cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Impetigo Patients

Impetigo is a common, highly infectious skin disease caused by bacterial infection and characterized by crusting skin lesions. It is most common in children, particularly children in unhealthy living conditions. In adults, it may follow other skin disorders. Impetigo is caused primarily by the bacteria Streptococcus pyogenes and/or Staphylococcus aureus, which can also be isolated from impetigo lesions.

This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in impetigo patients.

A randomized, parallel-group, double (Investigator, patient) blind, comparative dose range finding clinical trial.

The study will involve two treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% , in a blinded fashion. Patients will be treated twice daily for 7 days. Following the screening period and baseline visit, study subjects will return at days 3, 7 and 14. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of pure impetigo, impetigo contagiosa, or uncomplicated blistering impetigo
* Patients 2 years of age or older, and in general good health
* Patients with no less than two lesions and no more than seven lesions, area 0.5x0.5cm.
* No known medical conditions that, in the Investigator's opinion could interfere with study participation
* Patient / Patient's guardian (in the case of children) willing and able to comply with all requirement of the protocol
* Patient / Patient's guardian willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

* Presence of skin diseases at or near the investigational area
* Immunosuppressed state or other serious systemic disease
* Signs and/or symptoms of systemic infection
* Presence of skin infection/disorder not amenable to topical antibacterial treatment only
* Presence of secondarily-infected animal/human bite
* Presence of secondarily infected burn wound
* Topical or systemic use of medicinal or other products before or during the study (oral or topical antibiotics, oral or topical corticosteroids and immuno modulators); or other drugs, which in the Investigators opinion could confound the evaluation of the effect of the study drugs
* Known or suspected hypersensitivity to Minocycline or any of the excipients in the study medication
* Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomization
* Patients previously enrolled/randomized in this study
* Use of another investigational drug within 30 days prior to entry into this study.
* Pregnant or lactating women.
Prospective Observational Study to Evaluate the Safety of Immunotherapy As a Treatment for Hymenoptera Venom Allergy

Observational study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (multicentric) and data will be collected prospectively.

Observational study to evaluate the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting (safety evaluation), also it will be evulated the quality of life of the patient using one QoL questionnair before and after immunotherapy treatment.

The patients aged equal or more than 14 years old, not gender differentiation, and sensitised to heminoptera venom. The total number of participants is expected to be 120.

This study will be conducted in Spain (multicentric) and data will be collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

1. The study population consisted of allergic participants indicated for treatment with immunotherapy with hymenoptera venom (Apis mellifera or Vespula spp.) according to standard clinical practice.
2. Age equal to or older than 14 years, without gender differences.
3. Not having received immunotherapy with hymenoptera venom in the previous 5 years.
4. That they agree to participate in the study and sign the informed consent form. In the case of minors, the parent or guardian of the participant must also sign the informed consent form.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.
3. Participants who do not agree to participate and/or do not sign the informed consent form.
4. Participants who do not comply with the medical indications or do not show cooperation with respect to the immunotherapy treatment.
5. Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive treatment.
6. Participants in whom the administration of immunotherapy is contraindicated.
Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI)

Percutaneous coronary intervention (PCI) is associated with up to 30% incidence of myonecrosis, as reflected by elevation of cardiac enzymes in a successful procedure. Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption causing obstruction of blood ﬂow at capillary level resulting in micro-infarction. Recent studies have suggested that pretreatment with adenosine in the cath lab and Clopidogrel and statins greater than 6 hours before may be associated with a reduction in infarct size after reperfusion therapy for acute myocardial infarction. Whether pretreatment with adenosine decreases the incidence of myonecrosis in patients undergoing non-urgent PCI is not fully known. The investigators propose that adenosine-induced hyperaemia can potentially ameliorate the deleterious effects of distal embolization associated with non-urgent PCI through dilatation of the microvasculature. Mechanistically, this may reduce capillary obstruction by facilitating the throughput passage of embolized platelet thrombi out to the venous end of the coronary circulation, thereby reducing the incidence of post-PCI myonecrosis. In this prospective, randomized, open-label study, the investigators evaluated the incidence of myonecrosis after non-urgent PCI with a treatment with intracoronary adenosine compared with pretreatment of loading dose of Clopidogrel 300/600 mg \>/\< 6 hours.


Eligibility Criteria:
Inclusion Criteria:

* Baseline creatine-kinase (CK) and creatine-kinase-myocardial band (CK-MB) had to be within normal limits (a normal CK and CK-MB and elevated troponin allowed inclusion)

Exclusion Criteria:

* Occlusion resulting in Thrombolysis In Myocardial Infarction (TIMI) grade 0 antegrade ﬂow
* Thrombus-laden lesions
* Significant left main coronary stenosis
* Left ventricular ejection fraction 30%
* Inability to give informed consent
* Bradycardia with heart rate below 50 b.p.m.
* Allergy to adenosine
* The occurrence of myo-cardial infarction within one week
Sleep and Emotion Processing in Childhood

This research project will examine whether experimental sleep extension in children alters the neural and behavioral mechanisms by which short sleep is a risk factor for emotional/behavioral problems. Children ages 5.0-5.9 years with chronic insufficient sleep (≤9 h/night for ≥6 months) will be randomized to either a sleep Extension or to an active Control group. Extension group parents will participate in a 1-month individualized behavioral sleep intervention to promote targeted sleep duration improvements before beginning a 2-week sleep Extension schedule (8 week protocol). Brain and behavioral assessments will occur at Baseline and post sleep Extension.

Research on processes influencing the development of affective brain circuits is critical to elucidating the neurobiological substrates of psychiatric disorders. Mechanistic evidence from adults showing a sleep-dependent functional "disconnect" between brain regions central to adaptive emotion processing (i.e., regulation and expression) suggests that sleep loss is a fundamental target. Similar data in young children, however, do not exist. Early childhood is a sensitive period in the maturation of sleep and emotion processing and also a time when disturbance in both domains is commonly first detected. Further, epidemiological findings reveal that insufficient sleep in childhood is prevalent, associated with concurrent emotional problems, and predicts later mood and attentional disorders. Although the investigator's recent experimental findings indicate that acute sleep loss results in non-adaptive emotion processing in young children, the neural systems underlying such sleep-dependent effects are not known. Also, the vast majority of basic research on sleep and affective substrates has utilized sleep deprivation or sleep restriction protocols. The investigators will instead employ sleep extension in chronically sleep-restricted children, a highly translatable approach with significant public health implications.

This research project will examine whether experimental sleep extension in children alters the neural and behavioral mechanisms by which short sleep is a risk factor for emotional/behavioral problems. Children ages 5.0-5.9 years with chronic insufficient sleep (≤9 h/night for ≥6 months) will be randomized to either a sleep Extension or to an active Control group. Extension group parents will participate in a 1-month individualized behavioral sleep intervention to promote targeted sleep duration improvements before beginning a 2-week sleep Extension schedule (8 week protocol). Brain and behavioral assessments will occur at Baseline and post sleep Extension.

Eligibility Criteria:
Inclusion Criteria:

4.0-6.9 years Reportedly obtain ≤9 h of sleep/night for ≥6 months

Exclusion Criteria:

Nocturnal sleep disturbance determined by clinical cut-offs on the Children's Sleep Habits Questionnaire and the Pediatric Sleep Questionnaire Medications Developmental disabilities Chronic medical conditions Low-birth weight or pre-term term delivery Family history of psychiatric disorders Living at altitude \<1 year Metal implants or Claustrophobia
Impact of Dialysis Modality on Coagulation and Platelet Function

The investigators will evaluate the impact of dialysis modality (intermittent hemodialysis or continuous renal replacement therapy) in coagulation and platelet function in critically ill patients

An prospective observational study will be conducted to confirm the impact of two dialysis modalitites on coagulation and platelet function in critically ill patients requiring renal replacement therapy using laboratory test, Multiplate and ROTEM.

Eligibility Criteria:
Inclusion Criteria:

• Critically ill adult patients in surgical intensive care unit who require renal replacement therapy

Exclusion Criteria:

* Patients treated with anti-coagulation therapy due to thrombosis/embolism
* Patients who take anti-platelet drug due to cardiac or cerebrovascular diseased
* Patients treated with pharmacological prophylaxis of deep vein thrombosis
* Patients who received blood products within 24 hours of dialysis initiation
* Patients who do not want life-sustaining care including renal replacement therapy
Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy

The current study aims to explore the functional use of LFPs recorded intraoperatively for the optimization of a directional DBS lead programming

Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS electrode can predict the optimal stimulation parameters.

Aim-2: Compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral LFP patterns correlate with the presence of stimulation side effects.

This is a feasibility study designed to evaluate the usefulness of intraoperative LFP recordings obtained from the implanted DBS lead to predict ideal stimulation parameters. Additionally this study will compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral LFP patterns correlate with the presence of stimulation side effects.

Approximately 15 subjects will be enrolled in this clinical investigation. The clinical investigation will be conducted at 2 centers in the USA.

Subjects participating in this clinical investigation will monitored during DBS implant procedure and programming. The expected duration of enrollment is 8 months. The total duration of the clinical investigation is expected to be 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Ability to provide informed consent
* Diagnosis of idiopathic Parkinson's disease, and DBS consensus team review supporting the placement of STN DBS.

Exclusion Criteria:

* Subject is not a surgical candidate;
* In the Investigator's opinion the subject unable to tolerate multiple programming sessions within a single setting;
* Subject unable to comply with the follow-up schedule
A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects

The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects willing to comply with the study requirement.

Exclusion Criteria:

* Clinical significant disease.
* Sensitive to study medication.
* Not willing to comply with the study requirement.
Effect of Anesthetic Agents on Optic Nerve Sheath Diameter

The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.

Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases.

Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy

Exclusion Criteria:

* history of brain hemorrhage or brain infarction
* liver disease or end stage renal disease
* glaucoma or any signs of increased intraocular pressure
* combined wtih other types of operation
* patient refusal
* weight less than 40 kg or over 100 kg
Effects of Pilates Exercises on Core Stability After Recovery From COVID -19

This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to Effects of Pilates Exercises on core stability after Recovery from COVID - 19

145 male and female students who had infected with covid 19 with age 19 to 26 years old, will be recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be randomly assigned to a pilates and home exercises (PAH) group or a control group who will perform only home exercises (COH)

Four core endurance tests will be performed to assess the core stability

Pilates exercise program will be composed of Pilates mat exercise program for a period of 12 weeks and three sessions every week.

Each session took one hour. Every session started with 10 minutes of simple stretching movements to warm-up followed by the main part of the exercise plan for 40 min, followed by 10 minutes, some cool-down stretching.

When the 12-week study period will over, the core stability will be assessed by the endurance tests and Prokin system for balance

Eligibility Criteria:
Inclusion Criteria:

1. Persons who had mild to moderate covid- 19 illness.
2. Asymptomatic period of at least seven days (without chest pain, breathlessness).
3. No musculoskeletal damage.
4. No pregnancy.
5. No visually identified asymmetries in the spinal trunk and lower limbs.
6. None of the subjects has a history of balance training
7. Subjects will not have any diseases of the central nervous system.
8. Subjects with body mass index (BMI)\<25 kg/m2.

Exclusion Criteria:

1. Persons who had more severe covid 19 illnesses and were hospitalized.
2. Persons who had during their illness chest pain breathlessness, palpitation, symptoms, and signs of heart failure.

9. Subjects with cardiopulmonary disorders. 3. A history of previous back or abdominal surgery/injury 4. Evidence of a systemic or musculoskeletal disease within the past six months

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A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes

All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life. Fear of hypoglycemia results in glucose fluctuations (from high to low glucose levels). Young adults are particularly at risk because they report high levels of fear of hypoglycemia and poor glucose control. Currently, no diabetes self-management programs specifically address how to cope with fear of hypoglycemia. The investigators propose to pilot test a fear reduction intervention (Fear Reduction Efficacy Evaluation \[FREE\]) and its effects on fear of hypoglycemia, diabetes self-management, glucose control, and glucose variability.

In persons with type 1 diabetes (T1DM), hypoglycemia is the major limiting factor in achieving optimal blood glycemic control. All persons with T1DM are at risk for hypoglycemia (blood glucose level \< 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in a profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1DM are at greater risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1DM. The investigator's preliminary research identified that 77% of young adults with T1DM reported FOH, and FOH resulted in increased glycemic variability. Glycemic variability (GV) is the minute-to-minute fluctuation in blood glucose that can be missed if looking only at A1C, a longer-term measure. Increased GV is dangerous because it is associated with cardiovascular events and diabetes complications. A major gap exists in how to manage FOH as a component of diabetes self-management. The Investigators specifically aim to: (1) determine the feasibility and acceptability of a fear reduction program in young adults with T1DM, who experience FOH; and (2) determine the impact of an 8-week cognitive behavioral therapy (CBT)-based intervention on the outcomes: FOH, self-management behavior, glycemic control, and GV. To achieve these aims, the investigators propose a randomized controlled trial in 50 young adults aged 18 to 35 years with T1DM. At completion, FOH will be measured and glycemic patterns will be analyzed to determine differences between the FREE and control groups. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to reduce FOH and improve self-management, glycemic control, and GV. This program of research promises to reduce the development of diabetes complications and improve quality of life for young adults with T1DM.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of T1DM ≥ 1 year, receive medical care from an endocrinologist, use insulin pump therapy or multiple daily injection (MDI), have fear of hypoglycemia (screening questionnaire), and attended a basic diabetes educational program

Exclusion Criteria:

Pregnant or breastfeeding, have received therapy specifically for fear of hypoglycemia, have a co-existing chronic illness
Analysis of Endotoxin Activity in Patients With ECMO

Extra-corporeal membrane oxygenation (ECMO) can temporarily help patients gain time to wait for cardiopulmonary recovery or further treatment in patients with cardiopulmonary failure. Whether the blood flow provided by the ECMO can maintain the perfusion of various organs is an important factor affecting survival. Some ECMO patients died after the complication of sepsis. Our previous pilot analysis has recognized several ECMO patients with complicated sepsis has high endotoxin activity level. Endotoxemia can also occur in heart surgery and after cardiopulmonary bypass, trauma, organ transplantation, and out-of-hospital cardiac arrest patients. These trials used endotoxin activity analysis (EAA, EAATM, Spectral Diagnostics Inc., Canada) to analyze endotoxin activity. In addition, studies have indicated that the combination of procalcitonin (PCT) concentration and EAA activity can improve the accuracy of predicting sepsis. The primary aim of this study is to detect endotoxin activity in patients with ECMO support and compare whether the prognosis was associated with different level of EAA activity. The secondary aims are to analyze the risk factors leading to high EAA activity and investigate the diagnostic value of septic shock combining PCT examination. We suggest that the results of this study may help the ECMO medical team identify patients at high risk for septic shock and conduct adequate managements to improve patient survival and quality of life after survival.


Eligibility Criteria:
Inclusion Criteria:

* patients with ECMO support

Exclusion Criteria:

* \< 20 years old or \> 90 years old
* not be able to collect blood sample within 48 hours after placement of ECMO
* change plan to palliative care and plan to remove ECMO
* non-native speakers
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants

The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment compared to participants with normal renal (kidney) function. This study will last approximately 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Female participants are not of child-bearing potential
* Have a body mass index of 18 to 40 kilograms per square meter (kg/m\^2)
* Participants with normal renal function - healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function (assessed by estimated creatinine clearance \[CLcr\] greater than or equal to 90 milliliters per minute \[mL/min\] at screening)
* Participants with severe renal impairment - estimated CLcr less than 30 mL/min at screening and are not undergoing hemodialysis

Exclusion Criteria:

* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Participants who are unwilling to comply with the dietary requirements/restrictions during the study
* Hemoglobin less than 9 grams/deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease