louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02725242: Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma
Official title: A 12-week, Randomized, Parallel-group, Phase III Study Comparing the Efficacy of Once-daily Budesonide/Formoterol Turbuhaler (160/4.5 μg/d) and Twice-daily Budesonide Giona Easyhaler (400 μg/d) During Step-down Period in Well Controlled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Hat Yai Medical Education Center
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of Once-daily Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient.

Detailed description: The study will measure the efficacy of once daily low dose ICS/ LABA in well controlled asthmatic patient comparing with low dose ICS in step down circumstance.

Eligibility criteria: Inclusion Criteria:

* Asthmatic patients who have well controlled asthma at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
* Age more than 18 year-old
* Patients who able to do spirometry without contraindication
* History smoking less than 10 pack-years

Exclusion Criteria:

* History of using systemic steroid previous 4 week and respiratory infection
* History of pulmonary tuberculosis with residual lung lesion by chest radiograph
* recent serious medical condition such as myocardial infarction, stroke, pneumonia etc.

Primary outcomes:
measure: Change from baseline in Asthma Control Questionnaire (ACQ) score
timeFrame: Baseline and week 12
measure: Change from baseline in Asthma Controlled Test (ACT) score
timeFrame: Baseline, week 4, week 8 and week 12
Secondary outcomes:
measure: Change from baseline in Peak expiratory flow (PEF)
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change from baseline in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline and week 12
measure: Percentage of participants who were categorized from asthma controlled assessment following GINA guideline
timeFrame: Baseline, week 4, week 8 and week 12
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Narongwit Nakwan
state: Songkhla
Study officials:
affiliation: HatYai Hospital
name: Narongwit Nakwan, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01709942: Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)
Official title: Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: PCOS
OHSS
INFERTILITY
Keywords: GnRH antagonist
PCOS
OHSS
COH
IVF
Lead sponsor: Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor class: NETWORK
First posted: 2012-10-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.

Detailed description: Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For this reason in this study the degarelix was tested in order to minimize the risk of OHSS as well as to improve the pregnancy rate in these patients. The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in order to establish the best way to perform controlled hyperstimulation in IVF cycles and minimize the risk of OHSS.

Eligibility criteria: Inclusion Criteria:

* women with PCOS
* previous OHSS
* Infertility

Exclusion Criteria:

* more than 38 years old
* Body mass index pore than 30
* other systemic diseases

Primary outcomes:
measure: PREGNANCY RATE
timeFrame: 6 MONTHS
measure: ovarian hyperstimulation syndrome rate
timeFrame: 6 MONTHS
Secondary outcomes:
measure: implantation rate
timeFrame: 6 months
Other outcomes:
measure: number of mature oocytes
timeFrame: 6 months
Locations:
city: Rome
country: Italy
facility: Cerm-Hungaria
Study officials:
affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
name: Marco Sbracia, MD
role: STUDY_CHAIR
References:
citation: Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4.
Clinical trial NCT01556542: Drug Eluting Balloon in peripherAl inTErvention SFA
Official title: Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: peripheral arterial disease
drug-eluting balloon
restenosis
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.


Eligibility criteria: Inclusion Criteria:

* age\>18 years
* intermittent claudication(Fontane III or IV)
* angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm
* at least one below-knee vessel to the ankle

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent

Primary outcomes:
measure: angiographic binary restenosis
timeFrame: 12 months
Secondary outcomes:
measure: major amputation
timeFrame: 24 months
measure: target lesion revascularization
timeFrame: 24 months
measure: vessel reocclusion
timeFrame: 24 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
affiliation: Cardiovascular Department, San Donato Hospital, Arezzo, Italy
name: Francesco Liistro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.
Clinical trial NCT00911742: Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg
Official title: Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg OAD Formulation Versus Zytram® 200 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Labopharm Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects of either gender
* Age between 18 and 45 years
* Body mass index between 19 and 27kg/m2
* Normal medical history
* Normal or no clinically significant physical examination findings
* Normal or no clinically significant findings in analytical tests
* Negative hepatitis B, hepatitis C or HIV serology
* Negative drugs of abuse in urine
* Negative pregnancy test in females
* The subject understands and accepts the study procedures and grants in writing his/her informed consent

Exclusion Criteria:

* Did not fulfill the inclusion criteria
* Organic disorders or underwent major surgery, within 90 days before study screening
* Psychiatric history
* Alcohol drink intake greater than 30gr/day
* Cigarette smoking greater than 10 cigarettes/day
* Excessive consumption of food or beverages containing xanthines (more than five units of coffee, tea or cola per day)
* Medical treatment within 30 days before screening, and/or any medication 7 days before starting the study
* Participation in other clinical study or donate blood within 90 days before starting this study
* Antecedents of gastric, hepatic, renal and other kind of disorder that could affect ADME (absorption, distribution, metabolism or excretion of the study drug)
* Hepatitis B, hepatitis C or HIV positive serology
* Pregnant or breastfeeding
* Clinically relevant hypersensitivities (in particular to drugs)
* Woman taking oral contraceptive drugs
* Incapable of communicating and cooperating with investigators

Primary outcomes:
measure: AUC(0-t)
timeFrame: 48 hours
measure: AUC (0-∞)
timeFrame: 48 hours
measure: Cmax
timeFrame: 48 hours
Secondary outcomes:
measure: t1/2
timeFrame: 48 hours
measure: Tmax
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Hernandez-Lopez C, Martinez-Farnos L, Karhu D, Perez-Campos T, Rovira S, Encina G. Comparative bioavailability between two Tramadol once-daily oral formulations. Methods Find Exp Clin Pharmacol. 2006 Jul-Aug;28(6):373-8. doi: 10.1358/mf.2006.28.6.1007674.
Clinical trial NCT01280942: Early Warning System for Clinical Deterioration on General Hospital Wards
Official title: Early Warning System for Clinical Deterioration on General Hospital Wards.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Escalation of Care
Cardiopulmonary Arrest
Respiratory Arrest
Severe Sepsis
Septic Shock
Keywords: clinical deterioration
detection algorithms
automated warning systems
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-01-21
Enrollment: 20031
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Random allocation of study wards to intervention and control, with washout period and crossover of assignment.
Primary purpose: PREVENTION

Brief summary: The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.


Eligibility criteria: Inclusion Criteria:

* All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.

Exclusion Criteria:

* Minors, patients younger than 18 years old.

Primary outcomes:
measure: Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
timeFrame: Within 24 hrs of an EWS alert
Secondary outcomes:
measure: Clinical Outcomes and Process Measures
timeFrame: Hospital discharge
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Thomas C Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bailey TC, Chen Y, Mao Y, Lu C, Hackmann G, Micek ST, Heard KM, Faulkner KM, Kollef MH. A trial of a real-time alert for clinical deterioration in patients hospitalized on general medical wards. J Hosp Med. 2013 May;8(5):236-42. doi: 10.1002/jhm.2009. Epub 2013 Feb 25.
Clinical trial NCT04599842: Analgesic Effect of Erector Spinae Plane Block After Caesarean Section
Official title: Analgesic Effect of Erector Spinae Plane Block After Caesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ceserean Section and Postoperative Pain
Keywords: Ceserean section, ESP block, postoperative pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Our hypothesis was that bilateral ESP block applied from the transverse process of T9 in women who underwent elective cesarean section with pfannenstiel incision under spinal anesthesia could provide effective postoperative analgesia.The primary outcome in this study was total opioid consumption for 24 hours.

Material and Method: This randomized prospective study was carried out on 50 pregnant women who was scheduled for elective cesarean delivery via a Pfannenstiel incision with spinal anesthesia.Patients were randomly allocated in to two equal groups.Group SA was categorized as the group which spinal anaesthesia alone (SA) was performed, Group SA+ESP was categorized as group which SA+ESP block was performed. All groups received 7 mg isobaric bupivacaine +15 µg fentanyl intrathecally through spinal anesthesia. The SA+ESP group, ESP block was performed at the ninth thoracic transverse process with 20 ml 0.25% bupivacaine + 2 mg dexamethasone immediately after the operation. Total fentanyl consumption in 24 hrs, visual analogue scale (VAS) score for pain, time to the first analgesic request were evaluated postoperatively.


Eligibility criteria: Inclusion Criteria:pregnant women,38-42 gestational weeks, ASA I-II

Exclusion Criteria:

* ≤18 or ≥45 age, has emergency obstetric surgery, pregnancy induced hypertension, significantly systematic disease, foetal or placental abnormality, hypersensitivity or allergy history to medicine to be used in the study, BMI≥35, autonomic neuropathy, diabetic, contraindicate to apply neuroachylic anaesthesia, who was transferred to general anaesthesia, could not decide or did not want to participate in the study, had severe respiratory and cardiac disease, was transferred to general anaesthesia, has infection, spine or chest wall deformity in operation area, has opioid dependence, chronic analgesic usage, inability to use a patient-controlled analgesia (PCA) device, couldn't be able to cooperative and express their pain with visual analogue scale score (VAS).

Primary outcomes:
measure: The primary outcome in this study was total opioid consumption for 24 hours.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Yakutiye
country: Turkey
facility: Aysenur Dostbil
state: Erzurum
Study officials:
affiliation: Ataturk University, Department of Anesthesiology and Reanimation
name: Ilker Ince, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01605942: A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cataract
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.


Eligibility criteria: Inclusion Criteria:

* Planned single cataract extraction with lens implant
* Best-corrected visual acuity of 20/200 or better in the opposite eye

Exclusion Criteria:

* Glaucoma or history of intraocular hypertension in the study eye
* History of chronic ocular allergy in the last year requiring treatment
* Scheduled for cataract surgery in the non-study eye during study participation

Primary outcomes:
measure: Number of Patients With Clearance of Anterior Chamber Inflammation
timeFrame: Up to Day 71
Secondary outcomes:
measure: Plasma Levels of Dexamethasone
timeFrame: Day 2, Day 7, Day 14
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02803242: COPD Patient-Powered Research Network
Official title: COPD Patient-Powered Research Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disorder
Chronic Obstructive Lung Disease
Emphysema
Chronic Bronchitis
Keywords: copd
emphysema
bronchitis
bronchiectasis
Lead sponsor: COPD Foundation
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Hospitals, Center for Health Research
First posted: 2016-06-16
Enrollment: 75000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English speaking individuals who are over the age of 18 and have a diagnosis of COPD or fall into one of the following categories that put's them at risk - current or former smoker, environmental/occupational exposure, family history of respiratory disease or symptomatic of respiratory disease.

Brief summary: The COPD Patient-Powered Research Network (COPD PPRN) is a patient research registry with the goal of enrolling 75,000 or more COPD patients and those at risk who are willing to share their heath information over several years and participate in research. The COPD PPRN has built an online platform to allow volunteers to enroll electronically, complete surveys, be contacted about studies they qualify for and become connected to COPD resources. The goal of the registry is to speed research to find better treatments for COPD and ultimately a cure.


Eligibility criteria: Inclusion Criteria:

* 18 years or older that says yes to one of the following:
* COPD diagnosis
* Current or former smoker
* Family history of respiratory disease
* Symptomatic of respiratory disease

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Patient Reported Outcome Measurement Information System-29 (PROMIS-29)
timeFrame: 15 years
measure: COPD Assessment Test (CAT)
timeFrame: 15 years
measure: Modified Medical Research Council (MMRC) Dyspnea Scale
timeFrame: 15 years
measure: Charlson Comorbidity Index (CCI)
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: COPD Foundation
state: District of Columbia
Study officials:
References:
Clinical trial NCT05951842: Anesthesia, TIVA, Balanced Anesthesia, NK Cell
Official title: The Differences Between the Effects of Total Intravenous Anesthesia (TIVA) and Balanced Anesthesia on NK Cell and Cytokine Response in Colorectal Cancer Patients Undergoing Cytoreductive Surgery and HIPEC(Hyperthermic Intraperitoneal Chemotherapy)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anesthetic method was reported to have an impact on postoperative long-term outcome in cancer patients. In this study, we will investigate the effect of different anesthetic methods on NK cell activity, cytokine response and postoperative outcome in colorectal cancer patients undergoing CRS and HIPEC. We will compare propofol-based total intravenous anesthesia (TIVA) with balanced anesthesia to determine the effect of propofol, inhalation agent, and opioid on tumor genesis, recurrence, NK cell activity, cytokine response, and postoperative outcome.


Eligibility criteria: Inclusion Criteria:

1. Colorectal cancer patients undergoing elective cytoreductive surgery and HIPEC (20-70 yrs old)
2. American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria:

1. Patients under 20 years old.
2. Patients with long-term steroid therapy or immunosuppressive therapy.
3. Patients with long-term NSAIDs therapy.
4. Patients who cannot communicate with other person or with cognitive disorder.
5. Patients who cannot read the consent form.

Primary outcomes:
measure: Postoperative immune function (NK cell count)
timeFrame: Postoperative day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: