louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04374461: A Study of N-acetylcysteine in Patients With COVID-19 Infection
Official title: Phase II Study of N-acetylcysteine in Severe or Critically Ill Patients With Refractory COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Covid-19
Keywords: N-acetylcysteine
20-168
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-institution study that will be open at MSKCC's Manhattan campus. Patients will be enrolled into 2 separate arms. The mechanically ventilated \&/or managed in a critical-care arm is closed to accrual as of September 2020.
Primary purpose: TREATMENT

Brief summary: The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator.

The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.


Eligibility criteria: Inclusion Criteria:

* Documented COVID-19 infection (either performed on site or documented external report)
* Age ≥ 18

Arm A:

* Admission to an intensive care unit at MSK (M-11) and/or receiving mechanical ventilation
* Absolute lymphocyte count ≤ 1.0/mm3
* As the ALC of patients with lymphoid malignancies is unreliable, they may be enrolled at the discretion of the treating physician after review of their blood work.

Arm B:

* Arm B:Requiring 2L or more of supplemental oxygen by nasal cannula or higher to maintain SpO2 of 95%

Exclusion Criteria:

Arm B:

* requiring mechanical ventilation or admission to an intensive care unit at MSK (M11)

Primary outcomes:
measure: Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement
timeFrame: 1 year
measure: Arm B: number of patients who are discharged from the hospital due to clinical improvement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Santosha Vardhana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02736461: Factors Associated With Postoperative Strabismus After Floor Fracture Repair
Official title: Factors Associated With Postoperative Strabismus After Floor Fracture Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Fractures
Strabismus
Keywords: Orbital fractures
Strabismus
Predicting factors
orbital floor fractures
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.

Brief summary: In patients suffered from floor fractures, there are 21.9% complaining about diplopia before fracture repair surgery and 20.8% after operation. Even after 6 months, there still are 16.4% had similar conditions. Investigators are planned to find predicting factors to prevent such conditions from happening.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from floor fractures in Tri-Service General Hospital in past 10 years.

Exclusion Criteria:

* Prior ocular surgeries
* Multiple facial trauma or facial bone fractures

Primary outcomes:
measure: Strabismus happening
timeFrame: 6 months after orbital floor fracture repair surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
citation: Bartoli D, Fadda MT, Battisti A, Cassoni A, Pagnoni M, Riccardi E, Sanzi M, Valentini V. Retrospective analysis of 301 patients with orbital floor fracture. J Craniomaxillofac Surg. 2015 Mar;43(2):244-7. doi: 10.1016/j.jcms.2014.11.015. Epub 2014 Nov 29.
Clinical trial NCT02209961: Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract
Official title: To Check the Efficacy and Saftey of Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma and Ocular Hypertension
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with uncontrolled glaucoma

Brief summary: A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery.

Detailed description: The occurrence of both glaucoma and clinically relevant cataract in the same individual is a frequent condition, especially in the elderly population. Besides age, this might be related to the possible role of antiglaucoma medications in the progression of lens opacity.When both procedures are required, these can be performed separately or in combination.

Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.

The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG. This procedure would be theoretically more reproducible and simple to perform as well as less traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a similar way to trabeculectomy. This procedure can be performed on its own or in combination with phacoemulsification.

This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .

Eligibility criteria: Inclusion Criteria:

- age above 18

Exclusion Criteria:

- congenital glaucoma

Primary outcomes:
measure: Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .
timeFrame: within one to two years post surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rana N Hanna, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04937361: Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network
Official title: Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MDRO
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: University Hospital of Berlin
name: University Hospital of Cologne
name: University Hospital Freiburg
name: University of Giessen
name: University Hospital Tuebingen
First posted: 2021-06-24
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the prevalence, adult patients admitted to the hosptial within the last 3 days.

For BSI surveillance, adult inpatients with at least one blood culture positive for any of the target organisms: Staphylococcus aureus, Enterococcus spp., Escherichia coli, Enterobacter spp., Klebsiella spp., Acinetobacter baumannii, Pseudomonas aeruginosa.

Brief summary: Survey on the prevalence of MDRO to monitor the import of MDRO from the community. Rectal swabs will be taken and cultivated. Survey on community-onset and nosocomial bloodstream infections will be documented and strains will be isolated. For each BSI a clinical data set will be obtained (e.g. patient age, gender, date of hospitalization, antibiotic therapy). Genetic analysis of MDRO from the prevalence and BSI study. In a subset of patients the microbiome-resistome interactome will be analysed in more detail. Furthermore, the impact of infection control measures due to the Covid-19 pandemic on nosocomial BSI will be investigated.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* informed consent
* inpatient

Exclusion Criteria:

* less than 18 years old
* Not capable of giving informed consent
* outpatient

Primary outcomes:
measure: monitoring of MDRO prevalence
timeFrame: at hospital admission
measure: monitoring of blood stream infections
timeFrame: during hospitalization, up to 4 weeks
measure: integrate novel techniques for microbiome-resistome interaction analysis
timeFrame: through study completion, after 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Klinik für Infektiologie und Mikrobiologie
Study officials:
References:
Clinical trial NCT04339361: Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion
Official title: Comparative Safety and Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in Relieving Pain During Levonorgestrel IUD Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Contraception
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 111
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women


Eligibility criteria: Inclusion Criteria:

* nulliparous women requesting levonorgestrel IUD insertion

Exclusion Criteria:

* multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion

Primary outcomes:
measure: pain during IUD insertion
timeFrame: 2 minutes
Secondary outcomes:
measure: insertion duration
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01929161: Study of Wellness Behaviors as a Function of Oxytocin vs Placebo
Official title: Affective and Genomic Mediators of Sustained Behavior Change: A Randomized, Dual-blind, Placebo-controlled Experimental Design That Will Examine Wellness Behavior as a Function of Oxytocin vs. Placebo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sustained Positive Emotions
Sustained Positive Behavior Change
Keywords: positive emotions
meditation
oxytocin
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-08-27
Enrollment: 239
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The specific aim of this study is to test whether oxytocin (OT) boosts the positive emotion yield of a new wellness behavior (Lovingkindness meditation or Mindfulness meditation) and thereby increases nonconscious motives that shape daily behavioral decisions to repeat it, which in turn foster positive emotions that further augment nonconscious motives in an upward spiral dynamic.

The proposed research targets three hypotheses: (1) Oxytocin manipulation magnifies (i.e., moderates) the positive emotion yield of Lovingkindness meditation; (2) The positive emotion yield of meditation, which varies by experimental condition, increases the nonconscious incentive salience of Wellness Behavior-related cues; and (3) Behavioral decisions predict positive emotions, sparking the relationships among OT manipulation, positive emotion yield, and nonconscious incentive salience of Wellness Behavior-related cues.


Eligibility criteria: Inclusion Criteria:

* between the ages of 35 and 64 years old.
* Fluent in written and spoken English
* Willingness or interest in learning to meditate
* Computer literate with access to internet (weekly)

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Individuals on antihypertensive medication
* Individuals who have or have had a regular meditation practice
* Individuals who can read Chinese logographs

Primary outcomes:
measure: Change in positive emotions (as measured by the Modified Daily Emotions Scale)
timeFrame: Baseline and Weeks 1, 2, and 3
measure: Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure).
timeFrame: Baseline and Weeks 1, 2, and 3
measure: Changes in meditation time
timeFrame: Weeks 1, 2, and 3
Secondary outcomes:
measure: Cardiac Vagal Tone
timeFrame: Baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC PEP Lab
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Barbara L Fredrickson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00751361: Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial
Official title: Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Age Related Macular Degeneration
Keywords: Rheopheresis
Dry Age Related Macular Degeneration
AMD
apheresis
microcirculation
Lead sponsor: Apheresis Research Institute
Sponsor class: OTHER
First posted: 2008-09-11
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.


Eligibility criteria: Inclusion Criteria:

* 50 to 85 years old
* diagnosis of AMD in both eyes
* must have dry AMD in the study eye
* Study eyes with best-corrected ETDRS-visual acuity of 0.1-0.8
* peripheral veins allowing vascular access to establish the extracorporal circuit.

Exclusion Criteria:

* other retinal or choroidal disorders than AMD
* optic nerve disease, glaucoma
* conditions that limit the view of the fundus
* acute bleeding in any eye

General exclusion criteria for the treatment of Rheopheresis:

* anaemia
* haemorrhagic diathesis or coagulopathy
* diabetes
* serious acute or chronic kidney or liver failure
* hypotension systolic \< 100 mmHg
* chronic viral infection (HIV, hepatitis B, C)
* epilepsia, psychosis or dementia
* a malignant disease or any other condition with life expectancy \< 12 months
* known history of alcohol or drug abuse and long term serious nicotine abuse

Primary outcomes:
measure: The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups.
timeFrame: 30 weeks (7.5 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University of Frankfurt Department of Ophthalmology
Study officials:
affiliation: University of Frankfurt
name: Frank HJ Koch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00618761: Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Controls
Official title: Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Non-Diabetic Kidney Recipients, Insulin Independent Recipients of Beta-cell Grafts and Healthy Controls.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Pancreas Transplantation
Keywords: glucose clamp
beta-cell
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Fund for Scientific Research, Flanders, Belgium
First posted: 2008-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients.


Eligibility criteria: Inclusion Criteria:

* kidney pancreas recipients
* kidney recipients
* healthy volunteers
* beta-cell recipients
* immunosuppression with MMF-Tacrolimus
* 1-4 years after transplantation

Exclusion Criteria:

* high doses of steroids
* insulin dependent

Primary outcomes:
measure: insulin secretion during clamp test
timeFrame: time 0
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Endocrinology, Leuven, UZ-Gasthuisberg
Study officials:
affiliation: UZ-Gasthuisberg, Department of Endocrinology
name: Chantal Mathieu, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02807311: OPTIMIZATION OF NUTRITIONAL MANAGEMENT OF PATIENTS WAITING FOR LUNG TRANSPLANT INTO Strasbourg University Hospitals
Official title: OPTIMIZATION OF NUTRITIONAL MANAGEMENT OF PATIENTS WAITING FOR LUNG TRANSPLANT INTO Strasbourg University Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: Malnutrition
Undernutrition
lung transplantation
artificial nutrition
nutritional supplements
enteral nutrition
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 62
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: transplant patients between January 1, 2012 and December 31, 2015 aged over 16 years, with a BMI \<25 at the time of pre-transplant assessment

Brief summary: Undernutrition is the result of energy and protein deficiency and / or catabolic. These phenomena are observed daily in patients awaiting lung transplantation.

After lung transplantation that undernutrition is growing (on average 11% weight loss after the first observations in the continuing care of the University Hospital of Strasbourg). In other words the non-malnourished patients become. Hence the importance to reach every patient awaiting transplant, mainly to patients already malnourished before surgery.

Several studies have shown that early nutritional support has a direct effect on reducing comorbidities and the average length of stay. In the course of care of these patients it is necessary to intensify the dietary management to give them the best chance for early rehabilitation.

The main objective of the study is to evaluate the impact of the use of the SFNEP's nutritional care decision-making tree (Société Francophone Nutrition Clinique et Métabolisme) on the implementation of enteral nutrition by gastrostomy tube in patients awaiting for lung transplantation.


Eligibility criteria: Inclusion criteria:

transplant patients between January 1, 2012 and December 31, 2015 aged over 16 years, with a BMI \<25 at the time of pre-transplant assessment and that not oppose the use of his data.

Exclusion criteria:

* Cardiopulmonary Transplant Patients
* refusal to participate in the study

Primary outcomes:
measure: Assessment of the proportion undernourished patients by using the SFNEP's nutritional care decision-making tree
timeFrame: befor pulmonary transplantation, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de pneumologie - Nouvel Hôpital Civil
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Sophie BOURA, Dietician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00628511: Validation of Portable Monitoring Device for Diagnosing Sleep Apnea
Official title: A Validation Study of A New Diagnostic Device for Screening of Obstructive Sleep Apnea in High Risk Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: patients suspected of sleep apnea

Brief summary: portable monitoring device could diagnose sleep apnea in high risk patients.

Detailed description: This is a pilot study of another larger cohort investigating different algorithms in managing patients suspected of sleep apnea using portable monitoring device.

Portable monitoring device is applied simultaneously with PSG to compare it's accuracy and validity.

Eligibility criteria: Inclusion Criteria:

* patients suspected of sleep apnea

Exclusion Criteria:

* patient refuse to participate

Primary outcomes:
measure: validity of portable monitoring device
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese Univerisity of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: To K Wang, MBCHB
role: PRINCIPAL_INVESTIGATOR
References: