louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00824837: Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane
Official title: Randomised, Cross Over Pilot Study Comparing Removal of beta2-Microglobulin by Standard Haemodialysis to Haemodialysis With a Novel Dialysis Membrane (P2SH) in Chronic Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Renal Dialysis
Keywords: beta 2 microglobulin
haemodialysis
albumin
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
First posted: 2009-01-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 determine whether a novel haemodialysis membrane, compared with the standard dialysis membrane, will increase the removal of beta2-microglobulin in chronic dialysis patients.

Detailed description: Despite advances in treatment of kidney diseases, morbidity and mortality of chronic dialysis patients remains unsatisfactory. Standard haemodialysis membranes remove middle-sized molecule solutes poorly such as beta2-microglobulin, which has a pathogenic role in dialysis-related amyloidosis. Pre-dialysis beta2-microglobulin concentration has been shown to be independently predictive of mortality. A new polyamide haemodialysis membrane has been developed with increased pore size to increase the removal of middle-sized uraemic toxins such as beta2-microglobulin. This study aims to evaluate the effectiveness of the new membrane in beta2-microglobulin removal compared with standard haemodialysis membrane in dialysis patients and the degree of increased loss of albumin as a potential limiting factor of its use.

Eligibility criteria: Inclusion Criteria:

* Chronic haemodialysis patients for more than 2 years
* Urine output \<100 mL per day
* 3 haemodialysis sessions per week
* Permanent arteriovenous dialysis access

Exclusion Criteria:

* Serum albumin \<25 g/L

Primary outcomes:
measure: Beta2-microglobulin removal by new larger pore membrane versus standard haemodialysis membrane
timeFrame: 5 weeks (2 weeks in each arm, 1-week washout period)
Secondary outcomes:
measure: Albumin loss with the use of new larger pore membrane compared with standard haemodialysis membrane
timeFrame: 5 weeks (2 weeks in each arm, 1-week washout period)
measure: Removal of low-molecular-weight solutes by new larger pore membrane versus standard haemodialysis membrane
timeFrame: 5 weeks (2 weeks in each arm; 1-week washout period)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: Director Intensive Care Research, Austin Health
name: Rinaldo Bellomo, MBBS,MD,FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04288037: Fetal Heart Rate Variability and Fetal Growth Restriction
Official title: Fetal Heart Rate Variability Compared to Doppler Flows in the Growth Restricted Fetus: a Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Growth Retardation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
name: Hartmann Fonden
name: Augustinus Fonden
name: The Dagmar Marshall Foundation
name: AP Moeller Foundation
First posted: 2020-02-27
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women expecting a small for gestational age child. Danish.

Brief summary: There is growing evidence in the field of fetal heart rate variability revealing the fetal neurological state. Furthermore, fetal heart rate variability has shown potential as fetal surveillance in fetal growth restriction.

This study aim to investigate the association between fetal heart rate variability and doppler flow changes in growth restricted fetuses.


Eligibility criteria: Inclusion Criteria:

* singleton pregnant women with estimated fetal weight below 2 standard deviations (2SD) of mean for gestational age corresponding to minus 22%. Fetal weight assessed by doppler ultrasound.

Exclusion Criteria:

* Fetal malformations

Primary outcomes:
measure: Root mean square of successive inter beat interval differences RMSSD
timeFrame: 1/12-2020
measure: Standard deviation of normal to normal inter beat interval (SDNN)
timeFrame: 1/12-2020
measure: Low frequency power (LF-power)
timeFrame: 1/12-2020
measure: High frequency power (HF-power)
timeFrame: 1/12-2020
measure: Low frequency power/High frequency power (LF/HF)
timeFrame: 1/12-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Arhus Universityhospital
state: Aarhus N
Study officials:
References:
Clinical trial NCT01196637: Thoracic Outlet Syndrome: Case Reports and Analysis With Ultrasound Imaging
Official title: Thoracic Outlet Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Brachial Plexus Compression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Outlet Syndrome
Keywords: thoracic outlet syndrome
brachial plexopathy
ultrasonography
Lead sponsor: EMG Labs of Arizona Arthritis & Rheumatology Associates
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with upper limb symptoms of pain, numbness, tingling, or weakness, aggravated by arm abduction; Adult patients with no upper limb symptoms

Brief summary: Thoracic outlet syndrome is caused by compression of the brachial plexus, in most cases under the pectoralis minor muscle in the infraclavicular region of the shoulder. The hypothesis is that ultrasound imaging can be used to visualize brachial plexus compression and distortion of the pectoralis muscle during arm activity, such as abduction, and that normal subjects will not demonstrate any plexus compression or muscle distortion.

Detailed description: Four patients with thoracic outlet syndrome (TOS) underwent clinical exam and nerve testing to prove that they had TOS and no other nerve abnormality. They subsequently had ultrasound imaging of the shoulder (infraclavicular region) at rest and during arm abduction stress testing. Two control subjects had similar clinical exams and nerve testing to prove they did not have TOS, and then underwent similar ultrasound stress testing. The TOS patients demonstrated brachial plexus compression and pectoralis minor muscle distortion during the stress tests, and the normal subjects showed no plexus compression or muscle distortion.

Eligibility criteria: INCLUSION CRITERIA:

Thoracic outlet patients must have:

* symptoms consistent with thoracic outlet syndrome, and
* no electrical testing abnormality, and
* positive arm abduction stress tests.

Normal subjects must have:

* no upper limb symptoms, or
* normal nerve testing, and
* negative arm abduction stress test

EXCLUSION CRITERIA:

Thoracic outlet patients excluded if they have:

* nerve test abnormalities, or
* negative arm abduction stress test

Normals excluded if they have:

* abnormalities on nerve testing, or
* positive arm abduction stress tests

Primary outcomes:
measure: Brachial plexus compression on ultrasound imaging in thoracic outlet syndrome patients
timeFrame: 4 months
Secondary outcomes:
measure: No brachial plexus compression in normal subjects
timeFrame: 4 months
Other outcomes:
Locations:
city: Paradise Valley
country: United States
facility: EMG Labs of AARA
state: Arizona
Study officials:
affiliation: EMG Labs of AARA
name: Benjamin M Sucher, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01779037: IRF-PAI Functional Outcomes Data(With FIM Instrument Variables)
Official title: IRF-PAI Functional Outcomes Data(With FIM Instrument Variables)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart and Blood Disease
Muscle, Bone and Cartilage Disease
Nervous System Diseases
Skin and Connective Tissue Disease
Wounds and Injuries
Lead sponsor: Uniform Data System for Medical Rehabilitation
Sponsor class: OTHER
First posted: 2013-01-29
Sex: ALL
Minimum age (years): 7
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inpatient rehabilitation patients

Brief summary: IRF-PAI Functional Outcomes Data, including FIM instrument variables

Detailed description: United States IRF functional outcomes, medical and socio-demographic data for years 2002-2015

Eligibility criteria: Inclusion Criteria:

* Admission to an inpatient rehabilitation facility

Exclusion Criteria:

* Admission to acute, SNF setting, etc.

Primary outcomes:
measure: IRF-PAI Assessment Instrument(including the FIM instrument)
timeFrame: admission/discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: UDSMR
state: New York
Study officials:
References:
Clinical trial NCT03652337: Meibomian Gland Dysfunction Management
Official title: Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Contact Lens Discomfort
Meibomian Gland Dysfunction
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
Collaborators: name: American Academy of Optometry
First posted: 2018-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
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 compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.


Eligibility criteria: Inclusion Criteria:

* Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.

Exclusion Criteria:

* Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation.
* Subjects who have active ocular infections will be excluded from participation.

Primary outcomes:
measure: Symptomatic relief
timeFrame: 60 days
Secondary outcomes:
measure: Meibography
timeFrame: 60 days
measure: Lissamine green staining grade of the lid margin
timeFrame: 60 days
measure: Inflammatory activity
timeFrame: 60 days
measure: Tear break-up time
timeFrame: 60 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Rosenberg School of Optometry
state: Texas
Study officials:
affiliation: Professor
name: Srihari Narayanan, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. doi: 10.1097/ICO.0b013e3182a73843.
Clinical trial NCT01569737: Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
Official title: Prospective Multicenter Observational Study to Assess Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Contraception
Keywords: ella
ulipristal acetate
pregnancy
emergency contraception
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2012-04-03
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who have been exposed to ella during the menstrual cycle in which the pregnancy started or at any time during pregnancy will be enrolled in the study.

Brief summary: The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.


Eligibility criteria: * Pregnant women, exposed to ella during the menstrual cycle in which the pregnancy started (treatment failure) or at any time during pregnancy (inadvertent exposure during pregnancy)
* Adolescents and/or adults in the USA, depending on the respective State law

Primary outcomes:
measure: Number of Participants Who Experienced Assessed Pregnancy Outcomes
timeFrame: up to 9 months after pregnancy diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Planned Parenthood Federation of America, Inc
state: New York
Study officials:
affiliation: Planned Parenthood Gulf Coast
name: Paul Fine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05915637: Investigation of Preoperative Frailty in Elderly Patients With Colorectal Cancer and Correlation Between Preoperative Frailty and Early Postoperative Prognosis
Official title: Investigation of Preoperative Frailty in Elderly Patients With Colorectal Cancer and Correlation Between Preoperative Frailty and Early Postoperative Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 336
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer

Brief summary: To investigate and analyze the status of preoperative frailty and its influencing factors in elderly patients with colorectal cancer using FRALL scale and other related scales, and to explore the correlation between preoperative frailty and early prognosis in elderly patients with colorectal cancer, so as to attract the attention of medical staff to preoperative frailty in this population and provide a preliminary research basis for the study of frailty intervention in these patients.


Eligibility criteria: Inclusion Criteria:

1. age ≥60 years old;
2. Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer;
3. able to complete physical assessment without communication barriers;
4. voluntarily participated in this study after informed consent.

Exclusion Criteria:

1. taking antidepressants, levodopa, donepezil hydrochloride and other drugs;
2. patients with preoperative colorectal cancer surgery or neoadjuvant therapy;
3. patients with TNM stage Ⅳ;
4. complicated with other malignant tumors except primary skin cancer or melanoma.

Primary outcomes:
measure: Fatigue Assessment
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Yongmei Zhang
state: Guizhou
Study officials:
References:
Clinical trial NCT06309537: Chemoreflex Sensitivity in HFpEF
Official title: Chemoreflex Sensitivity in Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we will include

* symptomatic patients with a diagnosis of HFpEF
* asymptomatic individuals with echocardiographic signs of PH attributable to left ventricular diastolic dysfynction
* healthy controls

Brief summary: Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.

Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.

However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.

We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics.


Eligibility criteria: Inclusion Criteria:

* diagnosis of symptomatic HFpEF (group 1)
* diagnosis of asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of PH (group 2)
* healthy volunteers (group 3)

Exclusion Criteria:

* breastfeeding or childbearing

Primary outcomes:
measure: difference in chemoreflex sensitivity between HFpEF and healthy controls
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano
Study officials:
References:
Clinical trial NCT06197737: Specific Modified Exercise Program for Patients Having Chronic Asthma
Official title: Effects of Moderate Intensity Interval Training and Sprint Interval Training on Patients Having Chronic Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 78
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of moderate intensity interval training and sprint interval training on patients having chronic asthma.

Detailed description: Chronic asthma is a complex heterogeneous disease characterized by multiple aggravating factors. Asthma is treated with two types of medicines , long term medicines and quick relieve medicine. Although the relationship between asthma and the effects of HIIT/SIT were studied in the literature, there was not one comparing the results of these aforementioned studies. The purpose of this study is to find the effects of moderate intensity interval training and sprint interval training on pat determine effects of group wise physical activity on asthma related quality of life. To determine the effects of group wise physical activity on cardiorespiratory endurance

Eligibility criteria: Inclusion Criteria:

* Patients having chronic asthma
* Age between 15-25 years.
* Participants having no dyspnea at rest .
* Participants scoring 13 or less on borg scale
* Exclusion Criteria
* History of co-morbidities.
* History of recent fractures.
* Participants scoring greater than 13 on BORG scale

Exclusion Criteria:

* Exercise induced asthma (evaluated through BRUCE protocol).
* Individuals with co-morbidities related to any neurological, cardiovascular, psychological and musculoskeletal disorders .
* Patients score falling 15 or more on Borg scale.

Primary outcomes:
measure: Assessment of change in the Inspiratory Capacity
timeFrame: Baseline, 8th week and then 16th week
measure: Assessment of change in the Pulmonary Function
timeFrame: Baseline, 8th week and then 16th week
measure: Assessment of change in the Oxygen saturation
timeFrame: Baseline, 8th week and then 16th week
measure: Assessment of change in the Rate of perceived exertion / dyspnea
timeFrame: Baseline, 8th week and then 16th week
measure: Assessment of change in the cardiovascular endurance
timeFrame: Baseline, 8th week and then 16th week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Abasyn University
state: Federal Capital
Study officials:
affiliation: Riphah International University
name: Malik Muhammad Ali Awan, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04566237: Objective Measurements of the Opacification of the Lens After Vitrectomy
Official title: Objective Measurements of the Opacification of the Lens After Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitrectomy
Cataract
Keywords: Objective Scatter Index (OSI)
Optical Quality Analysis System (OQAS)
Average Lens Density (ALD)
IOLMaster® 700
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-09-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years.

In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication.

The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units.

Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group.

To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Indication for unilateral 3-way vitrectomy for retinal detachment, macular hole, epiretinal membrane, vitreous hemorrhage
* Bilateral phakic patient

Exclusion Criteria:

* Vitrectomy combined with cataract surgery
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Change in ALD value between baseline and 12 months after the intervention
timeFrame: Baseline and 12 months after vitrectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschuld
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Raphaël LEJOYEUX, MD
role: PRINCIPAL_INVESTIGATOR
References: