louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01933763: An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women 18 to 45 years of age (inclusive)
2. Body mass index 18.0 to 30.0 kg/m\^2 (inclusive)
3. Normal standard 12-lead ECG
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide signed informed consent
6. For sexually active men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during and for up to 3 months after participation in the study.

Exclusion Criteria:

1. Any clinically significant abnormalities or other characteristics that would preclude the subject from safely enrolling or successfully completing the study
2. History of drug or alcohol abuse within a year prior to the screening visit
3. Current regular smoking, or a history of smoking greater than ½ pack
4. Receipt of an investigational drug within 30 days of screening, or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subject's participation in this study
6. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit
7. Hospitalization for any reason within 60 days of screening
8. History or presence of malignancy (including carcinoma in situ) prior to the screening visit
9. Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol
10. Pregnant or breast-feeding women

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).

Primary outcomes:
measure: Number of TEAEs
timeFrame: day 1 to day 106
Secondary outcomes:
measure: Serum concentration
timeFrame: day 1 to day 106
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT05550363: A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2)
Official title: A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cataract
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
Primary purpose: TREATMENT

Brief summary: A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery


Eligibility criteria: Inclusion Criteria:

* Male or female subjects at least 40 years of age scheduled for cataract surgery
* Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
* Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.

Exclusion Criteria:

* Use of any corticosteroids within 7 days prior to Day 0
* Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.

Primary outcomes:
measure: Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
timeFrame: Day 8
Secondary outcomes:
measure: Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30
timeFrame: Days 1, 3, 15, and 30
measure: Mean ocular pain scores in the study eye
timeFrame: Days 1, 3, 15, and 30
measure: Proportion of subjects with absence of cells in the AC of the study eye
timeFrame: Days 1, 3, 15, and 30
measure: Proportion of subjects with absence of flare in the AC of the study eye
timeFrame: Days 1, 3, 15, and 30
measure: Mean AC cell score in the study eye
timeFrame: Days 1, 3, 15, and 30
measure: Mean AC flare score in the study eye
timeFrame: Days 1, 3, 15, and 30
measure: Rates of ocular (study eye and fellow eye) and non-ocular TEAEs
timeFrame: up to day 30
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02566863: Haemodynamic Effect of Dexmedetomidine
Official title: Haemodynamic Effect of Dexmedetomidine in Relation to Autonomic System Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Haemodynamic Effects of Dexmedetomidine
Keywords: dexmedetomidine
heart rate
heart rate variability
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Dexmedetomidine, selective alfa2 receptors agonist produces sympatholysis. As a result heart rate decreases. With low doses blood pressure also decreases, with higher dosing - systematic vascular resistance increases. The indication for the drug is to produce sedation during surgical procedures and in ICU patients.

The aim of a study is to verify, whether the haemodynamic effect (heart rate, blood pressure and heart rate variability during drug infusion) depend on pre-drug autonomic system activity. Autonomic system activity is assessed using heart rate variability (HRV)measurement before drug injection and during drug infusion. Heart rate and blood pressure measured before and during drug infusion will be analysed.

HRV measurement analysis will be based on continuous Holter ECG recording, taken before drug injection and during its infusion. 5 minutes intervals will be analysed , using Frequency Domain Measures of HRV. Surgical procedure will start after measurement have been taken.


Eligibility criteria: Inclusion Criteria:

* patients classified with American Society of Anesthesiologists Physical Status Classification System as 1 or 2 status
* planned eye surgery under sedation

Exclusion Criteria:

* patient's refusal
* contraindications to dexmedetomidine
* diseases/drugs that influence on autonomic nervous system activity

Primary outcomes:
measure: Changes of haemodynamics and heart rate variability parameters
timeFrame: up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Medical University of Gdansk
Study officials:
affiliation: Department of Ophthalmology, Medical University of Gdańsk
name: Magdalena A Wujtewicz, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03110263: i-Sleep: Internet-based Treatment for Insomnia
Official title: i-Sleep: Internet-based Treatment for Insomnia. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2017-04-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.


Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Meet ICSD-3 diagnostic criteria for Insomnia as confirmed by the telephone administered Interview
* Acess to the Internet
* Written informed consent

Exclusion Criteria:

* Physiological Insomnia
* Serious psychiatric co-morbidity that requires alternative treatment including major depression disorder, anxiety disorder, substance dependence, bipolar affective disorder, psychotic illness
* Epilepsy (seizure disorder)

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline
measure: Insomnia Severity Index (ISI)
timeFrame: 8-weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 6-months
Secondary outcomes:
measure: Diagnosis of Insomnia
timeFrame: Baseline, 8-weeks, 6-months
measure: Sleep-diary: Sleep efficiency (SE)
timeFrame: 8-weeks
measure: Sleep-Diary-data
timeFrame: 8-weeks
measure: Dysfunctional Beliefs and Attitudes about Sleep 16 (DBAS-16)
timeFrame: Baseline, 8-weeks, 6-months
measure: Patient satisfaction (ZUF-8)
timeFrame: 8-weeks
measure: Empowerment Scale (ES)
timeFrame: Baseline, 8-weeks, 6-months
measure: EuroQol
timeFrame: Baseline, 8-weeks, 6-months
measure: Usability: Satisfaction with the online program (SUS)
timeFrame: 8-weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 8-weeks, 6-months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Thomas Berger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04622163: Secondary Mentoring Program Evaluation
Official title: Department of Medicine Secondary Mentoring Program Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Mentorship is essential to job satisfaction and promotion among academic physicians, and literature suggests that a single mentor is rarely sufficient. The investigators are studying whether implementation of a secondary mentorship program among physicians at their institution leads to improved job satisfaction over 6 months.


Eligibility criteria: Inclusion Criteria:

Physician employed as full-time faculty in the Massachusetts General Hospital Department of Medicine.

Exclusion Criteria:

None

Primary outcomes:
measure: Job satisfaction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02780063: Medications Effect on Lenstar Measurements
Official title: The Effects of Dilation Medication on Lenstar Measurements for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Dilation
Intraocular
Ophthalmology
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Prior to cataract surgery the lens must be calculated to appropriately fit a patient for the intraocular lens implant. Lenstar is an optical biometer that calculates the axial length, keratometry, lens thickness, pupillometry, and anterior chamber depth. Dilation drops are routinely used in eye exams in addition to pre-cataract surgery. The dilation drops include Tropicamide 1%, and Phenylephrine 2.5%. The Tropicamide achieves the dilation of the pupil which causes an anterior rotation of the ciliary body, which may affect the Lenstar measurements. This study is to determine if dilating medications affect the lens power prediction for emmetropia by the Lenstar biometer. Prior to dilation, Lenstar biometry will be performed on each eye. Patients will receive dilation medication and after waiting 20 minutes Lenstar biometry will be performed on each eye. Dilation and measurement with Lenstar will be done as standard of care. Measurements and calculations from before and after will be compared.


Eligibility criteria: Inclusion Criteria:

* Candidates for cataract surgery undergoing routine evaluation of cataracts.

Exclusion Criteria:

* Patients that have had their cataracts removed
* Patients that cannot undergo routine evaluation for cataract surgery (because they are too ill to sit upright in a chair)

Primary outcomes:
measure: Baseline Lens Power will be compared to Post dilation measurements using Lenstar biometer
timeFrame: One Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ann Ostrovsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05195463: Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
Official title: Comparison of the Efficiency of Abdominal Corset and Core Stabilization Exercises in the Treatment of Postpartum Diastasis Recti Abdominis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastasis Recti
Keywords: diastasis recti abdominis
core stabilization exercise
physiotherapy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants will be randomly divided into three groups as core stabilization group, combination of core stabilization and corset group and only corset group.

Detailed description: 30 volunteer women who were diagnosed with diastasis recti abdominis by an obstetrician in Çamlıca Medipol Hospital, aged between 18-35 and met the inclusion criteria will be included in the study. Participants will be randomly divided into three groups. Participants in the first group will do core stabilization exercises for the transversus abdominis muscle 3 days a week for 8 weeks with 10 repetitions. In the second group, in addition to the first group, core stabilization exercises will be performed by wearing an abdominal corset. Participants included in the third group will be asked to wear only this corset all day (except for the bathroom) for 8 weeks. Anthropometric measurements, ultrasonographic evaluation, Visual Analogue Scale (VAS), Edinburgh Postnatal Depression Scale, abdominal muscle strength and endurance, Oswestry Disability Index will be evaluated as pretest and posttest.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 20-35,
* Having a normal birth,
* Being at least 6 weeks postpartum when DRA is diagnosed,
* Absence of any musculoskeletal or neurological problems,
* Volunteering to do the exercises

Exclusion Criteria:

* Cesarean delivery,
* Edinburgh Postnatal Depression questionnaire result being \>13,
* Having a systemic disorder

Primary outcomes:
measure: Ultrasanografic measurement
timeFrame: 5 minutes
measure: Visual Analogue Scale for pain assessment
timeFrame: 3 minutes
measure: Abdominal muscle strength measurement
timeFrame: 5 minutes
measure: Abdominal muscle undurance measurement
timeFrame: 5 minutes
measure: Edinburgh Postnatal Depression Scale
timeFrame: 5 minutes
measure: Oswestry Disability Index for assesment of pain and quality of life
timeFrame: 5 minutes
Secondary outcomes:
measure: Weight measurement
timeFrame: 2 minutes
measure: Height measurement
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: MERVE YILMAZ MENEK
role: STUDY_DIRECTOR
References:
Clinical trial NCT04982263: Blood Coagulation Abnormalities in COVID-19 (Corona Virus Disease-19) Patients
Official title: Blood Coagulation Abnormalities in COVID-19 Patients and Correlation With Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 125
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: Cases with confirmed COVID 19 disease

Brief summary: The role of the coagulation parameters in predicting the severity of COVID-19 disease will be assessed

Detailed description: In COVID-19 patients the coagulation parameters Prothrombin concentration (PC), Activated Partial Thromboplastin Time (aPTT), D Dimer, Antithrombin III (ATIII) and Fibrinogen are measured and correlation with disease severity is to be investigated

Eligibility criteria: Inclusion Criteria:

● Confirmed cases with COVID 19

Exclusion Criteria:

● Known history of blood coagulopathy disorder

Primary outcomes:
measure: correlation of disease severity with results of laboratory test
timeFrame: Baseline results of coagulation profile and baseline disease severity assessment
Secondary outcomes:
measure: Agreement of abnormalities in coagulation profile with measured inflammatory markers
timeFrame: baseline measurement of inflammatory markers
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag Univesity
name: Hend mohamed A Esmaeel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
citation: Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.
citation: Terpos E, Ntanasis-Stathopoulos I, Elalamy I, Kastritis E, Sergentanis TN, Politou M, Psaltopoulou T, Gerotziafas G, Dimopoulos MA. Hematological findings and complications of COVID-19. Am J Hematol. 2020 Jul;95(7):834-847. doi: 10.1002/ajh.25829. Epub 2020 May 23.
Clinical trial NCT00291863: Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis
Official title: Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Failure, End Stage
Peritoneal Dialysis
Keywords: end stage renal failure
peritoneal dialysis
simvastatin
endothelium
vasodilation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2006-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.

Detailed description: This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.

Eligibility criteria: Inclusion Criteria:

* end stage renal failure
* peritoneal dialysis
* LDL cholesterol \> 100mg/dL
* \> 18 years and \< 80 years

Exclusion Criteria:

* using statin or nitrate
* liver disease
* diabetes mellitus

Primary outcomes:
measure: endothelial venodilation
Secondary outcomes:
measure: Inflammation markers (C-reactive protein, IL-6, TNF)
measure: Lipoproteins
measure: Oxidative stress
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: São Lucas Hospital
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of São Paulo
name: Maristela Bohlke, master
role: PRINCIPAL_INVESTIGATOR
References: