louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00365950: 3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE
Official title: Clinical Trial of Two Durations of Warfarin Therapy in the Treatment of Deep Vein Thrombosis and/or Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Deep Vein Thrombosis With Pulmonary Embolism
Keywords: Duration of anticoagulation
Deep vein thrombosis and/or pulmonary embolism
Lead sponsor: British Thoracic Society
Sponsor class: OTHER
First posted: 2006-08-18
Enrollment: 2400
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: To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE

Detailed description: Multi-centre trial involving 46 hospitals in the United Kingdom, with patients entered by 137 Consultant Physicians. Consenting patients were randomised in a central office to either 3 months' or 6 months' anticoagulation. Information on progress of the patients was requested by the co-ordinating office at 3 months, 6 months and 12 months. Outcomes were measured as death from DVT/PE, non-fatal extensions or recurrences of DVT/PE and major haemorrhages during and after anticoagulation.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.

Exclusion Criteria:

* DVT/PE severe enough to require thrombolysis or pulmonary embolectomy.
* DVT/PE in the preceding 3 years.
* Neoplasia diagnosed/treated within previous 3 years.
* Pregnancy.
* Known major thrombophilias.
* Prolonged or continuous immobility or confinement to bed.
* Previous allergy to heparin or warfarin.
* Requirement for long-term anticoagulation.
* Inability to give informed consent.

Primary outcomes:
measure: Death due to DVT/PE
measure: Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.
measure: Number of major haemorrhages.
Secondary outcomes:
measure: Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Department of Chest Medicine, Llandough Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: Department of Chest Medicine, Llandough Hospital,
state: Wales
Study officials:
affiliation: Research Committee of the British Thoracic Society
name: Aziz Sheikh, MD,FRCGP
role: STUDY_CHAIR
References:
citation: Campbell IA, Bentley DP, Prescott RJ, Routledge PA, Shetty HG, Williamson IJ. Anticoagulation for three versus six months in patients with deep vein thrombosis or pulmonary embolism, or both: randomised trial. BMJ. 2007 Mar 31;334(7595):674. doi: 10.1136/bmj.39098.583356.55. Epub 2007 Feb 8.
Clinical trial NCT03843450: Culture System for Isolating Circulating Tumor Cells
Official title: Culture System for Isolating Circulating Tumor Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Detection of Cancer
Keywords: circulating tumor cells,WBCs adhesion, biomedical materials
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include polycythemia patients between the ages of 20 and 70. We just use the waste blood from patients' routine phlebotomy therapy. Also, to protect the vulnerable subjects, we don't recruit minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Brief summary: This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating cancer cells from the blood sample. The coating of the system has the characteristic that to make the WBCs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. The supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.


Eligibility criteria: Inclusion Criteria:

1. Polycythemia patients are between the ages of 20 and 70.
2. Willing to sign the consent form under the informed consent.

Inclusion Criteria:

Exclusion Criteria:

1. Vulnerable Subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Primary outcomes:
measure: Cancer Cell Isolation Efficiency of The Isolation System
timeFrame: 1 day
measure: WBCs adhesion ratio
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Institute of Biomedical Engineering, National Taiwan University
name: Tai-Horng Young
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02508350: The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
Official title: The Pharmacokinetics and Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The first objective of this study was to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.

Detailed description: Daptomycin is a novel lipopeptide exhibiting concentration-dependent bactericidal activity against multidrug-resistant Gram-positive pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA). In recent years, daptomycin plays an important role in the treatment of septic shock. The pharmacokinetics of daptomycin is significant changed in patients with septic shock, it is proved that the recent dosage regiment comes with a low blood drug concentration and unsatisfactory outcome. Although the high-dose daptomycin shows safety and effectiveness in the treatment of critically ill patient, but still the pharmacokinetics and pharmacodynamics data is scant. So the purposes of this study is to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.

Eligibility criteria: Inclusion Criteria:

* ≥18 years and ≤75 years
* confirmed or suspected bloodstream and soft tissue infections caused by a grampositive organism

Exclusion Criteria:

* known hypersensitivity to daptomycin or product excipients
* documented or suspected pneumonia caused by a grampositive organism
* infection with a daptomycin-resistant organism
* presence or history of rhabdomyolysis
* signs or symptoms of myopathy with an elevation of creatine phosphokinase concentrations 6.pregnancy or breast-feeding

Primary outcomes:
measure: Area under the curve(AUC)/Minimum inhibitory concentration(MIC)
timeFrame: 6 days
measure: Peak concentration (Cmax)/Minimum inhibitory concentration(MIC)
timeFrame: 6 days
Secondary outcomes:
measure: mortality rate
timeFrame: 28 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: southeast univerity, China
name: Yingzi - Huang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00163150: Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke
Official title: Lacunar-Brain Infarction Cerebral Hyperactivity And Atorvastatin Trial. A Placebo-Controlled Trial Of High-Dose Atorvastatin In Patients With Cerebral Small Vessel Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebrovascular Accident
Hypercholesterolemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 128
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 main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.


Eligibility criteria: Inclusion Criteria:

* clinically defined lacunar syndrome 3 months before inclusion
* small deep infarct on diffusion MRI (Diffusion Weighted Imaging)
* no atherothrombotic, cardio-embolic, or other rarer cause.

Exclusion Criteria:

* patients with past coronary event
* contra-indication for assessment of vasomotor reactivity
* patients being on statin therapy at the time of brain infarction
* contra-indication for statin therapy
* patient still under statin therapy

Primary outcomes:
measure: Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients. CVR, humeral and carotid vasoreactivity will be measured in all patients at M0 and M3.
Secondary outcomes:
measure: Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on endothelium dependant and independent vasomotoricity of humeral and / or common carotid artery (according to validation study) in lacunar patients.
Other outcomes:
Locations:
city: Paris, Cedex 18
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lavallee PC, Labreuche J, Gongora-Rivera F, Jaramillo A, Brenner D, Klein IF, Touboul PJ, Vicaut E, Amarenco P; Lacunar-BICHAT Investigators. Placebo-controlled trial of high-dose atorvastatin in patients with severe cerebral small vessel disease. Stroke. 2009 May;40(5):1721-8. doi: 10.1161/STROKEAHA.108.540088. Epub 2009 Mar 12.
Clinical trial NCT02061150: Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Sepsis
Keywords: Early onset GBS sepsis
Prevention
Maternal risk factors
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-02-12
Enrollment: 800
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asymptomatic term/near term newborns to a mother with infectious risk factors such as premature rupture of membranes, GBS-carrier etc, that underwent sepsis work up due to their maternal risk factors,

Brief summary: Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. Our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.


Eligibility criteria: Inclusion Criteria:

Term newborns with blood cultures taken from them the first 48 hrs

Exclusion Criteria:

* Preterm newborns
* Septic/ill appearing newborns
* Newborns requiring admission to NICU

Primary outcomes:
measure: Asymptomatic newborns that underwent sepsis workup
timeFrame: 3 years
Secondary outcomes:
measure: Positive blood cultures out of total cultures
timeFrame: 3 years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: The Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05429450: Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections
Official title: Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Associated Orbitopathy
Keywords: Thyroid associated orbitopathy
Grave's orbitopathy
Periocular injections
Methotrexate
Triamcinolone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to investigate the efficacy and safety of periocular injections of methotrexate in management of patients with active moderate to severe thyroid associated orbitopathy in comparison to periocular injections of triamcinolone acetonide.

Detailed description: Recruited subjects will be randomized such that one orbit receives 3 periocular injections of methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone acetonide at day 0, week 3 and week 6. All study subjects will be followed up for 6 months where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last injection

Eligibility criteria: Inclusion Criteria:

1. Bilateral moderate to severe thyroid associated orbitopathy.
2. Clinical Activity score (CAS) ≥ 3.
3. Duration of thyroid associated orbitopathy \< 2 years

Exclusion Criteria:

1. Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.
2. Glaucoma patients or those known to be steroid responders
3. Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess
4. Pregnancy
5. Previous orbital or lid surgeries
6. History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months

Primary outcomes:
measure: Change in clinical activity score (CAS)
timeFrame: 2 weeks, 1 month, 3 months and 6 months
Secondary outcomes:
measure: Change in proptosis
timeFrame: 2 weeks, 1 month, 3 months and 6 months
measure: Change in lid aperture
timeFrame: 2 weeks, 1 month, 3 months and 6 months
measure: Percentage of overall responders
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Haytham E. Nasr
role: STUDY_CHAIR
affiliation: Cairo University
name: Rania A. El Essawy
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Kareem B. Elessawy
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Islam Y. Swaify
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04289103: Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD
Official title: A Phase 3, Multicenter, Open Label, Study to Evaluate the EFficacy and SaFEty of Leukotac® (Inolimomab) in Pediatric Patients With Steroid Resistant Acute Graft Versus Host Disease (SR-aGvHD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Steroid Refractory GVHD
Lead sponsor: ElsaLys Biotech
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 65
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)


Eligibility criteria: Inclusion Criteria:

* Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)
* Age 28 days to \< 18 years old
* Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
* Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)
* Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)

Exclusion Criteria:

* Isolated stage 1 skin SR-aGvHD
* Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
* Acute GvHD after donor lymphocytes infusion (DLI)
* Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
* Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.
* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
* Known allergy or intolerance to Leukotac of one of its ingredients
* Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential
* Other ongoing interventional protocol that might interfere with

Primary outcomes:
measure: Overall response
timeFrame: Day 29 post inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03120403: Safety and Efficacy of Intrathecal Morphine in Children
Official title: Safety and Efficacy of Intrathecal Morphine in Children Undergoing Major Abdominal Surgeries, Dose-finding Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abdominal Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 45
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intratehcal injection of drug( morphine).
Primary purpose: TREATMENT

Brief summary: Postoperative pain in pediatrics can usually be well controlled with a combination of analgesics including acetaminophen ( paracetamol) ,NSIADS, opioids , and local/regional anesthesia.The use of epidural and subarachnoid morphine for analgesia in adults has grown almost as quickly as Morton's discovery of anesthesia in 1846. The application of these techniques to the pediatric patients has evolved much more slowly,although significant progress is being made by many investigators.

Detailed description: Advantage of intrathecal morphine as that extremely small doses of opioids are required when administrated intrathecally because they have direct access to spinal cord opioid receptors. Drug administered epidurally or caudally are required in much higher doses because they must first diffuse into the CSF before they reach spinal opioid receptors. As a result, the duration of action of intrathecal morphine is greater than that of single shot peridural techniques.

To investigate the safety and efficacy of intrathecal morphine in post operative pain relief in pediatric patients undergoing major abdominal cancer surgeries using different doses of intrathecal morphine (2 μg/kg , 5 μg/kg ,10μg/kg).

Eligibility criteria: Inclusion Criteria:

* pediatric patients aged 3-12 years , weighting between 10-30 kg , and of American Society of Anesthesiologists (ASA) physical status I and II scheduled for major abdominal surgeries , expected to last more than 90 minutes under general anesthesia combined with intratehcal morphine.

Exclusion Criteria:

* Children with sacral bone abnormalities ,spina bifida , coagulopathy , mental delay or retardation , known allergy to the study drugs , and local infection at the site of injection will be excluded from the study.

Primary outcomes:
measure: The face , Legs , Activity, Crying , and Consolability (FLACC) score
timeFrame: 24 hours (every 4 hours )
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05466903: Prospective, Randomized, Parallel Clinical Controlled Study of Early Diet Opening on Postoperative Gastrointestinal Hemorrhage in Patients With Colonic Polyps
Official title: Early Diet Opening on Postoperative Gastrointestinal Hemorrhage in Patients With Colonic Polyps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyp
Keywords: Colonic Polyp
Gastrointestinal Hemorrhage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Currently, hemorrhage remains the most common postoperative complication in patients with colon polyps, with an incidence of approximately 1.5%. The main reasons for postoperative hemorrhage are: the patient's own condition, the nature of the polyp and the operation. The number of patients treated for colon polyps has increased, postoperative care is confusing, medical resources are wasted, and the time span for postoperative diet recovery is large. However, studies on the effect of postoperative dietary recovery timing on postoperative polyp bleeding are rare.


Eligibility criteria: Inclusion Criteria:

* Age 18-75, no gender restrictions,
* Patients with colonic polyps identified by colonoscopy and requiring endoscopic treatment,
* Polyp size 0.5cm-2cm,
* Patients agreed to enroll and signed a written informed consent,
* Adherence is good and agrees to be treated and evaluated as required by the study protocol.

Exclusion Criteria:

* Patients with contraindications to endoscopic treatment of colonic polyps, including platelets ≤50×109/L, prothrombin time prolonged by 4 seconds or more, and INR≥2.0,
* Patients with severe heart, brain, lung, blood system diseases, uremia, connective tissue disease,
* Patients requiring treatment with NSAIDs, aspirin, glucocorticoids, or clopidogrel within the first 7 days of the study,
* During the course of the study, due to other concomitant/complications, patients who need to use drugs that affect the efficacy of the trial, including various anticoagulants, antiplatelet drugs and hemostatic drugs,
* Alcoholics, drug addicts or those with uncontrollable neuropsychiatric diseases and others who are not suitable for participating in the trial,
* Pregnant, breastfeeding women, or women in childbearing age who wish to become pregnant,
* Patients with malignant tumor of digestive system,
* Other circumstances in which the investigator believes that the patient should not participate in this trial

Primary outcomes:
measure: Postoperative bloody stool
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Gastroenterology, the 2nd Affiliated Hospital of Medical College, Zhejiang University
state: Zhe Jiang
Study officials:
References: