louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05215925: A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression
Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Advanced nsqNSCLC Patients With High EGFR Expression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HLX07, nsqNSCLC, High EGFR Expression
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Combination with Chemotherapy or Monotherapy in Advanced Non-squamous Non-small Cell Lung Cancer (nsqNSCLC) Patients with High EGFR Expression


Eligibility criteria: Inclusion Criteria:

1. Age\>=18Y
2. Good Organ Function
3. Expected survival time ≥ 3 months
4. Histologically confirmed, advanced/recurrent or metastatic nsqNSCLC
5. Measurable lesion according RECISTv1.1 by investigator
6. High EGFR expression H score ≥200
7. ECOG score 0-1

Exclusion Criteria:

1. Histologically, squamous NSCLC should be excluded. For tumors with adenocarcinoma and squamous carcinoma, if the adenoid component is dominant and the squamous component is \< 5%, the patients meet the inclusion requirements.
2. Previous treatment with EGFR inhibitors
3. Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
4. Active clinical severe infection;
5. A history of other malignancies within 5 years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin,etal.

Primary outcomes:
measure: ORR
timeFrame: up to 2 years
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Secondary outcomes:
measure: OS
timeFrame: from the date of first dose until the date of death from any cause，assessed up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References:
Clinical trial NCT01211925: Distal Venous Arterialisation of Ischemic Limb
Official title: Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Critical Limb Ischemia
Keywords: unreconstructable peripheral arterial disease
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2010-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.

Detailed description: The aim of this study was to estimate validity of distal venous arterialisation (DVA) as a limb salvage procedure. This prospective randomized study reported early results of 30 unreconstructible patients with critical limb ischemia (CLI) treated during 2009 year at Clinic for vascular surgery, Clinical Center of Serbia in Belgrade. Patients were divided in two groups, 10 treated with DVA and 20 conservatively (CT) using antiplatelet drugs.

Eligibility criteria: Inclusion Criteria:

* Absence of any possibility for direct revascularisation due to extensive occlusive disease of crural and pedal arteries
* Sufficient deep venous system and usable great saphenous vein as a graft for in situ bypass surgery according duplex scanning
* localized infective of necrotic process up to the metatarsal level
* Satisfactory general patient condition

Exclusion Criteria:

* advanced lower limb ischemia
* venous insufficiency of lower limb

Primary outcomes:
measure: limb salvage
timeFrame: 1 year
Secondary outcomes:
measure: lactate level in the blood of deep venous system
timeFrame: 1 year
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
Study officials:
affiliation: Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery
name: Predrag Vl Djoric, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04160325: Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery
Official title: The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.

Detailed description: For patients with Crohn's disease(CD), whether exclusive enteral nutrition(EEN) following bowel resection and anastomosis could delay the disease recurrence remains unkown. In this study， CD patients after surgery will be divided into two groups: one group is treated with 3 months' EEN and then turn to normal diet after 3 months; the other group is given with normal diet all through. All patients will be adminstrated with oral azathioprine after surgery. Then, the rates of 1 year postoperative endoscopic recurrence will be compared between groups.

Eligibility criteria: Inclusion Criteria:

* CD patients who undergoing bowel resection with anastomosis

Exclusion Criteria:

* patients who had administered with immunomodulators or biological agents patients who were created stoma

Primary outcomes:
measure: the 1 year postoperative anastomotic recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04099225: Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters
Official title: Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Smokers
Non-smokers
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers including never, active and former smokers

Brief summary: Multiple breath washout (MBW) using Sulphur hexafluoride (SF6) has the potential to reveal ventilation heterogeneity in obstructive lung disease which is frequent in patients with small airway disease. However, it is missed by commonly used tests with reference data being scarce and mostly restricted to younger collectives. We aimed to evaluate the influence of anthropometric parameters on SF6-MBW reference values in pulmonary healthy adults.


Eligibility criteria: Inclusion Criteria:

non-smoker

* no history of pulmonary disease
* absence of dyspnoea, cough, thoracic pain
* no self-reported smoking history
* normal lung function testing

  * normal shape of flow-volume curve
  * normal shape of flow-pressure curve
  * FEV1/FVC \>70% (forced expiratory volume in 1 second / forced vital capacity)
  * TLC \> 80% of predicted (total lung capacity)
  * TLCO/VA \> 80% of predicted (transfer factor corrected for ventilated alveolar volume)
  * R5 \< 150% of predicted (resistance at 5Hz, impulse oscillometry)

smoker

- as above, but with self-reported smoking history \>10 pack years

Exclusion Criteria:

* unwilling or unable to give informed consent
* history of any respiratory disease

Primary outcomes:
measure: Lung clearance index (LCI) derived from multiple breath washout testing (MBW)
timeFrame: 30 minutes
Secondary outcomes:
measure: Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW)
timeFrame: 30 minutes
measure: Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW)
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Mannheim
name: Frederik Trinkmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trinkmann F, Maros M, Roth K, Hermanns A, Schafer J, Gawlitza J, Saur J, Akin I, Borggrefe M, Herth FJF, Ganslandt T. Multiple breath washout (MBW) testing using sulfur hexafluoride: reference values and influence of anthropometric parameters. Thorax. 2021 Apr;76(4):380-386. doi: 10.1136/thoraxjnl-2020-214717. Epub 2021 Feb 16.
Clinical trial NCT05317325: A Translational Study of Tumor Antigen-pulsed DC Vaccine for ESCC
Official title: A Translational Study of Tumor Antigen-pulsed Dendritic Cell Vaccine for Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal cancer
tumour cell lysate
neoantigen
prime-boost
dendritic cell vaccine
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 20
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: The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-pulsed DC vaccine( OCDC and NeoDC) for postoperative adjuvant treatment of ESCC


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diagnosis of esophageal squamous cell carcinoma
* no preoperative adjuvant therapy
* Karnofsky performance status 0-2;
* The postoperative pathological stage is pT2-4 and / or N + M0 according to AJCC 8th
* Function of the main organs is normal;
* Edition Patient's written informed consent

Exclusion Criteria:

* Tumor emergencies;
* Abnormal coagulation function;
* Contagious diseases, such as HIV, HBV, HCV infection;
* Mental disorders;
* Concomitant tumors;
* Immunological co-morbidities

Primary outcomes:
measure: The number of treatment-related adverse events
timeFrame: From the first administration of vaccine to 3 months after the last administration
Secondary outcomes:
measure: Disease-free Survival
timeFrame: from the study start to 1 year after the study completion
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Sichuan University
name: Zhen-Yu Ding, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06753825: Childhood Migraine Treatment Noninvasive Pulsed Radiofrequency vs Flunarizine
Official title: Comparison of the Efficacy of Transcutaneous Pulsed Radiofrequency Therapy and Calcium Channel Blockers in Childhood Migraine Headache.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Migraine Disease
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Total 60 patients, per group 30 patients

Brief summary: The aim of this observational study was to investigate the long-term effects of patients receiving interventional transcutaneous electrode-pulsed radiofrequency therapy versus calcium channel blockers for the treatment of childhood migraine pain. The main question to be answered was.

Which of the long-term effects of interventional transcutaneous pulsed radiofrequency versus calcium channel blockers for the treatment of childhood migraine pain is more effective? Participants who have started both treatments will answer questions about their headaches in an online survey for 3 months as part of their regular medical care.

Detailed description: There are two groups in the trial. One group will receive transcutaneous pulsed radiofrequency treatment for a total of 3 weekly sessions. The other group will receive 1x 5 mg flunarizine active ingredient. Both groups will consist of 30 patients. All patients will be followed from the start of treatment and will be assessed at month 1 and month 3 using the paediatric migraine disability index, headache diaries and visual pain scale.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with migraine according to ICHD-3 Migraine criteria
* Being between the ages of 8-18
* Having 4 or more migraine attacks per month

Exclusion Criteria:

* Other primary or secondary headache diagnosis
* Patient could not be reached during follow-up

Primary outcomes:
measure: Headache diary
timeFrame: month 1 and month 3
Secondary outcomes:
measure: Pediatrik migraine disability scale PedMidas
timeFrame: month 1 and month 3
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
state: Yenimahalle
Study officials:
References:
Clinical trial NCT04413825: Early Systolic Notching in Pulmonary Embolism
Official title: Diagnostic Accuracy of Early Systolic Notching in Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Akdeniz University
name: Ege University
name: Antalya Training and Research Hospital
name: Rize Üniversitesi
name: Izmir Katip Celebi University
First posted: 2020-06-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who presented to the emergency department and underwent pulmonary CT angio imaging with suspicion of pulmonary embolism.

Brief summary: Venous thromboembolism (VTE), clinically seen as deep vein thrombosis (DVT) or pulmonary embolism (PE), is the third most common acute cardiovascular syndrome after myocardial infarction and stroke. In a study conducted by critical care and emergency physicians, lung ultrasonography (US) for pleural infarction areas, lower extremity venous US in terms of DVT, and focused cardiac US in terms of right ventricular strain were demonstrated with different diagnostic values for PE. However, no ultrasonographic method alone has a high diagnostic value for PE alone in the literature. In a recent study, it is stated that a new cardiac finding (early systolic notch- ESN) has high sensitivity (92%) and specificity (99%) in massive and submassive emboli. However, the limited patient population and the exclusion of many patient groups limits the applicability of the study and its use in other patient groups. With this study, it was aimed to determine the diagnostic value of ESN finding within the emergency department conditions by keeping the patient population wider.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing pulmonary CT angiography with suspicion of pulmonary embolism

Exclusion Criteria:

* Pregnant women,
* Patients under 18 years of age,
* Those who received thrombolytic therapy,
* Poor ultrasound imaging.

Primary outcomes:
measure: To determine the diagnostic accuracy of the ESN finding
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Facaulty of Medicine
Study officials:
References:
Clinical trial NCT03679325: Evaluation of Cardiac Variability After a Vitamine D Protocol and Whole Body Vibration
Official title: Heart Rate Variability in Healthy Older and Older COPD After Vitamine D Use and Whole Body Vibration Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Copd
Aging
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Evaluation of heart rate variability in time and frequency domains, in Chronic Obstructive Pulmonary Disease (COPD) after 03 months of vitamine D supplementation and whole body vibration (WBV) training


Eligibility criteria: Inclusion Criteria:

* COPD or healthy elderly sedentary according to International Physical Activity Questionnaire
* BMI between 22.9 and 28 kg/m2
* COPD with clinical-functional diagnosis of the disease according to Gold
* ex-smokers

Exclusion Criteria:

* Older patients with COPD who had episodes of exacerbation in the last three months
* Who participate in pulmonary rehabilitation programs in the last year
* Who used home oxygen therapy
* Patients with COPD-associated comorbidities
* Who were taking vitamin D

Primary outcomes:
measure: heart rate variability
timeFrame: before and immediately after the chronic intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT06548425: Smartphone Based Tele-rehabilitation on Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.
Official title: Effectiveness of Smartphone Based Tele-rehabilitation on Cardiovascular Functional Capacity and Sleep Quality Among Coronary Heart Disease Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To determine the effectiveness of smartphone based tele-rehabilitation on functional capacity and sleep quality among coronary heart disease patients.


Eligibility criteria: Inclusion Criteria:

* Both Male \& Female
* Age 20-69 years
* Participants should have a documented diagnosis of CAD, confirmed by a medical professional.
* Individuals with a history of myocardial infarction (heart attack), angina, or evidence of significant coronary artery stenosis.
* Stable CAD who are not experiencing acute coronary events, such as recent heart attacks or unstable angina.

Exclusion Criteria:

* Acute illness
* Uncontrolled hypertension
* Uncontrolled metabolic disease
* Bone fracture in the last 6 months
* Neurological diseases that limit the ability to ambulate or stand from a chair
* MSK disease
* Severe cardiovascular complications such as heart failure with reduced ejection fraction, severe arrhythmias.
* Patients with unstable conditions or cardiac episodes.
* Ejection fraction \< 40%

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 week
measure: Duke Activity Status Index
timeFrame: 8 week
measure: 6 Minute walk test
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Yusra Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04364425: Steroid Injection for Adhesive Capsulitis
Official title: Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose steroid for treating adhesive capsulitis.

Detailed description: Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with low dose steroid ) and group 2 (hydrodilatation with high dose steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, Shoulder Pain And Disability Index

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of adhesive capsulitis
2. a duration of complaints more than 3 months
3. a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.

Exclusion Criteria:

1. prior manipulation of the affected shoulder under anesthesia;
2. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
3. neurologic deficits affecting shoulder function in normal daily activities;
4. shoulder pain caused by cervical radiculopathy
5. a history of drug allergy to hyaluronic acid;
6. pregnancy or lactation;
7. received injection into the affected shoulder during the preceding 3 months

Primary outcomes:
measure: change in pain intensity
timeFrame: 0, 6, 12 wks.
Secondary outcomes:
measure: change in Shoulder Pain And disability index
timeFrame: 0, 6, 12 wks.
measure: change in glenohumeral joint range of motion
timeFrame: 0, 6, 12 wks.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei veteran general hospital
Study officials:
References: