cyrilzakka/clinical-trials huggingface dataset:
Driving Pressure During General Anesthesia for Open Abdominal Surgery

The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high PEEP strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for open abdominal surgery
* High or intermediate risk for postoperative pulmonary complications according to ARISCAT score \[J.Canet et al, Anesthesiology 2010;113\]
* General anesthesia

Exclusion Criteria:

* Laparoscopic surgery
* Surgery in prone or lateral position
* Combined procedure with open abdominal and intrathoracic surgery
* Body mass index \> 40 kg/m2;
* Reported pregnancy;
* Mechanical ventilation \> than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days;
* Any major previous lung surgery;
* History of previous severe chronic obstructive pulmonary disease (COPD) GOLD III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home;
* (previous) acute respiratory distress syndrome (ARDS);
* Expected to require postoperative mechanical ventilation;
* Persistent hemodynamic instability or intractable shock;
* Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's);
* Consented for another interventional study during anesthesia or refusal to participate in the study
Cost-Effectiveness Study of PEG-rhG-CSF in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma

This is a pharmacoeconomic research to explore the cost-effectiveness of PEG-rhG-CSF and rhG-CSF in prophylactic treatment of neutropenia in lymphoma patients. It should provide more scientific basis for clinical decision-making.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* histologically confirmed de novo Non Hodgkin's lymphoma (except highly aggressive lymphoma such as lymphoblastic lymphoma and Burkitt lymphoma)
* plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) ± Rituximab (R)
* KPS ≥70
* plan continuous PEG-rhG-CSF or rhG-CSF adiministration after at least 3 cycles of treatment for neutropenia prophylactic treatment
* absolute neutrophil count≥1.5×109/L，platelet count ≥100× 109/L，hemoglobin≥90g/L，while blood cell count≥3.0×109/L，without bleeding signs
* adquate liver and renal function as protocol discribed
* no serious cardiovascular disease as protocol discribed
* under good mental conditions and informed consented
* potential benefit for subjects based on investigators' decision

Exclusion Criteria:

* history of hematopoetic stem cell transplantationor organ transplantation
* uncontrollable infection
* allergic to study drugs or ingredients
* accepted any other investigational drug or participated another interventional study within 30 days during screening period
* other uncontrollable conditions judged by the investigator
* breast-feeding , pregnant or plan to be pregnant during study observation period
18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma

This is a study evaluating the positron-emitting radiopharmaceutical 18F-mFBG compared to 123I-mIBG scintigraphy for imaging of neuroblastoma

This is a prospective study designed to assess the use of 18F-mFBG PET imaging compared to 123I-mIBG scintigraphy in subjects with known or presumed neuroblastoma. Eligible participants will have either histopathologically established diagnosis of neuroblastoma or a presumed diagnosis based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results.

Subjects will only be administered 18F-mFBG if they have undergone or are scheduled to undergo a 123I-mIBG within +/- 7 days of the date of the 18F-mFBG scan. Subjects should not have received any chemotherapy, immunotherapy or radiotherapy between the clinical and 18F-mFBG imaging studies.

18F-mFBG PET studies will be evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side.

The clinical 123I-mIBG is also evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side.

Blinded readers will record whether findings on 18F-mFBG and 123I-mIBG scans are consistent with neuroblastoma.

Subject-level diagnostic performance will be assessed on the basis of differencies in lesion-counting between the blinded 18F-mFBG scan interpretation and the 123I-mIBG scan. In case of discrepancy, independently assessed by an Expert Panel.

Eligibility Criteria:
Inclusion Criteria:

1. An established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrolment in the trial; OR b) A presumed diagnosis of neuroblastoma based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results, including individuals in whom therapy has already been empirically initiated.
2. The subject has undergone or is scheduled to undergo evaluation of neuroblastoma disease status, including 123I-mIBG +/- 7 days to the date of 18F-mFBG imaging, with no therapy between such evaluation.
3. Ability of subject or subject's legal guardian to understand and sign a written informed consent document.

   -

   Exclusion Criteria:

1. Pregnancy

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A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint

The purpose of this study is to establish survivorship defined by the cumulative incidence of revision over the first 6 months post-implantation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female - skeletally mature adult (aged 22 or older)
* Participant, who in the opinion of the Investigator, is able to understand the purpose of the study and is willing to return for all the required post-operative standard of care follow-up visits and have their data collected
* Participant who is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor

Any one of below:

* Primary replacement after fracture of the radial head
* Participant needing a partial radial head replacement for degenerative or post-traumatic conditions presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: i) joint destruction and/or subluxation visible on x-ray and/or ii. resistance to conservative treatment
* Symptomatic sequelae after radial head resection
* Revision following failed radial head arthroplasty

Exclusion Criteria:

* Dislocations of radius on ulna that would not allow a radio-humeral articulation
* Rheumatoid arthritis
* Infection, sepsis, and osteomyelitis
* Uncooperative participant or participant with neurologic disorders who is incapable of following directions, osteoporosis, metabolic disorders which may impair bone formation, osteomalacia, distant foci of infections which may spread to the implant site, rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Participants with limited life expectancy due to significant medical co-morbidity
* Presence of major vascular or major nerve injury (radial, ulnar, medial, musculocutaneous)
* Women who are pregnant or lactating
* Unable to comply with study requirements example, with maintaining follow-up
* Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims
* Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months
* Demented or unable to provide informed consent
* Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete participant reported questionnaires or be compliant with follow-up requirements
Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.

All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

* Patients with diabetes, HIV, cancer or other immunocompromised patients.
* Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
* Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
* Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
* Finally, patients with sulfa allergy will be excluded.
Hospital-Induced Immobility

Inactivity and bedrest during hospitalisation have numerous negative consequences, and it is especially important that older patients are mobile during hospitalisation. In this study the investigators aimed to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative could increase mobilisation of patients in a geriatric and a medical ward. Furthermore, the investigators wanted to explore patients' and health care staffs' view on facilitators and barriers for mobilisation during hospitalisation

Staying in bed and being inactive during hospitalisation can lead to a range of adverse consequences especially among older adults. The consequences include loss of muscle mass and strength leading to problems with loss of functional independence, risk of re-hospitalisation, and death. Moreover, older adults do not recover as well as younger adults with poor long-term recovery. The lack of in-hospital mobilisation is due to several factors including the hospital culture and organisational factors. Therefore, it is necessary to bring attention to this problem among the hospital staff. The aim of this study is to identify whether the introduction of formal education of clinical staff and a Mobilisation Initiative can increase the number of patients mobilised for breakfast and lunch among patients admitted to geriatric and medical wards. The activities planned in this study is self-reported level of mealtime mobilisation and observations of the patients, focus group interviews and survey on mobilisation awareness among the clinical staff, introduction of formal education and a Mobilisation Initiative. As hypothesized, this will result in an increased awareness of in-hospital mobilisation leading to an increase in the number of patients mobilised at mealtimes. Accordingly, expectations are that this will affect the activity level of the hospitalised patients and reduce adverse consequences leading to an increase in functional independence and reduce the number of readmissions resulting in a socioeconomic benefit.

Eligibility Criteria:
Inclusion Criteria:

* In-hospital patients in the geriatric and medical ward at Copenhagen University Hospital, Rigshospitalet

Exclusion Criteria:

* Patients declared moribund or delirious in the electronical medical journal
* Patients isolated in the hospital room
* Patients requiring interpreter for communication
A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food

The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.


Eligibility Criteria:
Inclusion Criteria :

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
* Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Female subject who meets the criteria defined in the protocol for a highly effective contraception from at least 30 days before the first administration of trial medication until 7 days after last administration

Exclusion Criteria :

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 betas per minute (bpm) at screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) at screening
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behavior
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Incidence of Different Surgical Technics for Colorectal Deep Infiltrating EndoMetriosis on the Post-operative Fertility and Pregnancy Outcomes

Endometriosis is a disease that is very present on the current media scene. Its symptoms are very nonspecific and numerous. (dysmenorrhea, dyspareunia, dyschezia, urinary functional signs, infertility, chronic pelvic pain, etc.) Its prevalence is estimated at 10% of women and 20% of them have deep pelvic endometriosis. Colorectal lesions involving the rectosigmoid junction and the rectum represent the most severe forms and affect 5.3 to 12% of patients with deep pelvic endometriosis. Endometriosis is found in 20 to 50% of patients consulting for infertility and the rate of spontaneous pregnancy in patients with deep endometriosis is estimated to be between 8.7 and 13%. Surgery appears to improve fertility in women. However, several surgical techniques for deep endometriosis at the digestive level have been described, conservative or radical, without any having demonstrated its superiority both in terms of symptoms and fertility.

The aim of this study was to evaluate the incidence of different surgical technics (shaving vs. bowel resection) on post-operative fertility among patients with bowel deep infiltrating endometriosis and the pregnancy outcome


Eligibility Criteria:
Inclusion Criteria:

* Adult woman (≥18 years old).
* woman with a desire to become pregnant and who had undergone surgery for the management of deep digestive endometriosis between September 01, 2009 and October 31, 2016.
* Woman who has not expressed, after information, the reuse of her data for the purposes of this research.

Exclusion Criteria:

* Woman who expressed her opposition to participating in the study
* Woman who had undergone a surgical intervention for the management of deep digestive endometriosis between September 01, 2009 and October 31, 2016 and having no desire to become pregnant
* Woman under safeguard of justice
* Woman under guardianship or guardianship
Visual and Optics Impact of Refractive Surgery

Refractive surgery includes interventions to correct refractive errors, using a medical device such as a laser or an implant (intraocular lenses) or surgical instruments. The study distinguishes corneal interventions, carried on the surface of the eye, and intraocular interventions, performed on the lens or in the anterior or posterior chamber of the eye. The number of procedures in refractive surgery is growing significantly. They seem to offer satisfactory visual results but a number of issues remains unresolved. In order to get emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower orders (ie spherical refractive error and astigmatism). This increases high-order aberrations (the most common is a bright halo on the edge of the image). The cutting of the flap to the surface of the cornea in the case of LASIK increases high-order aberrations, which have the effect of reducing post-surgical visual performance (ie visual acuity and contrast sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a post-operative cornea is more complex. It is therefore necessary to limit these post-surgical aberrations and to identify their possible sources. Indeed, some authors have provided insight into the effects of some high-order aberrations, but the influence of several factors characterizing the preoperative eye on refractive surgery are still unknown, such as pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* patient candidate for Laser in Situ Keratomileusis (LASIK) refractive surgery
* 18 to 40 years old
* corrective glasses or lenses ranging from -9.00 to + 6.00 diopter
* astigmatism less than or equal to 5 diopter

Exclusion Criteria:

* patient opposition to participate in the study
* patient under legal protection
* Pregnant or breast feeding patient
* no health insurance coverage
A Prospective Study of Autologous Fat Grafting for Breast Augmentation

This research study is to evaluate the natural history of fat transplanted from a person's body to their breasts. We are seeking a natural, safe, and effective alternative to breast implants. Patients will undergo liposuction of their body followed by infiltration of this harvested fat around their breasts. The study protocol will involve preoperative and postoperative photographs, mammograms, and MRI to look for changes in the breast shape and size, as well as any internal changes in the breast tissue.

The current standard for breast augmentation involves placement of an implant. Although implants are safe, they are foreign bodies and thus have inherent risks including infection, failure, malposition, etc. In order to avoid the inherent risks of an implanted device, some surgeons and patients have elected to proceed with breast augmentation from autologous tissue. Early reports of autologous fat transplantation to the breasts were successful, but increases in breast volume were modest (Bircoll, 1987). There were also hypothetical concerns about changes in the breast tissue that would interfere with mammographic screening for breast cancer.

Spear et al (2005) performed autologous fat transplantation to reconstructed breasts in 37 patients with 2-dimensional photographic evidence of improved breast shape and volume suggesting that this technique can be effectively performed. However, these patients had all received mastectomies so mammographic screening was not indicated. Coleman and Saboeiro (2007) performed autologous fat transplantation to the breasts in 17 patients. Fifteen of the 17 patients received post-operative mammograms, 7 (47%) of which were abnormal. However, none of these abnormal findings interfered with cancer screening. Furthermore, 2 patients in the study did develop breast cancer which was successfully detected by mammography. Other studies have confirmed the ability to differentiate benign from malignant findings on mammogram after autologous fat transplantation. Pulagam et al (2006) reported long term (10 and 8 year) findings on 2 patients that underwent autologous fat transplantation to the breasts. Mammography and ultrasound were used to differentiate benign from malignant appearing calcifications. Some authors have speculated that autologous fat transplantation to the breast would lead to mammographic changes similar to routine breast procedures such as breast reduction and mastopexy (Coleman and Saboeiro, 2007).

Eligibility Criteria:
Inclusion Criteria:

* 20-50 years old
* willing to have mammogram, MRI, and photographs
* willing to follow study requirements and sign informed consent
* no previous breast surgeries
* must reside within 50 miles of the Washington, D.C. Metropolitan area

Exclusion Criteria:

* pregnant or nursing
* existing breast cancer
* advanced fibrocystic disease
* protease inhibitors
* any condition leading to surgical risk
* any disease known to affect wound healing
* abscess or infection in the body
* incompatible psychological factors
Pilot Study to Assess Number of Patients for Main Trial

The objective of the study was to investigate the efficacy of Bepanthen® wound healing ointment compared to placebo in a superficial abrasive wound model. The primary objective was the re-epithelization at Day 5.

The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15, assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36 (investigator and subject), and documentation and analysis of safety parameters.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV

Exclusion Criteria:

* Active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring
* History of keloids and hypertrophic scars
* History of plaster sensitivity
* Intake of drugs interfering with the immune system within 30 days before day 1 as well as during the study
* Concomitant therapy with substances affecting blood coagulation within up to 14 days prior to the start of the study as well as during the study
* Any condition or treatment which might influence the study
* Change of hormonal contraception within 3 months prior to enrolment and during the study
* Application of any topical treatment at the test areas during the conduct of the study
* Intensive ultraviolet-light exposure within two weeks before the beginning as well as during the study
* Removal of axillary lymph nodes
* Allergy to the ingredients of the test product
* Pregnancy or lactation
* Any illness on account of which the subject should not participate in the study in the opinion of the investigator
* Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
* Any history of drug addiction or alcoholism in the past 3 years
* Infectious diseases (e.g. hepatitis or AIDS)