louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00731484: Validation of TearLab Osmometer - Human Factor Usability Report
Official title: Validation of TearLab Osmometer - Human Factor Usability Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Disease
Tear Osmolarity
Tear Osmolality
Lead sponsor: TearLab Corporation
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Ophthalmic and optometric clinics.

Brief summary: The objective of this study is to validate the performance of the OcuSense TearLab™ osmolarity test when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from volunteer subjects and contrived tear samples.

Detailed description: To validate the performance and usability of the TearLab osmometer, specifically human factor usability, when used in the hands of intended users, i.e. ophthalmology and optometry clinics. This testing is required to insure that the Osmolarity System meets the Product Requirements and for completion of the Technical File, Design History File and FDA 510(k) Submission.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers representing the general population (a minimum of 120 subjects representing 50% of the total study population,
* Otherwise healthy volunteers previously-diagnosed with moderate or severe chronic dry eye and/or Sjogrens syndrome and/or designated as dry eye disease subjects by the OSDI questionnaire (a minimum of 40 subjects representing 50% of the total study population),
* Men or women,
* Adult 18 years or older,
* Contact lens wearers may participate,
* Patients having undergone refractive surgery may participate,
* Patients having undergone cataract surgery may participate

Exclusion Criteria:

* Eye pathology other than previously-diagnosed moderate or severe chronic dry eye and/or Sjogrens syndrome, Use of topical medication within the last 24 hours,
* Eye drop usage within the last 2 hours,
* Ocular surface staining within the last 2 hours,
* Other invasive ocular diagnostic testing within the last 2 hours,
* Crying within the last 30 minutes,
* Eye makeup present on the eye lid within 10 minutes of tear collection,
* Examination by slit lamp within 10 minutes of tear collection.

Primary outcomes:
measure: Tear Osmolarity in Human Measured by TearLab System
timeFrame: Single visit, at time of tear osmolarity testing.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Gordon Binder Weiss Vision Institute
state: California
city: Louisville
country: United States
facility: Kentucky Lion Eye Center, University of Louisville
state: Kentucky
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: Clinical Professor of Ophthalmology, Georgetown University
name: Michael A Lemp, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06730984: Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): a Prospective Randomized Controlled Study
Official title: Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tracheal Intubation
Endoscopic Submucosal Dissection
Endoscopy-Assisted
Video Laryngoscope
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 132
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: TREATMENT

Brief summary: This study plans to enroll 148 patients undergoing upper gastrointestinal endoscopic submucosal dissection (ESD). Patients will be randomly divided into a control group (conventional tracheal intubation) and an experimental group (endoscopy-assisted tracheal intubation). Patients meeting the inclusion criteria and not falling under the exclusion criteria will be invited to participate in the study. Upon providing voluntary consent, the research physician will arrange for the patient's inclusion in the study. After signing the informed consent form, the research physician will collect the patient's basic information, medical history, and other details, followed by timing the preoperative preparation period and evaluating postoperative discomfort


Eligibility criteria: Inclusion Criteria:

* Patients undergoing endoscopic submucosal dissection (ESD) at Ningbo University Affiliated First Hospital from December 2024 to December 2026.
* Aged between 18 and 75 years.
* Patients who voluntarily agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Individuals under 18 years of age.
* Patinents unwilling or unable to provide informed consent.
* Patients with severe chronic cardiac or pulmonary disease, or those who have required hospitalization for coronary or cerebrovascular events or radiotherapy within the past 3 months.
* Patients with severe abdominal symptoms such as severe pain, bloating, or nausea.
* Patients with inadequate preoperative preparation.
* Individuals requiring lifelong anticoagulant therapy, those with severe bleeding disorders, or those who have recently taken anticoagulant or antiplatelet medications.
* Pregnant or breastfeeding individuals.

Primary outcomes:
measure: preoperative preparation time
timeFrame: 10 mins
Secondary outcomes:
measure: The time to view the vocal cords (TVVC)
timeFrame: 1 min
measure: The time to advance the tracheal tube into trachea (TATT)
timeFrame: 1 min
Other outcomes:
Locations:
city: Ningbo
country: China
facility: the First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06131684: Amniotic Fluid Analysis
Official title: Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Obstetric Labor Complications
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective study that will aid in ensuring the feasibility of timely and correct aspiration of amniotic fluid by study research team that include the clinical team taking care of the patient during her labor, timely transport and interpretation of specimens. It will also assist in providing information for the computation of necessary statistical measures (e.g. sample size, power analysis, etc.) for the study cohorts that lack the needed data in the medical literature.

Detailed description: Can amniotic fluid be serially aspirated via an Intrauterine pressure catheter (IUPC) and successfully analyzed in labor? Do abnormal amniotic fluid results collected serially predict which laboring patients will develop an intrapartum infection? Can the results predict infection sooner than the current clinical diagnostic criteria as outlined by the 2015 NICHD guidelines? How do the sensitivity, specificity, positive and negative predictive values compare to the 2015 NICHD diagnostic criteria?

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Gestational age ≥ 37 weeks
* Age of participant ≥ 18 years old

Exclusion Criteria:

* Multiple gestation
* Gestational age \< 37 weeks
* Intrauterine fetal demise
* Fetal anomalies
* Pre-gestational Diabetics / Gestational Diabetics
* Chronic immune suppression with steroids (defined as \> 1 month of consistent steroid use)
* Oligohydramnios
* Women with documented non-obstetric infections within 2 weeks of admission; including use of any antibiotics within 2 weeks of admission for non-documented/suspected infections
* Repeat temperature not performed within 45 minutes of index fever (100.4 F)
* Index fever (100.4 F) is \> 1 hour after delivery
* Expectantly managed premature rupture of membranes

Primary outcomes:
measure: The number of patients who develop an intrapartum infection
timeFrame: From enrollment to delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science Univerity
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Adam Crosland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01901484: Schistosoma Mansoni Morbidity in Children Aged 1-5 Years
Official title: Intestinal Schistosomiasis in Children Aged 1-5 Years,Morbidity Assessment and the Effect of Praziquantel on Morbidity; Along Lake Victoria Shorelines.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intestinal Schistosomiasis
Keywords: Schistosoma mansoni
morbidity
chemotherapy
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2013-07-17
Enrollment: 800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged 1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the effects of the disease will be assessed.Children found positive with S. mansoni will be treated with praziquantel and followed up for a year.

Detailed description: The study has three phases: in the first phase (Phase I) a baseline pretreatment schistosomiasis morbidity assessment of children aged 1-5 years will take place. The Kato-Katz technique will be used to detect and enumerate S. mansoni eggs in faecal samples from each participating child. Communities with the highest S. mansoni prevalence and intensity will be chosen and included in the study. In the second phase (Phase II) the S. mansoni positive children will be divided randomly into two intervention groups, single and double dose praziquantel treatment arms. Abdominal ultrasound will be combined with clinical examination to accurately identify hepatosplenomegaly. The sizes of both the liver and spleen will be examined. Anthropometric measurements and Hb for each child will also be recorded. In the last phase (Phase III), the effect of praziquantel on S. mansoni morbidity will be evaluated in all the treated children aged 1-5 years.

Eligibility criteria: Inclusion Criteria:

1-5 years

Exclusion Criteria:

\<1-5\> years

Primary outcomes:
measure: Presence/absence of organomegaly at Day 0 and 8 months follow-up visits
timeFrame: 2 years
Secondary outcomes:
measure: Cure rate at 30 days after treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Child Health & Development Centre, College of Health Sciences , Makerere University
Study officials:
affiliation: CHDC-Makerere University
name: Allen Nalugwa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Annette Olsen, PhD
role: STUDY_DIRECTOR
affiliation: Ministry of Health, Vector Control Division
name: Edridah Muheki, PhD
role: STUDY_DIRECTOR
affiliation: School of Public Health, Makerere University
name: Fred Nuwaha, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04531384: Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.
Official title: Randomized Clinical Trial of Robot-Assisted Intelligent Rehabilitation Treatment in Comparison With Standard Treatment for Methamphetamine Use Disorders and Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amphetamine Addiction
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders.

Detailed description: Based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of Robot-assisted rehabilitation intelligent system in Chinese methamphetamine patients.

Eligibility criteria: Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders;
* Education level equal or more than 9 years;
* Have normal or corrected-to-normal vision;
* Have normal or corrected-to-normal hearing;
* Less than 3 months before last drug use;

Exclusion Criteria:

* Current substance use (except nicotine or caffeine);
* History of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions;
* Intelligence quotient less than 70.

Primary outcomes:
measure: Changes of galvanic skin response during the virtual reality based addiction assessment system
timeFrame: in 1 year
Secondary outcomes:
measure: Treatment motivation
timeFrame: in 1 year
measure: Anxiety
timeFrame: in 1 year
measure: Depression
timeFrame: in 1 year
measure: Attentional bias related to drugs and emotional stimulation
timeFrame: in 1 year
measure: Risky decision-making
timeFrame: in 1 year
measure: Reaction inhibition ability
timeFrame: in 1 year
measure: Changes of electroencephalogram power spectrum during the virtual reality based addiction
timeFrame: in 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Gaojing Rehabilitation Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Min Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04379284: Risks of COVID19 in the Pregnant Population
Official title: Risks of COVID19 in the Pregnant Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19
Keywords: COVID19
Coronavirus
Pregnancy
Viral infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women testing positive for COVID19 at any time during their pregnancy after 8 weeks gestation, with or without physical symptoms. Pregnant women with respiratory or other physical symptoms of COVID19 and uncertain or negative COVID19 test results at the onset of labor.

Infants of these women will be followed for outcomes.

Brief summary: It is unclear how COVID19 can be passed from mother to infant. The study investigators aim to collect maternal and neonatal samples from COVID19-infected pregnant women and compare them to pregnant women who have clinical indications for COVID 19 testing at the time of hospital admission but end up being COVID19 negative. Pregnant women who are either COVID19 positive or COVID19 negative with respiratory symptoms will be enrolled and followed during this study.

Detailed description: The objectives are to understand the prevalence of maternal fetal transmission, risk factors and outcomes of a COVID19 positive pregnancy, and how the virus can be passed from mother to infant in the pregnant population at Mayo Clinic Rochester MN. Assessments will include the viral detection and viral load in maternal and fetal specimens collected from COVID19 positive mother-baby dyads, presence of maternal and fetal inflammatory markers in blood and tissues, anti-COVID IgG and IgM in maternal and neonatal blood, viral load and viral antigens in maternal and fetal specimens. placental gross and histopathologic changes in COVID19 infected mothers, stratified by gestational age and disease severity, compared to control samples.

.

Eligibility criteria: Inclusion Criteria:

* Pregnant women ages 18 - 45 years of age and their newborn infants
* Willing and able to provide written informed consent
* Planning to deliver at Mayo Clinic in Rochester, MN

Exclusion Criteria:

* Positive for HIV, HBV, or TB
* Delivery does not occur at Mayo Clinic

Primary outcomes:
measure: Determine the prevalence of maternal fetal transmission of COVID19
timeFrame: 12 months
Secondary outcomes:
measure: Describe the outcomes of COVID19 positive pregnancies
timeFrame: 12 months
measure: Understand the placental impact of COVID19 in pregnancy at various gestational ages
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Regan N Theiler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01439984: Trial of PED-1 in Male Patients With Premature Ejaculation
Official title: A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premature Ejaculation
Keywords: PE
IELT
DCIT
Lead sponsor: Symyoo
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 159
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
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 whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.

Detailed description: This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be \> or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Informed consent for subjects and partners
* Men 20-65 ages
* Stable monogamous relation at least for 6 mo
* Premature Ejaculation Diagnosis Tool (PEDT) more than 9
* At least 6 mo of premature ejaculation Hx
* IELT of =\< 2 min in \>= 75% of evaluable events during 4 week screening period

Exclusion Criteria:

* History of medical or psychiatric illness
* Erectile dysfunction (\<21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction
* Partner sexual dysfunction
* Known hypersensitivity to clomipramine and contraindications for clomipramine

Primary outcomes:
measure: Intravaginal ejaculation latency time (IELT)(seconds)
timeFrame: 12 weeks
Secondary outcomes:
measure: Drug coitus interval time (hours)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
state: Gyeonggi-do
city: Uijeongbu-si
country: Korea, Republic of
facility: Uijeongbu St.Marry's Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St.Marry's Hospital
Study officials:
affiliation: Seoul St. Marry's Hospital
name: Whan-Seok Choi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02611284: Less Invasive Beractant Administration in Preterm Infants
Official title: Less Invasive Beractant Administration in Preterm Infants: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: Beractant
Feasibility Studies
Infant, Premature
Noninvasive Ventilation
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to assess the efficacy and feasibility of a new less invasive surfactant administration (LISA) technique with a specific designed cannula for surfactant administration using Beractant replacement in preterm infants \<32 weeks of gestation and compare short and long term outcomes with the intubation, administration of surfactant and extubation method (INSURE).

This was a single-center, prospective, open-label, non-randomized, controlled study with an experimental cohort of 30 patients treated with LISA and a retrospective control group comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was administered as exogenous surfactant in both groups if patients on nasal continuous positive airway pressure (nCPAP) during the first three days of life were needed of more than 30% of fraction of inspired oxygen inspired oxygen fraction (FiO2).


Eligibility criteria: Inclusion Criteria:

* Preterm infants of less than 32 weeks of gestation (WG)breathing spontaneously on nCPAP during the first three days of life that met exogenous surfactant administration criteria (Table l) were eligible to enroll in the study

Exclusion Criteria:

* Infants who met intubation criteria (Table 1) at the moment of the surfactant administration were excluded in both groups.

Primary outcomes:
measure: % patients >1 h of mechanical ventilation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: need for intermittent mechanical ventilation (iMV)
timeFrame: through study completion, an average of 1 year
measure: second dose of surfactant
timeFrame: through study completion, an average of 1 year
measure: bradycardia episodes
timeFrame: through study completion, an average of 1 year
measure: attempts to catheterize
timeFrame: through study completion, an average of 1 year
measure: surfactant reflux cases
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Ramos-Navarro C, Sanchez-Luna M, Zeballos-Sarrato S, Gonzalez-Pacheco N. Less invasive beractant administration in preterm infants: a pilot study. Clinics (Sao Paulo). 2016 Mar;71(3):128-34. doi: 10.6061/clinics/2016(03)02.