louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05717803: Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)
Official title: Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Segmentectomy
Lung Adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:

* The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm;
* The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.


Eligibility criteria: Inclusion Criteria:

* Patients who sign the informed consent form and are willing to complete the study according to the plan;
* Aged from 18 to 80 years old;
* ECOG equals 0 or 1;
* Not receiving lung cancer surgery before;
* Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
* Ground glass-dominant lung nodules
* Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm;
* cN0 without distant metastasis;
* Tumors could be completely resected assed by surgeons;
* Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

* CTR is not 0-0.5, or size is not 2-3cm;
* Tumors could not be completely resected assed by surgeons;
* Not lung adenocarcinoma diagnosed cytologically or pathologically;
* Receiving lung cancer surgery before;
* Receiving radiotherapy or chemotherapy.

Primary outcomes:
measure: 5-year disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Lung function test
timeFrame: Half year and one year after surgical resection
measure: 5-year overall survival
timeFrame: 5 years
measure: The site of tumor recurrence and metastasis
timeFrame: From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.
measure: Segmentectomy completion rate
timeFrame: From the beginning of the surgery to the end of the surgery.
measure: Radical segmentectomy (R0 resection) completion rate
timeFrame: From surgery to the release of the final pathology report, an average of two weeks.
measure: Surgery-related complications
timeFrame: From surgery to patient discharge or 30 days after surgery.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Haiquan Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03017703: The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes
Official title: The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Insulin Resistance
Keywords: Endothelial dysfunction
Insulin resistance
Type 2 diabetes
Mineralocorticoid blocker
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Diagnosed diabetic \< 5 Yrs.
* BMI \< 32 kg/m2
* Non-smoking
* Blood pressure \< 140/90 mmHg (treatment with maximum of two antihypertensive drugs)

Exclusion Criteria:

* Insulin treatment
* Hypertension (\>140/90 mmHg)
* Sequelae to diabetes
* Smoking
* Known chronic diseases
* Pregnancy or birth within 3 month
* Alcohol misuse

Primary outcomes:
measure: Vascular function
timeFrame: 8 weeks
measure: Insulin sensitivity measured by a insulin clamp
timeFrame: 8 weeks
Secondary outcomes:
measure: Vascular function
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Cardiovascular and Renal Research
Study officials:
affiliation: University of Southern Denmark
name: Stefan P Mortensen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finsen SH, Hansen MR, Hoffmann-Petersen J, Hojgaard HF, Mortensen SP. Eight weeks of mineralocorticoid blockade does not improve insulin sensitivity in type 2 diabetes. Physiol Rep. 2021 Aug;9(15):e14971. doi: 10.14814/phy2.14971.
citation: Finsen SH, Hansen MR, Hansen PBL, Mortensen SP. Aldosterone Induces Vasoconstriction in Individuals with Type 2 Diabetes: Effect of Acute Antioxidant Administration. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1262-e1270. doi: 10.1210/clinem/dgaa867.
Clinical trial NCT01772303: Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds
Official title: An Open-Label, Prospective, Multicenter Study to Assess the Safety and Efficacy of HO/03/03 10-40 Micro Gram (Wound Size Dependence) Applied Topically for up to 24 Weeks in Subjects With Various Etiologies of Hard-to-Heal Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hard to Heal Wounds
Keywords: Pressure Ulcers, diabetic Ulcers, post operational wounds
Lead sponsor: HealOr
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, prospective, open-label, outpatient study will assess the safety and efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100 subjects with Hard to Heal documented chronic wounds of various etiologies (pressure ulcers, diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis and trauma wounds) of at least 4 weeks documentation.

Detailed description: All subjects with a wound size of up to 56.25 cm2 (inclusive) will be administered 1 vial of 10 ml HO/03/03 10μg per administration. For each increase in wound size of up to 56.25 cm2 an additional vial of HO/03/03 10 μg will be added up to a maximal wound size area of 225 cm2 (will be measured by HealOr central reviewer) utilizing 40µg (4 vials) per administration. 15 min post treatment wounds will be dressed according to standard of care.

Eligibility criteria: Inclusion Criteria:

* Age 18 years old and above.
* Chronic wounds that have \< 30% change in area from Screening
* Have single / multiple wounds;
* Have a Hard-to-Heal wound(s) of various etiologies

Exclusion Criteria:

* Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), hepatic or per the physician's discretion.

Primary outcomes:
measure: Time to Heal
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Wound closure
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Maccabi Health Services, Wound Clinic
Study officials:
References:
Clinical trial NCT01513603: Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia
Official title: Phase II Trial of CLAG-M in Relapsed ALL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Burkitts Leukemia/Lymphoma
Chronic Myelogenous Leukemia
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.

Detailed description: Patients will receive standard dose CLAG-M (cladribine, cytarabine, mitoxantrone, filgrastim). Standard support care will be given. Efficacy will be assessed through bone marrow examinations and blood tests.

Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory acute lymphoblastic leukemia,
* Burkitts leukemia/lymphoma,
* Lymphoid blastic CML,
* Lymphoblastic lymphoma.

Primary outcomes:
measure: Complete remission percentage
timeFrame: 1 month
Secondary outcomes:
measure: Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: Westchester Medical Center/New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Karen Seiter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04750603: Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents
Official title: Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: a Randomized and Open Label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma in Children
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 92
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First phase: Randomized, double blind, double dummy. Second phase: open label
Primary purpose: TREATMENT

Brief summary: Exercise induced asthma (EIA) is common in adolescents. (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Adolescent asthmatics were referred for evaluation of EIA. Patients with a positive exercise challenge test, were allocated to a single administration of salbutamol and 22 to FF/VI in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat exercise test 24-hours after the last dose.

Detailed description: Exercise induced asthma (EIA) is common in adolescents. Relvar® (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Ninety-three adolescent asthmatics aged 12-18 years were referred for evaluation of EIA. 44 patients had a positive exercise challenge test (ECT), 22 (22/44) were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat ECT 24-hours after the last dose.

Eligibility criteria: Inclusion Criteria:

* Adolescent asthmatics aged 12-18 years
* Symptoms of shortness of breath on exercise and asthmatics before entry to military service
* Referral for evaluation of exercise challenge test

Exclusion Criteria:

* Baseline FEV1\<65% before exercise test
* Acute illness
* History of intolerance to beta agonists
* Use of the following medications prior to the study was restricted: inhaled corticosteroids or Montelukast (2 weeks), systemic steroids (2 months) and bronchodilators (24 hours)

Primary outcomes:
measure: Long term effect of FF/VI
timeFrame: 30-60 days
Secondary outcomes:
measure: Short term effect of FF/VI
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam
name: Lea Bentur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06653803: Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy
Official title: Ultrasound-guided Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Keywords: Rhomboid Intercostal Block
Retrolaminar Block
Regional Analgesia
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-22
Enrollment: 60
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: Background: Although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. Both Rhomboid intercostal block (RIB) and Retrolaminar block (RLB) are recent techniques used for pain control after such procedures

Objectives: To compare the effectiveness of RIB and RLB in providing postoperative analgesia after thoracoscopic sympathectomy in adult patients and their impact on the patient's outcomes.

Patients and Methods: This prospective, randomized (1:1), double-blind clinical trial; will be carried out on 60 patients scheduled for elective thoracoscopic sympathectomy under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group A; general anesthesia with intraoperative ipsilateral ultrasound-guided RIB, whereas in group B; general anesthesia with intraoperative ipsilateral ultrasound-guided RLB.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 18 to 60 years
* Body Mass Index (BMI) \< 35 kg/m²

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status \> II
* Age \< 18 years or \> 60 years
* Body Mass Index (BMI) ≥ 35
* Local infection at the puncture site
* Altered mental status
* Pregnant women
* Allergy to study drugs
* Chronic pain
* Coagulation abnormalities or on anticoagulants
* Severe hepatic or kidney disease

Primary outcomes:
measure: Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
measure: Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
timeFrame: 24 hours after the end of surgery
measure: Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
timeFrame: 24 hours after the end of surgery
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05477303: Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression
Official title: Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression Recognition and Analgesia Nociception Index
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Artificial Intelligence
Facial Expression
Analgesia
Pain, Postoperative
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were scheduled for elective laparoscopic abdominal surgery under general anesthesia

Brief summary: Patients' subjective complaints about pain intensity are difficult to objectively evaluate, and may lead to inadequate pain management, especially in patients with communication difficulties.

Detailed description: Analgesia nociception index (ANI 0-100) and patient-reported numeric rating scale (NRS 0-10) were trained on a convolutional neural network (CNN) model by linking the patients' facial expression with the score. By applying the predicted pain score by the AI model to evaluate pain, it is intended to measure the intensity of pain in an automatic, fast, and objective way for appropriate pain management.

Eligibility criteria: Inclusion Criteria:

* Patients aged 19-75 years who were scheduled for elective laparoscopic abdominal surgery under general anesthesia
* American Society of Anesthesiology (ASA) class I-II

Exclusion Criteria:

* Patients who have difficulty in communicating and reporting pain
* Underlying diseases: liver, kidney, brain
* Patients with BMI greater than 30 and less than 18.5
* Alcohol or drug dependent patients
* Patients with severe or acute respiratory failure
* Opioid, NSAID allergy
* Patients who are scheduled to be admitted to the intensive care unit after surgery
* Patients who undergo cooperative surgery

Primary outcomes:
measure: Facial expression
timeFrame: immediately preoperative, postoperative time
measure: analgesia nociception index
timeFrame: immediately preoperative, postoperative time
measure: numeric rating scale
timeFrame: immediately preoperative, postoperative time
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
Study officials:
References:
Clinical trial NCT03886103: Pharmacokinetics and Metabolism of (14C)-Labelled PXL770
Official title: Pharmacokinetics and Metabolism of [14C]-Labelled PXL770 Following a Single Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 8
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian males
* Age 30 to 65 years
* BMI 18.5 to 32.0 kg/m2 and body weight of 55 to 95 kg.
* Must be willing and able to communicate and participate in the whole study
* Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
* Must provide written informed consent
* Regular alcohol consumption of 4-14 units of alcohol per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
* Must agree to adhere to the contraception

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the previous 3 months or 90 days prior to Day 1
* any drug or alcohol abuse
* Current smokers and those who have smoked within the last 12 months.
* Radiation exposure, including that from the present study, excluding background adiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* No occupationally exposedworker, as defined in the Ionizing Radiation Regulations 2017, shall participate in the study
* Clinically significant abnormal biochemistry, hematology, coagulation or urinalysis as judged by the investigator
* Positive test for HIV, HBV, HBC
* eGFR \<80 mL/min
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
* Known sensitivity to any of the constituents or excipients of the study drug or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions)
* History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome
* Mental handicap

Primary outcomes:
measure: Mass balance recovery
timeFrame: From day 1 to day 7
Secondary outcomes:
measure: PK profile of total radioactivity
timeFrame: From day 1 to day 7
measure: PK profile of PXL770
timeFrame: From day 1 to day 7
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From day 1 to day 7
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient
Study officials:
References:
Clinical trial NCT04434703: Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)
Official title: Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF) A Randomized Clinical Trail :Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the aim of this study is clinically and radiographically evaluate the use of advance platelet rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge following tooth extraction

Detailed description: systemically healthy patients who have at least one non-restorable tooth in the upper inter-bicuspid region and are not seeking immediate or early implant treatment will be allocated in this study after performing nonsurgical periodontal therapy and preoperative periapical therapy to evaluate and improve the condition of the periodontal tissues.

Anesthesia will be given then flapless atraumatic extraction using periotomes followed by forceps after luxation. For all groups, the socket will be debrided using curette then

* group A, the socket will be filled with A.PRF
* group B the socket will be filled with PRF.
* group C no bio-additive will be added.
* Criss cross horizontal mattress suture will be applied to close the extraction wound.

PRF and A-PRF preparation :

10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.

* Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant
* Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients with at least one non restorable tooth in upper inter-bicuspid region.
* Stable periodontal condition with no acute periapical infection.
* Systematically healthy conditions.
* Cooperative patients.
* Intact buccal plate of bone.

Exclusion Criteria:

* Smokers.
* Patients seeking immediate or early implants.
* Pregnant females.
* Bone diseases.
* Drugs and diseases that may affect platelet count or function.

Primary outcomes:
measure: Change in bucco-lingual dimensions
timeFrame: 6 months
Secondary outcomes:
measure: change in alveolar bone height
timeFrame: 6 months
measure: bone dentistry
timeFrame: 6 months
measure: soft tissue healing
timeFrame: 6 months
measure: postoperative pain scores
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: School of dentistry , Cairo University
Study officials:
References: