cyrilzakka/clinical-trials huggingface dataset:
Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin

Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for clinical rational use of antimicrobial agents, and provide theoretical support for optimizing dosage regimen.

Compared with Imipenem/Cilastatin 2 hours continuous dosing method and two-step dosing method (0.5 hours before enter half dose, after 1.5 hours, the other half of the input dose) of blood drug concentration in the body than the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT \> MIC), blood drug concentration in the body more than 4 times the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT \> 4 MIC), blood drug concentration peak and the ratio of the minimal inhibitory concentrations (MIC) pathogens (Cmax/MIC), blood drug concentration (Tmax) used in the peak time, used to guide clinical patients with severe infection of Imipenem/Cilastatin usage.

Eligibility Criteria:
Inclusion Criteria:

* sepsis or severe sepsis or severe infections in the previous 48 hours
* treatment with imipenem/cilastatin (recommended by hospital microbiologists)
* expected duration of hospital stays in the ICU ≥ 72 h from recruitment
* recruited patients agreed to participate in this trial, and had set up a signed informed consent

Exclusion Criteria:

* with an allergy to carbapenems or with an adverse drug reaction to imipenem
* acute or chronic renal failure assessed by serum creatinine concentrations \> 280 μmol/L (or creatinine clearance \<20mL/min) or those requiring continuous renal replacement therapy
* drug or alcohol abuse
* Pregnant and lactant women
* patients near to death
Effect of an Experimental Gel Containing Copaiba Oil-resin in the Control of Dentin Hypersensitivity

This randomized, single-blind, placebo-controlled clinical trial aims to clinically evaluate the effect of an experimental gel containing copaiba oleo-resin in the control of dentin hypersensitivity (DH) in non-carious cervical lesions (NCCL). Seventy-five hypersensitive teeth will be selected into three groups (N=25) and approved in three treatment sessions. The groups will be: GROUP P= water-soluble placebo gel without active ingredient; GROUP KF2: Potassium nitrate 5% + Sodium fluoride 2%; GROUP GC: Gel containing copaiba oleo-resin. A visual analogue scale (VAS) will be used to compare the DH after tactile stimulation with an exploratory probe and evaporative stimulation with air jets. The DH assessments will be performed at four times: baseline, after 1 week, 15 days and 30 days after the beginning of treatment.

The sequence of application of the gels, whether active or placebo, will be as follows:

A professional prophylaxis will be performed using a rubber cup on the dental elements. The corresponding gel for each group will be applied with the aid of a micro-applicator and will remain undisturbed on the surface for 10 minutes. After the gel application time has elapsed, and while it is still on the teeth, the product will be rubbed with a micro-applicator using circular and intermittent movements. Subsequently, the gel will be removed with cotton and abundant water.

Eligibility Criteria:
Inclusion Criteria:

* hypersensitive areas on the vestibular surface of the teeth with exposed cervical dentin up to 1 mm deep and/or class I gingival recession according to the Miller classification;
* individuals who have at least two hypersensitive teeth
* periodontal health,
* good general physical health;
* willingness to participate in the research by providing written informed consent;
* no eating disorders or very acidic diets

Exclusion Criteria:

* presence of restorations;
* presence of dental caries and periodontal pockets;
* ongoing treatment with antibiotics and/or anti-inflammatory and/or analgesic drugs;
* professional desensitizing treatment received three months prior to the study;
* pregnancy or lactation; systemic diseases;
* pulpitis;
* use of orthodontic appliances or dental prostheses that may interfere with the assessment of hypersensitivity
Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation

Evaluation of clinical and radiological outcomes in patients undergoing Arthroscopic Rotator Cuff Repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of Artelon® Tissue Reinforcement, a synthetic device based on degradable polyurethaneurea.

The investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.


Eligibility Criteria:
Inclusion Criteria:

* a medium rotator cuff tear (from 1 to 3 cm, according to Cofield Classification) with an indication for arthroscopic repair
* signed informed consensus

Exclusion Criteria:

* previous fractures
* diabetes
* subscapularis tears
* tears \< 1cm or \> 3 cm
* reduced passive range of motion
* infections
* known mental or neurological disorders unwilling or unable to follow the post-surgery instructions
* conditions that contraindicate arthroscopic rotator cuff surgery
* patients without complete osteogenesis
* pregnant or breastfeeding women
Rehabilitation in Aortic Stenosis Patients

SURVEY OF THE FIELD Aortic stenosis (AS) is the most common valve disease and increasing due to a growing elderly population. The therapy is aortic valve replacement (AVR). Studies on postoperative rehabilitation of AS pts are scarce. In the few studies available, a mix of valve diseases is presented without considering the differences in pathophysiology and the training regimes are not clearly described.

PURPOSE, AIMS \& HYPOTHESIS The investigators purpose is to evaluate whether a supervised cardiac rehabilitation program improves the objective physical capacity and quality of life (QoL) of patients after AVR due to AS, and compare this to patients training by their own. The investigators hypothesize that supervised exercise training may be a more efficient way of rehabilitating these patients.

DESIGN This is a controlled randomized clinical trial comparing 12 weeks of supervised exercise training 3 times per week to home-based training based upon public health recommendations of minimum level of physical activity.

SIGNIFICANCE \& IMPLEMENTATION Positive results would support that an organized program of exercise training improves physical capacity and QoL in AS patients following AVR with potential benefit for both patients and society.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery with aortic valve replacement for aortic stenosis at the thoracic surgery department at Linköping University hospital, Linköping.
* Geographical residence no further from hospital than permitting visit to Supervised Exercise Training 3 times per week

Exclusion Criteria:

* Any concommitant heart disease
* Other surgical intervention at time of valve replacement
* Age under 18 years
* Symptomatic lung disease
* Any disability or disease hampering participation in exercise training
* Cannot communicate with spoken Swedish
The Effect of Preoperative Chewing Gum on Anxiety and Sore Throat in Patients With Laryngeal Mask Airway

This study was planned to investigate the effect of chewing gum in the preoperative period on patients' sore throat and anxiety levels.

Postoperative sore throat is a common complaint (1,2). It is reported in the literature that there are various pharmacological methods to reduce this condition, such as the use of nebula, corticosteroids, nonsteroidal anti-inflammatory drugs, or lidocaine. However, these methods have various advantages and disadvantages (3,4). Chewing gum, one of the non-pharmacological methods may be safer for the patient. Chewing gum increases salivary gland secretion and provides lubrication of the oral cavity (5). For this reason, it was thought that chewing gum before surgery could reduce throat pain after using a laryngeal mask due to the effect it provides. It has been determined that there are few experimental studies on the subject in the literature (6,7).

The presence of preoperative anxiety may lead to an increase in the need for intraoperative anesthesia and analgesic consumption in the postoperative period (8,9). However, it may cause a decrease in patient satisfaction and prolong the recovery process in the postoperative period (8,9). Pharmacological approaches can be applied to address this concern. However, non-pharmacological approaches may be safer for patients. Chewing gum during this process can also reduce patients' anxiety levels. A sufficient number of studies on the subject could not be found (10).

The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the patients before and after the surgery, the study will conduct with various data collection forms.

These forms are; patient Identification form, Amsterdam Preoperative Anxiety and Information Scale (APAIS), Visual Analogue Scale (VAS). Patients will randomize. The chewing gum group in group- I (n=46), and group II (n=46) will be the control group. We have two stage.In first stage; anxiety levels will be measured for both group. In second stage; throat pain will evaluated at 2.-4.-6. hours.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective surgery
* Being intubated with a laryngeal mask
* Being ASA (American Society of Anesthesiologists) I-II

Exclusion Criteria:

* Using cigarette

  * Having asthma
  * Having chronic laryngitis
  * Having gastroesophageal reflux
  * Steroid use in the preoperative or intraoperative period
  * Mallampati score greater than two
RB Liquid Biopsy Biorepository

Retinoblastoma (RB) is a primary eye cancer that forms in the back of the eye of infants and toddlers. Traditionally, RB is diagnosed without a biopsy; tumor can only be studied once an eye has been surgically removed.

Given this limitation, we use aqueous humor (AH), the clear fluid in the front of the eye to detect specific markers, or information, that comes from the tumor itself.

Retinoblastoma (RB) is a primary intraocular malignancy that forms in the retina of infants and toddlers. Traditionally, RB is diagnosed without tissue as direct tumor biopsy is prohibited due to risk of extraocular spread; tissue can only be obtained once an eye has been surgically removed.

Given this limitation, there are no eye-specific molecular biomarkers in current clinical practice for RB. The lack of in vivo molecular data without removing the eye limits our ability to prognosticate clinical outcomes and develop personalized treatment plans. It also limits our understanding of intratumoral dynamics throughout therapy.

The aqueous humor (AH) is a high-yield source of tumor-derived nucleic acid that can be utilized as a liquid biopsy in eyes with retinoblastoma. Detection of biomarkers from the AH may be used to prognosticate the likelihood of eye salvage and in the future may facilitate targeted, patient-centered therapies based on molecular biomarkers.

OBJECTIVES:

1. Systematically and prospectively record accurate and complete data regarding the clinical presentation, treatment, and outcomes of patients diagnosed with RB.
2. Collect, bank, preserve, and analyze biomaterials including AH, blood and saliva from patients with RB.
3. Correlate phenotypic data with genotypic findings from human biomaterials in retinoblastoma patients to identify clinically relevant biomarkers

Eligibility Criteria:
Inclusion Criteria:

* All patients, age 0 days to 18 years, with a diagnosis unilateral or bilateral retinoblastoma (RB) seen at CHLA (Children's Hospital Los Angeles).

Exclusion Criteria:

* Patients referred for second opinions only and not treated at CHLA for any reason.
Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia

With an efficient epidural analgesia the physiological effects of pain are disabled during labor. Pain may cause an increase of minute volume, oxygen consumption and a decrease of paCO2 (Arterial CO2 pressure). The study will evaluate the lung function before and after labor with and without epidural analgesia. With more efficient breathing, the occurence of atelectasis should be reduced; this effect will be investigated in these settings for the first time with the electrical impedance tomography, which is a completely non-invasive measure.

The bedside efficacy of the electrical impedance tomography (EIT) in intensive care settings during mechanical ventilation is known. However, no studies demonstrate its utility during epidural analgesia for labor.

The purpose of this study is to evaluate lung function and atelectasis in pregnant women with or without epidural analgesia, during labor and after delivery.

Only adult consenting patients ASA I \& ASA II (American Society of Anaesthesiologists) are included in the study. According to institutional protocols lumbal epidural catheter is inserted and tested at the start of the labor, while patients' parameters are monitored.

Refusal to epidural analgesia, technical difficulties to insert the epidural catheter or any medical contraindication will result in inclusion of these patients in the control group.

Measurement with EIT is not invasive and harmful neither for the mother nor for the child.

It consists of putting a belt around the chest; this belt is linked to a monitor which measures the impedance of the different lung regions.

Electrical impedance measurements will be done for short periods of maximum 5 min. each as follows:

1. Placement before injection of local anesthetics through the epidural catheter in the study goup; in the control subset placement of the belt will be done when an epidural anesthetic would have been considered.
2. 1 hour after placement of the belt
3. 1 hour after delivery

These periods will be compared.

Eligibility Criteria:
Inclusion Criteria:

* ASA I
* ASA II

Exclusion Criteria:

* Caesarian
* \< 18 years
* Expulsions
Effects of Breathing Exercises on Women With Primary Dysmenorhea

The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea.

Primary dysmenorrhea (PD) is the most common gynecological disorder and constitutes a serious health and economic problem. PD is defined as painful menstrual cramps in the lower abdomen during or a few days before the menstrual period with no detectable organic disease. Breathing exercises are an effective method for pain relief. However, breathing exercises need to be examined in PD management.

Eligibility Criteria:
Inclusion Criteria:

* Having PD symptoms according to the Primary Dysmenorrhea Consensus criteria,
* Having menstrual pain intensity of 4 or higher according to the Visual Analog Scale in the last 6 months,
* Having a regular menstrual cycle (28±7 days)
* Volunteering to participate in the study.

Exclusion Criteria:

* Being pregnant or suspected of pregnancy,
* Using oral contraceptives or antidepressants in the last 6 months,
* Using intrauterine devices,
* Having a history of other gynecological diseases
* Having pulmonary, neurological and/or systemic disease,
* Having undergone abdominal or cardiothoracic surgery within the last year.
A Registry Study on HIV-related Lymphoma

Retrospective und prospective registry on HIV-associated lymphoma. Data on characteristics, type and toxicity of treatment and outcome of patients with HIV-lymphoma will be collected.

To study characteristics, treatment approaches and outcome of HIV-infected patients with malignant lymphoma in the combination antiretroviral therapy (cART) era. HIV-infected persons diagnosed with non-Hodgkin lymphoma or Hodgkin lymphoma will be included. The choice of treatment is not specified by the registry study. However, the type of antineoplastic treatment should follow national or international recommendations and guidelines. Data will be pseudonymized by the data manager of the treating institution. Central data management is located at Red Cross Hospital Munich, Germany.

Eligibility Criteria:
Inclusion Criteria:

* Histology or cytology proven non-Hodgkin lymphoma or Hodgkin lymphoma
* HIV-infection at time of lymphoma diagnosis
* Lymphoma diagnosis since 01.01.2010
* Adult patients ≥ 18 years
* Written informed consent

Exclusion Criteria:

* HIV-diagnosis \> 3 months after the diagnosis of malignant lymphoma
* Non-Compliance or lack of opportunity for follow-up (for the prospective part of the study)
Complications After Thyroid Surgeries: 10 Years' Experience

Thyroidectomy is one of the commonest elective surgeries in surgical practice nowadays. It is associated with wide range of complications, from unnoticed events up to lifelong problems and even life-threatening complications. The most troublesome are bleeding, nerve injury and hypocalcemia. The current study was conducted to report the incidence and predictive factors for perioperative complications, aiming to point out preventive measures.

All files of all patients that had thyroidectomy in the hospital in the last 10 yeas will be reviewed. All demographic and peri-operative data will be collected, tabulated and analyzed.

Incidence and pre-operative predictive factors of every single complication will pointed out and discussed.

Eligibility Criteria:
Inclusion Criteria:

* All patients had thyroid disease and performed thyroidectomy in the last 10 years in our hospital.

Exclusion Criteria:

* Uncompleted files.
Complications in Lower Body Lifts

A prospective study on 50 consecutive patients who are going to have a lower body lift procedure is performed. Measures include comorbidities and complications. Risk factors assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max), current BMI, excess weight loss (EWL), type of weight loss and nicotine consumption.


Eligibility Criteria:
Inclusion Criteria:

* after massive weight loss
* age \> 18 years and \< 65 years
* excess weight loss \> 66%
* current body mass index \< 35
* stable weight after weight loss for at least 12 months

Exclusion Criteria:

* insulin dependent diabetes mellitus
Gamified Family-based Health Exercise Intervention to Improve Adherence to 24-h Movement Behaviors Recommendations in Children.

Physical inactivity is the fourth most important risk factor for mortality worldwide and it contributes to weight gain and obesity. On the contrary, it is established that regular physical activity is a prevention and managerial factor of these non-communicable diseases. Therefore, the goal of this study is to design and evaluate the effectiveness of a 12-week physical exercise and lifestyle improvement training program carried out in a family environment, through a web platform, and with "online" supervision. This platform will improve the physical conditioning and adherence to PE in a "family environment", and to promote good development of the child through physical activities and exercises that can be done as a family at home and/or outside.


Eligibility Criteria:
Inclusion Criteria:

* Participants without any physical or mental disorders that would prevent them from completing the assessments tests or participating in the exercise intervention program
* One parent/guardian must answer the questionnaires
* Informed consent from the participants parent(s)/guardian(s)

Exclusion Criteria:

* Participants with psychiatric disorders or chronic illness that limits their participation in physical activities
* Participants who do not comply with the established procedures
* Participants who do not understand the Spanish language
Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump

The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin and commonly used in the treatment of type 1 diabetes, where it obtained the marketing authorization for this indication. In the patient who have an insulin pump, insulin Aspart is given daily like a pre-prandial bolus (just before the meal). However, many patients perform their bolus after the meal. However this insulin administration modality is not clearly studied in the literature.

The functional insulin therapy is a method for adjusting insulin doses which tends to mimic the physiology, especially when food intake with proportional dose calculation to the amount of carbohydrates ingested by the use of ratios. This method of adaptation, increasingly used in France, is an extension in the use of subcutaneous insulin pump with a more precise determination of bolus doses with meals, and use of aids dose calculations (assistant wizard for instance). In practice every day, some patients perform their bolus immediately after eating, not just before, allowing them to know exactly the amount of ingested carbohydrates and not the one provided in advance.

This study is very interesting because it allows to compare the injection of an analogous bolus of fast insulin before and after the meal.

Eligibility Criteria:
Inclusion Criteria:

* Major patients with type 1 diabetes treated with insulin pump.

Exclusion Criteria:

* Unbalanced diabetes,
* Ongoing pregnancy known,
* Gastrointestinal neuropathy known,
* Chronic medical illness and psychiatric
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)

The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.

Autism is clearly a significant cause of disability in the pediatric population. Many children with Autism exhibit impaired protein digestion which may or may not manifest in self-restricted diets. The inability to digest protein affects the availability of essential amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.

Eligibility Criteria:
Inclusion Criteria:

* Meets the current Diagnostic and Statistical Manual with Mental Disorders (DSM-IV-TR) for Autism (Autistic Disorder), screened by SCQ and confirmed by ADI-R;

Exclusion Criteria:

* Patient weighing \< 13kg (28.6 lbs)
* Previous allergy to porcine (pork) products
* Previous history of severe head trauma or stroke, loss of consciousness, seizure (or need for seizure medication either present or past) within one year of entering study or uncontrolled systemic disease
* Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease, muscular dystrophy, known genetic disorder, blood dyscrasia, ongoing GI disease
* Evidence of severe, moderate or uncontrolled systemic disease; and/or any co-morbid condition which in the Investigator's or Medical Director's opinion makes it undesirable for the subject to participate in the study or jeopardizes compliance with the protocol;
* Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion);
* Ongoing dietary restriction for allergy or other reasons except nut allergies (lactose-free allowable);
* Use of of any stimulant medication must be discontinued 5 days prior to entering the study.
* Subject must have a stable dose of SSRI's for at least 30 days.
* Inability to ingest study drug and/or follow prescribed dosing schedule