louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05097950: Labor Induction and Pain Relief With Paracetamol Versus Placebo
Official title: Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2021-10-28
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. An assessment of pain management will be conducted using various assessment tools. additionally, mode of delivery and time from catheter insertion to delivery will be assessed.

Detailed description: Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter.

assessment of pain during catheter balloon insertion will be assessed using visual analogue scale (VAS) instrument with scores 1 to 10.

An assessment of pain management will also be conducted using various assessment tools:

1. Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals.
2. Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter.
3. Patient Experience Questionnaire - upon transfer to delivery room.
4. Socio-demographic Questionnaire

Additionally, obstetrics outcomes will be recorded including time from catheter to delivery, mode of delivery. these parameters will be compared between the two groups (those who recieved paracetamol versus normal saline 0.9%).

Eligibility criteria: Inclusion Criteria:

Women from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter Nulliparity

Exclusion Criteria:

1. Sensitivity to paracetamol.
2. Past Cesarean section
3. Multiple pregnancy

Primary outcomes:
measure: PAIN assessment during catheter balloon insertion
timeFrame: through study completion, an average of 1 year
measure: maternal satisfaction
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: need for additional analgesic agent
timeFrame: through study completion, an average of 1 year
measure: maternal mobility
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Inshirah Sgayer
Study officials:
References:
Clinical trial NCT04423250: Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical DeviceS
Official title: Pilot Study Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical Devices and the Economic Repercussions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for scheduled surgery in the UDG (Urology Digestive Gynecology) operating room.

Brief summary: assess the impact of the intervention of a clinical pharmacist expert in sterile medical devices


Eligibility criteria: Inclusion Criteria:

* - The patient must be a member or beneficiary of a health insurance plan.
* The patient is managed for scheduled surgery (full hospitalization or outpatient) in the UDG (Urology Digestive Gynecology) operating room.

Exclusion Criteria:

* - The subject is in a period of exclusion determined by a previous study.
* The subject is under judicial protection.
* The subject (or his/her legal representative) has expressed his/her opposition to participate in the study.
* The patient is undergoing emergency surgery in the UDG (Urology Digestive Gynecology) operating room.
* It is not possible to give informed information about the subject.

Translated with www.DeepL.com/Translator (free version)

Primary outcomes:
measure: identify compliance with the appropriate use of sterile medical devices
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de NIMES
Study officials:
References:
Clinical trial NCT02140450: Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection
Official title: Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection: the Effect of Pretreatment With Antiglaucoma Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure Change in Intravitreal Injection
Keywords: intraocular pressure, intravitreal injection, short term
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection.

Detailed description: Acute intraocular pressure elevation after intravitreal injection of bevacizumab was proven.Acute intraocular pressure elevation most probably is volume related and long term intraocular pressure elevation relates to pharmacologic features of the medications which results in anatomic changes in the angle of anterior chamber.Numerous studies found an intraocular pressure elevation right after the injection and quick normalization within maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can result in irreversible visual loss especially in patients with critical remaining nerve fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to prevent or even shorten this time of intraocular pressure elevation? We tried in our study to find a suitable response for a question above, so we used several anti-glaucoma agents (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent acute intraocular pressure elevation right after intravitreal bevacizumab injection.

Eligibility criteria: Inclusion Criteria:

* all patients who candidate for receiving intravitreal bevacizumab

Exclusion Criteria:

* patients who had advanced glaucoma
* patients who received antiglaucoma agents in the past
* patients who had corneal scar which affect IOP measurement

Primary outcomes:
measure: change in IOP
timeFrame: 0, 5, 10, 15, 30 minutes after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Retina Research Center, Khatam eye Hospital
state: Khorasan Razavi
Study officials:
affiliation: Retina Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
name: Nasser Shoeibi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shoeibi N, Ghosi Z, Jafari H, Omidtabrizi A. Effect of antiglaucoma agents on short-term intraocular pressure fluctuations after intravitreal bevacizumab injections. Int Ophthalmol. 2021 Mar;41(3):1081-1090. doi: 10.1007/s10792-020-01667-z. Epub 2021 Jan 2.
Clinical trial NCT05662150: Low-frequency Repetitive Nerve Stimulation in Myotonic Dystrophy Type 1
Official title: Is Low-frequency Repetitive Nerve Stimulation a Reliable Test to Evaluate the Neuromuscular Junction in Myotonic Dystrophy Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myotonic Dystrophy 1
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study design is a prospective cohort study. It aims to evaluate the neuromuscular junction in dystrophic myotonia 1 (DM 1) using low-frequency repetitive nerve stimulation (RNS) on several nerve-muscle pairs of the one side including proximal and distal muscles of upper and lower extremities. First, it will be investigated whether a decrement with 3 Hz stimulation, as described in literature, is reproducible in our patient population. If this is the case, it will be examined whether it is the consequence of a dysfunction of the neuromuscular junction or rather linked to a hypo-excitability of some muscle fibers due to myotonia. For this purpose, additional tests including short exercise test (to observe any decrement resulting from an inexcitability in myotonic muscle fibers) and needle EMG (for mapping myotonic discharges in the muscles tested with repetitive nerve stimulation) will be performed. Single fiber-EMG will not be provided in this study as an abnormal result does not necessarily indicate a dysfunction of the neuromuscular junction but could just as well be due to the muscular dystrophy in the context of DM1. Finally, it will be investigated if there is a correlation between the decrement

with 3 Hz stimulation and clinical signs as fixed muscle weakness (via Medical Research Counsil (MRC) scale, DM-activ scale \[30\]) and fatigue (via MG-ADL scale).


Eligibility criteria: Inclusion Criteria:

\* genetically confirmed DM1

Exclusion Criteria:

* minor age
* auto-immune diseases
* medical conditions involving the neuromuscular junction: (myasthenia gravis, Lambert-Eaton myasthenic syndrome, congenital myasthenia syndromes).

Primary outcomes:
measure: Reproducibility of rapid decrement at low frequency stimulation.
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of decrement with grade of EMG-myotonia
timeFrame: 1 year
measure: Is there any clinical expression (muscle fatigability) of a possible neuromuscular junction dysfunction
timeFrame: 1 year
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels Hoofdstedelijk Gewest
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Jella De Ville, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04323150: The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.
Official title: The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia, Respiratory-associated Microbiome and Contamination of Inanimate Surfaces: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Traumatic Brain Injury
Pancreatic Diseases
Trauma Injury
Seizures
Encephalitis
Abdominal Sepsis
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are suggesting that closed suction systems may reduce the risk of the ventilator - associated pneumoniae (VAP) and the contamination of the closest unanimated surfaces. In 2011 David et al. have shown that closed suction systems might reduce the incidence of the late VAP. Research team is thinking that preventive bundle with closed suction systems can prevent to onset of the VAP. All enrolled patients is randomizing into two groups: control group - conventional suctioning and research group - suctioning with closed suction system.


Eligibility criteria: Inclusion Criteria:

* invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

* hospital - acquired pneumonia
* community - acquired pneumoniae
* BMI \> 35 kg/cm2
* pregnancy
* tracheostomy

Primary outcomes:
measure: incidence of the ventilator - associated pneumoniae (VAP)
timeFrame: Change from Baseline CPIS at 96 hours
measure: Contamination of closet inanimate surfaces
timeFrame: Change from Baseline Microbiology researching at 96 hours
Secondary outcomes:
measure: Organ dysfunction
timeFrame: Change from Baseline SOFA at 96 hours
measure: Mortality
timeFrame: 28 days
measure: C - reactive protein
timeFrame: Change from Baseline CRP researching at 96 hours
measure: Procalcitonin
timeFrame: Change from Baseline CRP researching at 96 hours
measure: sTREM 1
timeFrame: Change from Baseline CRP researching at 96 hours
Other outcomes:
Locations:
city: Severodvinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"
Study officials:
References:
Clinical trial NCT05273450: An Intervention to Promote Use of Smoking Cessation Resources Among Adults Using Community Food Pantries
Official title: Promoting Smoking Cessation Among Individuals With Food Insecurity: Promoting the Use of Evidence-Based Tobacco Cessation Resources Through Community Food Pantries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Food Insecurity
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this pilot randomized controlled study is to raise awareness and use of an evidence-based tobacco cessation resource that is underutilized among smokers (the Ohio Tobacco Quitline), specifically targeting Cleveland-area residents who have experiences with food insecurity. The study will assess the feasibility and acceptability of conducting informational outreach on tobacco cessation resources in community settings in which there is a relatively high proportion of tobacco users (i.e., food pantries). The study will derive preliminary estimates regarding the effectiveness of tobacco cessation outreach, by assessing whether outreach activities result in changes in awareness/knowledge of the quitline and use/engagement of the quitline.


Eligibility criteria: Inclusion Criteria:

* Aged 21 or older
* Current tobacco smoker willing to receive information about quitting resources
* Lives in Cuyahoga County, Ohio
* Has a reliable telephone number and an email address

Exclusion Criteria:

* Aged 20 or younger
* Current non-smoker, or current smoking who is not willing to receive information about quitting resources
* Lives outside Cuyahoga County, Ohio
* Does not have a reliable telephone number and an email address

Primary outcomes:
measure: Awareness of the quitline
timeFrame: 3 months
measure: Use of the quitline
timeFrame: 3 months
measure: Use of the quitline
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
References:
Clinical trial NCT01560650: Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury
Official title: Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Cardiac Surgery Associated Acute Kidney Injury (CRITERIA STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: CRRT
cardiac surgery associated acute kidney injury
Intensity
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid doses of 35 ml/kg/h is better, but the result is according to white people, black people . It is Whether the best amount of replacement fluid for Chinese people, it is unclear. Especially,there is little evidence about the optimal dose from randomized trials in Cardiac surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14 days, 28 days, 90 days survival and renal function.

Detailed description: Acute kidney injury (AKI) is a major complication in patients with cardiac surgery and is an independent predictor of mortality. However, the optimal intensity of renal replacement therapy for such patients is still controversial. we randomly assigned the patients with Cardiac surgery-associated acute kidney injury (CSA-AKI) to continuous renal replacement therapy with different treatment dose (35ml / kg / h or 25ml/kg／h),The primary study outcome was death from any cause within 14, 28 and 90 days.

Eligibility criteria: Inclusion Criteria:

* \> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery

Exclusion Criteria:

* \< 18 years old,
* with chronic kidney disease,
* dialysis history, to leave the ICU patients with acute kidney injury (AKI). - chronic kidney disease,
* all causes kidney damage (pathology, hematuria, and radiographic abnormalities)\> = 3 months or glomerular filtration rate \< 60ml/min for 3 months or more.

Primary outcomes:
measure: death from any cause
timeFrame: 14, 28 ,90 and 365 days after randomization
Secondary outcomes:
measure: renal outcome of survivors
timeFrame: 14, 28 ,90 and 365 days after randomization
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nephrology Department,Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wei Shi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04627350: Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
Official title: Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: lung cancer
low dose CT
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: General University Hospital, Prague
First posted: 2020-11-13
Enrollment: 3200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Defined by eligibility criteria

Brief summary: The aim of this study is to evaluate and optimize entry criteria for the proposed programme for early detection of lung cancer in the Czech Republic.

An estimated 3200 high-risk (age 55-74 years, \>30 pack-years) asymptomatic individuals will undergo baseline low-dose chest CT (LDCT) and a follow-up LDCT at 1 year. Patients with poor performance status (PS) 2-4, history of malignancy in the past 10 years, chest CT in the past 1 year, bodyweight \>140kg will not be included.

The patients will fill out a questionnaire with basic data, including smoking history (pack-years), history of previous malignancy, CT imaging of the thorax, and will undergo spirometry.

Outcomes of the study include:

* optimization of entry criteria, optimization of timing of a follow-up LDCT and management of the patients, proposal of quality assurance indicators
* influence of screening on the stage of lung cancer at the time of the diagnosis and life-years lost
* cost-effectiveness of the screening program
* evaluation of the diagnostic yield for secondary findings (pulmonary fibrosis, cardiovascular risk)


Eligibility criteria: Inclusion Criteria:

* Age 55-74 years
* Smoking: \>= 30 pack-years, smoker or ex-smoker \<15 years
* Performance status (0-1) - can climb at least one floor without any difficulty or pause

Exclusion Criteria:

* Body weight above 140 kg
* Malignant disease within the last 10 years (except non-melanoma skin cancer).
* Chest CT less than one year ago
* Clinical signs suspicious of lung cancer (weight loss, new cough, hemoptysis)

Primary outcomes:
measure: The number of cancers detected at stage I
timeFrame: 2023
Secondary outcomes:
measure: The cost per diagnosis at a resectable stage
timeFrame: 2023
Other outcomes:
measure: Number of secondary examinations
timeFrame: 2023
measure: Number of secondary findings
timeFrame: 2023
Locations:
city: Prague
country: Czechia
facility: General University Hospital in Prague
Study officials:
affiliation: General University Hospital, Prague
name: Lukas Lambert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04546750: Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Official title: Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Varicose Veins of Lower Limb
Thromboses, Venous
Venous Insufficiency
Lead sponsor: Russian Phlebological Association
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The main cohort is formed from those who do not have varicose veins, who are affected by different factors that we register (various physical activities, the presence or absence of pregnancy, etc.).

An additional cohort is formed from those who have varicose veins at the time of inclusion.

The goal is to track the natural evolution (progression) of the disease, to evaluate the incidence and risk factors of complications.

An extremely important criterion for the formation of the study population is the possibility to control the lower legs veins of observed individuals by a qualified vascular specialist. To date, a qualitative assessment of veins according to the CEAP classification is a weak point in longitudinal epidemiological studies.

Brief summary: A prospective study of individuals without varicose veins and who have primary varicose veins to assess the morbidity, risk factors and natural course of chronic lower limb vein disease.

Detailed description: Multicenter prospective cohort observational study based on a termless epidemiological registry. Periodic inspection and collection of data from the subjects is carried out annually, in the last quarter of the current year. Patient data is recorded in a digital database and is constantly updated

Eligibility criteria: Inclusion Criteria:

* A family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself
* The possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals

Exclusion Criteria:

* Any invasive treatment of the chronic venous disorder in anamnesis
* Venous thrombosis in the anamnesis or at the time of inclusion

Primary outcomes:
measure: Incidence of primary varicose veins
timeFrame: 1 year
Secondary outcomes:
measure: Progression of primary varicose veins
timeFrame: 1 year
measure: Incidence of chronic venous insufficiency
timeFrame: 1 year
measure: Incidence of superficial vein thrombosis
timeFrame: 1 year
measure: Incidence of reticular and telangiectatic leg veins
timeFrame: 1 year
measure: Progression of reticular and telangiectatic leg veins
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: "Medalp" private surgery clinic
Study officials:
References: