louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00382122: Prevalence of Ocular Surface Disease in Glaucoma Patients
Official title: Prevalence of Ocular Surface Disease in Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Ocular hypertension
Dry eye
Ocular surface disease
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years or older with open-angle glaucoma or ocular hypertension were consecutively recruited for the study.

Brief summary: Demographic information and a brief medical and concomitant medicine history will be obtained from the glaucoma patient's records. Qualified patients will be asked to complete a questionnaire about their symptoms. Patients will then be scheduled to undergo three standard clinical tests of the ocular surface.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of glaucoma;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Inability to understand trial procedures;
* Inability to understand Informed Consent;
* Current use or use within the last 3 months of Restasis, steroids, or topical ocular non-steroidal anti-inflammatory drugs;
* Punctal plugs;
* Previous glaucoma, corneal, or conjunctival surgery;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: La Jolla
state: California
Study officials:
affiliation: University of California, San Diego
name: Felipe Medeiros, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Leung EW, Medeiros FA, Weinreb RN. Prevalence of ocular surface disease in glaucoma patients. J Glaucoma. 2008 Aug;17(5):350-5. doi: 10.1097/IJG.0b013e31815c5f4f.
Clinical trial NCT05105022: Propofol Versus Sevoflurane for Induction of GA in Infants
Official title: The Hemodynamic Effects of Propofol Versus Sevoflurane for Induction of Anesthesia in Healthy Infants as Measured by Electrical Cardiometry: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Induction of General Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 122
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This comparative study aims to investigate the haemodynamic safety profile for induction of general anesthesia in infants 3 months or less guided by electrical cardiometry parameters versus sevoflurane.

Detailed description: This study aims to investigate the hemodynamic effects of both propofol and sevoflurane for induction of anesthesia in infants less than 3 months of age by electrical cardiometry. The investigators hypothesized that propofol will have a safe hemodynamic profile for induction of anesthesia in infants less than 3 months of age as measured by electrical cardiometry in addition to its favorable pharmacokinetic profile of rapid induction and optimal intubation conditions.It is conducted at Abu Al Reesh Children's Hospital, Faculty of Medicine, Cairo University based on an institutional protocol used as a standard of care to induce anesthesia

Eligibility criteria: Inclusion Criteria:

* infants aged 3 months or less scheduled for elective surgery

Exclusion Criteria:

* significant structural congenital heart disease
* intracranial malformation.
* preexisting hemodynamic instability.
* history of seizures, opioids, and/or hypnotic administration.
* prematurity (defined as gestational age \<37 weeks)

Primary outcomes:
measure: cardiac index
timeFrame: 15 minutes
Secondary outcomes:
measure: MAP
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine- Cairo University
Study officials:
References:
Clinical trial NCT00071422: Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes
Official title: A Randomized, Double-blind, Placebo-controlled, Rising-dose, Multicenter Study to Evaluate the Efficacy and Safety of 90 Days of 300 or 600 mg Daily Subcutaneous Injections of INGAP Peptide in Insulin-using Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 diabetes
Lead sponsor: Exsulin Corporation
Sponsor class: INDUSTRY
First posted: 2003-10-23
Enrollment: 126
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 2 diabetes is a disease where the beta cells are unable to meet a person's insulin needs. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to improve the ability to produce insulin in type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria

* Age 35-70
* Using \>20 Units of insulin per day
* HbA1c from 6.5% to 10%
* No islet antibodies
* Otherwise healthy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Diabetes and Endocrine Associates
state: California
city: San Diego
country: United States
facility: VA Hospital UCSD
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Denver
country: United States
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Washington
country: United States
facility: MedStar Clinical Research Center
state: District of Columbia
city: Springfield
country: United States
facility: Future Care Studies
state: Massachusetts
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Buffalo
country: United States
facility: Diabetes-Endocrinology Center of WNY
state: New York
city: Durham
country: United States
facility: UNC Diabetes Care Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Group
state: North Carolina
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon
state: Oregon
city: Greer
country: United States
facility: Mountain View Clinical Research
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center - Texas Diabetes Institute
state: Texas
city: San Antonio
country: United States
facility: DGD Research Associates
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
Study officials:
References:
Clinical trial NCT04452422: Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology
Official title: High Prevalence of Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Venous Thrombosis
Keywords: non-severe COVID-19
neurovascular diseases
Doppler ultrasound
Deep venous thrombosis
Covid-19
SARS-CoV-2
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with COVID-19 confirmed with RT-PCER and/or chest CT-scan and with acute neurovascular disease defined as transient ischemic attack or acute ischemic stroke or venous cerebral thrombosis or hemorrhagic stroke.

Brief summary: Severe SARS-CoV-2 infection, responsible of COVID-19, is accompanied by many venous thromboembolic events. Antithrombotic treatment is the cornerstone of management of many neurovascular diseases (NVDs) and the benefit-risk ratio is crucial to avoid hemorrhagic complications. Therefore, in non-severe COVID-19 patients affected by NVDs, the diagnostic of deep venous thrombosis (DVT) is challenging. Using bedside Doppler ultrasonography (DUS) of lower limbs, this study investigated the rates of DVT in these patients in stroke unit.


Eligibility criteria: * Inclusion criteria:

  * Age\>18 years
  * COVID-19 confirmed with RT-PCER and/or chest CT-scan
  * Acute neurovascular disease defined as transient ischemic attack or acute ischemic stroke or venous cerebral thrombosis or hemorrhagic stroke.
* Exclusion criteria:

  * age\<18
  * Other neurovascular diseases

Primary outcomes:
measure: Number of cumulated deep venous thrombosis among the hospitalization
timeFrame: Day 7 after admisssion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Unité Neurovasculaire
Study officials:
References:
Clinical trial NCT02765022: Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.
Official title: Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection of Large Colorectal Lesions as Prophylaxis of Delayed Haemorrhage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Resection
Clip
Haemorrhage
Non-pedunculated Lesions
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions.
* Medium-high risk of delayed bleeding (DB risk score ≥ 4)
* Informed consent.

Exclusion Criteria:

* Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication.
* Lesions resected by endoscopic submucosal resection.
* Incomplete resections.
* Resections with suspected deep submucosal invasion.
* Mucosal defects treated with clips for known or suspected damage to the muscle layer.
* Lesions with low risk of delayed bleeding (DB risk score ≤3).
* Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Primary outcomes:
measure: Delayed hemorrhage
timeFrame: 15 days post-EMR
Secondary outcomes:
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Eduardo Albeniz Arbizu
state: Navarra
Study officials:
References:
citation: Albeniz E, Alvarez MA, Espinos JC, Nogales O, Guarner C, Alonso P, Rodriguez-Tellez M, Herreros de Tejada A, Santiago J, Bustamante-Balen M, Rodriguez Sanchez J, Ramos-Zabala F, Valdivielso E, Martinez-Alcala F, Fraile M, Elosua A, Guerra Veloz MF, Ibanez Beroiz B, Capdevila F, Enguita-German M. Clip Closure After Resection of Large Colorectal Lesions With Substantial Risk of Bleeding. Gastroenterology. 2019 Nov;157(5):1213-1221.e4. doi: 10.1053/j.gastro.2019.07.037. Epub 2019 Jul 27.
Clinical trial NCT00805922: A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Thailand
Official title: DiabCare Asia 2008. A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia and To Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 2342
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus being treated at general hospitals, diabetes clinics and referral clinics will be selected according to the inclusion and exclusion criteria.

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in Thailand.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients registered in the particular centre for more than 12 months.
* Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit.
* Patients willing to sign informed consent form.

Exclusion Criteria:

* Repetition of any patient as patients should not be included twice for any reason.
* Unwilling to participate or unable to comply with protocol requirements.

Primary outcomes:
measure: Mean blood glucose parameters of diabetic patients
timeFrame: Study start
Secondary outcomes:
measure: Patients' perception will be analysed through patient questionnaire measuring psychological well-being, quality of life and patients' compliant to treatment
timeFrame: Study start
measure: Physician perception of diabetes and its management will be analysed through physician questionnaire measuring awareness about HbA1c test and its goal, anti-diabetic treatment and barriers towards optimum diabetes control
timeFrame: Study start
measure: Duration of diabetes associated with highest number of diabetic complications
timeFrame: Study start
measure: Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy)
timeFrame: Study start
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03929822: Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis
Official title: Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Screening
Keywords: Mammography
Contrast-Enhanced Spectral Mammography
19-116
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women called back from an abnormal screening mammogram/tomosynthesis exam will be offered CESM as part of their diagnostic work up.

Brief summary: The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.


Eligibility criteria: Inclusion Criteria:

* Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.

Exclusion Criteria:

* Age \<30 years old
* Screening mammography with only calcifications abnormalities
* Male patients
* Pregnant or lactating patients
* Patients with any allergy to iodinated contrast
* Patients with eGFR \< 45
* Patients that may be treated with radioactive iodine

Primary outcomes:
measure: Diagnostic accuracy of CESM compared to mammography
timeFrame: 2 years
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: Janice Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00097422: OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)
Official title: An Open-Label, Dose Ranging, Randomized Clinical Evaluation of OPT-80 in Patients With Clostridium Difficile-Associated Diarrhea (CDAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea
Keywords: CDAD, diarrhea
Clostridium difficile-Associated Diarrhea
Lead sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2004-11-24
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 investigate the safety and perform preliminary clinical evaluation in patients with mild to moderate CDAD.

Detailed description: This is a dose-finding study to select a safe and efficacious dose of OPT-80. Patients will be evaluated for safety and efficacy and pharmacokinetic parameters will be investigated.

Eligibility criteria: Inclusion Criteria:

* Patients with CDAD

Exclusion Criteria:

* Patients with severe CDAD

Primary outcomes:
measure: Relief of symptoms of CDAD
Secondary outcomes:
measure: Recurrence Rate.
Other outcomes:
Locations:
city: New Hope
country: United States
facility: Advanced Biologics
state: Pennsylvania
Study officials:
References:
citation: Louie T, Miller M, Donskey C, Mullane K, Goldstein EJ. Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection. Antimicrob Agents Chemother. 2009 Jan;53(1):223-8. doi: 10.1128/AAC.01442-07. Epub 2008 Oct 27.
Clinical trial NCT00252122: Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease
Official title: A Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sickle Cell Disease
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2005-11-11
Enrollment: 3
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to provide a preliminary assessment of the feasibility and efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant to intravenous narcotics).

Detailed description: It is often difficult to manage acute painful crisis in patients with sickle cell disease. The usual management of these crises relies on hydration, administration of oxygen and narcotics, like morphine. A select group of patients, for unknown reasons, does not respond to this management and these patients often require prolonged use (several days) of intravenous narcotics. Narcotics have proven to be ineffective in controlling this type of pain and can cause multiple side effects (sedation, vomiting, respiratory depression). We propose to administer intravenous ketamine in this group of patients who are resistant to intravenous narcotics. Ketamine has been proven to be effective in controlling pain in multiple clinical situations. However, there are no data in the literature describing its use in patients with sickle cell disease.

Eligibility criteria: Inclusion Criteria:

* Children ages 7 to \<19
* Acute vaso-occlusive crisis
* Persistent pain despite initial pain management with intravenous (IV) opioids

Exclusion Criteria:

* Contraindications to the use of ketamine
* Mental retardation or psychological conditions that may affect the proper evaluation of pain and side effects
* Known allergy to ketamine

Primary outcomes:
measure: Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility.
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Arjunan Ganesh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05493722: Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Official title: Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Refractory Epilepsy
Deep Brain Stimulation
Keywords: Refractory Epilepsy
deep brain stimulation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be randomly assigned to a stimulation order at the baseline visit with optimized settings (OS) stimulation occurring for a total of 8 months and physician-selected settings (PS) stimulation chosen for a total of 4 months. For example, a patient may undergo PS setting stimulation from 4-8 months, then undergo OS setting stimulation from 8-12 and 12-16 months. Thus, there are three possible stimulation groups (1. PS, OS, OS; 2.OS, PS, OS; 3. OS, OS, PS).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.


Eligibility criteria: Inclusion Criteria:

* medically refractory epilepsy
* already have a deep brain stimulator in place

Exclusion Criteria:

* severe dementia at investigator discretion

Primary outcomes:
measure: Difference in broadband power with different settings
timeFrame: One year from baseline
measure: Difference in frequency band-specific low-frequency power (LFP) with different settings
timeFrame: One year from baseline
Secondary outcomes:
measure: Identify all seizures
timeFrame: one year from baseline
measure: Scores on Montreal Cognitive Assessment, MoCA
timeFrame: one year from baseline
measure: Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P)
timeFrame: One year from baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Robert McGovern, MD
role: PRINCIPAL_INVESTIGATOR
References: