louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04354545: Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
Official title: Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Ocular Surface Disease
Keywords: glaucoma
xiidra™
ocular surface discomfort
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2020-04-21
Enrollment: 75
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: Glaucoma patients suffering from ocular surface discomfort

Brief summary: To evaluate glaucoma patients' response to treatment with Xiidra, an FDA-approved drug for ocular surface discomfort, which will be prescribed as standard of care treatment.

Detailed description: To assess glaucoma patients' response to treatment with Xiidra (Lifitegrast ophthalmic solution) 5% for ocular surface discomfort caused, in part, by topical glaucoma antihypertensive medications.

Eligibility criteria: Inclusion Criteria:

* Currently using one or more topical glaucoma antihypertensives
* Self-described symptoms of ocular surface discomfort
* Xiidra is being prescribed as part of the subject's standard care

Exclusion Criteria:

* History of glaucoma filtration surgery, history of ocular surface surgery (pterygium, conjunctivoplasty, etc.),
* current use of topical cyclosporine
* current use of topical steroids
* incisional ocular surgery within 6 months

Primary outcomes:
measure: Change from baseline to week 12 in corneal fluorescein staining score
timeFrame: From baseline to Week 12
measure: Change from baseline to week 12 in eye dryness score (EDS)
timeFrame: From baseline to Week 12
measure: Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score
timeFrame: From baseline to Week 12
Secondary outcomes:
measure: Change at intermediate week visits in corneal fluorescein staining score
timeFrame: From baseline and at weeks 2, 6, and 12
measure: Change at intermediate week visits in eye dryness score (EDS)
timeFrame: From baseline and at weeks 2, 6, and 12
measure: Change at intermediate week visits in ocular surface disease index (OSDI) questionnaire score
timeFrame: From baseline and at weeks 2, 6, and 12
measure: Changes in the subcategories of ocular surface disease index (OSDI) questionnaire score at intermediate week visits
timeFrame: From baseline and at weeks 2, 6, and 12
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Doheny Eye Center UCLA
state: California
Study officials:
References:
Clinical trial NCT03666845: Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease
Official title: Plasma Ropivacaine Concentrations After Peripheral Nerve Block in Patients With Severe Renal Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regional Anesthesia Morbidity
Local Anesthetic Drug Adverse Reaction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic kidney disease

Brief summary: This prospective observational study aimed to examine the pharmacokinetics of ropivacaine in patients with chronic kidney disease after sciatic nerve block.

Sciatic nerve block for foot and ankle surgery will be performed using ropivacaine under ultrasound-guidance, and arterial blood test will be taken for total plasma ropivacaine concentration at 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for foot and ankle surgery
* Patients with chronic kidney disease (glomerular filtration rate \< 60 ml/min/1.73m2) (changed from 30 ml/min/1.73m2 to facilitate patient recruitment)
* Patients who are thought to be clinically helpful to receive sciatic nerve block rather than general anesthesia because of comorbidities such as cardiopulmonary dysfunction and cerebral dysfunction

Exclusion Criteria:

* Patients who need to renal replacement therapy, such as hemodialysis
* Patients with liver disease (aspartate transaminase OR alanine transaminase \> 80 IU/L)
* Patients with allergic disease
* Patients with previous history of drug allery
* Patients with chronic pain persisting 3 months

Primary outcomes:
measure: Plasma concentration of unbound ropivacaine
timeFrame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
Secondary outcomes:
measure: Plasma concentration of 3-OH-ropivacaine
timeFrame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
measure: Plasma concentration of pipecoloxylidide
timeFrame: 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block
measure: Postoperative pain score
timeFrame: 2, 6, 24 hours after sciatic nerve block
measure: Local anesthetic systemic toxicity
timeFrame: 2, 6, 24 hours after sciatic nerve block
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, Pf.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04381845: Immunity and Infections in the Psychiatric Population
Official title: Immunity and COVID Infections in the Psychiatric Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID
Psychiatric Disorders
Keywords: COVID infection
psychiatric population
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-05-11
Enrollment: 200
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: The main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients.

The secondary objective of this cohort follow-up is to:

1. Clinically characterize COVID patients who are positive for serological testing
2. Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis
3. Immunologically characterize COVID patients who are positive for serological testing
4. Exploring the links between susceptibility to COVID19 and erythrocytic blood groups

Detailed description: All patients accepting to participate will be included in participating psychiatry services and will have a COVID Serological Test for Inclusion with confirmation at J15 including immune-genetics data.

A Comparison of COVID patients versus no COVID patients will be based on a clinical examination (psychiatric, somatic) and blood samples collected at J0 and J15.

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Hospitalized in one of the participating psychiatric wards during the inclusion period
* Signed informed consent

Exclusion Criteria:

* Inability to obtain the consent of the patient or legal representative, if applicable
* Patient under safeguard of justice

Primary outcomes:
measure: Number of COVID-positive patients
timeFrame: day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
state: Ile De France
Study officials:
affiliation: Assistance Publique des Hopitaux de Paris
name: Marion LEBOYER, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340545: MR Elastography for the Herniated Intervertebral Disc
Official title: Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervertebral Disc Herniation
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2017-11-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Low back pain is a major cause of disability, especially in the working-age population. A total of 149 million working days are lost every year as a consequence of back pain. Intervertebral disc (IVD) degeneration is thought to play a major role in chronic back and neck pain. Decades of bench-top research in tissue mechanics have shown clear relationships between changes in mechanical properties and abnormal changes IVD structure and composition. Our overall hypothesis is that measurements of IVD mechanical properties can provide valuable information about its structure and composition for early diagnosis of degeneration, quantification of degeneration progress, and evaluation of treatment strategies. Magnetic Resonance Elastography (MRE) is an imaging method to quantify mechanical properties from soft tissues. The objectives of this study are to evaluating repeatability and collecting base line data from healthy individuals; and to apply MRE to patients with disc herniation.


Eligibility criteria: Inclusion Criteria:

* Healthy controls must be generally healthy individuals in the age range of 18-65.
* Patients, 18 to 65 years old, who have undergone or will undergo MRI as part of the diagnosis of back pain and are diagnosed with one or more herniated discs in the lumbar spine (aka, disc rupture).

Exclusion Criteria:

* Participants with a history of neurological injury or disease will be excluded.
* Participants with contraindications to MRI scanning will be excluded (e.g., electric/mechanical implant, device such as a pacemaker).
* Participants who are claustrophobic will be excluded.
* Participants who are \>250 lbs will be excluded (due to weight and physical constraints of - the scanner, i.e., 55 cm bore).
* Those unable to consent, pregnant women, children, and prisoners will be excluded.
* People under the age of 18 will be excluded as well.
* Individuals who do not understand English (written or spoken) will be excluded

Primary outcomes:
measure: Changes in mechanical properties of the herniated intervertebral disc
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: State College
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Daniel H Cortes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03717545: Second Transplantation for Graft Failure
Official title: Second Transplantation for Graft Failure After First Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Graft Failure
Stem Cell Transplant Complications
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. We performed a prospective single-arm study to investigate the safety and efficacy of a novel regimen.


Eligibility criteria: Inclusion Criteria:

* graft failure after first allogeneic stem cell transplantation
* no active infection or GVHD or severe organ dysfunction
* sign written informed consent

Exclusion Criteria:

* active infection, GVHD, organ failure
* expected life \< 28 days

Primary outcomes:
measure: engraftment
timeFrame: 28 days after second transplantation
Secondary outcomes:
measure: TRM at 28 day
timeFrame: 28 days after second transplantation
measure: TRM at 100d
timeFrame: day 100 after second transplant
measure: Overall survival at 100d
timeFrame: day100 after second transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
citation: Sun YQ, Wang Y, Wang FR, Yan CH, Cheng YF, Chen YH, Zhang YY, Han TT, Han W, Suo P, Xu LP, Zhang XH, Liu KY, Huang XJ. Graft Failure in Patients With Hematological Malignancies: A Successful Salvage With a Second Transplantation From a Different Haploidentical Donor. Front Med (Lausanne). 2021 Jun 4;8:604085. doi: 10.3389/fmed.2021.604085. eCollection 2021.
Clinical trial NCT00653445: Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg
Official title: A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Coronary Heart Disease
Atherosclerosis
Keywords: Low density lipoproteins
Hypercholesterolemia
Coronary Heart Disease
Rosuvastatin
Crestor
Ezetimibe
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-07
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 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.


Eligibility criteria: Inclusion Criteria:

* A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
* Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
* Discontinuation of all lipid lowering therapy at Visit 1.

Exclusion Criteria:

* History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
* Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
* Severe congestive cardiac failure (as defined by the protocol - Appendix I).
* Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..

Primary outcomes:
measure: To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6
Secondary outcomes:
measure: To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6
measure: Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe
Other outcomes:
Locations:
Study officials:
affiliation: Centre for prevention of cardiovascular disease, Texas, USA
name: Christine Ballantyne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02015845: Evaluation of Accuvein in Obese Patients
Official title: Evaluation of Accuvein in Obese Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Care
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 26
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 objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.


Eligibility criteria: Inclusion Criteria:

* obese adults ( BMI equal or greater 35) requiring a venous blood sampling or the placement of a venous peripheral catheter

Exclusion Criteria:

* pregnant woman

Primary outcomes:
measure: Percentage of success of the first vein puncture
timeFrame: one hour
Secondary outcomes:
measure: Score of evaluation of the device
timeFrame: one hour
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco-Britannique
state: Hauts de Seine
Study officials:
References:
Clinical trial NCT02100345: Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound
Official title: Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Endometriosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with bowel endometriosis

Brief summary: Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of abdominal pain and suffering during women's menstrual periods. A subgroup of patients with DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to assess the need for follow-up with transvaginal ultrasound during medical treatment.

Hypotheses:

Symptoms will follow growth of rectosigmoid endometriosis.

Material and methods:

Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and treatment with hormonal intrauterine device or continuous oral contraceptives will receive a questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion, (6) and 12 months later.

Perspectives:

Patients treated conservatively may be followed by questionnaires, thereby reducing the need for time consuming clinical controls.


Eligibility criteria: Inclusion Criteria:

* Medically treated bowel endometriosis

Exclusion Criteria:

* Age below 18 years
* Bowel resection of any kind
* Cancer

Primary outcomes:
measure: Transvaginal Ultrasound
timeFrame: 29 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
state: Region Midt
Study officials:
affiliation: Department of Obstetrics and Gynecology, Aarhus University Hospital
name: Mikkel Mr Seyer-Hansen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06153745: Aspheric Monofocal Intraocular Lens in Pediatric Patients
Official title: Aspheric Monofocal Intraocular Lens With Higher Order Aspheric Optic in Pediatric Patients: Early Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract in Child
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: To evaluate the performance a new aspheric monofocal intraocular lens (IOL) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery.

Detailed description: thirteen patients (mean age 7.6±3.8 years) who underwent cataract surgery and simultaneous implantation of the Tecnis Eyhance ICB00 IOL were evaluated. Visual acuity was assessed three months after surgery for distance (CDVA), intermediate (CIVA) and near visual acuity (CNVA).

Eligibility criteria: Inclusion Criteria:

* monolateral cataract

Exclusion Criteria:

* other ocular diseases
* systemic diseases

Primary outcomes:
measure: Corrected Distance Visual Acuity
timeFrame: 3 months postoperatively
measure: Corrected Intermediate Visual Acuity
timeFrame: 3 months postoperatively
measure: Corrected Near Visual Acuity
timeFrame: 3 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Luca Buzzonetti
Study officials:
affiliation: Bambino Gesù Children's Hospital, Rome, Italy
name: Luca Buzzonetti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01628445: Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
Official title: Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Diabetes
Insulin
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2012-06-26
Enrollment: 52
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: Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (\>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* BMI≤45 kg/m2
* A1c ≥7.5% and ≤10.5%

Exclusion Criteria:

* type 1 diabetes
* symptoms of poorly controlled diabetes
* eGFR \<50 ml/min/1.73m2

Primary outcomes:
measure: Change in A1c
timeFrame: Baseline to 24 wks
Secondary outcomes:
measure: Percentage of patients experiencing hypoglycemia
timeFrame: Baseline and 24 weeks
measure: Change in Systolic Blood pressure
timeFrame: Baseline and 24 weeks
measure: Change in diastolic blood pressure
timeFrame: Baseline and 24 weeks
measure: Change in waist circumference
timeFrame: Baseline and 24 weeks
measure: Change in body weight
timeFrame: Baseline and 24 weeks
measure: Change in heart rate
timeFrame: Baseline and 24 weeks
measure: Change in lipid profile
timeFrame: Baseline and 24 weeks
measure: Diabetes Treatment Satisfaction
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Percentage of patients achieving A1C < or equal to 7%
timeFrame: Baseline and 24 weeks
measure: Change in fasting blood glucose
timeFrame: Baseline adn 24 weeks
measure: Occurence of undetected hypoglycemia as measured by continuous glucose monitoring
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Postprandial glucose reduction through measurement of 7 point glucose profile
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group
state: Manitoba
Study officials:
affiliation: University of Mantioba
name: Vincent C Woo, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: