louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02032212: A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product
Official title: A Randomised, Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Imperial Brands PLC
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 12
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are otherwise known as electronic cigarettes. These may look like conventional cigarettes but do not contain tobacco.

The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.

This trial is to evaluate the pharmacokinetic profile of an EVP.

Detailed description: The principal part of this study evaluates the nicotine pharmacokinetic profile of conventional cigarettes, a nicotine inhalator, an unflavoured EVP and a flavoured EVP.

A second part investigates the nicotine delivery of an EVP with four different nicotine doses.

Eligibility criteria: Inclusion Criteria:

* BMI of 18-35kg/m2
* Subjects must be established smokers
* Subjects must have smoked five to 30 cigarettes per day for at least one year

Exclusion Criteria:

* Subjects who have used nicotine replacement therapy within 14 days of the screening
* Subjects who have donated blood within 12 months preceding study
* Subjects with relevant illness history
* Subjects positive for hepatitis or HIV
* Subjects with history of drug or alcohol abuse
* Subjects with lung function test or vital signs considered unsuitable
* Subjects who are trying to stop smoking

Primary outcomes:
measure: Nicotine Plasma Concentration
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
measure: Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
Secondary outcomes:
measure: Exhaled Carbon Monoxide
timeFrame: 25 minutes
measure: Nicotine Withdrawal Symptoms
timeFrame: 30 minutes after the third product use
measure: Nicotine Craving
timeFrame: 30 minutes after the third product use
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research
state: Wales
Study officials:
affiliation: Simbec Research
name: Girish Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00628212: Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes
Official title: A Phase II, Double-Blind, Placebo-Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus -Confirmative Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: insulin resistance
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-04
Enrollment: 324
Sex: ALL
Minimum age (years): 20
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 is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.


Eligibility criteria: Inclusion Criteria:

* Patients who are 20 - 75 years old
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is 6.5 - 9.5%
* Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with serious diabetic complications
* Patients who are habitual excessive alcohol consumption.
* Patients with severe hepatic disorder or severe renal disorder.
* Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Takikawa-shi
country: Japan
state: Hokkaidou
Study officials:
affiliation: Tokyo University
name: Takashi Kadowaki, Professor, MD,PhD
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Tadashi Yoshida, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03211312: Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases
Official title: Risk Factors and Prediction Model of Elderly Patients With Cardiovascular Diseases Undergoing Teeth Extraction Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Elderly Patients
Tooth Extraction
Keywords: Cardiovascular diseases
Prediction model
Dental extraction
Elderly patients
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 833
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population are all older patients with cardiac diseases undergoing teeth extraction surgery.

Brief summary: This study intends to investigate the relevant risk factors of perioperation complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems.

Hypothesis:Preoperative parameters could predict postoperative complications.

Detailed description: This study intends to investigate the relevant risk factors of perioperative complications or mortality in older patients with cardiac diseases undergoing teeth extraction surgery and this study aims to quantify the risk factors and then to establish the predictive scoring systems.

We hope that the benefits will include less patients becoming seriously postoperative complications and mortality after teeth extraction surgery.We also hope the information will help doctors understand the preoperative risks better and therefore make better informed decisions.This may also reduce the overall cost of surgery for patients and hospitals.

Eligibility criteria: Inclusion Criteria:1.Adults ≥60 years age 2.Males with cardiac diseases 3.Females with cardiac diseases 4.Listed for teeth extraction surgery

-

Exclusion Criteria:

* 1.patient with malignant arrhythmia 2.Age \<60 years age 3.Adults with learning disabilities or dementia 4.Patient unwilling/unable to consent 5.Prisoners

Primary outcomes:
measure: cardiac complications
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China.
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University,School of Medicie
name: shaojun ma, master
role: STUDY_DIRECTOR
References:
citation: Tang M, Hu P, Wang CF, Yu CQ, Sheng J, Ma SJ. Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients with Cardiovascular Diseases. Gerontology. 2019;65(6):591-598. doi: 10.1159/000497424. Epub 2019 May 2.
Clinical trial NCT04650412: Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit
Official title: Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Hypercapnic Respiratory Failure
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped
First posted: 2020-12-02
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (bundle of comorbidity care vs standard care)
Primary purpose: TREATMENT

Brief summary: The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.


Eligibility criteria: Inclusion Criteria:

* Consent form signed
* Acute hypercapnic respiratory failure defined as PaCO2 \> 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU

Exclusion Criteria:

* Age \< 18 years old
* Known or suspected neuromuscular diseases
* Pregnancy
* Iatrogenic respiratory failure (i.e. drug overdose, AHRF after starting opiates or increasing opiates dose)
* Life expectancy \< 3 months
* Confusion or major psychiatric illness
* Patient unable to be weaned from NIV

Primary outcomes:
measure: Hospital readmission
timeFrame: 1-year observation
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: Measured at regular 3, 6 and 12 months visits following patient's hospital discharge
measure: Cost-effectiveness
timeFrame: 1-year observation
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: University Hospital, Geneva
name: Dan Adler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06920212: Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease
Official title: Clinical Safety and Efficacy of FMT in the Treatment of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fecal Microbiota Transplantation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.


Eligibility criteria: Inclusion Criteria:

* The patients (aged 50-85 years) exhibited cognitive decline persisting for over six months;
* Primarily characterized by recent memory impairment and accompanied by reduced daily living abilities;
* MMSE scores ranging from 3 to 26;
* MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures.

Exclusion Criteria:

* Patients were excluded if they had severe visual, hearing, or language impairments;
* Tumors;
* hepatic/renal dysfunction.
* with conditions mimicking AD symptoms-such as normal pressure hydrocephalus, vascular dementia (VD or VaD);
* Parkinson's disease dementia (PDD)-were also excluded;
* patients who had participated in clinical drug trials within the past 30 days or consumed folate and vitamin B12 at doses exceeding twice the recommended intake were ineligible.

Primary outcomes:
measure: Efficacy endpoints
timeFrame: 0, 1month, 2months, 3months, 6months
measure: Efficacy endpoints
timeFrame: 0, 1month, 2months, 3months, 6months
measure: Efficacy endpoints
timeFrame: 0, 1month, 2months, 3months, 6months
measure: Efficacy endpoints
timeFrame: 0, 1month, 2months, 3months, 6months
measure: Changes in gut microbiota
timeFrame: 0, 1month, 2months, 3month, 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Le Wang
Study officials:
References:
Clinical trial NCT03590912: Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion
Official title: Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Otitis Media With Effusion
Lead sponsor: Lumbini Medical College
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.

Detailed description: Treatment groups would be:

1. Cefpodoxime + oxymetaxoline drops + levocetirizine
2. Fluticasone intranasal spray
3. Short term oral steroids
4. Wait and watch

Eligibility criteria: Inclusion Criteria:

* history of mild ear ache or decreased hearing for three or more months, plus
* intact and immobile tympanic membrane by pneumatic otoscopy
* Type B tympanogram

Exclusion Criteria:

* any external ear condition that hampers visualization of tympanic membrane
* lost to follow up

Primary outcomes:
measure: Non B type tympanogram
timeFrame: one month
Secondary outcomes:
measure: cost of treatment
timeFrame: one month
measure: Adverse effects
timeFrame: one month
Other outcomes:
Locations:
city: Tansen
country: Nepal
facility: Lumbini Medical College
state: Palpa
Study officials:
References:
Clinical trial NCT00940212: Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Male and Female Volunteers Without Childbearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety
tolerability
healthy
pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg
* Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study,or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness/infection or medical/surgical procedure or trauma,as judged by the Principal Investigator, within 3 months of the first administration of investigational product

Primary outcomes:
measure: To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits.
timeFrame: 3 day residential period plus 7-10 days follow up
Secondary outcomes:
measure: To characterise the pharmacokinetics of AZD2423 and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses ofAZD2423.
timeFrame: 3 day residential period plus 7-10 days follow up
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: PAREXEL Early Phase Clinical Uniit, Berlin Germany
name: Rainard Fuhr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Södertälje
name: Anders Neijber
role: STUDY_DIRECTOR
References:
Clinical trial NCT02067312: Effects of Traditional Thai Massage on Pain and Pain Related Parameters in Patients With Upper Back Pain
Official title: Effects of Traditional Thai Massage on Pain and Pain Related Parameters in Patients With Upper Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of Thai massage on pain related parameters including Pain intensity, 24 hours pain intensity, Pressure pain threshold, anxiety, muscle tension, cervical range of motion, pain frequency, patient satisfaction and side effect in patients with chronic upper back pain associated with myofascial trigger points


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age between 18 - 50 years old
* The participants have experienced spontaneous upper pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
* The participants will be able to follow instructions.
* Good communication and cooperation.

Exclusion Criteria:

* A history of the following diseases or disorders:
* Cervical radiculopathy
* Contraindications of traditional Thai massage
* Contagious skin disease
* Injury or inflammation of muscle
* Bone fracture and/or joint dislocation
* Open wound
* Uncontrolled hypertension
* Drug and/or alcohol intoxication

Primary outcomes:
measure: Pain score on Visual analog scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Pressure Pain Threshold as a measure by algometry
timeFrame: 5 weeks
measure: Muscle tension on Visual analog scale
timeFrame: 5 weeks
measure: Anxiety on State Anxiety Inventory
timeFrame: 5 weeks
measure: Cervical range of motion as a measure by Cervical Range of Motion Goniometer
timeFrame: 5 weeks
measure: Pain intensity on McGill Pain Questionnaire
timeFrame: 5 weeks
measure: Pain frequency occurred per week
timeFrame: 5 weeks
measure: 24 hours pain intensity on Visual analog scale
timeFrame: 5 weeks
measure: Patient satisfaction level
timeFrame: 3 weeks
measure: Number of Participants with Adverse Events
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: School of Health Science, Mae Fah Luang University
state: Chiang Rai
Study officials:
References:
Clinical trial NCT03623412: Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose Tolerance Test
Official title: Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Tolerance Impaired in Pregnancy
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to offer a 75g postpartum glucose tolerance test to women with minor degrees of glucose intolerance and to assess if these women are significantly different from women who were diagnosed as GDM (Gestational Diabetes Mellitus)


Eligibility criteria: Inclusion Criteria:

* healthy women (without pre-existing diabetes) who underwent an OGTT during pregnancy

Exclusion Criteria:

* pre-existing diabetes, or failed to perform the OGTT

Primary outcomes:
measure: Positive post-partum GTT results
timeFrame: 6-12 weeks post partum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00489112: The Use of Medical-Expulsive Therapy With Alfuzocine xl 10mg x1/d for Distal Ureterolithiasis.a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Distal Ureterolithiasis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-06-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: We will performe a prospective randomized study to evaluate the effects of the addition of alfuzocine xl 10 mg once a day for the conservative treatment of selected ureteral stones. A total of 60 patients with distal ureteral calculi will randomly divide into two treatment groups: group A (n=30) who will receive only analgetic therapy(Dipyrone)and diclofenac i.m. 75mg and group B (n=30) who will receive the same therapy plus alfuzocin xl (10 mg/daily) for a maximum of 2 weeks.No significant differences will be between the groups for age, gender distribution and mean stone size measured in the single largest dimension at presentation.Randomization will be done only with the patients permission after they had read a summary describing the goals of conservative management and a description of the drugs they would be taking. Potential side effects and complications of the drugs were discussed. The expulsion rate will the primary end-point of this study.


Eligibility criteria: Inclusion Criteria:

* Stone in the distal ureter until 1 cm of diameter

Exclusion Criteria:

* Evidence of urinary tract infection or sepsis
* Moderate or severe hydronephrosis
* Acute renal failure
* Ureteral stricture
* Stone with \>1cm of diameter
* Previuos use of alpha blocker
* Pregnancy
* Previuos ureteral endoscopic or open surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center,urology department
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: HaEmek MC
name: doron perez, M.D.
role: PRINCIPAL_INVESTIGATOR
References: