louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02382120: Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2
Official title: Accuracy and Precision of Non-invasive Effective Pulmonary Perfusion Measurement Using Volumetric Capnography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: carbon dioxide
cardiac output
ventilation
thermodilution
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac surgical ASA II-III patients.

Brief summary: Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation.

The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.

Detailed description: This is a prospective and observational study designed to test the accuracy and precision of the non-invasive capnodynamic cardiac output measurement in mechanically ventilated patients. We will study 30 patients undergoing cardiovascular by pass in which an invasive trans-thoracic thermodilution method (PICCOScience) is indicated - the reference method.

A pair of thermodilutions and capnodynamic cardiac output measurement will be performed along the surgery. Analysis of precision will be done at the begining of the protocol and during stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and regression analysis.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Programmed cardiac surgeries
* Surgeries with cardiopulmonary bypass

Exclusion Criteria:

* Emergency surgeries.
* Acute pulmonary diseases
* Contraindication of femoral catheters.
* Need of counter-pulsation baloon

Primary outcomes:
measure: Accuracy and precision of capnodynamic to measure cardiac output
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
state: Buenos Aires
Study officials:
affiliation: Hospital Privado de Comunidad de Mar del Plata
name: Gerardo Tusman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capek JM, Roy RJ. Noninvasive measurement of cardiac output using partial CO2 rebreathing. IEEE Trans Biomed Eng. 1988 Sep;35(9):653-61. doi: 10.1109/10.7266. No abstract available.
citation: Peyton PJ, Venkatesan Y, Hood SG, Junor P, May C. Noninvasive, automated and continuous cardiac output monitoring by pulmonary capnodynamics: breath-by-breath comparison with ultrasonic flow probe. Anesthesiology. 2006 Jul;105(1):72-80. doi: 10.1097/00000542-200607000-00015.
Clinical trial NCT03899220: Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders
Official title: Addressing Internalized Stigma and Shame as Barriers to Engagement in HIV Care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders (Project Matter)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
HIV/AIDS
Homosexuality, Male
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-04-02
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study will implement a pilot randomized controlled trial (RCT, N=60) to assess the feasibility and acceptability a refined emotion regulation intervention designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in HIV care.

Detailed description: Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will be randomized to an enhanced treatment as usual (E-TAU) arm or the intervention arm. All participants (in both the E-TAU and intervention groups) will receive a one-session behavioral engagement in care intervention, substance use treatment referral information, and the opportunity to discuss and problem solve barriers to substance use treatment with an interventionist, informed by motivational interviewing principles. After randomization, participants in the intervention group will attend 5 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, and cognitive restructuring. All participants will receive texts queries about antiretroviral therapy (ART) adherence and substance use, and participants in the intervention group will also receive text queries about mood. All participants will be compensated for every research visit and completed text message blocks.

Eligibility criteria: Inclusion Criteria:

* HIV positive
* Cisgender male
* Man who has sex with men (MSM)
* Elevated levels of internalized stigma related to HIV, substance use, or homophobia
* Poorly engaged in HIV care
* Able to provide informed consent
* 18 years or older
* English speaking

Exclusion Criteria:

* Women
* Non-cisgender men
* Do not identify as gay, bisexual, or MSM

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: change from baseline to 12 weeks after intervention completion
measure: Feasibility of Intervention
timeFrame: change from baseline to 12 weeks after intervention completion
Secondary outcomes:
measure: Engagement in HIV Care
timeFrame: change from baseline to 12 weeks after intervention completion
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
References:
Clinical trial NCT00820274: Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
Official title: Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Resistant Vascular Ulcers
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Etablissement Français du Sang
First posted: 2009-01-12
Enrollment: 10
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: To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.

To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.

To evaluate rate of amputations and recurrence at one year after complete cicatrisation

Detailed description: Treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. A cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week.

Main criterias:

Tolerance will be evaluated on clinical criterias. Efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months).

Secondary criterias:

Reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption.

Evaluation of infections, amputations, complete healing, improvement of quality of life by SF36 questionnaire and recurrence at one year for patients with complete healing.

Eligibility criteria: Inclusion Criteria:

* Obtained informed consent
* Leg or foot arterial or mixed ulcer older than at least 3 months

Exclusion Criteria:

* No obtained informed consent
* Possibility for surgical treatment (revascularisation)
* Age less than 18
* Pregnancy
* Indication for major amputation (below /above the knee)
* Venous ulcer
* Ulcer with infection and / or necrosis
* Mycotic ulcer

Primary outcomes:
measure: Measure of the diameter of the ulcer
timeFrame: Every week
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Médecine Interne et Pathologie Vasculaire
city: Bordeaux
country: France
facility: Service de Chirurgie Vasculaire et Viscérale
city: Limoges
country: France
facility: Service de Chirurgie Thoracique, cardiovasculaire et angiologie
Study officials:
affiliation: CHU Limoges
name: Francis Pesteil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05903274: JSP191 (briquilimab) in Subjects with LR-MDS
Official title: A Phase 1 Open-label, Dose-escalation, Safety, and Tolerability Study of JSP191 As a Second-line Therapy in Subjects with Lower-Risk Myelodysplastic Syndrome (LR-MDS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lower-risk Myelodysplastic Syndrome
Keywords: LR-MDS
cytopenia
Lead sponsor: Jasper Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 3 + 3 dose escalation/de-escalation design
Primary purpose: TREATMENT

Brief summary: A Phase 1 study in subjects with LR-MDS to assess the safety and tolerability of JSP191 as a second-line therapy.

Detailed description: An open-label, single-arm, dose-escalation study designed to determine the potential safety, efficacy, maximum tolerated dose (MTD) or optimal biologic dose (OBD), and recommended phase 2 dose (RP2D) of JSP191 (briquilimab) monotherapy for LR-MDS subjects with documented cytopenia (red blood cell-transfusion dependent, thrombocytopenia, and/or neutropenia).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* MDS with IPSS-R very low, low, or intermediate risk features
* Symptomatic cytopenias
* Women of childbearing potential (WOCBP) must agree to use an oral or implanted contraceptive, a double-barrier method of birth control, or an intrauterine device upon enrollment and through 3 months after receiving the last dose of JSP191
* Women not of childbearing potential must be post-menopausal (no menstrual period for a minimum of 12 months) or surgically sterilized and have a negative serum pregnancy test upon study entry
* Male subjects must be surgically sterile or willing to use contraception upon enrollment and through 3 months after receiving the last dose of JSP191
* Must be willing and able to provide informed consent

Exclusion Criteria:

* Anemia secondary to iron deficiency, vitamin B12 deficiency, or folate deficiency
* Prior allogeneic or autologous stem cell transplant
* Known history of human immunodeficiency virus (HIV) (no laboratory testing is required), or active infection with hepatitis B or hepatitis C
* Pregnant women or women who are nursing and do not wish to discontinue breastfeeding
* Any other medical condition that, in the opinion of the Investigator, could pose a significant safety risk to the subject or jeopardize the integrity of the study
* Subjects who, in the opinion of the Investigator, may not be able to comply with the requirements of the study

Primary outcomes:
measure: Safety and tolerability of JSP191
timeFrame: 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Jasper Therapeutics
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01099774: Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 597
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: This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Patient has ocular hypertension or glaucoma in both eyes
* Requires IOP-lowering therapy in each eye

Exclusion Criteria:

* Active or recurrent eye disease that would interfere with interpretation of study data in either eye
* History of any eye surgery or laser in either eye within 6 months
* Required chronic use of other eye medications during the study
* Anticipated wearing of contact lenses during the study.
* Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

Primary outcomes:
measure: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
timeFrame: Baseline, Week 12
measure: Average Eye IOP at Week 12
timeFrame: Baseline, Week 12
measure: Average Eye IOP at Week 6
timeFrame: Week 6
measure: Average Eye IOP at Week 2
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Day DG, Walters TR, Schwartz GF, Mundorf TK, Liu C, Schiffman RM, Bejanian M. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial. Br J Ophthalmol. 2013 Aug;97(8):989-93. doi: 10.1136/bjophthalmol-2012-303040. Epub 2013 Jun 6.
Clinical trial NCT03513874: Metformin Plus Insulin on Non-obese Autoimmune Diabetes
Official title: The Effect of Metformin as add-on to Insulin in Non-obese Patients With Autoimmune Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Autoimmune Diabetes
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes according to ADA criterias \<5 years.
* Age≥ 18 years and less than 70 years.
* Non-obese: defined as BMI less than 28 kg/m2
* Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
* Fasting or postprandial plasma C-peptide more than 100 pmol/L
* Written informed consent from the patient or family representative.

Exclusion Criteria:

* History of any malignancy or other severe diseases
* Female patients who are pregnant or breastfeeding before or during the three-year follow-up
* Poor compliance or refusal to participate.

Primary outcomes:
measure: Mean amplitude of glycemic excursions (MAGE)
timeFrame: 6 months
measure: Change in C-peptide
timeFrame: 6 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
measure: Change in daily insulin dose
timeFrame: 6 months
measure: Change in body mass index (BMI)
timeFrame: 6 months
measure: Change in lipid profiles
timeFrame: 6 months
measure: Adverse effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT06388174: Idiopathic Generalized Epilepsy Syndromes
Official title: Idiopathic Generalized Epilepsy Syndromes: Clinical Features and Long-term Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Epilepsy, Idiopathic Generalized
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are consecutively and prospectively recruited from epilepsy center and clinics

Brief summary: The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.

According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis.

Detailed description: the Long-term prognosis include the rate of drug-resistent epilepsy, relapse after drug withdrawn, common comorbidities such as mood disorders, attention deficit hyperactivity disorder (ADHD) and learning disabilities.

Eligibility criteria: Inclusion Criteria:

* Patients are consecutively and prospectively enrolled from epilepsy center, with newly diagnosed epilepsy or established epilepsy.
* Patients have a diagnosis of idiopathic generalized epilepsy (IGE), according to the 2022 diagnostic criteria.
* Comprehensive clinical information is collected, and 24 hour video-electroencephalography is performed.
* Sign the informed consent forms.

Exclusion Criteria:

* Other epilepsy syndromes are considered during follow-up, such as genetic generalized epilepsy.
* Lost to follow-up

Primary outcomes:
measure: The proportion of drug-resistent epilepsy
timeFrame: through study completion, an average of 1 year
measure: The proportion of seizure freedom
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The proportion of psychiatric comorbidity
timeFrame: through study completion, an average of 1 year
measure: The proportion of psychosocial outcome
timeFrame: through study completion, an average of 1 year
measure: The proportion of seizure relapse after antiseizure medication withdrawn
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Chunhong Shen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01314274: Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
Official title: A Randomized Double Blind Placebo Controlled Trial of Intranasal Submucosal Bevacizumab in Hereditary Hemorrhagic Telangiectasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HHT
Morbus Osler
Epistaxis
Keywords: Epistaxis
Osler
Weber
Rendu
HHT
Hereditary haemorrhagic telangiectasia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 15
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: In a case series intranasal submucosal bevacizumab has been shown to reduce epistaxis in patients suffering from Hereditary Haemorrhagic Telangiectasia together with KTP Laser therapy. The aim of this study is to evaluate the effectiveness of submucosal intranasal bevacizumab compared to placebo in a randomized double blind trial setting.


Eligibility criteria: Inclusion Criteria:

* Diagnosed and staged HHT (Shovlin et al 2000)
* Age 18-80
* Minimum of 2 episodes of epistaxis/ week
* Ability and willingness to complete diary and comply with study requirements.

Exclusion Criteria:

* Uncontrolled hypertension (systolic blood pressure \> 150mmHg, diastolic blood pressure \> 90mmHg)
* History of a thromboembolic event, including myocardial infarction or cerebral vascular accident
* Malignancy of the upper respiratory tract within the last year
* Recent (\<3 months) or planned surgery
* Proteinuria
* Nasal intervention (Laser or Cautery) in pretreatment phase
* Allergy to local anesthetic

Primary outcomes:
measure: relative change in average daily Epistaxis VAS scores compared to baseline
timeFrame: day 10 - 84 posttreatment
Secondary outcomes:
measure: Epistaxis Severity Score HHT-ESS compared to baseline
timeFrame: 3 months post treatment
measure: Epistaxis frequency, duration and severity compared to baseline
timeFrame: day 10 - 84 posttreatment
measure: Number of emergency department visits due to epistaxis compared to baseline
timeFrame: day 10 - 84 posttreatment
measure: lab results (ferritin values, Hb, Hct) compared to baseline
timeFrame: day 84 posttreatment
measure: Number of transfusions needed compared to baseline
timeFrame: day 10-84 posttreatment
measure: Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity
timeFrame: day 10-84 posttreatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Universitätsklinik für HNO, Medizinische Univeristät Wien
Study officials:
References:
citation: Riss D, Burian M, Wolf A, Kranebitter V, Kaider A, Arnoldner C. Intranasal submucosal bevacizumab for epistaxis in hereditary hemorrhagic telangiectasia: a double-blind, randomized, placebo-controlled trial. Head Neck. 2015 Jun;37(6):783-7. doi: 10.1002/hed.23655. Epub 2014 Apr 30.