louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05695781: Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.
Official title: A Multi-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: BRIM Biotechnology Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Masking
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye prior to enrollment;
* Have a history of use or desire to use eye drops;

Exclusion Criteria:

* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have used any eye drops within 2 hours of Visit 1;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;

Primary outcomes:
measure: Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score
timeFrame: 1-2 weeks
measure: Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warwick
country: United States
facility: Andover Eye Associates
state: Rhode Island
Study officials:
References:
Clinical trial NCT06484881: Clinical Study of Probiotic Treatment for Androgenetic Alopecia
Official title: Clinical Study of Probiotic Treatment for Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Androgenetic Alopecia
Female Pattern Baldness
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Follea International Limited
First posted: 2024-07-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the efficacy of DA-001 as an oral supplement for treatment of female pattern hair loss.

Detailed description: DA-001 is a botanical supplement demonstrated natural ingredients known to exert anti-androgen effects. The ingredients were tested in-vitro and have demonstrated the anti-androgen effect. This study aims to compare DA-001 to topical minoxidil in the treatment of female pattern hair loss (also known as androgenetic alopecia).

Eligibility criteria: Inclusion Criteria:

* Females Age 18 or older
* Diagnosed with female pattern hair loss
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives
* Women who are pregnant, lactating, or planning to become pregnant during the study period
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
* Subjects who have known allergies to any excipient in DA-001
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
* Subject is unable to provide consent or make the allotted clinical visits

Primary outcomes:
measure: Target Area Hair Counts
timeFrame: Week [0,12]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rome G. Marconi
name: Andy Goren, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05011981: Hemostatic Activity Following LAAO
Official title: Hemostatic Activity Following Left Atrial Appendage Occlusion
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2021-08-18
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Only patients already eligible for LAAO will be screened by clinical personnel and potentially recruited for participation. Blood samples will be systematically sampled during planned follow-up timepoints.

Brief summary: The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).

Detailed description: This is a prospective cohort study of patients undergoing transcatheter LAAO at Aarhus University Hospital. Hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 LAAO patients. Platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. Patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Atrial fibrillation (paroxysmal, persistent, or permanent)
* Admitted and eligible for LAAO
* Signed written consent

Exclusion Criteria:

* Known hereditary bleeding disorders (i.e. Hemophilia A and B, Von Willebrand disease)
* Platelet count \< 75 x 109/ml

Primary outcomes:
measure: Change in coagulation activity
timeFrame: 7 days, 14 days, 90 days
Secondary outcomes:
measure: Change in platelet activity
timeFrame: 7 days, 14 days, 90 days
measure: Additional measures of changes in coagulation and contact activation
timeFrame: 7 days, 14 days, 90 days
measure: Change in endothelial activation and response
timeFrame: 7 days, 14 days, 90 days
measure: Non-procedural bleeding events
timeFrame: 7 days, 14 days, 90 days
measure: Radiographical evidence of device endothelization
timeFrame: 7 days, 14 days, 90 days
measure: Radiographically confirmed device-related thrombosis
timeFrame: 7 days, 14 days, 90 days
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark
Study officials:
affiliation: Aarhus University Hospital
name: Anders Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02131181: Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients
Official title: Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients (POD-I)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: Delirium, postoperative delirium, elderly
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing scheduled non-cardiac operation

Brief summary: The purpose of this study is to determine the incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery.

Detailed description: The investigators have process of quality assurance for the study including data dictionary, data verification of case record form and site monitoring and auditing.

Eligibility criteria: Inclusion Criteria:

* Age \>/ 60 years
* American Society of Anesthesiologists (ASA) physical status 1-3
* Undergoing scheduled surgery
* Giving an informed consent

Exclusion Criteria:

* Impaired visual and auditory disturbance
* Cannot communicate with Thai language
* Undergoing neurosurgery

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week.
Secondary outcomes:
measure: Factor related to postoperative delirium
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Long-term outcomes (cognitive impairment)
timeFrame: 3 and 6 months after operation
Other outcomes:
Locations:
city: Maung
country: Thailand
facility: Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand
name: Tanyong Pipanmekaporn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banjongrewadee M, Wongpakaran N, Wongpakaran T, Pipanmekaporn T, Punjasawadwong Y, Mueankwan S. The role of perceived stress and cognitive function on the relationship between neuroticism and depression among the elderly: a structural equation model approach. BMC Psychiatry. 2020 Jan 20;20(1):25. doi: 10.1186/s12888-020-2440-9.
Clinical trial NCT01644981: Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia
Official title: Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2012-07-19
Enrollment: 110
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants born before 32 weeks gestational age

Brief summary: Serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm infants. Comparing pro-endothelin-1 with established clinical indices of bronchopulmonary dysplasia (BPD). Hypothesis: Pulmonary-vascular remodeling in infants developing BPD is directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker of BPD.


Eligibility criteria: Inclusion criteria:

* Very preterm infants born before 32 weeks gestational age

Exclusion criteria:

* Severe fetal malformation, congenital heart defect, inborn syndrome, cardiomyopathy, fetal hydrops

Primary outcomes:
measure: duration of supplemental oxygen requirement
timeFrame: 36 weeks postmenstrual age
Secondary outcomes:
measure: duration of respiratory pressure support
timeFrame: during hospitalisation
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Neonatology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Neonatology
name: Sven Wellmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03029481: Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma
Official title: Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Ewing Sarcoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: NantCell, Inc.
First posted: 2017-01-24
Sex: ALL
Minimum age (years): 48
Maximum age (years): 50
Standard ages: ADULT

Brief summary: Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.

More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Detailed description: Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.

More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Eligibility criteria: Inclusion Criteria:

Diagnosis: Confirmed translocation-positive Ewing sarcoma

Organ Function Requirements:

Serum creatinine \< 1.4 Adequate liver function

* Total bilitubin \<1.5x upper limit of normal for age
* SGPT (ALT) \< 5x upper limit of normal for age Adequate cardiac function \> 50% by echocardiogram Bone Marrow
* Absolute neutrophil count \> 750
* Platelet count \> 75

Exclusion Criteria:

* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained. Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy. Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy.
* Patients with known pre-existing diabetes mellitus will be excluded from study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04676581: Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years
Official title: Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leeches
Healthcare Associated Infection
Keywords: Leeches
Healthcare-associated infection
Hirudo Medicinalis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)

Brief summary: Venous congestion in transplanted or re-implanted tissues remains a common and chal-lenging complication in plastic and reconstructive surgery. Local application of medicinal leeches is effective to reduce postoperative venous congestion of the flap and to restore normal blood flow. However, leech therapy is associated with a number of risks, including infections. Indeed, leeches maintain a symbiotic relationship with Aeromonas species in order to digest blood in their gut. Aeromonas spp. infections can occur 1 to 30 days post-application of leeches and are associated with a dramatic decrease in flap salvage rates (88 to 30%). For these reasons, prophylactic antibiotics and, external decontamination are widely recommended throughout the course of leech therapy.

The aim of this study is to investigate the prevalence of side effects (anemia and infection) from patients treated with leeches in French Hospital.


Eligibility criteria: Inclusion Criteria:

* Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)

Exclusion Criteria:

* Hirudotherapy outside the inclusion period
* Hirudotherapy or less than 2 days of treatment

Primary outcomes:
measure: number of patients requiring a second surgery
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03635281: Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone in One Lung Ventilation
Official title: Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone on Ventilation Perfusion Mismatch and Respiratory Mechanics in One Lung Ventilation. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intraoperative driving pressure (∆P) has been recently identified as the greater independent predictor of postoperative pulmonary complications after one lung ventilation (OLV). The application of a positive end-expiratory pressure (PEEP) level of 5 or 10 cmH2O has been shown to reduce the ∆P and the V/Q mismatch (Spadaro 2017); however, the "optimal" PEEP level able to minimize the ∆P may change significantly across patients. The aim of this study is to describe the optimal PEEP levels in patients undergoing thoracic surgery


Eligibility criteria: Inclusion Criteria:

• Patients undergoing VATS with OLV ≥2 hours

Exclusion Criteria:

* ASA (American Society of Anesthesiologists Physical Status Classiﬁcation) score ≥ 4
* severe chronic respiratory failure (chronic obstructive pulmonary disease patients with GOLD stage 3 or 4
* preoperative hemoglobin less than 10 g ml-1
* hemodynamic instability (defined as a decrease in systolic arterial pressure of more than 20% from baseline),

Primary outcomes:
measure: pulmonary shunt, expressed as percentage, measured by ALPE system
timeFrame: 20 minutes after intervention
Secondary outcomes:
measure: intraoperative driving pressure, measured as plateau pressure - PEEP
timeFrame: 20 minutes after intervention
Other outcomes:
measure: intraoperative oxygenation, measured as PaO2/FIO2 ratio
timeFrame: 20 minutes after intervention
Locations:
city: Ferrara
country: Italy
facility: Università di Ferrara
Study officials:
References:
citation: Spadaro S, Grasso S, Karbing DS, Fogagnolo A, Contoli M, Bollini G, Ragazzi R, Cinnella G, Verri M, Cavallesco NG, Rees SE, Volta CA. Physiologic Evaluation of Ventilation Perfusion Mismatch and Respiratory Mechanics at Different Positive End-expiratory Pressure in Patients Undergoing Protective One-lung Ventilation. Anesthesiology. 2018 Mar;128(3):531-538. doi: 10.1097/ALN.0000000000002011.
citation: Spadaro S, Grasso S, Karbing DS, Santoro G, Cavallesco G, Maniscalco P, Murgolo F, Di Mussi R, Ragazzi R, Rees SE, Volta CA, Fogagnolo A. Physiological effects of two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation. J Clin Monit Comput. 2021 Oct;35(5):1149-1157. doi: 10.1007/s10877-020-00582-z. Epub 2020 Aug 20.
Clinical trial NCT03258281: Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus
Official title: Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus After Elective Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Dyslipidemia Associated With Type II Diabetes Mellitus
Percutaneous Coronary Intervention
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2) placebo.

Detailed description: This is a double-blind randomized clinical trial of evolocumab versus placebo in patients with ASCVD and DM on clopidogrel and aspirin undergoing PCI. The study is aimed to assess

1. the effect of evolocumab therapy on platelet activation and reactivity;
2. the effect of evolocumab on biomarkers of platelet activation and inflammation.

Eligible patients will be randomized prior to start the PCI equally to either:

1. 420 mg evolocumab ; or
2. placebo. The randomized treatment will be administered in subcutaneous injections.

The laboratory assessments will be performed before (baseline), and 16-24 hours and 30-days after randomization.

Subject participation will be 30 days from the randomization.

Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus
* Dyslipidemia
* Undergoing elective PCI

Exclusion Criteria:

* Patients with recent Acute Coronary Syndrome (≤1 month)
* Patients on dual antiplatelet treatment (DAPT) with ticagrelor or prasugrel
* Patients undergoing urgent/emergent PCI for stent thrombosis
* Severe acute or chronic medical or psychiatric condition
* Pregnancy
* Participation in another experimental clinical trial, without formal approval
* Unwillingness or inability to comply with the requirements of this protocol

Primary outcomes:
measure: Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
timeFrame: Baseline and after 30 days of treatment
Secondary outcomes:
measure: Change in ADP-unstimulated P-selectin Expression
timeFrame: Baseline and after 30 days of treatment
measure: Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)
timeFrame: Baseline and after 30 days of treatment
measure: Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI
timeFrame: Baseline and after 30 days of treatment
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
References: