cyrilzakka/clinical-trials huggingface dataset:
Early Targeted Antibiotic Therapy in Patients With Sepsis

The aim of this study is to assess the efficacy of early targeted antibiotic therapy in patients with sepsis and septic shock using the new biomarker Sirtuin 1 and PCR for bacterial resistance detection.

The primary outcome is change in SOFA score (ΔSOFA) which will be calculated by subtracting the final SOFA score and sirtuin 1 level at 5 days from the corresponding initial value at enrollment.

Secondary outcomes included mortality rates, ventilator free days and length of icu stay.

* A prospective, single-center, open labeled, randomized interventional study
* Patients will be recruited from a private hospital in Alexandria
* Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
* Fourty eight critically ill patients, with sepsis and septic shock according to the 2016 third international consensus definitions, will be included
* Patients with risk for Carbapenemase producing organisms:

  * Use of broad spectrum cephalosporins and/or carbapenems within the past three months
  * Polytrauma
  * Diabetes
  * Malignancy
  * Organ transplantation
  * Mechanical ventilation
  * Indwelling urinary or venous catheters
  * Overall poor functional status or severe illness
  * Residence in a long-term care facility(18-28).
* The baseline characteristics of the patients will be collected at the time of enrollment. The collected data included age, sex, ratio of septic shock to sepsis, ratio of ventilated to non-ventilated patients, source of infection, vital signs, laboratory data, arterial blood gas (ABG), APACHE II score, Glasgow Coma Scale score, and SOFA scores. The level of Procalcitonin (PCT) and Sirtuin-1 will also be measured at this time(29).
* Patients will be randomly allocated to antibiotic regimen guided by conventional culture technique (n=24) or targeted antibiotics therapy guided by resistance genotyping (n=24) (29, 30).
* Levels of Sirtuin1 will be detected using ELISA kits as prescribed by manufacturer.
* Traditional diagnostic microbiology techniques relying on the growth of organisms on appropriate culture media (Control group).
* Qualitative Multiplex pcr test will be used for rapid detection of carbapenemases genes (Intervention group)
* Statistical tests appropriate to the study will be conducted to evaluate significance of results
* Results, conclusion, discussion and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 18 years or older
2. A definite diagnosis of sepsis or septic shock according to the definition of the 2016 SCCM/ESICM task force.
3. Patients at risk for carbapenemase producing organisms

Exclusion Criteria:

1. Pregnant and lactating women
2. hematological disorders (e.g., leukemia, myelodysplastic syndrome, neoplastic metastases to bone marrow),
3. life-threatening diseases (e.g., malignant solid tumors), acquired immunodeficiency syndrome.
4. Lethal traumatic injury
5. Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II) score ≥34 (due to high predicted mortality of 80%)
6. Primary fungal or viral infections
Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer.

To assess the safety profile of these treatment regimen. To evaluate the duration of response of oxaliplatin/5-FU.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) except nasopharyngeal cancer.
* Patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective.
* Prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment.
* The disease must have been measurable by computed tomographic (CT) scan or MRI (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm.
* Patients must be 20 years of age and 75 years of age.
* Patients must have an ECOG performance status score 2.
* Patient's hematologic function, liver function and renal function must meet the eligibility requirements.
* Patients must sign the informed consent.

Exclusion Criteria:

* Patients with known hypersensitivity history to Platinum compounds or to 5-Fluorouracil.
* Patients with brain metastases.
* Patients with bone metastases only.
* Patients with pregnancy or breast-feeding.
* Patient with CTC (NCI Common Toxicity Criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable.
* Patients who have serious concomitant illness that might be aggravated by chemotherapy and other conditions which will be judged by physician's discretion.
* Patients who are receiving other anticancer cancer drug(s) for SCCHN.
Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral Palsy

Cerebral palsy (CP) in children and adolescents is frequently accompanied by gait abnormalities. Ankle-foot orthoses (AFO) have been suggested to improve the gait pattern. Compared to conventional AFO, modular AFO offer the opportunity to tune its response to the patient's gait characteristics and/or functional maturity. However, the evidence level is still small and AFO tuning is not yet established in clinical routine. The study will investigate individual tuning of custom-built ankle-foot-orthoses (AFO) using gait analyses


Eligibility Criteria:
Inclusion Criteria:

* Patients in outpatient treatment from the University Children's Hospital Basel (UKBB)
* Informed Consent provided as documented by signature
* Confirmed diagnosis of cerebral palsy
* Confirmed diagnosis of spastic equinus and/ or drop foot,
* Gait pathologies treated with conventional AFO
* Gross Motor Function Classification System (GMFCS) level I or II

Exclusion Criteria:

* Other neuromuscular diseases
* Previous surgical treatment to improve gait pathologies
* Injections of Botulinum toxin 6 month prior to study inclusion
* Inability or unwillingness to follow the procedures of the gait analysis
Remission of Lumbar Disc Herniation by Physiotherapy

This study was conducted with the aim of determining whether or not Non surgical spinal decompression therapy was effective in remission of herniation, decreasing pain and improving functional status.

Both groups received combination of electrotherapy, deep friction massage and stabilization exercise for fifteen session.

Combine group received non surgical spinal decompression therapy (NSDT) different from conventional physiotherapy group. Numeric Analog Scale, Straight leg raise (SLR) test, Oswestry Disability Index (ODI) were applied at baseline and after treatment. Disc height and herniation thickness were measured on Magnetic Resonance Imagination (MRI) which performed at baseline and three months after therapy.

Eligibility Criteria:
Inclusion Criteria:

diagnosed as lumbar disc herniation suffering from low back pain at least 8 weeks

Exclusion Criteria:

undergone any spinal surgery clinical diagnosis of osteoporosis clinical diagnosis of scoliosis and spondylolisthesis any neurological disease causes sensorial loss
The Association Between Autoimmune or Inflammation and Thyroid Disease

This study aims to evaluate the effects of thyroid functions on energy homeostasis and inflammation.

The subjects were enrolled for evaluation of thyroid functions. The associations between thyroid function and energy homeostasis and inflammation will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects visits outpatient department due to a suspicion of thyroid disease

Exclusion Criteria:

* Psychological disorders, severe inflammatory or infection diseases.
The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients

The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and produces an appropriate immune response against pertussis in blood and marrow transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-64
* BMT at the QEII Health Sciences Centre
* BMT within last 12 months
* Able to read and write English language
* Able to give consent

Exclusion Criteria:

* Active infection
* Active GVHD
* Recent IVIG
* Allergy to components of vaccine
* Diphtheria or tetanus vaccination within 18 months
The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients

This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.

This research is experimental. The study was conducted on 30 SLE patient subjects. the treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were collected. Statistical test with paired difference test with p \< 0.05

Eligibility Criteria:
Inclusion Criteria:

* Lupus paatients

Exclusion Criteria:

* Pregnancy
Comparison of the Panax Ginseng + Associations to Ginkgo Biloba in the Treatment of Cognitive Function Disorders

The purpose of this study is to evaluate the efficacy and safety of two different drugs in the treatment of patients diagnosed with memory difficulties and a decline in cognitive function.

This is a parallel distribution: a group of patients will be treated with a combination Panax Ginseng + Ginkgo Biloba + multivitamin + Polyminerals (EMS), and another group with Ginkgo Biloba (Tebonin ®).

STUDY DESIGN:

* multicenter, phase III, double-blind, randomized entry of patients, prospective and comparative
* The duration of the study: 60 days
* 3 visits (days 1, 30 and 60)
* Evaluate the effectiveness of the association
* Evaluate the safety of the combination
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

1. Patients of any race, sex, aged 18-60 years;
2. Patients presenting two or more symptoms associated with disorders of cognitive function such as memory impairment, poor concentration, depressed mood, decreased mental capacity, provided they score value is below 24 in the evaluation of the psychometric test (Mini Test-mental and WMS-R Logical Memory);
3. Consent of the patient (Signature of the IC);
4. Patients are able to read and write;
5. "Washout" of at least two weeks of the start of the study, in case of use of multivitamins or any other medication for symptomatic treatment of disorders of cognitive function.
6. Women of childbearing potential must submit βHCG negative serum;
7. Patients are able to understand and carry out the study procedures;

Exclusion Criteria:

1. Patients with hypersensitivity to the components of the formula;
2. Patients who are making use of levodopa or salicylates;
3. Routine use of medications that alter cognitive functions such as barbiturates, anticonvulsants, benzodiazepines, neuroleptics, alcohol and illicit drugs;
4. Pregnant or lactating women;
5. Participation in another clinical trial with investigational medication in the last 3 months;
6. Patients with prior knowledge of infectious disease;
7. Patients who are taking other multivitamins or any other medications for the symptomatic treatment of disorders of cognitive function, at least two weeks prior to study initiation.
8. Patients with organic dementias such as Alzheimer's, Pick's disease, Creutzfeldt-Jacob Disease, Huntington's, Parkinson's disease, dementia caused by human immunodeficiency virus (HIV), hypothyroidism, vascular dementia (arteriosclerotic dementia), dementia senile among others;
Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap

The purpose of this study is to compare vessel sealing system uvulopalatoplasty (VSSU) to the traditional uvulopalatal flap (UPF) in the treatment of sleep-disordered breathing with special regard to intraoperative bleeding, operative time, postoperative pain, postoperative hemorrhage and other adverse effects.

Uvulopalatopharyngoplasty is one of the common procedures performed by otolaryngologists to treat sleep-disordered breathing patients who have retropalatal obstruction. Intraoperative bleeding is a significant problem which requires hemostasis and causes prolonged operative time. Several different techniques are used to perform this operation, including cold knife, monopolar cautery, coblation, and radiofrequency. Efficacy in hemostasis and tissue trauma from different operative techniques may result in different operative time and different degrees of morbidity including intraoperative blood loss, postoperative pain, postoperative hemorrhage, and velopharyngeal insufficiency (VPI). The vessel sealing system has been widely used in head and neck surgery because of its effectiveness and safety. It was also found quite effective and safe in tonsillectomy procedures, providing excellent hemostasis and minimal tissue trauma.

Eligibility Criteria:
Inclusion Criteria:

* Patient planned for uvulopalatoplasty for indications of snoring or obstructive sleep apnea
* Written informed consent form is given from patient

Exclusion Criteria:

* Pregnancy
* History of bleeding disorders
* Patient unable to understand evaluation method
* Patient unable to be contacted via telephone
ROSA® Hip System THA PMCF

This study is a Prospective, Multicenter, Single-Arm, Cohort post-market study to evaluate the accuracy of acetabular implant position using the robotic-arm surgical assistant (ROSA® Hip System).

Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process.

The primary objective of this study is to assess the accuracy of acetabular implant position by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their intra-operative and/or post-operative full pelvis fluoroscopic or radiographic images show the postoperative acetabular inclination to be within this safe zone range.

Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results, and patient reported outcome measures.

Data collection will occur at the following intervals: Pre-operative, Operative, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 18 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 42 months.

Eligibility Criteria:
Inclusion:

1. Age 18 - 80 years
2. Body mass index ≤40 (BMI = kg/m2)
3. Patient is willing and able to provide informed consent
4. Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis or avascular necrosis of the hip based on Investigator's clinical judgment
5. Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System

Exclusion:

1. Has undergone an orthopaedic procedure of the spine or lower extremity, or is currently participating in a pain management clinical study of any joint, within the last 6 months or planned within the next 6 months
2. Patients receiving simultaneous bilateral hip arthroplasties are excluded from participation in this study; as well as any participants with staged bilateral arthroplasties within 6 months of each other
3. Active infection, sepsis, osteomyelitis
4. Patient is at a high risk for dislocation including those with long-segment spinal fusions (\>3 levels) and neuromuscular disorders
5. Inflammatory (rheumatoid or psoriatic arthritis) or post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis
6. Would, in the Investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule
7. Patient is considered a member of a vulnerable population (pregnant, prisoner, mentally incompetent, etc.)
8. Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure
Severe Prospective Observational COPD Catalonia

Multicenter observational study to characterize and follow-up a cohort of patients with severe chronic obstructive pulmonary disease (COPD) in Catalonia

Creation of the first multicenter observational study in Catalonia to characterize and follow-up of patients with severe chronic obstructive pulmonary disease. The follow-up will be up to 5 years, with a first initial visit and control visits every year. All patients will be recruited from respiratory departments from major hospitals from Catalonia, a region with approximately 8 million inhabitants and a wide web of public hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent: a signed and dated written informed consent prior to study participation
* Age: Subjects 35 years of age or order at visit 1.
* Severe COPD diagnosis: an established severe COPD defined by spirometry values:

  * A post-albuterol/salbutamol FEV1/FVC ratio of \<0.70 at visit 1. FEV1: forced expiratory volume at one second FVC: forced vital capacity.
  * A post-bronchodilator FEV1 \< 50% predicted normal
* Smoking history: ≥ 10 pack-years at visit 1
* Stable phase of the disease (not less than 4 weeks of stability prior visit 1)

Exclusion Criteria:

* Subjects not giving written informed consent.
* Subjects at risk of non-compliance, or unable to comply with the scheduled visits.
* Subjects affected mainly by another severe chronic respiratory disease that justifies the ventilatory alteration, for example pulmonary fibrosis or severe bronchiectasis
* Subjects with carcinoma that has not been in complete remission for at least 5 years.
* Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
* Newly diagnosed insulin naive patients
* Patients currently on human insulin or on basal insulin
* Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
* Usage should be in accordance with the current prescribing information (See attached prescribing information)

Exclusion Criteria:

* Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
* Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
* Pregnant women, those planning to become pregnant, or women who are breastfeeding
* Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
* Children below 6 years old
Repeated Cross Sectional Surveillance Study To Determine the Influenza Vaccination Rates in German Participants

Real-time monitoring of vaccination rates for Germany is unavailable, and up-to-date data publication is delayed, which makes it challenging to develop effective public health strategies to increase vaccination coverage.

This study aims to address the gap by assessing current influenza vaccination rates, particularly among those aged 60 and older, to inform public health interventions and encourage healthcare providers to recommend influenza vaccination more proactively.

The primary objective of this study is to determine the influenza vaccination rates in the German population during the current respiratory season. The study will focus on:

1. Assessing the vaccination rates among the two main age groups 18 years of age through and including 59 years of age and 60 years of age (inclusive) and older
2. Assessing the vaccination rate among individuals with risk-based vaccination recommendation according to Standing Committee on Vaccination (Ständige Impfkommission) (STIKO) The study will target a disproportionate sample of the German population regarding age: 30% aged 18 years of age through and including 59 year of age and 70% aged 60 years of age (inclusive) and older. Within these age groups, the study targets a representative distribution regarding gender and region.

This study is conducted as an online survey that will either be self-completed by the respondents (CAWI) or completed via an interviewer for a subgroup of respondents aged 70+ (CATI). The survey is estimated to last 10 minutes and will comprise of closed-ended questions only (i.e., respondents will not have the possibility to add any free-text). The survey will be conducted in German.

The panelists will be divided into strata based on demographic variables like gender and region. Within each stratum, participants will be randomly selected to participate in the survey.


Eligibility Criteria:
Inclusion Criteria:

* Reside in Germany at the time of survey completion
* Be at least 18 years old at the time of survey completion.
* Agree with privacy policy and AE (Adverse Event) reporting requirements before proceeding with the survey.
* Read and agree to the ICF (Informed Consent Form) by ticking a box before proceeding with the survey or telephone interview.

Exclusion Criteria:

* Participation in the study (= completed the survey or telephone interview) in a previous wave of the current season.
* Living in nursing home Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.