louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05871762: Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer
Official title: Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer-a National Multi-center, Prospective, Real World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Neoplasms
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 3705
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mid-low rectal cancer patients

Brief summary: The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.


Eligibility criteria: Inclusion Criteria:

* pathologically confirmed rectal adenocarcinoma
* located within 12cm below the anal verge

Exclusion Criteria:

* diagnosed with distant metastasis
* multiple primary colorectal cancers
* history of previous malignant tumors
* Pregnant or lactating women

Primary outcomes:
measure: 3-year OS
timeFrame: 3 years
Secondary outcomes:
measure: 3-year DFS
timeFrame: 3 years
measure: 3-year LR
timeFrame: 3 years
measure: 3-year distant metastasis rate
timeFrame: 3 years
measure: neoadjuvant therapy rate
timeFrame: at the time point of surgery of the primary lesion
measure: adjuvant therapy rate
timeFrame: at the time point of 3-year follow up
measure: EUS/MRI assessment rate
timeFrame: at the time point of surgery of the primary lesion
measure: R0 resection rate
timeFrame: at the time point of surgery of the primary lesion
measure: CCR
timeFrame: immediately after the completion of neoadjuvant therapy assessment
measure: pCR
timeFrame: immediately after the completion of surgery
measure: 30-day mortality
timeFrame: 30 days after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01039662: Reduction of the Dietary Glycemic Index (GI) by L-Arabinose and Indigestible Dextrin
Official title: Effects of the Combination of L-Arabinose and Indigestible Dextrin on Glycemic Index: a Double-Blind, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Unitika Ltd.
First posted: 2009-12-25
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on dietary glycemic index.


Eligibility criteria: Inclusion Criteria:

* Healthy as based on medical history and physical examination
* BMI is less or equal to 30 kg/m2
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Impaired Glucose Tolerance
* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 1 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication

Primary outcomes:
measure: Postprandial glucose level
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
References:
Clinical trial NCT03764462: Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-05
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers

Detailed description: This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults

Eligibility criteria: Inclusion Criteria:

* Healthy Adult aged 19 and more at the time of screening visit
* Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
* No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination

Exclusion Criteria:

* Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
* History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
* As a result of laboratory tests, the following figures: ALT or AST\> 2 times upper limit of normal range

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: pre-dose to 96 hours
measure: Area under the curve in time plot (AUCt)
timeFrame: pre-dose to 96 hours
Secondary outcomes:
measure: Area under the curve in time plot (AUCinf)
timeFrame: pre-dose to 96 hours
measure: Time to reach Cmax
timeFrame: pre-dose to 96 hours
measure: Effective half-life
timeFrame: pre-dose to 96 hours
measure: Clearance
timeFrame: pre-dose to 96 hours
measure: Volume of distribution
timeFrame: pre-dose to 96 hours
Other outcomes:
measure: Number of participants with adverse events
timeFrame: From Day 1 until 40 Days
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Young-Ran Yoon, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04725162: Epileptogenic Focus Localization for Children With Epilepsy Using 18F-FDG PET Molecular Imaging
Official title: Epileptogenic Focus Localization for Children With Epilepsy Using 18F-FDG PET Molecular Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Peidatrics
Positron emission tomography (PET)
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 234
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 130 pediatric patients with focal epilepsy, 67 age-matched controls, and 37 validation group children.

Brief summary: This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with epilepsy.

Detailed description: This retrospective study aimed to develop a new approach for automatic localization of epilepsy foci in children with intractable epilepsy.

Pediatric patients with intractable epilepsy would be retrospectively included in this study. The inclusion criteria included (1) age between 6 and 18 y; (2) detailed seizure semiology evaluation, MRI, EEG and interictal 18F-FDG PET/CT examination; (3) clinical diagnosis as focal epilepsy. The exclusion criteria included (a) any history of central nervous system disease; (b) poor image quality due to head movement.

Eligibility criteria: Inclusion Criteria:

* 1. age between 6 and 18 years.
* 2. detailed presurgical evaluation, including seizure semiology evaluation, MRI, EEG and interictal 18F-FDG PET/Computer Tomography (CT) examination.
* 3. clinical diagnosis as focal epilepsy.

Exclusion Criteria:

* 1. any history of central nervous system (CNS) disease such as trauma and CNS tumor.
* 2. poor image quality due to head movement.

Primary outcomes:
measure: Accuracy
timeFrame: Through study completion, about 6 months
measure: Kappa
timeFrame: Through study completion, about 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
citation: Zhang T, Li Y, Zhao S, Xu Y, Zhang X, Wu S, Dou X, Yu C, Feng J, Ding Y, Zhu J, Chen Z, Zhang H, Tian M. High-resolution pediatric age-specific 18F-FDG PET template: a pilot study in epileptogenic focus localization. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1560-1573. doi: 10.1007/s00259-021-05611-w. Epub 2021 Nov 8.
Clinical trial NCT06985862: Development of Artificial Intelligence Tools for the Detection of Stress Markers and Consideration of Stress States in the Monitoring of Subjects With Type 1 Diabetes
Official title: Development of Artificial Intelligence Tools for the Detection of Stress Markers and Consideration of Stress States in the Monitoring of Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Type 1
Keywords: stress
voice markers
glycemic control
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Stress refers to all the reactions of an organism subjected to exogenous or endogenous stress. In the context of diabetes, stress plays a critical role. There are two forms of stress: acute and chronic, both of which can have a significant impact on patients' glycaemic control. Acute stress, if repeated, can cause rapid increases in blood glucose levels, while chronic stress can lead to insulin resistance. It is therefore essential to develop tools for recognising and quantifying stress states specific to patients with diabetes. These tools would provide a better understanding of the role of stress in diabetes management, paving the way for more targeted therapeutic interventions and improving patients' quality of life.

We are currently training algorithms using advanced machine learning and artificial intelligence techniques to recognise and quantify stress states using existing databases, including voice and physiological data. These technological advances will make it possible to identify moments of stress more accurately and provide appropriate responses, thereby contributing to better diabetes management.

The SMART-T1D study is an ancillary study of the EVASTRESS study.


Eligibility criteria: Inclusion Criteria:

* Patient who has signed the SMART-T1D free and informed consent form
* Patient able to speak and read French

Exclusion Criteria:

* Mute patient.
* Patient with severe speech problems that may prevent voice recordings from being made.

Primary outcomes:
measure: Voice recording of participants
timeFrame: 14 days
Secondary outcomes:
measure: Diabetes-related distress in the test population
timeFrame: at inclusion and after 14 days
Other outcomes:
Locations:
city: Evry
country: France
facility: CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète)
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre-Yves Benhamou, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04055662: A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users Versus Cannabis Naïve Inflammatory Bowel Disease Patients
Official title: A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis Use, Opioid Consumption
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective IBD bowel surgery under general anesthesia

Brief summary: Cannabis is a drug that is widely used for recreational purpose. In most patients undergoing surgery, opioids are the most widely used mode of pain relief, during and following surgery. Anecdotally it has been observed that cannabis users required unexpectedly high doses of opioids. The purpose of this study is to compare opioid requirements between cannabis users and non- users after the surgery. Currently, post-operative opioid doses are determined based on various patient factors such as pre-operative opioid use, patient weight, age and sensitivity to opioids during surgery. Patients' requirements may be underestimated and opioid regimens need to be escalated in the first 24 hours in order to alleviate uncontrolled pain in cannabis users. Better understanding of the impacts of cannabis use on post-operative opioid requirements would help the Acute Pain Service optimize post-operative pain management for patients who use cannabis pre-operatively.


Eligibility criteria: Inclusion Criteria:

1. Consent to participate and signed consent form.
2. Age: 18-65 years.
3. Elective IBD bowel surgery under general anesthesia.
4. PCA use.

Primary outcomes:
measure: Opioid consumption
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
Study officials:
References:
Clinical trial NCT00260962: Olanzapine in the Treatment of Patients With Anorexia Nervosa
Official title: Olanzapine in the Treatment of Low Weight and Obsessional Thinking Among Those With Anorexia Nervosa: A Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia Nervosa
Keywords: Pilot Project,
Clinical Trial,
Treatment Outcome,
Psychopharmacology
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2005-12-02
Enrollment: 34
Sex: FEMALE
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 the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Detailed description: The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Eligibility criteria: Inclusion Criteria:

* those who meet DSM IV criteria of Anorexia Nervosa- either restricting or binge/purge subtype

Exclusion Criteria:

* patients who are actively self destructive and/or suicidal
* patients whose medical status is seriously compromised
* patients whose eating disorder is superimposed on a major psychiatric disorder such as schizophrenia, major affective disorders, dissociative disorder or an active substance abuse disorder.

Primary outcomes:
measure: Body Mass Index (BMI) (kg/m^2)
timeFrame: Baseline (week 2) and post-treatment (week 13)
Secondary outcomes:
measure: Obsessions
timeFrame: Pretreatment (Week 1) and Posttreatment (Week 13)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: H Bissada
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bissada H, Tasca GA, Barber AM, Bradwejn J. Olanzapine in the treatment of low body weight and obsessive thinking in women with anorexia nervosa: a randomized, double-blind, placebo-controlled trial. Am J Psychiatry. 2008 Oct;165(10):1281-8. doi: 10.1176/appi.ajp.2008.07121900. Epub 2008 Jun 16.
Clinical trial NCT05923762: Oral Health Related Quality of Life
Official title: Oral Health Related Quality of Life and Its Implications for Dental Health Care - a Swedish National Survey
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oral Health Related Quality of Life
Oral Disease
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Region Gävleborg
First posted: 2023-06-28
Enrollment: 3700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The target population is adults aged 18-85 years that resides in Region Dalarna, Sweden.

Brief summary: As oral health has a major impact on general health and quality of life, good oral health are essential. The aspects of oral health that are most important for each individual vary, and quality of life is subjective, and influenced by the person´s experiences, perceptions, expectations and ability to adapt to circumstances. FDI World Dental federations definition of oral health is; "Oral health is multifaceted and includes the ability to speak, smile, smell, taste, touch, chew, swallow, and convey a range of emotions through facial expressions with confidence and without pain, discomfort, and disease of the craniofacial complex.


Eligibility criteria: Inclusion Criteria: Read and understand Swedish -

Exclusion Criteria:

-

Primary outcomes:
measure: OHRQoL
timeFrame: 2024-01-15 - 2024-12-31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06298162: Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass
Official title: Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Gastric Bypass
Obesity, Morbid
Pouch Emptying
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RYGB, with succesful (\>35%) or unsuccesful (\<25%) weight loss

Brief summary: A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL\>35%) and bad responders (TWL\<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB).


Eligibility criteria: Inclusion Criteria:

* Women aged between 20 and 55 years
* Patients must be able to adhere to the study visit schedule and protocol requirements
* Patients must be able to give informed consent (IC) prior to any study procedures
* Patients who had a follow-up period up until two years after LRYGB and have successful or unsuccessful weight loss.
* Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician

Exclusion Criteria:

* Diabetes Mellitus
* Menopausal
* Gastrointestinal problems, gastric or intestinal diseases
* Drug or alcohol addiction
* Inability to stop smoking during the overnight fasting period
* Pregnant or lactating
* Having an intolerance or allergy for one of the components of the test product
* Inability to stop medications that affect gastrointestinal emptying like antisecretory drugs, narcotics and prokinetic agents
* Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
* Having a contra-indication to MRI scanning (including, but not limited to):

  * Pacemakers and defibrillators
  * Intraorbital or intraocular metallic fragments
  * Ferromagnetic implants

Primary outcomes:
measure: Pouch emptying rate measured with MRI
timeFrame: Two years after LRYGB
Secondary outcomes:
measure: subjective ratings of fullness
timeFrame: Two years after LRYGB
measure: subjective ratings of wellbeing
timeFrame: Two years after LRYGB
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Yonta Burgh
Study officials:
References:
Clinical trial NCT06585462: Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cardiometabolic Disease
Keywords: AMG 513
Cardiometabolic disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-09-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.


Eligibility criteria: Inclusion Criteria:

* Participants in the study will be males and females 18 to 65 years of age at the time of signing the informed consent with a body mass index (BMI) between ≥ 30 kg/m\^2 and ≤ 40 kg/m\^2.
* Females enrolled must be of non-childbearing potential.

Exclusion Criteria:

* History and/or clinical evidence of diabetes mellitus, including hemoglobin A1c ≥ 6.5% and/or a fasting glucose of ≥ 126 mg/dL (7 mmol/L) at screening.
* Triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL) at screening.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE)
timeFrame: Approximately 178 days (Part A) and 225 days (Part B)
Secondary outcomes:
measure: Maximum Observed Drug Concentration (Cmax) of AMG 513
timeFrame: Day 1 up to Day 57
measure: Time to Cmax (Tmax) of AMG 513
timeFrame: Day 1 up to Day 57
measure: Area Under the Concentration-time Curve (AUC) of AMG 513
timeFrame: Day 1 up to Day 57
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Oxnard
country: United States
facility: Fomat Medical Research
state: California
city: Aventura
country: United States
facility: Translational Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: