louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00729339: Role of Mosapride in Patients With Gastroesophageal Reflux Disease
Official title: Role of Mosapride in Patients With Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease
Mosapride
Lansoprazole
Lead sponsor: Lotung Poh-Ai Hospital
Sponsor class: OTHER
Collaborators: name: Tomorrow Medical Foundation
First posted: 2008-08-07
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world.

Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.

Detailed description: This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study.

This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole 30 mg once plus mosapride 5 mg tid daily in the second month.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 90 years old
* Outpatients
* Characteristic GERD symptoms: acid regurgitation, heart burn, or belching
* Erosive esophagitis on upper digestive endoscopy, based on Los Angeles classification

Exclusion Criteria:

* History of allergy to lansoprazole or mosapride
* Pregnant or lactating women
* Uremia
* Decompensated liver disease
* Age under 18 and over 90 years-old
* Lack of informed consent

Primary outcomes:
measure: Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)
timeFrame: before enrollment, one month after treatment, two months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Lotung Town, Ilan County
country: Taiwan
facility: Lotung Poh-Ai Hospital
Study officials:
affiliation: Lotung Poh-Ai Hospital
name: Hwai-Jeng Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03331939: Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition in Patients With Refractory Epilepsy
Official title: Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition : a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Refractory Epilepsy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pilot Study
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency VNS will have a positive effect on memory retention. The goal of this study to provide initial data to inform the design of a larger clinical trial to examine the efficacy of theta VNS.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Refractory Epilepsy
2. Previously implanted vagal nerve stimulator
3. Willingness and ability to undergo temporary changes to their VNS device settings

Exclusion Criteria:

1. \<18 years of age
2. Adults unable to consent
3. Pregnant women
4. Prisoners
5. \>20 on the Beck Depression Inventory (BDI)
6. \<24 on the Montreal Cognitive Assessment (MOCA)
7. Adults with diagnosis of developmental delay, intellectual disability, or traumatic brain injury (TBI).
8. Adults with reported history of learning disability.
9. Adults unable to use a computer with their dominant hand.
10. Status Epilepticus within the past 6 months

Primary outcomes:
measure: California Verbal and Learning Test 2nd edition group 1
timeFrame: hour 1.5
measure: California Verbal and Learning Test 2nd edition group 2
timeFrame: hour 2.25
measure: California Verbal and Learning Test 2nd edition group 3
timeFrame: hour 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03291639: Functional Plasticity of Human IL-17-producing CD8+ T Cells
Official title: Functional Plasticity of Human IL-17-producing CD8+ T Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IL-17+ CD8 T Cells in Cancer Patients
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 healthy donors and 20 cancer patients

Brief summary: Human Tc17 cells (IL-17-producing CD8+ T cells) have been found to contribute to different kinds of human inflammatory and malignant diseases. Previous studies indicate that Tc17 cells can convert to Tc1 cells (IFN-γ-producing CD8+ T cells) in tumor bearing mice to exert anti-tumor effect. Base on these results in murine models, human Tc17 may have potential in developing cancer immunotherapy. However, there is limited evidence to reveal the characteristics and functional plasticity of human Tc17 cells. In this proposal, we aim to optimize the differentiation of Tc17 cells and then investigate whether the reprograming of Tc17 to Tc1 cells can promote the anti-tumor cytotoxicity. Preliminarily, we isolated CD8+ T cells from the peripheral blood mononuclear cells of healthy donors to induce Tc17 differentiation. Human CD8+ T cells were stimulated with anti-CD3/anti-CD28 antibodies, TGF-β, IL-1β, IL-6, IL-23, IL-2, anti-IFN-γ, and anti-IL-4 antibodies. After 10 days in culture, there were 4% of IL-17A+IFN-γ- and 7% of IL-17A+IFN-γ+ CD8+ T cells. However, IFN-γ+ CD8+ T cells still represented high percentage, although it's significantly lower than that in Tc1 cells. Our preliminary study demonstrated that Tc17 cells expressed lower levels of cytotoxic molecules than Tc1 cells. We will further test if the expressions of cytotoxic molecules, including perforin and granzyme B, and EOMES will be enhanced by various cytokines. Ultimately, we will evaluate the functional plasticity of Tc17 cells under various cytokine stimulation. Collectively, success of this project will establish more insight for human Tc17 cells and provide the information for future developing human CD8+ T cell-mediate immunotherapy.


Eligibility criteria: Inclusion Criteria:

* cancer patients

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Functional plasticity of IL-17+ CD8 T cells
timeFrame: culture cells for 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT01153139: Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depression
Keywords: Transcranial Magnetic Stimulation
Depression
Theta Burst Stimulation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 32
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: Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects.

This sham-controlled study examines the effectivity of daily bilateral TBS to the dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the local standard of a combined pharmacological/psychotherapeutical treatment.


Eligibility criteria: Inclusion Criteria:

* major Depression
* informed consent

Exclusion Criteria:

* seizures in medical history
* metallic implants
* deep brain stimulation
* cardiac pacemaker
* brain trauma
* psychotic symptoms
* substance abuse
* pregnancy
* Benzodiazepines other than Lorazepam \>1mg/d

Primary outcomes:
measure: Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)
timeFrame: after the end of treatment (week 6)
Secondary outcomes:
measure: Change of the Hamilton rating scale for depression (HAMD 17)
timeFrame: baseline, after the end of treatment (week 6)
measure: Change of the Beck Depression Inventory (BDI)
timeFrame: baseline, after the end of treatment (week 6)
measure: Change of the Montgomery-Asberg rating scale for depression (MADRS) score
timeFrame: baseline, after the end of treatment (week 6)
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen, Department of Psychiatry and Psychotherapy
Study officials:
References:
Clinical trial NCT03313739: An Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women
Official title: The Effect of an Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Lead sponsor: Gonabad University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 46
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to assess the effects of an educational program that had designed based on teach back method in order to improve self-care competency among menopausal women.

Detailed description: In this study 60 menopausal women randomly allocated to intervention group(n=30) and control group(n=30).

Intervention group participated in an educational program that had designed in four sessions based on teach back method. Control group revived no education.

Eligibility criteria: Inclusion Criteria:

* menopausal women(1-5 years after menopause)
* no history of hysterectomy
* no history of oophorectomy
* literacy for reading and writing

Exclusion Criteria:

* no interest for continuing the study
* no participating in all educational sessions

Primary outcomes:
measure: self-care practice
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GMU
name: Narjes Bahri, PhD
role: STUDY_DIRECTOR
References:
citation: Bahri N, Yoshany N, Morowatisharifabad MA, Noghabi AD, Sajjadi M. The effects of menopausal health training for spouses on women's quality of life during menopause transitional period. Menopause. 2016 Feb;23(2):183-8. doi: 10.1097/GME.0000000000000588.
Clinical trial NCT05541939: Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
Official title: Phase 2 Randomized Single Ascending Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin Formulations on Postprandial Glucose and Insulin Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postbariatric Hypoglycemia
Lead sponsor: Vogenx, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).

Detailed description: This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH subjects to determine the effect of two mizagliflozin formulations This study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT).

Eligibility criteria: Inclusion Criteria:

* Roux-en-Y gastric bypass surgery performed \> 6 months prior to enrollment
* Diagnosis of PBH

Exclusion Criteria:

* History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia.
* Current use of insulin or insulin secretagogues.
* History of current dumping syndrome.
* History of current fasting hypoglycemia.
* Pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study.

Primary outcomes:
measure: Glucose Nadir After Mizagliflozin Dosing
timeFrame: 0-3 hours following liquid meal
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Aurora
country: United States
facility: University of Colorado / Anschutz Medical Campus
state: Colorado
Study officials:
References:
Clinical trial NCT04838639: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 When Administered Orally to Healthy and Obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Otsuka Pharmaceutical Factory, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2021-04-09
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age
2. Continuous non-smoker
3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs.
4. Women of non-childbearing potential only
5. Able to understand and sign a written informed consent form prior to initiation of study procedures.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated or has significant emotional problems
2. History or presence of clinically significant medical or psychiatric condition or disease
3. History or presence : Familial hyperlipidemia, Diabetes, Bleeding disorder(s), including relevant familial history, Thromboembolic disease, Bleeding in the gastrointestinal tract or CNS, Hepatobillary disease, Gilbert's syndrome
4. History or presence of alcohol or drug abuse.
5. Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are \> ULN at screening or check-in.
6. Positive urine drug or alcohol results.

Primary outcomes:
measure: The number and severity of treatment emergent adverse events (TEAEs)
timeFrame: Up to 35 days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Up to 35 days
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to 35 days
measure: Time to reach Cmax (Tmax)
timeFrame: Up to 35 days
measure: Apparent first-order terminal elimination half-life (t ½)
timeFrame: Up to 35 days
measure: Correlation between QTc and NO-13065 plasma concentrations
timeFrame: Up to 29 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Otsuka Pharmaceutical Factory, Inc.
name: Koushi Iwata
role: STUDY_CHAIR
References:
Clinical trial NCT05255939: Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
Official title: Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Procedural Complication
Keywords: Distal Radial Access
Radial Artery Occlusion
Major Adverse Cardiovascular Events
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The site of arterial access for coronary angiography and intervention has been the focus of research for decades as it is the source of major complications. Transradial access (TRA) reduces complications among patients undergoing percutaneous coronary procedures but is reported with the complication of radial artery occlusion (RAO) that limits the radial artery for future needs.

Distal radial access (dTRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dTRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort.

This study aims to reveal the feasibility and safety of dTRA and routine TRA procedures in acute coronary syndrome patients. The primary endpoints are forearm radical occlusion rate and major adverse cardiovascular events (MACEs) in the two groups, respectively. Investigators will also focus on puncture success in diagnostic and interventional cases, rate of One attempt success, access time, procedure time, crossover rate, contrast dose of patients, fluoroscopy time and dose, and healthcare cost of each group.


Eligibility criteria: Inclusion Criteria:

* presence of a pulse in the snuffbox

Exclusion Criteria:

* Absence of pulse
* Ultrasound indication of arterial occlusion or severe calcification
* Severe forearm artery malformation
* Patients with severe liver and renal failure, or abnormal coagulation function
* Established cardiogenic shock
* History of previous coronary artery bypass grafting and radial artery use.
* Raynaud's disease in the medical history

Primary outcomes:
measure: Forearm radical occlusion
timeFrame: during procedure
measure: MACEs
timeFrame: during procedure
Secondary outcomes:
measure: Rate of One attempt success
timeFrame: during procedure
measure: Access time
timeFrame: during procedure
measure: Procedure time
timeFrame: during procedure
measure: Crossover rate
timeFrame: during procedure
measure: Contrast dose
timeFrame: during procedure
measure: Fluoroscopy dose
timeFrame: during procedure
measure: hand hematoma
timeFrame: during procedure
measure: The total cost in hospitalization
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06290739: A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma
Official title: Development and Validation of a Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma: a Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrahepatic Cholangiocarcinoma
Machine Learning
Keywords: Intrahepatic Cholangiocarcinoma
machine learning
prognosis
online calculator
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The data was collected from patients who underwent curative-intent hepatectomy and were diagnosed with ICC pathologically. The data was collected from the hepato-biliary and pancreatic department of West China Hospital, SCU, between the periods of January 2010 to December 2016 and January 2019 to October 2023.

Brief summary: The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND.


Eligibility criteria: Inclusion Criteria:

* 1.Patients who were confirmed with intrahepatic cholangiocarcinoma 2. curative-intent hepatectomy 3. Without concurrent extrahepatic disease

Exclusion Criteria:

* 1.Patients lacking complete pathology information, 2. Patients who didn't get curative resection 3.Patients with concurrent extrahepatic disease or had missing follow-up data

Primary outcomes:
measure: Overall survival
timeFrame: 2010.01-2019.01
Secondary outcomes:
measure: Disease free survival
timeFrame: 2010.01-2019.01
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: