cyrilzakka/clinical-trials huggingface dataset:
Nutritional Care and Head Growth in Preterm Infants

As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units. A retrospective study included extremely low birth weight infants born in Lyon, France or in Stockholm, Sweden. Data on morbidity, treatments, care practices, macro-nutrient intakes and postnatal growth were collected to determine risk factors of extra uterine growth restriction at discharge.

By comparing postnatal growth in ELBW infants hospitalized in two European neonatal intensive care units with different nutritional and extra nutritional care,our objective was to evaluate the role of nutrition in this population of preterm infants.

In a retrospective study, all ELBW infants (birth weight under 1000 g) with a gestational age between 23 and 28 weeks were included if they were admitted during the first 24 hours of life and stayed for at least seven weeks in two European units (Lyon, france, and Stockholm, Sweden). Parenteral and enteral nutrition policies were detailed and protein and energy intakes were collected.Growth assessment Postnatal growth was precisely evaluated and compared in the two groups of infants.

Body weight, crown-heel length and head circumference were measured in both units at birth and until discharge. We calculated z-scores and changes in z-scores between birth and 36 weeks post-conceptional age (delta z-score) for body weight, HC, and crown-to-heel length using Olsen's references. Intra-uterine growth restriction was defined as a birth weight below or equal to minus two standard deviations. Extra-uterine growth restriction was defined as a z-score loss above or equal one standard deviation between birth and 36 weeks PCA. I

Eligibility Criteria:
Inclusion Criteria:

* birth weight under 1000 grams
* gestational age (GA) between 23 and 28 weeks
* born in 2012
* admitted during the first 24 hours of life
* stayed in one of the two studied units for at least 7 weeks before transfer to the referring hospital, discharge to home or death.

Exclusion Criteria:

* Neonates with congenital anomalies
Rational Approach to a Unilateral Pleural Effusion2

Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and \<33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies.

Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions \>10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone.

Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.

The investigators will perform two randomized studies to investigate whether

1. PET/CT is comparable to CT alone
2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with recurrent pleural effusion of unknown origin after a first pleural tap according to BTS guidelines.
2. Indication for thoracoscopy according to BTS guidelines.
3. Patients accept further investigation according to Danish and BTS guidelines.
4. Have received oral and written consent and agreed.
5. At the time of inclusion, above 18 years of age.

Exclusion Criteria:

1. Female patients: pregnancy or breastfeeding.
2. Lack of language comprehension.
3. Legally incompetent patients.
4. Life expectancy less than 3 month.
5. Contraindications to pleural tissue sampling.
Pharmacokinetics Of Celecoxib Test Formulations

The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers
* Body weight BMI 17.5-30.5

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* Positive urine drug screen
Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial

The gold standard for treating prosthetic joint infection (PJI) is two-stage exchange arthroplasty. This includes the first stage of debridement and removal of the artificial joint, and the second stage of reimplantation of the artificial joint. Methicillin-resistant staphylococcus aureus (MRSA) infection is one of the factors leading to the failure of artificial joint infection treatment. Before the second stage of the joint surgery, the surgeon will prescribe prophylactic antibiotics based on previous bacterial cultures. The usual preoperative antibiotic is a first-generation cephalosporin antibiotic. If it is MRSA, vancomycin will be given. Increasingly, literature reports link prosthetic joint infections to MRSA, but no changes have been made to the routine recommendation for MRSA prophylactic antibiotic use.

Daptomycin is a cyclic lipopeptide antibiotic that can rapidly penetrate biofilms and bones, and its safety and tolerability have been confirmed. Therefore, it can effectively combat Gram-positive organisms, including MRSA. Daptomycin has many characteristics of an ideal prophylactic: short infusion time, low adverse events during administration, and a range limited to Gram-positive organisms. We aim to assess whether adding antibiotics that cover MRSA would reduce prosthetic joint infections and increase surgical success rates, in addition to the standard recommended prophylactic antibiotics. Thus, this prospective randomized trial is designed to assess, besides using the first-generation cephalosporin antibiotic, the effects of adding an antibiotic with MRSA coverage (Daptomycin vs. Vancomycin).


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 or older with an infection that meets the 2018 International Consensus Meeting (ICM) criteria7 at the time of the first-stage resection arthroplasty with a gram-positive organism, especially MRSA.
2. Will undergo a second stage of reimplantation.

Exclusion Criteria:

1. Patients with a fungal infection or culture-negative infections
2. Known allergies to Cefazolin, Daptomycin, or Vancomycin.
3. Currently receiving surgical treatment for acute postoperative or acute hematogenous PJI.
4. Chronic kidney disease (Creatinine Clearance Rate \[CCR\] \< 30 ml/min/1.73m2)
Improving Care for Women With Urinary Incontinence (EMPOWER)

The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.

In the study, patients will be screened in primary care offices for symptoms of urinary incontinence. Women with positive screening results will be asked if they are interested in participating in an implementation study where women will be assigned to one of the three following groups:

1. Usual Care plus Patient Educational Opportunities - The patient's urinary incontinence will be managed using standard of care treatment by the patient's primary care provider. Patients will be offered educational opportunities about urinary incontinence.
2. Nurse Navigation - Along with the treatment described for "Usual Care plus Patient Educational Opportunities," a nurse navigator will work with the patient to implement behavioral changes and provide education and physical therapy options. In addition, the navigator will be available to answer the patient's questions in a timely fashion and help the patient move through the care pathway.
3. Nurse Navigation and ChatBot - Along with the treatment described for "Usual Care plus Patient Educational Opportunities" and "Nurse Navigation," this group will include a ChatBot feature which will allow a patient to directly and privately communicate with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and help the patient navigate the care pathway.

All participants will complete questionnaires throughout their enrollment and data will be collected from medical records. The study team will analyze the data at six months after the original appointment/study enrollment, assess adherence to therapy and how the therapy impacted the outcomes the team hopes to improve, such as improvement in symptoms. The study will be implemented over three subsequent time periods called Wave 1, Wave 2 and Wave 3 with primary care practices from two geographic regions being involved in each wave (6 regions total). Participants in Wave 1 will be followed for a total of 18 months, while participants in Wave 2 will be followed for a total of 12 months, and participants in Wave 3 will be followed for 6 months. Primary care providers at all participating practices will be offered educational opportunities related to urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

1. Female patient having a primary care provider visit at University Hospitals (UH) Cleveland Primary Care Institute (PCI)
2. ≥ 18 years old
3. Scores 1 or higher on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

Exclusion Criteria:

None
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.

One in eight women will develop breast cancer in her lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Nearly 100,000 patients undergo reconstruction with implants every year in the United States.

Surgical mesh devices, particularly acellular dermal matrices, are now used off-label by most reconstructive surgeons performing prosthetic breast reconstruction. In the past decade, surgeons have advocated a transition from submuscular reconstruction (placement of the implant under the pectoralis muscle) to pre-pectoral (placement above the pectoralis) and often consider mesh to be necessary for this procedure. Surgical mesh has not been approved by the FDA for breast reconstruction for either anatomic location. These mesh devices are considered Class III medical devices and FDA recently prioritized the evaluation of these products during a panel meeting in 2019.

No Level I randomized trial has been successfully performed to determine the actual risks and benefits of mesh devices in breast reconstruction. This study proposes a pilot study as the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. The goals are to demonstrate feasibility of such a study and to generate high level data toward the evaluation of safety and effectiveness of these products for the benefit of women's public health

Eligibility Criteria:
Inclusion Criteria:

* Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
* Prophylactic and oncologic mastectomies are both acceptable
* Nipple sparing and skin sparing mastectomy techniques are both acceptable

Exclusion Criteria:

* Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
* Bilateral reconstruction patients undergoing contralateral submuscular reconstruction
* Direct-to-implant reconstruction
* Pregnancy
* Delayed reconstruction
An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or recurrent mild to moderate left-sided active ulcerative colitis
* Mayo score of at least 4 but not greater than 10 points and a score of ≥ 2 for colonoscopy
* Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy
* The patient is compliant with Patient Daily Diary by having adequately responded to the questions on ≥5 of the most recent full 7 days before the Randomization Visit
* Negative stool test at screening to rule out parasites and bacterial pathogens

Exclusion Criteria:

* Patients receiving \> 2g/day of oral 5-aminosalicylic acid (5-ASA) products, or receiving topical rectal 5-ASA \> 3g/week, within 7 days prior to screening
* Severe/fulminant ulcerative colitis or toxic dilatation of the colon
* Prior bowel resection surgery
* Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates
* Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease
* Patients who are unable to fill in the Patient Daily Diary or follow data-capturing procedures
Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789

This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease


Eligibility Criteria:
Inclusion Criteria

* Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
* Women must be surgically sterile or postmenopausal
* Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.

Exclusion Criteria

* Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
* Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.
Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)

This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately controlled with existing therapies.

Duration of study period (per participant):

* Screening Period (2 to 4 weeks)
* Intervention Period (up to 52 weeks±3 days)


Eligibility Criteria:
Inclusion Criteria:

* Participants ≧18 years of age.
* Participants with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or had a medical contraindication / intolerance to SCS; and/or had prior surgery for NP at the screening visit, had:

  * An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
  * Ongoing symptoms (for at least 8 weeks prior to Visit \[V\] 1) of nasal congestion/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at the time of enrollment (V2), and loss of smell, rhinorrhea (anterior/posterior).
* Participant's body weight \> 30 kg at V1.
* Signed written informed consent.

Exclusion Criteria:

* Participant with conditions/concomitant diseases making them non evaluable at V1 or for the primary efficacy endpoint such as: Antrochoanal polyps; Nasal septal deviation that would occlude at least one nostril; Acute sinusitis, nasal infection or upper respiratory infection; Ongoing rhinitis medicamentosa; Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis; Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis;
* Participant with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc).
* Participant diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before V1 or during screening
* Undergone any and/or sinus intranasal surgery within 6 months before V1.
* Participant who had participated in prior dupilumab clinical study or had been treated with commercially available dupilumab

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

The goal of this subproject is to examine the hypothesized improvement of treatment with chess-based training and sleep enhancement, both together and on their own, in smokers.

Participants will undergo fMRI measurements, sleep monitoring. They will then be assigned to one of the four experimental groups, including high-intensity interval training with or without chess-based training.

This subproject aims to improve treatment outcome in patients with tobacco use disorder (TUD) by enhancing cognitive control. Evidence from the first funding period (1st FP) indicates that enhancing cognitive control using cognitive remediation training (CRT, in our case chess-based) can improve outcomes of a standard smoking cessation program. The current project will harness three means to build on this success of enhancing cognitive control by: 1. using our tried-and-tested chess-based training, 2. improving sleep using high-intensity interval training (HIIT), 3. increasing sleep-dependent consolidation of the chess-based training (see Figure 1). We hypothesize that chess-based training and sleep enhance treatment outcome, both together and on their own. To test our hypotheses, we will combine smoking cessation treatment with the aforementioned approaches as app-based add-ons (chess-based training and HIIT). This will not only allow us to apply the training in a cost-efficient way out-side the lab, it may also increase patients' compliance.

Eligibility Criteria:
Inclusion Criteria:

* severe tobacco use disorder (TUD) according to DSM-5
* sufficient ability to communicate with investigators and answer questions in both written and verbal format
* ability to provide fully informed consent and to use self-rating scales
* right-handedness
* HIIT can be performed without the risk of side effect (medical sports check)

Exclusion Criteria:

* severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
* history of brain injury
* severe physical diseases
* common exclusion criteria for MRI (e.g. metal, claustrophobia)
* positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
* psychotropic medication within the last 14 days
* pregnancy
The Effects of Postural Changes on Plantar Pressure in Patients With Ankylosing Spondylitis

Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. The purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in AS patients and to compare AS patients with and without postural changes and healthy subjects.

Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Reduction in flexibility and mobility is important factors that can cause impairment quality of life, reduction of exercise tolerance and pulmonary capacity with the progression of AS. Extra articular symptoms such as neurologic, cardiovascular and pulmonary involvement affect morbidity and mortality rate. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. Şahlı et al. concluded that 52% of AS patients had foot involvement but 35% of the patients had symptoms. To be determined plantar pressure distribution is important to be decided body weight distribution, postural control and selection of shoes. The purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in AS patients and to compare AS patients with and without postural changes and healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are aged between 18-55 years,
* Patients who got diagnosed according to Modified New York criteria
* Patients who are being followed at Firat University Department of Rheumatology.

Exclusion Criteria:

* Patients who have exercise habits
* Incooperation
* Malignancy
* Pregnancy
* Patients who have changes of medical treatment in the last 3 months
* Patients who have another disease that can effect pulmonary functions
The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success

The data of patients undergoing bronchoscopic volume reduction procedure will be analyzed retrospectively. Patients will be divided into two groups as patients with and without Pulmonary Rehabilitation before the procedure, and changes in functional levels of patients will be compared.

The data of patients who underwent bronchoscopic volume reduction between January 2013 and March 2019 will be examined.

Patients will be divided into two groups as pulmonary rehabilitation applied (PR group) and not applied (Control group) before the procedure.

Changes in the parameters of initial and rehabilitation follow-up will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-75
* Patients with a diagnosis of emphysema and bronchoscopic procedures

Exclusion Criteria:

• Patients who develop complications related to the procedure after bronchoscopic procedure.