louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00877461: Glucose Monitor Accuracy Investigation (Ⅰ)
Official title: Glucose Monitor Accuracy Investigation (Ⅰ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 308
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table 3

Brief summary: According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of fingertips and vein as samples to evaluate the accuracy of portable BGM.

Detailed description: The clinical medical technologists collected blood samples from 308 volunteers including 87 diabetics and 221 healthy people. The range of the blood glucose concentration was from 41.2mg/dL to 521mg/dL. The result of clinic evaluation shows that the accuracy of BGM matches the requirement of ISO15197(2003).

Eligibility criteria: Inclusion Criteria:

* volunteers with diabetes and non-diabetes

Exclusion Criteria:

* hypertension,fever,AIDS,hemophilia

Primary outcomes:
measure: glucose
timeFrame: 10 min
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Biomedical Engineering Department of National Taiwan University Hospital
name: Feng-Huei Lin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00613561: Early Diagnosis and Stem Cell Transplantation for Severe Immunodeficiency Diseases
Official title: Early Diagnosis and Stem Cell Transplantation for Severe Immunodeficiency Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Severe Immunodeficiency Diseases
Keywords: Patients with the Severe Immunodeficiency diseases
Severe Immunodeficiency diseases
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 25
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that children with severe primary immunodeficiencies will benefit from early stem cell transplantation utilizing a reduced intensity conditioning regimen. This regimen is associated with a low risk of complications and will lead to correction of the underlying immunological defects.


Eligibility criteria: Inclusion Criteria:

* Must show one of the following diseases:

  * SCIDS
  * Hyper-IgM
  * Wiskott-Aldrich Syndrome
  * Chediak-Higashi and Griscelli Syndromes
  * X-Linked Lymphoproliferative Diseases
  * IPEX Syndrome
  * NEMO Syndrome
  * other severe immunodeficiency diseases not stated above at the discretion of the Principal Investigator
* Informed Consent
* Adequate Renal Function
* Adequate Liver Function
* Adequate Cardiac Function
* Adequate Pulmonary Function
* Adequate Performance Statue
* Adequate Venous Access

Exclusion Criteria:

* Patient/Family has not signed informed consent
* Patient does not have a clear diagnosis of a severe immunodeficiency disease
* A suitable donor for the patient cannot be found
* Patient is HIV positive
* Patient has active Hepatitis B
* Patient is pregnant
* Patient is considered unsuitable for transplant at the discretion of the Principal Investigators or the medical director

Primary outcomes:
measure: To evaluate the efficacy of an optimized reduced intensity conditioning regimen using Fludarabine, Busulfan, and Anti-Thymocyte Globulin in preparing severe immunodeficiency patients for allogeneic hematopoietic progenitor cell transplantation
timeFrame: 5 years
Secondary outcomes:
measure: To prospectively follow the natural course of severe immunodeficiency diseases after transplantation
timeFrame: 5 years
measure: To measure the outcomes after stem cell transplantation using the reduced intensity transplant regimen.
timeFrame: 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Morris Kletzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03125161: Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
Official title: A Prospective, Randomized, One-center Study Comparing Hepatic Arterial Infusion Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Colorectal Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Adenocarcinoma Metastatic to the Liver
Keywords: colorectal cancer
liver metastasis
hepatic arterial infusion
chemotherapy
target therapy
conversional resection rates
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 150
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: TREATMENT

Brief summary: To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.


Eligibility criteria: Inclusion Criteria:

* All patients must meet the following criteria:
* Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease
* Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Age \> 18 years
* Subject life expectancy \> 3 months
* Platelets \> 100×103/mm3
* Total bilirubin \<1.5mg/dl
* Creatinine level \< 2.0 mg/dl
* All patients must sign an informed consent form

Exclusion Criteria:

* The CRLM is amenable to curative surgical therapy
* Prior radiation, TACE or HAI to the liver
* Uncorrectable coagulopathy
* Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
* Current or planned treatment with any experimental chemotherapy or target drugs

Primary outcomes:
measure: conversional resection rates
timeFrame: 2-4 months
Secondary outcomes:
measure: overall response rates
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hosptial, Fudan University
Study officials:
affiliation: Fudan University
name: Jianmin Xu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01068561: Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
Official title: Phase 1 Study Of Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Retinitis Pigmentosa
Keywords: Retinitis pigmentosa
stem cell
bone marrow
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-02-15
Enrollment: 5
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: The purpose of this study is to evaluate the short-term safety of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.

Detailed description: A prospective phase I, nonrandomized open-label study of retinitis pigmentosa patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be used to evaluate the short-term safety of intravitreal of ABMDSC: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of ABMDSC: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT \> 50um and not related to macular edema; 4) increase \> 5 letters on BCVA

Eligibility criteria: Inclusion Criteria:

* diagnosis of retinitis pigmentosa
* logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse

Exclusion Criteria:

* previous ocular surgery other than cataract
* presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation
* other ophthalmic disease like glaucoma and uveitis
* previous history of blood disorders like leukemia
* known allergy to fluorescein or indocyanine green
* known coagulation abnormalities or current use of anticoagulative medication other than aspirin.

Primary outcomes:
measure: severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Jose do Rio Preto
country: Brazil
facility: CPRS
state: SP
Study officials:
affiliation: Research Center Rubens Siqueira,Catanduva Medicine School and São Paulo University
name: Rubens C Siqueira, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05525611: Cabergoline as a Preventive Treatment for Chronic Migraine
Official title: Cabergoline as a Preventive Treatment for Chronic Migraine: an Investigator-Initiated, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled parallel study with a 12 weeks duration.
Primary purpose: TREATMENT

Brief summary: Headache disorders constitute a major global disease burden, and migraine - with a one-year prevalence of 15 % - is the sixth most disabling condition. Though a common disease, the pathogenesis is still unclear. Thus, the treatments have different mechanisms of action and preventive treatments are only effective in approximately 50% of chronic migraine patients. Recent evidence from mice models and a study of prolactine-associated headaches have indicated that dopamine agonists such as cabergoline might be used as a treatment of migraine.

The aim of this study is to test the hypothesis that the dopamine agonist cabergoline can be used as a treatment of chronic migraine. A randomized controlled trial of 24 patients with chronic migraine will be conducted, comparing cabergoline to placebo as an add-on medication to the patients' migraine treatment over a 12 weeks period. The primary outcome is change in migraine frequency, but also headache-related hospital contacts, and quality of life as well as prolactin levels and biomarkers of the pituitary-gonadal-axis. The results of the study will help understand the pathogenesis of migraine and might also introduce a more effective and affordable preventive migraine treatment.


Eligibility criteria: Inclusion Criteria:

* Migraine and more than 6 days with headache every months

Exclusion Criteria:

* Cardiac valve disease
* Hypertension
* Psychiatric disease
* Treated with dopamine receptor agonists, dopamin receptor antagonists, macrolides and itraconazole
* pregnant or breastfeeding

Primary outcomes:
measure: A change in days with headache in patients with chronic migraine
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital
state: Region Midtjylland
Study officials:
References:
Clinical trial NCT05640011: Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms
Official title: Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Mammography
Artificial intelligence
Tumor detection on mammograms
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman (40 to 75 years old) treated at the University Hospitals of Strasbourg between 2010 and 2020 for breast cancer

Brief summary: This aims to clinically validate, on a large population, a tumor detection aid software which has already been trained on a representative French population (from several hospital centers and liberals from several departments in the west and east of France).

This population consists of 1000 patients who have been treated for breast cancer (histologically proven by breast biopsy) and whose investigators have mammograms performed at the time of diagnosis. The control population consists of the unaffected breast of each patient (with the exception of the rare cases of bilateral cancers).

This innovative software has the main feature of recognizing healthy breast tissue, allowing the radiologist to focus on breast tissue at risk, improving the management of medical time and the management of "difficult" files.


Eligibility criteria: Inclusion Criteria:

* Adult woman (40 to 75 years old)
* Treatment at the University Hospitals of Strasbourg between 2010 and 2020 for breast cancer
* including mammography and histological evidence available
* Patient who has already given her consent for the reuse of her anonymous data for research purposes

Exclusion Criteria:

* Woman who expressed her opposition to participating in the study

Primary outcomes:
measure: Evaluate the diagnostic performance (sensitivity, specificity) for operator tumor detection assisted by mammographic diagnostic aid software, and compare it to the diagnostic performance of an unassisted operator.
timeFrame: Files analysed retrospectively from January 01, 2010 to January 01, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Radiologie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT06423911: Study of Olverembatinib (HQP1351) in Patients With CP-CML
Official title: This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Myeloid Leukemia
CML
CML, Chronic Phase
Lead sponsor: Ascentage Pharma Group Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part A 2:1 ratio Part B: control
Primary purpose: TREATMENT

Brief summary: A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

Detailed description: The hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B, olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation.

Eligibility criteria: Inclusion Criteria:

Patients eligible for inclusion in this study must meet all of the following criteria.

1. Age ≥ 18 years old.
2. Diagnosis of CML-CP
3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
5. Written informed consent obtained prior to any screening procedures.
6. Patients with adequate organ functions

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria.

1. For Part A only: T315I mutation at any time prior to starting study treatment.
2. Active infection that requires systemic drug therapy
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
6. Pregnant or nursing (lactating) women.

Primary outcomes:
measure: MMR rate Part A
timeFrame: 24 weeks
measure: MMR rate Part B
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT01101711: Endocrine Dysfunction and Quality of Life After Subarachnoid Hemorrhage
Official title: Endocrine Dysfunction and Quality of Life After Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocrine Dysfunction
Cerebral Infarctions
Quality of Life
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the southern part of Sweden who have suffered subarachnoid hemorrhage and admitted to the Department of Neurosurgery in Lund

Brief summary: Investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage (SAH), and to see if this has a relation to CNS lesions as evaluated by MRI and to common symptoms after SAH such as general exhaustion, lack of initiative, increased sleep demand and reduced quality of life.


Eligibility criteria: Inclusion Criteria:

* acute aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

* unable to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Neurosurgery
Study officials:
References:
Clinical trial NCT04964011: Board Game Intervention to Improve Cognitive and Daily Functioning
Official title: Board Game Intervention to Improve Cognitive and Daily Functioning in Elderly People With Mild Cognitive Impairment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Maximum age (years): 88
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background:

With the rapid rise of the aging population, the number of seniors with mild cognitive impairment (MCI) has increased, and without timely interventions, participants are at high risk of developing dementia. Board games have become a popular tool for cognitive training, but many board games may not be appropriate for seniors and lack the support of empirical research.

Objectives:

To examine the effectiveness of a 12-week board game intervention for MCI seniors in improving cognitive functioning and scores on the instrumental activities of daily living (IADL) scale.

Methods:

A single-blind randomized controlled trial was conducted to collect data from a long-term care facility in central Taiwan. Sixty-eight MCI seniors were recruited and randomized into a board game group (trial group) and a health promotion group (control group). Participants in both groups received a 2-hour intervention once a week for 12 weeks, with the trial group receiving 12 weeks of board games and the control group receiving 12 weeks of health promotion activities. Before and after the intervention, the primary assessment was conducted using the Saint Louis University Mental Status Exam, Contextual Memory Test, and Trail Making Test part-A; the secondary assessment was conducted using the IADL scale.


Eligibility criteria: Inclusion Criteria:

* aged 65 years or older without a diagnosis of dementia
* mild neurocognitive impairment

Exclusion Criteria:

* non-national senior citizens
* unable to understand the content and complete the questionnaire
* unable to participate in the full 12-week intervention
* had an acute illness such as a cold during the trial.

Primary outcomes:
measure: Saint Louis University Mental Status Exam (SLUMSE)
timeFrame: 15-25 minutes
measure: Contextual Memory Test (CMT)
timeFrame: 15-20 minutes
measure: Trail Making Test part-A (TMT-A)
timeFrame: 15-20 minutes
Secondary outcomes:
measure: Instrumental activities of daily living (IADL)
timeFrame: 10-20 minutes
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia Univeraity
state: WuFeng
Study officials:
References: