louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00228098: Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack.
Official title: Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
name: Hjernesagen
name: Funen County
First posted: 2005-09-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with stroke or transient ischemic attach should receive advise on smoking cessation. It is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.

The aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.

Detailed description: Patients with stroke or transient ischemic attach should receive advise on smoking cessation. It is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.

The aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.

Patients with stroke or transient ischemic attack are admitted to the department of neurology at Odense University hospital. Patient who are smokers on admission and age \< 76 years, inhabitants in Funen County and with symptoms developed before admission will be offered participation in the study unless they have severe stroke, stroke more than 3 weeks before admission, other severe disease or unable to participate.

Study participants will be randomised to either usual short advise on smoking cessation or an intensive smoking cessation program. All participants will be followed-up for 6 months with regard to smoking habits.

Eligibility criteria: Inclusion Criteria:

* Age \< 76 years
* Inhabitant in Funen County
* Acute stroke or transient ischemic attack
* Symptoms with onset before admission
* Current smoker on admission

Exclusion Criteria:

* Severe stroke
* Current stroke onset more than 3 weeks before admission
* Other severe disease
* Unable to participate

Primary outcomes:
measure: Smoking cessation rate
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Neurology
state: Funen
Study officials:
affiliation: Department of Neurology, Odense University Hospital. 5000 Odense C. Denmark
name: Søren Bak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03084198: Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
Official title: Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Failure, Acute
Keywords: Bioartificial Liver
Acute Liver Failure
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2017-03-20
Enrollment: 16
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: This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.

Detailed description: Liver damage remains a life-threatening syndrome. With the increasing number of patients awaiting transplantation, efforts have been made to develop extracorporeal methods to support or replace the function of the failing organ. A bioartificial liver support system has to provide the main functions of the liver: detoxification, synthesis, and regulation. It may prolonger the expected survival time of acute liver failure patients. Direct reprogramming of fibroblasts to hepatic lineages could offer a new type of solution to bioartificial liver support system. The investigators have already generated human induced hepatocytes (hiHeps) from fibroblasts by lentiviral expression of FOXA3, HNF1A, and HNF4A. hiHeps express hepatic gene programs, can be expanded in vitro, and display functions characteristic of mature hepatocytes, including cytochrome P450 enzyme activity and biliary drug clearance. hiHeps can restore the liver function and prolong survival. This study tends to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.

Eligibility criteria: Inclusion Criteria:

* Weight more than 45 kg;
* Age more than 18;
* Diagnosis of ALF;
* Subjects must not be listed for transplant at the time of Enrollment or, if listed, in the opinion of the Investigator are unlikely to be transplanted within 72 hours;

Exclusion Criteria:

* Acute clinical symptoms that are likely to result in death within 48 hours;
* Presence of sepsis or septic shock;
* Concomitant disease including chronic congestive heart failure, severe vascular disease, emphysema, AIDS, cancer;
* Portal hypertension;
* Liver dysfunction due to trauma;

Primary outcomes:
measure: Overall survival of ALF subjects
timeFrame: Study Day 1 through Study Day 28
Secondary outcomes:
measure: Complication rate
timeFrame: Study Day 1 through Study Day 60
Other outcomes:
Locations:
Study officials:
affiliation: Department of ICU, Shanghai East Hospital, School of Medicine, Tongji University
name: Shaolin Ma, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03459898: Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control
Official title: Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left-Sided Breast Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard treatment for breast cancer is surgery followed by adjuvant breast radiation therapy in most cases. For left sided breast cancers, the heart dose delivered by the radiation treatment is often of particular concern. In order to spare the heart, different strategies are currently available, including active breathing control (ABC) and voluntary deep in inspiration breath hold (DIBH) (both strategies are currently being used at our centre). To perform accurate heart-sparing treatments, it is important to ensure that patients are positioned consistently. One available approach is through surface imaging which tracks the position of a portion of the skin surface, known as the AlignRT system (VisionRT Ltd, London, UK).


Eligibility criteria: Inclusion Criteria:

* Women with diagnosis of left-sided breast malignancy
* Women who require left chest wall or breast irradiation status post mastectomy or lumpectomy
* Treatment with modified wide tangents to include IMCs
* Treatment with four-field technique
* Age \>18 years
* Performance status ECOG \<3
* Patient must be able to maintain a 30 second breath hold
* Conventional chest wall or breast radiation delivery dose of 50Gy/25 or hypofractionated chest wall/breast radiation delivery dose of 42.56Gy/16 with or without a boost

Exclusion Criteria:

* Right sided breast cancer patients
* Treatment with partial breast irradiation
* Previous left breast/chest wall irradiation
* Locally advanced breast cancer
* Pregnant patients
* Unable to follow commands

Primary outcomes:
measure: Reproducibility of ABC or vDIBH set-up as measured by Align RT.
timeFrame: 2 years
measure: Mean heart dose as determined using Align RT.
timeFrame: 2 years
Secondary outcomes:
measure: The impact of Align RT with vDIBH as compared to vDIBH without AlignRT on quality of life as assessed by the EORTC core QoL questionnaire.
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT04170998: Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type2 Diabetes
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 283
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control


Eligibility criteria: Inclusion Criteria:

* Patients with Type II diabetes mellitus aged 19 years or older
* Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy

  1. Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit
  2. Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit
* Subjects with 7.0%≤HbA1c≤10.5% at screening visit
* Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
* Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit

Exclusion Criteria:

* Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis
* patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
* Patients with severe infectious disease or severe traumatic systemic disorders
* End stage renal disease or dialysis patients
* Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies

Primary outcomes:
measure: Change from baseline in HbA1c (%) After 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in FPG(mg/dL) After 24 weeks
timeFrame: 24 weeks
measure: Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks
timeFrame: 24 weeks
measure: Change from baseline in 7-point SMBG After 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St, Mary's Hospital,The Catholic University of Korea
Study officials:
References:
Clinical trial NCT06501898: Tributyrin: Time Course & Efficacy to Improve Health & Performance
Official title: Tributyrin: Time Course & Efficacy to Improve Health & Performance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metabolite Concentration
Gut Permeability
Inflammation
Sleep
Performance
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Compound Solutions Inc.
First posted: 2024-07-15
Enrollment: 4
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. The study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, sleep, and performance as well as reduce inflammation. Participants will supplement for tributyrin for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.


Eligibility criteria: Inclusion Criteria:

* Age: 30-50 years
* Sedentary (\<150 minutes of aerobic exercise per week)

Exclusion Criteria:

* Chronic, uncontrolled metabolic, cardiovascular, gastrointestinal, or hepatic disease
* Consumption of supplements known to impact the microbiome, hydration status, core temperature, or exercise performance
* Experienced previous heat illness
* Known injuries that limit exercise
* BMI ≥ 40 kg/m\^2
* Pregnant

Primary outcomes:
measure: Metabolite Concentration
timeFrame: 2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation
Secondary outcomes:
measure: Gut permeability
timeFrame: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
measure: Inflammation
timeFrame: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
measure: Immune cell composition
timeFrame: 10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise)
measure: Sleep Quality
timeFrame: Four weeks prior to day of exercise bout
measure: Sleep quantity
timeFrame: Four weeks prior to day of exercise bout
measure: Substrate Utilization (mid-exercise)
timeFrame: During exercise bout
measure: Perceived exertion (mid-exercise)
timeFrame: During exercise bout
measure: Total completed distance (mid-exercise)
timeFrame: During exercise bout
measure: Maximum sprint power (mid-exercise)
timeFrame: During exercise bout
measure: Average sprint power (mid-exercise)
timeFrame: During exercise bout
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Institute of Sports Sciences & Medicine
state: Florida
Study officials:
References:
Clinical trial NCT04189198: A Comparison of 4% Articaine Versus 0.5%Bupivacaine for Ambulatory Surgery Under Supraclavicular Block
Official title: A Randomized Controlled Trial : Comparison of 4% Articaine Versus 0.5% Bupivacaine for Ambulatory Orthopaedic Surgery Under Supraclavicular Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Upper Limb Surgery
Hand Surgery
Keywords: Articaine
Bupivacaine
Ultrasound
Supraclavicular block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Effect of 2%Articaine versus 5%bupivacaine in pt undergoing short duration surgery in upper limb

Detailed description: The investigator aim to compare Articaine 2% versus bupivacaine 0.5% in patient undergoing upper limb procedure under ultrasound guided supraclavicular block as regard onset and duration of sensory and motor block

Eligibility criteria: Inclusion Criteria:

* upper limb surgery
* ganglion removal
* k wiring
* Carapal tunnel

Exclusion Criteria:

* Coagulopathy.
* infection at site of injection.
* patient refusal.
* hypersensitivity.

Primary outcomes:
measure: Duration of sensory block
timeFrame: Measured in minutes over 24 hours
measure: Durations of motor block
timeFrame: Measured in minutes over 24 hours
measure: Duration of analgesia
timeFrame: Measured in minutes over 24 hours
Secondary outcomes:
measure: Analgesia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hosptal
state: Abbasya
Study officials:
affiliation: Professor
name: Galal Mo El kadi, Doctor
role: STUDY_DIRECTOR
References:
citation: Armanious SH, Abdelhameed GA. A Randomized Controlled Trial: Comparison of 4% Articaine versus 0.5% Bupivacaine for Ambulatory Orthopedic Surgery under Supraclavicular Block. Anesthesiol Res Pract. 2020 Sep 24;2020:2194873. doi: 10.1155/2020/2194873. eCollection 2020.
Clinical trial NCT01303198: Autoset T Versus CPAP Therapy, a Comparison of Titration and Therapy
Official title: Autoset T Versus CPAP- Ein Titrations- Und Therapievergleich
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sleep Apnea Syndromes
Keywords: CPAP
APAP
sleep apnea
Lead sponsor: Kaiserswerther Diakonie
Sponsor class: OTHER
Collaborators: name: ResMed Foundation
First posted: 2011-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Part 1.Comparison of manual pressure titration in laboratory of sleep disorders with Autoset T APAP device from Resmed. Hypothesis: There is no difference in efficiency between manual and automatical titration.

Part 2. Comparison of CPAP and APAP therapy in the home while 3 month by Questionaire and device data.

Hypothesis: There is a difference in compliance and efficiency between CPAP and APAP mode.

Detailed description: A cross over, simple blind study design has been created for a controlled trial to compare pressure titration and therapy with the Autoset T device.

Part 1: After a baseline polysomnography (PSG) a selected group of patients with obstructive sleep apnea will be titrated in two more nights in a sleep lab under APAP mode and CPAP mode. We compare the sleep quality and the AHI, oxygen saturation, leakage.

Part 2: Over a time range of 12 weeks the patients got two kinds of therapy modes at home: CPAP and APAP (each six weeks. We compare the objective and subjective therapy by compliance, device data, Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI, german version).

Eligibility criteria: Inclusion Criteria:

* age from 18 to 80 years

Exclusion Criteria:

* pregnancy
* insomnia
* consumption of soporifics
* pulmonal or cardial diseases
* operation advised by ear, nose and throat specialist
* missing linguistic skills in german

Primary outcomes:
measure: AHI- score (apnea- hypopnea- index)
timeFrame: 3 months
Secondary outcomes:
measure: Number of device-using hours
timeFrame: 3 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Florence-Nightingale-Krankenhaus
state: Nordrhein Westphalen
Study officials:
affiliation: Diakonie Kaiserswerth
name: Hartmut Grueger, Arzt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457898: Non-invasive Mechanical Ventilation After Cardiac Surgery
Official title: Effects of Non-invasive Mechanical Ventilation on Hemodynamics and Gas Exchanges Parameters After Cardiac Surgery in Patients With Relative Hypoxemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Keywords: Cardiac surgery
Non-invasive ventilation
Lead sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2011-10-24
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac patients but more studies are necessary to clarify its respiratory and hemodynamic effects. Therefore, the investigators objective was to study its effects in the oxygenation index (PaO2/FiO2) and in hemodynamic variables in this group of patients.

Detailed description: * Postoperative cardiac surgery patients having a Swan-Ganz catheter and showing a PaO2/FiO2 between 150 and 300 (with FIO2 0.31), one hour after extubation, were included.
* Then, the patients were randomized into two groups: control and intervention group. Intervention group used NIV with a bi-level positive airway pressure (an inspiratory pressure to generate a tidal volume of 6ml/kg and an expiratory pressure of 7cmH2O) with a FIO2 0.4. Control group used oxygen by Venturi mask(FIO2 0.4) in order to keep a good oxygenation.
* In both groups measurements were done in basal situation, one and three hours after beginning the treatment and one hour after stop the treatment (FiO2 0.31).
* Variables studied included: PaO2/FiO2, PaO2, PaCO2, heart rate (HR), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP) and cardiac output (CO).

Eligibility criteria: Inclusion Criteria:

* Oxygenation index (PaO2/FiO2)between 150 and 300 one hour after extubation following cardiac surgery.
* Swan-Ganz catheter

Exclusion Criteria:

* Invasive mechanical ventilation more than 24 hours
* Serious obstructive pulmonary chronic disease (FEV1\<40%)

Primary outcomes:
measure: Oxygenation index (PaO2/FiO2)
timeFrame: 5 hours
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: 5 hours
measure: Mean arterial pressure (MAP)
timeFrame: 5 hours
measure: Pulmonary capillary wedge pressure (PCWP)
timeFrame: 5 hours
measure: Cardiac output (CO)
timeFrame: 5 hours
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Alessandra P Werlang, MsC
role: PRINCIPAL_INVESTIGATOR
References: