cyrilzakka/clinical-trials huggingface dataset:
Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography

This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.

The primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2D mammograms leads to a relevant increase in the detection rate of screening-detected invasive cancers compared to 2D full-field digital mammography in routine screening according to the European Guidelines. Furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis.

According to the pre-defined order of both primary endpoints and the primary objective of the study in the planning phase, the initial sample size calculation was based solely on the first primary endpoint (invasive breast cancer detection rate). Given the increasing national and international attention of interval cancers to assess the impact of potential overdiagnosis caused by tomosynthesis, we have planned a sample size increase from 80,000 to 120,000 study participants to achieve a reasonable statistical power for the evaluation of both primary endpoints. The revised sample size calculation was carried out without knowledge of the data from the currently recruiting TOSYMA study, i.e. all planning assumptions were based on external data that do not belong to the ongoing study.

Eligibility Criteria:
Inclusion Criteria:

* Women eligible to participate in the National Mammography Screening Program of Germany
* Informed decision for mammography screening
* Written informed consent
* No prior participation in the TOSYMA trial

Exclusion Criteria:

* Breast cancer up to 5 years prior to study invitation
* Previous mammography examination \< 12 months,
* Breast implants
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

* squamous cell carcinoma of the head and neck
* treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
* Treatment plan to receive standard cisplatin monotherapy
* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Adequate hematologic, renal and liver function
* Negative serum pregnancy test
* Use of effective contraception

Exclusion Criteria:

* Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
* Metastatic disease
* Prior radiotherapy to the region of the study cancer or adjacent anatomical
* Prior induction chemotherapy
* Receiving any approved or investigational anti-cancer agent other than those provided for in this study
* Concurrent participation in another interventional clinical study
* Inability to eat soft solid food at baseline
* Malignant tumors other than HNC within the last 5 years
* Active infectious disease excluding oral candidiasis
* Presence of oral mucositis at baseline
* Known history of HIV or active hepatitis B/C
* Female patients who are pregnant or breastfeeding
* Known allergies or intolerance to cisplatin and similar platinum-containing compounds
* Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
Effectiveness of Narrative Exposure Therapy Among Refugee Children and Adolescents

This study aims to understand how war trauma affects children's and adolescents' memory functions and mental health, and whether Narrative Exposure Therapy is effective in enhancing optimal memory functions and alleviating mental health problems. The study analyzes the mental health and cognitive and emotional healing mechanisms of therapeutic intervention among war-affected children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* 9-17 years old
* has spent some part of her/his life living in a country where organized violence was taking place, or at a refugee camp
* suffers from significant stress symptoms thought be trauma-related

Exclusion Criteria:

* acute psychosis
* intellectual disability
Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior Crowding

The aim of this study is to evaluate effects of clear aligners versus fixed appliances on occlusion after treatment of mild anterior crowding a T-scan study.

Intervention:

Group 1. Patients treated with clear aligner. Patients with mild anterior crowding will be treated with non-extraction treatment using clear aligners.

Group 2. Patients treated with fixed appliance. Patients with mild anterior crowding will be treated with non-extraction treatment using fixed appliances.

Observations:

Multi-bite closure of left and right excursive T-Scan® recordings were obtained before and after treatment from each subject to measure the occlusal parameters to be analyzed during this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the age (14-19 y).
* Fully erupted permanent dentition, 3rd molars excluded.
* Healthy, compliant, and motivated patients who can visit the department regularly.
* Non-extraction treatment.
* Class I with mild anterior crowding lower and/ or upper.
* Good oral and general health.

Exclusion Criteria:

* Previous orthodontic treatment.
* Craniofacial abnormalities, congenital syndromes of the craniofacial area.
* Anterior or posterior crossbite.
* Anterior or lateral open bite.
* Poor oral hygiene or periodontally compromised patient.
Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment

Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Implant positioning and component alignment are determining factors in patient outcome. Currently, different alignment strategies in TKA surgery are used such as Mechanical Alignment (MA) and Kinematical Alignment (KA). Recently, a new and individualized alignment strategy (inverse Kinematic Alignment/iKA) was introduced. Preliminary 1-year results of iKA are promising, however, clinical and functional outcome on the medium and longterm should be investigated. This project aims to compare patients with iKA TKA with MA TKA on clinical, functional and biomechanical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained prior to any screening procedures
2. Received a primary total knee replacement (incl. patella) robotically-assisted
3. Male or female
4. Age between 50 and 80
5. Able to walk independently

Exclusion Criteria:

1. Revision surgery
2. Patient with a history of neurological, psychiatric or neurodegenerative disease
3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
4. Other musculoskeletal lesions that may affect the gait pattern
Deep-learning Based Classification of Spine CT

It is time-consuming for spine surgeons or radiologists to conduct manual classifications of spinal CT, which may also be correlated with high inter-observer variance. With the development of computer science, deep learning has emerged as a promising technique to classify images from individual level to pixel level. The main of the study is to automatically identify and classify the lesions, or segment targeted structures on spinal CT with deep learning.

Computer tomography (CT) is one of the most important imaging tool to assist the diagnostic and treatment of spinal disease. Classification of specific targets (e.g. individuals, lesions, etc.) is one of the most common mission of medical image analysis. However, it is time-consuming for spine surgeons or radiologists to conduct manual classifications of spinal CT, which may also be correlated with high inter-observer variance. With the development of computer science, deep learning has emerged as a promising technique to classify images from individual level to pixel level. The main of the study is to automatically identify and classify the lesions, or segment targeted structures on spinal CT with deep learning.

Eligibility Criteria:
Inclusion Criteria:

- spinal thin layer CT

Exclusion Critera:

* medals or other implants induce artifact
* poor image quality
Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular septal position of the right ventricular lead in patients implanted with a pacemaker for conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing ; the primary endpoint is the evolution of the left ventricular ejection fraction assessed by contrast echocardiography at 18-months follow-up.

Classically the right ventricular pacing (RV) lead position is the RV apex. Several small studies suggested that the septal position which provided a more physiological conduction pattern would improve left ventricular function and dimensions and the patients' outcome.

The SEPTAL-PM study is a parallel randomized prospective simple-blinded and multicenter national study with a follow-up duration of 18 month. A total of 180 patients will be enrolled.

It was designed to demonstrate that in patients requiring permanent RV pacing for high degree atrio-ventricular conduction disorders the septal pacing would preserve the LVEF and LV dimensions but also the quality of life and the exercise tolerance.

The primary endpoint is the evolution of the LVEF assessed by contrast echocardiography. The secondary endpoints are: the quality of life SF 36 questionnaire, the NYHA class, the 6-minute-walk test, the QRS duration, the LV end-systolic and diastolic volumes, the NT-pro BNP, MMP 2-9 and TIMP-1 dosages, stimulation and detection ventricular thresholds.

Other reported parameters are: the probes position and electric parameters, all causes of mortality, cardiovascular mortality, hospitalisations for cardiovascular causes, serious adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old.
* Written informed consent.
* Permanent cardiac pacing indication for high degree AV block with ventricular rate less than 50 bpm according to the current guidelines of the European Society of Cardiology .
* Patients with sinus rhythm or permanent atrial fibrillation.

Non-inclusion Criteria:

* Indication for cardiac resynchronization.
* Indication for Intra cardiac defibrillators (ICD).
* Indication for AV node ablation for patients with atrial fibrillation.
* Patients already implanted with a pacemaker or an ICD.
* Myocardial infarction within the previous month.
* Surgically treated valvulopathy.
* Tricuspid Valve prothesis
* Cardiac surgery or coronary revascularization planned or within the 3 last months.
* Life expectancy less than 18 months.
* Pregnancy.
* Disability to give informed consent.
The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation

The QTc interval is affected by heart rate, medications and changes in the autonomic nervous system. The endotracheal laryngoscopy, the necessary step during general anesthesia, prolongs QTc interval. Changes in the flow of ion currents could result from the genetic variation of myocardial ion channels by gene polymorphism. This study is to investigate the association of cardiac ion channel related gene polymorphism and prolonged QTc interval after endotracheal intubation in adult patients.


Eligibility Criteria:
Inclusion Criteria:

1. 20-65 years old
2. scheduled for general anesthesia requiring direct laryngoscopy

Exclusion Criteria:

1. Patients taking antihypertensive medication (beta-blocker, CCB)
2. patients taking other medications known to affect QTc interval
3. Patients with abnormal ECG and prolonged QTc (\>500 msec)
4. Diabetes, liver disease, kidney disease, heart failure, congenital heart disease
5. Severe electrolyte imbalance
6. illiterate, foreigners who cannot understand the consent form
Confocal Laser Endomicroscopy Guided Cryobiopsy in the Diagnosis of Interstitial Lung Disease

A prospective multicenter randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of NCLE-NB-Rebus-guided peripheral pulmonary nodule biopsy, and to compare the diagnostic efficacy and safety of biopsy forceps biopsy and needle aspiration biopsy in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS.

A prospective, multicenter, randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of nCLE-NB-rEBUS guided peripheral pulmonary nodule biopsy. Patients with peripheral pulmonary nodules suspected of lung cancer and pulmonary tuberculosis were enrolled to sign informed consent. Subjects were randomized to the nCLE-NB-rEBUS Group (Group A) or the NB-rEBUS Group (Group B) subgroup (1:1 ratio) according to the random number table, and subjects randomly assigned to Group A or Group B were again randomized to the biopsy forceps subgroup or biopsy needle subgroup by the random number table. The diagnostic efficacy and safety of the NCLE-NB-REbus group and the NB-rEBUS group were compared to evaluate whether nCLE could improve the diagnostic rate of NB-REbus-guided peripheral pulmonary nodule biopsy. The diagnostic efficacy and safety of using biopsy forceps and biopsy needle in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS were compared to determine the reasonable biopsy method.

Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral pulmonary nodules suspected of lung cancer by CT examination
* Patients who intend to undergo a bronchoscopic lung biopsy to determine benign or malignant pulmonary nodules;
* Age ≥18 years
* Sign informed consent.

Exclusion Criteria:

* There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
* Tumors can be seen in the bronchus
* Hemodynamic instability;
* Refractory hypoxemia;
* Patients with pregnant and lactating patients
* Any illness or condition that interferes with the completion of the initial or subsequent assessment.
The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current treatments have focused on opening up the narrowed airways but, in addition, we know there is increased inflammation in the blood and these patients are at increased risk of heart disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the blood but may also reduce inflammation and lower the risk of heart disease. This study will explore whether simvastatin reduces one of the risk factors in patients with COPD in a short term proof of principle study. The key purpose is to determine whether simvastatin improves the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or blood inflammation and change in breathing ability


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 45-80 years;
* Confirmed COPD: FEV1 30-80% predicted, FEV1/FVC\<0.7, salbutamol reversibility \<12%, supportive smoking history
* If female of childbearing potential, have a negative serum pregnancy test at screening and use a medically acceptable form of contraception starting at screening and continuing throughout the study (defined as an oral contraceptive, or barrier method combined with a spermicide)
* Able to attend for regular clinic appointments
* In opinion of investigator, the patient will be able to comply with the requirements of the protocol
* Provide written informed consent.

Exclusion Criteria:

* Known hypersensitivity to or side effects relating to previous statin treatment, or current therapy which includes a statin, ezetimibe or fibrate
* Clinically significant liver function abnormality; alcohol excess
* Hypercholesterolaemia \> or equal to 6.5mmol/L
* Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
* Any condition judged by investigator that would cause the study to be detrimental to patient.
* Conditions: rheumatoid disease/other collagen vascular disease requiring therapy; diabetes mellitus; untreated hypothyroidism; inflammatory bowel disease; other respiratory disease; known alpha 1 antitrypsin deficiency; malignancy; documented history of ischaemic heart disease (IHD); cor pulmonale or known congestive heart failure; patients planning to undergo elective surgery during the study period.
* Exacerbation in the last 4 weeks.
* Significant hypoxia (PaO2 \<7.3kPa)
* Known lactose intolerance.
* Therapies: oral prednisolone for more than 1 week in the last 6 months; disease modifying drugs (Gold/ sulphasalazine etc); weight losing drugs; concomitant use of warfarin, cyclosporine; concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone). Use of any investigational drug within four weeks of the baseline visit.
Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies

This study is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder removal. The objective of this study is to compare Epidural versus General Anesthesia for postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy patients.

This is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adult patients that require an elective cholecystectomy.

Patients will be randomized 1:1 to receive either general anesthesia (Group A) or epidural anesthesia (Group B) for their laparoendoscopic single site incision (LESS) gallbladder removal surgery (cholecystectomy). Randomization will be achieved using a computer-generated list. The patient will know what are they are randomized to before entering the operating room because an epidural will need to be placed preoperatively. Standards for basic anesthetic monitoring approved by the American Society of Anesthesiologists will occur intraoperatively.

Postoperative evaluations will be completed by a medical professional that is blinded to the type of anesthesia used during the LESS surgery. Postoperative evaluations include a physical exam, adverse events, medication administration, vital signs and post-anesthesia recovery score for ambulatory patients (PARSAP) scores will be taken every 15 minutes until the patient has a score of at least 18.

Patients will be followed 90 days postoperatively to collect pain scores, analgesic use, adverse events, and quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years of age
* ASA I or II
* Patient has a diagnosis of biliary colic with documented cholecystitis, symptomatic gallstones, polyps by imaging or biliary dyskinesia with documented EF \< 30%
* No cardiopulmonary disease
* Normal coagulation profile

Exclusion Criteria:

* Any female patient, who is pregnant, suspected pregnant, or nursing
* Contraindication for pneumoperitoneum
* Contraindication for epidural anesthesia
* Allergy to local anesthetic agents
* Any patient with acute calculus or acalculous cholecystitis
* Any patient who has had an upper midline or right sub costal incision
* Any patient with preoperative indication for a cholangiogram
* Any patient with ASA ≥ 3
* Any patient who is undergoing Peritoneal Dialysis (PD)
* History of long term analgesic use requiring pain management (\>1 week)
* Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair
* Any patient with obstructive sleep apnea (OSA), history of OSA or at high risk of OSA as determined by the STOP Questionnaire
* BMI \> 35 kg/m2
* Any patient with a history of severe, uncontrolled GERD
Chemotherapy Supported by Autologous Hematopoietic Stem Cells

The aim of this project is to use autologous haematopoietic stem cell transfusion support to promote the reconstruction of haematopoietic function after chemotherapy for ovarian cancer. To explore the impact of stored haematopoietic stem cell support therapy on bone marrow protection after conventional chemotherapy for ovarian cancer in order to facilitate its clinical application.

Study design:In this prospective, single-center,non-randomised controlled study, patients with ovarian cancer were divided into two groups. The patients in the experimental group received autologous blood transfusion containing hematopoietic stem cells 1 day after conventional chemotherapy, while the control group only received conventional chemotherapy.

Case selection: Patients with primary ovarian cancer,ovarian cancer confirmed by histopathology, and three weeks of platinum-containing regimen chemotherapy.

Primary end point: 1)incidence and duration of grade 3/4 neutropenia in patients;2)hematopoietic reconstitution time in patients. Secondary endpoints: 1)the rate of reduction in chemotherapy dose and postponement of the course for chemotherapy;2) Incidence of febrile neutropenia (FN);3)Safety of hematopoietic stem cell reinfusion therapy (adverse events).

Safety assessment: laboratory safety testing, including platelet count,white blood cell and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, hypocalcemia,anemia and thrombocytopenia,bone pain, etc.

Eligibility Criteria:
Inclusion Criteria:

1）18-60 years old; 2)there are chemotherapy indicators for ovarian cancer;3)ovarian cancer diagnosed by histopathology;4)recurrent and metastatic ovarian cancer;5)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;6)the expected survival time was more than 3 months; 7)pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;8)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;9)the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations;10)bone marrow function is good,ability to perform stem cell mobilisation and collection.

Exclusion Criteria:

1) patients with bone marrow disease;2)central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with chemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection.