louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02741297: VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation
Official title: A Multi-Center Controlled Study to Characterize the Real-world Outcomes of High Rate Spinal Cord Stimulation Therapy Using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Spinal Cord Stimulation
Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.

Detailed description: The purpose of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.

Eligibility criteria: Key Inclusion Criteria:

* Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening
* Willing and able to comply with all protocol-required procedures and assessments/evaluations
* Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF) provided in local language

Key Exclusion Criteria:

* High surgical risk
* Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
* A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception.
* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
* Any diagnosis or condition that, in the clinician's best judgment, might confound reporting of study outcomes

Primary outcomes:
measure: Percentage of Low Back Pain Responders
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Schreiber Klinik
city: Naples
country: Italy
facility: Azienda Ospedale Monaldi
city: Velp
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Bristol
country: United Kingdom
facility: Southmead Hospital Bristol
city: London
country: United Kingdom
facility: St. Bartholomews Hospital
Study officials:
affiliation: St Bartholomew's Hospital, London, UK
name: Vivek Mehta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06142097: Sensor Technology Assessments of Reproductive Target Study
Official title: Sensor Technology Assessments of Reproductive Target Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Cycle
Ovulation
Menstruation
Lead sponsor: Ouraring Inc.
Sponsor class: INDUSTRY
Collaborators: name: UCSF Center for Reproductive Health
First posted: 2023-11-21
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sampling of individuals willing to travel to clinic and who meet other criteria

Brief summary: The objective of this study was to better understand female reproductive health in the context of using wearable technology. Participants were provided and wore an Oura Ring, tracked their menstrual cycles, provided at-home ovulation test results, and had their cycles monitored via trans-vaginal ultrasounds. The study aimed to collect data from females with regular menstrual cycles.


Eligibility criteria: Inclusion Criteria:

* Healthy women age 18-42 years
* Regular menstrual cycles every 25-32 days
* Own an iPhone or Android mobile device
* Agree to follow study protocol such as wearing the Oura Ring for the duration of the study, at-home ovulation testing, present for frequent ultrasounds

Exclusion Criteria:

* Non-English speaking
* Current use of hormonally active medications
* History of infertility
* History of recurrent pregnancy loss
* Current circadian disruptions

Primary outcomes:
measure: Retrospective ovulation day
timeFrame: 6 months
measure: Prospective ovulation day
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Center for Reproductive Health
state: California
Study officials:
affiliation: UCSF Center for Reproductive Health
name: Eleni Jaswa, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03666897: Markers of Recovery in StrokE Study (MORSE)
Official title: Markers of Recovery in StrokE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Georgetown University
First posted: 2018-09-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Our current biological understanding of stroke recovery in humans is extremely limited and this lack of knowledge is a major challenge in reducing stroke disabilities and deficits. Evidence of neural repair in humans can be gleaned indirectly through functional outcome measures, but we propose that metabolomics may also provide a minimally invasive window into human brain repair. This study will integrate clinical imaging and molecular biomarkers as a diagnostic tool in further understanding stroke recovery mechanisms.

Detailed description: Our long-term goal is to improve and hasten recovery following a stroke with translational research, which would combine the use of neuroimaging and identify neural repair metabolites. The objective and sequential step in fulfilling our long-term goal, is to identify differential expression of select stroke plasma biomarkers of neural repair, and image CST integrity in patients with good and poor recovery following an ischemic stroke. Diffusion tension imaging (DTI), will be used to image the neural repair as it occurs, further enhancing our understanding of stroke recovery. There are currently no known plasma biomarkers of neural repair. Identification of such biomarkers would be extremely valuable for designing stroke recovery drugs and timing rehabilitation therapies.

Eligibility criteria: Inclusion Criteria:

* Imaging confirmed ischemic stroke within 7 days of stroke onset
* Age \> 18 years
* NIHSS ≥ 1 on arm item OR NIHSS = 0 on arm item but \< 3/5 strength on MRC scale in distal joint (flex/ext elbow or grip/ext hand)
* Pre-stroke modified Rankin Scale (mRS) \< 3

Exclusion Criteria:

* Active malignancy (not thought to be cured or in remission)
* Anemia (HCT \< 25)
* Sepsis
* Suspected bacterial endocarditis

Primary outcomes:
measure: Establish plasma metabolite biomarkers that mirror neuronal repair and identify structural changes following ischemic strokes
timeFrame: 2 years
Secondary outcomes:
measure: Change in Fugl-Meyer
timeFrame: Baseline, 90 days post stroke
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospital
name: Malgorzata Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01023997: Central Corneal Thickness in Glaucoma
Official title: Central Corneal Thickness in Patients With Exfoliation Syndrome, Exfoliative Glaucoma, Exfoliative Glaucoma, Primary Open-angle Glaucoma and Ocular Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exfoliation Syndrome
Keywords: corneal thickness
exfoliation
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 700
Sex: ALL
Minimum age (years): 25
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals with and without exfoliation

Brief summary: The purpose of this study is to compare the central corneal thickness measurement in patients with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma.

Detailed description: To compare the central corneal thickness measurement in patients with exfoliation, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma. Prospective study in progress. Randomly selected patients undergo a comprehensive ophthalmic exam which includes 2 separate pachymetry measurements in 2 different examinations at the same time of the day (10:00 am) with 3 different pachymeters. The values obtained are correlated with a number of other glaucoma parameters. A thinner cornea may represent a specific attribute and an additional risk factor for patients with exfoliation. Evaluation of corneal thickness is an important exam in the management of patients with exfoliation.

Eligibility criteria: Inclusion Criteria:

* Exfoliation material on pupil
* Intraocular pressure below 21 mm Hg without glaucomatous damage
* Intraocular pressure above 21 mm Hg without glaucomatous damage
* Raised intraocular pressure with glaucomatous damage

Exclusion Criteria:

* Corneal disorders
* History of trauma
* Evidence of corneal abnormality that may influence IOP
* Contact lens use
* Corneal surgery

Primary outcomes:
measure: central corneal thickness
timeFrame: Morning measurement (10:00-11:00)
Secondary outcomes:
measure: Visual field, scanning laser polarimetry
timeFrame: 10:00-11:00
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Glaucoma Unit, 1st University Department of Ophthalmology
Study officials:
affiliation: 1st University Dept of Ophthalmology
name: Kostantinos Kaltsos, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04709497: Surgery for Primary Congenital Glaucoma in Neonates
Official title: Surgery for Primary Congenital Glaucoma in Neonates:Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Congenital Glaucoma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age.

Detailed description: This is a prospective, randomised controlled trial. We plan to recruit 60 infants with primary congenital glaucoma and younger than 1 month of age at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt. Eyes will be randomly assigned to undergo one of 3 surgical interventions: viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab).

The primary outcome of this study is compare the success rate in lowering IOP between the 3 surgical options in infants with Primary Congenital Glaucoma (PCG) below 1 month of age. The secondary clinical outcomes will include Intraocular pressure (IOP), horizontal corneal diameter, axial length, cup-disc ratio, refractive error and postoperative complications in these 3 surgical procedures. Data will be analysed. Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without antiglaucoma drugs (AGD) or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.

Eligibility criteria: Inclusion Criteria:

Primary Congenital Glaucoma in Neonates

Exclusion Criteria:

secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.

Primary outcomes:
measure: success rate in lowering intraocular pressure (IOP)
timeFrame: 3 years
Secondary outcomes:
measure: horizontal corneal diameter
timeFrame: 3 years
measure: axial length
timeFrame: 3 years
measure: cup-disc ratio
timeFrame: 3 years
measure: refractive error
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01391897: Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychiatric Disorder
Somatoform Disorders
PTSD
Keywords: somatoform disorders
PTSD
epigenetics
psychotherapy
psychosomatics
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study includes all patients selected for multi-modal inpatient or day-clinic treatment in the department of psychosomatic medicine (as part of the centre of psychiatry)of the hannover medical school - given the informed consent of the patients. The patients treated in this unit are first seen in primary care and sent to us because of e.g. depression, somatization, eating-disorders, panic disorders, PTSD, or other psychiatric diseases commonly refered to as "psychosomatic" in Germany. They are subject to at least 2 diagnostic sessions in which further treamtment options are assessed.

For about one third of the patients with grave psychiatric disorders, intensive "multimodal" psychotherapy in an inpatient or day-clinic setting is recommended.

Brief summary: This reported observational clinical study aims at identifying epigenetic markers in a sample of patients undergoing high dose inpatient psychotherapy suffering from a variety of psychiatric/psychosomatic diseases such as somatoform disorders, posttraumatic stress disorder (PTSD), depression, anxiety disorders and eating disorders.

The exact epigenetic markers that will be traced are yet to define.

The investigators believe that

1. Epigenetic patterns found in the group of psychiatric patients show differences from healthy controls
2. Different diagnosis show differences in epigenetic patterns as well
3. Epigenetic patterns correlate to the severity of the psychosocial disorder as measured in interviews or psychometric ratings
4. Epigenetic patterns can change under inpatient high dose psychotherapy
5. Changes correlate to clinical psychometric variables.


Eligibility criteria: Inclusion Criteria:

* informed consent given by the patient
* adulthood to 65 years
* stabel physical health
* at least fluent in German language (as it is a group-therapy)

Exclusion Criteria:

* psychiatric disorder such as substance addiction, psychosis, schizophrenia.
* insufficient understanding of the terms and conditions of the study
* insufficient emotional stability to fill out the psychometric forms required for the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: HannoverMS
state: Lower Saxony
Study officials:
References:
Clinical trial NCT03063697: Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure
Official title: Prospective, Multi-center, Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Essential Hypertension
Chronic Stable Angina
Congestive Heart Failure
Keywords: Carvedilol SR Cap
Essential hypertension
Chronic stable angina
Congestive heart failure
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2017-02-24
Enrollment: 20000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: in Korean 20,000 Patients with Essential hypertension, Chronic stable angina and Congestive heart failure

Brief summary: The purpose of this study is to Evaluate the Safety of DILATREND SR Cap. in Korean Patients with Essential hypertension, Chronic stable angina and Congestive heart failure for 52 weeks.


Eligibility criteria: Inclusion Criteria:

1. Age 19 years or older Patients with Essential hypertension, Chronic stable angina and Congestive heart failure
2. Possible to take Dilatrend SR on the label
3. not taking Caverdilol for 6 month from Agreement date
4. Agreement with written informed consent

Exclusion Criteria:

1. Pregnancy or lactation
2. Known hypersensitivity to Carvedilol
3. Cardiogenic shock
4. Abnormality of the conduction system as Severe bradycardia(In particular, pulse \<50beats / min), 2nd degree AV block, Complete AV block, Sinus Block, Sick Sinus Syndrome
5. Cor pulmonale
6. IDDM with ketoacidosis, metabolic acidosis
7. has severe heart disease(Heart failure NYHA functional class 4)
8. Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease
9. Secondary hypertension
10. Prinzmetal's angina
11. Acute pulmonary embolism
12. Pheochromocytoma
13. Take MAO lnhibitor(except for MAO-B)
14. Hypotension ( SBP 90mmHg or less)
15. Severe hepatic dysfunction
16. Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
17. Has edema glottitis
18. Has heart attack with complication
19. Fluid retention or overload to required intravenous inotropes
20. Allergic rhinitis

Primary outcomes:
measure: The incidence and severity of adverse events and adverse drug reactions at 24 weeks
timeFrame: for 24 weeks
measure: The incidence and severity of unexpected adverse events and adverse drug reactions at 24 weeks
timeFrame: for 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04138797: Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device
Official title: Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Electrophysiology
Electrocardiogram
Keywords: Signal Averaging ECG
HV interval
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: His-Ventricle (HV) measurement is only obtained invasively using transvenous catheters. This kind of procedure is routinely performed but some risks of complication exist. HV interval prolongation is correlated with increased risk of occurrence of complete atrioventricular block which could lead to syncope or cardiac sudden death. A new non invasive, high density and high fidelity system (BioSemi, BioSemi B.V., Amsterdam, Netherlands) can theorically collect such electrophysiological signal using a signal averaging acquisition method. We want to assess the possibility of non invasive HV interval measurement using this new device.


Eligibility criteria: Inclusion Criteria:

* Patients admitted at Bordeaux University Hospital for electrophysiological study with HV measurement.

Exclusion Criteria:

* Patients under 18 years old,
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Measurement of HV interval correlation by the intra-class correlation coefficient
timeFrame: Day 0
measure: Measurement of HV interval correlation by graphical representation
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Josselin DUCHATEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098097: Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011)
Official title: Post Marketing Observational/Non-Interventional Study Of Retreatment Of Chronic Hepatitis C With Peginterferon Alpha And Ribavirin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 963
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: Patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin

Brief summary: To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.

Detailed description: This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C of any genotype;
* Prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin did not result in a sustained virological response;
* Inclusion criteria listed on the approved label in each country;
* Willingness of the patient to participate and sign the Informed Consent Form.

Exclusion Criteria:

* Patient exclusion from this observational/non-interventional study will be determined by the treating physician and will be based on the local label in each country.

Primary outcomes:
measure: Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)
timeFrame: Up to 12 Weeks
measure: Incidence of Thrombocytopenia
timeFrame: Up to 12 Weeks
measure: Incidence of Treatment Discontinuations Due to Adverse Events
timeFrame: Up to 12 Weeks
measure: Incidence of Particular Adverse Events Resulting in Treatment Discontinuation
timeFrame: Up to 12 Weeks
measure: Incidence of Dose Modifications Due to Adverse Events
timeFrame: Up to 12 Weeks
Secondary outcomes:
measure: Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
References: