louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04882189: Study of Endothelial Cell Condition After Cataract Surgery Performed Using Capsulorhexis or ZEPTO
Official title: A Prospective Randomized Controlled Masked Study of Endothelial Cell Condition After Cataract Surgery Performed Using Manual Capsulorhexis or the ZEPTO Precision Capsulotomy System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endothelial Cell Density Loss
Lead sponsor: Centricity Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with symptomatic age-related lens cataract desiring lens extraction and IOL implantation.

Brief summary: This study will use images of the subjects' corneal endothelium obtained using non-invasive specular microscopy to obtain corneal endothelial cell density, the coefficient of variation in endothelial cell size, and the percentage of hexagonal endothelial cells following routine cataract surgery performed using the standard method of manual capsulorhexis compared to cataract surgery performed using Zepto Precision Capsulotomy System.


Eligibility criteria: Inclusion Criteria:

* Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age-related lens cataract, and then electing to undergo the study,
* Subjects must be willing and able to return for scheduled treatment and follow-up examinations at 1 and 3 months.

Exclusion Criteria:

* Pre-existing corneal endothelium pathology
* Presence of guttae
* Narrow angle glaucoma or advanced glaucoma
* Psuedoexfoliation
* Zonular abnormalities
* Corneal endothelial cell density less than 1800 cells/mm2
* Uveitis
* Anterior chamber depth less than 2.5mm or greater than 3.75mm
* Cataract grade LOCS II \> 3
* Posterior polar cataract
* Planned implantation of IOL \> 25D
* Prior ocular surgery in the study eye
* History of medications with potential corneal endothelial cell toxicity
* Any condition that in the surgeon's judgement should exclude the subject from study enrollment.
* Current participation in another drug or device clinical study, or participation in such a clinical study within the prior six months and during the duration of the current study

Primary outcomes:
measure: Endothelial Cell Density Loss
timeFrame: 3 months
Secondary outcomes:
measure: Endothelial Cell Density Loss
timeFrame: 1 month
measure: Coefficient of Variation in Endothelial Cell Size
timeFrame: 1 and 3 months
measure: % of hexagonal cells
timeFrame: 1 and 3 months
Other outcomes:
Locations:
city: Eagle Pass
country: United States
facility: UltraVision
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: UltraVision
state: Texas
Study officials:
References:
Clinical trial NCT05811689: Trabecular Bone Score in Multiple Sclerosis
Official title: Trabecular Bone Score (TBS) as an Innovative Parameter Evaluation for Bone Disease's in Multiple Sclerosis (MS) Patients and Impact of Osteoporosis on the Quality of Life of Patients With MS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Endocrine System Diseases
Neurologic Disorder
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 300 subjects aged between 20 and 65, belonging to the MS Outpatient Clinic of the IRCCS Centro Neurolesi Bonino Pulejo will be recruited

Brief summary: Assess bone quality in MS patients through TBS and evaluate the potential effects exerted by different drugs used in MS treatment, which may affect BMD and TBS in MS patients


Eligibility criteria: Inclusion Criteria:

* diagnosis of MS according to the latest revision of McDonald's criteria;
* patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (SPMS);
* absence of cortisone therapy for at least 6 months;

Exclusion Criteria:

patients already being treated with anti-osteoporotic drugs;

• medical conditions that preclude the execution of the densitometric examination

Primary outcomes:
measure: DXA scanner (Horizon© DXA System)
timeFrame: 6 months
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: 6 months
Other outcomes:
measure: TBS iNsight™ Hologic
timeFrame: 6 months
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
Study officials:
References:
Clinical trial NCT04906889: the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy
Official title: The Effect of Opioid-free Anesthesia Using Dexmedetomidine-lidocaine on Acute Postoperative Pain in Gynecological Laparoscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effect of opioid-free anesthesia using dexmedetomidine and lidocaine instead of remifentanil infusion, on the acute postoperative pain after the gynecological laparoscopy

Detailed description: This study is performed to investigate the effect of dexmedetomidine and lidocaine the postopeative pain, shivering, nausea and vomiting after the gynecological laparoscopy.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective gynecological laparoscopy

Exclusion Criteria:

* emergent surgery
* cancer surgery
* chronic pain requiring pain killers
* psychiatric disease
* preoperative bradycardia (HR \< 50 bpm)
* allergies
* pregnancy or breast feeding

Primary outcomes:
measure: postoperative pain in recovery room
timeFrame: 30 minuetes after the completion of surgery
Secondary outcomes:
measure: shivering in recovery room
timeFrame: 30 minuetes after the completion of surgery
measure: postoperative nausea and vomiting (PONV)
timeFrame: 30 minutes after the completion of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
city: Seocho
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
Study officials:
affiliation: Associate professor, Department of Anesthesiology and Pain Medicine
name: Young Eun Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03059589: Registry of Food Allergy Oral Immunotherapy Treatment
Official title: National Registry of Food Allergy Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Keywords: food anaphylaxis
peanut anaphylaxis
food oral immunotherapy
food allergy
food allergy treatment
Lead sponsor: Food Allergy Support Team
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to participating clinical sites with high probability of food allergy who choose to undergo food oral immunotherapy treatment.

Brief summary: The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.

Detailed description: Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.

Eligibility criteria: Inclusion Criteria:

* a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food,
* no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food

Exclusion Criteria:

* pregnancy
* severe asthma
* poorly controlled atopic dermatitis
* eosinophilic esophagitis

Primary outcomes:
measure: efficacy of food allergy treatment
timeFrame: 3 years
Secondary outcomes:
measure: epinephrine use
timeFrame: 3 years
measure: factors associated with the failure to reach the target dose of food ingestion
timeFrame: 3 years
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Food Allergy Center of FL
state: Florida
Study officials:
name: Hugh Windom, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wasserman RL, Factor JM, Baker JW, Mansfield LE, Katz Y, Hague AR, Paul MM, Sugerman RW, Lee JO, Lester MR, Mendelson LM, Nacshon L, Levy MB, Goldberg MR, Elizur A. Oral immunotherapy for peanut allergy: multipractice experience with epinephrine-treated reactions. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):91-6. doi: 10.1016/j.jaip.2013.10.001.
citation: Nachshon L, Goldberg MR, Elizur A, Levy MB, Schwartz N, Katz Y. A Web site-based reporting system for monitoring home treatment during oral immunotherapy for food allergy. Ann Allergy Asthma Immunol. 2015 Jun;114(6):510-5. doi: 10.1016/j.anai.2015.04.007. Epub 2015 May 1.
Clinical trial NCT04473092: Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort
Official title: Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who undergo TVMR for MR (age \>18yrs) at the PI´s site

Brief summary: To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.

Detailed description: Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied in patients on high surgical risk. Interventional mitral valve repair can be applied is routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge technique has been the solely available technlology in the marked for the last years, the recently introduced PascalTM technology represents a novel concept and is characterized by a central spacer, wider paddles, and larger dimensions. Implications of implantation of the PascalTM device on the mitral valve morphology and functionality concerning potential changes on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully understood. The current study will identify anatomical changes to optimize ideal patient selection and optimal treatment approaches of the PASCALTM device.

Eligibility criteria: Inclusion Criteria:

• All patients who undergo TVMR for MR (age \>18yrs) at the PI´s site

Exclusion Criteria:

* \<18yry
* Subject does not provide full consent

Primary outcomes:
measure: Morphologic and functional changes of mitral valve anatomy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine
state: NRW
Study officials:
affiliation: University Hospital Essen, Westgerman Heart- and Vascular Center, Department of Cardiology and Vascular Medicine
name: Peter Lüdike, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04934592: Correlation Between Non-motor Symptoms and Malnutrition in Patients With Parkinson's Disease
Official title: Correlation Between Non-motor Symptoms and Malnutrition in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson in the hospital

Brief summary: This study used Mini Nutrition Assessment (MNA) , Nutrition risk screening 2002(NRS-2002) and Non-motor Symptom Quest (NMSquest) to investigate the nutritional status of patients with Parkinson's disease, to analyze the correlation between non-motor symptoms and malnutrition in patients with Parkinson's disease (PD) , and to provide evidence for clinical treatment and early nutritional intervention.

Detailed description: Data were collected by questionnaire survey.For arkinson patients who were admitted to the facility between June 2020 and July 2021 were targeted. This study used convenience sampling and included criteria: length of stay \> 24 hours; Parkinson patients who met Chinese diagnostic criteria for Parkinson's disease (2016 edition) ; willing participants and able to complete the scale. Exclusion criteria: parkinsonism caused by cerebrovascular disease, encephalitis, traumatic brain injury, complete transfusion of blood, plasma, albumin within one month, severe gastrointestinal disease, metabolic disease, and other wasting diseases; Patients with critical illness, severe cognitive impairment, and inability to communicate. The study was approved by the medical ethics committee with the informed consent of all selected individuals and their families

Eligibility criteria: Inclusion Criteria:

* Length of stay \> 24 hours; Parkinson patients who met Chinese diagnostic criteria for Parkinson's disease (2016 edition) ; willing to participate in the study and able to complete the scale.

Exclusion Criteria:

* Parkinson's disease caused by cerebrovascular disease, Encephalitis, traumatic brain injury; patients who have received whole blood, plasma, albumin within one month; patients with severe gastrointestinal disease, metabolic disease and other wasting diseases; Patients with critical illness, severe cognitive impairment, and inability to communicate.

Primary outcomes:
measure: Incidence rate of nutritional risk Nutrition Assessment
timeFrame: Within 8 hours after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Medical College of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02681289: Physiotherapy of At-Risk Infants, Physiotherapist or Family?
Official title: Physiotherapy of At-Risk Infants, Physiotherapist or Family? A Randomized Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem With Growth of an Infant
Keywords: infant
risk
rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2016-02-12
Enrollment: 40
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants.

Detailed description: Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants. Eighteen at-risk infants between the ages of 0 and 12 months were assigned to the preterm and term groups according to their gestational and corrected age. Each group received GDNT for 45 min, three days per week for 12 weeks. The effectiveness of the therapy was measured using Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE), and Goal Attainment Scale (GAS).

Eligibility criteria: Inclusion Criteria:

* being diagnosed as "at-risk" by a pediatric neurologist, having intraventricular hemorrhage, periventricular leucomalacia, hypoxic ischemic encephalopathy, and prematurity, Apgar score of 5 or less at 5 min, chronic lung disease, seizures, meningitis, hyperbilirubinemia, being twins or triplets, and having intrauterine growth restriction;
* being outside of the neonatal intensive care unit;
* being between 0 and 12 months old (corrected age for premature infants);
* having a family acceptance for the participation in 12 weeks of therapy program.

Exclusion Criteria:

* having congenital anomalies, musculoskeletal disorders, cyanotic congenital heart disease and mechanical dependency, and
* lack of informed content by the parents.

Primary outcomes:
measure: Hammersmith Infant Neurological Examination (HINE)
timeFrame: 12 weeks
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: 12 weeks
measure: Goal Attainment Scale (GAS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Mintaze Kerem Gunel, PT, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Zafer Erden, PT, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06927089: Non-Invasive Hemodynamic Monitoring of MV ILD Patients With ARF
Official title: Non-Invasive Hemodynamic Monitoring of Interstitial Lung Disease Patients With Acute Respiratory Failure in Different Modes of Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Interstitial Lung Disease (ILD)
Keywords: ILD
MV
non-invasive hemodynamic monitoring
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interstitial lung disease patients with acute respiratory failure admitted to respiratory ICU in different modes of MV (NIV, invasive MV and HVNI).

Brief summary: Non-invasive hemodynamic monitoring of interstitial lung disease (ILD) patients admitted to respiratory ICU with acute respiratory failure and differentiate according to different modes of mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* Interstitial lung disease patients with acute respiratory failure admitted to respiratory ICU in different modes of MV (NIV, invasive MV and HVNI).

Exclusion Criteria:

-

Primary outcomes:
measure: Non-invasive Hemodynamic Monitoring
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT00004689: Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycobacterium Avium-intracellulare Infection
Keywords: bacterial infection
immunologic disorders and infectious disorders
mycobacterium avium infection
mycobacterium infection
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2000-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium avium complex (MAC) pulmonary disease.

II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC infection.

III. Determine the safety and tolerance of amithiozone with chronic dosing in these patients.

IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin, and amithiozone in the treatment of pulmonary MAC infection.

Detailed description: PROTOCOL OUTLINE: The is a randomized, open label study. All patients receive a core regimen of clarithromycin and streptomycin. Patients are randomized into two treatment arms. Arm I patients receive rifampin and ethambutol. Arm II patients receive amithiozone.

Patients are followed for one year to detect any relapse or other complications.

Patients not eligible for this randomized study may be entered on a short open label study with amithiozone.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Progressive pulmonary disease due to Mycobacterium avium complex (MAC) as defined by: Three of more sputum culture(s) positive for MAC Change in serial chest roentgenograms consistent with active mycobacterial disease over a 12 week period No other obvious cause of pulmonary disease
* Patients must have organisms that are: Susceptible to amithiozone AND Susceptible or moderately susceptible to the combination of rifampin and ethambutol, and to clarithromycin and streptomycin

--Prior/Concurrent Therapy--

* No likelihood of resectional thoracic surgery within 24 weeks of evaluation

--Patient Characteristics--

* Age: 18 and over
* Performance status: Not specified
* Hematopoietic: Not specified
* Hepatic: Bilirubin less than 3 times normal SGOT/SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal
* Renal: Creatinine clearance at least 30 mL/min
* Cardiovascular: No New York Heart Association class III or IV heart failure
* Other: No optic disease that precludes the use of ethambutol No hypersensitivity to rifampin, ethambutol, clarithromycin, streptomycin, or amithiozone HIV negative Not pregnant or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Jewish Health
name: Charles Arthur Peloquin
role: STUDY_CHAIR
References: