louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05378802: Predict Transpulmonary Pressure Through ZAM
Official title: Comparison of Spontaneous Breathing and Controlled Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Stable patient with ARF spontaneously breathing light sedation (not too awake but with stable breathing pattern) and EAdi \>8 uV. Four modes of mechanical ventilation were performed under different support level for the measuring of EAdi, air way pressure and other parameters.

Detailed description: 1. Mode NAVA spontaneous breathing select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM.

   Increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase).Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAMAt the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.
2. Mode N- PSV spontaneous breathing :PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM。At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.Increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM.At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.

   Make record of RR, Vt, Flow, Ti during both periods.
3. Mode VCV no spontaneous breathing：Set Vt, Ti and RR to match the breathing pattern observed during NAVA
4. Mode PCV no spontaneous breathing-do ZAM after each PS level：Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes.

Eligibility criteria: Inclusion Criteria:

* Stable patient with acute respiratory failure on invasive mechanical ventilation Can tolerate pressure support ventilation light sedation with RASS between -2 and 1

Exclusion Criteria:

* EAdi\<8 uV contraindication for nasogastric tube insertion neuromuscular disease affecting spontaneous breathing lack of informed consent, and patients included in other intervention study

Primary outcomes:
measure: Predicted transpulmonary pressure
timeFrame: 6 hours
Secondary outcomes:
measure: patient-ventilator breath contribution
timeFrame: 6 hours
measure: inspiratory flow
timeFrame: 6 hours
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda hospital, Southeast university
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Haibo Qiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04938102: Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction
Official title: Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophagogastric Junction Disorder
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.

Detailed description: Esophagogastric Outflow Obstruction (EGJOO) is a newer diagnosis in which some patients' symptoms resolve spontaneously or with conservative treatment, while others require treatment with botulinum toxin injected into the lower esophageal sphincter. Currently, there is no way to distinguish these two groups of patients upon diagnosis. EndoFLIP (endolumenal functional lumen imaging probe) is a new technology that can measure the distensibility index (DI) of the lower esophageal sphincter. Data has suggested that normal and abnormal DI measurements can categorize these patients and guide treatment course (1). Our study looks to confirm this finding.

1. Elsbernd et al. Clinical characteristics and treatment response of esophagogastric junction outflow obstruction. Gastroenterology 2019;156(6):S-1017.

Eligibility criteria: Inclusion Criteria:

* diagnosed with esophagogastric junction outflow obstruction by high resolution manometry

Exclusion Criteria:

* previous upper gastrointestinal surgery
* significant medical co-morbidities
* eosinophilic esophagitis
* severe reflux esophagitis (LA-classification C or D)
* large hiatal hernia
* patients experiencing significant weight loss suspicious for malignancy
* Vulnerable populations such as cognitively or decisionally impaired individuals, children, pregnant women, prisoners, and students or employees of the University of Kansas Health System or Medical Center

Primary outcomes:
measure: Symptom Resolution
timeFrame: 12 weeks.
Secondary outcomes:
measure: Percent change in symptom score
timeFrame: 12 weeks.
measure: Mean symptom scores
timeFrame: 12 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas Medical Center
name: Reza Hejazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06030102: Voiding Log and Fluid Intake Habits
Official title: Voiding Log and Fluid Intake Habits Among Young Healthy Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Young Healthy Patients
Lead sponsor: Ghurki Trust and Teaching Hospital
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 38
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population comprises of both male and females. Young Healthy population aged between 24 to 38 years

Brief summary: Health practitioners usually instruct patients with complaints of urinary incontinence and urinary tract infection regarding voiding and fluid intake habits. However poor drinking habits develop early in life, even prior to the symptoms presentation. Little is known about the voiding habits and fluid intake routine among healthy young population. The current study aims to assess the habits of drinking and voiding log among such population.


Eligibility criteria: Inclusion Criteria:

* Both male and female Adolescent healthy population

Exclusion Criteria:

* History of incontinence Symptoms of urinary tract infection History of any pelvic floor disorder

Primary outcomes:
measure: Fluid intake
timeFrame: 1 month
measure: Voiding
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Health Sciences
state: Punjab
Study officials:
affiliation: University of Health Sciences Lahore Pakistan
name: Prof.Dr.Javed Akram, MBBS,FRCP,MRCP
role: STUDY_CHAIR
affiliation: Penn Medicine Healthcare New Jersey, USA
name: Dr. Irum Shah
role: STUDY_DIRECTOR
affiliation: Lahore College of Physical Therapy, LM&DC Lahore Pakistan
name: Dr. Muhammad Sheraz Alam
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahore College of Physical Therapy, LM&DC Lahore Pakistan
name: Dr. Maleeha Fuad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005002: Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)
Official title: A Randomized, Double-Blind, Adjuvant-Controlled, Multicenter Study to Compare the Virologic and Immunologic Effect of Highly Active Antiretroviral Therapy (HAART) Plus Remune Versus HAART Plus Incomplete Freund's Adjuvant (IFA) in Antiretroviral-Naive Patients Infected With Human Immunodeficiency Virus Type 1 (HIV-1)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
CD4 Lymphocyte Count
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
remune
Combivir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 688
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.

Detailed description: All patients begin HAART at study entry (Day 1). Patients with a plasma HIV-1 RNA level less than or equal to 2,000 copies/ml at Week 8 are randomized to receive Remune or Incomplete Freund's Adjuvant (IFA) at Week 9. Patients who do not achieve a plasma HIV-1 RNA level of less than or equal to 2,000 copies/ml at Week 8 are not randomized and are terminated from the study. These patients are eligible to receive funding for up to a 3-month supply of nelfinavir (Viracept) and Combivir. Randomized patients receive Remune or IFA at Week 9 and approximately every 12 weeks thereafter until study completion (when the last patient reaches Week 48). Patients are considered virologic failures if they (1) fail to achieve a virologic response by Week 48 or (2) after achieving a virologic response, have a virologic relapse. Regardless of their previous response status, patients whose plasma HIV-1 RNA level increases to greater than 2,000 copies/ml while they are receiving protocol-specified HAART are eligible to receive salvage therapy and continue to receive Remune or IFA until study completion. Study visits occur at screening, Day 1, Weeks 4, 8, 9, 12, and then every 4 weeks thereafter until the last patient reaches Week 48. Patients who complete this study are eligible to participate in a rollover study.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are at least 13 years old (consent of parent or guardian required if under 18).
* Have a viral load of at least 10,000 copies/ml.
* Have a CD4 count of at least 250 cells/mm3.
* Have never taken any anti-HIV drugs before.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Agouron Pharmaceuticals Inc
state: California
Study officials:
References:
Clinical trial NCT03644784: Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam.
Official title: Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Insufficiency
Aortic Valve Regurgitation
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Yamaguchi University Hospital
name: Segeberger Kliniken GmbH
name: McGill University
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Erasmus Medical Center
First posted: 2018-08-23
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aortic regurgitation that are undergoing TAVR in the 5 centers

Brief summary: The ASSESS-REGURGE is a multicenter, multicontinental registry on protocoled aortographic image acquisition after implantation of a transcatheter aortic valve. After the implementation of the acquisition protocol, each participating site will use the standardized approach for their center in order to identify if the images are considered analyzable via videodensitometry quantitative assessment of aortic regurgitation.


Eligibility criteria: Inclusion Criteria:

* Eligible and undergoing TAVR procedure

Exclusion Criteria:

* Considered not eligible for TAVR procedure by the local Heart Team

Primary outcomes:
measure: Feasibility (percentage of the cases considered analyzable) of analysis of aortic regurgitation from aortograms using the videodensitometry technique
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Yamaguchi
country: Japan
facility: Yamaguchi University
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: London
country: United Kingdom
facility: Imperial College
Study officials:
affiliation: Imperial College London
name: Patrick W Serruys, MD, PhD
role: STUDY_CHAIR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Rodrigo Modolo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Yoshinobu Onuma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modolo R, Chang CC, Tateishi H, Miyazaki Y, Pighi M, Abdelghani M, Roos MA, Wolff Q, Wykrzykowska JJ, de Winter RJ, Piazza N, Richardt G, Abdel-Wahab M, Soliman OII, Onuma Y, Van Mieghem NM, Serruys PW. Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry. EuroIntervention. 2019 Aug 29;15(5):420-426. doi: 10.4244/EIJ-D-19-00362.
Clinical trial NCT05347784: Vital Values at Circadian Markers in Postoperative Patients
Official title: Characterization of Vital Sign Circadian Fluctuations in Postsurgical Patients With or Without Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Circadian Dysrhythmia
Keywords: Postoperative physiology
Vital signs
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are drawn from two studies:

Clinical trials registry: NCT03491137 and NCT04473001

Brief summary: To describe changes in various diurnal patterns in vital values after surgery. These will be analyzed based on whether the patients have complications or no complications.


Eligibility criteria: Inclusion Criteria:

* Admitted for surgery
* Expected time of surgery was more than 2 hours.
* Expected post-operative length of stay was more than 2 days.

Exclusion Criteria:

* Allergy to study materials
* Patients with a pacemaker
* Patients that were expected to be unable to cooperate with study procedures (for instance a Mini-Mental State Exam(MMSE \< 25)

Primary outcomes:
measure: Postoperative complications
timeFrame: From start of continuous monitoring until 12 hours after monitoring stopped.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT03235284: Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease
Official title: Efficacy of Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease ande Video Games
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index, Timed up and go and PDQ-39, and will then be randomized to receive 16 sessions of Exercises or Nintendo Wii alone or together. After this period the patients will be reassessed to verify the effects of the techniques.

Detailed description: Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Equilibrium Scale, Evaluated by the Dynamic Gait Index and the Timed up and go and PDQ-39. Later patients will be randomized to receive 16 sessions of Kinesiotherapy or Nintendo Wii alone or together, twice a week, for 50 minutes at the Neurociencias Outpatient Clinic of Teacher Magalhães Neto - FUBA. After this period the patients will be reassessed to verify the effects of the techniques.

Eligibility criteria: Inclusion Criteria:

* Age between 40 and 80 years,
* Stage 1 to 3 on the Hoehn and Yahr scale,
* Absence of visual or auditory impairment,

Exclusion Criteria:

* Presence of cognitive alterations according to MEEM: illiterate 19 points; 1 to 3 years of schooling 23 points; 4 to 7 years 24 points and above 7 years of 28 points
* Presence of other neurodegenerative diseases,
* Uncontrolled osteomioarticular or chronic diseases
* Participation in other rehabilitation programs.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Dynamic Gait Index - DGI
timeFrame: 8 weeks
measure: Timed Up and Go - TUG
timeFrame: 8 weeks
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Complex Hospital Professor Edgard Santos, Federal University of Bahia
state: Bahia
Study officials:
References:
Clinical trial NCT05434884: Clinical Performance of Two Cad-cam Fabricated Ceramic Restoration in Teeth Affected With MIH
Official title: Clinical Performance of Two CAD/CAM Fabricated Ceramic Restorations With Different Preparation Designs for Rehabilitation Of Permanent First Molars Affected With Molar Incisor Hypomineralisation (MIH): Clinical Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molar Incisor Hypomineralization
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Altura
First posted: 2022-06-28
Enrollment: 64
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT)
Primary purpose: TREATMENT

Brief summary: This study will be performed to evaluate the clinical performance (Plaque accumulation, fracture of (restoration or tooth), postoperative sensitivity, secondary caries, marginal fit and discoloration) of two CAD/CAM fabricated ceramic restorations (zirconia-reinforced lithium silicate glass ceramic and hybrid ceramic) with different preparation designs (modified occlusal veneer and endocrown) for rehabilitation of permanent first molars affected with different severity level of molar incisor hypomineralisation (MIH), evaluated at different time periods

Detailed description: Clinical evaluation of all restorations will be performed according to:

- Modified United States Public Health Service (USPHS) Ryge Criteria, at base line (1 week), 3, 6 and 12 months after cementation.

Eligibility criteria: Inclusion Criteria:-

* Patient from 8 to 13 years
* permanent first molar tooth affected with different severity levels of MIH
* Ability to physically and psychologically tolerate conventional restorative procedures.

Exclusion Criteria:.

* Patients have active periodontal diseases.
* Patient with poor oral hygiene and motivation.
* Patient with psychiatric problems or unrealistic expectations

Primary outcomes:
measure: retention
timeFrame: 1 year
measure: marginal integrity
timeFrame: 6 months
measure: colour stability
timeFrame: 12 months
measure: Elimination of sensitivity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dr.sara nabil
Study officials:
affiliation: doctor
name: Mona Hossam, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05005884: Possible Effects of Supplement Therapy With Oral Phenolics on Cluster of Differentiation 163 (CD-163) Biomarker of Patients With Age-related Macular Degeneration
Official title: Evaluation of the Possible Effects of Supplement Therapy With Oral Phenolics on Plasma CD-163 Biomarker in Patients With Different Subtypes of Age-related Macular Degeneration; a Double-blind Placebo Controlled Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Age Related Macular Degeneration
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Swiss Eye Institute
First posted: 2021-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this multi-center study, possible effects of supplement treatment with oral phenolics on plasma CD-163 and progression of dry and wet age-related macular degeneration (AMD) via evaluating the CD163 before and after the prescription of this drug will be evaluated in patients with dry type AMD and Neo vascular age-related macular degeneration (nAMD).

Both AMD subgroups will be recruited. In terms of evaluation of the effects of phenolics (500 mg caplets/day) on AMD progression, patients will be randomized and divided into 2 subgroups i.e. (i) receiving phenolics supplementation; and, (ii) receiving placebo for 1 month. The phenolics/placebo caplets will resemble completely and be encoded at origin; Neither the participants nor the researchers will be informed about the codes until the end of the study.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of intermediate to late AMD (dry AMD and nAMD )
* Age-matched controls without any sign of AMD
* Signed informed consent

Exclusion Criteria:

* Systemic disease or other eye-related diseases (diabetes, immunologic or inflammatory, active or chronic infectious disease, active malignancy, uveitis, retinal vascular occlusive disease, glaucoma)
* Systemic therapy with corticosteroids or biological drugs.

Primary outcomes:
measure: Concentration of Plasma CD-163
timeFrame: 1 month
Secondary outcomes:
measure: Decimal acuity of vision
timeFrame: 1 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References: