louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00379886: Comparison of Thiopental and Propofol as Anaesteticum During ECT
Official title: Comparison of Thiopental and Propofol as Anaesteticum During ECT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: ECT
Depression
Anesthiticum
Propofol
Thiopental
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-09-25
Enrollment: 100
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: Electroconvulsive therapy is the most effective treatment in severe depression and the effect is related to the generalized seizure induced by the treatment. General anesthesia is used during the treatment. Since only a brief period of unconsciousness is required anesthetics with a rapid recovery profile are used.

Methohexital, a barbiturat, is internationally considered "the golden standard", bot other short-acting anesthetics are used. In Denmark the most frequent used anestheticum for ECT is Thiopental, a barbiturat, but also Propofol, a non-barbiturat, is used in many psychiatric departments.

Several studies have shown that Propofol reduce seizure duration in comparison with barbiturates. So far, no studies have demonstrated any clinical implications of the reduced seiziure duration. However, these studies have included rather few patiens, most have been retrospective, and in the only prospective study conducted, uni-lateral ECT was used.

The aim of this study is to compare the clinical effect of ECT in patients anesthesized with either Propofol or Thiopental. The hypothesis is that the shorter duration of seizures found with Propofol as anestheticum will increase the number of treatments needed to clinial respons. Furthermore we want to study differences in EEG-relate parameters previously shown to have prognostic value. Hospitalized patients with major depression, who is to be treated with ECT, are randomized to anesthizia with either Thiopental or Propofol. They are rated with Hamilton depression scale and BDI before treatment, after six treatments and when treatment is concluded. When treatment is ended the patients are furthermore rated with MMSE to evaluate their degree of cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Major depression, hospitalized

Exclusion Criteria:

* age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases

Primary outcomes:
measure: Number of ECT-treatments required to treat depression
measure: Duration of seizures
measure: Amount of energy required to initiate seizure
Secondary outcomes:
measure: EEG-related parameters
measure: Changes in seizure-threshold
measure: Haemodynamic parameters
measure: Cognitive impairment
Other outcomes:
Locations:
city: Blegdamsvej 9
country: Denmark
facility: Rigshospitalet, Department of Psychiatry
state: Copenhagen
Study officials:
affiliation: Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark
name: Martin Balslev Jørgensen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00248222: Early Aerobic Training Program After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Cerebrovascular Accident
Keywords: Exercise
Rehabilitation
Aerobic training
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-11-03
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: The purpose of this study is to examine the feasibility and efficacy of an early supervised aerobic exercise program for patients following a minor ischemic stroke.

Detailed description: The purpose of this study is to examine the feasibility and efficacy of an early supervised aerobic exercise program for patients following a minor ischemic stroke. Patients after a minor ischemic stroke would be randomized within 1-3 weeks of stroke onset to a control group (6 weeks of low intensity stretching and coordination exercises followed by a supervised aerobic training program) or an experimental group (immediate aerobic training program). Patients will be evaluated for measures of ambulation endurance, mobility, gait, functional assessment and clinical follow-up after 6 weeks and again 3 months later.

Eligibility criteria: Inclusion Criteria:

* minor ischemic stroke

Exclusion Criteria:

* unstable angina
* severe lung disease
* severe symptomatic peripheral vascular disease
* dementia or other severe neurological disease
* other severe uncontrolled medical problem

Primary outcomes:
measure: 6 Minute Walk Test at 6 weeks
measure: Modified Bruce Exercise Test at 6 weeks
measure: Activity by Ankle accelerometer at 6 weeks
Secondary outcomes:
measure: Recurrent vascular events at 6 weeks
measure: METS at 6 weeks
measure: Stair climbing ascend and descend test at 6 weeks
measure: Four Square Step Test at 6 weeks
measure: Gait symmetry by SmartStep at 6 weeks
measure: Walking Impairment Questionnaire at 6 weeks
measure: Rivermead Mobility Index at 6 weeks
measure: Similar outcome measures 3 months later
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: David Tanne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00011622: Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Official title: Maternal Glucose Measurement in Pregnancy Using a Continuous Ambulatory Subcutaneous Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-02-26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This proposal is a pilot study to describe the variations of blood sugar in pregnant women with various degrees of glucose intolerance, and how they relate to standardized meals. Blood sugar control during pregnancy is important to prevent complications for the newborn. The variation and timing of the blood sugar measurements in gestational diabetics and how this relates to the baby's outcome is controversial. We will use an FDA approved device called Minimed Glucose Continuous Monitor, which is used in clinical practice for certain diabetics. It is very small, similar to a beeper, and is connected to the patient through a small plastic catheter subcutaneously. This measures blood sugar every five minutes for a total of 288 readings a day with minimum discomfort. The hypothesis of this study is that use of the Minimed glucose monitor will provide information about variations of blood sugar in gestational diabetics that is missed by capillary glucose monitors.

Our conclusions will allow us to compare blood glucose trends among the groups. After the data is analyzed in this pilot study, we plan to design a bigger study involving more subjects to study the impact of the blood sugar variations in the outcome of the newborn, and to obtain generalizable results for the population in general.

Detailed description: We will coordinate the study through the CRC. The women will have to come in only twice, to have the monitor placed and then taken off three days later. A blood sample will be collected at each visit. Meals and snacks will be provided for each day of the study, specially packaged, to supply an equivalent amount of calories for each subject. These will meet the nutritional requirements for both the mother and the fetus. Women will do separate fingerstick blood sugar measurements using a capillary glucometer four times a day, to ensure the accuracy of the sensor's readings.

Eligibility criteria: 1. Inclusion Criteria

* Pregnant women, between 28 and 36 weeks of gestation. Gestational age will be determined by a combination of the date of the last menstrual period and ultrasound, done during the first or second trimester of pregnancy.
* Previous glucose challenge test and if abnormal, an oral glucose tolerance test.
* Body mass index (BMI) between 25 and 30 Kg/m2.
* Gestational diabetes in a previous pregnancy, if glucose between pregnancies was normal.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Medical School
state: Texas
Study officials:
References:
Clinical trial NCT02607722: All-Case Surveillance of Ofev in Patients With IPF in Japan
Official title: The Special Drug Use-results Survey (All-Case Surveillance) of Ofev® Capsules in Patients With Idiopathic Pulmonary Fibrosis (IPF) in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 10117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 Japanese patients with IPF

Brief summary: This is a non-interventional study based on new data collection to gather real-world information (i.e., data under routine medical practice) on safety and effectiveness of the Ofev® Capsules treatment.

The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be followed up until discontinuation of Ofev® Capsules treatment.

As this is an observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for IPF must be according to regular medical practice and at the discretion of the physician (i.e., no randomised assignment of patient to treatment is performed).

All patients administrated Ofev® Capsules after the launch at the sites contracted with the sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected. However the patient registration continues until the approval condition has been removed.

Patients participating in the subsequent follow-up will undergo regular observations. These observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment. Patients will not be followed any longer once they are reported to have discontinued the Ofev® Capsules treatment.


Eligibility criteria: Inclusion criteria:

Essentially, patients are diagnosed with IPF based upon the most recent the American Thoracic Society (ATS), the European Respiratory Society (ERS), the Japanese Respiratory Society (JRS), and the Latin American Thoracic Association (ALAT) guideline.

Primary outcomes:
measure: Number of Patients With Any Suspected Adverse Drug Reactions (ADRs)
timeFrame: Up to 104 weeks
Secondary outcomes:
measure: Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104
timeFrame: At baseline and at week 104
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00327522: Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.
Official title: An Open, Phase I/II Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 11PCV Vaccine Given as a 2-Dose Vaccination in Adults Aged 18-40 Years Old.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prophylactic Pneumococcal Diseases
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

Detailed description: The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Eligibility criteria: Inclusion Criteria:

* healthy male or female between 18 and 40 years of age
* 23-valent pneumococcal polysaccharide vaccine naive adults.

Exclusion Criteria:

* Previous vaccination against Streptococcus pneumoniae.
* History of pneumonia within 3 years prior to the first vaccination
* Any confirmed or suspected immunosuppressive or immunodeficient condition
* All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
* Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
* History of administration of an experimental/licensed vaccine containing similar adjuvants.
* History of chronic alcohol consumption and/or drug abuse.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.

Primary outcomes:
measure: Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;
measure: Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06180122: The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter
Official title: The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein (CIV) Diameter, to Aid and Improve the Diagnosis of May Thurner Syndrome (MTS) in Patients Presenting With Unexplained Left Leg Swelling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: May-Thurner Syndrome
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this feasibility/pilot study is to investigate whether or not vascular ultrasound can be used to aid the diagnosis of May Thurner Syndrome, in adult patients presenting to the vascular department with unexplained left leg swelling. The main research objective it aims to answer are:

* The diameter variation of the left common iliac vein based on posture, using duplex ultrasound.
* To determine inter- and intra-observer variation of the diameter measurement of the left common iliac vein using duplex ultrasound.

Participants will have an ultrasound scan performed on their abdomen by three different clinical vascular scientists, and will have each scan performed whilst lying supine on an examination couch and again when the couch is tilted to 45 degrees.

Researchers will compare the results of symptomatic patients to asymptomatic patients, to see if there is a difference in the diameter of the left common iliac vein between these two groups.


Eligibility criteria: Inclusion Criteria:

* Participant has the capacity to consent
* Participant is required to have a vascular ultrasound scan in the vascular ultrasound department
* Participant is 18 years of age or older at the start of the study.

Exclusion Criteria:

* Previous iliac vein intervention or treatment for iliac vein disease
* Previous diagnosis of iliac vein thrombus
* Pregnancy
* Unable to provide appropriate informed consent
* The participant does not require a vascular ultrasound as part of their routine care
* Under 18 years of age at the start of the study

Primary outcomes:
measure: Left common iliac vein diameter
timeFrame: 6 months
Secondary outcomes:
measure: Inter-and intra-operator variation of the diameter measurement of the left common iliac vein
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: Greater London
Study officials:
References:
Clinical trial NCT01355822: Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies
Official title: Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies: a Prospective Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: High Risk Pregnancy
Keywords: abortion
perinatal death
IUGR
preterm birth
placental abruption
preeclampsia
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2011-05-18
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical underlying placental pathology revealing small placentas and maldevelopment of the decidual blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide (NO) donors can improve decreased uteroplacental perfusion without any negative effects on fetal circulation, these may prevent negative pregnancy outcomes in patients at risk.

The aim of this study is to evaluate the effectiveness of the long-lasting NO donor pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid gestation.


Eligibility criteria: Inclusion Criteria:

* pregnant women 190 to 236 weeks of gestation
* abnormal uterine Doppler as defined by bilateral notching, unilateral notching and increased impedance with mean resistance index (RI) \> 0.65 or with mean RI \> 0.7 without notching at time of enrollement
* informed consent

Exclusion Criteria:

* multiple gestation
* documented chromosomal or major fetal abnormalities
* rupture of membranes and/or clinical chorioamnionitis at time of enrolment
* maternal disease defined as contraindication for intake of PETN

Primary outcomes:
measure: Occurrence of perinatal death and/or IUGR defined as birth weight below the 10th percentile
timeFrame: 19 -40 weeks of gestation
Secondary outcomes:
measure: Development of IUGR and severe IUGR defined as birth weight below the 5th percentile
timeFrame: 19-40 weeks of gestation
measure: Preterm birth before completed 37 weeks of gestation and very early preterm birth before completed 32 weeks of gestation
timeFrame: 19 - 32 weeks of gestation
measure: Development of preeclampsia
timeFrame: 19 - 40 weeks of gestation
measure: Any form of placental abruption
timeFrame: 19 - 40 weeks of gestation
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital Jena, Department of Obstetrics
state: Thüringen
Study officials:
References:
Clinical trial NCT06874322: Voiceitt for People With Impairments in Speech
Official title: Voiceitt for People With Impairments in Speech
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Speech Impairment
Speech Disorder
Keywords: Speech Impairment
voice recognition tool
dictation tool
voice recognition app
dictation app
voiceitt app
speech disabilities
dysarthria
moderate dysarthria
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Duquesne University
First posted: 2025-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this pilot study is to evaluate the feasibility and preliminary effectiveness of the Voiceitt app in improving communication for individuals with speech impairments due to conditions such as cerebral palsy (CP), stroke, Amyotrophic Lateral Sclerosis (ALS), or Parkinson's disease.

Detailed description: Conditions like CP, ALS, Stroke or Parkinson's disease, etc., cause communication impairment. There are few augmentative communication options that allow people with these impairments to communicate effectively.

Voiceitt is an app that is designed to assist people with speech impairments by using a voice recognition and dictation tool that adapts to users' unique, non-standard speech patterns. However, its effectiveness in clinical populations has not been established. This study is bridging the gap in evaluating the preliminary effectiveness and feasibility of Voiceitt app in improving communication among people with mild to moderate speech impairments.

Eligibility criteria: Inclusion Criteria:

* Age 13 or older
* moderately severe speech dysarthria due to conditions such as CP, stroke, ALS or Parkinson's Disease, etc.
* Ability to understand and follow instructions for using the Voiceitt app.

Exclusion Criteria:

* Severe cognitive impairments that prevent the understanding of the Voiceitt app and required training.
* Patients who have additional speech impairments other than dysarthria, such as significant aphasia or verbal apraxia.
* Severe physical impairments that prevent interaction with the app.
* Non-English speakers.

Primary outcomes:
measure: Change in Communication Abilities as measured by SIR
timeFrame: Baseline (Day 1), 5-6 months, and 7-8 months
measure: Change in Communication Abilities as measured by Communication Effectiveness Index (CETI)
timeFrame: Baseline (day 1), 5-6 months, and 7-8 months
Secondary outcomes:
measure: User Satisfaction
timeFrame: 7-8 months
measure: Change in Communication-Related Frustration
timeFrame: 7-8 months
measure: Change in Participants' Accounts on Social Interaction Quality
timeFrame: 7-8 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Center for Assistive Technology
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brad E Dicianno, MD
role: PRINCIPAL_INVESTIGATOR
References: