louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04212403: Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
Official title: A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urosepsis
Bladder Cancer
Prostate Hyperplasia
Antibiotic Resistant Strain
Antibiotic Resistant Infection
Antibiotic-associated Diarrhea
Antibiotic Toxicity
Keywords: TURP
TURB
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 1350
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.
Primary purpose: PREVENTION

Brief summary: To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or \> 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.

Detailed description: Main objective:

To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or \> 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).

Secondary objective:

To investigate post-operative bacteriuria after TURB and TURP in our population.

Principal inclusion criterium:

Patients undergoing TURP or TURB.

Primary exclusion criterium:

TURP: pre-operative catheter or \> 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).

Primary endpoint:

Post-operative infection.

Secondary endpoint:

Post-operative bacteriuria.

Eligibility criteria: Inclusion Criteria:

* TURP or TURB.

Exclusion Criteria:

* TURP: pre-operative catheter/DJ/nephrostomy or \> 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter/DJ/nephrostomy or clinical signs of infection (fever, myctalgia).

Primary outcomes:
measure: % of patients with a post-operative infection.
timeFrame: From immediately post-op until at the control consultation 4 weeks after surgery.
Secondary outcomes:
measure: Incidence of post-operative bacteriuria.
timeFrame: From immediately post-op until at the control consultation 4 weeks after surgery.
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
Study officials:
affiliation: UHasselt
name: Koenraad van Renterghem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605003: Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device
Official title: Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sterility
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study compares the sterility of rigid nasoendoscopies after being sterilized with a conventional autoclave machine and a novel rig-S device that uses standard high level disinfectant

Detailed description: There is a standard operating procedure in rigid endoscopy cleaning, and it is performed after each clinical examination. The conventional autoclave is no longer used in the setting of an otorhinolaryngology (ORL) clinic as it is cumbersome and takes a lot of time, and also only cleans one endoscope at a time. There is no standardisation or device that has been reported, and cross contamination has been reported previously. The overturn of patients in the ORL clinic is high, and most practitioners chooses high level disinfectant as a method of sterilising the endoscopes. However, there is no proper device to place these disinfectants in, and results in many cases of broken scopes and cross contamination.

This study compares the sterility of the rigid endoscopes after being sterilised by the high level disinfectant that is placed in a novel rig-S device with the gold standard conventional autoclave.

The investigators selected all the rigid endoscopes performed in our ORL clinic and randomised them before subjecting them for a swab test for bacterial and fungal, and also used a test kit to test the presence of Hepatitis B.

Eligibility criteria: Inclusion Criteria:

All rigid endoscopes performed in ORL clinic

Exclusion Criteria:

Flexible endoscopes performed in ORL clinic

Primary outcomes:
measure: Microbial and Hepatitis B test
timeFrame: 3 days
Secondary outcomes:
measure: Acidity level
timeFrame: 4 hours
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Universiti Kebangsaan Malaysia
state: Kuala Lumpur
Study officials:
affiliation: Universiti Kebangsaan Malaysia Medical Centre
name: Salina Husain, MMED
role: STUDY_DIRECTOR
References:
Clinical trial NCT01166503: Early Versus Delayed Surgery for Infantile Esotropia
Official title: Early Versus Delayed Surgery for Infantile Esotropia: A Clinical Evaluation of Sensory and Motor Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esotropia
Keywords: pediatrics
Esotropia
Surgery
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-07-21
Enrollment: 71
Sex: ALL
Minimum age (years): 3
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with infantile esotropia will be enrolled from The Hospital for Sick Children in Toronto. Infants with characteristics that indicate low likelihood of spontaneous resolution will be studied.

Brief summary: The goal of this study is to determine whether corrective surgery done earlier than the current standard can better improve the visual and eye movement deficits in children with infantile esotropia (crossed eyes in infancy).

Detailed description: While there is a uniform agreement among pediatric ophthalmologists that most infantile esotropia requires surgical correction, the proper timing of surgery is controversial. In North America, the typical age at surgery ranges from 11-18 months. Unfortunately, despite successful surgical realignment of the eyes, the sensory and eye movement deficits often persist. Recently, some pediatric ophthalmologists have advocated earlier surgery. The rationale for early surgery stems from animal and human research showing that early realignment of the eyes within an early critical period allows normal development of the sensory and eye movement systems.

Eligibility criteria: Inclusion Criteria:

1. onset of esotropia after 10 weeks of age;
2. constant esotropia ≥ 20° (40 prism diopter or PD) at near (1/3 m) on two examinations, separated by 2-4 weeks; and
3. refractive error ≤ +3.00 diopters (far-sightedness).

Exclusion Criteria:

1. gestational age \< 34 weeks;
2. birth weight ≤ 1500 g;
3. ventilator treatment in the newborn period;
4. history of meningitis or other major medical event;
5. developmental delay;
6. incomitant or paralytic strabismus;
7. manifest nystagmus or head bobbing;
8. prior eye muscle surgery;
9. prior treatment of amblyopia or spectacle correction for refractive errors;
10. presence of structural ocular anomalies.

Primary outcomes:
measure: Motion visual evoked potential (mVEPs) asymmetry
timeFrame: at age 2 years
measure: Stereopsis
timeFrame: at 2 and 5 years of age
measure: Optokinetic nystagmus (OKN) asymmetry
timeFrame: at age 5 years
measure: Global Motion Perception
timeFrame: at 2 and 5 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Agnes Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097603: Larsen & Toubro (L&T) Noninvasive Blood Pressure Module Performance Validation
Official title: L&T Noninvasive Blood Pressure Module Performance Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: Non-Invasive Blood Pressure
Lead sponsor: Larsen & Toubro Limited
Sponsor class: INDUSTRY
First posted: 2010-04-01
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total 92 numbers of subjects or patients were studied during this study.

Brief summary: To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and pediatric population.


Eligibility criteria: Subjects: Healthy volunteers

Inclusion Criteria:

* Healthy subjects
* Age between 1 - 60 yrs
* Both genders
* Consenting for the study

Exclusion Criteria:

* Subjects suffering from cardiorespiratory, neurological or endocrinal disorders
* Subjects with alcohol abuse/dependance
* Female subjects who are pregnant or lactating
* Subjects with pace maker implantations

Subjects: Diseased subjects

Inclusion Criteria:

* Patients of hypertensive, ICU and in patients of different diseases
* Age between 1 - 80 yrs
* Both genders
* Consenting for the study

Exclusion Criteria:

* Healthy volunteers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01733303: Fracture and Fall Prevention in Elderly With Osteoporosis
Official title: Fracture and Fall Prevention in Elderly With Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.


Eligibility criteria: The inclusion criteria for osteopenia or osteoporosis group:

1. able to stand and walk for 5 minutes independently;
2. having normal or corrected to normal vision;
3. having age between \> 50 years
4. with osteopenia (-2.5 \< t-score \< -1.0) or osteoporosis (t-score \<-2.5).

The exclusion criteria for osteopenia or osteoporosis group:

1. being pregnant;
2. sensory-motor deficits;
3. inability of communication
4. lack of access to a telephone.

The inclusion criteria for control age-matched group:

1. able to stand and walk for 5 minutes independently;
2. having normal or corrected to normal vision;
3. having age between \> 50 years
4. without osteopenia or osteoporosis (t-score \> -1.0).

The exclusion criteria for control age-matched group:

1. being pregnant;
2. sensory-motor deficits;
3. inability of communication
4. lack of access to a telephone.

Primary outcomes:
measure: Changes of torque demand to capacity ratio 6 months
timeFrame: Change from Baseline intorque demand to capacity ratio at 6 months
measure: Changes of torque demand to capacity ratio at 3 months
timeFrame: Change from Baseline in torque demand to capacity ratio at 3 months
measure: Change of torque demand to capacity ratio at 12months
timeFrame: Change from Baseline in torque demand to capacity ratio at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Physical Therapy Center or the Orthopedic Center in the National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Weili Hsu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03903003: Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
Official title: In the Study; Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery Affecting Newborn
Keywords: high flow nasal oxygen (POİNT)
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

Detailed description: Patients who will undergo caesarean section under general anesthesia will be included in the study.

In the study; preoxygenation is applied to the caesarean sections under general anesthesia in two ways. Group1 includes preoxygenation masked patients.

Eligibility criteria: Inclusion Criteria:

* over 18 years old;
* Patients undergoing elective ceserian operation

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients under emergency conditions.

Primary outcomes:
measure: durations of stay
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli Derince Education and Research Hospital
Study officials:
affiliation: HEALTH AND SCİENCE UNIVERSITY MEDICAL SCHOOL
name: Mehmet Yılmaz
role: STUDY_DIRECTOR
References:
Clinical trial NCT03227003: DNA Methylation and 1-C Metabolism Nutrient Intake
Official title: Dietary Intake of One-carbon Metabolism Nutrients and DNA Methylation in Peripheral Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DNA Methylation
Lead sponsor: Cancer Council Victoria
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 5983
Sex: ALL
Minimum age (years): 27
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is a sub-sample of the Melbourne Collaborative Cohort Study (MCCS), with non-random sampling based on selection into of six case-control studies nested within the MCCS. The MCCS is a prospective cohort study of 41,513 people (17,044 men and 24,469 women) recruited between 1990 and 1994. The age range at recruitment was 27-80 (99.3% being aged 40-69). Southern European migrants to Australia were over-sampled to extend the range of exposures, including dietary patterns.

Participants in this sub-study had valid dietary intake data and valid measures of DNA methylation.

Brief summary: The present study used a sub-sample of the Melbourne Collaborative Cohort Study (MCCS) (Milne RL et al, Int J Epidemiol, 2017), who had valid data on dietary intakes (121-item food frequency questionnaire) and valid measures of DNA methylation using the HumanMethylation Infinium 450K Beadchip assay, or using LINE-1, Alu and Sat2 assays.

The investigators studied the association between nutrients involved in one-carbon metabolism and DNA methylation in peripheral blood.


Eligibility criteria: Inclusion Criteria:

* Selected into one of six case-control studies nested in the Melbourne Collaborative Cohort Study
* Completed a 121-item Food Frequency Questionnaire
* Had a blood DNA sample with a measure of methylation

Exclusion Criteria:

* Missing data in any of the outcome, exposure, or confounders (N=797 excluded)

Primary outcomes:
measure: Blood DNA methylation
timeFrame: 2014-2015
Secondary outcomes:
measure: Blood DNA methylation
timeFrame: 2014-2015
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Council Victoria
name: Graham G Giles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chamberlain JA, Dugue PA, Bassett JK, Hodge AM, Brinkman MT, Joo JE, Jung CH, Makalic E, Schmidt DF, Hopper JL, Buchanan DD, English DR, Southey MC, Giles GG, Milne RL. Dietary intake of one-carbon metabolism nutrients and DNA methylation in peripheral blood. Am J Clin Nutr. 2018 Sep 1;108(3):611-621. doi: 10.1093/ajcn/nqy119.
Clinical trial NCT03267303: A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
Official title: A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy
Keywords: Narcolepsy
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-30
Enrollment: 53
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria
2. Patients aged ≥16 to \<65 years at the time of obtaining informed consent
3. Outpatients

Exclusion Criteria:

1. Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder)
2. Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy
3. Patients with obstructive respiratory diseases (bronchial asthma, emphysema)
4. Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)

Primary outcomes:
measure: Mean sleep latency in maintenance of wakefulness test
timeFrame: 3 weeks
Secondary outcomes:
measure: Total score on the epworth sleepiness scale
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Osaka and other Japanese city
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
city: Seoul and other Korean city
country: Korea, Republic of
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Shigeru Okuyama
role: STUDY_DIRECTOR
References:
citation: Inoue Y, Uchiyama M, Umeuchi H, Onishi K, Ogo H, Kitajima I, Matsushita I, Nishino I, Uchimura N. Optimal dose determination of enerisant (TS-091) for patients with narcolepsy: two randomized, double-blind, placebo-controlled trials. BMC Psychiatry. 2022 Feb 22;22(1):141. doi: 10.1186/s12888-022-03785-7.
Clinical trial NCT02372903: Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
Official title: Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Chronic Pelvic Pain
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia.

N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 50 years;
* pain visual analog scale (VAS) score\>4
* laparoscopic diagnosis of endometriosis (performed in the last three years),
* no assumption of any drugs (in particularly estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists)
* persistence of symptoms by at least one month

Exclusion Criteria:

* presence of other associated diseases
* assumption of drugs
* menopause
* pregnancy
* unable or unwilling to give written consent patients
* adverse reaction or hypersensitivity to active substance or excipients

Primary outcomes:
measure: Change of Pelvic pain as measured by visual analogue scale
timeFrame: Change from Baseline Pelvic Pain at 90 days of treatment
Secondary outcomes:
measure: Change of Pelvic pain as measured by visual analogue scale
timeFrame: Change from baseline Pelvic Pain after 30 days from the suspension of the therapy
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: University of Cagliari,Obstetrics and Gynecological Department,
state: Cagliari
Study officials:
References: