cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Caspofungin

The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.

This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: broad spectrum anti-bacterial antibiotics plus caspofungin (70 mg i.v. on the first day day, and 50 mg i.v. on the consecutive days, once daily.

Blood samples (3 mL) will be collected 2, 4, 8,12 and 24 hours after each dose of caspofungin for 3 consecutive days. The standard arterial canula will be used to obtain samples.

30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum caspofungin concentration will be measured with high performance liquid chromatography.

Each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.

Eligibility Criteria:
Inclusion Criteria:

* Patients who require ICU treatment due to severe sepsis age
* 18-80 years
* an eligible consent obtained from the patient or his/her attendant

Exclusion Criteria:

* allergy to caspofungin
* lack of consent to participate in the study
* age of patients below 18 or above 80 years
How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response

This study compares two total knee replacement implants to asses muscle function and quality, and the immune response to the implants. 30 patients will receive the Smith and Nephew Journey II implant, while 30 patients will receive the Zimmer NexGen LPS-flex implant. 15 healthy controls will also be recruited and compared.

Patients will undergo biomechanics testing while they complete sit-to-stand, stand-to-sit, lateral step down, level walking, and single leg balance tasks up to 1 month before surgery, and 6 and 12 months after surgery. They will also undergo MRI imaging up to 1 month before surgery and 12 months after surgery to assess muscle quality. A secondary outcome will also be to analyze the immunological response in the patients who received femoral components made of oxidized zirconium versus contemporary components made of cobalt chrome. Fifteen healthy controls will also participate in the study and will undergo the biomechanical, MRI and blood draws at a single visit.

Eligibility Criteria:
Inclusion Criteria:

* The participants receiving a knee implant must requiring a total knee replacement

Exclusion Criteria:

* Any degenerative conditions (other than osteoarthritis at the affected knee) impacting joints of the lower extremities
* bilateral knee replacements
* previous joint replacement at the affected knee
* any other past or present conditions that may impact gait
* any active infection and any diagnosed conditions that may affect the local and systemic immune response (e.g., rheumatoid arthritis, HIV infection, lupus, pregnancy, and thrombocytosis)
* BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI \> 35 kg/m2 and a WC \> 102 cm in men or \> 88 cm in women will be excluded from the study.

Healthy Controls Inclusion

* controls must not suffer from lower extremity injuries or joint conditions that might alter gait dynamics Exclusion
* BMI and waist circumference (WC) will be another exclusion criterion since both BMI and WC are associated with health problems and gait abnormalities. Any patient with both BMI \> 35 kg/m2 and a WC \> 102 cm in men or \> 88 cm in women will be excluded from the study
Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

In this clinical trial will be checked, whether 2 hour ventilation with xenon has neuroprotective effects in patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation

Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation will be randomized in two groups. First group (Treatment group) will be inhalated with xenon within 2 hours in addition to therapeutical hypothermia. The second group (Control group) will be treated with therapeutical hypothermia in accordance to international guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation, which will be treated at Department of Internal Medicine I, University Hospital Aachen

Exclusion Criteria:

* Patients younger than 18 years
* Xenon allergy
* Pregnancy
* High expired oxygen requirement (\>70%) in order to maintain adequate arterial oxygen saturation (SpO2\>94%) at the beginning of treatment
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)

The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.


Eligibility Criteria:
Inclusion Criteria:

* History of FI for at least 6 months
* Baseline diary requirement for min # of FI episodes in a two-week period
* Ability to manage investigational device insertion and removal
* Successful fitting of study device
* Willing and able to give written informed consent to participate in the study

Exclusion Criteria:

* Chronic rectal, anal or pelvic pain
* Any vaginal prolapse that extends beyond the plane of the hymen.
* Previous rectal or pelvic floor surgery within the last 12 months (24 months in the case of cancer)
* Congenital anorectal malformation
* Chronic watery diarrhea unmanageable by drugs or diet as primary cause of FI
* Inflammatory bowel disease
* Presence of a vaginal, anal, rectal or urethral fistula or anastomosis
* Presence of a vaginal, rectal or bladder tumor
* Presence of an open wound or tear in the vagina or anus by exam
* Presence or history of rectovaginal fistula
* Atrophic vaginal tissue as determined by symptoms or visualization
* Current vaginal or urinary infection requiring treatment
* History of recurrent urinary or vaginal infections
* Subject is currently pregnant or planning pregnancy in next 5 months
* Concurrent use of any intra-vaginal device that would interfere with LivSure (now called Eclipse) placement or wearing
* Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.) or other factor that the investigator believes would interfere with study participation and/or increase subject risk
Aquatic Exercises VS Core Strengthening on Disability, Flexibility and Postural Stability in Weightlifters.

The study is randomized and single blinded.Ethical approval is taken from ethical committee of Riphah international university, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling technique. Subjects in group A will receive aquatic exercises. Group B will receive core strengthening.

The objective of the study is to determine the effects of aquatic exercises verses core strengthening on disability, flexibility and postural stability in weightlifters with chronic low back pain. The study is randomized and single blinded. Ethical approval is taken from ethical committee of Riphah international university Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A and group B through sealed envelope method by non probability convenient random sampling technique. subjects in group A will receive Aquatic exercises. Group B will receive Core strengthening. The outcome measures will be assessed by modified Oswestry Low back disability index , Modified finger_tip to floor method and New York Posture Rating Chart. The data will be analyzed by SPSS, Version 25. Statistical significance is P=0.05.

Eligibility Criteria:
Inclusion Criteria:

* Age of participants between 20-35 years
* Experienced male weightlifters from past 6 months to in practice.
* Participants must have chronic low back pain for at least three months before enrollin

Exclusion Criteria:

* Patients with significant back pain who need rapid medical or surgical treatment.
* History of respiratory or heart diseases
* Water related anxiety or inability to adapt to aquatic environment.
* Participants with prior back surgery i.e. had surgery within six months.
Sitosterolemia Extension Study (0653-004)(COMPLETED)

This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

The duration of treatment is 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with elevated sitosterol levels while taking current medication

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Necrotizing External Otitis : Study in a Regional Bone and Joint Infection Reference Center

The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling.


Eligibility Criteria:
Inclusion Criteria:

* patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center

Exclusion Criteria:

* none
Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma

This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.

Melasma is a very common pigmentation disorder which significantly alters quality of life as per its high visibility on the face. The objective is to compare the efficacy and tolerability of the new depigmenting formulation that addresses the different targets of hyperpigmentation and includes an inhibitor of melanin production with a breakthrough innovative mechanism of action versus Cysteamine 5% in the acute management of melasma over 4 months.

Statistics:

Sample size calculation: 120 patients (60 per group) are necessary to reach the non-inferiority objective of the Test Product versus Cysteamine 5% on the modified Melasma Area and Severity Index (mMASI) change from Baseline at Month 4. To allow a rate of subjects excluded from analysis (drop out, lost to follow-up, major deviation) at Month 4, 140 subjects in total (70 per group) are enrolled.

Statistical analysis: Continuous data collected at each visit will be summarized using common statistical measures such as the count of values, mean, standard deviation, median minimum and maximum. For categorical data, summaries will be provided in terms of frequency counts (n) and percentages (%).

Eligibility Criteria:
Inclusion Criteria:

* Facial epidermal melasma (exclude mixed and dermal melasma)
* Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face

Exclusion Criteria:

* Subjects with any other signs of significant irritation or skin disease
* Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
* Subjects who had a skin lightening procedure in the past 8 weeks
Neuromuscular Study to Assess Foot Intrinsic Muscles

The purposes of these studies are to investigate:

Differences in abductor hallucis muscles'EMG activities during different postural tasks between individuals with normal foot alignment and functional flat foot. Differences in abductor hallucis muscles'H-reflex amplitudes between individuals with normal foot alignment and functional flat foot. Changes in abductor hallucis muscles'EMG activities during different postural tasks after a 3-week short foot exercises training regimen in individuals with functional flat foot. Changes in abductor hallucis muscles'H-reflex amplitudes after a 3-week short foot exercises training regimen in individuals with functional flat foot. hypotheses: Peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. H-reflex amplitudes of abductor hallucis muscles were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. Changes of peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen. Changes of H-reflex amplitudes of abductor hallucis muscles were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen


Eligibility Criteria:
: Inclusion Criteria:

* Age between 20 and 45 years
* No ankle injury within the previous 6 months
* No diagnosed lower extremity injuries
* No ankle pain at the time of the study
* Foot posture index score: 0 to +5 for the normal foot (NF) group; +6 to +12 for the functional flat foot (FFF) group
* Navicular drop: 5-9 mm for the NF group; \> 10 mm for the FFF group

Exclusion Criteria:

* Foot posture index score: \<0
* Navicular drop\< 5 mm
* Leg length discrepancy \> 1.5 cm
* Diagnosed severe scoliosis
* Neurological injuries over lower extremities
Normal Variants and Pitfalls of 18F_FDG PET/CT in Pediatric Oncology

Detection Normal variants and pitfalls of 18_F _FDG PET/CT imaging in pediatic oncology.

Although pediatric cancer is relatively rare compared with adult cancer, it is the second most common cause of death, after injury in children and adolescents. lymphoma, Leukemia, and brain cancer, account for more than half of pediatric cancers, followed by neuroblastoma, soft-tissue sarcomas, Wilms tumors, and bone tumors .

18Fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) plays an important role, staging, restaging, response to treatment in childhood malignancies. PET-only examinations have been replaced by hybrid systems in the recent decades, where PET and CT are used together in oncology. In this imaging system, PET and CT are used together for functional data and morphological information, respectively. (2) Although 18F-FDG PET/CT is now well established as an accurate method for the staging and restaging of various cancers, it is also well recognized that many false-positive results can occur .

The normal distribution of FDG uptake in children differs from adults. Also, even though FDG is used widely in oncology, it is not tumor specific. Uptake of FDG may be seen in numerous benign conditions, including inflammation, infection, and trauma. Proper interpretation of pediatric FDG PET/CT studies requires knowledge of the normal distribution of FDG uptake in children, and an insight into the physiologic variants, benign lesions, and PET/CT related artifacts.

By understanding the potential causes of misinterpretation, we can increase the accuracy of interpretation, decrease the number of unnecessary follow-up studies and improve treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* All Pediatric Cancer patients referred to nuclear medicine unit to do 18F-FDG PET/CT study.

All patients \&gt; or = 18 years.

Exclusion Criteria:

* Severely ill patients. Patients with glucose level \&lt; 200 mg/dl.
Animal-Assisted Therapy in the Residential Treatment of Schizophrenia and Addictions

Animal-assisted therapy (AAT) is a complementary intervention of therapy that has shown positive results in the treatment of various pathologies. This study assesses the viability of the implementation and the efectiveness of an AAT program in patients diagnosed with substance abuse disorder and associated mental disorders (dual pathology).

Animal assisted therapy (AAT) is a complementary intervention to therapy that presents positive results in the treatment of different pathologies. The study assesses the implementation and effectiveness of a TAA program in patients diagnosed with substance use disorder and schizophrenia spectrum disorder.

Eligibility Criteria:
Inclusion Criteria:

* Meeting DSM-5 criteria for substance abuse disorder and the presence of schizophrenia
* Voluntary participant in the study and having signed the informed consent

Exclusion Criteria:

* Patients whose functioning could be altered by factors not specifically related to addictive pathology or mental disorder (severe cognitive impairment, intellectual deficiency or language barrier)
* Animal-specific phobia
Outcomes in Moderate Mixed Aortic Valve Disease

Mixed aortic valve disease (MAVD) is defined as the combination of aortic valve stenosis (AS) and regurgitation (AR) and is relatively frequent, with a reported prevalence up to 20-30% of patients with aortic valve disease. Mortality of patients with moderate MAVD (coexistence of both moderate AS and moderate AR) is largely unknown, and therefore there are currently no guidelines-based indications for surgical or transcatheter intervention for these patients, which is considered only when one of the two lesions (AS or AR) becomes severe. Of note, indication for valve intervention in patients with isolated moderate AS is currently under investigation in several randomized clinical trials but only in the presence of relevant symptoms and signs of left ventricular (LV) dysfunction. One initial single-center study including 250 patients with moderate MAVD has evaluated outcomes in this specific subgroup and showed that patients with asymptomatic moderate MAVD and preserved left ventricular ejection fraction (LVEF) had similar adverse event rates (progression to New York Heart Association (NYHA) class III-IV, aortic valve intervention or cardiac death) to patients with isolated asymptomatic severe AS with preserved LVEF. However, the results were primarily driven by the progression of the NYHA Class and aortic valve replacement, and larger multi-center studies are advocated to confirm these findings, which may therefore identify a (new) group of high risk patients who should in principle benefit from an aortic valve intervention as much as patients with isolated severe AS. In addition, prognostic factors (including clinical and echocardiographic characteristics) for risk-stratification of patients with moderate MAVD have not been identified, which may help to refine the indication for valve intervention and optimize patient management.

Hypothesis: Patients with moderate MAVD may have similar mortality rates compared to patients with isolated severe AS or severe AR and therefore benefit from aortic valve intervention. The presence of symptoms or impaired LV function may further identify a higher risk group together with other clinical or echocardiographic parameters.

Objectives:

1. To compare mortality rates in patients with moderate MAVD to isolated severe AS and isolated severe AR in a multi-center setting, adjusting for potential differences in clinical and echocardiographic variables and for the occurrence of aortic valve intervention.
2. To identify clinical and echocardiographic characteristics associated with increased mortality in this specific population and potentially propose dedicated risk scoring and adjusted cut-off values for the various parameters.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with concomitant moderate AS and moderate AR
2. Patients with isolated severe AS
3. Patients with isolated severe AR

Exclusion Criteria:

1. Previous aortic valve surgery
2. Concomitant left valvular heart disease more than mild grade
3. Acute AR
4. Bad echocardiographic image quality
Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States

The principle aim of the project is to analyze brain electrical activity and genetic information that will help identify the nature and cause of the disease schizophrenia. This effort should lay the groundwork for future treatment in schizophrenic patients.

There are several studies and hypotheses to be tested. This project includes a cross-sectional study design measuring brain waves, clinical symptoms, cognitive and functional ability, and genetic information in schizophrenic patients and normal controls. Subjects are expected to do a brain wave recording (EEG/ERP), role-play test designed to measure functionality and cognitive ability, and clinical symptom assessments. Expected duration of subject participation will be approximately 8 hours (about 2 visits). Outcome measures includes biomarkers, clinical symptoms and function, and genetic information.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female between ages 14-62 (clinical assessment and blood draw only above 62)
* Ability to give written assent (subjects who are below the age of 18)
* Ability to give written informed consent (age 18 or above)
* Sufficient understanding of the study and risks (ESC score 10 or above)
* Subjects above age 62 will not participate in brain electrical activity measurements although they may still participate in clinical assessments and blood draw.

Exclusion Criteria:

* Inability to sign informed consent/assent
* Any major medical illness that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, an other significant brain neurological conditions.
* Significant alcohol or drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
* Woman who is pregnant (child bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test).
* Can not refrain from using alcohol and/or marijuana 24 hours or more\& cigarette smoking half and hour or more prior to experiments.
An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO

The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, both male and female.
* Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018).

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) .
* Other inflammatory diseases.
* Active autoimmune diseases.
* Pregnant or lactating women.