louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00537277: Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs
Official title: A Titrate-To-Target Study of the Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs With / Without Once Daily Basal Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe.

This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus for more than 12 months
* HbA1c: 7.5 - 11.0%
* An antidiabetic regimen that has been stable for at least 3 months prior to screening
* An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin
* OADs dosed at 50% or more of the maximum recommended dose

Exclusion Criteria:

* Use of any insulin preparations other than NPH or glargine within the past 6 months
* Use of more than 60 units of insulin per day
* Morning time insulin administration
* Use of more than one insulin dose daily

Primary outcomes:
measure: Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
timeFrame: week 48
Secondary outcomes:
measure: Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
timeFrame: week 48
measure: Number of Hypoglycaemic Episodes
timeFrame: weeks 0-48
measure: Number of Diurnal Hypoglycaemic Episodes
timeFrame: weeks 0-48
measure: Number of Nocturnal Hypoglycaemic Episodes
timeFrame: weeks 0-48
measure: Number of Treatment Emergent Serious Adverse Events (SAEs)
timeFrame: weeks 0-48
Other outcomes:
Locations:
city: Istanbul
country: Turkey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02192177: Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.
Official title: Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Apoptosis
intrahepatic cholestasis
obstetric outcomes
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.

Brief summary: Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially late second and third trimester. We aimed to investigate the role of apoptosis in etiopathogenesis of obstetric cholestasis.

Detailed description: M30 (caspases cleaved Cytokeratin-18 (CK-18) fragment) is a specific apoptosis marker. We aimed to use it to evaluate the apoptotic process.

Eligibility criteria: Inclusion Criteria:

* Late second or third trimester of pregnancy.

Exclusion Criteria:

* Foreknown systemic diseases, multiple pregnancy, smoking cigarettes.

Primary outcomes:
measure: M30 value as Unit per Liter.
timeFrame: Four months.
Secondary outcomes:
measure: Percentage of delivery with cesarean section.
timeFrame: Four months.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
affiliation: Medical doctor
name: Ali O Ersoy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Del Ben M, Polimeni L, Baratta F, Bartimoccia S, Carnevale R, Loffredo L, Pignatelli P, Violi F, Angelico F. Serum Cytokeratin-18 Is Associated with NOX2-Generated Oxidative Stress in Patients with Nonalcoholic Fatty Liver. Int J Hepatol. 2014;2014:784985. doi: 10.1155/2014/784985. Epub 2014 Jan 29.
citation: Du Q, Zhang Y, Pan Y, Duan T. Lithocholic acid-induced placental tumor necrosis factor-alpha upregulation and syncytiotrophoblast cell apoptosis in intrahepatic cholestasis of pregnancy. Hepatol Res. 2014 May;44(5):532-41. doi: 10.1111/hepr.12150. Epub 2013 May 31.
Clinical trial NCT00565877: The Application of Neck Ultrasound in the Assessment of Peripherally Inserted Central Catheter (PICC) Tip Position
Official title: A Randomized, Controlled Trial Evaluating Post-Insertion Neck Ultrasound in Peripherally Inserted Central Catheter Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripherally Inserted Central Catheter Insertion Technique
Keywords: Catheter
Peripherally inserted central catheter
ultrasound
malposition
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2007-11-30
Enrollment: 300
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: Insertion of peripherally inserted central catheters (PICCs) at the bedside may result in tip malposition. This study was designed to evaluate whether the addition of ultrasound (US) inspection of the ipsilateral neck provides immediate recognition of PICCs in aberrant position facilitating catheter reposition prior to completion of the procedure.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years old) ordered for a peripherally inserted central catheter insertion

Exclusion Criteria:

* patients unable to provide informed consent
* previous peripheral inserted central catheter placement at the institution

Primary outcomes:
measure: Rate of PICCs in the ipsilateral internal jugular vein malposition as detected by post-procedure chest x-ray
timeFrame: Same day
Secondary outcomes:
measure: Duration of PICC procedure.
timeFrame: Same day.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: John P Kress, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05442177: Clinical Observation of Integrated Chinese Medicine With Western Medicine for the Reduction of Chemotherapy-induced Hematologic Toxicity
Official title: Clinical Observation of Integrated Chinese Medicine With Western Medicine for the Reduction of Chemotherapy-induced Hematologic Toxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelosuppression
Keywords: Traditional Chinese Medicine; radial pulse assessment; sphygmography; pulse diagnosis; myelosuppression; cancer
Lead sponsor: Taichung Tzu Chi Hospital
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer under chemotherapy and Integrated Chinese Medicine With Western Medicine.

Brief summary: We conducted an observational study to investigate the effectiveness and safety of Integrated Chinese Medicine With Western Medicine for bone marrow suppression induced by chemotherapy in patients with cancer. The TCM constitution and pulse diagnosis was also observed in the study.

Detailed description: Patients with cancer under chemotherapy and integrated Western and Chinese medicine were enrolled in this observational study. The assessment of radial pressure pulse (RPP) was performed before and after chemotherapy. The correlation between the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) of the RPP at six diagnosis positions and the blood cell counts before and after chemotherapy were analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients with cancer diagnosed through pathological histology
* Patients with cancer under chemotherapy and Integrated Chinese Medicine With Western Medicine
* Patients with an Eastern Cooperative Oncology Group Performance score of 0-2
* Patients having normal liver and kidney functions and electrocardiography and eligible for chemotherapy with normal bone marrow hematopoietic function
* Patients who were voluntarily involved in this study

Exclusion Criteria:

* Cases that did not meet the inclusion criteria
* Patients who could not cooperate with pulse diagnosis
* Patients with underlying diseases such as chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.
* Patients with severe infection
* Patients with severe cachexia

Primary outcomes:
measure: Chemotherapy-induced Hematologic Toxicity
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02410577: 89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme
Official title: A Pilot Study of 89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Keywords: 89Zr-J591
15-002
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2015-04-07
Enrollment: 2
Sex: ALL
Minimum age (years): 26
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test a new imaging agent called 89Zr-J591 (stands for humanized antibody called J591, that is attached to a radioactive material called Zirconium-89) in patients with glioblastoma multiforme.


Eligibility criteria: Inclusion Criteria:

* Patient age \> 25 years old and \< 80 years old
* Patients with reoccurrence of brain tumor
* The principal investigator or co-PI must review MRI and CT findings based on the radiologic assessment provided they meet the following imaging criteria (as established in the clinical trial 09-177):

OR

* Patients with newly diagnosed GBM and one of the following options:
* Eligible for surgery after the last research scan.
* Significant residual disease after initial surgery
* The principal investigator or co-PI must review MRI and CT findings and agree with the presence of significant residual disease
* Treatment (non-surgical) naïve
* Karnofsky Performance Score ≥ 70

Exclusion Criteria:

* Laboratory values:

  * Serum creatinine \>2.5 mg/dL.
  * AST (SGOT) \>2.5x ULN.
  * Bilirubin (total) \>1.5x ULN.
  * Serum calcium \>11 mg/dL.
* Pregnant or breastfeeding (if a female is of childbearing potential, and unsure of pregnancy status, a standard pregnancy test should be done).
* If an initial biopsy demonstrates neoplasm other than GBM
* Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject.
* Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements
* Prior treatment.
* Other serious illness (es), which might preclude completion of this, study or interfere with determination of causality of any adverse effects experienced in this study.

Primary outcomes:
measure: Binding of 89Zr-J591
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Joseph Osborne, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01864577: Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma
Official title: Efficacy of Negative Pleural Suction in Tube Thoracostomy for Patients With Penetrating and/or Blunt Chest Trauma: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemothorax
Pneumothorax
Hemopneumothorax
Chest Injury Trauma Blunt
Chest Injury Trauma
Chest Injury Penetrating Wound
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Hospital San Vicente Fundación
First posted: 2013-05-29
Enrollment: 110
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the use of negative pleural suction in tube thoracostomy is more effective than water seal alone for the treatment of pneumothorax and/or hemothorax in patients with chest trauma.


Eligibility criteria: Inclusion Criteria:

* Pneumothorax after penetrating o blunt chest trauma
* Hemothorax after penetrating o blunt chest trauma
* Hemopneumothorax after penetrating o blunt chest trauma
* Require tube thoracostomy

Exclusion Criteria:

* Invasive mechanical ventilation
* Emergent Surgery (thoracoscopy, open thoracotomy)
* Chronic pulmonary diseases (COPD, CRPD)
* Severe traumatic brain injury
* Glasgow coma scale upon arrival \<8/15

Primary outcomes:
measure: Lenght of Hospital stay
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of persistent bronchopleural fistulae
timeFrame: 30 days
measure: Incidence of coagulated Hemothorax
timeFrame: 30 days
measure: Incidence of empyema
timeFrame: 30 days
measure: Incidence of recurrent pneumothorax
timeFrame: 30 days
measure: Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy)
timeFrame: 30 days
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Camila Mejia, Resident, General Surgery
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00658177: Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction
Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-14
Enrollment: 463
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to investigate the efficacy and safety of Vardenafil


Eligibility criteria: Inclusion Criteria:

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* History of unresponsiveness to sildenafil
* Stable sexual relationship for \> 6 month.

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the US Product Information

Primary outcomes:
measure: Sexual Encounter Profile Question 2
timeFrame: 12 weeks
Secondary outcomes:
measure: Sexual Encounter Profile Question 3
timeFrame: 12 weeks
measure: Internation Index of Erectile Function-Erectile Function domain
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00298077: A Retrospective Review of Infections Usually Observed in Transplant Recipients
Official title: A Retrospective Review of Infections Usually Observed in Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Infection
transplant recipients
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-03-01
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: transplant recipients with infections

Brief summary: The study will identify patients with infections commonly observed in transplant recipients, describe the epidemiology of their infection, study the risk factors associated with various infections and examine strategies of early diagnosis and prevention of infection

Detailed description: The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, previous medical surgical conditions, microbiology and virology culture results, laboratory and radiographical data, antimicrobial usage of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, pathology and histology results, summaries of admissions, discharges, operations, death, medications, clinical outcome gender, height, weight, ethnicity, date of transplant, type of transplant, primary diagnosis, and past medical history. Also required are medical summaries of admissions, discharges, operations, and deaths

Eligibility criteria: Inclusion Criteria:

* Patients who receive medical care at UPMC
* Patients who developed infections usually observed in transplant recipients

Exclusion:

* Patients who do not receive medical care in UPMC Oakland campus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Eun Kwak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00897377: Treatment Strategy for Low-grade Gliomas
Official title: Treatment Strategy for Low-grade Gliomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Astrocytomas
Oligodendrogliomas
Oligoastrocytoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 500
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: Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence seems unavoidable in some patients because of the infiltrative growth of the tumors. How to treat LGGs is still under controversy. The role of radiation therapy and chemotherapy in the treatment of LGG need to be further investigated. The purpose of this study is the following:

1. to investigate the role of early radiation therapy in MRI-determined total resected LGGs;
2. to compare the efficacy of early radiation therapy and that of initial chemotherapy in the LGGs without total resection.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed newly diagnosed low-grade gliomas
* Karnofsky performance status of 60 or more

Exclusion Criteria:

* Previous history of radiation therapy or chemotherapy for gliomas
* Pregnant or breast feeding
* Diagnosis of another malignancy may exclude subject from study
* Evidence or history of bleeding diathesis
* Evidence or history of hypersensitivity to temozolomide

Primary outcomes:
measure: Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
timeFrame: 10 years
measure: Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhongping Chen, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01917877: Efficiency Study for Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis With Bevasizumab
Official title: Phase II Study of Bevasizumab in the Management of Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pulmonary Fibrosis
Keywords: Becacizumab
pulmonary fibrosis
irradiation
chemotherapy
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 30
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: Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not only compromise cancer treatment, but also influence patient's life qualities and even death. there are no specific treatment modalities for this treatment-induced complication. Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by Dexamethasone （10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone. The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30 cases.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

Exclusion Criteria:

* chronic pulmonary fibrosis and infection-induced pulmonary fibrosis
* active bleeding
* uncontrolled high blood pressure
* unstable systemic disease
* prior exposure to VEGF inhibitor

Primary outcomes:
measure: pulmonary function
timeFrame: up to 8 weeks
Secondary outcomes:
measure: thoracic CT scan
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
Study officials:
affiliation: Qingdao Central Hospital
name: youxin ji, md
role: PRINCIPAL_INVESTIGATOR
References: