louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00675220: Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™
Official title: A Prospective, Open-Labelled, Non-Controlled, Observational Study to Assess the Efficacy and Safety of NovoRapid™ FlexPen™ in the Treatment of Acute Hyperglycemia: A Post-Marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-09
Enrollment: 373
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Diabetes

Brief summary: This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as per normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetes mellitus (according to product labelling)

Exclusion Criteria:

* Hypoglycaemia
* Hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)

Primary outcomes:
measure: Safety profile of Insulin Aspart among Filipino patients
timeFrame: 1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first
Secondary outcomes:
Other outcomes:
Locations:
city: Manilla
country: Philippines
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00711620: Efficacy of Thymosin alpha1 for Severe Sepsis
Official title: Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Keywords: sepsis
Immunotherapy
Thymosin
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.

Detailed description: Severe sepsis is a disease of infectious origin with a high risk of death. Over the past decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight against infectious diseases, but it is unknown whether thymosin alpha1 is effective in treating severe sepsis.

Eligibility criteria: Inclusion Criteria:

* Severe sepsis according to ACCP/CCM criteria
* Patient or legally authorized representative able to provide informed consent

Exclusion Criteria:

* Subject is less than 18 years or more than 85 years of age
* If female, the subject is pregnant or nursing
* Subject is receiving immunosuppressive therapy such as cyclosporine, azothioprine,or cancer-related chemotherapy
* Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end-stage disease
* History of bone marrow, lung, liver, pancreas, or small-bowel transplantation
* Acute pancreatitis with no established source of infection

Primary outcomes:
measure: 28-day Mortality
timeFrame: 28 days
Secondary outcomes:
measure: SOFA score
timeFrame: 7 days
measure: Immune response to Thymosin alpha 1
timeFrame: 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Guan Xiangdong, M.D
role: STUDY_CHAIR
References:
citation: Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
Clinical trial NCT02575820: Old Blood and Postoperative Complications
Official title: The Effects of Old Red Blood Cell Transfusion on Morbidity in Patients Undergoing Revision Total Hip Arthroplasty: Retrospective Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Orthopedics
Postoperative Complications
Red Blood Cells
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent revision total hip replacement

Brief summary: The investigators sought to examine the effects of 'old' red blood cells on mortality and morbidity of patients who undergoing revision hip replacement arthroplasty. The investigators hypothesis is that patients have an increased risk of mortality and infection after 'old' red blood cells transfusions compared with those who received 'new' transfusions.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent revision total hip replacement

Exclusion Criteria:

* Patients who were not given red blood cells
* Patients who were given two units of which one unit was old and one was new

Primary outcomes:
measure: Mortality
timeFrame: postoperative 7 days
measure: Sepsis
timeFrame: postoperative 7 days
measure: Wound infection
timeFrame: postoperative 7 days
measure: Postoperative delirium
timeFrame: postoperative 7 days
measure: Postoperative bleeding
timeFrame: postoperative 7 days
Secondary outcomes:
measure: Transfusion related lung injury
timeFrame: postoperative 7 days
measure: Pulmonary edema
timeFrame: postoperative 7 days
measure: Pulmonary effusion
timeFrame: postoperative 7 days
measure: Myocardial ischemia
timeFrame: postoperative 7 days
measure: Pulmonary thromboembolism
timeFrame: postoperative 7 days
measure: Renal failure
timeFrame: postoperative 7 days
measure: Hepatic failure
timeFrame: postoperative 7 days
Other outcomes:
Locations:
city: Seongnamsi
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT03492320: Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
Official title: Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty
Knee Arthroplasty, Total
Knee Replacement, Total
Replacement, Total Knee
Total Knee Replacement
Health-Related Quality Of Life
Life Quality
Osteoarthritis Of Knee
Keywords: HRQoL
Quality of Life
End Stage Osteoarthritis
Total Knee Arthroplasty
WOMAC
SF 36
Total Knee Replacement
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 127
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR. This was a prospective longitudinal study, involving patients with symptomatic osteoarthritis at Prince of Wales Hospital Hong Kong. This study was conducted from March 2013 to December 2016. By universal sampling, patients who had experienced symptomatic OA visiting the Li Ka Shing Orthopaedic Specialist out-patient clinic were screened by a research nurse or a research assistant based on the inclusion criteria.

Brief summary: To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR

Detailed description: Total Knee Arthroplasty (TKA) remains the surgical gold standard treatment for patients suffering from end stage osteoarthritis (OA) of the knee. However, due to the high demand and scarce medical resources, the waiting time for surgery is astoundingly lengthy. Controversies are shown on numerous studies on whether physical functionality and mental status decline or remain stable over the waiting period. This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR.

Eligibility criteria: Inclusion Criteria:

1. diagnosed with symptomatic osteoarthritis
2. Enlisted on the TKA surgical waiting list
3. Ethnic Chinese
4. Fluent in Cantonese

Exclusion Criteria:

1. Evidence of cognitive dysfunction like dementia
2. Surgery scheduled within 30 days
3. Severe co-morbidity preluding participation

Primary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: From March 2013 to December 2016
measure: Self-Rated Questionnaire SF36
timeFrame: From March 2013 to December 2016
measure: Health Related Quality of Life (HRQoL) 15D
timeFrame: From March 2013 to December 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Ki Wai Ki Wai, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06729320: A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia
Official title: A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Refractory Immune Effector Cell-related Hemocytopenia
Lead sponsor: Beijing GoBroad Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 40
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 purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old (including boundary values), gender is not limited
2. ECOG score 0-2 points
3. Expected survival ≥6 months
4. Patients who have received immune effector cell therapy (marketed CAR-T cell therapy or dual antibody therapy) (no target), have grade 3-4 hemocytopenia after treatment, and do not recover to grade 2 within 3 weeks after conventional treatment. Defined as follows:

1) The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily

Exclusion Criteria:

1. Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion
2. Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)
3. Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study
4. Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research
5. There are other conditions that researchers believe are not suitable for inclusion

Primary outcomes:
measure: The recovery time of neutrophils
timeFrame: 1 year
measure: The recovery time of platelet
timeFrame: 1 year
measure: Safety of infusion
timeFrame: 1 year
Secondary outcomes:
measure: Recovery of hemoglobin levels after infusion
timeFrame: 1 year
measure: Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion
timeFrame: 1, 3, 6, and 12 months
measure: Overall survival rate
timeFrame: 2 and 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05233020: Robotic Versus Hybrid Assisted Ventral Hernia Repair
Official title: Robotic Assisted vs. Laparoscopic Hybrid IPOM Ventral Hernia Repair: a Prospective Randomized Study Comparing Postoperative Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Quality of Life
Recurrence
Keywords: Ventral hernia
Laparoscopy
Robot-assisted
pain
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).

Detailed description: Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.

Eligibility criteria: Inclusion Criteria:

* ventral hernia size 3-6 cm

Exclusion Criteria:

* previous ventral hernia

Primary outcomes:
measure: Robotic-assisted ventral hernia repair vs hybrid. Change in pain
timeFrame: 1-year
Secondary outcomes:
measure: Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.
timeFrame: 1-year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: gi -surgeon, clinical teacher
name: Pirjo Käkelä, PhD
role: STUDY_DIRECTOR
affiliation: gi-surgeon, clinical teacher
name: Pirjo Käkelä, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02738320: Patient Centered Quality Reporting
Official title: Patient Centered Quality Reporting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality Report Cards
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 225
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to develop a consumer friendly web-based interface between Nursing Home Compare (NHC) and an e-coaching/decision-aid tool (NHCPlus) and determine if use of NHCPlus facilitates and enhances access to and use of NHC.


Eligibility criteria: Inclusion Criteria:

* Patients who have been admitted as an inpatient into the departments of Medicine or Surgery at the UC Irvine Medical Center, and whose discharge plan is to a nursing home.
* Family members of these patients, if they are involved in the choice of nursing home, were also recruited to the study, either as joint decision makers with the patients or as proxy decision makers for the patient.

Exclusion Criteria:

* Patients less than 50 years of age.
* Patients unable to use NHCPlus technology or participate in the nursing home choice decision (i.e. non-English speaking, severely visual or hearing impaired, dementia, or other debilitating illnesses) will be excluded unless they have a representative/proxy who will be involved in the decision to select the nursing home.

Primary outcomes:
measure: Use of Nursing Home Compare information
timeFrame: up to 9 days post discharge
measure: Quality Measures of chosen nursing home
timeFrame: up to 9 days post-discharge
measure: Distance between patient/family residence and the chosen nursing home.
timeFrame: up to 9 days post-discharge
measure: Length of stay in hospital
timeFrame: between 1 and 68 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California
name: Dana Mukamel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06630520: Intraoperative Periarticular Injection in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
Official title: Intraoperative Periarticular Injection May Improve Postoperative Pain Scores and Reduce Opioid Consumption in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament (ACL) Tear
Arthroscopic Anterior Cruciate Ligament Reconstruction
Keywords: periarticular injection
morphine consumption
pain control
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-10-08
Enrollment: 288
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: In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. 300 patients who had undergone aACLR were randomly allocated to receive either a PAI or nPAI group. The primary outcome parameters were visual analogue scale (VAS) scores and cumulative morphine dose, through time. Secondary outcome parameters included drug-related adverse events.


Eligibility criteria: Inclusion Criteria:

* 1) Patients 18 years or older who had undergone a-ACLR with or without meniscus procedure for anterolateral instability of the knee; 2) agree to participate in this study and to be randomly allocated to either or peri-articular injection protocol and have signed an informed consent.

Exclusion Criteria:

* 1) patients with other concomitant injuries such as other ligamentous injury or fracture; 2) Allergy to any of the medication used in either protocol; 3) patient with history of the chronic pain 4) preoperative chronic opioid-dependent patients (exceeding 50 mg oral morphine equivalence per day at time of recruitment); 5) refuse to participate in this study.

Primary outcomes:
measure: VAS scores
timeFrame: at different time points (postoperative 4,8,24-hour, before discharge) after surgery
Secondary outcomes:
measure: cumulative morphine consumption (mg)
timeFrame: at post-operative 4, 8, 24-hour and before discharge
Other outcomes:
measure: drug related adverse events
timeFrame: within postoperative 2 weeks
measure: overall satisfaction scale (0-100 points)
timeFrame: at postoperative 2 weeks
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT01609920: Nodal Staging in Breast Cancer With MRL
Official title: Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasms
Keywords: MRI
lymph node metastases
breast cancer
gadofosveset
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL).

The diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.


Eligibility criteria: Inclusion Criteria:

1. Female patient with histopathologically confirmed breast cancer about to undergo nodal staging.
2. Willing and able to undergo all study procedures
3. Has personally provided written informed consent.

Exclusion Criteria:

1. Age \<18,
2. Pregnancy
3. Contra indications for MRL such as pacemaker, aneurysm clips or severe claustrophobia.
4. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
5. Being unable to give informed consent in person
6. Acute or chronic severe renal insufficiency (glomerular filtration rate \<45 mL/min/1.73m2)1.
7. Acute renal insufficiency of any severity due to the hepato-renal syndrome.
8. Known (or suspicion of) QT- prolongation

Primary outcomes:
measure: The diagnostic performance (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of axillary MRL in predicting the involvement of metastases
timeFrame: Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC) AZM
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: R.G.H. Beets-Tan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: