cyrilzakka/clinical-trials huggingface dataset:
Pain Study Using Intermittent Bupivacain Injections After Breast Reconstruction With DIEP Flap

patients are given bupivacain intermittent locally on the donor site after brest reconstruction with diep flap. The hypothesis was that this approach will reduce the need for rescue analgetic medication and pain perception within the three first days


Eligibility Criteria:
Inclusion Criteria:

* all patients planned to undergo reconstructive breast surgery with a DIEP

Exclusion Criteria:

* regular use of analgesics
* known allergic reaction to bupivacain
* bleeding disorders
* pregnancy
Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance

Aim of the study is to investigate the effects of high-protein, ultraprocessed foods on the regulation of energy balance in a metabolic chamber. The primary outcome parameter of the study is the energy balance (ad libitum energy intake and energy expenditure).

Each of the two study weeks starts with a 3-day run-in period with controlled diet at home, following 48 hours in a metabolic chamber. On the day the participants leave the metabolic chamber, they keep a food record over the rest of the day at home.

1. week: meals containing 30 % protein (80 % ultraprocessed high-protein foods), physical activity level (PAL) 1.45, 2 intervention days in the metabolic chamber: ad libitum energy intake
2. week: meals containing 13 % protein (80 % ultraprocessed foods with moderate protein content), physical activity level (PAL) 1.45, 2 intervention days in the metabolic chamber: ad libitum energy intake

Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI 19-29 kg/m2
* low-medium habitual physical activity
* women with regular menstrual cycle (during intervention in follicular phase)

Exclusion Criteria:

* smoking
* chronic illnesses (e.g. renal dysfunction)
* regular intake of medication
* food allergies / intolerances
* vegans and vegetarians
* regular high physical activity (exercise \>1 hour/d)
* current weight loss diet / weight loss of \>5 kg in the last 3 months
* pregnant / lactating women
* persons incapable of giving informed legal consent
* restraint eaters (according to the German version of the 'Three-Factor-Eating-Questionnaire', Stunkard und Messick (1985))
Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease

There are many children that have heart dysfunction because they are either born with Congenital Heart Disease (CHD) or developed poor heart function because their hearts are ill. The invention of medical technology helps in the treatment of these children. New heart echocardiogram (echo) techniques including Tissue Doppler (TDI), Tissue Synchronization Imaging (TSI) and 3 dimensional echocardiography (3D) are imaging technologies that we hope will help in the diagnosis and treatment of these children.

Tissue Doppler Imaging is a noninvasive technique that measures the speed of heart muscle movement. Tissue Synchronization Imaging measures how well the lower pumping chambers of the heart are working together. A 3D echo is a 3 dimensional picture of a beating heart that allows your doctor to see the heart from any angle. These techniques are noninvasive, meaning on the outside of your body. The size and function of the ventricles (the lower part of the heart) can change under different conditions. Using these techniques we will attempt to better determine how well the ventricles function during illness and health.

All subjects who are treated at Sibley Heart Center at Children's Healthcare of Atlanta with the diagnosis of a congenital heart defect or an acquired heart condition (i.e. heart failure) may be approached for possible participation into the study. These patients will include newly diagnosed patients as well as patients who were diagnosed in previous years and have received medical treatment for their defect or condition. The following describe study procedures:

Echocardiographic assessment Standard 2-dimensional, M-mode, and Doppler or 3-dimensional echocardiography evaluation will be performed. We will assess cardiac function using left ventricular shortening (SF) and ejection fractions (EF). The EF will be calculated using both M-Mode and by Simpson's rule. We will also perform tissue synchronization imaging (TSI) and tissue Doppler imaging (TDI) using the GE Vivid 7 echocardiographic system. Both TSI and TDI will assist investigators in assessing mechanical synchrony. The research echocardiograms will occur at the time of routine assessments.

Clinical assessment/data collection Clinical information from the chart will be collected for this study. The information will include the doctor's evaluation of general health, including diagnosis and the names of any medications the participant may be taking. If the child has undergone a routine MRI for the purpose of clinical care, the MRI measures will be collected in order to compare MRI images and measures to the new 3D echo technique. Finally, EKG data will be collected at each visit. EKGs are performed routinely for these patients however, if one is not performed, the study staff will perform an EKG assessment in order to have electromechanical information (i.e. arrhythmias) on all children participating.

Eligibility Criteria:
Inclusion Criteria:

Any child up to 21 years of age with a congenital heart defect -

Exclusion Criteria:

-
The Cortical Shield for Facial Bone Reconstruction

To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.

Patients requiring a single implant, presenting severe facial bone loss as a result of previous infection, failed socket grafting or trauma, will enter this cross-sectional study. Socket reconstruction and simultaneous implant placement will be performed through periosteal-guided bone regeneration (PGBR). Implant timing: immediate or delayed. Implants will be encased in a customized shield of autogenous cortical bone harvested from an adjacent site. A re-entry surgery will be performed at 12-17-weeks to evaluate bone regeneration. Peri-implant tissues will be assessed following established success criteria. Implants will be evaluated for the presence of Periimplantitis.

Eligibility Criteria:
Inclusion Criteria:

* ASA1 or ASA2 (American Society of Anesthesiologists)
* Healthy individuals with good oral hygiene and motivation
* No systemic uncontrolled diseases
* Not taking drugs known to modify bone metabolism

Exclusion Criteria:

* Individuals with untreated \& generalized severe periodontitis
* Heavy smokers (\>10 cigarettes/day)
* Poor oral hygiene
* Diabetes (HbA1C \>6.5% as cutoff value)
* Uncontrolled cardiovascular disease
* Poor overall health (ASA IV)
To Compare the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Reducing Rates of Endophthalmitis Following Cataract Surgery.

Patients with senile cataracts undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1ml/0.5mg) or intracameral cefazolin (0.1ml/1mg). The primary endpoint was the occurrence of endophthalmitis during the 3 month follow-up period. Secondary endpoints included best-corrected visual acuity (BVCA), the presence of anterior chamber (AC) inflammation with grading of AC cells and presence of flare, along with intraocular pressure (IOP), corneal cell thickness (CCT), central foveal thickness (CFT) and cell density.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥50 to \<80 years
* Undergoing cataract surgery under the care of one of three study investigators, all of whom were consultant level cataract surgeons
* Only those with senile cataracts, assessed using the Lens Opacities Classification System III scale (LOCS III) and without features of complex cataracts were included

Exclusion Criteria:

* \<50 or \>80 years old
* Prior ocular trauma, pregnant, previous history of refractive, corneal or intraocular surgery, cornea endothelial cell count \<1500/sqmm², concomitant ocular disease, allergy to penicillin, fluoroquinolone or cephalosporin, and abnormal biometric measurements
Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos

This is a pilot study that aims to develop a lung cancer screening program for workers in British Columbia, Canada exposed to asbestos who are at risk of developing lung cancer/pleural mesothelioma. This is high risk population is at of respiratory system diseases as a result of their occupational exposures. Additionally, knowledge garnered from this study will allow us to develop other studies that will further our understanding of asbestos related lung cancer and mesothelioma.


Eligibility Criteria:
Inclusion Criteria:

* Women or men age 50 to 79 years
* history of exposure to asbestos at work and one or more of the following:

  * lung cancer risk ≥2% over 3 years or
  * asbestosis or pleural plaques on a chest x-ray or
  * abnormal auto-antibodies level using the EarlyCDT test
* Capable of providing informed consent for screening procedures (low dose spiral CT, lung function, blood biomarkers).

Exclusion Criteria:

* Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, or any disorder, that in the opinion of the physician unlikely to benefit from screening due to shortened life-expectancy from co-existing illnesses
* Have been previously diagnosed with mesothelioma
* Have had other cancer within the past 5 years with the exception of the following cancers: non-melanomatous skin cancer,localized prostate cancer, carcinoma in situ (CIS) of the cervix, or superficial bladder cancer. Treatment of the exceptions must have ended \>6 months before registration into this study
* Pregnancy
* Unwilling to have a low dose CT scan of chest
* Unwilling to sign a consent
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People From China With Type 2 Diabetes

This study is looking at the way insulin icodec stays and moves over time in the blood after injections in Chinese people with type 2 diabetes.

Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin of the thigh. There will also be a run-in period that will last between 1 week and 8 weeks with daily doses of insulin degludec before start on insulin icodec.

The study will last for about 15 to 22 weeks. Participants will have about 17 visits with the study doctor including phone contact during your run-in period.

Participants will have blood samples taken at the clinic visits. Several samples of participants blood will be taken for up to 48 hours after getting the first and the last dose of insulin icodec.

Participants must be a Chinese person diagnosed with type 2 diabetes for at least 6 months and be on basal insulin treatment for at least 2 months before participating in the study.

Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period


Eligibility Criteria:
Inclusion Criteria:

* Chinese male or female
* Aged 18-64 years (both inclusive) at the time of signing informed consent
* Body mass index between 18 and 38 kg/m\^2 (both inclusive)
* HbA1c (glycated haemoglobin) below or equal to 9% at screening
* Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day greater than or equal to 60 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 60 days prior to the day of screening:
* Any metformin formulation
* Other oral antidiabetic drugs: DPP-4 (Dipeptidyl-peptidase-4) Inhibitors , SGLT2 (Sodium-glucose co-transporter-2) inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs)
* Oral or injectable GLP-1 (Glucagon Like Peptide 1) Receptor Agonists

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and run-in. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
Investigating Pompe Prevalence in Neuromuscular Medicine Academic Practices

The incidence of type II glycogen-storage disease (Pompe disease) varies depending on ethnicity and geographic region. As of 2010, nine studies have been published documenting the incidence of Pompe disease. It is most common within the African American population, with an incidence of 1 in 14,000. In the U.S. more broadly speaking, the combined incidence of all three variants of the disease is 1 in 40,000. These estimates relied on the frequencies of three mutations in the gene acid alpha-glucosidase (GAA), leading to variants of the disease. Criteria for inclusion in the studies were often non-selective; in many cases, molecular genetic screening was done at birth. With such a high prevalence of Pompe disease reported, it is expected that large university medical centers specializing in neuromuscular diseases would see a higher incidence of Pompe disease among their patients. From a comparable Italian multicenter study, it appears that Pompe disease accounts for 3% of all patients presenting with proximal weakness with or without CK elevation.

This study will measure the incidence of Pompe disease based on manifest laboratory abnormality, namely low GAA enzyme activity. Analysis of GAA enzyme activity will be determined through a blood sample of 4 mL. The study seeks to measure the epidemiology of Pompe disease by symptomatically screening all patients who present with symptoms of hitherto undiagnosed proximal weakness with or without elevation of the muscle enzyme, creatinine kinase (CK), or elevation of CK alone, at thirteen academic tertiary neuromuscular practices throughout the United States and Canada. Total recruitment is expected to be \~1,500 participants. It is anticipated that the number of incident Pompe cases in this cohort would be between 3-5%, i.e. 45-75 newly diagnosed cases of Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 8 years or older.
* Geographically accessible to one of the sites.
* One of these following three clinical situations: Complaint of proximal muscle weakness with or without elevation in creatinine kinase (CK); neck muscle weakness (either flexor or extensor) with or without elevation in CK; or elevation of CK in isolation.
* Capable and willing to provide informed consent or assent and follow study procedures.

Exclusion Criteria:

* Less than 8 years of age.
* Subjects with an alternative neuromuscular diagnosis that is responsible for subject's symptoms
* Incapable or unwilling to provide informed consent and to follow research procedures.
Polymorphism of beta2-adrenoceptor and Regular Use of Formoterol in Asthma

Polymorphism at codon 16 of the beta2-adrenoceptor (beta2-AR) affects the responsiveness to salmeterol in asthmatics. Data concerning formoterol are more controversial in literature. The aim of this study was to verify whether homozygote for arginine-16 (ArgArg16) and homozygote for glycine-16 (GlyGly16) genotypes differently influence the long-term responsiveness to formoterol.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate asthma
* Stable clinical conditions

Exclusion Criteria:

* Smokers
* Current therapy with oral steroids
* Exacerbations within the past 3 months
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients

The purpose of the study is to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients must meet all of the inclusion criteria listed below at the time of enrollment.

  1. Male and female patients 50 years of age and older.
  2. Resident of a participating long term care facility.
  3. Able to consume 30 mL of liquid solution two time per day by mouth or enteral feeding tube.
  4. Patient has had no antibiotics in the 4 weeks preceding enrollment in the study.
  5. Patient has been started on a broad spectrum antibiotic(s) for an infection other than gastroenteritis.
  6. Patient has a life expectancy greater than 6 months.
  7. Patient or health care agent is able and willing to sign a written informed consent.
  8. Patient or caregiver is able and willing to complete diary of daily bowel movement information (number, formed or unformed, time) during any portion of the 8 week study.

Exclusion Criteria:

1. Patient has an ileostomy.
2. Patient has a prior history of major gastrointestinal surgery such as partial small bowel or colon resection or gastric bypass.
3. Patient has a history of inflammatory bowel disease.
4. Patient has a history of chronic diarrhea associated with irritable bowel syndrome or other etiologies.
5. Patient has a history of severe constipation requiring use of enemas or disimpaction within 30 days prior to enrollment.
6. Patient has signs or symptoms of C. difficile infection including diarrhea.
7. Patient has signs or symptoms of acute or chronic diarrhea.
8. Patient has known sensitivity or allergy to rice or rice products.
9. Patient has significant medical problems which in the judgment of the principal investigator or medical monitor may interfere with participation in the study.
10. Patient is not receiving an antibiotic regimen consisting of a broad spectrum antibiotic.
11. Patient has participated in an investigational study using an investigational product within 30 days of randomization.
Affecting Factors for Chronic Pain After Mastectomy

Chronic post-mastectomy pain (CPMP) is a significant issue affecting many women after mastectomy. Factors like age, treatment type, and pre-surgery pain can increase the risk of developing this condition. By evaluating these factors, CPMP can be prevented more successfully and treatment strategies can be developed. This study aims to investigate the factors contributing to CPMP and contribute to the existing literature on this important topic.

Chronic post-mastectomy pain (CPMP) is a common condition and is a significant clinical problem with a prevalence reported in the literature of up to 50%. Approximately 10% of patients experience severe pain, which has a significant impact on their quality of life. Since mastectomy is a frequently performed procedure, this syndrome affects a large number of women. Therefore, it is important to better understand the factors associated with the development of persistent pain.

Several theories have been proposed regarding the development of CPMP, including increased peripheral nociceptor sensitivity (primary hyperalgesia) at the site of injury, central neuronal sensitivity (central hyperalgesia) in spinal and supraspinal regions innervating the injured area, and inflammatory changes triggered by the central nervous system. Recommended methods to prevent CPMP include careful dissection, reduction of inflammatory responses, and the use of minimally invasive surgical techniques to prevent peripheral and central neuronal sensitization.

Epidemiological studies-both retrospective and prospective-have identified some of these risk factors, such as younger age, chemotherapy, radiotherapy, and the presence of preoperative pain or severe acute postoperative pain. Unfortunately, there are few studies on this topic, and the literature needs further support.

The hypothesis in this study is that if investigator can identify the factors that increase chronic pain after mastectomy, investigator can take measures against these factors and reduce the development of chronic pain. Therefore, this study aims to identify the factors contributing to chronic pain after mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-80
* BMI 18-35 kg/m2
* ASA (American Society of Anesthesiologists) Scoring I-II-III
* Elective mastectomy surgery
* Elective mastectomy and axillary dissection surgery
* Patients who will undergo general anesthesia
* Patients who agree to participate in the study and sign a form

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* Patients who do not want to participate in the study
* Patients with chronic pain or chronic opioid use
* Patients with alcohol, substance or drug addiction
* Patients with a history of previous mastectomy
* Patients with limited cooperation such as dementia, psychiatric disorders
* Pregnant and breastfeeding patients will be excluded from the study
* Patients who cannot communicate in their native language will be excluded from the study