cyrilzakka/clinical-trials huggingface dataset:
CT-guided Lung Biopsy Risk Optimization Method

The purpose of this randomized controlled study is to evaluate the extent to which injection of a small amount of fluid in the pleural cavity at the biopsy site may reduce the risk of pneumothoraces, in addition to patient positioning to allow biopsy in gravity-dependent areas of the lung.

Study participants with written consent and the percutaneous, CT-guided lung biopsy already regularly indicated by the referring doctors (e.g., oncology) will be part of this study and will be randomized directly before the intervention. After randomization, the intervention is performed by Interventional Radiology, either with or without prior fluid administration into the pleural space. Three samples are taken using either an 18G or 20G coaxial needle, and any complications are treated according to the clinical standard. The lung biopsy will be only performed if clinically indicated and is not a study-specific intervention; data about the lung biopsy, like internal DICOM images of them retrieved from Inselspital's Picture Archiving and Communication System (PACS), laboratory results, and clinical information are retrieved from RIS (radiological information system) and iPDOS® and KISS by Epic® (electronic medical record) and the associated histopathological findings from the Institute of Pathology, University of Bern, will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent (knowledge of project languages), \>18 years.
* Indeterminate or suspicious lung lesion unsuitable for transbronchial biopsy or Status after unsuccessful transbronchial biopsy
* Indication for biopsy given by referring specialist (in patients).

Exclusion Criteria:

* Preintervention bleeding into the pleural cavity
* More than 1 lesion should be biopsied at the same time
* Infiltration of the thoracic wall
* Pregnancy
Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners

This study is to compare the diagnostic accuracy of digital models obtained via 10 digitization techniques to the reference standard of orthodontic plaster model through dental measurements


Eligibility Criteria:
Inclusion Criteria:

* adult patients seeking orthodontic treatment permanent dentition

Exclusion Criteria:

* deciduous or mixed dentition cleft lip and palate patients
The Clinical Cohort Study of Reproductive Health

The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART.

Safeguarding the health of women and children is an important part of The Healthy China 2030 Plan. Precisely controlling the fertility process will help to improve the quality of national population. Lots of studies have reported that environmental exposure, lifestyle, diet and other factors are related to fertility, female pregnancy and postpartum health, and offspring development. Some studies have found that assisted reproductive technology (ART) represents an increased risk of epigenetic-related diseases or birth defects.

The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART.

Eligibility Criteria:
Inclusion Criteria:

1. Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in study hospitals.
2. Men 22-55 years old
3. Women 20 - 45 years old

Exclusion Criteria:

1. Any individual or couple who is outside of age range .
2. Any couple who don't plan to complete their pregnancy check-up or deliver their babies in study hospitals.
3. Any couples had participated in other clinical studies.
Assessment of Er:YAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide

Introduction: Tooth whitening is an aesthetic procedure with rapid results that improves the self-esteem and self-image of patients. However, one of the side effects is dentinal hypersensitivity. The aim of the study is to assess the effectiveness of Er:YAG laser administered prior to bleaching with 35% hydrogen peroxide hypersensitivity.

Methods: The maxillary arch of participants 18 to 45 years of age will be treated using the split-mouth method. Grupo experimental: Hypersensitivity prevention protocol with Er:YAG laser followed by bleaching with 35% hydrogen peroxide; control group: hypersensitivity prevention protocol with neutral sodium fluoride for four minutes followed by bleaching with 35% hydrogen peroxide. Er:YAG laser (2940 nm) will be used with the following parameters: 0.15 W, 10 mJ, 15 Hz and SP mode (pulse duration: 300 µs), TIP: Cylindrical Quartz 1000/4, using the H14 handpiece (H14 for LightWalker AT; Fotona dd, Ljubljana, Slovenia). Each tooth (central incisor, lateral incisor and canine) will be irradiated twice for 10 s in an unfocused scanning motion in the cervical region at a working distance of 1 cm. The absolute risk and intensity of dentinal hypersensitivity during treatment will be assessed using the visual analogue scale. The change in color will be determined using an intraoral spectrophotometer in contact with the tooth. Assessments will be conducted before and after preventive treatment, immediately after treatment as well as 48 hours and one week after treatment. Different statistical tests will be used, with the significance level set at 5% (p ≤ 0.05).


Eligibility Criteria:
Inclusion Criteria:

* All anterior teeth present without caries or restorations;
* Absence of cervical lesions, dental pain and hypersensitivity prior to treatment;
* Not having previously undergone any tooth whitening procedure.

Exclusion Criteria:

* Smokers;
* Pregnant or nursing women;
* Individuals with gingivitis or periodontitis, those with enamel cracks detected by the transillumination test;
* Those with enamel defects or stains caused by tetracycline;
* Those with systemic diseases;
* Those taking nonsteroidal anti-inflammatory.
Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

Lead survivability will be summarized.

The purpose of this study is to evaluate long-term performance of the 4296 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4296 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

Eligibility Criteria:
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive an Attain Ability Model 4296 LV lead
* Patient within 30 day post implant enrollment window

Exclusion Criteria

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
AmbulaNCE Teletransmited PHOtography for Trauma REgulation

Physicians in charge of medical regulation within French SAMU have to take difficult decisions regarding patient's orientation (in or out-of hospital care) but suffer from lack of information. Such information usually consist in a simple phone conversation without any visual information. Visual assesment of the situation would be of great help, especially for traumatized patients.

Private Ambulance societies all over territory in charge of SAMU 86 now work with teletransmission devices allowing photography transmission.

The objective of the study is to determine if routine use of teletransmitted photography help SAMU 86's physians for a better orientation of non-severe traumatized patients, especially by avoiding unnecessary transportations to Emergency Departments.


Eligibility Criteria:
Inclusion Criteria:

* Emergency call at SAMU for trauma issue
* Pre-hospital management by private ambulance equipped with teletransmission device

Exclusion Criteria:

* Severe trauma with need of a pre-hospital emergency medical team
* Traffic accident
* Head trauma associated with anticoagulant therapy or platelet antiagregant therapy
* Pre-hospital management by firefighters
Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy

RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus G-CSF is more effective than antibiotic therapy alone for treating side effects caused by chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with or without G-CSF in treating children who have neutropenia and fever that are caused by chemotherapy.

OBJECTIVES:

* Determine whether filgrastim (G-CSF) used in addition to standard antibiotic therapy accelerates time to resolution of febrile neutropenia in children receiving chemotherapy.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive standard antibiotic therapy.
* Arm II: Patients receive treatment as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously or IV once a day until at least 2 consecutive afebrile days have passed and absolute neutrophil count is at least 500/mm3.

Patients are followed for 3 days.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically diagnosed cancer with fever and chemotherapy-induced neutropenia (absolute neutrophil count no greater than 500/mm3)

  * Acute onset of fever of at least 38.8 degrees Celsius that is not related to the administration of blood products or pyrogenic substances
* No acute myelogenous leukemia
* No myelodysplastic syndrome
* No solid tumor with bone marrow involvement

PATIENT CHARACTERISTICS:

Age:

* 21 and under

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Creatinine less than 1.5 times upper limit of normal

Renal:

* Not specified

Other:

* No patients in septic shock
* No prolonged fever of unknown origin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* See Chemotherapy

Chemotherapy:

* No prior or concurrent myeloablative chemoradiotherapy with bone marrow or peripheral stem cell rescue

Endocrine therapy:

* Not specified

Radiotherapy:

* See Chemotherapy
* No prior radiotherapy to marrow reserves (i.e., craniospinal and/or pelvic irradiation)

Surgery:

* Not specified

Other:

* At least 7 days since prior IV antibiotics
Assessment of Safety and Efficacy of Gabapentin After Surface Ablation, a Case Control Experimental Study

The current study aims at assessing the efficacy and safety of oral Gabapentin alone versus Diclofenac Potassium drugs for postoperative analgesia in patients undergoing surface ablation.

To estimate the analgesic effect and pain severity after surface ablation with oral Gabapentin intake in comparison with Diclofenac Potassium, where Gabapentin could be a better analgesic medication after surface ablation

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* preoperative stable refraction for at least one-year,
* normal corneal tomography with expected postoperative flat K reading not less than 38D, and postoperative residual stromal bed not less than 350 μm.

Exclusion Criteria:

* Patients with preoperative corrected distance visual acuity (CDVA) of worse than 20/30
* amblyopic patients,
* patients with a history of previous ocular surgeries,
* herpetic eye infection, or corneal dystrophies.
* Patients with other ocular conditions e.g. uveal or retinal diseases, and glaucoma
* Diabetics,
* Hypertensives,
* Kidney problems,
* breathing problems
* Adults older than 65 years.
* Previous allergy or adverse reaction to the used drugs.
* History of drug abuse or alcohol abuse problems
* History of mood problems, depression suicidal thoughts or behavior
Remission and Joint Damage Progression in Early Rheumatoid Arthritis

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) \<=2 years; MTX naive or \<=10 mg/wk for \<=3 weeks. No dose within 3 months prior to informed consent.
* C-Reactive Protein (CRP) \>= 4.5 mg/L (after amendment)
* Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
* Tender joints \>=12 and swollen joints \>=10

Exclusion Criteria:

* Women and men who are not willing to use birth control
* Diagnosed with other rheumatic disease
* History of cancer within 5 years
* Active tuberculosis
* Treatment with another investigation drug within 28 days
* Active bacterial or viral infection
Effect of mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure

This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of exercise capacity in heart failure patients before and after device implantation.


Eligibility Criteria:
Advanced Heart Failure-

Inclusion Criteria:

* Individuals with severely reduced left ventricular systolic function that are scheduled to undergo LVAD insertion

Exclusion Criteria:

* uncontrolled diabetes with peripheral neuropathy (interferes with acquisition of MSNA signal)
* Individuals with clinical right ventricular failure, defined as moderate-severely reduced RV systolic function on echocardiography, or clinical evidence of RV failure (elevated jugular venous pressures, significant peripheral edema)
* Individuals with moderate-severe preexisting aortic insufficiency, as these patients will typically undergo a Park stitch at time of CF-LVAD insertion to permanently close the aortic valve and prevent worsening aortic insufficiency; and
* Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)

Mild Heart Failure -

Inclusion Criteria:

* Individuals with medically managed left ventricular systolic function that are NOT scheduled to undergo LVAD insertion
* HF patients with ejection fraction \<35-40%

Exclusion Criteria:

* Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
* Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
* History of uncontrolled arrhythmias (e.g. ventricular tachycardia or nonsustained ventricular tachycardia).

Healthy Controls -

Inclusion Criteria:

- Persons without a past medical history of cardiovascular disease or related disease (e.g. hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic attack) and are not taking any cardiac-related medications (e.g. antihypertensive medications)

Exclusion Criteria:

* Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
* Disorders that adversely influence exercise ability (e.g. arthritis, peripheral ascular disease).
Impact of C-arm CT in Decreased Renal Function Undergoing TACE for Tx of Hepato-Cellular Carcinoma

Impact on contrast dose or total volume of contrast required to effectively treat the targeted tumor.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be affected by HCC
2. Patients must have diminished renal function (GFR\<60 ml/min/1.73m\^2)
3. Patients must be 18 years old or older
4. Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Subjects under the age of 18
2. Patients currently on dialysis
3. Pregnant women
Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery

Cardiopulmonary bypass-assisted surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. This may either be mild or lead to a more severe clinical condition. Inflammation after pediatric open heart surgery is a parameter affecting also duration of mechanical ventilatory support. Dexmedetomidine use was associated with a reduced increase in plasma IL-1, IL-6, TNF-a, and INF-g levels

Dexmedetomidine will be used during Cardiopulmonary bypass-assisted surgery for pediatric cardiac surgery

Eligibility Criteria:
Inclusion Elective repair of congenital heart disease with cardiopulmonary bypass Exclusion Reintervention surgery requirement for blood products from the start of CPB, preoperative intake of corticosteroids, deep hypothermia, those with preoperative low cardiac output, those with non-palpable peripheral pulses before surgery (e.g., accompanying coarctation of the aorta) or ischemic time during cardiopulmonary bypass more than 90 minutes
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Body Mass Index (BMI) between 18 and 27 kg/m\^2, both inclusive
* Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
* Smoke less than 10 cigarettes (or equivalent) per day
* Capable of giving written Informed Consent (IC)

Exclusion Criteria:

* Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
* Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
* Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
* Overt bleeding, including from gastrointestinal tract
* Hepatitis (B or C) infection
* HIV (human immunodeficiency virus) infection
Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also assess tissue anchor durability.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is \> 18 years of age and \< 65 years of age
2. Patient is \> 2 yrs post-Roux-en-Y bypass surgery
3. Patient initially achieved \> 50% EWL after Roux-en-Y bypass surgery
4. Patient is a reasonable risk to undergo general anesthesia
5. Patient is able to provide written informed consent

Exclusion Criteria:

1. Patient has an esophageal stricture or other anatomy/condition that would preclude the use and passage of the endolumenal instruments
2. Physician determines another causal factor for weight regain other than stoma or pouch dilation
3. Patient is non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise
Prevention of Parastomal Hernia With a Mesh

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.

A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.

Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.

Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.

Eligibility Criteria:
Inclusion Criteria:

* Clinical need of an enterostoma

Exclusion Criteria:

* Patients denies inclusion in the trial.