louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04952168: Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC
Official title: A Single Arm, Prospective, Open Clinical Study of Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC With EGFR Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC, Stage III
Keywords: Almonertinib
chemoradiotherapy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Prospective, open, single arm study to evaluate the efficacy and safety of the almonertinib combined with concurrent chemoradiotherapy in unresectable stage III NSCLC with EGFR mutation


Eligibility criteria: Inclusion Criteria:

1. Age ≥18, male or female.
2. Patients must provide written informed consent to participate in the study.
3. Patients must have biopsy proven unresectable stage III NSCLC (AJCC 8th).
4. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R).
5. Patients receiving almonertinib for 3 months and achieved stable disease, partial response or completely response.
6. ECOG score 0-1
7. Demonstrate adequate organ function Patients evaluated as Cr, PR and SD were given concurrent chemoradiotherapy 3 months after targeted therapy

Exclusion Criteria:

1. Patients progress in 3 months after almonertinib treatment
2. Patient can't tolerate radiotherapy or targeted therapy
3. Pregnant or nursing women

Primary outcomes:
measure: 2-year overall survival rate
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: yuan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06088368: Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method
Official title: Investigation of the Efficacy of Different Types of Lumbar Plexus Block Applied With Ultrasound-guided Shamrock Method
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Femoral Neck Fractures
Lumbosacral Plexus
Nerve Block
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The more effective use of ultrasound in regional anaesthesia techniques has made different block applications possible. Lumbar plexus block is also used for post-operative analgesia and surgical anaesthesia. Currently, in-plane ultrasound-guided LPB is widely used in short-axis imaging and Shamrock imaging.

Detailed description: The purpose of this use is to investigate the effectiveness of lumbar plexus block application applied with in-plane and out-of-plane methods accompanied by Shamrock imaging.

Eligibility criteria: Inclusion Criteria:

* 18-90 years old
* ASA (American Society of Anaesthesiologist) Score I-III risk class
* Patients who will undergo femoral neck fracture operation.

Exclusion Criteria:

* Local Anaesthetic Allergy
* With Bleeding Diathesis Disorder
* Mental Disorders
* Allergic to the medicines used
* Previous Cerebrovascular Disease
* Body Mass Index above 30

Primary outcomes:
measure: Block application time
timeFrame: up to 20 minutes
Secondary outcomes:
measure: Number of interventions
timeFrame: up to 20 minutes
measure: The number of needle guidance
timeFrame: up to 20 minutes
measure: sensory block
timeFrame: up to 40 minutes
measure: motor block
timeFrame: up to 40 minutes
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
name: Korgün Ökmen, Assoc. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02518568: Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia
Official title: Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Iron Deficiency Anemia
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2015-08-10
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.


Eligibility criteria: Inclusion Criteria:

* Women 18-45 years inclusive with iron deficiency anaemia
* haemoglobin level between 85 g/L and 105 g/L
* serum ferritin level \< 15 µg/L
* D14 +/- 7 days of the menstruation cycle on the day of pharmacokinetic evaluation

Exclusion Criteria:

* Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
* Haemochromatosis or iron overload of secondary origin (blood transfusion),
* Long term treatment known to modify iron absorption,
* Gastro duodenal ulcer,
* Inflammatory bowel disease or any digestive disease which could modify iron absorption,
* Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
* Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.

Primary outcomes:
measure: Maximum Plasma concentration (Cmax)
timeFrame: up to 24 hours after oral administration
measure: Time to Maximum Concentration (Tmax)
timeFrame: up to 24 hours after oral administration
measure: Area under the iron plasma concentration curve (AUC)
timeFrame: up to 24 hours after oral administration
Secondary outcomes:
measure: Tolerability of single administration
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Iasi
country: Romania
Study officials:
References:
Clinical trial NCT04459468: Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC
Official title: Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for Hepatocellular Carcinoma (HCC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HCC

Brief summary: This study will enroll patients with hepatocellular carcinoma being planned for TACE or other standard of care treatment (such as denovo ablation or Y90) and obtain blood samples pre and post treatment procedure for biomarker identification using bead based X-aptamer library. No intervention is planned.

Detailed description: This is a prospective, non-blinded, multi-arm study. Patients at 18 - 70 years old with liver cancer will be enrolled.

The approach is to identify novel proteomic biomarkers for HCC patients treated with Lipiodol TACE, denovo ablation or Y90 using beads-based X-aptamer library, then validate and create a biomarker panel that can be used to predict the outcome of HCC post treatment.

Lipiodol TACE, denovo ablation, or Y90 will be done as standard of care and the only thing done as research will be blood draws pre and post-TACE.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent.
2. Male or female aged 18-70years.
3. Diagnosed with primary or metastatic liver cancer.
4. Scheduled to undergo Lipoidal TACE, denovo ablation, or Yttrium-90 (Y90) radioembolization as part of standard of care.

Exclusion Criteria:

Subjects who have received chemotherapy, radiation or surgery for HCC.

Primary outcomes:
measure: Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients
timeFrame: 2 years
Secondary outcomes:
measure: Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients.
timeFrame: 2 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT01676168: To Study Gene Expression of Postburn Hypertrophic Scar
Official title: To Study Gene Expression of Postburn Hypertrophic Scar
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cicatrix, Hypertrophic
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient have hypertrophic scar.

Brief summary: Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.

Detailed description: Background: Postburn hypertrophic scar (HS) remains a challenging problem. Although varied clinical therapeutic methods have been used, none of them has been widely accepted as a standard care. As hypertrophic scar is hereditary, gene therapy can be a potential tool for scar treatment. To investigate the correlation between the clinical presentation of the hypertrophic scar and its gene expression, we propose an analysis of gene expression in the hypertrophic scar using DNA microarray and Real-Time Quantitative PCR. The study result may form the base of clinical treatment.

Methods and Materials: Thirty scar patients requiring surgical treatment in NTUH burn center will be enrolled into the study. Inclusion criteria: (1) Age between 20 and 80 (2) Patients with postburn hypertrophic scar require surgical treatment.

1. Hypertrophic scar and normal skin collection: Under Clinical Trial Informed Consent of Research Ethic Committee, scar and normal skin specimen of 1x1cm2 each will be collected and transported to tissue bank with a vacuum low temperature container. The specimen will be kept in a -80℃ refrigerator.
2. RNA extraction from skin tissue: The RNA extraction will be performed using kit available in the market. Spectrophotometer and gel electrophoresis will be used to measure the purity and concentration of RNA.
3. Gene expression analysis: DNA microarray and Real-Time Quantitative PCR will be used to analyze RNA expression of hypertrophic scar and normal skin.

Statistics: Student's t-test will be used to compare statistically gene expression between hypertrophic scar and normal skin. P \< 0.05 will be considered as statistical significance.

Eligibility criteria: Inclusion Criteria:

* age20\~80, hypertrophic scar patient

Exclusion Criteria:

* no specific limitation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH Burn lab
name: Kean Eng Yeong, college
role: STUDY_CHAIR
References:
Clinical trial NCT04235868: Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
Official title: Clinical Trial of Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 30
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: Chronic wounds do not heal for prolonged periods of time with the significant financial burden on the healthcare system. It has become increasingly essential to improve our clinical treatments. The most promising potential treatment options rely on stem cell-based therapies. A large body of evidence indicates that mesenchymal stem cells can promote wound closure of chronic wounds in animal models and in preclinical studies. MSCs efficacy depends mostly on their paracrine activity. All the bioactive factors and cytokines in MSCs secretions constitute can be collected in the conditioned medium. In here, stem cell-derived conditioned medium was further made into a lyophilized powder. Patients with chronic wounds were enrolled. The wounds in control group treated with fibroblast growth factor commonly used in clinical practice. The wounds in experimental group treated with lyophilized powder. The effectiveness and safety of lyophilized powder will evaluate for chronic wounds.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of chronic wounds; Male or female over 17; Psychologically stable and able to complete the experimental process. -

Exclusion Criteria:

wound greater than 10cm ×10cm; Exposure to radiation or use of hormones, chemotherapy, growth factor dressings and immunosuppressants within 3 months; Participated in other similar tests within 3 months; Pregnant, or lactating women; Severe infectious disease; Severe heart, liver, and kidney dysfunction; Had a history of cancer -

Primary outcomes:
measure: wound healing rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Xiaobing Fu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05889468: Postpartum ASA and NT-proBNP
Official title: The Association Between Postpartum Aspirin Use and NT-proBNP Levels as a Marker for Maternal Health Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Pressure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment Arm vs Placebo Arm
Primary purpose: TREATMENT

Brief summary: This study is a double-blinded randomized-controlled trial in which patients will be randomized to 81 mg of aspirin or placebo to be continued for 6 weeks' postpartum. The purpose of this study is to compare NT-proBNP levels at the 4-6 week postpartum visit between groups. There is currently no data on the maternal health effects associated with continuation of low-dose aspirin in the postpartum period. This study aims to fill a gap in the knowledge regarding the utility of low-dose aspirin following delivery.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* English-speaking
* postpartum
* have met USPSTF recommendations for low-dose aspirin use during pregnancy: \>1 high risk factor (history of preeclampsia in prior pregnancy, multifetal gestational, chronic hypertension, preexisting diabetes, renal disease, autoimmune disease) or \>2 moderate risk factors (nulliparity, obesity, family history of preeclampsia, sociodemographic characteristics, age 35 years or older, or personal history factors) and reported at least 50% compliance with aspirin during pregnancy.

Exclusion Criteria:

* hypersensitivity reaction to aspirin or other salicylates,
* history of gastrointestinal bleeding
* history of gastric or duodenal ulcers
* severe hepatic dysfunction
* bleeding disorders and diathesis
* known cardiac dysfunction with reduced ejection fraction, or are taking or prescribed ACE inhibitors.
* Patients who required ICU level care during their pregnancy will be excluded.

Primary outcomes:
measure: NT-proBNP Levels at 4-6 Weeks Postpartum
timeFrame: 4-6 weeks postpartum
Secondary outcomes:
measure: Number of Participants With Preeclampsia Diagnosis Postpartum
timeFrame: 6 weeks postpartum
measure: Number of Participants With Eclampsia
timeFrame: 4-6 weeks postpartum
measure: Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications
timeFrame: 6 weeks postpartum
measure: Number of Participants Requiring Initiation or Increase in Blood Pressure Medications
timeFrame: 4-6 weeks postpartum
measure: Number of Participants With Hospital Readmission for Bleeding-related Complications
timeFrame: 4-6 weeks postpartum
measure: Number of Participants Needing Blood Transfusion(s)
timeFrame: 4-6 weeks postpartum
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Brenna Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04954768: Epidemiological Characteristics of Elderly Trauma Patients in Zhejiang Province and Development of Geriatric Trauma Short-term Mortality Prediction Model
Official title: Epidemiological Characteristics of Elderly Trauma Patients in Zhejiang Province and Development of Geriatric Trauma Short-term Mortality Prediction Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma Injury
Old Injury
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 350
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Trauma patients aged 65 years or older

Brief summary: This is a retrospective study. Trauma patients aged 65 years or older will be included. The aims of this study are explore the epidemiological characteristics of elderly trauma patients in Zhejiang Province; establishment of early warning score system of elderly trauma death in Zhejiang Province; and horizontal comparison of the treatment level of elderly trauma in Zhejiang Province.


Eligibility criteria: Inclusion Criteria:

Trauma patients aged 65 years or older

Exclusion Criteria:

Secondary trauma due to other causes

Primary outcomes:
measure: the incidence of geriatric trauma in patients
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang university, school of medicine.
state: Zhejiang
Study officials:
References:
Clinical trial NCT00889668: Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device
Official title: Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: Glucose monitoring
GlucoTrack
Self glucose monitoring
Lead sponsor: Integrity Applications Ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 180
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics.

The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels.

The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes

Detailed description: See Brief summary

Eligibility criteria: Inclusion Criteria:

* Type 1or 2 Diabetes
* Anatomically suitable earlobe

Exclusion Criteria:

* Subjects requiring dialysis
* Any conditions that may hamper good contact between the PEC and the earlobe
* Pregnancy
* Nursing mothers

Primary outcomes:
measure: Clarke Error Grid
timeFrame: one year
Secondary outcomes:
measure: User Satisfaction
timeFrame: one year
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center, Dept of Internal Medicine C and Director of the Diabetes Unit at Soroka University Medical Center
name: Ilana Harman-Boehm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02618668: Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
Official title: Haemodynamic Stability of Ketamine / Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatitis
Cholangitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient \& doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists ( I ,II )

Exclusion Criteria:

1. Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity.
2. History of substance abuse or dependence.
3. History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs.
4. Pregnancy.

Primary outcomes:
measure: mean arterial blood pressure from baseline of patient undergoing Endoscopic Retrograde Cholangio pancreatography
timeFrame: every 5 minutes up to 30minutes
measure: saturation of oxygen from baseline of undergoing Endoscopic Retrograde Cholangio pancreatography
timeFrame: every 5 minutes up to 30 minutes
measure: Heart rate( beat/minute) from baseline of patient
timeFrame: every 5 minutes up to 30 minutes
measure: Recovery score of patient
timeFrame: up to 10 minutes after the end of procedure
Secondary outcomes:
measure: patient and doctor satisfaction score
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Mohamed A Bakr, Prof.
role: STUDY_CHAIR
affiliation: Assiut University
name: Nagwa m osman, Asst.prof.
role: STUDY_DIRECTOR
References: