemotherapy treatment.

Detailed description: This study retrospectively collected enhanced CT scan data, pathological paraffin blocks, and clinical data from pancreatic cancer patients who underwent surgery at multiple centers between March 2013 and May 2024. The pathological paraffin blocks were stained using immunohistochemistry for prognostic immune microenvironment markers, and patients were classified based on these results. Subsequently, deep learning features were extracted from enhanced CT scans, and a multimodal prediction model was constructed using imaging features and clinical information. The model's performance was evaluated using metrics including area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, and specificity.

Eligibility criteria: Inclusion Criteria:

1. Patients with pancreatic cancer, diagnosed through pathology;
2. Patients underwent surgery and received adjuvant chemotherapy after surgery.

Exclusion Criteria:

1. Missing or inadequate quality of CT,
2. Incomplete clinical or pathological data.
3. Multiple primary malignancies;
4. History of malignancy.

Primary outcomes:
measure: Performance of deep learning model
timeFrame: Baseline treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Yulian Wu, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681434: Bilateral Training Versus Unilateral Training in Stroke
Official title: Bilateral Training for Upper Extremity Hemiparesis in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Hemiparesis
Keywords: stroke
upper extremity
hemiparesis
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
First posted: 2008-05-21
Enrollment: 24
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: This randomized, single-blind study compares the effectiveness of bilateral training to unilateral training for individuals with moderate hemiparesis. We hypothesize that bilateral training will be superior to unilateral in the proximal extremity but not the distal one.

Detailed description: Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. Bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy.

This training study included 24 hours of treatment over eight weeks. The protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. Subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. The Motor Assessment Scale-Upper Limb Item and the Motor Status Scale are used as primary outcome measures. The Reaching Performance Scale and strength measures are secondary outcome measures. Assessments are administered pre-/ and post-training by a blind rater.

Eligibility criteria: Inclusion Criteria:

* cortical or subcortical stroke
* chronic condition (at least six months prior)
* ability to follow 2-step commands
* ability to give consent

Exclusion Criteria:

* lesion in brain stem or cerebellum
* visual field cut
* neglect
* uncontrolled hypertension
* angina
* COPD

Primary outcomes:
measure: Motor Assessment Scale
timeFrame: pre and post (week one and week 8)
measure: Motor Status Scale
timeFrame: pre and post, Week 0 and Week eight
Secondary outcomes:
measure: Reaching Performance Scale
timeFrame: pre and post training (Week 0 and week 8)
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago Department of Kinesiology and Nutrition
name: Mary E Stoykov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago Department of Kinesiology and Nutrition
name: Daniel M Corcos, PhD
role: STUDY_CHAIR
References:
citation: Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.
Clinical trial NCT01022034: Pexy Versus Non-pexy for Full Thickness Rectal Prolapse
Official title: Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Prolapse
Keywords: Rectal prolapse
mesh
recurrence
Lead sponsor: Societa Italiana di Chirurgia ColoRettale
Sponsor class: NETWORK
First posted: 2009-12-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.

Method: This is a multicenter randomized non-inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre-RCT meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves will be generated and compared using the Kaplan-Meier method and log-rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of \<0.01 was considered significant.


Eligibility criteria: Inclusion Criteria:

* informed consent
* mental ability to understand the procedure
* age range 18 to 70
* both sex

Exclusion Criteria:

* patients with recurrent rectal prolapse
* previous pelvic or colorectal surgery
* previous operation for fecal incontinence
* Cancer
* chronic intestinal Inflammatory diseases

Primary outcomes:
measure: long term recurrence of the rectal prolapse
timeFrame: after 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Stony brook University
state: New York
Study officials:
References:
Clinical trial NCT02134834: A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Bacterial Infections
Lead sponsor: Meiji Seika Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 40
Sex: MALE
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: The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.


Eligibility criteria: Inclusion Criteria:

* Caucasian males aged between 18 and 45 years (inclusive) at Screening
* A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
* Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
* Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1

Exclusion Criteria:

* Receipt of any investigational agent or drug within four months before Screening
* A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
* Hypersensitivity and/or allergy to drugs
* Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
* A history of chronic or recurrent infections or current active infection
* A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant
* A history or presence of malignancy
* Donation of blood (or loss of blood) greater than 400 ml within three months before Screening
* A history of smoking at any time within one year before Screening

Primary outcomes:
measure: Safety from baseline through the end of the study
timeFrame: Day 1 to Day 7
Secondary outcomes:
measure: Plasma PK parameters of OP0595 and its metabolites
timeFrame: Day 1 to Day 2
measure: Urine PK parameters of OP0595 and its metabolites
timeFrame: Day 1 to Day 2
Other outcomes:
Locations:
city: Perth,
country: Australia
state: Western Australia
Study officials:
affiliation: Meiji Seika Pharma Co., Ltd.
name: Mitsuharu Egawa
role: STUDY_CHAIR
References:
citation: Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.
Clinical trial NCT06215534: Glin3: Assessment of the Glycemic Responses to Nutritional Products
Official title: Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Keywords: Glycemic response
Glycemic Index
Nutritional products
Healthy individuals
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 12 products will be tested (2 x 6 products + each 3 contls) that means 18 ärms"in total
Primary purpose: OTHER

Brief summary: This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years
* Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria:

* Baseline fasting Glucose ≥6.1 at screening visit
* Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Known intolerance, sensitivity or allergy to test products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
* History of cancer in the prior two years, except for non-melanoma skin cancer.

Primary outcomes:
measure: The glycemic index of nutritional products
timeFrame: 6 months
Secondary outcomes:
measure: 1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
timeFrame: 6 months
measure: 2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Inquis Clinical research
Study officials:
References:
Clinical trial NCT01053234: Different Insulin Regimens and Postprandial Coagulation Activation
Official title: Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Cardiovascular Risk
Hemostasis
Inflammation
Endothelial Function
Keywords: Hyperglycaemia
Postprandial
Type 2 diabetes
Cardiovascular risk markers
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Ribe County Hospital
name: Novo Nordisk A/S
First posted: 2010-01-21
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. The investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.


Eligibility criteria: Inclusion Criteria:

* age 30-75 years
* BMI \> 25 kg/m2
* type 2 diabetes for more than 4 years
* pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months
* metformin with stable dose \>1000 mg/d for more than 12 weeks
* acetylsalicylic acid (75 mg/d) for more than 2 weeks
* no other anti-diabetic treatment 3 month previously
* HbA1c\<8.5% at recruitment.

Exclusion Criteria:

* creatinine \> 120 µmol/l
* ALAT /ASAT \> 2.5 x upper reference limit
* use of anticoagulants within 1 month previously
* any changes in dose of statins within 1 month previously
* night work
* present or planned pregnancy
* mental sickness or alcohol abuse
* clinically relevant major organ or systemic illness
* uncontrolled hypertension \>180/110 mmHg
* steroid treatment
* known or suspected allergy to trial medications.

Primary outcomes:
measure: Prothrombin fragment 1+2
timeFrame: 7.40; 9.30; 11.30; 13.30; 15.30
Secondary outcomes:
measure: C-reactive protein
timeFrame: 7.40; 9.30; 11.30; 13.30; 15.30
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of South West Denmark
Study officials:
affiliation: Department of Medicine, Hospital of South West Denmark
name: Jeppe Gram, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06756334: Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Official title: Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
PET/CT
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-03
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18F\]F-DCFPyL.

Detailed description: \[18F\]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[18F\]F-DCFPyL PET/CT.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 90 years old;
* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
* simultaneous \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL examinations within two weeks;
* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
* Sign informed consent.

Exclusion Criteria:

* Patients who cannot cooperate with the examination;
* Concurrent malignant tumors;
* Previous alcohol allergy;
* Patients with liver and kidney dysfunction;
* Other circumstances deemed by the investigator to be inappropriate for trial participation.

Primary outcomes:
measure: Standard uptake value(SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
measure: Number of lesions
timeFrame: 30 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
name: Qiang Xie, MD
role: STUDY_CHAIR
References: