louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01174342: Effect of Child Delivery on Intraocular Pressure
Official title: The Effect of Child Delivery on the Intraocular Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Delivery, Obstetric
Keywords: Intraocular pressure
Ocular tonometry
Obstetric delivery
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women candidate for chlid delivery

Brief summary: The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure in healthy women.

Detailed description: Little is known about the changes in intraocular pressure (IOP) during child delivery. During labor there are several stages which are accompanied by many physiological changes and pharmacological interventions that may potentially influence the IOP. Among these are delivery position (lying versus sitting or kneeling), vascular changes and pharmacological effects (anesthetic agents, oxytocin and other drugs). The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure (IOP) in healthy women. This will expend our understanding of the physiology of labor and its effect on the eye and it may serve as basis to determine the management of labor.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Pregnant women admitted to the labor room.
* Healthy women that do not take any systemic medications.
* No known ocular condition, except for refraction errors, strabismus or amblyopia.
* Eligible women who are able to sign an informed consent form.

Exclusion Criteria:

* Family history of glaucoma (first degree relatives).
* Known allergic reaction to local anesthesia (oxybuprocaine hydrochloride).
* Women who are unable to sign an informed consent form.

Primary outcomes:
measure: Intraocular Pressure
timeFrame: During child delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Fani Segev, M.D.
role: STUDY_CHAIR
affiliation: Meir Medical Center
name: Noa Geffen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02289742: Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric
Official title: Characterization of Pre-Lens Tear Film Stability of Daily Disposable Multifocal and Toric Contact Lenses Using Ring Mire Projection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Dailies AquaComfort Plus® Multifocal (DACP MF)
Dailies AquaComfort Plus® Toric (DACP Toric)
tear film stability
Non-Invasive Keratograph Break-Up Time (NIK-BUT)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear.

Detailed description: Two population groups (presbyopes and astigmats) will be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent document;
* Adapted, current soft contact lens wearer with either:

  1. A spectacle add between +0.50 and +2.50 (inclusive) \[Presbyopes group\]
  2. A spherical correction of an astigmatism up to 20% of the amount of the sphere \[Astigmats group\];
* Contact lens prescription in the power range specified in the protocol;
* Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
* Willing to wear study lenses up to 12 hours and attend all study visits;
* Can be successfully fitted with study lenses;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Use of artificial tears and rewetting drops during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pregnant or lactating;
* Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;
* Participation in any clinical study within 30 days of Visit 1;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
timeFrame: Hour 12, each product
Secondary outcomes:
measure: Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear
timeFrame: Hour 8, each product
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Manager, Global Med Affairs, Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT02122042: Hyperbaric Oxygen Therapy Can Improve Cognitive Deficits Post Low Grade Glioma Removal Surgery
Official title: Hyperbaric Oxygen Therapy Can Improve Cognitive Deficits Post Low Grade Glioma Removal Surgery - Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Post Low Grade Glioma Surgery
Cognitive Deficits
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-04-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic impairment after low grade glioma tumor removal surgery


Eligibility criteria: Inclusion Criteria:

* Post low grade glioma (WHO I-II) removal surgery 3-12 months prior to the inclusion in the study.
* All patients have to have persistent cognitive impairment (Mindstream score should be at least one SD lower than average) regarding without noticeable improvement during the last month prior to their enrolment.
* Age 18 years or older.

Exclusion Criteria:

* Dynamic neurologic/cognitive improvement or worsening during the past month; Previous brain radiotherapy and/or radiosurgery. Steroids dependence Chemotherapy in the past month or scheduled in the next 3 months Seizures 1 month previous to inclusion Had been treated with HBOT for any other reason 1 month prior to inclusion; Have any other indication for HBOT; Chest pathology incompatible with pressure changes; Inner ear disease; Patients suffering from claustrophobia; Inability to sign written informed consent; Smoking patients will not be allowed to smoke during the study and if they would not comply with this demand they will be excluded.

Primary outcomes:
measure: Neurocognitive functions
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Shai Efrati, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01568242: Changes in Vitreous Temperature During Phacoemulsification
Official title: Changes in Vitreous Temperature During Phacoemulsification
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Keywords: Cataract
Phacoemulsification
Temperature
Vitreous
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Temperature in the vitreous cavity decreases during vitrectomy, and the same effect is seen during an uneventful phaco surgery. Significant changes occur between the baseline temperature and after every step of the surgery.

Detailed description: A 23-gauge thermometer probe inserted prior to the beginning of the cataract surgery to measure the vitreous temperature at different stages of the procedure (capsulorrhexis, hydrodissection, phacomulsification, irrigation/aspiration and intraocular lens (IOL) implantation). Room temperature also registered during every step. At the end of the surgery, oral temperature will be measured.

Eligibility criteria: Inclusion Criteria:

* Patients from the Retina department that underwent phacoemulsification and vitrectomy

Exclusion Criteria:

* Posterior capsule rupture

Primary outcomes:
measure: Vitreous temperature
timeFrame: Every five minutes during a phacoemulsification procedure, and at every step of the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación Para Evitar la Ceguera en México
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Hugo Quiroz-Mercado, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00430742: An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)
Official title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Overweight and Obese Patients With Type 2 Diabetes Mellitus (T2DM) Followed by a 1-Year Extension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-02-02
Enrollment: 600
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: A worldwide study with extension in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug for weight loss on body weight.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 27 kg/m2 and 43 kg/m2 and HbA1c between 7.0% and 10%

Exclusion Criteria:

* History of major psychiatric disorder
* Blood pressure greater than 160/100
* Use of any antihyperglycemic agent other than metformin
* Triglycerides greater then 600 mg/dL

Primary outcomes:
measure: Body weight at 36 weeks, HbA1c at 36 weeks
timeFrame: 36 weeks
Secondary outcomes:
measure: Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks
timeFrame: 24 and 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kipnes MS, Hollander P, Fujioka K, Gantz I, Seck T, Erondu N, Shentu Y, Lu K, Suryawanshi S, Chou M, Johnson-Levonas AO, Heymsfield SB, Shapiro D, Kaufman KD, Amatruda JM. A one-year study to assess the safety and efficacy of the CB1R inverse agonist taranabant in overweight and obese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Jun;12(6):517-31. doi: 10.1111/j.1463-1326.2009.01188.x.
Clinical trial NCT06826742: Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery
Official title: Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cesarean Delivery
Keywords: methadone
morphine
intrathecal
cesarean
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Age over 18 years old
* Scheduled cesarean delivery

Exclusion Criteria:

* Any contraindication to the administration of a spinal technique for anesthesia
* History of intolerance or adverse reaction to opioid medications
* History of chronic pain, opioid use \>30 OME/day, or substance use disorder
* History of obstructive sleep apnea, chronic obstructive pulmonary disease, or respiratory compromise (SpO2 \<92% on room air, or has a pre-existing oxygen requirement)
* History of liver or kidney failure
* Diagnosis of pre-eclampsia with current pregnancy
* Depression requiring more than one medication
* Planned use of CSE technique
* BMI \>50.0 kg/m2
* ASA status IV, V
* No prior history of an ECG demonstrating QTc \> 440ms
* Surgical complication requiring conversion to general anesthesia

Primary outcomes:
measure: Total opioid consumption
timeFrame: 24 hours post-delivery, 48 hours post-delivery
Secondary outcomes:
measure: Obstetric Quality of Recovery-10 (ObsQoR-10) Scoring Tool
timeFrame: 24 hours, 48 hours, 7 days
measure: Numeric Rating Scale (NRS) pain score at rest
timeFrame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
measure: Numeric Rating Scale (NRS) for movement-evoked pain
timeFrame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
measure: Numeric Rating Scale (NRS) for pain in previous 24 hours
timeFrame: 12 hours, 24 hours, 36 hours, 48 hours, 7 days
measure: Pruritus
timeFrame: 12 hours, 24 hours, 36 hours, 48 hours
measure: Richmond Agitation Sedation Scale (RASS)
timeFrame: 12 hours, 24 hours, 36 hours, 48 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Emily E Sharpe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02963142: A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia
Official title: A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia
Respiration Failure
Pneumonia
Keywords: Intensive care
Extra-corporeal membrane oxygenation (ECMO)
Severe Respiratory Infections
Sequencing
Metagenome
Diagnosis
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: NIHR HPRU in Respiratory Infections
First posted: 2016-11-15
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults admitted to Extra-Corporeal Membrane Oxygenation (ECMO) and Intensive Care Units (ICU) centres in England for severe community-acquired pneumonia

Brief summary: Severe community acquired pneumonia is common and associated with high mortality. Conventional microbiological diagnostics identify pathogens in approximately half of cases, which is inadequate for both clinical and epidemiological purposes. This study applies next-generation sequencing based metagenomic techniques to patients with extremely severe community acquired pneumonia, to investigate the microbiome of severe community acquired pneumonia and evaluate metagenomic approaches as diagnostic tools.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 or over
* Admitted to a participating severe respiratory failure centre or ICU
* Admitted due to community acquired pneumonia (CAP) according to clinical and radiological criteria
* Tracheal intubation, receiving mechanical ventilation +/- ECMO
* Requires bronchoscopy as part of routine diagnostic care plan
* Bronchoscopy takes place within 72 hours of first admission to hospital

Exclusion Criteria:

* Any current or previous condition/circumstance that, in the opinion of the investigator or study nurse, may put the individual at risk if participating
* Patients receiving end of life care
* Hospitalisation within the previous 28 days (not including pre-ECMO hospitalisation for ECMO patients)
* Consent or assent not given

Primary outcomes:
measure: Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples
timeFrame: 28 days (From time of enrollment up until end of inclusion)
Secondary outcomes:
measure: Metagenomic detection of pathogen genomes compared to the results of conventional diagnostic techniques
timeFrame: 28 days (From time of enrollment up until end of inclusion)
Other outcomes:
Locations:
city: Paddington
country: United Kingdom
facility: Ajit Lalvani
Study officials:
affiliation: Imperial College London
name: Ajit Lalvani, MBBS,MRCP,FRCP
role: STUDY_CHAIR
References:
Clinical trial NCT02203942: Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis
Official title: Comparing NAAT Testing to Standard Methods in Diagnosis of Vaginal Infections in the General Gynecology and Vulvovaginal Referral Offices.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Vaginosis
Vulvovaginal Candidiasis
Trichomoniasis
Keywords: Bacterial Vaginosis
Vulvovaginal Candidiasis
Trichomoniasis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollments will include patients seeking care at Magee-Womens Hospital.

Brief summary: Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard.

The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).

Detailed description: Several commercial nucleic acid amplification tests (NAAT) are available to identify causative organisms. One of these commercial tests has undergone validation published in a scientific journal, only in an STD clinic population. The primary outcome of this study is to compare NAAT diagnostic methods to traditional gold-standard tests for BV, VVC and TV in symptomatic and asymptomatic women in the general gynecology office as well as in a vulvovaginitis referral office. Addressing incorrect evaluation and diagnosis will lead to correct treatment for women suffering from vaginitis.

Eligibility criteria: Inclusion Criteria:

1. Female participants aged 18 and older
2. Based on symptoms:

   * Symptomatic patients: with symptoms of vaginitis that include abnormal discharge, malodor, itching, irritation and / or discomfort
   * Asymptomatic controls: no vulvovaginal symptoms
3. Willing to provide written informed consent for participation in this study

Exclusion Criteria:

1. Use of oral antibiotics in the past 14 days
2. Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24 hour

Primary outcomes:
measure: Diagnosis of Vaginal Infections
timeFrame: approximately 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Harold C Wiesenfeld, MD, CM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06354842: Measurement of Sweat Sodium Concentration in Patients With Chronic Kidney Disease
Official title: Application of Pilocarpine Iontophoresis in Patients With Chronic Kidney Disease: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls older than 18 years old. Patients older than 18 years old with all grades of Chronic Kidney Disease (also patients receiving hemodialysis)

Brief summary: It has been shown that excretion of sodium and water through the skin in the form of sweat represents a regulatory mechanism of electrolyte- and fluid balance. Since patients with chronic kidney disease (CKD) exhibit increased skin sodium content, we investigated the feasibility of sweat testing as a novel experimental tool to a more complete assessment of fluid- and sodium homeostasis.

In this cross-sectional feasibility study, we applied pilocarpine iontophoresis to induce sweat testing in 58 patients across various stages of CKD including patients after kidney transplantation as well as a healthy control cohort (n=6) to investigate possible effects of CKD and transplantation status on sweat rate and sodium concentration. Due to non-linear relationships, we modeled our data using polynomial regression.

Decline of kidney function showed a significant association with lower sweat rates: adj R²= 0.2278, F(2, 61) = 10.29, p = 0.000141. Sweat sodium concentrations were increased in moderate CKD, however this effect was lost in end stage renal disease: adj R² = 0.3701, F(4, 59) = 10.26, p = 2.261e-06. We observed higher sweat weight in males compared to females.

Diagnostic sweat analysis represents an innovative and promising noninvasive option for more thorough investigation of sodium- and fluid homeostasis in CKD patients. Lower sweat rates and higher sweat sodium concentrations represent a unique feature of CKD patients with potential therapeutic implications.


Eligibility criteria: Inclusion Criteria:

Completed 18th year of life and the ability and willingness to provide informed consent

Exclusion Criteria:

General exclusion criteria were signs of acute infection, clinical signs of kidney graft rejection or pregnancy. Exclusion criteria for the healthy controls were pregnancy or the presence of chronic metabolic, renal, cardiovascular, or rheumatologic conditions, hypertension, chronic or recent intake (8 weeks prior to testing) of psychiatric or antihypertensive medication.

Primary outcomes:
measure: Sweat sodium concentration
timeFrame: Right after study inclusion of patients/subjects
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Johannes Kovarik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: