cyrilzakka/clinical-trials huggingface dataset:
Development of an Adjustment Assistance Tool Dosage of Fluoroquinolones in a Population Pharmacokinetic Model

Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat infections. Their efficacy has been shown to be linked to the ratio area under the curve (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to 40% in patients with an AUC/MIC below this threshold. These results have been reproduced recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar to the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be related with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ appears of potential interest, particularly in case of severe infections (intensive care unit (ICU) patients) or complicated and cost-related infections (osteoarticular infected (OAI) patients), with an increasing level of evidence of its use.

However, FQ TDM requires access to the full AUC of the drug with the need of many samples drawn to patients. This appears to be irreconcilable with clinical practice but can be achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating pharmacokinetic parameters of the drug by introducing covariates (demographic, biological, clinical...) and modelling inter-individual pharmacokinetic variability. The model created allows then accessing to individual parameters of patients and thus, estimating concentrations and AUC of the FQ. This approach may also be used in clinical practice to determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum of samples.

Open, prospective, monocentric pharmacokinetic study

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patients in intensive care : Infection treated with ciprofloxacin IV
* Osteoarticular infected patients : infection treated with oral ofloxacin
* Written consent to participate in the study

Exclusion Criteria:

* Pregnancy
* Adults subject to legal protection or deprived of their liberty
Virtual Reality in Aphasia Rehabilitation

Virtual reality-based aphasia rehabilitation has been shown to improve the language skills of individuals with aphasia in the chronic period after stroke. However, non-immersive or semi-immersive rehabilitation methods have often been adopted in the studies. Considering the importance of the visual given to the patient for naming, it can be thought that full immersive therapy may be more effective. Therefore, the aim of this study was to investigate the effect of cue-based aphasia naming therapy in a fully immersive virtual reality environment on aphasia severity and aphasia-related quality of life and to compare it with standard cue treatments.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with non-fluent aphasia by a neurologist
* at least 4 months after stroke
* A score of 29 and above on the language score sub-item of the GAT scale

Exclusion Criteria:

* severe sensory impairments (vision, hearing) that prevent participation in therapies
* severe motor dysfunction
* apraxia
* neglect
* dementia
* psychiatric disorders
* 3D vision problems
The Baltimore Experience Corps Study

The purpose of this study is to examine the effectiveness of the Experience Corps program in preventing or delaying physical disability in older adults, by studying the effects of volunteerism on physical, social and cognitive well-being.

The Baltimore Experience Corps Study is a randomized, controlled, community-based trial of the effectiveness of Experience Corps (EC) to determine if participation for adults 60 years and older, over two years of follow-up, results in better outcomes in the EC versus control arm in terms of mobility, strength, balance, and cognitive functioning.

The Experience Corps is a community-based model for health promotion for older adults embedded within a social engagement program. The program places older adult volunteers in meaningful roles in public elementary schools, bringing the time, experience, and wisdom of older adults to bear in improving academic and behavioral outcomes of children. The Experience Corps incorporates health promotion preventing disability and dependency associated with aging, into new, generative roles for older adults.

This program was initially designed by Dr. Linda Fried of this application, along with Marc Freedman of Civic Ventures, Inc. It has gone through two national demonstrations, neither of which evaluated the impact on older adults.

Eligibility Criteria:
Inclusion Criteria:

* 60 years or older
* Agree to commit to at least 1 year of participation in the EC and to participate at least 15 hours per week for the full school year, if randomized to the intervention group
* Meet minimum criteria for cognitive functioning necessary to function successfully in a school setting
* Functionally literate, using a nationally recognized and standardized evaluation which provides grade level equivalency in reading and spelling
* Ability to travel to the schools, if randomized to the intervention group
* Agree to accept randomization and to participate in evaluations
* Clearance on the Baltimore city public school's criminal background check, if randomized to intervention group
* Complete training, if randomized to intervention group

Exclusion Criteria:

* Under 60 years of age
SMS Reminders for Exercise Among Older Adults. Malaysian Physical Activity for Health Study

The purpose of the study is:

1) To evaluate the efficacy and feasibility of an SMS reminder intervention for promoting an health-related exercise programme (myPAtHS) among older Malaysian adults, in a randomized controlled trial (RCT).

Hypothesis: Frequency and duration of the exercise programme execution will be higher for the SMS reminder condition compared to the programme only condition. The effect may be reduced from post- to follow-up measurement (24 weeks after baseline and 12 weeks after post-measurement) but all outcomes will remain significantly higher at 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Mobile phone user
* Acceptable health that does not prevent exercise
* Acceptable command of the English language
* No engagement in a regular- structured exercise routine like gym training or other structured programmes
* Interest in an exercise programme
* Willing to attend scheduled follow-up sessions at 12 weeks (pre-post evaluation) and 24 weeks (post-intervention evaluation) after the first session

Exclusion Criteria:

* participants who have any medical condition or health concern that would restrict regular exercise based on one screening question. If this question will be answered with "yes" participants are advised to seek medical care.
Screening of Psycho-cognitive Troubles in Elderly Patients

The main objective of the study is to assess the rate of patients with psycho-cognitive troubles among hospitalised elderly patients.

It also aims to assess this rate among patients 1) when the geriatrics mobile unit is involved in the screening of these troubles and 2) when it is not.

All the patients (75 and older) hospitalised in the internal medicine department of a suburban Parisian hospital are included in the study and their psycho-cognitive functions assessed by a geriatrics physician, using 3 validated tests.

The result of this screening provides the rate of psycho-cognitive troubles among patients that would not have been tested by a geriatrics physician in usual care. It assesses the interest of a systematic evaluation of elderly patients by the geriatric mobile unit.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 75 years old or more
* hospitalised in internal medicine

Exclusion Criteria:

* patient confused (interference with the assessment of psycho-cognitive functions)
* diagnosis of dementia at admission
* refusal of the patient or close relative for participating in the study
* poor understanding of French language
* hospitalisation for less than 3 nights
Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.

The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia
* Allogeneic stem cell transplantation (related or unrelated)

Exclusion Criteria:

* Age under 18 years
* Cord blood transplantation
Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for Transurethral Resection of the Prostate (TURP) Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients

Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for TURP Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients.


Eligibility Criteria:
Inclusion Criteria:

* males (\> 65 yr) were scheduled to have spinal anaesthesia for TURP

Exclusion Criteria:

* patients with peripheral vascular disease
* chronic venous insufficiency
* prior deep vein thrombosis (DVT) defined by the presence of thrombosis on duplex or the presence of ultrasonographic signs indicating a previous DVT
* body mass index \>35
* prior lower limb surgery due to arterial or venous trauma
* history of diabetes or autonomic deficiency.
Metabolomic and Epigenetic Profiling of Bodyfluids From Lung and Brain Cancer Receiving Radiation Therapy

This research trial studies metabolomic and other molecular profiling to identify predictive biomarkers for radiation toxicity and survival in patients with lung or brain cancers receiving radiation therapy. Studying samples of blood, urine, and tissue from patients with lung or brain cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict which patients are at higher risk for developing radiation side effects and how well patients will respond to radiation treatment.

PRIMARY OBJECTIVES:

I. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for lung cancer associated with the development of radiation pneumonitis.

II. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for brain cancer associated with the development of radiation necrosis.

SECONDARY OBJECTIVES:

I. Metabolomic and epigenetic urine, blood, and tissue profiles of patients undergoing radiation therapy for lung and brain cancer associated with survival.

OUTLINE:

Collected blood, urine, and tissue samples are analyzed for biomarkers via metabolomic and epigenetic profiling using mass spectrometry, array, and sequencing-based technology.

Eligibility Criteria:
Inclusion Criteria:

* Consultation with the Radiation Oncology department of the Ohio State University (OSU) Comprehensive Cancer Center
* The following diagnoses will be included: malignant neoplasm of the brain; primary malignant neoplasm of trachea bronchus and lung; primary malignant neoplasm of the cervix uteri and primary malignant neoplasm the prostate

Exclusion Criteria:

* Being an inmate
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.

This is a single arm prospective study. Approximately 4 investigational sites will enroll and follow subjects who meet the study criteria.The study will span a total of approximately 18 months: an estimated 6 months for recruitment and 12 months for follow up. 50 subjects will be enrolled in the study. It is anticipated that given an average of 1.5 operated breasts per subject enrolled for Revision Augmentation surgery that 75 implantations of SERI® surgical scaffold will occur.

Eligibility Criteria:
Inclusion Criteria:

* Negative nicotine test at screening visit
* Previous augmentation with silicone-filled or saline-filled breast implants requiring Revision Augmentation surgery for increased nipple:inframammary fold distance
* Well vascularized skin flaps that can be approximated without tension

Exclusion Criteria:

* BMI (Body Mass Index) that is ≥ 30 kg/m2
* Active smoker or have smoked within 6 weeks prior to screening visit
* Pregnant or nursing
* Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
* Carcinoma of the breast
* Previous mastectomy or lumpectomy
* Abscess or infection in the body at the time of enrollment
* Had any disease, including uncontrolled diabetes (e.g., HbAIc \> 8%), that is clinically known to impact wound healing ability. For example: collagen-vascular, connective tissue or autoimmune disorders (e.g., Systemic Lupus, Rheumatoid Arthritis, Scleroderma)
* Subjects with diagnosed diabetes must have HbAIc ≤ 8% within 3 months of enrollment
* Showed tissue characteristics that were clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration
* Had, or was under treatment for, any condition that may have constituted an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
* History of prior implantation of any surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) in the breast
* Implantation of any non-SERI® surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) during the study period
* Product contraindications for use of SERI® Surgical Scaffold per the supplied package insert (e.g., hypersensitivity to silk)
Factors Influencing Hemoglobin Variability and Its Association With Mortality in Hemodialysis Patients

The aim of the study is to investigate the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemodialysis patients.

Fluctuation in hemoglobin levels that is known as hemoglobin variability during treatment with ESA is a well-documented phenomenon. Several factors have been found to affect hemoglobin variability, including drug related, such as pharmacokinetic parameters, patient-related differences in demographic characteristics and factors affecting clinical status, as well as clinical practice guidelines, treatment protocols and reimbursement policies. Inflammation is also an important factor associated with hemoglobin variability, and the consequences of persistent inflammatory activity are far-reaching in affected patients.

In present study, the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemodialysis patients are investigated.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* on chronic hemodialysis treatment

Exclusion Criteria:

* All patients had a minimum of six hemoglobin measurements within a 6- month period, and they were excluded if they received a kidney transplant during this period or those who had blood transfusions during the baseline period.
* Patients with serum ferritin\<100 μg/L were also excluded from the study because of reimbursement of our country.
Long-term Efficacy, Tolerance and Compliance of Panthera D-SAD® Mandibular Advancement Orthosis in Sleep Apnea

Obstructive sleep apnea (OSA) is a common, chronic and serious medical condition. Oral appliance therapy (OAT) also called mandibular advancement orthosis (MAO) provides long-term therapy for OSA patients. The Panthera D-SAD® is a computer aided design (CAD)/computer aided manufacturing (CAM), patient-matched, 3D printed, biocompatible nylon OAT. This five-year, observational prospective and multicenter study will assess the effectiveness of the PANTHERA D-SAD® orthosis on reducing the apnea hypopnea index (AHI) and obstructive sleep apnea-hypopnea syndrome (OSAHS) symptoms. Adherence, tolerance, and side effects will be evaluated.

An estimated ten sites composed of a professional dyad, a specialist in sleep disorders, and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients. The entry criteria include an AHI between 15 and 30 or higher if the patient meets certain medical and dental criteria, no prior use of OAT, and struggles or refuses continuous positive airway (CPAP) treatment. The professional collaborative nature of the study reflects real-world clinical practice.

Participants will be followed over the course of five years at the following time points. Visits include the following: Specialist in sleep disorders: (1) Inclusion, (2) 3 months, (3) 2 years, (4) 5 years. Specialist in manducatory apparatus (dentist): (1) Inclusion, orthosis set-up and titration, (2) 6 months, (3) 2 and (4) 5 years The efficacy of the Panthera D-SAD® MAO will be assessed by the treatment success rate at five years, defined as a reduction ≥ 50% in the initial AHI, when monitored by nocturnal breathing polygraphy (NP) or polysomnography (PSG). Secondary endpoints will also be obtained at the aforementioned time points for reporting. The results of this study will fulfill regulatory requirements for reimbursement in France.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18
* Moderate OSAHS or severe OSAHS and refuse or intolerance to treatment with continuous positive pressure
* Patient who has never worn MAO
* Accepting and able to complete questionnaires in French on the impact of their disease and their quality of life
* Informed and having signed a written consent
* Affiliated to a social security system

Exclusion Criteria:

* One or more contraindications to wearing a mandibular advancement orthosis
* Central sleep apnea
* Severe OSAHS associated with another sleep pathology
* Serious respiratory disorders other than OSAS
* Severe psychiatric or neurological disorders
* Progressive cancer and/or chronic joint, inflammatory or immunosuppressive disease
* Known allergy to one of the components of the medical device
* Simultaneous participation in another intervention research
* Vulnerable subjects
Acute Pancreatitis and Acute Fluid Collections

The purpose of this study is to evaluate if percutaneous drainage of sterile fluid collections recurring after initial aspiration in acute pancreatitis yielded better results than their conservative management.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs of acute pancreatitis and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination

Exclusion Criteria:

* Collections resulting from pancreatic surgery, chronic pancreatitis and encapsulated collections and collections with uncertainty about the relationship between the collections and clinical symptoms and signs of acute pancreatitis were excluded.
A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2

maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* BMI \< 30 kg/m2
* History of type 2 diabetes mellitus as confirmed by:
* onset of diabetes after 30 years of age and
* no insulin treatment in the first year after diagnosis
* Subjects on insulin treatment or on insulin treatment in combination with oral antidiabetics
* HbA1c \> 6.5% in medical history within the last 6 months despite insulin treatment
* Not previously treated with any pancreatic enzyme supplementation

Inclusion Criterion at Visit 1:

• FE-1 (fecal elastase 1) \<100μg/g of stool

Inclusion Criterion at Visit 2:

• 13C MTBT of \<29% 13CO2-CRR (Carbon dioxide-Cumulative Recovery Rate)

Exclusion Criteria:

* Treatment with systemic steroids for at least 3 weeks within past 6 months
* Patients with a known pancreatic exocrine insufficiency due to non-diabetic diseases, e.g., chronic pancreatitis, pancreatectomy, cystic fibrosis, celiac disease, shwachman-diamond syndrome, gastrectomy, etc.
* Any type of malignancy involving digestive tract in the last 5 years
* Any type of gastrointestinal surgery (except appendectomy and gallbladder resection)
* Short bowel syndrome
* Hemochromatosis
* Known late onset autoimmune diabetes in the adult
* Any history of drug abuse including alcohol
* Positive urine pregnancy test; lactation; females of child-bearing potential who are not using either an oral hormonal contraceptive or an intrauterine device
* Hypersensitivity to the active substance or to any of the excipients
* Intake of an experimental drug within 4 weeks prior to entry into this study
* Suspected non-compliance or non-cooperation
* History of human immunodeficiency virus (HIV) infection
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of female adults with acute pyelonephritis.

This was a randomized (1:1:1:1:1), double-blind, double-dummy, adaptive designed, Phase 2 study. Based on review of the efficacy and microbiology data, the DMC modified the randomization algorithm, and no further participants were enrolled in the following treatment arms after May 2019: the omadacycline 200 iv/100 iv, omadacycline 200 iv/300 po or 100 iv, and omadacycline 200 iv/450 po or 100 iv arms. After this change, participants were randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.

Eligibility Criteria:
Inclusion Criteria:

* Female participants, age 18-65 years who have signed the informed consent form
* Must have a qualifying acute pyelonephritis
* Participants must not be pregnant at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
* Must be able to comply with all of the requirements of the study

Exclusion Criteria:

* Males
* Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
* Infections that require antibacterial treatment for greater than 14 days
* Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
* Evidence of significant immunological disease
* Evidence of liver impairment or disease
* Evidence of unstable cardiac disease
* Severe renal disease or requirement for dialysis
* Evidence of septic shock
* Has a history of hypersensitivity or allergic reaction to any tetracycline or to levofloxacin
* Has received an investigational drug within the past 30 days
* Participants who are pregnant or nursing
* Unable or unwilling to comply with the protocol requirements