louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02457403: Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy
Official title: A Prospective, Randomized Clinical Trial Comparing Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy: Rotational Thromboelastography (ROTEM) Versus Conventional Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Coagulopathy
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).

Detailed description: Orthotopic liver transplantation (OLT) can be associated with significant bleeding requiring multiple blood product transfusions, especially in patients with severe liver dysfunction. Rotational thromboelastometry (ROTEM) is a point-of-care device that has been used successfully to monitor coagulation on whole blood samples during OLT. Whether it allows blood loss and transfusion to be reduced during OLT remains controversial. ROTEM or conventional coagulation tests were used in this study to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (FFP) during OLT. Patient characteristics as well as pre- and post- transplant laboratory data were collected. Intra-operative blood loss, type and amount of blood products transfused, and cost were compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Patients 18 and older, admitted to the hospital
* Patients who have clinically documented cirrhosis
* Patients who are coagulopathic (INR \> 1.5 and/or platelets \< 50,000)
* Patients undergoing an endoscopic procedure or neurosurgical procedure

Exclusion Criteria:

* Patients must not be pregnant
* Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis)
* Patients must not have an active infection (per PI discretion)
* Patients must not have any known hemostatic disorder

Primary outcomes:
measure: Intra-operative Blood Loss
timeFrame: Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).
Secondary outcomes:
measure: Number of Participants With Bleeding Events
timeFrame: Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months).
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor-Clinical
name: Adam J Hanje, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00201903: The Roles of Tissue Factor in Malignant Gliomas
Official title: The Roles of Tissue Factor in Malignant Gliomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Brain Tumors
Keywords: venous thromboembolism
brain tumours
glioma
tissue factor
blood coagulation
tumour progression
low molecular weight heparin
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ontario Cancer Research Network
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Detailed description: To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Eligibility criteria: Inclusion Criteria:

* participation in PRODIGE
* adult patients
* newly diagnosed, biopsy-confirmed grade III/IV malignant gliomas
* undergone craniotomy or stereotactic biopsy \> 2 days and \< 4 weeks before

Exclusion Criteria:

* have known hereditary thrombophilia
* are receiving experimental antiangiogenic therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Toronto-Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences and McMaster University
name: Agnes Lee, MD
role: STUDY_CHAIR
affiliation: Sunnybrook Health Sciences Centre
name: William Geerts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: James Perry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences and McMaster University
name: Janusz Rak
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences and McMaster University
name: Jeffrey Weitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02440503: How Infant Diets Would Affect Growth in Early Childhood
Official title: Effect of Complementary Feeding With Different Macronutrient Quantities on Growth and Body Composition: a Follow-up Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth
Body Composition
Gut Health
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 75
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 4-6 years of age

Brief summary: The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that included breastfed infants consuming different infant solid foods. The investigators results showed that different solid foods, especially the protein content of the food, is important on infant's gut bacteria profile and growth. Although the first year of life is critical in obesity development later in life, data are very limited on the effect of protein from solid foods, an important component of infant diet, especially in breast-fed infants. In this study, the investigators will re-contact these participants, who are now in their early childhood (\~5 years old), to evaluate the long-term effect of various macronutrient quantities in solid foods, by assessing the participants' growth, body composition, and gut bacteria profile.


Eligibility criteria: Inclusion Criteria:

* Those participants who completed the initial trial when they were infants.

Exclusion Criteria:

* None

Primary outcomes:
measure: Age adjusted height
timeFrame: Day 1: one time assessment during the participant's visit to Colorado Children's hospital
measure: Age adjusted weight
timeFrame: Day 1: one time assessment during the participant's visit to Colorado Children's hospital
Secondary outcomes:
measure: Percent body fat
timeFrame: Day 1: one time assessment during the participant's visit to Colorado Children's hospital
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UC Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Minghua Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609803: Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma
Official title: Tissue Microarray Studies of the 12q13-q14 Amplicon in Alveolar Rhabdomyosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Previously Treated Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-01
Enrollment: 99
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tissue samples from younger patients with rhabdomyosarcoma from 2006

Brief summary: This research trial studies protein expression in tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To investigate (in two stages) which proteins are overexpressed in association with 12q13-q14 amplification by applying fluorescence in situ hybridization (FISH) and immunohistochemical (IHC) assays to a panel of alveolar rhabdomyosarcomas (ARMS) cases organized into tissue microarrays.

OUTLINE:

Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.

Eligibility criteria: Inclusion Criteria:

* Slides of the 2006 alveolar rhabdomyosarcoma (ARMS) TMA and the 2009 ARMS/anaplastic embryonal rhabdomyosarcoma (ERMS) TMA

  * PAX3-FOXO1-positive tumors
  * PAX7-FOXO1-positive tumors
  * Fusion-negative tumors

Primary outcomes:
measure: Amplification and fusion status as a result of the 12q13-q14 amplification event
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Frederick Barr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175303: A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Lung Injury
Decidual Stromal Cells
Stem Cell Transplantation
Inflammation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.

Detailed description: Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Eligibility criteria: Inclusion Criteria:

* Patients with toxicity, inflammation or hemorrhages.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of adverse events
timeFrame: Up to one year after inclusion
Secondary outcomes:
measure: Anti-inflammatory and reparatory effects regarding different lesions.
timeFrame: Up to one year after inclusion
measure: Time to disappearance of hemorrhages.
timeFrame: Up to three months after inclusion
measure: Time to disappearance of paresis and/or paresthesias.
timeFrame: Up to one year after inclusion
measure: Time to disappearance of pain.
timeFrame: Up to one year after inclusion
measure: Time to disappearance of pulmonary infiltrates
timeFrame: Up to one month after inclusion
measure: Time to disappearance of oxygen supplementation
timeFrame: Up to one month after inclusion
measure: Incidence of severe infections
timeFrame: Up to one year after inclusion
measure: Incidence of graft versus host disease
timeFrame: Up to one year after inclusion
measure: Actuarial survival
timeFrame: Up to 5 years after inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Olle Ringdén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02509403: An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel
Official title: An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Urinary Tract Infections
Keywords: Perineal hygiene
Hygiene wipes
Hygiene Towels
Safety
Essential oils
Natural Health Product
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Taiga BioActives Inc.
First posted: 2015-07-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the safety (absence of skin irritation) of a feminine hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial. The feminine hygiene towel or wipe is an anti-bacterial Natural Health Product solution.

Detailed description: The design of the trial will be open-label and uncontrolled.

Eligibility criteria: Inclusion Criteria:

* Women aged ≥18 years willing to use the perineal towels for an entire month

Exclusion Criteria:

* Pregnancy or within 12 months post-partum
* Current vulvo-vaginitis
* Known allergies to tea-tree oil

Primary outcomes:
measure: Number of participants without any adverse events as a measure of safety
timeFrame: 45 Days
Secondary outcomes:
measure: Ease of use of the perineal hygiene wipe by the participants on a daily basis
timeFrame: 30 Days
measure: Self-reported comfort score on a scale of 1 to 10
timeFrame: 30 Days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
state: Alberta
Study officials:
affiliation: University of Alberta
name: Adrian S Wagg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Am J Med. 2002 Jul 8;113 Suppl 1A:5S-13S. doi: 10.1016/s0002-9343(02)01054-9.
citation: Dason S, Dason JT, Kapoor A. Guidelines for the diagnosis and management of recurrent urinary tract infection in women. Can Urol Assoc J. 2011 Oct;5(5):316-22. doi: 10.5489/cuaj.11214. No abstract available.
citation: Persad S, Watermeyer S, Griffiths A, Cherian B, Evans J. Association between urinary tract infection and postmicturition wiping habit. Acta Obstet Gynecol Scand. 2006;85(11):1395-6. doi: 10.1080/00016340600936977.
citation: Amiri FN, Rooshan MH, Ahmady MH, Soliamani MJ. Hygiene practices and sexual activity associated with urinary tract infection in pregnant women. East Mediterr Health J. 2009 Jan-Feb;15(1):104-10.
citation: Temple JG. Perineal hygiene in the prevention of recurring cystitis in women. Proc R Soc Med. 1972 Feb;65(2):169. doi: 10.1177/003591577206500222. No abstract available.
citation: Leydon GM, Turner S, Smith H, Little P; UTIS team. Women's views about management and cause of urinary tract infection: qualitative interview study. BMJ. 2010 Feb 5;340:c279. doi: 10.1136/bmj.c279.
Clinical trial NCT00169403: Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dystonia
Keywords: Idiopathic dystonia
deep brain stimulation
globus pallidus
generalised Idiopathic dystonia
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:

1. evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and
2. assess the recurrence of the motor symptoms after the switch off.


Eligibility criteria: Inclusion Criteria:

* Idiopathic generalised dystonia
* Pallidal stimulation

Exclusion Criteria:

* Mini-mental status (MMS) \< 24
* Severe psychiatric disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Study officials:
affiliation: Hôpital Saint-Antoine
name: Marie Vidailhet, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. doi: 10.1056/NEJMoa042187.
Clinical trial NCT03457584: Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling
Official title: Effect of Air-tamponade on Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 96
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: Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade.

Detailed description: Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. 23G-pars plana vitrectomy with membrane peeling is performed in all patients. Before surgery patients are randomized for BSS or air-tamponade. Optical coherence tomography (OCT) is performed 5 days after and 3 months after surgery, visual acuity is measured 3 months after surgery.

Eligibility criteria: Inclusion Criteria:

* epiretinal membranes and intraretinal cystoid changes

Exclusion Criteria:

* macular edema due to other reason than epiretinal membrane
* hereditary ocular disease
* pregnancy

Primary outcomes:
measure: resorption of intraretinal cystoid changes after surgery
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Study officials:
affiliation: VIROS at Hanuschkrankenhaus Vienna
name: Oliver Findl, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06598384: VA as Maintenance Therapy Post Allo-HSCT in MDS and AML
Official title: Venetoclax Combined With Azacytidine as Maintenance Therapy Post Allogeneic Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this phase 2 trial is to test the safety and efficacy of Venetoclax combined with Azacytidine as Maintenance Therapy post Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia.

Detailed description: The investigators will evaluate the efficacy and safety of venetoclax combined with azacytidine as maintenance therapy post hematopoietic stem cell transplantation in myelodysplastic syndromes and acute myeloid leukemia. overall survival (OS), cumulative 1-year relapse- and progression-free survival (RPFS), time to relapse, relapse rate, incidence of acute and chronic GVHD, time to treatment discontinuation will be counted.

Eligibility criteria: Inclusion Criteria:

* The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
* The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
* Patients aged ≥18 years with a diagnosis of MDS or AML according to World Health Organization criteria (WHO) who had undergone alloSCT with myeloablative or reduced-intensity conditioning regimens were eligible. Related and unrelated donors were permitted.
* Patients should be in morphologic complete remission (CR; ie, ≤5% bone marrow blasts) with absolute neutrophil counts ≥1.0×10\^9 /L and platelets ≥ 75×10\^ 9 /L before treatment.

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women.

Primary outcomes:
measure: Relapse Rate
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 years
measure: Progression Free Survival (PFS)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian
role: PRINCIPAL_INVESTIGATOR
References: